WO2018059178A1 - 一种左心室减容装置 - Google Patents

一种左心室减容装置 Download PDF

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Publication number
WO2018059178A1
WO2018059178A1 PCT/CN2017/099676 CN2017099676W WO2018059178A1 WO 2018059178 A1 WO2018059178 A1 WO 2018059178A1 CN 2017099676 W CN2017099676 W CN 2017099676W WO 2018059178 A1 WO2018059178 A1 WO 2018059178A1
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Prior art keywords
support frame
support
left ventricular
film
ventricular volume
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PCT/CN2017/099676
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English (en)
French (fr)
Inventor
李彪
葛均波
吕世文
周达新
李欣欣
沈雳
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宁波迪创医疗科技有限公司
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Publication of WO2018059178A1 publication Critical patent/WO2018059178A1/zh

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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
    • 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
    • A61B17/12—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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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

Definitions

  • the present application relates to the technical field of medical ventricular isolation devices, and in particular to a left ventricular volume reduction device.
  • Partial left ventriculectomy is a surgical procedure for the treatment of advanced dilated cardiomyopathy (DCM) in recent years. It was first proposed by Brazilian physician Batista in 1996. Because of the high mortality rate associated with heart failure and arrhythmia, left ventricular volume reduction surgery limits its widespread clinical application.
  • PVR Percutaneous ventricular restoration
  • Percutaneous ventricular remodeling is based on a left ventricular volume reduction device invented by Cardiokinetix, Inc., USA (US7887477B2, US2014/0179993A1, US2014/0296624A1 and US2014/0343356A1), which resembles a "parachute".
  • the device consists only of multiple support rods.
  • the support frame and the base are placed in the left ventricular apex through the femoral artery by a minimally invasive intervention method to isolate the abnormally contracted wall, thereby reducing the left ventricular volume and improving the clinical symptoms and cardiac function of patients with heart failure.
  • the device has the following defects: 1.
  • the clinical requirement is that the support rod of the device support frame, especially the distal end of the support rod, should be firstly gripped in a delivery catheter with a small inner diameter (about 4 mm) in the delivery system, and then released on the left.
  • the ventricle is restored to a diameter of about several tens of millimeters (65-95 mm).
  • Such a large amount of deformation causes a support rod with a limited elastic deformation range, especially the proximal end portion of the support rod undergoes a large plastic deformation, and thus the support of the support frame
  • the radial support force provided by the rod itself is seriously insufficient, and the device itself cannot achieve the fit with the left ventricular wall.
  • the balloon catheter is still needed to assist the distraction, so that the device is attached to the left ventricular wall, which results in a Series of problems, including: complicated surgical procedures, extended operative time, and increased delivery
  • LVESV left ventricular end-systolic volume
  • LVEDV left ventricular end-diastolic volume
  • LVEF left ventricular ejection fraction
  • the support rod collection center of the force impact device is further transmitted to the base, and the device
  • the support frame does not have shock absorption performance, and the shock absorption performance of the base is very limited, which leads to stress concentration of the support frame and the base of the device, and finally fatigue fracture.
  • relevant reports have been reported in the clinical follow-up of the product. It can cause great damage to the apex of the left ventricular wall, such as piercing the apex. 4. After the support of the device is released, the device can not be recycled again, and the device can not be repeatedly positioned.
  • the object of the present invention is to solve the problems existing in the prior art, and to provide a left ventricular volume reduction device with good volume reduction effect, strong shock absorption effect, simple operation and reproducible positioning.
  • a left ventricular volume reduction device includes a support frame and a base coupled to a bottom of the support frame, the support frame being composed of a plurality of support rods, the proximal ends of the support rods being gathered to form the support frame a bottom portion, the distal end of the support rod is adaptively opened away from the apex of the left ventricular wall, and includes a sub-umbrella in a space defined by the plurality of support rods, the auxiliary umbrella being composed of a plurality of auxiliary ribs.
  • the auxiliary rib extends from the central end to the apex direction, the terminal end thereof is connected to the support rod, the surface of the support frame is coated, and the plurality of the auxiliary ribs radially support the plurality of the support rods
  • the support frame is adapted to fit the inner wall of the left ventricle.
  • the surface of the support frame is entirely covered with a first film
  • the terminal end of the auxiliary rib is connected to the middle of the support rod
  • the plurality of the auxiliary ribs are in one-to-one correspondence with the plurality of support rods.
  • connection between the terminal end of the auxiliary rib and the support rod is a smooth transition, so that the distance from the apex portion of the support rod can be reversed.
  • the surface of the auxiliary umbrella is entirely covered with a second film
  • the proximal end of the auxiliary rib is connected to the middle of the support rod
  • the surface portion of the support frame is covered with a first film
  • the first a membrane extending from a connection point of the support rod to the secondary rib to a distal end of the support frame, a proximal end of the first membrane and a proximal end of the second membrane being sealingly connected, a plurality of the pair
  • the rib is in one-to-one correspondence with a plurality of the support rods.
  • the surface of the support frame is entirely covered with a first film
  • the surface of the auxiliary umbrella is entirely covered with a second film
  • the pair A proximal end of the rib is coupled to the base
  • the plurality of sub ribs and the second membrane define a bladder
  • the filling material is preset in the capsule body.
  • a hole is provided in the second film, and a check valve is disposed in the center end, and a filling material is injected into the capsule through the one-way valve.
  • the surface of the support frame is entirely covered with a first film
  • the surface of the auxiliary umbrella is entirely covered with a second film
  • the proximal end of the auxiliary rib is connected with the middle of the support rod, from the support
  • a hole is formed in the first film of the joint of the rod and the auxiliary rib to the proximal end of the support frame, and a capsule is defined between the first film and the second film.
  • a filling material is preset in the bladder or a one-way valve is provided in the central end, through which the filling material is injected into the capsule.
  • the central end is detachably connected to the push rod, or the bottom is detachably connected to the core rod, or the bottom end is detachably connected to the push rod while the bottom portion is also detachably connected to the core rod .
  • connection structure is provided between adjacent ones of the support bars or between adjacent ones of the secondary ribs.
  • a limited structure is disposed between the support rods or between the auxiliary ribs, and the limit structure is a plain, twill or satin fabric structure.
  • the central end is connected to the base by a spring.
  • the spring is constrained by a rail.
  • an anchor is provided on the distal end of the support rod.
  • the auxiliary umbrella and/or the support frame are formed by cutting and shaping a metal tube of a shape memory material, or the auxiliary umbrella and/or the support frame are formed by wire braiding of a shape memory material.
  • the shape memory material is selected from a metal material having a shape memory function such as a nickel titanium alloy or a cobalt chromium alloy.
  • the material of the film is selected from a degradable material such as expanded polytetrafluoroethylene, polyester, polyurethane elastomer, polyamide, silica gel, or polylactic acid, such as polylactic acid, or the like, or the film material is selected from the group consisting of animals. organization.
  • a degradable material such as expanded polytetrafluoroethylene, polyester, polyurethane elastomer, polyamide, silica gel, or polylactic acid, such as polylactic acid, or the like
  • polylactic acid such as polylactic acid, or the like
  • the film material is selected from the group consisting of animals. organization.
  • the base is elastic, and the material is selected from a metal material having a shape memory function such as a nickel titanium alloy or a cobalt chromium alloy, or a polymer material such as a polyamide, a polyether block amide or a polyurethane.
  • a metal material having a shape memory function such as a nickel titanium alloy or a cobalt chromium alloy
  • a polymer material such as a polyamide, a polyether block amide or a polyurethane.
  • a material having a developing function may be added to the material of the base, and the material having a developing function is selected from a metal such as a platinum-rhodium alloy, tantalum or tungsten, or a compound such as barium sulfate or cerium oxide.
