devices and methods for forming a fistula

专利摘要:
DlSPOSlTlVES AND METHODS FOR FORMING A FISTULA.The present invention relates to devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element can comprise one or more electrodes, mechanical cutting elements, laser sources and combinations thereof, and can be used to assist in fistula formation. In some cases, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and / or a shape-shifting element.
公开号:BR112013011944A2
申请号:R112013011944-6
申请日:2011-11-16
公开日:2020-08-25
发明作者:Gary H. Miller；Adam L. Berman；William E. Cohn；Dana R. Mester；Damian A. Jelich
申请人:TVA Medical, Inc；
IPC主号:

专利说明:

Patent Specification Report for "DJSPOSJTIVOS AND METHODS FOR FORMING A FISTULA". Cross-Reference to Related Orders This application claims priority from US Patent Application No. 61 / 414-357, filed on November 16, 2010, which is incorporated herein by reference in its entirety.
Field The present invention relates to devices and methods of forming a fistula. The devices and methods can be used to form a fistula between two blood vessels.
Background A fistula is usually a passage formed between two internal organs.
The formation of a fistula between two blood vessels can have one or more beneficial functions.
For example, the formation of a fistula between an artery and a vein can provide access to vascularity for patients on hemodialysis.
Specifically, the formation of a fistula between an artery and a vein allows blood to flow rapidly between the vases while passing through the capillaries.
Needles, catheters, or other cannulas can then be inserted into blood vessels near the fistula to draw blood from the circulatory system, pass it through a dialysis machine and return it to the body.
The accelerated flow provided by the fistula can provide efficient hemodialysis.
In a mature fistula, the flow rate through the fistula can be on the order of 300 to 500 ml / min, or it can be on the order of 30 to 1500 ml / min, or more.
In other cases, a fistula can be formed between two veins to form a venous venous fistula.
Such a venous venous fistula can be used to help treat portal venous hypertension.
Specifically, cirrhosis and other diseases of the liver can cause increased resistance to flow through the portal veins draining from the intestine to the liver.
This increased resistance can cause massive dilation of blood vessels, which can burst spontaneously.
To help prevent this undesirable outcome, a fistula can be formed between a portal vein and one of the main branches, reducing it. thus, the venous pressure in the portal vein.
As such, it can be useful to find improved ways to form a fistula between two blood vessels.
Brief Summary 5 The devices and methods for forming a fistula between two or more blood vessels are described here.
Generally, the devices described here comprise one or more catheters.
Each catheter generally comprises a distal end, an intermediate part and a proximal end.
The proximal end of the catheter may comprise one or more loops or adapters, which can be used to control
- or manipulate a catheter.
The handle or adapter may comprise one or more ports for introducing devices (for example, electrical wires, 'guide wires) or substances (for example, contrast fluid, perfusion fluid or the like) into the catheter.
The handle or adapter may additionally comprise one or more alignment projections which can be used to help align a catheter with respect to another catheter.
In some variations of the catheters described here, the catheters may comprise one or more alignment elements to help align one catheter with respect to another or with respect to an anatomical structure.
The alignment elements can be any suitable element or structure that can help align one or more catheters in one or more blood vessels. In some variations, one or more of the alignment elements can comprise one or more magnetic alignment elements.
Magnetic alignment elements can be used 25 to help advance a catheter through vascularity, can be used to bring two or more catheters within vascularity, or can be used to align axially and / or rotationally two or more catheters.
The magnetic alignment elements may or may not be arranged in one or more sets and each magnetic alignment element may be of any suitable shape or size.
In some variations, one or more magnetic alignment elements may be semi-cylindrical, cylindrical Olj with annular shape.
In other variations, one or more elements
3191.
Alignment '' can be in bar, ingot or box form. In other variations, the catheters may comprise one or more markers. In some of these variations, the marker can be viewed directly. In some of these variations , the catheters may comprise one or more marker strips along part of it, in other variations, the marker may be visualized indirectly (for example, through fluoroscopy, x-rays, or ultrasound visualization) In some of these variations, the device may comprise one or more marker strips that may allow for the rotational alignment of 10 one or more catheters In some variations of the devices and methods described herein, a catheter may comprise one or more elements for the formation of a fistula between the vessels The fistula-forming element can be any suitable mechanism for the formation of a perforation between two blood vessels For example, in some variations the catheter it may comprise one or more elements of mechanical cutting, such as, for example, a blade, a needle, a lancet, or the like. In other variations, the catheter may comprise one or more electrodes to cause ablation or otherwise vaporize tissue between two blood vessels. In some variations, the electrodes comprise one or more ablation surfaces to cause tissue ablation. In some variations, the ablation surface is flush with the catheter surface. In other variations, the ablation surface may have recesses in relation to the catheter surface. In other variations, the ablation surface can be adjustable with respect to the catheter surface. In some variations of the device and methods described here, a catheter may comprise one or more expandable structures. The catalog can comprise any number of expandable structures (for example, zero, one, two or three or more) and each expandable structure can be any expandable structure! (for example, a balloon, an expandable cage, entanglement or similar). The expandable structure or expandable structures can be used to help place the catheter in position.
with a fabric wall.
In other variations, one or more expandable structures can be used to dilate one or more parts of a blood vessel.
In other variations, one or more expandable structures can be used to expand or otherwise modify the size of a fistula.
In other variations, an expandable structure may comprise one or more electrodes that can be activated to distribute RF energy to one or more blood vessels, which can restrict blood flow through them.
Additionally or alternatively, an expandable structure can help anchor a catheter at least temporarily in a certain position within the vascular system.
In some variations, a catheter may comprise one or more components to join or otherwise fix a part of a first blood vessel to a second blood vessel.
In some variations, a catheter may comprise one or more components (for example, an electrode) configured to supply electrical, ultrasound or laser energy to the tissue.
In other variations, a catheter may comprise one or more needles configured to distribute an adhesive between a first blood vessel and a second blood vessel.
In other variations, In other additional variations, a catheter can be configured to develop one or more splinters, staples or other implants in the tissue of the first and second blood vessels.
Brief Description of the Drawings Figures 1A to 1C show different perspective views of the distal part of a variation of the catheters described here; 2 "Figures 2, 3, 4, 5, 6A, 6B, 7A, 7B and 8 show distal parts of the variations of the catheters described here; Figures 9A to 9D, IOA to LOC, 11 and 12 show variations of the catheters described here comprising one or more expandable elements; Figures 13A and 13B show the proximal parts of two variations of the catheters described here; Figure 14A illustrates a perspective view of a variation of a catheter comprising a marker strip.
Figure 14B illustrates a perspective view of a marker strip, while Figures 14C and 14D show side views of a marker strip; Figures 15A and 15B illustrate two variations of proximal parts plus the catheters described here; Figures 16A and 16B illustrate another variation of the catheters described here; Figures 17A and 17B illustrate a method by which an external magnet can be used to help advance a catheter through the vascular system; Figures 18A and 18B show variations of the catheters comprising electrodes with flat ablation surfaces; Figures 19, 20, 21A, 21B, 22, 23, 24A and 24B show distal parts of the variations in the catheters described here; Figure 25A illustrates a partial cross-sectional view of a distal part of a variation of the catheters described here.
Figures 25B to 25D show perspective views of the catheter of Figure 25A; Figure 26A shows a distal part of a variation of the catheters described here.
Figure 26B shows the catheter of Figure 26A with another variation of the catheters described here; Figures 27A and 27B show two perspective views of a variation of the catheters described here.
Figures 27C and 27D show two variations of the catheters described here located in blood vessels; Figures 28A and 29A show two variations of the electrodes suitable for use with the catheters described here.
Figures 28B and 29B show two variations of the catheters that include the electrodes of Figures 28A and 29A.
Figures 30, 31A and 31B, 32, 33A and 33B, 34, 35A and 35B and 36 show various variations of the catheters described here; Figures 37A and 37B show cross-sectional views of a variation of a catheter comprising a slide;
Figures 38A and 38B show a perspective view and a lateral cross-sectional view, respectively, of a variation of a catheter comprising a blade; Figure 39A shows a perspective view of a variation of a catheter comprising a blade; Figures 39B and 39C show cross-sectional side views of the catheter shown in Figure 39A.
Figures 40A and 40B, 41 and 42 show variations of the devices and methods for joining a first blood vessel to a second blood vessel; Figures 43 and 44 show variations of the catheters comprising optical fibers.
Detailed Description Devices and methods for forming a fistula are described here.
In some variations, devices and methods can be used to form a fistula between two blood vessels (for example, an arteriovenous fistula between an artery and a vein or a venous venous fistula between two veins). Generally, to form such a fistula between two blood vessels, one or more catheters are advanced in a minimally invasive manner through the vascular system to a target site.
In some cases, a single catheter can be located in a blood vessel to form a fistula with an adjacent blood vessel.
In other cases, a system comprising multiple catheters can be used to form a fistula.
For example, in some cases, a catheter can be located in each of the two blood vessels.
In these cases, it should be appreciated that each catheter may or may not have the same configuration of elements, and that some catheters may be different from or complementary to other catheters, as will be described in more detail.
One or a combination of catheters described here can be used to form a fistula, as will be described in more detail below.
Generally, each catheter will have a proximal end, a distal end, and an intermediate part connecting the proximal and distal ends.
The proximal end may comprise one or more adapters or loops, which can be used to assist in advancing, positioning and controlling the catheter within the vascular system, and can additionally be used to drive one or more components of the catheter and / or introduce one or more fluids or substances into and / or through the catheter.
The catheter can comprise one or more elements that can assist in the formation of the fistula.
In some variations, one or more parts (for example, distal end and / or intermediate part) of the catheter may comprise one or more alignment elements (for example, one or more magnets) that can help align the catheter with another position catheter - I swam in a related blood vessel and placed the catheters (and blood vessels) in approach.
In addition or alternatively, one or more parts (for example, the distal end and / or an intermediate part) of the catheter may comprise one or more mechanisms for the formation of a fistula.
The catheters can additionally comprise one or more lumens or passages extending at least partially along or through the catheter and can be used to pass one or more guidewires, one or more drugs or fluids (e.g., contrast agents, fluids infusion), combinations of the same or similar at least partially along or through the catheter.
The distal tip of the catheter can be configured to assist in advancing the catheter and / or to be non-traumatic.
In some variations, the tip may comprise one or more quick-exchange parts or other lumens for advancing the catheter through a guide wire.
In other variations, the tip portion may have a guide wire attached to or otherwise integrally formed with the catheter.
In addition, in some variations the catheters may additionally comprise one or more expandable external elements (e.g., a balloon, expandable cage, entanglement, or the like) that can help to position a catheter within a blood vessel.
Additionally or alternatively, the one or more expandable elements may affect blood flow through one or more blood vessels (for example, by temporarily stopping blood flow through the blood vessel, dilating one or more parts of a blood vessel, restrictin - one or more parts of a blood vessel, or the like). In some ca-. However, one or more expandable elements can act to temporarily anchor a part of the catheter with respect to a blood vessel.
In variations in which the catheter comprises one or more shape-defying elements, as will be described in greater detail below, the use of an expandable element to temporarily anchor a part of the catheter with respect to a blood vessel can assist changing the format of the catalog.
It should be appreciated that the catheters described here can have any combination of the elements mentioned above, each of which will be "described in greater detail below.
Figures 1A to 1C show an illustrative variation of a catheter (100) suitable for use in forming a fistula.
Specifically, Figure 1A shows a perspective view of the distal part (108) 15 of the catheter (100) with the sleeve (106) covering at least part of the catheter (100). Figure 1B shows a partially transparent view of the catheter (100) with the sleeve (106) illustrated as partially transparent.
Figure 1C shows a partially perspective view of the catheter (100) with the sleeve (106) and the catheter body illustrated as partially transparent.
As illustrated in these Figures, the catheter (100) may comprise an electrode (102) having an exposed ablation surface (105) and a guide wire (104) attached thereto.
Also as illustrated there is a proximal anchoring magnet (116), a distal anchoring magnet (118), and a quick exchange part (110) including first and second openings (112) and 25 (114) respectively) , each of which will be described in greater detail below.
To form a fistula using the catheter (100), the ablation surface (105) of the electrode (102) can be located in electrical contact with a target tissue, and a current can be supplied to the electrode (102 ) to cause ablation or vaporize the tissue.
Individual catheter components and methods will be described in more detail below.
Fistula Formation As mentioned above, the catheters described here can comprise one or more elements of formation of a fistula.
These fistula-forming elements can use any structure or mechanism capable of cutting, causing ablation, vaporizing, dissolving, or otherwise removing tissue between adjacent vessels, such as, for example, one or more electrical mechanisms (for example, one or more electrodes or electrocautery devices), one or more mechanical mechanisms (for example, one or more cutting blades, lancets, needles and the like), one or more chemical mechanisms (for example, example, one or more enzyme release devices), cryogenic cauterization devices, laser ablation devices (for example, one or more optical fiber laser light sources), combinations of the same or similar.
A catheter can have any suitable number (for example, zero, one, two, three or four or more) and a combination of these fistula-forming elements, and these fistula-forming elements can be located in or in any suitable part the catheter (for example, the distal end, an intermediate part, combinations thereof). In variations where a catheter comprises two or more elements of fistula formation, multiple elements of fistula formation can form multiple fistulas, simultaneously or sequentially.
In other variations, multiple fistula-forming elements can interact to form a single fistula.
In variations where a system comprising multiple catheters is used to create a fistula between two blood vessels, each catheter may comprise a fistula-forming element, but it is not necessary.
In fact, in some of these variations, only a catheter can comprise a fistula-forming element.
In some of these cases, the other catheter may still help to align the catheters and / or bring blood vessels closer, but may not directly contribute to tissue removal.
In variations where multiple catheters comprise, each, a fistula-forming element, the catheters may have complementary fistula-forming elements.
For example, in variations where two or more catheters comprise electrodes, as explained in more detail below, one catheter may comprise an electrode that acts as an active electrode, while another catheter may comprise an electrode that acts as an electrode. passive or grounding electrode.
Electrodes As mentioned above, in some variations of the catheters 5 described here, a catheter may comprise one or more electrodes for use in forming a fistula.
Generally, in these variations, a catheter may comprise an electrode body and at least one guide wire or other conductor attached to it for connecting the electrode to an electrosurgical generator.
In some variations, one or more parts of a guide wire can act as an electrode to cause tissue ablation.
A catheter can have any suitable number of electrodes (for example, zero, one, two, three or more), and each electrode can be positioned at any suitable point along the length of the catheter (ie, distal end, intermediate, etc.) and can be of any suitable size and shape, as discussed in more detail below.
It should be appreciated that when used with a direct current generator, an electrode can act as an active electrode (for example, where the current is transported away from the electrode to a grounded location), depending on the form in which it is used.
When a catheter having an active electrode is used in conjunction with a catheter having one or more passive grounding electrodes, electrical energy may have a tendency to flow from the active electrode through the tissue of intent and into the passive electrode.
In this way, the pair of electrodes can help prevent loss of energy to the surrounding tissue.
In some cases, one or more electrodes can be connected to an electrosurgical generator, power supply or other waveform generator that is configured to generate alternating current.
In some of these variations, two or more electrodes can be connected to the bipolar outputs of a generator.
In some of these variations, a first electrode is attached to the active output of the generator, and a return electrode (for example, a large metal plate or flexible metallic part) can be temporarily attached to the patient and connected to the return outlet. the generator.
In other of these variations, two or more electrodes can be attached to an active generator output, and a return electrode can be temporarily attached to the patient and connected to the generator return output.
In yet other variations, a first electrode can be attached to the active output of the generator, and a second electrode can be attached to the return output of generator 5 in a "monopolar focus" configuration. Generally, at least a part of each electrode can be exposed to the surrounding environment (for example, through one or more openings in the catheter body). This exposed surface can be configured to contact the surrounding tissue (for example, a wall of the guineum vessel) or fluids, and can act as an ablation surface so that the current can be supplied to and / or transported from the tissue through the ablation surface to facilitate the ablation or vaporization of the tissue.
In some variations, the ablation surface may be temporarily covered (for example, by a sheath or tubing) so that the ablation surface does not come into contact with the tissue.
In such cases, the temporary cover can be moved or removed to expose the ablation surface to the surrounding environment.
In other variations, the ablation surface may be temporarily placed in a recess or maintained within the catheter, and in some cases, it may be advanced out of the catheter to contact the tissue.
The ablation surface does not have to be mobile, and can instead be fixed with respect to the catheter.
Additionally or alternatively, in some variations, an exposed electrode surface may comprise a porous coating that allows current to be conducted to or from the same while preventing direct contact between two electrodes, as will be described in more detail below.
The electrodes can be made of any suitable material or combination of materials.
In some variations, the electrode may comprise one or more refractory metals.
For example, an electrode can comprise tungsten, molybdenum, niobium, tantalum, rhenium, combinations or alloys thereof.
The electrode ablation surface can be of any shape or size suitable for tissue ablation.
For example, the ablation surface can be oval, circular, rectangular, triangular, pentagonal, hexagon-
national, polygonal, irregularly shaped, or similar.
Alternatively or additionally, the ablation surface can be rough or otherwise standardized, as will be described in more detail below.
In variations where the ablation surface is exposed through one or more openings in the catheter body, these openings may at least partially define the size and shape of the ablation surface.
In variations where the catheter comprises a nest material, as will be described in more detail below, the nest material can at least partially define the size and shape of the ablation surface.
The size and shape of the ablation surface can help determine the size and shape of the resulting fistula.
The ablation surface can be of any suitable length (for example, about 0.15 cm, about 0.47 cm, between about 0.2 and about 0.5 cm, between about 0.2 and about 0.19 cm, about 0.38 cm, and about 0.5 cm and the like) and any suitable width (for example, 0.07 cm, about 0.15 cm, between about 0 , 06 cm and about 0.07 cm, between about 0.06 and about 0.12 cm, between about 0.12 and about 0.19 cm, and the like). In variations where the ablation surface is circular, cylindrical or semi-spherical, the ablation surface can have any suitable radius (for example, about 0.07 cm, about 0.10 cm, about 0.12 cm, and similar). In variations where a part of the electrode extends outside a part of the catheter, as will be described in greater detail below, the ablation surface can be of any suitable height (for example, about 0.25 mm, about 0 , 5 mm, about 0.75 mm, about 1 mm, between about 1 and about 1.5 mm, between about 0.25 mm and about 1 mm, between about 0.25 mm and about 0.75 mm, more than about 1.5 mm or similar). When two or more electrodes are used together to form a flistula, the two or more electrodes can be of different sizes.
For example, in some variations, a first electrode having a larger ablation surface (for example, a rectangular ablation surface about 0.50 cm (0.2 inches) by about 0.12 cm (0.05 inches) )) can be located in an artery, and a second electrode
~ having a smaller ablation surface (for example, a rectangular ablation surface of about 0.25 cm (0.1 inches) by about 0.12 cm (0.05 inches)) can be located in a vein.
In these variations, when an RF signal (for example, a sinusoidal waveform, 5 or similar) of a given power (for example, 40 W) is applied to the electrodes to form a fistula between the artery and the vein, the second electrode may have a higher current density than the first electrode because of its smaller ablation surface. This can cause the formation of the fistula to begin in the vein and spread through the artery.
