devices to obstruct or promote fluid flow

专利摘要:
DEVICES AND METHODS TO OBSTRUCT OR PROMOTE FLUID FLOW. The present invention relates to devices and methods for obstructing or promoting fluid flow through openings are disclosed. In an exemplary embodiment an obstruction device (10) is provided having an expandable external elongated tubular body (20), a guide element (30) extending from a distal end (20d) of the external body, and a sliding tube (40 ) disposed within the outer body, the proximal parts (20p, 40p) of the outer body and the sliding tube being fixedly matched. The sliding tube is configured to slide distally into the outer tubular body when the tubular body is expanded to form wings (24a, 24b). A cable (60) can be included as part of the device and it can be used to help position and lock a device location in an opening. Exemplary methods for delivering devices disclosed in this document are also provided.
公开号:BR112014014889B1
申请号:R112014014889-9
申请日:2012-12-18
公开日:2021-01-19
发明作者:James E. Coleman；Christy Cummins
申请人:James E. Coleman；Christy Cummins；
IPC主号:

专利说明:

Field
[001] The present invention relates to devices and methods for obstructing an opening or promoting fluid flow through an opening or conduit. Background
[002] Catheterization and interventional procedures, such as angioplasty or stent placement, are generally performed by inserting a hollow needle through the patient's skin and intervening tissue into the vascular system. A guidewire can then be passed through the needle lumen into the patient's blood vessel accessed by the needle. The needle can be removed, and an introducer sheath can be advanced over the guide wire into the blood vessel, for example, in combination with or following an dilator. A catheter or other device can then be advanced through a lumen of the introducer sheath and over the guide wire to a position to perform a medical procedure. Thus, the introducer sheath can facilitate the introduction of various devices into the blood vessel, while minimizing trauma to the blood vessel wall and / or minimizing blood loss during a procedure.
[003] Upon completing the procedure, the devices and introducer sheath are removed, leaving a perforation site in the blood vessel wall. External pressure can be applied to the drilling site until coagulation and wound closure occur. This procedure, however, can be time-consuming and expensive, requiring as much as an hour of a doctor's or assistant's time. It is also uncomfortable for the patient and requires the patient to remain immobilized in the operating room, catheter lab or retention area. Additionally, a risk of a hematoma exists from bleeding before hemostasis occurs. In this way, it may be desirable to seal the perforation using other techniques.
[004] It may also be desirable to also seal openings within a patient's body in other contexts. For example, in some cases it may be desirable to seal a fallopian tube to provide a form of birth control or disease prevention. It may also be desirable to seal openings that form in a body related to a defect or disease. In addition, in some cases it may be desirable to promote a flow of fluid through an opening, such as attaching a graft to a blood vessel. However, each of these techniques can be complicated by the limited nature of the space in which the procedures are to be performed and the devices and methods that currently exist to practice such techniques.
[005] As a non-limiting example, a repair that is opportune for improvement is the treatment of a leaking mitral valve. The mitral valve includes two leaflets (anterior and posterior) attached to a fibrous ring or annular. Contraction of the left ventricle in a healthy heart results in the mitral valve leaflets overlapping during contraction and preventing blood from flowing back into the left atrium. As a result of various heart diseases, the mitral ring can become distended, causing the leaflets to remain partially open during ventricular contraction and thus allowing blood regurgitation into the left atrium. In response to a reduced left ventricular ejection volume, the left ventricle attempts to compensate with a large stroke volume. Eventually, this increased workload results in dilation and hypertrophy of the left ventricle, further enlarging and distorting the shape of the mitral valve. The end result of this heart failure if left untreated can be left ventricular failure and death. Current methods that exist for treating such conditions are limited.
[006] Various devices have been suggested to percutaneously seal openings such as vascular perforations when closing the perforation site, as well as to seal other openings in a patient's body. A device that exists for vascular closure is a biodegradable plug that is delivered through an introducer sheath to a drilling site. When positioned, the plug seals the blood vessel and provides hemostasis. Such plugs, however, can be difficult to position properly with respect to the blood vessel. In addition, it is generally undesirable to expose the buffered material, for example, collagen, to the bloodstream where it can float downstream and create the risk of causing an embolism. Another technique involves percutaneously suturing an opening. Percutaneous suture devices, however, require significant professional knowledge by the user and can be mechanically complex and expensive to manufacture.
[007] Other closure devices include surgical fasteners. A known surgical fastener includes an annular base having legs that, in a loosened state, extend in a direction substantially perpendicular to a plane defined by the base and slightly inwardly towards each other. During use, the fastener is fitted around the outside of a cannula, thus deflecting the legs outward. The cannula is placed in an incision, and the fastener is slid along the cannula until the legs pierce the blood vessel. When the cannula is removed, the legs move towards each other and back to the loosened state to close the incision. Staples can also be used to close a wound or incision. Clamps, however, tend to have a large cross-sectional profile and for this reason it may not be easy to deliver them through a percutaneous site to obstruct an opening in a blood vessel wall.
[008] In this way, improved methods and devices for closing openings, including vascular perforation wounds, openings naturally occurring in a patient's body, openings that result from defects or diseases, and surgically created openings, are necessary. Improved methods and devices for promoting fluid flow through the openings are also desirable. summary
[009] The present invention in general provides devices and methods for obstructing an opening or promoting the flow of fluid through an opening. In an exemplary embodiment an obstruction device is provided having an elongated external tubular body, a guide element extending distally from a distal end of the external tubular body, and a sliding tube disposed within the external tubular body and having a proximal end which is fixedly matched to a proximal end of the outer tubular body. Both of a proximal part and a distal part of the external elongated tubular body can have a plurality of slits formed therein. The slits are configured to allow the proximal and distal parts to expand to form proximal and distal wings. The elongated outer tubular body can be configured to move along an outer surface of the slide tube as the proximal and distal parts expand to form the wings. In one embodiment, the slits in the proximal part can extend in a first direction around a circumference of the external tubular body, and the slits in the distal part can extend in a second opposite direction around a circumference of the external tubular body. The proximal and distal parts can be configured to expand in response to a torsional force that is applied to the external elongated tubular body. A compressive force can also be applied to more fully form proximal and / or distal wings.
[0010] Optionally, a cable can be included as part of the device. The cable may have a distal part disposed within the external tubular body and a proximal part that extends proximally from the proximal end of the external tubular body. A locking tool can be attached to the cable for the purpose of inducing tension in the cable.
[0011] The slip tube can have a variety of configurations, and in one embodiment the slip tube can be configured to obstruct fluid flow through the proximal wings when the proximal part of the external tubular body is expanded. Similarly, the guide element can be configured to obstruct fluid flow through the distal wings when the distal part of the outer tubular body is expanded. A distal end of the slide tube can be next to a proximal end of the guide element after the proximal and distal parts of the outer tubular body are expanded to form proximal and distal wings.
[0012] In one embodiment the device also includes an internal elongated tubular body that extends at least partially through the external elongated tubular body and through the sliding tube. A distal end of the internal elongated tubular body can be fixedly matched to the proximal end of the guide element. Alternatively, the distal end of the internal elongated tubular body can be fixedly matched to a distal tip at a distal end of the external elongated tubular body. The elongated inner tubular body may include a frangible part that allows a proximal part of the inner tubular body to be separated from a distal part of both the inner tubular body and the outer tubular body.
[0013] The device may also include an insertion guide that is configured to be attached to the proximal part of the internal elongated tubular body. The insertion guide can selectively expand and compress the external elongated tubular body and / or activate the frangible part of the internal elongated tubular body. In another embodiment, an insertion guide can extend through the elongated external tubular body, distal to the guide element.
[0014] A distal tip can be arranged at a distal end of the guide element. In one embodiment, the distal tip can be closed to prevent fluid from flowing through the elongated external tubular body. Alternatively, at least one of the guide tube, the ejector tube and the slide tube can be configured to prevent fluid from flowing through the external elongated tubular body.
[0015] In another exemplary embodiment of an obstruction device, the device includes a core pin, an elongated tubular body coupled to the core pin and which has proximal and distal expandable parts, and a sliding tube at least partially arranged inside of the elongated tubular body and having a proximal end that is matched to a proximal end of the elongated tubular body. The elongated tubular body can have at least two positions. In a first position, the proximal and distal parts are not expanded, and in a second position the proximal and distal parts are expanded to form proximal and distal wings. As the elongated body is moved from the first position to the second position, it slides proximally over the slide tube to cause the core pin to be moved to a distal end of the slide tube. In one embodiment, when the elongated body is in the second position, the distal part of the sliding tube is contiguous to the core pin. The expandable proximal and distal parts of the elongated tubular body can have a plurality of slits formed therein.
