Graft for repairing or replacing autologous valve of heart

Abstract

The invention relates to the technical field of grafts of autologous valves, in particular to a graft of an autologous valve for repairing or replacing a heart, which comprises a valve frame, a compensation suture ring, a base body and a valve, the compensation suture ring comprises a body and a compensation body, the body is fixedly mounted on the base body, one end of the compensation body is mounted on the body, and the valve is fixedly mounted on the body. The other end of the compensation body is mounted above the base body; the problems that an existing graft for repairing or replacing the autologous valve of the heart is prone to incomplete attachment in the operation process, gaps are generated, and readjustment is needed, so that the operation difficulty is high, the time is long, damage to the heart of a patient is easily increased, and the operation risk is increased are solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of autografts for repairing or replacing heart native valve, in particular to an autograft for repairing or replacing heart native valve. BACKGROUND

[0002] The existing autografts for repairing or replacing heart native valve are mainly artificial mechanical valves, biological valves and allografts, among which, mechanical valves are usually chosen by young patients to avoid secondary surgery caused by time decay of biological valves due to their super-long durability and stability.

[0003] However, the existing mechanical valves or biological valves are prone to cause gaps between the autografts and the heart tissue during the surgery due to the limitations of preoperative static assessment on dynamic organs and individual differences or personal factors of the doctors, thereby forming paravalvular leakage, and the doctors need to readjust the autografts, which not only increases the difficulty of the surgery but also prolongs the surgery time and increases the damage to the patient's heart, significantly increasing the risk of surgery.

[0004] For example, the Chinese invention patent with the application number "202010401941.1" and the name "autograft for repairing or replacing heart native valve" has a radially extending flange on the atrial side of the second covered stent in the expanded state, which is suitable for being located on the atrial side of the valve ring, and the end diameter of the atrial side of the second covered stent is larger than that of the ventricular side. The autograft adopts a double-layer stent structure, which can increase the anchoring force, improve the stability, and reduce the occurrence of paravalvular leakage and left ventricular outflow tract obstruction. However, the patent technology cannot avoid the readjustment of the autograft during the surgery, and it is still prone to cause high difficulty, long time, easy to increase the damage to the patient's heart and increase the risk of surgery.

[0005] Therefore, the present application provides an autograft for repairing or replacing heart native valve to solve the above problems. SUMMARY

[0006] The technical problem to be solved by the present application is that the existing autografts for repairing or replacing heart native valve are prone to cause gaps during the surgery and need to be readjusted, thereby causing high difficulty, long time, easy to increase the damage to the patient's heart and increase the risk of surgery.

[0007] The present application provides the following technical solution: an autograft for repairing or replacing heart native valve, comprising a valve frame, a compensation suture ring, a base body and a valve, the compensation suture ring comprising a body and a compensation body, the body being fixedly installed on the base body, one end of the compensation body being installed on the body, and the other end of the compensation body being installed above the base body.

[0008] The compensation bodies are installed along the circumference direction of the body, and are provided as multiple groups with replaceable and different sizes.

[0009] The compensation body has an L-shaped structure in cross section, and includes an extension body at one end of the base body, and the end of the extension body abuts against the valve.

[0010] The base body is fixedly installed with a limiting body above, and the end of the extension body is fixedly installed with a blocking body.

[0011] The compensation body includes an inclined body at one end of the body, and the surface where the body and the compensation body are attached is an inclined surface structure.

[0012] The extension body is provided with a through slot, and a sliding body is slidingly installed in the through slot, and the sliding body is provided as multiple groups with different lengths and replaceable.

[0013] The extension body is provided with a fixed slot, and the surface of the sliding body is fixedly installed with a clamping body.

[0014] The inner surface of the base body is provided with a groove, and a horizontal body is slidingly installed in the extension body, and the horizontal body penetrates through the extension body and is located inside the through slot.

