CA2080876A1 - Use of a stent with the capability to inhibit malignant growth in a vessel such as a biliary duct - Google Patents

Use of a stent with the capability to inhibit malignant growth in a vessel such as a biliary duct

Info

Publication number
CA2080876A1
CA2080876A1 CA2080876A CA2080876A CA2080876A1 CA 2080876 A1 CA2080876 A1 CA 2080876A1 CA 2080876 A CA2080876 A CA 2080876A CA 2080876 A CA2080876 A CA 2080876A CA 2080876 A1 CA2080876 A1 CA 2080876A1
Authority
CA
Canada
Prior art keywords
stent
vessel
radioisotope
wall
malignant cells
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.)
Abandoned
Application number
CA2080876A
Other languages
French (fr)
Inventor
Robert E. Fischell
Tim A. Fischell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2080876A1 publication Critical patent/CA2080876A1/en
Abandoned legal-status Critical Current

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
    • A61F2/82—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
    • 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
    • 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
    • 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
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/44—Radioisotopes, radionuclides
    • 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
    • A61N2005/1085—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy characterised by the type of particles applied to the patient
    • A61N2005/1089—Electrons

Abstract

USE OF A STENT WITH THE CAPABILITY TO INHIBIT
MALIGNANT GROWTH IN A VESSEL SUCH AS A BILIARY DUCT
ABSTRACT
A stent to inhibit malignant growth in a vessel is provided and includes a tubular structure whose external surface is adapted to engage the wall of a human vessel. The stent is patent throughout its entire interior length and is formed from a radioactive material which is radially expandable after insertion into the vessel of the human body.
The radioactive material is adapted to be imbedded into the vessel wall so that the radioactive material emits radiation that reduces the proliferation of malignant cells in the vessel wall that are in close proximity to the stent while simultaneously maintaining vessel patency.

Description

2 Q~ 6 USE OF A Sl'ENT WITH THE CAPABILIT~ TO INH-IBIT
MALIGNANT GROWTH IN A VESSEL SUCH AS A BILIARY DUCT

This invention is in the field of cancer treatment, specifically, a new method to open a vessel of the human body while simultaneously decreasing the growth rate of mal;gnant cells in that vessel, such as the bile duct and thereby maintain its patency.
BACKGROUND OF T~IE INV~NTION

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 Tirn A.. Fischell entitled "Intravascular Stent and Percutaneous Insertion ~atheter System for the Dilation of an Arterial Stenosis and the Prevention of Restenosis" which is incorporated herein by reference. Although an anti-thrombogenic coating can prevent acute thrombotic arterial closure and decrease the need for anticoagulant drug therapy, there is still an urgent need to decrease restenosis which is caused by intimal hyperplasia. Similarly, stents have been used in the bile duct of patients with liver cancer to maintain duct patency.
However, malignant cells soon grow through the stent and close the bile duct or severely impede its function.

SUMMARY OF THE INVENTION

It is well known that radiation therapy can reduce the proliferation of rapidly 2 ~ 7 ~

growingcancer cells in a malignant tumor. The present inYention utilizes a radioisotope which is integral to a stent which can irradiate the tissue in close proximity to the implantation site of the stent in order to reduce the rapid malignant cell growth in a vessel, such as a bile duct while simultaneously rnaintaining vessel patency.

BRIEF DESCRIPTION OF THE DRAWINCiS
:
FI(~. 1 is a cross section showing two turns of a radioisotope ~helical coil spring stent imbedded into a human vessel, such as the bile duct.
, FIG. 2 is a cross section through the spring wire of a helical coil spring stent 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.

D~TAILED DESCRIPTION OF THE DRAWINGS

As described in U.S. Patent No. 4,768,507, ;ntra-arterial stents can be made in the form of a deployable helical coil spring. FIGS. 5 and 6 of the 4,768,507 patent illustrate typical cross sections of such a spring wire, helical coil stent.

