CN103598939A - Safety improved pulmonary artery stent and pulmonary artery valve replacement device - Google Patents

Safety improved pulmonary artery stent and pulmonary artery valve replacement device Download PDF

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Publication number
CN103598939A
CN103598939A CN201310487738.0A CN201310487738A CN103598939A CN 103598939 A CN103598939 A CN 103598939A CN 201310487738 A CN201310487738 A CN 201310487738A CN 103598939 A CN103598939 A CN 103598939A
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CN
China
Prior art keywords
flared section
support
pulmonary artery
lung arterial
stent
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
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CN201310487738.0A
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Chinese (zh)
Inventor
曾敏
拉里·范
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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HANGZHOU QIMING MEDICAL DEVICE CO Ltd
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Priority to CN201310487738.0A priority Critical patent/CN103598939A/en
Publication of CN103598939A publication Critical patent/CN103598939A/en
Priority to PCT/CN2014/085471 priority patent/WO2015055052A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0013Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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

Abstract

The invention discloses a safety improved pulmonary artery stent and a pulmonary artery valve replacement device. The safety improved pulmonary artery stent comprises a pipe-shaped supporting net stent and two flaring sections which are connected with two axial ends of the supporting net stent; every flaring section is connected with an end portion of the supporting net stent through a fixing part; one ends of the flaring sections, which are back to the supporting net stent, is provided with a plurality of wave crests which are provided with smooth edges. The pulmonary artery valve replacement device comprises the safety improved pulmonary artery stent and a prosthesis valve which is arranged inside the pulmonary artery stent. According to the safety improved pulmonary artery stent, the flaring sections are connected with the supporting net stent through the fixing parts, namely, the flaring sections and the supporting net stent are connected in a detachable mode, the safety is improved, the utilization is flexible, and meanwhile machining difficulty is reduced.

