An anchoring system

Abstract

The present application relates to the field of medical devices, and in particular to an anchoring system, comprising an outer tube, an inner core rod arranged inside the outer tube, an elastic member and a plurality of anchoring needles, wherein the distal end of the outer tube is provided with an internal thread, the outer periphery of the anchoring needle is provided with an external thread matching the internal thread, the elastic member and the plurality of anchoring needles are sleeved on the inner core rod, and rotating the inner core rod can drive the anchoring needle to rotate. When pre-installed, the plurality of anchoring needles are sequentially arranged at the distal end of the elastic member, and the elastic member is in a pre-tightened state so that when the farthest anchoring needle is output, the adjacent anchoring needles are automatically pushed to the farthest end of the outer tube by the elastic member; when anchoring twice or multiple times, the operator can automatically and continuously push the anchoring needle to the farthest end of the outer tube without additional operation, the operation is convenient and stable, and can significantly shorten the intraoperative time.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to an anchoring system. Background Art

[0002] Minimally invasive interventional medical technology has emerged as a highly effective diagnostic and treatment method in recent years. Its advantages include minimal trauma, ease of use, precise insertion site, and minimal complications. It has become one of the most important diagnostic and treatment options for cardiovascular and cancer diseases. During interventional procedures, specialized physicians typically manually manipulate specialized devices to guide one or more slender, flexible catheters of varying shapes and functions through the complex and diverse internal environments of the patient's cardiovascular system, delivering catheters, guidewires, stents, and other devices to the intended lesion for minimally invasive treatment. Mitral valve disease is a common heart valve disease in adults. Mitral regurgitation (MR) is a serious condition affecting patients. Normally, the mitral valve in the human heart acts as a hemostatic valve, preventing the backflow of oxygen-rich blood from the lungs into the left atrium. MR occurs when the mitral valve closes improperly or becomes misaligned, significantly reducing cardiac pumping efficiency and even leading to heart failure. Mitral regurgitation is categorized as either functional or degenerative. Functional mitral regurgitation (FMR) is characterized by mitral annular dilatation, inadequate leaflet coaptation, and tethered mitral valve leaflets, resulting from left ventricular dysfunction and remodeling. The poor outcomes and high risks of surgical mitral valvuloplasty have driven the search for catheter-based and minimally invasive alternatives, such as percutaneous edge-to-edge repair, indirect annuloplasty, and direct annuloplasty. Mitral annuloplasty is one of the most common surgical procedures for FMR.

[0003] Patent CN202110926647.7 discloses a transcatheter annuloplasty system for cardiac valves. It includes a ring assembly comprising a polymer braided tube, anchors, a contraction wire, and a bidirectional contraction device; a delivery assembly for delivering the ring assembly to the target location; and a continuous anchoring assembly for securing the ring assembly at the target location. This patent solution aims to reduce the anchoring time of screws, thereby shortening surgical time. Specifically, this solution inserts multiple screws onto a screw rod and rotates an outer sleeve to push the screws downward. Once the first screw is anchored, the outer sleeve is further rotated to push the second screw downward, and so on, achieving continuous anchoring. However, there is a certain distance between adjacent screws, so the outer sleeve rotation time is long. Furthermore, given the long and tortuous path of the transvascular access, rotating the outer sleeve to push the screws out may cause damage to the blood vessels, or the outer sleeve rotation may be interfered with by the resistance of the blood vessels.

[0004] Therefore, technicians in this field are committed to developing an anchoring system to mainly solve the following problems: 1. Since there is a certain distance between adjacent screws, it takes a long time to deliver the screws by rotating the outer sleeve, which does not significantly shorten the intraoperative time. At the same time, the operator is not very convenient in operation; 2. Since the transvascular access path is long and winding, rotating the outer sleeve for a long time may cause damage to the blood vessels, or the outer sleeve may be interfered with by the resistance of the blood vessels when rotating.

