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EP0953320A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Medical device

Assignee: Medtronic Inc
•
Filing: 1999-04-30
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Granted: —
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Expires: 2019-04-30
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Abstract

Abstract The invention relates to a medical device useful for the localized delivery of a therapeutic agent having at least one blood-contacting surface comprising a porous material having dispersed therein an elutable therapeutic agent. Preferred devices include a structure including a porous polymeric material and an elutable therapeutic agent in the form of a solid, gel, or neat liquid, which is dispersed in at least a portion of the porous polymeric material. Methods for making a medical device having a blood-contacting surface are also provided. One method includes the use of a concentrating agent whereby to localise the therapeutic agent within the porous material. Another method involves multiple immersion steps without the use of a concentrating agent.

Inventors

  • 👤 Ronald J. Tuch

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 14:10
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/88; A61L; A61L29/00; A61L29/04; A61L29/041; A61L29/044; A61L29/06; A61L29/14; A61L29/145; A61L29/146; A61L29/16; A61L31/00; A61L31/04; A61L31/042; A61L31/043; A61L31/048; A61L31/06; A61L31/08; A61L31/10; A61L31/14; A61L31/145; A61L31/146; A61L31/16; A61F2/95; A61F2/958; A61F2210/00; A61F2210/0004; A61F2240/00; A61F2240/001; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/20; A61L2300/23; A61L2300/236; A61L2300/40; A61L2300/42; A61L2300/432

Claims Analysis

Total Claims: 24
Claim 1
Independent Claim 20 words
A medical device having at least one blood-contacting surface comprising a porous material having dispersed therein an elutable therapeutic agent.
Claim 2
Dependent Claim 47 words
A medical device as claimed in claim 1 having at least one blood-contacting surface comprising: a porous polymeric material; and an elutable therapeutic agent in the form of a solid, gel, or neat liquid, which is dispersed in at least a portion of said porous polymeric material.
Claim 3
Dependent Claim 18 words
A medical device as claimed in claim 1 or claim 2 wherein said porous material comprises a film.
Claim 4
Dependent Claim 22 words
A medical device as claimed in claim 1 or claim 2 wherein said porous material comprises an integral portion of the device.
Claim 5
Dependent Claim 43 words
A medical device as claimed in any one of claims 1 to 4 wherein said porous material is a natural hydrogel, a synthetic hydrogel, silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, or a combination of two or more of these materials.
Claim 6
Dependent Claim 22 words
A medical device as claimed in any one of claims 1 to 5 wherein said porous material comprises a non-swellable biostable polymer.
Claim 7
Dependent Claim 17 words
A medical device as claimed in any preceding claim wherein said therapeutic agent comprises an antithrombotic material.
Claim 8
Dependent Claim 19 words
A medical device as claimed in claim 7 wherein the antithrombotic material is heparin, a heparin derivative or analog.
Claim 9
Dependent Claim 22 words
A medical device as claimed in any of one of claims 1 to 6 wherein said therapeutic agent is a peptidic drug.
Claim 10
Dependent Claim 16 words
A medical device as claimed in any preceding claim having a generally cylindrical or sheet-like shape.
Claim 11
Dependent Claim 18 words
A medical device as claimed in any preceding claim comprising a catheter, a stent, or a guide wire.
Claim 12
Dependent Claim 12 words
A medical device as claimed in claim 11 comprising an intralumenal stent.
Claim 13
Dependent Claim 50 words
An intralumenal stent comprising: a generally cylindrical stent body; and an adherent layer on the stent body comprising a porous polymeric material and an elutable therapeutic agent in the form of a solid, gel, or neat liquid, which is dispersed in at least a portion of the porous polymeric material.
Claim 14
Independent Claim 82 words
A method for making a medical device, said method comprising the steps of: (a) providing a structure comprising a porous material; (b) contacting said structure with a concentrating agent whereby to disperse the concentrating agent throughout at least a portion of the porous material; (c) contacting said structure comprising a porous material and the concentrating agent with a solution of a therapeutic agent; and (d) removing the therapeutic agent from solution within the porous material at the locations of the concentrating agent.
Claim 15
Dependent Claim 33 words
A method as claimed in claim 14 wherein said concentrating agent is selected from the group of a binding agent, a sequestering agent, a nucleating agent, a seed crystal, or a combination thereof.
Claim 16
Dependent Claim 34 words
A method as claimed in claim 14 or claim 15 wherein step (d) is effected by reducing the temperature, changing the pH or changing the ionic strength of the solution of the therapeutic agent.
Claim 17
Independent Claim 77 words
A method for making a medical device, said method comprising the steps of: (a) providing a structure comprising a porous material; (b) immersing said structure in a saturated solution of a therapeutic agent for a sufficient period of time to allow the solution to fill the porous material; (c) removing the structure from the solution; (d) drying the structure; and (e) repeating steps (b) through (d) whereby to provide a therapeutic agent dispersed within the porous material.
Claim 18
Dependent Claim 28 words
A method as claimed in claim 17 further comprising a step of removing air bubbles from the porous material while immersed in the solution of the therapeutic agent.
Claim 19
Dependent Claim 34 words
A method as claimed in claim 18 wherein the step of removing air bubbles from the porous material is effected by applying ultrasonics, reduced pressure, elevated pressure, or a combination thereof, to the solution.
Claim 20
Independent Claim 26 words
A method as claimed in any one of claims 14 to 19 further comprising the step of applying an overlayer of a polymer to said structure.
Claim 21
Independent Claim 42 words
A method as claimed in any one of claims 14 to 20 wherein said porous material is a natural hydrogel, a synthetic hydrogel, silicone, polyurethane, polysulfone, cellulose, polyethylene, polypropylene, polyamide, polyester, polytetrafluoroethylene, or a combination of two or more of these materials.
Claim 22
Independent Claim 20 words
A method as claimed in any one of claims 14 to 21 wherein said therapeutic agent is an antithrombotic material.
Claim 23
Dependent Claim 17 words
A medical device obtainable by a process as claimed in any one of claims 14 to 22.
Claim 24
Dependent Claim 18 words
A substrate having at least one blood-contacting surface as defined in any one of claims 1 to 9.

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