[0016] The device may also include a distal tip that extends distally from the core pin. In another embodiment, the device may include a tool that is configured to extend distally beyond the core pin. The tool can be used to form an opening in fabric. The device may also include an ejector tube disposed within the elongated tubular body. In one embodiment, a distal part of the ejector tube is coupled to the core pin. The ejector tube can be frangible in such a way that its proximal part is frankly coupled to its distal part.
[0017] The device can additionally include an insertion instrument that is configured to be attached to the proximal part of the ejector tube. The insertion instrument can selectively expand and compress the elongated external tubular body and / or activate the frangible part of the ejector tube. In another embodiment, an insertion instrument can extend through the elongated external tubular body, distal to the core pin.
[0018] Optionally, a cable can be included as part of the device. The cable can be attached to the ejector tube, at the proximal or distal part of the tube. A locking tool can be attached to the cable for the purpose of inducing tension in the cable.
[0019] In other respects, the sliding tube can be configured to prevent fluid flow through the proximal wings of the external tubular body. Similarly, the core pin can be configured to prevent fluid flow through the distal wings of the outer tubular body.
[0020] In an exemplary embodiment of a method for obstructing an opening, the method includes advancing an elongated tubular body into an opening to be obstructed, applying a first force to the elongated tubular body to cause a proximal part of the tubular body elongated expand and form proximal wings, and apply a second force to the elongated tubular body to cause a distal part of the elongated tubular body to expand and form distal wings. Application of the first force can cause a distal end of the elongated tubular body to be displaced by a first distance in a proximal direction, and application of the second force can cause the distal end of the elongated tubular body to be displaced by a second distance in the direction proximal. In one embodiment, after the elongated tubular body is moved in the second distance, a sliding tube disposed within at least a part of the elongated tubular body adjoins a distal guide element at the distal end of the elongated tubular body.
[0021] Applying the first force may include applying a rotational force in a first direction. Additionally, applying the second force may include applying a rotational force in a second direction opposite to the first direction. The elongated tubular body may include an inner tube that extends at least partially through it. In such an embodiment, the tubular body can be frankly separated into a proximal and a distal part, and the proximal part can be removed from the elongated tubular body.
[0022] Optionally, a cable can be attached to the elongated tubular body, or to a component disposed therein, such as a sliding tube or an inner tube. The cable can be tensioned, which can help, for example, to establish and maintain a desired position of the tubular body. In one embodiment, before advancing the elongated tubular body through the opening, the opening can be formed. Components of the device that includes the elongated tubular element can assist in forming the opening.
[0023] The opening to be blocked can be located in several different locations. As a non-limiting example, the opening may be located in a fallopian tube, a heart, a blood vessel or a tongue. Brief Description of Drawings
[0024] This invention will be better understood from the detailed description below considered in combination with the accompanying drawings, in which:
[0025] Figure 1A is a side view of an exemplary embodiment of an obstruction device in an initial unformed configuration;
[0026] Figure 1B is an exploded view of the device of Figure 1A;
[0027] Figure 2 is a perspective view of an external elongated tubular element of the device of Figure 1 in an initial unformed configuration;
[0028] Figure 3 is an end view of the tubular element of Figure 2 before implementation;
[0029] Figure 4 is an end view of the tubular element of Figure 2 after implementation;
[0030] Figure 5 is a side view of the tubular element of Figure 2 after implementation;
[0031] Figure 6 is a cross-sectional side view of the tubular element of Figure 2 after implementation;
[0032] Figure 7 is a cross-sectional side view of the obstruction device of Figure 1 in the initial unformed configuration;
[0033] Figure 8 is a cross-sectional side view of the device of Figure 7 in a partially formed configuration;
[0034] Figure 9 is a cross-sectional side view of the device of Figure 8 in a fully formed configuration with an insertion guide coupled to it;
[0035] Figure 10 is a cross-sectional side view of the device of Figure 9 in a fully formed configuration with an insertion guide separate from it;
[0036] Figure 11A is a cross-sectional side view of another exemplary embodiment of an obstruction device in an initial unformed configuration with a former coupled to it;
[0037] Figure 11B is a cross-sectional side view of the device of Figure 11A in a fully formed configuration with a separate former;
[0038] Figure 11C is a side view of a delivery system coupled to the device and former of Figure 11A;
[0039] Figure 12 is a side view of an exemplary embodiment of a locking mechanism for use with the obstruction device of Figure 1;
[0040] Figure 13A is a perspective view of the locking mechanism of Figure 12;
[0041] Figure 13B is a perspective view of an alternative embodiment of a locking mechanism;
[0042] Figure 13C is a partially transparent side view of an additional alternative embodiment of a locking mechanism;
[0043] Figure 14 is a side view of an exemplary embodiment of an obstruction device in the initial unformed configuration;
[0044] Figure 15A is a cross-sectional side view of an exemplary embodiment of an implementation device in an initial unformed configuration;
[0045] Figure 15B is a cross-sectional side view of the device of Figure 15A in a fully formed configuration;
[0046] Figure 16A is a cross-sectional side view of an exemplary embodiment of a distal end of an obstruction device before or during insertion into an opening or formation of a perforation in tissue;
[0047] Figure 16B is a cross-sectional side view of the distal end of the device of Figure 16A after retraction of a distal tip from the distal end and separation of the distal end from a removable part of the obstruction device;
[0048] Figure 17A is a cross-sectional side view of another exemplary embodiment of an implementation device in an initial unformed configuration;
[0049] Figure 17B is a cross-sectional side view of the device of Figure 17A in a fully formed configuration;
[0050] Figure 18 is a schematic view of a heart having a leaking mitral valve to which a partially implemented obstruction device is adjacent;
[0051] Figure 19 is a schematic view of the heart of Figure 18 in which the obstruction device is fully implemented and arranged within the heart;
[0052] Figure 20 is a schematic view of the heart of Figure 19 in which a locking tool is attached to a cable extending from the obstruction device, before locking the locking tool;
[0053] Figure 21 is a schematic view of the heart of Figure 20 in which the locking tool is locked;
[0054] Figure 22 is another schematic view of a heart having a leaking mitral valve in which an obstruction device is fully implemented;
[0055] Figure 23 is a schematic view of the heart of Figure 22 in which a locking tool is attached to a cable extending from the obstruction device and is locked;
[0056] Figure 24 is also another schematic view of a heart having a leaking mitral valve in which multiple obstruction devices are implemented;
[0057] Figure 25 is a schematic view of a heart having cardiac arrhythmia in which an obstruction device is fully implemented;
[0058] Figure 26 is a schematic view of a trainer used in combination with delivery of the device of Figure 25 illustrating use of the trainer to surgically remove tissue from the heart;
[0059] Figure 27 is a schematic view of the heart of Figure 25 in which multiple obstruction devices are implemented;
[0060] Figure 28 is a schematic view of a region surrounding a tongue in which an obstruction device and a locking mechanism are arranged on the tongue;
[0061] Figure 29 is another schematic view of a region surrounding a tongue in which an obstruction device and a locking mechanism are arranged on the tongue and a magnetic source is arranged on the outside of a throat; and
[0062] Figure 30 is a schematic view of a coronary artery and a graft structure having an implementation device paired with it to place the artery and graft structure in fluid communication. Detailed Description
[0063] Certain exemplary modalities will now be described to provide a full understanding of the principles of structure, function, manufacture and use of the devices and methods disclosed in this document. One or more examples of these modalities are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods described specifically in this document and illustrated in the accompanying drawings are exemplary non-limiting modalities and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with an exemplary modality can be combined with the features of other modalities. Such modifications and variations are intended to be included in the scope of the present invention. In the present disclosure, equally numbered components of the modalities in general have similar features, and thus within a particular modality each feature of each equally numbered component is not necessarily fully elaborated in the description of the particular modality. In addition, to the extent that linear or circular dimensions are used in describing the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in combination with such devices and methods. Those skilled in the art will recognize that an equivalence for such linear and circular dimensions can be easily determined for any geometric shape.
[0064] Devices and methods for obstructing an opening in general are provided. The opening can be an naturally occurring opening, such as a fallopian tube, an opening resulting from a defect or disease, such as a defect associated with heart disease, or an opening resulting from a perforation, such as a wound in a vessel blood. In an exemplary embodiment an obstruction device is provided having an external elongated tubular body that is configured to expand and form wings near opposite ends of the opening. The device may include a component to block flow through the tubular body, and thus through the opening. The component to obstruct flow through the opening may be disposed within the external elongated tubular body, or it may extend outside the tubular body to block fluid flow even before the flow reaches the tubular body. Examples of obstruction components include distal and proximal wings implemented from the external elongated tubular body, a sliding tube disposed within the external elongated tubular body, a part of an ejector tube disposed within the external elongated tubular body, and one of a guide element or a distal tip extending distally from a distal end of the elongated external tubular body.