Description

Improve lung arterial support and the cusps of pulmonary valve displacement apparatus of safety
Technical field
The invention belongs to field of medical technology, relate in particular to a kind of lung arterial support and cusps of pulmonary valve displacement apparatus that improves safety.
Background technology
The cyanotic congenital heart disease patient of stenosis of right ventricular outflow tract, need to implement in early days and under extracorporeal circulation, open breast heart and entangle and control art infant or child.
Modal in the livid purple type Congenital Heart disease of stenosis of right ventricular outflow tract is Fa Luoshi tetra logy (TOF).Child medical center, Shanghai data shows that TOF operation most commonly encountered diseases people's age is 6 months~3 years old, and this age level surgical patient accounts for 74% of total operation number.Classical operation comprises that VSD repairs, the narrow releasing of right ventricular outflow tract obstruction and pulmonary artery (lobe ring and valve).
Conventionally, most of Fa Luoshi tetra logy merges supravalvular pulmonary stenosis (main pulmonary artery and [Dan arterial bifurcation are narrow), and main employing from outflow tract of right ventricle (RVOT) expands urethroptasty across valve of pulmonary trunk to main pulmonary artery (MPA) and [Dan arterial bifurcation (LPA and RPA) sticking patch.Child medical center, Shanghai data shows: in April, 1999 to 2011 year December, all TOF surgical patients record is transferred 1999,2000, calendar year 2001,2002,2003,2005,2007,2009,2011 and is added up to 9 years statistical number totally 1851 examples, wherein having done this type of sticking patch expansion urethroptasty has 1569 examples, accounts for sum 84.76%.
The sticking patch using in operation, the growth that can not comply with human body, be easy to produce narrow or valve pathological changes again, and with advancing age, the state of an illness can be more and more heavier.In addition, due to without valve, the concurrent serious pulmonary incompetence of postoperative meeting (PR).The PR of severe can cause right ventricular volume load to roll up, and can cause for a long time right ventricle chamber to expand in the past, and right ventricle shrinks ejection function decline thereupon, and patient moving tolerance obviously declines, and even occurs arrhythmia.The prompting of foreign study data is as right ventricle End-diastolic volume/body surface area (RV EDV Index) > 150ml/m 2time, patient even can die suddenly.Therefore, needs of patients is accepted again open chest surgery and is inserted new artificial lung arterial valve.But secondary or secondary are performed the operation above, not only operating difficulty is large, and has higher danger and mortality rate.
Application interventional therapy mode implanting pulmonary artery valve replacement device has not only effectively stopped Pulmonicly backflowing in a large number, improves lung tissue blood circulation and right ventricular function and has reached therapeutic purposes, and avoided open chest surgery again.
Cusps of pulmonary valve displacement apparatus of the prior art, the network of being made by memory metal material, and make in this support can unidirectional opening SANYE valve form, Fig. 1 has shown a kind of lung arterial support of existing cusps of pulmonary valve displacement apparatus, be netted shape of a saddle cylindrical structure, network structure is comprised of regular rhombus, conventionally, lung arterial support carries out cutting processing on the tubing of memory metal material by laser, form the hollow out shape of rhombus, after lung arterial support is released, lung arterial support spreading state as shown in Figure 1, but the restriction based on processing technique, the end at lung arterial support expansion two ends still can inevitably form sharp-pointed protuberance (as the m position in Fig. 1 and n position), sharp-pointed protuberance is easily poked blood vessel, tissue, operating difficulty and operation risk have been increased, in addition, because lung arterial support two ends are completely different from the shape at middle part, if whole lung arterial support is carried out to one cutting and heat treatment, difference due to different patient physiological structures, need the lung arterial support of the multiple different model of customization, corresponding cutting and Technology for Heating Processing, instrument is complicated, this has increased the cost of operation undoubtedly.
Summary of the invention
The invention provides a kind of lung arterial support that improves safety, safe and easy to process.
Improve a lung arterial support for safety, comprise the support rack of tubulose and two flared section that are connected with the axial two ends of described support rack respectively, each flared section is connected with the end of described support rack by fixture.
In the present invention, lung arterial support is modular structure, totally three modules: two flared section with support rack, during assembling, by fixture by flared section with support rack and be connected, therefore, the selection of fixture should facilitate the installation and removal of lung arterial support.
Described flared section supports one end of rack dorsad with some crests, and all crest positions are with level and smooth outer rim.Crest position is that crest position is curved with level and smooth outer rim, and avoided stabbing under the continuous kinestate of lung arterial support heart after release blood vessel, tissue, reduced operating difficulty, evaded operation risk, improved safety.
As preferably, at least one flared section is the wavy shaped configuration that single metal wire is coiled into.Flared section mainly plays supporting and location effect, can make lung arterial support firm be positioned at implantation position, flared section is made by single metal wire, can meet positioning requirements, and its processing is more prone to, single metal wire is carried out to the bending of proper angle, preferred, two flared section are the wavy shaped configuration that single metal wire is coiled into.
For ease of fixture, be fixed, one end of contiguous each flared section of described support rack has the some cells around circumferential distribution, and the trough position of described wavy shaped configuration is connected with the summit of described cell.
In each flared section, trough quantity is less than the quantity of the corresponding cell of described flared section.Like this, be separated with cell between between adjacent trough, flared section and to support the hollow out region forming between rack larger, reduces the barrier effect to blood flow.
Preferably, in each flared section, trough quantity is 1/2nd of the corresponding cell quantity of described flared section.Trough quantity crosses that I haven't seen you for ages affects the steadiness of lung arterial support location, is separated with a cell between between adjacent trough, makes to have larger area hollow out region between flared section and support rack when can guarantee to locate steadiness.
As preferably, described fixture is flexible binding strap.Can by flared section with support rack firmly together with colligation, and convenient operation.
The present invention also provides a kind of cusps of pulmonary valve displacement apparatus, comprises the lung arterial support of described raising safety and is arranged on the prosthetic valve in described lung arterial support.
Described support rack and the flared section overlay film contiguous with outflow tract of right ventricle.
