CN213076120U - Protective structure for a medical device having resilient or self-expanding properties - Google Patents

Protective structure for a medical device having resilient or self-expanding properties Download PDF

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CN213076120U
CN213076120U CN202020708126.5U CN202020708126U CN213076120U CN 213076120 U CN213076120 U CN 213076120U CN 202020708126 U CN202020708126 U CN 202020708126U CN 213076120 U CN213076120 U CN 213076120U
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protective structure
protection structure
layer protection
protection
medical device
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CN202020708126.5U
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赵庆洪
冯汉卿
刘青
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Beijing Advanced Medical Technologies Inc
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Beijing Advanced Medical Technologies Inc
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Abstract

The invention provides a protective structure of a medical instrument with rebound resilience or self-expansion performance, which comprises an inner layer protective structure and an outer layer protective structure, wherein the outer layer protective structure is arranged outside the inner layer protective structure, and continuously applies pressure to the medical instrument through the inner layer protective structure to keep the medical instrument in a stable state, wherein the outer layer protective structure is sleeved on the inner layer protective structure and can be completely moved and separated. The length of the protection structure can be made larger or smaller, the application range is wide, and the protection structure is suitable for protecting the balloon delivery of the peripheral vascular stent and also suitable for protecting the balloon delivery of the coronary vascular stent; when the outer layer protection structure is composed of more than two sections, the loading and unloading of the outer layer protection structure can be conveniently operated; when the protection structure is longer and the outer protection structure is multi-segment-time-saving, the problem that the inner protection structure and even the support are fixed and fall off due to influence of the overlong length of the outer protection structure in the removal process can be effectively avoided.

