WO2013073806A1 - Biodegradable stent including film for delivering biodegradable drugs - Google Patents

Biodegradable stent including film for delivering biodegradable drugs Download PDF

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Publication number
WO2013073806A1
WO2013073806A1 PCT/KR2012/009527 KR2012009527W WO2013073806A1 WO 2013073806 A1 WO2013073806 A1 WO 2013073806A1 KR 2012009527 W KR2012009527 W KR 2012009527W WO 2013073806 A1 WO2013073806 A1 WO 2013073806A1
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Prior art keywords
stent
biodegradable
film
drug delivery
expandable
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PCT/KR2012/009527
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French (fr)
Korean (ko)
Inventor
박정의
김문석
김용년
Original Assignee
(주)이화바이오메딕스
아주대학교 산학협력단
사회복지법인 삼성생명공익재단
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Priority to KR1020110118176A priority Critical patent/KR101273034B1/en
Priority to KR10-2011-0118176 priority
Application filed by (주)이화바이오메딕스, 아주대학교 산학협력단, 사회복지법인 삼성생명공익재단 filed Critical (주)이화바이오메딕스
Publication of WO2013073806A1 publication Critical patent/WO2013073806A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2/86Stents 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541Adjacent bands are arranged out of phase
    • 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
    • A61F2/91Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Abstract

The present invention provides a biodegradable stent including a film for delivering biodegradable drugs. According to the present invention, the film for delivering the biodegradable drugs is extended in the direction of the diameter of a blood vessel when a stent is expanded and is thus closely attached to a wall of the blood vessel. Thus, a large amount of blood clots that break loose from the wall of the blood vessel when the stent is expanded may be prevented from being moved along with blood flow. Also, in a case where the blood vessel is damaged when the stent is expanded within the blood vessel, the generation of blood clots and angiostenosis may be prevented from occurring while the drugs saturated in the film and/or the stent may be continuously discharged. Also, the biodegradable film having a plurality of fine holes may be decomposed first, and then the stent may be decomposed to safely remove the film and the stent within the blood vessel.

Description

Biodegradable Stent with Biodegradable Drug Delivery Film

The present invention relates to a biodegradable stent having a biodegradable drug delivery film, and more particularly, a soft biodegradable drug delivery film having a plurality of micro holes and having a short in vivo degradation time has a relatively long decomposition time. A biodegradable stent having a biodegradable drug delivery film provided on a biodegradable stent surface.

In addition, the present invention is a biodegradable drug delivery film provided on the surface of the stent to expand in the blood vessel is stretched in the direction of the diameter of the vessel in accordance with the stent expansion and close to the blood vessel wall when the stent is inflated, so that many blood clots of the vessel wall is released to the blood flow The present invention relates to a biodegradable stent having a biodegradable drug delivery film capable of preventing riding.

In addition, the present invention is a biodegradable film in which a plurality of microholes are formed at the same time to prevent blood clot formation and vascular narrowing while continuously releasing the film and / or the drug supported on the stent when the vessel is damaged when the stent is expanded in the vessel The first step is to decompose the biodegradable stent having a biodegradable drug delivery film that allows the stent to disintegrate, so that the stent can be safely extinguished in the blood vessel.

In addition, the present invention provides multiple films of a soft biodegradable material capable of supporting and continuously releasing a variety of drugs in a multi-layer on the surface of the biodegradable stent to deliver a variety of drugs sequentially and continuously In addition, micro holes are formed in the film to provide breathability between the inside and the outside of the expanded stent in the blood vessel, and at the same time, the film can be broken down into fine pieces during drug delivery, thereby preventing the formation of blood clots. A biodegradable stent having a transfer film.

In addition, the present invention provides an adaptation suitable for vascular shape by providing a plurality of biodegradable stent units are provided at regular intervals and provided with a soft biodegradable drug delivery film on the surface of the biodegradable stent units arranged at such intervals. It relates to a biodegradable stent having a biodegradable drug delivery film that can be applied to long blood vessels while having a structural structure.

A stent is a blockage of a site where a lesion, such as a stenosis caused by the deposition of a mixed plug of cholesterol or fat in a coronary artery, a blood vessel surrounding the heart, or a cancer in the internal passage (luminal), blocks the internal area and narrows it. It is being used to expand.

