Heart valve balloon dilation catheter with controllable cavity

Abstract

The heart valve balloon dilatation catheter comprises an annular balloon assembly, a catheter assembly and a handle, the center of the balloon assembly is provided with the cavity for blood circulation, and the far end of the catheter assembly penetrates through the cavity and then is connected with the far end of the balloon assembly. A first filling channel for filling the balloon assembly is arranged on the catheter assembly, an elastic balloon body capable of being filled and expanded is arranged at the position, located in the cavity, of the far end of the catheter assembly, the cavity can be filled with the elastic balloon body so that the size of the cavity can be changed, and a second filling channel for filling the elastic balloon body is arranged on the catheter assembly. The catheter assembly is further provided with a guide wire cavity channel. Compared with the prior art, the elastic balloon capable of being filled is arranged in the cavity of the balloon assembly, the size of the cavity is controlled, when the elastic balloon is not filled, blood flow can not be blocked, operative complications can be effectively avoided, and when the elastic balloon is filled and the cavity is completely sealed, radiography judgment can be conducted on the perivalvular leakage after TAVI operation.

Description

Technical Field

[0001] The present invention relates to a medical device, and particularly to a cardiac valve balloon dilation catheter with a controllable cavity. Background Art

[0002] When a traditional balloon catheter expands, it blocks blood flow, which is likely to cause adverse effects such as ischemia and complications. Currently, to solve this problem, Chinese Patent No.: CN201680062155.5, or Patent Application No.: CN202211359816.4, Invention Title: Expandable Perfusion Balloon with External Mesh and Related Methods disclose a balloon catheter that does not block blood flow with a cavity structure through balloon arrangement and external mesh structure. Although this structure can reduce intraoperative complications in transcatheter aortic valve implantation (TAVI), in its clinical application: post-dilation of cardiac valves, for blood flow, only when it is completely blocked can the leakage be accurately judged by the flow of contrast medium. However, due to the existence of the cavity structure (the cavity means that blood flow cannot be completely blocked), the contrast medium will quickly flow away from the cavity, so it is difficult to judge paravalvular leakage, resulting in difficulty in judging paravalvular leakage during angiography, which is an extremely important surgical diagnosis index. Summary of the Invention

[0003] The purpose of the present invention is to provide a cardiac valve balloon dilation catheter with a controllable cavity to solve the deficiencies of the prior art.

[0004] To solve the above problems, the present invention is implemented by the following technical solutions: A cardiac valve balloon dilation catheter with a controllable cavity includes an annular balloon assembly, a catheter assembly, and a handle. A cavity for blood flow is provided in the center of the balloon assembly. The distal end of the catheter assembly passes through the cavity and is connected to the distal end of the balloon assembly. A first inflation channel for inflating the balloon assembly is provided on the catheter assembly. An inflatable and expandable elastic balloon body is provided at the distal end of the catheter assembly located in the cavity. The elastic balloon body can fill the cavity to change the size of the cavity. A second inflation channel for inflating the elastic balloon body is provided on the catheter assembly. A guide wire channel is also provided on the catheter assembly.

[0005] Further, the catheter assembly includes an inner tube and an outer tube. The inner tube is coaxially arranged in the outer tube. The distal end of the inner tube passes through the distal end of the outer tube and through the cavity and is connected to the distal end of the balloon assembly. A gap is provided between the outer tube and the inner tube to form the first inflation channel. The guide wire channel and the second inflation channel are provided in the inner tube. The elastic balloon body is sealingly connected to the inner tube and communicates with the second inflation channel.

[0006] Further, an incision for cutting off the distal end of the second filling channel is provided on the distal tube body of the inner tube, so as to form a reduced-diameter section at the distal end of the inner tube. The guide wire lumen penetrates through the inner tube and the reduced-diameter section. The elastic balloon is arranged along the circumferential direction of the inner tube. The distal end of the elastic balloon is hermetically connected to the reduced-diameter section, and the proximal end is hermetically connected to a position of the inner tube close to the reduced-diameter section. The distal end of the balloon assembly is connected to the distal end of the reduced-diameter section.

