A delivery catheter and delivery device for artificial valve

Abstract

The present invention provides a delivery catheter and a delivery device for an artificial valve, wherein the delivery catheter comprises an outer tube assembly and an inner tube assembly, wherein the outer tube assembly comprises a sheath tube capable of accommodating an artificial valve and an outer tube fixedly connected to one end of the sheath tube, wherein the inner tube assembly comprises an inner tube and a fixing head fixedly connected to the inner tube, wherein the inner tube assembly is arranged in the cavity of the outer tube assembly, wherein a circumferential positioning fit is formed between the sheath tube and the fixing head, so that the inner tube can drive the fixing head and the sheath tube as a whole to rotate in a coordinated manner when the inner tube rotates in a circumferential direction, so as to adjust the matching between the artificial valve and the native valve ring and maintain the three-dimensional configuration required for positioning. After being adjusted in place, the outer tube acts as a driving force for the sheath tube, and when the sheath tube needs to move axially, it drives the sheath tube to move axially, so as to achieve the purpose of releasing the artificial valve.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a delivery catheter and a delivery device for an artificial valve. Background Art

[0002] With the development of social economy and the aging of population, the incidence of valvular heart disease has increased significantly. Studies have shown that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the first choice for patients with severe valvular disease. However, for the elderly, patients with multiple organ diseases, patients with a history of open-chest surgery, and patients with poor heart function, traditional surgical treatment has high risks and mortality rates. Some patients do not even have the opportunity for surgery. Transcatheter heart valve replacement has the advantages of no need for open-chest surgery, less trauma, and faster patient recovery, and has received widespread attention from experts and scholars.

[0003] During heart valve replacement surgery, the artificial valve needs to be released precisely. Due to the complex anatomical structure of the human body, artificial valves are often designed into irregular shapes. For example, in order to achieve the anchoring of the artificial valve, it is designed to fit the anatomical structure, and the cross-section of the stent is designed to be D-shaped, polygonal, etc. In order to accurately release the artificial valve with an irregular cross-section to the anatomical position, the delivery device needs to be able to adjust the angle of the artificial valve. However, since the delivery pathways of the femoral artery and femoral vein are non-linear, and the final configuration of the delivery device is not on the same plane, it is impossible for traditional delivery systems to simultaneously achieve circumferential rotation and keep the configuration unchanged. Summary of the invention

[0004] In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide a new type of artificial valve delivery catheter and delivery device to solve the problem that artificial valves with irregular cross-sections are difficult to release accurately.

[0005] According to one aspect of the present invention, there is provided a delivery catheter for an artificial valve, comprising an outer tube assembly and an inner tube assembly, wherein the outer tube assembly comprises a sheath tube capable of accommodating the artificial valve and an outer tube fixedly connected to one end of the sheath tube, and the inner tube assembly comprises an inner tube and a fixing head fixedly connected to the inner tube, the inner tube assembly is arranged in the cavity of the outer tube assembly, and a circumferential positioning fit is formed between the sheath tube and the fixing head.

[0006] Furthermore, in the above-mentioned delivery catheter of the artificial valve, the inner wall of the sheath tube and the outer wall of the fixing head form a nested structure.

[0007] Furthermore, in the above-mentioned delivery catheter for the artificial valve, the inner wall of the sheath is provided with a protrusion or a groove, and the outer wall of the fixing head is provided with a groove or a protrusion matching with the protrusion or groove of the inner wall of the sheath.

[0008] Furthermore, in the above-mentioned delivery catheter for the artificial valve, the outer wall of the fixing head is provided with at least one embedded section, and the friction force generated between the embedded section and the sheath is greater than the friction force generated between the valve and the sheath.

[0009] Furthermore, in the above-mentioned delivery catheter of the artificial valve, the static friction coefficient between the embedded section and the sheath tube is in the range of 0.1-1.5.

