Interventional system for delivering a valve clip
By designing an interventional system with a rotary locking mechanism and a multi-stage pipe body structure, the problem of the conveying system in the prior art being unable to lock and unidirectional bending angles and unidirectional bending angle adjustments are achieved, which significantly simplifies surgical operations and improves the control accuracy of the system.
Patent Information
- Application Number
- CN202110910712.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-08-09
- Publication Date
- 2025-06-13
- Estimated Expiration
- 2041-08-09
AI Technical Summary
The conveying system in the prior art cannot lock the angle of the bend in real time during rotation operation, and the conveying catheter can only meet the one-way bend angle and cannot meet the multi-directional bend requirement.
An interventional system including a fixed bracket, a first conveying module, a second conveying module and a third conveying module are designed, and a rotary locking mechanism and a multi-section pipe body structure are adopted. The adaptive section and the bending section are arranged in axial overlap, and the holding section and the bending section are arranged in axial dislocation to realize multi-directional bending and precise angle adjustment.
Real-time locking of rotation angle is achieved, clinical surgical operations are simplified, multi-directional curving needs are met, and the regulation accuracy of the interventional system is improved.
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Figure CN113509292B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical devices, and particularly to an interventional system for delivering a valve clip. Background Art
[0002] The mitral valve has a complex anatomical structure, including valve leaflets, annulus, chordae tendineae, and papillary muscles, which play important roles in maintaining the functions of the left and right ventricles respectively. Any disease that affects the structural integrity and normal function of the valve leaflets, annulus, chordae tendineae, papillary muscles, and left ventricle may lead to severe mitral regurgitation (MR), which can cause left ventricular failure, pulmonary hypertension, atrial fibrillation, stroke, and death. Mitral regurgitation can be divided into degenerative MR and functional MR. Degenerative MR is caused by pathological changes in one or more of the valve leaflets, annulus, chordae tendineae, and papillary muscles; functional MR is usually due to abnormal left ventricular function, such as annulus dilation, but the mitral valve itself is usually normal.
[0003] Currently, the treatment methods for MR mainly include drug therapy, surgical operation, and interventional therapy. Drug therapy can only improve the symptoms of patients and cannot extend their survival time. Surgical operations are mainly valve repair or valve replacement, which are recognized as the preferred treatment methods for mitral regurgitation and have been proven to relieve the symptoms of patients and extend their lifespan. However, for many high-risk patients with advanced age and multiple systemic diseases, the surgical risk is high and the survival benefit is small. According to European data, the surgical success rate of such patients is only 50%, and the surgical success rate of patients with severe functional MR is even as low as 16%. Therefore, transcatheter mitral valve repair and replacement can theoretically benefit high-risk patients who have lost the opportunity for surgery. Interventional therapy is to load an artificial implant onto a delivery system outside the body, deliver it to the mitral annulus along the vascular path or by puncturing the apex of the heart, and then release and fix it to completely or partially replace the function of the autologous valve. Currently, mitral valve interventional therapy has become one of the research hotspots in the related fields, and many products are under development. However, due to problems such as the complex structure of the mitral valve itself and its surrounding structures, the development of mitral valve interventional devices faces many special difficulties.
[0004] Patent CN112353537A discloses a delivery system with a locking mechanism, including an outer sheath tube and a handle fixedly connected to the proximal part of the outer sheath tube. The handle includes a locking mechanism and a driving mechanism. The locking mechanism includes a front housing and a locking component assembled into the front housing. The driving mechanism includes a knob, a screw, a slider, and a slide rail. The rotation of the knob can drive the driving mechanism to realize the release function of the delivery system. A positioning hole is provided on the distal end face of the knob, and the locking component is cooperatively connected with the positioning hole to realize the locking function of the delivery system. In this technical solution, when rotated to the desired angle, manual operation of the locking mechanism is required to maintain the desired bending angle, which is inconvenient in clinical surgical operations, and multiple lockings may be required during the adjustment process, making the operation more complicated and lengthening the surgical operation time.