[0005] Application Contents

[0006] The purpose of this application is to provide an anchoring system. This new anchoring mechanism has the following advantages: 1. After the first anchoring needle is output, the elastic part can automatically push the second anchoring needle to the distal end of the outer tube to continue anchoring without the need for unnecessary operations, which can significantly save surgical time; 2. The pitch of the needle head of the anchoring needle is the same as the pitch of the internal thread, which can effectively ensure the synchronization of the needle head and needle tail during rotation, avoiding impact on the tissue.

[0007] In order to solve the above technical problems, the present application solves the problem through the following technical solutions: an anchoring system, comprising an outer tube, an inner core rod arranged inside the outer tube, an elastic member and a plurality of anchoring needles, wherein the distal end of the outer tube is provided with an internal thread, the outer periphery of the anchoring needle is provided with an external thread matching the internal thread, the elastic member and the plurality of anchoring needles are sleeved on the inner core rod, and rotating the inner core rod can drive the anchoring needle to rotate. When pre-installed, the plurality of anchoring needles are sequentially arranged at the distal end of the elastic member, and the elastic member is in a pre-tightened state, so that when the farthest end anchoring needle is output, the adjacent anchoring needle is automatically pushed to the farthest end of the outer tube by the elastic member.

[0008] As a further improvement of the present invention, the inner core rod is rotated to drive the anchoring needle to rotate, so that the external thread on the anchoring needle cooperates with the internal thread, the anchoring needle rotates along the internal thread, and the anchoring needle is gradually output from the inside of the outer tube.

[0009] As a further improvement of the present invention, the anchoring needle is provided with a through hole, and the distal end of the inner core rod is provided with a rotating sleeve that cooperates with the through hole. The rotating sleeve is fixed at the distal end of the inner core rod. When the inner core rod is rotated, the rotating sleeve can drive the anchoring needle to rotate.

[0010] As a further improvement of the present invention, the inner core rod is a circular rod, and the rotating sleeve is located at the internal thread of the outer tube, wherein rotating the inner core rod can drive the farthest anchoring needle to rotate, and the remaining anchoring needles remain stationary in the circumferential direction.

[0011] As a further improvement of the present invention, the through hole of the anchoring needle and the outer periphery of the rotating sleeve are configured as a hexagonal structure.

[0012] As a further improvement of the present invention, the proximal end of the rotating sleeve and the distal end of the through hole are provided with mutually matching chamfered structures. The design of the chamfered structure makes it easier for the through hole to dock with the rotating sleeve and slide in smoothly.

[0013] As a further improvement of the present invention, the anchoring needle includes a puncture portion and a limiting portion, the external thread is provided on the periphery of the limiting portion, and the puncture portion has a spiral structure.

[0014] As a further improvement of the present invention, the pitch of the spiral puncture portion is equal to the pitch of the external thread; the advantage of such a design is that when the anchoring needle is rotated along the internal thread, its puncture portion (i.e., the spiral needle head portion) can run along the track of the internal thread, so that the front and rear parts of the anchoring needle rotate synchronously, avoiding certain damage to the tissue due to asynchrony during the rotation process, such as tearing the tissue.

[0015] As a further improvement of the present invention, when the last anchoring needle is matched with the internal thread of the outer tube, the elastic member is in a natural form, or the elastic member is still in a pre-tightened state; the purpose of this design is to ensure that each anchoring needle can be automatically pushed to the distal end of the outer tube (i.e., the internal thread), so that the inner core rod can drive the anchoring needle outward when rotating.

[0016] As a further improvement of the present invention, the elastic member is a spring with a helical structure, and the helical spring can be sleeved on the outer circumference of the inner core rod to save the internal space of the sheath tube.

[0017] As a further improvement of the present invention, the inner wall of the distal end of the outer tube is further provided with a smooth section, wherein the smooth section is located at the distal end of the internal thread, and the length of the smooth section is less than or equal to the length of the puncture portion; the advantage of such a design is that it can avoid the risk of the needle tip (i.e., the puncture portion) of the anchoring needle being exposed before the anchoring action is performed, thereby avoiding damage to the tissue and ensuring the safety of the device.