  • a plurality of sources are obtained through the sub-umbrella structure (including the sub-umbrella itself; the blood impacts the auxiliary umbrella and then transmits the support frame; the operator applies an external force to the auxiliary umbrella through the push rod, and transmits The radial support force to the support frame to the auxiliary ribs and finally the support frame enables the support frame to be deployed to the maximum extent, and finally fits the inner wall of the left inner core in an adaptive manner, thereby enhancing the sealing effect and avoiding the need to set in the prior art.
  • a series of problems caused by balloon catheter assisted distraction including: for patients, the increase in balloon and balloon passages in the delivery system increases the diameter of the delivery system, resulting in devices and delivery systems.
  • the auxiliary umbrella structure provided in the invention greatly enhances the volume reduction effect; as the heart contracts and relaxes, the auxiliary umbrella and the support frame cooperate to move the blood more out of the left ventricle, thereby improving the blood pumping of the left ventricle.
  • the sub-umbrella structure provided by the device of the invention has elasticity, and the spring material-like damping effect can be exerted through the introduction of the filling material and the spring, so that the whole device has sufficient anti-fatigue performance, and the support frame and the base are greatly reduced. The risk of fatigue fracture.
  • connection between the terminal end of the auxiliary rib and the support rod is a smooth transition, so that the distance from the apex portion of the support rod can be reversed, and repeated positioning can be realized, and can be recovered before being separated from the delivery system.
  • the radial support force of the entire device can be adjusted to be moderate, and the fatigue resistance of the device is further improved.
  • FIG. 1 is a schematic perspective view showing a first embodiment of a left ventricular volume reducing device of the present invention
  • Figure 2 is a front elevational view showing the first embodiment of the left ventricular volume reducing device of the present invention
  • FIG. 3A is a schematic view showing a state in which a first embodiment of a left ventricular volume reducing device of the present invention is released in a left ventricle;
  • FIG. 3B is a schematic view showing the process of implanting the left ventricle through the aortic approach according to the first embodiment of the left ventricular volume reduction device of the present invention
  • 4A is a schematic view showing the movement direction of the support rod and the anchor thorn of the first embodiment of the left ventricular volume reduction device of the present invention
  • FIG. 4B and FIG. 4c are schematic diagrams showing a state in which the first embodiment of the left ventricular volume reducing device of the present invention is partially recovered;
  • Figure 5 is a front elevational view showing a second embodiment of the left ventricular volume reducing device of the present invention.
  • 6A is a schematic view showing a movement direction of a support rod and an anchor of a second embodiment of the left ventricular volume reduction device of the present invention
  • 6B is a schematic view showing a state in which the auxiliary rib portion is in and out of the delivery catheter according to the second embodiment of the left ventricular volume reducing device of the present invention
  • 6C is a schematic view showing a state in which the support rod of the left ventricular volume reduction device of the present invention is placed in and out of the delivery catheter;
  • 6D is a schematic view showing a state in which the base of the left ventricular volume reduction device of the present invention is placed in and out of the delivery catheter;
  • Figure 7 is a front elevational view showing a third embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 8 is a front elevational view showing a fourth embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 9 is a front elevational view showing a fifth embodiment of the left ventricular volume reducing device of the present invention.
  • C is a partial cross-sectional view through the central axis of the center end of the auxiliary umbrella;
  • Figure 10 is a front elevational view of the connecting bone of the sixth embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 11 is a front elevational view of the connecting rod of the sixth embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 12 is a front elevational view of the connecting bone of the seventh embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 13 is a front elevational view of the connecting rod of the seventh embodiment of the left ventricular volume reducing device of the present invention.
  • Figure 14 is a front elevational view showing the eighth embodiment of the left ventricular volume reducing device of the present invention having a limiting structure
  • Figure 15 is a plan view of Figure 14;
  • Fig. 16 is a front elevational view showing the ninth embodiment of the left ventricular volume reducing device of the present invention having a stopper structure.
  • 1 is the support frame
  • 2 is the base
  • 3 is the auxiliary umbrella
  • 4 is the left ventricle
  • 5 is the filling material
  • 7 is the spring
  • 8 is the guide rail
  • 10 is the support rod
  • 11 is the first film
  • 12 is the bottom
  • 13 is the bottom
  • 14 is the connecting rod
  • 30 is the secondary rib
  • 31 is the second membrane
  • 32 is the central end
  • 33 is the sac
  • 34 is the connecting bone
  • 40 is the apex
  • 60 is the delivery catheter
  • 61 is the push Rod
  • 62 is a core rod
  • 120 is a coupling nut
  • 320 is a coupling nut
  • a 321 one-way valve is the a 321 one-way valve.
  • the proximal end of the present invention refers to the end that is close to the apex, and the distal end of the present invention refers to the end that is away from the apex.
  • the left ventricular volume reducing device of the present invention comprises a support frame 1 and a base 2 connected to the bottom portion 12 of the support frame 1.
  • the support frame 1 is composed of a plurality of support rods 10, and the support rod 10 is near. The end gathers to form the bottom portion 12 of the support frame 1.
  • the distal end of the support rod 10 is adaptively opened along the inner wall of the left ventricle 4, and includes a sub-umbrella 3 in the space defined by the plurality of support rods 10.
  • the plurality of auxiliary ribs 30 are formed.
  • the auxiliary ribs 30 extend from the central end portion 32 toward the apex 40, and the terminal ends thereof are connected to the central portion of the support rod 10.
  • the plurality of auxiliary ribs 30 are in one-to-one correspondence with the plurality of support rods 10, and are supported.
  • the surface of the frame 1 is entirely covered with the first film 11.
  • the support frame 1 and the auxiliary umbrella 3 are both made of a shape memory material selected from a metal material having a shape memory function such as a nickel titanium (NiTi) alloy or a cobalt chromium (CoCr) alloy.
  • a shape memory material selected from a metal material having a shape memory function such as a nickel titanium (NiTi) alloy or a cobalt chromium (CoCr) alloy.
  • the sub-anim 3 and the support frame 1 can be cut out of the sub-ribs 30 and the support rods 10 by a nickel-titanium alloy tube, and then spread by a mold and shaped by heat treatment.
  • the membrane material selectable on the first film 11 on the support frame 1 includes expanded polytetrafluoroethylene (ePTFE), polyester (PET), polyurethane elastomer (TPU), polyamide (PA), silica gel, degradable materials such as Polylactic acid (PLA), animal tissue, etc.
  • ePTFE expanded polytetrafluoroethylene
  • PET polyester
  • TPU polyurethane elastomer
  • PA polyamide
  • silica gel silica gel
  • degradable materials such as Polylactic acid (PLA), animal tissue, etc.
  • the bottom portion 12 of the support frame 1 is connected to the elastic base 2, and the optional elastic base material comprises a shape memory function metal material including a nickel titanium (NiTi) alloy, a cobalt chromium (CoCr) alloy, and the like, and a polyamide ( PA), polyether block amide Polymer materials such as (Pebax) and polyurethane (TPU).
  • the elastic base 2 is attached to the inner wall of the apex 40, and functions as a shock absorbing and releasing front positioning device.
  • the base 2 can also be added with a material having a developing function, such as a metal such as platinum-rhodium alloy, tantalum or tungsten, and barium sulfate or barium oxide.
  • the distal end (free end) of the support rod 10 may be provided with an anchor thorn 13 which penetrates into the inner wall of the left ventricle 4 to function as an anchoring device to prevent displacement of the device, as shown in Fig. 3A.
  • the present invention can place the device within the left ventricle 4 via an aortic intervention or through the apex 40. If a transarterial approach is used (as shown in Figure 3B), the operator pushes the device through a delivery catheter 60 of the conveyor system to a suitable location inside the left ventricle 4; releasing the base 2 to the inner wall of the apex 40 Contact; the delivery catheter 60 is then withdrawn to release the support frame 1. Since the auxiliary rib 30 of the auxiliary umbrella 3 and the support rod 10 of the support frame 1 are both made of a shape memory alloy material having superelasticity and shape memory function, and the plurality of auxiliary ribs 30 and the plurality of support rods 10 are one by one.
