Shock wave balloon catheter capable of being pre-expanded and using method

Abstract

The invention provides a pre-expanded shock wave balloon catheter and a use method. The shock wave balloon catheter comprises an inner tube, a pre-expanded balloon, a treatment balloon, a shock wave generating part and a liquid filling unit. The pre-expanding balloon is arranged on the outer wall of the far end of the inner tube; the treatment balloon is arranged at the position adjacent to the pre-expanding balloon and located on the side close to the near end of the inner tube, and the outer diameter of the pre-expanding balloon filled with liquid is larger than the outer diameter of the treatment balloon in the initial state. The shock wave generating part acts on the outer wall of the inner tube in the treatment balloon; and the liquid filling unit is used for filling and extracting liquid for the pre-expanded balloon and the treatment balloon. After the pre-expanding balloon performs pre-expanding work, the situation that a small-diameter common balloon catheter is additionally used for expanding a diseased region firstly, then the common balloon catheter is withdrawn, and then the diseased region is fed into the shock wave balloon catheter for shock wave treatment is not needed, so that the operation steps are reduced, the operation time is shortened, and the treatment cost is also reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a pre-expandable shock wave balloon catheter and a use method thereof. Background Art

[0002] In response to calcified lesions in blood vessels, a shock wave balloon catheter device is currently available on the market. The balloon on the catheter is pushed into the calcified area. The basic principle is to apply a certain electric field to the liquid in the balloon. The liquid cavitation occurs under the action of the electric field. The bubbles produced by cavitation collapse instantaneously, generating shock waves, which rupture the calcified plaques, thereby achieving the purpose of breaking up the calcified diseased tissue without causing damage to the vascular endothelium.

[0003] When using shock wave balloon catheters to treat intravascular occlusive lesions, a prerequisite for the success of the treatment is whether the balloon and electrode parts of the shock wave balloon catheter can smoothly reach the occlusive lesion. The basic structure of the shock wave balloon catheter currently on the market is that an electrode capable of generating shock waves is installed on the inner tube between the inner tube of the balloon catheter and the balloon, and the electrode is connected to a high-voltage pulse power supply through a wire. The basic structure of the electrode is a three-layer structure of an inner electrode, an insulating isolation layer, and an outer electrode, which will increase the outer diameter of the balloon catheter after folding, resulting in poor passability of the balloon catheter. For severe stenosis and occlusion lesions in blood vessels, it is difficult to directly push the shock wave balloon catheter with electrodes to the target location.

[0004] At present, in the face of such severe stenosis and occlusion, ordinary balloons with small folded outer diameter are generally used to pre-expand the severe stenosis and occlusion to reduce the degree of occlusion and open a channel for the shock wave balloon catheter to enter. Then the ordinary balloon is withdrawn from the blood vessel, and the shock wave balloon is sent into the blood vessel to perform shock wave treatment on the lesion. This increases the cost of treatment and the time of operation. Therefore, it is urgent to design a shock wave balloon catheter that can directly perform pre-expansion.

[0005] In view of this, this application is filed. Summary of the invention

[0006] The present invention provides a pre-expandable shock wave balloon catheter to solve at least one of the above technical problems.

[0007] A corona discharge shock wave balloon catheter comprises an inner tube for cooperating with a guide wire for traction; a pre-expansion balloon arranged on the outer wall of the distal end of the inner tube, an elastic space for accommodating a filling liquid is provided between the inner tube and the pre-expansion balloon; a treatment balloon arranged at an adjacent position to the pre-expansion balloon and located on the side close to the proximal end of the inner tube, an elastic space for accommodating a conductive liquid is provided between the inner tube and the treatment balloon, and the outer diameter of the pre-expansion balloon after being filled with liquid is larger than the outer diameter of the treatment balloon in an initial state; a shock wave generating part, the shock wave generating part is located on the outer wall of the inner tube in the treatment balloon; and a liquid filling unit, the liquid filling unit is used to fill and drain liquid from the pre-expansion balloon and the treatment balloon.

