CN106344081B - A kind of left ventricle volume reduction mechanism - Google Patents
A kind of left ventricle volume reduction mechanism Download PDFInfo
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- CN106344081B CN106344081B CN201610855426.4A CN201610855426A CN106344081B CN 106344081 B CN106344081 B CN 106344081B CN 201610855426 A CN201610855426 A CN 201610855426A CN 106344081 B CN106344081 B CN 106344081B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
-
- 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
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00592—Elastic or resilient implements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00615—Implements with an occluder on one side of the opening and holding means therefor on the other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00632—Occluding a cavity, i.e. closing a blind opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
- A61B2017/12095—Threaded connection
Abstract
The present invention relates to a kind of left ventricle volume reduction mechanisms, the pedestal being connect including supporting rack and with support frame as described above, support frame as described above by more support bar groups at, the proximal end of the supporting rod gather to form support frame as described above gather bottom end, it is opened to far from apex of the heart direction adaptability along left ventricle inner wall its distal end, the pedestal includes and the central end gathered bottom end and connect, with the more helical branches extended from the central end to apex of the heart direction, the more helical branches are symmetrical along the center axis rotation of the pedestal, and opening is integrally formed towards the horn-like of apex of the heart direction, support frame as described above is made of shape-memory material and surface is covered with film, the pedestal is made of elastic material, the pedestal is bonded with apex of the heart inner wall adaptability.Present invention reduces instrument displacement, risk of breakage, have good fatigue strength, reduce damage blood vessel and valvular risk.
Description
Technical field
The present invention relates to medical ventricles, and equipment technology field is isolated, more particularly to a kind of left ventricle volume reduction mechanism.
Background technology
In recent years, the illness rate of heart failure increases year by year, increasingly becomes serious public health problem, there is clinical symptoms
Patient is similar with malignant tumour.
Its cause of disease is numerous, and one of most common cause of disease is acute myocardial infarction AMI.Clinically, especially Anterior wall myocardial infarction closes
And left locular wall curvature and thickness can be changed in the patient of aneurysm, leads to the expansion and deformation of entire heart.Since aneurysm influences
Cardiac systolic function, the less left ventricular ejection of the paradoxical movement of aneurysm part.In addition cicatrization, cardiac muscle after myocardial infarction
Variation with edge tissues inherent characteristic increases the influence to contraction and diastolic function, eventually leads to heart failure, can be sent out when serious
Raw sudden death.For such patient, even if giving the drug therapy of optimization, wall tension increase can still cause the lasting expansion of left ventricle
, eventually lead to Cardial pump function heart failure.
For many years, it is always cardiac muscle that surgery ventricular remodeling art cuts off aneurysm, reduces left ventricle by open surgical method
Patients with heart failure reduces end-diastolic volume after infarct, mitigates wall tension and myocardial muscle load, improves the most effective of haemodynamics
Method.But surgery ventricular remodeling art risk is higher, maximum perspective study RESTORE project results show surgery ventricle
The Reconstruction 30d death rates are 5.3%, and five year survival rate is only 70%.
But although the innovation that the method and instrument of heart failure drugs treatment and non-drug therapy continue to develop, mental and physical efforts
The case fatality rate of failure especially ischemic heart failure and again admission rate are still high.
For many years, left ventricle isolation technology flourishes, and all kinds of instruments and technology are developed in succession, percutaneous left ventricle Reconstruction
There is apex aneurysm for ischemic heart failure patient after myocardial infarction using the method for minimally invasive intervention effectively to be controlled
It treats, on the one hand operation risk can be made to substantially reduce；On the other hand, tentative confirmation left ventricle subtracts presently relevant clinical test results
Hold left heart function, exercise tolerance and relevant the haemodynamics ginseng that mechanism can obviously improve heart failure after myocardial infarction patient
Number makes another selection for being reluctant to receive surgical patient.
Parachute ventricles shielding system (Parachute of Cardiokinetix companies) is first based on microcatheter technology
The percutaneous left ventricle of design reconstructs the internal structure of an organization, and is reported in earliest 2007, causes the great interest of medical field, and expansion is extensive therewith
Research, and up to a hundred experiences are had accumulated, and Europe CE certifications were obtained in 2011, the results show that Parachute is to mental and physical efforts
Failure achieves encouraging curative effect, can improve the five-year survival rate of patients with terminal to 80%, at present in America and Europe by 30%
Using more than 500.
