Search

CN-224220299-U - Implant and implant system

CN224220299UCN 224220299 UCN224220299 UCN 224220299UCN-224220299-U

Abstract

The utility model discloses an implant and an implant system, which belong to the technical field of interventional medical instruments, and aim to solve the problem that the existing implant is easy to fall off in the release process and after the release is finished, the implant comprises a main body (1) and at least one pair of clamping pieces (2); each clamping member (2) has a proximal portion close to the main body (1) and a distal portion distant from the main body (1), the width of the proximal portion of at least one clamping member (2) gradually increasing and the width of the distal portion gradually decreasing in a direction away from the central axis of the main body. The clamping piece of the implant has larger clamping width after being completely released, the contact area between the clamping piece and tissues is larger, the implant has good anti-falling performance after being semi-released and completely released, and the fixing capability of the implant after being semi-released and completely released is improved.

Inventors

  • GE SHUCHEN
  • ZHANG TAO
  • WANG LI

Assignees

  • 合源医疗器械(上海)有限公司

Dates

Publication Date
20260512
Application Date
20241231

Claims (20)

  1. 1. An implant, characterized in that, the implant comprises: A main body (1), and At least one pair of clamping members (2) connected to the main body (1); Wherein the at least one pair of clamps (2) comprises two clamps (2) which are arranged at intervals along the axial direction of the main body (1), each clamp (2) has a proximal end portion close to the main body (1) and a distal end portion far away from the main body (1), the width of the proximal end portion of at least one clamp (2) is gradually increased, and the width of the distal end portion is gradually decreased along the direction far away from the central axis of the main body (1).
  2. 2. Implant according to claim 1, characterized in that a plurality of pairs of said clamps (2) are arranged at intervals along the circumference of said body (1), said proximal portion and said distal portion being connected in sequence.
  3. 3. Implant according to claim 1, characterized in that each of said holders (2) comprises a first inner support section (21), a first outer support section (22), a second outer support section (23) and a second inner support section (24) connected in sequence, the proximal end of said first inner support section (21) and the proximal end of said second inner support section (24) being connected to the body (1), said proximal portion comprising said first inner support section (21) and said second inner support section (24) and said distal portion comprising said first outer support section (22) and said second outer support section (23).
  4. 4. An implant according to claim 3, characterized in that each of the clamping members (2) is wound from the same wire, the clamping members (2) being rotatable in a direction towards the side wall of the body (1) from a released state to a compressed state or the clamping members (2) being rotatable in a direction away from the side wall of the body (1) from a compressed state to a released state.
  5. 5. An implant according to claim 3, characterized in that the body (1) comprises a holder wound from the same wire as each clamping member (2), or that the body (1) comprises a sensor and a connection sleeve in which the sensor is arranged, and that each clamping member (2) further comprises a fixation part connected to the proximal part and to the sensor by clamping the connection sleeve.
  6. 6. An implant according to claim 3, characterized in that it further comprises a monitoring element (3), the monitoring element (3) being connected to the outer side wall of the body (1), the body (1) being a therapeutic element, the body (1) being capable of being pressed from a released state towards the monitoring element (3) into a compressed state, the implant being capable of being fitted into a delivery sheath (4) when both the grip (2) and the body (1) are in the compressed state.
  7. 7. Implant according to claim 6, characterized in that the holder (2) has a long axis and a short axis, the length of the long axis being greater than or equal to the length of the short axis, the length of the long axis being greater than twice the diameter of the monitoring element (3), the length of the long axis and/or the short axis being 6 mm-8 mm.
  8. 8. An implant according to claim 3, characterized in that the holder (2) has a long axis and a short axis, the distance between the short axis and the proximal end of the holder (2) being greater than half the long axis when the holder (2) is in the released state, the distance between the short axis and the proximal end of the holder (2) being 3-4 mm.
  9. 9. An implant according to claim 3, characterized in that the distance between the proximal end of the first inner support section (21) and the proximal end of the second inner support section (24) is 0-1 mm.
  10. 10. Implant according to any of claims 3-9, characterized in that the distal end of the first outer support section (22) and the distal end of the second outer support section (23) are connected by a connecting structure (25), which connecting structure (25) is a loop or knot structure.
  11. 11. Implant according to claim 10, characterized in that it further comprises developing structures wound around said connecting structures (25), the corresponding connecting structures (25) of the same pair of clamps (2) being mutually parallel.
  12. 12. Implant according to claim 10, characterized in that the connection structure (25) is the knotting structure, the connection structure (25) being located outside the distal end of the first outer support section (22) and the distal end of the second outer support section (23), the connection structure (25) having a ring-shaped structure and the connection structure (25) having a diameter of 1.5mm-3.5mm.
  13. 13. An implant according to claim 3, characterized in that the first outer support section (22) and the second outer support section (23) form a bending section with a radius of 0.2mm to 1mm, the first inner support section (21) and the first outer support section (22) form a bending section with a radius of 0.2mm to 1mm, and the second outer support section (23) and the second inner support section (24) form a bending section with a radius of 0.2mm to 1mm.
  14. 14. An implant according to claim 3, characterized in that the first inner support section (21), the first outer support section (22), the second outer support section (23) and the second inner support section (24) are each located in four different planes and/or that the lengths of the first inner support section (21), the first outer support section (22), the second outer support section (23) and the second inner support section (24) are all unequal.
  15. 15. Implant according to any one of claims 1-9, characterized in that in a pair of said clamps (2) the axial distance between two of said clamps (2) decreases gradually in a direction away from the central axis of the body (1).
  16. 16. Implant according to any one of claims 1-9, characterized in that in a pair of said clamps (2), two of said clamps (2) are a first clamp (27) and a second clamp (28), respectively; -an axial distance between a proximal end portion of the first clamping member (27) and a proximal end portion of the second clamping member (28) gradually decreases in a direction away from a central axis of the main body (1); The plane of the distal end portion of the first clamping piece (27) and the plane of the distal end portion of the second clamping piece (28) are perpendicular to the central axis of the main body (1).
  17. 17. Implant according to any one of claims 1-9, characterized in that the body (1) has a cylindrical structure, the number of clamping elements being three pairs, the clamping elements having a quadrangular structure.
  18. 18. Implant according to any one of claims 1 to 9, characterized in that in a pair of said clamps (2), two of said clamps (2) are in one-to-one correspondence along the axial direction of the body (1), the proximal ends of said clamps (2) are connected to said body (1), the proximal ends of two of said clamps (2) are circumferentially offset, the distal ends of two of said clamps (2) axially coincide; When the clamping piece (2) is in a release state, the long axis of the clamping piece (2) is deviated to one side of the main body (1).
  19. 19. Implant according to any of claims 1-9, characterized in that the setting direction is the direction from the proximal end of the holder (2) to the distal end of the holder (2), the long axis of the holder (2) deviating from the diameter of the body (1).
  20. 20. Implant system, characterized in that it comprises a delivery sheath (4) and an implant according to any one of claims 1-19, the delivery sheath (4) having a container in which the implant can be loaded in a compressed state, and in a released state the clamping member (2) having a major axis and a minor axis, the minor axis being of a size greater than the outer diameter of the container.