The stent is used to reinforce or expand the vessel wall once it reaches the treatment location while inserted inside the vessel. However, the use of the stent may cause bleeding due to damage and tearing of the blood vessel wall, and the stent may have a fundamental problem of vascular restenosis due to long-term transplantation into a narrowed coronary artery, such as stent thrombosis and late vascular restenosis. .

In this regard, in the case of coronary artery stenosis, a metal stent is introduced into the coronary artery, and the stent structure is expanded at the stenosis to treat the stenosis. Although the stent treatment is effective, the restenosis problem occurs and the thrombus Drugs such as solubilizers are injected separately from the stents, so there is a problem that the surgical treatment and the medication are performed separately from each other. An example of the treatment of the stenosis using this conventional metallic stent is schematically illustrated in FIG. 8.

Referring to FIG. 8, first, a balloon pottery 2 equipped with a stent 1 suitable for various conditions such as the length of the stenosis lesion L and the diameter of the blood vessel in the arterial vessel CA is selected, and FIG. As shown in), push to reach the position of the stenosis lesion (L). Thereafter, as shown in FIG. 1B, when the balloon of the balloon ceramic 2 is inflated, the stent 1 is plastically deformed. And, as shown in Figure 1 (c) is to remove the balloon conductor 2, once plastically deformed stent (1) is maintained in an expanded state even after removing the balloon conductor (2). Therefore, the stent 1 supports the arterial vessel CA in an expanded state, thereby preventing the vessels from narrowing.

However, in the prior art, when the stent swells during an atherosclerosis patient, many blood clots in the blood vessel wall fall off and move on the bloodstream, causing clots to accumulate at other sites. In addition, since the stent itself is a foreign substance to the human body, tissue cells in the blood vessel wall may receive a pressure injury and cause rapid cell proliferation, thereby causing restenosis. Restenosis occurs more frequently with longer stent length and with smaller stent bore diameter, and is reported to occur mainly between 1 and 3 months after insertion.

Once the restenosis occurs, the effect of the stent is halved. Therefore, various methods for preventing or treating such restenosis have been proposed. However, in the case of injecting a drug such as thrombolysis separately from the stent, the surgical operation treatment and the drug treatment are inconvenient to be performed separately from each other.

In this regard, a drug-release stent coated with a drug on a metal stent has been recently proposed. For example, Korean Patent Publication No. 10-0495875 discloses a fine slot or a separate slot on the surface of a strut constituting the stent. A stent has been disclosed in which a restenosis inhibiting effect can be obtained by applying or charging an anti- restenosis agent such as rapamycin or paclitaxel after forming a drug loading hole.

However, since the stent coated with the anti-vascular restenosis agent is made of a metal material, the stent is permanently installed. Therefore, in this case, due to the insertion process and permanently mounted stents, there is a high risk of side effects such as wounding in the artery wall and causing an inflammatory response.

In view of these problems, for example, a stent made of a biodegradable material has been proposed as described in Korean Patent Publication No. 10-0485013. However, the biodegradable stent has a cylindrical structure made by overlapping and wrinkling films of the same components having a predetermined area, so that a large amount can be decomposed and released into a blood vessel in a short time when the stent is disassembled. Decomposed stent components can accumulate in blood vessels and cause side effects such as blood clots.

Therefore, in the technical field to which the present invention belongs, there is a continuous demand for improvement of the structure of a stent made of a biodegradable material, and in particular, it effectively prevents distant migration and restenosis which may occur after the stent procedure. While there is still a need to provide a technique that allows the stent component to degrade gradually in sequential order rather than being degraded at one time.

The present invention has been invented to supplement the problems of the prior art described above and to provide various additional advantages. The present invention relates to a biodegradable stent having a biodegradable drug delivery film provided on a surface of a biodegradable stent having a plurality of microholes and having a short biodegradation time. It aims to provide.

In addition, the present invention is a biodegradable drug delivery film provided on the surface of the stent to expand in the blood vessel is stretched in the direction of the diameter of the vessel in accordance with the stent expansion and close to the blood vessel wall when the stent is inflated, so that many blood clots of the vessel wall is released to the blood flow It is an object of the present invention to provide a biodegradable stent having a biodegradable drug delivery film that can prevent riding.

