CN109984868A - Heart valve prosthesis and conveyer - Google Patents

Heart valve prosthesis and conveyer Download PDF

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Publication number
CN109984868A
CN109984868A CN201711487720.5A CN201711487720A CN109984868A CN 109984868 A CN109984868 A CN 109984868A CN 201711487720 A CN201711487720 A CN 201711487720A CN 109984868 A CN109984868 A CN 109984868A
Authority
CN
China
Prior art keywords
support
ring support
heart valve
valve prosthesis
ring
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201711487720.5A
Other languages
Chinese (zh)
Inventor
侍行坤
阳明
陈国明
李�雨
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
Shanghai Microport Cardioflow Medtech Co Ltd
Original Assignee
Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Minimally Invasive Xintong Medical Technology Co Ltd filed Critical Shanghai Minimally Invasive Xintong Medical Technology Co Ltd
Priority to CN201711487720.5A priority Critical patent/CN109984868A/en
Priority to PCT/CN2018/117162 priority patent/WO2019128582A1/en
Publication of CN109984868A publication Critical patent/CN109984868A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2412Heart 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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial 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

The present invention relates to the field of medical instrument technology more particularly to a kind of distensible ring supports, it may include: artificial valve is set on the ring support;Distensible support construction is connected with the ring support and expands with the expansion of the ring support, shrinks with the contraction of the ring support;Wherein, the support construction is used for when the ring support is in expansion state, provides the support force along the ring support radial direction to the ring support.Above-mentioned heart valve prosthesis, additional support force is radially provided to ring support by support construction, the support force of entire heart valve prosthesis can effectively be promoted, so that can effectively strut the calcified plaque at primary leaflet and leaflet or annulus using bracket, and in the effective vent for being able to maintain that artificial valve later.

Description

Heart valve prosthesis and conveyer
Technical field
The present invention relates to the field of medical instrument technology, more particularly to a kind of heart valve prosthesis and conveyer.
Background technique
The main cause of disease of aortic stenosis is mainly the sequelae of rheumatic fever, congenital aortic textural anomaly or old Year property calcific aortic valve etc. will lead to patient and the malaise symptoms such as expiratory dyspnea, angina pectoris, dizziness or syncope occurs, Severe aortic stenosis results even in patient's die by visitation of God.
Currently, being usually used through conduit aortic valve replacement (Transcatheter Aortic Valve Implantation, abbreviation TAVI) carry out aortic stenosis treatment, i.e., by a prosthese with valve through conduit delivery system System is placed in aortic root, to strut the calcified plaque at primary leaflet and leaflet or annulus using the prosthese, so that artificial Leaflet works instead of primary leaflet.
But the bracket support force of current valve prosthesis is insufficient, the effective vent area that will lead to valve is smaller, to make It obtains curative effect and is unable to reach expection;Especially for severe aortic stenosis in patients, since bracket support force is limited, or even meeting can not Effectively strut calcified plaque.Therefore, how the support force of lifting bracket has become a current industry problem urgently to be resolved.
Summary of the invention
Based on this, it is necessary to provide a kind of heart valve prosthesis and conveyer in view of the above technical problems, pass through and promote branch The support force of frame, the curative effect of Lai Tigao aortic stenosis.
A kind of heart valve prosthesis, it may include:
Distensible ring support;
Artificial valve is set on the ring support;
Distensible support construction is connected with the ring support and expands with the expansion of the ring support , it is shunk with the contraction of the ring support;Wherein, the support construction is used to be in expansion shape in the ring support When state, the support force along the ring support radial direction is provided to the ring support.
In an alternative embodiment, the ring support is using bracket prepared by marmem.
In an alternative embodiment, the ring support is reticular structure, has upper end and opposite with the upper end Lower end, the artificial valve includes leaflet interconnected and skirt, and the skirt is set to the lower end, and the support Structure setting is in the upper end.
In an alternative embodiment, the support construction is located at the annular branch of the opening apart from the upper end At 1/5th of frame to half, the skirt is located at six points of the ring support of the opening apart from the lower end One of at one third.