[0010] Furthermore, in the above-mentioned delivery catheter for the artificial valve, the embedded section includes a first strip-shaped unit and a second strip-shaped unit, and a first spring and a second spring are connected between the first strip-shaped unit and the second strip-shaped unit.

[0011] Furthermore, in the above-mentioned delivery catheter of the artificial valve, the delivery catheter also includes a pull wire, which is arranged at the connection between the first strip-shaped unit and the second strip-shaped unit and the first spring or the second spring, and the pull wire passes through the inner tube.

[0012] Furthermore, in the above-mentioned artificial valve delivery catheter, the first strip-shaped units and the second strip-shaped units are arranged on the outer wall of the fixing head in an axisymmetric distribution.

[0013] Furthermore, in the above-mentioned delivery catheter of the artificial valve, the sheath tube and the outer tube are connected via a bearing or an elastic material.

[0014] Furthermore, the delivery catheter of the artificial valve further includes a guide head connected to the inner tube, and the guide head has a streamlined shape structure.

[0015] Furthermore, in the above-mentioned delivery catheter for the artificial valve, the outer tube is a polymer tube or a composite tube of metal and polymer.

[0016] Furthermore, in the above-mentioned delivery catheter of the artificial valve, the inner tube is a single-lumen tube or a multi-lumen tube.

[0017] According to another aspect of the present invention, there is provided a delivery device for an artificial valve, comprising a handle and a delivery catheter connected to the handle, wherein an outer tube movable part and an inner tube movable part are provided in the handle, wherein the outer tube movable part is connected to the outer tube to drive the outer tube to perform axial movement, and the inner tube movable part is connected to the inner tube to drive the inner tube to perform circumferential rotation.

[0018] Furthermore, in the above-mentioned artificial valve delivery device, the handle is fixedly connected to the pull wire.

[0019] Compared with the prior art, the artificial valve delivery catheter of the present invention forms a circumferential positioning match between the sheath and the fixed head, which can achieve the inner tube to drive the fixed head and the sheath as a whole to rotate in a coordinated manner when rotating in the circumferential direction, so as to adjust the matching between the artificial valve and the native valve ring and maintain the three-dimensional configuration required for positioning. After being adjusted in place, the outer tube acts as the driving force of the sheath, and when the sheath needs to move axially, it drives the sheath to move axially to achieve the purpose of releasing the artificial valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic diagram of the structure of an artificial valve delivery catheter according to an embodiment of the present invention;

[0021] Figure 2 This is a schematic diagram of the structure of the guide head and inner tube assembly according to an embodiment of the present invention;

[0022] Figure 3 This is a schematic structural diagram of an artificial valve delivery device according to an embodiment of the present invention;

[0023] Figure 4 This is a schematic diagram of the handle structure of an embodiment of the present invention;

[0024] Figure 5 It is a cross-sectional view of the nested matching structure of the sheath tube and the fixing head according to an embodiment of the present invention;

[0025] Figure 6 This is a schematic diagram of the matching structure of the concave and convex shapes of the sheath tube and the fixing head according to an embodiment of the present invention;

[0026] Figure 7 for Figure 6 A magnified view of the structure of the sheath tube and the fixed head;

[0027] Figure 8 This is a cross-sectional view of the structure of an embedded section provided on the outer wall of a fixed head according to an embodiment of the present invention;

[0028] Fig. 9 This is a schematic diagram of the structure of the embedded segment according to an embodiment of the present invention;

[0029] Fig.10 It is a schematic diagram of the structural state of the sheath tube and the fixed head being separated when the pull wire is tightened according to the embodiment of the present invention;

[0030] Fig.11 for Fig.10 A magnified view of the structure of the sheath tube and the fixed head when they are separated;

[0031] Fig.12 It is a schematic diagram of the locking structure state of the sheath tube and the fixed head when the pull wire is loosened according to an embodiment of the present invention;

[0032] Fig.13 for Fig.12 A magnified view of the partial structure of the sheath tube and the fixed head in the locked state;

[0033] 1-delivery catheter; 2-handle; 3-artificial valve; 11-guide head; 12-sheath; 13-outer tube; 14-fixing head; 15-inner tube; 21-outer tube movable part; 22-inner tube movable part; 141-embedded section; 1411-first strip unit; 1412-second strip unit; 1421-first spring; 1422-second spring; 142-pull wire. DETAILED DESCRIPTION

[0034] In order to make the creative features, technical means and objectives of the present invention easier to understand, the present invention is further described below in conjunction with specific embodiments.