In addition, the present invention is a biodegradable film in which a plurality of microholes are formed at the same time to prevent blood clot formation and vascular narrowing while continuously releasing the film and / or the drug supported on the stent when the vessel is damaged when the stent is expanded in the vessel It is an object of the present invention to provide a biodegradable stent having a biodegradable drug delivery film in which the stent is decomposed and then the film and the stent are safely extinguished in the blood vessel.

In addition, the present invention provides multiple films of a soft biodegradable material capable of supporting and continuously releasing a variety of drugs in a multi-layer on the surface of the biodegradable stent to deliver a variety of drugs sequentially and continuously In addition, micro holes are formed in the film to provide breathability between the inside and the outside of the expanded stent in the blood vessel, and at the same time, the film can be broken down into fine pieces during drug delivery, thereby preventing the formation of blood clots. It is an object to provide a biodegradable stent having a transfer film.

In addition, the present invention provides an adaptation suitable for vascular shape by providing a plurality of biodegradable stent units are provided at regular intervals and provided with a soft biodegradable drug delivery film on the surface of the biodegradable stent units arranged at such intervals. It is an object of the present invention to provide a biodegradable stent having a biodegradable drug delivery film that can be applied to long blood vessels while having a structural structure.

This object is achieved by a biodegradable stent having a biodegradable drug delivery film provided according to the present invention. As an example, a biodegradable stent having a biodegradable drug delivery film of the present invention may be used inserted into the lumen or blood vessel of the airways, gastrointestinal tract, bile duct, and the like.

Biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention,

It includes a plurality of elastic struts arranged radially expandable and connected in a zigzag form, and a plurality of elastic strut joints connecting the plurality of elastic struts in a longitudinal direction and extending in a radial direction, and in the lumen or blood vessel of the human body The cylindrical expandable stent part is open at both ends of the biodegradable material that is decomposed after a certain period of time in,

It includes a film portion made of a biodegradable material provided surrounding the expandable stent portion and formed with a plurality of micro holes and decomposed within a shorter time period than the expandable stent portion is decomposed.

According to the above configuration, the biodegradable stent having the biodegradable drug delivery film of the present invention is provided with a film portion provided on the surface of the expandable stent portion which is inserted into the blood vessel and expands in the blood vessel diameter direction as the expandable stent portion expands. By sticking to it, many blood clots in the walls of the blood vessels can fall off and travel through the bloodstream when the stent is inflated. In addition, fine holes are formed in the film part to provide breathability between the inside and the outside of the expandable stent part expanded in the blood vessel, and at the same time, the film part may be decomposed into fine pieces during drug delivery, thereby preventing thrombus generation. The biodegradable film portion having a plurality of micro holes is first decomposed and then the expandable stent portion is decomposed so that the film portion and the expandable stent portion can be safely dissipated in the blood vessel.

In the biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention, the film portion may be supported with a rapamycin-based drug. The rapamycin-based drug supported on the film portion is continuously released for about a week to treat vascular damage caused by expansion of the expandable stent in the blood vessel and prevent restenosis.

In the biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention, the film portion is preferably in the form of a plurality of fine holes formed on a cylindrical base film of a thin film. The base film may have a ductility and extend in the radial direction as the expandable stent part extends in the radial direction, but may have physical properties that do not return to its original shape once stretched. This is to prevent the phenomenon of narrowing the blood vessel by returning the stretched film part to the original shape in order to keep the blood vessel passage expanded after the expansion of the stent in the blood vessel.

More preferably, the film portion may be provided in a multi-layer on the surface of the expandable stent portion to deliver various drugs sequentially and continuously.

In the biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention, the expandable stent part may be mounted with a steroid-based drug. Steroid-based drugs mounted on these expandable stents are continuously released for 3 weeks to 1 month to prevent abnormal cell proliferation in blood vessels.

