A precisely controlled anchoring system

Abstract

The present application relates to the field of medical devices, and in particular to a precisely controllable anchoring system, comprising a delivery catheter, a positioning bracket arranged in the delivery catheter, an anchoring device and a guiding mechanism, wherein the guiding mechanism connects the anchoring device and the positioning bracket, the positioning bracket comprises a connecting portion and a supporting portion, the guiding mechanism is connected to the supporting portion, and the position where the guiding mechanism is connected to the supporting portion is called an anchoring point, and the supporting portion can be attached to cardiac tissue after release, wherein a control member is provided in the delivery catheter, the distal end of the control member is connected to the supporting portion, and operating the control member causes the supporting portion to undergo local deformation, the anchoring point to be displaced, and the anchoring device to reach the target anchoring position; in the present invention, the positioning bracket can be adjusted in position according to actual conditions after release, so that its anchoring position is more precise.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a precisely controllable 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 US63 / 106324 discloses an internal catheter (20) extending through a cavity to a subject's heart (42), with a tether (63) extending distally from a first end of the tether through the internal catheter and surrounding a distal portion (22) of the heart. The internal catheter is located at the subject's heart, then extends proximally next to the internal catheter, terminating at a second end of the tether outside the subject, such that both ends of the tether are disposed outside the subject. An anchor (150) advances along the first portion of the tether through the internal catheter and anchors around the heart's valve annulus, such that the tether forms a ring around the valve annulus. Outside the subject, the first and second ends of the tether are slidably coupled, and the resulting slidable coupling advances toward the heart, such that the tether forms a closed ring around the valve annulus. In this solution, multiple anchoring points need to be located based on medical imaging, resulting in a very lengthy intraoperative time, which is extremely detrimental to the patient's postoperative recovery and can cause multiple complications. Furthermore, there is no guidance mechanism to guide the anchoring system during anchoring, making it difficult for the operator to accurately anchor to the target position, placing extremely high demands on the operator and resulting in a high surgical failure rate.

[0004] Therefore, technicians in this field are committed to developing a precisely controllable anchoring system, mainly to solve the following problems: 1. The instrument does not have a precise device for guiding the positioning of the anchoring device, which leads to lengthy intraoperative time and causes various complications; 2. The existing positioning device cannot adjust the anchoring point after release, and the physiological and anatomical structures of different patients vary greatly, making it difficult to adjust the position based on real-time images. Summary of the Invention

[0005] The purpose of this application is to provide a precisely controllable anchoring system. The new anchoring mechanism has the following advantages: 1. It can accurately guide the anchoring device to the predetermined anchoring point, reducing intraoperative operation time and reducing operation difficulty; 2. It can adjust the position of the anchoring point in real time according to the image to ensure that the instrument can be accurately anchored at the target position.

[0006] In order to solve the above technical problems, the present application solves them through the following technical solutions: a precisely controllable anchoring system, comprising a delivery catheter, a positioning bracket arranged in the delivery catheter, an anchoring device and a guiding mechanism, wherein the guiding mechanism connects the anchoring device and the positioning bracket, the positioning bracket comprises a connecting part and a supporting part, the guiding mechanism is connected to the supporting part, and the position where the guiding mechanism is connected to the supporting part is called an anchoring point, and the supporting part can be attached to the heart tissue after release, wherein a control member is provided in the delivery catheter, the distal end of the control member is connected to the supporting part, and the operation of the control member causes the supporting part to undergo local deformation, the anchoring point is displaced, and the anchoring device can reach the target anchoring position.

[0007] As a further improvement of the present invention, the support portion includes an expansion segment and an abutment segment. After the positioning stent is released, the abutment segment is used to abut against heart tissue. Specifically, the abutment segment is used to abut against autologous valve ring tissue.

[0008] As a further improvement of the present invention, the distal end of the control member is connected to the outer circumference of the abutment section, and the guiding mechanism is connected to the inner circumference of the abutment section.

[0009] As a further improvement of the present invention, the guiding mechanism includes a guide wire and a disassembly wire, and a connecting hole is provided on the anchoring device. The guide wire passes through the anchoring device and is detachably connected to the positioning bracket through the disassembly wire. The anchoring device reaches a preset anchoring point on the positioning bracket along the guide wire.

[0010] As a further improvement of the present invention, a hole or a ring for limiting position is provided on the expansion section, and the control member passes through the hole or the ring for limiting position and is connected to the abutment section.

[0011] As a further improvement of the present invention, in the cross section of the delivery catheter axis, the abutment segment is a straight line segment.

[0012] As a further improvement of the present invention, after the positioning bracket is released, the axial length of the abutting section can be extended or shortened by pulling the control member.