[0035] like Figure 1 As shown, the delivery catheter for an artificial valve provided in an embodiment of the present invention comprises an outer tube assembly and an inner tube assembly, wherein the outer tube assembly comprises a sheath tube 12 capable of accommodating an artificial valve 3 and an outer tube 13 fixedly connected to one end of the sheath tube 12, and the inner tube assembly comprises an inner tube 15 and a fixing head 14 fixedly connected to the inner tube 15, and the inner tube assembly is arranged in the cavity of the outer tube assembly.

[0036] like Figure 1-2 As shown, the delivery catheter of the artificial valve of the present invention further includes a guide head 11, which is connected to the inner tube 15. Preferably, the guide head 11 of the present invention has a streamlined shape structure, which can avoid scratching the inner wall of the blood vessel and is also conducive to guiding the entire delivery catheter to advance along the blood vessel channel.

[0037] In the implementation of the present invention, the sheath 12 is smoothly fixedly connected to the outer tube 13. The outer tube 13 serves as the driving force of the sheath 12. When the sheath 12 needs to move axially, it drives the sheath 12 to move axially to successfully load and release the artificial valve 3.

[0038] The sheath tube 12 of the present invention forms a circumferential positioning fit with the fixed head 14. When the sheath tube 12 needs to move circumferentially, the inner tube 15 serves as a driving force for the fixed head 14, and the fixed head 14 serves as a driving force for the sheath tube 12, driving the sheath tube 12 to move circumferentially.

[0039] In a specific implementation, since the inner tube 15 is also connected to the guide head 11, the guide head 11 will also rotate, while the outer tube 13 does not move at this time, so as to maintain the three-dimensional configuration required for the positioning of the delivery catheter.

[0040] like Figure 3 As shown, the delivery device of the artificial valve provided in the embodiment of the present invention comprises a handle 2 and a delivery catheter 1 connected to the handle 2. In practice, the present invention refers to the direction toward the delivery catheter 1 as the distal end, and the direction toward the handle 2 as the proximal end.

[0041] like Figure 4As shown, the handle 2 of the present invention is provided with an outer tube movable part 21 and an inner tube movable part 22. The outer tube movable part 21 is connected to the outer tube 13 to drive the outer tube 13 to move axially, and the inner tube movable part 22 is connected to the inner tube 15 to drive the inner tube 15 to rotate circumferentially.

[0042] In a specific implementation, the present invention drives the inner tube movable part 22 to rotate circumferentially by the handle 2, and then the inner tube 15 drives the fixing head 14 and the sheath tube 12 to rotate in coordination as a whole, so as to adjust the matching between the artificial valve 3 and the native valve ring. After the adjustment is in place, the handle 2 drives the bearing to drive the outer tube movable part 21 to move axially, and then the outer tube 13 drives the sheath tube 12 to move axially relative to the inner tube 15, so as to realize the loading and release of the artificial valve 3.

[0043] Optionally, the handle driving in the embodiment of the present invention can be performed by electric driving or manual driving.

[0044] In the embodiment of the present invention, the circumferential positioning cooperation between the sheath tube 12 and the fixing head 14 is realized in the following two ways:

[0045] Embodiment 1: Figure 5 As shown, the inner wall of the sheath tube 12 and the outer wall of the fixing head 14 form a nested structure, and the nested structure can achieve the fixation of the sheath tube 12 and the fixing head 14 in the circumferential direction. Figure 6-7 As shown, the inner wall of the sheath tube 12 is provided with a protrusion or a groove (C), and the outer wall of the fixing head 14 is provided with a groove or a protrusion matching with the protrusion or groove of the inner wall of the sheath tube 12 .

