A device for prosthetic valve implantation

Abstract

The application discloses a device for artificial valve implantation and belongs to the technical field of medical instruments. The device for artificial valve implantation comprises a guide part, the front end of the guide part is provided with a conical guide head, and the tip of the guide head is an arc-shaped smooth structure; the side wall of the guide part is provided with a first pressure sensor and a second pressure sensor, the first pressure sensor and the second pressure sensor are arranged along the axial direction of the guide part, and the first pressure sensor is located adjacent to the guide head. The above scheme can solve the problem that the device for transcatheter aortic valve implantation mainly depends on the experience of an operator and the judgment of a position in an intraoperative imaging, thereby leading to inaccurate positioning of a valve implantation, especially in the case that an aortic valve is seriously calcified, an anatomic structure is complex or a valve ring is inclined, which can easily lead to inaccurate positioning of the valve, and further cause complications such as perivalvular leakage, valve deviation or insufficient implanting depth.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a device for artificial valve implantation. BACKGROUND

[0002] Aortic valve stenosis (AS) is one of the most common heart valve diseases, especially in the elderly population, the incidence increases significantly; its main pathological process includes valve leaflet calcification, fibrosis, and stenosis of the valve orifice, eventually leading to excessive load on the left ventricle, heart failure, and even sudden death. The traditional treatment is open chest surgical aortic valve replacement (SAVR), but it is traumatic and has a long recovery time, which is not suitable for high-risk patients with age or underlying diseases.

[0003] With the development of minimally invasive medical technology, in the late 20th century, the medical community proposed transcatheter aortic valve implantation (TAVI, Transcatheter Aortic Valve Implantation), which does not require thoracotomy, and through the femoral artery, carotid artery or apical path, the artificial valve is delivered to the aortic valve position and released, replacing the original dysfunctional valve; TAVI significantly reduces postoperative mortality and complication rates, and has become a core minimally invasive method for AS treatment.

[0004] However, the guide wire and valve delivery system of the existing transcatheter aortic valve implantation device mainly rely on the experience of the operator and the position judgment of intraoperative angiography, which is difficult to ensure the accuracy of valve positioning, especially in the case of severe calcification of the aortic valve, complex anatomical structure or existence of valve ring deflection, etc. It is easy to cause inaccurate positioning of the valve, and further cause complications such as paravalvular leakage, valve migration or insufficient implantation depth. SUMMARY

[0005] The present application discloses a device for artificial valve implantation to solve the problem that the current transcatheter aortic valve implantation device mainly relies on the experience of the operator and the position judgment of intraoperative angiography, which leads to inaccurate positioning of the valve, especially in the case of severe calcification of the aortic valve, complex anatomical structure or existence of valve ring deflection, etc. It is easy to cause inaccurate positioning of the valve, and further cause complications such as paravalvular leakage, valve migration or insufficient implantation depth.

[0006] In order to solve the above problems, the present application adopts the following technical scheme:

[0007] The device for artificial valve implantation comprises a guide part, the front end of the guide part is provided with a conical guide head, and the tip of the guide head is an arc-shaped smooth structure; the side wall of the guide part is provided with a first pressure sensor and a second pressure sensor, the first pressure sensor and the second pressure sensor are arranged along the axial direction of the guide part, and the first pressure sensor is located adjacent to the guide head.

[0008] Optionally, the guide head is provided with an ultrasonic sensor, and the ultrasonic sensor is connected with a surgical control terminal for ultrasonic imaging of intraoperative tissue structures.

[0009] Optionally, the guide part is a hollow tubular structure, and the hollow lumen of the guide part is used for wiring arrangement of the first pressure sensor, the second pressure sensor and the ultrasonic sensor connected with the surgical control terminal; or the guide part is a solid tubular structure, and the line for connecting the first pressure sensor, the second pressure sensor and the ultrasonic sensor with the surgical control terminal is embedded in the inside of the guide part.

[0010] Optionally, the tail end of the guide head is circumferentially provided with a plurality of elastic legs, the elastic legs are used for cooperating with the artificial valve carried by the push tube; when the artificial valve is in a folded state, the elastic legs abut against the front outer surface of the artificial valve, and when the artificial valve is fully unfolded, the artificial valve is expanded to be separated from the elastic legs.

[0011] Optionally, the elastic leg is provided with a protrusion towards the inner side of the push tube, and the shape of the protrusion is arranged as an arc or a triangular structure.

[0012] Optionally, the number of the protrusions is at least two, and the protrusions are distributed at intervals along the length direction of the elastic leg.