[0008] Preferably, the outer diameter of the pre-expansion balloon after being filled with fluid is 1 / 2 to 9 / 10 of the outer diameter of the treatment balloon in the fluid-filled state.

[0009] Preferably, the shock wave generating part includes an inner electrode sheet, an insulating isolation layer and a conductive wire, the inner electrode sheet is glued to the outer wall of the inner tube, the conductive wire is electrically connected to the inner electrode sheet, the insulating isolation layer is tubular and is arranged on the outer periphery of the inner electrode sheet and the conductive wire, glue is injected between the insulating isolation layer and the inner tube, and the insulating isolation layer is provided with an electrode hole corresponding to the inner electrode sheet.

[0010] Preferably, the inner electrode sheet is a single-layer metal sheet or a double-layer metal sheet formed by flattening a metal capillary sleeve on a bare metal portion of a conductor.

[0011] Preferably, it further comprises an outer electrode ring, which is sleeved on the outer periphery of the insulating isolation layer and is electrically connected to the inner electrode sheet through the electrode hole.

[0012] Preferably, the pre-expansion balloon and the treatment balloon are not connected to each other, and the filling unit includes a first filling tube and a second filling tube, the first filling tube passes through the portion of the treatment balloon and is sleeved in the insulating isolation layer and is connected to the pre-expansion balloon, and the second filling tube is connected to the treatment balloon.

[0013] Preferably, it further comprises an outer tube, a push rod, a catheter joint and a wire joint, the proximal end of the outer tube and the distal end of the push rod are welded, and the proximal end of the push rod and the distal end of the catheter joint are fixed by bonding or welding.

[0014] The catheter joint is provided with a first liquid-filling joint connected to the first liquid-filling tube and a second liquid-filling joint connected to the second liquid-filling tube; a wire extends from a proximal port of the catheter joint and is connected to the wire joint.

[0015] Preferably, the pre-expansion balloon and the treatment balloon are connected, and a transition section is provided between the pre-expansion balloon and the treatment balloon.

[0016] Preferably, the pre-expanding balloon and the therapeutic balloon are connected, and the pre-expanding balloon is truncated cone-shaped, and the therapeutic balloon is tubular, the outer diameter of the proximal end of the pre-expanding balloon is greater than the outer diameter of the distal end, and the outer diameter of the proximal end of the pre-expanding balloon is equal to the outer diameter of the therapeutic balloon.

[0017] The present invention also provides a method for using a pre-expanded shock wave balloon catheter, which is used for the pre-expandable shock wave balloon catheter as described above, comprising:

[0018] In the first step, in the initial state, the pre-expansion balloon is in a folded state, and the treatment balloon is folded and closely attached to the outside of the insulating isolation layer.

[0019] The second step is to insert the proximal end of the guide wire in the blood vessel into the distal hole of the inner tube, push the balloon catheter along the distal direction of the guide wire, make the proximal end of the guide wire pass through the proximal hole of the inner tube, and then continue to push the inner tube forward until the pre-dilation balloon reaches the occluded lesion.

[0020] In the third step, conductive liquid is filled into the pre-dilation balloon through the liquid filling unit to expand the folded pre-dilation balloon, and the outer wall of the pre-dilation balloon is closely attached to the inner cavity of the occluded lesion and expands, thereby reducing the degree of occlusion of the occluded lesion.

[0021] In the fourth step, the conductive liquid in the pre-expansion balloon is withdrawn through the liquid filling unit to shrink and fold the pre-expansion balloon.

[0022] Step 5: Continue to push the inner tube forward along the guide wire until the treatment balloon reaches the occluded lesion.

[0023] The sixth step is to fill the therapeutic balloon with conductive liquid through the liquid filling unit to expand the folded therapeutic balloon, so that the outer wall of the therapeutic balloon is closely attached to the inner cavity of the occluded lesion, and the shock wave generating part is activated to generate shock waves to break up the occluded lesion.

[0024] Step 7: close the shock wave generating unit, and draw back the conductive liquid in the treatment balloon through the liquid filling unit, so that the treatment balloon shrinks and folds;

[0025] Step 8. Remove the balloon catheter from the blood vessel.