[0065] Figures 1A to 10 illustrate an exemplary embodiment of an obstruction device 10 that can be used to obstruct an opening. As shown in Figures 1A and 1B, the device 10 includes a generally elongated tubular body 20 having the proximal and distal ends 20p, 20d and various components attached thereto and / or disposed within it. These components may include, for example, a guide element or core pin 30, a slide tube 40, an ejector tube 50, a distal tip or guide tip 70 and a guide or insertion shaft 80, each of which will be discussed in more detail below. In general, the elongated tubular body 20 includes the proximal and distal parts 20a, 20b which are configured to expand to fit tissue adjacent to an opening between them, while one or more of the components fixed and / or arranged in the tubular body 20 are configured to obstruct the opening in which the device 10 is arranged. The parts 20a, 20b of the body 20 which are configured to expand, for example, the wings 24a, 24b, can also close the opening.
[0066] Figures 2 to 6 illustrate the external elongated tubular body 20 in more detail. As illustrated in the configuration not implemented in Figure 2, each of the proximal and distal parts 20a, 20b includes a plurality of the slits 22a, 22b formed therein and configured to allow parts of the elongated tubular body 20 between the pluralities of the slits 22a, 22b expand radially. An intermediate part 23 of the tubular body 20, located between the proximal and distal parts 20a, 20b, can be free of cracks and it can be configured to be positioned within an opening to be obstructed. The intermediate part 23 can have a fixed or adjustable length that corresponds to a thickness of the fabric walls.
[0067] Slits 22a, 22b in the proximal and distal parts 20a, 20b can extend in any direction, and each part 20a, 20b can include any number of slits. Preferably, the slits 22a, 22b are configured in such a way that certain parts of the elongated tubular body 20 between the slits 22a, 22b will extend outwardly away from a central geometry axis A of the tubular body 20 when the body 20 is axially compressed and / or rotated. As a result, one or more wings 24a, 24b will be formed on each of the distal and proximal parts 20a, 20b to fit fabric between them to help establish and maintain a location of device 10. Device 10 can also include flaps 25a on the proximal part 20a to assist in wing formation, as further discussed below. Flaps can also be formed on the distal part 20b if desired. In some embodiments, as shown in Figures 8 to 10, the wings 24a, 24b may include the tangs with fabric 28 that generally extend perpendicularly to the formed wing and provide additional assistance in maintaining a location of the device 10.
[0068] In an exemplary embodiment, as shown in Figure 2, the slits 22a, 22b can be substantially S-shaped. The slits 22a, 22b can extend longitudinally along the elongated tubular body 20 in a proximal-distal direction , and they can be spaced axially around the elongated tubular body 20. More preferably, the slits 22a in the distal part 20a can extend in a first direction around a circumference of the elongated tubular body 20 and the slits 22b in the proximal part 20b can extend in a second opposite direction around the circumference of the elongated tubular body 20. A configuration like this allows the tubular body 20 to be rotated in a first direction to cause only one of the proximal and distal parts 20a, 20b to expand radially , and then be rotated in a second opposite direction to cause the other part of the proximal and distal parts 20a, 20b to expand radially. The proximal and distal parts 20a, 20b can be adapted to move towards each other as they expand by rotation and are compressed in shape, thus allowing the wings to fit fabric between them.
[0069] Figures 3 and 4 show views of the distal end of the tubular body 20 in its pre-implemented configuration and after partial or total implementation, respectively. In the pre-implemented configuration shown in Figure 3, the elongated tubular body 20 has a diameter that is configured to fit within an opening. Figure 4 illustrates the distal part 20b radially expanded to form the distal wings 24b. When the proximal part 20a is expanded radially to form the proximal wings 24a, the proximal wings 24a can be aligned with the distal wings 24b to facilitate lumen joining. In such a case, the distal end view of the tubular body 20 would be as shown in Figure 4 both before and after implementation of the proximal wings 24a. The proximal wings 24a can also be displaced radially from the distal wings. In the illustrated embodiment, the slits 22a, 22b are configured in such a way that each of the proximal and distal parts 20a, 20b includes six wings, however the proximal and distal parts can include any number of wings.
[0070] Figure 5 shows the external tubular body 20 in an implemented configuration. In the implemented configuration, the proximal part 20a is expanded to form the proximal wings 24a, and the distal part 20b is expanded to form distal wings 24b. The wings 24a, 24b are formed by the material between the slits 22a, 22b, which is deformed outwardly as the external elongate body 20 is rotated and then compressed. The wings 24a, 24b can be formed concurrently or sequentially, for example, by implementing the distal wings 24b before the proximal wings 24a. In addition, the central part 23 can optionally be compressed by applying an axial force to the external tubular body 20, thus decreasing the distance between the wings 24a, 24b. This can be achieved, for example, by forming the intermediate part 23 of telescopic tubes.
[0071] Figure 6 shows a cross-sectional view of the tubular body 20 implemented in Figure 5. The asymmetric profile of the slits 22a, 22b can allow the wings 24a, 24b to be formed so that the internal base folding angles α1, α2 are smaller than the respective external base folding angles β1, β2. As a result, the wings 24a, 24b will also extend towards each other. The internal base folding angles α1, α2 can be the same or different in the proximal and distal parts 20a, 20b, as can the external base folding angles β1, β2. If each of the external base folding angles β1, β2 is about 90 degrees, the wings 24a, 24b extend substantially parallel to each other, while the external and basic base folding angles β1, β2 may allow the wings 24a, 24b are angled towards each other at one end and away from each other at the opposite end. Those skilled in the art will recognize that the slits can have multiple configurations so that certain parts of the wings are perpendicular to the central part of the device with other parts of the wings being tilted towards each other or away from each other.
[0072] Alternative configurations for elongated tubular bodies that can be used in combination with the precepts in this document can be found at least in U.S. Patent #No. 7,625,392 to Coleman et al., Entitled "Wound Closure Devices and Methods", and in U.S. Patent Application Publication #No. 2010/0114128 by Coleman et al., Entitled "Gastric Bypass Devices and Procedures", the contents of which are incorporated into this application in their entirety by reference. Those skilled in the art will understand how to incorporate the precepts of these various modalities into the devices and methods disclosed in this document without departing from the spirit of the invention.
[0073] The distal end 20d of the tubular body 20 can be coupled to a guide element or core pin 30, which can be provided to help guide the device 10 to its desired location and / or to help close an opening in the which device 10 is arranged. In the illustrated embodiment the core pin 30 is generally cylindrical, hollow and includes a hole extending through it. A distal end 30d of the core pin 30 can be tapered in the distal direction as shown to help guide the device 10 to a desired location. The core pin 30 may also include a stop surface 32, which can prevent the tubular body 20 from being displaced further distally when compressive force is applied to it. As shown in Figures 7 to 10, the distal end 20d of the tubular body 20 can be coupled to the core pin 30 on the stop surface 32. Additionally, as illustrated, the core pin 30 can optionally extend into a elongated tubular body part 20. Although in the illustrated embodiment the core pin 30 is generally hollow and includes a hole extending through it, in other embodiments the core pin 30 can be solid or closed in such a way that it is a component of the device 10 that encloses an opening in which the device 10 is arranged.
[0074] As additionally shown in Figures 7 to 10, a slide tube 40 can be arranged within the external elongated tubular body 20. Slide tube 40 can be configured to slide into device 10 and assist in both actuation and obstruction of the device 10. In the illustrated embodiment the slide tube 40 is generally cylindrical in shape and includes a hole through it in such a way that the tube 40 can receive an axis, such as the ejector tube 50, along the which tube 40 can slide. As shown in Figure 7, the sliding tube 40 can extend distally in such a way that it extends beyond the proximal slits 22a when the tubular body 20 is not implemented. In addition, when the proximal wings 24a are formed, for example, in Figures 8 to 10, the slide tube 40 can remain arranged over an opening below the formed wings 24a to prevent fluid from passing into the expanded wings 24. Likewise, such as shown in Figures 9 and 10, the core pin 30 can prevent fluid from passing into the expanded distal wings 24b. As a result, fluid shifting through the internal hole of the implant cannot migrate through the slits at the base of the distal and proximal wings 24b, 24a as these are sealed by the core pin 30 and the slip tube 40.
