Patent US5674192A successfully refreshed from Google Patents.
US5674192A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Drug delivery
Assignee: Boston Scientific Scimed Inc
•
Filing: 1993-07-23
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Granted: 1997-10-07
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Expires: 2013-07-23
Abstract
Abstract The invention features a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. The catheter is constructed for insertion in a body lumen and has a catheter shaft and an expandable portion mounted on the catheter shaft. The expandable portion is expandable to a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen. In one embodiment, at least a portion of the exterior surface of the expandable portion is defined by a coating of a tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is an aqueous solution of a preselected drug to be delivered to the tissue or plaque. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of the drug from the hydrogel polymer coating during compression of the hydrogel polymer coating against the wall of the lumen when the expandable portion is expanded. In other embodiments the polymer is released from the expandable portion in response to pressure, to coat the wall of the body lumen.
Inventors
- 👤 Ronald A. Sahatjian
- 👤 James J. Barry
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 14:11
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61F; A61F2/00; A61F2/82; A61F2/86; A61F2/90; A61K; A61K38/00; A61K38/16; A61K38/43; A61K38/46; A61K38/48; A61K38/49; A61K48/00; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61L; A61L29/00; A61L29/08; A61L29/085; A61L29/14; A61L29/145; A61L29/16; A61L31/00; A61L31/08; A61L31/10; A61L31/14; A61L31/145; A61L31/16; A61L33/00; A61L33/0005; A61L33/0011; A61L33/0023; A61L33/0029; A61M16/00; A61M16/04; A61M16/0475; A61M16/0477; A61M16/0481; A61M25/0043; A61M25/0045; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0013; A61F2250/00; A61F2250/0058; A61F2250/0067; A61L2300/00; A61L2300/20; A61L2300/252; A61L2300/256; A61L2300/258; A61L2300/40; A61L2300/416; A61L2300/42; A61L2300/45; A61L2300/60; A61L2300/602; A61L2300/606; A61L2300/62; A61L2300/622; A61M2025/0046; A61M2025/0057; A61M25/01; A61M25/09; A61M2025/09175; A61M2025/09183; A61M2025/1043; A61M2025/105; A61M2025/1086; A61M2205/00; A61M2205/02; A61M2205/0266
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
312 words
A method of gene therapy comprising: rapidly delivering a dose of a preselected nucleic acid drug to tissue at a desired location deep within the body while simultaneously maintaining pressure on said tissue at said location, by: providing a catheter having a catheter shaft constructed for delivery deep into the body by urging from a proximal end an expandable portion mounted on said catheter shaft, said expandable portion being expandable in response to controlled expansion pressure to engage the tissue, at least a portion of the exterior surface of the expandable portion being defined by a coating of a swellable hydrogel polymer having said nucleic acid drug incorporated therein, said hydrogel polymer selected to cause the coating to reach a characteristic swollen state thicker than the thickness of the coating in its dry state as a result of absorption of fluid, and, when in said swollen state, said coating being compressible, in response to compressive pressure from said expandable portion to introduce an effective portion of said drug into said tissue while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid drug into cells at said location occurs, preparing said expandable portion by introducing said nucleic acid to said hydrogel polymer coating, positioning said expandable portion with said hydrogel coating in a pre-swollen state deep in the body at the point of desired nucleic acid drug application, transfecting said nucleic acid drug into cells at said location by expanding said expandable portion to cause immediate delivery of said nucleic acid drug by forcing said hydrogel polymer coating against the tissue for a brief interval, during which said dose of said nucleic acid is rapidly delivered to said tissue while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid into cells at said location occurs, contracting said expandable portion, and removing said catheter from said body lumen.
Claim 2
Independent Claim
312 words
A method of gene therapy comprising: rapidly delivering a dose of a preselected nucleic acid drug to tissue at a desired location deep within the body while simultaneously maintaining pressure on said tissue at said location, by: providing a catheter having a catheter shaft constructed for delivery deep into the body by urging from a proximal end an expandable portion mounted on said catheter shaft, said expandable portion being expandable in response to controlled expansion pressure to engage the tissue, at least a portion of the exterior surface of the expandable portion being defined by a coating of a swellable hydrogel polymer having said nucleic acid drug incorporated therein, said hydrogel polymer selected to cause the coating to reach a characteristic swollen state thicker than the thickness of the coating in its dry state as a result of absorption of fluid, and, when in said swollen state, said coating being compressible, in response to compressive pressure from said expandable portion to introduce an effective portion of said drug into said tissue while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid drug into cells at said location occurs, preparing said expandable portion by introducing said nucleic acid to said hydrogel polymer coating, positioning said expandable portion with said hydrogel coating in a pre-swollen state deep in the body at the point of desired nucleic acid drug application, transfecting said nucleic acid drug into cells at said location by expanding said expandable portion to cause immediate delivery of said nucleic acid drug by forcing said hydrogel polymer coating against the tissue for a brief interval, during which said dose of said nucleic acid is rapidly delivered to said tissue while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid into cells at said location occurs, contracting said expandable portion, and removing said catheter from said body lumen.
Claim 3
Dependent Claim
14 words
The method of claim 1, wherein said nucleic acid drug is naked nucleic acid.
Claim 4
Dependent Claim
14 words
The method of claim 1, wherein said nucleic acid drug encodes an anti-proliferative agent.
Claim 5
Dependent Claim
17 words
The method of claim 3, wherein said nucleic acid drug binds to the coding region of c-myb.
Claim 6
Dependent Claim
14 words
The method of claim 1, wherein said nucleic acid drug encodes a thrombolytic agent.
Claim 7
Dependent Claim
25 words
The method of claim 5 wherein said nucleic acid drug encodes a member from the group consisting of urokinase, pro-urokinase, streptokinase and tissue plasminogen activator.