[0026] The present invention also provides a method of use when the pre-expansion balloon and the treatment balloon of the shock wave balloon catheter are in a connected structure, which differs from the above method in that when the pre-expansion balloon or the treatment balloon is filled with liquid through the liquid filling unit, the pre-expansion balloon and the treatment balloon are expanded together, and when the pre-expansion balloon or the treatment balloon is drained of liquid through the liquid filling unit, the pre-expansion balloon and the treatment balloon are contracted and folded together.

[0027] The pre-expanded shock wave balloon catheter of the present invention pre-expands severe stenosis lesions by adding a pre-expanding balloon with a smaller outer diameter to the outer wall of the distal end of the inner tube, which can pre-expand occluded lesions. Since the pre-expanding balloon does not need to carry electrodes, its outer diameter in the initial state can be small enough.

[0028] After the pre-dilation balloon has been pre-dilated, it allows the therapeutic balloon with electrodes to reach the lesion site for shock wave therapy. There is no need to use an additional small-diameter ordinary balloon catheter to dilate the lesion site, then withdraw the ordinary balloon catheter, and then insert the shock wave balloon catheter for shock wave therapy. This reduces the number of operating steps, reduces operating time, and also reduces treatment costs.

[0029] Furthermore, the present invention also provides a method for using a pre-expandable shock wave balloon catheter in which a pre-expanding balloon and a treatment balloon are connected. The method is simple and easy to understand. Compared with the existing method for using a shock wave balloon catheter that requires pre-expanding, the method reduces the operating steps, reduces the operating time, and also reduces the treatment cost. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic structural diagram of the initial state of the pre-expandable shock wave balloon catheter according to the first embodiment of the present invention;

[0031] Figure 2 yes Figure 1 Schematic diagram of the structure in a liquid-filled state;

[0032] Figure 3 1 is a schematic structural diagram of the initial state of the pre-expandable shock wave balloon catheter according to the second embodiment of the present invention;

[0033] Figure 4 yes Figure 3 Schematic diagram of the structure in a liquid-filled state;

[0034] Figure 5 1 is a schematic structural diagram of the initial state of the pre-expandable shock wave balloon catheter according to the third embodiment of the present invention;

[0035] Figure 6 yes Figure 3 Schematic diagram of the liquid filling state structure.

[0036] Reference numerals:

[0037] 1. Inner tube; 11. Quick guidewire exchange port; 2. Pre-dilation balloon; 3. Treatment balloon; 4. Shock wave generating part; 41. Inner electrode sheet; 42. Insulating isolation layer; 43. Wire; 44. Outer electrode ring; 51. First liquid-filling tube; 52. Second liquid-filling tube; 53. Total liquid-filling tube; 61. Outer tube; 62. Push rod; 63. Wire connector; 7. Catheter connector, 71. First liquid-filling connector; 72. Second liquid-filling connector; 73. Total liquid-filling connector; 8. Visualizing marker ring. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the invention claimed for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0039] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicating orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0040] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0041] First embodiment:

[0042] Please refer to Figure 1 to Figure 2 A pre-expanded shock wave balloon catheter comprises an inner tube 1, a pre-expanded balloon 2, a treatment balloon 3, a shock wave generating part 4 and a liquid filling unit.

[0043] The inner tube 1 is used to cooperate with the guide wire traction; the pre-expansion balloon 2 is arranged on the outer wall of the distal end of the inner tube 1, and there is an elastic space for accommodating filling liquid between the inner tube 1 and the pre-expansion balloon 2; the treatment balloon 3 is arranged at an adjacent position of the pre-expansion balloon 2, and is located on the side close to the proximal end of the inner tube 1, and there is an elastic space for accommodating conductive liquid between the inner tube 1 and the treatment balloon 3, the outer diameter of the pre-expansion balloon 2 in the initial state is smaller than the outer diameter of the treatment balloon 3 in the initial state, and the outer diameter of the pre-expansion balloon 2 after filling with liquid is larger than the outer diameter of the treatment balloon 3 in the initial state.

