CA2031891C - Intra-arterial stent with the capability to inhibit intimal hyperplasia - Google Patents
Intra-arterial stent with the capability to inhibit intimal hyperplasia Download PDFInfo
- Publication number
- CA2031891C CA2031891C CA002031891A CA2031891A CA2031891C CA 2031891 C CA2031891 C CA 2031891C CA 002031891 A CA002031891 A CA 002031891A CA 2031891 A CA2031891 A CA 2031891A CA 2031891 C CA2031891 C CA 2031891C
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- Prior art keywords
- stent
- radioisotope
- artery
- arterial
- radioactive
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- 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
-
- 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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- 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
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
- A61K51/1282—Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0095—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof radioactive
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Dispersion Chemistry (AREA)
- Pathology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Surgery (AREA)
- Medicinal Chemistry (AREA)
- Radiation-Therapy Devices (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Chairs Characterized By Structure (AREA)
- Sorption Type Refrigeration Machines (AREA)
- Jib Cranes (AREA)
- Surgical Instruments (AREA)
- Thermotherapy And Cooling Therapy Devices (AREA)
- Electrotherapy Devices (AREA)
- External Artificial Organs (AREA)
- Materials For Medical Uses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
Abstract
It is well known that radiation therapy can reduce the proliferation of rapidly growing cancer cells in a malignant tumor. The present invention utilizes a radioisotope which is integral to an arterial stent which can irradiate the tissue in close proximity to the implantation site of the stent in order to reduce the rapid tissue growth caused by arterial wall trauma resulting from balloon angloplasty or atherectomy.
Description
INTRA-ARTERIAL STENT WITH THE CAPABILITY TO INHIBIT
INTIMAL HYPERPLASIA
This invention is in the field of intra-arterial stents that are used to maintain patency of an arterial lumen typically subsequent to balloon angioplasty or atherectomy.
BACKGROUND OF THE INVENTION
Since the mid-to late-1980s, intra-arterial stents have found extensive use as a treatment to prevent restenosis subsequent to balloon angioplasty or atherectomy. A
recurrent problem is that excessive tissue growth (intimal hyperplasia) at the site of the balloon dilation or atherectomy plaque excision results in restenosis of the artery.
One possible solution to this problem is to coat the stent with an anti-thrombogenic surface so as to reduce platelet and fibrin deposition. This is described in U.S. Patent No. 4,768,507 issued September 1988, to Robert E. Fischell and Tim A..
Fischell entitled "Intravascular Stent and Percutaneous Insertion Catheter System for the Dilation of an Arterial Stenosis and the Prevention of Restenosis". ich is Although an anti-thrombogenic coating can prevent acute thrombotic arterial closure and decrease the need for anticoagulent drug therapy, there is still an urgent need to decrease restenosis which is caused by intimal hyperplasia.
SUMMARY OF THE INVENTION
It is well known that radiation therapy can reduce the proliferation of rapidly growing cancer cells in a malignant tumor.
In accordance with one aspect of the present invention, a radioactive source is utilized which is integral to an arterial stent which can irradiate the tissue in close proximity to the implantation site of the stmt in order to reduce the rapid tissue growth caused by arterial wall trauma resulting from balloon angioplasty or atherectomy.
In accordance with another aspect of the present invention, a radioactive source is utilized which is provided on a thin wire which temporarily places the radioactive source adjacent a stenotic site within an artery to reduce the proliferation of the growth of cells at the stenotic site.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross section showing two turns of a radioisotope helical coil spring stent imbedded into a balloon dilated or atherectomized plaque within a human artery.
FIG. 2 is a cross section through the spring wire of a helical coil spring stmt showing a radioisotope core material within a spring material.
FIG. 3 is a cross section through the spring wire of a helical coil spring stent showing a thin plating of radioisotope material on the exterior surface.
FIG. 4 is a cross section through a central core spring wire of a helical coil sprang stent showing a radioisotope plating which is covered with an anti-thrombogenic coating.
