Ventricular connection mechanism and ventricular assist system

Abstract

A ventricular connection mechanism (1) and a ventricular assist system. The ventricular connection mechanism (1) comprises a suture ring (10) and a clamping assembly (20). The suture ring (10) is provided with an accommodating hole (13) allowing an inlet pipe of a ventricular assist device to pass through, and a first annular groove (111) surrounding the accommodating hole (13) is provided in the suture ring (10), to divide the suture ring (10) into a sealing portion (15) surrounding the accommodating hole (13) and a suture portion (14) surrounding the first annular groove (111); and the clamping assembly (20) comprises a clamping ring (21), wherein at least part of the clamping ring (21) is embedded in the first annular groove (111), the clamping ring (21) is sleeved on the sealing portion (15), the clamping ring (21) clamps the inlet pipe by means of the sealing portion (15), and the inner diameter of the clamping ring (21) is adjustable, so as to adjust the tightness of the sealing portion (15) clamping the inlet pipe.

Description

Ventricular connection mechanism and ventricular assist system

[0001] This application claims priority to the Chinese patent application No. 202311858924.0 filed with the China Patent Office on December 30, 2023, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the field of medical device technology, and in particular to a ventricular connection mechanism and a ventricular assist system. Background Art

[0003] Ventricular assist devices (VADs) assist the heart in pumping blood and are commonly used in the treatment of cardiovascular disease. During VAD implantation, a ventricular attachment mechanism is typically used to secure the VAD to the heart tissue. However, conventional VADs are prone to blood leakage after blood pump installation, requiring improvement. Summary of the Invention

[0004] Based on this, the present application provides a ventricular connection mechanism and a ventricular assist system that can achieve 360° sealing of the inlet tube along the circumferential direction, avoid the formation of a gap between the sealing part and the inlet tube, and reduce the chance of blood leakage.

[0005] An embodiment of the first aspect of the present application provides a ventricular connection mechanism, the ventricular connection mechanism comprising:

[0006] a sewing ring, the sewing ring being provided with a receiving hole for the inlet tube of the ventricular assist device to pass through, the sewing ring being provided with a first annular groove surrounding the receiving hole to separate the sewing ring into a sealing portion surrounding the receiving hole and a sewing portion surrounding the first annular groove; and

[0007] The clamping assembly includes a clamping ring, at least a portion of which is embedded in the first annular groove, and the clamping ring is sleeved on the sealing portion. The clamping ring clamps the inlet pipe through the sealing portion, and the inner diameter of the clamping ring is adjustable to adjust the tightness of the sealing portion clamping the inlet pipe.

[0008] An embodiment of the second aspect of the present application provides a ventricular assist system, which includes a ventricular assist device and the above-mentioned ventricular connection mechanism. The ventricular assist device includes an inlet tube, which is inserted into the accommodating hole.

[0009] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will become apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments or descriptions of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0011] FIG1 is a schematic structural diagram of the ventricular connection mechanism provided in this application from one perspective.

[0012] FIG. 2 is an exploded view of the ventricular connection mechanism shown in FIG. 1 from a different perspective.

[0013] FIG3 is a schematic structural diagram of the sewing ring of the ventricular connection mechanism shown in FIG1 .

[0014] FIG. 4 is a top view of the ventricular connection mechanism shown in FIG. 1 .

[0015] FIG5 is a cross-sectional view of the ventricular connection mechanism shown in FIG4 along direction II.

[0016] FIG6 is a partial enlarged view of point A in FIG5 .

[0017] FIG. 7 is a schematic back view of a sewing ring according to an embodiment.

[0018] FIG8 is another partial enlarged view of point A in FIG5.

[0019] FIG9 is a schematic structural diagram of the clamping ring and locking assembly of the ventricular connection mechanism shown in FIG1 .

[0020] FIG10 is a schematic structural diagram of the fixing ring of the ventricular connection mechanism shown in FIG1 .

[0021] FIG11 is a cross-sectional view of the ventricular connection mechanism shown in FIG1 in an exploded state.

[0022] FIG12 is a partial enlarged view of point B in FIG6 .

[0023] FIG13 is a schematic structural diagram of another ventricular connection mechanism provided in this application.

[0024] FIG14 is a partial enlarged view of point C in FIG13 .

[0025] FIG15 is a schematic structural diagram of the ventricular connection mechanism shown in FIG13 from another perspective. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solutions and advantages of this application more clearly understood, the following further describes this application in detail with reference to the accompanying drawings, i.e., embodiments. It should be understood that the specific embodiments described herein are only used to explain this application and are not intended to limit this application.

[0027] It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or indirectly connected to the other element.

[0028] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. Throughout the description of this application, "plurality" means two or more, unless otherwise specifically defined.

[0029] In order to illustrate the technical solution of the present application, the following description is given with reference to specific drawings and embodiments.

[0030] During blood pump implantation surgery, a ventricular connection mechanism is typically used to securely mount the blood pump to the heart. Specifically, the ventricular connection mechanism is fixed to the outer wall of the heart, and the blood pump's inlet tube passes through the ventricular connection mechanism and extends into the ventricle, where it is then locked securely in place. The inventors of this application have discovered that with conventional ventricular connection mechanisms, there is a risk of blood leaking from the openings in the annular disk. Furthermore, the thickness of conventional ventricular connection mechanisms increases the risk of contact between the ventricular assist device installed within the ventricular connection mechanism and other organs within the chest cavity.