Currently, clinical effectiveness teaches that the effect of percutaneous left ventricle Reconstruction can compare favourably with traditional surgery, but
It is that it is similarly faced with the technical barriers such as mechanism fracture, mechanism displacement, complication height.Equally, there is also deficiencies by Parachute
With great operation difficulty.
The invention Parachute left ventricle volume reductions mechanism of Cardiokinetix companies in the U.S., patent of invention is such as
Described in US8377114B2, US2014/017993A1, US2014/0343356A1, which relates to a kind of left ventricle volume reduction machine
Structure, the invention are related to an inverted umbrella-shaped structure, using expanded ptfe (ePTFE) overlay film be fixed on one expansion
On NiTi (NiTi) shape memory alloy metal skeleton, and use one in flat, it is generally petal, and petal
Edge is by being fixedly connected with the pedestal in closed state.The mechanical defect is：1, according to Ventricular torsion motion theory, heart exists
In addition to the periodic contractile diastole campaign in radial direction (perpendicular to base center axis) during shrinking with diastole beating, also
The periodic reverse twist motion of circle rotation direction (being rotated along base center axis) can occur, which discharges in the heart
After nose part, periodic contractile diastole campaign in the radial direction can only be resisted, to carry out the buffering of radial direction, but the bottom of due to
Seat petal edge is in closed state by being fixedly connected, and can not resist the periodic reverse twist motion of circle rotation direction, because
This can not generate the cushioning effect of circle rotation direction, in turn result in a series of problems, including mechanism is driven and is displaced,
The fatigue fracture of pedestal, metallic framework edge anchor thorn fracture, has relevant report in the Clinical Follow-up of the product at present.2,
Since pedestal is generally petal, and petal edge is in closed state by being fixedly connected, and causes to be fit into delivery sheath
The overall space of Shi Suozhan is larger, therefore it is required that delivery sheath is relatively large in diameter, which increase mechanisms in the operations such as importing and release
The risk of process medium vessels and heart valve tissue damage, also limits the scope of application of mechanism；3, after mechanism release completely,
Since (being parallel to base center axis) generates periodic impact force to the blood in heart in the axial direction, the power beater mechanism
Metallic framework collects center and then is transmitted to base center, and is difficult to disperse impact force from base center in flat pedestal
Entire pedestal, including petal edge are reached, therefore pedestal does not generate the effect of damping really in the axial direction, eventually leads to gold
Belong to the metallic framework fatigue fracture that skeleton collects central area, has relevant report in the Clinical Follow-up of the product at present.
Patent CN104739460A describes a kind of left ventricle volume reduction mechanism, and the mechanism body is using Nitinol pipe through swashing
Multi-layer net designs made of light cutting, is pierced into core indoor wall by the main body top far from the apex of the heart, pedestal is compiled by titanium-nickel wire
The modes such as knit into cage structure.The mechanism base there are still the problem identical as Parachute left ventricle volume reduction mechanism bases,
I.e.：1, according to Ventricular torsion motion theory, heart is during shrinking and diastole beating in addition to radial direction is (perpendicular to pedestal
Central shaft) on periodic contractile diastole campaign, the period (rotated along base center axis) it also occur that circle rotation direction
Property reciprocal twist motion, which discharges behind apex of the heart part, can only resist periodic contractile diastole in the radial direction
Movement to carry out the buffering of radial direction, but since pedestal petal edge is by being fixedly connected in closed state, can not resist circle
The periodic reverse twist motion of all direction of rotation, therefore the cushioning effect of circle rotation direction can not be generated, in turn result in one
Series of problems, including mechanism are driven and are displaced, the fatigue fracture of pedestal, the thorn fracture of metallic framework edge anchor；2, due to
(being parallel to base center axis) generates periodic impact force, the main body of the power beater mechanism to blood in heart in the axial direction
Collect center and then be transmitted to pedestal, although the pedestal uses the structure design of the materials such as wire interlacing in the axial direction
Can play cushioning effect, but between wire under the action of periodic shock power can constantly phase mutual friction, be easy to cause
Fatigue fracture；Furthermore 3, the cage structure pedestal of braiding causes mechanism overall length too long, increases the rigidity of system, inconvenient
It is imported in tortuous blood vessel and heart approach system in system, while also bringing great operation difficulty to operation, and be situated between
It is larger to enter the space needed in the process, these may all increase to blood vessel and the traumatogenic risk of heart.
