Shock wave catheter and calcified tissue removing device

Abstract

The utility model is suitable for the technical field of interventional medical instruments, and provides a shock wave catheter and a calcified tissue removing device. The shock wave catheter comprises a balloon, an inner tube, an outer tube, an electrode assembly, a nicking assembly and a filtering device. The far end of the inner tube penetrates through the balloon, and the far end of the balloon is connected to the far end of the inner tube. The inner tube is sleeved with the outer tube, and the near end of the balloon is connected to the far end of the outer tube. The electrode assembly is arranged on the inner tube in the balloon, and the electrode assembly is provided with an electrode hole. The nicking assembly comprises a nicking wire arranged on the outer surface of the balloon, the axis of the electrode hole intersects with the nicking wire, and meanwhile the far end of the inner tube is connected with a filtering device. Therefore, stress generated by shock waves is more concentrated, the crushing capacity is high, the calcium compound shattering effect is good, the filtering device can intercept shattered lesion particles, the lesion particles are well prevented from flowing to the far end of the blood vessel, and the use safety is improved.

Description

Technical Field

[0001] The present application belongs to the technical field of interventional medical devices, and in particular relates to a shock wave catheter and a calcified tissue removal device. Background Art

[0002] The application of shock wave balloons in the treatment of severely calcified blood vessels has significant clinical significance. Currently, shock wave balloons are commonly used to treat moderate or severe calcified lesions. During treatment, the shock wave balloon is delivered to the lesion. After the shock wave balloon is filled with an expansion medium and adheres to the inner wall of the blood vessel, the ultrasonic generator is activated to generate shock waves, which shatter the moderate or severe calcified lesions and thus improve the degree of vascular stenosis.

[0003] However, existing shock wave catheters are usually unable to intercept and block the shattered calcified lesion particles, and the shock wave energy conduction and amplification effects are insufficient, resulting in poor fragmentation effect on hard lesions. Summary of the Invention

[0004] In view of this, the present invention provides a shock wave catheter and a calcified tissue removal device to solve the problem of poor calcification shattering effect and inability to intercept shattered diseased particles.

[0005] In order to solve the above problems, the technical solution of the present utility model is achieved as follows:

[0006] A shock wave catheter comprises: a balloon; an inner tube, the distal end of the inner tube passes through the balloon and at least partially passes out from the distal end of the balloon, the distal end of the balloon is sealed and connected to the distal end of the inner tube; an outer tube is connected to the inner tube, the distal end of the outer tube is sealed and connected to the proximal end of the balloon, the outer tube has at least a first channel for inputting a filling medium into the balloon; an electrode assembly is arranged on the inner tube located in the balloon, the electrode assembly has an electrode hole for generating shock waves; the electrode assembly comprises an outer electrode, an inner electrode and an insulating tube, the electrode hole is formed on the outer electrode and is arranged to pass through the thickness of the outer electrode; the inner electrode is sleeved in the outer electrode; the insulating tube is arranged between the outer electrode and the inner electrode, the insulating tube is provided with an insulating hole, the insulating hole One-to-one correspondence with the electrode holes and coaxial arrangement; a scoring assembly, comprising a scoring wire arranged on the outer surface of the balloon, the scoring wire being used to conduct the shock wave to the calcified part of the blood vessel, the axis of the electrode hole intersecting with the scoring wire; the electrode assembly comprising an outer electrode, an inner electrode and an insulating tube, the electrode hole being formed on the outer electrode and being arranged through the thickness of the outer electrode; the inner electrode being sleeved inside the outer electrode; the insulating tube being arranged between the outer electrode and the inner electrode, an insulating hole being opened on the insulating tube, the insulating hole being one-to-one correspondence with the electrode hole and coaxial arrangement; a filtering device, connected to the distal end of the inner tube passing through the outside of the balloon, the filtering device having an expanded state and a contracted state, the filtering device being used to collect broken pathological particles in the blood in the expanded state.

[0007] In some embodiments, the filtering device includes: a bracket that can be expanded or contracted, the bracket having a fixed end and an open end, the fixed end is connected to the distal end of the inner tube, and the opening direction of the open end is facing away from the balloon; a filter membrane, including an inlet end for allowing the diseased particles to enter and a tail end for intercepting and collecting the diseased particles, and the inlet end is connected to the open end.

[0008] In some embodiments, the bracket includes a plurality of circumferentially distributed corrugated rods and connecting rods, the two ends of each of the corrugated rods being connected to two adjacent connecting rods in sequence, and one end of two adjacent corrugated rods being connected to the same connecting rod; the other end of each of the connecting rods is connected to form the fixed end, and the corrugated rods are enclosed to form the open end; wherein, in the expanded state, the radial space inside the bracket increases along the direction from the fixed end to the open end.

[0009] In some embodiments, the radial space inside the filter membrane increases along the direction from the tail end to the inlet end.

[0010] In some embodiments, at least a developing line is provided on the corrugated rod; and / or developing rings are provided on the fixed end and the tail end respectively; and / or the distal end of the inner tube passes through the tail end and is connected to a guide head.

[0011] In some embodiments, there are three electrode holes, at least three scoring wires, the axis of each electrode hole intersects with at least one scoring wire, and the axis of each electrode hole intersects with a different scoring wire.

[0012] In some embodiments, the scoring wire includes a supporting portion and a scoring portion, wherein the supporting portion is connected to the outer surface of the balloon, the scoring portion is connected to the supporting portion, and the tip is facing away from the balloon; wherein the cross-section perpendicular to the length direction of the scoring wire is "triangular".

[0013] In some embodiments, the scoring wire is extended along the length direction of the balloon, the distal end of the scoring wire extends to the distal end of the balloon, and the proximal end of the scoring wire extends to the proximal end of the balloon.

[0014] In some embodiments, the scoring assembly further includes a distal fixing tube and a proximal telescopic tube, wherein the distal fixing tube is sleeved on and connected to the distal end of the balloon, one end of the proximal telescopic tube is connected to the proximal end of the scoring wire, and the other end of the proximal telescopic tube is connected to the outer tube.

[0015] In some embodiments, the electrode assembly includes:

[0016] An outer electrode, wherein the electrode hole is formed on the outer electrode and is arranged through the thickness of the outer electrode; an inner electrode; and an insulating tube, which is arranged between the outer electrode and the inner electrode. The insulating tube is provided with insulating holes, which correspond one to one with the electrode holes and are coaxially arranged.