[0044] The shock wave generating unit 4 acts on the outer wall of the inner tube 1 in the treatment balloon 3 ; the liquid filling unit is used for filling and draining the pre-expansion balloon 2 and the treatment balloon 3 .

[0045] The pre-expanded shock wave balloon catheter of the present invention pre-expands severe stenosis lesions by adding a pre-expanding balloon 2 with a smaller outer diameter to the outer wall at the distal end of the inner tube 1 for pre-expanding occluded lesions. Since the pre-expanding balloon 2 does not need to carry electrodes, its outer diameter in the initial state can be small enough.

[0046] After the pre-expansion balloon 2 has been pre-expanded, it allows the treatment balloon 3 with electrodes to reach the lesion site for shock wave therapy. There is no need to use an additional small-diameter ordinary balloon catheter to expand the lesion site, then withdraw the ordinary balloon catheter, and then insert the shock wave balloon catheter for shock wave therapy. This reduces the number of operating steps, reduces the operating time, and also reduces the cost of treatment.

[0047] The shock wave generating part 4 includes an inner electrode sheet 41, an insulating isolation layer 42 and a wire 43. The inner electrode sheet 41 is glued to the outer wall of the inner tube 1. The wire 43 is electrically connected to the inner electrode sheet 41. The insulating isolation layer 42 is tubular and is arranged on the outer periphery of the inner electrode sheet 41 and the wire 43. Glue is injected between the insulating isolation layer 42 and the inner tube 1, and the insulating isolation layer 42 is provided with an electrode hole corresponding to the inner electrode sheet 41.

[0048] In this embodiment, an outer electrode ring 44 is further included. The outer electrode ring 44 is sleeved on the outer periphery of the insulating isolation layer 42 and is electrically connected to the inner electrode sheet 41 through the electrode hole.

[0049] The outer electrode ring 44 is a conductive metal ring, which is sleeved on the outer circumference of the insulating isolation tube. The width of the outer electrode ring 44 is smaller than the length of the inner electrode sheet 41, so that the two ends of the inner electrode sheet 41 can leak out from the two ends of the outer electrode ring 44 respectively. On the insulating isolation layer 42 at one end or both ends of the outer electrode ring 44, at the position facing the inner electrode sheet 41, part of the insulating layer is ablated by laser to form an electrode hole, and part of the inner electrode sheet 41 leaks out. The two inner electrode sheets 41 are wrapped by the same insulating isolation layer 42, and each inner electrode sheet 41 has at least one electrode hole facing the insulating isolation layer 42. When the balloon is filled with conductive liquid, the conductive liquid contacts the inner electrode through the electrode hole. When a pulsed high voltage is applied between the inner electrode sheet 41 and the outer electrode ring 44, a high-temperature plasma channel is formed in the liquid in the electrode hole between the inner electrode sheet 41 and the outer electrode ring 44, thereby generating a shock wave to break up the calcified lesions in the blood vessels. An outer electrode ring 44, an insulating isolation layer 42, two inner electrode sheets 41, multiple electrode holes and wires 43 form a group of electrodes. One or more groups of electrodes can be installed axially in the inner tube 1 in the shock wave therapy balloon 3. When there are multiple groups of electrodes, the multiple groups of electrodes can be connected in series or in parallel. Multiple groups of electrodes are connected in series or in parallel on the inner tube 1, so that the range of shock waves generated can be wider and the shock waves generated in each area are more uniform.

