A fixator for a cardiac implantable device
By designing an annular connecting ring and an embedded sealing ring and connecting part, the problem of patient tissue injury caused by excessive axial height of the cardiac assist device fixator is solved, achieving a stable connection and seal between the fixator and the myocardial surface, and reducing the risk to patients.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- HANGTIANTAIXIN TECH CO LTD
- Filing Date
- 2023-07-21
- Publication Date
- 2026-05-26
AI Technical Summary
The fixation device of existing cardiac assist devices has a large axial height, which can easily press against other tissues in the patient's body, leading to frequent chest pain.
A fixator for cardiac implantation devices is designed, which adopts an annular connecting ring, an embedded sealing ring and a connecting part. The sealing ring is embedded in a first groove and the connecting part is embedded in a second groove. It is fixed to the myocardial surface by sutures, thereby reducing the axial height of the fixator and increasing the contact area with the myocardial surface.
While ensuring fixation and sealing, it reduces the risk of injury to patients from the fixation device and cardiac assist device, and reduces the space occupied by the fixation device in the human body.
Smart Images
Figure CN116672095B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a fixator for cardiac implantation devices. Background Technology
[0002] Heart failure, or HF for short, is simply the inability of the heart to pump enough blood to maintain the circulation of blood throughout the body. According to statistics from the World Health Organization, there are currently only three treatment options for heart failure patients: conservative drug therapy, heart transplantation, and cardiac assistive therapy. Among these, drug therapy has relatively poor efficacy, and heart transplantation is extremely difficult due to the limited availability of donors. Therefore, cardiac assistive therapy is recognized worldwide as the most effective treatment for various types of end-stage heart failure. Cardiac assistive therapy requires the implantation of a cardiac assist device using a fixator. The fixator needs to secure the implanted cardiac device and seal the cardiac incision to prevent postoperative bleeding and infection. However, currently available fixators for cardiac assist devices that provide both fixation and sealing are divided into two separate components, with the two components stacked axially. While this design offers the advantage of convenient installation, the axial height of the fixator is relatively large, which can easily push against other tissues in the patient's body after the cardiac assist device is implanted. In severe cases, patients may experience frequent chest pain.
[0003] Therefore, how to reduce the axial height of the fixator while ensuring its fixation and sealing effect, thereby reducing the risk of injury to patients from the fixator and cardiac assist devices, is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention
[0004] In view of this, the purpose of the present invention is to provide a fixator for cardiac implantation devices that reduces the axial height of the fixator while ensuring the fixation and sealing effect of the fixator, thereby reducing the risk of injury to the patient from the fixator and cardiac assist device.
[0005] To achieve the above objectives, the present invention provides the following technical solution:
[0006] A fixator for a cardiac implantable device, comprising:
[0007] The connecting ring includes an isolated first groove and a second groove, wherein the first groove is recessed from the inner circumference of the connecting ring toward the outer circumference, and the second groove is recessed from the outer circumference of the connecting ring toward the inner circumference.
[0008] A sealing ring is embedded in the first groove. The sealing ring has an annular shape, and the inner diameter of the sealing ring is smaller than the inner diameter of the connecting ring.
[0009] A connecting part is embedded in the second groove and fixedly connected to the connecting ring. The outer diameter of the connecting part is larger than the outer diameter of the connecting ring. The connecting part is sutured and fixed to the surface of the myocardium by a first suture.
[0010] Preferably, in the fixator for the cardiac implantation device described above, the maximum thickness of the connecting ring is the same as the maximum thickness of the connecting portion along the axial direction of the connecting ring.
[0011] Preferably, in the above-mentioned fixator for cardiac implantation devices, the connecting part includes a liner and a film that fits and covers the surface of the liner. The liner has an annular configuration and a flexible protruding rib that engages with the second groove at its inner circle. The film has a loose and porous structure.
[0012] Preferably, in the fixator for the cardiac implantation device described above, the connecting part is embedded in the second groove, and the covering film is fixedly connected to the bottom of the second groove by a second suture.
[0013] Preferably, in the fixator for the above-mentioned cardiac implantation device, an inclined guide portion is provided on one side of the sealing ring.
[0014] Preferably, in the fixator for the cardiac implantation device described above, the sealing ring is interference-fitted with the first groove.
[0015] Preferably, in the fixator for the cardiac implantation device described above, the protruding rib is interference-fitted with the second groove.
[0016] Preferably, in the fixator for the above-mentioned cardiac implantation device, the covering is fitted onto the surface of the liner and fixed to the liner by a third suture.