[0005] Patent CN110292464A discloses an adjustable-bending interventional valve delivery system, including an adjustable-bending sheath tube, a sheath core placed inside the adjustable-bending sheath tube, and an operating handle connected to the proximal ends of both the adjustable-bending sheath tube and the sheath core. The adjustable-bending sheath tube includes a tube body and a traction wire. The tube body has a distal end and a proximal end. The distal end of the tube body is bent by the pulling of the traction wire, and the proximal end of the traction wire is connected to the operating handle. The operating handle includes: a fixed body with a hollow structure; a traction member slidably installed inside the fixed body and connected to the traction wire; a driving mechanism installed on the fixed body to drive the traction member to move; a control mechanism installed on the fixed body to drive the adjustable-bending sheath tube to move. This technical solution can only meet the angle control in a single adjustable-bending direction. However, the blood vessels in the human body are tortuous. Especially when entering the right atrium through the inferior vena cava and then passing through the atrial septum to reach the left atrium, and further aligning with the mitral valve orifice, its access route requires at least two adjustable bends at different angles, and the existing solutions cannot meet its adjustable-bending requirements.
[0006] In summary, the delivery systems in the prior art only have adjustable bends in one direction and cannot meet the regulation requirements of two or more adjustable bending degrees. And simply stacking adjustable-bending tubes will cause the inner adjustable-bending sheath tube to be affected by the angle of the outer adjustable-bending sheath tube, resulting in interference and inaccurate angle regulation. Moreover, the adjustable-bending angle cannot be locked in real time during the rotation operation, which is inconvenient for operation. Summary of the Invention
[0007] In view of the above and other more ideas, this application is proposed.
[0008] One of the purposes of this application is to overcome the deficiencies of the prior art. For problems such as the adjustable-bending angle not being able to be locked in real time during the rotation operation of a delivery system and the delivery catheter only being able to meet the one-way adjustable-bending angle, an interventional system for delivering a valve clip is provided.
[0009] According to another aspect of the present application, an interventional system for delivering a valve clip on a delivery system is provided, including: a fixed bracket, a first delivery module, a second delivery module, and a third delivery module; wherein, the first delivery module includes a first control body and a first delivery tube, and the second delivery module includes a second control body and a second delivery tube; and, a part of the second delivery tube is disposed within the first delivery tube; both the first delivery module and the second delivery module are provided with a rotation locking mechanism, the rotation locking mechanism is cooperatively fixed with the fixed bracket, rotating the first control body or the second control body can drive the first delivery tube or the second delivery tube to rotate, and, the rotation locking mechanism can lock the rotation angle in real time; wherein, the first delivery tube includes a first tube body and a bending section disposed at the distal end of the first tube body; the second delivery tube includes a second tube body, an adaptive section disposed at the distal end of the second tube body, a holding section disposed at the distal end of the adaptive section, and a bending adjustment section disposed at the distal end of the holding section; wherein, the adaptive section and the bending section are axially overlapped; and, the holding section is axially misaligned with the bending section or a part of the holding section is axially overlapped with the bending section, and wherein, the third delivery module includes a third control body and a third delivery assembly, and a part of the third delivery assembly is disposed within the second delivery tube.
[0010] According to one embodiment, the rigidity strength of the second tube body is greater than that of the adaptive section; and, the rigidity strength of the adaptive section is less than that of the holding section; the adaptive section is a flexible section, and the adaptive section and the bending section are axially overlapped, so that when the bending section is bent, the adaptive section will not affect the bending degree of the bending section.
[0011] According to one embodiment, the rigidity strength of the holding section is greater than that of the bending adjustment section; the holding section is a tube body with a relatively large rigidity strength.
[0012] According to one embodiment, a first transition section is provided between the second tube body and the adaptive section, and the rigidity strength of the first transition section is between that of the second tube body and the adaptive section; and a second transition section is provided between the adaptive section and the holding section, and the rigidity strength of the second transition section is between that of the adaptive section and the holding section; and a third transition section is provided between the holding section and the bending adjustment section, and the rigidity strength of the third transition section is between that of the holding section and the bending adjustment section; the designs of the first transition section, the second transition section, and the third transition section are for the need of performance transition from strong to weak or from weak to strong between tube bodies with different strengths, so as to avoid breakage between tube bodies with different strengths.