[0007] Further, the balloon assembly is composed of a plurality of balloons arranged annularly.

[0008] Further, the elastic balloon is a compliant balloon.

[0009] Further, the elastic balloon is made of block polyether amide resin, thermoplastic polyurethane rubber, thermoplastic elastomer, silica gel, rubber or latex.

[0010] Further, a first interface, a second interface and a third interface are provided at the proximal end of the handle. The second interface is communicated with the first filling channel, the third interface is communicated with the second filling channel, and the first interface is communicated with the guide wire lumen.

[0011] Further, the first interface is coaxially arranged with the handle, and the second interface and the third interface are respectively arranged on the side wall of the handle.

[0012] Compared with the prior art, the present invention realizes the control of the size of the cavity by arranging an inflatable elastic balloon in the cavity of the balloon assembly. When the elastic balloon is not inflated, blood flow can pass through without being blocked, effectively avoiding surgical complications. When the elastic balloon is inflated and completely closes the cavity, it can be used for angiographic judgment of paravalvular leakage after TAVI (transcatheter aortic valve implantation). BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 is a schematic external structure diagram of the present invention.

[0014] Figure 2 is a schematic structural diagram of the inner tube of the present invention.

[0015] Figure 3 is a diagram showing the positional relationship between the balloon assembly and the elastic balloon of the present invention.

[0016] Figure 4 is a schematic internal structure diagram of the catheter assembly of the present invention.

[0017] Figure 5 is a schematic internal structure diagram of the handle of the present invention.

[0018] Figure 6 is Figure 5 a partial cross-sectional view of the marked position A in

[0019] Figure 7 is Figure 5 Partial sectional view at position B marked in

[0020] Figure 8 is Figure 5 Partial sectional view at position C marked in

[0021] Figure 9 Schematic diagram of the first usage method of the present invention.

[0022] Figure 10 Schematic diagram of the second usage method of the present invention. Detailed implementation mode

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

[0024] In the present invention, the distal end refers to the end far from the surgical operator; the proximal end refers to the end close to the surgical operator.

[0025] As Figures 1 to 4 shown, the present invention discloses a balloon-expandable catheter for a heart valve with a controllable cavity, which successively includes a tip 5, a balloon assembly 1, an elastic balloon 4, a catheter assembly 2, and a handle 3 from the distal end to the proximal end, wherein: The balloon assembly 1 is arranged by surrounding a plurality of balloon bodies 102 in a circle. The balloon bodies are connected to each other or connected into one body by means of tape wrapping, etc. A cavity 101 for blood to pass through is provided in the center thereof; connecting rods are respectively provided at the proximal and distal ends of the balloon body. The distal end of the balloon assembly 1 is fixedly connected to the catheter assembly 2 and the tip 3 through the connecting rod at the distal end, and the proximal end of the balloon assembly 1 is fixedly connected to the tube wall of the catheter assembly 2 through the connecting rod at the proximal end. A through hole is provided on the connecting rod at the proximal end, which is communicated with the inner cavity of the balloon body; The catheter assembly 2 is provided with a first inflation channel 201 for inflating the balloon assembly 1, a second inflation channel 202 for inflating the elastic balloon body 4, and a guide wire channel 203; the proximal ends of the first inflation channel 201, the second inflation channel 202, and the guide wire channel 203 all penetrate through the proximal end of the catheter assembly 2, and the distal end of the guide wire channel 203 penetrates through the distal end of the catheter assembly 2. The tip 3 is a sleeve, which is sleeved on the distal end of the catheter assembly 2. The connecting rod at the distal end, the tip 3, and the distal end of the catheter assembly 2 are welded or bonded and fixed, and the connecting rod at the proximal end is communicated with the first inflation channel 201; The elastic balloon body 4 can be inflated and expanded, and is arranged circumferentially around the catheter assembly 2. The elastic balloon body 4 is located in the cavity 101. The proximal and distal ends of the elastic balloon body 4 are hermetically connected to the catheter assembly 2 by welding or bonding respectively, and the second inflation channel 202 is communicated with the inner cavity of the elastic balloon body 4; The handle 3 is provided with three channels respectively communicating with the first inflation channel 201, the second inflation channel 202 and the guide wire lumen 203.

