Shock wave generator and shock wave balloon catheter device

Abstract

The utility model provides a shock wave generator and a shock wave balloon catheter device, and relates to the technical field of medical instruments, the shock wave generator comprises an inner electrode, an insulating sleeve, an outer electrode and a supporting structure, the insulating sleeve is sleeved on the outer side of the inner electrode, and a first through hole is arranged on the insulating sleeve; the outer electrode sleeves the outer side of the insulating sleeve, and a second through hole is formed in the outer electrode; the supporting structures are fixed to the outer electrode and distributed on the periphery of the second through hole, and in the opening direction of the second through hole, the distance between the end of each supporting structure and the axis of the outer electrode is larger than the radius of the outer surface of the outer electrode; the supporting structure is arranged on the outer surface of the outer electrode, when the shock wave generator makes contact with the balloon, the supporting structure in the shock wave generator can support the inner wall of the balloon, the outer electrode and the inner wall of the balloon are spaced by a certain distance and cannot make contact with each other, and electric arcs and heat generated by discharging of the shock wave generator are prevented from acting on the balloon; and the problem that the balloon is broken is solved.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field especially, it relates to a shock wave generator and shock wave balloon catheter device. BACKGROUND

[0002] The global population aging trend and the younger of cardiovascular disease lead to the morbidity of vascular calcification to rise.Vascular calcification is a kind of more difficult disease to treat, and the effective treatment means that doctors can choose for calcified blood vessels is limited.

[0003] As a new technology, intravascular lithotripsy (IVL) is different from traditional calcified lesion treatment technology in working principle, can release non-focusing pulse acoustic pressure wave to the lesion when the balloon low pressure expands, to efficiently and safely destroy the superficial and deep calcification.In addition, the shock wave lithotripsy learning curve is extremely short, and the scope of application is wide, whether it is left main lesion, angled lesion, incomplete stent expansion, or annular, eccentric calcification and superficial, deep calcification, etc., all show obvious advantages.

[0004] But actual use is accompanied by the balloon internal pressure increasing, the influence such as blood vessel bending, the shock wave generator that should be in the balloon axial position will have different degrees of position deviation, and the condition of complete adhesion with the balloon wall occurs from time to time;Shock wave generator produces heat and arc when producing shock wave, combined with the thin wall thickness of intravascular compliant balloon, the risk of balloon rupture under the action of heat during treatment is greatly increased, and even it may endanger the life of the patient.

[0005] Therefore, a new device needs to be developed to solve the above technical problems. UTILITY MODEL CONTENT

[0006] The utility model aims at providing a shock wave generator and shock wave balloon catheter device to solve the problems existing in the prior art, by setting up the support structure on the outer surface of the outer electrode, when the shock wave generator contacts the balloon, the support structure in the shock wave generator will support the inner wall of the balloon, the outer electrode has a certain interval with the inner wall of the balloon and does not contact, to avoid the arc and heat generated by the discharge of the shock wave generator acting on the balloon, to cause the problem of balloon rupture.

[0007] To achieve the above object, the utility model provides the following scheme:

[0008] The shock wave generator comprises an inner electrode, an insulating sleeve, an outer electrode and a support structure, the insulating sleeve is sleeved outside the inner electrode, the insulating sleeve is provided with a first through hole, the outer electrode is sleeved outside the insulating sleeve, the outer electrode is provided with a second through hole corresponding to the first through hole, the support structure is fixed on the outer electrode, the support structure is distributed on the periphery of the second through hole, and the distance between the end of the support structure and the axis of the outer electrode is greater than the outer surface radius of the outer electrode in the opening direction of the second through hole, so that the outer electrode is prevented from contacting the inner wall of the balloon.

[0009] As an embodiment, the support structure is a fixing sleeve sleeved on the outer electrode, the fixing sleeve is provided with a third through hole opposite to the second through hole, and the diameter of the third through hole is not less than that of the second through hole.

[0010] As an embodiment, the support structure comprises at least two support rings sleeved on the outer electrode, and the support rings are distributed on both sides of the second through hole in the axial direction of the outer electrode.