Directional formation of the fistula can help prevent extravasation (eg, loss of blood to the surrounding tissue) in cases where a fistula is not fully formed between an artery and a vein (such as the formation partial fistula starting in an artery may have a higher risk of extravasation than the formation of partial fistula starting in a vein). In some variations, the ablation surface can be flush with an external surface of the catheter body.
Figure 2 illustrates a variation of the catheter (200) comprising an electrode body (202) having an ablation surface (205) - In addition, the guide wire (204), the proximal anchoring magnet (206) is illustrated , and the distal anchoring magnet (208). As illustrated in Figure 2, the ablation surface (205) can be exposed through the catheter (200) and can be substantially flush with the external surface of the catheter (200) - While illustrated in Figure 2 as having a cylindrical electrode body ( 202) with a rounded rectangular ablation surface (205), it should be appreciated that the electrode body (202) can have any suitable shaped ablation surface (205), as mentioned above.
While the catheter (200) is illustrated in Figure 2 as comprising a proximal (206) and distal (208) anchoring magnet, it should be appreciated that the catheter (200) can have any alignment elements or combinations of alignment as described in more detail below, or you may not understand any alignment element.
, 0
W As illustrated in Figure 2, the ablation surface (20'5) can be leveled with the catheter (200), and thus, it can have a rounded surface. In other variations of the device described here, a catheter may comprise an electrode where one or more parts of the ablation surface can be flat. For example, Figures 18A and 18B illustrate end views of two variations of catheters having flat ablation surfaces. Figure 18A illustrates a first variation of the catheter (1800) comprising a catheter body (1802) and an electrode (1804) comprising a flat ablation surface (1806). A flat ablation surface 10 (1806) can help provide a better tissue apposition between the "electrode (1804) and the tissue (not shown). Specifically, when two catheters, each comprising an electrode having a surface of flat ablation (such as the ablation surface (1806)), are placed in different blood vessels, and are placed closer together (for example, through one or more of the alignment elements or shape change elements described in more detail below), the two ablation surfaces can cause the vessel tissue to flatten at least temporarily between them, this can increase the electrical insulation of the flattened tissue (for example, the current supplied to an active electrode it will have to pass through the flattened tissue as it travels to the grounding electrode, instead of being lost to other fluids or surrounding tissue), which can assist in the formation of the fistula. Since the ablation surface (1806) shown in Figure 18A may not be completely flush with the outer surface of the catheter body (1802), the plane of the illustrated ablation surface (1806) does not protrude beyond the edge of the catheter body (1802). In other variations, however, a flat ablation surface can be recessed within the catheter body, or can project from there. For example, Figure 18B illustrates another variation of the catheter (1808) comprising a catheter body (1810) and an electrode (1812) comprising a flat ablation surface (1814). As illustrated here, the plane of the ablation surface (1814) can project over a distance (X) from the catheter body (18'10). This distance (X) can be any suitable distance, such as, for example, about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, between about 0, 1 and about 1.5 mm, between about 0.25 and about 1 mm, between about 0.25 and about 0.75 mm, or the like.
A projected ablation surface (1814) can press into the tissue as the catheter (1808) is brought in the direction of another catheter, which can help to increase tissue apposition with the ablation surface, which can assist in ablation of the fabric.
In some variations, the electrode can be configured so that the distance (x) is adjustable.
For example, in these variations, one or more parts of the device (for example, a rod, guide wire, or other drive mechanism) can adjust the protrusion of the device.
For example, in some variations, the distance (x) can be adjusted between about 0 mm and about 1.5 mm, between about 0 mm and about 1.0 mm, between about 0 mm and about 0.5 mm, between about 0.25 mm and about 0.75 mm and the like.
It should also be appreciated that the ablation surface can be configured to move from a position with recesses and a position with projection.
In some variations, one or more electrode ablation surfaces may be standardized, but need not be.
Figure 28A illustrates a first variation of the electrode (2800) comprising a surface (2802). As illustrated here, the surface (2802) can be flat, and can be made of a conductive material.
The surface (2802) can act as an ablation surface when the electrode (2800) is used with one or more of the catheters described here.
For example, Figure 28B illustrates a variation of the catheter (2804) comprising the electrode (2800) at least partially housed in a nino material (2806) within the catheter body (2808). As illustrated here, the surface (2802) can act as an ablation surface.
It should be appreciated that while illustrated in Figure 28B as comprising a plurality of Coupling Magnets (2810) (which will be described in greater detail below) located both proximally and distally with respect to the electrode (2800), one must appreciate that the catheter (2804) can comprise any suitable alignment element or combinations of alignment elements as described in greater detail below.
Figure 29A illustrates a second variation of an electrode (2900) comprising a patterned surface (2902) - As illustrated here, the electrode (2900) can comprise a body (2904) made of a conductive material.
A first body side (2904) can comprise a plurality of channels (2906) which can define a plurality of projections (2908), each having an elevated surface (2910). The channels (2906) can be at least partially filled with a non-conductive encapsulation material (not shown) such as, for example, one or more ceramic materials, parylene, one or more polymeric resins (for example, polyether polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (for example, aluminum oxide), combinations thereof and the like.
For example, Figure 29B shows a variation of the catheter (2912) comprising an electrode (2900) at least partially housed in a nest material (2913) within the catheter body (2915). As illustrated here, an encapsulating material (2914) can fill the electrode channels (2900) so that the encapsulating material (2914) and the raised surfaces (2910) form a patterned flat surface (2902). The patterned surface (2902) can be exposed through the catheter body (2915), and can act as an ablation surface, as will be described immediately below.
It should be noted that while Figure 29B is illustrated as comprising a plurality of Coupling Magnets (2916) (which will be described in greater detail below), located both proximally and dally with respect to the electrode ( 2900), it should be appreciated that the catheter (2912) can comprise any alignment elements or combinations of alignment elements as described in greater detail below.
When the patterned surface (2902) is used as an ablation surface. the raised surfaces (2910) of the projections (2908) may be able to conduct electrical energy to the fabric, while the encapsulating material (2914) can prevent or resist the flow of e-
'nergy through it.
Since only part of the standardized surface (2902) can be conductive across raised surfaces (2910),
effective electrode area provided by the standardized surface (2902) is reduced- When a power output is applied to an electrode, the reduced effective electrode area can increase the current density in the conductive parts of the electrode (for example , high conductive surfaces (2910) of the electrode (2900). Current can accumulate at the edges of the high surfaces (2910) and the increased current density can cause the current to spark between electrodes, which can assist in ablation or 10 vaporization of the tissue.
While illustrated in Figures 29A and 29B as tri-angular or square and cross-sectional area, the projections (2908) (and their raised surfaces (2910)) can have any suitable cross-shape or shape such as, for example, rectangles, trapezoids, circles, ovals, polygons, shapes with irregular geometry, or similar.
Projections (2908) and channels (2906) can be formed in any suitable way.
In some variations, one or more channels can be formed (for example, by cutting, engraving, notching or the like) in a block of material (such as the electrode (2800) described above with respect to Figures 28A 20 and 28B) to define the projections (2908). In other variations, one or more projections can be formed separately from a base element, and then they can be attached to the base element.
In variations where a catheter comprises a flat ablation surface, the flat ablation surface may have any suitable transverse shape (for example, a circle, oval, triangle, square, rectangle, pentagon, hexagon, other polygon, irregular or similar shape) - res). In addition or alternatively, the ablation surface can be patterned, as described in greater detail above.
Figure 3 illustrates a variation of the catheter (300) comprising an electrode body (310) 30 with a hexagonal ablation surface (311) protruding from the catheter (300). Also illustrated here are the proximal anchoring magnet (302) , the distal anchoring magnet (304), a lumen (308) and an electrical conductor
concentric (314), each of which will be described in greater detail below.
Additionally, while the flat ablation surfaces (1806) and (1814) are illustrated in Figures 18A and 18B, respectively as being parallel to the catheter bodies ((1802) and (1804), respectively), it is appreciated that a flat ablation surface can be angled with respect to a catheter body.
It should also be appreciated that the electrode may have an ablation surface that protrudes from the catheter body, but does not comprise a flat surface.
For example, in some variations, with an ablation surface (103) of the catheter (100) shown in Figures 1A to 1C, and described in greater detail below, the ablation surface can be hemispherical.
In variations where one or more parts of an electrode body protrude from the catheter body, one or more parts of the catheter can taper to help reduce the trauma that can be caused by the projected ablation surface (or edges of it) as a catheter is advanced through a blood vessel. In some variations, the ablation surface itself can be tapered.
In other variations, one or more additional components, such as the catheter body or a material to nest the electrode (as will be described in greater detail below), can taper to the ablation surface.
For example, Figure 4 presents a variation catheter (400) comprising an electrode (402) having an ablation surface (404) projecting from the surface of the catheter (400). Also illustrated here is the nest material (406) partially covering the electrode (402). As illustrated in Figure 4, the nest material (406) can taper from the catheter surface (400) to the ablation surface (404), which can help to minimize tissue trauma.
As mentioned immediately above, in some variations, one or more parts of an electrode can be at least partially covered or housed in a nest material.
In fact, in some of these variations, the entire electrode body except the ablation surface is covered with a nest material.
The nest material can serve
. various useful purposes- As described immediately above, the nino material can help prevent damage caused by the electrode to the fabric as
P that the catheter is advanced through a blood vessel. In some variations, the nest material can hold one electrode in place with respect to 5 one or more other cathode electrodes (for example, one or more alignment elements, or the like). In addition, in some cases, the nest material can isolate the electrode body from surrounding tissue or other parts of the catheter, which can protect the other parts of the catheter. For example, the thermal insulation provided by the nest material can protect other catheter components from the heat that can be generated by the electrode. In addition or alternatively, the electrical insulation provided by the nest material can help to minimize the current flow to other parts of the catheter or surrounding tissue. The nest material can be made of any thermally and / or electrically resistant material. 15 Examples of suitable nest materials include, but are not limited to, ceramic materials, parylene, one or more polymeric resins (eg, polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more oxides of metal (for example, aluminum oxide), combinations thereof, or the like. In some cases, the nest material 20 can be a machined solid or it can be molded. In other cases, the nest material may be plasma sprayed, coated or otherwise deposited on one or more parts of the electrode. It should also be appreciated that in variations where one or more parts of the electrode are mobile with respect to the catheter, the nest material may or may not be mobile with respect to the catheter. The nest material and the electrode can move together, but they don't have to. In some of these variations, one or more parts / parts of the nest material can move with the electrode, while one or more parts / parts of the nest material remain fixed with respect to the catheter. In addition, the nest material can be configured to house or otherwise maintain one or more alignment elements (for example, one or more Magnets) as will be described in more detail below.
In some variations, a nest material can provide directed heat dissipation, so that heat is directed towards the center of the ablation surface away from the edge of the ablation surface.
For example, the nest material can be made of various materials with different heat transfer properties, where the nest material near the edge of the ablation surface can be made of a material that is resistant to the transfer of heat. heat, while the nest material near the center of the ablation surface can be made of a material that has efficient heat transfer properties.
The middle intermediate positions between the edge and the center of the ablation surface can have intermediate heat transfer properties.
Alternatively, the nest material can be made of a single material whose density varies from the edge to the center of the ablation surface, for example, the material of the edge region may have a density that is greater than the density of the material in the central region.
Any suitable heat and / or current nest material and configurations can be used to direct or otherwise regulate the temperature and / or current that may be a result of electrode activation.
As mentioned above, a nest material can help to protect or isolate one or more parts of an electrode body from surrounding tissue.
Although the catheter body can cover one or more parts of a nest material, the catheter body does not have to do this. For example, Figure 19 illustrates a variation of the catheter (1900). Illustrated here are the distal catheter body (1902), the proximal catheter body (1904), and q nest material (1906) housing the electrode (1908) and coupling magnets (1910). In these variations, the proximal (1904) and distal (1902) catheter bodies can be attached to the nest material (1906) so that a circumference of at least part of the dwarf nest material (1906) is covered by a catheter body.
In such cases, the diameter of the nest material (1906) and the electrode (1908) can be increased, which can allow the size of the electrode ablation surface (1908) to be increased without increasing the overall diameter of the catheter (1900) .
In other variations of the catheters described here, an ablation surface can be at least partially placed in a den- recess. within a catheter surface.
In some cases, direct contact between an electrode surface and a blood vessel can result in the deposition of carbon on the surface during tissue ablation.
As such, a super. Recessed ablation surface can help cause tissue ablation while minimizing the accumulation of carbon on the ablation surface by providing the spacing between the ablation surface and the blood vessel wall, specifically, when a catheter is located against a blood vessel wall, blood or other fluid may be temporarily trapped within the recessed part.
Blood can provide an efficient conduction medium to help transfer the ablation energy to a blood vessel wall without the accumulation of carbon on the ablation surface, which can help prevent or otherwise reduce degradation. electrode installation.
Figure 5 illustrates a variation of the catheter (500) comprising an electrode (502) with a recessed electrode ablation surface (504). Also illustrated is a nest material (506) covering at least part of the electrode (502). As noted above, the nest material (506) can help separate the isolated ablation surface (504) and the electrode (502) from the remaining components of the catheter (500). The size, shape and depth of the opening can be determined in part by the desired volume of blood that must be maintained or otherwise imprisoned in the recessed part of the catheter (500). It should be appreciated that although illustrated in the above variations 25 as having a single ablation surface, the electrodes described here may have more than one ablation surface.
Each electrode can have one, two, three, four or more ablation surfaces, and each ablation surface can have any suitable placement relative to the catheter body.
For example, in some variations an electrode may have a first ablation surface on a first side of the catheter and a second ablation surface located distally or proximally to the first ablation surface along the first catheter side. .
Depending on the spacing between the first and second ablation surfaces, this can contribute to the formation of two fistulas, or an enlarged fistula.
In other variations, the two or more ablation surfaces may be on different sides of the catheter, for example, a first ablation surface 5 may be on one part of the catheter, and a second ablation surface. can be located about 10 °, about 20 °, about 30 °, about 45 °, about 60 °, about 90 °, about 120 °, about 150 °, about 180 °, about 200 °, about 300 °, etc., from the first ablation surface.
Additionally, in some variations, at least a portion 10 of the electrode body can be housed within the nest material.
In these variations, the housed part of the electrode can be any size or shape suitable.
For example, in the variation of the catheter (200) illustrated in Figure 2, the electrode body (202) comprises a cylindrical part (204) housed within the catheter body.
Alternatively, the housed part may have an elongated shape having a rectangular, triangular, elliptical, ovoid, polygonal or irregular cross section.
In other additional variations, the electrode housing may be semi-cylindrical, a quarter cylinder, or another suitable fractionated portion of a cylinder.
For example, Figure 6A illustrates a variation of the catheter (600) comprising an electrode body (602) 20 having an ablation surface (603), guide wire (604), proximal anchoring magnet (604), distal anchoring (606), a lumen (608). In this variation, the housed part of the electrode body (602) can be semi-cylindrical.
Variations having a semi-cylindrical electrode body may allow the lumen (608) to pass through it, as will be described in greater detail.
In other variations, the electrode may have an opening through it, so that a lumen of the catheter can pass through it.
For example, in the variation of the catheter (300) illustrated in Figure 3 and described in greater detail below, the electrode body (310) is illustrated as having an opening defined here, so that the lumen (308) can pass through the electrode body (310). While many of the catheter variations described above are illustrated as having an electrode or electrodes that are attached with respect to the catheter body, it should be appreciated that the electrodes (or one or more parts thereof) described here can also be adjustable or adjustable. otherwise mobile with respect to the catheter body.
For example, an electrode can be positioned so that an ablation surface of the same 5 can be substantially flush with or placed in a recess. into the catheter as the catheter is advanced through a blood vessel to the target site, and can subsequently be adjusted to project from the catheter body.
In some cases, the entire electrode body can be adjustable, while in other cases only a 10 part of the electrode is adjustable.
Any suitable mechanism can be used to adjust the electrode, such as, for example, a spring mechanism.
Figures 7A and 7B illustrate a variation of a catheter (700) comprising a movable electrode (702) and sleeve (704). As illustrated here, the electrode (702) can comprise a guidewire electrode, which can be movable between a retracted configuration, in which the electrode (702) is retained within the catheter (as shown in Figure 7A) and a protube configuration - rant, in which the electrode (702) protrudes from the surface of the catheter (700) (as shown in Figure 7B). The electrode (702) may or may not be naturally oriented to project from the catheter.
When electrode 20 (702) is naturally oriented to project from the catheter, as in the variation illustrated in Figures 7A and 7B, a structure can be used to retain or maintain electrode (702) in a retracted configuration.
For example, the sleeve (704) can be used to control the protrusion of the electrode (702). The sleeve (704) can be distally advanced to maintain the electrode (702) in a retracted configuration, as shown in Figure 7A.
The sleeve (704) can then be removed proximally to expose the electrode (702), which can then move naturally to a projected configuration, as shown in Figure 7B.
The electrode (702) can project in any suitable amount from the surface of the catheter (700) 30 (for example, between about 0.1 mm to about 1 mm, about 0.25 mm to about 0.5 mm, about 0.75 mm to about 1.0 mm, and the like). While illustrated in Figures 7A and 7B as being naturally
oriented in a designed configuration, the electrode can be manually adjustable between a retracted configuration and a projected configuration.
For example, Figure 8 shows a variation of a catheter (800) with a laminated spring electrode (802) that can be driven by 5 wires (804). As illustrated here, the wire (804) can be slidably arranged. inside the stem (806). The movement of the wire (804) can pass the electrode (802) between a retracted configuration and a projected configuration.
The amount of projection of the electrode (802) can be determined at least in part by the amount of movement of the wire (806), allowing for additional user control in deploying the electrode.
In other variations, the wire (804) can be attached to the haste (806), and the rod (806) can be movable within the catheter (800) to advance or retract the wire (804). In these variations, the amount of electrode projection (802) can be determined at least in part by the amount of movement of the rod (806). 15 In variations where the electrode comprises a spring electrode or another foldable electrode, one or more parts of the electrode may be covered by a nest material, such as that described above.
Figure 20 illustrates a variation of a catheter (2000) comprising a foldable electrode (2002). As illustrated here, the catheter (2000) can comprise a catheter body (2001), electrode (2002) and a distal coupling magnet assembly (2004). At least part of the electrode (2002) can be covered / coated with an insulating material (2006) so that the uncovered part (2008) of the electrode (2002) can act as an ablation surface.
The isolated part of the electrode (2002) can be coated in any suitable manner (for example, plasma spray, flame spring, dip coating or the like), and the insulating material (2006) can be any suitable material, such as a or more of the nest materials described above.
A rod, stiffened guide wire, or other drive mechanism (not shown) can be used to move the electrode (2002) between a low profile configuration (not shown), in which the electrode (2002) is housed inside or flush with the catheter body (2001), and a foldable configuration, as shown in Figure 20, to move the electrode
2'5 / 91
(2002) for a folded configuration, the drive mechanism can compress the electrode (2002) so that it bends, flexes or. otherwise deform away from the catheter body (2001). It should also be noted that in some cases, the electrode (2002) can naturally bend or flex 5 from the catheter body (2001), and a mechanism. The drive (or a sleeve) can be used to move the electrode (2002) to a low profile configuration.
