CN107510518B - The deposit method of support system and bracket - Google Patents

The deposit method of support system and bracket Download PDF

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Publication number
CN107510518B
CN107510518B CN201610429827.3A CN201610429827A CN107510518B CN 107510518 B CN107510518 B CN 107510518B CN 201610429827 A CN201610429827 A CN 201610429827A CN 107510518 B CN107510518 B CN 107510518B
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China
Prior art keywords
bracket
restraint device
support system
chamber
component
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CN201610429827.3A
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Chinese (zh)
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CN107510518A (en
Inventor
陈树国
孟娟
罗七一
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Shanghai Minimally Invasive Medical Devices (group) Co Ltd
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Shanghai Minimally Invasive Medical Devices (group) Co Ltd
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Priority to CN201610429827.3A priority Critical patent/CN107510518B/en
Priority to PCT/CN2017/085862 priority patent/WO2017215427A1/en
Publication of CN107510518A publication Critical patent/CN107510518A/en
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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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821Ostial stents

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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)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention provides a kind of support system and the deposit methods of bracket.The support system includes bracket and restraint device, and the bracket, which is pressed, to be held on component, and the restraint device is located at the outside of bracket and including chamber, when the chamber fills, the rebound of the restraint device limit bracket.The deposit method of the bracket includes that bracket pressure is held on to the surface of component;Bracket and component are placed in the restraint device with chamber, fluid is injected in Xiang Suoshu chamber and keep restraint device full.The present invention can effective limit bracket contour dimension, tie bracket entering the pervious radial rebound of human body.Particularly, after bracket pressure is held after removal pressure grip, support system of the invention can be arranged on bracket, and then keep restraint device full to continue pressure and hold bracket, it will be further reduced because of the volume that removal presses the at once radial rebound due to that occur after grip to increase after bracket pressure is held, to effectively solve the problems, such as the at once radial rebound diminution of bracket.

Description

The deposit method of support system and bracket
Technical field
The invention belongs to the field of medical instrument technology, in particular to the system and deposit method of a kind of polymer support
Background technique
Important intervention apparatus of the bracket as treatment hemadostewnosis, has obtained widely answering in cardiovascular disease field With.One of metallic support can permanently retain in human body after completing treatment task, thus, it is coronarius to there is weakening MRI or CT images, the formation for hindering offshoot circulation, inhibit the defects of blood vessel positivity remodeling at interference surgery revascularization.For this purpose, Biodegradable scaffold becomes the necessary technology means solved these problems.
Existing Biodegradable scaffold is usually made of degradable polymer material or metal material, in implantation lesion It can play the role of support blood vessels behind position in a short time, realize revascularization.After treatment is completed, biodegradable branch The organic matter that frame can be degraded into human body environment can be absorbed by the body, be metabolized, the final bracket can disappear.Wherein, bracket Before being sent into lesion vessels, state is held for pressure, pressure holds the surface that the bracket under state is fixed on a sacculus, and then uses When, pressure holds the bracket under state and is delivered to lesion vessels in company with sacculus, later, carries out pressurising to sacculus, it is made to expand and synchronize Promote stent-expansion, to be close to vascular wall.
But after polymer support pressure is held in balloon surface, a degree of radial rebound can occur for bracket, i.e. bracket is de- After tripping compression apparatus, due to pressing the removal of grip, bracket, which can gradually expand, to become larger, and biggish outer diameter is unfavorable for bracket across narrow Narrow vascular lesion limits the use of bracket.
To solve the above problems, widespread practice is in polymer support storing process, to it, radially rebound is limited System.Such as: PCT Patent Application WO2012166661A1 discloses a kind of double shielding nested structure, which is socketed in pressure and holds Rack surface under state, wherein the protective case of outer layer constrains the protective case of internal layer, and then fetters bracket rebound, and interior The protective case of layer is splitted, and can smoothly be removed protective case from rack surface.Although the patent limits polymer support and is depositing Radial rebound during storage still can not limit at once radial rebound of the polymer support after pressure holds machine removal.