In the biodegradable stent having a biodegradable drug delivery film of one embodiment of the present invention, the stretchable stent of the expandable stent portion is preferably stretchable in the radial direction but no change in the longitudinal direction. This allows the expansion and expansion of the expandable stent part due to the expansion of the inflatable pottery introduced into the stent (see FIG. 8) so that the expansion of the expandable stent part can be easily expanded while the deformation of the expansion stent occurs less easily. For sake.

In the biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention, the steroid (Steroid) -based drug is applied to the surface of the expandable stent portion sprayed or inserted into a slot formed in the stretched strut Can be mounted.

In the biodegradable stent having a biodegradable drug delivery film of an embodiment of the present invention, the decomposition period of the film portion is 1 month, the decomposition period of the expandable stent portion is preferably 3 months.

In a biodegradable stent having a biodegradable drug delivery film according to another embodiment of the present invention, a plurality of expandable stent portions are provided at regular intervals, and the plurality of expandable stent portions disposed at such regular intervals are integrally formed with the film portion. It is characterized by being provided while surrounding. By constructing the stent as described above, it is possible to provide a biodegradable stent having a biodegradable drug delivery film that can be applied to long blood vessels while having an adaptive structure suitable for vascular shape.

In a biodegradable stent having a biodegradable drug delivery film of another embodiment of the present invention, at least one side of the expandable stent portion supportive stent portion having a plurality of parallel straight support structure for supporting the film portion Can lead. Preferably, the expandable stent part and the supportable stent part may be alternately disposed.

According to the present invention, the biodegradable drug delivery film provided on the surface of the stent expanded in the blood vessel is stretched in the direction of the diameter of the blood vessel as the stent expands and adheres to the blood vessel wall so that when the stent is expanded, many blood clots in the blood vessel wall come off and enter the bloodstream. The movement can be prevented.

In addition, according to the present invention, if the vessel is damaged during expansion of the stent in the vessel, biodegradability in which a plurality of microholes are formed at the same time while preventing the formation of blood clots and vascular narrowing while continuously releasing drugs supported on the film and / or stent The film decomposes first and then the stent decomposes so that the film and stent can be safely dissipated in the blood vessel.

In addition, the present invention provides multiple films of a soft biodegradable material capable of supporting and continuously releasing a variety of drugs in a multi-layer on the surface of the biodegradable stent to deliver a variety of drugs sequentially and continuously In addition, fine holes are formed in the film, which provides air permeability between the inside and the outside of the expanded stent in the blood vessel, and at the same time, the film may be decomposed into fine pieces during drug delivery, thereby preventing the formation of blood clots. .

In addition, the present invention provides an adaptation suitable for vascular shape by providing a plurality of biodegradable stent units are provided at regular intervals and provided with a soft biodegradable drug delivery film on the surface of the biodegradable stent units arranged at such intervals. It has the additional advantage that it can be applied to long blood vessels while having a structural structure.

1 is a front view of a biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention, a longitudinal cross-sectional view and a partially enlarged cross-sectional view along the line AA ′.

Figure 2 is a cross-sectional view along the line B-B 'of the biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention.

Figure 3 is a perspective view showing the inside by partially cutting the film portion in the biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention.

Figure 4 (a) is a perspective view of the expandable stent excluding the film portion of the biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention, Figure 4 (b) is the expansion for clarity The stent part is shown in an unfolded open manner.

Figure 5 (a) is a cross-sectional view showing a state before the biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention is introduced into the blood vessel passage (BP) with the lesion site (L) and unfolded to be. Figure 5 (b) is expanded in accordance with the expansion of the balloon of balloon balloon (not shown for convenience of description) introduced into the expandable stent portion of the biodegradable stent having a biodegradable drug delivery film according to an embodiment of the present invention It is sectional drawing which shows the state in which a stent part expands radially and accordingly, a film part expands and adheres to the blood vessel wall BB which has the lesion site L. As shown in FIG.

6 and 7 are views illustrating the configuration of a biodegradable stent having a biodegradable drug delivery film according to another embodiment of the present invention.

FIG. 8 is a diagram schematically illustrating the principle of endovascular stenting.

Hereinafter, exemplary embodiments of the present invention will be described with reference to the accompanying drawings. The following examples of the present invention are not intended to limit or limit the scope of the present invention only to embody the present invention. From the detailed description and examples of the present invention, those skilled in the art to which the present invention pertains can easily be interpreted as belonging to the scope of the present invention. References cited in the present invention are incorporated herein by reference.