[0018] As a further improvement of the present invention, the anchoring system also includes a stabilizing sleeve, which is arranged in the elastic member and sleeved on the proximal end portion of the inner core rod, and the stabilizing sleeve has rigidity; the purpose of such design is that the stabilizing sleeve can prevent the proximal end portion of the inner core rod from interfering with the elastic member during rotation.

[0019] As a further improvement of the present invention, the anchoring system can be used to fix both the heart valve stent and the ring shrinking forming device.

[0020] Compared with the prior art, the advantages of this application are:

[0021] 1. Unlike the prior art, which requires a long time for continuous anchoring, is cumbersome to operate, and may cause damage to the patient's blood vessels, in one embodiment of the present application, multiple anchoring needles are pre-installed inside the outer tube, and the elastic member is in a pre-tightened state. When the anchoring needle at the farthest end is rotated by the inner core rod and output to the outside of the outer tube, the remaining anchoring needles will be automatically pushed to the far end by the elastic member. When anchoring is needed again, it is only necessary to rotate the inner core rod to anchor the anchoring needle at the required position. Its continuous anchoring requires fewer operating steps and a short intraoperative time. It does not require the inner core rod to be rotated for a long time to avoid possible damage to the patient's blood vessels. The device has high safety and stable performance, and has good clinical value.

[0022] 2. Different from the prior art, in one embodiment of the present application, a rotating sleeve is provided at the distal end of the inner core rod, and the rotating sleeve is arranged at the internal thread of the outer tube. In this way, when the farthest anchoring needle rotates, the remaining anchoring needles remain stationary, avoiding excessive resistance when the inner core rod rotates, and at the same time avoiding friction interference between the remaining anchoring needles and the outer tube.

[0023] 3. Different from the prior art, in one embodiment of the present application, the through hole of the anchoring needle and the rotating sleeve are configured as a hexagonal structure, and the proximal end of the rotating sleeve and the distal end of the through hole are provided with mutually matching chamfers, which enables the anchoring needle to slide smoothly into and dock with the rotating sleeve during the rotation output process, thereby ensuring the stability of the device operation.

[0024] 4. Different from the prior art, in one embodiment of the present application, the pitch of the spiral puncture portion is equal to the pitch of the external thread; the advantage of this design is that when the anchoring needle rotates along the internal thread, its puncture portion (i.e., the spiral needle head portion) can run along the track of the internal thread, so that the front and rear parts of the anchoring needle rotate synchronously, avoiding certain damage to the tissue due to asynchrony during the rotation process, such as tearing of the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram of the outer pipe of the anchoring system of the present invention.

[0026] Figure 2 Schematic diagram of the structure of the anchoring system of the present invention.

[0027] Figure 3 Schematic diagram of the structure of the anchoring needle of the present invention.

[0028] Figure 4 Another view of the anchoring needle of the present invention.

[0029] Figure 5It is a structural schematic diagram of the inner core rod of the present invention.

[0030] The numbers in the accompanying drawings indicate the following parts: 1-outer tube, 11-internal thread, 12-smooth section, 2-inner core rod, 21-rotating sleeve, 3-elastic member, 4-anchoring needle, 41-external thread, 42-through hole, 43-puncture portion, 44-limiting portion, 5-chamfered structure, 6-stabilizing sleeve. Implementation Method

[0031] The present application is further described in detail below with reference to the accompanying drawings and embodiments.