In addition, radiation sterilization, such as electron beam, gamma radiation are generally selected in polymer support sterilizing, due to irradiated rays Make polymer segment that fracture degradation occur, makes polymer support molecular weight and molecular weight, and then influence polymer support performance, therefore, It needs to reduce absorbed dose of the polymer support in sterilization process, slows down the decline of molecular weight, improve the property of polymer support Energy.In addition, polymer support in sterilization process, due to the effect of radiation, increases polymer support system temperature, simultaneously Polymer support also inevitably undergoes some hot environments, hot environment is easy to make to polymerize in storage transportational process Ageing failure occurs for object bracket, so, it needs to avoid or slow down polymer support and is sterilizing and storing the high temperature in transportational process Environment, to improve the performance of polymer support.Sterilizing and high temperature can not be alleviated or be eliminated to bracket protective case in the prior art The technical issues of polymer support caused by under environment fails.
Summary of the invention
The purpose of the present invention is to provide a kind of support system and the deposit methods of bracket, to realize the radial direction of bracket Constraint and protection.
To achieve the above object and other related purposes, the present invention provides a kind of support systems, comprising:
One bracket, the bracket, which is pressed, to be held on a component;And
One restraint device, the restraint device are located at the outside of the bracket, and the restraint device includes a chamber;It is described When chamber fills, the restraint device limits the rebound of the bracket.
Preferably, in the support system, the restraint device is a ring bodies, and the ring bodies includes an appearance The inner surface that face and an inner surface, the bracket and component are contained in the ring bodies is formed by space.
Preferably, in the support system, the chamber is between the outer surface and inner surface.
Preferably, in the support system, the restraint device includes a first surface and a second surface, described First surface and second surface are alternatively arranged the outside in the bracket and component.
Preferably, in the support system, the chamber is between the first surface and second surface.
Preferably, in the support system, the restraint device is made of polymer.
Preferably, in the support system, the restraint device is by one of following material or a variety of is made: poly- Tetrafluoroethene, polyvinyl chloride, polyurethane, polyethylene, polypropylene, ethylene-acetic ethylene ester copolymer, gathers to benzene two nylon Formic acid glycol ester, lactide-glycolide copolymer, ethenol copolymer.
Preferably, in the support system, the restraint device is located at an external component and is formed by cavity.
Preferably, in the support system, the chamber is full by a gas or liquid.
Preferably, in the support system, the liquid is the suspension containing heavy metal, to radiation-screening beam.
Preferably, in the support system, the suspension containing heavy metal include one of following metal or It is a variety of: lead, boron, tungsten, barium, tin and lanthanum.
Preferably, in the support system, all or part of high score by the agent containing metal developing of the restraint device Sub- polymer is made.
Preferably, in the support system, the restraint device is close to the part of the bracket by showing without metal The high molecular polymer of shadow agent is made.
Preferably, in the support system, the liquid is the mixing of salt water or water and ethyl alcohol, ethylene glycol, glycerol Solution.
To achieve the above object and other related purposes, the present invention provides a kind of deposit methods of bracket, comprising:
One bracket pressure is held on to the surface of a component;
The bracket and component are placed in the restraint device with a chamber;
A fluid is injected into the chamber and keeps the restraint device full.
Preferably, in the deposit method of the bracket, the restraint device is sheathed on the bracket and component, Or the restraint device is helically wound around on the bracket and component.
In conclusion restraint device of the invention can effectively limit bracket contour dimension, tie bracket enter human body Pervious radial rebound.
Particularly, restraint device of the invention can be arranged on bracket, in turn after removal pressure grip after bracket pressure is held Restraint device is filled to continue pressure and hold bracket, the at once radial rebound due to that will occur after removal pressure grip after bracket pressure is held increases Big volume further reduces, to effectively solve the problems, such as the at once radial rebound diminution of bracket.
Particularly, it can be passed through the suspension containing heavy metal in the chamber of restraint device of the invention or described about get one's things ready It sets and is at least partly made of the high molecular polymer of the agent containing metal developing, there are more for component carried due to support system etc. Initial contaminating bacteria, it is therefore desirable to higher radiation sterilization dose, but cause bracket by more radiation, generate molecular weight drop Solution, and then bracket performance is influenced, and the initial contaminating bacteria of brace sections itself is less or does not have substantially, does not need higher radiation and goes out Microbial inoculum amount, so, it selects the suspension with radiation shield function or polymer composites as restraint device, can reduce The radiation absorbed dose of bracket improves the performance of bracket.
