CN114590487A - Implant packaging container and implant packaging composition - Google Patents
Implant packaging container and implant packaging composition Download PDFInfo
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- CN114590487A CN114590487A CN202011433300.0A CN202011433300A CN114590487A CN 114590487 A CN114590487 A CN 114590487A CN 202011433300 A CN202011433300 A CN 202011433300A CN 114590487 A CN114590487 A CN 114590487A
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- 239000007943 implant Substances 0.000 title claims abstract description 120
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 42
- 239000000203 mixture Substances 0.000 title claims description 7
- 238000007789 sealing Methods 0.000 claims abstract description 11
- 230000007704 transition Effects 0.000 claims description 3
- 239000007788 liquid Substances 0.000 abstract description 15
- 239000000428 dust Substances 0.000 abstract description 3
- 238000000034 method Methods 0.000 description 11
- 238000004873 anchoring Methods 0.000 description 8
- 238000010586 diagram Methods 0.000 description 8
- 210000003709 heart valve Anatomy 0.000 description 7
- 210000001519 tissue Anatomy 0.000 description 7
- 239000000463 material Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 4
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 3
- 206010067171 Regurgitation Diseases 0.000 description 3
- 210000004115 mitral valve Anatomy 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- 208000031481 Pathologic Constriction Diseases 0.000 description 2
- 210000001765 aortic valve Anatomy 0.000 description 2
- 229920001296 polysiloxane Polymers 0.000 description 2
- 210000003102 pulmonary valve Anatomy 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 230000036262 stenosis Effects 0.000 description 2
- 208000037804 stenosis Diseases 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 210000000591 tricuspid valve Anatomy 0.000 description 2
- 241000283073 Equus caballus Species 0.000 description 1
- 230000004308 accommodation Effects 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 210000002837 heart atrium Anatomy 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
- B65D81/22—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient in moist conditions or immersed in liquids
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D21/00—Nestable, stackable or joinable containers; Containers of variable capacity
- B65D21/02—Containers specially shaped, or provided with fittings or attachments, to facilitate nesting, stacking, or joining together
- B65D21/0209—Containers specially shaped, or provided with fittings or attachments, to facilitate nesting, stacking, or joining together stackable or joined together one-upon-the-other in the upright or upside-down position
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
- B65D25/107—Grooves, ribs, or the like, situated on opposed walls and between which the articles are located
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
- B65D41/04—Threaded or like caps or cap-like covers secured by rotation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D53/00—Sealing or packing elements; Sealings formed by liquid or plastics material
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Description
技术领域technical field
本发明属于医疗器械技术领域,具体涉及一种植入体包装容器及植入体包装组合物。The invention belongs to the technical field of medical devices, and in particular relates to an implant packaging container and an implant packaging composition.
背景技术Background technique
本部分提供的仅仅是与本公开相关的背景信息,其并不必然是现有技术。This section provides merely background information related to the present disclosure and is not necessarily prior art.
人类心脏包括四个心脏瓣膜,它们决定了血液流经心脏的路径:二尖瓣、三尖瓣、主动脉瓣和肺动脉瓣。二尖瓣和三尖瓣是位于心房与心室之间的房室瓣,而主动脉瓣和肺动脉瓣则是位于离开心脏的动脉中的半月瓣。理想地,心脏瓣膜的各天然瓣叶在瓣膜处于打开位置中时彼此远离地运动,且在瓣膜处于关闭位置中时相接触或“合紧”。瓣膜可能产生的问题包括:狭窄,此时瓣膜没有适当地打开;和/或机能不全或返流,此时瓣膜没有适当地闭合。狭窄和机能不全可能在同一个瓣膜中并发。瓣膜功能障碍的影响不同,且返流或回流通常对患者造成相对严重的生理后果。The human heart consists of four heart valves, which determine the path blood flows through the heart: the mitral, tricuspid, aortic, and pulmonary valves. The mitral and tricuspid valves are atrioventricular valves located between the atria and ventricles, while the aortic and pulmonary valves are semilunar valves located in the arteries that leave the heart. Ideally, the native leaflets of the heart valve move away from each other when the valve is in the open position and touch or "close" when the valve is in the closed position. Problems that can arise with the valve include: stenosis, when the valve does not open properly; and/or insufficiency or regurgitation, when the valve does not close properly. Stenosis and insufficiency may coexist in the same valve. The effects of valve dysfunction vary, and regurgitation or regurgitation often has relatively severe physiological consequences for the patient.