[0046] Optionally, the shape of the protrusions or grooves on the inner wall of the sheath tube 12 and the outer wall of the fixing head 14 can be square, triangle, circle or other irregular shapes, etc. Moreover, the number of the protrusions or grooves can be one or more.

[0047] Optionally, the plurality of protrusions or grooves may be of the same shape or of different shapes, and may be evenly distributed on the circumference of the outer wall of the fixing head 14 and the inner wall of the sheath tube 12, or unevenly distributed on the circumference of the outer wall of the fixing head 14 and the inner wall of the sheath tube 12. Preferably, the plurality of protrusions or grooves are symmetrically distributed on the circumference of the outer wall of the fixing head 14 and the inner wall of the sheath tube 12.

[0048] Although the concave and convex shapes of the sheath tube 12 and the fixing head 14 in the embodiment of the present invention can be switched, since the wall thickness of the tube is relatively small, it is a better choice to make the inner wall of the sheath tube 12 into a convex structure.

[0049] Embodiment 2: Figure 8As shown, the outer wall of the fixing head 14 is provided with at least one embedded section 141, and the friction force generated between the embedded section 141 and the sheath tube 12 is greater than the friction force generated between the artificial valve 3 and the sheath tube 12, so that the friction force generated between the fixing head 14 and the sheath tube 12 is greater than the valve release force and the recovery force. In this embodiment, the sheath tube 12 and the fixing head 14 are locked by friction force to achieve coordinated rotation.

[0050] Specifically, one or more sections of material with a high friction coefficient are embedded in the outer wall of the fixing head 14 , and the outer diameter of the embedded section 141 can be changed to achieve friction locking and unlocking between the embedded section 141 and the sheath tube 12 .

[0051] Preferably, in the above-mentioned artificial valve delivery device, the static friction coefficient between the embedding section 141 and the sheath tube 12 is in the range of 0.1-1.5.

[0052] Furthermore, if Fig. 9 As shown, the embedding section 141 of the present invention includes two parts, a first strip unit 1411 and a second strip unit 1412 , and a first spring 1421 and a second spring 1422 are connected between the first strip unit 1411 and the second strip unit 1412 .

[0053] Furthermore, if Fig.10 As shown, the embodiment of the present invention further includes a pull wire 142 , which is disposed at the connection between the first strip unit 1411 and the second strip unit 1412 and the first spring 1421 or the second spring 1422 , and the pull wire 142 passes through the inner tube 15 and is connected to the handle 2 .

[0054] Preferably, the pull wire 142 may be a single-strand wire or a multi-strand wire, including but not limited to a single solid metal wire, a multi-strand winding metal rope, etc. In practice, the present invention can adjust the outer diameter of the embedded section 141 by axially pulling the pull wire 142 .

[0055] like Figure 10-11 As shown, when the pull wire 142 is tightened, the first spring 1421 (or the second spring 1422) is compressed, the first strip unit 1411 and the second strip unit 1412 of the embedded section 141 are forced to move closer, and the fixed head 14 is separated from the sheath tube 12, and the movement of the two is not affected by each other. Figure 12-13 As shown, when the pull wire 142 is loosened, the first strip unit 1411 and the second strip unit 1412 of the embedded section 141 press against the sheath tube 12 outward, and the fixing head 14 and the sheath tube 12 are locked by the friction force of the embedded section 141 to achieve coordinated rotation.

[0056] Preferably, in the delivery device of the artificial valve of the present invention, the first strip unit 1411 and the second strip unit 1412 are axially symmetrically distributed on the outer wall of the fixing head 14, so that the pull wire 142 can be conveniently connected to all the embedded segments on one side.