  • the auxiliary umbrella 3 generates a radial supporting force toward the left ventricular wall and applies the force to the support frame 1.
  • the support frame 1 can be maximally driven by the structure of the auxiliary umbrella 3. Expand and finally fit snugly against the inner wall of the left ventricle 4.
  • the effect of adapting to the inner wall of the left ventricle 4 is completely achieved by the introduction of the para-umbrella structure, and does not need to be assisted by the balloon catheter, thus avoiding the need to set the balloon catheter auxiliary support in the prior art.
  • a series of problems caused by opening including: for patients, the increase in the balloon and balloon channels in the delivery system increases the diameter of the delivery system, which in turn causes damage to the blood vessels and heart valves when the device and delivery system enter the human blood vessels and heart.
  • the high risk increases the cost of the device, thereby increasing the economic burden of the patient; for the operator, due to the complicated structure of the delivery system, the operation is complicated, the surgical procedure is complicated, and the operation time is prolonged.
  • the base 12 can be provided with a coupling nut 120 having an internally threaded configuration, detachably coupled to the plunger 62 in the delivery system, rotating the plunger 62, the final release device in the left ventricle 4, and on the base 12
  • Other structures, such as snaps, may also be provided to enable detachable attachment to the core rod 62.
  • the operator can selectively push the push rod 61 slightly toward the proximal direction according to the deployment condition of the support frame 1, and additionally apply a force to the auxiliary umbrella of the device.
  • the support frame 1 is further expanded by the expansion of the auxiliary rib 30 of the sub-bladder 3, thereby further enhancing the adhesion effect and preventing leakage of the support frame edge caused by poor device isolation.
  • the central end portion 32 may be provided with a coupling nut 320 having an internal thread structure, detachably coupled to the push rod 61, rotating the push rod 61, and finally releasing the device in the left ventricle 4; a buckle may also be provided at the center end portion 32.
  • Other configurations are provided to detachably connect to the push rod 61.
  • the operator can operate the push rod 61 to release the repositioning function of the device after releasing the support frame 1 and before disassembling the core rod 62, that is, the operator fixes the core rod 61 and applies it by the push rod 61.
  • a pulling force in the distal direction the pulling force will be transmitted to the auxiliary rib 30 through the central end 31, and then transmitted to the support rod 10 of the support frame 1, so that the support rod 10 and the anchor 13 are along the A direction shown in Fig. 4a.
  • the center shaft of the support frame 1 is gathered, and the different stages of the folding are as shown in FIG. 4B and FIG. 4C.
  • the state of the support frame 1 and the auxiliary umbrella 3 after the final gathering is as shown in FIG. 4C.
  • the push rod 61 and the core are fixed.
  • the relative position between the rods 62 allows the operator to operate the mandrel 62 or the push rod 61 or the delivery catheter 60 to adjust the position of the device within the left ventricle for repositioning.
  • the operator can fix the core
  • the rod 62 again selectively exerts a thrust in the proximal direction by the push rod 61, acting on the central end 32 of the sub-umbrella 3 of the device, the support rod 10 and the anchor 13 along the B shown in Fig. 4A
  • the direction is fully developed away from the central axis of the support frame 1, and the different stages of the unfolding are as shown in FIG. 4C and FIG.
  • the second embodiment is different from the first embodiment in that the surface of the support frame 1 is only partially covered with the first film 11, that is, the support rod 10 covering the support frame 1.
  • the connection point with the auxiliary rib 30 extends to the distal end region of the support frame 1, and the surface of the auxiliary umbrella 3 is entirely covered with the second film 31, and the proximal end of the first film 11 and the proximal end of the second film 31 are sealed. .
  • the optional membrane material of the second membrane 31 on the parachute 3 includes expanded polytetrafluoroethylene (ePTFE), polyester (PET), polyurethane elastomer (TPU), polyamide (PA), silica gel, degradable materials such as Polylactic acid (PLA), animal tissues and the like, after the device is released, the device exhibits many advantages due to the introduction of the second film 31, including: 1. Further reducing the volume of the left ventricle, that is, the II region shown in Fig. 3B, Therefore, the volume reduction effect is greatly enhanced; 2. The large periodic impact force of the blood in the heart in the axial direction (parallel to the central axis of the support frame) first impacts the auxiliary umbrella 3 instead of directly impacting the collection center of the support frame 1.
  • ePTFE expanded polytetrafluoroethylene
  • PET polyester
  • TPU polyurethane elastomer
  • PA polyamide
  • silica gel silica gel
  • degradable materials such as Polylactic acid (PLA), animal tissues and
  • the auxiliary umbrella has an elastic action and can exert a spring-like shock absorbing effect, so that The whole device has shock absorption performance, and greatly reduces the risk of fatigue fracture of the support frame and the base; 3.
  • the blood impacts the auxiliary umbrella 3, the blood turns to the impact support frame to form an impact force on the radial direction of the support frame, and Parachute can also provide enough To the supporting force, the support frame is fully extended, and it is not necessary to use other devices, such as a balloon, to assist the distraction.
  • the heart can continuously maintain the inner wall of the left ventricle during the entire systolic and diastolic periodic movement. State, minimizing the risk of device leakage and enhancing the isolation effect; 4.
  • the heart squeezes the support frame 1, and the support frame 1 transmits the pressing force to the auxiliary umbrella 3 through its support rod 10, the auxiliary umbrella 3
  • the contraction movement also occurs, and the cooperative pressing movement of the support frame 1 and the auxiliary umbrella 3 of the entire device, like the lateral pressing of the letter W, causes the blood to be pumped more out of the left ventricle, thereby improving the pumping function of the left ventricle, Improve the effectiveness of the device.
  • the process of accessing the delivery catheter 60 of the present embodiment has the following features: under the action of the push rod 61 of the delivery system, when the device in the fully released deployment state is to be admitted to the delivery catheter 60, the parachute a smooth transition of the junction of the terminal end of the bone 30 and the support rod 10 such that the distal end portion of the support rod 10 (i.e., its attachment point to the secondary rib 30 on the support rod 10 extends to the distal end region of the support frame 1) and
  • the anchor 5 can be flipped in the A direction shown in Figure 6a, which enters different stages of the delivery catheter 60 as shown in Figure 6B, Figures 6C and 6D, and the distal tip of each of the support rods 10 will Flip at a certain angle (usually greater than 90°); when the device in the delivery catheter 60 is to be pushed out of the delivery catheter 60, the distal end portion of the support rod 10 and the anchor 5 move in the B direction shown in Figure 6A, and In contrast to the various stages of the delivery
  • the third embodiment is different from the first embodiment in that the proximal end of the auxiliary rib 30 of the auxiliary umbrella 3 is connected to the bottom 12, and the surface of the auxiliary umbrella 3 is completely covered.
  • the second membrane 31, the plurality of secondary ribs 30 and the second polymeric membrane 18 define a bladder 33, which is preferably spherical or ellipsoidal.
  • the number of the auxiliary ribs 30 and the support rods 10 may be identical or inconsistent.
  • the auxiliary ribs 30 and the support rods 10 are not identical, only the auxiliary ribs 30 and the second membrane 31 may be enclosed into one capsule. 33, the shock absorption effect is increased, and the durability life of the device, particularly the capsule 33, can be improved.
  • auxiliary rib 30 is connected to the bottom 12 of the support frame 1, so that the device under the continuous impact of blood flow in the left ventricle, supports the capsule 33, increases the shock absorption effect, and improves the device, particularly the capsule 33. Durable life.
  • this design can also reduce the diameter of the delivery catheter 60 of the delivery system, reduce the trauma of the device during the surgical procedure such as delivery or release, and improve the scope of application of the device.