Particularly, the mixed of salt water or water and ethyl alcohol, ethylene glycol, glycerol etc. can be passed through in the chamber of restraint device of the invention Solution is closed, the liquid with refrigerating function is selected, can be carried out in radiation sterilization or storing process in bracket, bracket is carried out cold But, it avoids the heated heating of bracket and fails.
Detailed description of the invention
Fig. 1 is that the bracket pressure of one embodiment of the invention is held in the main view on a sacculus,
Fig. 2 is the main view that the bracket after the pressure of one embodiment of the invention is held is loaded on restraint device;
Fig. 3 is the end view drawing that the bracket after pressure shown in Fig. 2 is held is loaded on restraint device;
Fig. 4 is the stereoscopic schematic diagram that the bracket after pressure shown in Fig. 2 is held is loaded on restraint device;
Fig. 5 is the main view when restraint device of one embodiment of the invention is full;
Fig. 6 is end view drawing when restraint device shown in fig. 5 is full;
Fig. 7 is stereoscopic schematic diagram when restraint device shown in fig. 5 is full;
Fig. 8 is the main view that the bracket after the pressure of another embodiment of the present invention is held is loaded on restraint device;
Fig. 9 is the end view drawing that the bracket after pressure shown in Fig. 8 is held is loaded on restraint device;
Figure 10 is the stereoscopic schematic diagram that the bracket after pressure shown in Fig. 8 is held is loaded on restraint device;
Figure 11 is the main view when restraint device of another embodiment of the present invention is full;
Figure 12 is end view drawing when restraint device shown in Figure 11 is full;
Figure 13 is stereoscopic schematic diagram when restraint device shown in Figure 11 is full.
Detailed description of the invention in figure is as follows:
1- bracket;2- sacculus;3- ring bodies;4- connecting tube;5- conveyor screw;The outer surface 31-;32- inner surface;33- chamber; 51- first surface;52- second surface;53- chamber.
Specific embodiment
Below in conjunction with deposit method of the drawings and specific embodiments to support system proposed by the present invention and bracket make into One step is described in detail.According to following explanation and claims, advantages and features of the invention will be become apparent from.It should be noted that Attached drawing is all made of very simplified form and using non-accurate ratio, only to convenient, lucidly aid illustration is of the invention The purpose of embodiment.Particularly, since each attached drawing wants content outstanding different, different ratios is often used.
Herein, " proximal end " and " distal end " is from using doctor's angle of the medical instrument to carry out read fortune for mutual member Part or the relative bearing of movement, relative position, direction, although it is restrictive, " proximal end " that " proximal end " and " distal end ", which is not, The Medical Devices are often referred in course of normal operation close to one end of doctor, and " distal end " typically refers to initially enter patient's body Interior one end.
Herein, "inner" or " inside " refer to that the direction of the axis close to bracket, "outside" or " outside " refer to far from branch The direction of the axis of frame.
As used in the specification and the appended claims, singular "a", "an" and "the" includes Plural reference, in addition in addition non-content explicitly points out.As used in the specification and the appended claims, term "or" Usually carried out with including the meaning of "and/or" using, in addition in addition non-content explicitly points out.
Inventor has found prior art research: once for pressing the compressing force for the compression set for holding polymer support to go It removes, radial rebound can occur at once for polymer support;However, the double shielding referred in background technique is set in polymer support After upper, since radial rebound has occurred before socket for polymer support, so, outer diameter when being held compared to pressure, Polymer-supported Outer diameter when pressure is held is still greater than in the outer diameter after double shielding is arranged and covers in frame, especially when double shielding set and polymer support it Between there are when gap, be mounted with double shielding set polymer support can also further recoil to fitting protective case inner wall.Therefore And although existing double shielding set limits the radial rebound of polymer support, the outer diameter of bracket to a certain extent Do not reduce, even when there are when gap, the radial rebound size of polymer support can also expand between protective case and bracket, Radial rebound binding effect is less desirable.
Inventor also studies the prior art discovery: polymer support is deposited by over-radiation sterilizing and/or polymer support The excessively high performance that will affect polymer support of environment temperature is stored up, bracket protective case in the prior art only realizes radial return It the constraint of bullet and avoids rack outer surface is caused to damage, without solving over-radiation sterilizing and storage environment temperature Excessively high technical problem.
In order to solve the problems, such as solve above-mentioned technical problem in it is one or more, the invention proposes a kind of support system with And the deposit method of bracket.
