WO2023040680A1 - 植入式医疗器械 - Google Patents

植入式医疗器械 Download PDF

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Publication number
WO2023040680A1
WO2023040680A1 PCT/CN2022/116791 CN2022116791W WO2023040680A1 WO 2023040680 A1 WO2023040680 A1 WO 2023040680A1 CN 2022116791 W CN2022116791 W CN 2022116791W WO 2023040680 A1 WO2023040680 A1 WO 2023040680A1
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WO
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Prior art keywords
clamping
arm
locking member
auxiliary
main
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PCT/CN2022/116791
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English (en)
French (fr)
Inventor
胡贯朋
徐军
林林
Original Assignee
上海汇禾医疗器械有限公司
上海汇禾医疗科技有限公司
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Application filed by 上海汇禾医疗器械有限公司, 上海汇禾医疗科技有限公司 filed Critical 上海汇禾医疗器械有限公司
Publication of WO2023040680A1 publication Critical patent/WO2023040680A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • the embodiments of the present application relate to the technical field of medical devices, in particular to an implantable medical device.
  • Mitral valve, tricuspid valve, aortic valve, pulmonary valve and other common diseases are valvular insufficiency.
  • Current treatment options include aggressive surgical approaches.
  • Commonly used thoracotomy is highly invasive and requires establishment of extracorporeal circulation, which has a high incidence of complications and risk of infection. Patients need to bear huge intraoperative and postoperative risks, as well as huge mental and economic pressure.
  • an existing instrument uses a torsion spring to drive the clamping arm to clamp the target tissue.
  • the present application provides an implantable medical device that can provide reliable and stable clamping force and is suitable for clamping target tissues of different thicknesses.
  • the application provides an implantable medical device, a mandrel; a locking structure, which includes a main base and an auxiliary base coaxially connected by the mandrel, and can be between a locked state and an unlocked state Switching; and a plurality of clamping structures, each of which includes a main clamping member on the main base and an auxiliary clamping member on the auxiliary base; wherein, when the When the locking structure is in the unlocked state, the clamping distance and clamping angle between the main clamping piece and the auxiliary clamping piece in each of the clamping structures can be adjusted; wherein, when When the locking structure is in the locked state, the shortest clamping distance and the smallest clamping angle can be formed between the main clamping part and the auxiliary clamping part in each clamping structure .
  • the main base includes an adjustment seat and a clamping seat, the adjustment seat is positioned at the end of the mandrel, and the clamping seat is movably passed through the mandrel and located on the adjustment seat.
  • the main clamping member includes at least two main clamping arms and at least two elastic arms, each of the main clamping arms is pivotally connected to the clamping seat, and each of the elastic arms is pivotally connected to the adjusting seat and each of the main clamping arms;
  • the auxiliary clamping member includes at least two auxiliary clamping arms arranged on the auxiliary base, each of the auxiliary clamping arms and each of the main clamping arms are Arranged in pairs; wherein, the elastic arm can drive the main clip arm to pivot relative to the clamping seat according to the distance between the clamping seat and the adjusting seat; wherein, each of the Different clamping distances can be formed between the main clamping arm and each of the auxiliary clamping arms according to the distance between the auxiliary base and the clamping seat.
  • the clamping structure further includes an abutment wall provided on the auxiliary base; wherein, when the main clamping arm can pivot relative to the clamping seat to gradually approach the auxiliary clamping arm , and push the auxiliary clamping arm to pivot relative to the auxiliary base until the auxiliary clamping arm abuts against the abutting wall.
  • the locking structure includes a first locking member provided on the adjustment seat and a second locking member provided on the auxiliary base; wherein, when the first locking member and When the second locking parts lock each other, the clamping seat and the auxiliary base can form the shortest distance, so that each of the main clamping arms and each of the auxiliary clamping arms can form the shortest clamping distance. distance, and the clamping seat also forms the shortest distance from the adjustment seat, so that the pivot angle of the main clamp arm relative to the mandrel is minimized, and the main clamp arm abuts against the The clamping angle between the auxiliary clamping arms of the abutting wall is minimized.
  • the elastic arm can produce different degrees of elastic compression deformation to form different arm lengths; wherein, when the first locking member and the second locking member are locked together, the elastic arm A continuous resisting force can be applied to the main clamping arm, and the main clamping arm can apply a reverse force to the elastic arm according to the thickness of the target tissue, so that the elastic arm produces different degrees of elastic deformation , until the elastic resisting force of the elastic arm reaches a balance with the opposing force of the main clamp arm.
  • the mandrel is detachably connected to the main base; wherein, when the first locking member and the second locking member are locked to each other, the mandrel can be respectively connected to the The primary base and the secondary base are dissociated and withdrawn from the implantable medical device.
  • the auxiliary base when the auxiliary base is forced to move in a direction away from the adjustment seat in the axial direction of the mandrel, at least one of the first locking member and the second locking member elastically deformable so that the first locking part and the second locking part are disengaged from each other.
  • the first locking member may include a first slope
  • the second locking member may include a second slope; wherein, when the first locking member and the second locking member lock each other When tight, the first slope and the second slope abut against each other.
  • the locking structure further includes a release member provided on the clamping seat; wherein, the release member can move relative to the clamping seat between an abutment position and a non-abutment position; When the release member is at the abutting position, the second locking member can be disengaged from the first locking member; when the releasing member is at the non-abutting position, the first locking member The second locking piece can be locked with the first locking piece.
  • the clamping seat includes an accommodating portion
  • the releasing member includes a body and an abutting portion; wherein, the accommodating portion is used for accommodating the body, and defines the release member relative to the The movement stroke of the clamping seat is for the release member to move between the abutment position and the non-abutment position relative to the clamping seat; when the release member is in the abutment position, The abutting portion can abut against the side wall of the second locking member, so that the second locking member elastically deforms radially outward relative to the mandrel to disengage from the first locking member. Leave.
  • the release member further includes an extension arm extending from the body, and the extension arm includes a first side and a second side oppositely disposed; wherein, the abutting portion is provided on the extension arm On the first side, the clamping seat is provided with a first boss structure; wherein, when the release member is at the abutting position relative to the clamping seat, the first boss structure can abut against supporting the second side of the extension arm, so that the extension arm is elastically deformed radially outward relative to the mandrel, and providing the abutting portion to abut against the side wall of the second locking member .
  • the second side of the extension arm is provided with a second boss structure; wherein, when the release member is at the abutting position relative to the clamping seat, the first boss The structure can abut against the second boss structure to elastically deform the extension arm radially outward relative to the mandrel.
  • the first boss structure includes a first guide slope
  • the second boss structure includes a second guide slope
  • the first guide slope and the second guide slope can cooperate to guide the The releasing member moves between the abutting position and the non-abutting position relative to the clamping seat.
  • one of the first locking member and the second locking member includes a locking hook
  • the other of the first locking member and the second locking member includes a locking groove
  • the implantable medical device of the embodiment of the present application switches between the locked state and the unlocked state by means of the locking structure, so as to adjust the clamping distance and clamping angle of the clamping structure. Or make the clamping structure form the shortest clamping distance and the minimum clamping angle, so that the application can not only repeatedly adjust the clamping operation for the target tissue, but also provide reliable and stable clamping force, thereby improving Surgical success rate.
  • the elastic arm of the clamping structure can provide continuous elastic resistance to the main clamping arm, and at the same time, the main clamping arm can also The thickness of the tissue exerts a reverse force on the elastic arm, so that the elastic arm produces different degrees of elastic deformation until the elastic resisting force of the elastic arm and the reverse force of the main clamp arm reach a balance.
  • the The clamping structure is suitable for clamping target tissues of different thicknesses.
  • FIG. 1 is a schematic diagram of the three-dimensional structure of the implantable medical device of the present application.