Description

Protective structure for a medical device having resilient or self-expanding properties
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a protective structure of a medical instrument with resilience or self-expansion performance.
Background
Interventional therapy is a general term for a series of techniques for minimally invasive treatment of human lesion parts by using guide wires, catheters and other interventional devices with the assistance of imaging equipment. Vascular intervention is one of the most common types of treatment. The vascular intervention treatment comprises Percutaneous Transluminal Angioplasty (PTA), vascular stent implantation, thrombolysis treatment, embolism treatment, plaque rotary cutting, thrombus suction and other technologies.
Vascular stenting has been in progress for over 30 years, from bare metal stents to drug eluting stents and even today's emerging bioabsorbable stents, and continues to push forward interventional therapies. A vascular stent is a porous tubular structure that functions to open and maintain a stenosis or to occlude a vessel in an open manner and to prevent restenosis. Stents generally fall into two broad categories: a ball-expanded stent and a self-expanding stent. Balloon stents are typically pre-compressed on a balloon catheter, delivered to the lesion along a guide wire, and expanded from a crimped or stored state by injecting a fluid into the balloon to apply a radial expansion pressure to the stent, which presses the stenotic plaque against the vessel wall, thereby removing the obstruction to blood flow. Then, the saccule is decompressed and withdrawn out of the body, and the stent is expanded to the size matched with the normal blood vessel due to plastic deformation, so that the balloon can not retract to the original size after external force is removed, and the wall adhesion is kept, therefore, the smoothness of the lumen is maintained. The stent has certain radial supporting force and fatigue resistance, and can be continuously supported on a narrow part and keep enough inner cavity size in a certain period, thereby achieving the purpose of reestablishing blood flow. Self-expanding stents are typically constructed of a shape memory material that is expanded from a crimped or stored state and against the vessel wall when the radial constraint is released in a controlled manner by a crimping delivery catheter to the site of the lesion.
Before reaching the lesion, the self-expanding stent needs to be constrained to a smaller radial dimension in order to reach the lesion vessel by interventional means. A polymeric stent sheath is typically used to achieve radial constraint for the stent storage and delivery process. The balloon-expandable stent often does not need radial restraint during the delivery process of the stent, but after the stent and the balloon catheter are assembled or packaged, a polymer stent protective sleeve can be adopted to protect the stent body or the surface drug coating.
Chinese patent application publication No. CN103826687A discloses a polymeric stent sheath medical device comprising a polymeric stent (10) crimped to a catheter of a dilatation balloon (12). After crimping, a sheath pair (20, 30) is placed over the crimped stent to reduce recoil of the crimped polymer stent and maintain stent-balloon engagement relied upon to secure the stent to the balloon when the stent is delivered to a target site in the body. The sheath is removed by a health professional prior to placing the stent in the body. The length of the protective sleeve is at least twice of that of the support, and the length of the support is not too large, so that the length of the protective sleeve is too long. Therefore, this invention is not applicable to peripheral vascular stents having a length in the range of 50 to 200 mm.
Disclosure of Invention
In order to overcome the technical problem that the length of the protective sleeve is too large in the prior art, the protective sleeve is a protective structure of a medical apparatus with resilience or self-expansion performance, is wide in application range, and is suitable for not only coronary vessels but also peripheral vessels.
In order to achieve the purpose, the invention adopts the following technical scheme: the utility model provides a medical instrument's protection architecture with resilience or from expansibility, includes inlayer protection architecture and outer protection architecture, the setting of outer protection architecture is in the inlayer protection architecture outside, just outer protection architecture passes through inlayer protection architecture give medical instrument continuously exert pressure, make medical instrument keeps stable state wherein, outer protection architecture suit just can break away from completely on the inlayer protection architecture.
Preferably, the outer protective structure may be composed of a single or a plurality of tubes of the same diameter and length.
In any of the above embodiments, preferably, the cross section of the outer layer protection structure is a complete closed circle.
In any of the above schemes, preferably, the cylindrical surface of the outer layer protection structure may be distributed with holes of various shapes to reduce the frictional resistance when the outer layer protection structure is sleeved in/removed from the inner layer protection structure.
In any of the above schemes, preferably, the inner layer protection structure is composed of two semicircular pipes, and one end of the inner layer protection structure is fixedly connected with the semicircular pipes or is an integral tubular object with one open end.
In any of the above embodiments, preferably, the length of the inner layer protection structure is equal to the length of the medical device to be protected plus 40 mm.
In any of the above embodiments, preferably, in the inner layer protection structure, the length of the medical device to be protected ranges from 5mm to 200 mm.
In any of the above embodiments, preferably, the inner layer protection structure is mounted on the protected medical device with both ends thereof extending 20mm beyond the medical device, and is used for holding the inner layer protection structure by hand during mounting and removal.
In any of the above schemes, preferably, one end of the outer layer protection structure can be expanded into a bell mouth to facilitate the insertion/removal of the outer layer protection structure from the inner layer protection structure, and the un-expanded length of the outer layer protection structure is the length of the protected medical device plus 2 mm.
In any of the above embodiments, the inner layer and the outer layer are preferably made of PTFE, PP, PE, PEBAX, Nylon, FEP, ETFE, etc. with smooth surface.
In any of the above embodiments, the inner and outer protective structures may be formed by injection molding, extrusion, or the like.