Claim 8
Dependent Claim
13 words
The method of claim 5 wherein said thrombolytic drug is tissue plasminogen activator.
Claim 9
Dependent Claim
19 words
The method of claim 1 wherein said drug is a mixture of nucleic acids encoding thrombolytic and anti-proliferative agent.
Claim 10
Dependent Claim
19 words
The method of claim 1 wherein said nucleic acid drug is delivered as a mixture with an anti-thrombogenic drug.
Claim 11
Dependent Claim
19 words
The method of claim 1, wherein said nucleic acid drug is a nucleic acid incorporated in a viral vector.
Claim 12
Dependent Claim
17 words
The method of claim 1 wherein said nucleic acid drug viral vector is a retrovirus or adenovirus.
Claim 13
Dependent Claim
14 words
The method of claim 1 wherein said nucleic acid drug is incorporated in liposome.
Claim 14
Dependent Claim
14 words
The method of claim 1 wherein said nucleic acid drug is an antisense oligonucleotide.
Claim 15
Dependent Claim
14 words
The method of claim 1 wherein said drug is in the form of microparticles.
Claim 16
Dependent Claim
12 words
The method of claim 1 wherein said drug is an encapsulated microparticle.
Claim 17
Dependent Claim
46 words
The method of claim 1 further comprising positioning said expandable portion at a point of occlusion in a vascular lumen and expanding said expandable portion at pressures sufficient to simultaneously dilate said vessel and deliver said nucleic acid drug by compression of said hydrogel polymer coating.
Claim 18
Dependent Claim
25 words
The method of claim 1 wherein said expandable portion is a dilatation balloon expandable to pressures in the range of about 1 to 20 atmospheres.
Claim 19
Dependent Claim
18 words
The method of claim 1 further comprising delivering 20% or more of said drug solution during said compression.
Claim 20
Dependent Claim
21 words
The method of claim 1 comprising delivering said drug in about ten minutes or less and thereafter constructing the expandable portion.
Claim 21
Dependent Claim
17 words
The method of claim 1 including applying heat to said polymer to control the rate of administration.
Claim 22
Dependent Claim
13 words
The method of claim 1 wherein said expandable portion is an inflatable balloon.
Claim 23
Independent Claim
132 words
A method of gene therapy comprising: rapidly delivering a dose of a preselected nucleic acid drug to tissue at a desired location within the body while simultaneously maintaining pressure on said tissue at said location, by: providing a catheter having a catheter shaft constructed for delivery into the body and an expandable balloon attached to the shaft; inserting the catheter into the body, until said expandable balloon is positioned at the location of desired nucleic acid drug application, expanding the balloon until it contacts tissue at said location; delivering said dose of said nucleic acid from the surface of the balloon, while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid into cells at said location occurs, contracting said expandable balloon and removing said catheter from said body lumen.
Claim 24
Independent Claim
132 words
A method of gene therapy comprising: rapidly delivering a dose of a preselected nucleic acid drug to tissue at a desired location within the body while simultaneously maintaining pressure on said tissue at said location, by: providing a catheter having a catheter shaft constructed for delivery into the body and an expandable balloon attached to the shaft; inserting the catheter into the body, until said expandable balloon is positioned at the location of desired nucleic acid drug application, expanding the balloon until it contacts tissue at said location; delivering said dose of said nucleic acid from the surface of the balloon, while simultaneously maintaining pressure on said tissue, whereby transfection of said nucleic acid into cells at said location occurs, contracting said expandable balloon and removing said catheter from said body lumen.
Claim 25
Dependent Claim
16 words
The method of claim 22 wherein the balloon has a surface coating comprising the nucleic acid.
Claim 26
Dependent Claim
12 words
The method of claim 23 wherein the surface coating comprises a hydrogel.
References Cited (Backward Citations)
DE380205C
Cited
DE1196327B
Cited
US3699956A
Cited
US4026296A
Cited
JPS536430A
Cited
JPS5435036A
Cited
US4299226A
Cited
US4481323A
Cited
US4364392A
Cited
US4330497A
Cited
US4448195A
Cited
GB2112646A
Cited
US4515593A
Cited
US4423725A
Cited
US4769013A
Cited
SU1069826A1
Cited
US4820270A
Cited
US4603152A
Cited
US4693243A
Cited
US4714460A
Cited
US4592340A
Cited
US4589873A
Cited
EP0166998B1
Cited
US4876126A
Cited
US4832688A
Cited
US4784647A
Cited
US4923450A
Cited
US4983166A
Cited
US4950256A
Cited
EP0372088A1
Cited
WO1989012478A1
Cited
US5232444A
Cited
US4909258A
Cited
US5213580A
Cited
US5163906A
Cited
EP0379156A2
Cited
US5091205A
Cited
US5021044A
Cited
US5328470A
Cited
US5047045A
Cited
US5041100A
Cited
US4994033A
Cited
EP0399712A1
Cited
US5026607A
Cited
US4993412A
Cited
WO1991008790A1
Cited
US5135516A
Cited
US5049132A
Cited
US5120322A
Cited
US5180366A
Cited
WO1992011895A1
Cited
US5304121A
Cited
US5102402A
Cited
US5370614A
Cited
US5213576A
Cited
WO1993011751A1
Cited
US5336615A
Cited
US5330467A
Cited
US5304120A
Cited
US5336178A
Cited
US5439446A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2000-10-06 | 2001-04-07 | 2001-10-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-10-06 | 2005-04-07 | 2005-10-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-10-06 | 2009-04-07 | 2009-10-07 | $7700.00 | Window Closed / Lapsed |