[0031] In order to improve at least some of the above problems, the present application provides a ventricular connection mechanism and a ventricular assist system. By setting the sewing ring to a structure with a sealing portion surrounding the inner hole, a clamping ring is arranged on the outer periphery of the sealing portion, so that the sealing portion can be sealed and fitted with the inlet tube, thereby achieving 360° sealing of the inlet tube along the circumference of the sewing ring by using a sewing ring with a specific structure, thereby reducing the chance of blood leakage. In addition, the sewing ring also has a suture portion surrounding the outer periphery of the sealing portion. By providing an annular groove surrounding the inner hole on the sewing ring, the sewing ring is divided into a sealing portion surrounding the accommodating hole and a suture portion of the annular groove, so as to avoid increasing the axial thickness of the sewing ring caused by providing the sealing portion on the surface of the sewing ring, so that the sealing portion and the suture portion at least partially overlap in the axial direction of the sewing ring, reducing the thickness of the sewing ring along the axial direction of the sewing ring, thereby reducing the height of the ventricular assist device protruding from the outer surface of the heart after being installed in the heart, and further reducing the risk of the ventricular assist device contacting other organs in the chest cavity. Therefore, the ventricular connection mechanism of the present application can reduce the probability of blood leakage at the connection between the ventricular connection mechanism and the inlet tube of the ventricular assist device while minimizing the increase in thickness of the ventricular connection mechanism. The ventricular connection mechanism and ventricular assist system provided by the present application are described in detail below in conjunction with the specific embodiments and the drawings in the specification.

[0032] 1 to 4 , an embodiment of the present application provides a ventricular connection mechanism 1 for fixing a ventricular assist device to cardiac tissue. The ventricular connection mechanism 1 includes a sewing ring 10 and a clamping assembly 20 .

[0033] The sewing ring 10 is used to secure to cardiac tissue. Specifically, the sewing ring 10 has a receiving hole 13 for the inlet tube of the ventricular assist device to pass through. The sewing ring 10 also has a first annular groove 111 surrounding the receiving hole 13, thereby separating the sewing ring 10 into a sealing portion 15 surrounding the receiving hole 13 and a sewing portion 14 surrounding the first annular groove 111.

[0034] The clamping assembly 20 includes a clamping ring 21, at least a portion of which is embedded in the first annular groove 111, and the clamping ring 21 is sleeved on the outer periphery of the sealing portion 15, and the clamping ring 21 clamps the inlet pipe through the sealing portion 15. The inner diameter of the clamping ring 21 is adjustable, that is, the clamping ring 21 can be retracted radially inwardly under the action of an external force to adjust its inner diameter, so as to adjust the tightness of the sealing portion 15 clamping the inlet pipe. The radial direction of the clamping ring 21 refers to the radius or diameter direction of the clamping ring 21. In this embodiment, the clamping ring 21 is completely embedded in the first annular groove 111. In other embodiments, the clamping ring 21 can also be partially located in the first annular groove 111, and the other part can be located outside the first annular groove 111 and protrude from the surface of the sewing ring 10.

[0035] The ventricular connection mechanism 1 is constructed by providing a receiving hole 13 in the sewing ring 10 for the inlet tube of the ventricular assist device to pass through, and providing a first annular groove 111 in the sewing ring 10 surrounding the receiving hole 13 to form a sealing portion 15 surrounding the receiving hole 13. Furthermore, at least a portion of a clamping ring 21 is embedded in the first annular groove 111, so that the clamping ring 21 is positioned around the outer periphery of the sealing portion 15. Thus, by adjusting the inner diameter of the clamping ring 21, the diameter of the receiving hole 13 can be reduced, thereby adjusting the tightness with which the sealing portion 15 grips the inlet tube, ensuring a tight fit between the sealing portion 15 and the inlet tube. This achieves a 360° seal around the circumference of the sewing ring 10, preventing any gaps between the sealing portion 15 and the inlet tube, and reducing the risk of blood leakage. The circumference of the sewing ring 10 refers to the circumferential direction of the sewing ring 10.

[0036] At least a portion of the clamping ring 21 is embedded in the first annular groove 111 defined in the sewing ring 10, such that the clamping ring 21 and the sewing ring 10 at least partially overlap along the axial direction of the sewing ring 10. This reduces the thickness of the ventricular connection mechanism 1 at the sewing ring 10, thereby reducing the height of the ventricular assist device protruding from the outer surface of the heart after installation, thereby reducing the risk of contact between the ventricular assist device and other organs within the chest cavity. In this embodiment, the axial direction of the sewing ring 10 refers to the direction that coincides with the extension direction of the central axis of the sewing ring 10.

[0037] Please refer to Figures 1 and 3. The material of the sewing ring 10 can be a soft gel with good biocompatibility, such as silicone, so that the sewing ring 10 can fit the heart tissue easily and the suture thread can easily pass through the sewing ring 10. Furthermore, the ventricular connection mechanism 1 can also include a sewing cloth (not shown), which is covered on the surface of the sewing ring 10 and the clamping ring 21 to make the sewing ring 10 and the clamping ring 21 more tightly combined. Furthermore, the suture thread passes through the sewing cloth and the suture portion 14 of the sewing ring 10 and is sutured to the heart tissue, thereby fixing the ventricular connection mechanism 1 to the heart tissue. Preferably, the material of the sewing cloth is a textile fabric, such as polyester cloth.