[0013] According to an embodiment, the holding section is a straight section, and the holding section does not conform to the curvature of the bending section; the straight section can ensure that the proximal part of the bending section is not affected by the bending curvature of the bending section and maintains a high degree of freedom, so as to facilitate precise bending adjustment thereof.
[0014] According to an embodiment, the rigidity strength of the first tube body is greater than that of the bending section; wherein, a fourth transition section is provided between the first tube body and the bending section, and the rigidity strength of the fourth transition section is between that of the first tube body and the bending section.
[0015] According to an embodiment, the bending section is provided with a radial support structure, and when the bending section is in a bent state, the radial support structure provides a radial support force for the bending section; this radial support structure can prevent the bending section from being bent during bending adjustment, resulting in extrusion of its lumen, affecting the delivery and operation of the second delivery tube.
[0016] According to an embodiment, the first delivery tube further includes a pull ring and a bending adjustment member. The pull ring is arranged at the distal end of the bending section, and one end of the bending adjustment member is fixed to the pull ring and the other end extends to the proximal end of the first tube body; wherein, at least two bending adjustment members are provided, and one ends of the bending adjustment members are fixed at different positions on the circumference of the pull ring; the purpose of such a design is that when a single bending adjustment member is used for bending adjustment, it can only be a curvature adjustment in a single dimension or a single direction, while setting multiple bending adjustment members and fixing one ends at different positions on the circumference of the pull ring can achieve curvature adjustment in multiple dimensions or multiple directions, meeting different surgical access methods, and having good clinical significance.
[0017] According to an embodiment, the inner layer of the first delivery tube is covered with a film, and an anti - detachment film structure is provided at the distal end of the first delivery tube.
[0018] According to an embodiment, the rotation locking mechanism includes a rotating member and a locking device. The rotating member is connected to the first or second control body and can rotate relatively. The first or second control body is provided with a number of locking holes; and when the rotation rotates relative to the first or second control body to a required angle, the locking structure cooperates with the locking holes and makes the first or second delivery module maintain at the required angle.
[0019] According to an embodiment, the locking device includes a device body, an elastic member arranged in the device body and a locking member. One end of the elastic member is fixed in the device body and the other end cooperates with the locking member; wherein, at least part of the locking member extends out of the outside of the device body, and the locking member can be engaged with the locking hole to achieve locking.
[0020] According to an embodiment, the locking member is generally in a spherical or hemispherical configuration.
[0021] According to one embodiment, the third conveying assembly includes an adapter pipe, an outer pipe, a central control pipe, an inner pipe, and a control wire, which are arranged from outside to inside in sequence. The third control body includes a shrapnel release control member, an inner pipe control member, a central control pipe control member, a locking control member, and a locking judgment device. Among them, a part of the adapter pipe is arranged in the second conveying module. The control wire is connected to the shrapnel release control member, the central control pipe is connected to the central control pipe control member, and the inner pipe is connected to the inner pipe control member. The inner pipe control member is connected to the locking control member, and the locking judgment device cooperates with the locking control member.
[0022] According to one embodiment, the inner pipe includes an inner core and a torque transmission member. The torque transmission member is spirally attached along the outer circumference of the inner core and fixed to the inner core.
[0023] Compared with the prior art, the advantages of the technical solution of the present application at least include the following:
[0024] According to an idea of the present application, the rotation locking mechanism can lock the rotation angle in real time, which greatly facilitates the clinical operation of doctors. Moreover, the adaptive section and the bending section are axially overlapped. When the bending section is bent, the adaptive section can conform to the bending degree of the bending section and will not interfere with the bending of the bending section. At the same time, the maintaining section will not conform to the bending degree of the bending section, so that the bending section still has a high degree of freedom, ensuring that the bending section will not be affected by the curvature of the bending section during bending. Such a clever design enables the first conveying pipe and the second conveying pipe not to interfere with each other during bending respectively, which not only meets the bending requirements in multiple directions but also can perform precise angle adjustment, having great clinical significance.
