Vasectomy device used to remove vas obstruction
专利摘要:
公开号:SU1836115A3 申请号:SU894743153 申请日:1989-12-08 公开日:1993-08-23 发明作者:D Kletshka Garold 申请人:D Kletshka Garold; IPC主号:
专利说明:
The invention relates to a new and improved device for plastic surgery on vessels for compression and / or removal of atherosclerotic plaques, thrombi, stenoses, occlusions, clots, potentially embolic material, etc. (hereinafter referred to as blockages) from veins, arteries, vessels, ducts and the like (hereinafter referred to as vessels), The device also has the capacity 10 to handle the following conditions or characteristics of the following procedures. as congenital or acquired stenosis or blockages, thromboembolectomy, percutaneous aspiration, cerebral em- 15 pain, congenital or acquired blockage or stenosis of the aorta, renal, coronary, pulmonary, iliac, femoral, popliteal, peroneal, connected, 20 auxiliary, brachial , vertebral, cerebral and / or cerebellar artery, or any other accessible artery, or their branches, congenital or acquired blockage or stenosis of the superior vena cava, inferior vena cava, common iliac, internal iliac, external iliac, femoral, greater saphenous, lesser saphenous, posterior tibial, peroneal, popliteal, 30 pulmonary, coronary, coronary sunus, anonymous, brachial, head, forearm, internal cervical, external cervical, cerebral, cerebellar, cranial or vertebral veins, or other 35 available veins, or their branches, atheromatous damage to the graft or its branches, h acupressure or stenosis of the joints between and among grafts, veins, arteries, organs and ducts, bleeding of the vena cava, congenital and acquired intracardiac blockages, stenoses, shunts and / or aberrant messages, congenital or acquired cardiovascular blockages, 45 stenoses and / or diseases, infusion of thrombolytic agents, thromboembolic events, diagnostic catheterization, clot removal, intrahepatic and / or suprahepatic biliary flow blockages 50 (eg, stones, sediments or structures), intracardiac and / or intradural foreign bodies, renal dialysis, congenital or acquired esophageal and / or gastrointestinal blockages and / or stenoses, unorganized atheromatosis, dialysis fistula stenosis, ruptured cerebral aneurysms, arterio-arterial, arteriovenous and / or venous venous fistula, ureteral blockages (eg, stones, sediments and structures), dysplasia renal artery, carotid artery and / or other blood nasal vessels, and / or atherosclerosis of an accessible artery, vein or their branches. Such procedures can be performed on humans and other applications. As used throughout the specification and claims, angioplasty will not be limited and will include: any medical and / or veterinary procedures and treatment-treatments referred to in the preceding paragraph, procedures and treatments / treatments similar to those described in the preceding paragraph, and any other treatment-treatment or procedure involving the removal of blockages from vessels or vascular-like structures, regardless of whether such structures are part of a living organism or interact with it. It should be apparent to those skilled in the art that, in addition to the device and procedures associated with plastic surgery on vessels, the present invention can be used to remove blockages from non-living tubes, tubes, fiber channels and other structures (also hereinafter referred to as vessels) in non-medical or industrial applications. For example, the device according to the invention could be used to remove blockages from a fluid supply pipe in a device under conditions where it is undesirable to break the blockage into particles so that they continue to flow freely through the pipe, i. E. in a device (machine) that continues to operate, and such particles could disrupt continuous operation. The term plastic surgery as used throughout the specification and claims is intended to encompass all of these applications. The devices of the prior art, representing conventional plastic vascular devices, are generally a catheter containing a balloon that is inserted into the occluded vessel. The expansion of the balloon at the location of the blockage presses the blockage against the inner wall of the vessel. When the balloon is removed, the blockage remains pressed against the vessel wall and the effective diameter of the vessel through which blood can flow increases at the location of the blockage. An important issue is the formation of fine particulate matter during the blockage removal operation. These particles are carried away by the fluid flowing in the vessel and can lead to embolism, clots, seizure, kidney failure, heart failure, gangrene, tissue damage, lumbar shunt surgery, death, and other unwanted side effects and complications. Therefore, it is required to create a vascular plastic surgery device that essentially prevents all physiologically significant particles from escaping from the blockage area, thereby preventing the possibility of adverse side effects from surgery and treatment / treatment associated with it10 in and treatment / treatment associated with astic surgery on the vessels. The present invention contemplates a vascular plastic surgery device for use