[0026] When the elastic balloon body 4 is inflated, it can fill the cavity 101 and change the size of the cavity 101, and the size can be the radial size and / or the axial size of the cavity 101.

[0027] In the present invention, the elastic balloon body 4 is a compliant balloon, which is made of block polyether amide resin (Pebax), thermoplastic polyurethane rubber (TPU), thermoplastic elastomer (TPE), silica gel, rubber or latex. Due to the concave surface formed by the mutual contact between the inner wall balloon bodies in the balloon assembly, the compliant balloon can ensure close surface-to-surface contact in such situations.

[0028] The elastic balloon body 4 can extend along the axial direction of the catheter assembly 2.

[0029] Such as Figure 1 、 Figure 2 And Figure 3 As shown in, the catheter assembly 2 includes an inner tube 204 and an outer tube 205. The inner tube 204 is coaxially arranged in the outer tube 205. The distal end of the inner tube 204 passes through the distal end of the outer tube 205 and passes through the cavity 101 and then is connected to the distal end of the balloon assembly 1. The diameter of the inner tube 204 is smaller than that of the outer tube 205. A gap is provided between the outer tube 205 and the inner tube 204 to form the first inflation channel 201. The guide wire lumen 203 and the second inflation channel 202 are arranged in the inner tube 204. The length of the inner tube 204 is greater than that of the outer tube 205. The connecting rod at the proximal end of the elastic balloon body 4 is fixedly connected to the tube wall of the inner tube 204 by welding or bonding. The distal end of the outer tube 205 is provided with a sealing surface for sealing the distal end of the first inflation channel 201, and only the hole communicating with the through hole of the proximal connecting rod is reserved and sealed. The elastic balloon body 4 is hermetically connected to the inner tube 204 and communicates with the second inflation channel 202.

[0030] Such as Figure 2 And Figure 4As shown, an incision is provided on the distal tube body of the inner tube 204 to cut off the distal end of the second filling channel 202, so that a reduced-diameter section 206 is formed at the distal end of the inner tube 204. The length of the second filling channel 202 is less than that of the guide wire channel 203. The guide wire channel 203 penetrates through the inner tube 204 and the reduced-diameter section 206. The elastic balloon body 4 is arranged along the circumferential direction of the inner tube 204. The distal end of the elastic balloon body 4 is hermetically connected to the reduced-diameter section 206, and the proximal end is hermetically connected to the position of the inner tube 204 close to the reduced-diameter section 206. The distal end of the balloon assembly 1 is connected to the distal end of the reduced-diameter section 206. Both the second filling channel 202 and the guide wire channel 203 are arranged deviating from the axis of the inner tube 204. Among them, the cross-sectional shape of the second filling channel 202 can be arc-shaped, but the present invention is not limited thereto and can also be circular. Setting it as arc-shaped can increase the cross-sectional area, while the cross-sectional shape of the guide wire channel 203 is circular, which is convenient for the guide wire to pass through. The guide wire channel 203 penetrates through the proximal end and the distal end of the inner tube 204, while the second filling channel 202 penetrates through the proximal end of the inner tube 204 and the incision at the distal end. The distal end of the reduced-diameter section 206 is inserted into the tip 5 and is fixedly connected to the tip 5 and the connecting rod at the distal end.