Support system provided by the invention, comprising: bracket, which, which is pressed, is held on component;And restraint device, this is about Bundle device is located at the outside of bracket, which includes a chamber;When the chamber fills, which is returned Bullet.
Support system of the invention is particularly suitable for constraining the radial rebound of the bracket made of polymer material, because poly- Polymer scaffold is after pressure is held, and compared to metallic support, radial rebound is more serious, and more holds in radiation sterilization and hot environment Easily fail.Below with the specific structure and deposit method of specific embodiment the present invention will be described in detail the support system.
Firstly, Fig. 1 is that the bracket pressure of one embodiment of the invention is held in the main view on a sacculus.As shown in Figure 1, loading Before, the pressure of bracket 1 is held on a sacculus 2, so that bracket 1 realizes expansion by sacculus 2.Here, the sacculus 2 is for filling When the component of fixed bracket 1.Moreover, the bracket 1 is mainly held in the surface of sacculus 2 by a compression set (holding machine as pressed) pressure On.
Press the bracket 1 after holding for example in straight tube-like comprising several ring waveform brace sections.Particularly, the bracket 1 by Degradable polymer is made.
Then, Fig. 2 be one embodiment of the invention pressure hold after bracket be loaded into main view on restraint device, Fig. 3 is The bracket shown in Fig. 2 pressed after holding is loaded into the end view drawing on restraint device, and Fig. 4 is that the bracket after pressure shown in Fig. 2 is held loads In the stereoscopic schematic diagram on restraint device, Fig. 5 is the main view when restraint device of one embodiment of the invention is full, and Fig. 6 is Fig. 5 Shown in restraint device it is full when end view drawing, Fig. 7 is stereoscopic schematic diagram when restraint device shown in fig. 5 is full.
As shown in Fig. 2~7, the restraint device of the present embodiment is a ring bodies 3, and the ring bodies 3 includes an appearance The inner surface 32 that face 31 and an inner surface 32, the bracket 1 and sacculus 2 are contained in ring bodies 3 is formed by space.Institute The chamber 33 for stating restraint device is located between the outer surface 31 and inner surface 32 of ring bodies 3, and can be by an external equipment by gas Body or liquid are passed through the chamber 33 to full.Ring bodies 3 expands when the design of the chamber 33 is to allow full, The ring bodies 3 is that radial direction forces in bracket 1, then compressed stent 1 to suitable size.
The external equipment includes a connecting tube 4, the chamber of the connecting tube 4 and ring bodies 3, so that fluid fills Enter the pressurising realized in the chamber to ring bodies 3.
It further,, need to be by bracket for the radial direction rebound of limit bracket 1 after bracket 1 removes the pressure grip of compression set 1 is fitted into ring bodies 3, so that 3 circumferential closure covered stent 1 of ring bodies, as shown in figs. 2 to 4;Later, it is set by the outside The standby chamber 33 that fluid is filled with to ring bodies 3 so that the chamber 33 generate it is full, during the filling process, limitation ring bodies 3 to Outside, i.e., it expands backwards to 1 direction of bracket, so that ring bodies 3 can only be inside, i.e., is expanded towards 1 direction of bracket, as shown in Fig. 5~7, And then can limit bracket 1 radial rebound.
It is preferred that amount of expansion of the support system of the present embodiment according to fluid output quantity control ring bodies 3, with compressed stent 1 To suitable size.Specifically, the bracket 1 is held by compression set pressure to first external diameter first;After pressing grip removal, institute State bracket 1 recoil at once second external diameter (second external diameter be greater than first external diameter;Such as polymer support 1: second external diameter is usually 1.01~1.5 times of one outer diameter), then, compressed stent 1 can be continued when the ring bodies 3 of the present embodiment fills to third outer diameter, institute Third outer diameter is stated greater than first external diameter.
Inventor studies discovery: the bracket 1 is after grip is pressed in removal, if only by the bilayer referred in background technique Protective case is limited, then after removal double shielding set, the bracket 1 will recoil to the 4th outer diameter, and (the 4th outer diameter is greater than the Two outer diameters).But the support system of the present embodiment can control ring bodies 3 during inward expansion, contacts and further compresses Bracket 1, so that bracket 1 is compressed into the third outer diameter.The third outer diameter both can be greater than first external diameter and less than the 4th outside Diameter, also greater than second external diameter and less than the 4th outer diameter.Preferably, the third outer diameter is greater than first external diameter and is less than or equal to Second external diameter.