[0032] The proximal end mentioned in this application refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Specific embodiments

[0033] like Figure 1 and Figure 2 As shown, an anchoring system comprises an outer tube 1, an inner core rod 2 arranged inside the outer tube 1, an elastic member 3 and a plurality of anchoring needles 4, wherein the distal end of the outer tube 1 is provided with an internal thread 11, the outer periphery of the anchoring needle 4 is provided with an external thread 23 that cooperates with the internal thread 11, the elastic member 3 and the plurality of anchoring needles 4 are sleeved on the inner core rod 2, and rotating the inner core rod 2 can drive the anchoring needle 4 at the distal end to rotate, so that the external thread 23 on the anchoring needle 4 at the distal end cooperates with the internal thread 11, the anchoring needle 4 rotates along the internal thread 11, and the anchoring needle 4 at the distal end is gradually output from the interior of the outer tube 1 and anchored fixed at the target implantation position; wherein, when the instrument is pre-installed, the multiple anchoring needles 4 are arranged in sequence at the distal end of the elastic member 3, and the elastic member 3 is in a pre-tightened state, so that when the anchoring needle 4 at the distal end is output, the remaining anchoring needles 4 can be automatically pushed to the distal end of the outer tube member 1 by the elastic member 3. When it is necessary to anchor again, it is only necessary to rotate the inner core rod 2 to drive the anchoring needle 4 at the distal end to be output to the target position; when anchoring for the second or multiple times, the operator can automatically and continuously push the anchoring needle 4 to the distal end of the outer tube member 1 without additional operation. The operation is convenient and stable, and can significantly shorten the intraoperative time.

[0034] In this embodiment, the anchoring needle 4 is provided with a through hole 42. Figure 4 As shown, the distal end of the inner core rod 2 is provided with a rotating sleeve 21 that cooperates with the through hole 42. The rotating sleeve 21 is fixed to the distal end of the inner core rod 2. When the inner core rod 2 is rotated, the rotating sleeve 21 can drive the anchoring needle 4 to rotate.

[0035] In this embodiment, the inner core rod 2 is a round rod. Figure 5As shown, the rotating sleeve 21 is located at the internal thread 11 of the outer pipe 1, as shown in FIG. Figure 2 As shown, rotating the inner core rod 2 can drive the most distal anchoring needle 4 to rotate, while the remaining anchoring needles 4 remain stationary in the circumferential direction.

[0036] In this embodiment, the through hole 42 of the anchoring needle 4 and the outer periphery of the rotating sleeve 21 are configured as a hexagonal structure.

[0037] In this embodiment, the proximal end of the rotating sleeve 21 and the distal end of the through hole 42 are provided with chamfered structures 5 that cooperate with each other. Figure 4 and Figure 5 As shown, the design of the chamfered structure 5 makes it easier for the through hole 42 to dock with the rotating sleeve 21 and slide in smoothly.

[0038] In this embodiment, the anchoring needle 4 includes a puncture portion 43 and a limiting portion 44, the external thread 41 is arranged on the periphery of the limiting portion 44, and the puncture portion 43 has a spiral structure; further, the pitch of the spiral puncture portion 43 is equal to the pitch of the external thread 41, as shown in FIG. Figure 3 and Figure 4 As shown; the advantage of this design is that when the anchoring needle 4 is rotated along the internal thread 11, its puncture portion 43 (i.e., the spiral needle head portion) can run along the track of the internal thread 11, so that the front and rear parts of the anchoring needle 4 rotate synchronously, avoiding certain damage to the tissue due to asynchrony during the rotation process, such as tearing the tissue.

[0039] In this embodiment, when the last anchoring needle 4 is engaged with the internal thread 11 of the outer tube 1, the elastic member 3 is in a natural form; the purpose of this design is to ensure that each anchoring needle 4 can be automatically pushed to the distal end of the outer tube 1 (i.e., the internal thread 11), so that the inner core rod 2 can drive the anchoring needle 4 to be output outward when rotating.

[0040] In this embodiment, the elastic member 3 is a spring with a helical structure. The helical spring can be sleeved on the outer periphery of the inner core rod 2 to save the internal space of the sheath tube.

[0041] In this embodiment, the inner wall of the distal end of the outer tube 1 is further provided with a smooth section 12, wherein the smooth section 12 is located at the distal end of the internal thread 11, and the length of the smooth section 12 is less than or equal to the length of the puncture portion 43; the advantage of such a design is that it can avoid the risk of the needle tip (i.e., the puncture portion 43) of the anchoring needle 4 being exposed before the anchoring action is performed, thereby avoiding damage to the tissue and ensuring the safety of the device.