In variations in which a catheter comprises a foldable electrode, it should be appreciated that one or more ablation surfaces of the electrode can be standardized, as described in greater detail above.
Figure 30 illustrates a variation of a catheter (3000) comprising a foldable electrode (3002). As illustrated here, the catheter may comprise an electrode (3002) having a first electrode part (3003) and a second standard electrode part (3004), a 15 catheter body (3006), and a nest material ( 3008) housing the coupling magnets (3010) and having a rail (3012). The electrode (3002) can be advanced from a retracted position in which the electrode (3002) is contained within the rail (3012) of the nest material (3008). To unfold the electrode (3002), the first electrode part (3003) can be configured to bend or flex towards the far side of the catheter body (3006), similar to the electrode (2002) described above with respect to Figure 20. The second electrode part (3004) can be attached to the first electrode part (3003), so that the second electrode part (3004) extends from the catheter body (3006) when the first electrode part (3003) ) bends or flexes 25 away from the catheter body (3006). The second electrode part (3004) can comprise one or more patterned surfaces, such as a patterned surface (2902) of the electrode (2900) described above with reference to Figures 29A and 29B.
In some variations, at least a part of the first electrode part (3003) can be covered or otherwise coated 30 with one or more insulating materials, such as one or more of the nest materials described above.
While illustrated in Figure 30 as having two coupling magnets (3010) located distally from the electrode (2900),
"it should be appreciated that the catheter (3000) can comprise any alignment elements or combinations of alignment elements, such as @
those described in greater detail below.
As mentioned above, in variations where a catheter comprises an electrode, the catheter may additionally comprise a wire or other conductive structure that can electrically connect the electrode to a current source or ground to 'transport the current to or from the electrode .
In some variations, as will be described in greater detail below, one or more parts of the wire or conductive structure can act as an electrode to cause tissue ablation- A wire can be placed inside the catheter, outside the catheter, or a combination of them.
In some variations where the wire is disposed externally with respect to the catheter, the wire can. be embedded in the catheter wall, fixed along an external surface of the catheter and / or at least partially covered by a sheath or other non-conductive material (such as one or more nest materials as described in more details above). For example, in the variation of the catheter (100) illustrated in Figures 1A to 1C and described in greater detail below, the wire (104) can at least partially be located along the external surface of the catheter.
As illustrated here, the yarn can be further protected against the surrounding fabric by the sleeve (106). In other variations, the wire may be at least partially disposed within the catheter.
In some of these variations, the wire may comprise a concentric electrical conductor that can be arranged around one or more parts of the device.
For example, in the variation of catheter 25 (300) illustrated in Figure 3 and described in greater detail above, the concentric electrical conductor (314) can be connected to the electrode (310). As shown here, the concentric electrical conductor (314) can be arranged around part of the lumen (308) - The concentric electrical conductor (314) may or may not be a stranded material, and can be made of any conductive material 30 suitable, such as copper, gold, platinum and the like.
In some variations, the wire may be electrically insulated by a non-conductive material, such as parylene, ceramic, po | itetraf | uroeti | eno,
polyetherterketone, fluorinated ethylene-propylene, or the like.
Electrical insulation can serve several useful purposes.
In some cases, insulation can help prevent loss of wire current.
In other cases, the insulation may protect the wire from inadvertent contact with the fabric or other components of the device.
It must be appreciated that any of the ca-. The ethers described here can comprise any electrode or combination of electrodes, any conductive wire or material, and / or any insulation or nest material as described above.
The wire can be operationally connected to one or more generators to supply RF energy to the electrode.
The generator can supply any current adequate to the electrodes that may cause tissue ablation.
In some variations, the generator can be configured to supply power between about 10 W and about 300 W.
In other variations, the generator can be configured to supply power between about 100 W and about 200 VV. 15 In some variations, the generator can be configured to generate a pulsed current.
In some of these variations, the amplitude of the pulsed current can vary between pulses.
In other variations, the generator can be configured to generate alternating current.
In these variations, one or more electrodes can be attached to the bipolar or monopolar outputs of the generator, as described in greater detail above.
In variations where the generator is configured to generate alternating current, the current can have any suitable frequency range, such as, for example, about 300 KHz to about 9.5 MHz.
It should also be appreciated that the generator can be configured to provide a plurality of power outlets.
For example, in some variations a generator can be configured to supply a first outlet to fuse blood vessel tissue (as will be described in more detail below) and can be configured to supply a second outlet to cause ablation or vaporize the fabric.
As mentioned above, one or more parts of a guide wire 30 can act as an electrode to cause tissue ablation or vaporization.
For example, Figures 21A and 21B illustrate a variation of the catheter (2100). As illustrated, the catheter (2100) comprises a distal catheter body (2102), a proximal catheter body (2104), nest material (2106) comprising coupling magnets (2108) and rail (2110), and the guide wire (2112). In these variations, at least part of the guide wire (2112) can be discovered (for example, not electrically insulated through one or more 5 insulating coatings, nesting materials, or other non-insulating materials)
N conductors), so that the exposed part of the guide wire (2112) can act as an ablation surface from which the current can be distributed to cause ablation, vaporize or otherwise remove the tissue. In addition, a distal part of the guidewire (2112) can be oriented away from the catheter (2100), and can be moved between three positions. In a first position (not shown), the guidewire (2112) can be maintained or otherwise lodged within the catheter (2100), which can allow the low profile advance of the catheter (2100) through vascular systenia. The guide wire (2112) can then be advanced (or in some cases, removed) so that the orientation of the guide wire (2112) causes a distal part of the guide wire (2112) to protrude out of the catheter (2100 ) through the rail (2,110), as shown in Figure 21A. In some cases, this orientation may push or otherwise press the guide wire (2112) against the blood vessel tissue (unglazed). A current can then be supplied to the guide wire (2112) to cause ablation of the blood vessel tissue. As the blood vessel tissue ablates, the orientation of the guide wire (2112) can continue to push the distal part of the guide wire (2112) through the tissue, where it can come into contact with one or more parts of a second catheter (such as, for example, an electrode comprising a pian ablation surface such as that described above), in an adjacent blood vessel. In addition, the guide wire (2112) can be further advanced (or removed) during ablation to move the guide wire (2112) to a second position, as shown in Figure 21B. As the guidewire (2112) is moved, it can move through blood vessel tissue to cause ablation of a tract or pathway in the tissue, which can facilitate the formation of the fistula. After ablation, the guidewire (2112) can then be returned to its original low profile configuration (or a different low profile configuration), and the catheter can be repositioned or removed. Figures 31A and 31B illustrate other variations of the catheter
V (3100). Specifically, Figure 31A illustrates a perspective view of the catheter (3100), comprising the catheter body (3102), the nest material (3104), with the rail (3106), coupling magnets (3108), and for- guide wire. killed (3110). Figure 31B illustrates the catheter (3'1 00) with the catheter body (3102) removed. Additionally, illustrated in Figure 31B, are the anchoring magnets (3112). Similar to the guide wire (3110) described above with reference to Figures 21A and 21B, at least a portion of the guide wire (3110) can be discovered and thus can act as an ablation surface to cause ablation or vaporization of the tissue . In addition, the distal part of the guide wire (3110) can be configured to orient away from the catheter (3100) and can be movable between three positions. In the first position (not shown), the guide wire (3110) can be maintained or otherwise housed within the catheter (3100) (for example, inside the nest material (3104) and / or the catheter body (3102)), which can allow the low profile advancement of the catheter (3100) through the vascular system. The guidewire (3110) can then be removed (or in some cases, advanced) so that the orientation of the guidewire (3110) can cause the distal part of the guidewire (3110) to orient 20 Ionge from the body catheter (3102), as shown in Figures 31A and 31B. As illustrated here, the guide wire (3110) may comprise a first segment (3114) housed at least partially within the catheter body (3102), a first angled segment (3116) extending from a distal end of the first segment (3114), and a second angled segment (3118) extending from a distal end of the first angled segment (3116). The first angled segment (3116) can extend from the first segment (3114) at a first angle (Oj), so that when the guide wire (3110) guides away from the catheter body (3102), the first angled segment (3116) angled away 30 from the catheter body (3102) at the first angle (Oi). The first angle (Eh) can be any suitable angle (for example, about 30 degrees, about 45 degrees, about 60 degrees, between about 30 degrees and about 60 degrees, between about 15 degrees and about 75 degrees, or the like). The second angled segment (3118) can be angled with respect to the first
V angled segment (3116) at a second angle (02). The second angle (02) can be any suitable angle (for example, about 100 degrees, about 135 degrees, about 170 degrees, between about 100 degrees and about # 170 degrees, or the like). In the variation illustrated in Figures 31A and 31B, the guide wire (3110) can be configured so that when the guide wire (3110) guides the second angled part (3118) it is approximately parallel to the longitudinal geometric axis of the catheter body (3102) , and separated from the catheter body 10 (3102) by a distance (x). The distance (x) can be any value suitable to extend at least partially through the vascular tissue during ablation (for example, less than 1 mm, between about 1 mm and about 2 mm, between about 1 mm and about 3 mm, more than about 4 mm, and the like). 15 When the catheter (3100) is located inside a blood vessel (not shown) and the guide wire (3110) extends outward from the catheter (3100), the first (3116) and the second (3118) angled sections of the guide wire (3110) can be oriented into the tissue of the blood vessel. When the guide wire (3110) is used to cause tissue ablation, this orientation may cause the guide wire (3110) to press through or otherwise cause the vessel tissue to ablate, as the wire guide (3110) passes through the blood vessel tissue, it may come into contact with one or more parts of a second catheter (shown) located in an adjacent blood vessel, as will be described in 25 more details below . In some variations, the guide wire (3110) can be additionally removed (or advanced) during ablation to slide the guide wire (3110) with respect to the catheter to a third position (not shown). As the guide wire (3110) is moved, it can move through the blood vessel tissue to cause ablation of a tract or pathway 30 in the tissue, which can facilitate the formation of the fistula. After ablation, the guide wire (3110) can then be returned to a low profile (for example, by removing the guide wire (3110) with respect to the catheter body (3102)), and the catheter
"ter can be repositioned or removed. One or more parts of the guide wire (3110) can be coated or
And otherwise covered with one or more insulating materials. For example, as illustrated in Figures 31A and 31B, an insulating material (3122) can co-
5. at least partially break the guide wire (3110). The insulating material can co-. any suitable part or parts of the guide wire. For example, in variation. illustrated in Figures 31A and 31B, an insulating material (3122) can cover the first segment (3114) and the first angled segment (3116), but not the second angled segment (3118). In other variations, the insulating material (3122) can cover the first segment (3114) and only partially cover the first angled segment (3116), so that the second angled segment (3118) and a part of the first angled segment. (3116) remain uncovered. In these variations, the second angled segment (3118) and the uncovered part of the first angled segment (3116) 15 can act as an ablation surface. When the insulating material (3122) covers multiple segments of the guide wire (3110), the same material can cover each segment, or different insulating materials can cover the different ones. different segments. The insulating material (3122) can comprise any suitable material or materials, as described above. In some variations, the insulating material (3122) may comprise polyetheretherketone. Figure 32 illustrates another variation of the catheter (3200) comprising a guide wire (3202) having a first segment (3204), a first angled segment (3206), and a second angled segment (3208). As illustrated here, the catheter (3200) can comprise a catheter body (3210) having a recessed region (3212). The catheter (3200) can comprise a lumen (3214) or other passage extending through the catheter body (3210). The lumen (3214) can extend through the catheter body (3210) both proximally and distally with respect to the recessed region (3212), or it can extend only through the body of 30 catheter (3210) only proximally of the recessed region (3212) - As with the guide wire (3110) described above with respect to Figures 31A and 31B, at least part of the guide wire (3202) is uncovered, and the guide wire
(3202) can be movable from a low profile configuration and an oriented configuration in which the first angled segment (3206) angled away from the first segment (3204) and the catheter body (3210). When in a low profile configuration, the first (3206) and second m 5 (3208) angled segments can be at least partially restricted within the lumen (3214). In some variations, at least a part of the first angled segment (3206) and / or second angled segment (3208) may be temporarily housed in a part of the lumen (3214) distally from the recessed region (3212). In these variations, the guide wire 10 (3202) can be removed with respect to the catheter body (3210) to release the first angled segment (3206) and the second angled segment (3208) of the lumen (3214), which can allow these segments guide away from the catheter body (3210) as described above.
In other variations, at least part of the first angled segment (3206) and / or 15 second angled segment (3208) can be temporarily housed in a part of the lumen (3214) proximally to the region with recess (3212). In these variations, the guide wire (3202) can be removed to release the first angled segment (3206) and the second angled segment (3208) of the lumen (3214). As shown in Figure 32, an insulating material (3216) (such as one or more insulating materials described above) can cover the first segment (3204) and can partially cover the first angled segment (3206), leaving the second angled segment ( 3208) and a part of the first angled segment (3206) exposed.
In some variations, one or 25 more insulating materials may also partially cover the second angled segment (3208), but they do not have to.
The exposed parts of the first (3206) and second (3208) angled segments can act as an ablation surface to cause ablation or vaporization of the tissue.
The catheter body (3210) can also comprise one or more insulating nest materials (not shown) or coatings that can help protect the catheter body (3210) from and in some cases redirect heat and energy produced by the guide wire (3202) during ablation-
Additionally, in some variations, the guide wire (3202) can be additionally removed (or advanced) during the ablation to slide the. guide wire (3202) with respect to the catheter. As the guide wire (3202) is moved, it can move through the blood vessel tissue to cause ablation to a tract or path in the tissue, which can facilitate the formation of. fistula. After ablation, the guide wire (3202) can then be returned to a low profile, for example, by removing the guide wire (3202) so that the first angled segment (3206) and the second angled segment (3208) are pulled into the lumen (3214). 10 As mentioned above, in some variations one or more parts of the ablation surface of an electrode from a first catheter may extend or otherwise be advanced through the vessel tissue
No blood during ablation. When a second catheter is located in an adjacent blood vessel, this advance through the blood vessel tissue can cause the ablation surface to come into contact with one or more parts of the second catheter. When the second catheter comprises an electrode having an exposed conductive surface, direct contact between the electrodes of each catheter may cause the energy source (eg, an electrosurgical generator) to shut down or otherwise interrupt the tissue ablation. In other cases, contact between the electrode of the first catheter and the second catheter can damage one or more components of the second catheter. Accordingly, in some variations, it may be desirable to configure a catheter to include one or more sections that can accommodate contact with an active electrode without interrupting the ablation or otherwise damage one or more parts of the catheter. Figures 33A and 33B illustrate such a variation of a catheter (3300). As illustrated here in Figure 33A, the catheter (3300) can comprise a catheter body (3302), nest material (3304) with pocket (3306), Coupling magnets (3308), and electrodes (3310). Figure 33B illustrates catheter 30 (3300) with the catheter body (3302) removed. Additionally illustrated are the anchor magnets (3312). Generally, the pocket (3306) can be configured to receive a portion of an electrode from a second catheter.
For example, when the catheter (3300) is located inside a blood vessel (not shown), and a second catheter is located in an adjacent blood vessel, the catheter (3300) can be positioned with respect to - second catheter so that the pocket (3306) can be aligned with an electrode (not shown) of the second catheter.
The alignment can result from the attraction between the catheter alignment elements (3300) (for example, Coupling magnets (3308) and / or Anchor magnets (3312) and corresponding alignment elements of the second catheter, as will be described in more detail. below.
During ablation, the electrode of the second catheter can pass between blood vessels, where it can be received by the pocket (3306). The nest material (3304) can be formed from or coated with an insulating material, so that the energy distributed by the electrode does not damage the catheter (3300) as the electrode is received by the pocket (3306). The pocket (3306) can be configured to receive any suitable electrode, as described in greater detail above.
For example, in some variations, the plug (3306) can be configured to receive a part of a guide wire, such as the wire (2112) of the catheter (2100) described above with reference to Figures 21A and 21B, the guide wire ( 3110) d catheter (3100) described above with respect to Figures 31A and 31B, the guide wire (3202) described above with respect to Figures 32A and 32B, and the like.
For example, in some variations, coupling magnets and catheter anchoring magnets (3300) and (3100) can be configured so that when catheters (3300) and (3100) are placed in blood vessels adjacent, the pocket (3306) of the catheter (3300) can be substantially aligned with respect to the rail (3106). When the guide wire (3110) is advanced (or removed) so that a distal part of the guide wire (3110) is oriented out of the rail (3106), the guide wire (3110) can be activated to cause ablation tissue, as described in more detail below.
As the guide wire (3110) causes ablation through the fabric, one or more parts of the guide wire (3110) (for example, the second angled part (3118)) may enter or otherwise be received by the pocket (3306) ).
While illustrated in Figures 33A and 33B as having electrodes (3310), the catheter (3300) does not need to comprise any electrodes.
In variations that do not include electrodes (3310), the electrodes (3310) can act as a passive grounding electrode for an active electrode 5 of a second catheter (for example, guide wire (3110) of the catheter (3100) described above) or vice versa, which can assist in tissue ablation.
While illustrated in Figures 33A and 33B as having two electrodes (3310), it should be appreciated that the catheters described here can comprise any suitable number of electrodes (for example, zero, one, two, or three or more 10 electrodes) . For example, Figure 34 illustrates a variation of a catheter (3400) comprising a single electrode (3402). Also shown are the catheter body (3404) and the nest material (3406) with the pocket (3408) and the alignment electrode (3402) and coupling magnets (3410). The pocket (3408) can be configured to receive one or more parts of an electrode from a second catheter, as described in greater detail below.
While the electrode (3402) is proximal to the pocket (3408), in the variation of the catheter (3400) illustrated in Figure 34, in other variations the electrode (3402) can be positioned distally in relation to the pocket (3408). In some variations, a catheter may comprise a pocket 20 lined with an electrode.
Figures 35A and 35B illustrate a variation of the catheter (3500). As illustrated in Figure 35A, the catheter can comprise a catheter body (3501) and the nest material (3502). The nest material (3502) can house the electrode (3504) and coupling magnets (3506) - Figure 35B illustrates the catheter (3500) with the catheter body (3501) removed, 25 and additionally illustrates the anchoring magnets (3510). The pocket (3508) can be formed on the electrode (3504), and can be configured to receive a portion of an electrode from a second catheter.
In some variations, the pocket (3508) can be electrically and / or thermally insulated by depositing one or more insulating coatings (for example, a refractory metal oxide coating 30) on the surfaces of the pocket (3508), which it can allow the pocket (3508) to receive and contact at least part of an electrode without the pocket (3508) providing a direct electrical connection.
In other variations, the pocket (3508) can be configured to allow electrical conduction through it without direct physical contact with an external electrode.
For example, in some of these variations, the pocket (3508) may be covered or otherwise covered with a porous insulating coating (for example, a porous metal oxide coating). When the pocket (3508) receives an electrode (for example, one or more guide wire electrodes described above), the porous coating may allow electrical conduction through the pocket (3508) without the physical electrode pocket with direct electrode, the which can prevent short circuit or interruption of ablation.