[0017] In some embodiments, two groups of electrode assemblies are spaced apart on the inner tube located inside the balloon, the outer electrode near the distal end of the balloon is connected to an external power source via a first wire, the inner electrode near the distal end of the balloon is connected to the inner electrode near the proximal end of the balloon via a second wire, and the outer electrode near the proximal end of the balloon is connected to the external power source via a third wire; wherein a second channel is provided in the inner tube for at least the first wire and the third wire to pass through.

[0018] In some embodiments, the length of the inner electrode is greater than the length of the outer electrode, and the length of the insulating tube is greater than the length of the inner electrode.

[0019] In some embodiments, notches are provided at both ends of the inner electrode.

[0020] An embodiment of the present application also provides a calcified tissue removal device, comprising: the above-mentioned shock wave catheter, wherein a third channel is provided in the inner tube, a suction hole is provided on the inner tube between the balloon and the filtering device, and the suction hole is connected to the third channel; a suction device, at least for aspirating fragmented diseased particles, the suction device is connected to the third channel; a pulse generator, for generating electrical energy, the pulse generator is electrically connected to the electrode assembly via a wire; a filling device, at least for delivering a filling medium to the balloon, the filling device is connected to the first channel.

[0021] The present invention provides a shock wave catheter and calcified tissue removal device. The shock wave catheter comprises a balloon, an inner tube, an outer tube, an electrode assembly, a scoring assembly, and a filter. The distal end of the inner tube passes through the balloon and is sealably connected to the distal end of the inner tube. The outer tube is connected to the inner tube, and the proximal end of the balloon is sealably connected to the distal end of the outer tube. The electrode assembly is disposed on the inner tube within the balloon and has electrode holes for generating shock waves. The scoring assembly is configured to include a scoring wire disposed on the outer surface of the balloon, with the axis of the electrode holes intersecting the scoring wire. Furthermore, a filter is connected to the distal end of the inner tube, where it passes outside the balloon. This arrangement allows the scoring wire to contact the calcification and be positioned directly above the electrode holes, thereby concentrating the stress generated by the shock wave, improving the fragmentation capability and achieving a more effective calcification fragmentation effect. Furthermore, the filter can intercept the fragmented diseased particles, effectively preventing them from flowing to the distal end of the blood vessel. Therefore, the safety of using the calcified tissue removal device having the shock wave catheter is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 Schematic diagram of the overall structure of the waveguide provided in an embodiment of the present application;

[0023] Figure 2 This is a schematic structural diagram of the filtration device provided in an embodiment of the present application in an expanded state;

[0024] Figure 3 yes Figure 2 a schematic cross-sectional view of a filtration device;

[0025] Figure 4 is a cross-sectional schematic diagram of the scored wire provided in an embodiment of the present application connected to a balloon;

[0026] Figure 5 Schematic diagram of the cross section of the scored wire provided in the embodiment of the present application;

[0027] Figure 6 is a schematic cross-sectional view of a scored wire provided in another embodiment of the present application;

[0028] Figure 7 1 is an exploded schematic diagram of the outer electrode, insulating tube and inner electrode provided in an embodiment of the present application;

[0029] Figure 8 is a schematic structural diagram of an electrode assembly provided in an embodiment of the present application;

[0030] Figure 9 is a schematic structural diagram of the inner electrode provided in an embodiment of the present application;

[0031] Figure 10 This is a schematic structural diagram of a calcified tissue removal device provided in an embodiment of the present application;

[0032] Figure 11 This is a schematic diagram of the operating steps of the calcified tissue removal device provided in an embodiment of the present application.

[0033] Description of reference numerals:

[0034] 1. Shock wave guide tube; 10. Guide head; 11. Balloon; 111. Inner cavity; 12. Inner tube; 120. Guidewire port; 121. Second channel; 123. Suction port; 13. Outer tube; 131. First channel; 14. Electrode assembly; 141. Electrode port; 142. Outer electrode; 143. Inner electrode; 1431. Incision; 144. Insulating tube; 1441. Insulating port; 145. First conductor; 146. Second conductor; 147 15. Scoring assembly; 151. Scoring wire; 1511. Support portion; 1512. Scoring portion; 152. Distal fixed tube; 153. Proximal telescopic tube; 16. Filter device; 161. Bracket; 1611. Fixed end; 1612. Open end; 162. Filter membrane; 1621. Inlet end; 1622. Tail end; 163. Development line; 17. First development ring; 18. Second development ring; 19. Third development ring;

[0035] 2. Calcified tissue removal device; 21. Suction device; 22. Pulse generator; 23. Filling device; 3. Delivery catheter; 4. Guide wire; 5. Calcified lesion tissue. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0037] The various specific technical features described in the specific embodiments may be combined in any suitable manner, unless they are inconsistent. For example, different embodiments and technical solutions may be formed by combining different specific technical features. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this utility model will not be described separately.

[0038] In the following description, the terms "first, second, ..." are used solely to distinguish different objects and do not imply any similarities or connections between the objects. It should be understood that the directions "above," "below," "outside," and "inside" refer to directions during normal use. The directions "left" and "right" refer to the left-right directions shown in the corresponding schematic diagrams, which may or may not be the left-right directions during normal use.

[0039] It should be noted that the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not preclude the presence of additional identical elements in the process, method, article, or apparatus comprising that element. "A plurality" means greater than or equal to two.

[0040] like Figure 1 As shown, an embodiment of the present application provides a shock wave catheter 1 for inserting into a calcified blood vessel and, when energized, generating shock waves that act on the calcifications, thereby breaking up the calcifications and achieving the purpose of treating the calcified blood vessel. The term "distal end" herein refers to the end of the shock wave catheter 1 that inserts into the blood vessel, or the end that is closer to the area to be treated. The term "proximal end" refers to the end of the shock wave catheter 1 that is closer to the operator, or the end that is connected to the operating device.