[0013] As a further improvement of the present invention, a first arc segment is provided between the connecting portion and the expansion segment, and a second arc segment is provided between the expansion segment and the abutment segment.

[0014] As a further improvement of the present invention, after the positioning bracket is released, the first arc segment and the second arc segment cause the abutting segment to move toward the proximal end.

[0015] As a further improvement of the present invention, the hole or ring for limiting is arranged on the second arc segment. Its purpose is that when the control member is pulled, the hole or ring for limiting can disperse the lateral force brought by the control member to the positioning bracket, so that its abutment segment is only subjected to axial force, thereby making the axial length of the abutment segment extend or shorten to adjust the position of the anchor point on the abutment segment.

[0016] As a further improvement of the present invention, the distal end of the abutment segment gathers toward the interior of the positioning stent and forms a closed shape, and the closed shape is intended to prevent the positioning stent from being hooked to the chordae tendineae or leaflet tissue when released.

[0017] As a further improvement of the present invention, an adjustment line is provided in the delivery catheter, and the adjustment line is connected to the distal end of the abutment segment. Pulling the adjustment line can make the distal end of the abutment segment gather toward the inside of the positioning bracket, and the adjustment line makes the shape of the distal end of the abutment segment controllable.

[0018] As a further improvement of the present invention, after the positioning stent is released, the abutment section is in close contact with the autologous valve annulus tissue, wherein the diameter of the positioning stent is greater than or equal to the diameter of the autologous valve annulus, ensuring that the abutment section can be in close contact with the autologous valve annulus tissue.

[0019] As a further improvement of the present invention, the positioning stent is a grid-shaped stent with a preset shape, and after the positioning stent is released, the abutment section is located at the autologous valve ring; the positioning stent is woven with memory metal wire (such as nickel-titanium alloy).

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

[0021] 1. In the prior art, the device used to guide the positioning of the anchoring device in the instrument cannot adjust the various anchoring points in real time according to the image after release to adapt to the physiological and anatomical structures of different patients; in one embodiment of the present application, the anchoring device is preset with multiple anchoring points on the positioning bracket through a guide mechanism. When the positioning bracket is released, the anchoring device reaches the preset anchoring point under the guidance of the guide mechanism. At this time, the surgeon can determine whether the anchoring point is the target anchoring position based on the image. If not, the control member can be pulled to cause local deformation of the support part, thereby moving the preset anchoring point, and finally adjusting the anchoring point to the target anchoring position to complete the anchoring. The operation method is convenient, and the anchoring point can be controlled in real time by operating the control member to ensure that the anchoring position is the optimal position. The accuracy of the instrument is greatly improved, and it can cope with the diverse physiological and anatomical structures of different patients, reduce intraoperative time, and facilitate the patient's later recovery, which has great clinical significance.

[0022] 2. Different from the prior art, in one embodiment of the present application, a hole or ring for limiting is provided on the second arc segment. The purpose is that when the control member is pulled, the hole or ring for limiting can disperse the lateral force brought to the positioning bracket by the control member, so that the abutment segment is only subjected to axial force, thereby making the axial length of the abutment segment extend or shorten, so as to accurately control the position of the anchor point on the abutment segment.

[0023] 3. Different from the prior art, in one embodiment of the present application, the arrangement of the first arc segment and the second arc segment effectively shortens the axial height of the positioning stent after release, and the height of the distal end of the abutment segment is close to the height of the distal end of the delivery catheter, so that the release position of the positioning stent can be determined by the distal end of the delivery catheter. At the same time, the softness of the abutment segment can be increased to avoid damage to the heart tissue when it abuts against the heart tissue.

[0024] 4. Different from the prior art, in one embodiment of the present application, the distal end of the abutment segment gathers toward the interior of the positioning stent and forms a closed shape. The closed shape can prevent the positioning stent from being hooked to the chordae tendineae or leaflet tissue when released.

[0025] 5. Different from the prior art, in one embodiment of the present application, an adjustment line is provided in the delivery catheter, and the adjustment line is connected to the distal end of the abutment segment. Moreover, pulling the adjustment line can make the distal end of the abutment segment gather toward the inside of the positioning stent. The adjustment line makes the shape of the distal end of the abutment segment controllable, ensuring that the positioning stent will not hook onto the heart tissue when released. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a structural diagram of the anchoring system in Example 1 of the present invention.

[0027] Figure 2 for Figure 1 A partial enlarged view of part A in the middle.

[0028] Figure 3 This is a schematic structural diagram of the anchoring device in Example 1 of the present invention.

[0029] Figure 4 This is a schematic structural diagram of the positioning bracket in Example 1 of the present invention.

[0030] Figure 5 Schematic diagram of the structure of the guide mechanism in Example 1 of the present invention.