[0025] According to an idea of the present application, the bending section is also provided with a radial support structure, which can prevent the bending section from being bent during bending, resulting in the extrusion of its lumen and affecting the conveying and operation of the second conveying pipe.
[0026] According to an idea of the present application, there are at least two bending members, and one end of each bending member is fixed at different positions on the circumference of the pull ring. Such a design can achieve multi-dimensional and multi-directional bending of the bending section, meeting the bending requirements of different surgical access methods and having great clinical significance.
[0027] According to an idea of the present application, the inner pipe needs to rotate during operation, and the torque transmission member can better transmit the torque force, effectively prevent the inner core from being twisted off, and at the same time, the torque transmission member and the inner core are in a fixed relationship, avoiding the inner pipe from being stretched during axial operation and affecting the accuracy of control.
[0028] Embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. Some of these other technical effects may be described below and are foreseeable and understandable by those skilled in the art after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] By referring to the following description in conjunction with the drawings, the above-mentioned features and advantages of these embodiments, as well as other features and advantages and the ways to achieve them, will become more obvious, and the embodiments of the present application can be better understood. In the drawings:
[0030] Figures 1a to 1c FIG. is a schematic diagram of the overall structure of the intervention system of the present invention and a structural diagram of the first delivery tube and the second delivery tube.
[0031] Figures 2a to 2c FIG. is a layout diagram of the second delivery tube of the present invention and a schematic diagram of the internal and external structures of the first delivery tube.
[0032] Figures 3a to 3d FIG. is a schematic diagram of the structure of the rotary locking mechanism of the present invention.
[0033] Figures 4a to 4b FIG. is a schematic diagram of the structure of the third delivery component and the valve clip of the present invention and a schematic diagram of the structure of the inner tube.
[0034] Figures 5a to 5e FIG. is a schematic diagram of the process of bending the first delivery tube and the second delivery tube of the present invention and reaching the target position.
[0035] Figures 6a to 6e FIG. is a schematic diagram of the process of completing the implantation of the valve clip of the present invention.
[0036] The features referred to by each number in the drawings are as follows:
[0037] 1 - Fixed bracket, 11 - Fixed base, 12 - First support frame, 13 - Second support frame, 14 - Third support frame, 2 - First conveying module, 21 - First control body, 22 - First conveying pipe, 221 - First pipe body, 2211 - Fourth transition section, 2212 - Radial support structure, 222 - Bending section, 223 - Pull ring, 224 - Bending adjustment part, 225 - Anti - demoulding structure, 3 - Second conveying module, 31 - Second control body, 32 - Second conveying pipe, 321 - Second pipe body, 322 - Adaptive section, 323 - Holding section, 324 - Bending adjustment section, 325 - First transition section, 326 - Second transition section, 327 - Third transition section, 4 - Third conveying module, 41 - Third control body, 411 - Elastic piece release control part, 412 - Inner pipe control part, 413 - Central control pipe control part, 414 - Locking control part, 415 - Locking judgment device, 42 - Third conveying component, 421 - Control wire, 422 - Outer pipe, 423 - Central control pipe, 424 - Inner pipe, 4241 - Inner core, 4242 - Torque transmission part, 5 - Rotation locking mechanism, 51 - Rotating part, 52 - Locking device, 521 - Device body, 522 - Elastic piece, 523 - Locking piece, 53 - Locking hole, 6 - Valve clip, 61 - Inner locking piece, 62 - Outer connecting rod. Detailed implementation mode
[0038] In the following descriptions of the drawings and the detailed implementation mode, the details of one or more embodiments of the present application will be elaborated. From these descriptions, drawings, and claims, other features, purposes, and advantages of the present application can be clearly understood.