Support system in the present invention is greater than first external diameter with third outer diameter and is less than second external diameter preferably, using Before, by discharging the pressure of ring bodies 3, bracket 1 is taken out from ring bodies 3.Similarly, after the bracket 1 takes out, can also The 4th outer diameter is recoiled to, but since bracket 1 is by the prolonged compression constraint of ring bodies 3, the 4th outer diameter is obvious Second external diameter can be lower than, and close to third outer diameter.
By taking the bracket 1 of 3.0mm specification (material thickness) as an example, following table shows that bracket 1 is held after machine pressure holds deformation by pressure, Double shielding set (i.e. after removal ring bodies 3 and double shielding set) is about in restraint device through this embodiment and background technique Shu Hou, the situation of change of outer diameter:
Wherein: "-" indicates that the double shielding set of background technique does not have third outer diameter.
As seen from the above table, before use, the 4th outer diameter (outer diameter after removing restraint device) of the bracket 1 of the present embodiment 1.2mm is significantly less than the 4th outer diameter 1.42mm of bracket 1 in background technique, thus, the radial rebound of bracket 1 is effectively limited, Preferably reduce bracket 1 passes through outer diameter.
In the present embodiment, the ring bodies 3 is set to an external component and is formed by cavity, the external component to During the filling process, limitation ring bodies 3 is expanded towards backwards to 1 direction of bracket.
The external component is preferably a coil pipe, and the coil pipe can be disc-shaped, can also be in Back Word type.Just using coil pipe In carrying.It should be understood that the external component includes but is not limited to coil pipe, as long as limitation ring bodies 3 can be played towards back Expansion is generated to the direction of bracket 1.
In preferred embodiment, the ring bodies 3 is made of polymer.The ring bodies 3 by one of following material or It is a variety of to be made:
Polytetrafluoroethylene (PTFE), nylon, polyvinyl chloride, polyurethane, polyethylene, polypropylene, ethylene-vinyl acetate combined polymerization Object, polyethylene terephthalate, lactide-glycolide copolymer, ethenol copolymer.
Since polymer has preferable deformation expanding ability at normal temperature, so, using effect is good, especially when bracket 1 When being accordingly made of polymer, the ring bodies 3 of polymer will not stick together with 1 surface of bracket, in this way will not be to 1 surface of bracket It damages, is also convenient for bracket 1 and is taken out from ring bodies 3.
Preferably, the length of the ring bodies 3 is more than or equal to the length of bracket 1, bracket 1 is completely covered.
In addition to the ring bodies 3 being sheathed on the bracket 1 after pressure is held shown in Fig. 2~7, the restraint device can also be spiral shell Rotation is wound in the conveyor screw 5 on the bracket 1 after pressure is held, specifically as depicted in figures 8-13.The conveyor screw 5 by sheet material from it is inner to Outer cans, such structure can equally play the role of the rebound of limit bracket 1 when full.
Fig. 8 is the main view that the bracket after the pressure of another embodiment of the present invention is held is loaded on restraint device, and Fig. 9 is Fig. 8 Shown in pressure hold after bracket be loaded into end view drawing on restraint device, Figure 10 is that the bracket after pressure shown in Fig. 8 is held is loaded into Stereoscopic schematic diagram on restraint device, Figure 11 are the main view when restraint device of another embodiment of the present invention is full, Tu12Shi End view drawing when restraint device shown in Figure 11 is full, Figure 13 are stereoscopic schematic diagrams when restraint device shown in Figure 11 is full
Conveyor screw 5 shown in Fig. 8~13, including a first surface 51 and a second surface 52, first table Face 51 and second surface 52 are alternatively arranged the outside in bracket 1 and sacculus 2.The chamber 53 of the conveyor screw 5 is located at described the Between one surface 51 and second surface 52.Similarly, the external equipment is connected to the chamber 53 of conveyor screw 5 by connecting tube 4, with Gas or fluid are provided to conveyor screw 5, to realize the expansion of conveyor screw 5.
The conveyor screw 5 is similarly set in the external component with cavity (such as coil pipe), to limit conveyor screw 5 towards backwards It expands in the direction of bracket 1.
Further, the present invention includes but is not limited to cyclic annular or spiral helicine restraint device, as long as the restraint device fills It is capable of the rebound of limit bracket 1 when being full of.