[0075] In one embodiment, a proximal end 40p of the sliding tube 40 is coupled to the proximal end 20p of the tubular body 20 in such a way that forces applied to the sliding tube 40 are transferred to the tubular body 20. For example, if a torsional force in the T1 direction is applied to the proximal end 40p of the sliding tube 40, then the force can be transferred to the proximal end 20p of the tubular body 20. Likewise, if an axial force in the G direction is applied to the proximal end 40p, then the force can be transferred to the proximal end 20p. Alternatively, the torsional and compressive forces can be applied to the tubular body 20, which can then be transferred to the adjacent sliding tube 40. As shown in Figures 7 to 10, as the axial force is applied to the device 10 in the direction G, the sliding tube 40 slides distally towards the core pin 30, and the proximal end 20p of the tubular body 20 is also distally displaced while the body 20 expands to form the wings 24b, 24a.
[0076] In an alternative embodiment, the slide tube 40 can be configured to remain substantially stationary while the external elongated tubular body 20 slides along an outer surface of the slide tube 40. The proximal end 40p of the slide tube can be coupled to the proximal end 20p of the tubular body 20. The core pin 30, which can be mated to the distal end 20d of the tubular body 20, can be configured to slide towards the slide tube 40 to drive the wings 24 of the body tubular 20. Although the actuation of the wings 24 is described in more detail below, in this alternative embodiment, sliding the core pin 30 in the direction of the sliding tube 40 can cause a first force to be applied to the external elongated tubular body 20 of such that the body 20 is displaced by a first distance in a proximal direction to expand and form the proximal wings 24a, and to slide the nucleus pin oil 30 additionally in the direction of the sliding tube 40 can cause a second force to be applied to the external elongated tubular body 20 such that the body 20 is displaced by a second distance in a proximal direction to expand and form the distal wings 24b . Those skilled in the art will recognize that the devices and procedures associated with actuation of the external elongated tubular body 20 can be modified, for example, actuating the distal wings 24b before activating the proximal wings 24a, without departing from the spirit of the invention on the basis, at least in part, in the other components associated with the body 20, the direction of the forces being applied to the body 20, and the desired implementation order of the wings 24.
[0077] As further shown in Figures 7 to 10, the device 10 can include an ejector tube 50 disposed within the external elongated tubular body 20 such that the slide tube 40 can slide along it. The ejector tube 50 can be substantially solid throughout to provide obstruction of the opening in which it is arranged. In general, the ejector tube 50 can include two parts, an implant part 50i and a removable part 50r. In an exemplary embodiment, the ejector tube 50 is frangible in a separable fracture 54, which separates the distal implant part 50i from the proximal removable part 50r. The separable fracture 54 can be a weakened part of the ejector tube 50, thus allowing the ejector tube 50 to be frangible. After positioning the device 10 in an opening, the ejector tube 50 can be divided into two parts 50i and 50r and the removable part 50r can be removed from the implant.
[0078] In the embodiment illustrated in Figures 1B and 7 to 10, a proximal end 50p includes a hole for receiving an insertion instrument, and a distal end 50d includes a hole for receiving a guide tip 70 and a proximal end 30p of the pin core 30. Optionally, a cable fixation 56, such as a hole, can be provided in the ejector tube 50 to allow a cable 60 to be coupled to device 10. In the illustrated embodiment, the cable fixation 60 is located on the implant part 50i and so the cable 60 can remain with the implant even after the removable part 50r is removed. In other embodiments a cable fixture can be included as an element of the removable part 50r and thus a cable associated with it can be removed after implantation. In addition, a cable fixture can be included in any of the other removable or implanted components of the device 10 as desired.
[0079] As shown in Figures 7 to 10, the distal end 50d of the ejector tube 50 can be coupled to a proximal end 30p of the core pin, and the proximal end 50p can receive an insertion instrument. Although in the illustrated embodiment the proximal end 50p extends beyond the proximal end 20p of the tubular body 20 when the tubular body is in an unimplemented configuration, in other embodiments the proximal end 50p can be flush with the proximal end 20p or terminate before it. As a result of this configuration, forces applied to the insertion instrument can be applied to the ejector tube 50, which in turn can be transferred to each of the core pin 30, the slide tube 40 and the tubular body 20.
[0080] The cable 60 can optionally be associated with the obstruction device 10, for example, by connecting to the device 10 in the cable fixing 56. The cable 60 can extend proximally to the obstruction device 10 and can help to place the device 10 in a desired location by acting as a tensioning element. For example, a user can pull the cable to position the device 10 in a desired location, or the cable 60 can work in combination with a tool or locking mechanism 90 to help maintain a location of the device 10, as described in more detail. details below. The cable 60 can be selectively disassociated from the device 10 as desired. Additionally, in modalities in which the cable is not configured to remain as part of the implant, the cable 60 can be configured to pull one or more of the components of the device or system intended to be removed from the surgical site, such as the removable part 50r of the implant. ejector tube 50. Even when cable 60 is configured to remain a component of the implanted part of device 10, cable 60 can be used to remove device 10 from the opening into which it is later implanted.
[0081] An additional component that can be used to help guide the obstruction device 10 to a desired location is an optional guide tip 70. As shown, the guide tip 70 is coupled to the proximal end 30p of the core pin 30, which in turn is coupled to the distal end 50d of the ejector tube 50. The guide tip 70 can extend through and distally beyond a distal end 30d of the core pin 30. The guide tip 70 can be substantially solid , thus occluding the opening in which the device 10 is arranged. An end end 72 of the guide tip 70 may have a variety of shapes to help provide obstruction, but in the illustrated embodiment the end end 72 is substantially spherical and has a diameter configured to obstruct an opening. In an exemplary embodiment, the diameter of the end end 72 is greater than a diameter of the elongated body of the guide tip 70. The guide tip 70 can also be substantially flexible to help direct the obstruction device 10 through a tortuous lumen.
[0082] Also another component that can be used to help direct the obstruction device 10 to a desired location is an optional proximal insertion guide 80. As shown, the insertion guide 80 can be substantially elongated and solid and, similar to the guide tip 70, it can be substantially flexible to help direct the obstruction device 10. The insertion guide 80 can be formed of various rigid and / or flexible materials, such as Nitinol® or stainless steel. In use, the insertion guide 80 can be removably and replacably attached to the proximal end 50p of the ejector 50 and extend proximally from there towards an insertion instrument. The insertion guide 80 can act as a tensioning element capable of allowing axial and rotational forces to be transmitted through it and thus to the elongated tubular body 20.
[0083] The part extending proximally of the insertion guide 80 can be received by an instrument to insert and / or position the obstruction device 10. In an embodiment illustrated in Figures 11A and 11B, the insertion instrument includes a trainer 100 ' having an external axis 102 'and a hole extending through it in which the insertion guide 80' can be arranged to couple the former 100 'to the obstruction device 10'. The device 10 'may include many of the same components as the device 10, including an elongated tubular body 20', a core pin 30 ', a slide tube 40', an ejector tube 50 ', a cable 60' and a tip. 70 'guiding. An additional connection between the former 100 ’and the obstruction device 10’ can also be made between the former 100 ’and the elongated tubular body 20’. A distal end 102d 'of the outer axis 102' may include receiving protrusions configured to be complementary to the flaps (similar to the flaps 25a of the device 10) at the proximal end of the elongated tubular body 20 'so that the former 100' can be coupled and selectively decoupled from the obstruction device 10 '.
[0084] In one embodiment, the insertion guide 80 'can be rotatably arranged within the outer axis 102' to allow the insertion guide 80 'to selectively apply compressive forces and / or torsional forces to the elongated tubular body 20'. After implantation, the external axis 102 ’can be disconnected from the obstruction device 10’, for example, by detaching the protrusions 103 ’from the flaps 25a’ and disconnecting the insertion guide 80 ’from the former 100’. In the illustrated embodiment the former 100 'is disconnected from the obstruction device 10' after the ejector tube 50 'is separated into two parts. The former 100 ', which is slidably attached to the insertion guide 80', which itself is attached to the removable part 50r 'of the ejector tube 50', is pulled proximally away from the obstruction device, thus disassociating the removable part 50r ', the insertion guide 80' and the former 100 'of the obstruction device 10'. In an alternative embodiment, the insertion guide can remain attached to the part of the device that remains in the implant location, for example, to assist later in guiding and tensioning the device instead of a cable or beyond.
