GB2346559A - Endoluminal stent - Google Patents
Endoluminal stent Download PDFInfo
- Publication number
- GB2346559A GB2346559A GB9930534A GB9930534A GB2346559A GB 2346559 A GB2346559 A GB 2346559A GB 9930534 A GB9930534 A GB 9930534A GB 9930534 A GB9930534 A GB 9930534A GB 2346559 A GB2346559 A GB 2346559A
- Authority
- GB
- United Kingdom
- Prior art keywords
- core
- agents
- therapeutic agent
- lining
- endoluminal stent
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Abstract
An endoluminal stent has a core 1 such as stainless steel which has an expandable capability through the provision of slits which form interstices 1a after assisted or self-expansion following which the core is sufficiently rigid to support the vessel into which it is inserted. The core 1 is shown here in a partially expanded. The core 1 has an outer covering 2 of a material such as Dacron or PTFE which is coated on surface with an agent or agents such as collagen or gelatin, in order to decrease the material porosity and enhance incorporation into surrounding tissues. This coating in itself may be bonded with or incorporate a therapeutic agent or agents such as Heparin or an antibiotic. Internally the core 1 includes a lining 3 of a material similar to the outer covering layer and this may also be coated with an agent or agents such as collagen or gelatin, in order to decrease the material porosity and enhance incorporation into surrounding tissues. The outer covering and the lining are joined around the ends of the core. The stent thus provides smoothed blood flow as well as reducing re-stenosis due to muscle cell growth as well as offering a means for long term delivery of a therapeutic agent.
Description
2346559 TITLE Endoluminall Stent This invention relates to an improved
construction of an endoluminal stent, such devices being used for example, to hold open blood vessels dilated by angioplasty, particularly blood vessels having a higher flow, such as the iliac arteries. However, endoluminal stent devices may be deployed elsewhere in the mammalian body (usually human) for example, along the length of the gut, the bile duct, the pancreatic duct or the urethra. Such devices usually comprise io a tubular cage structure which is inserted collapsed into a blood vessel, or other tubular structure, and thereafter expanded using a balloon catheter or using the self-expanding properties of the alloy from which it is constructed, for example. Stent devices having an open lattice structure are used normally with the lattices providing for expansion of the stent after insertion. A disadvantage of such constructions, however, is that the interstices allow for smooth muscle cell growth to invade through the stent, thus once again blocking the lumen.
To help counter this effect, it has been proposed previously to provide a form of covering over the stent in order to "close-off 'the interstices.
Thus, it has been proposed for example, to provide a stent device which is embedded completely within a PTFE covering and whereby the covering yields and expands with the stent itself when deployed.
One of the objects of this invention is to provide an endoluminal stent giving an improved blood flow and longer in s Wt therapeutic life.
A further and preferred object of this invention is to provide a stent which is 2 capable of delivering a therapeutic agent or agents over a period of time. Such an agent might be directed specifically at preventing the growth of smooth muscle cells locally.
In a preferred embodiment this invention seeks to provide an endoluminal stent giving an improved blood flow over the surface that would, in addition, prevent re-stenosis of the arterial lumen due to the growth of muscle cells through the interstices of said stent. However, growth of cells around the ends of such a stent device would still not be prevented and which, in turn, may cause a re-stenosis of the lumen.
Broadly, and in accordance with a first aspect of this invention, there is provided an endoluminal stent having a rigid or semi-rigid, preferably metallic, self-supporting tubular core which may be expanded outwardly and including an outer expandable, preferably a porous or semi-porous, absorbent or fabric covering and an inner expandable, preferably a porous, absorbent or fabric lining, the covering and the lining being joined or continuous around the ends of the tubular core.
In a modification, and also according to this invention, there is provided a stent with open interstices, that is without the coverings, which interstices are filled with a bio-polymer carrier substance The linings, within and without, may or may not in themselves be covered with a bio-polymer carrier medium for example, collagen or gelatin and may be a fabric material either of a woven or non-woven kind, such as Dacron (a Trade Mark), or an expandable material such as PTFE. Other materials may be used such as polyurethanes.
I I 3 Broadly, and in accordance with a second aspect of this invention, there is provided an endoluminal stent comprising a preferably metallic self- supporting core with a plurality of regularly or irregularly extending slits or cuts running longitudinally along the core whereby the core may be expanded such that the s slits open up to define the interstices with preferably an outer covering of an expandable material provided over the core and an internal expandable lining within the core, one or other or both of said coverings or linings being capable of both part-retaining and permitting diffusion of a therapeutic agent or agents held therein retained in the sifts or interstices of the core, preferably incorporated or lo held within a biologically inert, biodegradable bio-polymer. Said bio- polymer, or similar, holding or incorporating a therapeutic agent or agents in both the metallic framework of the stent device core in addition to being located within the now expanded interstices of the device.