Cause mechanism fatigue disconnected in conclusion existing left ventricle volume reduction mechanism can not be fully solved Ventricular torsion movement
The problem of splitting and shifting.Seriously affect the postoperative quality of life of patient, or even influence the service life, this illustrate mechanism safety and
Validity is in urgent need to be improved.It is heart while shrinking and diastole to trace it to its cause, and also with twist motion, one is generated to mechanism
The power of periodic radial rotation.
Invention content
In view of this, reducing percutaneous left ventricle Reconstruction instrument displacement, fracture wind the purpose of the present invention is to provide a kind of
The left ventricle volume reduction mechanism of danger.
The purpose of the present invention is achieved through the following technical solutions：
A kind of left ventricle volume reduction mechanism, including supporting rack and the pedestal that is connect with support frame as described above, support frame as described above is by more
Root support bar group is at the bottom end of gathering to form support frame as described above, the distal end edge of the supporting rod are gathered in the proximal end of the supporting rod
Left ventricle inner wall is opened to far from apex of the heart direction adaptability, the pedestal include with the central end gathered bottom end and connect,
With the more helical branches extended from the central end to apex of the heart direction, the more helical branches are along in the pedestal
Mandrel rotational symmetry, and opening is integrally formed towards the horn-like of apex of the heart direction, support frame as described above is made of shape-memory material
And surface is covered with film, the pedestal is made of elastic material, and the pedestal is bonded with the inner wall adaptability of the apex of the heart.
Preferably, the helical branches are equipped with crimping in the free end close to the apex of the heart, and the crimping is against the apex of the heart
On inner wall.
Preferably, the crimping passes through part series connection of connecting.
Preferably, the helical branches are equipped with bulb in the free end close to the apex of the heart, and the bulb is against the apex of the heart
On inner wall.
Preferably, through-hole is set in the bulb, in order to which the series connection part connects the bulb across the through-hole.
Preferably, extension rod is set on the helical branches, and one end of the extension rod is close with the helical branches
Apex of the heart end connects, and the other end of the extension rod extends rear steering far from the apex of the heart and the parallel or separate pedestal to apex of the heart direction
The direction of central axes extends.
Preferably, it is provided with hangnail on the extension rod.
Preferably, enhancing structure is equipped between the adjacent helical branches.
Preferably, it is provided with enhancing structure between the helical branches and the central end.
Preferably, the surface of the pedestal is completely or partially covered with film.
It is furthermore preferred that the membrane material be selected from expanded PTFE, polyester, polyurethane elastomer, polyamide, silica gel,
Or animal tissue or degradation material, the degradation material include polylactic acid etc..
Preferably, the pedestal and or support frame as described above shaped after cutting system by the metal tube of marmem material
At.
Preferably, the pedestal and or support frame as described above made by the woven sizing of wire of marmem material
At.
It is furthermore preferred that the shape memory alloy material is selected from Nitinol, cochrome；The material of the pedestal is selected from
Metal material with shape memory function, including Nitinol, cochrome or high molecular material include that polyamide, polyethers are embedding
Section amide, polyurethane, polyimides, polyether-ketone.
It is furthermore preferred that the submount material can also add the material with developing function, which includes selected from metal
Platinumiridio, tantalum, tungsten or compound include barium sulfate, bismuth oxide.
Preferably, support frame as described above and the pedestal are integral structures.
Preferably, the bottom end of gathering is provided with connector, one end of the connector is connect with the pedestal, described
The other end of connector and push rod are detachably connected.
Compared with the existing technology, the beneficial effects are mainly as follows：
1, the helical branches of pedestal setting of the present invention in rotational symmetry and are helical form along the central shaft of pedestal, can not only be supported
Periodic contractile diastole campaign on anti-radial direction (perpendicular to base center axis), to carry out the cushioning effect of radial direction,
The periodic reverse twist motion that circle rotation direction (being rotated along base center axis) can also be resisted, to generate circle rotation side
To cushioning effect, it ensure that pedestal and Ventricular torsion move synchronously, mechanism is made in the twist motion for substantially reducing heart
At torsion, and then reduce pedestal, supporting rod, anchor thorn etc. mechanism assemblies fatigue fracture；Pedestal fortune synchronous with Ventricular torsion
It is dynamic that pedestal is made to be constantly in fit-state with apex of the heart part, the risk that mechanism is displaced is substantially reduced, entire mechanism is promoted
Mechanical stability, also enhance isolation effect.
