CN113069673B

CN113069673B - Sectional type medical drug stent

Info

Publication number: CN113069673B
Application number: CN202110306277.7A
Authority: CN
Inventors: 高成; 唐烈; 陆剑锋; 张珊
Original assignee: Polyrey Medical Tech Suzhou Co ltd
Current assignee: Polyrey Medical Tech Suzhou Co ltd
Priority date: 2020-09-30
Filing date: 2021-03-23
Publication date: 2023-02-28
Anticipated expiration: 2041-03-23
Also published as: CN113069673A; CN113069674B; CN214712944U; CN214712943U; CN113069674A

Abstract

The invention relates to a sectional medical drug stent, which comprises a plurality of stent components and a connecting film; each bracket component comprises an independent bracket and a fixed film; the independent stents are sequentially arranged at intervals along the axial direction of the sectional medical drug stent, each independent stent comprises a stent body, an inner wrapping film and an outer wrapping film, a gap is formed between each wrapping film and the stent body, and drugs are filled in the gap; the plurality of independent supports are connected only through the fixed membrane, and the connecting covering membrane is fixedly connected with the fixed membrane. The sectional type medical drug bracket can well coat the drug in the coating film, thereby avoiding the problem that the drug falls off from the sectional type medical drug bracket; moreover, by arranging the independent brackets at intervals, different medicines can be coated in the types of the medicines coated in the independent brackets according to actual needs; in addition, two adjacent bracket components are connected through the connecting covering film, so that the sectional type medical drug bracket is more flexible to use.

Description

Sectional type medical drug stent

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a sectional type medical drug stent for treating pathological obstruction.

Background

In the existing pathological change dilatation, a layer of degradable medicine protective film is coated on the surface of an integrally woven stent, medicines are distributed on a high polymer film through a spraying technology, the medicine exerting time is concentrated, and the medicine supplying time is short; and because of the integrity of the film, only one medicine can be sprayed, and different pathologies cannot be treated; in addition, before the operation enters the human body, the sprayed medicine easily falls off, so that the medicine is lost, and the operation effect is influenced.

In addition, in current angioplasty, a one-piece woven stent or a one-piece laser engraved stent is generally used. The problem of insufficient supporting force of the braided bracket exists at present; the use of laser sculpture integral type support lacks the flexibility, and the doctor needs implant a plurality of supports simultaneously according to the difference of blood vessel diameter during the operation, leads to treatment cost height, and the patient is difficult to accept.

Therefore, in order to solve the above technical problems, there is a need to provide a sectional type medical drug stent, which not only can avoid the problem that the drug falls off from the stent before and during the implantation process of the stent, but also can be applied to the blood vessels with large differences in the inner diameters of the blood vessels, so as to increase the flexibility of the stent in use, reduce the number of the blood vessel stents implanted into the body of a patient, reduce the treatment cost, and reduce the burden of the patient.

Disclosure of Invention

The invention aims to solve the technical problem of providing a sectional medical drug stent which is not easy to cause drug loss due to the fact that drugs fall off from the sectional medical drug stent before entering a human body and can be suitable for blood vessels with large differences of inner diameters of the blood vessels.

In order to achieve the purpose, the invention adopts the technical scheme that:

a segmented medical drug stent having an expanded state and a contracted state, the segmented medical drug stent having an inner diameter when in the expanded state that is greater than an inner diameter when in the contracted state; the sectional medical drug stent comprises a plurality of stent components and connecting covering films which are respectively and fixedly connected with two adjacent stent components;

each of the bracket assemblies includes:

the independent stents are sequentially arranged at intervals along the axial direction of the sectional type medical drug stent, each independent stent comprises a closed annular stent body, an inner wrapping film and an outer wrapping film, the inner wrapping film and the outer wrapping film are respectively arranged on the inner side and the outer side of the stent body, two shaft ends of the inner wrapping film are respectively sealed with two shaft ends of the outer wrapping film to form a wrapping film, a gap is formed between the wrapping film and the stent body, and drugs are filled in the gap;

and the independent brackets are only connected through the fixed film, and the connecting covering film is fixedly connected with the fixed film.