The construction according to a first aspect of this invention thus provides for a covering and lining of a fabric material to be provided preferably on both external and internal surfaces of the stent, thus preventing external intrusion through the interstices of the rigid core as well as improving blood flow through the internal passage formed by the core.
In the second aspect of this invention, provision is made for incorporating a therapeutic agent or agents, with or without a bio-polymer carrier medium, in or between the two coverings such that the agent or agents may be retained in the slits or interstices of the core to be diffused over a period of time following insertion of the stent into a blood vessel or other tubular structure.
The therapeutic agent or agents may be carried, for example, by means of 4 an impregnated Collagen sponge or gel film or the like which may form an additional layer preferably enclosed on both sides by the coverings or linings. Other carriers may be used to hold the therapeutic agent or agents.
Further and preferred features of this invention together with one practical s construction will now be described in the following and by reference to the accompanying drawings, wherein:
Figure 1 shows in side elevation a stent with a part of the core and the outer covering removed for clarity, and Figure 2 shows an end elevation of the stent shown in Figure 1.
Referring to the drawings, the endoluminal stent of this invention includes a core 1 of stainless steel or an alloy such as nitinol which has an expandable capability. The construction is such that after assisted or self-expansion, the core is sufficiently rigid to support the vessel into which it is inserted. The core 1 is shown here in a partially expanded state. Interstices or the spaces between the metal parts are here referenced la.
According to this invention the core 1 has an outer covering 2 of a material such as Dacron or PTFE. Where Dacron material is used, this may be coated on a single surface or both surfaces with an agent or agents such as Collagen or gelatin, in order to decrease the material porosity and enhance incorporation into surrounding tissues. This coating in itself may in turn be bonded with or incorporate a therapeutic agent or agents such as Heparin or an antibiotic.
Internally, the core 1 includes a lining 3 of a similar or other material to the outer covering layer. Where Dacron material is used, this may be coated on a single surface or both surfaces with an agent or agents such as Collagen or I gelatin, in order to decrease the material porosity and enhance incorporation into surrounding tissues. This coating in itself may in turn be bonded with or incorporate a therapeutic agent or agents such as Heparin or an antibiotic.
The outer covering layer may be connected with the inner lining layer at spaced locations by means of suitable glueing, suturing or welding or contact by any other means. At the ends of the stent the covering and lining may also be joined over and around the end of the core by using such means or by using stitching thereby sealing in the metallic core completely. This will provide potential space for retention of an appropriate therapeutic agent or agents ic which may be carded between the interstices of the core 1 and passed through either the outer covering and/or the lining. With such an arrangement a therapeutic agent or agents may be diffused over a period of time into the surrounding arterial wall or if appropriate, into the bloodstream or into the wall of another tubular structure.
It is thus a particular feature of this invention to provide a stent device incorporating a therapeutic agent or agents which is retained within the stent structure, that is within the interstices and/or over the metallic parts, to be diffused into the surrounding arterial wall (or bloodstream if appropriate) during the useful life of the device or part thereof.
The material used to cover the metallic stent core should have certain expansible properties.
In a further embodiment the outer covering 2 and lining 3 may be bonded by means of any substance which holds the coverings together through the interstices in the core 1. In this construction the bonding agent or agents itself 6 may incorporate a required therapeutic agents.
This invention also contemplates a method of treatment of the body and particularly any blood vessel or other tubular or elongate structure, for example a urethra or bile duct or other part of the gastro-intestine tract or uro-genital s tract, which comprises the insertion of an endoluminal stent substantially as hereinbefore disdosed with the stent device incorporating means for retention of a therapeutic agent or agents, the agent or agents being effective on an ongoing basis following insertion of the stent.
According to another aspect of this invention there is provided the use of an lo endoluminal stent substantially as described and disclosed herein for the purpose of administering a therapeutic agent or agents to the flow of blood through a vessel in a mammalian body or other tubular or elongate structure, for example a urethra or bile duct or other part of the gastrointestine tract or urogenital tract.
