Self-compressing shockwave balloon and balloon catheter

Abstract

The application discloses a self-compression shock wave balloon, which comprises a balloon body, the balloon body comprises an outer layer balloon and an inner layer balloon, the inner layer balloon is arranged in the cavity of the outer layer balloon, the inner layer balloon and the outer layer balloon are coaxially arranged, the outer layer balloon and the inner layer balloon have independent cavities respectively, a through hole is arranged at the distal end of the inner layer balloon, a spacing is arranged between the inner layer balloon and the outer layer balloon after the inner layer balloon and the outer layer balloon are fully expanded, a shock wave emitter is arranged on the outer peripheral wall of the inner layer balloon, a self-compression support is arranged on the outer wall of the inner layer balloon, the shock wave emitter is arranged at the opposite position of the support body of the self-compression support, and the shock wave emitter and the self-compression support are insulatively arranged. The application further discloses a balloon catheter. Compared with the prior art, the shock wave emitter can be ensured to be almost equal to the lesion position at the bending position of the physiological morphology of the blood vessel, the uniform emission of the shock wave energy is realized, and the effectiveness of the shock wave is improved.

Description

Technical Field

[0001] This invention relates to a medical device, and more particularly to a self-compressible shockwave balloon and balloon catheter. Background Technology

[0002] Currently, the shock wave energy of shock wave catheters on the market is emitted from the shock wave emitter on the balloon catheter shaft to the surrounding area of ​​the balloon. The shock wave energy propagates through the fluid inside the balloon, penetrates the balloon wall, and reaches the inner wall and middle layer of the blood vessel.

[0003] This design has the following drawbacks:

[0004] After the balloon is inflated, the tortuosity of the blood vessels causes the inflated balloon to follow the vascular morphology, resulting in the catheter axis with the shock wave emitter being almost non-coaxial with the tortuous balloon, but rather eccentrically positioned within the working section of the balloon. According to the characteristics of shock wave energy propagation, the balloon side closer to the emitter will receive greater shock wave energy, while the balloon side farther from the emitter will receive almost no shock wave energy. This means the shock wave energy emitted by the balloon diffuses unevenly in all directions, posing a potential threat to the product's safety and effectiveness.

[0005] For balloons of different diameters, after inflation, the distance between the wall of a larger diameter balloon and the transmitter on the balloon catheter axis is greater than that of a smaller diameter balloon. This results in a smaller shock wave energy emitted by a larger diameter shock wave balloon compared to a smaller diameter balloon, even with the same transmitter output shock wave energy. This affects the effectiveness of the product, especially as larger diameter shock wave balloons may not even be effective in breaking up intravascular calcifications. Summary of the Invention

[0006] The purpose of this invention is to provide a self-compressible shock wave balloon and balloon catheter, and the technical problem to be solved is to ensure the uniform emission of shock wave energy.

[0007] To solve the above problems, the present invention adopts the following technical solution: a self-compressible shockwave balloon, comprising a balloon body, the balloon body including an outer balloon and an inner balloon, the inner balloon being disposed in the cavity of the outer balloon, the inner balloon and the outer balloon being coaxially arranged, the outer balloon and the inner balloon having separate independent cavities, a through hole being provided at the distal end of the inner balloon, when the inner balloon and the outer balloon are fully expanded, a gap is provided between them, a shockwave emitter is provided on the outer peripheral wall of the inner balloon, a self-compressible support is provided on the outer wall of the inner balloon, the shockwave emitter is located at a position opposite to the support body of the self-compressible support, the shockwave emitter and the self-compressible support are insulated from each other, under normal conditions, the self-compressible support is in a contracted state, causing the inner balloon to be tightened, when the inner balloon is filled with liquid, the inner balloon forces the self-compressible support to expand.

[0008] Furthermore, the self-compressing stent is arranged in a serpentine or zigzag shape along at least one circumference of the inner balloon.

[0009] Furthermore, the shock wave emitter includes multiple metal electrodes and electrode leads fixed on the outer wall of the inner balloon. The metal electrodes are electrically connected to the electrode leads. A first insulating layer is provided outside the metal electrodes, and a first perforation hole is provided on the first insulating layer to expose part of the metal electrodes.