  • Fig. 2 is a side structural view of the implantable medical device of the present application.
  • Fig. 3 is a schematic diagram of an exploded structure of the implantable medical device of the present application.
  • 4 to 6 are structural schematic diagrams of the locking structure of the implantable medical device of the present application switching from an unlocked state to a locked state.
  • Figures 7 to 12 are structural schematic diagrams of the locking structure of the implantable medical device of the present application switching from the locked state to the unlocked state, wherein Figure 9 and Figure 10 are respectively along the A-A section line and B-B section of Figure 8 Schematic diagram of a cross section of a line.
  • Fig. 13 and Fig. 14 are partial structural schematic diagrams of the auxiliary clamping part of the implantable medical device of the present application.
  • 15 to 16 are partial structural schematic diagrams of the release member and the clamping seat of the implantable medical device of the present application.
  • 17 to 18 are structural schematic diagrams of the release member of another embodiment of the implantable medical device of the present application.
  • 19 to 20 are schematic diagrams of the implantable medical device after the mandrel is withdrawn according to the present application.
  • 21 to 22 are schematic diagrams of the locking structure of another embodiment of the implantable medical device of the present application.
  • FIG. 23 to FIG. 28 are illustrations of target tissue clamping operations performed by the implantable medical device of the present application.
  • Figure 29 is an illustration of a prior art instrument.
  • the clamping device 1 of this embodiment can be used as an edge-to-edge repair implant in the field of interventional treatment of structural heart disease, which can reach the designated anatomical position through a minimally invasive transvascular approach or transatrial appendage, and realize the repair treatment of heart leaflets .
  • the implantable medical device 1 of the present application can be connected to a delivery system 40, so that the implantable medical device 1 can be delivered to a predetermined position (such as the heart) in the patient through the delivery system 40, and The implantable medical device 1 is controlled to perform the clamping operation of the target tissue (such as the heart valve leaflet). After the clamping operation is completed, the delivery system 40 can be dissociated from the implantable medical device 1 and withdrawn from the patient's body.
  • a predetermined position such as the heart
  • the target tissue such as the heart valve leaflet
  • the implantable medical device 1 of the present application mainly includes a mandrel 10 , a locking structure 20 , and a plurality of clamping structures 30 .
  • the locking structure 20 includes a main base 202 and an auxiliary base 208, which can be coaxially connected by the mandrel 10.
  • the main base 202 and the auxiliary base 208 can be locked or disengaged from each other, so that the locking structure 20 Toggles between locked and unlocked states.
  • Each clamping structure 30 includes a main clamping member 302 disposed on the main base 202 and an auxiliary clamping member 308 disposed on the auxiliary base 208 .
  • the clamping distance and clamping angle between the main clamping part 302 and the auxiliary clamping part 308 in each clamping structure 30 can be adjusted.
  • the shortest clamping distance and The minimum clamping angle is used to clamp the target tissue between the main clamping part 302 and the auxiliary clamping part 308 of each clamping structure 30 .
  • the target tissue is, for example, a heart valve leaflet.
  • the main base 202 includes an adjustment seat 204 and a clamping seat 206, the adjustment seat 204 is positioned at the end of the mandrel 10, the clamping seat 206 is movably installed on the mandrel 10 and is located at the adjustment Between the seat 204 and the auxiliary base 208.
  • the main clamping member 302 includes at least two main clamping arms 304 and at least two elastic arms 306, each main clamping arm 304 is pivotally connected to the clamping seat 206, and opposite ends of each elastic arm 306 are pivotally connected to the adjusting seat 204 With each main clamp arm 304.
  • the main clamping member 302 of this embodiment may include two main clamping arms 304 pivotally connected to opposite sides of the clamping seat 206 , and corresponding to the two main clamping arms 304 .
  • Two elastic arms 306 wherein opposite ends of each elastic arm 306 are pivotally connected to the adjustment base 204 and each main clip arm 304 .
  • the clamping seat 206 can move back and forth along the mandrel 10 relative to the adjusting seat 204 to drive the main clamping arm 304 to pivot relative to the clamping seat 206 via the elastic arm 306 .
  • the main clamping arm 304 can be driven relative to the clamping seat via the elastic arm 306 206 pivots, so that the pivot angle of the main clamp arm 304 relative to the mandrel 10 gradually decreases (that is, switches from the non-clamping state in FIG. 1 to the clamping state in FIG. 4 ).
  • the main clamping arm 304 can be driven relative to the clamping seat via the elastic arm 306 206 is reversely pivoted, so that the pivot angle of the main clamp arm 304 relative to the spindle 10 is gradually increased.
  • the auxiliary clamping member 308 may include at least two auxiliary clamping arms 309 disposed on the auxiliary base 208 , each auxiliary clamping arm 309 and each main clamping arm 304 are set in pairs.
  • the clamping seat 206 can be separated from the adjusting seat 204 by a preset distance under the elastic force of the elastic arm 306, so that the clamping seat 206 can be axially positioned relative to the mandrel 10.
  • the The auxiliary base 208 is controlled to reciprocate relative to the clamping seat 206 along the axial direction of the mandrel 10 to adjust the clamping distance D between each main clamp arm 304 and each auxiliary clamp arm 309 .
  • the clamping structure 30 may further include an abutting wall 310 disposed on the auxiliary base 208 .
  • each auxiliary clamp arm 309 (for example, a root portion of the auxiliary clamp arm 309 close to the auxiliary base 208 ) can be elastically deformed to pivot relative to the auxiliary base 208 .
  • each auxiliary clamping arm 309 can be positioned relative to the auxiliary base 208 in an unstressed state, and form a preset clamping angle with the abutting wall 310 (refer to the states shown in FIGS. 2 and 13 ); or Each auxiliary clamp arm 309 can be elastically deformed to pivot relative to the auxiliary base 208 under a stressed state, so that the pivot angle between each auxiliary clamp arm 309 and the abutting wall 310 is reduced.
  • each auxiliary clamping arm 309 can be connected to a traction member 42 (such as a pull cord), so as to drive each auxiliary clamping arm 309 to pivot relative to the auxiliary base 208, so that each auxiliary clamping arm 309 and the abutting wall 310 The pivot angle between them decreases gradually.
  • a traction member 42 such as a pull cord
  • the main clamping arm 304 can pivot relative to the clamping seat 206 to gradually approach the auxiliary clamping arm 309, and push the auxiliary clamping arm 309 to pivot relative to the auxiliary base 208 until the auxiliary clamping arm 309 abuts against abut against the wall 310 (refer to the state shown in FIG. 4 to FIG. 6 and FIG. 14 ).
  • the locking structure 20 may include a first locking member 210 disposed on the adjustment seat 204 and a second locking member 212 disposed on the auxiliary base 208 .
  • the clamping seat 206 can form the shortest distance from the auxiliary base 208, so that each The shortest clamping distance is formed between the main clamp arm 304 and each auxiliary clamp arm 309, and the clamping seat 206 also forms the shortest distance from the adjustment seat 204, so that the pivot angle of the main clamp arm 304 relative to the spindle 10 is minimized , and minimize the clamping angle between the main clamp arm 304 and the auxiliary clamp arm 309 abutting against the abutting wall 310 .
  • the elastic arm 306 can produce different degrees of elastic compression deformation to form different arm lengths.
  • the elastic arm 306 can apply a continuous thrust force to the main clamping arm 304, and at the same time, the main clamping arm 304 can also flex toward the main clamping arm 304 according to the thickness of the target tissue.
  • the arm 306 exerts a reverse force to make the elastic arm 306 elastically deform in different degrees until the elastic resisting force of the elastic arm 306 and the reverse force of the main clamp arm 304 reach a balance.