[0017] Preferably, in the fixator for the cardiac implantation device described above, both the first groove and the second groove are annular in shape.
[0018] As can be seen from the above technical solution, the fixator for a cardiac implantation device provided by the present invention includes a connecting ring, a sealing ring, and a connecting part. The connecting ring has an annular structure and includes a first groove and a second groove that are isolated from each other. The isolation means that the first groove and the second groove are two independent and non-connected grooves. Specifically, the first groove is recessed from the inner circumference of the connecting ring towards the outer circumference, and the second groove is recessed from the outer circumference of the connecting ring towards the inner circumference. It should be noted that the annular surface of the connecting ring is used for fixed connection with the myocardial surface, while the inner circle of the connecting ring is used for the cardiac implantation device to pass through for implantation and fixation in the heart. The fixation of the cardiac implantation device is achieved through the sealing ring, which is embedded in the first groove. The sealing ring is also annular in shape. Specifically, the inner diameter of the sealing ring is smaller than the inner diameter of the connecting ring, so that the portion of the sealing ring protruding from the central hole of the connecting ring can be engaged and fixed with the groove on the cardiac implantation device. It should also be noted that the sealing ring is suitable for… The adaptively designed component, when embedded in the first groove, maintains connection while sealing against the inner wall of the first groove. The inner ring of the sealing ring can be designed according to the size requirements of the cardiac implantation device for a sealed connection. The connecting part is embedded in the second groove and fixedly connected to the connecting ring. The outer diameter of the connecting part is larger than that of the connecting ring. The purpose of the connecting part is to increase the contact area with the myocardial surface while being fixedly connected to the connecting ring, allowing the first suture to achieve a larger suture area by suturing the connecting part and the myocardial surface. This results in a more stable connection between the connecting ring and the myocardium. In this structure, the connecting ring serves as the basic carrier, and both the sealing ring and the connecting part are embedded and snap-fit connections to the connecting ring, rather than the stacked structures used in existing technologies. This reduces the space occupied in the thickness direction of the fixator connecting ring, thereby reducing the space occupied by the fixator and cardiac implantation device within the body and lowering the risk of injury to the patient from the fixator and cardiac implantation device. The fixator for cardiac implantation devices provided by the present invention has a ring-shaped connecting ring with grooves, and a sealing ring is embedded in the first groove to achieve a sealed connection with the cardiac implantation device through the sealing ring. At the same time, the connecting part is embedded in the second groove to expand the contact area between the fixator and the myocardial surface through the connecting part. The fixator provided by the present invention can achieve a good fixed connection with the myocardial surface by suturing the connecting part to the myocardial surface through the first suture. Attached Figure Description
[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0020] Figure 1 This is a schematic diagram of an explosion of the fixator for a cardiac implantation device provided in an embodiment of the present invention;
[0021] Figure 2 This is a schematic diagram of the connecting ring structure provided in an embodiment of the present invention;
[0022] Figure 3 This is a schematic diagram of the installation of a fixator for a cardiac implantation device provided in an embodiment of the present invention;
[0023] Wherein, 10 is the connecting ring, 110 is the first groove, 120 is the second groove, 20 is the sealing ring, 30 is the connecting part, 310 is the liner, 3110 is the raised rib, 320 is the covering membrane, 40 is the first suture line, and 50 is the myocardial surface. Detailed Implementation
[0024] The core of this invention is to disclose a fixator for cardiac implantation devices, which ensures the fixation and sealing effect of the fixator while reducing the axial height of the fixator, thereby reducing the risk of injury to the patient from the fixator and cardiac assist device. This is a technical problem that urgently needs to be solved by those skilled in the art.
[0025] To enable those skilled in the art to better understand the present invention, embodiments of the present invention will be described below with reference to the accompanying drawings. Furthermore, the embodiments shown below do not limit the scope of the invention as described in the claims. Additionally, the complete contents of the configurations shown in the embodiments below are not limited to those necessary for the solution of the invention described in the claims.