[0010] Furthermore, a second perforated hole is provided at the position opposite to the metal electrode of the self-compressing bracket, and the second perforated hole is opposite to the position of the first perforated hole, so that the self-compressing bracket can serve as a conductor connecting each metal electrode. A second insulating layer is provided on the self-compressing bracket to attach and fix the metal electrode and the inner balloon.

[0011] Furthermore, the self-compression bracket is made of nickel-titanium alloy.

[0012] Furthermore, the outer balloon is made of nylon material.

[0013] Furthermore, the inner balloon is made of silicone material.

[0014] The present invention also discloses a balloon catheter, including a guidewire catheter and the aforementioned self-compressible shockwave balloon. The guidewire catheter is provided with an outer tube having a double-lumen structure. The self-compressible shockwave balloon is located at the distal end of the outer tube. The distal end of the guidewire catheter passes through the cavity of the inner balloon and is connected and fixed to the distal end of the self-compressible shockwave balloon. A tip is provided at the distal end of the self-compressible shockwave balloon and is connected and fixed to the guidewire catheter. The cavity of the outer balloon is connected to one cavity of the outer tube, and the cavity of the inner balloon is connected to the other cavity of the outer tube.

[0015] Compared with the prior art, this invention, by setting up a double balloon and placing the shock wave transmitter in the inner balloon, can ensure that the position of the shock wave transmitter is almost equal to that of the lesion site even at the bending points of the blood vessel's physiological morphology, thereby achieving uniform emission of shock wave energy and improving the effectiveness of the shock wave. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the structure of the self-compressing shock wave balloon of the present invention.

[0017] Figure 2 yes Figure 1 A sectional view along the A-A direction.

[0018] Figure 3 yes Figure 1 A cross-sectional view along the B-B direction.

[0019] Figure 4 This is a schematic diagram of the folded shape of the balloon body of the present invention.

[0020] Figure 5 This is a schematic diagram of the connection between the shock wave emitter and the self-compression bracket of the present invention.

[0021] Figure 6 This is a schematic diagram of the self-compression bracket of the present invention under normal conditions.

[0022] Figure 7 This is a schematic diagram of the forced expansion of the self-compression bracket of the present invention. Detailed Implementation

[0023] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments.

[0024] In this invention, the distal end refers to the end furthest from the surgeon; the proximal end refers to the end closest to the surgeon.

[0025] like Figure 1 and Figure 2As shown, this invention discloses a self-compressible shockwave balloon, comprising a balloon body 1. The balloon body 1 has a double-layer structure, including an outer balloon 2 and an inner balloon 3. The inner balloon 3 is disposed within the cavity of the outer balloon 2, and the inner balloon 3 and the outer balloon 2 are coaxially arranged. The outer balloon 2 and the inner balloon 3 have separate independent cavities. A through hole is provided at the distal end of the inner balloon 3 to allow liquid to enter the cavity of the outer balloon 2 through the through hole after the inner balloon 3 is first inflated with liquid. The outer balloon 2 is inflated with fluid. After the inner balloon 3 and the outer balloon 2 are fully inflated, a gap is provided between the inner balloon 3 and the outer balloon 2. A shock wave emitter 4 is attached and fixed to the outer peripheral wall of the inner balloon 3. A self-compressing support 5 is fitted onto the outer wall of the inner balloon 3. The shock wave emitter 4 is positioned opposite the support body of the self-compressing support 5. The shock wave emitter 4 is insulated from and attached to the self-compressing support 5. Under normal conditions, the self-compressing support 5 is in a contracted state (e.g., Figure 4 and Figure 6 As shown), the inner balloon 3 is tightened. When the inner balloon 3 is filled with fluid, the inner balloon 3 forces the self-compressing stent 5 to expand. Figure 7 As shown in the figure, when the liquid in the inner balloon 3 is extracted, the inner balloon 3 is compressed under the action of the self-compressing stent 5.

[0026] By setting the inner balloon 3, the problem of shock wave failure caused by the large distance between the shock wave emitter 4 and the lesion site can be prevented. Moreover, by adopting the above structure, the shock wave emission power can be reduced in a balloon structure of the same size, thus reducing damage to non-lesion sites.