[0039] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the drawings. The illustrated embodiments can be other embodiments and can be implemented or executed in various ways. The examples are provided by way of explanation of the disclosed embodiments rather than limitation. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of the present application without departing from the scope or essence of the disclosure of the present application. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still produce additional embodiments. Therefore, the disclosure of the present application covers such modifications and variations that fall within the scope of the appended claims and their equivalent elements.
[0040] Similarly, it can be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising", or "having" and their variants herein is intended to open - endedly include the items listed thereafter, their equivalents, and additional items.
[0041] The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the present application.
[0042] In the present application, the terms "proximal" or "proximal side" refer to the end or side closer to the surgical operator, and "distal" or "distal side" refer to the end or side farther from the surgical operator.
[0043] The delivery systems in the prior art only have bending adjustment in one direction and cannot meet the regulation requirements of two or more bending curvatures. Simply stacking the bending tubes will cause the inner bending sheath tube to be affected by the angle of the outer bending sheath tube, resulting in interference and inaccurate angle regulation. Moreover, the bending angle cannot be locked in real time during rotation operation, making the operation inconvenient.
[0044] One of the purposes of the embodiments described below is to address the above-mentioned defects and other problems. Embodiment 1
[0045] As Figures 1a to 1c shown, an interventional system for delivering a valve clip on a delivery system according to an embodiment of the present application is illustrated, including: a fixed bracket 1, a first delivery module 2, a second delivery module 3, and a third delivery module 4; wherein, the first delivery module 2 includes a first control body 21 and a first delivery tube 22, and the second delivery module 3 includes a second control body 31 and a second delivery tube 32; and, a part of the second delivery tube 32 is disposed inside the first delivery tube 22; the first delivery module 2 and the second delivery module 3 are both provided with a rotation locking mechanism 5, the rotation locking mechanism 5 is fixedly coupled with the fixed bracket 1, rotating the first control body 21 or the second control body 31 can drive the first delivery tube 22 or the second delivery tube 32 to rotate, and, the rotation locking mechanism 5 can lock the rotation angle in real time, greatly facilitating the operation of clinical surgery and also improving the accuracy of the regulation of the interventional system; wherein, the first delivery tube 22 includes a first tube body 221 and a bending section 222 disposed at the distal end of the first tube body 221; the second delivery tube 32 includes a second tube body 321, an adaptive section 322 disposed at the distal end of the second tube body 321, a holding section 323 disposed at the distal end of the adaptive section 322, and a bending adjustment section 324 disposed at the distal end of the holding section 323; wherein, the adaptive section 322 and the bending section 222 are axially overlapped; and, the holding section 323 is axially misaligned with the bending section 222 or a part of the holding section 323 is axially overlapped with the bending section 222, and wherein, the third delivery module 4 includes a third control body 41 and a third delivery assembly 42, and a part of the third delivery assembly 42 is disposed inside the second delivery tube 32.
[0046] In the first embodiment, the fixed bracket 1 includes a fixed base 11, a first support frame 12, a second support frame 13, and a third support frame 14 disposed on the fixed base 11. Among them, the second support frame 13 and the third support frame 14 are of an integral structure, and the second support frame 13 and the third support frame 14 can slide relative to the fixed base 11. This sliding method can be manually adjusted or electrically adjusted, which is not limited herein.
[0047] In the first embodiment, the rigid strength of the second pipe body 321 is greater than that of the adaptive section 322; and the rigid strength of the adaptive section 322 is less than that of the holding section 323; the adaptive section 322 is a flexible section, and the adaptive section 322 and the bending section 222 are axially overlapped, so that when the bending section 222 is bent, the adaptive section 322 will not affect the bending curvature of the bending section 222.
[0048] In the first embodiment, the rigid strength of the holding section 323 is greater than that of the bending adjustment section 324; the holding section 323 is a pipe body with a relatively large rigid strength.
