Shock wave basket electrode catheter

Abstract

The shock wave mesh basket electrode catheter comprises an inner tube and an outer tube, the inner tube is arranged in the outer tube and extends out of the far end of the outer tube, the far end of the inner tube is provided with a tip, the near end of the outer tube is connected with a handle, the handle is connected with a plug through a cable, and the plug is used for being connected with an external shock wave device. A mesh basket part is arranged on the inner tube, a balloon and a shock wave generator are arranged on the mesh basket part, and the mesh basket part has self-expansion performance so that a cage-shaped structure can be formed after expansion. According to the embodiment, the risks that the artificial valve is difficult to position and fix in the operation process, the artificial valve is not suitable to release and difficult to remove and the like can be effectively avoided, the operation time is shortened, and the operation operation and prognosis effects are greatly improved.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices, and in particular to a shock wave basket electrode catheter. Background Art

[0002] Heart valve calcification is the main pathological manifestation of heart valve stenosis and regurgitation, which usually occurs in the elderly; vascular calcification is a common pathological manifestation of atherosclerosis, hypertension, diabetic vascular disease, vascular damage, chronic kidney disease and aging. At present, the treatment methods for heart valve calcification and vascular calcification include: drug therapy, surgical replacement or interventional replacement.

[0003] The effects of existing drug treatments are very limited, while existing surgical or interventional replacement methods have disadvantages such as being highly traumatic to the patient and time-consuming. Summary of the invention

[0004] The purpose of the embodiments of the present disclosure is to provide a shock wave basket electrode catheter to solve the problems existing in the prior art. In order to solve the technical problems, the embodiments of the present disclosure adopt the following technical solutions:

[0005] The disclosed embodiment provides a shock wave basket electrode catheter, comprising an inner tube and an outer tube, wherein the inner tube is arranged inside the outer tube and extends out from the distal end of the outer tube, a tip is arranged at the distal end of the inner tube, the proximal end of the outer tube is connected to a handle, the handle is connected to a plug for connecting to an external shock wave device via a cable, a basket portion is arranged on the inner tube, a balloon and a shock wave generator are arranged on the basket portion, and the basket portion has a self-expanding property so as to form a cage-like structure after expansion.

[0006] In some embodiments, the basket portion includes a deformable frame body, one end of the frame body is connected to the tip, and the other end is connected to the distal end of the outer tube, the frame body includes a plurality of branches, insulating tubes are provided on the branches, a balloon and at least one shock wave generator are provided on the insulating tube, and the balloon covers the shock wave generator after being inflated and expanded.

[0007] In some embodiments, each of the branches in the frame body includes a fixed beam and a connecting beam, one end of the fixed beam is connected to the distal end of the outer tube through a fixing ring, and the other end is connected to the proximal end of the connecting beam, and the distal end of the connecting beam is connected to the tip through a mesh portion.

[0008] In some embodiments, the fixing ring is a barrel-shaped structure with a plurality of openings on its wall surface. The plurality of openings are arranged at predetermined intervals, and the size of the openings matches the size of the fixing beam so that the fixing beam can be inserted into the corresponding opening.

[0009] In some embodiments, a sleeve is disposed between the balloon and the distal end of the outer tube, and both ends of the sleeve are respectively connected to the balloon and the outer tube.

[0010] In some embodiments, the shock wave generator is in the form of an electrode pair, wherein the electrode pair includes two electrodes separated by a predetermined gap, and the two electrodes are positive and negative electrodes to each other.

[0011] In some embodiments, the electrode comprises a hollow cylindrical segment, a protrusion is arranged on the end surface of the cylindrical segment, and the protrusions of two electrodes are arranged opposite to each other.

[0012] In some embodiments, two adjacent electrode pairs are arranged 90° apart.

[0013] In some embodiments, the handle is connected to the proximal end of the outer tube via a stress relief tube.

[0014] In some embodiments, the proximal end of the inner tube passes through the handle and is connected to the first tail stock, and the outer tube passes through the handle and is connected to the second tail stock.