[0015] The beneficial effects of the present application are as follows: 1、The present application can select and replace multiple groups of compensation bodies with different sizes to seal the gap during the operation, so that the artificial heart valve does not need to be adjusted or reinstalled, thereby reducing the difficulty of the operation and shortening the operation time, which is beneficial to reduce the stimulation to the heart and reduce the risk of the operation; at the same time, when the closing angle and position of the valve are adjusted during the operation, different sizes of sliding bodies can be selected and installed to abut against the adjusted valve, so as to prevent the valve from exceeding the original active position due to structural damage or constraint failure, and to enhance the stability of use.

[0016] 2、In the present application, the compensation body is fixed by the cooperation of the blocking body and the limiting body, and when the sliding body is installed in the through slot, the horizontal body is also extruded to move and insert into the groove, so as to fix the compensation body, and when the sliding body is pulled out and away from the through slot, the inclined horizontal body also leaves the groove to release the fixation of the compensation body, so as to improve the fixity of the compensation body through the mortise and tenon structure, and enhance the stability during use. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the specific embodiments or the prior art of the present application, the following will briefly introduce the drawings needed to be used in the specific embodiments or prior art description. Obviously, the drawings described below are some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort based on these drawings.

[0018] Figure 1 It is a schematic diagram of the overall structure of the present application. Figure 2 It is a schematic diagram of the front view of the present application. Figure 3 It is a schematic diagram of the enlarged structure of A in the present application. Figure 2 Figure 4 It is a schematic diagram of the top view of the present application.

[0019] In the figure: 1, compensation suture ring; 11, body; 12, compensation body; 121, extension body; 122, blocking body; 123, inclined body; 124, through slot; 125, sliding body; 126, fixing slot; 127, clamping body; 128, groove; 129, horizontal body; 2, base body; 21, limiting body; 3, valve. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below in combination with the drawings. Obviously, the described embodiments are some of the embodiments of the present application, not all the embodiments. Therefore, the following detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but only represents some embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative effort belong to the scope of protection of the present application.

[0021] It should be noted that: similar reference numbers and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

[0022] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", "back" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship when the product of the present application is usually placed. Such terms are only for the convenience of describing the present application and simplifying the description, and are not intended to indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.​

[0023] It should be noted that in the description of the present application, unless otherwise explicitly specified and limited, the terms "arrangement", "installation", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be connected inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0024] On the basis of the technical problems that the existing graft for repairing or replacing the autologous valve of the heart is prone to incomplete fitting to produce gaps during the operation process and needs to be adjusted again, thereby causing high difficulty and long time of the operation, and easily increasing the damage to the heart of the patient and increasing the risk of the operation, the present disclosure provides a graft for repairing or replacing the autologous valve of the heart, comprising a valve frame, a compensation suture ring 1, a base body 2 and a valve 3, the compensation suture ring 1 comprises a body 11 and a compensation body 12, the body 11 is fixedly installed on the base body 2, and one end of the compensation body 12 is installed on the body 11, and the other end of the compensation body 12 is installed above the base body 2.

[0025] It should be noted that the valve frame can adopt any valve 3 support that can be used in the prior art.

[0026] The base body 2 is sutured on the valve frame, the valve 3 is rotatably installed in the base body 2, the body 11 of the compensation suture ring 1 is sutured on the base body 2, and in addition, any fixation method that can be used in the prior art can be used.

[0027] The compensation body 12 is fixed on the body 11 in a detachable and replaceable manner, so that when the artificial valve 3 does not fit tightly with the surface of the heart to produce gaps due to improper operation during the operation process of repairing or replacing the autologous valve 3 of the heart, the gaps are plugged by detaching and replacing the compensation body 12, so that the artificial heart valve 3 does not need to be adjusted or reinstalled, thereby reducing the difficulty of the operation and shortening the operation time, which is beneficial to reduce the stimulation to the heart and reduce the risk of the operation.

[0028] The compensation body 12 is installed in multiple along the circumferential direction of the body 11, and the compensation body 12 is provided in multiple groups in replaceable and different sizes.