[0049] In the first embodiment, as Figure 1c and 2a shown, a first transition section 325 is provided between the second pipe body 321 and the adaptive section 322, and the rigid strength of the first transition section 325 is between that of the second pipe body 321 and the adaptive section 322; and a second transition section 326 is provided between the adaptive section 322 and the holding section 323, and the rigid strength of the second transition section 326 is between that of the adaptive section 322 and the holding section 323; and a third transition section 327 is provided between the holding section 323 and the bending adjustment section 324, and the rigid strength of the third transition section 327 is between that of the holding section 323 and the bending adjustment section 324; the designs of the first transition section 325, the second transition section 326, and the third transition section 327 are for the need of performance transition from strong to weak or from weak to strong between pipe bodies of different strengths, to avoid breakage between pipe bodies of different strengths.
[0050] In the first embodiment, the holding section 323 is a straight section, and the holding section 323 does not conform to the curvature of the bending section 222; the straight section can ensure that the proximal part of the bending adjustment section 324 is not affected by the bending curvature of the bending section 222 and maintains a high degree of freedom, so as to facilitate precise bending adjustment of it.
[0051] In the first embodiment, the rigidity strength of the first pipe body 221 is greater than that of the bending section 222; wherein, a fourth transition section 2211 is provided between the first pipe body 221 and the bending section 222, and the rigidity strength of the fourth transition section 2211 is between that of the first pipe body 221 and the bending section 222.
[0052] In the first embodiment, the bending section 222 is provided with a radial support structure 2212. As Figure 2b shown, when the bending section 222 is in a bent state, the radial support structure 2212 provides a radial support force for the bending section 222; this radial support structure 2212 can prevent the bending section 222 from being bent during bending adjustment, resulting in the extrusion of its lumen, which affects the transportation and operation of the second delivery pipe 32.
[0053] In the first embodiment, the first delivery pipe 22 further includes a pull ring 223 and a bending adjustment member 224. As Figure 2c shown, the pull ring 223 is arranged at the distal end of the bending section 222, one end of the bending adjustment member 224 is fixed to the pull ring 223, and the other end extends to the proximal end of the first pipe body 221; wherein, at least two bending adjustment members 224 are provided, and one ends of the bending adjustment members 224 are fixed at different positions on the circumference of the pull ring 223; the purpose of such a design is that when a single bending adjustment member 224 is used for bending adjustment, it can only be a curvature adjustment in a single dimension or a single direction, while setting multiple bending adjustment members 224 and fixing one ends at different positions on the circumference of the pull ring 223 can achieve curvature adjustment in multiple dimensions or multiple directions, meet different surgical access methods, and have good clinical significance.
[0054] In the first embodiment, the inner layer of the first delivery pipe 22 is covered with a film, and an anti - detachment film structure 225 is provided at the distal end of the first delivery pipe 22; in the clinical operation for treating mitral regurgitation, the implant instrument needs to enter the patient's heart in real time to test whether its specifications are appropriate. If the specifications are not appropriate, the implant instrument needs to be withdrawn along the original path. During the withdrawal process, the instrument may scratch the inner layer film of the first delivery pipe 22, resulting in the need to re - insert a delivery pipe as a passage, which will greatly increase the patient's surgical process. Therefore, in this technical solution, the anti - detachment film structure 225 is designed at the distal end of the first delivery pipe 22, which can effectively prevent the implant instrument from scratching and tearing the inner layer film during recovery, and has good clinical significance.
[0055] In the first embodiment, the rotation locking mechanism 5 includes a rotating member 51 and a locking device 52. The rotating member 51 is connected to the first or second control body 31 and can rotate relatively. The first or second control body 31 is provided with a plurality of locking holes 53. And when the rotation rotates relative to the first or second control body 31 to a required angle, the locking device 52 cooperates with the locking holes 53 to keep the first or second conveying module 3 at the required angle.
[0056] In the first embodiment, the locking device 52 includes a device body 521, an elastic member 522 arranged in the device body 521, and a locking member 523. One end of the elastic member 522 is fixed in the device body 521, and the other end cooperates with the locking member 523. Wherein, at least a part of the locking member 523 extends out of the outside of the device body 521, and the locking member 523 can be engaged with the locking hole 53 to achieve locking, as Figures 3a to 3d shown.