[0050] In this embodiment, the pre-expansion balloon 2 and the treatment balloon 3 are not connected to each other, the inner wall of the distal end of the pre-expansion balloon 2 is welded to the outer periphery of the distal end of the inner tube 1, and the proximal end of the inner tube 1 extends from the proximal tube opening of the pre-expansion balloon 2, passes through the inner cavity of the treatment balloon, and is welded to the side wall opening on the outer tube to facilitate traction with the guide wire. The proximal end of the pre-expansion balloon 2 is sleeved with the distal end of the treatment balloon 3, and at the same time, the distal end of a first filling tube 51 for filling the pre-expansion balloon 2 passes through the inner cavity of the treatment balloon 3, and is inserted into the inner cavity of the pre-expansion balloon 2 from the proximal tube opening of the pre-expansion balloon 2, and then the proximal end of the pre-expansion balloon 2, the distal end of the treatment balloon 3, the outer wall of the first filling tube 51, and the outer wall of the inner tube 1 are welded together, so that the pre-expansion balloon 2 and the treatment balloon 3 are not connected to each other.

[0051] The liquid filling unit includes a first liquid filling tube 51 and a second liquid filling tube 52. The first liquid filling tube 51 is partially sleeved through the treatment balloon 3 and connected to the insulating isolation layer 42 and the pre-expansion balloon 2. The proximal end of the treatment balloon 3 is welded to the distal end of the outer tube 61. The second liquid filling tube 52 is inserted into the inner cavity of the treatment balloon 3 from the proximal tube opening of the treatment balloon 3 and is connected to the treatment balloon 3.

[0052] In this embodiment, it also includes an outer tube 61, a push rod 62, a catheter joint 7 and a wire 43 joint. The proximal end of the outer tube 61 and the distal end of the push rod 62 are welded, and the proximal end of the push rod 62 and the distal end of the catheter joint 7 are welded.

[0053] The catheter connector 7 is provided with a first liquid filling connector 71 connected to the first liquid filling tube 51 and a second liquid filling connector 72 connected to the second liquid filling tube 52 ; the wire 43 extends from the proximal end of the catheter connector 7 and is connected to the wire 43 connector.

[0054] There is an opening on the side wall at the proximal end of the outer tube 61, and the proximal end of the inner tube 1 passes through the opening. The outer wall of the inner tube 1 and the inner wall of the opening of the side wall of the outer tube 61 are welded together to form a guide wire quick exchange port 11.

[0055] Preferably, the outer diameter of the pre-dilation balloon after filling with fluid is 1 / 2 to 9 / 10 of the outer diameter of the treatment balloon in the filled state; this facilitates the two balloons to enter the blood vessel one after the other, achieving the effect of completing pre-dilation and treatment by pushing the catheter in one go.

[0056] Preferably, both the pre-dilation balloon 2 and the treatment balloon 3 are provided with an X-ray-opaque developing marker ring 8 .

[0057] In this embodiment, there are two X-ray-opaque developing marking rings 8 in each of the pre-expansion balloon 2 and the treatment balloon 3, which can be used to assist in determining the position of the pre-expansion balloon 2 and the shock wave treatment balloon 3 in the blood vessel during the process of pushing the shock wave balloon catheter.

[0058] The method of using the corona discharge shock wave balloon catheter of this embodiment is to insert the proximal end of the guide wire into the inner tube 1 from the distal hole of the inner tube 1 of the shock wave balloon catheter, push the shock wave balloon catheter along the distal direction of the guide wire, and make the proximal end of the guide wire pass through the guide wire rapid exchange port. Continue to push the shock wave balloon catheter, the shock wave balloon catheter enters the blood vessel along the guide wire until the pre-expansion balloon 2 reaches the occluded lesion, the first filling port of the catheter connector 7 is connected to a pressure pump filled with liquid (physiological saline, contrast agent or a mixture of physiological saline and contrast agent), and the filling liquid is filled into the pre-expansion balloon 2 through the first filling port and the first filling channel to expand the pre-expansion balloon 2 and pre-expand the occluded lesion, then the pressure pump is depressurized, the liquid is withdrawn, and the pre-expansion balloon 2 is refolded, and the shock wave balloon catheter is continued to be pushed forward to make the shock wave treatment balloon 3 reach the lesion position, and the conductive liquid is injected into the shock wave treatment balloon 3 through the second filling port and the second filling channel of the catheter connector 7 to inflate the shock wave treatment balloon 3, and then the wire 43 connector is connected to the high-voltage pulse power supply, and a high-voltage pulse voltage is applied to the electrode in the shock wave treatment balloon 3 catheter, and the electrode generates a shock wave, thereby breaking the occluded lesion. Then the conductive liquid is withdrawn to refold the shock wave treatment balloon 3, and the shock wave balloon catheter is withdrawn.