In an alternative embodiment, the support construction includes sleeve and Duo Gen support rod, the sleeve with it is described Ring support coaxial arrangement, the both ends of the every support rod are connect with the sleeve and the ring support respectively;
Wherein, the multiple support rod is uniformly distributed along the circumferential direction of the ring support, for propping up to the annular Frame provides radially balanced support force;.
In an alternative embodiment, the multiple support rod and the ring support are to be cut using same root tubing Made of integral structure.
In an alternative embodiment, the support rod includes sequentially connected fixed part, folding portion and support portion;
Wherein, the fixed part is used to connect with the ring support for being fixed on the sleeve, the support portion, The folding portion is for keeping having a support angle between the fixed part and the support portion.
In an alternative embodiment, when the ring support is in expansion state, the value model of the support angle Enclose is 60 °~120 °.
In an alternative embodiment, the support angle is 90 °.
In an alternative embodiment, when the ring support is in contraction state, the support angle is 180 °.
In an alternative embodiment, multiple strip grooves are opened up on the outer surface of the sleeve;
Wherein, the extending direction of the strip groove is parallel with the axial direction of the sleeve, the support rod it is described solid Determine portion and be embedded in correspondingly to be fixed in the strip groove.
In an alternative embodiment, the sleeve is hollow rod structure;Along the axis of the sleeve in the strip groove Multiple first through hole are offered to direction;The first through hole is corresponded on the fixed part offers multiple second through-holes;
Wherein, the first through hole is sequentially passed through by suture and the second through-hole corresponding with the first through hole will be described Fixed part is fixed in the strip groove.
In an alternative embodiment, above-mentioned heart valve prosthesis may also include that
Multiple hangers are circumferentially uniformly and fixedly arranged at the opening of the upper end of the ring support, for described The loading of heart valve prosthesis.
In an alternative embodiment, the lower end of the ring support, which opens up, has vacant position, and the vacancy is from the ring The opening of shape pedestal lower end rises, and along the ring support axial direction, is formed in the circumferential direction of the ring support The grid missing of part.
In an alternative embodiment, the quantity of the vacancy is one, two or more;A kind of conveyer can wrap It includes:
Conical head, sheath, inner core, fixing head, inner tube and control handle;
The distal end of said inner tube is linked together with the fixing head, and proximal end is connect with the control handle;
The inner core is located within said inner tube, and the distal end of the inner core passes through the fixing head and the conical head connects It connects, proximal end is connect with the control handle;
Said inner tube is located within the sheath, has an annular compartment between the sheath and said inner tube, for holding Set heart valve prosthesis described in the above-mentioned any one in contraction state;Have between said inner tube and the inner core another Annular compartment, for accommodating the support construction for being in contraction state.
In an alternative embodiment, the conical head is contacted with the sheath, for preventing the sheath from stabbing blood Tube wall.
In an alternative embodiment, the taper head surface coated high molecular material, the conical head are remembered by shape The material for recalling alloy weaves.
In an alternative embodiment, above-mentioned conveyer further include can a loudspeaker section, the proximal end of the loudspeaker section with The sheath is connected, and distally contacts with the conical head, and the loudspeaker section is for preventing the sheath from stabbing vascular wall.
In an alternative embodiment, the loudspeaker section contraction state is horn-like, and unfolded state is and the sheath With the hollow cylinder of diameter.
In an alternative embodiment, the loudspeaker section surface coated high molecular material, the loudspeaker section are remembered by shape The material for recalling alloy weaves.
In an alternative embodiment, the fixing head is tubular structure, and there is the groove that can cooperate with hangers on surface.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of one embodiment cardiac valve prosthesis;
Fig. 2 is the schematic diagram of support construction shown in Fig. 1;
Connection schematic diagram when Fig. 3 is in contraction state between support rod and sleeve;
Fig. 4 is the side view of ring support shown in Fig. 1;
Fig. 5 is the perspective view of ring support shown in Fig. 1;
Fig. 6 is the structural schematic diagram of the conveyer in one embodiment in contraction state;
Fig. 7 is the structural schematic diagram of the conveyer in another embodiment in contraction state.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to the accompanying drawings and embodiments, right The present invention is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, and It is not used in the restriction present invention.