[0031] Figure 6-Figure 12 Schematic diagram of the operation process of a precisely controllable anchoring system in Example 1 of the present invention.

[0032] The numbers in the accompanying drawings indicate the following parts: 1-delivery catheter, 2-positioning stent, 21-connecting portion, 22-supporting portion, 221-deployment segment, 222-aft segment, 23-first arc segment, 24-second arc segment, 3-anchoring device, 4-guiding mechanism, 41-guide wire, 42-disassembly wire, 5-anchoring point, 6-control member, 7-adjustment wire. DETAILED DESCRIPTION

[0033] The present application is further described in detail below with reference to the accompanying drawings and embodiments.

[0034] 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.

[0035] like Figure 1 and Figure 3 As shown, when the anchoring system is used for mitral valve ring plasty treatment, a precisely controllable anchoring system includes a delivery catheter 1, a positioning stent 2 arranged in the delivery catheter 1, an anchoring device 3 and a guiding mechanism 4, wherein the guiding mechanism 4 connects the anchoring device 3 and the positioning stent 2. Specifically, the guiding mechanism 4 includes a guide wire 41 and a disassembly wire 42. Figure 5 As shown, the anchoring device 3 is provided with a connecting hole, and the guide wire 41 passes through the anchoring device 3 and is detachably connected to the positioning bracket 2 through the detachment wire 42. Figure 3 As shown, the anchoring device 3 arrives at the preset anchoring point 5 on the positioning bracket 2 along the guide wire 41. The positioning bracket 2 includes a connecting portion 21 and a supporting portion 22. The guiding mechanism 4 is connected to the supporting portion 22, and the position where the guiding mechanism 4 is connected to the supporting portion 22 is called the anchoring point 5. Figure 2As shown, the support portion 22 can be attached to the heart tissue after being released (in clinical surgery, the support portion 22 is attached to the native valve ring), wherein a control member 6 is provided in the delivery catheter 1, the distal end of the control member 6 is connected to the support portion 22, and the proximal end of the control member 6 extends outside the body, as shown in FIG. Figure 1 As shown, the control member 6 is operated to cause the support portion 22 to undergo local deformation, further causing the anchor point 5 preset on the support portion 22 to shift, as shown in FIG. Figure 7 He Ru Figure 8 As shown, the anchoring device 3 can reach the target anchoring position after adjustment; in the solution of the present invention, the anchoring device 3 is preset with multiple anchoring points 5 on the positioning bracket 2 through the guiding mechanism 4. After the positioning bracket 2 is released, it can be guided by the guiding mechanism 4 to reach the preset anchoring point 5, such as Figure 9 He Ru Figure 10 As shown, at this time, the operator can determine whether the anchor point 5 is the target anchor position based on the image. If not, Figure 7 As shown, the control member 6 can be pulled to cause the support portion 22 to undergo local deformation, thereby causing the preset anchor point 5 to move, and finally the anchor point 5 is adjusted to the target anchor position, as shown in FIG. Figure 8 As shown, anchoring is completed.

[0036] In this embodiment, the support portion 22 includes an expansion section 221 and a contact section 222. Figure 4 As shown, after the positioning stent 2 is released, the abutment segment 222 is used to abut against the heart tissue. Specifically, the abutment segment 222 is used to abut against the autologous valve ring tissue.

[0037] In this embodiment, the distal end of the control member 6 is connected to the outer circumference of the abutment section 222 , and the guiding mechanism 4 is connected to the inner circumference of the abutment section 222 .

[0038] In this embodiment, the expansion section 221 is provided with a hole or ring for limiting position, and the control member 6 passes through the hole or ring for limiting position and is connected to the abutment section 222. Figure 1 shown.

[0039] In this embodiment, on the cross section of the axis of the delivery catheter 1 , the abutment section 222 is a straight line section.

[0040] In this embodiment, after the positioning bracket 2 is released, the control member 6 can be pulled to extend or shorten the axial length of the abutting section 222 .

[0041] In this embodiment, a first arc segment 23 is provided between the connecting portion 21 and the expansion segment 221, and a second arc segment 24 is provided between the expansion segment 221 and the abutment segment 222. Figure 1 and Figure 4 shown.

[0042] In this embodiment, after the positioning bracket 2 is released, the first arc segment 23 and the second arc segment 24 cause the abutting segment 222 to move toward the proximal end.

[0043] In this embodiment, the hole or ring for limiting is arranged on the second arc segment 24. Its purpose is that when the control member 6 is pulled, the hole or ring for limiting can disperse the lateral force brought to the positioning bracket 2 by the control member 6, so that its abutment segment 222 is only subjected to axial force, thereby making the axial length of the abutment segment 222 extend or shorten to adjust the position of the anchor point 5 located on the abutment segment 222.