[0085] The trainer 100 'can be an insertion instrument by itself. Alternatively, the former 100 'may be part of a delivery system configured to drive the former and the insertion guide, and thus the obstruction device. An exemplary embodiment of a delivery system like this is illustrated in Figure 11C. As shown, the former 100 'is coupled to the obstruction device 10' at the distal end 102d 'of the forming shaft 102', and is coupled to a driver 108 'at a proximal end 102p' of the forming shaft 102 '. The actuator 108 ’can be configured to apply various forces to the insertion guide 80’ and the former 100 ’, and thus to the obstruction device 10’. For example, actuator 108 'may include a handle 109' coupled to the insertion guide 80 'and configured to apply a first torsional force to the insertion guide 80' when the handle 109 'is rotated in a first direction R1 to cause the insertion guide 80 'rotate. The handle 109 'can also be configured to apply a compressive force to the insertion guide 80' in a direction B after rotation of the handle 109 'in the first direction R1 is complete. This actuation can cause the wings of an obstruction device to be formed. The handle 109 'can also be rotated in a second opposite direction R2 to apply a second torsional force, which can be followed by applying a compressive force in direction B to implement a second set of wings of an obstruction device. In other embodiments, there may be separate controls for applying torsional and compressive forces. The delivery system may also include a lever 107 'configured to separate an ejector tube into an implant part and a removable part. As shown, lever 107 'can be rotated in a direction C, to exert a force on the handle 109' in direction B. This movement can cause a pulling force to be exerted on the insertion guide 80 'and a compressive force in formator 100 ', thus dividing an ejector tube in its separable fracture. The delivery system can also include other controls, such as controls for selectively tensioning the 60 'cable. Those skilled in the art will recognize several other designs and types of insertion instruments, trainers and delivery systems that can be used to position the devices of the nature described in this document in openings. By way of non-limiting example, the trainers and insertion instruments disclosed in U.S. Patent #No. 7,625,392 and U.S. Patent Application Publication #No. 2010/0114128 by Coleman et al., Which were previously incorporated in their entirety by reference, can be configured for use with the devices disclosed in this document.
[0086] As shown in Figures 12 and 13A, a locking mechanism or tool can optionally be attached to the cable 60 to help maintain a location of the device 10 within the body. The locking mechanism 90 can be configured to slide along the cable 60 in two directions and to selectively lock on the cable 60 to induce tension in the cable 60. Inducing tension in the cable 60 can induce tension in the obstruction device 10, thus allowing the obstruction device 10 is kept in a desired location. Locking mechanism 90 can be initially connected to cable 60, or it can be attached to cable 60 at any time during a surgical procedure.
[0087] In the embodiment illustrated in Figures 12 and 13A, the locking mechanism 90 is cylindrical in shape and includes a threaded hole 92 for cable passage 60 and a threaded fastener 94 to selectively engage with cable 60 to lock and unlock the mechanism locking mechanism 90. As shown, threaded fastener 94 can be rotated to tighten, which causes cable 60 to be locked in position within locking mechanism 90 to lock cable 60. Threaded fastener 94 can be rotated on opposite direction to disengage the locking mechanism 90 and the cable 60, thus allowing the locking mechanism 90 to slide freely along the cable 60 in either direction. In an alternative embodiment, the threaded fastener 94 can be replaced by a key that is selectively predisposed to fit and thus tension the cable 60. Pushing the key in the direction of the cable 60 allows the locking mechanism 90 to slide in one or the other direction along the cable 60. The key can then be released to lock the locking mechanism 90 on the cable 60 and tension the cable 60 again.
[0088] Another alternative embodiment of a locking mechanism is illustrated in Figure 13B. As shown, the locking mechanism 90 'is disk-shaped, has a hole 92' disposed therein for the passage of the cable 60 ', and includes a plurality of spikes 94' extending in a proximal direction P. spikes 94 'is such that the locking mechanism 90' can only move in a distal direction D, thus additionally tensioning the cable 60 ', because any force applied in the proximal direction will cause the spikes 94' to be directed towards the cable 60 'and to lock it in position.
[0089] Figure 13C also illustrates another embodiment of a 90 "locking mechanism. This 90" locking mechanism operates similar to the anchoring and obstruction device 10. It includes an elongated tubular body 92 "having a hole 92b" disposed in the same and is configured to position the proximal and distal wings 94a "and 94b" in modes described in this document with respect to devices formed in a similar manner. As shown, the cable 60 "can be laid through at least part of the locking mechanism 90". In an exemplary embodiment, the distal wings 94b "can be positioned first and then pushed against fabric to create tension in the 60" cable. Once the desired tension in the cable 60 "is reached, the proximal wings 94a" can then be positioned, thereby locking the cable 60 "between the wings 94a" and 94b ".
[0090] Another embodiment of a device is illustrated in Figure 14. Device 110 includes many of the same components as device 10, including the illustrated external elongated tubular body 120 having a plurality of slots 122b, 122a formed therein and a former 200 having one or more protrusions 202 configured to fit in the notches 125a of the outer tubular body 120. In this embodiment, however, the distal tip 170 of the illustrated embodiment is a conical element having a helical thread 172 extending through a greater part of the distal tip 170 The distal tip 170 can be attached to a distal end 120d of the outer tubular body 120, or alternatively to one or more components disposed within the tubular body 120, such as an ejector tube (similar to ejector tube 50) or an insertion guide (similar to insertion guide 80). The distal tip 170 can be used to pierce fabric to create an opening in which to place the obstruction device 110. The distal tip 170 can be rotated clockwise to cause the helical thread 172 to advance the device 110 into the perforated fabric. . By positioning the device 110 in the desired location, wings of the outer tubular body 120 can be implemented as described in this document. In one embodiment, the distal tip 170 can be arranged in a hard material, such as bone, to prevent movement of the tubular body 120 when forces are applied to the device 110. In such an embodiment, the distal tip 170 can serve a purpose similar to the stop surface 32d and the proximal end 30p of the core pin 30, i.e., it can prevent distal movement of the external elongated tubular body 120.
[0091] In another embodiment of an implementation device, illustrated in Figures 15A and 15B, an insertion guide 280 may extend beyond a distal end 210d of the device 210. As shown in Figure 15A, prior to positioning the device 210, the insertion guide 280 extends through the entire external elongated tubular body 220, the sliding tube 240, the ejector tube 250 and the core pin 230. Thus, in this embodiment, the ejector tube 250 includes a hole arranged through it, and its break point 254 is located in it. The insertion guide 280 can be removably attached to a removable part 250r of the ejector tube 250. After wings of the outer tubular body 220 are formed, the ejector tube 250 can be divided into its implant part 250i and its removable part 250r, and the removable part 250r and the insertion guide 280 can be removed. As a result, as shown in Figure 15B, a channel 282 remains disposed through device 210. This channel 282 can be occluded by any device known to those skilled in the art, or alternatively, if obstruction is not desired, channel 282 it can remain open to allow fluid to flow through it.
[0092] Figures 16A and 16B illustrate an additional obstruction device 310 having a distal tip 370 which is in the form of an elongated pointed axis extending through device 310 and out of a distal end 330d of core pin 330. Such as shown, an intermediate part 370i that is proximal to an end end 370d of distal tip 370 is threaded and is configured to fit with complementary threads arranged in a core pin hole 330. distal tip 370 can be used to pierce fabric for create an opening in which to place the obstruction device 310. The distal tip 370 can be configured similar to the ejector tube 50 of the device 10, in which it can be frangible at a break point 374 so that an implant part 374i can remain while a removable part 370r can be removed. After implementation of the device 310, as shown in Figure 16B, the distal tip 370 can be rotated within the core pin 330 in such a way that the distal tip 370 is entirely disposed within the core pin 330. As shown, the tip distal 370 can still close the opening by extending through device 310.
[0093] In another embodiment, the device can be modified to allow fluid flow through it. For example, one embodiment of a device having an implantable flexible tubular element extending from a distal end thereof is illustrated in Figures 17A and 17B. The flexible implantable tubular element 496 is designed to be a fluid conduit, and so this modality is generally not considered to be an obstruction device. As shown, and similar to device 210, the insertion guide 480 extends through device 410 and is connected to the ejector tube 450 disposed within the outer tubular body 420. The implantable flexible tubular body 496 is coupled to a distal end 430d of the core pin 430 and extends distally parallel to at least part of the insertion guide 480. After the tubular body 420 is implemented to form the wings 424a and 424b, for example, by the insertion guide 480 and the former 500, the guide insert 480 and the former 500 can be removed in such a way that the flexible tubular element 496 allows fluid to pass through the device 410. A distal end 496d of the tubular element 496 can be coupled to a fluid path as desired.
[0094] In an alternative embodiment, the flexible tubular element 496 can be coupled to the distal end 430d of the core pin 430, but it can start in an unimplemented position in which it does not extend distally beyond the insertion guide 480. After the wings 424a, 424b of the outer tubular body 420 are implemented and the device 410 is secured in its desired location, the flexible tubular element 496 can be implemented to extend distally and function as described in this document by sliding the insertion guide 480 into one proximal direction and separate it from the positioned 410 device. Still in an additional alternative embodiment, the flexible tubular element 496 can be a positionable obstruction material that can be configured to be positioned over the hole extending through the device 410 to obstruct the hole. For example, after the insertion guide 480 is removed, the flexible tubular element 496 can be positioned to cover the bore of the device 410 and obstruction can result. Obstruction can also result simply when positioning the device 410 because the device 410 can significantly reduce the diameter of the opening in which it is arranged.