2, the helical branches structure of pedestal setting of the present invention makes the helical branches of pedestal (be parallel to pedestal in the axial direction
Central shaft) on freely can flexibly stretch, have the function of spring-like, greatly improve damping effect, therefore blood flow can be slowed down
Apex of the heart position is impacted, the apex of the heart caused by reduction is possible damages；Also the risk of reducing mechanism fatigue fracture simultaneously.
3, pedestal of the present invention is integrally formed horn-like, has fine solid space visual impression, behaviour when convenient for patient's positioning
Work judges.
4, pedestal of the present invention is not fixedly connected between the helical branches in apex of the heart region, efficiently reduces conveying sheath
Pipe diameter, and then reduce in mechanism implantation process to human tissue injuries such as blood vessel and heart valves；Operation risk is reduced, is increased
Success rate of operation.
5, pedestal cover film of the present invention, the not only safety of assurance mechanism release process, but also improve the biology after mechanism implantation
The safety of performance etc..
6, pedestal setting of the present invention there is series connection part flexible can make operator that mechanism are easily fit into conveying
It is easy to operate in sheath；The relative position between each helical branches and relative motion can be also effectively constrained but not limited, is avoided
Pedestal tangling between when releasing release in delivery sheath, it is ensured that mechanism discharges the safety of process.
7, movement of the pedestal of the present invention between the helical branches in apex of the heart region is relatively independent, is suitable for different inner wall tables
The ventricle in face expands the accommodation of mechanism.
8, enhancing structure of the invention makes the relative position of the distal portions of helical branches be fixed or effectively be limited,
Enhance the mechanical stability of pedestal or even entire mechanism.When blood impacts, enhancing structure is on the central shaft along pedestal
Also it can carry out a degree of flexible, further increase the damping effect of pedestal, the risk of its fatigue fracture is also greatly lowered.
Description of the drawings
Fig. 1 is the front view of first embodiment of the invention；
Fig. 2 is the structural schematic diagram of first embodiment of the invention；
Fig. 3 is end structure illustration of the first embodiment of the invention pedestal close to apex of the heart one end；
Fig. 4 is that first embodiment of the invention discharges the status diagram in left ventricle；
Fig. 5 is the structural schematic diagram of second embodiment of the invention；
Fig. 6 is that second embodiment of the invention discharges the status diagram in left ventricle；
Fig. 7 is the structural schematic diagram of third embodiment of the invention；
Fig. 8 is end structure illustration of the third embodiment of the invention pedestal close to apex of the heart one end；
Fig. 9 is the structural schematic diagram of four embodiment of the invention；
Figure 10 is the structural schematic diagram of fifth embodiment of the invention；
Figure 11 is the front view after fifth embodiment of the invention extension rod cover film.
1 is supporting rack, and 2 be pedestal, and 3 be connector, and 4 be film, and 5 be the apex of the heart, and 6 be central end, and 7 be anchor thorn, and 8 be spiral
Branch, 9 be left ventricle, and 81 be crimping, and 82 be bulb, and 83 be enhancing structure, and 84 be extension rod, and 85 be hangnail, and 86 be series connection part,
87 be series connection film, and 88 be through-hole, and 10 be supporting rod, and 12 be to gather bottom end.
Specific implementation mode
To make the objectives, technical solutions, and advantages of the present invention more comprehensible, develop simultaneously embodiment referring to the drawings, right
The present invention is further described.
Proximal end of the present invention refers to one end close to the apex of the heart, and the distal end refers to one end far from the apex of the heart.