Described film wraps up described fixture.
If there is no specified otherwise in the present invention, when describing the structure of lung arterial support, all refer to the structure under complete spreading state in human body.
Compared with prior art, beneficial effect of the present invention is:
(1) in prior art, whole lung arterial support is integrated Carving Machining and forms, in the present invention, two flared section are three modules with supporting rack, flared section is connected by fixture with support rack, between described flared section and support rack, be the mode of removably connecting, tool has the following advantages:
First, adopt one artistic carving, the end at lung arterial support two ends can inevitably form sharp-pointed protuberance, and the present invention can overcome this defect completely, can to flared section, carry out separately the processing of suitable shape, then is installed on support rack.Again, because adapting to the physiological structure, the diseased region that solve most of patients, the adjustment by lung arterial support length there are differences problem, in prior art, need to prepare for different patients the lung arterial support of Multiple Type, in the present invention, according to patient's real needs, only need to prepare the support rack of different length, will support rack accordingly and flared section is installed together, the mode of modular combination can adapt to patient's demand more flexibly; In addition, the present invention, support rack is tubulose, when the support rack of different length is shaped, can only use same mould, without a kind of support one mold, greatly provides cost savings.
(2) although the present invention will become and removably connect between flared section and support rack, fixture and overlay film, when guaranteeing valve compliance, do not affect the steadiness of lung arterial support location.
Accompanying drawing explanation
Fig. 1 is the structural representation of lung arterial support in prior art.
Fig. 2 is the perspective view that the present invention improves the lung arterial support of safety.
Fig. 3 is the front view that the present invention improves the lung arterial support of safety.
Fig. 4 is the simple structure schematic diagram of the present invention's lung arterial support of improving safety.
Fig. 5 is the structural representation that the present invention improves one of them flared section in the lung arterial support of safety.
Fig. 6 is the structural representation that the present invention improves another flared section in the lung arterial support of safety.
Fig. 7 is that the present invention improves the flared section structural representation fixing with supporting rack in the lung arterial support of safety.
The specific embodiment
Below in conjunction with specific embodiment, the present invention is further explained.
Fig. 2~Fig. 4 shows the structure of lung arterial support of the present invention, comprises two flared section that support rack 1 and be connected with the support axial two ends of rack 1 respectively, is respectively and flows out flared section 2a and flow to flared section 2b.
Support rack 1 in a tubular form, by continuous rhombus, formed, certainly also can not have strict requirement by oval, irregularly shaped composition, as long as guarantee support force and the compliance of lung arterial support.The diameter and the length that support rack 1 can adopt stock size, also can customize targetedly according to patient's concrete condition.
Support the contiguous one end of flowing out flared section 2a of rack 1 and there are 12 cells around circumferential distribution, called after first module lattice 3, support the contiguous one end that flows to flared section 2b of rack 1 and also there are 12 cells around circumferential distribution, called after second unit lattice 4, differentiation in the name that first module lattice in literary composition and second unit lattice only carry out for convenience of describing, not represents different structures.
Flow out flared section 2a and be substantially positioned at main pulmonary artery near pulmonary artery branch port part, as shown in Figure 5, flowing out flared section 2a is the wavy shaped configuration that single metal wire is coiled into, crest 5 positions of wavy shaped configuration are circular arc, the trough 6 of this wavy shaped configuration is connected with the summit of first module lattice 3, at this position, fixture 7 is connected flared section 2a with the end of supporting rack 1, in addition, the wavy shaped configuration of this flared section 2a has six crests 5 and six troughs 6, between between adjacent trough 6, be separated with first module lattice 3, thus, flow out flared section 2a and support between rack 1 and surround six hollow out regions.
Flow to flared section 2b and be substantially positioned at outflow tract of right ventricle position, with the similar that flows out flared section 2a, as Fig. 6, flow to the wavy shaped configuration that flared section 2b is also coiled into for single metal wire, the crest position of wavy shaped configuration is circular arc, the trough of this wavy shaped configuration is connected with the summit of second unit lattice 4, at this position, fixture is connected with the end of supporting rack 1 flowing to flared section 2b, in addition, this wavy shaped configuration that flows to flared section 2b has six crests and six troughs, between between adjacent trough, be separated with second unit lattice 4, thus, flow to flared section 2b and support between rack 1 and surround six hollow out regions, at least two crest positions that flow to flared section 2b can be used for being connected with induction system.
Fixture 7 is flexible binding strap, by flowing out flared section 2a and flowing to the end with supporting rack 1 that flared section 2b is corresponding, fix respectively, take and flow out flared section 2a as example describes, as shown in Figure 7, be wound around flexible binding strap and both be connected by being wound around at the position, summit of trough and first module lattice.Two ends 8a and the 8b of flexible binding strap can be connected, or fix by modes such as knotting, bonding, hot melts.Certainly, in the present invention, flow out flared section or flow to flared section and be not restricted to this kind of fixing means with supporting rack, can select flexibly.
In the present invention, lung arterial support is divided into three module, between two flared section (flow to flared section and flow out flared section) and support rack, removably connect, supporting rack can carve on memory metal tubing, flow to flared section and flow out flared section and be bent to form by single metal wire, finally will flow to flared section, outflow flared section and support rack again and be connected, and support the length of rack and can select flexibly according to patient's disease, flowing to flared section and flow out flared section can be general.
The present embodiment also provides a kind of cusps of pulmonary valve displacement apparatus, support rack and flow to flared section 2b position overlay film, supporting rack inseam and be shaped with prosthese SANYE valve, flowing out flared section 2a and wrapped up by film, flow out between flared section 2a and support rack and still there is hollow out region, to guarantee that blood flow is unimpeded.In order further to strengthen fixture intensity, after increase implantation, tissue is climbed and is covered simultaneously, and available film wraps up fixture.