Fig. 1 is the structural schematic diagram of one embodiment cardiac valve prosthesis.As shown in Figure 1, a kind of heart valve prosthesis It may include distensible ring support 100, artificial valve 101 and distensible support construction 10;Ring support 100 can be use Diamond-mesh structure prepared by the marmems such as Nitinol, to pass through external force to ring support 100 to its shape Shape is constrained, and to make its contraction, after external force disappears, ring support 100 is gradually expanded again as its original shape.Artificial valve Film 101 is arranged on ring support 100, for strutting such as primary leaflet and leaflet or valve using the ring support 100 When calcified plaque at ring, replaces primary leaflet and realize corresponding physiological function;Support construction 10 and 100 phase of ring support It connects and is expanded with the expansion of ring support 100, shunk with the contraction of the ring support, in annular When bracket 100 is in unfolded state, the support additional along the radial direction of the ring support 100 is provided to the ring support 100 Power, and then the support force of entire heart valve prosthesis 101 can be effectively promoted, so that ring support 100 can be effective The calcified plaque at primary leaflet and leaflet or annulus is strutted, and can also effectively maintain opening for artificial valve 101 later Mouth size.
Specifically, ring support 100 has upper end 201 and the lower end 202 relative to upper end 201, and blood is through lower end 202 It flows into heart valve prosthesis, and is flowed out through upper end 201.Support construction 10 is set at upper end 201, it is preferable that be set to away from At 1/5th of the ring support 100 of opening from upper end 201 to half;Artificial valve 101 includes at least three Leaflet (such as three leaflets) leaflet interconnected (such as three leaflets) and skirt 103, skirt 103 setting with lower end 202 at, it is excellent Selection of land is set to 1/6th of the ring support 100 of the opening apart from the lower end at one third, and each leaflet One end of (not shown) is connect with skirt, and the other end of the leaflet is then fixed with connection structures such as suture rings 102 On ring support 100.Meanwhile the opening in the upper end of ring support 100 201 is additionally provided with multiple hangers 104, it is multiple Hangers 104 is uniformly distributed along the circumferential direction of ring support 100, in order to which the loading of heart valve prosthesis is implanted into.
Fig. 2 is the schematic diagram of the support construction in Fig. 1 in expansion state.As shown in Fig. 2, in an optional embodiment In, above-mentioned support construction 10 may include sleeve 110 and Duo Gen support rod 105, and sleeve 110 and ring support 100 are coaxially disposed, And one end of every support rod 105 can be connect with sleeve 110, the other end then can be connected to the bracket node 109 of ring support 100 On (as shown in Figure 4), bracket node 109 is the intersection point of two adjacent networks on ring support 100;Wherein, above-mentioned More support rods 105 along sleeve 110 circumferential direction uniformly or non-uniform Distribution, with for ring support 100 be in expansion When state, the support force along 100 radial direction of ring support is provided using sleeve 110 as fulcrum to ring support 100.
The schematic diagram of support rod when Fig. 3 is in contraction state.As shown in figures 2-3, above-mentioned support rod 105 is Using the marmems such as nickel titanium alloy, adnic, copper aluminum series alloy, copper Zn based alloy, iron-based alloy institute The structure of preparation so that the support rod 105 can have a shape memory function, and then with contractile 100 phase of ring support It is compatible.I.e. when ring support 100 is in contraction state, support rod 105 is able to maintain axial parallel (as schemed with sleeve 110 3, shown in 6), in order to the loading of heart valve prosthesis;And when ring support 100 is in unfolded state, due to support rod 105 The alloy with shape memory function used, therefore support rod 105 can restore preset bending shape, with sleeve 110 And there is preset angle (as shown in Figure 2,4) between ring support 100, and then promote the radial support power of ring support 100.