According to the invention, through the integral improvement on the sectional medical drug stent, on one hand, a plurality of independent stents which are mutually spaced are arranged, and each independent stent adopts a coating film to coat the stent body and the drug in the coating film, so that the support of the independent stent on the lumen is ensured, and the drug can be well prevented from falling off from the coating film; on the other hand, the plurality of independent brackets are connected into a whole through the fixing film, so that the sectional type medical drug bracket has good bending performance, and the drug can be further prevented from falling from the sectional type medical drug bracket; on the other hand, the plurality of bracket components are connected through the connecting covering film, so that the sectional medical drug bracket can be suitable for blood vessels with large change of the inner diameter of the blood vessel and angular change such as bifurcation.

According to some specific and preferred embodiments, the drugs filled in the gaps of the plurality of independent stents are the same or different. The invention adopts a plurality of independent brackets, thereby avoiding the limitation that one film can only be sprayed with one drug due to the integrity of the film, and leading the sectional medical drug bracket of the invention to coat different drugs to carry out targeted treatment on different patients and different pathologies.

According to some specific and preferred embodiments, in each independent stent, the drugs are circumferentially arranged on the stent body in a surrounding manner, so that when the stent body is supported on the inner wall of the lumen, the drugs can be better contacted with the inner wall of the lumen, and the time and the distance for the drugs to reach the treatment site are shortened.

According to some specific and preferred embodiments, the stent body has a wavy annular structure, so that the stent body can be well contracted and expanded and can provide a good lumen supporting force.

According to some specific and preferred embodiments, the stent body is circular in cross-section.

According to some specific and preferred embodiments, the fixed membrane comprises an outer fixed membrane coated outside the independent supports, the outer fixed membrane is made of degradable materials, so that after the outer fixed membrane is degraded, the independent supports can be exposed, and the medicine can be released from the coated membrane conveniently.

Furthermore, the connection covering film, the covering film and the stent body are made of degradable materials, and the degradation speed of the connection covering film is greater than or equal to that of the outer fixing film and is greater than that of the covering film and that of the stent body. The materials of the connecting covering film, the external fixed film, the covering film and the stent body are selected according to the required degradation time, and the high polymer materials with different degradation times are the existing materials.

According to some specific and preferred embodiments, the stent body is made of a polylactic acid-based polymer or a bioabsorbable magnesium alloy material.

According to some specific and preferred embodiments, the fixing films comprise an inner fixing film positioned in a plurality of the independent stents and an outer fixing film positioned outside the plurality of the independent stents, the inner fixing film is fixedly connected with the inner covering film, and the outer fixing film is fixedly connected with the outer covering film; through setting up internal fixation membrane and external fixation membrane simultaneously, can be better with the medicine cladding in the medical medicine support of sectional type, the influence of the medical medicine support of sectional type to the blood flow that the internal fixation membrane can avoid implanting moreover, the damage of stake body to the vascular wall can be avoided to the external fixation membrane.

Further, the inner fixing film and the outer fixing film are made of degradable materials, and the degradation time of the inner fixing film and the degradation time of the outer fixing film can be the same or different.

Further, both axial ends of the inner fixed film are respectively closed with both axial ends of the outer fixed film.

According to some specific and preferred embodiments, micropores for releasing the drug are formed on the covering film and the fixing film, respectively, so that a part of the drug can be slowly released from the micropores before the fixing film and the covering film are not degraded, thereby achieving the effect of slow release.

According to some specific and preferred embodiments, the inner and outer cover films are of equal width.

According to some specific and preferred embodiments, when the segmented medical drug stent is in a deployed state, the inner diameters of stent bodies in each stent component are the same or different, and an included angle is formed between every two adjacent stent components.

Further, the inner diameter of each bracket component in the unfolding state is gradually reduced from one end to the other end.

According to the optimal embodiment of the invention, after a plurality of independent stents are expanded and fixed, the degraded external fixed membrane exposes out of the independent stents, the coating membrane is matched with different high polymer materials, so that the degradation speed and the sequence are controllable, meanwhile, the release time and the release amount are manually arranged, the coated medicine can be released in the blood vessel of a patient in a fixed time and fixed amount according to the actual requirements, the medicine can be released for a long time, the continuous treatment effect is achieved on the lesion part, meanwhile, different medicines can be coated, the targeted treatment can be carried out on different patients and different pathologies, the medicine release on the lesion part has the controllability, the purpose of accurately treating the lesion is achieved through targeted and differentiated treatment of different lesions, the risk of treatment failure is reduced, and the cure probability of the patient is improved. And, connect two bracket components through connecting the tectorial membrane, the diameter difference of two bracket components can be great to adapt to the great department of blood vessel diameter difference, improve the flexibility that the medical drug stent of sectional type used, reduce the quantity of implanting the internal vascular support of patient, reduce treatment cost, alleviate patient's burden.

Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:

the sectional type medical drug stent can well coat the drug in the coating film, thereby avoiding the problem that the drug falls off from the sectional type medical drug stent when the sectional type medical drug stent is not implanted into the body or in the implantation process; moreover, by arranging the independent brackets at intervals, different medicines can be coated in the types of the medicines coated in the independent brackets according to actual needs, so that the medicine release maneuverability of the lesion is higher and more targeted; in addition, two adjacent bracket components are connected through the connecting covering film, so that the sectional type medical drug bracket is more flexible to use and can be suitable for more types of blood vessels.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

FIG. 1 is a partial perspective view of a single stent assembly of a preferred embodiment of the present invention secured in a blood vessel by balloon expansion and with the stent body shown in phantom;

FIG. 2 is a partial perspective view of a segmented medical drug stent secured in a blood vessel by balloon expansion with the stent body shown in phantom according to a preferred embodiment of the present invention;

FIG. 3 is an exploded view of the preferred embodiment of the present invention;

FIG. 4 is an enlarged view of A in FIG. 3;

FIG. 5 is a schematic structural view of a free-standing stent with a part of an outer coating film removed according to a preferred embodiment of the present invention;

in the figure: 10. the stent comprises an inner fixed membrane 101, a channel 12, an independent stent 121, a coating membrane 122, a stent body 124, a medicament 1211, an inner coating membrane 1212, an outer coating membrane 14, an outer fixed membrane 130, a stent component 140 and a connecting coating membrane.

Detailed Description

In the following, only certain exemplary embodiments are briefly described. As those skilled in the art would recognize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the embodiments of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

In the description of the embodiments of the present invention, it should be understood that the terms "length", "inside", "upper", and the like indicate orientations or positional relationships based on those shown in fig. 1, and are only used for convenience in describing the embodiments of the present invention and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the embodiments of the present invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of the present invention, "a plurality" means two or more unless specifically limited otherwise.

In the embodiments of the present invention, unless otherwise explicitly specified or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly, e.g., as being fixedly connected, detachably connected, or integrated; the connection can be mechanical connection, electrical connection or communication; either directly or indirectly through intervening media, either internally or in any other relationship. Specific meanings of the above terms in the embodiments of the present invention can be understood by those of ordinary skill in the art according to specific situations.

In embodiments of the present invention, unless expressly stated or limited otherwise, the recitation of a first feature "on" or "under" a second feature may include the recitation of the first and second features being in direct contact, and may also include the recitation of the first and second features not being in direct contact, but being in contact with another feature between them. Also, the first feature "on," "above" and "over" the second feature may include the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature includes the first feature being directly above and obliquely above the second feature, or simply meaning that the first feature is at a lesser level than the second feature.

The following disclosure provides many different embodiments or examples for implementing different configurations of embodiments of the invention. To simplify the disclosure of embodiments of the invention, the components and arrangements of specific examples are described below. Of course, they are merely examples and are not intended to limit embodiments of the present invention. Furthermore, embodiments of the present invention may repeat reference numerals and/or letters in the various examples, such repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed.

Embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

As shown in fig. 1 and fig. 2, the present embodiment provides a sectional medical drug stent, which includes a plurality of stent assemblies 130, and a connection covering film 140 respectively fixedly connected to two adjacent stent assemblies 130; the number of the bracket assemblies 130 can be selected according to the requirement, and for example, the number can be 2, 3, and the like.

As shown in fig. 3, each stent assembly 130 includes an inner fixation membrane 10, a plurality of individual stents 12, and an outer fixation membrane 14.

The internal fixation film 10 is cylindrical, a channel 101 is arranged in the internal fixation film, the balloon can be conveniently installed in the channel 101, and after the sectional type medical drug stent 1 is unfolded, the blood flow can conveniently pass through the channel and the influence on the flow of the blood flow is not easily caused.