1 to 4 illustrate a biodegradable stent 10 (hereinafter referred to as a 'stent') with a biodegradable drug delivery film provided in accordance with one embodiment of the present invention. This is, for example, the stent 10 is inserted into the lumen or blood vessels of the airways, gastrointestinal tract, bile ducts, etc., and may be used in the same manner as in FIG. 8.

As shown in (a) of FIG. 1 and its longitudinal section is shown in (b) of FIG. 1, the stent 10 according to an embodiment of the present invention has a cylindrical thin film portion ( 12) may comprise an expandable stent portion 14 coated or disposed. As shown in Figure 2, the stent 10 according to an embodiment of the present invention consisting of a film portion 12 surrounding the expandable stent portion 14 may be 18.33 ± 0.1 mm in total length as an example , Diameter D may be 2.69 ± 0.05mm. In addition, as an example, the thickness t 1 of the film part 12 may be 0.02 mm, and the thickness t 2 of the expandable stent part 14 may be 0.12 mm.

However, the present invention is not limited thereto, and the dimensions of the stent 10 of the present invention may be changed according to various conditions such as the size, length, and shape of blood vessels, and thus, the thickness t 1 and expandability of the film part 12. It will be readily understood by those skilled in the art that the thickness t 2 of the stent portion 14 can also be changed as appropriate.

As shown in FIGS. 1 to 3, the film part 12 surrounding the expandable stent part 14 has a plurality of micro holes 124 and is shorter than a period in which the expandable stent part 14 is decomposed. It consists of a biodegradable material that decomposes within a period of time. Both the film part 12 and the expandable stent part 14 are made of a biodegradable material, but have different characteristics in that the decomposition period is different due to different physical properties in the manufacturing process. According to a preferred embodiment, the film portion 12 is preferably a biodegradable material which can be disintegrated and disappeared within about one month, and the expandable stent portion 14 preferably has a longer decomposition period. For example, the biodegradable material is preferably decomposed within about 3 months.

In addition, the expandable stent part 14 may be loaded with a steroid (Steroid) -based drug. The steroid-based drug mounted on the expandable stent part 14 is continuously released for about 3 weeks to 1 month to prevent the proliferation of cell abnormalities in blood vessels. The steroid-type drug extends to the expandable stent part. 14 may be applied to the surface by a spray method or loaded into the slot 142a formed in the elastic strut 142 to be described later.

The film part 12 may be loaded with rapamycin-based drugs. The rapamycin-based drug supported on the film part is continuously released for about one week to treat vascular damage caused by expansion of the expandable stent part 14 in the blood vessel passage (BP) and prevent restenosis (Fig. 5).

Looking at the structure, the expandable stent portion 14 constituting the stent 10 of the present invention is as shown in Fig. 4 (a), in order to facilitate understanding as shown in Fig. 4 (b) in an open plane It may be shown in an expanded state. As shown in FIG. 4, the expandable stent part 14 includes a plurality of elastic struts 142 that are expandable in a radial direction (d direction) and are connected in a zigzag form, and the plurality of elastic struts 142. Are connected to each other in the longitudinal direction (s direction) and may be composed of a plurality of strut joints 144 stretchable in the radial direction (d direction). Expandable stent portion 14 has a cylindrical shape with both ends open as a whole.

As shown in FIG. 4B, the stretchable strut 142 of the expandable stent portion 14 is stretchable in the radial direction (d direction) but preferably does not change in the longitudinal direction (s direction). Do. This is because the expandable stent 142 and the strut joint 144 easily open when the expandable stent part 14 is expanded due to the expansion of the balloon ceramic (not shown) introduced into the stent 10. In order to make it easy to expand, the elastic strut 142 is less likely to occur. In addition, as described above, the slot 142a may be formed in the stretch strut 142 for drug loading.