in vascular plastic surgery or other medical, veterinary, non-medical, or industrial applications where removal of a blockage from a vessel or vessel-like structure can form particles which, if left in the vessel, can cause adverse complications and results. The device for plastic surgery 45 on vessels includes an operating element, means for controlling the operating element, a balloon trap, means for expanding the balloon trap, means for removing particles and a multi-channel catheter. The operating element can be one of many known methods or devices for removing and / or crushing a blockage in a vessel, including, but not limited to, balloons, 55 cutting rotors, fiber meshes, and lasers! This operating element is controlled in the device according to the present invention by the same control means previously known for such devices. I or mechanisms. In the case of a balloon, at least one channel through which the expansion medium can be injected will be one corresponding control means. In the case of a laser, the corresponding control means would be a switch that turns on the laser. The balloon trap serves as a barrier preventing physiologically significant particles detached from the location of the blockage during plastic surgery on a vessel or other use of the device according to the present invention from gradually leaking out of the blockage area and creating complications, the trap collects particles so that they can be removed from the blockage area. The balloon trap may be impervious to fluid flow in the vessel, or may be a membrane or similar structure having pores through which the vessel fluid may pass. The balloon trap is expanded to the correct functional position using the expansion tool. which can be adapted to suit the nature of the balloon trap. When the balloon trap is inflatable, the expansion means is at least one channel through which the expansion medium is injected. Alternatively, the expansion means can be at least one expanding spring, an expanding tab or an expanding petal on or in a balloon trap. The balloon trap expands when the springs, tongues, and petals are pushed outwardly by the operation of the operating element, threads, pins, nubs, or other means. In some applications, the control means for the balloon operating element and the expansion means for the inflatable element may be formed by a dual-function channel through which the expansion medium is injected. Particles are removed from the vessel through at least one particle removal aperture (hole) and at least one particle removal channel. A pressure drop is created between the particle removal channel and the vessel so that the particles are pushed out or pulled out 8 the particle removal aperture. Alternatively, the particles can be collected by the balloon trap and retained therein as the balloon trap is constricted and then removed with the device. Also describes another device for plastic surgery on vessels, which includes only a balloon trap, expansion means, particle removal means and catheter bundle. Fig. 1 is a cross-sectional diagram showing the use of a preferred embodiment of the invention; figure 2 is a schematic cross-sectional view; figure 3 is an illustrative view of the invention; Figures 4 and 5 are simplified cross-sectional views of alternative embodiments of the invention: Figure 6 is an illustrative view of an alternative embodiment of the invention; Fig. 7 is a sectional view taken along line 7-7 in Fig. 5; Fig. 810 is simplified cross-sectional views of other alternative embodiments of the invention; Fig. 11 is an illustrative view of another alternative embodiment of the invention; Fig. 12 is an illustrated view of an alternative balloon trap; in fig. 13a is an illustrated view of another alternative embodiment of the invention; in fig. 136 is a cross-sectional view of the device of FIG. 13a; FIG. 14 is an illustrative partial view of an alternative embodiment of the invention; 15 is an illustrative view of a mechanism for expanding a balloon trap of a device according to the present invention; FIG. 16 is a perspective view of a component of the mechanism of FIG. 15; FIG. 17 is an illustrative view of the expanded mechanism of FIG. 15; Figure 18 is an illustrative view of an alternative mechanism for expanding a balloon trap according to the present invention; in fig. 19-22 are illustrative views of an alternative mechanism for expanding a balloon trap; Figures 23-25 are illustrative views of an alternative mechanism for expanding the balloon trap. A vascular plastic surgery device can take many forms, each of which includes a structure that serves as a barrier preventing the gradual leakage of physiologically significant particles detached from the occlusion site during plastic surgery on a vessel, or other use of the device from the area of the occlusion. and creating complications and a trap that collects physiologically significant particles so that they can be removed from the treatment-treatment site. A particle is physiologically significant if it is potentially! can cause frustration or other adverse complication if it migrated from the blockage into the body. Particles formed from