FI(3. 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 malignant cells (M) in bile duct ~BD). The arrows 12 pointing outward from the cross section 10 indicate the omnidirectional emission of particles from the stent wire. The purpose of this radiation is to decrease the rate of malignant cell growth of the bile duct (BD). Thus it would be expected that closure of the bile duct, which frequently occurs after stent implantation, will be signi~lcantly reduced.

~he radioisotope used for this purpose rnay be an alpha, beta or gamma emitter. The half-life would ideally be between 10 hours and 1000 days. An optimum emitter might be a beta emitting isotope such as vanadium 48 which has a half-life of 16 days and only ~% 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 can 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 stent 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.

8 ~ ~

Although helical coil spring stents have generally been described herein, the concept of utilizing a radioactive material within the stent's structure so as to attenuate malignant cell growth in a vessel, such as a bile duct is certainly applicable to any stent design.
Furthermore, the temporary placement at the site of the bile duct of a radioactive source within the lurmen of the bile duct, 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 'oe practiced otherwise than as specifically described herein.

Claims (11)

What is claimed is:
1. A stent comprising a generally tubular structure whose external surface is adapted to engage the wall of a human vessel, said stent being patent throughout its entire interior length and being formed from a radioactive material which is outwardly, radially expandable after insertion into a vessel of the human body, the radioactive material being adapted to be imbedded into the vessel wall so that the radioactive material preferentially emits radiation that can reduce the proliferation of malignant cells in the vessel wall that are in close proximity to said stent while simultaneously maintaining vessel patency.
2. The stent of claim 1 in which the radioactive material emitting the radiationis a radioisotope.
3. The stent of claim 2 in which said radioisotope is integrally formed within the structural material of said generally tubular structure of the stent.
4. The stent of claim 2 in which said radioisotope is plated onto said generallytubular structure of the stent.
5. The stent of claim 2 in which said radioisotope is a beta particle emitting radioisotope.
6. A stent comprising a generally tubular, thin-walled structure adapted to be expanded radially outward against the wall of a vessel in a human body at least part of said stent being formed from a radioisotope material which is radially expandable, said radioisotope material being adapted to be imbedded into the vessel wall and further being adapted to decrease the rate of growth of the malignant cells while simultaneously maintaining vessel patency.
7. The stent of claim 6 in which said radioisotope has a half-life of less than 1000 days.
8. A method to simultaneously decrease growth of malignant cells in a vessel of a living body while maintaining vessel patency the method comprising:

insertion of an expandable stent into the vessel, at least part of said stent being formed from a radioisotope material
9. The method of claim 8 wherein said stent is inserted into a bile duct.
10. The method of claim 8 further comprising the step of excising at least some of the malignant tissue in the bile duct by means of an atherectomy catheter prior to insertion of the stent.
11. A method to simultaneously decrease growth of malignant cells in a vessel of a living body while maintaining vessel patency the method comprising:

percutaneous insertion of a radioisotope source into a vessel by means of a catheter so that it is positioned at the site of the malignant cells, said radioisotope source being formed from a plurality of thin, wire-like, interconnected, radially expandable parts in the form of an expandable stent, radially expanding the radioisotope source so that it becomes imbedded in the vessel; and, removal of the catheter from the vessel.
CA2080876A 1991-10-21 1992-10-19 Use of a stent with the capability to inhibit malignant growth in a vessel such as a biliary duct Abandoned CA2080876A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/779,641 US5176617A (en) 1989-12-11 1991-10-21 Use of a stent with the capability to inhibit malignant growth in a vessel such as a biliary duct
US779,641 1991-10-21

Publications (1)

Publication Number Publication Date
CA2080876A1 true CA2080876A1 (en) 1993-04-22

Family

ID=25117047

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2080876A Abandoned CA2080876A1 (en) 1991-10-21 1992-10-19 Use of a stent with the capability to inhibit malignant growth in a vessel such as a biliary duct

Country Status (3)

Country Link
US (1) US5176617A (en)
EP (1) EP0539165A1 (en)
CA (1) CA2080876A1 (en)

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