A controlled release device on an implant prosthesis delivery system

Abstract

This application relates to the field of medical devices, and particularly to a controllable release device on an implantable prosthesis delivery system, which includes an implantable prosthesis, a connecting device, a rotating device, and a limiting member; wherein, a limiting member is arranged on the rotating device, and the connecting device is connected through the limiting member to realize the linkage between the connecting device and the rotating device; and, the implantable prosthesis is detachably connected to the connecting device through the limiting member; in the present invention, the limiting member is connected to the rotating device, the implantable prosthesis is detachably connected to the connecting device through the limiting member, the middle sheath can axially move relative to the inner core tube. When the middle sheath withdraws proximally relative to the inner core tube, the limiting member is driven to retreat, so that the implantable prosthesis is separated from the connecting device, realizing controllable release. The operation is convenient and the controllable stability is high, which has good clinical significance.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to a controlled release device on an implant prosthesis delivery system. Background Art

[0002] Aortic stenosis (AS) is one of the common valvular diseases. For a long time, surgical aortic valve replacement has been the only recognized long-term effective treatment method. Nevertheless, due to concerns about the high risk assessment of surgery and postoperative complications, 1 / 3 - 2 / 3 of the patients still give up surgical treatment. Therefore, once symptoms appear, the average annual mortality rate of patients reaches 50% - 60%. Due to the continuous innovation of cardiac intervention means and medical devices, medical catheter treatment, especially percutaneous aortic valve replacement (PAVR), has gradually become the mainstream surgical method. Clinical trials have confirmed its simplicity and feasibility, bringing good news to many patients who cannot accept surgical treatment.

[0003] There are mainly three surgical approach options for the current percutaneous aortic valve replacement, namely the antegrade technique (puncturing through the femoral vein and atrial septum), the retrograde technique (retrograde entry into the aortic arch through the femoral artery), and the direct path valve replacement technique without extracorporeal circulation (through the apex of the heart). Among them, the second one is the most convenient and fast and is widely used. The existing stent delivery systems on the market are represented by the Edwards balloon-expandable SAPIEN valve stent delivery system and the Corevalve self-expanding ReValving valve stent delivery system. R & D personnel continuously provide technical solutions and device innovations to improve the survival rate of patients and improve the living conditions of patients.

[0004] Nevertheless, PAVR still faces technical problems such as target population selection, long-term efficacy, and complications. Research shows that the improvement of valve stent delivery systems and operation techniques plays a crucial role in suppressing complications such as aortic perforation, paravalvular leakage, thrombosis, and stroke.

[0005] However, in the prior art, the detachable connection between the implant prosthesis and the delivery system needs to set relevant control mechanisms in the sheath tube to achieve the detachable function. This will increase the diameter of the delivery sheath tube, especially in the case of vascular access methods, which is particularly disadvantageous. The thick delivery sheath tube increases the access resistance and damages the patient's blood vessels. Therefore, medical staff and patients are urgently hoping for a delivery device with a smaller diameter of the delivery sheath tube and yet can meet the requirements of controlled release.

[0006] Application Content

[0007] The object of the present invention is to overcome the deficiencies of the prior art and provide a controlled release device on an implantable prosthesis delivery system for patients with aortic stenosis who require interventional treatment. The present invention solves the problem of realizing the function of controlled release on the existing delivery system while meeting the requirement of reducing the delivery pipe diameter.

[0008] To solve the above technical problems, the present application is solved by the following technical solutions: A controlled release device on an implantable prosthesis delivery system, comprising an implantable prosthesis, a connecting device, a rotating device and a limiting member; wherein, a limiting member is arranged on the rotating device, and the connecting device is connected through the limiting member to realize the linkage between the connecting device and the rotating device; and, the implantable prosthesis is detachably connected to the connecting device through the limiting member.

[0009] In one embodiment, the rotating device can axially move relative to the connecting device.

[0010] In one embodiment, it further comprises a linear member and a fixing member; a guiding channel is arranged on the fixing member, one end of the linear member is connected to the rotating device, and the other end passes through the guiding channel; and, by manipulating the linear member, the rotating device can rotate circumferentially relative to the fixing member.

[0011] In one embodiment, one end of the limiting member is connected to the rotating device, and the other end is detachably connected to the implantable prosthesis; or the limiting member is connected to the rotating device, and both ends of the limiting member are detachably connected to the implantable prosthesis.