[0038] Continuing with Figures 1 and 2, the sewing ring 10 comprises a top surface 141 and a bottom surface 142 facing away from the top surface 141. The bottom surface 142 is configured to conform to the outer wall of the heart. A first annular groove 111 is exposed on the top surface 141; that is, the first annular groove 111 is formed by the top surface 141 being recessed toward the bottom surface 142. The first annular groove 111 is an annular groove structure. The first annular groove 111 is disposed around the outer circumference of the sealing portion 15, and at least a portion of the clamping ring 21 is embedded in the first annular groove 111. This provides a tighter connection between the clamping ring 21 and the sewing ring 10. Compared to conventional methods of suturing the clamping ring and the sewing ring, embedding at least a portion of the clamping ring 21 in the first annular groove 111 minimizes the gap between the clamping ring 21 and the sewing ring 10, which could lead to blood leakage, during the pulling process when the sewing ring is sutured to the heart.

[0039] Referring to Figures 5 and 6, the first annular groove 111 has a groove bottom surface 1112, and a first axial spacing G1 is defined between the groove bottom surface 1112 and the suture top surface 141. The clamping ring 21 has a ring top surface 214 facing away from the groove bottom surface 1112, and a second axial spacing G2 is defined between the ring top surface 214 and the groove bottom surface 1112. In this embodiment, the second axial spacing G2 is less than or equal to the first axial spacing G1, that is, the clamping ring 21 does not bulge outward after being installed in the first annular groove 111, so that the thickness of the suture ring 10 is the same as the thickness of the ventricular connection mechanism 1 at the suture ring 10, further reducing the overall axial height of the suture ring 10 and the risk of the ventricular assist device contacting other organs in the chest cavity. The axial spacings in both the first axial spacing G1 and the second axial spacing G2 refer to the distance along the axial direction of the suture ring 10.

[0040] Referring to Figures 7 and 8, in one embodiment, the sewing ring 10 further comprises a second annular groove 121. The first annular groove 111 and the second annular groove 121 are disposed on opposite sides of the sewing ring 10, i.e., the second annular groove 121 is exposed on the sewing bottom surface 142. The second annular groove 121 is an annular groove structure, and the first annular groove 111 and the second annular groove 121 correspond to and are spaced apart along the axial direction of the sewing ring 10. The axial spacing between the first annular groove 111 and the second annular groove 121 along the sewing ring 10 means that a certain thickness of soft rubber is disposed between the bottom surfaces of the first annular groove 111 and the second annular groove 121, i.e., the two bottom surfaces are not connected. The second annular groove 121 corresponds to the first annular groove 111 along the axial direction of the sewing ring 10, which means that the orthographic projection of the edge of the second annular groove 121 on the sewing top surface 141 is located within the first annular groove 111, or the orthographic projection of the edge of the first annular groove 111 on the sewing bottom surface 142 is located within the second annular groove 121, wherein the orthographic projection refers to the projection along the axial direction of the sewing ring 10.

[0041] By opening a second annular groove 121 corresponding to the position of the first annular groove 111 on the sewing bottom surface 142, the thickness of the sewing ring 10 at the position corresponding to the first annular groove 111 can be reduced, which is beneficial to improving the elastic deformation ability of the sealing part 15, making it easier for the sealing part 15 to retract under the clamping action of the clamping ring 21, facilitating the sealing fit between the sealing part 15 and the inlet pipe, and avoiding the situation where the sealing part 15 cannot retract.

[0042] In this embodiment, the depth of the second annular groove 121 is d, and the minimum distance between the bottom surfaces 1112 of the first annular groove 111 and 1212 of the second annular groove 121 is t. That is, the sewing ring 10 has a minimum thickness t at the first annular groove 111, where: 0.2 ≤ d / t ≤ 0.4. This ensures the connection strength between the sealing portion 15 and the suture portion 14 while allowing the sealing portion 15 to retract more easily under the clamping action of the clamping ring 21, making it easier for medical personnel to operate the clamping ring 21 to clamp the inlet tube of the ventricular assist device. When d / t is less than 0.2, the depth of the second annular groove 121 is too small, or the thickness of the sewing ring 10 at the corresponding position of the first annular groove 111 is too thick, which is not conducive to the retraction of the sealing part 15; when d / t is greater than 0.4, the depth of the second annular groove 121 is too large, or the thickness of the sewing ring 10 at the corresponding position of the first annular groove 111 is too thin, which easily leads to the breakage of the connection between the sealing part 15 and the sewing part 14.

[0043] Referring to Figure 9, in one embodiment, the clamping assembly 20 further comprises two connecting arms connected to the clamping ring 21. The two connecting arms can be moved closer or further apart to adjust the inner diameter of the clamping ring 21. Each connecting arm comprises a support and an extension. The support extends axially along the clamping ring 21, one end of the support being connected to the clamping ring 21, and the extension extends radially away from the clamping ring 21 from the end of the support distal to the clamping ring 21. The extension is used to connect with a locking component or to be grasped by an operator using a hand or tool to adjust the distance between the two connecting arms, thereby adjusting the inner diameter of the clamping ring 21.