the blockage, or any other particles detached from the inner wall of the vessel, are hereinafter generally referred to as particles. Figure 1 shows an example of using the preferred embodiment of the present invention. The device is inserted into vessel 1 according to well known methods. The device can be inserted at any point in relation to the location of the Blockage 2, which is consistent with the required treatment-treatment protocol. The balloon 3 is aligned with the occlusion 2 using methods well known in the art. Then the device is oriented so that the balloon trap 4, which performs the function of the balloon trap, is located in the rearward direction, downstream of the direction of fluid flow 5 from the blockage point 2. The embodiment in Fig. 1 makes it possible to insert the balloon 3 before fishing with a cylinder 4 from a point downstream of the blockage 2. Liquid, air or other expanding medium is injected into the device • through the channels into the catheters 6 so that the trap balloon 4 expands first so that it forms a seal against the inner wall of the vessel 1 after the balloon 3. Alternatively, the trap balloon 4 and the balloon 3 can expand simultaneously, or balloon 3 can expand to a balloon trap 4. However, if essentially all physiologically significant particles detached from the blockage site 2 are to be captured by balloon trap 4, as is the preferred operation of the device, the balloon trap should be fully expanded to how the balloon will be fully expanded 3. When the balloon 3 is expanded, the blockage 2 is crushed against the inner wall of the vessel 1, so that the effective inner diameter of the vessel 1 through which liquid can flow expands. Crushing the blockage 2 forms particles that can be freely torn off from either side of the balloon 3. The balloon 3 is then narrowed. The blockage particles are then, according to the preferred embodiment, pushed against the balloon trap 4 by the fluid pressure in the vessel 1 or, in an alternative embodiment, are drawn into the balloon 4 trap due to the formation of a pressure difference between the vessel and the channels in the catheter 6. The particles are pushed or pulled into the catheter 6 through the aperture 7 to remove particles, from where they are ejected or stored in the balloon trap 4 so that when it narrows, the particles remain inside and are removed with the balloon trap 4. j The balloon 3 in the device serves as an operating element, which can be replaced by any known means, which include balloons, meshes, cutting rotors and lasers. Each type of operating element will have its own unique control mechanism, which, in the case of a balloon, fills the balloon, in the case of a laser or cutting instrument, turns it on. These different mechanisms are referred to here in their totality as controls. Although the figures show a point trap 4 having a generally conical shape, the balloon trap 4 can be of any shape as long as a seal is achieved with the inner wall of the vessel 1 to be treated and the shape facilitates the capture of particles. The balloon trap 4 and the operating means can be positioned relative to each other in any configuration that allows the balloon trap 4 to achieve a seal with the inner wall of the vessel 1 and to trap and retain particles during its expansion. The preferred embodiment, shown in FIGS. 2 and 3, allows the introduction of the balloon trap 4 up to the balloon 3 from a point upstream of the occlusion 3. By changing the relative position of the balloon trap and the operating element in this device, the occlusion can be treated by the approximation from the most favorable direction in the vessel. The balloon trap 4 expands by supplying an expanding medium to the expansion channel 8 of the balloon trap, which (medium) fills the balloon 4 trap. The balloon 3 expands by introducing the expanding medium into the balloon expansion channel 9, which fills the balloon 3 through the balloon expansion aperture 7, thus thereby crushing the blockage 2 against the inner wall of the vessel 1. When the vessel is a living tissue such as a vein, artery, or duct in a person or animal, balloon 3 is inflated to a pressure in the range of preferably 3-15 atm or more, depending on the application. The correct pressure will depend on the treatment protocol, the type of organism being treated, the type of vessel being treated, and the material of the balloon. The appropriate expansion pressures for a given situation will be apparent to those skilled in the art. I After the balloon 3 has been slightly narrowed, the particles are pushed towards the trap-balloon 4 by the flow of liquid 5 in the vessel. Aperture 7 for removing particles and channel 10 for removing particles are open, and since the trap-balloon 7 blocks the normal flow of liquid 5, particles and part of the liquid are pushed into the aperture 7 for removing particles and out of channel 10 for removing particles for ejection. Those particles that are not pushed into the particle removal aperture 7 are pushed into the top of the balloon trap 4, where they can be trapped after the balloon trap 4 has narrowed. Alternatively, the particle removal channel 10 