I 7
Claims (1)
- CLAIMS:1. An endoluminal stent having a rigid or semi-rigid self-supporting tubular core which may be expanded outwardly and including an outer expandable, absorbent or fabric covering and an inner expandable absorbent or fabric lining, the covering and the lining being joined or continuous around the ends of the tubular core.2. An endoluminal stent according to claim 1, wherein the core is metallic io and/or the outer covering is porous or semi-porous and/or the inner lining is porous.3. An endoluminal stent according to claim 1 or 2, wherein the covering and the lining are covered with a bio-polymer carrier medium, preferably Collagen or is gelatin, the covering and the lining being a fabric material either of a woven or non-woven kind or an expandable material such as PTFE or a polyurethane.4. An endoluminal stent according to any preceding claim, wherein the covering and/or the lining incorporate a therapeutic agent or agents.5. An endoluminal stent according to and preceding claim, wherein the core includes interstices facilitating expansion, said interstices holding a therapeutic agent.8 6, An endoluminal stent comprising a metallic self-supporting core with a plurality of regularly or irregularly extending slits or cuts running longitudinally along the core whereby the core may be expanded such that the slits open up to define interstices, the core supporting preferably an outer covering of an expandable material provided over the core and an internal expandable lining within the core, one or other or both of said coverings or linings being capable of both part-retaining and permitting diffusion of a therapeutic agent or agents held therein and/or retained in the slits or interstices of the core.io 7. An endoluminal stent according to claim 6, wherein the therapeutic agent is incorporated or held within a biologically inert, biodegradable bio-polymer, the said bio-polymer, or similar, holding or incorporating a therapeutic agent or agents in both the metallic framework of the stent device core in addition to being located within the expanded interstices of the device.is 8. An endoluminal stent according to claim 6 or 7, wherein the therapeutic agent or agents, with or without a bio-polymer carrier medium, are located in or between the two coverings such that the agent or agents are retained in the slits or interstices of the core to be diffused over a period of time following insertion of the stent into a blood vessel or other tubular structure.9. An endoluminal stent according to any preceding claim 6 to 8, wherein the therapeutic agent or agents are carried by means of an impregnated collagen sponge or gel film or the like which may form an additional layer preferably I I 9 enclosed on both sides by the coverings or linings 10. The use of an endoluminal stent in accordance with any preceding claim or as disclosed herein for the purpose of administering a therapeutic agent or agents to the flow of blood through a vessel in a mammalian body or other tubular or elongate structure, for example a urethra or bile duct or other part of the gastro-intestine tract or uro-genital tract.11. A method of treatment of the body and particularly any blood vessel or other lo tubular or elongate structure, for example a urethra or bile duct or other part of the gastro-intestine tract or uro-genital tract, which method comprises the insertion of an endoluminal stent according to any preceding claim or substantially as hereinbefore disclosed with the stent device incorporating means for retention of a therapeutic agent or agents, the agent or agents being effective on an ongoing basis following insertion of the stent.12. An endoluminal stent substantially as herein described and as illustrated by or with reference to the drawings.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9828592.7A GB9828592D0 (en) | 1998-12-23 | 1998-12-23 | Endoluminal stent |
GBGB9912729.2A GB9912729D0 (en) | 1998-12-23 | 1999-06-01 | Endoluminal stent |
Publications (2)
Publication Number | Publication Date |
---|---|
GB9930534D0 GB9930534D0 (en) | 2000-02-16 |
GB2346559A true GB2346559A (en) | 2000-08-16 |
Family
ID=26314918
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
GB9930534A Withdrawn GB2346559A (en) | 1998-12-23 | 1999-12-23 | Endoluminal stent |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU1879000A (en) |
GB (1) | GB2346559A (en) |