[0044] Specifically, in the illustrated embodiment, the clamping ring 21 has an opening 213 extending along the circumference of the clamping ring 21, and a first end 211 and a second end 212 forming the opening 213. The first end 211 and the second end 212 are disposed opposite each other along the circumference of the clamping ring 21, and are spaced apart from each other to form the opening 213. The inner diameter of the clamping ring 21 can be adjusted by adjusting the size of the opening 213. Two connecting arms are fixedly connected to the first end 211 and the second end 212, respectively. The circumferential direction of the clamping ring 21 refers to the circumferential direction of the clamping ring 21, and in this embodiment, the circumferential direction of the clamping ring 21 coincides with the circumferential direction of the sewing ring 10.

[0045] In this embodiment, the two connecting arms are respectively a first connecting arm 221 and a second connecting arm 222 , wherein the first connecting arm 221 is fixedly connected to the first end 211 , and the second connecting arm 222 is fixedly connected to the second end 212 .

[0046] The first connecting arm 221 includes a first pillar 2213 and a first extension portion 2214. The first pillar 2213 is connected between the first end 211 and the first extension portion 2214. The first pillar 2213 extends axially along the clamping ring 21. The first extension portion 2214 extends from the end of the first pillar 2213 away from the first end 211 along the radial direction of the clamping ring 21 toward the direction away from the clamping ring 21.

[0047] The second connecting arm 222 includes a second pillar 2223 and a second extension portion 2224, the second pillar 2223 is connected between the second end 212 and the second extension portion 2224, the second pillar 2223 extends along the axial direction of the clamping ring 21, and the second extension portion 2224 extends from the second pillar 2223 away from the second end 212 along the radial direction of the clamping ring 21 toward away from the clamping ring 21.

[0048] 3 and 9 , in one embodiment, a first escape groove 143 is defined on the suture portion 14. The first escape groove 143 is in communication with the first annular groove 111 and is exposed on the suture top surface 141. The ends of the two connecting arms' struts connected to the clamping ring 21 are received in the first escape groove 143, while the extensions are located outside the first escape groove 143. Specifically, the ends of the first strut 2213 and the second strut 2223 connected to the clamping ring 21 are received in the first escape groove 143, while the first extension 2214 and the second extension 2224 are both located outside the first escape groove 143, facilitating connection with the locking component or for an operator to grasp by hand or with a tool. In this embodiment, the first pillar 2213 and the second pillar 2223 both extend along the axial direction of the sewing ring 10 in a direction away from the sewing bottom surface 142, and the first extension portion 2214 and the second extension portion 2224 are spaced a distance from the sewing portion 14 in the axial direction of the sewing ring 10, thereby avoiding the first connecting arm 221 and the second connecting arm 222 from colliding with the sewing portion 14 when the clamping ring 21 retracts, that is, when the first connecting arm 221 and the second connecting arm 222 approach each other, to ensure that the clamping ring 21 can smoothly retract along the radial direction of the clamping ring 21.

[0049] 3 , 6 and 8 , the sealing portion 15 is a substantially annular structure. The inner circumference of the sealing portion 15 is the wall of the accommodating hole 13 , and the outer circumference of the sealing portion 15 is the wall of the first annular groove 111 close to the accommodating hole 13 .

[0050] Furthermore, the outer circumference of the sealing portion 15 is provided with a first flange 152 extending radially outward from the sealing portion 15. The first flange 152 is an annular structure, spaced apart from the groove bottom surface 1112 of the first annular groove 111, and forms a first slot 155. At least a portion of the clamping ring 21 is disposed in the first slot 155 between the first flange 152 and the groove bottom surface 1112 of the first annular groove 111. Specifically, the inner circumference of the clamping ring 21 is provided with a first step 23. The first step 23 is an annular structure and protrudes radially inward from the clamping ring 21. The first step 23 is inserted into and engaged with the first slot 155. That is, the first step 23 abuts between the first flange 152 and the groove bottom surface 1112. In other words, at least a portion of the first step 23 is received in the first slot 155, and the first step 23 is clamped between the first flange 152 and the groove bottom surface 1112. In this way, the first flange 152 can limit the clamping ring 21 from the axial direction of the sewing ring 10, thereby enhancing the connection strength between the sewing ring 10 and the clamping ring 21 and preventing the clamping ring 21 from separating from the sewing ring 10 during operation.

[0051] Furthermore, the sealing portion 15 defines a notch 151, the position of which corresponds to the position of the opening 213 of the clamping ring 21. The notch 151 corresponding to the position of the opening 213 of the clamping ring 21 means that the width of the notch 151 is greater than the width of the opening 213, and the edge of the opening 213 is located within the edge of the notch 151 along the radial extension of the clamping ring 21; or, the width of the opening 213 is greater than the width of the notch 151, and the edge of the notch 151 is located within the edge of the opening 213 along the radial extension of the clamping ring 21; or, the width of the opening 213 is equal to the width of the notch 151.

[0052] The position of the notch 151 corresponds to the position of the opening 213 of the clamping ring 21, and the notch 151 is arranged on the side of the sealing portion 15 facing away from the accommodating hole 13, so that when the inner diameter of the clamping ring 21 is reduced, the sealing portion 15 at the notch 151 can be deformed toward the accommodating hole 13, thereby avoiding the outward deformation of the position of the sealing portion 15 corresponding to the notch 151, which causes a gap problem between the sewing ring 10 and the inlet tube of the ventricular assist device, thereby ensuring the sealing performance of the sewing ring 10 on the inlet tube and further reducing the risk of bleeding.