As an example, the length S1 of the elastic strut 142 may be 1.3 mm, the width W may be 0.84 mm, and the length S2 of the strut joint 144 may be 0.4 mm. However, the present invention is not limited thereto, and the dimensions of the stent 10 of the present invention may be changed according to various conditions such as the size, length, and shape of blood vessels, and thus the length and width of the stretchable strut 142 and the strut joint portion ( It will be readily understood by those skilled in the art that the length of 144 can also be appropriately altered.

On the other hand, the expandable stent portion 14 is, for example, polyglycolide (polyglycolide), polylactide (polylactide), polycaprolactone (polycaprolactone), trimethylene carbonate (trimethylene carbonate), polyhydroxy alkanoate (polyhydroxy alkanoates, polypropylene fumarate and polyester, or at least one polymer selected from the group consisting of polyesters or copolymers thereof or mixtures thereof.

As shown in FIGS. 2 and 3, the film portion 12 is generally cylindrical in shape surrounding the outer surface of the expandable stent portion 14. The film portion 12 is preferably in the form of a plurality of fine holes 124 on the cylindrical base film 122 of a thin film. These microholes 124 provide breathability between the inside and outside of the expandable stent portion 14 expanded in the blood vessel, and at the same time allow the base film 122 to break down into small pieces when the base film 122 is disassembled, It can provide an advantage of not causing it.

The film part 12 is a biocompatible material capable of supporting and continuously releasing a drug, and may use the material used in the above-described expandable stent part 14, and as another example, polyethyleneglycol (PCLA) -PCLA (poly (epsilon-caprolactone-co-D, L-lactide)) can be used. In addition, the polymer may be prepared using a polymer to which at least one substance selected from the group consisting of caprolactone, glycolide, lactide, paradioxanone and trimethylene carbonate is added.

Note that the base film 122 of the film portion 12 has a ductility and extends in the radial direction as the expandable stent portion 14 extends in the radial direction but does not return to its original shape once stretched. Ready to have This is to prevent the phenomenon of narrowing the blood vessel by returning the stretched film part to the original shape in order to keep the blood vessel passage expanded after the expansion of the stent in the blood vessel.

In addition, as shown in (b) of FIG. 2, the film part 12 may be provided as multiple layers 12a, 12b, and 12c on the expandable stent part 14 to sequentially and continuously deliver various drugs. .

As described above, the stent 10 according to an embodiment of the present invention is an expandable stent portion 14 and an outer surface of the expandable stent portion 14 forming an expandable skeleton made of elastic struts. Coated film portion 12. For example, when performing a stent in an atherosclerosis patient, in the conventional case, when a stent is expanded, many blood clots in the blood vessel wall fall off and enter the blood vessels between the strut structures forming the stent, thereby causing a blood vessel narrowing problem. There was a problem. In contrast, the stent 10 according to the present invention provides an advantage that the micro clots can be prevented from flowing into the blood vessel because the space between the strut structures is blocked by the film for drug delivery.

That is, the state shown in (a) of FIG. 5 is a state in which the stent is introduced into the blood vessel passage (BP) with the lesion site (L), the expandable stent part 14 and the same. The surrounding film portion 12 is in an unexpanded state. In addition, in the state of FIG. 5A, the expandable stent part 14 expands in the radial direction according to the expansion of the balloon (not shown for convenience of description) of the inflatable ceramic introduced into the expandable stent part 14. As a result, the film portion 12 is stretched to closely adhere to the blood vessel wall BB having the lesion site L (see FIG. 5B).

Therefore, in the biodegradable stent 10 having the biodegradable drug delivery film of the present invention, the film portion 12 provided on the surface of the expandable stent portion 14 that is inserted into the blood vessel passage BP and is expanded is the expandable stent portion. (14) When the stent 10 is expanded, the blood vessels are stretched in the direction of the blood vessel in the radial direction and close to the blood vessel wall BB to prevent many blood clots of the blood vessel wall from falling off and moving in the blood flow. In addition, the minute holes 124 are formed in the film part 12 to provide ventilation between the inside and the outside of the expandable stent part 14 expanded in the blood vessel passage BP, and the film part 12 during the drug delivery process. ) Can be decomposed into fine pieces to prevent thrombus generation, and the biodegradable film portion 12 having a plurality of micro holes 124 is first decomposed and then the expandable stent portion 14 is decomposed. The portion 12 and the expandable stent portion 14 can be safely extinguished in the blood vessel.