[0012] In one embodiment, it further comprises an inner core tube and a middle sheath tube, the connecting device is sleeved on the inner core tube, the rotating device is sleeved on the middle sheath tube, and the middle sheath tube can axially move relative to the inner core tube.

[0013] In one embodiment, the connecting device is provided with a through hole, and the limiting member passes through the through hole and is detachably connected to the implantable prosthesis.

[0014] In one embodiment, the connecting device comprises a connecting base and a connecting hole arranged on the connecting base, the implantable prosthesis is provided with a disassembly hole, during pre-installation, the disassembly hole passes through the connecting hole, one end of the limiting member passes through the disassembly hole, and when one end of the limiting member withdraws from the disassembly hole, the implantable prosthesis is separated from the connecting device.

[0015] In one embodiment, the limiting member is a metal wire or rod.

[0016] In one embodiment, the guiding channel is provided inside the fixing member; alternatively, the guiding channel is provided on the outer periphery of the fixing member; or part of the guiding channel is provided inside the fixing member while part of the guiding channel is provided on the outer periphery of the fixing member.

[0017] In one embodiment, the guiding channel may be an axially arranged through hole on the fixing member.

[0018] In a preferred embodiment, the through hole is provided with a rounded structure to avoid cutting the linear member.

[0019] In another embodiment, a guide rail is provided on the outer periphery of the fixing member, and the guiding channel is arranged inside the guide rail.

[0020] In another embodiment, an outer covering layer is provided on the outer periphery of the fixing member, and the guiding channel is formed by the gap between the fixing member and the outer covering layer.

[0021] In one embodiment, the delivery system further includes an implant prosthesis and a wire winding mechanism; the implant prosthesis is connected to the connecting device, the other end of the linear member passes through the guiding channel and is connected to the wire winding mechanism, and operating the wire winding mechanism can make the connecting device rotate circumferentially relative to the fixing member.

[0022] In one embodiment, the implant prosthesis is an artificial heart valve prosthesis.

[0023] In another embodiment, the implant prosthesis is a vascular stent.

[0024] In a preferred embodiment, when the delivery system is used for aortic replacement surgery, the artificial heart valve prosthesis includes a stent body and a positioning member. The artificial heart valve prosthesis first releases the positioning member to position the positioning member at the bottom of the aortic sinus to complete pre-positioning, and then releases the stent body.

[0025] In one embodiment, when the implant prosthesis needs to be circumferentially adjusted in the human heart, the wire winding mechanism can be operated to make the linear member drive the connecting device and further drive the implant prosthesis to rotate circumferentially.

[0026] In one embodiment, the rotating device is provided with a first connection point and a second connection point. Among them, the linear member is connected to the first connection point and the second connection point; and when the linear member pulls the first connection point to rotate relative to the guiding channel, the implant prosthesis rotates circumferentially in the clockwise direction; when the linear member pulls the second connection point to rotate relative to the guiding channel, the implant prosthesis rotates circumferentially in the counterclockwise direction.

[0027] In one embodiment, the included angle formed by the central connection lines of the first connection point, the second connection point and the fixing member on the cross-section of the connection mechanism is α.

[0028] In one embodiment, the included angle α is 0° to 150°.

[0029] In one embodiment, on the cross-section of the connection mechanism, the central connection line between the center of the guiding channel and the center of the fixing member bisects the included angle α.

[0030] In one embodiment, the wire winding mechanism includes an outer housing, a wire winding rod, and a control knob; one end of the wire winding rod is connected to the control knob, and the other end portion of the wire winding rod is partially inserted into the outer housing; and, the other end portion of the wire winding rod is provided with a first point position and a second point position.

[0031] In one embodiment, the other end of the first flexible member is connected to the first point position, and the other end portion of the first flexible member is wound around the wire winding rod in a clockwise direction; the other end of the second flexible member is connected to the second point position, and the other end portion of the second flexible member is wound around the wire winding rod in a counterclockwise direction.

[0032] When the control knob rotates clockwise, the first flexible member is in a taut state and further drives the connection mechanism to rotate clockwise, and, the second flexible member is in a relaxed state.