[0053] In this embodiment, the notch 151 is provided on the first flange 152 and extends along the circumference of the sewing ring 10. The notch 151 axially penetrates the first flange 152 on opposite sides of the first flange 152. The axial direction of the first flange 152 coincides with the axial direction of the sewing ring 10. In other embodiments, when the sealing portion 15 lacks the first flange 152, the notch 151 may alternatively be provided on the annular wall of the sealing portion 15, suffice being provided on the side of the sealing portion 15 facing away from the receiving hole 13.

[0054] Please refer to Figures 4, 10 and 11. In one embodiment, the ventricular connection mechanism 1 further includes a fixing ring 40. The fixing ring 40 is disposed on the sewing ring 10. The fixing ring 40 can be clamped by a clamp (not shown) so that the clamp can clamp the ventricular connection mechanism 1.

[0055] The fixing ring 40 includes a ring body 41 and a protruding buckle 42. The ring body 41 is an annular structure that is fixed to the sewing ring 10 and surrounds the clamping ring 21. The protruding buckle 42 is provided on the ring body 41 and protrudes from the ring body 41 to be clamped by the clamp, so that the clamp can firmly clamp the ventricular connection mechanism 1, thereby facilitating the implantation of the ventricular assist device.

[0056] The buckle 42 includes a main body 421 and a protrusion 422. The main body 421 is connected to the top end of the ring body 41 and extends axially along the ring body 41. The top end of the ring body 41 refers to the end of the ring body 41 facing away from the groove bottom surface 1112 of the first annular groove 11. The axial direction of the ring body 41 aligns with the axial direction of the sewing ring 10. The protrusion 422 is connected to the end of the main body 421 facing away from the ring body 41 and protrudes outward from the main body 421 in the radial direction of the clamping ring 21. The protrusion 422 is configured to engage with the clamp to enhance the secure grip of the ventricular connection mechanism 1. In the illustrated embodiment, the main body 421 is a rectangular columnar structure, and the protrusion 422 is a circular arc-shaped protrusion. In other embodiments, the main body 421 may also be a cylindrical structure, and the protrusion 422 may be a triangular protrusion, without limitation.

[0057] In this embodiment, there are multiple protrusions 42, each spaced apart along the circumference of the ring body 41. The circumference of the ring body 41 is the circumferential direction of the ring body 41. Furthermore, the multiple protrusions 42 are evenly spaced along the circumference of the ring body 41, meaning that the central angles between adjacent protrusions 42 are equal. For example, in one embodiment, the ring body 41 is provided with five protrusions 42, and the central angles between adjacent protrusions 42 are 72°. This ensures that the force applied to the retaining ring 40 is more evenly distributed when the clamp is clamped. In another embodiment, the multiple protrusions 42 can also be unevenly spaced along the circumference of the ring body 41, meaning that the central angles between adjacent protrusions 42 are unequal. This is not a limitation here.

[0058] In other embodiments, the number of the protrusion 42 can also be one, and the protrusion 42 can be annular and can be clamped by the clamp, thereby facilitating the implantation of the ventricular assist device. In other embodiments, the number of the protrusion 42 can also be two, and the two protrusions 42 can be roughly semi-annular.

[0059] In one embodiment, the buckle 42 and the ring body 41 are integrally formed, for example, by injection molding, to increase the connection strength between the buckle 42 and the ring body 41. In another embodiment, the buckle 42 can be fixed to the top of the ring body 41 by welding or gluing.

[0060] Referring to Figures 5 and 11 , in this embodiment, the ring body 41 of the fixing ring 40 and the clamping ring 21 are both mounted within the first annular groove 111. This eliminates the need for a separate groove in the suture area outside the first annular groove 111 to accommodate the ring body 41. This ensures the width of the suture area of ​​the suture portion 14, facilitating the surgeon's attachment of the suture portion 14 to the heart. Furthermore, since both the ring body 41 of the fixing ring 40 and the clamping ring 21 are mounted within the first annular groove 111, eliminating the need for a separate groove and simplifying the manufacturing process of the ventricular connection mechanism 1.

[0061] In other embodiments, the ring body 41 of the fixing ring 40 and the clamping ring 21 can be installed in different positions so that the installation of the ring body 41 and the clamping ring 21 do not affect each other, thereby facilitating the installation of the ring body 41 and the clamping ring 21. For example, the clamping ring 21 is installed in the first annular groove 111, and the ring body 41 is fixed to the suture top surface 141. Alternatively, the ring body 41 is fixed in another groove different from the first annular groove 111, as long as it can be clamped by the clamp.

[0062] In this embodiment, the ring body 41 is disposed in the first annular groove 111 and sleeved outside the clamping ring 21 , and the protruding buckle 42 extends along the axial direction of the ring body 41 and protrudes outside the first annular groove 111 .

[0063] Furthermore, the first annular groove 111 further includes a groove side surface 1114. This side surface 1114 is located on one side of the groove bottom surface 1112 and faces the sealing portion 15. The groove side surface 1114 is spaced apart from and opposite to the sealing portion 15. The groove side surface 1114 forms the inner circumferential surface of the suture portion 14. A second flange 24 is provided on the outer circumference of the clamping ring 21. The second flange 24 extends from the outer circumference of the clamping ring 21 toward the groove side surface 1114. The second flange 24 is an annular structure and is disposed around the first step 23. The second flange 24 extends in a direction opposite to that of the first step 23, that is, toward the ring body 41 of the fixing ring 40.