[0029] The plurality of compensation bodies 12 in the circumferential direction can be individually disassembled and replaced, so as to compensate for the position and fill the gap for any position area, thereby improving the flexibility during installation and use, and facilitating the avoidance of the gap leading to paravalvular leakage. The plurality of groups with different sizes can improve the adaptability during replacement, so as to replace and block the corresponding size compensation body 12 for different size gaps, thereby improving the adaptability and portability during use.

[0030] It should be noted that the compensation body 12 can be equally divided into any number in the circumferential direction, which is not described here.

[0031] The cross section of the compensation body 12 is L-shaped structure, and the compensation body 12 located at one end of the base body 2 includes an extension body 121, and the end of the extension body 121 abuts against the valve 3.

[0032] The compensation body 12 with L-shaped cross section can be fixed on the base body 2 by clamping the extension body 121, thereby improving the fixing performance and facilitating the stability of the use state, and the end of the extension body 121 can abut against the surface of the valve 3 during fixing, thereby limiting the position of the valve 3 during closing, avoiding the valve 3 exceeding the original active position due to the damage or constraint failure of the artificial heart valve 3 structure during long-term use, thereby facilitating the stability of the valve 3 during long-term use.

[0033] The base body 2 is fixedly installed with a limiting body 21, and the end of the extension body 121 is fixedly installed with a blocking body 122.

[0034] When disassembling and replacing the compensation body 12, the compensation body 12 is inserted or pulled out along the base body 2 in the axial direction, so that the blocking body 122 and the limiting body 21 relatively move until dislocation, thereby realizing the fixation of the compensation body 12 or the release of the fixation, and then completing the installation or disassembly and replacement of the compensation body 12. The cooperation of the blocking body 122 and the limiting body 21 can ensure that the compensation body 12 is stably installed on the base body 2.

[0035] It should be noted that the blocking body 122 and the limiting body 21 are made of any material that can be implanted in the heart in the prior art, and in the embodiment of the present disclosure, the autologous valve 3 tissue is used.

[0036] The compensation body 12 located at one end of the body 11 includes an inclined body 123, and the surface of the body 11 and the compensation body 12 is an inclined surface structure.

[0037] In the process of installing the compensator 12, the inclined body 123 of the compensator 12 is lowered along the inclined surface structure and increasingly fits the surface of the heart, thereby gradually fitting through the guidance of the inclined surface, thereby enhancing the fitting of the compensator 12 and the heart tissue through the guidance of the inclined surface structure, and facilitating to ensure the stability in the use state and prevent paravalvular leakage.

[0038] The extension body 121 is provided with a through groove 124, and the sliding body 125 is installed in the through groove 124, and the sliding body 125 is provided in multiple groups with different lengths and is replaceable.

[0039] The compensator 12 is provided with any number of sliding bodies 125 in the circumferential direction, and the two sliding bodies 125 are installed on the two symmetric compensators 12 in the embodiment of the present disclosure.

[0040] In use, the sliding body 125 can be located in the through groove 124 and abut against the surface of the valve 3, thereby avoiding the structure damage or constraint failure of the artificial heart valve 3 in long-term use, so that the valve 3 exceeds the original active position, thereby facilitating to ensure the stability of the closed valve 3 in long-term use.

[0041] Due to the dynamic physiological state and individual differences, the preoperative static evaluation cannot simulate the intraoperative state, so it is necessary to accurately adjust the closing angle and position of the valve 3 in the valve 3 during the operation.

[0042] When adjusting the closing angle and position of the valve 3 in the artificial heart valve 3 during the operation, the sliding body 125 with different lengths is replaced by disassembling, and the adjusted valve 3 is abutted, thereby improving the adaptability of the adjusted valve 3 closing angle and position through the multiple groups of sliding bodies 125 with different lengths and replaceable, and facilitating to improve the adaptability to abut against the valve 3 in the use state, prevent the structure damage or constraint failure of the valve 3 from exceeding the original active position.