可采用各种不同类型的心脏瓣膜手术来对病变的或者其他方式有缺陷的心脏瓣膜进行修复或置换。近年来,瓣膜置换术主流是微创方案植入心脏瓣膜,让患者避免了开胸手术之苦。可扩张瓣膜假体被压缩在递送装置的导管周围或导管内,插入到患者的诸如股动脉之类的体腔中,并被递送至心脏中所期望的位置处,然后瓣膜假体在该位置部署。瓣膜假体结构可以呈现多种形式,并且可以例如由一种或多种可生物相容的合成材料制成的组织、合成聚合物、自体移植组织、同种移植组织、异种移植组织、或一种或多种其它合适的材料形成。在一些瓣膜假体中,瓣膜可形成自例如牛、猪、马、羊的和/或其它合适的动物的组织。瓣膜假体可以包括心脏瓣膜组织、心包和/或其它合适的组织,还可包括或形成一个或多个瓣叶。例如,瓣膜假体可以呈以下形式:三叶牛心包瓣膜、二叶瓣膜或其它合适的瓣膜。A variety of different types of heart valve surgery are available to repair or replace diseased or otherwise defective heart valves. In recent years, the mainstream of valve replacement is the minimally invasive method of implanting the heart valve, which allows patients to avoid the pain of open-heart surgery. The expandable valve prosthesis is compressed around or within a catheter of a delivery device, inserted into a patient's body cavity, such as the femoral artery, and delivered to the desired location in the heart, where the valve prosthesis is then deployed . Valve prosthetic structures can take a variety of forms, and can be, for example, tissue made from one or more biocompatible synthetic materials, synthetic polymers, autografted tissue, allografted tissue, xenografted tissue, or a one or more other suitable materials. In some valve prostheses, the valve may be formed from tissue such as bovine, porcine, equine, ovine, and/or other suitable animals. A valve prosthesis may include heart valve tissue, pericardium, and/or other suitable tissue, and may also include or form one or more valve leaflets. For example, the valve prosthesis may be in the form of a tricuspid bovine pericardial valve, a bicuspid valve, or other suitable valve.
为了保证瓣膜从生产厂家运输到医院途中处于无菌环境的同时最小化对相对脆弱的生物人工心脏瓣膜的损害可能性,瓣膜假体通常被包装在填充有诸如戊二醛之类的溶液的容器中以在将瓣膜假体附连于递送装置以递送至患者之前对瓣膜假体进行消毒和保存。因此盛放瓣膜的容器应具有良好的密封性并且容易旋开,不与戊二醛发生反应,放在手术台上不易滑动并且运输时易于叠放。To ensure that the valve is transported from the manufacturer to the hospital in a sterile environment while minimizing the potential for damage to the relatively fragile bioprosthetic heart valve, valve prostheses are typically packaged in containers filled with solutions such as glutaraldehyde The valve prosthesis is sterilized and preserved prior to attaching the valve prosthesis to the delivery device for delivery to the patient. Therefore, the container holding the valve should have good sealing and be easy to unscrew, not react with glutaraldehyde, not easy to slide on the operating table, and easy to stack during transportation.
发明内容SUMMARY OF THE INVENTION
本发明的目的是至少解决现有技术中瓣膜假体递送至患者之前对瓣膜假体进行运输、消毒和保存不当的问题。该目的是通过以下技术方案实现的:It is an object of the present invention to at least address the prior art problems of improper transport, sterilization and preservation of valve prostheses prior to delivery to the patient. This purpose is achieved through the following technical solutions:
一种植入体包装容器,包括:容纳体;盖体,所述盖体可与所述容纳体密封连接形成容纳腔,所述容纳腔可容纳所述植入体;支撑体,所述支撑体设置在所述容纳腔内,所述支撑体上设置有中空的容纳区,所述容纳区设置成容纳植入体;所述支撑体包括手柄,所述手柄可固定所述植入体。An implant packaging container, comprising: a accommodating body; a cover body, the cover body can be sealed with the accommodating body to form a accommodating cavity, the accommodating cavity can accommodate the implant body; a supporting body, the supporting body The support body is arranged in the accommodating cavity, and the support body is provided with a hollow accommodating area, and the accommodating area is configured to accommodate the implant body; the support body includes a handle, and the handle can fix the implant body.
在一实施例中,所述支撑体包括:本体,所述容纳区设置在所述本体上,所述本体设置成固定所述植入体;所述手柄连接在所述本体上,所述手柄设置成固定所述植入体的系绳。In one embodiment, the support body includes: a body, the accommodating area is arranged on the body, and the body is arranged to fix the implant; the handle is connected to the body, and the handle is A tether configured to secure the implant.
在一实施例中,所述手柄包括:第一连接部,所述第一连接部的一端连接在所述本体的上表面上;第一手持部,所述第一手持部与所述第一连接部上远离所述本体的一端相连,且所述第一手持部相对于所述第一连接部向所述本体的中心倾斜。In one embodiment, the handle includes: a first connecting part, one end of the first connecting part is connected to the upper surface of the main body; a first hand-holding part, the first hand-holding part and the first hand One end of the connecting portion away from the body is connected, and the first handle portion is inclined toward the center of the body relative to the first connecting portion.