[0057] In the first embodiment, the locking member 523 is generally spherical or hemispherical in configuration.
[0058] In the first embodiment, the third conveying component 42 includes a connecting pipe (not shown), a control wire 421, an outer pipe 422, a middle control pipe 423, and an inner pipe 424 arranged in sequence from outside to inside. The third control body 41 includes a shrapnel release control member 411, an inner pipe control member 412, a middle control pipe control member 413, a locking control member 414, and a locking judgment device 415. Wherein, a part of the connecting pipe (not shown) is arranged in the second conveying module 3. The control wire 421 is connected to the shrapnel release control member 411. The middle control pipe 423 is connected to the middle control pipe control member 413. The inner pipe 424 is connected to the inner pipe control member 412. And the inner pipe control member 412 is connected to the locking control member 414. The locking judgment device 415 cooperates with the locking control member 414, as Figure 4a shown.
[0059] In the first embodiment, the inner pipe 424 includes an inner core 4241 and a torque transmission member 4242. The torque transmission member 4242 is spirally attached along the outer periphery of the inner core 4241 and fixed to the inner core 4241, as Figure 4b shown.
[0060] In the first embodiment, a valve clip 6 for repairing mitral regurgitation is further included. The valve clip 6 includes an inner locking member 61 and an outer connecting rod 62. Moreover, the inner locking member 61 is detachably connected to the inner tube 424. Operating the locking control member 414 can control the inner locking member 61 to lock the valve clip 6, and the locking judgment device 415 can be used to judge the locking effect thereof; the outer connecting rod 62 is detachably connected to the outer tube 422, and the central control tube 423 can control the detachable connection between the valve clip 6 and the third delivery assembly 42; and, an elastic piece for capturing the valve leaflet is further provided on the valve clip 6. The elastic piece is detachably connected to the control wire 421, and the release of the elastic piece is controlled by the elastic piece release control member 411.
[0061] An exemplary operation process of an intervention system for delivering the valve clip 6 on a delivery system in the first embodiment for repairing the mitral valve is as follows:
[0062] 1. Operate the first module so that the first delivery tube 22 enters the right atrium from the inferior vena cava, and operate the first delivery module 2 so that the bending section 222 can be adjusted in angle. Further rotate the first control body 21 so that the first delivery tube 22 rotates. When the required angle is adjusted, the rotation locking mechanism 5 automatically locks this angle. At this time, the adaptive section 322 of the second delivery tube 32 bends along with the curvature of the bending section 222;
[0063] 2. Further operate the second control body 31 to adjust the angle of the bending section 324 of the second delivery tube 32. At the same time, the second control body 31 can also be rotated so that the second delivery tube 32 rotates to adjust the required angle, and finally the distal end of the second delivery tube 32 can be aligned with the mitral valve orifice;
[0064] 3. Further push the third delivery module 4 so that the valve clip 6 enters the left ventricle, and adjust the position so that the elastic piece captures the valve leaflet. After the elastic piece captures the valve leaflet, operate the elastic piece release control member 411 to release the elastic piece and further operate the locking control member 414 to control the inner locking member 61 to lock the valve clip 6;
[0065] 4. Use the locking judgment device 415 to judge whether the valve clip 6 is in a locked state. If it is in a locked state, operate the central control tube control member 413 to make the central control tube 423 retreat proximally, so that the valve clip 6 is detached from the delivery system. Finally, the delivery system is withdrawn from the body to complete the implantation of the valve clip 6.
[0066] The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, structures, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents are intended to be defined by the appended claims.
[0067] The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, constructions, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents thereof are intended to be defined by the appended claims.