[0043] The extension body 121 is provided with a fixing groove 126, and the sliding body 125 is fixedly installed with a clamping body 127 on the surface.

[0044] In the process of installing or replacing the sliding body 125, the sliding body 125 is moved into the through groove 124, and the clamping body 127 is clamped into the fixing groove 126 in the process of moving the sliding body 125, thereby fixing the sliding body 125 through the clamping of the clamping body 127 and the fixing groove 126.

[0045] It should be noted that the clamping body 127 can adopt any material that can be implanted into the heart in the prior art, such as synthetic high polymer material polyether ether ketone and polyurethane.

[0046] The inner surface of the base 2 is provided with a groove 128, and the extension body 121 is slidably provided with a cross body 129, which penetrates the extension body 121 and is located inside the through groove 124.

[0047] During the installation of the sliding body 125, the sliding body 125 is moved in the through groove 124, and the sliding body 125 extrudes the cross body 129, so that the cross body 129 is moved and inserted into the groove 128 to fix the compensation body 12, so as to fix the compensation body 12 while replacing the sliding body 125 which limits the valve 3 at different closing positions and angles, thereby improving the stability during installation.

[0048] The compensation body 12 provided with the sliding body 125 is fixedly provided with a side body on both sides of the upper circumference, and the rest of the compensation body 12 is provided with a side groove on one side in the circumferential direction and is fixedly provided with a side body on the other side. The side bodies on both sides of the compensation body 12 provided with the sliding body 125 are clamped into the side groove, and the side bodies of the rest of the compensation body 12 are clamped into the side groove of the adjacent compensation body 12, so as to complete the fixation of all the compensation bodies 12, thereby ensuring that all the compensation bodies 12 remain stable during use.

[0049] The cross body 129 is provided in an inclined structure and the lower end is close to the sliding body 125, and the upper surface of the end close to the sliding body 125 is inclined.

[0050] After the sliding body 125 is moved away from the through groove 124 in the lying state of the operator during the operation, the cross body 129 of the inclined structure can be automatically slid into the through groove 124 to release the fixation of the compensation body 12.

[0051] It should be noted that the cross body 129 is fixedly provided with a side body, and the distance of the cross body 129 sliding into the through groove 124 can be controlled through the side body, so as to prevent the cross body 129 from completely entering the through groove 124 to block the installation of the sliding body 125.

[0052] In actual use: In the implantation operation of repairing or replacing the heart autologous valve 3, when the improper operation of the operator causes the artificial valve 3 to not closely adhere to the surface of the heart to generate a gap, the operator selects a compensation body 12 with a suitable size according to the current gap to replace, so as to block the gap to avoid paravalvular leakage caused by the gap, and the artificial heart valve 3 does not need to be adjusted or reinstalled, thereby reducing the operation difficulty and shortening the operation time, which is beneficial to reduce the stimulation to the heart and reduce the operation risk.

[0053] In the process of replacing the compensator 12, the original compensator 12 needs to be disassembled first, that is, the slide body 125 is pulled out to make the clamping body 127 leave the fixing groove 126 and make the horizontal body 129 slide into the through groove 124 through the inclined groove 128, so as to release the fixing of the compensator 12, and then the operator pulls out the compensator 12 to make the limiting body 21 and the blocking body 122 relatively move until dislocation, so as to release the fixing of the compensator 12.

[0054] After pulling out the slide body 125 and releasing the fixing of the compensator 12, a suitable compensator 12 is selected according to the size of the current gap for replacement and installation.

[0055] In the process of installing the compensator 12 with a suitable size, the compensator 12 is first inserted axially along the base body 2, so that the blocking body 122 and the limiting body 21 relatively move until dislocation, so as to fix or release the compensator 12, and at the same time, the end gradually fits the surface of the heart through the inclined surface structure. After inserting the compensator 12, the slide body 125 is inserted along the through groove 124 until the clamping body 127 is located in the fixing groove 126 for fixing, and in the process of moving the slide body 125 in the through groove 124, the horizontal body 129 is pressed, so that the horizontal body 129 is inserted into the groove 128 to fix the compensator 12, so as to fix the compensator 12 while replacing the slide body 125 for limiting the valve 3 at different closing positions and angles, which is beneficial to improve the stability during installation.