can be connected to a means for creating a differential between the vessel and a particle removal channel 10, which will actively draw particles and part of the liquid from the vessel for discharge. Alternatively, the device may contain as many particle removal apertures and channels as can be accommodated in the device. The preferred embodiment also includes a flow path 11 that can be used to administer medication, take fluid samples, insert a guidewire to assist insertion of a vascular surgery device, and any other desired purpose. Figure 4 shows an alternative embodiment of the invention in which the flow channel 11 is eliminated. Figure 4 and the remaining figures with cross-sectional views show a simplified version in comparison with figure 2 as a result of eliminating the indication of the thickness of the walls forming different channels, chambers and elements included in the depicted devices. Figures 5 and 6 show an embodiment of the invention in which the particle removal aperture 7 is included in the trap balloon 4. The particle removal apertures 7 can be of any shape and are located in the trap balloon 4, which creates a liquid flow in the vessel or a pressure drop is formed to pull the particles into the aperture. As many apertures can be used as can be located in the device, provided that their function is preserved. The conical shape of the balloon trap 4 facilitates the introduction of particles into the apertures 7 to remove particles, but is not essential. Figure 7 shows an example of one possible orientation of the apertures 7 for removing particles in the trap-balloon 4. Figure 8 shows an embodiment of the invention with a flow channel 11, having arpertures 7 for removing particles in a trap-balloon 4. Figure 9 shows an embodiment of the invention in which the balloon 3 and the trap balloon 4 are expanded by introducing an expanding medium through a dual-functional expansion channel 12. Balloon 3, balloon trap 4 and dual function expansion channel 12 must be of the correct size, configuration and designed to expand balloon 3 and balloon trap 4 in the required order and so that balloon 3 can partially narrow when leaving the balloon trap 3 fully expanded for particle collection capability, FIG. 10 shows an embodiment of the invention as in FIG. 9 but with the addition of a guide wire channel 13 into which the guide wire can be inserted to facilitate insertion and positioning of the device. FIG. 11 shows an embodiment of the invention with a dual-function expansion channel 12 for a balloon 3 and a balloon trap 4. The dual-functional expansion channel 12 is bifurcated. The embodiment of FIG. 11 also has another type of particle removal aperture 7 that is not located in the trap balloon 4. Finally, the illustrated embodiment includes a flow channel 11. 12 shows another embodiment of the balloon trap 4, in which the balloon trap is a membrane 14. The configuration of the particle removal apertures and channels normally interacting with the balloon trap means is not included. The membrane 14 of the trap-balloon has one or more pores 15 through which liquid, substances in the liquid and physiologically insignificant particles can pass. When the balloon 3 is partially constricted, the flow of fluid 5 and its corresponding pressure will be restored and the membrane 14 of the trap-balloon will act as a sieve, collecting all physiologically significant particles that have formed. When the canister trap membrane 14 is constricted, the entrained particles are retained and can be removed with a plastic vessel operation device. The pore size 15 may vary depending on the use of the device. Pores 15 must be small enough to capture all physiologically significant particles. The location of the blockage zone in relation to the area where traitorous particles could cause adverse complications will determine what particle size is physiologically significant. In traditional plastic surgery on vessels, the pore size has a diameter of about 2 microns. The 2 µm pore will capture any large enough particle to block the capillaries (approximately 3-4 µm diameter). Larger pore sizes may be appropriate for other medical or non-medical device applications. The balloon trap can also be made in the form of a balloon trap membrane 14. The particles will be pushed into the balloon trap, where they can be captured and stored as the device shrinks and retreats. Blind pockets or cavities can also be included in the balloon trap or on the side of the multichannel catheter to facilitate placement of particles in a favorable position for subsequent retrieval when the balloon trap is narrowed and removed. When the balloon trap is narrowed, it covers all the particles, enveloping them. Similar means can also be included in the membrane means of the trap-balloon. Figures 13a and 136 show embodiments of the invention containing only a trap-balloon 4, a catheter bundle 6, ·. channel 8 for expansion of the trap-balloon, the inner chamber of the trap-balloon, apertures 7 for removing particles and channel 10 for removing particles. The balloon trap means in this embodiment can be inserted through the central channel in a conventional