  • the distal end of the secondary rib 30 is merged with the central end 32, and the push rod 61 implanted in the delivery conduit 60 of the volume reduction device can be detachably coupled to the central end 32 by a coupling nut 320 provided in the central end portion 32.
  • a one-way valve 321 can be further disposed in the central end portion 32.
  • the one-way valve 321 can pass through the core rod 62 to facilitate the implantation of the device, and can also play a limiting role in one-way circulation, that is, the operator can be used to pass the main
  • the filling material 5 is injected into the interior of the bladder 33 through the mouth of the one-way valve 321, and the filling material 5 is prevented from overflowing out of the bladder 33 in the opposite direction.
  • the filling material 5 may be a liquid material such as physiological saline or blood; it may be in the form of a liquid before injection, and is injected into the inside of the capsule 33 to be a gelled or solid material, such as a PEG-based polymer; Absorbable materials such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and related copolymers or blends; also vascular blocking embolic materials such as microcoils , cyanoacrylate type tissue glue (such as NBCA), ionic polymer (such as Eudragit-E), polyvinyl alcohol (PVA) particles, polyvinyl acetate (PVAc), absolute ethanol, ethylene vinyl alcohol copolymer ( EVAL), alginate (such as calcium alginate), gelatin sponge, PHEMA and other elastic microspheres, chalk powder, autologous blood clots, etc.
  • PVA polylactic acid
  • PGA polyglycolic acid
  • PCL polycaprolact
  • the filling material 5 is filled in the bladder 33, not only the same volume reduction effect as in the second embodiment is obtained, but also the shock absorbing effect of the auxiliary umbrella 3 is further enhanced, and the fatigue resistance of the auxiliary umbrella 3 or the entire apparatus is improved.
  • the filling material 5 can be preset to avoid subsequent injections.
  • a check valve 321 can also be disposed in the bottom portion 12 to facilitate the operator to inject through the apical route.
  • Preset filling material 5 In the device, the same effects as those described in the embodiment can be obtained.
  • the fourth embodiment is different from the first embodiment in that the surface of the sub-anim 3 is entirely covered with the second film 31, and the connection point between the support rod 10 and the sub-rib 30 is provided.
  • a hole is formed in the first film 11 to the proximal end of the support frame 1, and a bladder 33 is defined between the first film 11 and the second film 31.
  • the size of the pores in the first membrane 11 can be large or small, and it is only required to pass through the gas molecules, and the substances inside the capsules 33 are not transmitted, which facilitates the discharge of air before the operation of the device.
  • the inside of the bladder body 33 of the present embodiment can be injected or preset with a one-way valve 321 provided in the center end portion 32 or the bottom portion 12, and the same effects as those described in the third embodiment can be obtained.
  • the fifth embodiment is different from the second embodiment in that a spring 7 is further disposed between the bottom portion 12 of the support frame 1 and the center end portion 32 of the sub-bladder 3.
  • the spring 7 has relatively strong elastic deformation ability, including stretching ability and compression ability, and can adjust the relative distance between the center end portion 32 and the bottom portion 12 of the support frame 1 to a large extent, so that the device can be easily installed and released before surgery. It has a stronger left ventricular adaptability. More importantly, the spring 7 provides a relatively strong elastic force, which further enhances the shock absorption effect of the device under the action of blood flow. Minimize the damage to the inner wall of the apex 40 of the left ventricle 4, and further improve the fatigue resistance of the device.
  • the central axis of the spring 7 should always coincide with the center of the bottom 12 of the support frame 1 and the auxiliary umbrella 3
  • the line between the centers of the central ends 32 i.e., the central axis of the central axis of the support frame 1 is added, as shown in the partial cross-sectional view C of the center axis in Fig. 9, can be disposed outside or inside the spring 7
  • the guide rail 8 of the shaft on the central axis of the support frame 1 is restrained so that the central axis of the spring 7 is always coaxial with the central axis of the support frame 1 in the elastic deformation.
  • Embodiment 6 is different from the above embodiment in that a connection structure is added between the sub-ribs 30 or between the support rods 10.
  • the connecting structure is a connecting bone 34 located between the auxiliary ribs 30 of the auxiliary umbrella 3 and forming a fixed connection, which not only increases the radial supporting force of the device, but also allows the device to better fit the left ventricle.
  • the inner wall of 4 further increases the adhesion effect of the support frame 1 and the inner wall of the left inner core, thereby reducing the occurrence of side leakage; and greatly improving the fatigue fracture resistance of the device. As shown in FIG.
  • the connecting structure is a connecting rod 14 which is located between the support rods 10 of the support frame 1 and forms a fixed connection, and the same effect as the connecting bone 34 can be obtained.
  • the auxiliary umbrella 3 and the support frame 1 can respectively cut the auxiliary rib 30 and the support rod 10 by a nickel-titanium alloy tube, and then be opened by a mold, and shaped into a shape as shown in FIG. 11 by heat treatment; nickel-titanium alloy wire can also be used. After being entangled in a weaving process, and then using a mold, it is shaped into a final shape by heat treatment. Of course, it is also possible to adopt a combination of cutting and intertwining knitting processes, and then shape it into a shape as shown in FIG. 10 by means of heat treatment using a mold.
  • connection structure as in the sixth embodiment is added between the auxiliary ribs 30 or between the support rods 10, which can achieve the effect of the third embodiment.
  • the same effects as in the sixth embodiment can be obtained.
  • the difference between the eighth embodiment and the sixth embodiment is that a finite position structure is disposed between the auxiliary ribs 30 of the sub-umbrella 3, and the limit structure can be up and down. Alternately shuttle the plain, twill or satin fabric structure to facilitate the radial support of the adjustment device to a moderate level, so that the introduction of the parachute 3 does not affect the normal contraction of the heart, and also reduces the risk of fatigue fracture at the connection point of the device. .
  • a limit structure can also be provided between the support rods 10 of the support frame 1 to obtain the same effect as the provision of a limit structure between the auxiliary ribs 30 of the auxiliary umbrella 3.
  • the difference between the embodiment 9 and the third embodiment is that the limiting structure as described in the embodiment 8 is disposed between the auxiliary ribs 30, and the auxiliary ribs having the limiting structure form a mesh shape.
  • the limit structure can be a plain, twill or satin weave structure which is alternately shuttled up and down, which can facilitate the radial support force of the adjusting device to be moderate, and can also reduce the risk of fatigue fracture of the connection point of the device.