[0056] In the operation, when the closing angle and position of the valve 3 are adjusted due to dynamic physiological state and individual difference, the operator pulls out the slide body 125 and selects a suitable slide body 125 for installation according to the adjusted closing angle and position of the valve 3.

[0057] In the process of pulling out the slide body 125, the flexible clamping body 127 is first pulled out by applying force to one end of the slide body 125 and leaving the fixing groove 126, and then the slide body 125 gradually moves away from the through groove 124 for replacement. After the slide body 125 leaves the through groove 124, the inclined horizontal body 129 slides away from the groove 128 due to its own weight. After the operator pulls out the slide body 125, a suitable slide body 125 is selected to be reinserted into the through groove 124 and the clamping body 127 is inserted into the fixing groove 126 for fixing, and in the process of sliding the slide body 125 in the through groove 124, the slide body 125 presses the horizontal body 129 and makes the horizontal body 129 enter the groove 128 to fix the compensator 12, so as to fix the compensator 12 while replacing the slide body 125 for limiting the valve 3 at different closing positions and angles, which is beneficial to improve the stability during installation.

[0058] After replacing the compensator 12 and the slide body 125, the subsequent operation continues until the operation is completed.

[0059] Those skilled in the art should understand that the present application is not limited by the above-mentioned embodiments, the above-mentioned embodiments and descriptions in the specification are only to illustrate the principles of the present application, and various changes and improvements can be made to the present application without departing from the spirit and scope of the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. A graft for repairing or replacing an autologous heart valve, comprising a valve frame, a compensating suture ring (1), a base (2), and a valve (3), characterized in that: The compensating suture ring (1) includes a body (11) and a compensating body (12). The body (11) is fixedly installed on the base (2). One end of the compensating body (12) is installed on the body (11), and the other end of the compensating body (12) is installed above the base (2).

2. The graft for repairing or replacing an autologous heart valve according to claim 1, characterized in that: Multiple compensators (12) are installed along the circumference of the body (11), and the compensators (12) are configured as multiple sets of replaceable and different sizes.

3. The graft for repairing or replacing an autologous heart valve according to claim 2, characterized in that: The cross-section of the compensator (12) is L-shaped. One end of the compensator (12) located on the base (2) includes an extension body (121), and the end of the extension body (121) abuts against the valve (3).

4. A graft for repairing or replacing an autologous heart valve according to claim 3, characterized in that: A limiting body (21) is fixedly installed above the base (2), and a stop (122) is fixedly installed at the end of the extension body (121).

5. A graft for repairing or replacing an autologous heart valve according to claim 4, characterized in that: The compensator (12) is located at one end of the body (11) and includes an inclined body (123). The side of the body (11) and the compensator (12) that are in contact is an inclined structure.

6. A graft for repairing or replacing an autologous heart valve according to claim 5, characterized in that: The extension body (121) has a through groove (124) inside, and a slide body (125) is slidably installed in the through groove (124). The slide body (125) is configured as multiple sets of different lengths that can be replaced.

7. A graft for repairing or replacing an autologous heart valve according to claim 6, characterized in that: The extension body (121) has a fixing groove (126) inside, and the slide body (125) has a clip (127) fixedly installed on its surface.

8. A graft for repairing or replacing an autologous heart valve according to claim 7, characterized in that: The inner surface of the substrate (2) is provided with a groove (128), and a horizontal body (129) is slidably installed in the extension body (121). The horizontal body (129) penetrates the extension body (121) and is located inside the through groove (124).

9. A graft for repairing or replacing an autologous heart valve according to claim 8, characterized in that: The groove (128) is an inclined structure with its lower horizontal end close to the slide body (125), and the upper surface of the horizontal body (129) near the slide body (125) is an inclined surface.

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