  • the main clamping arm 304 and the elastic arm 306 can be adaptively adjusted according to the actual thickness of the currently clamped target tissue, so that Different minimum pivot angles are formed between each main clamp arm 304 and the mandrel 10.
  • This design can not only provide the implantable medical device 1 of the present application for clamping target tissues of different thicknesses, but also ensure the The target tissue can be effectively clamped, which can further improve the success rate of heart leaflet repair surgery.
  • the elastic arm 306 of the present application can be designed to have superelasticity, so that target tissues of different thicknesses can not only be effectively clamped, but also receive approximately equal clamping forces.
  • the elastic arm 306 may include at least one of an arcuate bent portion, an S-shaped bent portion, and a Z-shaped bent portion, or the elastic arm 306 may also include at least one of a rhombus ring and a circular ring, whereby The structural strength of the elastic arm 306 is further enhanced to improve the clamping stability.
  • the mandrel 10 is detachably connected to the main base 202, wherein, when the first locking member 210 and the second locking member 212 are locked to each other (that is, the locking structure 20 shown in FIG. state), the mandrel 10 can be separated from the main base 202 and the auxiliary base 208 respectively, and withdrawn from the implantable medical device 1 (refer to FIG. 19 to FIG. 20 ), thereby reducing the amount of implant left in the patient
  • the volume and/or weight of the conventional medical device 1 can be improved to improve the use experience of patients.
  • the mandrel 10 can also be designed as a component of the delivery system 40, so that after the clamping operation of the implantable medical device 1 on the target tissue is completed by the delivery system 40, the mandrel 10 can be moved along with the delivery system 40. Evacuate together.
  • the first locking member 210 may include a locking hook
  • the second locking member 212 may include a locking groove, but it is not limited thereto, and other locking designs that can be repeatedly operated may also be used. There is no limit to this. .
  • the first locking member 210 and the second locking member At least one of the 212 can be elastically deformed, so that the first locking member 210 and the second locking member 212 are disengaged from each other, so that the locking structure 20 is switched from a locked state to an unlocked state for readjusting the target tissue clamping position.
  • the first locking member 210 may include a first slope 214
  • the second locking member 212 may include a second slope 216, wherein, when the first locking member 210 and the second locking member 212 are locked together , the first inclined surface 214 and the second inclined surface 216 can abut against each other, and through the above-mentioned inclined surface design, when the first locking member 210 and the second locking member 212 lock each other, the first inclined surface 214 and the second inclined surface The component force generated by 216 will not cause the first locking member 210 and the second locking member 212 to disengage from each other, so as to ensure the stability of the locking state.
  • a greater force when a greater force is applied to the auxiliary base 208, a greater component force will be generated between the first inclined surface 214 and the second inclined surface 216, and this greater component force can make, for example, the second locking
  • the two locking grooves of the member 212 are elastically deformed outward relative to the radial direction of the mandrel 10 to disengage from the two locking hooks of the first locking member 210 .
  • the locking structure 20 further includes a release member 218 disposed on the clamping seat 206 (refer to the embodiment shown in FIGS. 1 to 20 ).
  • the release member 218 can move relative to the clamping seat 206 between an abutting position and a non-abutting position, wherein, when the releasing member 218 is in the abutting position, the second locking member 212 can be in contact with the second locking member.
  • a locking member 210 is disengaged from each other (refer to the states shown in FIGS. state shown in Figure 4 to Figure 6).
  • the clamping seat 206 includes an accommodating portion 220
  • the releasing member 218 includes a body 222 and an abutting portion 224 (see FIG. 15 to FIG. 16 for cooperation).
  • the accommodating portion 220 of the clamping seat 206 is used to accommodate the body 222, and defines the movement stroke of the release member 218 relative to the clamping seat 206, so that the release member 218 is in the abutting position relative to the clamping seat 206 (refer to 7 to 10) and the non-abutting position (refer to the state shown in FIGS. 4 to 5).
  • the abutting portion 224 can abut against the sidewall of the second locking member 212 , so that the second locking member 212 is elastic radially outward relative to the mandrel 10 deform to separate from the first locking member 210 (refer to the states shown in FIGS. 7 to 10 ).
  • the release member 218 further includes an extension arm 226 extending from the body 222, and the extension arm 226 includes a first side 226a and a second side 226b oppositely disposed.
  • the abutting portion 224 is disposed on the first side 226a of the extension arm 226 (refer to FIG. 17 to FIG. 18 ), and the clamping seat 206 is provided with a first boss structure 228 (refer to FIG. 16 ).
  • the first boss structure 228 can abut against the second side 226 b of the extension arm 226 , so that the extension arm 226 is relative to the radial direction of the mandrel 10 .
  • the second side 226b of the extension arm 226 is provided with a second boss structure 230 (refer to FIG. 15 ), wherein, when the release member 218 is at the abutting position relative to the clamping seat 206, the first boss structure 228 The second boss structure 230 can be pressed against, so that the extension arm 226 is elastically deformed radially outward relative to the core shaft 10 .
  • the design of the first boss structure 228 and/or the second boss structure 230 in this application can further facilitate the disengagement operation between the second locking member 212 and the first locking member 210 .
  • the first boss structure 228 includes a first guide slope 232
  • the second boss structure 230 includes a second guide slope 234
  • the first guide slope 232 and the second guide slope 234 can cooperate cooperate to guide the release member 218 to move relative to the clamping seat 206 between the abutment position and the non-abutment position.
  • the first guiding slope 232 and the second guiding slope 234 can guide the first boss structure 228 and the second boss The structure 230 moves relatively so that the release member 218 can smoothly move from the non-abutting position to the abutting position. Furthermore, when the releasing part 218 and the second locking part 212 in the abutting position are separated from each other, the first guiding slope 232 and the second guiding slope 234 can guide the first boss structure 228 and the second boss structure 230 to reverse Relatively move to assist the release member 218 to automatically reset from the abutting position to the non-abutting position.
  • the adjustment seat 202 (for example, driven by the conveying system 40 ) to move along the axial direction of the mandrel 10 toward the direction of approaching the auxiliary base 208, so that the distance between the adjustment seat 202 and the auxiliary base 208 gradually decreases, so that The clamping distance between the main clamp arm 304 and the auxiliary clamp arm 309 in each clamping structure 30 gradually decreases, and the main clamp arm 304 pivots relative to the mandrel 10, and drives the auxiliary clamp arm 309 relative to the auxiliary base 208 pivot together until the auxiliary clip arm 309 abuts against the abutting wall 310 (that is, switches from the state shown in FIG. 1 to the state shown in FIG. 3 ).
  • the adjusting seat 202 Drive the adjusting seat 202 to move along the axial direction of the mandrel 10 toward the auxiliary base 208, so that the first locking member 210 on the adjusting seat 202 and the second locking member 212 on the auxiliary base 208 are locked together, In this way, the shortest clamping distance and the minimum clamping angle are formed between the main clamping part 302 (main clamping arm 304) and the auxiliary clamping part 308 (auxiliary clamping arm 309), thereby clamping the target tissue (refer to FIG. 5 status shown).
  • the The system 40 drives the adjusting seat 202 to move toward the auxiliary base 208 along the axial direction of the mandrel 10, so that the releasing member 218 provided on the clamping seat 206 is pushed against the releasing member 218 through the adjusting seat 202, so that the releasing member 218 is relative to the clamping
  • the seat 206 moves from the non-abutting position to the abutting position, so that the abutting portion 224 on the release member 218 abuts against the side wall of the second locking member 212, so that the second locking member 212 is diametrically opposed to the spindle 10 Elastically deform outward so as to separate from the first locking member 210 (refer to FIG. 7 to FIG. 10 ).
  • the clamping seat 206 is reset from the abutting position to the non-abutting position (refer to FIG. 11 to FIG. 12 ).