[0064] The second flange 24 is spaced from the bottom surface 1112 of the first annular groove 111 to form a second slot 241. The ring body 41 of the fixing ring 40 is disposed between the second flange 24 and the groove side surface 1114. The inner circumference of the fixing ring 40 is further provided with a second step 43. In this embodiment, the second step 43 is an annular structure.

[0065] The second step 43 is inserted and engaged with the second slot 241. That is, the second step 43 abuts between the second flange 24 and the bottom surface 1112 of the first annular groove 111. In other words, the second step 43 is at least partially received in the second slot 241 and is clamped between the second flange 43 and the bottom surface 1112 of the first annular groove 111. In this way, the second flange 24 can limit the position of the retaining ring 40 in the axial direction of the sewing ring 10, allowing the clamping ring 21 to press the retaining ring 40 into the first annular groove 111, thereby strengthening the connection between the retaining ring 40 and the sewing ring 10 and preventing the retaining ring 40 from separating from the sewing ring 10 during operation. In one embodiment, the protruding buckle 42, the ring body 41, and the second step 43 are integrally formed.

[0066] Please refer to FIG. 7 , FIG. 8 and FIG. 12 . The clamping ring 21 further has a connecting portion 25 . The connecting portion 25 connects the first step 23 and the second flange 24 . The connecting portion 25 , the first step 23 and the second flange 24 together form the clamping ring 21 .

[0067] The second step 43 includes a step surface 431 , a step side surface 432 and a chamfered surface 433 . The step surface 431 faces away from the groove bottom surface 1112 , the step side surface 432 faces away from the groove side surface 1114 , and the chamfered surface 433 connects the step surface 431 and the step side surface 432 .

[0068] In this embodiment, the included angle α1 between the chamfered surface 433 and the stepped surface 431 is greater than 90°, and the included angle α2 between the chamfered surface 433 and the stepped side surface 432 is greater than 90°. The height H1 of the chamfered surface 433 along the axial direction of the retaining ring 40 is greater than the height H2 of the stepped side surface 431 along the axial direction of the retaining ring 40 to avoid the connection portion 25. The axial direction of the retaining ring 40 is aligned with the axial direction of the sewing ring 10. This allows the first step 23 of the clamping ring 21 to fit into the first slot 155 ( FIG. 3 ), preventing the clamping ring 21 from colliding with the retaining ring 40 during installation and facilitating installation of the clamping ring 21 after the retaining ring 40 is already installed.

[0069] Please continue to refer to Figures 3, 9 and 10. Furthermore, the ring body 41 is provided with a second avoidance groove 412, and the second avoidance groove 412 passes through the inner and outer sides of the ring body 41 along the radial direction of the clamping ring 21, and the second avoidance groove 412 is correspondingly connected to the first avoidance groove 143, and the first connecting arm 221 and the second connecting arm 222 are also arranged in the second avoidance groove 412. In this way, the first connecting arm 221 and the second connecting arm 222 are avoided from colliding with the fixing ring 40 when they approach each other, thereby ensuring that the clamping ring 21 can smoothly retract inward along the radial direction of the clamping ring 21.

[0070] Referring to Figures 13 to 15 , in one embodiment, the ventricular connection mechanism 1 optionally further comprises a locking assembly 50, which is capable of driving the first connecting arm 221 and the second connecting arm 222 toward or away from each other. When the locking assembly 50 drives the first connecting arm 221 toward the second connecting arm 222, the clamping ring 21 retracts. This retraction of the clamping ring 21 reduces the diameter of the accommodating hole 13, thereby allowing the sealing portion 15 to seal against the inlet tube. That is, the inner wall of the sealing portion 15 is in close contact with the outer wall of the inlet tube.

[0071] The locking assembly 50 includes a fixed base 51, a movable base 52, and a locking member 53. The fixed base 51 is connected to the first connecting arm 221, and the movable base 52 is connected to the second connecting arm 222. The movable base 52 and the fixed base 51 move in conjunction with each other. One end of the locking member 53 is connected to the fixed base 51, and the other end of the locking member 53 selectively connects to or disconnects from the movable base 52. The fixed base 51 and the movable base 52 are respectively connected to the extensions of the two connecting arms. Specifically, the fixed base 51 and the movable base 52 are respectively connected to the first extension 2214 of the first connecting arm 221 and the second extension 2224 of the second connecting arm 222.

[0072] Specifically, one end of the locking member 53 is rotatably connected to the fixed seat 51, and the other end of the locking member 53 is provided with a snap-fitting portion 531. The movable seat 52 is provided with a curved surface 512, and the snap-fitting portion 531 is used to cooperate with the curved surface 512 of the movable seat 52. When the locking member 53 is driven to rotate relative to the fixed seat 51, the snap-fitting portion 531 contacts the curved surface 512 of the movable seat 52 and pushes the movable seat 52 to move closer to the fixed seat 51, thereby driving the second connecting arm 222 to move closer to the first connecting arm 221, thereby causing the clamping ring 21 to retract radially. After the clamping ring 21 retracts into place to clamp the inlet pipe, the snap-fitting portion 531 engages with the curved surface 512 of the movable seat 52 to maintain the clamping ring 21 in the retracted state. It is understandable that there are many other ways in which the locking assembly 50 can drive the first connecting arm 221 and the second connecting arm 222 to approach each other, which are not limited to the above-mentioned embodiments and are not described in detail here.