[0057] Optionally, the sheath tube 12 and the outer tube 13 of the present invention are connected by a bearing or an elastic material. The elastic material includes but is not limited to silicone material, PU material, Pebax nylon elastomer engineering polymer, etc. Preferably, the sheath tube 12 and the outer tube 13 are connected by a bearing, and unlimited circumferential rotation can be achieved. The sheath tube 12 and the outer tube 13 are connected by a spring or an elastic material, and have a limit angle when rotating circumferentially, and the limit angle will be determined according to the characteristics of the spring or the elastic material itself.

[0058] In the embodiment of the present invention, the handle 2 drives the bearing to drive the axial movement of the outer tube movable part 21, and then the outer tube 13 drives the sheath tube 12 to move axially relative to the inner tube 15, so as to achieve the loading and release of the artificial valve 3. In addition, the handle 2 drives the bearing to drive the circumferential rotation of the inner tube movable part 22, so that the inner tube 15 drives the fixed head 14 and the sheath tube 12 to rotate in coordination, so as to adjust the release angle of the artificial valve 3, so as to achieve the purpose of accurate release.

[0059] Optionally, the outer tube 13 of the present invention can be a controllable bending tube such as a polymer tube or a metal and polymer composite tube. In practice, the outer tube 13 is a polymer composite tube with a metal structure on the inner surface, and at least one metal wire is buried in the outer tube 13. The bending angle, position and direction of the outer tube 13 are controlled by pulling different metal wires. Preferably, in order to improve the accuracy of the control bending, multiple metal wires are buried in the controllable bending tube.

[0060] Optionally, the inner tube 15 of the present invention is a single-lumen tube or a multi-lumen tube. Since the pull wire 142 passes through the inner tube 15, the inner tube 15 also has the function of passing the guide wire, so the inner tube 15 is preferably a multi-lumen tube. The multi-lumen tube can not only provide a channel for the pull wire 142, but also provide a channel for the guide wire, ensuring that the two play their respective roles without affecting each other.

[0061] The artificial valve loading process of the embodiment of the present invention is as follows: drive the handle 2 to make the sheath 12 retreat until the front end face of the sheath 12 is located on the rear side of the fixing head 14, exposing the fixing head 14, and then clamp the self-expanding artificial valve 3 in the fixing head 14. After the artificial valve 3 is stable, drive the outer tube 13 forward until the sheath 12 completely wraps the artificial valve 3, and the front end face of the sheath 12 is against the end face of the guide head 11, and the loading of the artificial valve is completed.

[0062] The artificial valve delivery process of the embodiment of the present invention is as follows: the entire artificial valve delivery device is extended into the puncture port along the guide wire and enters the human body. Then, the sheath tube 12 holding the artificial valve 3 is passed through the atrial septum along the vascular passage of the femoral vein and delivered to the diseased valve ring.

[0063] The release process of the artificial valve in the embodiment of the present invention is as follows: first, the outer tube 13 is controlled to bend, and after being adjusted into place, the outer tube 13 is fixed. At this time, the inner tube 15 is driven by the handle 2 to rotate circumferentially, and the circumferential rotation of the inner tube 15 can simultaneously drive the fixing head 14 and the sheath tube 12 to rotate in coordination, thereby adjusting the relative position of the artificial valve 3 and the native valve ring to ensure that the artificial valve 3 better fits the native valve ring. After the artificial valve 3 is adjusted circumferentially into place, the handle 2 drives the outer tube 13 to drive the sheath tube 12 to move axially toward the proximal end, and begins to release the artificial valve 3 until the artificial valve 3 is completely released to the designated position and detached from the delivery device.

[0064] Preferably, in the embodiment of the present invention, during the release process of the artificial valve, the release of the artificial valve 3 can be suspended at any time, and the circumferential rotation action of the inner tube 15 can be switched to better achieve real-time alignment and precise release of the artificial valve 3.