plastic vessel operation so that it can expand downstream of the plug. The embodiment shown in FIG. 13a and 13b, can be used in any situation where the formation of particles is possible, not necessarily from a blockage, which can cause adverse complications if not removed, For example, in any operation in which - clamping of blood vessels is performed, the particles can come off the materials, which chipped inside, but did not strongly clog the vessel. Such particles can cause the same complications that are associated with particles released from a blockage during traditional plastic surgery on a vessel. The device can be inserted "downstream" or upstream of the nip to capture and remove any particles that come off. It is important to note that in any embodiment of the invention, the different channels contained in the catheter 6 can be arranged concentrically, so that they all have one common central axis, individually, so that each channel is independent of all others, or as a combination of concentric and separate structures. Trap-balloon 4 or membrane 14 mo-. They can be made or expanded in any way that creates a shape that forms an airtight seal with the inner wall of the vessel 1 to be processed. By using known barrier methods, the trap balloon 4 or membrane 14 can be induced to expand to achieve the desired shape and create a seal (without an underlying expansion support mechanism). Alternatively, the trap balloon 4 or the membrane 14 can be expanded with echanism supporting the expansion. 14 shows a plurality of expansion springs 16 that expand the balloon trap 6. The expansion springs can be made of plastic, metal, or any other material. The device also includes means for pulling the springs into a compressed position for inserting and removing the device into and out of the vessel, respectively. The constriction (retract) means can be fibers that expand backward from the expansion springs 16, a sheath that surrounds the springs and retains them prior to expansion, or other means. FIGS. 15-17 show an assembly including a plurality of flared tongues 17 and a tongue ring 18 disposed within the constricted means of a balloon trap 4. The tongues may also be made of plastic, metal, or other material of a suitable property to impart to the balloon trap 4 the required shape. Each flared tongue 17 is connected to a tongue ring 18 of a tongue earring 19, which permits movement of the expanding tongue in an expanded position and without peripheral movement around the tongue ring 18. FIG. 17 shows the extended position of the tongue assembly. On Fig shows another mechanism supporting expansion. The assembly includes a plurality of flared tabs 17 that are connected to a tongue ring 18. In the tongue ring 18 is centered an expansion pin (shaft) 20 having an expansion assembly 21 and a constriction assembly 22. The expansion stud 20 extends back into the catheter 6 so that it can be manipulated. When the expanding pin 20 moves away from the balloon trap 4, the expanding assembly 21 contacts the expanding tabs 17 and urges them inward, thereby narrowing the balloon trap 4. The channel can be YU; included in the expansion pin 20 for inserting the guide wire. If correctly positioned in relation to the balloon 3, the balloon trap 4 can also expand and contract under the action of the balloon 3 as the balloon expands and contracts. FIG. 19-22 show the expansion means. including a plurality of expanding petals 23 and parachute lines 24. The expanding petals 23 must be made of a deformable material that can support the balloon trap 4, as well as assume any 15 position or shape in which it is formed. In Figures 19-22, the expanding petals 24 are connected at one end to the tip of the balloon trap 4. The other end rests on or near the constricted balloon 20 3. When the balloon 3 is expanded, it induces the expanding petals 23 into a position in which they drive the trap - balloon 4 in contact with the inner wall of the vessel 1. Lanyards 24 are not tensioned. After crushing the blockage, as shown in Fig. 21, balloon 3 is partially constricted, so that the flow of liquid 5 and the associated pressure is partially restored and urges the particles towards the trap balloon 4 for 30 removal. The parachute lines 24 remain relaxed. When the particles are collected and / or removed, the balloon 4 tapers more so that the parachute lines 24 become taut and pull back the petals 35 23. As shown in FIG. 22, the features of other expansion means may also be combined with the expanding petals / parachute lines configuration. to create an appropriate degree of control over the expansion and contraction of the balloon trap. The extent to which balloon 3 can be expanded or contracted in order to induce the expansion means to function properly depends on the specifics. device design. Alternatively, the flare tabs 23 can be made of a material that is rigid and does not deform significantly, similar to materials that can be used to make the flare springs 16 in FIG. 14. The flared petals 23 do not make direct contact with the balloon 3. Each flared petal 23 is assembled with a bulge 25 which rests on the surface of the balloon 3. as