[0011] As an embodiment, the support structure comprises strip-shaped protrusions fixed on the outer surface of the outer electrode, each strip-shaped protrusion is arranged in the axial direction of the outer electrode, and the strip-shaped protrusions are distributed on both sides of the second through hole in the circumferential direction of the outer electrode.

[0012] As an embodiment, the outer surface of the strip-shaped protrusion is arc-shaped.

[0013] As an embodiment, a plurality of strip-shaped protrusions are uniformly distributed in the circumferential direction of the outer electrode.

[0014] As an embodiment, the support structure is made of an insulating material.

[0015] As an embodiment, the material of the support structure is one or more of tetrafluoroethylene, polyurethane, polyamide, polyether amide resin, polyimide (PI) and polyethylene terephthalate.

[0016] As an embodiment, the support structure is fixed on the outer surface of the outer electrode in the form of heat shrinkage, adhesion or light curing.

[0017] The utility model discloses still a kind of Shockwave balloon catheter device, including inner tube, balloon and the Shockwave generator as described above, the balloon is fixed on the inner tube;The Shockwave generator is located inside the balloon, and the inner electrode of the Shockwave generator is sleeved on the inner tube.

[0018] The utility model has the following technical effects relative to prior art:

[0019] The utility model discloses a support structure is arranged on the outer surface of the outer electrode, when the shock wave generator is applied in the balloon catheter device, even if the inner tube is bent and deviates from the central axis position of the balloon, makes the shock wave generator contact the balloon, the support structure in the shock wave generator will support in the inner wall of the balloon, and the outer electrode has a certain interval with the inner wall of the balloon and will not contact, avoids the heat and electric arc of the shock wave generator discharge and acts on the balloon, leads to the problem of the rupture of the balloon, thereby guaranteeing the normal treatment of the shock wave balloon catheter device. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the technical scheme in the embodiment of the utility model or prior art, the following will briefly introduce the drawing needed to be used in the embodiment, and obviously, the drawing in the following description is only some embodiments of the utility model, and for those skilled in the art, other drawings can also be obtained according to these drawings without paying the creative labor.

[0021] Figure 1 For the structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0022] Figure 2 For the structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0023] Figure 3 For the structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0024] Figure 4 For Figure 3 The structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0025] Figure 5 For the structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0026] Figure 6 For the structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other;

[0027] Figure 7 For Figure 6 The structure schematic view that the shock wave generator contacts the inner wall of the balloon in the prior art shock wave balloon catheter device when in use, the inner tube is bent and leads to the shock wave generator and the inner wall of the balloon contact each other.

[0028] BRIEF DESCRIPTION OF DRAWINGS

[0029] 1, Shock wave generator; 11, Inner electrode; 12, Insulating sleeve; 121, First through hole; 13, Outer electrode; 131, Second through hole; 14, Protective sleeve; 141, Third through hole; 15, Support ring; 16, Strip-shaped protrusion; 2, Balloon; 3, Inner tube; 4, Blood vessel. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0031] The purpose of the present application is to provide a shock wave generator and a shock wave balloon catheter device to solve the problems existing in the prior art. By providing a support structure on the outer surface of the outer electrode, when the shock wave generator contacts the balloon, the support structure in the shock wave generator will be supported on the inner wall of the balloon, and the outer electrode and the inner wall of the balloon have a certain interval and do not contact, avoiding the problem that the arc and heat generated by the discharge of the shock wave generator act on the balloon, causing the balloon to rupture.

[0032] In order to make the above-mentioned purposes, features and advantages of the present application more apparent and easy to understand, the present application will be further described in detail below with reference to the drawings and specific embodiments.