[0013] Optionally, the guide head is a structural member made of a medical flexible material, the elastic leg is a structural member made of a memory alloy material, and is coated with a layer of medical flexible material.

[0014] Optionally, the tail end face of the guide head is provided with an annular groove surrounding the guide part, the inner diameter of the annular groove is matched with the outer diameter of the guide part, the outer diameter of the annular groove is matched with the outer diameter of the front section of the push tube, and the annular groove is used for embedding cooperation with the front end of the push tube.

[0015] Optionally, the inner side wall of the annular groove and the outer wall of the front section of the push tube are respectively provided with an annular clamping groove and an annular convex rib, and the annular clamping groove and the annular convex rib are limitingly matched.

[0016] The technical scheme adopted by the present application can achieve the following beneficial effects:

[0017] The device for artificial valve implantation disclosed in the present application, by the first pressure sensor and the second pressure sensor arranged in the guide part, after the guide head crosses the valve, since the left ventricular pressure is greater than the aortic pressure, when the first pressure sensor crosses the valve with the continuous advancement of the guide part, a pressure difference will be generated with the second pressure sensor, and the advancement of the guide part is stopped when the first pressure sensor and the second pressure sensor generate the pressure difference, and the front section of the push tube is limited by the conical structure of the guide part, thereby realizing the positioning of the artificial valve and ensuring the accuracy of the implantation positioning; therefore, compared with the current most systems which rely on the experience of the operator to judge the position of the valve ring according to DSA, TEE or preoperative CT, the present application realizes the active positioning function of the device itself, which not only improves the accuracy of positioning, especially in complex cases such as severe calcification and valve ring anatomical variation, can solve the problem that the positioning and release position of the valve is difficult to accurately control, but also provides the possibility for the automatic positioning research and development of the system device. BRIEF DESCRIPTION OF DRAWINGS

[0018] The accompanying drawings, which are included to provide a further understanding of the present application and are incorporated in and constitute a part of this application, illustrate embodiments of the present application and together with the description serve to explain the present application. In the drawings:

[0019] Figure 1 It is a structural schematic view of the guide part disclosed in the embodiments of the present application;

[0020] Figure 2 It is a side view of Figure 1 ;

[0021] Figure 3 It is a structural schematic view of the cooperation between the guide head and the front section of the push tube disclosed in the embodiments of the present application; Figure 2

[0022] Figure 4 It is a structural schematic view of the cooperation between the guide head and the front section of the push tube disclosed in the embodiments of the present application;

[0023] BRIEF DESCRIPTION OF DRAWINGS

[0024] 100-guide part, 101-first pressure sensor, 102-second pressure sensor, 110-guide head, 111-elastic leg, 112-annular groove, 113-protrusion, 200-push tube, 201-annular convex rib, 210-artificial valve. DETAILED DESCRIPTION

[0025] ​In order to make the objects, technical solutions and advantages of the present application clearer, the technical solutions of the present application will be described below in connection with specific embodiments of the present application and corresponding drawings. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0026] The technical solutions disclosed in the various embodiments of the present application will be described in detail below in connection with the drawings.

[0027] Please refer to Figures 1 to 4 As shown in the drawings, the embodiments of the present application disclose a device for artificial valve implantation, the disclosed device for artificial valve implantation comprises a guide part 100, the front end of the guide part 100 is provided with a conical guide head 110, and the tip of the guide head 110 is a smooth structure with an arc shape; the side wall of the guide part 100 is provided with a first pressure sensor 101 and a second pressure sensor 102, the first pressure sensor 101 and the second pressure sensor 102 are arranged along the axial direction of the guide part 100, and the first pressure sensor 101 is located near the guide head 110.

[0028] Among them, through the first pressure sensor 101 and the second pressure sensor 102 arranged on the guide part 100, after the guide head 110 crosses the valve, since the left ventricular pressure is greater than the aortic pressure, as the guide part 100 continues to advance, the first pressure sensor 101 will cross the valve and generate a pressure difference with the second pressure sensor 102, and the advancement of the guide part 100 will be stopped when the first pressure sensor 101 and the second pressure sensor 102 generate a pressure difference, and the front segment of the push tube 200 is limited by the conical guide part 100, thereby realizing the positioning of the artificial valve 210 and ensuring the accuracy of the implantation positioning.