  • the method of using the implantable medical device 1 of the present application to perform heart valve leaflet repair will be exemplarily described below with reference to FIGS. 23 to 28 .
  • the implantable medical device 1 is delivered to the vicinity of the target tissue 2 to be repaired (eg heart valve leaflet) through the delivery system 40 (refer to FIG. 23 ).
  • the target tissue 2 to be repaired eg heart valve leaflet
  • the distance between the adjustment seat 204 and the clamping seat 206 of the implantable medical device 1 is controlled by the delivery system 40 to increase, so that the main clamping arm 304 is driven to pivot relative to the clamping seat 206 via the elastic arm 306 to open, that is, , the pivot angle between the main clamp arm 304 and the mandrel 10 is increased, and the distance between the auxiliary base 208 and the clamping seat 206 is controlled to increase, so that the clamp between the auxiliary clamp arm 309 and the main clamp arm 304
  • the closing distance is increased so that the target tissue to be clamped is positioned between the main clamping arm 304 and the auxiliary clamping arm 309 (refer to FIG. 24 ).
  • the delivery system 40 controls the distance between the auxiliary base 208 and the clamping seat 206 of the implantable medical device 1 to decrease, so that the clamping distance between the main clamp arm 212 and the auxiliary clamp arm 309 decreases, thereby The target tissue 2 is clamped between the primary clamp arm 212 and the secondary clamp arm 308 (refer to FIG. 25 ).
  • the implantable medical device 1 of the present application retains the individual capture function of each target tissue 2 (valve leaflet). Specifically, when the clamping position of a single target tissue 2 is not ideal, it can 42 Pull the auxiliary clamp arm 309 to release the target tissue clamped between the auxiliary clamp arm 309 and the main clamp arm 304 (that is, from the state of Fig. 25 to Fig.
  • the traction member 42 is released to make the auxiliary clamping arm 309 pivot relative to the auxiliary base 208 toward the main clamping arm 304 under the action of the elastic restoring force, so that the target tissue 2 (such as a heart valve leaflet) is clamped Between the main clamping arm 212 and the auxiliary clamping arm 308 (refer to FIG. 25 ), until the clamping state of the target tissue 2 meets expectations.
  • the distance between the adjustment seat and the clamping seat 206 of the implantable medical device 1 is controlled by the delivery system 40 to decrease, so that the main clamping arm 304 is driven to pivot in reverse relative to the clamping seat 206 via the elastic arm 306, so that the main The pivoting angle between the clamp arm 304 and the mandrel 10 gradually decreases, and drives the auxiliary clamp arm 309 to gradually move closer to the direction of the mandrel 10 until the first locking member 210 on the adjustment seat 204 and the auxiliary The second locking elements 212 on the base 208 are locked to each other.
  • the auxiliary clamp arm 309 will be pressed against the abutting wall 310 by the thrust of the main clamp arm 304, and at the same time , the main clamp arm 304 can also apply a reverse force to the elastic arm 306 according to the different thicknesses of the clamped target tissue 2, so that the elastic arm 306 produces different degrees of elastic compression deformation until the elastic arm 306 moves towards the main clamp arm 304.
  • the applied elastic resisting force reaches a balance with the reverse force applied by the main clamp arm 304 to the elastic arm 306, thereby ensuring that the target tissue 2 can be stably and firmly clamped between the main clamp arm 304 and the auxiliary clamp arm 309 (refer to Figure 27).