In addition, reducing preparation process difficulty and manufacturing cost in order to promote heart valve prosthesis integration performance, can be used Same root tubing prepares ring support 100 and support rod 105, i.e. the knot that is integrally formed of ring support 100 and support rod 105 Structure, such as the NiTi tubing that outer diameter is 5~15mm can be used, after the diameter dimension after sizing is chosen in cutting according to actual needs, Carry out heat treatment shaping, form the ring support (in unfolded state) that diameter is 20~40mm, such as can by such as cutting, it is hot Processing sizing etc. turns down bracket internally to form above-mentioned support rod 105.Certainly, above-mentioned ring support 100 and support Bar 105 can also mutually independent two components, and connected by such as welding manner, the rotatable connection structure of setting Together.
Meanwhile the default angle when ring support 100 is in unfolded state, between support rod 105 and ring support 100 In the range of 60 °~120 °, such as 60 °, 80 °, 100 ° or 120 ° etc., to ensure that support rod 105 can be to ring support 100 Enough radial support power is provided;In order to enable support rod 105 provides maximum support force to ring support 100, may make Keep support rod 105 perpendicular to the outer profile of ring support 100 when ring support 100 is in unfolded state, i.e., support rod 105 with There is 90 ° of angle between ring support 100;Default angle between support rod 105 and sleeve 110 is also at 60 °~120 ° In range, such as 60 °, 70 °, 90 °, 110 ° or 120 ° etc., to ensure that support rod 105 can obtain the radial support of sleeve 110 Power;In order to enable support rod 105 provides maximum support force to ring support 100, unfolded state can be in ring support 100 When make support rod 105 perpendicular to the outer profile of sleeve 110, i.e., with 90 ° of angle between support rod 105 and sleeve 110.
In an alternative embodiment, as shown in figures 2-3, every support rod 105 may each comprise sequentially connected fixation Portion 105A, folding portion 105B and support portion 105C;Fixed part 105A can be used for being fixed on sleeve 110, and folding portion 105B can be used for Being kept fixed between portion 105A and support portion 105C when ring support 100 is in unfolded state has a support angle, support Portion 105C can be used for being connect with ring support 100 to provide radial support force to ring support 100.
Wherein, that is, folding portion 105B can should for using structure prepared by the marmems such as nickel titanium alloy Folding portion 105B has shape memory function, to keep straight bar shape (such as Fig. 3,6 when ring support 100 is in contraction state It is shown), in order to the loading of heart valve prosthesis;And when ring support 100 is in unfolded state, folding portion 105B can be extensive Multiple bending shape, so that there is preset support angle (as shown in Figure 2,4) between support portion 105C and fixed part 105A, with Support portion 105C is enabled to provide the branch along 100 radial direction of the ring support to ring support 100 for fulcrum with sleeve 110 Support force.
In addition, the value range of above-mentioned preset support angle be 60 °~120 °, such as 60 °, 75 °, 90 °, 105 ° or 120 ° etc., to ensure that support portion 105C can be obtained along the enough support forces of the radial direction of sleeve 110;In order to utmostly make It obtains support rod 105 and provides maximum support force to ring support 100, can to prop up when ring support 100 is in unfolded state For support part 105C perpendicular to fixed part 105A, i.e. support angle between support portion 105C and fixed part 105A is 90 °.
In another alternative embodiment, as shown in figures 2-3, multiple strip grooves are offered on the outer surface of sleeve 110 111, and the extending direction of each strip groove 111 is parallel with the axial direction of sleeve 100, above-mentioned fixed part 105A mono- is a pair of It is embedded in answering and is fixed in strip groove, so that every support rod 105 is fixedly connected with sleeve 110;In addition, solid in order to be promoted The shape of fixed effect, strip groove is matched with the shape of fixed part 105A, so that fixed part 105A can more firmly consolidate It is scheduled in corresponding strip groove 111.Wherein, the axial length of sleeve 110 can be 5~10mm, and the length of fixed part 105A can Length for 3~5mm, and folding portion 105B can be 1~3mm.
In another alternative embodiment, as shown in figures 2-3, sleeve 110 can be hollow rod structure (i.e. hollow circle Column construction), and the axial direction in strip groove 111 along sleeve 110 offers multiple first through hole (not shown)s, and First through hole is corresponded on fixed part 105A and also offers multiple second through-holes 112, in order to utilize the connections knots such as suture Structure, the second through-hole 112 for sequentially passing through first through hole and being stacked with the first through hole, fixed part 105A is fixed on corresponding In strip groove 111.