[0059] Second embodiment:

[0060] Based on the first embodiment, please refer to Figures 3-4, the difference is that the pre-expansion balloon 2 and the treatment balloon 3 are connected, and a transition section is provided between the pre-expansion balloon 2 and the treatment balloon 3. Therefore, the conductive liquid from the treatment balloon 3 can be directly filled between the inner tube 1 and the pre-expansion balloon 2. The liquid filling unit is simplified, and the first liquid filling tube 51 and the second liquid filling tube 52 are not required. Only one total liquid filling tube 53 is required, and only one total liquid filling connector 73 is required on the catheter connector 7.

[0061] In this embodiment, in the liquid-filled state, the outer diameter of the transition section is smaller than the outer diameter of the treatment balloon 3 and larger than the outer diameter of the pre-expansion balloon 2 .

[0062] The present invention provides a method for using a pre-expanded shock wave balloon catheter compatible with the present embodiment, which is used for the pre-expandable shock wave balloon catheter as described above, comprising:

[0063] In the first step, in the initial state, the pre-expansion balloon 2 is in a folded state, and the treatment balloon 3 is folded and closely attached to the outside of the insulating isolation layer 42 .

[0064] In the second step, the proximal end of the guide wire in the blood vessel is inserted into the distal hole of the inner tube 1, and the balloon catheter is pushed along the distal direction of the guide wire so that the proximal end of the guide wire passes through the proximal hole of the inner tube 1, and then the inner tube 1 is pushed forward until the pre-dilation balloon 2 reaches the occluded lesion.

[0065] In the third step, conductive liquid is filled into the treatment balloon 3 through the liquid filling unit to expand the folded pre-expansion balloon 2 and the treatment balloon 3. The outer wall of the pre-expansion balloon 2 is closely attached to the inner cavity of the occluded lesion and expands, so that the occlusion degree of the occluded lesion is reduced.

[0066] In the fourth step, the conductive liquid in the treatment balloon 3 and the pre-expansion balloon 2 is withdrawn through the liquid filling unit, so that the pre-expansion balloon 2 and the treatment balloon 3 are contracted and folded.

[0067] Step 5: Continue to push the inner tube 1 forward along the guide wire until the treatment balloon 3 reaches the occluded lesion.

[0068] In the sixth step, conductive liquid is filled into the treatment balloon 3 through the liquid filling unit to expand the folded pre-expansion balloon 2 and the treatment balloon 3, and the outer wall of the treatment balloon 3 is closely attached to the inner cavity of the occluded lesion. The shock wave generating part 4 is started to generate shock waves to break up the occluded lesion.

[0069] The seventh step is to close the shock wave generating unit 4, and to withdraw the conductive liquid in the treatment balloon 3 and the pre-expansion balloon 2 through the liquid filling unit, so that the pre-expansion balloon 2 and the treatment balloon 3 shrink and fold; and to withdraw the balloon catheter from the blood vessel.

[0070] The method of use adapted by the embodiment of the present invention is simple and easy to understand, and compared with the existing method of using the shock wave balloon catheter that requires pre-dilation, it reduces the operation steps, reduces the operation time, and also reduces the treatment cost.

[0071] Third embodiment:

[0072] Based on the second embodiment, please refer to Figures 5-6 The difference is that the pre-expanding balloon 2 and the therapeutic balloon 3 are connected, and the pre-expanding balloon 2 is truncated cone-shaped, and the therapeutic balloon 3 is tubular, the outer diameter of the proximal end of the pre-expanding balloon 2 is greater than the outer diameter of the distal end, and the outer diameter of the proximal end of the pre-expanding balloon 2 is equal to the outer diameter of the therapeutic balloon 3.