In addition, while the variations of the catheters described immediately comprise each pocket for receiving an electrode from a second catheter, it should be appreciated that the catheters described here do not need to comprise a pocket.
In fact, in some variations, one or more parts of the device can be electrically isolated or partially electrically isolated to allow direct contact with one or more electrodes of a second catheter.
For example, Figure 36 illustrates a variation of catheter (3600). As illustrated here, the catheter (3600) can
· Comprise a catheter body (3602) and nest material (3604). The 2'0 nest material (3604) can accommodate an electrode (3606) and coupling magnets (3608) in it.
The electrode (3606) may additionally comprise one or more coated segments (3610). The coated segment (3610) may comprise an insulating coating (as described in greater detail above) or a partially insulating coating (for example, a porous coating as described immediately above). The catheter (3600) can interact with a second catheter (not shown) so that when the catheters are located in adjacent blood vessels, an electrode from the second catheter can extend through the tissue of the vessel during ablation and contact the coated segment (3610) without damaging or causing 30 Short circuit to the device.
While the coated segment (3610) of the electrode (3606) shown in Figure 36 may have recesses in relation to the rest of the electrode, it should also be noted that in some variations the segment
coated element (3610) can be leveled with respect to the uncoated parts of the electrode (3606). Mechanical Cutting Elements In some variations, a catheter may comprise one or more mechanical cutting elements.
For example, in some variations, a catheter may comprise a blade that can be advanced or otherwise extended from the catheter to cut tissue.
Figure 22 illustrates a variation of the catheter (2200) comprising a nest material (2201) comprising the rail (2202) and a blade (2204). The blade (2204) can have any suitable shape and configuration (for example, single edge, double edge, pointed, rounded or the like). The blade (2204) can be coupled in a rotating, translated or other way to the catheter (2200) so that it can be unfolded through the rail (2202) to cut the tissue.
In some variations, the blade (2204) can be configured 15 to oscillate with respect to the catheter (2200) to cut the tissue.
The blade (2204) can be unfolded by any suitable mechanism (for example, one or more mechanical actuators, actuated on a Magnet basis, eietronic actuators or the like), and can be removed into the rail (2202) to allow the advance or removal of the low profile of the catheter.
In some 20 variations, as will be described in greater detail below, the slide (2204) can be used to pierce one or more balloons in a corresponding catheter in another blood vessel. Additionally, in some variations, the slide (2204) can be electrically connected to an electrosurgical generator so that (âmina (2204) can act as an electrode, like the electrodes described in greater detail above.
Figures 37A and 37B illustrate cross-sectional views of a variation of the catheter (3700), and illustrate a mechanism by which a slide (3702) can be advanced out of the catheter (3700). The catheter (3700) can comprise a recess (3704) in the catheter body (3705). The blade (3702) can be movable from a low profile configuration, in which the blade (3702) is housed in the recess (3704), (as shown in Figure 37A) for a cutting configuration, in which the blade (3702) is advanced out of the recess (3704) (as shown in Figure 37B) - The catheter (3700) can comprise a rotation arm (3706) and an activation wire (3708), which can help move the blade (3702) between the retracted and cut configurations, as will be described in more detail below.
They are also illus-
In Figure 37A and 37B, the coupling magnets (3710) are located proximally and distally with respect to the blade (3702), although it can be appreciated that the catheter (3700) does not need to comprise any alignment element or can comprise any suitable alignment element or combinations of alignment elements as described in 10 more details below- As illustrated in Figure 37A and 37B, the rotation arm (3706) can be pivotally connected to the blade (3702) at a first point joint (3712) at or near a first end of the rotation arm (3706) and can also be pivotally connected to the catheter body (3705) at a second point of articulation (3714) at or near a second end the rotation arm (3706). The points of articulation described here can comprise one or more pins, projections, other structures that allow the rotation movement between two elements.
For example, as illustrated in Figures 37A and 37B, the second pivot point (3714) can comprise a pin (3716). In some variations, the second pivot point (3714) can be additionally configured to move along the longitudinal geometric axis of the catheter body (3705). For example, the pin (3716) of the second pivot point (3714) can be slidably arranged on a rail (3718) within 25 of the catheter body (3705), so that the pin (3716) can rotate and slide with respect to the rail (3718) and the catheter body (3705). The blade (3702) can be additionally articulated to the catheter body (3705) at a third point of articulation (3720) - In addition, the activation wire (3708) can be connected to the rotation arm (3706) at or near 30 of its second end.
For example, in the variation of the catheter (3700) illustrated in Figures 37A and 37B the activation wire (3708) can be fixed to a part of the pin (3716).
The activation wire (3708) can be manipulated to move the blade (3702) into a retracted position (as shown in Figure 37A) and an extended cut position (as shown in Figure 37B). The activation wire (3708) can be pulled proximally with respect to the longitudinal geometrical axis of the catheter (3702), which can cause the second. articulation point (3714) slides proximally to the catheter body.
As the second pivot point (3714) moves proximally towards the third pivot point (3720), the rotating arm (3706) and the blade (3702) can each rotate away from the body catheter (3705), as illustrated in Figure 37B.
When the catheter (3700) is located in a blood vessel, rotation of the blade (3702) into a cutting position can cause the blade (3702) to cut tissue from the vessel.
To return the blade (3702) to a retracted position, the activation wire (3708) can be advanced distally with respect to the 15 catheter (3700), which can move the second pivot point (3714) away from the third pivot point (3720), which can cause the pivoting arm (3706) and blade (3702) to rotate back towards the catheter body.
It should also be noted that in some variations, the catheter (3700) can be configured so that the distal advance of the activation wire causes the rotation arm (3706) and the blade (3702) to rotate the blade to a extended position, while the proximal withdrawal of the activation wire causes the rotation arm (3706) and the blade (3702) to rotate the blade (3702) to a retracted position.
Figures 38A and 38B show another variation of a catheter 25 (3800) comprising a blade (3802). As illustrated in a perspective view in Figure 38A, the catheter (3800) can comprise a catheter body (3804), and a recess (3806) in the catheter body (3804) through which the blade (3802) can extend .
Also shown are the guide plates (3810) on both sides of the recess (3806), and the activation wire 30 (3814). Figure 38B shows a lateral cross-sectional view taken along the longitudinal geometric axis of the catheter (3800) - As illustrated here, the blade (3802) can be pivotally attached to one or more of the guide plates
"(3810) at a pivot point (3812). In some variations, the pivot point (3812) may comprise one or more pins or projections, - as described immediately above.
As shown in Figure 38B, a distal part of the activation wire
, 5 tion (3814) can be attached to the blade (3802), and can extend through a lumen (3816) or another passage in the catheter body (3804). A proximal part of the activation wire (3814) can be manipulated to remove or advance the activation wire (3814) into the lumen (3816), and this movement can cause the blade (3802) to rotate with respect to the point articulation 10 (3812). In the variation shown in Figures 38A and 38B, withdrawing the activation wire (3814) can cause the blade (3802) to rotate outwardly from the catheter body (3804) (as shown in Figure 38A), while advancing . the activation wire (3814) can cause the blade (3802) to rotate to a retracted position (as shown in Figure 38B) - 15 When the catheter (3800) is advanced into a blood vessel (not shown), the catheter (3800) can be advanced with the blade (3802) in a retrald position within the catheter body (3804). When the catheter (3800) is positioned inside the blood vessel, a user can withdraw or otherwise retract the wire to rotate the blade (3802) to an extended position, where the blade (3802) can cut the tissue.
When the blade (3802) is in an extended position, the catheter can optionally be moved with respect to the blood vessel to cut the tissue.
Additionally or alternatively, the pivot point (3812) can be movable with respect to the catheter body (3804), so that the pivot point (3812) and 25 the blade (3802) can be moved along the axis longitudinal geometry of the catheter body (3804). After the cutting action by the blade (3802), the activation wire (3814) can be advanced to return the blade (3802) to a retracted position.
The catheter (3800) can optionally be repositioned and reactivated to cut tissue at another site, or catheter 30 (3800) can be removed from the blood vessel.
While the catheter (3800) is illustrated above as being configured so that the withdrawal of the activation wire (3814) extends the blade (3802) from the catheter body (3804) and the feed retracts the blade (3802) inward of the catheter body (3804), it should be appreciated that the catheter (3800) can be configured so that the ¶
advance of the activation wire (3814) can extend the blade (3802) from the catheter body (3804) and withdrawal of the activation wire (3814) can retract the blade m 5 (3802) into the catheter body (3804) . Figures 39A and 39C illustrate another variation of a catheter (3900) comprising a blade (3902) - Figure 39A illustrates a perspective view of part of the catheter (3900) with the blade (3902) in an extended position from a recess (3904) in the body of 10 catheters (3906). Figures 39B and 39C illustrate lateral transverse views of the catheter (3900) along its longitudinal geometric axis.
As illustrated here, the Blade (3902) can be attached to a first wire part (3908) and a second wire part (3910). The first wire portion may be attached to or otherwise engage a translational wire (3912) at connection point 15 (3914). In some of these variations, the first part of yarn (3908) and the second part of yarn (3910) may comprise a memory effect material, and may be configured so that the first part of yarn (3908) and a - second part of the wire (3910) guide the blade (3902) away from the translation wire (3912) and towards an extended position, as shown in Figure 39C.
To move the blade (3902) from an extended position to a retracted position, as shown in Figure 39B, the second wire part (3910) can be pulled away from the connection point (3914) in the direction of the arrow (3916). This can cause the first (3908) and second (3910) parts of wire to straighten at least partially, which can withdraw the blade (3902) into the catheter body (3906). The second wire part (3910) can be locked or otherwise fixed with respect to the translation wire (3912) to hold the blade (3902) in a retracted position.
To use the blade (3902) to assist in the formation of a fistula, the catheter (3900) can be advanced into a blood vessel (not shown) with the blade (3902) in a retracted position.
Once positioned (for example, using one or more alignment elements, visualization methods or the like), the blade (3902) can be moved
b vi'da 'to a strained position.
To do this, the second part of the wire (3910) can be unlocked with respect to the translation wire (3912), which can allow the first (3908) and second (3910) parts of the wire to return to their outward-oriented positions , thereby extending the blade (3902) to an extended position, as shown in Figure «39C.
In some variations, a user may advance or otherwise move the second part of the wire (3910) towards the connection point (3914) to help orient the blade (3902) in an extended position.
As the blade (3902) extends from the catheter body (3906) it can cut the tissue.
In some variations, the second wire part (3910) can be locked or otherwise fixed with respect to the translation wire (3912) to keep the blade (3902) in an extended position.
Once extended from the catheter body (3906), the translation wire (3912) can be advanced or removed with respect to the catheter body (3906) to convey the blade (3902) along the longitudinal geometric axis of the catheter, which can allow the blade (3902) to cut through a larger tract of tissue.
In addition or alternatively, the catheter (3900) can be advanced or. removed in relation to the blood vessel with the blade (3902) extended to cut a larger tract of the tissue.
The second part of the wire (3910) can then be removed with respect to the translation wire (3912) and connection point (3914) to return the blade (3902) to a retracted position, and the catheter (3900) can be repositioned or removed.
It should be appreciated that the variations described above of the catheters comprising blades can include any of the additional device features described herein.
For example, catheters can comprise one or more alignment elements.
In these variations, the catheters may comprise one or more anchor magnets and / or one or more coupling magnets.
Additionally or alternatively, the catheter may comprise one or more shape-changing elements and / or 30 or more markers, as will be described in greater detail below.
Laser Energy In some variations, the catheters described here can be
~.
configured to deliver laser energy to the tissue to vaporize or otherwise remove the tissue during the formation of the fistula. Generally, variations of these catheters can comprise an optical fiber that can rotate from a proximal part of the catheter to a distal part of the catheter.
. 5 A proximal part of the 'optical fiber can be operationally connected (for example, via an SMA connect, or similar), to a laser generator. The laser energy produced by the laser generator can propagate or otherwise pass through the optical fiber, and can be distributed from the optical fiber to the tissue to vaporize the tissue. In some variations the catheter may comprise one or more lenses , mirrors, diffusers, and / or other components that can redirect the light from the optical fiber towards the fabric. The laser generator can be configured to produce any suitable laser energy. In some variations, it may be desirable to produce light energy having a wavelength with high water absorption, which can promote the absorption of energy by the tissue of the vessel. In some variations, the laser generator can be configured to generate infrared energy. Examples of suitable wavelengths include, but are not limited to, about 730 nanometers, between about 680 nanometers and about 780 nanometers, about 820 nanometers, between about 750 nanometers and about 870 nanometers, about 930 nanometers, between about 880 nanometers and about 980 nanometers, about 970 nanometers, between about 920 and about 1020 nanometers, about 1200 nanometers, between about 1150 nanometers and about 1250 nanometers, about 1450 nanometers, between about 1400 nanometers - about 25 nanometers and about 1500 nanometers, about 1950 nanometers, between about 1900 nanometers and about 2000 nanometers, about 2900 nanometers, between about 2850 nanometers and about 2950 nanometer or similar. Examples of suitable laser generators include, but are not limited to, diode lasers, diode-pumped lasers, Nd-YAG lasers and syllables. Figure 43 illustrates a distal part of a variation of the catheter (4300) that can be configured to deliver laser energy to the tissue.
" of.
As illustrated here, the catheter (4300) can comprise the catheter body (4302), optical fiber (4304), and irrigation lumen (4306). As illustrated here, the optical fiber (4304) can run along the longitudinal geometric axis (4310) of the catheter body (4302), and a distal part of the optical fiber (4304) 5 can bend to direct the distal end of the optical fiber (4304) out of one side of the catheter body (4302). The distal part of the optical fiber (4304) can bend at any angle (0) with respect to the longitudinal geometric axis (4310) of the catheter body (4302). In some variations, the angle (t)) can be about 45 degrees.
In other variations, the angle (0) can be about 90 degrees.
In still other variations, the angle (0) can be between about 45 degrees and about 90 degrees.
In other additional variations, the angle (0) can be less than about 45 degrees, or greater than about 90 degrees.
When the distal end of the optical fiber (4304) is directed 15 towards the side of the catheter body (4302), the laser energy can be passed through the optical fiber (4304) and can exit through the side of the catheter body (4302), where it can vaporize, cause ablation or otherwise remove tissue.
In some variations, it may be desirable to pass a gas (e.g., carbon dioxide) or fluid (e.g., saline) between the distal end of the optical fiber (4304) and the fabric during vaporization of the fabric.
Accordingly, in some variations, one or more fluids can be passed through the catheter body (4302) through the irrigation lumen (4306) and be distributed between the optical fiber (4304) and the tissue (not shown). The gas or fluid can be introduced continuously or intermittently during the vaporization of the tissue, and can help to minimize or otherwise prevent excessive heating or damage to the surrounding tissue.
In addition, in some variations, it may be desirable to space the optical fiber outlet (4304) from the fabric.
In some cases, the spacing of the tissue's optical fiber output can affect the energy density of the laser energy supplied and / or the size of the formed fistula.
In some variations, the catheter may comprise a space (4308) between the end of the optical fiber (3404) and the side wall of the catheter body (4302). The space (4308) can separate the end of the optical fiber (3404) from the side wall of the catheter body (4302) by any suitable amount (for example, about 0.5 mm, about 1 mm, about 1.5 mm, between about 0.5 mm and about 1.5 mm, more than about 1.5 mm, and the like). Add
. 5 cionally, in variations where an irrigation lumen (4306) is used to distribute a gas or fluid between the optical fiber outlet (4304) and the fabric, the gas or fluid can be distributed into or through space (4308 ). As mentioned above, in some variations, a catheter 10 may comprise one or more lenses, diffusers, mirrors or the like, to alter or otherwise redirect the light that passes through an optical fiber.
For example, Figure 44 illustrates a variation of a catheter (4400) comprising a diffuser (4410) that can redirect the laser energy delivered through an optical fiber (4404). As illustrated, the catheter (4400) can comprise a catheter body (4402), an irrigation lumen (4406), an optical fiber (4404), and a diffuser (4410). The diffuser (4410)
, can be fixed at or near the distal end of the optical fiber (4404), and can redirect the light from the optical fiber (4404) out through the side of the catheter body (4402). In some variations, a space (4408) within the catheter body (4402) can separate an outlet from the diffuser (4410) from the tissue.
In addition, the irrigation lumen (4406) can be positioned to pass the fluid between the diffuser (4410) and the fabric (not shown), as described immediately above.
Alignment Elements
25 In some variations, the catheters described here can
hold one or more alignment elements to help align or otherwise reposition the catheters when located in the vascular system
home.
For example, in some cases alignment elements can help
bring two or more catheters (and with them, two or more vessels
Bloodthirsty) closer to each other.
In other cases, the alignment elements can help ensure that one or more catheters are in proper axial or rotational alignment with respect to another catheter (or catheter).
te'res). Ensuring proper catheter and blood vessel position can help facilitate the formation of a fistula with one or more of the fistula-forming elements described above. In some variations, the catheters may comprise mechanical alignment characteristics, such as protuberances, grooves, flat surfaces, and the like that may or may not interact with one or more of the alignment characteristics on another catheter. Additionally or alternatively, a catheter may have one or more magnetic components that can interact with one or more magnetic components from another catheter or one or more magnets positioned outside the body. In other additional variations, the catheter may comprise
V one or more markers that can help the user to align one or more catheters. In other additional variations, a catheter may comprise one or more reshaping elements to adjust the placement of a catheter. It should be appreciated that each of the catheters described here 15 can comprise any alignment element or combination of alignment elements described below, and in variations where the catheter comprises a flistula-forming element, it can understand what! either a fistula-forming element or combination of elements described in greater detail above. 20 Magnets As mentioned above, a catheter can comprise one or more magnetic alignment components. These magnetic alignment components can be attracted to one or more additional elements (for example, one or more parts of a second catheter, one or more Magnets or other components located outside the body) to help position or align the catheter inside a vessel. For example, one or more magnets located outside the body can interact with the magnetic alignment components of a catheter to help facilitate catheter advancement through the vascular system, as will be described in more detail 30 below. In other cases, a catheter may comprise one or more "anchoring" magnetic alignment elements that act to attract the catheter towards one or more parts of a second catheter, placing,
'so, we are approaching.
In other variations, a 'catheter may comprise one or more "coupling" magnetic alignment elements, which can act to rotate (and / or axially) and / or combine a catheter surface with one or more surfaces or parts
, 5 of a second catheter.
A catheter can comprise any number of individual magnets (for example, zero, one, two, three, four, five, six, seven or eight or more, etc.). Each magnetic component can be any suitable magnet or magnetic material.
For example, in some variations, a catheter can comprise one or more rare earth magnets (for example, neo- "dimio magnets or samarium-cobalt magnets) and / or one or more selectively activated electromagnets.
In variations where a catheter comprises a plurality of magnets, these magnets can be grouped into one or more sets.
These magnetic assemblies can be located inside or outside a catheter 15 (or a combination thereof), and can be positioned anywhere along the length of the catheter.
When two or more y catheters comprise magnets or magnet assemblies, each magnet or magnet assembly may be configured or arranged to align with one or more magnets or magnet assemblies from a second catheter.