在一实施例中,所述第一连接部上设置有第一固定孔,所述第一固定孔设置成供所述系绳穿设;所述第一手持部与所述第一连接部的连接处设置有第二固定孔,所述系绳依次穿过所述第一固定孔和所述第二固定孔,并以至少一圈的方式缠绕在所述第一连接部上。In one embodiment, the first connecting portion is provided with a first fixing hole, and the first fixing hole is configured to allow the tether to pass through; A second fixing hole is provided at the connection part, and the tether passes through the first fixing hole and the second fixing hole in sequence, and is wound on the first connection part in at least one circle.
在一实施例中,所述第一手持部上交错设置有至少两个固定部,所述系绳依次穿过所述第一固定孔和所述固定部,并以至少一圈缠绕在所述第一连接部上。In one embodiment, at least two fixing parts are alternately arranged on the first hand-held part, the tether passes through the first fixing hole and the fixing part in sequence, and is wound around the fixing part in at least one circle. on the first connecting part.
在一实施例中,所述容纳体内设置有第一限位部,所述第一限位部凸出于所述容纳体的内表面,所述盖体向所述容纳体的方向凹陷形成第二限位部,所述第二限位部的内表面和所述第一限位部分别与所述支撑体的两端限位配合。In one embodiment, the accommodating body is provided with a first limiting portion, the first limiting portion protrudes from the inner surface of the accommodating body, and the cover body is recessed in the direction of the accommodating body to form a first stopper. Two limiting portions, the inner surface of the second limiting portion and the first limiting portion are respectively engaged with the two ends of the support body for limiting fit.
在一实施例中,所述支撑体朝向所述第一限位部的一侧设置有第三限位部,所述第三限位部包括凹槽,且所述第三限位部与所述第一限位部以轮廓匹配的方式限位配合。In one embodiment, a side of the support body facing the first limiting portion is provided with a third limiting portion, the third limiting portion includes a groove, and the third limiting portion is connected to the first limiting portion. The first limiting portion is limited and matched in a contour matching manner.
在一实施例中,所述盖体朝向所述容纳体的一侧设置有第一接触面,所述容纳体朝向所述盖体的一侧设置有第二接触面,且所述第一接触面与所述第二接触面中至少一个为斜面,所述第一接触面与所述第二接触面配合以实现所述盖体与所述容纳体之间的密封。In one embodiment, a side of the cover body facing the accommodating body is provided with a first contact surface, a side of the accommodating body facing the cover body is provided with a second contact surface, and the first contact surface is At least one of the surface and the second contact surface is an inclined surface, and the first contact surface cooperates with the second contact surface to achieve sealing between the cover body and the accommodating body.
在一实施例中,所述容纳体的外周设置有第四限位部,且所述第四限位部与所述容纳体的外壁之间圆弧过渡连接。In one embodiment, a fourth limiting portion is provided on the outer periphery of the accommodating body, and an arc transition connection is formed between the fourth limiting portion and the outer wall of the accommodating body.
在一实施例中,所述植入体包装容器还包括密封件,所述密封件设置在所述盖体与所述容纳体之间。In one embodiment, the implant packaging container further includes a sealing member disposed between the cover body and the accommodating body.
一种植入体包装组合物,包括植入体和上述任一植入体包装容器,所述植入体置于所述支撑体的容纳区。An implant packaging composition, comprising an implant and any one of the above-mentioned implant packaging containers, the implant is placed in the accommodating area of the support body.
在一实施例中,所述植入体包括锚定部,所述锚定部位于所述支撑件的下方。In one embodiment, the implant includes an anchoring portion located below the support.
在一实施例中,所述植入体架于所述支撑体上。In one embodiment, the implant is mounted on the support.
在一实施例中,所述植入体置于所述包装容器的容纳腔时,所述系绳固定在所述手柄上,且所述系绳与所述植入体之间的部分处于松弛状态。In one embodiment, when the implant is placed in the accommodating cavity of the packaging container, the tether is fixed on the handle, and the part between the tether and the implant is relaxed. state.
根据本发明实施例的植入体包装容器,将植入体放入在容纳区内,再将支撑体和植入体一同放入盖体和容纳体所形成的容纳腔中,使植入体浸在储存液中,最后将盖体扣合在容纳体上,两者之间形成密封连接,以避免外界环境中灰尘或液体进入到容纳腔中,避免植入体被污染或损坏。支撑体上设置有中空的容纳区,当植入体放入容纳区后,实现了对植入体周向的固定,减少了在运输过程中植入体的晃动。According to the implant packaging container of the embodiment of the present invention, the implant is placed in the accommodating area, and then the support body and the implant are put into the accommodating cavity formed by the cover and the accommodating body together, so that the implant is After being immersed in the storage liquid, the cover body is finally fastened on the receiving body, and a sealed connection is formed between the two to prevent dust or liquid from the external environment from entering the receiving cavity and prevent the implant from being polluted or damaged. The support body is provided with a hollow accommodating area, and when the implant body is placed in the accommodating area, the circumferential fixation of the implant body is realized, and the shaking of the implant body during transportation is reduced.