[0073] Thus, the pre-expansion balloon 2 and the treatment balloon 3 are divided into two sections from the distal end to the proximal end: a truncated cone section and a tubular treatment section. The truncated cone section of the pre-expansion balloon 2 has no electrodes inside, while the tubular treatment section has electrodes inside. The diameter of the shock wave treatment section balloon is the same as that of the equal diameter section balloon. The diameter of the pre-expansion section balloon in the folded state and the liquid-filled state gradually increases, and the diameter of the pre-expansion balloon 2 gradually increases from the distal end to the proximal end.

[0074] The method of using the pre-expanded shock wave balloon catheter of this embodiment can be further optimized compared to the method of using the second embodiment. The solution is that between the seventh step and the eighth step, the second step to the seventh step are performed multiple times until all the occluded lesions are opened, and then the eighth step is performed to withdraw the balloon catheter from the blood vessel to complete the shock wave treatment operation.

[0075] The above are only preferred implementations of the present invention. The protection scope of the present invention is not limited to the above embodiments. All technical solutions under the concept of the present invention belong to the protection scope of the present invention.

Claims

1. A pre-expandable shock wave balloon catheter, characterized in that: include, The inner tube is used to cooperate with the guide wire traction; A pre-expansion balloon is arranged on the outer wall of the distal end of the inner tube, and an elastic space for accommodating a filling liquid is provided between the inner tube and the pre-expansion balloon; A treatment balloon is arranged adjacent to the pre-expansion balloon and is located on the side close to the proximal end of the inner tube, an elastic space for accommodating conductive liquid is provided between the inner tube and the treatment balloon, the outer diameter of the pre-expansion balloon in an initial state is smaller than the outer diameter of the treatment balloon in an initial state; and the outer diameter of the pre-expansion balloon after being filled with liquid is larger than the outer diameter of the treatment balloon in an initial state; A shock wave generating part, the shock wave generating part is located on the outer wall of the inner tube in the treatment balloon; A filling unit is used to fill and drain the pre-expansion balloon and the treatment balloon.

2. The pre-expandable shock wave balloon catheter according to claim 1, characterized in that: The outer diameter of the pre-expansion balloon after being filled with fluid is 1 / 2 to 9 / 10 of the outer diameter of the treatment balloon in the fluid-filled state.

3. The pre-expandable shock wave balloon catheter according to claim 1, characterized in that: The shock wave generating part comprises an inner electrode sheet, an insulating isolation layer and a conducting wire. The inner electrode sheet is glued to the outer wall of the inner tube. The conducting wire is electrically connected to the inner electrode sheet. The insulating isolation layer is tubular and is arranged on the outer periphery of the inner electrode sheet and the conducting wire. Glue is injected between the insulating isolation layer and the inner tube, and the insulating isolation layer is provided with an electrode hole corresponding to the inner electrode sheet.

4. The pre-expandable shock wave balloon catheter according to claim 3, characterized in that: The inner electrode sheet is a single-layer metal sheet or a double-layer metal sheet formed by flattening a metal capillary tube on the exposed metal part of the conductor; it also includes an outer electrode ring, which is sleeved on the outer periphery of the insulating isolation layer and electrically connected to the inner electrode sheet through the electrode hole.

5. The pre-expandable shock wave balloon catheter according to claim 3, characterized in that: The pre-expansion balloon and the treatment balloon are not connected to each other, and the filling unit includes a first filling tube and a second filling tube. The first filling tube passes through a portion of the treatment balloon and is connected to the insulating isolation layer and is connected to the pre-expansion balloon, and the second filling tube is connected to the treatment balloon.

6. The pre-expandable shock wave balloon catheter according to claim 5, characterized in that: It also includes an outer tube, a push rod, a catheter joint and a wire joint, wherein the proximal end of the outer tube and the distal end of the push rod are welded, and the proximal end of the push rod and the distal end of the catheter joint are welded; The catheter joint is provided with a first liquid-filling joint connected to the first liquid-filling tube and a second liquid-filling joint connected to the second liquid-filling tube; a wire extends from a proximal port of the catheter joint and is connected to the wire joint.