Claims
1. An interventional system for delivering a valve clip, comprising: a fixed stent, a first delivery module, a second delivery module, and a third delivery module; characterized in that the first delivery module includes a first control body and a first delivery tube, and the second delivery module includes a second control body and a second delivery tube; and, part of the second delivery tube is disposed within the first delivery tube; both the first delivery module and the second delivery module are provided with a rotation locking mechanism, the rotation locking mechanism is fixedly engaged with the fixed stent, rotating the first control body or the second control body can drive the first delivery tube or the second delivery tube to rotate, and, the rotation locking mechanism can lock the rotation angle in real time; wherein, the first delivery tube includes a first tube body and a bending section disposed at the distal end of the first tube body; the second delivery tube includes a second tube body, an adaptive section disposed at the distal end of the second tube body, a holding section disposed at the distal end of the adaptive section, and a bending adjustment section disposed at the distal end of the holding section; wherein, the adaptive section and the bending section are axially overlapped; and, the holding section is axially misaligned with the bending section or part of the holding section is axially overlapped with the bending section, and wherein, the third delivery module includes a third control body and a third delivery assembly, part of the third delivery assembly is disposed within the second delivery tube; the holding section is a straight section, and, the holding section does not conform to the curvature of the bending section; the adaptive section is a flexible section.
2. The interventional system for delivering a valve clip according to claim 1, characterized in that the rigidity strength of the second tube body is greater than that of the adaptive section; and, the rigidity strength of the adaptive section is less than that of the holding section.
3. The interventional system for delivering a valve clip according to any one of claims 1-2, characterized in that a first transition section is provided between the second tube body and the adaptive section, and the rigidity strength of the first transition section is between that of the second tube body and the adaptive section; a second transition section is provided between the adaptive section and the holding section, and the rigidity strength of the second transition section is between that of the adaptive section and the holding section; and a third transition section is provided between the holding section and the bending adjustment section, and the rigidity strength of the third transition section is between that of the holding section and the bending adjustment section.
4. The interventional system for delivering a valve clip according to claim 1, characterized in that the bending section is provided with a radial support structure, and when the bending section is in a bent state, the radial support structure provides a radial support force for the bending section.
5. The interventional system for delivering a valve clip according to claim 1, characterized in that the first delivery tube further includes a pull ring and a bending adjustment member, the pull ring is disposed at the distal end of the bending section, one end of the bending adjustment member is fixed to the pull ring and the other end extends to the proximal end of the first tube body; wherein, at least two bending adjustment members are provided, and, one ends of the bending adjustment members are fixed at different positions on the circumference of the pull ring.
6. The interventional system for delivering a valve clip according to claim 1, characterized in that, the rotation locking mechanism includes a rotating member and a locking device, the rotating member is connected to the first control body or the second control body and can rotate relatively, and the first control body or the second control body is provided with a plurality of locking holes; and when the rotating member rotates relative to the first control body or the second control body to a required angle, the locking device cooperates with the locking holes and enables the first delivery module or the second delivery module to be maintained at the required angle.
7. The interventional system for delivering a valve clip according to claim 6, characterized in that, the locking device includes a device body, an elastic member arranged in the device body and a locking member, one end of the elastic member is fixed in the device body and the other end cooperates with the locking member; wherein, at least part of the locking member extends out of the outside of the device body, and the locking member can be engaged with the locking hole to achieve locking.
8. The interventional system for delivering a valve clip according to claim 7, characterized in that, the locking member has a spherical or hemispherical structure.
9. The interventional system for delivering a valve clip according to claim 1, characterized in that, the third delivery assembly includes a connecting pipe, an outer pipe, a middle control pipe, an inner pipe and a control wire arranged in sequence from outside to inside, and the third control body includes a shrapnel release control member, an inner pipe control member, a middle control pipe control member, a locking control member and a locking judgment device; wherein, part of the connecting pipe is arranged in the second delivery module, the control wire is connected to the shrapnel release control member, the middle control pipe is connected to the middle control pipe control member, the inner pipe is connected to the inner pipe control member; and the inner pipe control member is connected to the locking control member, and the locking judgment device cooperates with the locking control member.
10. The interventional system for delivering a valve clip according to claim 9, characterized in that, the inner pipe includes an inner core and a torque transmission member, and the torque transmission member is spirally attached along the outer periphery of the inner core and fixed to the inner core.
Citation Information
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Bendable intervention valve conveying system
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