[0041] like Figure 1 and Figure 2 As shown, an embodiment of the present application provides a shock wave catheter 1, comprising a balloon 11, an inner tube 12, an outer tube 13, an electrode assembly 14, a scoring assembly 15, and a filter device 16. Balloon 11 is made of a semi-compliant material, Pebax (polyether block polyamide), or a non-compliant material, nylon. Balloon 11 has an inner cavity 111, which can be filled with a conductive liquid. The burst pressure of balloon 11 can reach up to 24 atm (atm, a unit of atmospheric pressure). This high burst pressure reduces the risk of balloon 11 rupture during surgery.

[0042] like Figure 1As shown, in some embodiments, both the inner tube 12 and the outer tube 13 are made of a material with good flexibility and a certain degree of bending resistance. The materials may include polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and other materials that meet medical standards. The outer tube 13 is connected to the inner tube 12, forming a tubular assembly that is inserted into the blood vessel to deliver the balloon 11 to the calcified lesion 5 and to introduce a filling medium (such as a conductive liquid) into the lumen 111 of the balloon 11 to inflate the balloon 11. Specifically, the distal end of the inner tube 12 passes through the interior of the balloon 11 and at least partially exits the distal end of the balloon 11. The distal end of the balloon 11 is sealingly connected to the distal end of the inner tube 12. The outer tube 13 is sleeved onto the inner tube 12, with its distal end sealingly connected to the proximal end of the balloon 11. The outer tube 13 has at least a first channel 131 for introducing the filling medium into the balloon 11. With this arrangement, the two ends of the balloon 11 are sealed and connected, so that the inner cavity 111 of the balloon 11 can only communicate with the outside world through the first channel 131, so that the filling medium can enter the inner cavity 111 of the balloon 11 through the first channel 131 to expand the balloon 11. At the same time, a guidewire cavity can also be set inside the inner tube 12, and the guidewire cavity is used for the guidewire 4 to pass through. The side wall of the inner tube 12 is provided with a guidewire port 120 for the guidewire 4 to enter and exit, and the guidewire cavity extends along the length direction of the inner tube 12 to the distal opening. The guidewire 4 has high softness and strength, and the guidewire can pass through the calcified lesion tissue 5, thereby guiding the balloon 11 to pass through the calcified lesion tissue 5, that is, it can improve the passability of the shock wave balloon catheter 1 in the blood vessel.

[0043] like Figure 1As shown, in some embodiments, an electrode assembly 14 is disposed on the inner tube 12 within the balloon 11. The electrode assembly 14 has an electrode aperture 141 for generating shock waves. Specifically, the electrode assembly 14 is connected to an external device capable of providing high voltage and high current (such as a pulse generator). When energized, it generates a potential difference that generates shock waves. The generated shock waves act on the scoring assembly 15, thereby shattering vascular calcifications in contact with the scoring assembly 15. The scoring assembly 15 includes a scoring wire 151 disposed on the outer surface of the balloon 11. The scoring wire 151 is used to transmit the shock waves to the calcified areas of the blood vessels. The axis of the electrode aperture 141 intersects the scoring wire 151. Specifically, the scoring wire 151 is made of a superelastic metal material. The superelastic metal easily returns to its original state after deformation, making it easier for the physician to remove the shock wave catheter 1 from the patient's blood vessels. The scoring wire 151 is preferably made of nickel-titanium alloy. The scoring wire 151 can be fixed to the balloon 11 by means such as laser welding, with the distal end of the scoring wire 151 fixed to the distal end of the balloon 11, and the proximal end of the scoring wire 151 connected to the proximal end of the balloon 11. After the balloon 11 is inflated and expanded, the scoring wire 151 contacts the calcifications in the blood vessels, thereby allowing the energy of the shock wave to be transferred to the calcifications. In addition, the scoring wire 151 intersects with the axis of the electrode hole 141, that is, the scoring wire 151 is distributed directly above the electrode hole 141. This design allows the scoring wire 151 to withstand the maximum shock wave energy from the front, thereby improving the efficiency of shattering the calcifications.

[0044] Specifically, the scoring wire 151 is positioned directly above the electrode hole 141. When the shock wave reaches the top of the scoring wire 151, the calcification in contact with the top of the scoring wire 151 is more likely to produce regular, axially penetrating cracks due to stress concentration, thereby improving the shattering efficiency. Furthermore, using the scoring wire 151 to directly transmit the shock wave vibration energy can effectively enhance its shattering efficiency. When the shock wave energy is not used, the scoring wire 151 can be used alone to physically squeeze and crush hard calcified lesions, thereby greatly increasing the ability to crush hard calcified lesions. Furthermore, the regular cracks produced are also beneficial for subsequent treatment, improving the success rate of surgery and reducing patient complications, demonstrating a clever design.

[0045] like Figure 1 and Figure 2As shown, in some embodiments, a filter device 16 is connected to the distal end of the inner tube 12, which extends outside the balloon 11. The filter device 16 has an expanded state and a contracted state. In the expanded state, the filter device 16 is used to collect fragmented diseased particles in the blood. Specifically, after the balloon 11 is positioned below the vascular lesion through pushing, the distal end of the inner tube 12 is positioned in front of the balloon 11 along the direction of blood flow within the vessel. When calcified lesions 5 are shattered, the fragmented calcifications become diseased particles and follow the blood flow toward the distal end of the vessel. Therefore, by connecting the filter device 16 to the distal end of the inner tube 12, which extends outside the balloon 11, fragmented diseased particles in the blood can be filtered and collected in front of the vascular lesion, effectively preventing them from flowing to the distal end of the vessel and causing other problems. Furthermore, the filter device 16 can be expanded or contracted as needed, ensuring that it can remain contracted during pushing, with a smaller volume facilitating pushing within the vessel, while expanding when filtering is required, creating a larger filtration area and effectively collecting diseased particles.

[0046] In an embodiment of the present application, a shock wave catheter 1 is provided, wherein the distal end of the inner tube 12 passes through the balloon 11, and the distal end of the balloon 11 is sealedly connected to the distal end of the inner tube 12. The outer tube 13 is sleeved on a portion of the inner tube 12, and a portion of the side wall of the outer tube 13 is connected to the side wall of the inner tube 12, and a guide wire port 120 is formed, and the proximal end of the balloon 11 is sealedly connected to the distal end of the outer tube 13. The electrode assembly 14 is arranged on the inner tube 12 located in the balloon 11, and the electrode assembly 14 has an electrode hole 141 for generating shock waves. The scoring assembly 15 is arranged to include a scoring wire 151, the scoring wire 151 is arranged on the outer surface of the balloon 11, and the axis of the electrode hole 141 intersects with the scoring wire 151. At the same time, a filter device 16 is connected to the distal end of the inner tube 12 passing outside the balloon 11. This arrangement, with scored wire 151 contacting the calcification and positioned directly above electrode aperture 141, further concentrates the stress generated by the shock wave, enhancing the fragmentation capability and effectively shattering the calcification. Furthermore, filter device 16 intercepts the shattered diseased particles, effectively preventing them from migrating to the distal end of the blood vessel and improving safety.