shown in FIG. 23. Alternatively, a bulge may be formed in a recess on the side of the catheter so that the flared petal is flush with the catheter in the constricted state, thereby providing smoother catheter insertion. The bulge 25 is connected to the flared petal 23 by means of a flexible shoulder 26 of the bulge. As the balloon 3 expands, the bulge 25 moves along the surface of the balloon 3 and the balloon trap 4 is urged into its expanded position, as shown in FIG. 24. When the balloon 3 is fully expanded, the shoulder 26 of the bulge will flex and the bulge 25 will press against the flared petal 23 from its natural position, as shown in FIG. 24. When the balloon 3 is constricted, the bulge arm 26 returns to its natural position while keeping the expanding tab 23 in contact with the inner wall of the vessel 1, as shown in FIG. 25. The fluid flow 5 and its corresponding pressure will be partially restored and the particles can be captured and discarded as described above. When the balloon 3 has contracted further, the shoulder 26 of the thickening fully returns to its natural position, and the expanding petal 23 will return to its natural position, as shown in Fig. 23, thereby narrowing the trap-balloon 4. The degree to which balloon 3 should expanding or contracting to induce the expansion means to function properly will depend on the specific design of the device. Alternatively, the shoulder 26 of the bulge can be removed and the bulge 25 can be connected to the balloon 3. When the balloon 3 expands, the bulge 25 urges the expanding petals 23 into an expanded position. The bulge 25 should be located on the surface of the container so that the container 3 can be partially narrowed without compromising the tightness between the trap container 4 and the inner wall of the vessel 1, thereby allowing the collection of particles.
权利要求:
Claims (15) [1] (34) 1. A DEVICE FOR VESSEL OPERATIONS FOR REMOVING OCCLUSION OF A VESSEL, comprising a multichannel catheter with a dilating means, characterized in that, in order to prevent the possibility of adverse side effects, it is equipped with an operating electrode with a control means, while the catheter has an operation for removing particles, and the expanding means is made in the form of a balloon trap. [2] 2. The device according to claim 1, characterized in that the operating element is shaped like a balloon. [3] 3. The device according to claim 1, characterized in that the control means is made in the form of one of the catheter channels connected to the cavity of the operating element in the form of a balloon through the opening. [4] 4. Device pop, 1, featuring themes. that the dilator is connected to one of the channels of the catheter. [5] 5. The device of item 1, characterized in that the operating element in the form of a balloon and a trap are connected at least to one of the channels of the catheter. [6] 6. A device according to claim 1, characterized in that the trap is provided with means for expanding it. [7] 7. A device according to claim 6, characterized in that the expansion means is made in the form of at least one tongue hermetically in contact with the inner surface of the vessel. [8] 8. The device according to claim 6, characterized in that the means for expansion is made in the form of a hairpin with expanding constriction fixed at its ends; with nodes. - | [9] 9. The device according to claim 6, characterized by; with the fact that the expansion device is made in the form of petals, some ends of which are connected to the trap, and the others to the operating element in the form of a balloon, by means of flexible rods. [10] 10. A device according to claim 9, characterized in that the flexible rods are connected to the balloon by means of nubs movably mounted on the surface of the balloon. [11] 11. The device according to claim 1, where the trap is made in the form of a membrane with at least one pore. [12] 12. A device according to claim 1, characterized in that at least one aperture of the trap is connected to one of the channels of the catheter to remove particles. [13] 13. A device according to claims 1 and 2, characterized by the fact that the trap is made with an aperture for removing particles. SU 1836115AZ [14] 14. A device according to claim 1, 12, 13, characterized in that the particle removal aperture is connected to the pressure drop generating means. [15] 15. Device according to claim 1, characterized by the fact that the catheter has an additional channel for the guide wire.
类似技术:
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同族专利:
公开号 | 公开日 AU611182B2|1991-06-06| US4794928A|1989-01-03| EP0371986A1|1990-06-13| DE3887896D1|1994-03-24| CA1324552C|1993-11-23| WO1988009683A1|1988-12-15| EP0371986A4|1990-09-05| EP0371986B1|1994-02-16| AU1991288A|1989-01-04|
引用文献:
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申请号 | 申请日 | 专利标题 US07/061,104|US4794928A|1987-06-10|1987-06-10|Angioplasty device and method of using the same| PCT/US1988/001979|WO1988009683A1|1987-06-10|1988-06-07|An angioplasty device| CA000586442A|CA1324552C|1987-06-10|1988-12-20|Angioplasty device| 相关专利
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