On the other hand, the stent 10 according to the embodiment illustrated in Figures 1 to 4 is suitable for use in short length blood vessels. When applied to relatively long blood vessels, stents 20 and 30 according to the embodiment shown in FIGS. 6 and 7 may be used.

6 and 7, the stent 20, 30 is provided with a plurality of expandable stents 214, 234, 314, 334, 354 at regular intervals and a plurality of expandable stents disposed at such regular intervals (214, 234, 314, 334, 354) is provided while integrally surrounding the film portion.

The stent 20, 30 according to these other embodiments has a plurality of parallel straight lines to support the film portions 222, 322, 342 between the expandable stents 214, 234, 314, 334, 354. The supportable stent portions 224, 324, and 344 of the same material (hereinafter, the same material as the expandable stent portion) having a supporting structure may be followed.

In other words, in the case of the stent 20 according to the embodiment shown in FIG. 6, two expandable stent parts 214 and 234 are provided at regular intervals, and both ends of the expandable stent parts 214 and 234 are provided. And a first region 21 and a third region 23 composed of film portions 212 and 232 surrounding them. For reference, in FIG. 6, for convenience of description, the film portions 212 and 232 are displayed in dotted lines and the transparent stent portions 214 and 234 inside the film portions 212 and 232 are projected in a transparent state. Shown to be visible.

In addition, the intermediate second region 22 may be composed of only the film part 222 positioned between the two expandable stent parts 214 and 234, and a plurality of parallel parts may be used to support the film part 222. It may further include a support stent 224 of the same material having a straight support structure.

In the case of the stent 10 of FIGS. 1 to 4, the expandable stent portion 14 may relatively firmly support the blood vessel wall BB, but has a disadvantage in that a large amount of material to be decomposed. Therefore, as in the case of the stent 20 as shown in FIG. 6, a supportive stent part having a structure that is capable of supporting at least the film part 222 for drug delivery while having a small amount of material to be decomposed ( 224) provides the advantage of reducing the amount of material to be released into the blood when the stent 20 disintegrates after drug delivery is complete.

Similarly, the stent 30 according to the embodiment shown in FIG. 7 is provided with a plurality of expandable stent portions 314, 334, and 354 at regular intervals, and in FIG. 7, three expandable stent portions for convenience of illustration. 314, 334, 354 are provided. The stent 30 of FIG. 7 has a structure similar to a beads, and the first region 31, the third region 33, and the fifth region 35 are expandable stent portions 314 and 334, respectively. 354 has a structure provided with film portions 312, 332, 352 surrounding the outside, for example a coated structure, while the second region 32 and the fourth region 34 therebetween are each film It may be composed only of the portions 322, 342, and in order to support the film portions 322, 342, a supportive stent portion 324, 344 of the same material having a plurality of parallel straight-line support structures is further added. It may include.

As such, when the supportable stent parts 324 and 344 are further included, the expandable stent parts 314, 334 and 354 and the supportable stent parts 324 and 344 are alternately disposed. By constructing the stent 30 as described above, it is possible to provide a biodegradable stent having a biodegradable drug delivery film that can be applied to long blood vessels while having an adaptive structure suitable for blood vessel shape.

For reference, in FIG. 7, the film parts 312, 332, and 352 are displayed in a dotted line for the convenience of explanation, and the inside of the expandable stent part 314 inside the film parts 312, 332, and 352 is transparent. 334, 354) is shown to be visible.

As mentioned above, although this invention was demonstrated to the said Example, this invention is not limited to this. Those skilled in the art can make modifications and changes without departing from the spirit and scope of the present invention, and it will be appreciated that such modifications and changes also belong to the present invention.