[0044] In this embodiment, the distal end of the abutment section 222 gathers toward the interior of the positioning stent 2 and forms a closed shape. The closed shape is intended to prevent the positioning stent 2 from being hooked to the chordae tendineae or leaflet tissue when released.

[0045] In this embodiment, an adjustment line 7 is provided in the delivery catheter 1, and the adjustment line 7 is connected to the distal end of the abutment section 222. Pulling the adjustment line 7 can make the distal end of the abutment section 222 gather toward the inside of the positioning bracket 2. The adjustment line 7 makes the shape of the distal end of the abutment section 222 controllable, such as Figure 4 shown.

[0046] In this embodiment, the positioning stent 2 is a grid-shaped stent with a preset shape, and after the positioning stent 2 is released, the abutment section 222 is located at the autologous valve annulus; the positioning stent 2 is woven with memory metal wire (such as nickel-titanium alloy).

[0047] The operation process of the precisely controllable anchoring system includes the following steps.

[0048] 1) The delivery catheter 1 enters the heart along the path of the guide wire in the blood vessel, such as Figure 6 As shown, the position of the distal end of the delivery catheter 1 is observed by imaging, and when it reaches a suitable position, the positioning stent 2 is released, as shown in FIG. Figure 7 As shown;

[0049] 2) The abutting segment 222 of the positioning stent 2 is released first, and as the first arc segment 23 and the second arc segment 24 are released, the axial height of the positioning stent 2 is shortened, and the abutting segment 222 is closely attached to the autologous valve annulus tissue;

[0050] 3) Observe through the image whether the anchor point 5 is the ideal anchor position. If not, pull the control member 6 to locally deform the abutment section 222 so that the anchor point 5 moves to the ideal anchor position. Figure 8Then the anchoring device 3 is operated to reach the anchoring position along the preset path of the guide mechanism 4 to complete the anchoring, as shown in FIG. Figure 9-11 As shown;

[0051] 4) After the anchoring is completed, the ring is further reduced and the instrument is removed from the body to complete the operation. Figure 12 shown.

[0052] The solution of the present invention is not limited to mitral valve ring reduction treatment, but can also be used for tricuspid valve ring reduction treatment or atrioventricular valve replacement treatment.

[0053] 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. A precisely controllable anchoring system comprising a delivery catheter, a positioning stent disposed within the delivery catheter, an anchoring device, and a guiding mechanism, wherein the guiding mechanism connects the anchoring device and the positioning stent, characterized in that: The positioning bracket includes a connecting portion and a supporting portion, the guiding mechanism is connected to the supporting portion, and the position where the guiding mechanism is connected to the supporting portion is called an anchoring point, and the supporting portion can be attached to the cardiac tissue after being released, wherein a control member is provided in the delivery catheter, the distal end of the control member is connected to the supporting portion, and the operation of the control member causes the supporting portion to undergo local deformation, the anchoring point is displaced, and the anchoring device can reach the target anchoring position, the supporting portion includes an expansion segment and an abutting segment, after the positioning bracket is released, the abutting segment is used to abut the cardiac tissue, the distal end of the control member is connected to the outer circumference of the abutting segment, and the guiding mechanism is connected to the inner circumference of the abutting segment, the expansion segment is provided with a hole or ring for limiting, the control member passes through the hole or ring for limiting and is connected to the abutting segment; after the positioning bracket is released, pulling the control member can extend or shorten the axial length of the abutting segment.

2. A precisely controllable anchoring system according to claim 1, characterized in that: On the cross section of the delivery catheter axis, the abutment segment is a straight segment.

3. The precisely controllable anchoring system according to claim 1, characterized in that: A first arc segment is provided between the connecting portion and the expansion segment, and a second arc segment is provided between the expansion segment and the abutment segment. After the positioning bracket is released, the first arc segment and the second arc segment cause the abutment segment to move toward the proximal end.

4. The precisely controllable anchoring system according to claim 3, characterized in that: The hole or ring for limiting is provided on the second arc segment.

5. The precisely controllable anchoring system according to claim 1, characterized in that: The distal end of the abutting section gathers toward the interior of the positioning bracket and forms a closed shape.

6. The precisely controllable anchoring system according to claim 1, characterized in that: An adjustment line is provided in the delivery catheter, and the adjustment line is connected to the distal end of the abutment section. Pulling the adjustment line can cause the distal end of the abutment section to gather toward the interior of the positioning bracket.

7. The precisely controllable anchoring system according to claim 1, characterized in that: After the positioning stent is released, the abutting section is in close contact with the autologous valve ring tissue.

8. The precisely controllable anchoring system according to claim 1, characterized in that: The positioning stent is a grid-shaped stent with a preset shape, and after the positioning stent is released, the abutment section is located at the autologous valve annulus.

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