巴西专利BR112014032669B1 DEVICE WITH MULTIPLE SHOCK WAVE SOURCES

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专利摘要:
shock wave balloon catheter with multiple shock wave sources. The present invention relates to an apparatus that includes a balloon adapted to be placed adjacent to a calcified region of a body. the balloon is inflatable with a liquid. the apparatus further includes a shock wave generator within the balloon which produces shock waves which propagate through the liquid to impinge on the calcified region adjacent to the balloon. the shock wave generator includes a plurality of shock wave sources distributed within the balloon.
公开号:BR112014032669B1
申请号:R112014032669-0
申请日:2013-06-27
公开日:2021-06-22
发明作者:John M. Adams；Thomas G. Goff；Doug Hakala
申请人:Shockwave Medical, Inc.；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[001] This application claims priority to patent application no. U.S. 13/534,658, filed June 27, 2012, which is incorporated herein by reference in its entirety. BACKGROUND
[002] Aortic calcification, also called aortic sclerosis, is an accumulation of calcium deposits in the aortic valve in the heart. This often results in a heart murmur, which can easily be heard with a stethoscope over the heart. However, aortic calcification usually does not significantly affect aortic valve function.
[003] In some cases, however, calcium deposits thicken and cause narrowing in the opening of the aortic valve. This impairs blood flow through the valve, causing chest pain or a heart attack. Doctors refer to such a narrowing as aortic stenosis.
[004] Aortic calcification typically affects older adults. But when it occurs in younger adults, it is often associated with an aortic valve defect that has been present from birth (congenital) or with other illnesses such as kidney failure. An ultrasound of the heart (echocardiogram) can determine the severity of the aortic calcification and also prove other possible causes of a heart murmur.
[005] Currently there is no specific treatment for aortic calcification. General treatment includes monitoring for further developments of heart disease. Cholesterol levels are also checked to determine the need for cholesterol-lowering medications in the hope of preventing progress of aortic calcification. If the valve becomes severely narrow, aortic valve graft surgery may be necessary.
[006] The aortic valve area can be opened or enlarged with a balloon catheter (balloon valvuloplasty), which is introduced in a very similar way to cardiac catheterization. With balloon valvuloplasty, the area of the aortic valve typically increases slightly. Patients with critical aortic stenosis can therefore experience temporary improvement with this procedure. Unfortunately, most of these valves narrow over a period of six to 18 months. Therefore, balloon valvuloplasty is useful as a short-term measure to temporarily relieve symptoms in patients who are not candidates for aortic valve prosthesis.
[007] Patients who require urgent non-cardiac surgery, such as a hip replacement, may benefit from aortic valvuloplasty prior to surgery. Valvuloplasty improves cardiac function and chances of survival from non-cardiac surgery. Aortic valvuloplasty can also be useful as a bridge to aortic valve prosthesis in the elderly patient with poorly functioning ventricular muscle. Balloon valvuloplasty can temporarily improve ventricular muscle function and thereby improve surgical survival. Those who respond to valvuloplasty with improved ventricular function are expected to benefit even more from the aortic valve prosthesis. Aortic valvuloplasty in these high-risk elderly patients has a similar mortality (5%) and serious complication rate (5%) as aortic valve prosthesis in surgical candidates.
[008] The transarterial aortic valve prosthesis is a new procedure in which the aortic valve is replaced by a self-expanding balloon or nitinol-expandable valve structure. Such procedures benefit from a smooth, non-calcified circumference to secure the new valve. Large calcium deposits can cause leakage around the valve, preventing consistent attachment and shape of the valve to the aorta. Thus, there is a need for a calcium-free valve bed to secure such self-expanding valves.
[009] An alternative method and system for treating stenotic or calcified aortic valves is disclosed and claimed in copending application no. U.S. 12/611,997, filed November 11, 2009, for ONDA DE SHOCK VALVULOPLASTY SYSTEM. As described herein, a balloon is placed adjacent to leaflets of a valve to be treated and is inflatable with a liquid. Inside the balloon is a shock wave generator that produces shock waves that travel through the liquid and impinge on the valve. Incident shock waves soften, break and/or loosen the calcified regions for removal or displacement to open the valve or widen the valve opening.
[0010] The approach mentioned above provides a more tolerable treatment for aortic stenosis and calcified aortic valves than the previously performed aortic valve prosthesis. It is also a more effective treatment than current valvuloplasty therapy. For patients undergoing catheter-based or transaotic aortic valve prostheses, this new method can smooth and open the annular space of the aortic valve more effectively than current valvuloplasty and prepare the area for a released valve by catheter.
[0011] In the shock wave valvuloplasty described above, the impact intensity of the shock waves decreases as a function of the distance from the point of origin of the shock wave to the valve. More specifically, the shock intensity of the shock waves is inversely proportional to the square of the distance from the point of origin of the shock wave to the valve. Therefore, under the application of shock waves, it would be desirable to maximize their effectiveness in order to be able to minimize the distance between the shock wave source and the location of the valve being treated at that moment.
[0012] Similar problems are present in angioplasty. In this, a calcified region of a vein or artery may extend over some longitudinal distance from the vein or artery. A point shock wave source inside an angioplasty balloon, in such cases, would not be uniformly effective across the extension of the calcified region, due to the varied distance from the shock wave source to the various parts of the calcified region.
[0013] The present invention addresses this and other matters of importance in providing the most efficient and effective possible treatment of valvuloplasty and angioplasty. SUMMARY
[0014] In one embodiment, an apparatus comprises a balloon adapted to be placed adjacent to a calcified region of a body. The balloon is inflatable with a liquid. The apparatus further includes a shock wave generator within the balloon which produces shock waves which propagate through the liquid to impinge on the calcified region adjacent to the balloon. The shock wave generator includes a plurality of shock wave sources distributed within the balloon, wherein the plurality of shock wave sources is more than two shock wave sources. These shock wave sources can be distributed both longitudinally and circumferentially within the balloon for optimal effect.