  • the delivery system 40 (preferably, may further include the mandrel 10) and the implantable medical device 1 are dissociated from each other, so that the delivery system 40 (including the mandrel 10) is withdrawn, thereby completing the target tissue 2 (such as a heart valve). leaf) clamping operation (refer to Figure 28).
  • the implantable medical device switches between the locked state and the locked state by controlling the locking structure, so as to adjust the main clamping part and the auxiliary clamping part in each clamping structure
  • the implantable medical device can repeatedly adjust the clamping position of the target tissue between the main clamping part and the auxiliary clamping part, and has the advantages of simple and safe manipulation, which can effectively improve the success rate of the operation.
  • the elastic arm in the clamping structure can continuously apply elastic resisting force to the main clamping arm, and at the same time, the main clamping arm can also According to the actual thickness of the clamped target tissue, a reverse force is applied to the elastic arm, so that the elastic arm produces different degrees of elastic deformation until the elastic resisting force of the elastic arm and the reverse force of the main clamp arm reach a balance.
  • the design can effectively clamp different tissue thicknesses and the clamping force is approximately equal, and can provide stable and reliable clamping force for the target tissue, so as to improve the success rate of mitral and tricuspid regurgitation surgery.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本申请提供一种植入式医疗器械，主要包括芯轴、锁紧结构、夹持结构，其中，锁紧结构的主基座和辅基座可借由芯轴共轴连接并可在锁紧状态和非锁紧状态之间切换，当锁紧结构处于非锁紧状态时，可供调节夹持结构的夹合间距以及夹合角度，当锁紧结构处于锁紧状态时，可使夹持结构形成最短的夹合间距以及最小化的夹合角度。借此，本申请的植入式医疗器械可提供稳定且可靠的夹持力，并可适于夹持不同厚度的目标组织。

Description

植入式医疗器械 技术领域
本申请实施例涉及医疗器械技术领域，尤其涉及一种植入式医疗器械。
背景技术
二尖瓣，三尖瓣，主动脉瓣，肺动脉瓣等常见发病为瓣膜关闭不全。当下的治疗手段包括积极地进行外科手术方法。常用的开胸手术侵入性大，需要建立体外循环，具有较高的并发症发生率和感染风险。患者需要承受巨大的术中和术后风险，以及巨大的精神和经济压力。当前已经存在一些植入式器械，但在治愈过程中大都需要改变心脏的结构，给心脏术后带了具大的压力以及不适应性。如图29所示的一种现有的器械，采用扭转弹簧提供驱动夹持臂夹紧目标组织，该技术在操作时需要较大的推力推动元件往下从而打开夹持臂，这就需要推力杆具有很强的支撑性，然后经导管手术时，输送***需要通过血管，因此对推力杆尺寸要求极高，且需要随血管通路弯曲而具有柔韧性。并且扭簧的扭力也受到限制。该方案实现起来难度较大。因此，需要提供一种新的植入器械以解决上述问题中的至少一项。
发明内容
鉴于上述问题，本申请提供一种植入式医疗器械，可提供可靠且稳定的夹持力，并可适于夹持不同厚度的目标组织。
本申请提供一种植入式医疗器械，芯轴；锁紧结构，其包括借由所述芯轴共轴连接的主基座和辅基座，并可在锁紧状态和非锁紧状态之间切换；以及多个夹持结构，各所述夹持结构分别包括设于所述主基座上的主夹持件和 设于所述辅基座上的辅夹持件；其中，当所述锁紧结构处于所述非锁紧状态时，可供调节各所述夹持结构中的所述主夹持件与所述辅夹持件之间的夹合间距和夹合角度；其中，当所述锁紧结构处于所述锁紧状态时，各所述夹持结构中的所述主夹持件与所述辅夹持件之间可形成最短的夹合间距和最小化的夹合角度。
可选地，所述主基座包括调节座和夹持座，所述调节座定位于所述芯轴的端部，所述夹持座活动穿设于所述芯轴上并位于所述调节座和所述辅基座之间；所述主夹持件包括至少两个主夹臂以及至少两个弹性臂，各所述主夹臂枢接所述夹持座，各所述弹性臂枢接所述调节座与各所述主夹臂；所述辅夹持件包括设于所述辅基座上的至少两个辅夹臂，各所述辅夹臂与各所述主夹臂为成对设置；其中，所述弹性臂可根据所述夹持座与所述调节座之间的间隔距离，而驱动所述主夹臂相对于所述夹持座枢转；其中，各所述主夹臂与各所述辅夹臂之间可根据所述辅基座与所述夹持座的间隔距离，而形成不同的所述夹合间距。
可选地，所述夹持结构还包括设于所述辅基座上的抵接壁；其中，当所述主夹臂可相对于所述夹持座枢转以逐渐接近所述辅夹臂，并抵推所述辅夹臂相对于所述辅基座联动枢转，直至所述辅夹臂抵接至所述抵接壁。
可选地，所述锁紧结构包括设于所述调节座上的第一锁紧件和设于所述辅基座上的第二锁紧件；其中，当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述夹持座可与所述辅基座形成最短间隔距离，使得各所述主夹臂与各所述辅夹臂之间形成最短的夹合间距，且所述夹持座还与所述调节座形成最短间隔距离，使得所述主夹臂相对于所述芯轴的枢转角度最小化，并使得所述主夹臂与抵接至所述抵接壁的所述辅夹臂之间的所述夹合角度最小化。
可选地，所述弹性臂可产生不同程度的弹性压缩变形以形成不同的臂长；其中，当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述弹性臂可向所述主夹臂施加持续的抵推力，且所述主夹臂可根据所述目标组织的厚度向所 述弹性臂施加反向作用力，以使所述弹性臂产生不同程度的弹性变形，直至所述弹性臂的所述弹性抵推力与所述主夹臂的所述反向作用力达到平衡。
可选地，所述芯轴可拆卸地连接所述主基座；其中，当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述芯轴可分别与所述主基座和所述辅基座解离，并从所述植入式医疗器械上撤离。
可选地，当所述辅基座受力沿所述芯轴的轴向朝远离所述调节座的方向移动时，所述第一锁紧件和所述第二锁紧件中的至少一个可弹性变形，使得所述第一锁紧件和所述第二锁紧件相互解离。
可选地，所述第一锁紧件可包括第一斜面，所述第二锁紧件可包括第二斜面；其中，当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述第一斜面与所述第二斜面相互抵接。
可选地，所述锁紧结构还包括设于所述夹持座上的释放件；其中，所述释放件可相对于所述夹持座在抵接位置和非抵接位置之间移动；当所述释放件处于所述抵接位置时，所述第二锁紧件可与所述第一锁紧件相互解离；当所述释放件处于所述非抵接位置时，所述第二锁紧件可与所述第一锁紧件相互锁紧。