To sum up, support system of the invention can effectively limit bracket 1 contour dimension, tie bracket 1 enter human body with Preceding radial rebound.Particularly, after pressure grip of the bracket (especially polymer support) in removal compression set, this is implemented The restraint device of example is loaded on bracket 1, later, makes restraint device by the full expansion of fluid, and then continue compressed stent 1, the volume that removal presses the at once radial rebound due to occurred after grip to increase after bracket 1 is pressed and held is further reduced, to have Effect solves the problems, such as the at once radial rebound diminution of bracket 1, in order to which bracket 1 passes through narrow vascular lesion.
Support system provided by the present invention is in addition to can be other than the physical damnification to avoid bracket 1, moreover it is possible to avoid because excessively Irradiation or environment temperature rise caused bracket performance decline.
For the restraint device of ring bodies 3, it is passed through the liquid with refrigerating function in the chamber 33 of the ring bodies 3, Bracket 1 can be cooled down when bracket 1 carries out radiation sterilization or storage, avoid the heated heating of bracket 1 and fail (main It is the reduction of mechanical property).Liquid with refrigerating function should select freezing point low, and the liquid of good cooling results such as selects cold salt The mixed solution etc. of water or water and ethyl alcohol, ethylene glycol, glycerol etc..It is preferred that the liquid with refrigerating function is salt water, pass through salt water Pressurization expands ring bodies 3, fetters to bracket 1.Since salt water has good cooling effect, so that bracket 1 is sterilizing There is lower temperature in transport storing process, moreover, the bracket that the bracket 1 of the present embodiment is cooling relative to salt-free water, goes out The temperature of bacterium and transport storing process experience is lower, and bracket performance is more preferable.
Alternatively, the heavy metal suspension with radiation shield function is passed through in the chamber 33 of the ring bodies 3, to shield Radiation beam.The heavy metal suspension with radiation shield function is selected, absorption of the bracket 1 during radiation sterilization can be reduced Dosage slows down the radiation degradation and molecular weight and molecular weight of bracket 1, it is ensured that bracket performance.Heavy metal with radiation shield function is outstanding Supernatant liquid can choose the water-soluble liquid suspensions of the heavy metal compounds such as the biggish lead of atomic number, boron, tungsten, barium, tin, lanthanum, can also With the water-soluble liquid suspensions for selecting these metallic compounds to be mixed.
In other embodiments, in order to avoid because the decline of bracket performance caused by overirradiation, is used to prepare constraint The polymeric oxidizer of device has a polymer composites of radiation-resistant glass, polymer as escribed above and leaded, boron, tungsten, The material that barium, tin, lanthanum etc. have the heavy metal compound of larger atomic number compound, to shield X-ray, gamma-rays or electron beam Radiation etc..Because including the system of bracket 1, such as stent delivery system, in radiation sterilization, due to the component of system carrying (such as conduit, coil pipe) there are more initial contaminating bacterias, it is therefore desirable to which higher radiation sterilization dose causes bracket 1, especially It is polymer support, will receive more radiation, and then polymer is made to generate molecular weight degradation, it is final to influence bracket performance.But It is that the initial contaminating bacteria of bracket 1 itself is less or does not have substantially, does not need higher radiation sterilization dose.Therefore, selection has The polymer composites of radiation shield function can reduce the radiation absorbed dose of bracket as restraint device, improve bracket Performance.
Using the restraint device of conveyor screw 5 as signal, the second layer (one layer i.e. far from bracket 1) of the conveyor screw 5 by Polypropylene and barium sulfate composite material are prepared.The conveyor screw 5 of composite material preparation has significant shielding for ray radiation Effect, shielding rate reach 60% or more, can effectively slow down bracket 1 (especially polymer support) during radiation sterilization Radiation degradation and molecular weight and molecular weight make bracket 1 still keep preferable performance after sterilization.The first layer of the conveyor screw 5 is (i.e. Close to one layer of bracket 1) it is prepared using the polymer without heavy metal, bracket 1, and energy are directly contacted to avoid heavy metal Effective radiation-screening.It can be passed through the liquid with refrigerating function in the chamber 53 of conveyor screw 5 in this embodiment, it both can be with The radiation absorbed dose for reducing bracket 1, can also reduce backing temp.