[0015] The disclosed embodiments can effectively avoid risks such as difficulty in positioning and fixing the artificial valve during surgery, and difficulty in removing the artificial valve due to improper release, thereby shortening the operation time and greatly improving the surgical operation and prognosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0017] Figure 1 It is a schematic diagram of the structure of the shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0018] Figure 2 It is a schematic structural diagram of a basket portion in a shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0019] Figure 3 A schematic diagram of the arrangement of electrode pairs in a shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0020] Figure 4 It is a schematic diagram of the structure of the electrode in the shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0021] Figure 5It is a structural schematic diagram of a frame body in a shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0022] Figure 6 This is a schematic diagram of the connection between the frame body and the fixing ring in the shock wave basket electrode catheter of the embodiment of the present disclosure;

[0023] Figure 7 It is a schematic structural diagram of a fixing ring in a shock wave basket electrode catheter according to an embodiment of the present disclosure;

[0024] Figure 8 The diagram is a schematic diagram of the arrangement of the shock wave basket electrode catheter in the body according to an embodiment of the present disclosure.

[0025] Reference numerals:

[0026] 100-shock wave basket electrode catheter; 101-balloon; 102-basket; 103-outer tube; 104-stress relief tube; 105-handle; 106-cable; 107-plug; 108-first tailstock; 109-second tailstock; 110-tip; 111-inner tube; 112-frame body; 112a-branch; 113-insulating tube; 114-shock wave generator; 115-sleeve; 116-cylindrical section; 117-protrusion; 118-first electrode pair; 118a-first positive electrode; 118b -first negative electrode; 119-second electrode pair; 119a-second positive electrode; 119b-second negative electrode; 120a-first beam; 120b-second beam; 120c-third beam; 120d-fourth beam; 120e-fifth beam; 121-fixed beam; 122-fixed ring; 122a-first opening; 122b-second opening; 122c-third opening; 122d-fourth opening; 122e-fifth opening; 125-heart valve; 126-left ventricle; 127-channel; 128 aortic arch. DETAILED DESCRIPTION

[0027] Various aspects and features of the present disclosure are described herein with reference to the drawings.

[0028] It should be understood that various modifications may be made to the embodiments of the present application. Therefore, the above description should not be considered as limiting, but only as an example of an embodiment. Other modifications within the scope and spirit of the present disclosure will occur to those skilled in the art.

[0029] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the general description of the present disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

[0030] These and other characteristics of the present disclosure will become apparent from the following description of a preferred form of embodiment given as a non-limiting example, with reference to the attached drawings.

[0031] It should also be understood that, although the present disclosure has been described with reference to some specific examples, those skilled in the art will be able to realize many other equivalent forms of the present disclosure that have the features described in the claims and are therefore within the scope of protection defined thereby.

[0032] The above and other aspects, features and advantages of the present disclosure will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0033] Specific embodiments of the present disclosure are described hereinafter with reference to the accompanying drawings; however, it should be understood that the embodiments claimed are merely examples of the present disclosure, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid obscuring the present disclosure with unnecessary or redundant details. Therefore, the specific structural and functional details claimed herein are not intended to be limiting, but merely serve as a basis and representative basis for the claims to teach those skilled in the art to use the present disclosure in a variety of ways with substantially any suitable detailed structure.

[0034] This specification may use the phrases "in one embodiment," "in another embodiment," "in a further embodiment," or "in other embodiments," all of which may refer to one or more of the same or different embodiments according to the present disclosure.

[0035] The present disclosure provides a shock wave basket electrode catheter 100, which is used to transmit shock waves in a blood vessel to achieve blood vessel perforation and angioplasty. Figure 1-Figure 8 As shown, the shock wave basket electrode catheter 100 includes an inner tube 111 and an outer tube 103, wherein the inner tube 111 is disposed inside the outer tube 103 and extends from the distal end of the outer tube 103, wherein the inner tube 111 is a hollow tube, and the hollow tube forms a guide wire cavity to accommodate a guide wire with a diameter of 0.010-0.035 inches. A tip 110 is disposed at the distal end of the inner tube 111, and the tip 110 is used to facilitate the shock wave basket electrode catheter 100 to enter the human body.