[0047] like Figure 1 and Figure 2As shown, the filter device 16 includes a support 161 and a filter membrane 162. The support 161 can be expanded or contracted, and the filter membrane 162 is connected to the support 161. The support 161 has a fixed end 1611 and an open end 1612. The fixed end 1611 is connected to the distal end of the inner tube 12, and the open end 1612 is opened in a direction away from the balloon 11. The filter membrane 162 includes an inlet end 1621 for allowing diseased particles to enter and a tail end 1622 for intercepting and collecting diseased particles. The inlet end 1621 is connected to the open end 1612 to connect the filter membrane 162 to the support 161. Specifically, the support 161 is a hollow structure made of a shape memory alloy that can be expanded and contracted. In a normal state, the support 161 is in an expanded state. Thus, the support 161 can contract when subjected to external force and automatically return to its normal shape when the external force is removed. The filter membrane 162 completely covers the open end 1612 of the outermost stent 161; the good wall adhesion performance is achieved through the above-mentioned stent 161 structure. The filter membrane 162 completely covers the open end 1612 of the stent 161, which also reduces the probability of intravascular thrombus or calcified fragments getting stuck on the edge of the filter membrane 162 or the edge of the stent 161, making it impossible to be successfully captured.

[0048] In the expanded state, the outer diameter of the open end 1612 matches the diameter of the blood vessel to be protected, and can be set between 5mm and 20mm depending on the specifications. This provides sufficient radial support force to ensure that the stent 161 can be fully expanded and adhered to the wall in the blood vessel, avoiding damage to the blood vessel due to excessive support force.

[0049] Optionally, the bracket 161 is formed by cutting a memory alloy tube and then shaping it to maintain good elasticity. The fixed end 1611 is formed by retaining a length of the cut tube and can be connected to the distal end of the inner tube 12 by bonding, crimping, etc. through methods such as grooving, leaving an extended section, etc.

[0050] like Figure 3 As shown, the filter membrane 162 is made of a polymer film material that is punched and then shaped, and is distributed with multiple filter holes. The pore size of the filter holes is preferably between 80 microns and 180 microns to ensure that no thrombus or calcified fragments are leaked while allowing blood to flow smoothly.

[0051] like Figure 2As shown, in some embodiments, the stent 161 includes a plurality of circumferentially distributed corrugated rods 1613 and connecting rods 1614. The two ends of each corrugated rod 1613 are sequentially connected to two adjacent connecting rods 1614, and one end of two adjacent corrugated rods 1613 is connected to the same connecting rod 1614. In this way, the other ends of the connecting rods 1614 are connected to form a fixed end 1611, and the corrugated rods 1613 enclose an open end 1612. In the expanded state, the radial space inside the stent 161 increases from the fixed end 1611 to the open end 1612. This arrangement not only requires less material for the overall production of the stent 161, which helps reduce the volume after compression, but also, in the expanded state, the stent 161 has a roughly lotus-shaped structure, which can reliably achieve effective collection of pathological particles.

[0052] Specifically, the filter device 16 is usually compressed in the delivery catheter to achieve pushing in the blood vessel. Since the fixed end 1611 is fixed to the first tube body, the second developing ring 18 is fixed to the tail end 1622 and is slidably mounted on the inner tube. When the filter device 16 is compressed by the delivery catheter, the second developing ring 18 slides toward the distal end, and the radial diameter is reduced, so that it can be loaded into the inner cavity of the delivery catheter 3. During the treatment process, when the delivery catheter transports the filter device 16 to the distal end of the diseased blood vessel, the position of the shock wave catheter 1 is stabilized and the delivery catheter is withdrawn, so that the filter device 16 is separated from the delivery catheter and deployed. Due to its good elasticity, the stent 161 will automatically deploy and adhere to the blood vessel wall after leaving the inner cavity of the delivery catheter 3.

[0053] like Figure 2 As shown, the radial space inside the filter membrane 162 increases from the tail end 1622 toward the inlet end 1621. Thus, the filter membrane 162 forms a net-like structure. The inlet end 1621 has a larger area, facilitating the entry of diseased particles, while the tail end 1622 gradually shrinks, thereby gradually collecting the intercepted diseased particles.

[0054] like Figure 2As shown, in some embodiments, a developing line 163 is provided on at least the corrugated rod 1613. The developing line 163 is composed of a developing metal wire (such as tantalum, platinum-tungsten alloy, platinum, platinum-iridium alloy and other metal wires) and is wound around the corrugated rod 1613. The specific position of the open end 1612 of the stent 161 in the blood vessel can be known through the developing line 163. And / or, a first developing ring 17 and a second developing ring 18 are respectively provided on the fixed end 1611 and the tail end 1622, and the first developing ring 17 and the second developing ring 18 are composed of developing metal rings. The first developing ring 17 is sleeved on the fixed end 1611 and fixed, and the fixed end 1611 is fixed on the inner tube. The second developing ring 18 is fixed to the tail end 1622 and is slidably sleeved on the inner tube, so that the position of the fixed end 1611 of the bracket 161 and the position of the tail end 1622 of the filter membrane 162 can be known through the first developing ring 17 and the second developing ring 18, which facilitates timely manipulation during the operation; and / or, the distal end of the inner tube 12 passes through the tail end 1622 and is connected to the guide head 10. The guide head 10 is a relatively soft composite hollow tube composed of low-density polyethylene and high-density polyethylene. The guide head 10 is the first to enter the blood vessel. The distal end of the guide head 10 is set to have a pointed tip and is smoothly chamfered. This not only facilitates entry into the blood vessel, but also better prevents damage to the blood vessel wall during pushing.