[0033] Compared with the prior art, the advantages of the present application are as follows:

[0034] 1. In the prior art, the distal end of the control wire is used to limit and controllably release the implanted prosthesis, and the other end of the control wire must pass through a long delivery sheath. During the delivery process, the delivery sheath must perform a series of actions such as bending or rotating to release the implanted prosthesis, which may cause the control wire to twist or even entangle with each other inside the delivery sheath, making the operation of controllable release uncontrollable; in an embodiment of the present invention, the limiting member is connected to the rotating device, and the implanted prosthesis is detachably connected to the connecting device through the limiting member. Also, because the middle sheath can axially move relative to the inner core tube, when the middle sheath withdraws proximally relative to the inner core tube, it drives the limiting member to retreat, thereby separating the implanted prosthesis from the connecting device to achieve controllable release. The limiting member can complete controllable release only at the distal end of the delivery sheath, with convenient operation and high controllable stability, having good clinical significance;

[0035] 2. In an embodiment of the present invention, when the rotating device rotates circumferentially relative to the fixed member, the rotating device can drive the limiting member, the connecting device, and the implant prosthesis to rotate circumferentially. The limiting member not only realizes the controllable release of the implant prosthesis and the connecting device but also can drive the connecting device to rotate circumferentially, meeting the requirements of versatility, with a simple structure and a very ingenious design;

[0036] 3. In the prior art, usually, by controlling and rotating the end of the tube, the force is transmitted to the other end of the tube through rotation to achieve the purpose of adjusting the angle. However, torsional force will be generated during the rotation of the tube, resulting in inaccurate adjustment. Especially when the length of the tube is longer or in the face of a complex and twisted blood vessel morphology, the adjustment accuracy will decrease sharply, and there are problems such as adjustment delay or even inability to adjust. When adjusting in the vascular access, due to the existence of a certain degree of multiple twists in the blood vessel itself, the difficulty and timeliness of adjustment are further increased, which is not conducive to the positioning operation of the surgery; In an embodiment of the present invention, by pulling the linear member, the connecting device can be rotated circumferentially relative to the fixed member. Most of the force acts between the guiding channel and the first connection point / second connection point, with extremely small loss, and the feedback of the adjustment is very timely and the accuracy is high. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1a and 1b are the overall structural schematic diagram and the operation principle diagram of the implant prosthesis, the connecting device, the rotating device, and the limiting member of the present invention.

[0038] Figures 2a - 2c are the overall structural schematic diagram of the implant prosthesis delivery system and the structural schematic diagram of the connecting device of the present invention.

[0039] Figures 3a - 3d are the schematic diagram of the positional relationship between the guiding channel and the fixed member and the schematic diagram of the positional relationship between the rotating device and the guiding channel of the present invention.

[0040] Figures 4a - 4d is the structural schematic diagram of the wire winding mechanism of the present invention.

[0041] Figures 5a - 5g is the schematic diagram of the operation process of the implant prosthesis delivery system of the present invention.

[0042] The names of the parts referred to by the numbers in the attached drawings are as follows: 1 - rotating device, 11 - first connection point, 12 - second connection point, 2 - connecting device, 21 - connecting base, 22 - connecting hole, 23 - through hole, 3 - limiting member, 4 - implant prosthesis, 41 - stent body, 42 - positioning member, 43 - disassembly hole, 5 - wire winding mechanism, 51 - outer housing, 52 - wire winding rod, 521 - first point position, 522 - second point position, 53 - control knob, 6 - inner core tube, 7 - middle sheath tube, 8 - linear member, 81 - first flexible member, 82 - second flexible member, 9 - fixing member, 91 - guiding channel. Detailed implementation mode

[0043] The present application will be further described in detail below with reference to the attached drawings and embodiments.

[0044] In the present application, the proximal end refers to the end close to the surgeon, and the distal end refers to the end far from the surgeon. Specific embodiment

[0045] In the prior art, usually by controlling and rotating the end of the tube, the force is transmitted to the other end of the tube through rotation to achieve the purpose of adjusting the angle. However, torsional force will be generated during the rotation of the tube, resulting in inaccurate adjustment. Especially when the length of the tube is longer or in the face of a complex and twisted blood vessel morphology, the adjustment accuracy will decrease sharply, and there are problems such as adjustment delay or even inability to adjust. When adjusting in the vascular access, due to the existence of a certain degree of multiple twists in the blood vessel itself, the difficulty and timeliness of adjustment are further increased, which is not conducive to the positioning operation of the surgery.