[0095] Although not illustrated, any of the alternative devices 110, 210, 310 and 410 can include a cable similar to the cable 60 of device 10. The cable can be configured to match any part of the alternative devices, depending on whether it is It is desired that the cable remains or is removed after the device has been positioned. Also, although not shown in the devices 110, 210, 310 and 410 discussed above, a slide tube similar to the slide tube 40 of the device 10 can be incorporated into these devices by those skilled in the art. The sliding tube can be attached to a proximal end of the tubular body 120, 220, 320 and 420 of each device 110, 210, 310 and 410.
[0096] Each of the components of devices 10, 110, 210, 310 and 410 can be formed from a variety of materials. Thus, each of the respective external tubular bodies, core pins, sliding tubes, ejector tubes, guiding tips, insertion guides, locking mechanisms and flexible tubular elements can be formed from a variety of materials including absorbable and non-absorbable materials . Some of the materials may be the same for the different components, while other materials may be different. Exemplary materials include, by way of non-limiting example, any resorbable materials (for example, biocompatible and / or bioabsorbable), including, for example, titanium (and titanium alloys), magnesium alloys, stainless steel, polymeric materials (synthetic and / or natural), shaped memory material such as Nitinol®, ceramic, etc. Materials that are not normally radiopaque, for example, magnesium alloys, can be enhanced and made visible by X-rays with the addition of materials visible by X-rays, such as iron oxide particles, stainless steel, titanium, tantalum, platinum, or any other suitable equivalent. In addition, non-permeable materials, such as polyethylene terephthalate and polyvinylidene chloride, and semipermeable materials, such as polylactide, can also be used to form the various components.
[0097] In general the materials used for the core pins, sliding tubes, ejector tubes and locking mechanisms can be more rigid than the materials used for the external tubular bodies, guiding tips, insertion guides and tubular elements flexible. In an exemplary embodiment, each of an external tubular body, a core pin, a sliding tube, an ejector tube and a guiding tip is formed of grade 316VLM stainless steel, an insertion guide is formed of a steel wire stainless, a locking mechanism is formed of stainless steel or Nitinol, and a flexible tubular element is formed of stainless steel. The cable can also be formed from a variety of materials, including both absorbable and non-absorbable materials. Exemplary materials include, by way of non-limiting example, polyglycolic acid, polylactic acid, polydioxanone, polypropylene and nylon. In an exemplary embodiment, a cable is formed of stainless steel.
[0098] The size and shape of the components of the devices described in this document may depend at least on the way in which they will be used and the location in which they will be positioned. In the illustrated embodiments, the devices, and thus components thereof, are generally cylindrical in shape, however other shapes can be adapted for use without departing from the spirit of the invention. In an exemplary embodiment, the device has a length L (Figure 1) in the range of about 15 millimeters to about 25 millimeters and a diameter D (Figure 1) in the range of about 1 millimeter to about 3 millimeters. In one embodiment, the length L of the device is approximately 18 millimeters and the diameter D is approximately 1.54 millimeters. Each of the components associated with this can be dimensioned and modeled accordingly.
[0099] The devices disclosed in this document can be operated in a variety of ways, depending at least in part on the features incorporated into them. However, in an exemplary use of the obstruction device 10 of Figures 1-10, a trainer is coupled to the device 10 at the proximal end 20p of the outer tubular body 20 and the insertion guide 80 is disposed within a hole in a axis of the trainer . The insertion guide 80 can be rotated and retracted proximally along the longitudinal geometric axis of the device 10 to apply to the obstruction device 10 both a torsional force in a first direction T1 and a compressive force in a proximal direction B. The application of the forces torsional and compressive results in the core pin 30 moving proximally towards the sliding tube 40 and the proximal wings 24a being implemented, as shown in Figure 8. The wings 24a can be implemented partially or entirely to achieve a desired configuration.
[00100] Once the proximal wings 24a are implemented, the insertion guide 80 can be rotated and retracted proximally along the longitudinal geometric axis of the device 10 to apply to the obstruction device 10 both a torsional force in a second opposite direction T2 as for a compressive force in the proximal direction B. The application of the torsional and compressive forces results in the core pin 30 moving further proximally in the direction of the sliding tube 40 and in the distal wings 24b being implemented, as shown in Figure 9. The wings 24b can be implemented partially or entirely to achieve a desired configuration. In an exemplary embodiment, after implementation of the distal wings 24b, as shown in Figures 9 and 10, the distal end 50d of the ejector tube 50 is contiguous with the proximal end 30p of the core pin 30.
[00101] After the obstruction device 10 is activated to its desired configuration, the trainer, as well as a part of the obstruction device, can be removed from the surgical site. This can be achieved by applying a tensile load to the system, thus causing the ejector tube 50 to be divided at the break point 54. In the illustrated embodiment, the insertion guide 80 is retracted proximally to apply a force of 50% to the ejector tube 50. traction in the proximal direction B. While this load is being applied, a force in the opposite direction G is applied to the obstruction device 10 because the tubular body 20 and the sliding tube 40 can no longer travel in the proximal direction B since the proximal end of the obstruction device 10 adjoins the distal end of the former, resulting in the force in the opposite direction G. As a result of these opposing forces in directions B and G, the ejector tube 50 is divided at the break point 54 to separate the part of implant 50i and the removable part 50r. As shown in Figure 10, the insertion guide 80 and the removable part 50r, together with the former (not shown), are removed while the distal tip 70, the core pin 30, the tubular body 20, the tube slip 40, the implant part 50i and the cable 60 remain to obstruct the opening in which the device 10 is arranged. Although not shown in Figures 1-10, the locking mechanism 90 can be slidably attached to the cable 60. The locking mechanism 90 can be selectively locked on the cable to induce tension on the cable to help maintain a location of the locking device. obstruction 10 as described herein and to induce tissue compression between the obstruction device 10 and the locking mechanism 90.
[00102] Several different areas of the body can be treated using the devices and methods revealed in this document. For example, in an exemplary embodiment illustrated in Figures 18 to 21, any of the various obstruction devices disclosed in this document can be used to repair a mitral valve leaking 2010 from a heart 2000. As shown, an 510 obstruction device similar to devices 10, 110, 210, 310 and 410 can be inserted through a wall 2002 of the heart 2000, through the right ventricle 2004, through the interventricular septum 2006, through the left ventricle 2008, through the papillary muscles 2012 and into the wall left ventricular muscle muscle 2008 where repair is desired. Prior to insertion of the 510 device, a drilling tool can be used to pre-form holes used to access the desired surgical site that are not naturally occurring in the body, or the 510 device can include a distal guiding tip configured to form perforations in tissue , similar to the tip on devices 110, 210, 310 and 410.
[00103] The device 510 can be positioned as previously described so that the wings of an external tubular body 520 engage the fabric surrounding the device 510. For example, the external elongated tubular body 520 of the device 510 can be positioned through an opening in the left ventricle 2008 to position distal slits on one side and proximal slits on the other. A rotational force in a first direction is applied to the tubular body 510 to expand the distal part 520d of the body in such a way that the distal wings fit with the outer wall 2014 of the left ventricle 2008. Subsequently, a rotational force in a second opposite direction is applied to the tubular body 510 to expand the proximal part 520p of the body. Optionally, an axial force in the distal direction can be applied as one or the other or both wings are rotated and expanded, thereby compressing a central part of the body 520 disposed between them. Any number of trainers, insertion instruments or positioning systems can be used to apply rotational and / or axial forces to the 510 device.
[00104] After positioning the device 510 in the opening, as shown in Figure 19, the instrument (s) used to position the device 510 can be removed from the surgical site. As shown, a cable 560 can be attached to a part of the device 510 that remains implanted in the opening. A locking mechanism 590 can be associated with a proximal end of the cable 560, as shown in Figure 20. The locking mechanism 590 induces tension along the cable 560 when it is slid and selectively latched along the cable 560. As tension in cable 560 increases, the external cardiac walls 2002 and 2014 are pulled closer together and thus the mitral valve leaflets 2010 are taken for coaptation, as shown in Figure 21. Those skilled in the art will be able to determine the degree of desired coaptation to eliminate mitral valve regurgitation, and thus the amount of tension desired in cable 560. The degree of need and the effect of tension on heart components can be assessed, for example, using indirect imaging devices such as transesophageal echocardiography, echocardiography transthoracic or other imaging devices.