可选地，所述夹持座包括容置部，所述释放件包括本体和抵接部；其中，所述容置部用于容置所述本体，并定义所述释放件相对于所述夹持座的移动行程，以供所述释放件相对于所述夹持座在所述抵接位置与所述非抵接位置之间移动；当所述释放件处于所述抵接位置时，所述抵接部可抵接所述第二锁紧件的侧壁，使得所述第二锁紧件相对于所述芯轴径向向外弹性变形以与所述第一锁紧件相互解离。
可选地，所述释放件还包括自所述本体延伸的延伸臂，所述延伸臂包括相对设置的第一侧和第二侧；其中，所述抵接部设于所述延伸臂的所述第一侧，所述夹持座上设有第一凸台结构；其中，当所述释放件相对于所述夹持座处于所述抵接位置时，所述第一凸台结构可抵顶所述延伸臂的所述第二侧， 使得所述延伸臂相对于所述芯轴的径向向外弹性变形，并提供所述抵接部抵接所述第二锁紧件的侧壁。
可选地，所述延伸臂的所述第二侧设有第二凸台结构；其中，当所述释放件相对于所述夹持座处于所述抵接位置时，所述第一凸台结构可抵顶所述第二凸台结构，以使所述延伸臂相对于所述芯轴径向向外弹性变形。
可选地，所述第一凸台结构包括第一引导斜面，所述第二凸台结构包括第二引导斜面，所述第一引导斜面和所述第二引导斜面可协同配合，以引导所述释放件相对于所述夹持座在所述抵接位置和所述非抵接位置之间移动。
可选地，所述第一锁紧件和所述第二锁紧件中的一个包括锁钩，所述第一锁紧件和所述第二锁紧件中的另一个包括锁槽。
由以上技术方案可见，本申请实施例的植入式医疗器械，借由锁紧结构在锁紧状态与非锁紧状态之间切换，以供调节夹持结构的夹合间距与夹合角度，或使夹持结构形成最短的夹合间距以及最小化的夹合角度，借此，本申请不仅可针对目标组织的夹持操作进行反复调整，亦可提供可靠且稳定的夹持力，从而提高手术成功率。
再者，本申请实施例的植入式医疗器械在锁紧结构处于锁紧状态时，夹持结构的弹性臂可向主夹臂提供持续的弹性抵推力，同时，主夹臂亦可根据目标组织的厚度向弹性臂施加反向作用力，以使弹性臂产生不同程度的弹性变形，直至弹性臂的弹性抵推力与主夹臂的反向作用力达到平衡，借由此结构设计，可供夹持结构适于夹持不同厚度的目标组织。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请实施例中记载的一些实施例，对于本领域普通技术人员来讲，还可以根据这些附图获得其他的附图。
图1为本申请植入式医疗器械的立体结构示意图。
图2为本申请植入式医疗器械的侧视结构图。
图3为本申请植入式医疗器械的分解结构示意图。
图4至图6为本申请植入式医疗器械的锁紧结构由非锁紧状态切换至锁紧状态的结构示意图。
图7至图12为本申请植入式医疗器械的锁紧结构由锁紧状态切换至非锁紧状态的结构示意图，其中，图9和图10分别为沿图8的A-A剖面线和B-B剖面线的截面示意图。
图13和图14为本申请植入式医疗器械的辅夹持件的局部结构示意图。
图15至图16为本申请植入式医疗器械的释放件和夹持座的局部结构示意图。
图17至图18为本申请植入式医疗器械的另一实施例的释放件的结构示意图。
图19至图20为本申请撤离芯轴后的植入式医疗器械的示意图。
图21至图22为本申请植入式医疗器械的另一实施例的锁紧结构的示意图。
图23至图28为利用本申请植入式医疗器械执行目标组织夹持操作的示例图。
图29为现有技术的器械的示例图。
元件标号
1：植入式医疗器械；
10：芯轴；
20：锁紧结构；
202：主基座；
204：调节座；
206：夹持座；
208：辅基座；
210：第一锁紧件；
212：第二锁紧件；
214：第一斜面；
216：第二斜面；
218：释放件；
220：容置部；
222：本体；
224：抵接部；
226：延伸臂；
226a：第一侧；
226b：第二侧；
228：第一凸台结构；
230：第二凸台结构；
232：第一引导斜面；
234：第二引导斜面；
30：夹持结构；
302：主夹持件；
304：主夹臂；
306：弹性臂；
308：辅夹持件；
309：辅夹臂；
310：抵接壁；
40：输送***；
42：牵引件；
2：目标组织。
具体实施方式
为了使本领域的人员更好地理解本申请实施例中的技术方案，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅是本申请实施例一部分实施例，而不是全部的实施例。基于本申请实施例中的实施例，本领域普通技术人员所获得的所有其他实施例，都应当属于本申请实施例保护的范围。
本实施例的夹合器械1可作为结构性心脏病介入治疗领域的缘对缘修复植入体，其能够通过经血管微创入路或者经心耳到达指定解剖位置，实现心脏叶瓣的修复治疗。
请配合参考图2，本申请的植入式医疗器械1可与输送***40相互连接，以借由输送***40将植入式医疗器械1输送至患者体内的预设位置(例如心脏)，并控制植入式医疗器械1执行目标组织(例如心脏瓣叶)的夹持操作，在夹持操作完成后，输送***40可与植入式医疗器械1相互解离，并从患者体内撤离。
如图1至图3所示，本申请的植入式医疗器械1主要包括芯轴10、锁紧结构20、多个夹持结构30。
锁紧结构20包括主基座202和辅基座208，其可借由芯轴10共轴连接，主基座202和辅基座208可相互锁合或相互解离，以使锁紧结构20在锁紧状态和非锁紧状态之间切换。
各夹持结构30分别包括设于主基座202上的主夹持件302和设于辅基座208上的辅夹持件308。
于本实施例中，当锁紧结构20处于非锁紧状态时，可供调节各夹持结构30中的主夹持件302与辅夹持件308之间的夹合间距和夹合角度，当锁紧结构20处于锁紧状态时(参考图5、图19所示状态)，各夹持结构30中的主夹持件302与辅夹持件308之间可形成最短的夹合间距和最小化的夹合角度，借以夹持目标组织于各夹持结构30的主夹持件302与辅夹持件308之间。
于本实施例中，目标组织例如为心脏瓣叶。
请配合参考图2至图3，主基座202包括调节座204和夹持座206，调节座204定位于芯轴10的端部，夹持座206活动穿设于芯轴10上并位于调节座204和辅基座208之间。
可选地，主夹持件302包括至少两个主夹臂304以及至少两个弹性臂306，各主夹臂304枢接夹持座206，各弹性臂306的相对两端枢接调节座204与各主夹臂304。
如图1至图3所示，本实施例的主夹持件302可包括枢接于夹持座206的相对两侧的两个主夹臂304，以及对应于两个主夹臂304设置的两个弹性臂306，其中，各弹性臂306的相对两端分别枢接调节座204和各主夹臂304。
于本实施例中，夹持座206可沿芯轴10相对于调节座204往复移动，以经由弹性臂306驱动主夹臂304相对于夹持座206枢转。
例如，当夹持座206沿着芯轴10的轴向朝接近调节座204的方向移动时(即图2所示的F1方向)，可经由弹性臂306驱动主夹臂304相对于夹持座206枢转，使得主夹臂304相对于芯轴10的枢转角度逐渐减小(即由图1的非夹合状态切换至图4的夹合状态)。反之，当夹持座206沿着芯轴10的轴向朝远离调节座204的方向移动时(即图2所示的F2方向)，可经由弹性臂306驱动主夹臂304相对于夹持座206反向枢转，使得主夹臂304相对于芯轴10的枢转角度逐渐增大。
可选地，辅夹持件308可包括设于辅基座208上的至少两个辅夹臂309，各辅夹臂309与各主夹臂304为成对设置。
于本实施例中，夹持座206可受弹性臂306的弹性作用力与调节座204间隔预设距离，以使夹持座206相对于芯轴10轴向定位，于此状态下，可通过控制辅基座208沿芯轴10的轴向相对于夹持座206往复移动，以调节各主夹臂304与各辅夹臂309之间的夹合间距D。
可选地，夹持结构30还可包括设于辅基座208上的抵接壁310。
于本实施例中，各辅夹臂309的至少一部分(例如辅夹臂309接近辅基座208的根部部分)可弹性变形，以相对于辅基座208枢转。
具体地，各辅夹臂309可在未受力状态下相对于辅基座208定位，并与抵接壁310之间形成预设夹合角度(参考图2、图13所示状态)；或者，各辅夹臂309可在受力状态下产生弹性变形以相对于辅基座208枢转，使得各辅夹臂309与抵接壁310之间的枢转角度减小。
可选地，各辅夹臂309的端部可连接牵引件42(例如拉绳)，借以驱动各辅夹臂309相对于辅基座208枢转，使得各辅夹臂309与抵接壁310之间的枢转角度逐渐减小。
可选地，当主夹臂304可相对于夹持座206枢转以逐渐接近辅夹臂309，并抵推辅夹臂309相对于辅基座208联动枢转，直至辅夹臂309抵接于抵接壁310上(参考图4至图6、图14所示状态)。
可选地，锁紧结构20可包括设于调节座204上的第一锁紧件210和设于辅基座208上的第二锁紧件212。
具体地，当第一锁紧件210与第二锁紧件212相互锁紧时(参考图5、图6、图19)，夹持座206可与辅基座208形成最短间隔距离，使得各主夹臂304与各辅夹臂309之间形成最短的夹合间距，且夹持座206还与调节座204形成最短间隔距离，使得主夹臂304相对于芯轴10的枢转角度最小化，并使得主夹臂304与抵接至抵接壁310的辅夹臂309之间的夹合角度最小化。