Claims (11)

  1. It includes a plurality of elastic struts arranged radially expandable and connected in a zigzag form, and a plurality of elastic strut joints connecting the plurality of elastic struts in a longitudinal direction and extending in a radial direction, and in the lumen or blood vessel of the human body The cylindrical expandable stent part is open at both ends of the biodegradable material that is decomposed after a certain period of time in,
    Biodegradable having a biodegradable drug delivery film provided surrounding the expandable stent portion and formed with a plurality of micro holes and a film portion made of a biodegradable material that decomposes within a shorter time period than the expandable stent portion is decomposed Stent.
  2. The method of claim 1,
    The film portion is a biodegradable biodegradable drug delivery film having a rapamycin (Rapamycin) -based drug for treating vascular damage caused by expansion of the expandable stent in the blood vessel and prevent restenosis is supported Stent stent.
  3. The method according to claim 1 or 2,
    The film portion of the biodegradable stent having a biodegradable drug delivery film, characterized in that a plurality of micro holes formed on the cylindrical base film of a thin film.
  4. The method of claim 3,
    The base film has a ductility and has a biodegradable drug delivery film, characterized in that it extends in the radial direction as the expandable stent portion extends in the radial direction, but has a property that does not return to its original shape once stretched. Biodegradable Stents.
  5. The method according to claim 1 or 2,
    The film portion is provided in a multi-layer (multi-layer) on the surface of the expandable stent portion biodegradable stent having a biodegradable drug delivery film, characterized in that to continuously and continuously deliver a variety of drugs.
  6. The method of claim 1,
    Biodegradable stent having a biodegradable drug delivery film, characterized in that the expandable stent portion can be loaded with a steroid (Steroid) -based drugs for preventing abnormal cell proliferation in blood vessels.
  7. The method of claim 1,
    The stretchable strut of the expandable stent portion is biodegradable stent having a biodegradable drug delivery film, characterized in that configured to be stretchable in the radial direction but not in the longitudinal direction.
  8. The method of claim 6,
    The biodegradable stent having a biodegradable drug delivery film, characterized in that the steroid (Steroid) -based drug is applied to the surface of the expandable stent portion by spraying or loaded into a slot formed in the stretched strut.
  9. The method according to claim 6 or 7,
    A biodegradable stent having a biodegradable drug delivery film, characterized in that the plurality of expandable stents are provided at regular intervals and provided with a plurality of expandable stents arranged at regular intervals surrounding the film portion.
  10. The method of claim 9,
    At least one side of the expandable stent portion biodegradable stent having a biodegradable drug delivery film, characterized in that the supportive stent portion having a plurality of parallel linear support structure for supporting the film portion.
  11. The method of claim 10,
    Biodegradable stent having a biodegradable drug delivery film, characterized in that the expandable stent portion and the supportable stent portion are alternately disposed.
PCT/KR2012/009527 2011-11-14 2012-11-12 Biodegradable stent including film for delivering biodegradable drugs WO2013073806A1 (en)

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WO2020197262A1 (en) * 2019-03-25 2020-10-01 의료법인 성광의료재단 Fibrosis-inducing drug-eluting stent for blocking electric conduction

Citations (4)

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Publication number Priority date Publication date Assignee Title
JPH11299901A (en) * 1998-04-16 1999-11-02 Johnson & Johnson Medical Kk Stent and its manufacture
KR20070044223A (en) * 2005-10-24 2007-04-27 사회복지법인 삼성생명공익재단 Vascular stent which is specially designed for the multiple drug loading and better drug elution
KR20080031842A (en) * 2006-10-06 2008-04-11 코디스 코포레이션 Bioabsorbable device having encapsulated additives for accelerating degradation
US20090012595A1 (en) * 2003-12-15 2009-01-08 Dror Seliktar Therapeutic Drug-Eluting Endoluminal Covering

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Publication number Priority date Publication date Assignee Title
US7942920B2 (en) 2003-02-25 2011-05-17 Cordis Corporation Stent with nested fingers for enhanced vessel coverage

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11299901A (en) * 1998-04-16 1999-11-02 Johnson & Johnson Medical Kk Stent and its manufacture
US20090012595A1 (en) * 2003-12-15 2009-01-08 Dror Seliktar Therapeutic Drug-Eluting Endoluminal Covering
KR20070044223A (en) * 2005-10-24 2007-04-27 사회복지법인 삼성생명공익재단 Vascular stent which is specially designed for the multiple drug loading and better drug elution
KR20080031842A (en) * 2006-10-06 2008-04-11 코디스 코포레이션 Bioabsorbable device having encapsulated additives for accelerating degradation

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