[00105] In some embodiments, an insertion guide, similar to insertion guide 80, can be used to help position the device. Optionally, the insertion guide can remain attached to the 510 device even after implantation is complete. As a result, in a case in which the elongated tubular body 520 is positioned within the tissue in a sub-ideal position, the guide can be used to position the body 520 in a more desirable location. A guide like this can also be configured to be separable, similar to the ejector tube 50, and so a part of the guide can be removed while another part can remain attached to the 510 device. In addition, in other embodiments, it may be preferable to predispose a guide wire through the path through which device 510 is configured to pass. The 510 device can then be inserted using the guide wire to help place the 510 device in the desired location. Cable 560 can also help to deploy device 510 in its desired location, even before having a locking mechanism on it.
[00106] An alternative method for repairing a mitral valve leaking 2010 from a heart 2000 is shown in Figures 22 and 23. This method includes inserting a device 610 having an elongated tubular body 620 configured to expand, as described in this document, through a vascular structure such as the superior or inferior vena cava 2020, 2030, advance device 610 through tricuspid valve 2022, into the right ventricle 2004, through the interventricular septum 2006, through the left ventricle 2008, through the papillary muscles 2012 and into the muscular wall 2014 of the left ventricle 2008. The device 610 can be positioned in a manner similar to the method of positioning described with respect to the device 510 in such a way that the elongated tubular body 620 is positioned inside or outside the muscle wall of the ventricle left 2014. The insertion instrument (s) used to position the 610 device can then be disconnected ( s) of the device, and a cable 660 attached to the part of the device 610 that remains in the opening can extend from the elongated tubular body 620 in a proximal direction, through the ventricle chamber, and exit the heart 2000 through the right ventricular side of the interventricular septum 2006.
[00107] A locking mechanism 690 can be attached to the cable 660 and advanced along the cable 660 to tension it. As the locking mechanism 690 is advanced distally to further tension the cable 660, the interventricular cardiac wall and the left ventricular wall are pulled closer together, and thus the mitral leaflets are taken for coaptation, as shown in Figure 23 Any part of the cable 660 that extends proximally to the locking mechanism 690 can be left in place and tunneled into a subcutaneous pouch formed, for example, in the neck or subcalvicular region. By allowing the excess to remain, the tension in cable 660 can be readjusted selectively at a later date by readjusting the locking mechanism 690. Alternatively, the excess cable 660 can be cut and removed from the body via the vascular structure.
[00108] Figure 24 also illustrates an additional method for repairing a 2010 mitral valve leaking into a 2000 heart using two or more obstruction devices. The method includes inserting a first device 710 having an elongated tubular body 720 configured to expand as described in this document and a cable 760 attached to it via a 2016 aortic valve for left ventricle 2008, and then being positioned in the interventricular septum 2006 as shown or in addition to the septum 2006 and anchored to the right ventricular side of the interventricular septum 2006, for example, to the right ventricle 2004 or to the external cardiac wall 2002. Additionally, a second device 711 having an elongated tubular body 721 configured to expand as described in this document and a cable 761 attached to it is positioned on the left ventricular muscle wall 2014 as shown or inside the left ventricle 2008, as well as on the papillary muscles 2012. Each of the cables 760 and 761 can be connected via a locking mechanism 790 configured to slide along cables 760 and 761. As locking mechanism 790 is slid distally along cables 760 and 761, the interventricular septum 2006 and the left ventricular wall 2014 are pulled together together, and thus the mitral valve leaflets 2010 are taken for coaptation.
[00109] Those skilled in the art will understand that with any of the related modalities for treating a mitral valve in a heart, other valves within the heart or other valves within a patient's body in general can be treated in a similar way. Likewise, although in the illustrated modalities the devices are described as being inserted into a particular wall or chamber, those skilled in the art will understand that the devices can be positioned on other parts of tissue in the region being treated so that the tissue can be pulled further close together to close the region being treated. In addition, although particular paths are revealed to guide the devices into and through the heart, any number of paths can be used without departing from the spirit of the invention.
[00110] The devices and methods disclosed in this document can also be used to treat irregular heartbeat, sometimes referred to as cardiac dysrhythmia. An example of a cardiac dysrhythmia is atrial fibrillation. As shown in Figures 25 to 27, after a location 2050 of the abnormal cardiac conduction path within the heart muscle 2000 is identified, a device 810 having an elongated tubular body 820 configured to expand as described in this document can be inserted into the location of abnormal driving 2050 and implemented. Before separating the insertion instrument (s) from the 810 device, one or more of the components of the instrument (s) may be used as an ablation catheter. For example, as illustrated in Figure 26, an outer tube 902 of a trainer 900 can act as a single electrical pole. A second electrical pole can be formed by a back plate (not shown) in contact with the patient's external body. By passing an electrical current such as a high voltage direct current or a radio frequency source through the expanded elongated tubular body, the 2050 site of the abnormal electrical focus in the heart muscle is removed surgically. The insertion instrument (s) can then be separated from the device 810, leaving the device 810 implanted within the wall 2014 of the heart 2000 where the abnormal conduction site 2050 existed. As illustrated in Figure 27, a plurality of devices 810 can be arranged on the heart muscle in this way to help treat cardiac dysrhythmia. Using the 810 device in this mode allows for more complete transmural ablation of cardiac tissue and also reduces the likelihood of perforation of the cardiac muscle because of the sealing nature of the positioned 810 device.
[00111] Treatment is not limited to hearts. Other openings that exist naturally, such as a fallopian tube, can be blocked using the devices and methods disclosed in this document. Likewise, openings resulting from disease or defects, or even openings created as part of a surgical procedure, can also be blocked according to the devices and methods disclosed in this document.
[00112] As a non-limiting example, a treatment for sleep apnea that includes delivering devices of the nature disclosed in this document to a tongue 2100 is illustrated in Figure 28. As shown, a device 910 having an elongated tubular body 920 configured for expand to form the wings 924a and 924b as described in this document and a cable 960 extending proximally thereto is positioned in a posterior region 2100p of the tongue 2100. As shown, a locking mechanism 990 is coupled to the cable 960 and is placed close from an anterior region 2100a of the tongue 2100. In the illustrated embodiment, the locking mechanism 990 also includes an elongated tubular body 992 having the expandable wings 994a and 994b. In one embodiment, the distal and proximal wings 924b and 924a of the elongated tubular body 920 are expanded, and then tension is applied to the cable 960 to cause a space between the device 910 and the locking mechanism 990 to be reduced, preferably by dragging the device 910 towards the locking mechanism 990. This has the effect of opening the pharynx 2110, allowing more air to pass through the airway and into the lungs. Once a desired position is reached, the proximal and distal wings 994a and 994b of the locking mechanism 990 can be expanded to maintain the position of the device 910. After implementation, any insertion instruments used to implement one or the other or both of the device 910 and locking mechanism 990 can be separated and removed.
[00113] Figure 29 illustrates an additional method for treating sleep apnea using the devices and methods disclosed in this document. The method for implementing the device 910 'and the locking mechanism 990' in a language 2100 may be similar to the methods disclosed with respect to Figure 28. In the embodiment illustrated in Figure 29, however, one of the device 910 'or the locking mechanism lock 990 'can include magnetic properties in such a way that a magnetic source 998' provided in the vicinity of device 910 'or lock mechanism 990' can magnetically interact with source 998 '. As shown, the magnetic source 998 'is arranged on the outside of a throat 2120 and is configured to pull the locking mechanism 990' towards it in a M direction. As a result, tongue 2100 is pulled away from the pharynx 2110 and the space in the airway for air to pass into the lungs increases.
[00114] Modalities that are used to form a channel through an opening and thus do not obstruct the opening can also have a variety of applications. These embodiments include devices 210 and 410, however those skilled in the art will recognize that any of the devices and obstruction methods disclosed in this document can be easily adapted to perform the opposite function of allowing fluid to flow through the device.