于本实施例中，弹性臂306可产生不同程度的弹性压缩变形以形成不同的臂长。
其中，当第一锁紧件210与第二锁紧件212相互锁紧时，弹性臂306可向主夹臂304施加持续的抵推力，同时主夹臂304亦可根据目标组织的厚度向弹性臂306施加反向作用力，以使弹性臂306产生不同程度的弹性变形，直至弹性臂306的弹性抵推力与主夹臂304的反向作用力达到平衡。
也就是说，在第一锁紧件210和第二锁紧件212相互锁紧时，主夹臂304 和弹性臂306可根据当前所夹持的目标组织的实际厚度而进行自适应调节，使得各主夹臂304与芯轴10之间形成不同的最小枢转角度，此设计不仅可提供本申请的植入式医疗器械1适于夹持不同厚度的目标组织，亦可确保各种厚度的目标组织均能被有效地夹紧，此可进一步提高心脏叶瓣修复手术的成功率。
较佳地，本申请的弹性臂306可设计为具有超弹性，使得不同厚度的目标组织不仅均能被有效地夹紧且所受到的夹紧力也近似相等。
可选地，弹性臂306可包括弓形弯折部、S型弯折部、Z型弯折部中的至少一个，或者，弹性臂306也可包括菱形环、圆形环中的至少一个，借以进一步增强弹性臂306的结构强度，以提高夹持稳定性。
可选地，芯轴10为可拆卸地连接主基座202，其中，当第一锁紧件210与第二锁紧件212相互锁紧(即图5所示的锁紧结构20处于锁紧状态)时，芯轴10可分别与主基座202和辅基座208解离，并从植入式医疗器械1上撤离(参考图19至图20)，从而减少留置于患者体内的植入式医疗器械1的体积和/或重量，以提高患者的使用体验。
可选地，亦可将芯轴10设计为输送***40的组成部件，以在借由输送***40完成植入式医疗器械1针对目标组织的夹持作业后，令芯轴10随输送***40一并撤离。
于本实施例中，第一锁紧件210可包括锁钩，第二锁紧件212可包括锁槽，但并不以此为限，亦可采用其他可重复操作的锁紧设计，本申请对此不作限制。。
请参考图21至图22，于本实施例中，当辅基座208受力沿芯轴10的轴向朝远离调节座204的方向移动时，第一锁紧件210和第二锁紧件212中的至少一个可弹性变形，使得第一锁紧件210和第二锁紧件212相互解离，而令锁紧结构20由锁紧状态切换至非锁紧状态，以供重新调整目标组织的夹持位置。
可选地，第一锁紧件210可包括第一斜面214，第二锁紧件212可包括第二斜面216，其中，当第一锁紧件210与第二锁紧件212相互锁紧时，第一斜面214与第二斜面216可相互抵接，借由上述的斜面设计，使得当第一锁紧件210与第二锁紧件212相互锁紧时，第一斜面214与第二斜面216所产生的分力不会使得第一锁紧件210与第二锁紧件212相互脱离，以确保锁紧状态的稳定性。
再者，当针对辅基座208施加更大的作用力时，第一斜面214与第二斜面216之间亦将产生更大的分力，此更大的分力可使得例如第二锁紧件212的两个锁槽相对于芯轴10的径向向外弹性变形，以与第一锁紧件210的两个锁钩相互脱离。
于另一实施例中，锁紧结构20还包括设于夹持座206上的释放件218(参考图1至图20所示实施例)。
于本实施例中，释放件218可相对于夹持座206在抵接位置和非抵接位置之间移动，其中，当释放件218处于抵接位置时，第二锁紧件212可与第一锁紧件210相互解离(参考图7至图10所示状态)，当释放件218处于非抵接位置时，第二锁紧件212可与第一锁紧件210相互锁紧(参考图4至图6所示状态)。
可选地，夹持座206包括容置部220，释放件218包括本体222和抵接部224(配合参考图15至图16)。
其中，夹持座206的容置部220用于容置本体222，并定义释放件218相对于夹持座206的移动行程，以供释放件218相对于夹持座206在抵接位置(参考图7至图10所示状态)和非抵接位置(参考图4至图5所示状态)之间移动。
于本实施例中，当释放件218处于抵接位置时，抵接部224可抵接第二锁紧件212的侧壁，使得第二锁紧件212相对于芯轴10径向向外弹性变形以与第一锁紧件210相互解离(参考图7至图10所示状态)。
可选地，释放件218还包括自本体222延伸的延伸臂226，延伸臂226包括相对设置的第一侧226a和第二侧226b。
于本实施例中，抵接部224设于延伸臂226的第一侧226a(参考图17至图18)，夹持座206上设有第一凸台结构228(参考图16)。
具体地，当释放件218相对于夹持座206处于抵接位置时，第一凸台结构228可抵顶延伸臂226的第二侧226b，使得延伸臂226相对于芯轴10的径向向外弹性变形，以供抵接部224抵接第二锁紧件212的侧壁。
较佳地，延伸臂226的第二侧226b设有第二凸台结构230(参考图15)，其中，当释放件218相对于夹持座206处于抵接位置时，第一凸台结构228可抵顶第二凸台结构230，以使延伸臂226相对于芯轴10径向向外弹性变形。
综上所述，本申请借由第一凸台结构228和/或第二凸台结构230的设计，可进一步有利于第二锁紧件212与第一锁紧件210之间的解离操作。
可选地，参考图15至图16，第一凸台结构228包括第一引导斜面232，第二凸台结构230包括第二引导斜面234，第一引导斜面232和第二引导斜面234可协同配合，以引导释放件218相对于夹持座206在抵接位置和非抵接位置之间移动。
具体地，当处于非抵接位置的释放件218受到外力抵推相对于夹持座206移动时，第一引导斜面232和第二引导斜面234可引导第一凸台结构228和第二凸台结构230相对移动，以供释放件218顺利地由非抵接位置移动至抵接位置。再者，当处于抵接位置的释放件218与第二锁紧件212相互分离后，第一引导斜面232和第二引导斜面234可引导第一凸台结构228和第二凸台结构230反向相对移动，以协助释放件218由抵接位置自动复位至非抵接位置。
以下将结合1至12示例性说明本申请的锁紧结构的锁紧和非锁紧切换操作。
驱动调节座202(例如借由输送***40驱动)沿芯轴10的轴向朝接近 辅基座208的方向移动，以使调节座202和辅基座208之间的间隔距离逐渐减小，使得各夹持结构30中的主夹臂304与辅夹臂309之间的夹合间距逐渐减小，且主夹臂304相对于芯轴10枢转，并驱动辅夹臂309相对于辅基座208一并枢转，直至辅夹臂309抵接于抵接壁310上(即由图1所示状态切换至图3所示状态)。
驱动调节座202沿芯轴10的轴向朝接近辅基座208的方向移动，使得调节座202上的第一锁紧件210与辅基座208上的第二锁紧件212相互锁合，借以使得主夹持件302(主夹臂304)与辅夹持件308(辅夹臂309)之间形成最短的夹合间距和最小化的夹合角度，从而夹持目标组织(参考图5所示状态)。
在第一锁紧件210与第二锁紧件212相互锁紧的状态下，若需重新调整主夹臂304与辅夹臂309之间的目标组织的夹持位置，可借由借由输送***40驱动调节座202沿芯轴10的轴向朝接近辅基座208的方向移动，以经由调节座202抵顶设于夹持座206上的释放件218，使得释放件218相对于夹持座206由非抵接位置移动至抵接位置，以借由释放件218上的抵接部224抵接第二锁紧件212的侧壁，使得第二锁紧件212相对于芯轴10径向向外弹性变形，从而与第一锁紧件210相互解离(参考图7至图10)。
驱动调节座202沿芯轴10的轴向朝远离辅基座208的方向移动，使得调节座202上的第一锁紧件210与辅基座208上的第二锁紧件212相互远离，并驱动辅基座208相对于夹持座206移动，以使夹持座206上的释放件218与第二锁紧件212相互分离，使得第二锁紧件212弹性恢复，同时，释放件218相对于夹持座206由抵接位置复位至非抵接位置(参考了图11至图12)。
以下将配合参阅图23至图28示例性描述利用本申请的植入式医疗器械1执行心脏瓣叶修复治疗的使用方法。
通过输送***40将植入式医疗器械1输送至待修复的目标组织2(例如心脏瓣叶)附近(参考图23)。
通过输送***40控制植入式医疗器械1的调节座204与夹持座206之间的间隔距离增加，以经由弹性臂306驱动主夹臂304相对于夹持座206枢转而打开，亦即，主夹臂304与芯轴10之间的枢转角度增大，并控制辅基座208与夹持座206之间的间隔距离增加，使得辅夹臂309与主夹臂304之间的夹合间距增加，以供待夹持的目标组织定位主夹臂304和辅夹臂309之间(参考图24)。
通过输送***40控制植入式医疗器械1的辅基座208与夹持座206之间的间隔距离减小，使得主夹臂212与辅夹臂309之间的夹合间距减小，借以将目标组织2夹持在主夹臂212和辅夹臂308之间(参考图25)。