[0055] To prevent thrombus or calcified material from slipping through the second developing ring 18, the inner diameter of the second developing ring 18 is slightly larger than the outer diameter of the inner tube. For example, the inner diameter of the second developing ring 18 is 0.1-1 mm larger than the outer diameter of the inner tube. To reduce the sliding resistance of the second developing ring 18, a lubricating coating is provided on the outer surface of the inner tube.

[0056] In some embodiments, there are N electrode holes 141 and M scoring wires 151, and the axis of at least one electrode hole 141 intersects with a scoring wire 151; where N ≥ 1 and M ≥ 1. Specifically, the number of electrode holes 141 can be greater than the number of scoring wires 151. This allows a portion of the shock wave generated by the electrode holes 141 to be transmitted to the scoring wires 151, while the remaining portion directly impacts the blood vessels. Alternatively, the number of electrode holes 141 can be less than the number of scoring wires 151. This allows some scoring wires 151 to correspond to electrode holes 141 and thus receive the shock wave generated by them, while other scoring wires 151, which do not correspond to electrode holes 141, only serve to locate the scoring wires. Alternatively, the number of electrode holes 141 can be equal to the number of scoring wires 151, with a one-to-one correspondence. This allows each scoring wire 151 to receive the shock wave generated by the electrode holes 141. The specific arrangement can be selected based on actual design requirements.

[0057] like Figure 1 and Figure 4As shown, in some embodiments, in order to better ensure the effect of crushing the calcifications in the blood vessels, it is optional to set three electrode holes 141 and at least three scoring wires 151, and the axis of each electrode hole 141 intersects with at least one scoring wire 151, and the scoring wire 151 intersected by the axis of each electrode hole 141 is different. Specifically, the electrode holes 141 are evenly distributed in the circumferential direction of the electrode assembly 14, so that the scoring wires 151 are also evenly distributed in the circumferential direction of the balloon 11, and at least one electrode hole 141 is directly opposite to a scoring wire 151. Such a setting is conducive to the uniform distribution of the shock wave energy generated by the electrode holes 141 along the circumference of the balloon 11 surface and the energy is relatively strong, thereby achieving the purpose of effectively crushing the calcifications in contact with the scoring wires 151.

[0058] In some possible implementation schemes, each scoring wire 151 provided on the balloon 11 can be extended in the direction of both ends of the balloon 11 except for the portion that ensures that it maintains a facing relationship with the corresponding electrode hole 141. The extension length can be extended to the proximal and distal ends of the balloon 11, or can be spaced at a preset distance, such as 1mm or 2mm. The extension method can be a straight extension along the length direction of the balloon 11, so that the shock wave on the scoring wire 151 can be distributed in a straight line, so that the shattered calcification can produce regular straight cracks. Of course, the scoring wire 151 can also be extended in a spiral or corrugated manner. The length and extension method of the scoring wire 151 can be sufficient to achieve effective treatment of the calcified area. The setting method is flexible and diverse and can meet different design requirements.

[0059] like Figure 4 and Figure 5 As shown, in some embodiments, the scoring wire 151 includes a support portion 1511 and a scoring portion 1512, the support portion 1511 is connected to the outer surface of the balloon 11, the scoring portion 1512 is connected to the support portion 1511, and the tip is facing away from the balloon 11; wherein, the cross-section perpendicular to the length direction of the scoring wire 151 is "triangular". Specifically, the scoring wire 151 provided on the balloon 11 is shaped as follows: the cross-sectional shape obtained perpendicular to the length direction of the scoring wire 151 is "triangular". In this way, the support portion 1511 is connected to the balloon 11 and has a larger contact area, while one end of the scoring portion 1512 is connected to the support portion 1511, and the other end extends in a direction away from the support portion 1511 and is formed with a tip, which is used to contact the calcification in the blood vessel, so that the stress is more concentrated, which is conducive to shattering the calcification.

[0060] like Figure 5As shown, in some embodiments, the scoring wire 151 can be configured to have at least one of the following features: (1) the total height H1 of the scoring wire 151 is set to 0.2 mm to 0.35 mm; (2) the angle θ of the scoring portion 1512 is set to 20° to 60°; (3) the chamfer R1 of the tip of the scoring portion 1512 is set to 0.01 mm to 0.03 mm; (4) the chamfer R2 on both sides of the length direction of the support portion 1511 is set to 0.02 mm to 0.04 mm. This configuration allows the cross section perpendicular to the length direction of the scoring wire 151 to be in an equilateral triangle (e.g., Figure 5 As shown, in this cross-sectional shape, the line connecting the two ends of the support portion 1511, with the tip as the vertex, and the line connecting the two ends of the support portion 1511, as well as the line between the two ends of the support portion 1511, enclose the shape. While providing sufficient stress, the scoring wire 151 also allows the entire shock wave guide 1 to have a smaller folding profile, facilitating smooth passage of the shock wave guide 1 through the lesion. Furthermore, the cross-sectional support portion 1511 of the scoring wire 151 can be rounded. The rounded corners R2 are 0.02-0.04 mm, and the top rounded corners R1 are 0.005-0.015 mm. The rounded corners R1 and R2 prevent the scoring wire 151 from scratching the balloon 11 during folding, thereby improving the safety of the balloon 11.

[0061] like Figure 6 As shown, in other embodiments, the cross-section of the notched wire 151 is an isosceles triangle structure, and the notched wire 151 has at least one of the following characteristics: (1) the total height H2 of the notched wire 151 is set to 0.2 mm to 0.35 mm; (2) the angle β of the notched portion 1512 is set to 20° to 60°; (3) the chamfer R2 of the tip of the notched portion 1512 is set to 0.01 mm to 0.03 mm; (4) the chamfer R3 on both sides of the support portion 1511 in the length direction is set to 0.02 mm to 0.04 mm.

[0062] In some embodiments, the scoring wire 151 extends along the length of the balloon 11, with the distal end of the scoring wire 151 extending to the distal end of the balloon 11, and the proximal end of the scoring wire 151 extending to the proximal end of the balloon 11. Specifically, the scoring wire 151 extends according to the outer contour of the balloon 11, so that it can follow the shape of the balloon 11 when the balloon 11 expands or contracts, without restricting the shape change of the balloon 11. The connection between the distal end of the scoring wire 151 and the distal end of the balloon 11, and between the proximal end of the scoring wire 151 and the proximal end of the balloon 11 can be achieved by laser welding or bonding, etc., which provides good flexibility.