[0026] like Figure 1 , Figure 2 and Figure 3As shown, the fixator for a cardiac implantation device provided in this embodiment of the invention includes a connecting ring 10, a sealing ring 20, and a connecting portion 30. The connecting ring 10 has an annular structure and includes a first groove 110 and a second groove 120 that are isolated from each other. The isolation means that the first groove 110 and the second groove 120 are two independent and non-communicating grooves. Specifically, the first groove 110 is recessed from the inner circumference of the connecting ring 10 towards the outer circumference, and the second groove 120 is recessed from the outer circumference of the connecting ring 10 towards the inner circumference. It should be noted that the annular surface of the connecting ring 10 is used for fixed connection with the myocardial surface 50, while the inner circle of the connecting ring 10 is used for the cardiac implantation device to pass through for implantation and fixation in the heart. The fixation of the cardiac implantation device is achieved through the sealing ring. The sealing ring 20 is embedded in the first groove 110 and is also annular. In particular, the inner diameter of the sealing ring 20 is smaller than the inner diameter of the connecting ring 10, so that the part of the inner circle of the sealing ring 20 protruding from the central hole of the connecting ring 10 can be snapped and fixed with the groove on the cardiac implantation device. It should be noted that the sealing ring 20 is an adaptively designed component. When embedded in the first groove 110, it can maintain the connection while contacting and sealing with the inner wall of the first groove 110. The inner ring of the sealing ring 20 can be designed according to the size requirements of the cardiac implantation device to seal and connect with the cardiac implantation device. The connecting part 30 is embedded in the second groove 120 and fixedly connected with the connecting ring 10. At the same time, the outer diameter of the connecting part 30 is larger than the outer diameter of the connecting ring 10.
[0027] It should be noted that the purpose of the connecting part 30 is to increase the contact area with the myocardial surface 50 while being fixedly connected with the connecting ring 10, so that the first suture 40 can obtain a larger suture area by suturing the connecting part 30 and the myocardial surface 50, thereby making the connection between the connecting ring 10 and the myocardium more stable. In the above structure, the connecting ring 10 is used as the basic carrier, and both the sealing ring 20 and the connecting part 30 are embedded and snapped into the connecting ring 10, rather than the stacked structure in the prior art. This reduces the space occupied in the thickness direction of the fixator connecting ring 10, thereby reducing the space occupied by the fixator and cardiac implantation device in the human body and reducing the risk of injury to the patient by the fixator and cardiac implantation device.
[0028] The fixator for cardiac implantation devices provided in this embodiment of the invention features a ring-shaped connecting ring 10 with grooves, and a sealing ring 20 is embedded in a first groove 110 to achieve a sealed connection with the cardiac implantation device. Simultaneously, a connecting portion 30 is embedded in a second groove 120 to expand the contact area between the fixator and the myocardial surface 50. By suturing the connecting portion 30 and the myocardial surface 50 with a first suture 40, a good fixed connection between the fixator and the myocardial surface 50 provided in this embodiment of the invention can be achieved.
[0029] Furthermore, the connecting part 30 is embedded in the second groove 120 and fixedly connected to the connecting ring 10. In a preferred embodiment of the present invention, the maximum thickness of the connecting ring 10 in the axial direction is the same as the maximum thickness of the connecting part 30. That is, the integral structure formed by the connecting part 30 after being embedded in the second groove 120 and the connecting ring 10 is preferably a circular ring structure with the same thickness in the annular area. This makes the height of the fixator for the cardiac implantation device provided in the embodiment of the present invention the same as the thickness of the connecting ring 10 in the axial direction, so as to minimize the thickness occupation of the fixator for the cardiac implantation device in the patient's body and reduce the risk of the fixator injuring the patient.
[0030] Furthermore, in a specific embodiment of the present invention, the connecting part 30 includes a liner 310 and a cover 320, wherein the cover 320 is attached to and wraps the surface of the liner 310. The cover 320 is preferably a surgical implant-grade fabric material, which has better extensibility and is loose and porous than the liner 310. It can cover the edge of the liner 310 to avoid the liner 310 from injuring the patient's internal tissues. The liner 310 has a ring-shaped configuration, and the inner circular wall of the liner 310 is provided with a flexible protruding rib 3110 that engages with the second groove 120. Through the deformation capability of the protruding rib 3110 to engage with the second groove 120, a good fixed connection between the connecting part 30 and the connecting ring 10 can be achieved.
[0031] In order to enhance the connection between the connecting part 30 and the connecting ring 10 and prevent relative slippage between them, in a specific embodiment of the present invention, the connecting part 30 is embedded in the second groove 120 by the protruding rib 3110 of the liner 310, and the bottom area of the second groove 120 and the covering film 320 on the protruding rib 3110 are fixedly sewn together by the second suture line to strengthen the connection effect between the connecting part 30 and the connecting ring 10.