Fig. 4 is the side view of ring support shown in Fig. 1, and Fig. 5 is the perspective view of ring support shown in Fig. 1.Such as Fig. 1,4 Described in~5, in an alternative embodiment, the lower end 202 of ring support 100, which opens up, has vacant position 108, and vacancy 108 is from institute The opening for stating ring support lower end rises, along 100 axial direction of ring support, the shape on 100 circumference of ring support At part grid missing, that is, the opening close to the ring support lower end, is arranged along the ring support 100 is circumferential It is at least spaced apart there are two network by a vacancy 108 in the first row network of column, which can be triangle Shape, in Fig. 1, along any two network in the first row network of 100 circumferential array of ring support all by One vacancy 108 is spaced apart.By vacancy 108 to be used for when heart valve prosthesis low level is implanted into the patient, by adjusting making Vacancy 108 is obtained to be aligned with right hat sinus side and then avoid being expressed to conductive beam.Wherein, above-mentioned vacancy 108 can be along ring support 100 Circumferential direction uniformly or non-uniform Distribution, in order to adjust the direction of Heart valve prothesis implantation.
As shown in figure 4, in an alternative embodiment, in the outer surface of the central region of adjacent rings bracket 100 On be additionally provided with multiple spine structures 106, in Heart valve prothesis implantation patient's body be pierced into calcification primary leaflet or Ring support 100 is fixed positioning for assisting, avoids valve to aorta direction play by annulus.Wherein, above-mentioned more A spine structure 106 can be uniformly distributed along the circumferential direction of ring support 100, to promote the stability of its stationary positioned.
Meanwhile spine structure 106 and ring support 100 are the integral structure made of the cutting of same root tubing, with into The reduction technology difficulty and production cost of one step.In addition, the material of spine structure 106 can also be marmem, in ring It is attached onto when shape bracket 100 is in contraction state with ring support 100, and when ring support 100 is in unfolded state It is raised in the ring support, loading and conveying in order to heart valve prosthesis, and unfolded state is in ring support 100 When, keep with 60 °~120 ° of angle between the outer surface of ring support 100, such as with such as 60 °, 85 °, 90 °, 115 ° or 120 ° equal angular angles, to ensure that spine structure 106 can be pierced at scheduled position.
In above-mentioned heart valve prosthesis embodiment, by the way that support construction on a toroidal support is arranged, in ring support When in expansion state (i.e. Heart valve prothesis implantation patient's body), which can provide additional to ring support Radial support power guarantees the valve of entire heart valve prosthesis effectively to promote the tension at heart valve prosthesis site of valve orifice With scheduled effective vent area;Simultaneously as vacancy is set at the lower end of ring support, it can be by adjusting the valve of implantation The direction of film enables the vacancy at lower end to be aligned with right hat sinus side, effectively to avoid due to ring support squeezes conductive beam Caused by block complication, and due to opened up on ring support have vacant position meeting so that ring support expand when, annular branch The support force of frame itself is insufficient, and support force additional provided by support construction efficiently solves the problems, such as this.In addition, edge The spine structure of the support rod and setting of ring support circumferential direction distribution on a toroidal support can also effectively increase heart valve Effective height range when Using prosthesis, even if so that heart valve prosthesis occurs dislocation in implantation (as high-order or low level is planted Enter) when can ensure that ring support can strut primary structure.
