Adjustable elbow of transcatheter aortic valve conveying system

Abstract

The utility model discloses an adjustable elbow of transcatheter aortic valve delivery system, which comprises an adjustable elbow body and a traction wire, the adjustable elbow body comprises an adjustable elbow outer tube, an adjustable elbow middle tube and an adjustable elbow inner tube from outside to inside, and a tubular traction wire channel is embedded between the adjustable elbow inner tube and the adjustable elbow middle tube. The traction wire channel extends in the axial direction of the adjustable elbow body, the traction wire penetrates through the traction wire channel, the far end of the traction wire is fixedly connected with the far end of the adjustable elbow body, and a first hollowed-out hole and a second hollowed-out hole which are symmetrically cut about the axis of the pipe body are formed in the pipe body at the far end of the middle pipe of the adjustable elbow. The first hollowed-out holes and the second hollowed-out holes are distributed at intervals in a staggered mode in the axial direction of the adjustable elbow middle pipe. Compared with the prior art, the middle pipe of the adjustable bent pipe adopts the pipe body with the cutting hollow hole, so that the bending direction accuracy of the adjustable bent pipe is realized, the adjustable bent pipe is not influenced by the path of the traction wire, and accurate bending adjustment is realized.

Description

Technical Field

[0001] The utility model relates to a medical device, in particular to an adjustable elbow for a transcatheter aortic valve delivery system for cardiac interventional therapy. Background Art

[0002] Transcatheter aortic valve replacement (TAVR) is a minimally invasive valve replacement surgery. Through an interventional catheter, an artificial heart valve is delivered to the position of the aortic valve, thereby completing the implantation of the artificial valve and restoring the valve function. TAVR was initially called transcatheter aortic valve implantation (TAVI). Since the implanted valve functionally replaces the original diseased valve, it is now mostly called transcatheter aortic valve replacement (TAVR). During the whole process of delivering the artificial heart valve to the expected position, in order to avoid or reduce the damage of the instrument to the blood vessels near the aortic arch during the delivery process, the assistance of an adjustable elbow is required to achieve this process, and this process especially depends on the bending performance of the adjustable elbow.

[0003] The existing adjustable elbow is tubular and consists of three layers of materials arranged coaxially. The inner layer usually uses materials such as PTFE, FEP, and ETFE; the middle layer is a reinforcing layer, usually using a coiled tube or a spring tube to ensure the strength of the adjustable elbow; the outer layer mostly uses materials such as Pebax, PA, and PVP. A channel is arranged in the pipe wall. The traction wire passes through the channel from the proximal end of the adjustable elbow and is fixed at the distal end of the adjustable elbow. Fixing the proximal end of the adjustable elbow and pulling the traction wire can achieve the bending action of the adjustable elbow. In order to achieve the expected bending result, the position of the traction wire channel must be on the same generatrix of the adjustable elbow (that is, on the outer wall of the pipe, the line segment perpendicular to the cross-section of the pipe) throughout the whole process from the beginning to the end. Otherwise, when pulling the traction wire, the adjustable elbow will have unexpected bending, deflection or even kinking, affecting the surgical effect and even causing the surgical interruption, increasing the risk to the patient. Summary of the Utility Model

[0004] The purpose of the utility model is to provide an adjustable elbow for a transcatheter aortic valve delivery system, and the technical problem to be solved is to improve the accuracy of the bending direction and the accuracy of the bending amplitude of the adjustable elbow.

[0005] To solve the above problems, the present utility model adopts the following technical solutions: An adjustable bending tube of a transcatheter aortic valve delivery system includes an adjustable bending tube body and a traction wire. The adjustable bending tube body includes an outer adjustable bending tube, an intermediate adjustable bending tube, and an inner adjustable bending tube from outside to inside. A tubular traction wire channel is embedded between the inner adjustable bending tube and the intermediate adjustable bending tube. The traction wire channel extends along the axial direction of the adjustable bending tube body. The traction wire passes through the traction wire channel, and the distal end of the traction wire is fixedly connected to the distal end of the adjustable bending tube body. On the distal tube body of the intermediate adjustable bending tube, first hollow holes and second hollow holes are symmetrically cut and arranged with respect to the axis of the tube body. The first hollow holes and the second hollow holes are arranged at intervals and staggered along the axial direction of the intermediate adjustable bending tube.

[0006] Further, the intermediate adjustable bending tube is a metal tube.

[0007] Further, a traction wire fixing ring is provided at the distal end of the adjustable bending tube body. The traction wire fixing ring is fixed on the intermediate adjustable bending tube, and the distal end of the traction wire is fixedly connected to the traction wire fixing ring.

[0008] Further, a fixing hole is provided at the distal end of the intermediate adjustable bending tube, and the distal end of the traction wire is fixedly connected to the fixing hole.

[0009] Further, the fixing hole is arranged opposite to the first hollow hole.

[0010] Further, a pre-bent section is provided at the distal end of the adjustable bending tube body.

[0011] Further, two traction wire channels are arranged in parallel. The traction wire passes through one of the traction wire channels, extends out from the distal end of this traction wire channel, then penetrates into the distal end of the other traction wire channel, and exits from the proximal end of this traction wire channel.