附图说明Description of drawings
通过阅读下文优选实施方式的详细描述,各种其他的优点和益处对于本领域普通技术人员将变得清楚明了。附图仅用于示出优选实施方式的目的,而并不认为是对本发明的限制。而且在整个附图中,用相同的参考符号表示相同的部件。在附图中:Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are for the purpose of illustrating preferred embodiments only and are not to be considered limiting of the invention. Also, the same components are denoted by the same reference numerals throughout the drawings. In the attached image:
图1为本发明实施例的植入体包装容器的立体结构示意图;1 is a schematic three-dimensional structure diagram of an implant packaging container according to an embodiment of the present invention;
图2为本发明实施例的植入体的立体结构示意图;2 is a schematic three-dimensional structural diagram of an implant according to an embodiment of the present invention;
图3为本发明一种实施例的包装容器的分解结构示意图;3 is a schematic diagram of an exploded structure of a packaging container according to an embodiment of the present invention;
图4为图3所示的盖体和容纳体的剖面示意图;4 is a schematic cross-sectional view of the cover body and the accommodating body shown in FIG. 3;
图5为图3所示的支撑体的立体结构示意图;FIG. 5 is a schematic three-dimensional structure diagram of the support body shown in FIG. 3;
图6为图3所示的植入体装入支撑体后的侧视图;6 is a side view of the implant shown in FIG. 3 after being loaded into a support body;
图7为本发明另一种实施例的包装容器的分解结构示意图;7 is a schematic diagram of an exploded structure of a packaging container according to another embodiment of the present invention;
图8为图7所示的剖面示意图;Fig. 8 is the sectional schematic diagram shown in Fig. 7;
图9为图7所示的支撑体的立体结构示意图;FIG. 9 is a schematic three-dimensional structure diagram of the support body shown in FIG. 7;
图10为图7所示的支撑体的另一方向的立体结构示意图;FIG. 10 is a schematic three-dimensional structure diagram of the support body shown in FIG. 7 in another direction;
图11为图7所示的植入体装入支撑体后的侧视图;Figure 11 is a side view of the implant shown in Figure 7 after being loaded into a support;
图12为本发明实施例的植入体包装容器叠放的剖面示意图。FIG. 12 is a schematic cross-sectional view of stacking implant packaging containers according to an embodiment of the present invention.
附图中各标记表示如下:The symbols in the accompanying drawings are indicated as follows:
100、植入体包装容器;100. Implant packaging container;
1、容纳体;11、第一限位部;12、第二接触面;13、第四限位部;14、外螺纹;15、凸起;1. accommodating body; 11. the first limit part; 12, the second contact surface; 13, the fourth limit part; 14, the external thread; 15, the protrusion;
2、盖体;21、第二限位部;22、第一接触面;23、内螺纹;2. Cover body; 21. Second limiting part; 22. First contact surface; 23. Internal thread;
3、支撑体;31、容纳区;32、本体;33、手柄;34、第三限位部;321、开口;331/333、第一连接部;332/334、第一手持部;第一连接部第一手持部3311/3331、第一固定孔;3312、第二固定孔;第一固定孔3341、凹槽;3342、第一固定部;3343、第二固定部;3344、防滑结构;3. Supporting body; 31. Receiving area; 32. Main body; 33. Handle; 34. Third limiting part; 321. Opening; 331/333, first connecting part; 3311/3331, the first fixing hole; 3312, the second fixing hole; the
4、密封件;4. Seals;
5、植入体;51、第一部分;52、第二部分;53、系绳;511、锚定部。5. Implant; 51. First part; 52. Second part; 53. Tether; 511. Anchor.
具体实施方式Detailed ways
下面将参照附图更详细地描述本公开的示例性实施方式。虽然附图中显示了本公开的示例性实施方式,然而应当理解,可以以各种形式实现本公开而不应被这里阐述的实施方式所限制。相反,提供这些实施方式是为了能够更透彻地理解本公开,并且能够将本公开的范围完整的传达给本领域的技术人员。Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be more thoroughly understood, and will fully convey the scope of the present disclosure to those skilled in the art.