[0015] The balloon is elongated with a longitudinal dimension along its length and the plurality of shock wave sources extend along a portion of the longitudinal dimension. The balloon has a sidewall and the shock wave sources are in a non-touch relationship to the sidewall of the balloon. The shock wave generator may be an electric arc shock wave generator and the shock wave sources may include a plurality of electrodes. The electric arc shockwave generator may additionally include at least one counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite a voltage polarity applied to the plurality of electrodes.
[0016] The shock wave generator may include an elongated conductor and an insulator that overlaps the elongated conductor. The insulator may have a plurality of distinct openings, each opening to expose the elongated conductor to the fluid, to form the plurality of electrodes. An insulated wire can be employed to form the elongated conductor and the superimposed insulator.
[0017] The apparatus may additionally include an elongated carrier. The carrier can extend through the balloon and be sealed to it. The insulated wire can be wrapped around the carrier inside the balloon. The carrier may include a guidewire lumen. The insulated wire may be wound around the carrier to form electrode coil turns and the apparatus may additionally include a lead wire wound around the carrier within the balloon and between the electrode coil turns to form the counter electrode.
[0018] The shock wave generator may include an elongated cylindrical conductor and an insulator that overlaps the elongated cylindrical conductor. The insulator may have a plurality of distinct openings, each opening to expose the elongated cylindrical conductor to the fluid to form the plurality of electrodes. The apparatus may additionally include an elongated carrier which extends through the balloon and is in sealed relationship thereto. The elongated cylindrical conductor can overlap the carrier within the balloon. The elongated carrier may include a guidewire lumen.
[0019] The shock wave generator may be an electric arc shock wave generator, wherein the shock wave sources include a plurality of electrodes, wherein the apparatus additionally includes an elongated carrier having a longitudinal dimension extending through the balloon and being in sealed relationship thereto, wherein the elongate carrier has a guidewire lumen that extends along at least a portion of the longitudinal dimension of the elongate carrier, and wherein at least some of the plurality of electrodes are distributed along the elongated carrier within the balloon.
[0020] The elongated carrier can be formed of an insulating material. The shock wave generator may include at least one conductor extending within the elongated carrier spaced apart from the guidewire lumen and along at least a portion of the longitudinal dimension of the elongated carrier and a plurality of distinct parts of the material. elongated carrier insulator is removed to expose corresponding portions of the at least one conductor to form the at least some of the plurality of electrodes. At least some of the discrete parts removed from the elongated carrier insulating material may contain a conductive filler. Conductive fillers can be conductively attached to the elongated conductor.
[0021] The elongated carrier can be formed of an insulating material. The shock wave generator may include at least first and second elongated conductors extending within the elongated carrier with spaced relation to each other and the guidewire lumen and along at least a portion of the longitudinal dimension of the carrier. elongated. A plurality of discrete portions of the elongated carrier insulating material may be removed to expose corresponding portions of the at least first and second conductors to form the at least some of the plurality of electrodes.
[0022] The discrete parts removed from the elongated carrier insulating material that expose the corresponding parts of one of at least first and second conductors are greater in dimension than the discrete parts removed from the elongated carrier insulating material that expose the corresponding parts of one of the at least first and second conductors. The at least some of the discrete portions removed from the elongated carrier insulating material can contain a conductive filler and at least some of the conductive fillers can be conductively attached to the elongated conductors.
[0023] The plurality of electrodes are arranged in a series circuit relationship. Alternatively, the plurality of electrodes are arranged in parallel circuit relationship. The apparatus may additionally include a power supply and a multiplexer that selectively couples the power supply to the plurality of electrodes, one at a time. In another embodiment, the plurality of electrodes may be arranged in a plurality of series circuit arrangements and the apparatus may additionally include a multiplexer that selectively couples the power supply to the series circuit arrangements one at a time.
[0024] The plurality of shock wave sources can be disposed along a path that defines a cycle. The balloon can be configured to be placed adjacent to leaflets of a valve, the balloon having a first chamber being adjacent to one side of the leaflets and a second chamber being adjacent to an opposite side of the leaflets. The plurality of shockwave sources may be arranged to define a cycle of shockwave sources within one of the first and second chambers of the balloon.
[0025] The balloon can be configured to be placed adjacent to leaflets of a valve, the balloon having a first chamber being adjacent to one side of the leaflets and a second chamber being adjacent to an opposite side of the leaflets, and in that the plurality of shock wave sources may be arranged to define a first cycle of shock wave sources within the first chamber of the balloon and a second cycle of shock wave sources within the second chamber of the balloon.
[0026] According to another embodiment, an apparatus comprises an elongated carrier and a balloon loaded on the elongated carrier in a sealed relationship thereto. The balloon is adapted to be placed adjacent to a calcified region of a body and is inflatable with a liquid. The apparatus additionally includes an electric arc shock wave generator within the balloon. The electric arc shock wave generator includes more than two electrodes distributed within the balloon. Each electrode is adapted to produce shock waves that propagate through the liquid to impact the calcified region adjacent to the balloon. The apparatus further includes a counter electrode adapted to be in contact with the liquid and to receive a voltage polarity opposite to that applied to more than two electrodes.