[0027] Once balloon 1 reaches the lesion site, both the inner and outer balloons inflate to the nominal pressure. The self-compressing stent 5, under the expansion of the inner balloon 3, extends the shockwave transmitter to a position close to the inner wall of the outer balloon. Pulsed energy is released, and the shockwave transmitter delivers shockwave energy to the vascular wall and medial calcification, achieving uniform energy distribution and avoiding the effects of transmitter misalignment. Furthermore, the proximity of the shockwave transmitter to the vessel wall allows for the use of lower energy levels to complete the treatment.

[0028] like Figure 4 and Figure 5 As shown, the self-compressing stent 5 is arranged in a serpentine or zigzag shape along the circumference of the inner balloon 3 at least once, preferably in a serpentine shape, and the whole loop is in a ring shape.

[0029] like Figure 5 As shown, the shock wave emitter 5 includes multiple metal electrodes 6 and electrode leads 7. The metal electrodes 6 are covered with a first insulating layer 8. The first insulating layer 8 has a first perforation 9 that exposes part of the metal electrodes 6. The first perforation 9 faces the self-compression bracket 5. The electrode leads 7 may include at least one positive electrode and one negative electrode.

[0030] like Figure 1 and Figure 2 As shown, in this invention, the metal electrode 6 is disposed on the U-shaped bend 61 of the self-compressing bracket 5, located between the self-compressing bracket 5 and the inner balloon 3. A second hollow hole 10 is provided on the U-shaped bend 61 of the self-compressing bracket 5, and the second hollow hole 10 is opposite to the first hollow hole 9. Here, the self-compressing bracket 5 can be set as a conductor. When used as a conductor, the self-compressing bracket 5 can be made of conductive metal material and serve as a connecting line for connecting each metal electrode 6. A second insulating layer 11 is provided on the U-shaped bend 61 of the self-compressing bracket 5 to attach and fix the metal electrode 6 and the inner balloon 3. The second insulating layer 11 completely exposes the U-shaped bend 61. The electrode lead 7 is provided with a positive line and a negative line. The positive line is connected to one of the metal electrodes, and the negative line is connected to the other metal electrode.

[0031] In this invention, the liquid is a conductive liquid.

[0032] In this invention, the second insulating layer 11 is UV adhesive, and the first insulating layer 8 is polyimide (PI) material.

[0033] As a preferred embodiment, when the self-compression bracket 5 is a conductor, the self-compression bracket 5 is made of nickel-titanium alloy shape memory metal.

[0034] The outer balloon 2 is preferably made of nylon material; the inner balloon 3 is made of silicone material.

[0035] like Figures 1 to 3 As shown, the present invention also discloses a balloon catheter, including a guidewire catheter 100 and the aforementioned self-compressible shockwave balloon. The guidewire catheter 100 is externally provided with an outer tube 101 having a double-lumen structure. In this invention, the outer tube 101 has a double-layer structure with a cavity between the two layers. The self-compressible shockwave balloon is located at the distal end of the outer tube 101. The proximal end of the inner balloon 3 is connected and fixed to the distal end of the inner layer of the outer tube 101, and the proximal end of the outer balloon 2 is connected and fixed to the distal end of the outer layer of the outer tube 101, so that the cavity of the outer balloon 2 communicates with the cavity between the two layers of the outer tube 101. The cavity of the inner balloon 3 is connected to the cavity of the inner tube of the outer tube 101. The guidewire catheter 100 passes through the cavity of the inner tube of the outer tube 101 and is coaxially arranged. The distal end of the guidewire catheter 100 passes through the cavity of the inner balloon 3 and is connected and fixed to the distal end of the self-compressing shock wave balloon. A tip 102 is provided at the distal end of the self-compressing shock wave balloon and is connected and fixed to the guidewire catheter 100. When the liquid enters the inner balloon 3 from the cavity of the inner tube of the outer tube 101, the liquid enters the cavity of the outer balloon 2 through the through hole while the inner balloon 3 expands, causing the outer balloon 2 to expand.

[0036] like Figure 1 and Figure 2 As shown, the guidewire catheter 100 is a tube with a lumen, and a radiopaque ring 103 is provided on the part of the guidewire catheter 100 located in the balloon body 1.