[0031] As Figures 5 to 8 shown, the proximal end of the handle 3 is provided with a first interface 301, a second interface 302 and a third interface 303. Among them, the first interface 301 is coaxially arranged with the handle 3. The second interface 302 and the third interface 303 are respectively arranged on the side wall of the handle 3. The handle 3 is a cylinder and has an opening at its distal end. The proximal end of the catheter assembly 2 is hermetically connected to the distal end of the handle 3. The first interface 301 is communicated with the guide wire channel 203. The second interface 302 is communicated with the first filling channel 201. The third interface 303 is communicated with the second filling channel 202. In the present invention, in addition to being communicated with the guide wire channel 203, the first interface 301 is sealed with respect to the second interface 302, the first filling channel 201, the third interface 303 and the second filling channel 202; in addition to being communicated with the first filling channel 201, the second interface 302 is sealed with respect to the first interface 301, the guide wire channel 203, the third interface 303 and the second filling channel 202; in addition to being communicated with the second filling channel 202, the third interface 303 is sealed with respect to the first interface 301, the guide wire channel 203, the second interface 302 and the first filling channel 201.

[0032] As Figures 5 to 8As shown, in the present invention, the center of the handle 3 has through holes with different diameters in multiple segments. There are three segments of through holes, and their diameters gradually decrease from the distal end to the proximal end, namely the first through-hole segment 304, the second through-hole segment 305, and the third through-hole segment 306. The diameter of the first through-hole segment 304 is equal to the outer diameter of the outer tube 205. The second interface 302 is arranged at the position of the first through-hole segment 304 and is in communication with it. The proximal end of the inner tube 204 extends out from the proximal end of the outer tube 205, and the extended part 2041 is provided with an adaptation segment 2042 whose diameter is matched with the diameter of the third through-hole segment 306. The guide wire channel 203 is arranged on the central axis of the adaptation segment 2042. At the part where the adaptation segment 2042 is connected to the extended part 2041, there is a cut surface 2043. The proximal segment of the second filling channel 202 penetrates through the cut surface 2043. The third interface 303 is arranged at the transition position between the second through-hole segment 305 and the third through-hole segment 306. The third interface 303 is in communication with the second filling channel 202 through a tube through-hole on the cut surface 2043. This transition position is adapted to the cut surface 2043. The adaptation segment 2042 is inserted into the third through-hole segment 306, and the adaptation segment 2042 is tightly and sealedly connected to the third through-hole segment 306. The outer tube 205 is tightly and sealedly connected to the first through-hole segment 304. The extended part 2041 is tightly and sealedly connected to the second through-hole segment 305.

[0033] During clinical use, the first interface 301 is used to connect the guide wire. Both the second interface 302 and the third interface 303 are used to connect a syringe or a stamping pump for filling the balloon assembly 1 and the elastic balloon body 4. When only filling the liquid through the second interface 302, at this time only the balloon assembly 1 is filled, and the elastic balloon body 4 is in the initial state. At this time, the cavity 101 is the largest. At the same time, the liquid can be filled through the third interface 303 to make the elastic balloon 4 expand and fill, so as to adjust the size of the cavity 101. When the filling volume of the elastic balloon reaches the rated value, the balloon cavity 101 is closed (completely filled and sealed).

[0034] As Figure 9 shown, two separate syringes or pressure pumps 6 and 7 can be respectively connected to the second interface 302 and the third interface 303. During use, first fill the balloon assembly 1 to the target pressure or volume through the syringe or the pressure pump 6, and then fill the elastic balloon body 5 to the target volume through the syringe or the pressure pump 7, and then the control of the cavity 101 can be achieved.

[0035] As Figure 10As shown, for implementation method 2, connect the inlet of the overflow valve 8 through a syringe or a pressure pump 6, and connect the two outlets of the overflow valve 8 to the second interface 302 and the third interface 303 respectively; set the overflow valve 8 to the target pressure (0.1 - 0.4 Mpa). When in use, completely fill the liquid in the syringe or the pressure pump 6 into the catheter assembly. During filling, the liquid in the syringe or the pressure pump 6 will preferentially be injected into the balloon assembly 1 from the outlet of the overflow valve 8. Therefore, the balloon assembly 1 will be first filled to the target pressure and volume set by the overflow valve 8. At this time, the cavity 101 is in the initial maximum state. At this time, continuously injecting liquid and adjusting the overflow valve 8 can achieve the adjustment of the size of the cavity 101.