[0027] In a further embodiment, a method includes the steps of inserting a balloon into a body adjacent to a calcified region, inflating the balloon with a liquid to bring the balloon into contact with the calcified region, placing, within the balloon, a shockwave generator that includes more than two shockwave sources and distributes more than two shockwave sources within the balloon, and causes the shockwave sources to form propagating shockwaves through the liquid and affect the calcified region.
[0028] The insertion step may include inserting the balloon into an artery or vein in the body. The balloon may be elongated having a longitudinal dimension and the dispensing step may include distributing the shock wave sources along a portion of the longitudinal dimension.
[0029] The insertion step may include inserting the balloon into a valve in the body. The distribution step may include distributing the shock wave sources along a trajectory that defines a cycle.
[0030] The balloon can be configured to be placed adjacent to valve leaflets and to have a first chamber adapted to be adjacent to one side of the leaflets and a second chamber adapted to be adjacent to an opposite side of the leaflets. The insertion step may include inserting the balloon into the valve with the first chamber adjacent to one side of the leaflets and the second chamber adjacent to the opposite side of the leaflets. The dispensing step may include distributing the shock wave sources along a path that defines a cycle of shock wave sources within one of the first and second chambers of the balloon.
[0031] In yet another embodiment, the balloon is configured to be placed adjacent to valve leaflets, wherein the balloon has a first chamber to be adjacent to one side of the leaflets and a second chamber to be adjacent to an opposite side of the leaflets, wherein the insertion step includes inserting the balloon into the valve with the first chamber adjacent to one side of the leaflets and the second chamber adjacent to the opposite side of the leaflets, and wherein the dispensing step includes distributing the shock wave sources to define a first cycle of shock wave sources within the first chamber of the balloon and to define a second cycle of shock wave sources within the second chamber of the balloon.
[0032] The balloon has a sidewall and the delivery step may include distributing the shock wave sources in a non-touch relationship with respect to the sidewall of the balloon. The shock wave generator may be an electric arc shock wave generator, the shock wave sources may include a plurality of electrodes, and the step of causing may include applying voltage pulses between the plurality of electrodes and a counter electrode to form the shock waves.
[0033] According to another modality, one method comprises inserting a balloon into a body adjacent to a calcified region, inflating the balloon with a liquid to make the balloon contact the calcified region, placing it inside the balloon, more than two electrodes in a non-touch relation to the balloon and adjacent to the calcified regions, place a counterelectrode in contact with the liquid and apply voltage pulses between the more than two electrodes and the counterelectrode, in which the voltage pulses have a first polarity applied to the two or more electrodes and a second polarity applied to the counterelectrode, which causes more than two electrodes to form shock waves that propagate through the liquid and impinge on the calcified region. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The features of the present invention that are considered innovative are presented with particularity in the attached claims. The various described embodiments of the invention, together with representative features and advantages thereof, may be better understood by referring to the following description taken in conjunction with the attached drawings, in the various figures, whose similar reference numbers identify identical elements , and where:
FIGURE 1 is a simplified drawing of an angioplasty system embodying the invention, which includes a side view of a dilatation angioplasty balloon catheter that includes a plurality of shock wave sources, in accordance with a modality;
[0036] FIGURE 2 is a side view of the catheter of FIGURE 1 showing an alternative electrode structure that may be employed within the angioplasty dilatation balloon catheter of FIGURE 1;
[0037] FIGURE 3 is a side view of the catheter of FIGURE 1 showing yet another alternative electrode structure that may be employed within the angioplasty dilatation balloon catheter of FIGURE 1;
[0038] FIGURE 4 is a partial sectional view illustrating alternative aspects of the electrode structure of FIGURE 3 for providing the plurality of shock wave sources;
FIGURE 5 is a side view of another angioplasty dilatation balloon catheter that includes a plurality of shock wave sources, in accordance with a further embodiment of the invention;
[0040] FIGURE 6 is a perspective view illustrating a way in which an electrode structure of the catheter of FIGURE 5 can be produced to provide the plurality of shock wave sources, in accordance with an embodiment of the invention;
[0041] FIGURE 7 is another perspective view illustrating another aspect of the electrode structure of FIGURE 5, according to an embodiment of the invention;
[0042] FIGURE 8 is a simplified schematic diagram of a shock wave angioplasty system embodying the invention, in which the electrodes of the shock wave source are arranged in a parallel circuit;
[0043] FIGURE 9 is a simplified side view of the left ventricle, aorta and aortic valve of a heart with a valvuloplasty treatment catheter, embodying the invention, within the aortic valve of the heart;
[0044] FIGURE 10 is a perspective view, on an enlarged scale, of the electrode structure employed in the valvuloplasty catheter of FIGURE 9;
[0045] FIGURE 11 is another simplified side view of the left ventricle, aorta and aortic valve of a heart with a dual chamber valvuloplasty treatment catheter, embodying the invention, within the aortic valve of the heart;
[0046] FIGURE 12 is a partial side view, on an enlarged scale, of an angioplasty catheter with an electrode structure that can be employed in the embodiments herein, in which the electrodes are arranged in a series circuit;
[0047] FIGURE 13 is a simplified schematic diagram of a shock wave angioplasty system embodying the invention, wherein the electrodes of the shock wave source are circuited in series;
[0048] FIGURE 14 is a simplified schematic diagram of a shock wave angioplasty system embodying the invention, in which the shock wave source electrodes are disposed in multiple circuits in series with each circuit in series being individually activated ;