7. The pre-expandable shock wave balloon catheter according to claim 3, characterized in that: The pre-expansion balloon is connected to the treatment balloon, and a transition section is provided between the pre-expansion balloon and the treatment balloon.

8. The pre-expandable shock wave balloon catheter according to claim 3, characterized in that: The pre-expansion balloon is connected to the treatment balloon, and the pre-expansion balloon is truncated cone-shaped, and the treatment balloon is tubular, the outer diameter of the proximal end of the pre-expansion balloon is greater than the outer diameter of the distal end, and the outer diameter of the proximal end of the pre-expansion balloon is equal to the outer diameter of the treatment balloon.

9. A method for using a pre-expanded shock wave balloon catheter, characterized in that: A pre-expandable shock wave balloon catheter as claimed in any one of claims 1 to 6, comprising: In the first step, in the initial state, the pre-expansion balloon is in a folded state, and the treatment balloon is folded and closely attached to the outside of the insulating isolation layer; The second step is to insert the proximal end of the guide wire in the blood vessel into the distal hole of the inner tube, push the balloon catheter along the distal direction of the guide wire, make the proximal end of the guide wire pass through the proximal hole of the inner tube, and then continue to push the inner tube forward until the pre-expansion balloon reaches the occluded lesion; The third step is to fill the treatment balloon with conductive liquid through the liquid filling unit to expand the folded pre-expansion balloon, and the outer wall of the pre-expansion balloon is closely attached to the inner cavity of the occluded lesion and expands, so that the occlusion degree of the occluded lesion is reduced; Step 4: The conductive liquid in the pre-expanded balloon is withdrawn through the liquid filling unit to shrink and fold the treatment balloon; Step 5: Continue to push the inner tube forward along the guide wire until the treatment balloon reaches the occluded lesion; Step 6: Fill the treatment balloon with conductive liquid through the liquid filling unit to expand the treatment balloon, so that the outer wall of the treatment balloon is closely attached to the inner cavity of the occluded lesion, and the shock wave generating part is activated to generate shock waves to break up the occluded lesion; Step 7: close the shock wave generating unit, and draw back the conductive liquid in the treatment balloon through the liquid filling unit, so that the treatment balloon shrinks and folds; Step 8. Remove the balloon catheter from the blood vessel.

10. A method for using a pre-expanded shock wave balloon catheter, characterized in that: A pre-expandable shock wave balloon catheter as claimed in claim 8 or 9, comprising: In the first step, in the initial state, the pre-expansion balloon is in a folded state, and the treatment balloon is folded and closely attached to the outside of the insulating isolation layer; The second step is to insert the proximal end of the guide wire in the blood vessel into the distal hole of the inner tube, push the balloon catheter along the distal direction of the guide wire, make the proximal end of the guide wire pass through the proximal hole of the inner tube, and then continue to push the inner tube forward until the pre-expansion balloon reaches the occluded lesion; The third step is to fill the treatment balloon with conductive liquid through the liquid filling unit, so that the folded pre-expansion balloon and the treatment balloon are expanded, and the outer wall of the pre-expansion balloon is closely attached to the inner cavity of the occluded lesion and expands, so that the occlusion degree of the occluded lesion is reduced; Step 4: The conductive liquid in the treatment balloon and the pre-expansion balloon is withdrawn through the liquid filling unit, so that the pre-expansion balloon and the treatment balloon are contracted and folded; Step 5: Continue to push the inner tube forward along the guide wire until the treatment balloon reaches the occluded lesion; Step 6: Fill the treatment balloon with conductive liquid through the liquid filling unit to expand the folded pre-expansion balloon and the treatment balloon, so that the outer wall of the treatment balloon is closely attached to the inner cavity of the occluded lesion, and the shock wave generating part is activated to generate shock waves to break up the occluded lesion; Step 7: close the shock wave generating unit, and draw back the conductive liquid in the treatment balloon and the pre-expansion balloon through the liquid filling unit, so that the pre-expansion balloon and the treatment balloon shrink and fold; Step 8. Remove the balloon catheter from the blood vessel.

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