[00115] An example of a modality in which a device is used to form a channel includes creating a junction between the end of a tubular body and a side wall of another tubular body. An application like this is illustrated in Figure 30, in which a device 1010 having an elongated tubular body 1020 configured to expand as described in this document and a flexible tubular element 1096 extending from a distal end 1020d of body 1020 creates a junction between a coronary artery 2200 and a graft structure 2220. The device 1010 can be inserted into the coronary artery 2200 in such a way that the distal end 1020d of the body 1020 is located in the direction of fluid flow from the graft 2220. The distal wings 1024b of the body 1020 they can be implemented first and then positioned adjacent to perforation 2210. Graft 2220 can then be extended distally and thus a distal end 2220d of the same is in communication with perforation 2210 in coronary artery 2200. Subsequently, the proximal wings 1024a of body 1020 can subsequently be implemented, thus locking and sealing the 2220 graft against the coronary artery 2200. The insert used to implement the device 1010 can then be separated from the device 1010 and removed from the internal lumen of the graft 2220. The proximal end 2220p of the graft 2220 can then be attached to another source blood flow. These procedures can be formed with a variety of blood vessels and graft structures. Those skilled in the art will realize additional features and advantages of the invention based on the modalities described above. In this way, the invention is not to be limited to what has been shown and described particularly, except as indicated by the appended claims. For example, although components may have been described as being separate, but coupled to one another, those skilled in the art will understand that some of these components may form a single component. Non-limiting examples include: the guide tip 70 and the core pin 30 of the device 10 and one or more of the removable part 50r of the ejector tube 50, a former and any delivery system associated therewith. Likewise, although components of a device may have been described as being coupled to a particular component, components may be coupled to other parts in some cases. As a non-limiting example, the guide tip 70 can be coupled to the core pin 30 as opposed to the implant part 50i of the ejector tube 50. Still further, those skilled in the art will understand that the devices disclosed in this document can be adapted for use in any of the techniques disclosed in this document, and likewise, the techniques disclosed in this document may be adapted for use in combination with any of the devices disclosed in this document. All publications and references cited in this document are expressly incorporated into this document by reference in their entirety.

权利要求:
Claims (18)
[0001]
1. Obstruction device (10, 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010) characterized by the fact that it comprises: an external elongated tubular body (20, 120, 220, 320, 420 , 520, 620, 720, 820, 920, 1020) having proximal and distal parts (20a, 20b), the proximal part (20a) having a plurality of proximal slits formed therein and configured to allow the proximal part to expand to form proximal wings (24a), and the distal part (20b) having a plurality of distal slits formed therein and configured to allow the distal part (20b) to expand to form distal wings (24b); an elongated guide element (30) extending distally from a distal end (20d) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and configured accordingly so that a proximal end (30p) of the guide element (30) is disposed within the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) at least before and after the proximal (24a) and distal (24b) wings are formed; and a sliding tube (40) disposed within the proximal part (20a) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and having a proximal end ( 40p) fixedly married to a proximal end (20p) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020), the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) being configured to move along an outer surface of the slide tube as the proximal and distal parts (20a, 20b) expand to form wings proximal and distal (24a, 24b), where a distal end (40d) of the sliding tube (40) adjoins a proximal end (30p) of the guide element (30) when the proximal and distal parts of the external tubular body ( 20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) are expanded to form proximal and distal wings (24a, 24b).
[0002]
2. Device according to claim 1, characterized by the fact that it still comprises a cable (60) having a distal part disposed within the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720 , 820, 920, 1020), and a proximal part (20a) extending proximally from the proximal end (20p) of the elongated external tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0003]
3. Device according to claim 2, characterized by the fact that it still comprises a locking tool (90) coupled to the cable (60) and configured to induce tension in the cable (60).
[0004]
4. Device according to claim 1, characterized in that the sliding tube (40) is configured to obstruct fluid flow through the proximal wings (24a) when the proximal part (20a) is expanded.
[0005]
5. Device according to claim 1, characterized by the fact that it still comprises an internal elongated tubular body (50) extending at least partially through the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and through the sliding tube (40).
[0006]
6. Device according to claim 5, characterized by the fact that a proximal end (30p) of the guide element (30) is fixedly married to a distal end (50d) of the internal elongated tubular body (50).
[0007]
7. Device according to claim 5, characterized in that the internal elongated tubular body (50) has a distal end (50d) that is fixedly attached to a distal tip at a distal end (20d) of the elongated tubular body external (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0008]
8. Device according to claim 5, characterized in that the internal elongated tubular body (50) includes a frangible part formed therein and configured to allow a proximal part of the internal elongated tubular body (50) to be separated from a distal part (20b) of the elongated tubular body and the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0009]
9. Device according to claim 8, characterized by the fact that it still comprises an insertion guide (80) coupled to the proximal part of the internal elongated tubular body (50), the insertion guide (80) being configured to expand and selectively compress the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and activate the frangible part of the internal elongated tubular body (50).
[0010]
10. Device according to claim 1, characterized by the fact that it still comprises a distal tip arranged at a distal end (30d) of the guide element (30), the distal tip being closed to prevent fluid from flowing through the tubular body external elongated (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0011]
11. Device according to claim 1, characterized by the fact that at least one of the guide element (30) and the sliding tube (40) is closed to prevent fluid from flowing through the elongated tubular body.
[0012]
12. Device according to claim 1, characterized in that the slits in the proximal part extend in a first direction around a circumference of the elongated tubular body, and the slits in the distal part extend in a second opposite direction around an elongated tubular body circumference.
[0013]
13. Device according to claim 1, characterized by the fact that the proximal and distal parts are configured to expand in response to a torsional force applied to them.
[0014]
14. Obstruction device (10, 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010) characterized by the fact that it comprises: an external elongated tubular body (20, 120, 220, 320, 420 , 520, 620, 720, 820, 920, 1020) having proximal and distal parts (20a, 20b), the proximal part (20a) having a plurality of proximal slits formed therein and configured to allow the proximal part (20a) expand to form proximal wings (24a), and the distal part (20b) having a plurality of distal slits formed therein and configured to allow the distal part (20b) to expand to form distal wings (24b); an elongated guide element (30) extending distally from a distal end (20d) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020); an internal elongated tubular body (50) extending at least partially through the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020); and a sliding tube (40) disposed within the proximal part (20a) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and configured to extend distally in addition to the plurality of proximal slits to prevent fluid from passing through the expanded proximal wings (24a), the sliding tube (40) having a proximal end (40p) fixedly married to a proximal end (20p) of the external elongated tubular body ( 20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and an orifice extending through it so that an inner surface of the slide tube (40) is exposed by the holes that slide into the along an external surface of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020), in the direction of the guide element (30), as far as the proximal parts and distal expand to form proximal and distal wings (24a, 24b).
[0015]
15. Device according to claim 14, characterized in that a distal end (40d) of the sliding tube (40) adjoins a proximal end (30p) of the guide element (30) when the proximal and distal parts of the external tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) are expanded to form proximal and distal wings (24a, 24b).
[0016]
16. Device according to claim 14, characterized by the fact that it still comprises a cable (60) having a distal part disposed within the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720 , 820, 920, 1020), and a proximal part (20a) extending proximally from the proximal end (20p) of the elongated external tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0017]
17. Obstruction device (10, 110, 210, 310, 410, 510, 610, 710, 810, 910, 1010) characterized by the fact that it comprises: an external elongated tubular body (20, 120, 220, 320, 420 , 520, 620, 720, 820, 920, 1020) having proximal and distal parts (20a, 20b), the proximal part (20a) having a plurality of proximal slits formed therein and configured to allow the proximal part (20a) expand to form proximal wings (24a), and the distal part (20b) having a plurality of distal slits formed therein and configured to allow the distal part (20b) to expand to form distal wings (24b); a guide element (30) coupled to and extending distally from a distal end (20d) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020), a elongated flexible distal element extending distally from the guide element (30) and through a hole defined by the guide element (30), the guide element (30) and the flexible distal element being configured to prevent the distal end (20d) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020); a sliding tube (40) disposed within the proximal part (20a) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020) and having a proximal end (40p ) fixedly married to a proximal end (20p) of the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020), the external elongated tubular body (20, 120, 220 , 320, 420, 520, 620, 720, 820, 920, 1020) being configured to move along an external surface of the slide tube (40) as the proximal and distal parts expand to form the proximal wings and distal (24a, 24b); and a cable (60) having a distal part disposed within the external elongated tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020), and extending through the sliding tube ( 40), and having a proximal end extending proximally beyond the proximal end (20p) of the elongated external tubular body (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020).
[0018]
18. Device according to claim 17, characterized by the fact that a distal tip of the flexible distal element has a diameter that is greater than the diameter of an elongated tubular body (20, 120, 220, 320, 420, 520 , 620, 720, 820, 920, 1020) of the flexible distal element.

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US10980523B1|2019-11-01|2021-04-20|Stephanie Toy|Medical device to access pericardial space with control|

法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-10-22| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-09-24| B09A| Decision: intention to grant|

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2021-01-19| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US13/333,242|2011-12-21|

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US13/333,242|US9247930B2|2011-12-21|2011-12-21|Devices and methods for occluding or promoting fluid flow|

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PCT/EP2012/076029|WO2013092636A1|2011-12-21|2012-12-18|Devices and methods for occluding or promoting fluid flow|

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