[0049] FIGURE 15 is a simplified drawing of another angioplasty system embodying the invention, which includes a side view of an angioplasty dilatation balloon catheter that includes a plurality of shock wave sources that are selectively coupled to a power supply, one at a time, according to another modality; and
[0050] FIGURE 16 is a timing diagram illustrating the way in which the electrodes of FIGURE 15 can be selectively coupled to a power source. DETAILED DESCRIPTION
FIGURE 1 shows an angioplasty system 10 embodying the invention that includes an angioplasty dilatation balloon catheter 20 that includes a plurality of shock wave sources, in accordance with an embodiment of the invention. Catheter 20 includes an elongated carrier 21 and an expansion balloon 26 formed over the carrier 21 in sealed relationship thereto at a seal 23. The balloon 26 forms an annular channel 27 over the carrier 21, through which fluid such as as a saline solution, it can be admitted into the balloon to inflate the balloon. Carrier 21 includes a guidewire lumen 29. The guidewire lumen is arranged to receive a guidewire that can be used to direct the catheter to a desired location to locate the balloon adjacent to a region of an artery or artery. vein that is treated.
[0052] An electrode structure 40 is carried by the carrier 21. The electrode structure 40 includes an insulated wire 42 wrapped around the carrier 21. Within the insulation of the insulated wire 42 are a plurality of apertures 44 that expose the corresponding discrete parts of the insulated wire conducting the saline solution inside the balloon. Each opening 44 forms a corresponding electrode or shock wave source 46. As can be seen in FIGURE 1, a plurality of more than two electrodes is formed in this manner and in a non-touch relationship to the side walls of the balloon 26.
[0053] The electrode structure 40 also includes a counter electrode 24. The counter electrode 24 is disposed in non-touch relationship to the side walls of the balloon 26 and serves as a common electrode to cause an electrical arc to occur between each of the electrodes 46 and the common electrode 24, when a suitable high voltage is applied between the electrodes 46 and the counter electrode 24.
[0054] For this purpose, electrodes 24 and 46 are fixed to a source 30 of high voltage pulses through a connector 32. Electrodes 24 and 46 are formed of metal, such as stainless steel or tungsten, and are placed at a controlled distance away to allow a reproducible arc for a given voltage and current. Electric arcs between electrode 24 and electrodes 46 in the fluid are used to generate shock waves in the fluid. Variable high voltage pulse generator 30 is used to release a flow of pulses through electrode 24 and electrodes 46 to create a flow of shock waves within and along longitudinal length 25 of balloon 26 and within the artery that is. treated (not shown). The magnitude of shock waves can be controlled by controlling the magnitude of pulsed voltage, current, duration and repetition rate. The insulating nature of balloon 26 protects the patient from electrical shock.
[0055] The balloon 26 can be filled with water or saline in order to gently fix the balloon to the artery walls in direct proximity to the calcified lesion. The fluid may also contain an x-ray contrast for fluoroscopic visualization of the catheter during use. As mentioned earlier, carrier 21 includes a lumen 29 through which a guidewire (not shown) can be inserted to guide the catheter into position. Once the catheter is positioned using the guidewire (not shown) and guidewire lumen 29, the physician or operator can start with low energy shock waves and increase energy as needed to break the calcified plaque. Such shock waves will be conducted through the fluid, through the balloon, through the blood and vessel wall to the calcified lesion, where the energy will break through the hardened plaque without excessive balloon pressure being applied to the artery walls.
[0056] The voltage required to produce the arcs will depend on the span between the electrodes and is generally 100 to 3000 volts. The pulse duration will also depend on the surface area of electrodes 24 and 46 and needs to be sufficient to generate a gas bubble on the electrode surface to cause a plasma arc of electric current to jump each bubble and, under each occurrence, create a rapidly expanding, collapsing bubble, which creates the mechanical shock wave in the balloon. Such shock waves can be as short as a few microseconds. Both the expansion and rapid collapse of a bubble create shock waves. Pulse duration can be adjusted to favor one over the other. A large vapor bubble will generate a stronger shock wave than a small one. However, more power is needed in the system to generate this large steam bubble. Traditional lithotriptors attempt to generate a large vapor bubble to maximize the collapsing bubble's shock wave. Inside a balloon, such large vapor bubbles are less desirable because of the risk of balloon rupture. By adjusting the pulse width to a narrow pulse of less than two microseconds or even less than a microsecond, a rapidly expanding vapor bubble and shock wave can be generated, while the final vapor bubble size can be minimized . The short wrist width also reduces the amount of heat in the balloon to improve fabric safety.
[0057] FIGURE 2 shows another electrode structure 140 that may be employed in catheter 20 of FIGURE 1. Similar to the electrode structure of FIGURE 1, electrode structure 140 of FIGURE 2 includes an insulated wire 142 wound over carrier 21 to form electrode coil turns 144. Within the insulation of the insulated wire 142 are a plurality of openings 146 that expose the corresponding discrete portions of the insulated conductor wire to the saline solution within the balloon. Each opening 146 forms a corresponding electrode or shock wave source 148.
[0058] Electrode structure 140 additionally includes a lead wire wound about carrier 21 within balloon 26. Lead wire 150 is wound between turns of electrode coil 144 to form a counter electrode 152. This provides more uniform spacing. between electrodes 148 and counter electrode 152. All electrodes 148 and 152 are disposed in non-touch relationship to the side walls of balloon 26.
[0059] FIGURE 3 shows another electrode structure 240 that may be employed in the catheter 20 of FIGURE 1. Here, the electrode structure 240 of catheter 20 includes an elongated cylindrical conductor 242 formed of metal, such as stainless steel or tungsten, overlying carrier 21. Electrode structure 240 additionally includes an insulator 244 that overlies elongated cylindrical conductor 242. Insulator 244 has a plurality of distinct apertures 246 that expose corresponding areas of the elongated cylindrical conductor to saline within the balloon 26. Each opening 246 forms a corresponding electrode 248. Another electrode 250 forms a common electrode. All electrodes 248 and 250 are disposed in non-touch relationship to the sidewalls of balloon 26.