As shown in fig. 3 to 5, a plurality of independent brackets 12 are axially sleeved outside the inner fixing film 10, and the plurality of independent brackets 12 are arranged at intervals; each independent bracket 12 comprises a coating film 121 and a bracket body 122 arranged in the coating film 121; a gap is formed between the coating film 121 and the annular bracket body 122 and is used for filling the medicine 124; each coating film 121 comprises an inner coating film 1211 and an outer coating film 1212 sleeved outside the inner coating film 1211, the inner coating film 1211 is sleeved outside the inner fixing film 10 and is fixedly connected with the inner fixing film 10, and the annular support body 122 is sleeved outside the inner coating film 1211.

The outer fixing film 14 is cylindrical, covers the plurality of outer covering films 1212, and is fixedly connected to the outer covering films 1212.

The connection coating 140 may be fixedly connected to the inner fixing film 10, or fixedly connected to the outer fixing film 14, or fixedly connected to both the inner fixing film 10 and the outer fixing film 14.

The coating film 121 of each independent stent 12 can adopt materials with different properties to achieve different degradation times according to requirements, so that the degradation speed and the degradation sequence become controllable, the medicine 124 in the coating film 121 is released in a timed and quantitative manner, the purpose of accurately treating pathological changes is achieved, and a continuous treatment effect is achieved for the pathological change parts. The annular stent body 122 has a high ability to withstand radial pressure. The medicine 124 is arranged in the gap formed by the inner coating 1211 and the outer coating 1212, so that the medicine 124 is prevented from falling off, and the treatment effect is improved. The independent supports 12 are limited and combined through the matching of the inner fixing film 10 and the outer fixing film 14, so that when the medical segmented drug support is implanted, the independent supports 12 can be combined together as required, the independent supports 12 are prevented from moving, the independent supports 12 can accurately reach the lesion part, and the medical segmented drug support is more beneficial to bending by adopting the films to connect the independent supports 12. The inner fixing film 10, the outer fixing film 14 and the annular stent body 122 can be expanded and degraded at a designated time, and the time before the inner fixing film 10 and the outer fixing film 14 are degraded can provide the time for the drug stent to be fixed in the blood vessel for a long time, and the drug stent cannot be influenced when the blood vessel moves and bends.

According to the invention, the medicine 124 is preferably arranged on the annular bracket body 122 in a circumferential direction in a surrounding manner, so that the medicine 124 is uniformly distributed, and the treatment efficiency and effect are improved.

In order to enhance the expansion of the annular stent body 122 to the blood vessel and to stabilize the annular stent body 122 in the blood vessel, the annular stent body 122 preferably has a wavy annular structure.

In the present invention, it is preferable that the cross section of the annular stent body 122 is circular to avoid damage to the blood vessel.

According to the invention, preferably, two axial ends of the inner fixed film 10 are respectively sealed with two axial ends of the outer fixed film 14, so that the plurality of independent brackets 12 are further limited.

The width of the inner wrapping film 1211 is preferably equal to that of the outer wrapping film 1212, the structure is simple, and the stability of the medicine 123 between the inner wrapping film 1211 and the outer wrapping film 1212 is improved.

In order to further prevent the falling of the medicine 123, it is preferable that both axial ends of the inner wrap 1211 are respectively sealed with both axial ends of the outer wrap 1212.

In the present application, the inner covering film 1211 and the outer covering film 1212, the inner covering film 1211 and the inner fixing film 10, the outer covering film 1212 and the outer fixing film 14, and the connection covering film 140 and the inner fixing film 10 and/or the outer fixing film 14 may be fixedly connected by sewing, sealing, or heat pressing.

In the present application, the inner fixing film 10, the inner covering film 1211, the stent body 122, the outer covering film 1212, the outer fixing film 14 and the connection covering film 140 are all made of degradable materials, and the degradation speed of the connection covering film 140 is greater than or equal to that of the fixing film and greater than that of the covering film and greater than that of the stent body 122, so as to avoid the risk that the connection covering film 140 is dissociated in the blood vessel due to degradation of the fixing film prior to the connection covering film 140, wherein the control of different degradation speeds is realized by selecting polymer materials with different degradation speeds; the specific degradation rate can be determined according to the actual needs of the patient during treatment.