[0073] In one embodiment, the first connecting arm 221 and the fixing seat 51 can be fixed by welding or bonding. As shown in Figure 15, one of the first connecting arm 221 and the fixing seat 51 is provided with a first protrusion 2211, and the other is provided with a first groove 511. The first protrusion 2211 is embedded in the first groove 511, so that the first connecting arm 221 and the fixing seat 51 are connected. On this basis, the first connecting arm 221 and the fixing seat 51 can also be fixed by welding or bonding. In this embodiment, the end of the first connecting arm 221 is provided with a first protrusion 2211, and the fixing seat 51 is provided with a first groove 511. Since the first protrusion 2211 is embedded in the first groove 511, the first groove 511 has a certain limiting effect on the first protrusion 2211, thereby improving the connection strength between the first connecting arm 221 and the fixing seat 51. It is understandable that in other embodiments, the first protrusion 2211 may also be provided on the fixing base 51 , and correspondingly, the first groove 511 may be provided on the first connecting arm 221 , thereby also increasing the connection strength between the first connecting arm 221 and the fixing base 51 .

[0074] Furthermore, the first connecting arm 221 has a first inclined surface 2212 facing away from the first end 211. The first inclined surface 2212 is arranged at an angle relative to the extension direction of the first connecting arm 221. The first inclined surface 2212 cooperates with the surface of the fixing seat 51 facing the clamping ring 21. Specifically, the first inclined surface 2212 contacts and cooperates with the fixing seat 51, and the first connecting arm 221 is then connected and fixed to the fixing seat 51 by welding or bonding. The contact and cooperation between the first inclined surface 2212 and the fixing seat 51 can increase the contact area between the first connecting arm 221 and the fixing seat 51, thereby further strengthening the connection between the first connecting arm 221 and the fixing seat 51.

[0075] In one embodiment, the second connecting arm 222 and the movable seat 52 can be fixed by welding or bonding. As shown in Figure 15, one of the second connecting arm 222 and the movable seat 52 is provided with a second protrusion 2221, and the other is provided with a second groove 521. The second protrusion 2221 is embedded in the second groove 521, so that the second connecting arm 222 is connected to the movable seat 52. On this basis, the second connecting arm 222 and the movable seat 52 can also be fixed by welding or bonding. In this embodiment, the end of the second connecting arm 222 is provided with a second protrusion 2221, and the movable seat 52 of the locking assembly 50 is provided with a second groove 521. The second protrusion 2221 is embedded in the second groove 521, so that the second groove 521 has a certain limiting effect on the second protrusion 2221, thereby improving the connection strength between the second connecting arm 222 and the movable seat 52. It is understandable that in other embodiments, the second protrusion 2221 may also be provided on the movable seat 52 , and correspondingly, the second groove 521 may be provided on the second connecting arm 222 , which can also enhance the connection strength between the second connecting arm 222 and the movable seat 52 .

[0076] Furthermore, the second connecting arm 222 has a second inclined surface 2222 facing away from the second end 212, and the second inclined surface 2222 is arranged at an angle relative to the extension direction of the second connecting arm 222. The second inclined surface 2222 cooperates with the surface of the movable seat 52 facing the clamping ring 21. Specifically, the second inclined surface 2222 contacts and cooperates with the movable seat 52, and the second connecting arm 222 and the movable seat 52 are then connected and fixed by welding or bonding. The contact and cooperation between the second inclined surface 2222 and the movable seat 52 can increase the contact area between the second connecting arm 222 and the movable seat 52, thereby strengthening the connection between the second connecting arm 222 and the movable seat 52.

[0077] The present application also provides a ventricular assist system, comprising a ventricular assist device (not shown) and a ventricular connection mechanism 1 according to any of the above-described embodiments. The ventricular assist device comprises an inlet tube, which is disposed in the accommodating hole 13. Thus, by driving the clamping ring 21 to retract radially inwardly through the locking assembly 50, the sewing ring 10 can be driven to retract inwardly, thereby causing the sewing ring 10 to clamp the inlet tube circumferentially, thereby sealing the inlet tube and reducing the chance of blood leakage.

[0078] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention, and should all be included in the scope of protection of the present invention.

Claims

1. A ventricular connection mechanism, characterized in that, Comprising: A suture ring, the suture ring is provided with a receiving hole for the inlet pipe of the ventricular assist device to penetrate, and a first annular groove surrounding the receiving hole is formed on the suture ring, so as to divide the suture ring into a sealing portion surrounding the receiving hole and a suturing portion surrounding the first annular groove; And A clamping assembly, the clamping assembly includes a clamping ring, at least part of the clamping ring is embedded in the first annular groove, and the clamping ring is sleeved on the sealing portion, the clamping ring clamps the inlet pipe through the sealing portion, and the inner diameter of the clamping ring is adjustable to adjust the tightness of the sealing portion clamping the inlet pipe.

2. The ventricular connection mechanism according to claim 1, wherein The suture ring has a suture bottom surface and a suture top surface opposite to the suture bottom surface, the suture bottom surface can be attached to the outer wall of the heart, and the first annular groove is exposed on the suture top surface; the first annular groove has a groove bottom surface, and there is a first axial distance between the groove bottom surface and the suture top surface; the clamping ring has a ring top surface opposite to the groove bottom surface, and there is a second axial distance between the ring top surface and the groove bottom surface, and the second axial distance is less than or equal to the first axial distance.