[0065] In summary, when the sheath 12 of the embodiment of the present invention needs to make axial movement, the outer tube 13 serves as the driving force of the sheath 12, but the fixed head 14 is fixed; and when the sheath 12 needs to make circumferential movement, the inner tube 15 serves as the driving force of the fixed head 14, and the fixed head 14 serves as the driving force of the sheath 12, driving the sheath 12 to move circumferentially, while the outer tube 13 remains stationary, thereby achieving coordinated circumferential movement of the sheath 12 and the fixed head 14, and no interference in axial movement; and the sheath 12 is driven by the outer tube 13 to move axially, but the circumferential movement is not interfered with.

[0066] In the embodiment of the present invention, the overall configuration of the delivery device remains unchanged, that is, the artificial valve can move circumferentially while the external control bend remains stationary, thereby solving the problem of accurate release of artificial valves with irregular cross-sections.

[0067] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. The present invention may be subject to various changes and improvements without departing from the spirit and scope of the present invention. These changes and improvements fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A delivery catheter for an artificial valve, characterized in that: The invention comprises an outer tube component and an inner tube component, wherein the outer tube component comprises a sheath tube (12) capable of accommodating an artificial valve (3) and an outer tube (13) fixedly connected to one end of the sheath tube (12); the inner tube component comprises an inner tube (15) and a fixing head (14) fixedly connected to the inner tube (15); the inner tube component is arranged in the cavity of the outer tube component, and a circumferential positioning fit is formed between the sheath tube (12) and the fixing head (14); the outer wall of the fixing head (14) is provided with at least one embedded section (141), and the friction force generated between the embedded section (141) and the sheath tube (12) is greater than the friction force generated between the artificial valve (3) and the sheath tube (12). The embedded section (141) comprises a first strip-shaped unit (1411) and a second strip-shaped unit (1412), and a first spring (1421) and a second spring (1422) are connected between the first strip-shaped unit (1411) and the second strip-shaped unit (1412); the delivery catheter further comprises a pull wire (142), and the pull wire (142) is arranged at a connection between the first strip-shaped unit (1411) and the second strip-shaped unit (1412) and the first spring (1421) or the second spring (1422), and the pull wire (142) passes through the inner tube (15); the inner tube (15) is a single-lumen tube or a multi-lumen tube.

2. The delivery catheter for an artificial valve according to claim 1, characterized in that: The inner wall of the sheath tube (12) and the outer wall of the fixing head (14) form a nested structure.

3. The delivery catheter for an artificial valve according to claim 2, characterized in that: The inner wall of the sheath tube (12) is provided with a protrusion or a groove, and the outer wall of the fixing head (14) is provided with a groove or a protrusion matching the protrusion or the groove on the inner wall of the sheath tube (12).

4. The delivery catheter for an artificial valve according to claim 1, characterized in that: The static friction coefficient between the embedded section (141) and the sheath tube (12) is in the range of 0.1-1.

5.

5. The delivery catheter for an artificial valve according to claim 1, characterized in that: The first strip-shaped units (1411) and the second strip-shaped units (1412) are arranged on the outer wall of the fixing head (14) in an axisymmetric distribution.

6. The delivery catheter for an artificial valve according to claim 1, characterized in that: The sheath tube (12) and the outer tube (13) are connected via a bearing or an elastic material.

7. The delivery catheter for an artificial valve according to claim 1, characterized in that: It also comprises a guide head (11) connected to the inner tube (15), wherein the guide head (11) has a streamlined outer structure.

8. The delivery catheter for an artificial valve according to claim 1, characterized in that: The outer tube (13) is a polymer tube or a composite tube of metal and polymer.

9. A delivery device for an artificial valve, characterized in that: The invention comprises a handle (2) and a delivery catheter as claimed in any one of claims 1 to 8 connected to the handle (2), wherein an outer tube movable part (21) and an inner tube movable part (22) are arranged in the handle (2), the outer tube movable part (21) is connected to the outer tube (13) to drive the outer tube (13) to move axially, and the inner tube movable part (22) is connected to the inner tube (15) to drive the inner tube (15) to rotate circumferentially.

10. The artificial valve delivery device according to claim 9, characterized in that: The handle (2) is fixedly connected to the pull wire (142).

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