[0063] like Figure 1As shown, in some embodiments, the scoring assembly 15 further includes a distal fixing tube 152 and a proximal telescopic tube 153. The distal fixing tube 152 is sleeved and connected to the distal end of the balloon 11. One end of the proximal telescopic tube 153 is connected to the proximal end of the scoring wire 151, and the other end is connected to the outer tube 13. Specifically, the distal fixing tube 152 is made of Pebax (Chinese name: polyether block polyamide), and the proximal telescopic tube 153 is an elastically deformable silicone tube. One end of the proximal telescopic tube 153 is connected to the scoring wire 151, and the other end is welded to the outer tube 13. By providing the proximal telescopic tube 153, the shape of the balloon 11 changes during inflation and depressurization. The proximal telescopic tube 153, which is located proximal to the scoring wire 151, elastically deforms accordingly, allowing axial movement without affecting the shape of the balloon 11, resulting in a sophisticated design.

[0064] like Figure 1 and Figure 7 As shown, in some embodiments, the electrode assembly 14 includes an outer electrode 142, an inner electrode 143, and an insulating tube 144. An electrode hole 141 is formed on the outer electrode 142 and is set to pass through the thickness of the outer electrode 142. The inner electrode 143 is sleeved inside the outer electrode 142, and the insulating tube 144 is set between the outer electrode 142 and the inner electrode 143. The insulating tube 144 is provided with an insulating hole 1441. The insulating hole 1441 corresponds to the electrode hole 141 one by one and is coaxially arranged. Specifically, since the electrode assembly 14 is fixed to the first tube body 12 located in the balloon 11, when the electrode assembly 14 includes the above-mentioned structural design, the inner electrode 143 is fixed to the first tube body 12 by UV glue (UV is the abbreviation of Ultraviolet Rays, and the Chinese name of UV glue is: shadowless glue or photosensitive glue) to achieve the fixation of each group of electrode assemblies 14. The outer electrode 142 and the inner electrode 143, as well as the insulating tube 144 and the inner electrode 143, are also bonded together using UV glue. The materials of the outer electrode 142 and the inner electrode 143 can be nickel-titanium alloy, stainless steel, platinum, titanium and titanium alloy, or tungsten-copper alloy, thus having good electrical conductivity. The material of the insulating tube 144 can be polyimide, polyurethane, or a mixture of the two, to achieve good insulation performance. The insulating tube 144 is arranged between the outer electrode 142 and the inner electrode 143. The number of insulating holes 1441 provided on the insulating tube 144 remains the same as the number of electrode holes 141 provided on the outer electrode 142. Moreover, the size of the insulating holes 1441 is the same as and concentric with the electrode holes 141 on the outer electrode 142. This design creates a potential difference between the portion of the inner electrode 143 exposed at the insulating holes 1441 of the insulating tube 144 and the edge of the electrode hole 141 on the outer electrode 142, which can generate a shock wave, thereby effectively generating a shock wave.

[0065] Specifically, in some embodiments, there is no restriction on the shape of the electrode hole 141 and the insulating hole 1441, which can be circular, rectangular, elliptical, triangular, diamond-shaped, etc., and can be optionally set to circular. The diameter range of the circular through-hole is 0.05-0.5mm. The length and width range of the rectangular and diamond-shaped through-holes are 0.05-0.5mm, the long and short axis range of the elliptical is 0.05-0.5mm, and the side length parameter range of the triangle is 0.05-0.5mm. When using a triangle, rectangle or diamond, since the discharge through-hole discharges through the tip, a lower input voltage can be used to generate a shock wave, reducing the load on the electrical equipment.

[0066] like Figure 1 and Figure 8 As shown, in some embodiments, two sets of electrode assemblies 14 are spaced apart on the inner tube 12 located within the balloon 11. An outer electrode 142 near the distal end of the balloon 11 is connected to an external power source via a first wire 145. An inner electrode 143 near the distal end of the balloon 11 is connected to the inner electrode 143 near the proximal end of the balloon 11 via a second wire 146. The outer electrode 142 near the proximal end of the balloon 11 is connected to a third wire 147 and connected to the external power source. A second channel 121 is provided within the inner tube 12 for at least the first wire 145 and the third wire 147 to pass through. In this way, the outer electrode 142 near the distal end of the balloon 11 is connected to the external power source via the first wire 145, the inner electrode 143 near the distal end of the balloon 11 is connected to the inner electrode 143 near the proximal end of the balloon 11 via the second wire 146, and the outer electrode 142 near the proximal end of the balloon 11 is connected to the external power source via the third wire 147. The two sets of electrode assemblies 14 are connected in series via a first wire 145, a second wire 146, and a third wire 147, forming a circuit loop. The other ends of the first and third wires 145, 147 can be connected to a high-voltage, high-current device to generate electrical energy. Furthermore, the end of the first wire 145 intended for connection to an external high-voltage, high-current device can be passed through the inner electrode 143 near the proximal end of the balloon 11. Finally, both the first and third wires 145, 147 are passed through the second channel 121 to connect to an external high-voltage, high-current device (e.g., a pulse generator 22). This arrangement minimizes the overall dimensions of the balloon 11, reducing its folded profile and facilitating its passage through stenotic vessels. Furthermore, the connections between the wires and electrodes can be laser welding, soldering, or other methods to ensure good electrical conductivity at each connection.

[0067] In other embodiments, depending on the treatment location, multiple sets of electrode assemblies 14, such as three or four sets, may be spaced apart on the first tubular body 12 within the balloon 11, but this is not limited to these sets. Each electrode assembly 14 can be connected in series with conductive wires and then connected to a single external high-voltage, high-current device. Alternatively, the electrode assemblies 14 can be distributed as needed, such as connecting two sets in series, then connecting them in parallel, and then connecting them to the same external high-voltage, high-current device. Alternatively, two sets can be connected in series and then connected to different external high-voltage, high-current devices, providing flexibility in the design.

[0068] In some embodiments, the distance between two adjacent electrode assemblies 14 is in the range of 2-10 mm. Of course, the distance between the two can be adjusted and selected according to the distance and range of the treatment site, and is not specifically limited.