应理解的是,文中使用的术语仅出于描述特定示例实施方式的目的,而无意于进行限制。除非上下文另外明确地指出,否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的,并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在,但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" can also be intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprising", "comprising", "containing" and "having" are inclusive and thus indicate the presence of stated features, steps, operations, elements and/or components, but do not preclude the presence or addition of one or Various other features, steps, operations, elements, components, and/or combinations thereof.
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出,否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。因此,以下讨论的第一元件、部件、区域、层或部段在不脱离示例实施方式的教导的情况下可以被称作第二元件、部件、区域、层或部段。Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be restricted by these terms. These terms may only be used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of example embodiments.
为了便于描述,可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系,这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如,如果在图中的装置翻转,那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此,示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures, such as "inner", "outer", "inner" ", "outside", "below", "below", "above", "above", etc. This spatially relative term is intended to include different orientations of the device in use or operation other than the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "above the other elements or features" above features". Thus, the example term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
根据本发明一个实施例的植入体包装容器100,包括:The
容纳体1;
盖体2,盖体2可与容纳体1密封连接形成容纳腔,容纳腔设置成可储放储存液和容纳植入体;
支撑体3,支撑体3设置在容纳腔内,支撑体3形成有中空的容纳区31,支撑体3设置成固定位于容纳区31内的植入体5。The supporting
根据本发明实施例的植入体包装容器100,将植入体5放入在容纳区31内,再将支撑体3和植入体5一同放入盖体2和容纳体1所形成的容纳腔中,使植入体5浸在储存液中,最后将盖体2扣合在容纳体1上,两者之间形成密封连接,以避免外界环境中灰尘或液体进入到容纳腔中,避免植入体5被污染或损坏。支撑体3上形成有中空的容纳区31,当植入体5放入容纳区31后,实现了对植入体5周向的固定,减少了在运输过程中植入体5的晃动,且保证植入体5的动物源性材料能始终与空气隔绝。According to the
在本发明的一些实施例中,盖体2与容纳体1之间为可拆卸连接,为了便于植入体5取出,可以是螺纹连接、卡接、螺钉连接或其他连接方式,在一个实施例中,盖体2与容纳体1之间采用螺纹连接。在容纳体1的外壁设置有外螺纹14,在盖体2的内壁设置有内螺纹23,通过内外螺纹的配合实现盖体2与容纳体1之间的密封连接。下文中的“内”和“外”为相对含义,盖体2和容纳体1朝向支撑体3的一侧为内,盖体2和容纳体1朝向外界环境的一侧为外。In some embodiments of the present invention, the
在本发明的一些实施例中,支撑体3由高分子材料制成,生物相容性好,可以长期存放于生理盐水,戊二醛等液体中,在一个实施例中,支撑体3采用医用级高纯度的PC材料制成。In some embodiments of the present invention, the
在本发明的一些实施例中,植入体5可以是带有动物源性材料的植入体,下面以植入体5为瓣膜假体为例进行说明。如图2所示,植入体5包括第一部分51、第二部分52和系绳53,第一部分51的周向上设置有锚定部511,锚定部511设置在第一部分51的外表面且朝向第二部分52径向向外延伸;第二部分52的一端与第一部分51外周相连,第二部分52的最大外径大于第一部分51的最大外径,系绳53连接在第一部分51上远离第二部分52的另一端。对应的瓣膜假体,第一部分51包括支架,第二部分52包括裙边。在进行植入体5储存的过程中,需要尽量避免容器与锚定部511的接触,避免影响锚定部511的形态。如图3和图5至图10所示,支撑体3包括本体32,容纳区31设置在本体32上,容纳区31设置成可容纳植入体5的第一部分51,且容纳区31的尺寸大于第一部分51的最大外径(除锚定部511外的其它部分的最大外径)但小于第二部分52的最大外径。将植入体5放入在容纳区31内,为了避免影响锚定部511的形态,将容纳区31的尺寸设置为大于第一部分51的最大外径,放置时,锚定部511与第一部分51相连的一端位于本体32的下方。该种设置方式除了避免与锚定部511之间的接触,还能避免支撑体3对第一部分51造成挤压,在相对限制植入体5位置的同时不至于对第一部分51产生影响,另外,容纳区31也给植入体5留有一定活动空间,使得在运输过程中,容纳区31内储存液晃动时,植入体5也可一定程度上随储存液同步晃动,减少储存液对第一部分51的撞击。支撑体3还包括手柄33,手柄33连接在本体32上,手柄33设置成固定系绳53。系绳53的固定方式可以是缠绕在手柄33上,也可以直接在手柄33上打结,还可以通过其他方式固定在手柄33上,以上方式均是对系绳53的固定方式的示例。将系绳53固定在手柄33上后,使得系绳53不会在运输过程中缠绕在第一部分51、第二部分52或者支撑体3上,为后续取用过程提供便利。In some embodiments of the present invention, the implant body 5 may be an implant body with animal-derived materials, and the following description will be given by taking the implant body 5 as a valve prosthesis as an example. As shown in FIG. 2 , the implant 5 includes a
可以理解的是,在其它实施例中,植入体也可以直接架于支撑体上,只要避免支撑体挤压植入体或植入体上的锚刺即可。It can be understood that, in other embodiments, the implant can also be directly supported on the support body, as long as the support body can avoid pressing the implant body or the anchor barb on the implant body.