DETAILED DESCRIPTION OF THE DRAWINGS
As described in U.S. Patent No. 4,768,507, intra-arterial stents can be made in the form of a deployable helical coil spring. FIGS. S and 6 of the 4,768,507 patent illustrate typical cross sections of such a spring wire, helical coil stent.
FIG. 1 of the present invention shows a cross section 10 of two turns of a helical coil spring stent that has been fabricated from a pure metal or alloy which has been irradiated so that it has become radioactive; i.e., it is a radioisotope . These two turns are shown imbedded into plaque P within the arterial wall AW. The arrows pointing outward from the cross section 10 indicate the omnidirectional emission of particles from the stmt wire. The purpose of this radiation is to decrease the rate of proliferative cell growth of the traumatized arterial wall AW (which growth is termed "intimal hyperplasia"). Thus it would be expected that restenosis, which frequently occurs after stent implantation, will be significantly reduced.
The radioisotope used for this purpose may be an alpha, beta or gamma emitter. The half-life would ideally be between 10 hours and 100 days. An optimum emitter might be a beta emitting isotope such as vanadium 48 which has a half-life of lb days and only 8% of its emitted energy is from gamma radiation. The ideal attribute of a beta emitter is that the radiation does not travel very far in human tissue. Thus only the tissue in close proximity to the radioisotope stent will be affected. Furthermore only moderate levels of radiation are desired since it is known that very high levels can cause injury to nonproliferating tissues.
Another method to make the material of the stent spring wire is from a metal into which is alloyed an element that c:an be made into a radioisotope. For example, phosphorus 32, a 14.3 day half-life beta emitter, could be alloyed into steel which could be used for the stent wire.
FIG. 2 shows a stmt wire cross section in which a wire made from a radioisotope core material 20 is formed within an outer covering 22 that has the attributes that are desirable for being a coil spring stent.
FIG. 3 shows a cross section of an alternative embodiment of the present invention in which a radioisotope coating 30 is plated onto a spring material core 32.
For example, the beta emitting isotope gold 198 (half life 2.7 days) could be used to coat any suitable spring metal material.
FIG. 4 shows a more complex stmt cross section in which a core 40 of some material ideally suited for stents is plated with a radioisotope coating 42 which is, in turn, coated with an anti-thrombogenic coating 42 such as carbon as described in U.S. Patent No. 4,768,507.
INTIMAL HYPERPLASIA
This invention is in the field of intra-arterial stents that are used to maintain patency of an arterial lumen typically subsequent to balloon angioplasty or atherectomy.
BACKGROUND OF THE INVENTION
Since the mid-to late-1980s, intra-arterial stents have found extensive use as a treatment to prevent restenosis subsequent to balloon angioplasty or atherectomy. A
recurrent problem is that excessive tissue growth (intimal hyperplasia) at the site of the balloon dilation or atherectomy plaque excision results in restenosis of the artery.
One possible solution to this problem is to coat the stent with an anti-thrombogenic surface so as to reduce platelet and fibrin deposition. This is described in U.S. Patent No. 4,768,507 issued September 1988, to Robert E. Fischell and Tim A..
Fischell entitled "Intravascular Stent and Percutaneous Insertion Catheter System for the Dilation of an Arterial Stenosis and the Prevention of Restenosis". ich is Although an anti-thrombogenic coating can prevent acute thrombotic arterial closure and decrease the need for anticoagulent drug therapy, there is still an urgent need to decrease restenosis which is caused by intimal hyperplasia.
SUMMARY OF THE INVENTION
It is well known that radiation therapy can reduce the proliferation of rapidly growing cancer cells in a malignant tumor.
In accordance with one aspect of the present invention, a radioactive source is utilized which is integral to an arterial stent which can irradiate the tissue in close proximity to the implantation site of the stmt in order to reduce the rapid tissue growth caused by arterial wall trauma resulting from balloon angioplasty or atherectomy.
In accordance with another aspect of the present invention, a radioactive source is utilized which is provided on a thin wire which temporarily places the radioactive source adjacent a stenotic site within an artery to reduce the proliferation of the growth of cells at the stenotic site.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross section showing two turns of a radioisotope helical coil spring stent imbedded into a balloon dilated or atherectomized plaque within a human artery.