3. The ventricular connection mechanism according to claim 1, wherein The suture ring is further provided with a second annular groove, the first annular groove and the second annular groove are arranged on opposite sides of the suture ring, the first annular groove and the second annular groove are axially corresponding along the suture ring, and are axially spaced along the suture ring.

4. The ventricular connection mechanism according to claim 3, wherein, The depth of the second annular groove is d, and the minimum distance between the groove bottom surface of the first annular groove and the groove bottom surface of the second annular groove is t, where: 0.2≤d / t≤0.

4.

5. The ventricular connection mechanism according to claim 1, characterized in that, The outer peripheral surface of the sealing portion is provided with a first flange extending radially outward along the sealing portion, the first flange and the groove bottom surface of the first annular groove are spaced apart to form a first slot; a first step is provided on the inner circumference of the clamping ring, and the first step is in plug-in fit with the first slot.

6. The ventricular connection mechanism according to claim 1, characterized in that, The ventricular connection mechanism further includes a fixing ring, the fixing ring includes a ring body and a convex buckle; wherein, the ring body is fixed on the suture ring and surrounds the clamping ring; the convex buckle protrudes from the ring body for being clamped by a clamp.

7. The ventricular connection mechanism according to claim 6, characterized in that, The suture ring has a suture bottom surface and a suture top surface opposite to the suture bottom surface, the suture bottom surface can be attached to the outer wall of the heart, and the first annular groove is exposed on the suture top surface; both the ring body of the fixing ring and the clamping ring are installed in the first annular groove.

8. The ventricular connection mechanism according to claim 7, wherein, The outer peripheral surface of the sealing portion is provided with a first flange extending radially outward along the sealing portion, the first flange and the groove bottom surface of the first annular groove are spaced apart to form a first slot; a first step is provided on the inner circumference of the clamping ring, and the first step is in plug-in fit with the first slot; the first annular groove further has a groove side surface, the groove side surface is spaced apart from and opposite to the sealing portion; a second flange is provided on the outer circumference of the clamping ring, the second flange extends towards the groove side surface, the second flange and the groove bottom surface of the first annular groove are spaced apart to form a second slot, the ring body of the fixing ring is arranged between the second flange and the groove side surface, and a second step is further protruded on the inner circumferential surface of the ring body, and the second step is in plug-in fit with the second slot.

9. The ventricular connection mechanism according to claim 8, characterized in that, The clamping ring has a connecting portion connecting the first step and the second flange; the second step includes a step surface facing away from the bottom surface of the groove, a step side surface facing away from the side surface of the groove, and an inclined cutting surface connecting the step surface and the step side surface, and the included angles between the inclined cutting surface and the step surface and the step side surface are both greater than 90°; the height of the inclined cutting surface in the axial direction of the fixed ring is greater than the height of the step side surface in the axial direction of the fixed ring to avoid the connecting portion.

10. The ventricular connection mechanism according to claim 1, characterized in that, The clamping ring has an opening formed along the circumference of the clamping ring, and the inner diameter of the clamping ring can be adjusted by adjusting the size of the opening; the sealing portion is provided with a notch corresponding to the position of the opening, and the notch is arranged on the side of the sealing portion facing away from the accommodating hole, so that when the inner diameter of the clamping ring shrinks, the sealing portion at the notch can deform towards the accommodating hole.

11. The ventricular connection mechanism according to claim 10, wherein, The outer peripheral surface of the sealing portion is provided with a first flange extending radially outward along the sealing portion, and the first flange is spaced from the bottom surface of the first annular groove to form a first slot, and at least part of the clamping ring is arranged in the first slot; the notch is arranged on the first flange and extends along the circumference of the suture ring, and the notch also axially penetrates opposite sides of the first flange along the sealing ring.

12. The ventricular connection mechanism according to claim 1, wherein, The clamping assembly further includes two connecting arms connected to the clamping ring, and the two connecting arms can move relatively closer or farther away to adjust the inner diameter of the clamping ring. Each connecting arm has a pillar and an extension portion. The pillar extends along the axial direction of the clamping ring, one end of the pillar is connected to the clamping ring, and the extension portion extends radially away from the clamping ring from the end of the pillar away from the clamping ring; a first avoidance groove is formed in the suture portion, and the first avoidance groove communicates with the first annular groove. One ends of the pillars of the two connecting arms connected to the clamping ring are received in the first avoidance groove, and the extension portions are located outside the first avoidance groove.

13. The ventricular connection mechanism according to claim 12, characterized in that, The ventricular connection mechanism further includes a locking assembly, and the locking assembly includes a fixed seat, a moving seat and a locking member. The fixed seat and the moving seat are respectively connected to the extension portions of the two connecting arms. One end of the locking member is connected to the fixed seat, and the other end of the locking member can be connected to or separated from the moving seat; And / or, the first extension portion and the second extension portion are spaced from the suture ring by a distance in the axial direction of the suture ring.

14. The ventricular connection mechanism according to claim 1, wherein, The material of the suture ring is soft rubber; the ventricular connection mechanism further includes a suture cloth, and the suture cloth covers the surfaces of the suture ring and the clamping ring.

15. A ventricular assist system, characterized in that, The ventricular assist system includes a ventricular assist device and the ventricular connection mechanism according to any one of claims 1-14. The ventricular assist device includes an inlet pipe, and the inlet pipe is inserted through the accommodating hole.

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