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Abstract

一种左心室减容装置，包括支撑架（1）和与支撑架（1）的底部（12）连接的底座（2），支撑架（1）由多根支撑杆（10）组成，支撑杆（10）的近端聚拢形成支撑架（1）的底部（12），支撑杆（10）的远端沿左心室（4）内壁向远离心尖（40）方向适应性张开，在多根支撑杆（10）限定的空间内还包括副伞（3），副伞（3）由多根副伞骨（30）组成，副伞骨（30）从中心端部（32）向心尖（40）方向延伸，其终端与支撑杆（10）连接，支撑架（1）的表面被覆膜，多根副伞骨（30）径向支撑多根支撑杆（10）使得支撑架（1）适应性贴合左心室（4）内壁。解决了现有技术中输送系统的结构复杂，手术步骤复杂的问题；减容效果好，心室泵血功能增强，封堵效果增强，操作简单，可重复定位及回收。

Description

一种左心室减容装置
相关申请
本申请要求2016年09月28日申请的，申请号为201610855427.9，名称为“一种左心室减容装置”的中国专利申请的优先权，在此将其全文引入作为参考。
技术领域
本申请涉及医用心室隔离器械技术领域，特别是涉及一种左心室减容装置。
背景技术
近年来心力衰竭的患病率逐年增高，成为严重的公共卫生问题，据报道，每年全球有1700万人死于心血管疾病，其中一半以上死于急性心肌梗死，即使患者存活后也容易发展为慢性心力衰竭。据估计中国急性心肌梗死的发病率约为45/10万～55/10万，目前仍呈上升趋势，心力衰竭患病率为0.9％，病因中冠心病由1980年的36.8％上升至2000年的45.6％，居各种病因之首。急性心肌梗死后大约有20％～50％的患者会发展为心力衰竭，特别是前壁心肌梗死，心力衰竭为各种心脏病的严重阶段，其发病率高，5年存活率与恶性肿瘤相仿。
左心室减容术(partial left ventriculectomy，PLV)是近年来治疗晚期扩张型心肌病(DCM)的一种手术方法，是1996年由巴西医师Batista首次提出。因左心室减容术存在着较高的与心力衰竭、心律失常相关的病死率，所以限制了其在临床的广泛应用。
经皮左心室重建术(percutaneous ventricular restoration，PVR)是治疗或减轻心衰症状的新途径，是针对急性心肌梗死患者易发的心力衰竭的陈旧前壁心肌梗死伴心力衰竭患者的前沿治疗方法。
经皮心室重建术是基于美国Cardiokinetix公司发明的一种左心室减容装置Prachute(US7887477B2，US2014/0179993A1,US2014/0296624A1和US2014/0343356A1)，形似“降落伞”，该装置仅包括多跟支撑杆组成的支撑架和底座，采用微创介入的方法，经股动脉置入到左室心尖部，将异常收缩的室壁隔离开，从而减少左室容积，改善心力衰竭患者临床症状及心功能。该装置存在如下缺陷：1、临床要求该装置支撑架的支撑杆，特别是支撑杆的远端，应先压握在输送系统内很小内径(约4mm)的输送导管中，而后释放在左心室，再恢复成直径大约几十毫米(65-95mm)，如此大的变形量导致弹性形变范围有限的支撑杆，特别是支撑杆的近端部分发生了巨大的塑性形变，因而支撑架的支撑杆自身提供的径向支撑力严重不足，装置自身无法实现与左心室壁的贴合，因此该装置在释放后仍需要球囊导管辅助撑开，使装置与左心室壁贴合，这导致一系列问题，包括：手术步骤复杂，手术时间延长，也增加了输送 系统结构的复杂程度；输送系统中球囊及球囊通道的增加使输送系统直径增大，进而造成装置和输送系统进入人体血管和心脏时对血管和心脏瓣膜等损伤的高风险；无疑，也增加该装置的成本，加剧患者的经济负担。2、临床应用显示，术后12个月，患者左室收缩末期容积(LVESV)减小16％和左室舒张末期容积(LVEDV)减小14％，其减容效果并不是很理想，减容程度并不充分。左室射血分数(LVEF)虽有适度增加，但包括左心室的泵血功能在内的心功能等改善均不理想，因为该装置基本不具备辅助泵血功能。3、装置释放后，由于心脏内的血液在轴向方向(平行于支撑架中心轴)产生较大的周期性的冲击力，该力冲击装置的支撑杆汇集中心进而传递到底座，而该装置的支撑架不具备减震性能，且底座的减震性能十分有限，导致该装置支撑架以及底座易发生应力集中，最终发生疲劳断裂，目前在该产品的临床随访中已有相关报道，这也会造成装置对左心室壁心尖部位巨大的损伤，例如刺穿心尖。4、该装置在支撑架释放完毕后，无法再进行装置的回收，也不能实现装置的重复定位。
发明内容
本发明目的在于解决现有技术中存在的问题，提供一种减容效果好，减震效果强，操作简单及可重复定位的左心室减容装置。
本发明目的是通过以下技术方案来实现的：
一种左心室减容装置，包括支撑架和与所述支撑架的底部连接的底座，所述支撑架由多根支撑杆组成，所述支撑杆的近端聚拢形成所述支撑架的所述底部，所述支撑杆的远端沿左心室内壁向远离心尖方向适应性张开，在多根所述支撑杆限定的空间内还包括副伞，所述副伞由多根副伞骨组成，所述副伞骨从中心端部向心尖方向延伸，其终端与所述支撑杆连接，所述支撑架的表面被覆膜，多根所述副伞骨径向支撑多根所述支撑杆使得所述支撑架适应性贴合所述左心室内壁。
本发明目的还通过以下优选的技术方案来进一步实现：
优选的，所述支撑架的表面全部覆有第一膜，所述副伞骨的终端与所述支撑杆的中部连接，多根所述副伞骨与多根所述支撑杆一一对应。
更优选的，所述副伞骨的终端与所述支撑杆的连接处为平滑过渡，使得所述支撑杆的远离心尖部分能够翻转。
优选的，所述副伞的表面全部覆有第二膜，所述副伞骨的近端与所述支撑杆的中部连接，所述支撑架的表面部分覆有第一膜，所述第一膜从所述支撑杆与所述副伞骨的连接点延伸至所述支撑架的远端，所述第一膜的近端和所述第二膜的近端密封连接，多根所述副伞骨与多根所述支撑杆一一对应。
优选的，所述支撑架的表面全部覆有第一膜，所述副伞的表面全部覆有第二膜，所述副 伞骨的近端与所述底部连接，多根所述副伞骨和所述第二膜限定出一个囊状体。
更优选的，在所述囊状体内预置填充材料。
更优选的，在所述第二膜上设置有孔，在所述中心端部内设置单向阀，通过所述单向阀向所述囊状体内注射填充材料。
优选的，所述支撑架的表面全部覆有第一膜，所述副伞的表面全部覆有第二膜，所述副伞骨的近端与所述支撑杆的中部连接，从所述支撑杆与所述副伞骨的连接点至所述支撑架的近端的第一膜上设置有孔，所述第一膜和所述第二膜之间限定出一个囊状体。
更优选的，在所述囊状体内预置填充材料，或者在所述中心端部内设置单向阀，通过所述单向阀向所述囊状体内注射填充材料。
优选的，所述中心端部与推送杆可拆卸连接，或者所述底部与芯杆可拆卸连接，或者所述中心端部与推送杆可拆卸连接的同时所述底部也与芯杆可拆卸连接。
优选的，在相邻的所述支撑杆之间或者在相邻的所述副伞骨之间设有连接结构。
优选的，在所述支撑杆之间或者在所述副伞骨之间设置有限位结构，所述限位结构为平纹、斜纹或缎纹的织物组织结构。
优选的，所述中心端部通过弹簧与所述底座连接。
更优选的，所述弹簧通过导轨限位。
优选的，在所述支撑杆的远端上设有锚刺。
优选的，所述副伞和\或支撑架由形状记忆材质的金属管切割定型制成，或者所述副伞和\或支撑架由形状记忆材质的金属丝编织定型制成。
更优选的，所述形状记忆材料选自镍钛合金、钴铬合金等具有形状记忆功能的金属材料。