[0060] FIGURE 4 is a partial sectional view illustrating alternative aspects of the electrode structure 240 of FIGURE 3 for providing the plurality of shock wave sources. Here, at least some of the openings 246 are filled with a conductive material to form the electrodes 249. The conductive filling that forms electrodes 249 can be the same material that forms the conductive cylinder 242 or it can be of a different conductive material. It serves to raise the surface of the electrodes above the insulator 244, which, in some cases, can result in more reliable arcing.
[0061] Referring now to FIGURE 5, is a side view of another angioplasty dilatation balloon catheter 320 that includes a plurality of shock wave sources in accordance with a further embodiment of the invention. Again, catheter 320 includes an elongated carrier 321 and an angioplasty dilating balloon 326 at the distal end thereof, in sealed relationship thereto. Balloon 326 and carrier 321 form a channel 327 through which the balloon can be filled with a liquid, such as water or saline. Carrier 321 also includes a guidewire lumen 329 that is adapted to receive a guidewire 330.
[0062] Catheter 320 additionally includes an electrode structure 340 that includes a first plurality of electrodes 332 and a second plurality of electrodes 342. Electrodes 332 and 342 are disposed in a non-touch relationship to the side walls of balloon 326 During the angioplasty treatment, a voltage having a first polarity is applied to the first plurality of electrodes 332 and a reverse polarity is applied to the second plurality of electrodes 342. If the voltage across electrodes 332 and 342 is applied as described above, an arc will form between the matching pairs of electrodes 332 and 342 to produce matching shock waves. In this way, shock waves are produced along the longitudinal dimension of balloon 326.
[0063] It can be seen in FIGURE 5 that the 332 electrodes are larger in size and have a greater surface area in contact with the saline solution in the balloon than the 342 electrodes. This reduces the impedance to plasma arc formation, allowing that plasma arcs are produced shortly after voltage is applied to the electrodes. This has also been found to cause larger plasma arcs to form, producing stronger shock waves. This further helps in controlling the electrodes through which the electrical arcs will be produced.
[0064] FIGURE 6 is a perspective view illustrating a way in which an electrode structure of the catheter of FIGURE 5 can be produced to provide the plurality of shock wave sources, in accordance with an embodiment of the invention. In FIGURE 6, it can be seen that electrode structure 340 includes a first conductor 344 and a second conductor 346. Conductors 344 and 346 extend along and into carrier 321. Conductors 344 and 346 can be made to extend along and inside the carrier 321 by co-extruding the conductors 344 and 346 with the elongated carrier during the manufacture of the carrier 321. After the extrusion process, openings 348 and 350 can be formed in the carrier 321 to expose the parts. corresponding conductors 344 and 346. This results in the formation of electrodes 332 and 342, respectively. FIGURE 7 shows that openings, such as opening 350 formed in carrier 321, can be filled with a conductive filler to form electrode 342.
[0065] FIGURE 8 is a simplified schematic diagram of a shock wave angioplasty system 410 embodying the invention, wherein the shock wave source electrodes are arranged in a parallel circuit. For purposes of this description, catheter 320 of FIGURE 5 should be used for illustration. The system includes a high voltage generator 430, a connector 432, and a catheter 320. Catheter 320 includes the first plurality of electrodes 332 and a second plurality of electrodes 342. Each electrode of the first plurality of electrodes 332 finds a corresponding electrode on the second plurality of electrodes 342. Connector 422 connects each of the electrodes of the first plurality of electrodes 332 to the positive (+) side of the voltage generator 430 through a resistor R and each of the electrodes of the second plurality of electrodes 342 to the negative side ( -) of the 430 voltage generator. Resistance R can be supplied through individual resistive elements or through the resistivity in the conductors that connect the electrodes to the connector and are provided to equalize the current available for each pair of electrodes. This ensures that no electrode pairs dissipate the available current, eliminating all other electrode pairs from producing an arc flash.
FIGURE 9 is a simplified side view of the left ventricle 500, aorta 502 and aortic valve 504 of a heart with a valvuloplasty treatment catheter 510 embodying the invention within the aortic valve of the heart. Catheter 510 includes a treatment balloon 526 placed on either side of the aortic valve leaflets 506. Heart valves, such as aortic valve 504, can become stenotic and calcified. More particularly, the valve opening defined by the leaflets can become stenotic and calcified. This can restrict the size of the opening as the 506 valve leaflets are thickened with calcium deposits and fibrous tissue. The 506 thick leaflets and smaller valve opening restrict blood flow from the heart, creating overwork for the heart and poor cardiac output. Current treatment includes valve replacement or attempts to stretch the annular space of the valve with a balloon.
[0067] Treatment balloon 526 includes two longitudinally spaced chambers 528 and 530 placed on opposite sides of aortic valve leaflets 506. Balloon 526 may be made of a malleable or non-malleable material. The balloon is at the distal end of a carrier 521. The catheter is placed in position by an elongated delivery tube 532.
[0068] The two longitudinally spaced chambers 530 and 528 share a common inflation lumen 534 of carrier 521 to allow balloon 526 to be filled with a liquid, such as saline. Alternatively, balloon chambers 530 and 528 may not share the same inflation fluid path.
[0069] Catheter 510 includes a plurality of shock wave sources that produce electrical arcs within the balloon to produce shock waves within the confined liquid. Shock waves propagate through the liquid and hit the balloon wall and valve. Incident shock waves cause the calcified material on the valve to rupture and/or soften. This allows the valve opening to be widened or calcified material to be removed.
[0070] In accordance with the embodiment of FIGURE 9, catheter 510 includes an electrode structure 540 within balloon chamber 528. Electrode structure 540 can be seen in greater detail in FIGURE 10. The electrode structure generally includes a plurality of electrodes 542 distributed in a path defining a cycle and a common electrode or counter electrode 544. distinct part of the insulation removed to form the electrodes. Each of the electrodes 542 forms a shock wave source. As seen in FIGURE 9, electrodes 542 are arranged to be in non-touch relationship to the side walls of balloon 526.