FIG. 2 is a cross section through the spring wire of a helical coil spring stmt showing a radioisotope core material within a spring material.
FIG. 3 is a cross section through the spring wire of a helical coil spring stent showing a thin plating of radioisotope material on the exterior surface.
FIG. 4 is a cross section through a central core spring wire of a helical coil sprang stent showing a radioisotope plating which is covered with an anti-thrombogenic coating.
DETAILED DESCRIPTION OF THE DRAWINGS
As described in U.S. Patent No. 4,768,507, intra-arterial stents can be made in the form of a deployable helical coil spring. FIGS. S and 6 of the 4,768,507 patent illustrate typical cross sections of such a spring wire, helical coil stent.
FIG. 1 of the present invention shows a cross section 10 of two turns of a helical coil spring stent that has been fabricated from a pure metal or alloy which has been irradiated so that it has become radioactive; i.e., it is a radioisotope . These two turns are shown imbedded into plaque P within the arterial wall AW. The arrows pointing outward from the cross section 10 indicate the omnidirectional emission of particles from the stmt wire. The purpose of this radiation is to decrease the rate of proliferative cell growth of the traumatized arterial wall AW (which growth is termed "intimal hyperplasia"). Thus it would be expected that restenosis, which frequently occurs after stent implantation, will be significantly reduced.
The radioisotope used for this purpose may be an alpha, beta or gamma emitter. The half-life would ideally be between 10 hours and 100 days. An optimum emitter might be a beta emitting isotope such as vanadium 48 which has a half-life of lb days and only 8% of its emitted energy is from gamma radiation. The ideal attribute of a beta emitter is that the radiation does not travel very far in human tissue. Thus only the tissue in close proximity to the radioisotope stent will be affected. Furthermore only moderate levels of radiation are desired since it is known that very high levels can cause injury to nonproliferating tissues.
Another method to make the material of the stent spring wire is from a metal into which is alloyed an element that c:an be made into a radioisotope. For example, phosphorus 32, a 14.3 day half-life beta emitter, could be alloyed into steel which could be used for the stent wire.
FIG. 2 shows a stmt wire cross section in which a wire made from a radioisotope core material 20 is formed within an outer covering 22 that has the attributes that are desirable for being a coil spring stent.
FIG. 3 shows a cross section of an alternative embodiment of the present invention in which a radioisotope coating 30 is plated onto a spring material core 32.
For example, the beta emitting isotope gold 198 (half life 2.7 days) could be used to coat any suitable spring metal material.
FIG. 4 shows a more complex stmt cross section in which a core 40 of some material ideally suited for stents is plated with a radioisotope coating 42 which is, in turn, coated with an anti-thrombogenic coating 42 such as carbon as described in U.S. Patent No. 4,768,507.
~
Although helical coil spring stents have generally been described herein, the concept of utilizing a radioactive material within the stent structure so as to attenuate intimaI hyperplasia is certainly applicable to any stent design. Furthermore, the temporary placement at the site of the vessel wall trauma of a radioactive source within the arterial lumen, for example a thin wire with a radioactive tip which wire can be withdrawn after a limited time is also envisioned:
~ Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims, the invention may be practiced other<vise than as specifically described herein.
Although helical coil spring stents have generally been described herein, the concept of utilizing a radioactive material within the stent structure so as to attenuate intimaI hyperplasia is certainly applicable to any stent design. Furthermore, the temporary placement at the site of the vessel wall trauma of a radioactive source within the arterial lumen, for example a thin wire with a radioactive tip which wire can be withdrawn after a limited time is also envisioned:
~ Various other modifications, adaptations, and alternative designs are of course possible in light of the above teachings. Therefore, it should be understood at this time that within the scope of the appended claims, the invention may be practiced other<vise than as specifically described herein.
Claims (11)
1. An intra-arterial stent comprising a generally tubular structure whose external surface engages the arterial wall and which is patent throughout its entire interior length, said stent being adapted to be inserted within an artery of a human body at least part of said stent being formed from a radioactive material which emits radiation that can reduce the proliferation of cells in the arterial call that are in close proximity to said stent.