In any of the above schemes, preferably, the inner layer and the outer layer protection structure are sleeved in sequence, the inner layer protection structure is sleeved firstly, the two semicircular tubes completely cover the medical apparatus and instruments to be protected, the far end and the near end of each semicircular tube exceed 20mm, then the outer layer protection structure is sleeved by the far end, and the outer layer protection structure completely covers the medical apparatus and instruments to be protected. The removing process comprises the steps of holding the inner-layer protection structure immovably by a hand close to one side of the near end, holding the outer-layer protection structure slightly by the other hand and removing the outer-layer protection structure towards the far end until the outer-layer protection structure is completely removed, then loosening the inner-layer protection structure, holding the inner-layer protection structure from the far end of the inner-layer protection structure, slowly removing the inner-layer protection structure, and finishing the removal of the two layers of protection structures.
Has the advantages that: the length of the protective structure can be larger or smaller, the application range is wide, and the protective structure is suitable for protecting the balloon delivery of the peripheral vascular stent and also suitable for protecting the balloon delivery of the coronary vascular stent; when the outer layer protection structure is composed of more than two sections, the loading and unloading of the outer layer protection structure can be conveniently operated; when the protection structure is longer and the outer protection structure is multi-segment-time-saving, the problem that the inner protection structure and even the support are fixed and fall off due to influence of the overlong length of the outer protection structure in the removal process can be effectively avoided.
Drawings
Fig. 1 is a schematic structural view of a preferred embodiment of a protective structure for a medical device having resilient or self-expanding properties according to the present invention.
Fig. 2 is a schematic view of an inner layer protection structure of the protection structure shown in fig. 1.
Fig. 3 is a cross-sectional view of the inner layer protective structure shown in fig. 2.
Fig. 4 is a schematic view of an outer protective structure of the protective structure of fig. 1.
Fig. 5 is a schematic structural view of another preferred embodiment of a protective structure for a medical device having resilient or self-expanding properties according to the present invention.
Fig. 6 is a schematic structural view of another preferred embodiment of a protective structure for a medical device having resilient or self-expanding properties according to the present invention.
Wherein, the reference numerals mean:
1-an inner layer protection structure; 2-outer layer protection structure, 3-bracket, 4-hole; 5-a conveying system; 6-distal end of delivery system; 1 a-an opening of the inner protective structure; 9-delivery system, 9P-delivery system distal end;
11-semicircular tube, 12-distal end, 13-proximal end.
Detailed Description
For a more clear understanding of the contents of the invention, reference is now made to the following description taken in conjunction with the accompanying drawings.
Example 1
The protective structure of the saccule-delivered blood vessel stent is composed of an inner protective structure 1 and an outer protective structure 2 as shown in figures 1-2. The setting of outer protective structure 2 is in the 1 outside of inlayer protective structure, just outer protective structure 2 passes through inlayer protective structure 1 give support 3 continuously exert pressure, make the support keeps stable state wherein, outer protective structure 2 suit just can break away from completely on inlayer protective structure 1.
The section of the outer layer protection structure 2 is a complete closed circle and is a single-length tube-packed object.
The inner layer protection structure 1 is composed of two semicircular pipes 11, and one end of each semicircular pipe is fixedly connected with the corresponding inner layer protection structure or the corresponding inner layer protection structure is an integral tubular object with an opening at one end. The length of the inner layer protection structure 1 is equal to the length of the bracket needing protection plus 40 mm. When the inner layer protection structure 1 is installed on the protection bracket, two ends of the inner layer protection structure respectively exceed the medical apparatus by 20mm, and the inner layer protection structure is pinched by hands when being installed and removed. The inner layer protection structure 1 is composed of two semicircular pipes 11, the inner diameters of the two semicircular pipes 11 are not larger than the outer diameter of the protected medical apparatus (support), and the inner layer protection structure can also be composed of an integral pipe with one end cut into two halves, and the cutting length of the integral pipe is the length of the protected medical apparatus plus 20 mm.
The materials of the inner layer and the outer layer protective structure can be composed of PTFE, PP, PE, PEBAX, Nylon, FEP, ETFE and other materials with smooth surfaces. Can be prepared by injection molding, extrusion and the like.
The inner layer protection structure 1 is sleeved in the inner layer protection structure, the fixed end is a near end 12, one end of an opening 1a of the inner layer protection structure is a far end 13, two semicircular tubes completely cover the medical instrument to be protected, the far end 13 and the near end 12 exceed 20mm respectively, then the far end 13 is sleeved in the outer layer protection structure 2, and the outer layer protection structure 2 completely covers the medical instrument to be protected. The removing process comprises the steps of pinching the inner-layer protection structure 1 by a hand close to one side of the near end 12, slightly pinching the outer-layer protection structure 2 by the other hand, removing the inner-layer protection structure towards the far end 13 until the outer-layer protection structure 2 is completely removed, loosening the inner-layer protection structure 1, pinching the inner-layer protection structure from the far end 13 of the inner-layer protection structure 2, slowly removing the inner-layer protection structure, and removing the two layers of protection structures.
The protective structure of this embodiment, because the outer protective structure is a single length, is recommended for use with stents having a length of less than 60 mm.
The conveying system 9 of the stent 3 can use a balloon catheter, the stent 3 is pressed and held on the balloon catheter, then the inner-layer protection structure 1 is sleeved from the far end 9P of the conveying system through the opening end and covers the stent in the balloon catheter, an operator pinches the inner-layer protection structure at the near end 13, and then the outer-layer protection structure 2 is sleeved on the inner-layer protection structure 1 to fix and protect the stent 3. When the support 3 is needed to be used, the outer-layer protection structure 2 is taken down from the far end 9P of the conveying system, an operator holds the inner-layer protection structure of the near end 13, and then the inner-layer protection structure 1 is taken down, so that a doctor can conveniently operate the support.