优选的，所述膜的材料选自膨体聚四氟乙烯、聚酯、聚氨酯弹性体、聚酰胺、硅胶、或聚乳酸等可降解材料，例如聚乳酸等，或者所述膜材料选自动物组织。
优选的，所述底座是弹性的，材料选自镍钛合金、钴铬合金等具有形状记忆功能的金属材料或聚酰胺、聚醚嵌段酰胺、聚氨酯等高分子材料。
优选的，在所述底座的材料中还可以添加具有显影功能的材料，所述具有显影功能的材料选自铂铱合金、钽、钨等金属，或者硫酸钡、氧化铋等化合物。
与现有技术相比，本发明的有益效果主要体现在：
1.本发明中通过副伞结构，获得多种来源(包括副伞自身提供的；血液冲击副伞后转而传递支撑架而形成的；操作者通过推送杆额外施加外力在副伞上，传递至副伞骨最终扩张支撑架的)的对支撑架的径向支撑力，使得支撑架最大限度地展开，最终适应性地贴紧左心室内壁，增强封堵效果，避免现有技术中必须设置球囊导管辅助撑开导致的一系列问题，包括：对于患者，输送系统中球囊及球囊通道的增加使输送系统直径增大，进而造成装置和输送系 统进入人体血管和心脏时对血管和心脏瓣膜等损伤的高风险，增加该装置的成本，进而加剧患者的经济负担；对于操作者，因输送系统结构复杂带来使用操作繁琐，手术步骤复杂，手术时间延长。
2.本发明中设置的副伞结构使减容效果大大增强；随着心脏的收缩舒张周期运动，副伞与支撑架协同运动，将血液更多地泵出左心室，提高左心室的泵血功能。
3.本发明的装置设置的副伞结构具有弹性，通过填充材料和弹簧的引入，可发挥出如弹簧般的减震效果，使整个装置具备足够强的抗疲劳性能，大大降低支撑架，底座等疲劳断裂的风险。
4.本发明的装置中副伞骨的终端与所述支撑杆的连接处为平滑过渡，使得所述支撑杆的远离心尖部分能够翻转，可实现重复定位，在脱离输送系统之前还可回收。
5.本发明的装置中通过在副伞以及支撑架中引入连接结构或限位结构，使得整个装置径向支撑力得以调节至适中，同时进一步提高装置的抗疲劳性能。
附图说明
图1为本发明左心室减容装置的第一实施例的立体结构示意图；
图2为本发明左心室减容装置的第一实施例的主视图；
图3A为本发明左心室减容装置的第一实施例在左心室中释放后的状态示意图；
图3B为本发明左心室减容装置的第一实施例经主动脉途径植入左心室的过程示意图；
图4A为本发明左心室减容装置的第一实施例支撑杆以及锚刺的运动方向示意图；
图4B和图4c为本发明左心室减容装置的第一实施例被部分回收的状态示意图；
图5为本发明左心室减容装置的第二实施例的主视图；
图6A为本发明左心室减容装置的第二实施例支撑杆以及锚刺的运动方向示意图；
图6B为本发明左心室减容装置的第二实施例副伞骨部分进出输送导管的状态示意图；
图6C为本发明左心室减容装置的第二实施例支撑杆进出置于输送导管中的状态示意图；
图6D为本发明左心室减容装置的第二实施例底座进出置于输送导管中的状态示意图；
图7为本发明左心室减容装置的第三实施例的主视图；
图8为本发明左心室减容装置的第四实施例的主视图；
图9为本发明左心室减容装置的第五实施例的主视图；C为通过副伞中心端部的中心轴的局部剖视图；
图10为本发明左心室减容装置的第六实施例的连接骨的主视图；
图11为本发明左心室减容装置的第六实施例的连接杆的主视图；
图12为本发明左心室减容装置的第七实施例的连接骨的主视图；
图13为本发明左心室减容装置的第七实施例的连接杆的主视图；
图14为本发明左心室减容装置的第八实施例具有限位结构的主视图；
图15为图14的俯视图；
图16为本发明左心室减容装置的第九实施例具有限位结构的主视图。
其中，1是支撑架，2是底座，3是副伞，4是左心室，5是填充材料，7是弹簧，8是导轨，10是支撑杆，11是第一膜，12是底部，13是锚刺，14是连接杆，30是副伞骨，31是第二膜，32是中心端部，33是囊状体，34是连接骨，40是心尖，60是输送导管，61是推送杆，62是芯杆，120是连接螺母，320是连接螺母，321单向阀。
具体实施方式
为使本发明的目的、技术方案及优点更加清楚明白，以下结合附图并举实施例，对本发明进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本发明，并不用于限定本发明。
本发明所述的近端是指接近心尖的一端，本发明所述的远端是指远离心尖的一端。
实施例1：
如图1和2所示，本发明的左心室减容装置，包括支撑架1和与支撑架1的底部12连接的底座2，支撑架1由多根支撑杆10组成，支撑杆10的近端聚拢形成支撑架1的底部12，支撑杆10的远端沿左心室4内壁向远端方向适应性张开，在多根支撑杆10限定的空间内还包括副伞3，副伞3由多根副伞骨30组成，副伞骨30从中心端部32向心尖40方向延伸，其终端与支撑杆10的中部连接，多根副伞骨30与多根支撑杆10一一对应，支撑架1的表面全部覆盖有第一膜11。
所述支撑架1和副伞3均由形状记忆材料制成，形状记忆材料选自镍钛(NiTi)合金、钴铬(CoCr)合金等具有形状记忆功能的金属材料。如图1所示的形状，副伞3和支撑架1可用一根镍钛合金管切割出副伞骨30和支撑杆10，然后用模具撑开，利用热处理的方式定型而成。支撑架1上的第一膜11可选择的膜材料包括膨体聚四氟乙烯(ePTFE)、聚酯(PET)、聚氨酯弹性体(TPU)、聚酰胺(PA)、硅胶、可降解材料如聚乳酸(PLA)、以及动物组织等，装置释放之后支撑架1沿左心室4的形状贴合于左心室4的内壁上，支撑架1上的第一膜11可隔离左心室4靠近心尖40部分的无效心肌，减少左心室4的容积，防止心脏进一步扩大，同时也减小心室壁张力。
支撑架1的底部12与弹性底座2相连接，可供选择的弹性底座材料包括镍钛(NiTi)合金、钴铬(CoCr)合金等在内的具有形状记忆功能的金属材料，以及聚酰胺(PA)、聚醚嵌段酰胺 (Pebax)、聚氨酯(TPU)等的高分子材料。弹性底座2贴住心尖40的内壁，起装置减震和释放前定位的作用，底座2也可以通过添加具有显影功能的材料，如铂铱合金、钽、钨等金属，以及硫酸钡、氧化铋等化合物，加强显影的效果，以增强手术过程中的定位可视化。支撑杆10的远端(自由端)可设锚刺13，锚刺13刺入左心室4内壁起到锚定装置的作用，防止该装置的移位，如图3A所示。
本发明可经过主动脉介入或经心尖40将装置放置于左心室4内。如采用微创手术的经主动脉介入途径(如图3B所示)，操作者经输送器系统的输送导管60将装置推送到左心室4内部的合适位置；释放底座2使之与心尖40内壁接触；再后撤输送导管60释放支撑架1。由于副伞3的副伞骨30与支撑架1的支撑杆10均由具有超弹性和形状记忆功能的形状记忆合金材料制成，又由于多根副伞骨30与多根支撑杆10一一对应，副伞3会产生朝向左心室壁的径向支撑力并将该力作用在支撑架1上，在没有外界的约束下，支撑架1在副伞3结构的驱使下能得到最大限度地展开，最后适应性地贴紧左心室4内壁。这种适应性贴紧左心室4内壁的效果完全是通过副伞结构的引入来完成，而并不需要借助于球囊导管辅助撑开，因此避免了现有技术中必须设置球囊导管辅助撑开导致的一系列问题，包括：对于患者，输送系统中球囊及球囊通道的增加使输送系统直径增大，进而造成装置和输送系统进入人体血管和心脏时对血管和心脏瓣膜等损伤的高风险，增加该装置的成本，进而加剧患者的经济负担；对于操作者，因输送系统结构复杂带来使用操作繁琐，手术步骤复杂，手术时间延长。