Embodiment 1：
As shown in Figures 1 to 4, a kind of left ventricle volume reduction mechanism includes the pedestal 2 of supporting rack 1 and the connection of supporting rack 1；It is described
Supporting rack 1 includes the more supporting rods 10 opened to 5 direction adaptability of the separate apex of the heart, and the proximal end of the more supporting rods 10 merges
It is formed together and gathers bottom end 12, the distal end of the supporting rod 10 pierces 7 with anchor, and support frame as described above 1 is released in left ventricle 9
When, 10 adaptability of supporting rod is pierced into core indoor wall to be anchored left ventricle volume reduction mechanism close to core indoor wall, the anchor thorn 7；
The pedestal 2 include with the central end 6 gathered bottom end 12 and connect, and extend from central end 6 to apex of the heart direction more
Root helical branches 8, the more helical branches 8 are symmetrical along the center axis rotation of pedestal 2, and opening is integrally formed towards the apex of the heart
5 it is horn-like, the central end 6 can be equipped with connector 3, the connector 3 be screw thread, buckle or other forms, so as to
It is detachably connected with the push rod of implantation volume reduction mechanism.
After the pedestal 2 is released in left ventricle 9,2 adaptability of pedestal is set close to left ventricle apex of the heart position inner wall, pedestal 2
The helical branches set in rotational symmetry and are helical form along the central shaft of pedestal, can not only resist radial direction (perpendicular to pedestal
Central shaft) on periodic contractile diastole campaign, to carry out the cushioning effect of radial direction, moreover it is possible to resist circle rotation direction
The periodic reverse twist motion of (being rotated along base center axis), to generate the cushioning effect of circle rotation direction, this guarantee
Pedestal and Ventricular torsion move synchronously, and substantially reduce the twist motion of the heart torsion caused by mechanism, and then reduce bottom
The fatigue fracture of the mechanism assemblies such as seat, supporting rod, anchor thorn；Pedestal and Ventricular torsion move synchronously so that pedestal and apex of the heart part
Be constantly in fit-state, substantially reduce the risk that mechanism is displaced, promote the mechanical stability of entire mechanism, also enhance every
From effect.Meanwhile helical branches structure makes helical branches 8 in the axial direction can be free on (central shaft for being parallel to pedestal 2)
It is flexible, have the function of spring-like, greatly improve damping effect, therefore blood flow can be slowed down, apex of the heart position is impacted, reduction can
The apex of the heart caused by energy damages；Also reduce the risk of mechanism fatigue fracture.
In addition, since opening has been integrally formed towards the horn-like of the apex of the heart 5 in pedestal 2, this provides good solid space
Visual impression is convenient for operation judges of the patient when positioning base 2 is in left ventricle apex of the heart position.
Based on the anti-fatigue performance of pedestal 2, the size with the matched delivery sheath of volume reduction mechanism, and manufacture
The cross section of the considerations such as realization method, the helical branches 8 of pedestal 2 can be set to rectangle (as shown in Figure 1), and circle is (such as Fig. 5 institutes
Show), semicircle, trapezoidal and other any shapes, the helical branches 8 also can be configured to such as screw blade, the shapes such as fan leaf
Shape, entire helical branches 8 also can be configured to cross sectional dimensions gradual change, such as gradually from central end 3 towards 5 direction size of the close apex of the heart
Greatly, as shown in Figure 3.
The pedestal 2 and or supporting rack 1 can by marmem material metal tube after cutting shape be made such as Fig. 1
Shape, or by marmem material wire it is woven sizing be made, as shown in Figure 8.The shape memory closes
Golden material is selected from the metal material with shape memory function such as Nitinol, cochrome.The pedestal 2 can also be by poly- ammonia
The flexible high molecular material such as ester, polyamide, polyether block amide, polyimides, polyether-ketone passes through the techniques systems such as injection molding
At.2 material of the pedestal can also add the material with developing function, such as platinumiridio, tantalum, tungsten metal or barium sulfate,
The compounds such as bismuth oxide, to enhance in surgical procedure such as the visualization of positioning.