Each magnet can be fixed on or over a
20 teter by any suitable method.
For example, in some variations,
one or more magnets can be embedded, adhered or attached by friction inside a catheter.
Each magnet can have any suitable diameter (for example, about 0.19 cm, about 0.20 cm, about 0.07 cm, about 0.27 cm, or the like), or length (for example, about 5 mm, about 25 10 mm, about 15 mm, about 20 mm, or similar), and can be separated from adjacent magnets by any suitable distance (for example, about 1 mm, about 5 mm, and simiiares). In some variations, the magnets in a set may have alternating polarity (for example, each magnet will have the opposite polarity to any adjacent magnet), combined polarity, or
30 combination thereof.
In other variations, one or more parts of the category
ter can be made of a magnetic material and / or can be embedded with one or more magnetic materials / particles.
Each magnet can have any shape suitable for placement inside or outside the catheter.
Magnets can be cylindrical, semi-cylindrical, in. tube-shaped, box-shaped, or the like.
For example, in the variation of the catheter (200) illustrated in Figure 2 and described in greater detail
. 5 above, the catheter (200) may comprise a proximal anchoring magnet assembly (206) and a distal anchoring magnet assembly (208), the Magnets of each of which are cylindrical.
Alternatively, in the variation of the catheter (600) illustrated in Figure 6A, the catheter (600) may comprise a set of proximal anchoring magnet (604) and a set of distal anchoring magnet 10 (606), s Magnets of each of the which are semi-cylindrical.
In these variations, a lumen and / or guidewire (such as lumen (608) and guidewire (605)) can pass through or along the anchor magnet assemblies, since semi-cylindrical magnets only occupy a part of the interior of the catheter (600). While the magnets in the proximal (604) and distal 15 (606) magnet assemblies are illustrated in Figure 6A as being configured so that the apex of each semi-cylinder is aligned with the ablation surface (603), it should be appreciated that the Magnets can be positioned in any way relative to a fistula-forming component.
For example, Figure 6B illustrates another variation of the catheter (610) comprising the electrode body 20 (612) having the ablation surface (613), proximal anchoring magnet assembly (614), distal anchoring magnet assembly (616), guide wire (615) and lumen (618). In this variation, the apex of each Magnet in the Proximal (614) and Distal (616) Anchor Magnet sets can be perpendicular to the ablation surface (613) - The change in the orientation of the Magnets with respect to 25 the ablation surface (613) it can affect the resistance of the magnetic force between the catheter (610) and another catheter (not shown) when placed in a blood vessel.
It should be appreciated that each individual Magnet or set of Anchor Magnet can have any position of rotation with respect to the ablation surface (613), which may or may not be equal to the position of rotation 30 like another Magnet or set of magnets .
In some variations, one or more Magnets may have one or more lumens or passages through them, which may allow one or more other components (for example, a guide wire, a drive mechanism, lumen, combinations thereof or similar) of the catheter passing through the Magnets- For example, in the variation of the catheter (300) illustrated in Figure 3, the catheter (300) comprises the sets of anchor magnet 5 proximal and distal ((302) and (304) respectively) having Tube-shaped Magnets.
As shown here, the concentric electrical conductor (314) can pass through the magnets of the proximal anchor magnet set (302), and the lumen (308) can pass through the magnets of the proximal and distal anchor magnet sets ( (302) and (304), respectively) - 1O In some variations, one or more magnetic alignment components may comprise one or more box-shaped magnets (for example, a magnet with a substantially rectangular cross section) . Figure 23 illustrates a variation of the catheter (2300). illustrated here is a tip (2302), the distal anchoring magnet assembly (2304), proximal anchoring magnet assembly (2306), and nest material (2308) comprising the coupling magnets (2310), electrode body (not illustrated) with ablation surface (2312) and marker (2316). The catheter (2300) further comprises a catheter body (or a plurality of catheter segments, as described above), but the catheter body is not illustrated in Figure 23 in order to highlight the internal components of the catheter (2300). In addition, while illustrated in Figure 23 as comprising the Coupling (2310) and Marker (2316) Magnets (each of which is described in more detail below), catheter (2300) is not required.
As shown in Figure 23, the distal anchoring magnet set (2304) comprises a cylindrical anchoring magnet (2316) and a box-shaped anchoring magnet (2314), while the proximal anchoring magnet set (2306) comprises a box-shaped anchoring magnet (2314). It should be appreciated that the Anchor Magnet sets can have any suitable combination of Magnets, such as one or more magnets described above.
In variations comprising one or more box-shaped magnets, such box-shaped magnets (2314) of the catheter
(2300), Box Magnets can help bring the catheter into proximity with a second catheter, but it also helps to rotate the catheter in relation to the second catheter.
Specifically, when two box-shaped magnets are associated with separate catheters, the
. The resistance to attraction between the two magnets can be greater when the Magnets are aligned.
For example, in the variation of the catheter (2300) illustrated below, a front surface (2320) of the box-shaped magnet (2314) may align with a front surface of another box-shaped magnet (not shown) of a catheter in another blood vessel.
Specifically, the force of attraction between the Magnets can be greater when the front surfaces are aligned with each other, so that the Magnets can rotate naturally or facilitate rotation to the aligned position.
In variations where a catheter comprises a nesting material, the nesting material can accommodate one or more coupling magnets to magnetically and temporarily couple a surface or part of the nesting material to one or more parts of another catheter or device.
Specifically, coupling magnets can be configured so that the attraction force between two catheters is greater when one surface of each catheter is aligned with the other.
For example, in the variation of catheter 20 (2300) illustrated in Figure 23 above, the nest material (2308) comprises coupling magnets (2310). In such cases, the longitudinal geometric axis of the coupling magnets (2310) can be substantially transversal to the longitudinal geometric axis of the catheter.
In addition, Coupling Magnets (2310) may have a combined flat surface which can attract a flat combined surface of a Coupling Magnet from another catheter (not shown). As described in greater detail above with respect to flat ablation surfaces, the combined flat surfaces of a coupling magnet can act to flatten the tissue between two catheters, which can assist in ablation across the ablation surface. 30 While the nest material (2308) is illustrated in Figure 23 as housing a single coupling magnet (2310) on each side of the ablation surface (2314), it should be appreciated that a catheter can
any appropriate number of magnets for coupling.
Figures 24A and 24B illustrate two variations of the catheters comprising coupling magnets.
Figure 24A illustrates a first variation of the catheter (2400). Illustrated here are the catheter body (2402) and nest material (2406) located
. 5 adding an electrode (2408) and a set of distal coupling magnet (2412), where the electrode (2408) comprises the ablation surface (2410). While illustrated in Figure 24A, as comprising two coupling magnets (2414), the distal coupling magnet assembly (2412) can comprise any suitable number of coupling magnets (2414) (for example, one, two , three or more). In other variations, a nest material may comprise a plurality of coupling magnet assemblies.
For example, Figure 24B illustrates a variation of the catheter (2416) comprising a catheter body (2418), nest material (2420) housing the electrode (2422) with the ablation surface (2424), magnet assembly proximal coupling (2426) and distal coupling magnet set (2428). Each coupling magnet assembly can comprise any suitable number of coupling magnets (2430), as mentioned immediately above.
In some variations, such catheters (2400) and (2416) described 20 above with respect to Figures 24A and 24B, the catheter can be configured so that a fistula-forming element can be located in proximity to the distal end of the catheter body.
These variations can be particularly useful when it is desirable to form a fistula close to a tissue structure, blockage, or other impediment that limits the ability of blood vessels to be approached.
In variations where a catheter comprises a set of electromagnets, the electromagnets can be activated independently or they can be activated as a group.
For example, the electromagnets of a magnet set can be activated one at a time to help ensure a certain orientation of alignment with respect to another magnetic device, for example, Proximal magnets can be activated before the activation of the distal magnets , each other magnet can be activated in sequence, etc.
Alternative-
In addition, two or more Magnets can be activated simultaneously to promote secure attachment to another magnetic device.
Shape-Changing Elements In some variations, the catheter may comprise one or more 5 shape-changing elements to approximate two or more blood vessels. guineas.
In these variations, the reshaping member may have a first configuration during advancing the catheter through the vascular system.
Once the catheter reaches a target location, the shape-changing element can be changed to a second configuration, 10 which can change the overall shape of the catheter.
As the catheter changes shape, the catheter can move or reconfigure one or more parts of the blood vessel, which can help to bring that part or parts of the blood vessel closer together to one or more parts of a second blood vessel guinea.
The shape of a catheter can be changed in any suitable way.
In some variations, a catheter may comprise one or more retraction wires that can be pulled or pushed to deform or otherwise change the shape of the catheter.
In other variations, a catheter may comprise one or more shaped wires that can alter the shape of the catheter, as will be described in greater detail below. 20 Figures 25A to 25D illustrate a variation of the catheter (2500). Specifically, Figure 25A illustrates a partial catheter cross-sectional area (2500). Illustrated are the catheter body (2502), the nest material (2504) housing the Coupling Magnets (2508) and an electrode body (not shown) comprising the ablation surface (2506), formatted guide wire 25 ( 2510), straightening cannula (2512) and torque transmission sheath (2514). A part of the catheter body (2502) is not illustrated in Figure 25A to help illustrate the other elements of the catheter (2500) - While illustrated in Figure 25A as having an electrode housed within the nest material (2504) to define the ablation surface (2506), the catheter (2500) 30 can comprise any suitable fistula-forming element, such as those described in greater detail above.
Additionally, while illustrated in Figure 25A as comprising a plurality of Coupling Magnets (2508), the catheter (2500) is not required.
In variations where the catheter comprises one or more magnets, the catheter can comprise any magnet or combination of magnets as described above.
Finally, the catheter (2500) may or may not comprise a torque transmission sheath 5 (2514), which can help to rotate the catheter, as will be described in greater detail below.
The formatted guide wire (2510) can be used to change the shape of the catheter (2500). Specifically, the shaped guide wire (2510) can be preformed with one or more folds or curves.
A straightening cannula (2512) can be advanced over the guide wire (2510) to temporarily straighten or otherwise restrict the folds and curves of the shaped guide wire (2510), thus making the distal part of the catheter ( 2500) substantially straight, as shown in Figure 25B.
The catheter (2500) can be advanced into a blood vessel (not shown), at which point the straightening cannula (2512) can be removed.
Once removed, the formatted guide wire (2510) can return to its original configuration, which can cause the catheter (2500) to change shape, as shown in Figure 25C.
When the catheter (2500) is located in a blood vessel, this change in shape can change the shape of one or more blood vessels.
For example, Figure 25D illustrates a variation in which two catheters (2518) and (2520) are located in the adjacent blood vessels (2522). As illustrated here, the catheters (2518) and (2520) may comprise the components of the catheter (2500) described immediately above- When the straightening cannulas (not shown ") for each of the catheters (2518) and (2520) were removed , the guide wires of each catheter can assume a folded / curved configuration, which can cause the distal parts of each catheter to bend or flex towards each other, thus bringing a part of the blood vessels (2522 ) closer to each other as shown in Figure 25D.
One or more fistula-forming elements can then be activated to form a fistula between the adjacent blood vessels (2522). The formatted guide wire (2510) can act as a guide wire to carry current to or from an electrode, but it need not be.
In fact, in some variations, a device may comprise a formed wire and a separate guide wire.
In variations where a catheter does not comprise an electrode, the catheter may comprise a shaped wire, but none
, 5 guide wire.
It should also be noted that in some variations, a formatted element can be located outside the catheter.
In some of these variations, the formatted element can be at least partially covered by one or more hems or other covers, such as those described above.
It should also be appreciated that any formatted structure suitable to be used to change the shape of the catheters described here.
In variations where a catheter comprises one or more expandable structures (for example, a balloon or the like), as will be described in more detail below, the expandable structure can be used in conjunction with a reshaping element to assist to position a catheter inside a vessel.
For example, in the variation of the catheter (2500) described above with respect to Figures 25A to 25D, the catheter (2500) may comprise one or more expandable structures (not shown), such as one or more inflatable balloons.
These expandable structures can be expanded within a blood vessel to temporarily hold catheter 20 (2500) in place with respect to the vessel.
When the formatted guide wire (2510) and the straightening cannula (2512) are used to move the catheter body (2502) between a fold configuration and a straight configuration, the contact between the expandable structure and the surrounding tissue can help move the blood vessel with the catheter body (2502). In some variations, the catheter (2500) may comprise a single expandable structure, which can be located proximally or distally with a reference to the fold of the shaped guide wire (2510). In other variations, the catheter (2500) may comprise one or more expandable structures on each side of the fold of the formed guide wire (2510). In variations where a formatted guide wire comprises multiple multiple folds, the expandable structures can be positioned proximally and / or distally to dotas, some Olj none of the folds.
It should also be noted that expandable structures can be used in
together with any suitable shaped alteration element (for example, a forged cord, a retraction cord, or the like) and can be used to provide temporary fixation between the catheter body and the vessel tissue in an appropriate manner. 5 Markers The catheters described here can comprise one or more markers that can allow viewing of one or more parts of a catheter during positioning and / or orientation.
In some variations, the marker can be viewed directly.
In other variations, the marker can be visualized indirectly (for example, through ultrasound, fluoroscopy and / or X-ray visualization). Markers can be located anywhere in relation to the catheter, for example. example, one or more catheter surfaces, inside the catheter.
In some variations, one or more parts of the catheter can be made of an ecologic or radiographic material.
A marker can be attached to the catheter by any suitable method, for example, by mechanical fixation (for example, embedding in a part of the catheter, circumferential circumscription, or the like), adhesive bonding, soldering, combinations of the same or similar, Figures 14A to 14D illustrate a variation of the catheter (1400) 20 comprising marker strips (1402). Also illustrated in Figure 14A are the anchoring magnets (1410), and the electrode (1404) partially covered by the nest material (1406) and comprising an ablation surface (1408). The catheter (1400) can comprise any suitable number of marker strips (1402), and each marker strip (1402) 25 can be positioned at any suitable location at or on the catheter (1400). The marker strips (1402) may comprise cut-out regions that can assist a technician in determining the position of a catheter using one or more imaging techniques.
Specifically, Figure 14B illustrates a perspective view of a marker strip (1402) comprising a first cutout region (1412) and a second cutout region (1414). The first (1412) and the second (1414) cut-out regions are illustrated in Figures 14B to 14D as having the same shape, but need not be.
When the marker strip (1402) is viewed (for example, using ultrasound or fluoroscopy), a user can see the negative space formed by the overlapping segment (1416) of the first (1412) and second (1414) regions cropped.
The shape of this overlapping segment
. 5 (1416) can change as the catheter (1400) (and with it, the marker strip (1402)) is rotated.
Eventually, the rotation of the marker strip (1402) may reach a point where the first (1412) and second (1414) cutout regions overlap completely or substantially, as illustrated in Figure 14D.
When the marker range (1402) reaches this "aligned" configuration (or when two markers on associated catheters are each in an "aligned" configuration), a user may know that the catheter is in a rotating orientation suitable for active. of a fistula-forming element.
For example, in the variation of the catheter shown in Figure 14A, the ablation surface (1408) can be positioned with respect to the marker strips (1402) so that the ablation surface (1408) faces an direction perpendicular to the clipping regions.
When used in conjunction with a second catheter (not shown) having a second set of marker strips (not shown), the marker strips for each of the catheters can be used to rotationally and / or axially position the catheters so that one or more fistula-forming elements are properly positioned to form a fistula.
While illustrated in Figures 14A to 14D as having a bilobular shape, the cutout regions can have any shape or combination of shapes, for example, rectangular, circular, elliptical, multilobular shapes, alphanumeric symbols, any formed with one or more geometric axes of symmetry (for example, bilateral symmetry), and the like.
In some variations, the cutout regions may have a directional shape, which may have a tapered part that indicates the location of the electrode ablation surface 30, for example, a polygon with an acute angle apex, arrow and similar.
First and second cutout regions can have the same shape as each other, or they can each have different shapes.
Other guidance markers can be provided on the catheter and / or electrode as desired and described below.
While illustrated in Figures 14A to 14D as comprising marker strips, it should be appreciated that the catheters described here can comprise any markers.
. 5 that is capable of indirect visualization.
In other variations, the catheter may comprise one or more visual markers that can help to align two or more catheters with respect to each other.
For example, Figures 15A and 15B illustrate a variation of the catheter (1500) comprising a side strip (1504) that can help guide the catheter (1500). Specifically, the side strip (1504) can be a visual marker with a known location with respect to a fistula-forming element (1508). For example, in the variation shown in Figures 15A and 15B, the side strip (1504) is aligned longitudinally with the fistula-forming element (1508). When the distal end of the catheter (1500) is located on the body (and therefore cannot be viewed directly), the side strip (1504) (which can remain at least partially out of the body) can provide a visual indication as to the rotational orientation of the fistula-forming element (1508). When two catheters (1500) are located in two blood vessels (not shown), 20 as illustrated in Figure 15B, the relative positioning of the lateral strips (1504) can provide an indication of the relative positioning of the two catheters.
For example, as illustrated in Figure 15B, when the lateral strips (1504) of each catheter (1500) are directly opposite each other, the fistula-forming elements (1508) of each catheter (1500) can be 25 in adequate guidance for activating the fistula-forming elements.
The iateral strip (1504) can be applied to the catheter (1500) in any suitable way (for example, by marking with paint, texturing, applying one or more colored adhesives, etc.). External Positioning 30 In some variations of the catheters described here, a catheter may comprise one or more balloons or other expandable structures.
These expandable structures can serve one or more functions.
In some cases, an expandable structure can help affix an electrode surface (or other fistula-forming element) against one or more vessel walls. This apposition can help to flatten temporarily or otherwise reassign the tissue, and can act to displace blood from the area.
. In addition, during fistula formation, the expandable member may continue to push the flistula forming member against the tissue as it is removed from the vessel wall. In some variations, the expandable structure can be configured to help provide apposition between the catheter and a vessel wall, while still allowing blood to flow through the blood vessel. In some cases, one or more expandable structures may help to modify or otherwise alter the size or shape of a fistula. In still other cases, expandable structures 0 can be used to expand, contract or otherwise displace a portion of one or more blood vessels. In some of these variations, this displacement can help bring a part of the blood vessel closer to a surface of the skin. In other additional variations, as mentioned above, one or more expandable structures can be used to hold a catheter in place with respect to a blood vessel, and can assist in repositioning the blood vessel. As mentioned above, in some variations of the catheters described here, the catheter may comprise one or more balloons. For example, Figures 9A to 9D show several illustrations of the catheters comprising a balloon. In some variations, the balloon can be configured to push a part of a catheter (for example, an ablation surface or other fistula-forming element) in contact with a wall of the blood vessel. For example, Figure 9A shows a variation of the catheter (900) comprising a balloon (902), and an electrode body (not shown) having an exposed ablation surface (904). The balloon (902) can have an unfolded unmounted configuration (not shown) for low profile feed and an expanded unfolded configuration (as illustrated in Figure 9A). In the variation shown in Figure 9A, the balloon (902) can be mounted non-concentric to the catheter (900) away from the
ablation surface (904) so that the expansion of the balloon (902) within a blood vessel can orient, press or otherwise push the + ablation surface (904) against a wall of the blood vessel. In variants where the catheter has a flat ablation surface, expansion. 5 of the balloon (902) can help to flatten the tissue against the ablation surface. Additionally, the balloon (902) can assist in the formation of the fistula by continuing to push the ablation surface (904) against and through the blood vessel wall as the tissue undergoes ablation, vaporization or removal in another way. In still other cases, the expansion of the balloon (902) can help to displace the blood from the vicinity of the ablation surface (904), which in turn can minimize the loss of current to the blood during the ablation. In cases where a catheter comprises an electrode with recesses, as described in greater detail above, the expansion of a balloon can displace part of the blood from the area while causing another part of the blood to be trapped within the recessed part. In cases where the catheter (900) comprises one or more shape-changing elements, the engagement between the balloon (902) and the surrounding blood vessel (not shown) can help keep the catheter (900) in place and can additionally assist in the repositioning of the tissue of the vessel when the catheter (900) changes shape.