[0071] In use, a polarity, such as, for example, the positive polarity, of the arc voltage can be applied to the plurality of electrodes 542. The negative polarity can be applied to the counter electrode 544. 542 electrodes are distributed throughout the cycle, as shown, the spacing between the electrodes and the valve will remain essentially constant to enable the entire aortic valve to be treated without diminished shock wave intensities.
[0072] FIGURE 11 is another simplified side view of the left ventricle 500, aorta 502 and aortic valve 504 of a heart with another valvuloplasty treatment catheter 610 embodying the invention, within the aortic valve of the heart. Catheter 610 includes a treatment balloon 626 placed on either side of the aortic valve leaflets 506. The treatment balloon 626 includes two longitudinally spaced chambers 628 and 630 placed on opposite sides of the aortic valve leaflets 506. The balloon 626 may be produced by a malleable or non malleable material. The balloon is at the distal end of a carrier 621. The catheter is placed in position by an elongated delivery tube 632.
[0073] The two longitudinally spaced chambers 630 and 628 share a common inflation lumen 634 of carrier 621 to allow balloon 626 to be filled with a liquid, such as saline. Alternatively, balloon chambers 630 and 628 may not share the same inflation fluid path.
[0074] Each of the balloon chambers 628 and 630 of the catheter 610 includes a plurality of shock wave sources that produce electrical arcs within their respective balloon chambers to produce shock waves within the confined liquid. Shock waves propagate through the liquid and hit the balloon wall and valve. Incident shock waves cause the calcified material on the valve to rupture and/or soften. This allows the valve opening to be widened or calcified material to be removed.
[0075] According to the embodiment of FIGURE 11, catheter 610 includes an electrode structure 640A and 640B within balloon chambers 628 and 630, respectively. The electrode structures can take the form of electrode structure 540, as shown in FIGURE 10. Due to the fact that the electrodes are distributed in each balloon chamber 628 and 630 over a cycle, as shown, the spacing between the electrodes and the valve on each side of the valve will remain essentially constant to enable both sides of the entire aortic valve to be treated without diminished shock wave intensities.
[0076] FIGURE 12 is a partial side view, on an enlarged scale, of an angioplasty catheter with an electrode structure that can be employed in the embodiments herein, in which the electrodes are arranged in a series circuit. Catheter 710 can be seen to include an angioplasty balloon 726 that is loaded into the distal end of an elongated insulated carrier 721 in sealed relationship thereto. As in previous embodiments, the carrier has a 729 guidewire lumen.
Embedded within carrier 721 is a conductor 740 that extends to the distal end of the carrier and then back toward the proximal end as shown. At points along carriage 721 and conductor 740, portions of carriage 721 are removed. The corresponding parts of the conductor are also removed. Each part of the conductor removed forms a pair of electrodes. For example, removed portion 742 forms a pair of electrodes 743. Similarly, removed portions 744 and 746 form electrode pairs 745 and 747, respectively. One side of openings 742, 744, and 746 is coated with a conductive material to make an electrode 743a, 745a, and 747a of each electrode pair larger in surface area than its other corresponding electrode.
[0078] Each of the electrode pairs 743, 745 and 747 forms a shock wave source. As can be seen in FIGURE 13, the electrode pairs 743, 745 and 747 are arranged in a series circuit. They are connected to a 730 high voltage source via a 732 connector. The larger electrode 743a, 745a and 747a of each electrode pair ensures that all of the electrode pairs reliably arc when high voltage is applied across the sequence of shock wave sources.
[0079] FIGURE 14 is a simplified schematic diagram of a shock wave angioplasty system 800 embodying the invention, in which the shock wave source electrodes are disposed in multiple circuits in series, with each circuit in series being individually activated. To that end, the 800 system includes 802, 804, and 806 series circuits of electrode pairs connected to a multiplexer 734 through a 732 connector. The multiplexer is arranged to connect a high voltage source 730 through each 802 series circuit , 804 and 806 individually, one at a time, or in any combination.
[0080] FIGURE 15 is a simplified drawing of another angioplasty system 900 embodying the invention, which includes a side view of an angioplasty dilatation balloon catheter 910 that includes a plurality of shock wave sources that are coupled to selectively to a power source, one at a time, according to another embodiment, and FIGURE 16 is a timing diagram illustrating the manner in which the electrodes of FIGURE 15 can be selectively coupled to a power source. . System 900 includes a catheter 920 and high voltage power supply 930, and a connector 934. Catheter 920 includes an angioplasty balloon 926 loaded into a carrier 921 in a sealed relationship thereto and arranged to be inflated by a liquid, such as saline solution. Catheter 920 also includes electrodes 940, 942 and 944 loaded onto carrier 921 in non-touch relationship to the side walls of balloon 926, and a counter electrode 946, also loaded onto carrier 921. Electrodes 940, 942 and 944 are connected, each to a multiplexer 934 from the 930 high voltage source. When an electrode is activated, a high voltage from the 930 source is applied across an electrode selected from the electrodes and the counter electrode to create an electric arc. The electric arc causes a plasma to be formed. The creation of the plasma causes a shock wave. Therefore, each electrode 940, 942 and 944 forms a shock wave source. Shock waves are propagated through the liquid to impact the sidewall of the balloon and the calcium deposit to disrupt the calcium deposit.
[0081] As can be seen in FIGURE 16, the multiplexer 934 can activate the shock wave sources one at a time. This reserves all the high voltage for each shockwave source to thereby form maximum intensity shockwaves to be applied to all calcium deposits along the balloon. Shock waves can be of repeatable intensity. Longitudinal movement of the catheter to treat calcium deposits is not required. [0082] While particular embodiments of the present invention have been shown and described, modifications may be made and it is therefore intended to include all such changes and modifications that are encompassed by the true spirit and scope of the invention.