Left ventricle volume reduction provided by the present invention mechanism can be used to be implanted into through the apex of the heart or the approach intervened through aorta,
It is positioned in left ventricle 9 according to the approach intervened through aorta, wherein the central end and push rod of left ventricle volume reduction mechanism
It is connected, first takes in left ventricle volume reduction mechanism and push rod in delivery sheath；Then, push rod push left ventricle volume reduction mechanism
Suitable position in into left ventricle 9, pedestal first is released from delivery sheath, then supporting rack 1 starts to discharge, until with a left side
Ventricle 9 is adapted, and anchor thorn 7 is pierced on the myocardium inner wall of left ventricle 9, and mechanism is made to be anchored.Push rod is finally rotated, push is made
Bar is detached from central end 3.Since movement of the pedestal between the helical branches in apex of the heart region is relatively independent, pedestal is suitable
The ventricle for answering different inner wall surfaces expands the accommodation of mechanism.Since pedestal 2 is between the helical branches in apex of the heart region
Without being fixedly connected for " closing " formula as using in the prior art so that shared when pedestal is implemented into delivery sheath
Overall space becomes smaller, this effectively reduces delivery sheath diameter, and then reduces mechanism in implantation process to blood vessel and heart
The human tissue injuries such as valve, reduce operation risk, increase success rate of operation.
Film 4 is covered on support frame as described above 1,4 material of the film includes expanded PTFE, polyester, elastic polyurethane
Body, polyamide, silica gel, animal tissue, degradation material (such as polylactic acid etc.), device discharge rear support frame 1 along left ventricle 9
Adhered shape is on the inner wall of left ventricle 9, and finally, left ventricle 9 can be isolated close to the invalid of apex of the heart part in the film 4 on supporting rack 1
Cardiac muscle reduces the volume of left ventricle 9, prevents heart from further expanding, while also reducing the tension of ventricle wall.
Also optionally covering has certain elastic film 4 to the pedestal 2, its pedestal is to the heart after being discharged with reducing mechanism
The stimulation of point 5 improves the safety of biological property after mechanism implantation etc..The cover film such as on the helical branches 8 of pedestal 2
4, it, can also be effective the advantages of each helical branches 8 are together in series, series connection film 87 flexible is formed, can both play 1 pedestal of embodiment
Ground constrains but does not limit the relative position between each helical branches 8 and relative motion, avoids pedestal from being released from delivery sheath and releases
Tangling between when putting, it is ensured that mechanism discharges the safety of process.
Embodiment 2：
As shown in Figure 5 and Figure 6, on the basis of embodiment 1, embodiment 2 difference from example 1 is that, it is described
Helical branches 8 are equipped with crimping 81 close to one end of the apex of the heart 5, and in one embodiment, the crimping 81 is the helical branches 8
Proximal end, which smoothly extends, to be curled into closed circle to the axial direction of pedestal 2 again or is curled into hook-shaped.The crimping 81 is against the apex of the heart 5
Inner wall on.This design has many advantages, such as, including：Convenient for easily releasing mechanism from delivery sheath, prevent from hanging intrathecal
Wall；Enhance the visualization in surgical procedure, location determination when convenient for mechanism release；After mechanism release is in left ventricle 9, both may be used
It is adapted with 5 inner wall of the apex of the heart with smooth, Ventricular torsion can also be reduced and move the torsion generated to mechanism, anti-locking mechanism occurs
Displacement reduces the complication such as side leakage.
Another difference is that the crimping 81 is connected fully or partially through series connection part 86, the series connection part 86
For line, silk or fiber, make series connection part that there is flexibility, as shown in figure 5, series connection part 86 flexible also can reach the identical effect of cover film
Fruit.86 alternative material of series connection part flexible includes polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyester, polyamides
Amine, polytetrafluoroethylene (PTFE), polyarylate, degradation material (such as polylactic acid), polyglycolic acid, sheep casing, animal tendon tissue.This
Outside, by means of part 86 of connecting, entire mechanism can be easily fit into delivery sheath by operator.
Embodiment 3：
As shown in fig. 7, on the basis of embodiment 1, embodiment 3 difference from example 1 is that, the spiral point
The proximal end of branch 8 is equipped with bulb 82, and this design has many advantages, such as, including：Convenient for mechanism is easily released from delivery sheath,
It prevents from hanging sheath inner wall；Enhance the visualization in surgical procedure, location determination when convenient for mechanism release；Mechanism is discharged in left ventricle
After in 9, both can be smooth be adapted with 5 inner wall of the apex of the heart can also reduce Ventricular torsion and move the torsion generated to mechanism, prevent
Locking mechanism is displaced, and reduces the complication such as side leakage.In addition, through-hole 88 can be set in bulb 82, such as the partial sectional view A institutes of Fig. 8
Show, the through-hole 88 is for wearing series connection part 86.