It should be appreciated that while illustrated in Figure 9A as having a balloon (902), the catheters described here can achieve one or more of these functions using any expandable structure or suitable structures (for example, one or more expandable jars, interlaced) 25 ments, structures, beams, or similar). The balloons described here can have any suitable shape (for example, cylindrical, semi-cylindrical, circular, trapezoidal, rectangular, fractional parts thereof, and the like), and can be made of any suitable material or combinations of materials (for example, one or more non-elastic, elastic or semi-elastic materials (30 COS).
Additionally, while the balloon (902) shown in Figure 9A as being mounted on the opposite side of the catheter (900) from the super
ablation surface (904), it should be noted that the balloon (902) can be positioned in any way with respect to the catheter (900). For example, in al-. In some variations, a balloon (or other expandable structure) can be positioned so that its expansion creates a directional distension of a blood vessel.
For example, Figure 9B illustrates a variation of a - catheter (910) comprising a balloon (912) and the ablation surface (914) of an electrode (not shown). As illustrated here, the balloon (912) can be positioned in the catheter (910) so that the balloon (912) expands in an almost orthogonal direction with respect to the direction in which the ablation surface (914) is facing.
When the catheter (910) is located in the blood vessel and the ablation surface (914) is aligned with another catheter in an adjacent blood vessel, expansion of the balloon (912) can cause directional distention of a vessel blood towards the skin superimposed on the blood vessel, which, in turn, can cause the skin to distend.
This distension can provide a user with a visual indication of the placement of the balloon (912), thereby allowing a user or operator to locate the balloon and blood vessel from outside the body.
This visualized location can provide an Iocal through which a user can externally access the blood vessel (for example, by piercing with a needle or similar). In some cases, a balloon or other expandable structure can help to alter and / or regulate blood flow through a blood vessel.
For example, in some variations, the expansion of a balloon can dilate one or more parts of a blood vessel, which can encourage increased blood flow through that part of the blood vessel.
In other variations, an expandable element may temporarily obstruct a blood vessel, or it may reduce blood flow through it.
In some of these variations, the expandable element may comprise one or more electrodes, which can be used to help reduce blood flow through a part of a blood vessel.
Figure 9C illustrates a variation of the catheter (930) comprising an ablation surface (932) and the balloon (934). As illustrated here, the balloon (934) is positioned concentric around the catheter (930), and can comprise a plurality of electrodes (936) disposed in the balloon (934). Although illustrated in Figure 9C as being located distally in the catheter (900) in relation to the ablation surface (932), it should be appreciated that the balloon (934) can be
.5 located proximally to the ablation surface (932) and / or can be mounted non-concentricly away from the ablation surface (932). In fact, in some variations (as described in greater detail below), the catheter can comprise the balloon both proximally and distally with respect to the ablation surface, each of which can comprise one or more electrodes.
While illustrated in Figure 9C as having a plurality of circumferentially arranged electrodes (936), the balloon (934) can comprise any suitable number of electrodes (for example, zero, one, two, three, four or more) and each electrode it can completely or partially circumscribe the balloon (934). 15 The balloon (934) can be expanded into the blood vessel to temporarily obstruct the vessel.
Additionally, one or more electrodes
, (936) can be activated to partially restrict the blood vessel and reduce flow through at least part of the vessel.
Specifically, electrical energy can be distributed to the vessel wall to induce neurosis and / or a proliferative cell response, which can reduce the internal diameter of the blood vessel, thereby reducing blood flow through it.
The balloons described immediately above can be used to alter or otherwise regulate blood flow with respect to a fistula.
Figure 9D illustrates an example of how the catheter (930) can be used to affect blood flow with respect to the fistula.
As illustrated here, the catheter (930) can be advanced into an arterial vessel (940) which is in close proximity to a corresponding venous vessel (942). A second catheter (as shown) can be located in the venous vessel (942), and one or 30 more alignment elements (not shown) can be used to help bring the arterial (940) and venous (942) vessels together. The ablation surface (932) can be activated (alone, or in conjunction with one or more electrodes from another catheter) to form an arteriovenous fistula, through which blood can flow (as represented by the arrow (932)). The arrow (941). indicates the direction of blood flow in the arterial vessel (940) and the arrow (943) indicates the direction of blood flow in the venous vessel (942). As illustrated in
. 5 Figure 9D, the catheter (930) can be advanced in a backward direction (that is, against the bloodstream) into an arterial vessel (940), so that the balloon (934) is located upstream the ablation surface (932) and the resulting flistula.
In such cases, the balloon (934) can be expanded in the arterial vessel (940) to at least partially obstruct the vessel and temporarily prevent it or reduce the flow of arterial blood through it, which, in turn, can help prevent loss of current during the formation of the fistula.
Additionally, the electrodes (936) can be activated to damage or mark the surrounding tissue, which can reduce the flow through it. This can be used to help prevent one or 15 more potential complications with the formation of the fistula, such as the theft syndrome.
For example, theft syndrome can occur when a fistula is formed between an artery and a vein, and blood flows through the resulting fistula at a rate that results in insufficient blood flowing distally or downstream of the fistula in the artery. This can result in tissue necrosis, and may require an additional surgical procedure to prevent limb loss.
Accordingly, the electrodes (936) can be activated to reduce the flow through a vein, which can reduce the flow through the fistula, and can thus reduce the likelihood of theft syndrome. 25 While illustrated in Figure 9D as being retroactively advanced and located upstream of the ablation surface (932), the balloon (934) can alternatively be located downstream of the ablation surface (932) and the resulting fistula.
In some of these variations, the catheter (930) can be advanced in an anti-retroactive manner (that is, with the flow of 30 blood) into the arterial vessel (940). In another variation, a catheter can be advanced retroactively, but a balloon can, instead, be located proximally in the catheter with respect to the
blation.
In still other variations, a catheter can be moved into the blood vessel to change the position of a balloon between positions. upstream and downstream and vice versa.
When a balloon is located downstream in an arterial vessel (940), the balloon can be expanded
, 5 to expand the vessel (940) to increase blood flow through it, or it can be restricted using one or more electrodes to reduce blood flow through it.
The dilation of the downstream part of the arterial vessel (940) can divert blood away from the fistula, while restricting the downstream part can encourage increased blood flow through the fistula.
It should be appreciated that one or more balloons and / or electrodes can be located in a venous vessel upstream or downstream with respect to a fistula to dilate and / restrict parts of the venous vessel.
Arterial and / or venous dilation or restriction can help to assist in the maturation of the fistula and / or prevent venous hypertension, as will be described in greater detail 15 below.
While illustrated in Figures 9A to 9D as having a single balloon, it should be appreciated that the catheters described here can have any suitable number of balloons, expandable elements or combinations
" of the same.
In fact, the catheters described can comprise a plurality of expandable elements for positioning the catheter within a blood vessel, pushing an electrode ablation surface against a blood vessel wall, and / or regulating the flow of blood. blood in the vicinity of the target site of the vascular system.
Figure IOA shows a variation of a catheter (1000) comprising an ablation surface (1006), a first balloon (1002) located near the ablation surface and comprising circumferential electrodes (1008), and a second base - wool (1004) located distally from the ablation surface.
While only the first balloon (1002) is illustrated in Figure IOA as having electrodes (1008), it should be appreciated that any other balloons 30 (for example, no balloon, only a first balloon (1002), only a second balloon (1004 ), or both the first (1002) and second (1004) balloons) may comprise any suitable number of electrodes (for example,
"one, two, three, four or more electrodes). The first (1002) and the second ('1004) balloons can be triggered independently to regulate blood flow k within a blood vessel.
For example, the catheter (1000) can be inserted into a vein (not shown), in which the direction of flow of
, 5 'blood is represented by the arrow (1001). The second balloon (1004) can be e2 (applied to dilate the downstream part of the vein, while the circumferential electrodes (1008) of the first balloon (1002) can be activated to restrict the vein.
In other cases, the catheter (1000) can be inserted in the opposite direction (or the balloons can be positioned in another way), so that the second balloon (1004) can be used to expand the upstream part, and the first balloon (1002) may restrict the downstream part.
In still other cases, the balloon can be configured to expand both upstream and downstream parts, or can be configured to restrict both upstream and downstream parts.
Again, it should be appreciated that any expandable structure or structures can be used by the catheters.
Figure 108 illustrates another variation of the catheter (1010) comprising an electrode with an ablation surface (1016), a proximal balloon (1012) and a distal balloon (1014). The proximal balloon (1012) can comprise a fixed volume body and can additionally comprise a circumferential band element (1118) around a part of the balloon (1012). The circumferential band electrode (1118) can expand and disassemble as an expandable element.
Figure 10OC illustrates another variation of a catheter (1020) with a distal balloon (1024), a proximal expandable wire loop (1022), and an ablation surface (1026). The wire loop (1022) 25 can be movable between a low profile, unfolded configuration (not shown), and an expanded and unfolded configuration (as illustrated in Figure 1OC). The wire loop (1022) can be moved between the unfolded configuration and the unfolded configuration using any suitable mechanism (for example, hinged radial beams, winding mechanism, etc.) and RF energy can be applied to the wire loop (1022) to induce tissue necrosis, as described above.
In some variations, once a fistula has been formed, one or more balloons or other expandable structures can be used to modify the size or shape of a fistula.
For example, Figure 11 q illustrates a variation of the catheter (1100). As illustrated here, the catheter (1100) can comprise an electrode ablation surface (1102) and a balloon
. 5 of lateral extension (1104). The side extension balloon (1104) can be configured to expand in two or more directions, and can be used to change the shape or size of a fistula.
Specifically, the ablation surface (1102) (or other suitable fistula-forming element) can be used to form a fistula (not shown) between two vessels (not shown), and the catheter (1100) can be subsequently moved to position the lateral extension balloon (1104) adjacent or close to the fistula.
The balloon (1104) can then be expanded and a portion of the balloon (1104) can push into the fistula, thereby changing its size and / or shape.
The balloon (1104) can be a fixed volume structure, or it can be made of one or more elastic or semi-elastic materials.
It should also be appreciated that the lateral extension balloon (1104) can comprise two or more separate balloons.
Additionally, the lateral extension balloon (1104) can comprise folds (1106) or other surface modifications to regulate the degree of expansion, which can also provide traction or friction fixation to the blood vessel wall at the target site of the system vascular.
For example, in the variation shown in Figure 11, folds (1106) can engage the tissue around the fistula to help move or adjust that tissue.
In other variations of the catheters described here, a catheter may comprise one or more bays that can be configured to allow blood to flow through them.
For example, Figure 12 illustrates another variation of the catheter (1200) comprising a plurality of ring-shaped balloons (1202). In addition, an electrode ablation surface (1204) is illustrated here. In these variations, expansion of the balloon (1202) may allow increased apposition and blood displacement 30 between the ablation surface (1204) and a vessel wall (not shown), as described in greater detail above.
Additionally, the lumens (1208) inside each of the ring-shaped balloons (1202) can allow blood to pass through them- That way, the catheter (1200) can be left inside a blood vessel (not shown) per
W an extended period of time without substantially affecting the blood flow through it. For example, in some cases it may be necessary to leave the catheter (1200) in a blood vessel for a period of time. extended, during which it may not be possible to block all flow through the blood vessel. It should be appreciated that one or more of the balloons (1202) can also be configured to dilate one or more parts of a blood vessel, and / or can comprise one or more electrodes to help restrict a blood vessel, as described in larger sections. details above. In some variations, one or more balloons from a catheter can carry or be inflated with a contrast material to aid in viewing the catheter. In some variations, one or more of these balloons can be punctured to release the contrast agent into the blood vessel 15, which can be used to assess whether a fistula is being formed properly. For example, Figures 26A and 26B illustrate a variation of the catheter (2600). As illustrated here, the catheter (2600) can comprise a catheter body (2602) such as the distal balloon (2604), the central balloon (2606) and the proximal balloon (2608). The catheter (2600) may additionally comprise one or more shape-changing elements or alignment elements, such as those described above. In addition, while illustrated in Figures 26A, 26B as having three balloons, the catheter (2600) can comprise any suitable number of balloons (for example, one, two, three, four or more). Each of the balloons (2604), (2606) and 25 (2608), is illustrated in Figures 26A and 26B as being concentrically mounted around the catheter body (2602), but can be mounted in any suitable manner as described in further details above. When the catheter (2600) is located in a blood vessel (not shown), the distal balloons (2604), center! (2606) and proximal (2608) can be inflated. These balloons can be inflated using any suitable fluid (for example, saline, water, one or more contrast solutions, or the like). In some variations, all three balloons are inflated with the same fluid.
In other variations, the distal (2604) and proximal (2608) balloons are inflated with a first fluid (for example, a first contrast solution), while the central balloon (2606) is inflated with a second fluid (for example , a second contrast solution has
, 5 going to a higher or lower contrast level). In other variations, each balloon is inflated with a different solution.
When the balloons are inflated, the
· Proximal balloon (2608) and distal / u (2604) can engage an internal surface of the blood vessel to prevent fluid from flowing through it.
For example, in cases where the proximal balloon (2608) is located in a blood vessel 10 upstream with respect to the blood flow, the balloon filling next! (2608) can temporarily interrupt blood flow through the blood vessel. In some cases, a second catheter (2610) can be located in an adjacent blood vessel (not shown), as illustrated in Figure 26B.
The second catheter (2610) can comprise a catheter body (2611), and a nest material (2614) housing a guidewire electrode (2612), as described in greater detail above.
While illustrated in Figure 26B as comprising a guide wire electrode (2612), it should be appreciated that the second catheter (2610) can comprise any suitable fistula-forming element 20 as described in greater detail above.
In some of these cases, the catheter (2600) and the second catheter (2610) can be aligned (for example, using one or more alignment elements such as those described above), so that the nest material (2614) can be in axial and rotational alignment with the central balloon 25 (2606), and the current can be applied to the guidewire electrode (2612) to cause ablation to the vessel tissue between the catheters, thus forming a fistula (not shown) ). During or after the formation of the fistula, one or more parts of the guidewire electrode (2612) may pierce or otherwise penetrate the central balloon (2606) to release one or more fluids from it. 30 When this fluid comprises one or more contrast solutions, that fluid can be visualized (for example, by fluoroscope) as it passes through the fistula.
That way, as the i68 / 91 contrast fluid passes between the blood vessels, a user can determine that the fistula has been formed in a way that allows the fluid flow to pass.
En-. as the central balloon (2606) is discussed above as being punctured, it should be appreciated that any balloon or catheter balloons (2600) can be
5 perforated by a fistula-forming element.
Catheter Body The catheters described throughout the description can be any angled body suitable for advancement through at least a part of the vascular system.
The catheters can be hollow, partially hollow, and / or partially solid.
One or more parts of the catheter can be flexible or. semi-flexible, one or more parts can be rigid or semi-rigid, and / or one or more parts of the catheter can be changed between flexlve configurations! and rigid.
The flexible parts of the catheter can allow the catheter to navigate through tortuous blood vessels to reach a desired target location.
The catheters described here can be made of any material or combination of materials.
For example, catheters can comprise one or more metals or metal alloys (for example, nickel and titanium alloys, copper, zinc, aluminum and nickel alloys, copper, aluminum and nickel alloys, and the like), and / or a or more polymers (for example, silicone, polyvinyl chloride, latex, polyurethane, polyethylene, PTFE, nylon and the like). Catheters can have any suitable dimensions.
For example, catheters can be of any suitable length that allows the catheter to be advanced from a point outside the body to a target location.
The catheters can have any diameter suitable for intravascular use, such as, for example, about 1.9 mm (5.7 French), about 2.03 mm (6.1 French), approximately of 2.33 mm (7 French), about 2.76 mm (8.3 French), between about 1.66 mm (5 French) and about 3 mm (9 French), between about 1, 66 mm (5 French) and about 2.33 mm (7 French), between about 2 mm (6 French) and about 3 mm (9 French), or the like. 30 Some variations of the catheters described here may have a lumen, cut or passage extending at least partially through the length of the catheter, Lumens can be used to pass one or more devices (for example, a guidewire) and / or one or more substances (eg, contrast solution, infusion fluid, one or more solutions containing drugs, etc.) through a part of the device.
For example, the variation of the catheter (300) illustrated in Figure 3 and described in greater
. 5 details above comprise a lumen (308) passing through it.
Although illustrated in Figure 3 as passing concentricly through the Magnets, it must be appreciated that a lumen can have any position in relation to other components of the device.
For example, in the variation of the catheter (600) of Figure 6A, the lumen (608) may extend along the side of one or more magnets of the proximal (604) and distal (606) anchoring magnets. .d
In other additional variations, a lumen can be fixed or otherwise run along an outer surface of the catheter.
When lodged at least partially within the catheter body, a lumen can pass between any part or parts of the catheter.
For example, in the variations described immediately above, the lumens may exist outside the most distal pier of the catheter.
In other variations, a lumen end may be located in an intermediate part of the catheter.
In some variations, a lumen can be divided into several sub-lumens.
For example, Figures 16A and 16B illustrate a perspective view and a partially transparent view, respectively, of a variation of the catheter (1600) - The catheter (1600) with the main lumen is illustrated here ( 1610) which subdivides into first (1602), second (1604) and third (1606) and fourth (1608) lumens at a distal tip (1601) of the catheter.
The main magnet (1610) can be divided into any suitable number of 25 lumens (for example, two, three, four, five or more) and each of these lumens can have ends at any of the appropriate points on the catheter.
In variations where a main lumen is divided into two or more lumens, the two or more lumens can supply one or more fluids or other substances to two or more points simultaneously. 30 The catheters described here throughout the description may have any suitable tip part.
In some variations, the tip may be rounded or blunt to help minimize trauma to tissue during
during the catheter advance.
Additionally or alternatively, the distal tip can be at least partially tapered.
A tapered tip can assist the catheter in navigating through the vascular system and / or can help dilate blood vessels during advancement.
The tip of the catheter can
. 5 be integral with the rest of the catheter body, or it may be a separate component attached to the catheter body.
In some of these variations, the tip of the catheter can be fixed releasably (for example, by screw fitting, pressure fitting, friction fitting or similar) to the catheter, which can allow a user to select a part of tip that 10 is suitable for a particular patient or blood vessel.