[0036] The cavity structure of the present invention is controllable. It can be used to prepare for the judgment of paravalvular leakage after TAVI by closing the cavity structure. When the cavity is closed, the structural stability of the balloon assembly can be improved, as well as the supportability of the balloon assembly. It can also perform a short-term occlusion of the aorta and judge the paravalvular leakage after the operation through angiography. When the cavity is opened, the cardiac load can be effectively reduced, the convenience and reliability of the surgical operation can be improved, and serious intraoperative complications can be avoided.

Claims

1. A heart valve balloon dilatation catheter with a controllable cavity, comprising an annular balloon assembly (1), a catheter assembly (2), and a handle (3), wherein a cavity (101) for blood circulation is provided at the center of the balloon assembly (1), the distal end of the catheter assembly (2) passes through the cavity (101) and is connected to the distal end of the balloon assembly (1), and a first filling channel (201) is provided on the catheter assembly (2) for filling the balloon assembly (1), characterized in that: The distal end of the catheter assembly (2) is provided with an inflatable elastic balloon body (4) at the cavity (101); the elastic balloon body (4) can fill the cavity (101) to change the size of the cavity (101); a second filling channel (202) for filling the elastic balloon body (4) is provided on the catheter assembly (2); and a guide wire cavity (203) is also provided on the catheter assembly (2).

2. The heart valve balloon dilatation catheter with controllable cavity according to claim 1, characterized in that: The catheter assembly (2) comprises an inner tube (204) and an outer tube (205); the inner tube (204) is coaxially arranged in the outer tube (205); the distal end of the inner tube (204) passes through the distal end of the outer tube (205) and the cavity (101) and is connected to the distal end of the balloon assembly (1); a gap is provided between the outer tube (205) and the inner tube (204) to form a first filling channel (201); a guidewire lumen (203) and a second filling channel (202) are provided in the inner tube (204); and the elastic balloon body (4) is sealed and connected to the inner tube (204) and is in communication with the second filling channel (202).

3. The heart valve balloon dilatation catheter with controllable cavity according to claim 2, characterized in that: The distal tube body of the inner tube (204) is provided with an incision for cutting off the distal end of the second filling channel (202), so that the distal end of the inner tube (204) forms a variable diameter section (206), the guide wire cavity (203) passes through the inner tube (204) and the variable diameter section (206), the elastic balloon body (4) is arranged along the circumference of the inner tube (204), the distal end of the elastic balloon body (4) is sealedly connected to the variable diameter section (206), the proximal end is sealedly connected to a position of the inner tube (204) close to the variable diameter section (206), and the distal end of the balloon assembly (1) is connected to the distal end of the variable diameter section (206).

4. The heart valve balloon dilatation catheter with controllable cavity according to claim 1, characterized in that: The balloon assembly (1) is composed of a plurality of balloon bodies (102) arranged in a ring shape.

5. The heart valve balloon dilatation catheter with controllable cavity according to claim 1, characterized in that: The elastic balloon body (4) is a compliant balloon.

6. The heart valve balloon dilatation catheter with controllable cavity according to claim 5, characterized in that: The elastic balloon body (4) is made of segmented polyetheramide resin, thermoplastic polyurethane rubber, thermoplastic elastomer, silicone, rubber or latex.

7. The heart valve balloon dilatation catheter with a controllable cavity according to any one of claims 1 to 6, characterized in that: The proximal end of the handle (3) is provided with a first interface (301), a second interface (302), and a third interface (303); the second interface (302) is in communication with the first filling channel (201); the third interface (303) is in communication with the second filling channel (202); and the first interface (301) is in communication with the guidewire cavity (203).

8. The heart valve balloon dilatation catheter with controllable cavity according to claim 7, characterized in that: The first interface (301) is coaxially arranged with the handle (3), and the second interface (302) and the third interface (303) are respectively arranged on the side walls of the handle (3).

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