[0029] Therefore, compared with the current most systems which rely on the experience of the operator to judge the position of the valve ring according to DSA, TEE or preoperative CT, the present application realizes the active positioning function of the device itself, which not only improves the accuracy of positioning, especially in complex cases such as severe calcification and valve ring anatomical variation, and can solve the problem of difficult accurate control of the positioning and release position of the valve, but also provides the possibility for the automatic positioning research and development of the system device.

[0030] Meanwhile, in order to provide visual feedback for the operator during the operation, an ultrasonic sensor can also be arranged on the guide head 110 and connected with the operation control terminal, so that during the operation, the image of the tissue structure such as the valve and the annulus can be collected in real time through ultrasonic imaging to avoid the influence of blood and the like, and the operator can be assisted to judge the valve alignment, the annulus position and the anchoring quality, etc., to provide visual operation for the release action, so as to better ensure the operation effect and even provide the possibility for the subsequent device system to automatically identify the release development according to the ultrasonic imaging.

[0031] It is easy to understand that, as shown in Figure 3 In the embodiment, the guide part 100 can be a hollow tubular structure, so that the hollow lumen of the guide part 100 can provide convenience for the wiring arrangement of the first pressure sensor 101, the second pressure sensor 102 and the ultrasonic sensor connected with the operation control terminal.

[0032] Of course, as other embodiments, the guide part 100 can also be designed as a solid tubular structure, and the first pressure sensor 101, the second pressure sensor 102 and the line of the ultrasonic sensor connected with the operation control terminal are buried in the inside of the guide part 100.

[0033] In the device for artificial valve implantation disclosed in the embodiment, as shown in Figure 1 and Figure 4 A plurality of elastic legs 111 can be arranged circumferentially at the tail end of the guide head 110, and the elastic legs 111 are used to cooperate with the artificial valve 210 carried by the push tube 200; when the artificial valve 210 is in a folded state, the elastic legs 111 abut against the front outer surface of the artificial valve 210, and when the artificial valve 210 is completely unfolded, the artificial valve 210 is expanded to separate from the elastic legs 111; the elastic legs 111 are structural members with one end fixed and the other end as a flexible free end.

[0034] Based on the structure of the elastic legs 111 of the guide head 110, a damping effect can be formed during the unfolding and releasing process of the artificial valve 210, so as to improve the hand feeling of the operator during the release operation; especially, the elastic legs 111 always maintain contact with the outer side surface of the artificial valve 210 before the artificial valve 210 is completely unfolded, so that the operator can perform pre-release on the artificial valve 210, and if the release position is not ideal, the artificial valve 210 can be folded back under the elastic recovery force of the elastic legs 111, so as to adjust the release position of the artificial valve 210.

[0035] Preferably, as shown in Figure 4As shown, the elastic leg 111 can be provided with two protrusions 113 or grooves towards the inner side of the push tube 200, and spaced along the length direction of the elastic leg 111, so that through the protrusions 113 or grooves provided on the elastic leg 111, during the expansion of the artificial valve 210, the sliding process of the artificial valve 210 expanding the elastic leg 111, the protrusions 113 or grooves can play a certain limiting effect, and through the protrusions 113 or groove structure, there is a strong damping feeling, which is conducive to the multi-stage control of the expansion release of the artificial valve 210; and the shape of the protrusions 113 or grooves is provided in an arc or triangular structure, which can not only limit the pre-release of the expansion of the artificial valve 210, but also avoid completely blocking the expansion release of the artificial valve 210.

[0036] It should be noted that the number of protrusions 113 or grooves is not limited in the present embodiment, and can be increased or decreased according to the clinical use requirements; at the same time, the guide head 110 is a structural member made of polyimide material and other medical flexible materials, so as to conform to the aortic arch and valve orifice curvature; the elastic leg 111 is a structural member made of memory alloy material, and is coated with a layer of polyimide material and other medical flexible materials, which not only ensures the elastic effect of the elastic leg 111, but also ensures the safety.

[0037] The device for artificial valve implantation disclosed in the present embodiment can also include a push tube 200, wherein the push tube 200 is used to carry the artificial valve 210, move the artificial valve along the guide part 100 to the target position, and realize the expansion release control of the artificial valve 210 at the target position through the balloon of the push tube 200.

[0038] At the same time, the push tube 200 can also be provided with an operation handle and a traction line, and the bending and axis angle of the push tube 200 can be controlled and adjusted by pulling the traction line provided on the push tube 200 through the operation handle, so as to control the coaxial alignment of the artificial valve 210 and the valve ring; since the push tube 200 belongs to the prior art, the structure and implementation manner thereof will not be described in detail in the present embodiment, and the specific can be referred to the prior art disclosed in the patents with the patent numbers of "202110801252.4" and "202280020414.3".