Example 2
The protective structure of the stent for balloon delivery is different from that of the embodiment 1 in that the outer protective structure 2 can be composed of two tubes with the same diameter and length.
Example 3
The protective structure of the balloon-delivered stent is different from the protective structure of the balloon-delivered stent in example 1, and the outer layer protective structure 2 can be composed of three tubular objects with the same diameter and length.
Example 4
The protective structure of the stent for balloon delivery is different from that of the stent of the embodiment 1, and as shown in fig. 5, the outer protective structure 2 can be composed of four tubular objects with the same diameter and length.
The protection structure of embodiment 2-4, outer protection architecture 2 is the multistage, can reduce frictional force, has avoided influencing the fixed and problem that drops of inlayer protection architecture or even support because outer protection architecture length overlength leads to in the in-process that drops.
Example 5
The protective structure of the stent for balloon delivery is different from the protective structures of the embodiments 1 to 4, as shown in fig. 6, holes 4 with various shapes can be distributed on the cylindrical surface of the outer protective structure 2 to reduce the frictional resistance when the outer protective structure is sleeved in/removed from the inner protective structure.
Example 6
The protective structure of the bracket for balloon delivery is different from the protective structure of the embodiment 1-4 in that one end of the outer protective structure 2 can be expanded into a bell mouth to facilitate the insertion/removal of the protective structure from the inner protective structure 1, and the un-expanded length of the outer protective structure is the length of the protected medical device plus 2 mm.
The length of the protection structure in the above embodiment can be made larger or smaller, the application range is wide, and the protection structure can be suitable for the protection of balloon delivery of a peripheral vascular stent and can also be suitable for the protection of balloon delivery of a coronary vascular stent; when the outer layer protection structure is composed of more than two sections, the loading and unloading of the outer layer protection structure can be conveniently operated; when the protection structure is longer and the outer protection structure is multi-segment-time-saving, the problem that the inner protection structure and even the support are fixed and fall off due to influence of the overlong length of the outer protection structure in the removal process can be effectively avoided.
It will be understood by those skilled in the art that the protective structure of the invention includes any combination of the inventive concepts and detailed description of the invention set forth above and illustrated in the accompanying drawings, which are not intended to be limiting in any way and which, for the sake of brevity of this description, do not describe in any way the individual aspects which form the combination. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. The utility model provides a protection architecture of medical instrument with resilience or from expansibility, includes inlayer protection architecture and outer protection architecture, and outer protection architecture sets up in the inlayer protection architecture outside, just outer protection architecture passes through inlayer protection architecture give medical instrument continuously exert pressure, make medical instrument keeps stable state wherein, its characterized in that, outer protection architecture suit just can break away from completely on the inlayer protection architecture.
2. The protective structure of claim 1 wherein said outer protective structure is comprised of a single or a plurality of tubes of the same diameter and length.
3. The protective structure according to claim 2, wherein the cylindrical surface of the outer protective structure is distributed with holes of different shapes to reduce frictional resistance when the outer protective structure is inserted into/removed from the inner protective structure.
4. A protective structure as claimed in claim 2 or 3 wherein said inner protective structure is formed from two semi-circular tubes and is fixedly attached at one end or is a one-piece tubular member with an open end.
5. The protective structure of claim 4 wherein said inner protective structure has a length equal to the desired length of said medical device plus 40 mm.
6. The protective structure of claim 5 wherein said medical device is protected by a length in the range of 5mm to 200mm in said inner protective structure.
7. The protective structure of claim 5 wherein the inner protective structure is mounted on the medical device to be protected with each end extending 20mm beyond the medical device for manual grasping of the inner protective structure for installation and removal.
8. The protective structure of claim 1 or 7, wherein the outer protective structure is flared at one end to facilitate its insertion/removal from the inner protective structure, and has an overall length of 2mm plus the length of the medical device to be protected.
9. The protective structure of claim 8 wherein the inner and outer protective structures are comprised of a smooth surfaced material selected from the group consisting of PTFE, PP, PE, PEBAX, Nylon, FEP, ETFE.
10. The protective structure according to claim 1 or 9, wherein the inner and outer protective structures are nested in the order of the inner protective structure such that the two semicircular tubes completely cover the medical device to be protected and the distal and proximal ends each exceed 20mm, and then nested from the distal end into the outer protective structure which completely covers the medical device to be protected; the removing process comprises the steps of holding the inner-layer protection structure immovably by a hand close to one side of the near end, holding the outer-layer protection structure slightly by the other hand and removing the outer-layer protection structure towards the far end until the outer-layer protection structure is completely removed, then loosening the inner-layer protection structure, holding the inner-layer protection structure from the far end of the inner-layer protection structure, slowly removing the inner-layer protection structure, and finishing the removal of the two layers of protection structures.
CN202020708126.5U 2020-04-30 2020-04-30 Protective structure for a medical device having resilient or self-expanding properties Active CN213076120U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111529154A (en) * 2020-04-30 2020-08-14 北京阿迈特医疗器械有限公司 Protective structure for a medical device having resilient or self-expanding properties

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111529154A (en) * 2020-04-30 2020-08-14 北京阿迈特医疗器械有限公司 Protective structure for a medical device having resilient or self-expanding properties

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