其中,本体32为扁平的环形结构,容纳区31为支撑体3上设置的通孔,通孔的形状可以是圆形、三角形或椭圆形,在一个实施例中,通孔的形状为圆形。将通孔朝向植入体5的一侧进行圆角处理,减少尖锐结构,以减少对植入体5的磨损。Wherein, the
在本发明的一些实施例中,在进行植入体5的固定时,系绳53和第一部分51依次穿过容纳区31,由于第一部分51上第二部分52的最大外径大于第一部分51的最大外径,容纳区31阻挡植入体5的进一步移动,最终将系绳53固定在手柄33上。当需要取用植入体5时,需要将系绳53从手柄33上拆解,再将第一部分51和系绳53依次从容纳区31中撤出。为了缩短植入体5从支撑体3上的拆卸时间,便于植入体5的装入和取出,如图3、图5、图7、图9和图10所示,在支撑体3上还设置有开口321,开口321与容纳区31连通,将系绳53从手柄33上拆解后,使第一部分51从容纳区31中撤出,最后使系绳53或系绳53和部分第一部分51从开口321中移出即可。应当理解,在其它实施例中,本体32上也可以不设置与容纳区31连通的开口321。In some embodiments of the present invention, when the implant 5 is fixed, the
在本发明的一些实施例中,根据前文所述,系绳53有多种固定方式,下面以其中一种固定方式为例进行说明。如图3至图6所示,手柄33包括第一连接部331,第一连接部331的一端连接在本体32的上表面上,将第一部分51穿过容纳区31后,将系绳53缠绕在第一连接部331上,在运输过程中,为避免因晃动导致系绳53松脱,在第一连接部331上靠近本体32的一端上还设置有第一固定孔3311,系绳53穿过第一固定孔3311后再缠绕到第一连接部331上。为了保证系绳53固定后的可靠性,手柄33还包括第一手持部332,第一手持部332与第一连接部331上远离本体32的一端相连,且第一手持部332与第一连接部331的连接处设置有第二固定孔3312,缠绕完成的系绳53穿过第二固定孔3312,系绳53缠绕在第一连接部331上的两端分别被第一固定孔3311和第二固定孔3312固定,防止系绳53松脱。另外,第一手持部332相对于第一连接部331向本体32的中心倾斜,也就是第一手持部332向靠近容纳体1中心的方向倾斜与容纳体1之间形成间隙,方便操作者取用植入体5的时候,有足够空间进行抓取。In some embodiments of the present invention, according to the foregoing, the
其中,系绳53在第一连接部331上缠绕至少一圈,为了增加固定的效果,系绳53以多圈的方式固定在第一连接部331上。第一连接部331和第一手持部332均呈柱状,可以为圆柱状,也可以为棱柱状,第一连接部331与第一手持部332之间为固定连接,第一连接部331与本体32之间固定连接。第二固定孔3312除了设置在第一连接部331和第一手持部332的连接处,也可以设置在第一连接部331上,还可以设置在第一手持部332上。第一手持部332上设置有防滑结构3344,以增加操作者取用时与第一手持部332之间的摩擦力,可以是表面做成凸起或网格的纹样;可以选择摩擦力大的材料,比如软质的橡胶、硅胶;还可以是加工曲线或弧形。在一个实施例中,第一手持部332上设置有多个凸起。Wherein, the
可以理解的是,在运输过程中,为了减少系绳对植入体的牵拉,容纳区31内储存液晃动时,使得植入体5也可一定程度上随储存液同步晃动,减少储存液对第一部分51的撞击,植入体放置在容器中时,系绳与植入体之间的部分应处于松弛状态。It can be understood that, in order to reduce the pulling of the tether on the implant during transportation, when the storage liquid in the
在本发明的一些实施例中,如图4、图8和图12所示,在植入体5进行运输的过程中,为了提高运输效率,各个植入体包装容器100之间可叠放设置,也就是植入体包装容器100的数量为至少两个,为了避免彼此滑动导致倒塌,容纳体1的底部的最大尺寸小于设置在盖体2上的第二限位部21的最大尺寸,相邻放置的两个植入体包装容器的其中一个的容纳体1的底部与其中另一个的第二限位部21配合。进一步地,需要避免叠放的植入体包装容器100倒塌,同时也需要相邻的两个植入体包装容器100容易分离,在容纳体1的底部设置有凸起15,此时,可以通过设置凸起15的轮廓尺寸与第二限位部的尺寸相匹配,通过凸起15与第二限位部21接触,使容纳体1的底面与另一植入体包装容器100的盖体2表面接触,同样可以避免两个叠放容器之间的滑动引起的倒塌。In some embodiments of the present invention, as shown in FIG. 4 , FIG. 8 and FIG. 12 , during the transportation of the implant 5 , in order to improve the transportation efficiency, each