Claims (10)

1. improve a lung arterial support for safety, comprise the support rack of tubulose and two flared section that are connected with the axial two ends of described support rack respectively, it is characterized in that, each flared section is connected with the end of described support rack by fixture.
2. the lung arterial support of raising safety as claimed in claim 1, is characterized in that, described flared section supports one end of rack dorsad with some crests, and all crest positions are with level and smooth outer rim.
3. the lung arterial support of raising safety as claimed in claim 2, is characterized in that, at least one flared section is the wavy shaped configuration that single metal wire is coiled into.
4. the lung arterial support of raising safety as claimed in claim 3, it is characterized in that, one end of contiguous each flared section of described support rack has the some cells around circumferential distribution, and the trough position of described wavy shaped configuration is connected with the summit of described cell.
5. the lung arterial support of raising safety as claimed in claim 4, is characterized in that, in each flared section, trough quantity is less than the quantity of the corresponding cell of described flared section.
6. the lung arterial support of raising safety as claimed in claim 5, is characterized in that, in each flared section, trough quantity is 1/2nd of the corresponding cell quantity of described flared section.
7. the lung arterial support of raising safety as claimed in claim 1, is characterized in that, described fixture is flexible binding strap.
8. a cusps of pulmonary valve displacement apparatus, is characterized in that, comprise the lung arterial support of the raising safety as described in claim 1~7 and be arranged on as described in prosthetic valve in lung arterial support.
9. cusps of pulmonary valve displacement apparatus as claimed in claim 8, is characterized in that, described support rack and the flared section overlay film contiguous with outflow tract of right ventricle.
10. cusps of pulmonary valve displacement apparatus as claimed in claim 9, is characterized in that, described film wraps up described fixture.
CN201310487738.0A 2013-10-17 2013-10-17 Safety improved pulmonary artery stent and pulmonary artery valve replacement device Pending CN103598939A (en)

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CN201310487738.0A CN103598939A (en) 2013-10-17 2013-10-17 Safety improved pulmonary artery stent and pulmonary artery valve replacement device
PCT/CN2014/085471 WO2015055052A1 (en) 2013-10-17 2014-08-29 Safety improved pulmonary artery stent and pulmonary artery valve replacement apparatus

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WO2015055052A1 (en) * 2013-10-17 2015-04-23 杭州启明医疗器械有限公司 Safety improved pulmonary artery stent and pulmonary artery valve replacement apparatus
CN104720936A (en) * 2015-03-26 2015-06-24 杭州启明医疗器械有限公司 Valve stent safe to use and valve replacement device with same
CN104720937A (en) * 2015-03-26 2015-06-24 杭州启明医疗器械有限公司 Valve support for decreasing compression length and valve replacement device with valve support
CN105287051A (en) * 2015-09-30 2016-02-03 复旦大学附属中山医院 Artificial aortic valve ring system implanted through peripheral arterial approach
WO2017121192A1 (en) * 2016-01-11 2017-07-20 北京迈迪顶峰医疗科技有限公司 Apparatus, having spinous positioning rods, for transcatheter delivery of aortic valve
CN110013352A (en) * 2018-01-07 2019-07-16 苏州杰成医疗科技有限公司 Prosthetic heart valve delivery system
CN110545756A (en) * 2017-02-27 2019-12-06 杜拉有限责任公司 Novel transcatheter valve replacement device
CN111407466A (en) * 2020-03-27 2020-07-14 山东大学齐鲁医院 Implantable biological valve
US11857441B2 (en) 2018-09-04 2024-01-02 4C Medical Technologies, Inc. Stent loading device
US11931253B2 (en) 2020-01-31 2024-03-19 4C Medical Technologies, Inc. Prosthetic heart valve delivery system: ball-slide attachment
US11938024B2 (en) 2013-03-14 2024-03-26 Jc Medical, Inc. Methods and devices for delivery of a prosthetic valve
US11944537B2 (en) 2017-01-24 2024-04-02 4C Medical Technologies, Inc. Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve
US11957577B2 (en) 2017-01-19 2024-04-16 4C Medical Technologies, Inc. Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves
US11992403B2 (en) 2020-03-06 2024-05-28 4C Medical Technologies, Inc. Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells

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