Description

Implant and implant system Technical Field The utility model relates to the technical field of interventional medical instruments, in particular to an implant or an implant system. Background Heart failure is a clinical syndrome caused by ventricular filling and abnormal ejection function, and can be classified into three types, i.e., heart failure with a reduced ejection fraction, heart failure with a slightly reduced ejection fraction, and heart failure with a retained ejection fraction. In chronic heart failure patients with retained and reduced ejection fraction, sustained left atrial pressure elevation is the leading cause of pulmonary congestion, and 90% of heart failure patients are therefore admitted to treatment. The heart chamber shunt channel is built through the permanent implant, blood in the left atrium is shunted to the right atrium, the expected purpose of reducing left heart load is achieved, clinical symptoms and life quality of patients are improved, the pressure in the left atrium is monitored in a wireless mode, early discovery, early intervention and medication adjustment are achieved, heart failure deterioration is prevented, so that heart failure management strategies are optimized, heart failure re-hospitalization rate of the patients is reduced, and mortality of the patients is reduced. The two functions together, and the left atrium pressure monitoring is used for early intervention and adjustment of medication, so that abnormal rise of the left atrium pressure of a patient is avoided, and the safety of atrial bypass therapy is improved. In the prior art, the left and right atrial walls are often clamped with clamping members so that the shunt or sensor is secured to the atrial septum. However, the existing clamping member designs still suffer from a number of drawbacks. For example, in one existing shunt structure, as shown in fig. 1, the body 1 is additionally provided with an adjustable clamping member 2 as a fixing structure, so that in order to facilitate the delivery of the implant to the target tissue, the clamping member 2 can only be turned over to the outer surface of the body 1 at the connection point between the body 1 and the clamping member 2 to compress the implant, and the shape of the clamping arm itself cannot be changed, so that when the size of the clamping arm itself is too large, the volume of the compressed implant is too large, but when the size of the clamping member 2 is small, the clamping area of the clamping member 2 is small, so that stable clamping is difficult to achieve, and the implant is easy to fall off during and after the release is completed. Disclosure of utility model In order to solve the problem that the existing implant is easy to fall off in the release process and after the release is completed, the utility model provides an implant and an implant system, wherein a clamping piece of the implant has a larger clamping width after the implant is completely released, the contact area between the clamping piece and tissues is larger, the implant has good falling-off prevention performance after the implant is semi-released and completely released, and the fixation capacity of the implant after the semi-release and the release is improved. The technical scheme adopted by the embodiment of the utility model for solving the technical problems is as follows: There is provided an implant comprising a body and at least one pair of clamps connected to the body, wherein a pair of clamps comprises two clamps arranged at intervals along an axial direction of the body, each of the clamps having a proximal portion close to the body and a distal portion away from the body, the width of the proximal portion of at least one of the clamps gradually increasing and the width of the distal portion gradually decreasing in a direction away from a central axis of the body. In one possible implementation, a plurality of pairs of the clamping members are arranged at intervals along the circumferential direction of the main body, and the main body, the proximal end portion and the distal end portion are sequentially connected. In one possible implementation manner, each clamping piece comprises a first inner supporting section, a first outer supporting section, a second outer supporting section and a second inner supporting section which are sequentially connected, wherein the proximal end of the first inner supporting section and the proximal end of the second inner supporting section are connected with the main body, the proximal end part comprises the first inner supporting section and the second inner supporting section, and the distal end part comprises the first outer supporting section and the second outer supporting section. In one possible implementation, each clamping member is wound from the same wire, and the clamping member can rotate in a direction approaching the side wall of the main body, and can be switched from a release state to a compression st