在一个实施方式中，底部12可设有具有内螺纹结构的连接螺母120，与输送系统中的芯杆62可拆卸连接，旋转芯杆62，最终释放装置于左心室4内；在底部12上也可设置卡扣等其它的结构以实现与芯杆62可拆卸连接。当然，操作者在释放支撑架1后及拆卸芯杆62之前，也可以根据支撑架1的展开情况，有选择性地稍向近端方向推动推送杆61，额外施加作用力于装置的副伞3的中心端部32上，通过副伞3的副伞骨30的撑开最终更进一步扩张支撑架1，进一步增强贴壁效果，避免装置隔离不良发生的支撑架边缘泄露。中心端部32可设有具有内螺纹结构的连接螺母320，与推送杆61可拆卸连接，旋转推送杆61，最终释放装置于左心室4内；在中心端部32上也可设置卡扣等其它的结构以实现与推送杆61可拆卸连接。
如图4A-4C所示，操作者在释放支撑架1后及拆卸芯杆62之前，还可以操作推送杆61实现装置的重复定位功能，即：操作者固定芯杆61，通过推送杆61施加一个朝远端方向的拉力，拉力将通过中心端部31传递到副伞骨30，进而传递到支撑架1的支撑杆10，使支撑杆10以及锚刺13沿着图4a所示的A方向向支撑架1的中心轴收拢，其收拢的不同阶段如图4B，图4C所示，最终收拢后的支撑架1及副伞3的状态如图4C所示，此时固定推送杆61与芯杆62之间的相对位置，操作者便可操作芯杆62或推送杆61或输送导管60调整装置在左心室内的位置，进行再次定位。当装置在左心室内的位置调整完毕后，操作者可固定芯 杆62，再次有选择性地通过推送杆61施加一个朝近端方向的推力，作用于装置的副伞3的中心端部32上，支撑杆10以及锚刺13沿着图4A所示的B方向向远离支撑架1的中心轴充分展开，其展开的不同阶段如图4C，图4B所示，通过对副伞3的推力从而更进一步撑开支撑架1，进一步增强贴壁效果。这样的设计，保证需要重复定位该装置时，支撑杆10以及锚刺13能轻松地收拢或展开，因此本实施例的左心室减容装置可保证装置在左心室4中的良好可重复定位性。
实施例2
如图5所示，以实施例1为基础，实施例2与实施例1的不同之处在于，支撑架1的表面仅部分覆有第一膜11，即覆盖支撑架1上的支撑杆10与副伞骨30的连接点延伸至支撑架1的远端区域，而副伞3的表面全部覆有第二膜31，第一膜11的近端与第二膜31的近端为密封连接。
副伞3上的第二膜31可选择的膜材料包括膨体聚四氟乙烯(ePTFE)、聚酯(PET)、聚氨酯弹性体(TPU)、聚酰胺(PA)、硅胶、可降解材料如聚乳酸(PLA)、以及动物组织等，装置释放之后，由于第二膜31的引入，使得装置表现出诸多优点，包括：1.进一步减少左心室的容积，即图3B所示的II区域，因而使减容效果大大增强；2.心脏内的血液在轴向方向(平行于支撑架中心轴)较大的周期性的冲击力首先冲击副伞3，而不是直接冲击支撑架1的汇集中心(底部12)，又由于副伞3的副伞骨30有具有超弹性和形状记忆功能的形状记忆合金材料制成，使得副伞具有弹性作用，可发挥出弹簧般的减震效果，所以使整个装置具备了减震性能，也大大降低支撑架，底座等疲劳断裂的风险；3.血液冲击副伞3后，血转而流向冲击支撑架，形成对支撑架径向方向的冲击力，另外副伞也可提供足够的径向支撑力，使得支撑架完全撑开，不必借助其它装置，如球囊来辅助撑开，因此装置植入后，心脏在整个收缩舒张周期性运动过程中，均可持续保持贴紧左心室内壁的状态，最大限度的降低装置泄露风险，增强隔离效果；4.在心脏收缩过程中，心脏挤压支撑架1，支撑架1通过其支撑杆10将挤压力传递至副伞3，副伞3也发生收缩运动，整个装置的支撑架1和副伞3的协同挤压运动，如同对字母W的横向挤压，使血液更多地泵出左心室，因而提高左心室的泵血功能，改善了装置的有效性。
如图6A-6D所示，本实施例装置进出输送导管60的过程具有如下特点：在输送系统的推送杆61的作用下，当处于完全释放展开状态的装置要收入输送导管60时，副伞骨30的终端与支撑杆10的连接处的平滑过渡，使得支撑杆10的远端部分(即：支撑杆10上其与副伞骨30的连接点延伸至支撑架1的远端区域)以及锚刺5可沿着图6a所示的A方向翻转，其进入输送导管60的不同阶段如图6B，图6C和图6D所示，每个支撑杆10的远离心尖部分会 做一定角度(通常大于90°)的翻转；当输送导管60中的装置要被推出输送导管60时，支撑杆10的远端部分以及锚刺5沿着图6A所示的B向运动，和进入输送导管60的各个阶段相反，其从输送导管60中出来的不同阶段按图6D，图6C和图6B的顺序依次进行，支撑杆10的远离心尖部分也会相对输送导管60做相反的一个翻转。这样的设计，保证需要回收该装置时，支撑杆10的远端部分以及锚刺5能顺利地进入输送导管60中，因此本实施例的左心室减容装置可保证装置在左心室4中的良好可重复定位性，还可完全回收。
实施例3
如图7所示，以实施例1为基础，实施例3与实施例1的不同之处在于，副伞3的副伞骨30的近端与底部12连接，副伞3的表面全部覆有第二膜31，多根副伞骨30和所述第二高分子膜18限定出一个囊状体33，囊状体33优选球形或椭球形。这里副伞骨30与支撑杆10的数量可以一致也可以不一致，当副伞骨30与支撑杆10的数目不一致时，只能使得副伞骨30和第二膜31围成一个的囊状体33，增加减震效果，提高装置特别是囊状体33的耐用寿命即可。
副伞骨30的近端与支撑架1的底部12连接，使得装置在左心室内血流不断冲击下，起到支撑囊状体33，增加减震效果，提高装置特别是囊状体33的耐用寿命。此设计除了起到实施例2中副伞3的效果外，还可降低输送系统的输送导管60的直径，减少装置在输送或释放等手术过程中对患者的创伤，提高装置的适用范围。
副伞骨30远端合并于中心端部32，植入减容装置的输送导管60中的推送杆61可与中心端部32通过中心端部32内设的连接螺母320拆卸连接。中心端部32内可进一步设置单向阀321，单向阀321既可内通芯杆62，便于装置的植入；又可发挥单向流通的限制作用，即：可便于操作者采用经过主动脉介入途径，通过单向阀321的口部将填充材料5注射入囊状体33内部，且防止填充材料5反向溢出到囊状体33外。填充材料5可为液体材料，如生理盐水，血液；可为注射前液体状，注射到囊状体33内部后为固化成凝胶状或固态状的材料，如PEG基高分子；可为生物可吸收类的材料，如聚乳酸(PLA)，聚乙醇酸(PGA)，聚己内酯(PCL)，以及相关共聚物或共混物；也可为血管阻塞类栓塞材料，如微弹簧圈，氰基丙烯酸酯类组织胶(如NBCA)，离子型聚合物(如Eudragit-E)，聚乙烯醇(PVA)颗粒，聚醋酸乙烯酯(PVAc)，无水乙醇，乙烯乙烯醇共聚物(EVAL)，藻酸盐(如海藻酸钙)，明胶海绵，PHEMA等弹性微球，白芨粉，自体血块等。填充材料5在囊状体33内填充完毕后不仅起到与实施例2相同的减容效果，同时进一步增强副伞3的减震效果，提高副伞3乃至整个装置的抗疲劳性能。当然所述填充材料5可以预置，避免后续的注射。
另外，底部12内也可设置单向阀321，便于操作者经心尖途径注入。预置填充材料5于 装置中，也可以取得本实施例所述相同的效果。
实施例4
如图8所示，以实施例1为基础，实施例4与实施例1的不同之处在于，副伞3的表面全部覆有第二膜31，支撑杆10与副伞骨30的连接点至所述支撑架1的近端的第一膜11上设置有孔，第一膜11和第二膜31之间限定出一个囊状体33。