Embodiment 4：
As shown in Fig. 8, Fig. 9 and Figure 10, on the basis of embodiment 3, embodiment 4 and embodiment 3 the difference is that,
Enhancing structure 83 is added between the adjacent helical branches 8, or is provided between central end 6 and helical branches 8
Enhancing structure 83.The enhancing structure 83 can be bar as shown in figure 9, or the enhancing structure 83 is that multiple bars are connected with each other,
As shown in figure 8, the enhancing structure 83 is that silk or line weave, as shown in Figure 10.When the enhancing structure 83 by
When flexible filaments or line are made, the pedestal 2 and support frame as described above 1 can be with relative motions so that the pedestal 2 and support frame as described above
1 can not be coaxial, to adapt to the internal structure of left ventricle 9.In some embodiments, the bar uses linear type, can also select
With such as with 8 same or similar shaped form of helical branches.Enhancing structure 83 makes the relative position of the distal portions of helical branches 8
It is fixed or is effectively limited, enhance the mechanical stability of pedestal 2 or even entire mechanism.When blood impacts, enhancing structure
83 can also carry out a degree of flexible on the central shaft along pedestal 2, further increase the damping effect of pedestal 2, also greatly
The risk of its fatigue fracture of amplitude reduction.
Embodiment 5：
As shown in Figure 10, on the basis of embodiment 4, embodiment 5 and embodiment 4 the difference is that, in the spiral shell
It revolves and extension rod 84 is set in branch 8, one end of the extension rod 84 is connect with the proximal end of the helical branches 8, the extension rod
84 other end extends rear steering far from the apex of the heart to 5 direction of the apex of the heart and parallel or direction far from 2 central axes of the pedestal extends.
That is,：Helical branches 8 to apex of the heart direction close to one end of the apex of the heart 8 after extending a distance again by inwardly and being directed away from the heart outside
Sharp direction bending ultimately forms extension rod 84.Extension rod 84 improves the contact area of pedestal and 9 inner wall of left ventricle, enhances whole
The mechanical stability of a mechanism reduces the risk that the apex of the heart damages in mechanism and mechanism is displaced.
Can also be arranged on extension rod 84 towards left ventricular wall and far from apex of the heart direction hangnail 85, the design of this hangnail,
Both it can guarantee that mechanism smoothly comes in and goes out delivery sheath, can also assign the anti-displacement performance of pedestal 2, further increase entire mechanism
Stability.
Certainly, on the extension rod 84 of pedestal 2 can cover film 4, each extension rod is connected, formed series connection film 87, such as scheme
Shown in 11, the advantages of can both having played 1 pedestal of embodiment, can also effectively constrain but not be the opposite position limited between each extension rod
It sets and relative motion, avoids pedestal tangling between when releasing release in delivery sheath, it is ensured that mechanism discharges the safety of process
Property.
Finally it should be noted that the foregoing is merely the preferred embodiment of the present invention, it is not limited to this
Invention, all within the spirits and principles of the present invention made by all any modification, equivalent and improvement etc., should be included in this hair
Within bright protection domain.
Claims (11)
1. a kind of left ventricle volume reduction mechanism, it is characterised in that：Including supporting rack (1) and the pedestal being connect with support frame as described above (1)
(2), support frame as described above (1) is made of more supporting rods (10), and the proximal end of the supporting rod (10) is gathered to form support frame as described above
(1) gather bottom end (12), the distal end of the supporting rod (10) is along left ventricle (9) inner wall to far from the apex of the heart (5) direction adaptability
Open, the pedestal (2) include with the central end (6) gathered bottom end (12) and connect, and from the central end (6) to
The more helical branches (8) that the apex of the heart (5) direction extends, the more helical branches (8) are revolved along the central shaft of the pedestal (2)
Turn symmetrical, and opening is integrally formed towards the horn-like of the apex of the heart (5) direction, support frame as described above (1) is made of shape-memory material
And surface is covered with film (4), the pedestal (2) is made of elastic material, and the pedestal (2) and the inner wall of the apex of the heart (5) adapt to
Property fitting.
2. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：The helical branches (8) are close to the apex of the heart
(5) free end is equipped with crimping (81), and the crimping (81) is against on the inner wall of the apex of the heart (5).