在本发明的一些实施例中,如图4和图8所示,盖体2为一端开口的筒状结构,盖体2的上表面向容纳体1的方向凹陷形成第二限位部21,盖体2的侧壁与第二限位部21之间形成容纳槽,盖体2的内螺纹23设置在侧壁的内表面上。在容纳槽内可设置密封件4,密封件4设置在盖体2与容纳体1之间,使容纳腔处于密封状态。In some embodiments of the present invention, as shown in FIG. 4 and FIG. 8 , the
在本发明的一些实施例中,如图4和图8所示,盖体2向容纳体1的方向凹陷形成第二限位部21,在盖体2的侧壁与第二限位部21之间形成的容纳槽上设置有第一接触面22,第一接触面22为斜面,容纳体1与盖体2配合的内表面设置有第二接触面12,第二接触面也可为斜面。将盖体2拧在容纳体1上时,第一接触面22与第二接触面12配合以实现盖体2与容纳体1之间的密封,且第一接触面22的倾角大于等于第二接触面12的倾角,使得盖体2与容纳体1螺纹连接后,第一接触面22和第二接触面12使得容纳体1顶部有一个轻微的扩张,使得密封性加强。可以理解的是,在其它实施例中,只要第一接触面和第二接触面之间存在角度差,也就是说,至少一个为斜面,就能加强密封。In some embodiments of the present invention, as shown in FIG. 4 and FIG. 8 , the
在本发明的一些实施例中,如图4和图8所示,容纳体1的外周设置有第四限位部13,第四限位部13设置在外螺纹14的下方,且第四限位部13与容纳体1的外壁之间圆弧过渡连接,方便操作者使用时,抓住容纳体1防止容器掉落。In some embodiments of the present invention, as shown in FIGS. 4 and 8 , the outer periphery of the
其中,第四限位部13的最大外径与盖体2的最大外径相等,在使用过程中,两者可以顺畅过度,不产生间隙,不易被污染,也便于操作者将盖体2与容纳体1分离。Among them, the maximum outer diameter of the fourth limiting
在本发明的一些实施例中,下面以另一种固定方式为例进行说明。如图7至图11所示,手柄33包括第一连接部333,第一连接部333连接在本体32上,将第一部分51穿过容纳区31后,将系绳53缠绕在第一连接部333上,在运输过程中,为避免晃动导致系绳53松脱的问题,因此在第一连接部333上设置有第一固定孔3331,系绳53穿过第一固定孔3331后再缠绕到第一连接部333上第一固定孔。为了保证系绳53固定后的可靠性,手柄33还包括第一手持部334,第一连接部333的尺寸小于第一手持部334的尺寸,也就是第一连接部333与第一手持部334的连接处尺寸突增,使系绳53缠绕后一直保持在本体32和第一手持部334之间,在第一手持部334上还交错设置有至少两个固定部,系绳53先穿过第一固定孔3331,再缠绕在第一连接部333上,最终固定在固定部上,利用两个固定部交错设置和与系绳53之间的摩擦力实现对系绳53的另一端的固定,防止系绳53松脱。另外,第一手持部334相对于第一连接部333向本体32的中心倾斜,也就是第一手持部334向远离容纳体1的方向倾斜与容纳体1内壁之间形成间隙,方便操作者取用植入体5的时候,有足够空间进行抓取。In some embodiments of the present invention, another fixing manner is used as an example for description below. As shown in FIG. 7 to FIG. 11 , the
其中,系绳53在第一连接部333上缠绕至少一圈,为了增加固定的效果,系绳53以多圈的方式固定在第一连接部333上。第一连接部333与本体32连接的一端尺寸可以大于第一连接部333的中间区域,或者,第一连接部333与本体32连接的一端设置有加强筋,以增加第一连接部333与本体32之间的连接可靠性。Wherein, the
在本发明的一些实施例中,如图10所示,第一手持部为了减小固定部所占用的额外空间以保证操作者有足够空间进行抓取,在第一手持部334上设置有凹槽3341,凹槽3341的一侧设置有至少一个第一固定部3342,另一侧设置有至少一个第二固定部3343,第一固定部3342和第二固定部3343交错设置,使得凹槽3341上形成类似S形的槽孔,第一固定部3342和第二固定部3343均位于凹槽3341内,不会额外占用空间,保证第一手持部334与容纳体1之间的间隙。利用第一固定部3342和第二固定部3343交错设置和与系绳53之间的摩擦力实现对系绳53的另一端的固定,防止系绳53松脱。当第一固定部3342和第二固定部3343均为一个时,在第一手持部334上形成“S”型固定槽,对系绳53的另一端进行约束,避免系绳53松脱。当第一固定部3342和第二固定部3343为至少两个时,在第一手持部334上形成多个连续的“S”型固定槽,对系绳53的另一端进行约束,避免系绳53松脱。为使系绳更好地卡入S型固定槽内,第一手持部334与第一连接部333的连接处还设有与凹槽3341连通的通槽(图未标识),从而,系绳可以直接经该通槽卡入凹槽3341内。In some embodiments of the present invention, as shown in FIG. 10 , in order to reduce the extra space occupied by the fixing part and ensure that the operator has enough space for grasping, the