第一膜11上的孔尺寸可大可小，只需满足透过气体分子，而囊状体33内部的物质不会透过，便于装置手术前的空气排出。本实施例的囊状体33内可通过中心端部32或底部12内设置的单向阀321注射或预置填充材料，取得与实施例3所述相同的效果。
实施例5
如图9所示，以实施例2为基础，实施例5与实施例2的不同之处在于，支撑架1的底部12与副伞3的中心端部32之间进一步设置弹簧7。弹簧7具有比较强的弹性变形能力，包括拉伸能力和压缩能力，可以在很大程度上调节中心端部32与支撑架1的底部12之间的相对距离，使装置便于术前安装，释放后具有更强的左心室适应性。更重要的是，弹簧7提供比较强的弹力，在血流冲击作用下，进一步增强装置减震的效果。最大限度地降低对左心室4心尖40部位内壁的损伤，进一步改善装置的抗疲劳性能。
为尽可能发挥弹簧的功能，弹簧7在变形过程，特别是在心脏收缩期收血液冲击而受到压缩的过程中，弹簧7的中心轴线应始终重合于支撑架1的底部12中心与副伞3中心端部32中心之间的连线(即可增设支撑架1的中心轴的中轴线)，对此如图9中对中轴线的局部剖视图C所示，可在弹簧7外部或内部设置同轴于支撑架1中轴线的导轨8进行限位，使弹簧7在弹性变形中弹簧7的中心轴线一直同轴于支撑架1的中轴线。
实施例6
实施例6与上述实施例的不同之处在于，在副伞骨30之间或在支撑杆10之间增加了连接结构。如图10所示，连接结构为位于副伞3的副伞骨30之间且形成固定连接的连接骨34，这不仅增加了装置的径向支撑力，使装置可以更好地贴合左心室4的内壁，从而更进一步增加支撑架1与左心室内壁的贴壁效果，因而降低侧漏的发生；而且大幅提升了装置的抗疲劳断裂性能。如图11所示，连接结构为位于支撑架1的支撑杆10之间且形成固定连接的连接杆14，同样可以取得与连接骨34相同的功效。副伞3和支撑架1分别可用镍钛合金管切割出副伞骨30和支撑杆10，然后用模具撑开，利用热处理的方式定型成如图11所示的形状；也可用镍钛合金丝经经相互缠绕的编织工艺，然后用模具，利用热处理的方式定型成最终形 状；当然，也可以采用切割和相互缠绕的编织工艺相结合的方式，然后用模具，利用热处理的方式定型成如图10所示的形状。
实施例7
如图12和图13所示，以实施例3为基础，在副伞骨30之间或在支撑杆10之间增加了如实施例6的连接结构，既可起到实施例3的效果，也可起到与实施例6相同的效果。
实施例8
如图14和图15所示，以实施例6为基础，实施例8与实施例6的不同之处在于，副伞3的副伞骨30之间设置有限位结构，限位结构可以为上下交替穿梭编织的平纹、斜纹或缎纹的织物组织结构，以便于调节装置的径向支撑力至适中，使得副伞3的引入不影响心脏的正常收缩，也可降低装置连接点疲劳断裂的风险。当然，支撑架1的支撑杆10之间也可设置限位结构，取得与在副伞3的副伞骨30之间设置限位结构相同的功效。
实施例9
在实施例3的基础上，实施例9与实施例3的不同之处在于，副伞骨30之间设置如实施例8介绍的限位结构，具有限位结构的副伞骨形成网状的球或椭球状，如图16所示。限位结构可以为上下交替穿梭编织的平纹、斜纹或缎纹的织物组织结构，可便于调节装置的径向支撑力至适中，也可降低装置连接点疲劳断裂的风险。
最后应当说明的是，以上所述仅为本发明的较佳的实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (14)

  1. 一种左心室减容装置，其特征在于：包括支撑架(1)和与所述支撑架(1)的底部(12)连接的底座(2)，所述支撑架(1)由多根支撑杆(10)组成，所述支撑杆(10)的近端聚拢形成所述支撑架(1)的所述底部(12)，所述支撑杆(10)的远端沿左心室(4)内壁向远离心尖(40)方向适应性张开，在多根所述支撑杆(10)限定的空间内还包括副伞(3)，所述副伞(3)由多根副伞骨(30)组成，所述副伞骨(30)从中心端部(32)向心尖方向延伸，其终端与所述支撑杆(10)连接，所述支撑架(1)的表面被覆膜，多根所述副伞骨(30)径向支撑多根所述支撑杆(10)使得所述支撑架(1)适应性贴合所述左心室(4)内壁。
  2. 根据权利要求1所述的左心室减容装置，其特征在于：所述支撑架(1)的表面全部覆有第一膜(11)，所述副伞骨(30)的终端与所述支撑杆(10)的中部连接，多根所述副伞骨(30)与多根所述支撑杆(10)一一对应。
  3. 根据权利要求2所述的左心室减容装置，其特征在于：所述副伞骨(30)的终端与所述支撑杆(10)的连接处为平滑过渡，使得所述支撑杆(10)的远离心尖部分能够翻转。
  4. 根据权利要求1所述的左心室减容装置，其特征在于：所述副伞的表面全部覆有第二膜(31)，所述副伞骨(30)的近端与所述支撑杆(10)的中部连接，所述支撑架(1)的表面部分覆有第一膜(11)，所述第一膜(11)从所述支撑杆(10)与所述副伞骨(30)的连接点延伸至所述支撑架(1)的远端，所述第一膜(11)的近端和所述第二膜(31)的近端密封连接，多根所述副伞骨(30)与多根所述支撑杆(10)一一对应。
  5. 根据权利要求1所述的左心室减容装置，其特征在于：所述支撑架(1)的表面全部覆有第一膜(11)，所述副伞的表面全部覆有第二膜(31)，所述副伞骨(30)的近端与所述底部(12)连接，多根所述副伞骨(30)和所述第二膜(31)限定出一个囊状体(33)。
  6. 根据权利要求5所述的左心室减容装置，其特征在于：在所述囊状体(33)内预置填充材料(5)。
  7. 根据权利要求5所述的左心室减容装置，其特征在于：在所述第二膜(31)上设置有孔，在所述中心端部(32)内设置单向阀(321)，通过所述单向阀(321)向所述囊状体(33)内注射填充材料(5)。
  8. 根据权利要求1所述的左心室减容装置，其特征在于：所述支撑架(1)的表面全部覆有第一膜(11)，所述副伞的表面全部覆有第二膜(31)，所述副伞骨(30)的近端与所述支撑杆(10)的中部连接，从所述支撑杆(10)与所述副伞骨(30)的连接点至所述支撑架(1)的近端的第一膜(11)上设置有孔，所述第一膜(11)和所述第二膜(31)之间限定出一个囊状体(33)。
  9. 根据权利要求8所述的左心室减容装置，其特征在于：在所述囊状体(33)内预置填充材料(5)，或者在所述中心端部(32)内设置单向阀(321)，通过所述单向阀(321)向所述囊状体(33)内注射填充材料(5)。
  10. 根据权利要求1所述的左心室减容装置，其特征在于：所述中心端部(32)与推送杆(61)可拆卸连接，或者所述底部(12)与芯杆(62)可拆卸连接，或者所述中心端部(32)与推送杆(61)可拆卸连接的同时所述底部(12)也与芯杆(62)可拆卸连接。
  11. 根据权利要求1所述的左心室减容装置，其特征在于：在相邻的所述支撑杆(10)之间或者在相邻的所述副伞骨(30)之间设有连接结构。
  12. 根据权利要求1所述的左心室减容装置，其特征在于：在所述支撑杆(10)之间或者在所述副伞骨(30)之间设置有限位结构，所述限位结构为平纹、斜纹或缎纹的织物组织结构。
  13. 根据权利要求1所述的左心室减容装置，其特征在于：所述中心端部(32)通过弹簧(7)与所述底座(2)连接。
  14. 根据权利要求13所述的左心室减容装置，其特征在于：所述弹簧(7)通过导轨(8)限位。
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