[0036] Furthermore, the proximal end of the outer tube 103 is connected to a handle 105 . Preferably, the handle 105 is connected to the proximal end of the outer tube 103 via a stress relief tube 104 .

[0037] Further, the proximal end of the inner tube 111 passes through the handle 105 and is connected to the first tailstock 108, and the outer tube 103 passes through the handle 105 and is connected to the second tailstock 109. Here, the first tailstock 108 can be used to pass a guide wire, and the second tailstock 109 can be used to pass a liquid. In addition, the handle 105 is connected to a plug 107 via a cable 106, and the plug 107 here is used to be connected to an external shock wave device.

[0038] In order to support the blood vessels when the shock wave basket electrode catheter 100 is inserted into the human body, a basket portion 102 is provided on the inner tube 111. The basket portion 102 has a self-expanding property and can form a cage-like structure after expansion. Specifically, the basket portion 102 includes a deformable frame body 112, one end of which is connected to the tip 110, and the other end is connected to the distal end of the outer tube 103. The frame body 112 can be attached to the tube body of the inner tube 111 when not in use, and can be radially expanded outward to form a basket-like structure when needed.

[0039] Specifically, the frame body 112 includes a plurality of branches 112a, wherein the number of the branches 112a is 3-10, the distal end of each branch 112 is connected to the tip 110, and the proximal ends of the plurality of branches 112 are connected to the distal end of the outer tube 103.

[0040] Here, an insulating tube 113 is arranged on the branch 112a, and the insulating tube 113 may be arranged at the middle section of the branch 112a, that is, the part of the basket portion 102 that contacts the blood vessel wall after expansion; at least one shock wave generator 114 is arranged on the insulating tube 113, and the shock wave generator 114 is in the form of an electrode pair, and the electrode pair is fixed to the insulating tube 113 by welding, gluing, riveting or any other suitable method. In this way, the shock wave device located outside is connected to the shock wave generator 114 through the cable 106, so that the shock wave is emitted by the shock wave generator 114.

[0041] Furthermore, a balloon 101 is sleeved on the outside of the insulating tube 113. The balloon 101 here can contact the vascular wall of the blood vessel to achieve support after being filled and expanded, and can also cover the shock wave generator 114. The distal end of the balloon 101 is fixed on the branch 112a to form a fixed point, and the fixing method here can be gluing, welding, binding, etc. The balloon 101 here is wrapped around the outside of the shock wave transmitter, and it has a through hole for electrolyte liquid to flow in, and the electrolyte liquid is used to conduct the shock wave.

[0042] In addition, the balloon 101 here can be a compliant balloon made of soft materials such as natural latex, silicone, TPU, etc., or it can be a semi-compliant or non-compliant balloon made of polymer materials such as PET, PP, polyethylene, polyamide, etc.

[0043] Further, the frame body 12 here is used to support the shock wave generator 114 and the balloon 101, and the material of the frame body 112 can be stainless steel, titanium alloy, nickel titanium alloy, nickel alloy, titanium and other metal materials. Each branch 112a in the frame body 112 includes a fixed beam 121 and a connecting beam, and the fixed beam 121 and the connecting beam here can be formed in one piece, wherein one end of the fixed beam 121 is connected to the distal end of the outer tube 103, and the other end is connected to the proximal end of the connecting beam, and a plurality of connecting beams are connected to the tip 110 through a mesh portion. The mesh portion is used here to make the frame body 12 more stable. Preferably, the length of the fixed beam 121 here is 0.2-1.5mm, and the width is 0.1-1.0mm.

[0044] In a specific implementation of this embodiment, the frame body 112 includes five branches 112a, each of the branches 112a includes a fixed beam 121 and a connecting beam, where the connecting beam can be a first beam 120a, a second beam 120b, a third beam 120c, a fourth beam 120d or a fifth beam 120e, and the above five connecting beams are spaced apart from each other after being opened.