Foregoing description is only the description to present pre-ferred embodiments, not to any restriction of the scope of the invention, this hair Any change, the modification that the those of ordinary skill in bright field does according to the disclosure above content, belong to the protection of claims Range.

Claims (15)

1. a kind of support system characterized by comprising
One bracket, the bracket, which is pressed, to be held on a component;And
One restraint device, the restraint device, which is located at the outside of the bracket and is set to an external agency, is formed by cavity Interior, the restraint device includes a chamber;When the chamber fills, the restraint device limits the rebound of the bracket, and institute External agency is stated to expand for limiting the restraint device during the filling process in the chamber towards backwards to holder orientation.
2. support system as described in claim 1, which is characterized in that the restraint device is a ring bodies, the ring bodies Including an outer surface and an inner surface, the inner surface that the bracket and component are contained in the ring bodies is formed by space In.
3. support system as claimed in claim 2, which is characterized in that the chamber is between the outer surface and inner surface.
4. support system as described in claim 1, which is characterized in that the restraint device includes a first surface and one second Surface, the first surface and second surface are alternatively arranged the outside in the bracket and component.
5. support system as claimed in claim 4, which is characterized in that the chamber is located at the first surface and second surface Between.
6. support system as described in claim 1, which is characterized in that the restraint device is made of polymer.
7. support system as claimed in claim 6, which is characterized in that the restraint device is by one of following material or more Kind be made: polytetrafluoroethylene (PTFE), nylon, polyvinyl chloride, polyurethane, polyethylene, polypropylene, ethylene-acetic ethylene ester copolymer, Polyethylene terephthalate, lactide-glycolide copolymer, ethenol copolymer.
8. support system as described in claim 1, which is characterized in that the chamber is full by a gas or liquid.
9. support system as claimed in claim 8, which is characterized in that the liquid is the suspension containing heavy metal, to shield Cover radiation beam.
10. support system as claimed in claim 9, which is characterized in that the suspension containing heavy metal includes following metal One of or it is a variety of: lead, boron, tungsten, barium, tin and lanthanum.
11. support system as claimed in claim 6, which is characterized in that the restraint device is all or part of by showing containing metal The high molecular polymer of shadow agent is made.
12. support system as claimed in claim 11, which is characterized in that the restraint device close to the part of the bracket by High molecular polymer without metal developing agent is made.
13. support system as claimed in claim 8, which is characterized in that the liquid be salt water or water and ethyl alcohol, ethylene glycol, The mixed solution of glycerol.
14. a kind of deposit method of bracket characterized by comprising
One bracket pressure is held on to the surface of a component;
The bracket and component are placed in the restraint device with a chamber;
The restraint device is placed in the external agency with a cavity;
A fluid is injected into the chamber and fills the restraint device, and the restraint device is described during the filling process External agency limits and is only oriented towards the holder orientation expansion.
15. the method for bracket storage as claimed in claim 14, which is characterized in that the restraint device is sheathed on the bracket And on component or the restraint device is helically wound around on the bracket and component.
CN201610429827.3A 2016-06-12 2016-06-16 The deposit method of support system and bracket Active CN107510518B (en)

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PCT/CN2017/085862 WO2017215427A1 (en) 2016-06-12 2017-05-25 Restriction apparatus, stent system, and method for using restriction apparatus

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CN110123497A (en) * 2018-02-02 2019-08-16 上海微创医疗器械(集团)有限公司 The protective device and medical device of bracket
CN112315636B (en) * 2020-11-27 2022-06-03 南京浩衍鼎业科技技术有限公司 Pressing and holding device system for intracranial degradable stent

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US20050049672A1 (en) * 2003-03-24 2005-03-03 Murphy Kieran P. Stent delivery system and method using a balloon for a self-expandable stent
US20080039924A1 (en) * 2006-08-08 2008-02-14 Medlogics Device Corporation Channeled Self-Expanding Stent Delivery System
EP2334267A1 (en) * 2008-09-10 2011-06-22 EV3, Inc. Stents and catheters having improved stent depoyment
US9149376B2 (en) * 2008-10-06 2015-10-06 Cordis Corporation Reconstrainable stent delivery system
US10098771B2 (en) * 2013-09-25 2018-10-16 Abbott Cardiovascular Systems Inc. Clip sheath for a polymer scaffold
CN103876868B (en) * 2014-04-17 2016-01-20 重庆医科大学附属儿童医院 Expansible Esophageal Stent

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