[0037] In this invention, the proximal end of the balloon catheter is connected to an operating handle with a guidewire lumen and a fluid inlet, which is not specifically limited here.

[0038] In this invention, a self-compressible stent serves as a crucial component of the shockwave transmitter. Once the balloon reaches the lesion site, the outer tube is inflated, expanding both the inner and outer balloons to their nominal pressure. The shockwave transmitter on the self-compressible stent, under the influence of the inner balloon's expansion force, is pushed outwards to a position close to the inner wall of the outer balloon. Pulse energy is released, and the shockwave transmitter delivers shockwave energy to the vessel wall and medial calcification, achieving uniform energy distribution and avoiding the effects of relative misalignment. Furthermore, the proximity of the shockwave transmitter to the vessel wall allows for the use of lower energy levels to complete the treatment. After the inner and outer balloons are depressurized, the shockwave transmitter, under the self-compression of the self-compressible stent, retracts to its initial position, and the balloon is withdrawn from the body, completing the treatment process.

Claims

1. A self-compressible shockwave balloon, comprising a balloon body (1), characterized in that: The balloon body (1) includes an outer balloon (2) and an inner balloon (3). The inner balloon (3) is located in the cavity of the outer balloon (2). The inner balloon (3) and the outer balloon (2) are coaxially arranged. The outer balloon (2) and the inner balloon (3) have separate independent cavities. A through hole is provided at the distal end of the inner balloon (3) so that after the inner balloon (3) is first inflated with liquid, the liquid can enter the cavity of the outer balloon (2) through the through hole to inflate the outer balloon (2). When the inner balloon (3) and the outer balloon (2) are fully inflated, a gap is provided between them. A shock wave emitter (4) is provided on the outer peripheral wall of the inner balloon (3), and a self-compressing support (5) is provided on the outer wall of the inner balloon (3). The shock wave emitter (4) is located at a position opposite to the support body of the self-compressing support (5). The shock wave emitter (4) and the self-compressing support (5) are insulated from each other. Under normal conditions, the self-compressing support (5) is in a contracted state, which tightens the inner balloon (3). When the inner balloon (3) is filled with liquid, the inner balloon (3) forces the self-compressing support (5) to expand. The self-compressing support (5) is arranged in a serpentine or zigzag shape along the circumference of the inner balloon (3) at least once. The shock wave emitter (4) includes multiple metal electrodes (6) fixed on the outer wall of the inner balloon (3) and electrode leads (7). The metal electrodes (6) are electrically connected to the electrode leads (7). A first insulating layer (8) is provided outside the metal electrodes (6). A first perforated hole (9) is provided on the first insulating layer (8) to expose part of the metal electrodes (6). The self-compression bracket (5) has a second hollow hole (10) at the position opposite to the metal electrode (6). The second hollow hole (10) is opposite to the first hollow hole (9) so that the self-compression bracket (5) can be used as a conductor to connect each metal electrode (6). A second insulating layer (11) is provided on the self-compression bracket (5) to attach and fix the metal electrode (6) and the inner balloon (3).

2. The self-compressible shockwave balloon according to claim 1, characterized in that: The self-compression bracket (5) is made of nickel-titanium alloy.

3. The self-compressible shockwave balloon according to claim 2, characterized in that: The outer balloon (2) is made of nylon material.

4. The self-compressible shockwave balloon according to claim 3, characterized in that: The inner balloon (3) is made of silicone material.

5. A balloon catheter, comprising a guidewire catheter (100), characterized in that: It also includes a self-compressible shockwave balloon as described in any one of claims 1-4, wherein the guidewire catheter (100) is provided with an outer tube (101) having a double-lumen structure, the self-compressible shockwave balloon is located at the distal end of the outer tube (101), the distal end of the guidewire catheter (100) passes through the cavity of the inner balloon (3) and is connected and fixed to the distal end of the self-compressible shockwave balloon, and a tip (102) is provided at the distal end of the self-compressible shockwave balloon and is connected and fixed to the guidewire catheter (100), the cavity of the outer balloon (2) is connected to one of the cavities of the outer tube (101), and the cavity of the inner balloon (3) is connected to the other cavity of the outer tube (101).

Images