Fig. 6 is the structural schematic diagram of the conveyer in one embodiment in contraction state.A kind of conveyer may include cone Forming head 301, inner tube 305, control handle (do not indicate) loudspeaker section 302, sheath 303 and fixing head 304 in figure, sheath 303 it is remote End is connect with loudspeaker section 302, and the proximal end of the sheath 303 is then connected to control handle, and the distal end of inner tube 305 is connected to fixing head 304, proximal end is then connected to control handle.There is an annular compartment, any one above-mentioned implementation between sheath 303 and inner tube 305 Heart valve prosthesis (be in compressive state) in example is accommodated in the chamber of sheath 303, in order to by the heart valve prosthesis Loading is internal to patient's, for replacing the aorta petal that lesion occurs.Wherein, which is coated with macromolecule Material, can be for using the shapes such as nickel titanium alloy, adnic, copper aluminum series alloy, copper Zn based alloy, iron-based alloy note Recall structure made of alloy braiding, can shrink and expand under lesser pressure condition and (be unfolded), and in contraction-like Presented when state it is horn-like, and in unfolded state Shi Weiyu sheath 303 with diameter hollow cylinder.
As shown in Figs 1-4, the opening of the upper end of ring support 100 is provided with hangers 104 and is fixed on correspondingly Determine on first 304, heart valve prosthesis is loaded to the scheduled position of patient's body, and then replaces hair using artificial valve The aorta petal of sick change.As shown in fig. 6, running through a seal wire 307 in inner core 306, the both ends of seal wire from conical head 301 and are controlled Handle is pierced by, wherein control handle can be used for controlling sheath 303, inner tube 305 and inner core 306 and move forward and backward.
It is unlike the embodiments above, in another embodiment, as shown in fig. 7, conical head 301 is contacted with sheath 303, 301 surface of conical head is coated with high molecular material, using such as with such as nickel titanium alloy, adnic, copper aluminum series alloy, The marmems such as copper Zn based alloy, iron-based alloy braiding made of structure, can be shunk under lesser pressure condition with Expansion (is unfolded or expands).
In actual application, heart valve prosthesis is loaded in the low temperature environments such as ice-water bath in vitro to as shown in FIG. 6 In conveyer sheath, specifically, the loudspeaker section 302 that can first drop back and sheath 303 make the exposure of fixing head 304;Wherein, it is arrived in recession When 304 part of fixing head, expanding loudspeaker section 302 using external force is with sheath 303 with the hollow cylinder of diameter.Secondly, handle Hangers 104 on ring support 100 snaps fit onto the corresponding card slot of fixing head 304, and inner core 306 is made to pass through ring support 100 sleeve 110 is connected to conical head 301.Then, loudspeaker section 302 and sheath 303 are pushed ahead, makes to be mounted with artificial valve And the ring support 100 in compressive state is put into sheath 303, and the external force applied to loudspeaker section 302 is removed, it is made to restore former State, and the loudspeaker section 302 is bonded with conical head 301, to complete the loading operation of heart valve prosthesis.
Later, conveyer is passed through into seal wire 307, crosses the aortic valve position that bow reaches lesion along femoral artery, loudspeaker of dropping back Section 302 and sheath 303, loudspeaker section 302, which is expanded to, is completely exposed fixing head 304, and hangers 104 falls off from fixing head 304 at this time, And ring support 100 is matched with primary annulus, gradually to discharge heart valve prosthesis, sleeve 110 is not also from inner core 306 at this time It is detached from;Wherein, during heart valve prosthesis discharges, ring support 100 can strut primary leaflet and leaflet or annulus The calcified plaque at place, and loudspeaker section 302 can be expanded to the hollow cylinder with sheath 303 with diameter.Finally, to heart valve prosthesis Completely after release, inner tube 305 of dropping back, so that sleeve 110 passes through fixing head 304, inner core 306 of dropping back, until conical head 301 passes through Sleeve 110 withdraws from conveyer, and sleeve 110 is completely disengaged from inner core 306 at this time, and loudspeaker section 302 bounces back to rapidly original state, into And heart valve prosthesis is loaded to scheduled position.
In the embodiment of above-mentioned conveyer, the size of conical head 301 is less than the internal diameter of sleeve 110, in ring support 100 After release, which can be pierced by from sleeve 110;Simultaneously as the size of conical head 301 is much smaller than sheath 303 Diameter to play connection and smooth effect, and then is kept away so loudspeaker section 302 is arranged between conical head 301 and sheath 303 Exempt from the tube wall when being implanted into human body of sheath 303 and scratches blood vessel.In addition, preparing loudspeaker section 302 using shape memory alloy material, can make The loudspeaker section 302 is both ends when be in swelling state (i.e. unfolded state) with the hollow cylinder of diameter, in order to load with When release, ring support 100 can pass through the loudspeaker section 302.