[0046] In this embodiment, a controllable release device on an implant prosthesis delivery system includes an implant prosthesis 4, a connecting device 2, a rotating device 1 and a limiting member 3, as Figure 1a and 1b shown; wherein, a limiting member 3 is arranged on the rotating device 1, and the connecting device 2 is connected through the limiting member 3 to realize the linkage between the connecting device 2 and the rotating device 1; and, the implant prosthesis 4 is detachably connected to the connecting device 2 through the limiting member 3.

[0047] In this embodiment, the rotating device 1 can axially move relative to the connecting device 2.

[0048] In this embodiment, it further includes a linear member 8 and a fixing member 9; a guiding channel 91 is arranged on the fixing member 9, one end of the linear member 8 is connected to the rotating device 1, and the other end passes through the guiding channel 91; and, by manipulating the linear member 8, the rotating device 1 can rotate circumferentially relative to the fixing member 9.

[0049] In this embodiment, one end of the limiting member 3 is connected to the rotating device 1, and the other end is detachably connected to the implant prosthesis 4; alternatively, the limiting member 3 is connected to the rotating device 1, and both ends of the limiting member 3 are detachably connected to the implant prosthesis 4.

[0050] In this embodiment, an inner core tube 6 and a middle sheath tube 7 are further included. The connecting device 2 is sleeved on the inner core tube 6, the rotating device 1 is sleeved on the middle sheath tube 7, and the middle sheath tube 7 can axially move relative to the inner core tube 6, as Figure 2a and 2b shown.

[0051] In this embodiment, the connecting device 2 is provided with a through hole 23, as Figure 2c shown, and the limiting member 3 passes through the through hole 23 and is detachably connected to the implant prosthesis 4.

[0052] In this embodiment, the connecting device 2 includes a connecting base 21 and a connecting hole 22 provided on the connecting base 21. The implant prosthesis 4 is provided with a disassembly hole 43. During pre-installation, the disassembly hole 43 passes through the connecting hole 22, and one end of the limiting member 3 passes through the disassembly hole 43. When one end of the limiting member 3 withdraws from the disassembly hole 43, the implant prosthesis 4 is separated from the connecting device 2.

[0053] In this embodiment, the limiting member 3 is a wire or a rod.

[0054] In this embodiment, the guiding channel 91 is provided inside the fixing member 9, as Figure 3a shown; or the guiding channel 91 is provided on the outer periphery of the fixing member 9, as Figure 3b shown; or part of the guiding channel 91 is provided inside the fixing member 9, and at the same time part of the guiding channel 91 is provided on the outer periphery of the fixing member 9, as Figure 3c shown.

[0055] In this embodiment, the delivery system further includes an implant prosthesis 4 and a wire winding mechanism 5; the implant prosthesis 4 is connected to the connecting device 2, as Figure 2a shown, and the other end of the linear member 8 passes through the guiding channel 91 and is connected to the wire winding mechanism 5, as Figure 4d shown. Operating the wire winding mechanism 5 can cause the connecting device 2 to rotate circumferentially relative to the fixing member 9.

[0056] In this embodiment, the implant prosthesis 4 is an artificial heart valve prosthesis.

[0057] In a preferred embodiment, when the delivery system is used in an aortic replacement surgery, the artificial heart valve prosthesis includes a stent body 41 and a positioning member 42. The artificial heart valve prosthesis first releases the positioning member 42 to position the positioning member 42 at the bottom of the aortic sinus to complete pre-positioning, and then releases the stent body 41.

[0058] In this embodiment, when the implant prosthesis 4 is delivered to the human heart and needs to be circumferentially adjusted in angle, the wire winding mechanism 5 can be operated so that the linear member 8 drives the connecting device 2 and further drives the implant prosthesis 4 to rotate circumferentially.

[0059] In this embodiment, the rotating device 1 is provided with a first connection point 11 and a second connection point 12. Among them, the linear member 8 is connected to the first connection point 11 and the second connection point 12; and when the linear member 8 pulls the first connection point 11 to rotate relative to the guiding channel 91, the implant prosthesis 4 rotates circumferentially in the clockwise direction; when the linear member 8 pulls the second connection point 12 to rotate relative to the guiding channel 91, the implant prosthesis 4 rotates circumferentially in the counterclockwise direction.

[0060] In this embodiment, the included angle formed by the center connection lines of the first connection point 11, the second connection point 12 and the fixing member 9 on the cross-section of the connecting mechanism is a, as Figure 3d shown.

[0061] In this embodiment, the included angle a is 0° to 150°.