其中,第一连接部333和第一手持部334均呈柱状,可以为圆柱状,也可以为棱柱状,在一个实施例中,第一连接部333和第一手持部334均呈四棱柱状。第一连接部333与第一手持部334之间为固定连接,第一连接部333与本体32之间固定连接。固定部除了设置在第一手持部334上,也可以设置在第一连接部333上,还可以设置在第一手持部334和第一连接部333上。The
在本发明的一些实施例中,如图9至图11所示,第一手持部334为四棱柱状,第一手持部334包括第一表面、与第一表面相对的第二表面,连接第一表面和第二表面的第三表面,与第三表面相对的第四表面。其中第一表面靠近容纳体1的内表面。固定部设置在第一手持部334朝向容纳体1内壁的一侧上,也就是固定部设置在第一表面上。第三表面和第四表面上均设置有防滑结构3344,以增加操作者取用时与第一手持部334之间的摩擦力,可以是表面做成凸起结构或网格的纹样;可以选择摩擦力大的材料,比如软质的橡胶、硅胶;还可以是加工曲线或弧形。在一个实施例中,第三表面和第四表面上设置有多个凸起结构。In some embodiments of the present invention, as shown in FIG. 9 to FIG. 11 , the
在本发明的一些实施例中,如图3、图4和图8所示,将植入体5装入后,需要尽可能避免植入体5在容纳区31内的运动,包括旋转运动和直线运动。在容纳体1内设置有第一限位部11,盖体2向容纳体1的方向凹陷形成第二限位部21,通过第一限位部11和第二限位部21的内表面分别与支撑体3的两端限位配合来限制支撑体3的直线运动。In some embodiments of the present invention, as shown in FIG. 3 , FIG. 4 and FIG. 8 , after the implant body 5 is installed, it is necessary to avoid the movement of the implant body 5 in the
其中,第一限位部11凸出于容纳体1的内表面,可以为凸棱或凸点,第一限位部11与容纳体1之间为固定连接。为了使第一限位部11对支撑体3限制的均匀性,第一限位部11的数量为至少一个,在一个实施例中,第一限位部11设置有六个,六个第一限位部11间隔均匀设置在容纳体1内。第一限位部11可以连接在容纳体1的底部,也可以连接于容纳体1的内侧壁,还可以均与底部和内侧壁连接。在一个实施例中,每一个第一限位部11分别与容纳体1的底部和内侧壁连接,以增加第一限位部11的连接可靠性和稳定性,进而增加对支撑体3的限位效果。第二限位部21为盖体2向容纳体1凹陷形成的结构,盖体2的外表面和内表面一同向容纳体1的方向均匀凹陷形成第二限位部21。将植入体5装入后,第二限位部21的内表面和第一限位部11分别与支撑体3的两端限位配合,具体来说,手柄33背离本体32的一侧与第二限位部21的内表面接触,本体32背离手柄33的一侧与第一限位部11接触。The first limiting
在本发明的一些实施例中,根据前文所述,第一限位部11和第二限位部21限制了支撑体3的直线运动,下面具体描述对支撑体3旋转运动的限制。如图5、图6和图8至图11所示,支撑体3朝向第一限位部11的一侧设置有第三限位部34,第三限位部34与第一限位部11以轮廓匹配的方式限位配合,第三限位部34包括凹槽。凹槽的开口朝向容纳体1的底部和内侧壁,顶部封闭,通过这样的结构,与第一限位部11相匹配,限制了支撑体3的圆周方向运动。优选第一限位部11与第三限位部34的数量相等。In some embodiments of the present invention, according to the foregoing, the first limiting
以上,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以权利要求的保护范围为准。The above are only preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art who is familiar with the technical scope disclosed by the present invention can easily think of changes or substitutions, All should be included within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.
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