[0042] In this embodiment, the anchoring system further comprises a stabilizing sleeve 6, which is disposed within the elastic member 3 and sleeved on the proximal end of the inner core rod 2. Figure 2 As shown, the stabilizing sleeve 6 has rigidity; the purpose of this design is that the stabilizing sleeve 6 can prevent the proximal end portion of the inner core rod 2 from interfering with the elastic member 3 during rotation.

[0043] In this embodiment, the anchoring system can be used to fix the ring shrinking molding device, and the device used for valve ring shrinking molding is gradually anchored on the autologous valve ring through the anchoring system.

[0044] In another embodiment, the anchoring system can also be used in the treatment of valve stent replacement, for example, to anchor the leak-proof ring portion of the valve stent on the native valve annulus.

[0045] The foregoing description of several embodiments of the present application has been presented for illustrative purposes. It is not intended to be exhaustive or to limit the present application to the precise configurations, configurations, and / or steps disclosed, and it is apparent that many modifications and variations are possible in light of the above teachings. It is intended that the scope of the invention and all equivalents thereof be defined by the appended claims.

Claims

1. An anchoring system, characterized in that: The invention comprises an outer tube, an inner core rod arranged inside the outer tube, an elastic member and a plurality of anchoring needles, wherein the distal end of the outer tube is provided with an internal thread, the outer periphery of the anchoring needle is provided with an external thread matching the internal thread, the elastic member and the plurality of anchoring needles are sleeved on the inner core rod, and rotating the inner core rod can drive the anchoring needle to rotate. When pre-installed, the plurality of anchoring needles are sequentially arranged at the distal end of the elastic member, and the elastic member is in a pre-tightened state so that when the distalmost anchoring needle is output, the adjacent anchoring needles are pulled out by the elastic member. The outer tube is automatically pushed to the farthest end of the outer tube; and the inner core rod is rotated to drive the anchoring needle to rotate, so that the external thread on the anchoring needle cooperates with the internal thread, and the anchoring needle is gradually output from the inside of the outer tube; the anchoring needle includes a puncture part and a limiting part, the external thread is arranged on the outer periphery of the limiting part, the puncture part has a spiral structure, and the inner wall of the distal end of the outer tube is also provided with a smooth section, wherein the smooth section is located at the distal end of the internal thread, and the length of the smooth section is less than or equal to the length of the puncture part.

2. An anchoring system according to claim 1, characterized in that: The anchoring needle is provided with a through hole, and the distal end of the inner core rod is provided with a rotating sleeve that cooperates with the through hole. When the inner core rod is rotated, the rotating sleeve can drive the anchoring needle to rotate.

3. An anchoring system according to claim 2, characterized in that: The inner core rod is a circular rod, and the rotating sleeve is located at the internal thread of the outer tube, wherein rotating the inner core rod can drive the farthest anchoring needle to rotate, and the remaining anchoring needles remain stationary in the circumferential direction.

4. An anchoring system according to claim 2, characterized in that: The through hole of the anchoring needle and the outer circumference of the rotating sleeve are arranged in a hexagonal structure.

5. The anchoring system according to claim 2, characterized in that: The proximal end of the rotating sleeve and the distal end of the through hole are provided with chamfered structures that match each other.

6. An anchoring system according to claim 1, characterized in that: The pitch of the spiral puncture portion is equal to the pitch of the external thread.

7. The anchoring system according to claim 1, characterized in that: When the last anchoring needle is engaged with the internal thread of the outer tube, the elastic member is in a natural state, or the elastic member is still in a pre-tightened state.

8. An anchoring system according to claim 7, characterized in that: The elastic member is a spring with a helical structure.

9. The anchoring system according to claim 1, characterized in that: The anchoring system further includes a stabilizing sleeve, which is disposed in the elastic member and sleeved on the proximal end portion of the inner core rod, and the stabilizing sleeve has rigidity.

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