[0032] Furthermore, in a preferred embodiment of the present invention, an inclined guide portion is provided on one side of the sealing ring 20. When the sealing ring 20 is installed, the guide portion is located on the side opposite to the myocardial surface 50. When the cardiac implantation device passes through the fixator provided in the embodiment of the present invention, it is easier to perform axial alignment through the guide portion, and it is easier to pass through the fixation frame and perform snap-fit fixation with the sealing ring 20.
[0033] Furthermore, in a preferred embodiment of the present invention, the sealing ring 20 is interference-fitted with the first groove 110, that is, the outer diameter of the sealing ring 20 is interference-fitted with the bottom diameter of the first groove 110. The interference fit of the sealing ring 20 into the first groove 110 can ensure the connection effect between the sealing ring 20 and the connecting ring 10. At the same time, the interference fit can make the sealing ring 20 fill the first groove 110, thereby enhancing the sealing performance of the sealing ring 20.
[0034] It should be noted that the sealing ring 20 is made of medical-grade rubber or silicone, which has good deformation ability and sealing performance, while avoiding rejection reactions in the patient's internal tissues.
[0035] Based on the above embodiments, the connecting part 30 and the second groove 120 are also interference fit, that is, the inner diameter of the raised rib 3110 of the upper liner 310 of the connecting part 30 is interference fit with the bottom diameter of the second groove 120, thereby achieving a stable connection effect between the connecting part 30 and the connecting ring 10.
[0036] Furthermore, in a specific embodiment of the present invention, the connecting part 30 is a pre-assembled structure to facilitate its connection with the connecting ring 10. In order to ensure a good connection effect between the film 320 and the liner 310, it is preferable that after the film 320 is fitted onto the surface of the liner 310, the liner 310 and the film 320 are sewn together by the third stitch.
[0037] Furthermore, the first groove 110 and the second groove 120 can be of any configuration. A stable connection can be achieved simply by designing the sealing ring 20 and the connecting part 30 as corresponding snap-fit structures. For the convenience of production and installation, in a preferred embodiment of the present invention, the first groove 110 and the second groove 120 are both annular configurations.
[0038] The terms "first," "second," and "third," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units may include steps or units not listed, but rather steps or units not listed.
[0039] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims
1. A fixator for a cardiac implantable device, characterized in that, include: The connecting ring (10) includes an isolated first groove (110) and a second groove (120), wherein the first groove (110) is recessed from the inner circumference of the connecting ring (10) toward the outer circumference, and the second groove (120) is recessed from the outer circumference of the connecting ring (10) toward the inner circumference. A sealing ring (20) is embedded in the first groove (110). The sealing ring (20) has an annular structure, and the inner diameter of the sealing ring (20) is smaller than the inner diameter of the connecting ring (10). The part of the inner circle of the sealing ring (20) that protrudes from the central hole of the connecting ring (10) is engaged and fixed with the groove on the cardiac implantation device. A connecting part (30) is embedded in the second groove (120) and fixedly connected to the connecting ring (10). The outer diameter of the connecting part (30) is larger than the outer diameter of the connecting ring (10). The connecting part (30) is sutured and fixed to the surface of the myocardium (50) by a first suture (40). The connecting part (30) includes a liner (310) and a covering (320) that fits and wraps the surface of the liner (310). The liner (310) has a ring-shaped configuration and a flexible protruding rib (3110) that engages with the second groove (120) is provided at its inner circle. The covering (320) has a loose and porous structure. In the axial direction of the connecting ring (10), the maximum thickness of the connecting ring (10) is the same as the maximum thickness of the connecting part (30).
2. The fixator for a cardiac implantable device as described in claim 1, characterized in that, The connecting part (30) is embedded in the second groove (120), and the covering film (320) is fixedly connected to the bottom of the second groove (120) by a second suture.
3. The fixator for a cardiac implantable device as described in claim 1, characterized in that, An inclined guide portion is provided on one side of the sealing ring (20).
4. The fixator for a cardiac implantable device as described in claim 1, characterized in that, The sealing ring (20) is interference-fitted with the first groove (110).
5. The fixator for a cardiac implantable device as described in claim 1, characterized in that, The raised rib (3110) is interference-fitted with the second groove (120).
6. The fixator for a cardiac implantable device as described in claim 1, characterized in that, The film (320) is fitted onto the surface of the liner (310) and is sewn to the liner (310) by a third suture.
7. The fixator for a cardiac implantable device as described in claim 1, characterized in that, Both the first groove (110) and the second groove (120) are annular.