WO (1) | WO2000038590A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023032084A1 (en) * | 2021-09-01 | 2023-03-09 | オリンパス株式会社 | Stent device and stent delivery system |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20070032853A1 (en) | 2002-03-27 | 2007-02-08 | Hossainy Syed F | 40-O-(2-hydroxy)ethyl-rapamycin coated stent |
US6503556B2 (en) | 2000-12-28 | 2003-01-07 | Advanced Cardiovascular Systems, Inc. | Methods of forming a coating for a prosthesis |
CA2382318A1 (en) * | 1999-09-23 | 2001-03-29 | Edwards Lifesciences Corporation | Double layer intraluminal graft |
US6540776B2 (en) | 2000-12-28 | 2003-04-01 | Advanced Cardiovascular Systems, Inc. | Sheath for a prosthesis and methods of forming the same |
BR0103255A (en) * | 2001-05-16 | 2003-05-20 | Christiane Dias Maues | Cylindrical tubular prosthetic device; and prosthetic device with biological cover for drug release; and its intraluminal splitting system |
AUPR560201A0 (en) * | 2001-06-08 | 2001-07-12 | Cocks, Graeme | Stent |
DE10135275A1 (en) * | 2001-07-13 | 2003-01-30 | Jotec Gmbh | Implant and process for its manufacture |
US6675809B2 (en) | 2001-08-27 | 2004-01-13 | Richard S. Stack | Satiation devices and methods |
US7083822B2 (en) * | 2002-04-26 | 2006-08-01 | Medtronic Vascular, Inc. | Overlapping coated stents |
US7029495B2 (en) | 2002-08-28 | 2006-04-18 | Scimed Life Systems, Inc. | Medical devices and methods of making the same |
US20050118344A1 (en) | 2003-12-01 | 2005-06-02 | Pacetti Stephen D. | Temperature controlled crimping |
US7854756B2 (en) | 2004-01-22 | 2010-12-21 | Boston Scientific Scimed, Inc. | Medical devices |
US8216299B2 (en) | 2004-04-01 | 2012-07-10 | Cook Medical Technologies Llc | Method to retract a body vessel wall with remodelable material |
US20060020329A1 (en) * | 2004-05-26 | 2006-01-26 | Medtronic Vascular, Inc. | Semi-directional drug delivering stents |
US20070208409A1 (en) * | 2006-03-01 | 2007-09-06 | Boston Scientific Scimed, Inc. | Flexible stent-graft devices and methods of producing the same |
US7737060B2 (en) * | 2006-03-31 | 2010-06-15 | Boston Scientific Scimed, Inc. | Medical devices containing multi-component fibers |
US7846199B2 (en) | 2007-11-19 | 2010-12-07 | Cook Incorporated | Remodelable prosthetic valve |
US9205177B2 (en) | 2009-03-04 | 2015-12-08 | Peytant Solutions, Inc. | Stents modified with material comprising amnion tissue and corresponding processes |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5334201A (en) * | 1993-03-12 | 1994-08-02 | Cowan Kevin P | Permanent stent made of a cross linkable material |
WO1995029647A2 (en) * | 1994-04-29 | 1995-11-09 | Scimed Life Systems, Inc. | Stent with collagen |
WO1996000103A1 (en) * | 1994-06-27 | 1996-01-04 | Endomed, Inc. | Radially expandable polytetrafluoroethylene and expandable endovascular stents formed therewith |
EP0792627A2 (en) * | 1994-06-08 | 1997-09-03 | Cardiovascular Concepts, Inc. | System for endoluminal graft placement |
US5735892A (en) * | 1993-08-18 | 1998-04-07 | W. L. Gore & Associates, Inc. | Intraluminal stent graft |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0853465A4 (en) * | 1995-09-01 | 1999-10-27 | Univ Emory | Endovascular support device and method of use |
ZA9710342B (en) * | 1996-11-25 | 1998-06-10 | Alza Corp | Directional drug delivery stent and method of use. |
-
1999
- 1999-12-23 WO PCT/GB1999/004388 patent/WO2000038590A1/en active Application Filing
- 1999-12-23 GB GB9930534A patent/GB2346559A/en not_active Withdrawn
- 1999-12-23 AU AU18790/00A patent/AU1879000A/en not_active Abandoned
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5334201A (en) * | 1993-03-12 | 1994-08-02 | Cowan Kevin P | Permanent stent made of a cross linkable material |
US5735892A (en) * | 1993-08-18 | 1998-04-07 | W. L. Gore & Associates, Inc. | Intraluminal stent graft |
WO1995029647A2 (en) * | 1994-04-29 | 1995-11-09 | Scimed Life Systems, Inc. | Stent with collagen |
EP0792627A2 (en) * | 1994-06-08 | 1997-09-03 | Cardiovascular Concepts, Inc. | System for endoluminal graft placement |
WO1996000103A1 (en) * | 1994-06-27 | 1996-01-04 | Endomed, Inc. | Radially expandable polytetrafluoroethylene and expandable endovascular stents formed therewith |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2023032084A1 (en) * | 2021-09-01 | 2023-03-09 | オリンパス株式会社 | Stent device and stent delivery system |
Also Published As
Publication number | Publication date |
---|---|
WO2000038590A1 (en) | 2000-07-06 |
AU1879000A (en) | 2000-07-31 |
GB9930534D0 (en) | 2000-02-16 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
WAP | Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1) |