2. The stent of Claim 1 in which the radioactive material emitting the radiation is a radioisotope.
3. The stent of Claim 2 in which said radioisotope is located at the core of said generally tubular structure of the stem.
4. The stent of Claim 2 in which said radioisotope is plated onto said generally tubular structure of the stent.
5. The stent of Claim 2 including an outer coating of anti-thrombogenic material.
6. The stent of Claim 2 in which said radioisotope is a beta particle emitting radioisotope.
7. An intra-arterial stent comprising a generally tubular, thin-walled structure adapted to be expanded radially outward against the wall of an artery in a human body at least part of said stent being formed from a radioisotope material which emits radiation that can reduce the proliferation of cells in close proximity to said stent.
8. The stent of Claim 7 in which said radioisotope has a half-life of less than 100 days.
9. An arterial restenosis prevention device comprising an elongated wire having a radioactive tip inserted into an artery of a human body for temporary placement adjacent a stenotic site within said artery for reducing the proliferation of the growth of cells at said stenotic site.
10. The device of claim 9 wherein the radioisotope tip includes a beta-particle emitter radioisotope.
11. A thin wire-like structure for use in the prevention of restenosis of an artery following arterial trauma, the thin wire-like structure comprising a reversibly slidable radioactive source in the form of a radioactive end portion tip insertable temporarily into the artery at the trauma site and serving when so inserted to prevent restenosis of the artery at the trauma site, wherein said radioactive tip includes a beta-particle emitter radioisotope and emits beta-particles within said artery.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US448,691 | 1989-12-11 | ||
US07/448,691 US5059166A (en) | 1989-12-11 | 1989-12-11 | Intra-arterial stent with the capability to inhibit intimal hyperplasia |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2031891A1 CA2031891A1 (en) | 1991-06-12 |
CA2031891C true CA2031891C (en) | 2000-10-24 |
Family
ID=23781289
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002031891A Expired - Lifetime CA2031891C (en) | 1989-12-11 | 1990-12-10 | Intra-arterial stent with the capability to inhibit intimal hyperplasia |
Country Status (9)
Country | Link |
---|---|
US (1) | US5059166A (en) |
EP (2) | EP0433011B1 (en) |
JP (1) | JP2803366B2 (en) |
AT (2) | ATE108635T1 (en) |
AU (1) | AU624310B2 (en) |
CA (1) | CA2031891C (en) |
DE (2) | DE69010864T2 (en) |
DK (1) | DK0433011T3 (en) |
ES (2) | ES2058822T3 (en) |
Families Citing this family (372)
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US5649977A (en) * | 1994-09-22 | 1997-07-22 | Advanced Cardiovascular Systems, Inc. | Metal reinforced polymer stent |
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1990
- 1990-12-10 CA CA002031891A patent/CA2031891C/en not_active Expired - Lifetime
- 1990-12-11 DK DK90313433.6T patent/DK0433011T3/en active
- 1990-12-11 DE DE69010864T patent/DE69010864T2/en not_active Expired - Lifetime
- 1990-12-11 AT AT90313433T patent/ATE108635T1/en not_active IP Right Cessation
- 1990-12-11 JP JP2409726A patent/JP2803366B2/en not_active Expired - Lifetime
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- 1990-12-11 DE DE69030118T patent/DE69030118T2/en not_active Expired - Fee Related
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- 1990-12-11 EP EP90313433A patent/EP0433011B1/en not_active Expired - Lifetime
- 1990-12-11 EP EP93203354A patent/EP0593136B1/en not_active Revoked
- 1990-12-11 ES ES93203354T patent/ES2097972T3/en not_active Expired - Lifetime
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CA2031891A1 (en) | 1991-06-12 |
EP0593136B1 (en) | 1997-03-05 |
DE69030118T2 (en) | 1997-06-12 |
JP2803366B2 (en) | 1998-09-24 |
ATE108635T1 (en) | 1994-08-15 |
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EP0433011B1 (en) | 1994-07-20 |
JPH04126139A (en) | 1992-04-27 |
EP0433011A1 (en) | 1991-06-19 |
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