[0062] In this embodiment, on the cross-section of the connecting mechanism, the center connection line between the center of the guiding channel 91 and the center of the fixing member 9 bisects the included angle a.

[0063] In this embodiment, the wire winding mechanism 5 includes a housing 51, a wire winding rod 52, and a control knob 53, as Figures 4a - 4d shown; one end of the wire winding rod 52 is connected to the control knob 53, and the other end portion of the wire winding rod 52 is partially disposed in the housing 51; and the other end portion of the wire winding rod 52 is provided with a first point 521 and a second point 522.

[0064] In this embodiment, the other end of the first flexible member 81 is connected to the first point 521, and the other end portion of the first flexible member 81 is wound around the wire winding rod 52 in the clockwise direction; the other end of the second flexible member 82 is connected to the second point 522, and the other end portion of the second flexible member 82 is wound around the wire winding rod 52 in the counterclockwise direction.

[0065] When the control knob 53 rotates clockwise, the first flexible member 81 is in a tensioned state and further drives the connecting mechanism to rotate clockwise, and the second flexible member 82 is in a relaxed state.

[0066] The operation process of this application is as follows:

[0067] 1. The delivery system enters the heart through a transvascular access method, and then releases the positioning member 42 on the implant prosthesis 4, such as Figure 5a and 5b shown;

[0068] 2. By observing the position of the positioning member 42 and the aortic sinus, if the positions do not correspond, the wire member 8 can be pulled by operating the wire winding mechanism 5, so that the wire member 8 drives the rotating device 1 to rotate, and the rotating device 1 further drives the limiting wire 3 to rotate, such as Figure 5c shown, and the limiting wire 3 further drives the connecting device 2 and the implant prosthesis 4 to rotate, and finally determines the position of the positioning member 42 and the sinus bottom;

[0069] 3. When the positioning member 42 reaches the sinus bottom, such as Figure 5d and 5e shown, further release the stent body 41 and withdraw the delivery system to complete the implantation, such as Figures 5f - 5g shown.

[0070] The above content is only the preferred embodiment of this application. For those of ordinary skill in the art, according to the idea of this application, there will be changes in the specific implementation manner and application scope. The content of this specification should not be construed as a limitation to this application.

Claims

1. A controlled release device on an implantable prosthesis delivery system, characterized in that: It includes an implant prosthesis, a connecting device, a rotating device and a limiting member; wherein, the limiting member is arranged on the rotating device and connects the connecting device through the limiting member to realize the linkage between the connecting device and the rotating device; and, the implant prosthesis is detachably connected to the connecting device through the limiting member; the rotating device can axially move relative to the connecting device; the connecting device is provided with a through hole, and the limiting member passes through the through hole and is detachably connected to the implant prosthesis; it further includes a linear member and a fixing member; the fixing member is provided with a guiding channel, one end of the linear member is connected to the rotating device, and the other end passes through the guiding channel; and, by manipulating the linear member, the rotating device can be circumferentially rotated relative to the fixing member, the rotating device is provided with a first connection point and a second connection point, wherein, the linear member is connected to the first connection point and the second connection point; and, when the linear member pulls the first connection point to rotate relative to the guiding channel, the implant prosthesis rotates circumferentially in the clockwise direction; when the linear member pulls the second connection point to rotate relative to the guiding channel, the implant prosthesis rotates circumferentially in the counterclockwise direction.

2. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: One end of the limiting member is connected to the rotating device, and the other end is detachably connected to the implant prosthesis.

3. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: It further includes an inner core tube and a middle sheath tube. The connecting device is sleeved on the inner core tube, the rotating device is sleeved on the middle sheath tube, and the middle sheath tube can axially move relative to the inner core tube.

4. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: The connecting device includes a connecting base and a connecting hole arranged on the connecting base. The implant prosthesis is provided with a disassembly hole. During pre-installation, the disassembly hole passes through the connecting hole, and one end of the limiting member passes through the disassembly hole. When one end of the limiting member withdraws from the disassembly hole, the implant prosthesis is separated from the connecting device.

5. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: The limiting member is a metal wire or rod.

6. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: The guiding channel is arranged inside the fixing member.

7. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: The guiding channel is arranged on the outer periphery of the fixing member.

8. The controlled release device on an implantable prosthesis delivery system according to claim 1, characterized in that: Part of the guiding channel is arranged inside the fixing member, and at the same time part of the guiding channel is arranged on the outer periphery of the fixing member.

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