The porite portion of the catheter can help guide a catheter through the vascular system.
In some variations, one (humen can run%
through the catheter to a tip of the catheter.
In these variations, a guidewire can be threaded through the lumen, and the catheter can be advanced through the guidewire to a target site.
In other variations, a guide wire can be attached to the tip of the catheter.
For example, in the variation, a guide wire can be attached to the tip of the catheter.
For example, in the variation of the catheter (1600) shown in Figures 16A and 16B and described in greater detail below, the tip (1601) can comprise a guide wire (1612) that is attached to and extends 20 from the tip ( 1601). The guidewire (1612) can be advanced into the vascular system to help guide the catheter to a target location.
In other variations, a tip may comprise a quick-change part.
For example, in the variation of the catheter (100) shown in Figures 1A to 1C above, the tip of the catheter (100) comprises a quick exchange part 25 (100) having a first and a second opening ((112) and ( 114) respectively) who are in communication with each other.
A guide wire (not shown) can be screwed through the first (112) and second (114) openings, so that the quick exchange part (100) (and with it, the catheter (100)) can be advanced to the along the guide wire to a target location.
While illustrated in Figure 1A to 1C as being located at the tip of the catheter (100), it should be appreciated that the quick exchange part (100) can be located at any suitable point along the length of the catheter (1OO) - Some variations of catheters described here may comprise a torsion transmission sheath- As the length of a catheter is increased, one or more rotational forces are applied to one. The proximal end may have a reduced ability to rotate the distal end of the catheter. To help prevent torsion transmission problems, the catheter may comprise a torque transmission sheath arranged in or on the catheter. A torsion transmission sheath can be made from any rigid or reinforced material that can withstand 10 rotational forces (eg, stainless steel, memory-effect alloys, and various plastics) that can allow the professional to adjust the location and rotating orientation of the distal part of the catheter when it is inserted into a blood vessel. In some variations, the catheter may comprise one or 15 more suction ports. In these variations, the suction ports can be used to remove blood or other fluids from a part of a vessel. blood. For example, Figures 27A to 27D illustrate a variation of one; catheter (2700) comprising suction ports (2702). Figure 27A illustrates a perspective view of the catheter (2700), comprising suction ports (2702), sleeve (2704), nest material (2706) housing a spring electrode (2708) and coupling magnets (2710 ), proximal balloon (2712), and distal baião (2714). While illustrated in Figure 27A as having a spring wire electrode (2708) and coupling magnets (2710), the catheter (2700) can comprise any suitable combination of fistula forming elements and / or alignment elements, such as those described in greater detail below. The sleeve (2704) can be advanced to cover one or more components of the catheter (2700), as illustrated in Figure 27B, which can help facilitate the low profile advance of the catheter (2700) through the tissue.
When the catheter (2700) is located in a blood vessel, 30 suction ports (2702) can be used in conjunction with proximal (2712) and distal (2714) balloons to temporarily remove blood and / or any other fluids from a part of a blood vessel before or during
both the formation of fistula.
For example, Figures 27C and 27D illustrate a method by which the catheter (2700) can be used to form a fistula (not shown). As illustrated in Figure 27C, the catheter (2700) can be advanced into the vein (2716), while a second catheter (2718)
, 5 can be advanced into the artery (2720). The second catheter (2718) may comprise a flat electrode ablation surface ((not shown), may comprise another suitable fistula-forming element as described in greater detail above, or may not comprise any fistula-forming element .
During the advancement of catheter 10 (2700), the sleeve (2704) can be in an advanced position in which the sleeve (2704) covers one or more elements of the catheter (2700). For example, the sleeve (2704) can cover the spring wire electrode (2708) (not shown in Figures 27C and 27D to keep the spring wire electrode in a low profile configuration). 15 Once the catheters have been advanced, the sleeve (2704) can be removed to reveal one or more components of the catheter.
For example, when the mandrel (2704) is removed, the spring wire electrode (2708) (not shown in Figures 27C and 27D) may extend from the catheter towards the second catheter (2718) (and in some cases, towards of one or more 20 fistula-forming elements of the second catheter (2718)). Additionally, one or more alignment elements can help to position the catheter (2700) with respect to the second catheter (2718). For example, coupling magnets (2710) can be attracted to and align with one or more Coupling magnets (not shown) of the second catheter (2718) to orient the spring wire electrode (not shown in Figures 72C and 27D ) with respect to the second catheter (2718), as illustrated in Figure 27C.
Once the catheters are in place and properly aligned, the proximal (2712) and distal (2714) balloons can be inflated, as shown in Figure 27C.
In some cases, balloons (2712) and (2714) can hold catheter (2700) 30 in place with respect to the blood vessel.
In addition, each balloon can temporarily seal that part of the blood vessel from the rest of the blood vessel.
Once the proximal (2712) and distal (2714) balloons have been inflated, a vacuum or other suction can be applied to the suction ports (2702) so that any "fluid between the proximal (2712) and distal aloes ( 2714) is removed from the vein (2716) .In cases where the proximal balloons
. 5 (2712) and distal (2714) create a seal within the vein (2716), suction can also cause a part of the vein (2716) to disassemble around the catheter (2700), as illustrated in Figure 27D.
At this point, current can be supplied to the spring wire electrode (2708) (and in some cases carried away by a second electrode grounding electrode 10 (2718) to cause ablation and / or vaporization of the tissue between the catheters .
In other cases, the current can be supplied to an active electrode (not shown) of the second catheter (2718) and carried away by the spring wire electrode (2708). Additionally, since any blood or other fluids have been removed from the vein (2716) via suction parts (2702), 15 there may be a reduction in the loss of current to the surrounding fluids during tissue ablation.
While the catheters (2700) and (2718) are shown in Figures 27C and 27D as being located in a vein (2716) and artery (2720), respectively, it should be appreciated that these catheters can be located in any one of the suitable blood vessels.
In 20 some variations, the catheter (2700) can be located in an artery while the second catheter (2718) can be located in a vein.
In another variation, both catheters are placed in the veins.
It must be appreciated that both catheters can comprise suction ports.
Proximal Adapters 25 The catheters described here may comprise one or more proximal adapters and / or loops at a proximal end thereof.
These elements can help advance or align the catheters, activate one or more fistula-forming elements, and / or distribute one or more fluids or substances within or through the catheter.
Figures 13A and 13B illustrate two variations of adapters suitable for use with the catheters described here.
Figure 13A illustrates a variation of the catheter (1300) comprising an adapter (1 302). The catheter (1300) can comprise any suitable fistula-forming element and / or alignment accessories, such as those described above.
As illustrated here, the adapter (1302) is com-. it comprises a first door (1306), a second door (1308), a third door (1312). Although illustrated in Figure 13A as having three doors,
. 5 the adapter can comprise any suitable number of ports (for example, zero, one, two, three, quart or more), and each port can serve any useful function (for example, introducing one or more elements or substances into or through the catheter). For example, in the variation shown in Figure 13A, the first port (1306) can be used to introduce a fluid or substance (for example, contrast agents, rinse agents, therapeutic agents, and / or intravenous fluids) into a lumen (not shown), and can be connected to a liquid or gaseous fluid source (for example, a fluid pump, a syringe, etc.). Similarly, the second door (1308) can allow the introduction of an electrosurgical wire 15 (1320) to drive an electric current to an electrode (not shown). In variations where the catheter (1300) does not comprise an electrode, any suitable control element (for example, a push rod, a guide wire, or the like) can enter the catheter through a port to control the formation of fistula.
Finally, the third port (1312) can allow one or more devices (for example, a guidewire) to pass through the catheter through the hemostatic valve (1316). While illustrated in Figure 13A as having a hemostatic valve (1316), the third port (1312) does not need to have such a valve.
It should be appreciated that each of the ports on a proximal adapter can converge in a single lumen, or can provide access to different lumens.
Additional ports can be provided as desired for other functions, such as a viewing port, a trigger port, a suction port, and the like.
Ports can have any suitable connection form factor, such as a screwed connector, luer connector, or the like. 30 Figure 13B illustrates another variation of catheter (1318). As shown here, the catheter (1318) comprises the same proximal adapter as the variation of the catheter (1300) illustrated in Figure 13A, and thus the same
The reference labels are used for the variation shown in Figure 13B. Additionally illustrated in Figure 13B is the sleeve (1322) that can be supplied through a part catheter, and can be used to regulate the contact between an electrode ablation surface (1304) and a vessel wall. (not illustrated). The position of the sleeve (1322) can be controlled at least in part by a hub (1324). A user can manipulate the hub (1324) to move the sleeve (1322) proximally or distally with respect to the catheter (1300). This, in turn, can cause the sleeve (1322) to cover or expose the electrode ablation surface (1304).
10 Some variations of the adapters comprise one or more alignment accessories that can help the technician to orient one catheter in relation to the other. For example, the adapter variation (1502) illustrated in Figures 15A and 15B and described in greater detail above can comprise an alignment projection (1506), where the rotating orientation of the alignment projection (1506) maps to a rotational orientation corresponding to the electrode ablation surface of the fistula formation set. For example, when two catheters (1500) are located in two adjacent blood vessels (not shown), the alignment projections (1506) of each catheter (1500) can be aligned with each other to align the forming components. respective fistula (1508) in each catheter. It should be appreciated that any of the catheters described here comprise any combination of fistula forming elements, alignment elements, catheter bodies, proximal adapters, and / or expandable structures as described above, and the catheter or combination of catheters can be used to form a fistula in any suitable way.
Systems Also described here are systems for forming a fistula between blood vessels. Generally, the system may comprise a first catheter, which may comprise one or more elements of fistula formation. The first catheter can comprise any of the fistula-forming elements or combination of the fistula-forming elements as described in greater detail above. For example, in
In some variations, the first catheter may comprise one or more electrodes, which may comprise any electrode structures described in greater detail above. In some variations, the first catheter may comprise one or more mechanically cut elements, such as one or more of the blades described in greater detail above. Additionally or alternatively, the first catheter may comprise one or more optical fibers that can be used to deliver laser energy to the tissue. 10 In variations where the first catheter comprises an electrode-based fistula-forming element, the system may comprise one or more grounding electrodes, which in some variations may be positioned outside a patient. In some variations, the first catheter may comprise 15 or more alignment elements. In some variations, the first catheter may comprise one or more reshaping elements that can be used to reshape the first catheter- In some of these variations, the first catheter may comprise a shaped wire and / or one or more retraction wires, as described in greater detail above. In addition or alternatively, the first catheter may comprise one or more markers, such as those described in greater detail above. In addition or alternatively, the first catheter may comprise one or more magnets. In these variations, the first catheter may comprise any combination of alignment magnets and / or coupling magnets. 25 In some variations, the first catheter may comprise one or more sets of Magnet near a fistula-forming element. Additionally or alternatively, the first catheter may comprise one or more sets of distal magnet with respect to a fistula forming element. The first catheter can comprise any suitable catheter body, as described in greater detail above. In some variations, the first catheter may comprise one or more lumens if it extends
at least partially through the catheter body. In some variations, the first catheter can be configured to be advanced through or along a guidewire. In some variations, the first catheter may comprise a lumen through a guide wire through which it can pass.
m 5 In other variations, the first catheter may comprise a quick exchange part. Additionally, in some variations the first catheter - may comprise one or more expandable elements, as described in greater detail above. In some variations, the first catheter may comprise one or more balloons. In some of these variations, the first catheter may comprise one or more balloons proximal to the fistula-forming element, and / or may comprise one or more distal balloons with respect to the fistula-forming element. In some variations, the system may additionally comprise a second catheter. In some variations, the second catheter may comprise a fistula-forming element, but is not required. In variations where the second catheter comprises a fistula-forming element, the second catheter can comprise any of the fistula-forming elements or combinations of fistula-forming elements as described in greater detail above. For example, in some variations, the second catheter may comprise one or more electrodes, which may comprise any of the electrode structures described in greater detail above. In some variations, the second catheter may comprise one or more elements. mechanical cutting elements such as one or more of the blades described in greater detail above. Additionally or alternatively, the second catheter may comprise one or more optical fibers that can be used to deliver laser energy to the tissue. The fistula-forming element of the second catheter can be the same or different from the fistula-forming element of the first catheter. In some variations, the first catheter may comprise an electrode that is configured to extend through the vessel tissue during fistula formation (for example, one or more of the wire electrodes or other foldable electrodes described in greater detail below) , the
the second catheter can be configured to receive or otherwise contact one or more parts of the first catheter electrode during ablation.
In some variations, the second catheter may comprise one or more recesses or pockets for receiving part of the first cathode electrode.
. 5 ter, as described in greater detail above.
In some variations, an electrode from the second catheter can be configured to receive an electrode from the first catheter during fistula formation.
In some variations, the electrode or other receiving surface may comprise one or more insulation coatings, as described in greater detail above. 10 In some variations, the second catheter may comprise one or more alignment elements.
In some variations, the second catheter may comprise one or more reshaping elements that can be used to reshape the second catheter.
In some of these variations, the second catheter may comprise a formed wire and / or one or more retraction wires, as described in greater detail above.
Additionally or alternatively, the second catheter can
. comprise one or more markers, such as those described in greater detail above.
Additionally or alternatively, the second catheter may comprise one or more magnets.
In these variations, the second catheter may comprise any combination of alignment magnets and / or coupling magnets.
In some variations, the second catheter may comprise one or more sets of magnets proximal to a fistula-forming element.
Additionally or alternatively, the second catheter may comprise one or more distal magnet assemblies with respect to a fistula-forming element.
In variations where both the first and second catheters comprise alignment elements, the catheters can comprise the same configuration of the alignment elements, or can comprise different configurations of the alignment elements.
The second catheter can comprise any suitable catheter body 30, as described in greater detail below.
In some variations, the second catheter may comprise one or more lumens extending at least partially through the catheter body.
In some
7 "9/91
Variations, the second catheter can be configured to be advanced on or along a guide wire.
In some variations, the second catheter may comprise a lumen through which the guide wire can pass.
In other variations, the second catheter may comprise a rapid exchange part
. 5 da.
Additionally, in some variations, the second catheter may comprise one or more expandable elements, as described in greater detail above.
In some variations, the second catheter may comprise one or more balloons.
In variations in which the second catheter comprises a fistula-forming element, the second catheter may comprise one or more balloons proximal to the fistula-forming element, and / or may comprise one or more distal balloons with respect to the forming element. fistula.
Methods The methods described here can be used to create a fistula between two closely associated blood vessels (for example, between a vein and an artery, between two veins, etc.). Usually,
. in these methods, one or more fistula-forming elements can be activated to puncture or otherwise create a passageway between the two blood vessels so that blood can flow directly between the two adjacent blood vessels.
When such a fistula is formed, haemostasis can be created without the need for a separate device or structure (for example, a suture, stent, shunt, or similar) connecting or uniting blood vessels -
Generally, the methods described here comprise access
25 to a first blood vessel with a first catheter. and the advance of the first
first catheter to a target location within a blood vessel.
In some of these methods, a second blood vessel is accessed with a second catheter, and advanced to a locus! target within the second vessel.
In some of these methods, a first catheter is advanced into an artery, and the second catheter is advanced into a vein.
In other methods, a first catheter is advanced into a first vein, and a second catheter is advanced into a second vein.
In other-
In other additional methods, the first catheter is advanced into a first artery and a second catheter is advanced into a second artery.
The first and / or second catheters may be advanced in any suitable manner, such as using a Seldinger technique or other
. 5 similar technique.
Advancement may or may not occur under indirect visualization (for example, through fluoroscopy, X-rays or ultrasound) - The first and second catheters can be advanced in the same way, or they can be advanced in different ways.
In variations where one of the catheters is configured for advancement via a guidewire (for example, catheter (100) 10 described above with respect to Figures 1A to 1C), the catheter can be advanced along a guidewire.
In variations where one of the catheters has a guide wire attached to its tip (for example, the catheter (1600) described above with respect to Figures 16A and 16B), the guide wire can be advanced through the vascular system to a target location.
In other variations, one or more external Magnets 15 can help advance or position a catheter at a target location.
For example, Figures 17A and 17B illustrate a perspective view and a side view, respectively, of an external magnet (1700) that can be used to help advance the catheter (1702) into a blood vessel (1704) . The external magnet (1700) can interact with any suitable part 20 of the catheter (for example, a fixed guide wire (1706), one or more magnetic alignment elements, etc.) to create a force of attraction between the catheter (1702) and the external magnet (1700). This force of attraction can be used to pull, push or otherwise manipulate the catheter during advancement. Once the first and / or second catheters have been advanced, 25 in the respective blood vessels, the catheters can be adjusted to affect the positioning of the catheters within the blood vessels and / or the positioning of the blood vessels in relation to each other.
In variations where a first catheter has been advanced into a first blood vessel and a second catheter has advanced into a second blood vessel, the first and second catheters can be adjusted to place at least part of the first and second catheters towards each other, which can act to bring blood vessels closer together.
In some variations, each of the first or second catheters may comprise one or more magnetic alignment elements, such as OS µ described in greater detail above.
Magnetic alignment elements can result in an attractive force between the first and second
, 5 catheters, which can pull the catheters towards each other.
In some cases, this force of attraction may be sufficient to compress the tissue between the first and second catheters.
For example, in variations where the first and second catheters comprise flat ablation surfaces, as described above, the force of attraction can flatten and / or compress the vessel tissue between the ablation surfaces.
In other variations, the first and / or second catheter may comprise one or more shape-changing elements, as described with respect to the catheter (2500) in Figures 25A to 25D, and the method comprises changing the shape of the first and / or second catheters using the format-changing elements.
Changing the shape of the first and / or second catheters can help bring the first and second blood vessels closer, as described above.
In addition, the format change can also act to compress the tissue between the first and second blood vessels, as mentioned above.
bad. 20 In some variations, the adjustment of the first and second catheters may comprise the alignment of the catheters axially and / or rotatively.
For example, catheters can be oriented so that a fistula-forming element of the first or second catheter is positioned to form a fistula at a given location.
In variations 25 where both the first and second catheters comprise fistula-forming elements (for example, an active electrode and a grounding electrode), the catheters can be oriented to align these fistula-forming elements.
The catheters can be aligned in any suitable way.
In variations where the first and / or second catheters comprise one or more markers, as described above, the markers can be viewed (for example, through fluoroscopy, X-rays, or the like) to ensure that the catheters have the axial and / or ra-
dial with respect to each other.
Additionally, in variations where the first and / or second catheters comprise one or more magnetic alignment elements (for example, one or more coupling magnets, as described in greater detail above), the alignment elements
. 5 magnets can be used to orient axially and / or rotatively the first catheter with respect to the second catheter.
Additionally, in some variations, one or more balloons or expandable elements, such as those described above, can be used to help position the first and / or second catheters, or they can act to keep the first and / or second catheters in place inside the blood vessels.
For example, in some variations, the expansion of a balloon or expandable element of one of the catheters can engage the inside of a blood vessel, which can hold that catheter in place within the blood vessel.
In other methods, the expansion of the balloon or expandable element 15 may orient or otherwise press a fistula-forming element against the blood vessel tissue, which can assist in the formation of a fistula.