[0012] Further, two traction wire channels are arranged in parallel. The traction wire passes through one of the traction wire channels, extends out from the distal end of this traction wire channel, then penetrates into the distal end of the other traction wire channel, and exits from the proximal end of this traction wire channel.

[0013] Further, the inner adjustable bending tube is made of polytetrafluoroethylene material.

[0014] Further, the outer adjustable bending tube is made of nylon elastomer.

[0015] Compared with the prior art, in the present utility model, the intermediate tube of the adjustable bending tube adopts a tube body with cut-out hollow holes, realizing the precise control of the bending direction of the adjustable bending tube, making the adjustable bending tube not affected by the path of the traction wire, and achieving precise bending adjustment. Description of the Drawings

[0016] Figure 1This is the external view schematic diagram of the adjustable elbow pipe of the present utility model.

[0017] Figure 2-1 This is the structural schematic diagram of the adjustable elbow pipe of the present utility model.

[0018] Figure 2-2 is Figure 2-1 The partial enlarged view marked A.

[0019] Figure 2-3 This is the internal structural schematic diagram of the adjustable elbow pipe of the present utility model.

[0020] Figure 3 This is the structural schematic diagram of the middle pipe of the adjustable elbow pipe of the present utility model.

[0021] Figure 4 This is the structural schematic diagram of the adjustable elbow pipe of the present utility model provided with a pre-bending section. Detailed implementation manners

[0022] The present utility model will be further described in detail below with reference to the accompanying drawings and embodiments.

[0023] As Figure 1 and Figure 2-1 shown, the present utility model discloses an adjustable elbow pipe of a transcatheter aortic valve delivery system, which includes a traction wire fixing ring 6, a traction wire 1, and an adjustable elbow pipe body 11.

[0024] As Figure 2-1 , Figure 2-2 and Figure 2-3 shown, the adjustable elbow pipe body 11 is tubular, the distal end of the adjustable elbow pipe body 11 is bendable, the adjustable elbow pipe body 11 includes an adjustable elbow outer pipe 2, an adjustable elbow middle pipe 3, and an adjustable elbow inner pipe 4 from outside to inside. A tubular traction wire channel 5 is embedded between the adjustable elbow inner pipe 4 and the adjustable elbow middle pipe 3. The traction wire channel 5 extends along the axial direction of the adjustable elbow pipe body. A traction wire fixing ring 6 is provided at the distal end of the adjustable elbow pipe body. The traction wire fixing ring 6 is sleeved on the adjustable elbow middle pipe 3. The traction wire fixing ring 6 is fixedly covered on the adjustable elbow middle pipe 3 by fusion welding the adjustable elbow outer pipe 2. The traction wire 1 passes through the traction wire channel 5, and the distal end of the traction wire 1 is connected and fixed to the traction wire fixing ring 6.

[0025] In the present utility model, the adjustable elbow inner tube 4 can be made of polytetrafluoroethylene (PTFE) material. The adjustable elbow intermediate tube 3 is made of a metal tube with a certain torsional stiffness and bending resilience toughness, including but not limited to stainless steel, aluminum alloy, etc. The adjustable elbow outer tube 2 can be made of nylon elastomer (Pebax), ensuring that the traction wire 1 can move relative to the adjustable elbow when being pulled, so that the adjustable elbow can produce a bending effect. However, the present utility model is not limited thereto. The adjustable elbow outer tube 2 can be made of the same material or made of different materials in segments. The traction wire 1 and the traction wire fixing ring 6 can be connected and fixed by welding, winding or other means.

[0026] As Figure 3 shown, on the distal tube body of the adjustable elbow intermediate tube 3, a first hollowing hole 9 and a second hollowing hole 7 are provided which are symmetrically cut with respect to the tube axis of the adjustable elbow intermediate tube 3. The first hollowing hole 9 and the second hollowing hole 7 are arranged at intervals and staggered along the axial direction of the adjustable elbow intermediate tube 3 to limit the distal end of the adjustable elbow intermediate tube 3 to bend only in one plane in two opposite directions. The cutting directions of the first hollowing hole 9 and the second hollowing hole 7 are perpendicular to the axis of the adjustable elbow intermediate tube 3. The cutting width and cutting interval of the hollowing holes can be readjusted and arranged according to the bending performance to be achieved.

[0027] By using a metal tube as the base tube and making the above-mentioned adjustable elbow intermediate tube 3 on the tube body in a cutting form, the bending direction of the adjustable elbow can be limited to one plane, and it can bend in the direction of the traction wire in this plane. Also, by adjusting the hollowing width, interval density and shape of the first hollowing hole 9 and the second hollowing hole 7, the bending position, bending angle, bending feedback sensitivity and other bending performances of the adjustable elbow under the action of external force can be changed. In this way, the adjustable elbow body has bending selectivity. When a pulling force is applied to the traction wire, the distal end of the adjustable elbow body bends, and the hollowing holes can limit the adjustable elbow body to bend only in the direction with the hollowing holes and on the side where the traction wire is fixed, improving the accuracy of the bending direction and the accuracy of the bending amplitude of the adjustable elbow.