It is unlike the embodiments above, in another embodiment, as shown in fig. 7, the low temperature environments such as ice-water bath in vitro In middle loading heart valve prosthesis to conveyer sheath, specifically, as shown in fig. 7, the sheath 303 that can first drop back, makes fixing head 304 Exposure;Secondly, the hangers 104 on ring support 100 is snapped fit onto the corresponding card slot of fixing head 304, at this point, conical head 301 Deformation occurs under the extruding of sleeve 110, drives coupled inner core 306 to pass through sleeve 110, then pushes ahead sheath 303, make to be mounted with artificial valve and the ring support 100 in compressive state is put into sheath 303, to complete heart valve vacation The loading operation of body.
Later, conveyer is passed through into seal wire 307, crosses the aortic valve position that bow reaches lesion along femoral artery, sheath of dropping back 303, hangers 104 falls off from fixing head 304 at this time, and ring support 100 is matched with primary annulus, gradually to discharge heart valve Film prosthese, sleeve 110 is not detached from from inner core 306 also at this time;Wherein, during heart valve prosthesis discharges, annular branch Frame 100 can strut the calcified plaque at primary leaflet and leaflet or annulus;Then, recession inner tube 305, so that sleeve 110 is worn Fixing head 304 is crossed, inner core 306 of dropping back withdraws from conveyer by sleeve 110 after deformation occurs up to conical head 301, at this time sleeve 110 completely disengage from inner core 306, and heart valve prosthesis is loaded to scheduled position.
In conclusion implantable cardiac valve prosthesis documented by an embodiment of the present invention and conveyer, by setting The support construction at bracket site of valve orifice is set, with when ring support is in unfolded state, which can be to annular Bracket provides additional radial support power, effectively to promote the tension at heart valve prosthesis site of valve orifice, guarantees entire heart The valve of valve prosthesis has scheduled effective vent area;Simultaneously as vacancy is arranged at the lower end of ring support, can lead to The direction of the valve of adjustment implantation is crossed, the vacancy for flowing into place can be aligned with right hat sinus side, effectively to avoid because of annular Bracket extruding preach beam and caused by block complication, and due to opening up meeting of having vacant position on ring support so that annular is propped up When frame is expanded, the support force of ring support itself is insufficient, and support force additional provided by support construction efficiently solves This problem.In addition, the support rod and setting spine structure on a toroidal support along the distribution of ring support circumferential direction can also Effectively increase effective height range when Heart valve prothesis implantation, even if so that the appearance in implantation of heart valve prosthesis note is wrong It can ensure that ring support can strut primary structure when position.In addition, based on conveying designed by above-mentioned heart valve prosthesis Device can play connection and smooth effect by special loudspeaker section or special conical head, and then sheath is avoided to plant Tube wall scratches blood vessel when entering human body.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.

Claims (23)

1. a kind of heart valve prosthesis characterized by comprising
Distensible ring support;
Artificial valve is set on the ring support;
Distensible support construction is connected with the ring support and expands with the expansion of the ring support, with The contraction of the ring support and shrink;
Wherein, the support construction is used for when the ring support is in expansion state, is provided to the ring support along described The support force of ring support radial direction.
2. heart valve prosthesis according to claim 1, which is characterized in that the ring support is to be closed using shape memory Bracket prepared by gold.
3. heart valve prosthesis according to claim 1, which is characterized in that the ring support is reticular structure, is had Upper end and the lower end opposite with the upper end, the artificial valve include leaflet interconnected and skirt, the skirt setting In the lower end, and the support construction is set to the upper end.
4. heart valve prosthesis according to claim 3, which is characterized in that the support construction is located at apart from the upper end Opening the ring support 1/5th at half, the skirt is located at the opening apart from the lower end The ring support 1/6th at one third.