[0045] Further, the plurality of fixed beams 121 are fixed to the distal end of the outer tube 103 by means of a fixing ring 122. The fixing ring 122 here is a barrel-shaped structure, and a plurality of openings are arranged on its wall surface. The plurality of openings are arranged at predetermined intervals. The width and length of the openings here are consistent with the width and length of the fixed beams 121, so that the fixed beams 121 are inserted into the corresponding openings. For this reason, the number of the openings here is the same as the number of the fixed beams 121. Specifically, the fixing ring 122 is fixed to the fixed beams 121 by welding. The welding methods here include laser welding, resistance welding, brazing, gluing, riveting, and the like.

[0046] In a specific implementation of this embodiment, the fixing ring 122 is provided with a first opening 122a, a second opening 122b, a third opening 122c, a fourth opening 122d and a fifth opening 122e corresponding to the first beam 120a, the second beam 120b, the third beam 120c, the fourth beam 120d and the fifth beam 120e respectively.

[0047] In this embodiment, the voltage / current pulse is received and conducted by the cable 106, and the shock wave generator 114 is electrically connected to the cable 106 to receive the voltage / current pulse to generate a shock wave. The shock wave emitted by the shock wave generator 114 passes through the balloon 101 and contacts the blood vessel wall, thereby serving as a plaque-breaking electrode pair to send shock waves to, for example, plaques in a blood vessel. When there are multiple shock wave generators 114, multiple pairs of shock wave generators 114 are arranged in sequence along the extension direction of the insulating tube 113.

[0048] Furthermore, in order to achieve filling of the balloon 101, a sleeve 115 is provided between the balloon 101 and the distal end of the outer tube 103, and the two ends of the sleeve 115 are respectively connected to the balloon 101 and the outer tube 103, wherein the proximal end of the balloon 101 is connected to the distal end of the sleeve 115. In this embodiment, there is a cavity for liquid to flow in between the outer tube 103 and the inner tube 111, and the cavity is connected to the proximal end of the sleeve 115, and the distal end of the sleeve 115 is connected to the balloon 101, so that the liquid flows out of the outer tube 103 and enters the balloon 101 through the sleeve 115, so that the interior of the balloon 101 is filled with liquid, and the balloon 101 is filled by applying pressure.

[0049] Furthermore, when the shock wave generator 114 is in the form of an electrode pair, the electrode pair includes two electrodes separated by a predetermined gap, and the two electrodes can be positive and negative electrodes to each other. In the present embodiment, the electrode is electrically connected to the cable 106 for receiving the voltage / current pulse to generate a shock wave. The electrode is connected to the electrode wire by welding. The electrode wire in the present embodiment extends toward the proximal end of the outer tube 103 to be connected to the cable 106, thereby receiving and conducting the voltage / current pulse through the cable 106.

[0050] The gap between the two electrodes here is 0.1-2.0 mm, so that shock waves can be emitted through the electrodes. The distribution of the electrodes here specifically emits shock waves toward the outside of the circumference, which can ensure that the shock waves propagate in the diameter direction and achieve directional softening of the calcified heart valve.

[0051] Furthermore, the electrodes here have different structures. In one embodiment, the electrode includes a hollow cylindrical section 116, and a protrusion 117 is provided on the end surface of the cylindrical section 116. The electrode material used as the electrode here can be stainless steel, tungsten, platinum iridium, nickel, iron, steel and / or other conductive materials. The diameter of the cylindrical section 116 here is 0.1-0.8 mm and the length is 0.2-2.0 mm, and the width of the protrusion 117 is 0.1-0.5 mm and the length is 0.1-0.8 mm. The protrusions 117 of the two electrodes in each electrode pair here can preferably be arranged relative to each other, and the spacing between the protrusions 117 of the two electrodes is preferably 0.05-2.0 mm.