Once the catheter or catheters have been positioned and adjusted, one or more fistula-forming elements can be used 20 to create a fistula between the two blood vessels.
For example, in some variations, one of the first and second catheters comprises a fistula-forming element (eg, an electrode, a cutting blade, or the like), while the other catheter does not comprise a forming element. fistula.
In other variations, both characters comprise a fistula-forming element.
In some of these variations, the fistula-forming elements of the first and second catheters act to form different fistulas.
In other variations, the fistula-forming elements of the first and second catheters interact to form the same fistula.
For example, in some variations of the first and second 30 catheters, each comprises at least one electrode- In these methods, current can be supplied to the electrode or electrodes of one of the catheters, it can be carried away by the electrode or electrodes the other catheter, and can 'cause the tissue to ablate or vaporize as the current passes through it.
Any suitable combination of electrodes as described above can be used to form the fistula. In other methods, as described above, the formation of a fistula comprising
, 5 of a perforation of a balloon of the first or second catheter, which can release one or more contrast solutions into the blood vessels.
Additionally, in some variation, a balloon can be used to modify a fistula after the fistula has been formed.
In addition, one or more balloons can be activated to let the fetal blood flow through the fistula.
For example, in variations where an arteriovenous fistula is formed, it may be beneficial to dilate one or more parts of the artery and / or vein.
Specifically, the part of the artery upstream of an arteriovenous fistula can be expanded to increase flow through the fistula.
Alternatively or additionally a part of a vein downstream of a fistula can be enlarged to help increase the flow through the fistula.
In some variations, one or more parts of the expandable elements may comprise an electrode to induce neurosis or swelling in a part of a blood vessel to reduce the flow through it.
For example, in some variations a part of a vein upstream of a fistula can be at least partially blocked to minimize venous hypertension.
It should be appreciated that any of the catheters described above can be used to form a fistula using the methods above.
For example, in some variations, a first catheter may be advanced into a first blood vessel, and the first catheter may comprise one or more fistula-forming elements, such as those described in greater detail above.
For example, in some variations, the first catheter may comprise one or more blades or other mechanically cut elements.
In some of these variations, the first catheter may comprise one or more of the catheter blade mechanisms (2200), (3700), (3800) and / or (3900) described above with respect to Figures 22, 37, 38 and 39 , respectively.
In other variations, the first catheter may comprise one or more electrodes.
The electrode can comprise one or more ablation surfaces, such as those described in greater detail above.
In some variations, the electrode may comprise a guide wire, where part of the guide wire acts as an ablation surface.
For example,
. 5 the first catheter may comprise one or more of the catheter guidewire electrodes (2100), (3100) and / or (3200) described above with reference to Figures 21, 31 and 32, respectively.
In other variations, the first catheter may comprise one or more optical fibers or other elements for distributing laser energy to the blood vessel tissue.
It must be noted that in some variations the first catheter may comprise a combination of two or more elements of fistula formation.
The fistula-providing element of the first catheter can be activated or otherwise used to form a fistula between the first blood vessel and a second adjacent blood vessel. 15 In some variations, a second catheter can be located in the second blood vessel.
In some variations, the second catheter may comprise a fistula-forming element (such as one or more fistula-forming elements described in greater detail above), but it does not need to.
In variations in which the first catheter comprises one or more electrodes, the second catheter can also comprise one or more electrodes.
In some of these variations, current can be passed between the electrodes of the first catheter and the electrode of the second catheter during tissue ablation.
In variations where the fistula-forming element of the first catheter is configured to extend or otherwise move through the blood vessel tissue during tissue fistula formation (for example, a lamina or other mechanical cut, one or more of the electrodes described above), the second catheter may comprise one or more sections or elements of contact or receiving the fistula-forming element of the first catheter as it passes through the fabric.
For example, in some variations, the second catheter may comprise one or more lined pockets or parts, such as those described above with respect to catheters (3300), (3400), (3500), and (3600) and Figures
33A to 33B, 34, 35A and 35B and 36, respectively.
In some of these variations, the pocket or coated part can be configured to receive or contact an electrode from the first catheter as it passes through the tissue of the vessel.
In some variations, the electrode of the first catheter may
, 5 must be positioned so that it contacts one or more electrodes of the second catheter.
In some of these variations, the electrode may comprise one or more coated parts- In some of these variations, the coated parts may comprise a porous coating, so that current can pass through the porous coating between the electrodes, but contact direct physical contact between the two electrodes can be avoided.
Additionally or alternatively, in some variations the second catheter may comprise one or more balloons (for example, such as the distal balloon 7 (2604), the central balloon (2606) and the proximal balloon (2608) of the catheter (2600) described above with respect to Figures 26A and 26B)., so that the advancement of a fistula-forming element (for example, an electrode, a mechanical cutting blade) can pierce one or more of the balloons.
In
. some variations, this can release one or more fluids (for example, a contrast solution) from there.
In some variations, it may be desirable to form a fistula in a directional manner so that an opening is formed in a first blood vessel before the formation of a second blood vessel.
For example, in variations where a fistula is formed between an artery and a vein, it may be desirable to start fistula formation in the vein.
In these variations, an opening can be formed in a vein before an opening can be formed in the artery.
If during the fistula formulation one or more catheters fail so that a complete fistula is not formed, this directional fistula formation can prevent the formation of an opening being formed in the artery without a corresponding opening being formed in the vein.
When an opening is formed in the artery without the complete formation of a fistula, blood pressure can push blood into the extravascular space around the blood vessels, which in some cases may require a surgical procedure for repair. Conversely, training
opening an opening in a vein without a complete fistula may result in some extravascular bleeding, but venous pressure may be low enough that significant bleeding does not occur, which may allow the blood vessel to heal on its own.
While
, 5 described above as being used to directionally form a fistula in a vein in an artery, it should also be appreciated that in some cases it may be desirable to form a fistula in an artery to a vein from a first vein to a second vein, or from a first artery to a second artery.
In other variations still, the catheters can be configured to form the fistula through the first and second blood vessels substantially simultaneously.
nea. %
In order to form a fistula from a first blood vessel (for example, a vein) in a second blood vessel (for example, an artery), a first catheter comprising a fistula-forming element can be placed in the first blood vessel
. neo.
The fistula-forming element can be any of the fistula-forming elements as described in greater detail below.
In some variations, a second catheter can be located in the second blood vessel.
In variations where the fistula-forming element comprises a blade or other mechanical cutting mechanism, the blade can be activated to pierce or otherwise pass through the tissue of the first blood vessel.
As the blade passes through the tissue of the first blood vessel, it also cuts through the tissue of the second blood vessel.
In variations where the first catheter comprises one or more electrodes, the electrodes can directionally form a fistula from the first blood vessel to the second blood vessel.
In some variations, the electrode can be connected to a current generator (for example, via the monopolar current generator outlet) and an ablation surface can be located outside the patient, and the current can be applied to the tissue through the electrode of the first catheter.
The tissue of the first blood vessel, being located closer to the electrode, may undergo ablation or vaporization more quickly than the tissue of the second blood vessel. Additionally, in the oride variations the electrode is configured to extend V! through the tissue, the electrode can first contact and cause ablation of the first blood vessel tissue before contacting and cause tissue ablation. 5 of the second blood vessel. Additionally, in some variations, this directional fistula formation can form a larger opening in the first blood vessel than the opening formed in the second blood vessel. This can be useful in cases where the first blood vessel is a vein and the second blood vessel is an artery, since a larger opening can
1.0 'provide less resistance to blood flow than a smaller opening, the formation of a larger opening in the vein can promote the flow from the artery to the vein, which can reduce the likelihood of blood leaking through. through the fistula into the extravascular space. As mentioned above, when a first catheter is located in a first blood vessel and a second catheter is located in a second blood vessel, the first and second catheters can be aligned using one or more alignment elements. The first and second catheters can comprise any alignment elements or combination of alignment elements as described in greater detail above. In some variations, the first and / or second catheters may comprise one or more coupling magnets proximal to a fistula-forming element. Additionally or alternatively, the first and / or second catheters may comprise one or more distal coupling magnets for a fistula-forming element. Additionally, or alternatively, the first and / or second catheters may comprise one or more anchoring magnets proximal to a fistula-forming element. Additionally or alternatively, the first and second catheters may comprise one or more distal anchoring magnets for a fistula-forming element. When the first catheter is located in a first blood vessel and the second catheter is located in a second blood vessel, the alignment elements of the first and second catheters can interact to help bring the first and second catheters closer together.
according to blood vessels. In other cases, the alignment elements
W can be used to direct a fistula-forming element (such as that described above) from the first catheter towards the tissue of the second vessel and / or one or more parts (e.g., a fistula-forming element, a pocket or similar) of the second catheter. In some cases, it may be desirable to hold a first "blood vessel in place with respect to a second blood vessel. Accordingly, in some methods described here, at least a part of a first blood vessel can be joined or fixed with respect to at least a portion of a second blood vessel. In some variations, the first and second blood vessels may be joined before the fistula forms. In other variations, a portion of a first blood vessel may be joined
W is attached to a second blood vessel during fistula formation. In other variations, the first and second blood vessels can be joined 15 after the formation of the fistula. When a first blood vessel is attached to or attached to a second blood vessel before fistula formation, this connection can help to minimize the relative movement between the first and second blood vessels during fistula formation. In addition, a connection between a first and a second blood vessel can help prevent relative movement between the first and second blood vessels after the formation of the fistula, which can reduce the likelihood that the blood may leak. out of the fistula and into the extravascular space. In methods where a first blood vessel is joined or otherwise fixed with respect to a second blood vessel, the blood vessels can be joined properly. In some variations, one or more catheters can be configured to deliver electrical, ultrasonic or laser energy to the blood vessels to fuse a part of a first blood vessel with a part of a second blood vessel. In some cases, this application of energy can result in the denaturation of proteins in the vessel walls, and the denatured proteins in each vessel wall can mix after the application of energy, which can act to fuse blood vessels together. other.
Figures 40A and 40B illustrate a method by which a first blood vessel (4000) can be joined to a second blood vessel (4002). The first blood vessel (4000) can be an artery or a vein,. 5 and the second blood vessel (4002) can be an artery or a vein. As illustrated in Figure 40A, a first catheter (4004) can be advanced "into the first blood vessel (4000) and a second catheter (4006) can be advanced into the second blood vessel (4002). first (4004) and the second (4006) catheters can each comprise 10 electrodes (4008). In some variations, once advanced into the
W blood vessels, the first (4004) and second (4006) catheters can be manipulated to bring the first blood vessel (4000) closer to the second
WN blood vessel (4002). In some variations, the first and second catheters have one or more alignment elements (not shown), as described in greater detail above, can help to bring blood vessels closer together. Once positioned, energy can be distributed. to the vessel tissue through one or more of the electrodes (4008), which can create a fused region (4010) of the vessel tissue. The fused region (4010) can act to hold the first blood vessel (4000) in place with respect to the second blood vessel (4002) - The electrodes (4008) can form a fused region (4010) of any shape or size appropriate. In some variations, the electrodes (4008) can be configured to form a rectangular fused region (4010). In other variations, the electrodes can be configured to form a circular or oval fused region 25 (4010). In other variations, one or more biocompatible patches can be applied to a first blood vessel and a second blood vessel. In some variations, a needle or other delivery device can be introduced through the skin to a position close to the first and second blood vessels, and you can inject the patch to connect the first blood vessel and second blood vessel. In these variations, a first catheter comprising one or more alignment elements can
can be placed in the first blood vessel, a second catheter comprising one or more alignment elements can be placed in the
V second blood vessel, and the alignment elements (for example, one or more Magnets and / or one or more reshaping parts) can act - 5 to bring the first and second blood vessels together, so that the adhesive one first and second blood vessels to retain them in an approximate position. In other variations, a catheter located in one of the blood vessels can be used to deliver one or more biocompatible patches. Figure 41 illustrates a method, in which a first catheter (4100) can be inserted into a first blood vessel (4102). In some variations, a second catheter (4104) can be inserted into a second blood vessel (4106). In these variations, the first (4100) and second (4104) catheters can each comprise one or more alignment elements that can act to approximate the blood vessels as described in greater detail above. The first catheter (4100) can comprise a needle (4106), which can be advanced from the first catheter (4100) to pierce the tissue of the first blood vessel (4102). When a distal end of the needle (4106) is advanced out of the blood vessel (4102), an adhesive (4108) can be distributed out of the needle (4106) between the first (4012) and second (4106) vessels blood vessels to join blood vessels. In other variations, a catheter can deliver one or more splinters, clamps or other implants to connect a first blood vessel to a second blood vessel. Figure 42 illustrates a method in which the first catheter (4200) can be inserted into a first blood vessel (4202). In some variations, a second catheter (4204) can be introduced into a second blood vessel (4206) - In these variations , the first (4200) and second (4204) catheters can each comprise 30 one or more alignment elements, which can act to approximate the blood vessels as described in greater detail above. The first catheter (4206) can be configured to deploy one or more splinters
(4108), staples (4110), or other implants.
Barbs (4108), staples (4110) or other implants can be distributed at least partially through the tissue of the first blood vessel (4202) and at least partially through the tissue of the second blood vessel (4206) and can act to
. 5 retain the tissue of the first blood vessel (4202) in place with respect to the tissue of the second blood vessel (4206). While illustrated in Figure 42 as being used to distribute splinters (4108) and staples (4110), the catheter (4200) can be configured to distribute one or more splinters, one or more staples, one or more additional implants, or a combination of the same 10.
When one or more catheters are used to join or otherwise connect a first blood vessel to a second blood vessel, it should be appreciated that one or more of the same catheters can also be used to form a fistula between the first and second blood vessels.
In some variations, the same mechanism that is used to join the first and second blood vessels can also be used to form a fistula.
For example, in variations where a catheter comprises an electrode, the same electrode can be used to fuse the tissue of the vessel (for example, when a first energy outlet is applied to the electrode) and to create a fistula between the two blood vessels (for example, when a second energy outlet is applied to the electrode). In other variations, a catheter may comprise a first component for joining two blood vessels and a separate fistula-forming element, as described in greater detail above.

权利要求:
Claims (24)
[1]
1. System for forming a fistula between two blood vessels characterized by the fact that it comprises: a first catheter comprising a catheter body, a guide wire and at least one alignment element, in which the guide wire is mobile between a low profile configuration and an extended position where at least a part of the guide wire extends away from the catheter body, and where the guide wire is spring oriented towards the extended position.
[2]
2. System according to claim 1, characterized by the fact that it also comprises a second catheter.
[3]
3. System, according to claim 2, characterized by the fact that the second catheter comprises a region with recesses.
[4]
4. System according to claim 3, characterized by the fact that the recessed region is a pocket configured to receive at least part of the guide wire when the guide wire extends away from the catheter body of the first catheter.
[5]
5. System according to claim 4, characterized by the fact that the second catheter comprises at least one alignment element, and where the at least one alignment element of the first catheter and the at least one alignment element of the second catheters are configured to align the first catheter and the second catheter so that the guidewire enters at least partially into the pocket when the guidewire extends away from the catheter body of the first catheter.
[6]
6. System according to claim 4, characterized by the fact that the pocket is formed in a nest material housed at least partially within the catheter body of the second catheter.
[7]
7. System according to claim 4, characterized by the fact that the pocket is formed in an electrode housed at least partially within the catheter body of the second catheter.
[8]
8. System according to claim 4, characterized by the fact that the pocket is at least partially covered by an insulating material.
[9]
9. System according to claim 8, characterized by the fact that the insulating material is porous.
[10]
1 O. System according to claim 1, characterized by the fact that the guide wire comprises a first segment housed at least partially within the catheter body of the first catheter, a first angled segment extending from from a distal end of the first segment, and a second angled segment extending from a distal end of the first angled segment.
[11]
11. System according to claim 10, characterized by the fact that at least one insulation material covers the first segment and the first angled segment of the guide wire.
[12]
12. System according to claim 10, characterized by the fact that at least one insulating material covers the first segment of the guide wire and partially covers the first angled segment of the guide wire.
[13]
13. Method of forming a fistula between a first blood vessel and a second blood vessel characterized by the fact that it comprises: advancing a first catheter into the first blood vessel, where the first catheter comprises a catheter body, a wire guide and at least one alignment element, where the guide wire is movable between a low profile position and an extended position where at least part of the guide wire extends away from the catheter body, and where the guide wire is oriented by spring towards the extended position; advancing a second catheter into the blood vessel, where the second catheter comprises at least one alignment element; positioning the first catheter and the second catheter so that the guide wire is aligned with the second catheter; moving the guide wire from a low profile position to an extended position; and ablation of the tissue with the guide wire to form the fistula.
[14]
14. Method according to claim 13, characterized by
the fact that the second catheter comprises a pocket, where the positioning of the first catheter and the second catheter comprises the alignment of the guide wire with the pocket.
[15]
15. Method according to claim 13, characterized by the fact that the second catheter comprises a balloon, and where the ablation of the tissue with the guide wire comprises perforation of the balloon with the guide wire.
[16]
16. Method, according to claim 13, characterized by the fact that the first blood vessel is a vein and the second blood vessel is an artery. 1O
[17]
17. Method, according to claim 13, characterized by the fact that it further comprises the placement of an earth electrode outside the first blood vessel and the second blood vessel, and where the ablation of the tissue comprises the passage of chain between the guide wire and the grounding electrode.
[18]
18. Method according to claim 13, characterized by the fact that the guide wire comprises a first segment housed at least partially within the catheter body of the first catheter, a first angled segment extending from a distal end of the first segment, and a second angled segment extending from a distal end of the first angled segment.
[19]
19. Method according to claim 18, characterized by the fact that at least one insulating material covers the first segment and the first angled segment of the guide wire.
[20]
20. Method according to claim 18, characterized by the fact that at least one insulating material covers the first segment of the guide wire and partially covers the first angled segment of the guide wire.
[21]
21. Method, according to claim 13, characterized by the fact that the first catheter comprises a shape-changing element, and further comprises the repositioning of the first blood vessel by changing the shape of the first catheter with the element change of shape of the first catheter.
[22]
22. The method of claim 21, characterized by
[23]
the fact that the second catheter comprises a shape-changing element, and also comprises the repositioning of the second blood vessel by changing the shape of the second catheter with the shape-changing element of the second catheter. 23. Method, according to claim 22, characterized by the fact that the second catheter comprises at least one expandable element, and where the positioning of the first and second catheters includes the expansion of at least one element expandable from the second catheter to hold the second catheter in place with respect to the second blood valve.
[24]
24. Method, according to claim 21, characterized by the fact that the first catheter comprises at least one expandable element, and where the placement of the first and second catheters comprises the expansion of at least one expandable element of the first catheter to keep the first catheter in place with respect to the first blood vessel.

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法律状态:
2020-09-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-09-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-04-13| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-08-03| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

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2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2021-11-30| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2022-02-22| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/11/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |

优先权:

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申请号 | 申请日 | 专利标题

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US41435710P| true| 2010-11-16|2010-11-16|

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US61/414,357|2010-11-16|

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PCT/US2011/061026|WO2012068273A1|2010-11-16|2011-11-16|Devices and methods for forming a fistula|

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