[0028] Of course, the present utility model can also adopt not to set the traction wire fixing ring 6, and set a fixing hole 8 at the distal end of the adjustable elbow intermediate tube 3 to replace the function of the traction wire fixing ring 6 (as Figure 3 shown). The traction wire 1 passes through the traction wire channel 5 and is connected and fixed to the fixing hole 8 at the distal end of the adjustable elbow intermediate layer 3. The fixing hole 8 is arranged opposite to the first hollowing hole 9.

[0029] As Figure 2-2As shown, in the present utility model, two traction wire channels 5 can be arranged in parallel. The traction wire 1 passes through one of the traction wire channels 5, extends out from the distal end of this traction wire channel 5, then penetrates into the distal end of the other traction wire channel 5, and exits from the proximal end of this traction wire channel 5. Using two traction wire channels can wrap the entire traction wire as much as possible, reducing the exposed part of the traction wire, thereby ensuring a smaller frictional force during the use of the traction wire.

[0030] As Figure 4 shown, the adjustable bent pipe body 11 of the present utility model can also be pre-bent at the distal end of the adjustable bent pipe body 11 so that the distal end of the adjustable bent pipe body forms a pre-bent section 10, realizing that the adjustable bent pipe body is default in a bent state. Here, the structure of the adjustable bent pipe body can be composed of the above-mentioned three-layer structure of the adjustable bent pipe outer tube 2, the adjustable bent pipe middle tube 3, and the adjustable bent pipe inner tube 4, and the traction wire 1 uses a metal guide wire 12. During use, the bent pipe body can be made straight again by inserting the metal guide wire 12, and the bending degree of the pipe body can be adjusted according to the depth of the metal guide wire inserted into the bent pipe, thereby meeting the surgical requirements for the bending performance. The metal guide wire 12 is arranged on the inner side of the bending direction of the pre-bent section 10.

[0031] With a more precise bending direction and bending angle, the present utility model enables the delivery system to reach the designated position more easily, reducing the number of attempts required to place the valve, thereby avoiding possible blood vessel injuries caused thereby. At the same time, it greatly reduces the time required to deliver the valve and shortens the operation time.

Claims

1. An adjustable elbow tube of a transcatheter aortic valve delivery system, comprising an adjustable elbow tube body (11) and a traction wire (1), characterized in that: The adjustable bend pipe body (11) comprises, from outside to inside, an adjustable bend pipe outer tube (2), an adjustable bend pipe middle tube (3), and an adjustable bend pipe inner tube (4); a tubular traction wire channel (5) is embedded between the adjustable bend pipe inner tube (4) and the adjustable bend pipe middle tube (3); the traction wire channel (5) extends along the axial direction of the adjustable bend pipe body; the traction wire (1) passes through the traction wire channel (5); the distal end of the traction wire (1) is connected and fixed to the distal end of the adjustable bend pipe body (11); a first hollow hole (9) and a second hollow hole (7) are provided on the distal end of the adjustable bend pipe middle tube (3) which are symmetrically cut and arranged with respect to the axis of the pipe body; the first hollow hole (9) and the second hollow hole (7) are arranged alternately and spaced along the axial direction of the adjustable bend pipe middle tube (3).

2. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 1, characterized in that: The adjustable elbow intermediate pipe (3) is a metal pipe.

3. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 2, characterized in that: The distal end of the adjustable bend pipe body (11) is provided with a traction wire fixing ring (6), the traction wire fixing ring (6) is fixed on the adjustable bend intermediate pipe (3), and the distal end of the traction wire (1) is connected and fixed to the traction wire fixing ring (6).

4. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 1, characterized in that: The distal end of the adjustable elbow intermediate tube (3) is provided with a fixing hole (8), and the distal end of the traction wire (1) is connected and fixed to the fixing hole (8).

5. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 4, characterized in that: The fixing hole (8) is arranged opposite to the first hollow hole (9).

6. The adjustable elbow of the transcatheter aortic valve delivery system according to any one of claims 1 to 5, characterized in that: The distal end of the adjustable bending pipe body (11) is provided with a pre-bending section (10).

7. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 6, characterized in that: Two traction wire channels (5) are arranged in parallel. The traction wire (1) passes through one of the traction wire channels (5), extends from the distal end of the traction wire channel (5), enters from the distal end of the other traction wire channel (5), and passes out from the proximal end of the traction wire channel (5).

8. The adjustable elbow of the transcatheter aortic valve delivery system according to any one of claims 1 to 5, characterized in that: Two traction wire channels (5) are arranged in parallel. The traction wire (1) passes through one of the traction wire channels (5), extends from the distal end of the traction wire channel (5), enters from the distal end of the other traction wire channel (5), and passes out from the proximal end of the traction wire channel (5).

9. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 1, characterized in that: The adjustable elbow inner tube (4) is made of polytetrafluoroethylene material.

10. The adjustable elbow of the transcatheter aortic valve delivery system according to claim 1, characterized in that: The outer tube (2) of the adjustable elbow is made of nylon elastomer.

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