[0033] Embodiment 1:

[0034] As Figures 3 to 7As shown, the embodiment provides a shock wave generator 1, which comprises an inner electrode 11, an insulating sleeve 12, an outer electrode 13 and a support structure. The inner electrode 11 is used to receive a high-voltage electric signal from a pulse generator. The material of the inner electrode 11 is usually a corrosion-resistant and highly conductive metal, such as platinum, stainless steel or titanium alloy. When applied in a shock wave balloon 2 catheter device, the inner electrode 11 is fixed on an inner tube 3. The insulating sleeve 12 is sleeved on the outer side of the inner electrode 11, which is used to isolate the inner electrode 11 from the outer electrode 13 to prevent short circuit caused by direct connection between the inner electrode 11 and the outer electrode 13. The material of the insulating sleeve 12 is usually a high-temperature-resistant and high-dielectric-strength material, such as polyimide. The outer electrode 13 is sleeved on the outer side of the insulating sleeve 12 to form a loop with the inner electrode 11. The insulating sleeve 12 is provided with a first through hole 121, and the outer electrode 13 is provided with a second through hole 131 corresponding to the first through hole 121. The second through hole 131 is usually concentrically arranged with the first through hole 121. The diameter of the second through hole 131 is not less than that of the first through hole 121, so that the shock wave is emitted from the first through hole 121 and the second through hole 131 to control the action range of the shock wave. The support structure in the embodiment is fixed on the outer electrode 13. The support structure is distributed on the periphery of the second through hole 131. In the opening direction of the second through hole 131, the distance between the end of the support structure and the axis of the outer electrode 13 is greater than the outer surface radius of the outer electrode 13. When the shock wave generator 1 in the embodiment is applied in the balloon 2 catheter device, even if the inner tube 3 is bent and deviates from the central axis of the balloon 2, so that the shock wave generator 1 contacts the balloon 2, the support structure in the shock wave generator 1 will be supported on the inner wall of the balloon 2, and the outer electrode 13 will not contact the inner wall of the balloon 2, thereby avoiding the heat generated by the discharge of the shock wave generator 1 from being transferred to the balloon 2 through heat conduction. The electric arc generated by the discharge of the shock wave generator 1 will not act on the balloon 2 due to the existence of the interval between the outer electrode 13 and the balloon 2, so that the problem of the rupture of the balloon 2 does not occur, thereby ensuring the normal progress of the treatment process of the shock wave balloon 2 catheter device.

[0035] In the embodiment, the support structure is made of an insulating, low-thermal-conductivity and heat-resistant material, such as polytetrafluoroethylene (PTFE), polyurethane (PU), nylon, polyether amide resin (Pebax), polyimide (PI) and polyethylene terephthalate (PET).

[0036] As shown in the drawings, Figure 3 , Figure 4As shown in the figure, the support structure in the embodiment can be a fixing sleeve sleeved on the outer electrode 13, and the fixing sleeve is provided with a third through hole 141 opposite to the second through hole 131, and the diameter of the third through hole 141 is not less than that of the second through hole 131, so that the shock wave can smoothly radiate from the first through hole 121, the second through hole 131 and the third through hole 141. When the shock wave generator 1 contacts the inner wall of the balloon 2, the fixing sleeve contacts the inner wall of the balloon 2, and the actual discharge position is spaced apart from the inner wall of the balloon 2, so that the heat and arc generated by the discharge position do not directly act on the inner wall of the balloon 2.

[0037] As another embodiment, as shown in Figure 5 , the support structure includes at least two support rings 15 sleeved on the outer electrode 13, and the support rings 15 are coaxially arranged on the outer electrode 13 and are distributed on both sides of the second through hole 131 along the axial direction of the outer electrode 13. When the shock wave generator 1 contacts the inner wall of the balloon 2, the support rings 15 contact the inner wall of the balloon 2, so that the heat and arc generated by the discharge position do not directly act on the inner wall of the balloon 2.

[0038] As another embodiment, as shown in Figure 6 , Figure 7 , the support structure includes a strip-shaped protrusion 16 fixed on the outer surface of the outer electrode 13, and each strip-shaped protrusion 16 is arranged along the axial direction of the outer electrode 13 and is distributed on both sides of the second through hole 131 along the circumferential direction of the outer electrode 13. When the shock wave generator 1 contacts the inner wall of the balloon 2, the strip-shaped protrusions 16 on both sides of the second through hole 131 contact the inner wall of the balloon 2, so that the heat and arc generated by the discharge position do not directly act on the inner wall of the balloon 2.

[0039] In order to reduce the contact stress between the strip-shaped protrusion 16 and the inner wall of the balloon 2, the outer surface of the strip-shaped protrusion 16 in the embodiment is arc-shaped.