[0069] like Figure 7 and Figure 8 As shown, in some embodiments, the length of the inner electrode 143 is set to be greater than the length of the outer electrode 142, while the length of the insulating tube 144 is set to be greater than the length of the inner electrode 143. In this way, the outer electrode 142 and the inner electrode 143 are separated by the insulating tube 144, which effectively avoids the generation of shock waves at both ends of the outer electrode 142 and the inner electrode 143, thereby not affecting the stability of the potential difference at the position of the electrode hole 141. In addition, the longer inner electrode 143 has a larger contact area with the first tube body 12, which facilitates the fixing of the inner electrode 143 to the first tube body 12 using UV glue to prevent the electrode assembly 14 from sliding.

[0070] like Figure 8 and Figure 9 As shown, in some embodiments, cutouts 1431 may be provided at both ends of the inner electrode 143. Specifically, the number of cutouts 1431 provided may be one or more. When provided in a plurality, each cutout 1431 may be provided in a uniformly distributed manner. The cutouts 1431 are used to fix the wires, that is, the first wire 145, the second wire 146 and the third wire 147 mentioned above may be inserted into the corresponding cutouts 1431 when provided to achieve fixation. Furthermore, the cutouts 1431 may also accommodate the wires connected to the outer electrode 142, thereby preventing the wires connected to the outer electrode 142 from protruding, thereby increasing the shock wave guide tube 1 (refer to Figure 1 ) Overall flexibility.

[0071] In some embodiments, the inner tube 12 is a hollow tube extruded from nylon material, and the outer tube 13 is a multi-layer composite hollow tube composed of PTFE (PTFE is the abbreviation of Polytetrafluoroethylene, and its Chinese name is polytetrafluoroethylene), PE (PE is the abbreviation of Polyethylene, and its Chinese name is polyethylene), Pebax (Chinese name: polyether block polyamide) or nylon material. The inner layer (the inner wall of the second channel 121) is a PTFE layer. PTFE has an extremely low friction coefficient, which is beneficial for the passage of the guide wire during surgery. The outermost layer is a Pebax or nylon layer, which can provide sufficient support strength, thereby improving the overall pushability.

[0072] like Figure 1 As shown, in some embodiments, the inner tube 12 located in the inner cavity 111 of the balloon 11 is also provided with a third developing ring 19, which is used by the doctor to accurately position the balloon 11 during surgery. Specifically, two third developing rings 19 are usually provided and arranged in an interval distribution manner. One third developing ring 19 is close to the distal end of the balloon 11, and the other third developing ring 19 is close to the proximal end of the balloon 11. Both developing rings 17 are installed on the inner tube 12. The setting of the developing ring can serve as an imaging marker (such as with X-ray imaging), so that the specific position can be determined in the image, preventing the doctor from pushing the balloon 11 to other blood vessels of the patient and causing unnecessary harm to the patient. The developing ring material is tantalum, platinum-tungsten alloy, platinum, platinum-iridium alloy, etc. In the embodiment of the present application, the developing ring is set to platinum-iridium alloy, which has excellent developing performance.

[0073] In some other embodiments, the inner tube 12 may be formed by a multi-lumen tube, and the multiple cavities inside the multi-lumen tube are respectively used to form a guide wire cavity and a suction cavity, etc., which can be specifically allocated and set according to usage needs.

[0074] like Figure 10 As shown, the present invention also provides a calcified tissue removal device 2, comprising the shock wave catheter 1 described in any of the above embodiments, and further comprising a suction device 21, a pulse generator 22, and a filling device 23. A third channel (suction cavity) is provided in the inner tube 12, and a suction hole 123 is provided on the inner tube 12 between the balloon 11 and the filter device 16 (refer to FIG. Figure 1 ), the suction hole 123 is connected to the third channel. Specifically, the inner tube 12 is provided with at least two independent (non-connected) lumens, comprising a suction lumen (the third channel) and a guidewire lumen. One end of the suction lumen is connected to the suction hole 123, and the other end is connected to the suction device 21. The suction device 21 is capable of generating a suction force to at least aspirate fragmented diseased particles. Thus, when the suction device 21 is activated, diseased particles intercepted by the filter 16 enter the suction lumen through the suction hole 123 and are removed by suction.

[0075] In some other embodiments, the outer tube 13 may be formed by a multi-cavity tube, and the multiple cavities inside the multi-cavity tube are respectively used to form the first channel 131, the second channel 121, etc., which can be specifically allocated and set according to usage needs.

[0076] The pulse generator 22 is used to generate electrical energy. It is electrically connected to the electrode assembly 14 via wires (a first wire 145, a second wire 146, and a third wire 147). The wires (the first wire 145, the second wire 146, and the third wire 147) are confined within the second channel 121. When connected to the electrode assembly 14, the pulse generator 22 is controlled to emit a preset number of pulses, which are then converted into shock wave energy by the electrode assembly 14, thereby applying the shock wave energy to the calcified lesions. The pulse generator 22 can accurately output shock waves by adjusting at least one energy parameter, such as voltage, current, or output power, for different applications and shock wave components of different specifications. For example, for shock wave components used to eliminate heart valve calcification, the output voltage range is 4 kV to 8 kV. For shock wave components used to eliminate vascular calcification, the output voltage range is 1.5 kV to 4 kV.

[0077] The filling device 23 is used to deliver a filling medium to the balloon 11 and is in communication with the first channel 131. Specifically, the filling device 23 can both inflate and relieve pressure on the balloon 11. After inflation, the balloon 11 can dilate the blood vessel and squeeze the scoring wire 151 to score and cut calcified tissue. After pressure relief, the balloon 11 shrinks in size, facilitating its removal from the blood vessel.

[0078] The calcified tissue removal device 2 provided in the present embodiment features a shock wave guide 1 that generates a more concentrated shock wave with a stronger crushing ability, effectively shattering calcified material. Furthermore, the filter 16 intercepts the shattered diseased particles, effectively preventing them from migrating to the distal end of the blood vessel. This improves the safety of the calcified tissue removal device 2.