权利要求:
Claims (16)
[0001]
1. A device comprising: an axially extended elongated element (721); a balloon (726) surrounding a portion of the elongated element, the balloon being fillable with a conductive liquid, characterized in that it further comprises: a first pair of electrodes having spaced first and second electrodes (743, 7443a ) and a second pair of electrodes having the first and second electrodes spaced apart (745, 745a), the electrode pairs being located within and spaced from the balloon (726) and within the conductive liquid, wherein the pairs of electrodes are configured to produce shock waves that propagate through the liquid; and a high voltage source (730) connectable to the first electrode of the first pair of electrodes, the second electrode of the first pair being connected to the first electrode of the second pair, and the second electrode of the second pair being connectable to the source of high voltage, and wherein, when a high voltage pulse is supplied to the first and second pairs of electrodes, a first arc is generated in the conducting liquid allowing current to flow through the first pair of electrodes and a second arc is generated in the conductive liquid allowing current to flow through the second pair of electrodes, thus creating a series connection extending from the first electrode in the first pair of electrodes to the second electrode in the second pair.
[0002]
2. Device according to claim 1, characterized in that one electrode in each pair has a surface area greater than the surface area of the other electrode in the pair.
[0003]
3. Device according to claim 1 or 2, characterized in that it further includes a third pair of electrodes that have the first and second electrodes spaced apart (747, 747a), the second electrode of the second pair of electrodes is connectable to the first electrode of the third electrode pair and the second electrode of the third electrode pair is connectable to the high voltage source.
[0004]
4. Device according to claim 1 or 2, characterized in that it further includes a third pair of electrodes that have the first and second electrodes spaced apart (804) and a fourth pair of electrodes that have the first and the second electrodes spaced apart (804), the second electrode of the third electrode pair being connected to the first electrode of the fourth electrode pair, wherein the device further includes a multiplexer (734) to selectively connect the high voltage source to the first and to the second pair of electrodes or to the third and fourth pairs of electrodes.
[0005]
5. Device according to claim 4, characterized in that the second electrode of the second pair of electrodes and the second electrode of the fourth pair of electrodes are connectable to a common conductor, which provides a return path to the source of high voltage.
[0006]
6. Device according to any one of claims 1 to 5, characterized in that at least two of the pairs of electrodes are spaced longitudinally along the elongated element.
[0007]
7. Device according to any one of claims 1 to 6, characterized in that the elongated element comprises a guidewire lumen (729).
[0008]
8. Device according to any one of claims 1 to 7, characterized in that the balloon is a single-chamber angioplasty balloon.
[0009]
9. Device according to any one of claims 1 to 7, characterized in that the balloon includes two chambers (626) configured for valvuloplasty.
[0010]
10. A device comprising: an axially extended elongated element (721); a balloon (726) surrounding a portion of the elongated element, the balloon being fillable with a conductive liquid, characterized in that it further comprises: a plurality of electrode pairs (802, 804) located within and spaced from of the balloon and within the conductive liquid, where the electrode pairs are configured to produce shock waves that propagate through the liquid; a high voltage source (730) connectable to the electrodes; and a multiplexer (734), and wherein the plurality of electrode pairs includes a first set of two electrode pairs (802) with an electrode of one pair that is connected to an electrode of the other pair, the electrode pairs further include a second set of two pairs of electrodes (804) with an electrode of one pair that is connected to an electrode of the other pair, and wherein the multiplexer (734) selectively connects the high voltage source to one or the other of the first and second sets of electrode pairs, the connected set operating in series through an arc generated in the conductive liquid allowing current to flow through each pair of electrodes.
[0011]
11. Device according to claim 10, characterized in that one electrode in each pair has a surface area greater than the surface area of the other electrode in the pair.
[0012]
12. Device according to claim 10 or 11, characterized in that an electrode in the first set of two pairs and an electrode in the second set of two pairs are connectable to a common conductor that provides a return path to the source of high voltage.
[0013]
13. Device according to any one of claims 10 to 12, characterized in that at least two of the pairs of electrodes are spaced longitudinally along the elongated element.
[0014]
14. Device according to any one of claims 10 to 13, characterized in that the elongated element comprises a guidewire lumen (729).
[0015]
15. Device according to any one of claims 10 to 14, characterized in that the balloon is a single-chamber angioplasty balloon.
[0016]
16. Device according to any one of claims 10 to 14, characterized in that the balloon includes two chambers (626) configured for valvuloplasty.