[0040] When the support structure is a cylindrical protective sleeve 14 or a plurality of support rings 15, in addition to the shock wave emitting position of the second through hole 131, other positions on the outer electrode 13 will not contact the inner wall of the balloon 2 under the support of the support structure, and the protection effect is better. In order to continue to achieve this technical effect, when the support structure is a strip-shaped protrusion 16, a plurality of strip-shaped protrusions 16 are uniformly distributed along the circumferential direction of the outer electrode 13, and the number of strip-shaped protrusions 16 can be 4-8.

[0041] When the support structure is a protective sleeve 14 or a support ring 15, it can be fixed on the surface of the outer electrode 13 by heat shrinking or bonding; when the support structure is a strip-shaped protrusion 16, it can be fixed on the outer surface of the outer electrode 13 by bonding or photocuring. The thickness of the support structure is 0.015mm-0.5mm, and specifically, it can be 0.025mm-0.1mm.

[0042] Embodiment 2:

[0043] The embodiment discloses a shock wave balloon catheter device, which comprises an inner tube 3, a balloon 2 and the shock wave generator 1 in embodiment 1, the balloon 2 is fixed on the inner tube 3 and used for supporting a blood vessel 4; the shock wave generator 1 is located in the interior of the balloon 2, and the inner electrode 11 in the shock wave generator 1 is sleeved on the inner tube 3.

[0044] The adaptive changes according to actual demands are within the protection scope of the utility model.

[0045] The principle and implementation mode of the utility model are described by applying specific examples in the utility model, and the above embodiment is only used for helping to understand the method and core idea of the utility model; meanwhile, according to the idea of the utility model, the specific implementation mode and application range will have changes for the general technical personnel in the field. In conclusion, the content of the specification should not be understood as the limitation of the utility model.

Claims

1. A shock wave generator, characterized in that, include: Internal electrode; An insulating sleeve is fitted over the outside of the inner electrode, and a first through hole is provided on the insulating sleeve. An external electrode is sleeved on the outside of the insulating sleeve, and a second through hole corresponding to the first through hole is provided on the external electrode; The system includes a support structure fixed to the external electrode and distributed around the periphery of the second through hole. In the opening direction of the second through hole, the distance between the end of the support structure and the axis of the external electrode is greater than the outer surface radius of the external electrode, which is used to prevent the external electrode from contacting the inner wall of the balloon.

2. The shock wave generator according to claim 1, characterized in that, The support structure is a fixed sleeve fitted onto the outer electrode. The fixed sleeve is provided with a third through hole that is directly opposite the second through hole. The diameter of the third through hole is not less than that of the second through hole.

3. The shock wave generator according to claim 1, characterized in that, The support structure includes at least two support rings sleeved on the outer electrode, and the support rings are distributed on both sides of the second through hole along the axial direction of the outer electrode.

4. The shock wave generator according to claim 1, characterized in that, The support structure includes strip-shaped protrusions fixed on the outer surface of the outer electrode. Each strip-shaped protrusion is arranged along the axial direction of the outer electrode and distributed on both sides of the second through hole along the circumferential direction of the outer electrode.

5. The shock wave generator according to claim 4, characterized in that, The outer surface of the strip-shaped protrusion is arc-shaped.

6. The shock wave generator according to claim 4, characterized in that, Multiple strip-shaped protrusions are evenly distributed along the circumference of the outer electrode.

7. The shock wave generator according to claim 1, characterized in that, The support structure is made of insulating material.

8. The shock wave generator according to claim 7, characterized in that, The supporting structure is made of one or more of the following materials: tetrafluoroethylene, polyurethane, polyamide, polyetheramide resin, polyimide, and polyethylene terephthalate.

9. The shock wave generator according to claim 1, characterized in that, The support structure is fixed to the outer surface of the external electrode by heat shrinking, bonding or photocuring.

10. A shockwave balloon catheter device, characterized in that, include: Inner tube; A balloon, the balloon being fixed to the inner tube; And the shock wave generator as described in any one of claims 1 to 9, wherein the shock wave generator is located inside the balloon, and the inner electrode of the shock wave generator is sleeved on the inner tube.

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