需说明的是，本申请的植入式医疗器械1保留了各目标组织2(瓣叶)的单独捕捉功能，具体而言，当单个目标组织2的夹持位置不理想时，可通过牵引件42牵拉辅夹臂309，以释放夹持于辅夹臂309和主夹臂304之间的目标组织(即由图25至图26的状态)，从而重新捕捉目标组织2，并在调整完成之后，释放牵引件42以使辅夹臂309在弹性恢复力的作用下相对于辅基座208朝接近主夹臂304的方向枢转，以使目标组织2(例如心脏瓣叶)被夹持在主夹臂212和辅夹臂308之间(参考图25)，直至目标组织2的夹持状态满足预期。
通过输送***40控制植入式医疗器械1的调节座与夹持座206之间的间隔距离减小，以经由弹性臂306驱动主夹臂304相对于夹持座206反向枢转，使得主夹臂304与芯轴10之间的枢转角度逐渐减小，并带动辅夹臂309随之一并向芯轴10的方向逐渐靠拢，直至调节座204上的第一锁紧件210与辅基座208上的第二锁紧件212相互锁紧。
于理想状态下，当第一锁紧件210与第二锁紧件212相互锁紧时，辅夹臂309将受到主夹臂304的抵推力紧紧地抵靠在抵接壁310上，同时，主夹臂304还可根据被夹持的目标组织2的不同厚度向弹性臂306施加反向作用力，以使弹性臂306产生不同程度的弹性压缩变形，直至弹性臂306向主夹 臂304施加的弹性抵推力与主夹臂304向弹性臂306施加的反向作用力达到平衡，从而确保目标组织2可被稳定且牢固的夹持在主夹臂304和辅夹臂309之间(参考图27)。
将输送***40(较佳地，可进一步包括芯轴10)与植入式医疗器械1相互解离，以将输送***40(包括芯轴10)撤出，从而完成目标组织2(例如心脏瓣叶)的夹合操作(参考图28)。
综上所述，本申请提供的植入式医疗器械通过控制锁紧结构在锁紧状态和所锁紧状态之间切换，以供调节各夹持结构中的主夹持件与辅夹持件之间的夹合间距和夹合角度，或使各夹持结构中的主夹持件与辅夹持件之间形成最短的夹合间距和最小化的夹合角度，借此，本申请的植入式医疗器械可供重复调整目标组织在主夹持件与辅夹持件之间的夹持位置，并具有操控简单且安全的优点，可以有效提高手术成功率。且
再者，本申请的植入式医疗器械，在当锁紧结构处于锁紧状态时，夹持结构中弹性臂可向主夹臂持续地施加弹性抵推力，同时，主夹臂亦可根据其所夹持的目标组织的实际厚度而向弹性臂施加反向作用力，以令弹性臂产生不同程度的弹性变形，直至弹性臂的弹性抵推力与主夹臂的反向作用力达到平衡，此设计可使得不同组织厚度均能被有效地夹紧且夹紧力近似相等，并可为目标组织提供稳定且可靠的夹持力，以提升二、三尖瓣反流治疗手术的成功率。
最后应说明的是：以上实施例仅用以说明本申请实施例的技术方案，而非对其限制；尽管参照前述实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围。

Claims (14)

  1. 一种植入式医疗器械，其特征在于，包括：
    芯轴；
    锁紧结构，其包括借由所述芯轴共轴连接的主基座和辅基座，并可在锁紧状态和非锁紧状态之间切换；以及
    多个夹持结构，各所述夹持结构分别包括设于所述主基座上的主夹持件和设于所述辅基座上的辅夹持件；
    其中，当所述锁紧结构处于所述非锁紧状态时，可供调节各所述夹持结构中的所述主夹持件与所述辅夹持件之间的夹合间距和夹合角度；
    其中，当所述锁紧结构处于所述锁紧状态时，各所述夹持结构中的所述主夹持件与所述辅夹持件之间可形成最短的夹合间距和最小化的夹合角度。
  2. 根据权利要求1所述的植入式医疗器械，其特征在于，
    所述主基座包括调节座和夹持座，所述调节座定位于所述芯轴的端部，所述夹持座活动穿设于所述芯轴上并位于所述调节座和所述辅基座之间；
    所述主夹持件包括至少两个主夹臂以及至少两个弹性臂，各所述主夹臂枢接所述夹持座，各所述弹性臂枢接所述调节座与各所述主夹臂；
    所述辅夹持件包括设于所述辅基座上的至少两个辅夹臂，各所述辅夹臂与各所述主夹臂为成对设置；
    其中，所述弹性臂可根据所述夹持座与所述调节座之间的间隔距离，而驱动所述主夹臂相对于所述夹持座枢转；
    其中，各所述主夹臂与各所述辅夹臂之间可根据所述辅基座与所述夹持座的间隔距离，而形成不同的所述夹合间距。
  3. 根据权利要求2所述的植入式医疗器械，其特征在于，所述夹持结构还包括设于所述辅基座上的抵接壁；其中，
    所述主夹臂可相对于所述夹持座枢转以逐渐接近所述辅夹臂，并抵推所述辅夹臂相对于所述辅基座联动枢转，直至所述辅夹臂抵接至所述抵接壁。
  4. 根据权利要求3所述的植入式医疗器械，其特征在于，所述锁紧结构包括设于所述调节座上的第一锁紧件和设于所述辅基座上的第二锁紧件；其中，
    当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述夹持座可与所述辅基座形成最短间隔距离，使得各所述主夹臂与各所述辅夹臂之间形成最短的夹合间距，且所述夹持座还与所述调节座形成最短间隔距离，使得所述主夹臂相对于所述芯轴的枢转角度最小化，并使得所述主夹臂与抵接至所述抵接壁的所述辅夹臂之间的所述夹合角度最小化。
  5. 根据权利要求4所述的植入式医疗器械，其特征在于，所述弹性臂可产生不同程度的弹性压缩变形以形成不同的臂长；其中，
    当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述弹性臂可向所述主夹臂施加持续的抵推力，且所述主夹臂可根据所述目标组织的厚度向所述弹性臂施加反向作用力，以使所述弹性臂产生不同程度的弹性变形，直至所述弹性臂的所述弹性抵推力与所述主夹臂的所述反向作用力达到平衡。
  6. 根据权利要求4所述的植入式医疗器械，其特征在于，
    所述芯轴可拆卸地连接所述主基座；其中，
    当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述芯轴可分别与所述主基座和所述辅基座解离，并从所述植入式医疗器械上撤离。
  7. 根据权利要求4所述的植入式医疗器械，其特征在于，当所述辅基座受力沿所述芯轴的轴向朝远离所述调节座的方向移动时，所述第一锁紧件和所述第二锁紧件中的至少一个可弹性变形，使得所述第一锁紧件和所述第二锁紧件相互解离。
  8. 根据权利要求7所述的植入式医疗器械，其特征在于，所述第一锁紧件可包括第一斜面，所述第二锁紧件可包括第二斜面；
    其中，当所述第一锁紧件与所述第二锁紧件相互锁紧时，所述第一斜面与所述第二斜面相互抵接。
  9. 根据权利要求4所述的植入式医疗器械，其特征在于，所述锁紧结构还包括设于所述夹持座上的释放件；其中，
    所述释放件可相对于所述夹持座在抵接位置和非抵接位置之间移动；
    当所述释放件处于所述抵接位置时，所述第二锁紧件可与所述第一锁紧件相互解离；
    当所述释放件处于所述非抵接位置时，所述第二锁紧件可与所述第一锁紧件相互锁紧。
  10. 根据权利要求9所述的植入式医疗器械，其特征在于，所述夹持座包括容置部，所述释放件包括本体和抵接部；
    其中，所述容置部用于容置所述本体，并定义所述释放件相对于所述夹持座的移动行程，以供所述释放件相对于所述夹持座在所述抵接位置与所述非抵接位置之间移动；
    当所述释放件处于所述抵接位置时，所述抵接部可抵接所述第二锁紧件的侧壁，使得所述第二锁紧件相对于所述芯轴径向向外弹性变形以与所述第一锁紧件相互解离。
  11. 根据权利要求10所述的植入式医疗器械，其特征在于，所述释放件还包括自所述本体延伸的延伸臂，所述延伸臂包括相对设置的第一侧和第二侧；其中，
    所述抵接部设于所述延伸臂的所述第一侧，所述夹持座上设有第一凸台结构；
    其中，当所述释放件相对于所述夹持座处于所述抵接位置时，所述第一凸台结构可抵顶所述延伸臂的所述第二侧，使得所述延伸臂相对于所述芯轴的径向向外弹性变形，并提供所述抵接部抵接所述第二锁紧件的侧壁。
  12. 根据权利要求11所述的植入式医疗器械，其特征在于，所述延伸臂的所述第二侧设有第二凸台结构；
    其中，当所述释放件相对于所述夹持座处于所述抵接位置时，所述第一 凸台结构可抵顶所述第二凸台结构，以使所述延伸臂相对于所述芯轴径向向外弹性变形。
  13. 根据权利要求12所述的植入式医疗器械，其特征在于，所述第一凸台结构包括第一引导斜面，所述第二凸台结构包括第二引导斜面，所述第一引导斜面和所述第二引导斜面可协同配合，以引导所述释放件相对于所述夹持座在所述抵接位置和所述非抵接位置之间移动。
  14. 根据权利要求4所述的植入式医疗器械，其特征在于，所述第一锁紧件和所述第二锁紧件中的一个包括锁钩，所述第一锁紧件和所述第二锁紧件中的另一个包括锁槽。
PCT/CN2022/116791 2021-09-16 2022-09-02 植入式医疗器械 WO2023040680A1 (zh)

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