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同族专利:

公开号 | 公开日

CA2877160A1|2014-01-03|

EP3909529A4|2021-11-17|

US9993292B2|2018-06-12|

CN104582597A|2015-04-29|

EP2866689A1|2015-05-06|

CA3079283C|2020-11-03|

EP3909529A1|2021-11-17|

US20170258523A1|2017-09-14|

US10682178B2|2020-06-16|

AU2018204691A1|2018-07-19|

AU2013284490A1|2015-01-15|

EP2866689B1|2021-07-21|

AU2013284490B2|2018-05-17|

US20140243820A1|2014-08-28|

WO2014004887A1|2014-01-03|

BR112014032669A2|2017-06-27|

US9011463B2|2015-04-21|

JP2015522344A|2015-08-06|

JP6104375B2|2017-03-29|

US20140005576A1|2014-01-02|

ES2881349T3|2021-11-29|

US20200383724A1|2020-12-10|

CA3079283A1|2014-01-03|

US9642673B2|2017-05-09|

CA2877160C|2021-01-26|

CN104582597B|2017-02-01|

AU2018204691B2|2019-06-27|

US20180256250A1|2018-09-13|

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-05-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-06-22| 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 27/06/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US13/534,658|US9642673B2|2012-06-27|2012-06-27|Shock wave balloon catheter with multiple shock wave sources|

US13/534,658|2012-06-27|

PCT/US2013/048277|WO2014004887A1|2012-06-27|2013-06-27|Shock wave balloon catheter with multiple shock wave sources|

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