[0052] In a specific embodiment, a first electrode pair 118 and a second electrode pair 119 are provided on the insulating tube 113, wherein the first electrode pair 118 comprises a first positive electrode 118a and a first negative electrode 118b which are arranged opposite to each other, and the second electrode pair 119 comprises a second positive electrode 119a and a first negative electrode 119b which are arranged opposite to each other. In a preferred embodiment, more electrode pairs, such as 3-6 pairs of electrode pairs, may be provided along the length direction of the insulating tube 113, so as to facilitate the rupture of the calcified plaque along the length direction of the valve.

[0053] Furthermore, two adjacent electrode pairs may be set at a certain angle to facilitate breaking up plaques at different positions. For example, two adjacent electrode pairs may be set at 90° apart, that is, the line connecting the protrusions 117 of the two electrodes in the first electrode pair 108 and the line connecting the protrusions 117 of the two electrodes in the second electrode pair 109 are set at 90° apart in the radial direction.

[0054] The two electrodes in the electrode pair in this embodiment are exposed to the outside. The arrangement process of this electrode pair is simple. At the same time, the protrusion 117 of the electrode can greatly increase the shock wave generated by the tip discharge and ensure the directional release of the shock wave, thereby constraining and focusing the energy.

[0055] The disclosed embodiment can selectively excite different electrode pairs to send shock waves. For example, a certain electrode pair can be selected to send shock waves, or the electrode pairs can be excited sequentially, or all electrode pairs can be excited simultaneously, which greatly facilitates the operator's operation during the operation.

[0056] In addition, the shock wave basket electrode catheter involved in the embodiment of the present disclosure also includes a developing component, which is located on the shock wave transmitter 114 and / or the balloon 101, and can help doctors accurately locate the device of the shock wave basket electrode catheter 100 to ensure that the shock wave transmitter 114 and / or the balloon 101 are in the target area to be treated for treatment.

[0057] When the shock wave basket electrode catheter of the embodiment of the present disclosure is used, it can be positioned in the blood vessel of the aortic arch 128 at the calcified heart valve 125. Since the basket portion has self-expansion properties, the blood in the left ventricle 126 can be transported to the whole body through the channel 127 during operation, ensuring adequate blood supply to the human body. At the same time, based on the internal electrode specificity of the balloon 101, the shock wave is emitted toward the outside of the circumference and is ensured to propagate in the diameter direction, thereby softening the calcified heart valve in a direction.

[0058] Specifically, at least a portion of the outer surface of the balloon 101 is in contact with the valve calcification lesion area, and an arc is generated by applying an instantaneous high voltage to the electrode pair inside the balloon 101. Shock waves accompanying the expansion and collapse of bubbles generated by the arc are generated, and the shock waves generated by the electrode pair are radially transmitted to the surface of the balloon 101 through the liquid inside the balloon 101, and then transmitted to the calcified lesion through the surface of the balloon 101. Among them, when the shock wave is transmitted forward to the calcified lesion, the compression stress of the shock wave will cause the calcified tissue inside the vascular occlusion to soften and lyse, so that the shock wave basket electrode catheter can pass through the vascular occlusion, and then the shock wave generated by the electrode pair further breaks and lyses the calcified tissue, achieving a good effect of opening the blood vessel. In addition, shock waves of appropriate intensity can satisfy the need to destroy calcified tissue without placing additional burden on the soft tissue around the calcified tissue.

[0059] In this embodiment, the balloon is introduced through the femoral artery until it contacts the target area to be treated. The shock wave generated by the electrode pair is transmitted to the target area to be treated through the electrolyte liquid in the balloon. The calcified part in the target area to be treated is softened under the action of the shock wave energy, thereby improving the opening and closing state of the valve leaflets during operation, thereby achieving the effect of treating calcification. At the same time, it is also beneficial to the release of the heart valve, accurate positioning, peripheral adhesion to blood vessels, and reduction of peripheral leakage.