3. left ventricle volume reduction according to claim 2 mechanism, it is characterised in that：The crimping (81) passes through part (86) of connecting
Series connection.
4. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：The helical branches (8) are close to the apex of the heart
(5) free end is equipped with bulb (82), and the bulb (82) is against on the inner wall of the apex of the heart (5).
5. left ventricle volume reduction according to claim 4 mechanism, it is characterised in that：Through-hole (88) is set in the bulb (82).
6. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：It is arranged on the helical branches (8) and prolongs
One end of stock (84), the extension rod (84) is connect with the proximal end of the helical branches (8), the extension rod (84) it is another
It holds to the apex of the heart (5) direction and extends direction extension of the rear steering far from the apex of the heart and the parallel or separate pedestal (2) central axes.
7. left ventricle volume reduction according to claim 6 mechanism, it is characterised in that：It is provided with down on the extension rod (84)
It pierces (85).
8. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：The adjacent helical branches (8) it
Between be equipped with enhancing structure (83).
9. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：The helical branches (8) with it is described in
Enhancing structure (83) is provided between heart end (6).
10. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：The surface whole of the pedestal (2) or portion
Divide and is covered with film (4).
11. left ventricle volume reduction according to claim 1 mechanism, it is characterised in that：Support frame as described above (1) and the pedestal
(2) it is integral structure.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610855426.4A CN106344081B (en) | 2016-09-28 | 2016-09-28 | A kind of left ventricle volume reduction mechanism |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610855426.4A CN106344081B (en) | 2016-09-28 | 2016-09-28 | A kind of left ventricle volume reduction mechanism |
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| CN106344081A CN106344081A (en) | 2017-01-25 |
| CN106344081B true CN106344081B (en) | 2018-11-02 |
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| CN201610855426.4A Active CN106344081B (en) | 2016-09-28 | 2016-09-28 | A kind of left ventricle volume reduction mechanism |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN109528368B (en) * | 2018-12-04 | 2024-03-08 | 上海心瑞医疗科技有限公司 | Cardiac isolation device |
| EP4029476A4 (en) * | 2020-11-23 | 2022-10-19 | Jiangsu Trulive Medtech Co., Ltd | Valve prosthetic device for implantation in heart |
| CN216318211U (en) * | 2021-02-03 | 2022-04-19 | 上海臻亿医疗科技有限公司 | Heart valve anchoring mechanism and heart valve prosthesis device |
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|---|---|---|---|---|
| CN1384726A (en) * | 1999-10-27 | 2002-12-11 | 阿特里泰克公司 | Barrier device for covering ostium of left atrial appendage |
| CN104706444A (en) * | 2015-03-03 | 2015-06-17 | 上海形状记忆合金材料有限公司 | Volume reduction device for left ventricle |
| CN204520840U (en) * | 2015-02-13 | 2015-08-05 | 上海形状记忆合金材料有限公司 | Improve the device of cardiac function |
| CN105658148A (en) * | 2013-06-26 | 2016-06-08 | W.L.戈尔及同仁股份有限公司 | Occlusive device |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8257428B2 (en) * | 1999-08-09 | 2012-09-04 | Cardiokinetix, Inc. | System for improving cardiac function |
| US7399271B2 (en) * | 2004-01-09 | 2008-07-15 | Cardiokinetix, Inc. | Ventricular partitioning device |
| EP2493417B1 (en) * | 2009-10-26 | 2017-06-21 | Cardiokinetix, Inc. | Ventricular volume reduction |
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2016
- 2016-09-28 CN CN201610855426.4A patent/CN106344081B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1384726A (en) * | 1999-10-27 | 2002-12-11 | 阿特里泰克公司 | Barrier device for covering ostium of left atrial appendage |
| CN105658148A (en) * | 2013-06-26 | 2016-06-08 | W.L.戈尔及同仁股份有限公司 | Occlusive device |
| CN204520840U (en) * | 2015-02-13 | 2015-08-05 | 上海形状记忆合金材料有限公司 | Improve the device of cardiac function |
| CN104706444A (en) * | 2015-03-03 | 2015-06-17 | 上海形状记忆合金材料有限公司 | Volume reduction device for left ventricle |
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