[0079] like Figure 11 As shown, the operating method of the calcified tissue removal device 2 provided in the embodiment of the present application is:

[0080] S1: First, the shock wave catheter 1 is placed in the delivery catheter, and the guide wire is inserted through the calcified lesion. The shock wave catheter 1 is inserted along the guide wire to the proximal end of the calcified lesion;

[0081] S2 The shock wave catheter 1 continues to be inserted and passes through the lesion, so that the filter device 16 is at the distal end of the calcified lesion and the balloon 11 is below the calcified lesion;

[0082] S3 retracts the delivery catheter to the outside of the proximal end of the balloon 11, and the filter device 16 contacts the blood vessel wall after self-expansion; then the balloon 11 is filled through the filling device 23, so that the balloon 11 expands and fits the calcified tissue, and the pulse generator 22 is started. The electrode assembly 14 performs arc discharge after receiving the electrical energy from the pulse generator 22 to create a short-duration high-voltage pulse in the balloon 11. The high-voltage pulse causes bubbles to be generated in the filling medium in the balloon 11 that is close to the electrode assembly 143. The energy generated when the bubbles expand and burst acts on the adjacent filling medium to push the filling medium in the balloon 112 to generate a shock wave moving toward the inner wall of the balloon 112. The shock wave propagates within the filling medium and strikes the intravascular calcified lesion through the wall of the balloon 11, thereby cracking and fragmenting the calcified lesion. As the balloon 11 is further pressurized, the scoring wires 151 act on the calcified tissue, and the pressure of the balloon 11 is superimposed to further fragment the calcified tissue. The blood flow carries the fragmented lesion particles toward the filter device 16, where the filter membrane 162 intercepts the fragmented lesion particles.

[0083] After the S4 operation is completed, the balloon 11 is deflated by the filling device 23, and the filtering device 16 intercepts a large amount of broken lesion particles, resulting in less calcified tissue remaining and the expansion of the blood vessel lumen;

[0084] S5 pushes the delivery catheter, which enables the filter device 16 to be folded and accommodated in the delivery catheter, and the entire shock wave catheter 1 is withdrawn from the body.

[0085] In addition, in steps S3 and S4, a suction device 21 may be connected to suction the tiny diseased particles during the treatment process, thereby expelling the tiny diseased particles from the body.

[0086] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A shock wave guide tube, characterized in that: include: balloon; an inner tube, wherein the distal end of the inner tube passes through the balloon and at least partially passes out of the distal end of the balloon, and the distal end of the balloon is sealingly connected to the distal end of the inner tube; an outer tube connected to the inner tube, wherein the distal end of the outer tube is sealedly connected to the proximal end of the balloon, and the outer tube has at least a first channel for inputting a filling medium into the balloon; An electrode assembly is disposed on the inner tube located within the balloon, the electrode assembly having an electrode hole for generating shock waves; the electrode assembly comprises an outer electrode, an inner electrode, and an insulating tube, the electrode hole being formed on the outer electrode and extending through the thickness of the outer electrode; the inner electrode is sleeved within the outer electrode; the insulating tube is disposed between the outer electrode and the inner electrode, the insulating tube having insulating holes formed therein, the insulating holes corresponding one-to-one with the electrode holes and being coaxially disposed; A scoring assembly includes a scoring wire disposed on the outer surface of the balloon, the scoring wire being used to transmit the shock wave to the calcified portion of the blood vessel, the axis of the electrode hole intersecting the scoring wire; there are three electrode holes, at least three scoring wires are disposed, the axis of each electrode hole intersects with at least one scoring wire, and the axis of each electrode hole intersects with a different scoring wire; The filtering device is connected to the distal end of the inner tube passing through the outside of the balloon. The filtering device has an expanded state and a contracted state. The filtering device is used to collect broken diseased particles in the blood in the expanded state.

2. The shock wave guide according to claim 1, wherein The filtering device comprises: a stent capable of expansion or contraction, the stent having a fixed end and an open end, the fixed end being connected to the distal end of the inner tube, and the open end being oriented in a direction away from the balloon; The filter membrane comprises an inlet end for allowing the diseased particles to enter and a tail end for intercepting and collecting the diseased particles, wherein the inlet end is connected to the opening end.

3. The shock wave guide tube according to claim 2, wherein: The bracket includes a plurality of corrugated rods and connecting rods distributed along the circumference, wherein the two ends of each corrugated rod are sequentially connected to two adjacent connecting rods, and one end of two adjacent corrugated rods is connected to the same connecting rod; the other ends of the connecting rods are connected to form the fixed end, and the corrugated rods enclose the open end; Wherein, in the expanded state, the radial space inside the bracket increases along the direction from the fixed end to the open end.

4. The shock wave guide tube according to claim 2, wherein: Along the direction from the tail end to the inlet end, the radial space inside the filter membrane increases.

5. The shock wave guide according to claim 1, wherein The scoring wire includes a supporting portion and a scoring portion, wherein the supporting portion is connected to the outer surface of the balloon, the scoring portion is connected to the supporting portion, and the tip is facing away from the balloon; wherein the cross-section perpendicular to the length direction of the scoring wire is "triangular".

6. The shock wave guide according to claim 1, wherein The scoring wire is extended along the length direction of the balloon, the distal end of the scoring wire extends to the distal end of the balloon, and the proximal end of the scoring wire extends to the proximal end of the balloon.

7. The shock wave guide according to claim 6, wherein: The scoring assembly also includes a distal fixing tube and a proximal telescopic tube. The distal fixing tube is sleeved on and connected to the distal end of the balloon. One end of the proximal telescopic tube is connected to the proximal end of the scoring wire, and the other end of the proximal telescopic tube is connected to the outer tube.

8. The shock wave guide according to claim 1, wherein The length of the inner electrode is greater than that of the outer electrode, and the length of the insulating tube is greater than that of the inner electrode.

9. The shock wave guide according to claim 1, wherein Two ends of the inner electrode are provided with cutouts.

10. A calcified tissue removal device, characterized in that: include: The shock wave catheter according to any one of claims 1 to 9, wherein a third channel is provided in the inner tube, a suction hole is provided on the inner tube between the balloon and the filtering device, and the suction hole is connected to the third channel; a suction device, at least for sucking out the fragmented diseased particles, the suction device being in communication with the third channel; a pulse generator, configured to generate electrical energy, the pulse generator being electrically connected to the electrode assembly via a wire; A filling device is at least used to deliver a filling medium to the balloon, and the filling device is communicated with the first channel.

Images