5. heart valve prosthesis according to claim 1, which is characterized in that the support construction includes sleeve and Duo Gen branch Strut, the sleeve and the ring support are coaxially disposed, the both ends of the every support rod respectively with the sleeve and described Ring support connection.
6. heart valve prosthesis according to claim 5, which is characterized in that the multiple support rod is along the ring support Circumferential direction distribution, for providing support force radially to the ring support.
7. heart valve prosthesis according to claim 5, which is characterized in that the multiple support rod and the ring support For the integral structure made of the cutting of same root tubing.
8. heart valve prosthesis according to claim 5, which is characterized in that the support rod includes sequentially connected fixation Portion, folding portion and support portion;
Wherein, for the fixed part for being fixed on the sleeve, the support portion is described for connecting with the ring support Folding portion is for keeping having a support angle between the fixed part and the support portion.
9. heart valve prosthesis according to claim 8, which is characterized in that when the ring support is in expansion state, The value range of the support angle is 60 °~120 °.
10. heart valve prosthesis according to claim 9, which is characterized in that the support angle is 90 °.
11. heart valve prosthesis according to claim 8, which is characterized in that when the ring support is in contraction state, The support angle is 180 °.
12. heart valve prosthesis according to claim 8, which is characterized in that opened up on the outer surface of the sleeve multiple Strip groove;
Wherein, the extending direction of the strip groove is parallel with the axial direction of the sleeve, the fixed part of the support rod Insertion is fixed in the strip groove correspondingly.
13. heart valve prosthesis according to claim 8, which is characterized in that the sleeve is hollow rod structure;The item Axial direction in shape slot along the sleeve offers multiple first through hole;The first through hole is corresponded on the fixed part to open up There are multiple second through-holes;
Wherein, the first through hole and the second through-hole corresponding with the first through hole are sequentially passed through for the fixation by suture Portion is fixed in the strip groove.
14. heart valve prosthesis according to claim 3, which is characterized in that further include:
Multiple hangers are circumferentially uniformly and fixedly arranged at the opening of the upper end of the ring support, are used for the heart The loading of valve prosthesis.
15. heart valve prosthesis according to claim 3, which is characterized in that the lower end of the ring support opens up free It lacks, the vacancy is from the opening of the ring support lower end, along the ring support axial direction, in the annular branch The grid missing of the part formed in the circumferential direction of frame.
16. heart valve prosthesis according to claim 15, which is characterized in that the quantity of the vacancy is one, two Or it is multiple.
17. a kind of conveyer characterized by comprising
Conical head, sheath, inner core, fixing head, inner tube and control handle;
The distal end of said inner tube is linked together with the fixing head, and proximal end is connect with the control handle;
The inner core is located within said inner tube, and the distal end of the inner core passes through the fixing head and connect with the conical head, closely End is connect with the control handle;
Said inner tube is located within the sheath, has an annular compartment between the sheath and said inner tube, at accommodating In the heart valve prosthesis as described in any one of claim 1~16 of contraction state;Said inner tube and the inner core it Between there is another annular compartment, for accommodate the support construction in contraction state.
18. conveyer according to claim 17, which is characterized in that the conical head is contacted with the sheath, for preventing Only the sheath stabs vascular wall.
19. conveyer according to claim 18, which is characterized in that the taper head surface coated high molecular material, institute Conical head is stated to be woven by the material of marmem.
20. conveyer according to claim 17, which is characterized in that further include a loudspeaker section, the proximal end of the loudspeaker section It is connected with the sheath, is distally contacted with the conical head, the loudspeaker section is for preventing the sheath from stabbing vascular wall.
21. conveyer according to claim 20, which is characterized in that the loudspeaker section contraction state is horn-like, expansion State is with the sheath with the hollow cylinder of diameter.
22. conveyer according to claim 20, which is characterized in that the loudspeaker section surface coated high molecular material, institute Loudspeaker section is stated to be woven by the material of marmem.
23. conveyer according to claim 17, which is characterized in that the fixing head is tubular structure, and surface has can be with The groove of hangers cooperation.
CN201711487720.5A 2017-12-30 2017-12-30 Heart valve prosthesis and conveyer Pending CN109984868A (en)

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