[0060] Compared with traditional surgical or interventional replacement methods, it is less traumatic to the patient and takes less time. For example, when faced with problems such as severe valve calcification and inability to accurately place the heart valve during surgery, the disclosed embodiments can effectively avoid risks such as difficulty in positioning and fixing the artificial valve during surgery and difficulty in removing the artificial valve due to inappropriate release, thereby shortening the operation time and greatly improving the surgical operation and prognosis.

[0061] In addition, although each operation is described in a specific order, this should not be understood as requiring these operations to be performed in the specific order shown or in a sequential order. Under certain circumstances, multitasking and parallel processing may be advantageous. Similarly, although some specific implementation details are included in the above discussion, these should not be interpreted as limiting the scope of the present disclosure. Some features described in the context of a separate embodiment can also be implemented in a single embodiment in combination. On the contrary, the various features described in the context of a single embodiment can also be implemented in multiple embodiments individually or in any suitable sub-combination mode.

[0062] Although the subject matter has been described in language specific to structural features and / or methodological logical actions, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. On the contrary, the specific features and actions described above are merely example forms of implementing the claims.

[0063] Multiple embodiments of the present disclosure are described in detail above, but the present disclosure is not limited to these specific embodiments. Those skilled in the art can make various variations and modifications to the embodiments based on the concepts of the present disclosure, and these variations and modifications should all fall within the scope of protection required by the present disclosure.

Claims

1. A shock wave basket electrode catheter, characterized in that: The invention comprises an inner tube and an outer tube, wherein the inner tube is arranged inside the outer tube and extends out from the distal end of the outer tube, a tip is arranged at the distal end of the inner tube, the proximal end of the outer tube is connected to a handle, the handle is connected to a plug for connecting to an external shock wave device through a cable, a basket part is arranged on the inner tube, a balloon and a shock wave generator are arranged on the basket part, and the basket part has a self-expanding property so as to form a cage-like structure after expansion.

2. The shock wave basket electrode catheter according to claim 1, characterized in that: The basket portion includes a deformable frame body, one end of the frame body is connected to the tip, and the other end is connected to the distal end of the outer tube. The frame body includes a plurality of branches, insulating tubes are arranged on the branches, a balloon and at least one shock wave generator are arranged on the insulating tube, and the balloon covers the shock wave generator after being inflated and expanded.

3. The shock wave basket electrode catheter according to claim 2, characterized in that: Each of the branches in the frame body includes a fixed beam and a connecting beam, one end of the fixed beam is connected to the distal end of the outer tube through a fixed ring, and the other end is connected to the proximal end of the connecting beam, and the distal end of the connecting beam is connected to the tip through a mesh portion.

4. The shock wave basket electrode catheter according to claim 3, characterized in that: The fixing ring is a barrel-shaped structure, and a plurality of openings are arranged on its wall surface. The plurality of openings are arranged at predetermined intervals, and the size of the openings matches the size of the fixing beam so that the fixing beam can be inserted into the corresponding opening.

5. The shock wave basket electrode catheter according to claim 2, characterized in that: A sleeve is arranged between the balloon and the distal end of the outer tube, and two ends of the sleeve are respectively connected with the balloon and the outer tube.

6. The shock wave basket electrode catheter according to claim 1, characterized in that: The shock wave generator is in the form of an electrode pair, which includes two electrodes separated by a predetermined gap, and the two electrodes are positive and negative electrodes to each other.

7. The shock wave basket electrode catheter according to claim 6, characterized in that: The electrode comprises a hollow cylindrical section, a protrusion is arranged on the end surface of the cylindrical section, and the protrusions of the two electrodes are arranged opposite to each other.

8. The shock wave basket electrode catheter according to claim 6, characterized in that: Two adjacent electrode pairs are arranged 90° apart.

9. The shock wave basket electrode catheter according to claim 1, characterized in that: The handle is connected to the proximal end of the outer tube through a stress relief tube.

10. The shock wave basket electrode catheter according to claim 1, characterized in that: The proximal end of the inner tube passes through the handle and is connected to the first tail stock, and the outer tube passes through the handle and is connected to the second tail stock.

Images