In the present invention, the annular stent body 122 is preferably made of a polylactic acid polymer material, and can be degraded by itself when reaching the designed life without being taken out of the blood vessel, but is not limited to the polylactic acid polymer material, and may also be made of a bioabsorbable magnesium alloy material.

When the medical stent is used, the sectional medical stent is in a contraction state in an initial state, a saccule (not shown in the figure) is arranged in the channel 101 of the internal fixed membrane 10, and the saccule is provided with an inflatable and air-extracting connecting port; the medicine stent enters a blood vessel with pathological changes of a human body through a guide wire (not shown in the figure), the saccule is inflated, and the medicine stent is then stretched to the unfolding state so that the inner diameter of the medicine stent is larger than that of the sectional type medical medicine stent in the contraction state; after the balloon is pumped out, the drug stent is fixed at the lesion part; after the drug stent is expanded, a plurality of independent stents 12 are embedded into the vessel wall for fixation after a period of time, and will not fall off even if the vessel moves and contracts, and the inner fixed membrane 10 and the outer fixed membrane 14 are degraded at the design time; the plurality of independent supports 12 are exposed after the outer fixed film 12 is degraded, and due to the independent arrangement of the plurality of independent supports 12, the degradation speed and the degradation sequence are controllable by adopting the collocation of different high polymer materials for the plurality of coating films 121, so that different degradation time is achieved; under the action of different degradation times of the plurality of coating films 121, the drugs can be released according to different sequences, different times and different dosages, and different drugs can be matched in each segment; the vessel recovers the blocked lumen by the expansion of the plurality of annular stent bodies 122 and the release of the drug 124, and the plurality of annular stent bodies 122 reach the design life and start to degrade by themselves without being taken out.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A segmented medical drug stent having an expanded state and a contracted state, the segmented medical drug stent having an inner diameter in the expanded state that is greater than the inner diameter in the contracted state; the sectional medical drug stent is characterized by comprising a plurality of stent components and connecting covering films which are respectively and fixedly connected with two adjacent stent components;

each of the bracket assemblies includes:

the independent stents are sequentially arranged at intervals along the axial direction of the sectional type medical drug stent, each independent stent comprises a closed annular stent body, an inner wrapping film and an outer wrapping film, the inner wrapping film and the outer wrapping film are respectively arranged on the inner side and the outer side of the stent body, two shaft ends of the inner wrapping film are respectively sealed with two shaft ends of the outer wrapping film to form the wrapping films, a gap is formed between each wrapping film and the stent body, drugs are filled in the gap, and the drugs filled in the gaps of the independent stents are the same or different;

the independent supports are connected only through the fixed film, the connecting film is fixedly connected with the fixed film, the fixed film comprises an outer fixed film coated outside the independent supports, the outer fixed film is made of degradable materials, the independent supports are exposed after the outer fixed film is degraded, and due to the independent arrangement of the independent supports, the degradation speed and the degradation sequence are controllable through the matching of different high polymer materials of the coating films, so that different degradation time is achieved; under the action of different degradation times of the coating films, the medicaments can be released according to different sequences, different times and different dosage;

in each independent stent, the drugs are circumferentially arranged on the stent body, the connecting covering film, the covering film and the stent body are made of degradable materials, and the degradation speed of the connecting covering film is greater than or equal to that of the outer fixing film and is greater than that of the covering film.

2. The segmented medical drug stent of claim 1, wherein: the stent body is made of polylactic acid polymer or bioabsorbable magnesium alloy material.

3. The segmented medical drug stent of claim 1, wherein: the fixed membrane comprises a plurality of internal fixed membranes positioned in the independent supports and a plurality of external fixed membranes positioned outside the independent supports, the internal fixed membranes are fixedly connected with the internal coated membranes, and the external fixed membranes are fixedly connected with the external coated membranes.

4. The segmented medical drug stent of claim 3, wherein: the two shaft ends of the inner fixed film are respectively sealed with the two shaft ends of the outer fixed film.

5. The segmented medical drug stent of claim 1, wherein: micropores for releasing the medicine are respectively formed on the coating film and the fixed film.

6. The segmented medical drug stent of claim 1, wherein: the width of the inner coating film is equal to that of the outer coating film.

7. The segmented medical drug stent of claim 1, wherein: when the sectional type medical medicine stent is in an unfolding state, the inner diameters of stent bodies in each stent component are the same or different, and an included angle is formed between every two adjacent stent components.