[0039] In order to improve the cooperation operation effect of the guide part 100 and the push tube 200, the guide part 100 can be provided with a plurality of guide grooves 112, and the push tube 200 can be provided with a plurality of protrusions 113. Figure 3 and Figure 4As shown, the tail end face of the guide head 110 can also be provided with an annular groove 112 surrounding the guide part 100, the inner diameter of the annular groove 112 is adapted to the outer diameter of the guide part 100, and the outer diameter of the annular groove 112 is adapted to the outer diameter of the front section of the push tube 200. In this way, when the front section of the push tube 200 is pushed along the guide part 100 to the guide head 110, the front section of the push tube 200 can be embedded in the annular groove 112 of the guide head 110. When adjusting the axis angle of the push tube 200, the guide part 100 can be synchronously adjusted adaptively, thereby better ensuring the coaxiality of the guide head 110, the guide part 100 and the push tube 200 to further ensure the accuracy of the release position of the artificial valve 210.

[0040] Preferably, the inner side wall of the annular groove 112 and the outer wall of the front section of the push tube 200 can also be respectively provided with an annular clamping groove and an annular convex rib 201. In this way, the limiting cooperation of the annular clamping groove and the annular convex rib 201 can better improve the reliability of the embedded cooperation of the guide head 110 and the front section of the push tube 200, facilitate the synchronous operation of the push tube 200 and the guide part 100, and ensure the coaxiality of the guide head 110, the guide part 100 and the push tube 200.

[0041] The above embodiments of the present application mainly describe the differences between the embodiments, and the different optimization features of the embodiments can be combined to form a better embodiment without contradiction. In view of the brevity of the text, the details are not repeated here.

[0042] The above only describes the embodiments of the present application and is not intended to limit the present application. The present application can be variously changed and modified by those skilled in the art. Any modification, equivalent replacement, improvement, etc. within the spirit and principles of the present application shall be included in the scope of the claims of the present application.

Claims

1. A device for implanting an artificial valve, characterized in that, The device includes a guide section, the front end of which is provided with a conical guide head, the tip of which has a smooth, arc-shaped structure; the sidewall of the guide section is provided with a first pressure sensor and a second pressure sensor, which are arranged along the axial direction of the guide section, with the first pressure sensor located near the guide head; the tail end of the guide head is provided with a plurality of elastic legs along the circumferential direction, which are used to cooperate with the artificial valve mounted on the push tube; when the artificial valve is in a folded state, the elastic legs abut against the front outer surface of the artificial valve; when the artificial valve is fully unfolded, the artificial valve opens and disengages from the elastic legs.

2. The device for artificial valve implantation according to claim 1, characterized in that, The guide head is equipped with an ultrasound sensor, which is connected to the surgical control terminal for intraoperative ultrasound imaging of tissue structures.

3. The device for artificial valve implantation according to claim 2, characterized in that, The guide section is a hollow tubular structure, and the hollow cavity of the guide section is used for the wiring arrangement of the first pressure sensor, the second pressure sensor, and the ultrasound sensor to the surgical control terminal; or, the guide section is a solid tubular structure, and the wiring of the first pressure sensor, the second pressure sensor, and the ultrasound sensor to the surgical control terminal is buried inside the guide section.

4. The device for implantation of an artificial valve according to any one of claims 1 to 3, characterized in that, The elastic support leg has a protrusion or groove on the inner side facing the push tube, and the protrusion or groove is shaped as an arc or a triangle.

5. The device for artificial valve implantation according to claim 4, characterized in that, The number of protrusions is at least two, and they are spaced apart along the length of the elastic support leg.

6. The device for artificial valve implantation according to claim 5, characterized in that, The guide head is a structural component made of medical flexible material, and the elastic support leg is a structural component made of shape memory alloy material and covered with a medical flexible material layer.

7. The device for implantation of an artificial valve according to any one of claims 1 to 3, characterized in that, The tail end face of the guide head is provided with an annular groove surrounding the guide part, and the inner diameter of the annular groove is adapted to the outer diameter of the guide part, and the outer diameter of the annular groove is adapted to the outer diameter of the front section of the push tube. The annular groove is used to embed and cooperate with the front end of the push tube.

8. The device for artificial valve implantation according to claim 7, characterized in that, The inner sidewall of the annular groove and the outer sidewall of the front section of the push tube are respectively provided with an annular groove and an annular protrusion, and the annular groove and the annular protrusion are matched for limiting.

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