US6270515B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for closing a septal defect
Assignee: Boston Scientific Scimed Inc
•
Filing: 1997-02-26
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Granted: 2001-08-07
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Expires: 2017-02-26
Abstract
Abstract A device for closing off a septal defect including a polymeric self-hardening material in a specific conformation which is delivered by a catheter means to the area of defect either directly on the cardiac tissue or into a balloon which spans both surfaces of the defect, and hardened in-situ by change in pH or ionic concentration, organic solvents, by permeation of a secondary material capable of precipitation, or by exposure to heat, light or laser energy. In blood, the device may be hardened through photopolymerization or a cooperative effect of coagulation, precipitation or ionization. The device can be made of biodegradable material impregnated with growth factors, mitogenic factors or other determinants which can improve tissue growth such that tissue ingrowth can occur over a period of time. The catheter itself may be an ultrasonic imaging catheter.
Inventors
- 👤 Bradley Linden
- 👤 II Donald F. Palme
- 👤 Paul J. Buscemi
- 👤 Thomas J. Holman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:03
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/14; A61L31/16; A61B; A61B17/00; A61B17/0057; A61L31/04; A61L31/043; A61L31/044; A61L31/048; A61L31/06; A61L31/148; A61B2017/00535; A61B2017/00557; A61B2017/00575; A61B2017/00579; A61B2017/00592; A61B2017/00601; A61B2017/00606; A61B2017/00615; A61L2300/00; A61L2300/40; A61L2300/412; A61L2300/414
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
170 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said polymeric material being a bioabsorbable polymeric material that reacts to heat, light, alterations in pH or chemical reactants said plug being unitary in construction and having a first end and a second end; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; iii) means for releasably securing the plug to the catheter, the plug being directly introduced into the area of a septal defect; and iv) curing means; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; and e) releasing the plug from the catheter and curing the polymeric material in situ, whereby the plug remains, permanently plugging the defect.
Claim 2
Independent Claim
170 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said polymeric material being a bioabsorbable polymeric material that reacts to heat, light, alterations in pH or chemical reactants said plug being unitary in construction and having a first end and a second end; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; iii) means for releasably securing the plug to the catheter, the plug being directly introduced into the area of a septal defect; and iv) curing means; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; and e) releasing the plug from the catheter and curing the polymeric material in situ, whereby the plug remains, permanently plugging the defect.
Claim 3
Dependent Claim
16 words
The method of claim 1 wherein the polymeric material includes growth factors and other nitrogenic agents.
Claim 4
Independent Claim
151 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug having a first end and a second end, said plug comprising a balloon filled with polymeric material; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; and iii) means for releasably securing the plug to the catheter the plug being introduced into the area of a septal defect; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; e) inflating the balloon by filling it with polymeric material such that the balloon spans both surfaces of the defect; and e) releasing the plug from the catheter, whereby the plug remains, permanently plugging the defect.
Claim 5
Independent Claim
151 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug having a first end and a second end, said plug comprising a balloon filled with polymeric material; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; and iii) means for releasably securing the plug to the catheter the plug being introduced into the area of a septal defect; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; e) inflating the balloon by filling it with polymeric material such that the balloon spans both surfaces of the defect; and e) releasing the plug from the catheter, whereby the plug remains, permanently plugging the defect.
Claim 6
Dependent Claim
34 words
The method of claim 3 wherein the catheter includes a fluid delivery lumen, and the method further comprises the step of hardening the polymeric material after delivering the plug to the area of defect.
Claim 7
Dependent Claim
13 words
The method of claim 3 wherein the balloon is made of bioabsorbable material.
Claim 8
Dependent Claim
18 words
The method of claim 3 wherein the balloon and polymeric material include growth factors and other mitogenic agents.
Claim 9
Dependent Claim
12 words
The method of claim 3 wherein the polymeric material is a foam.
Claim 10
Independent Claim
206 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said plug having a first end and a second end, said plug further comprising (i) a dual-lobed balloon made of polymeric material, and (2) a liquid solution which is introduced into the balloon at an elevated temperature and hardens into a gel upon cooling in situ to body temperature; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; iii) means for releasably securing the plug to the catheter the plug being directly introduced into the area of a septal defect; and iv) means associated with said balloon for delivering said liquid solution; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; e) delivering said liquid solution, thereby filling the balloon with said solution; and f) releasing the plug from the catheter and curing or hardening the plug in situ, whereby the plug remains, permanently plugging the defect.
Claim 11
Independent Claim
206 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said plug having a first end and a second end, said plug further comprising (i) a dual-lobed balloon made of polymeric material, and (2) a liquid solution which is introduced into the balloon at an elevated temperature and hardens into a gel upon cooling in situ to body temperature; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; iii) means for releasably securing the plug to the catheter the plug being directly introduced into the area of a septal defect; and iv) means associated with said balloon for delivering said liquid solution; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; e) delivering said liquid solution, thereby filling the balloon with said solution; and f) releasing the plug from the catheter and curing or hardening the plug in situ, whereby the plug remains, permanently plugging the defect.
Claim 12
Dependent Claim
31 words
The method of claim 8 wherein the liquid solution introduced into the balloon comprises a water soluble composition selected from the group consisting of gelatin, collagen, albumin, agar and mixtures thereof.
Claim 13
Dependent Claim
32 words
The method of claim 9 wherein the composition further includes bioactive components selected from the group consisting of collagen, albumin, βFibroblastic Growth Factor, angiogenic factors, RGD adhesion sequences, antibiotics and mixtures thereof.
Claim 14
Dependent Claim
14 words
The method of claim 8 wherein the balloon is made of biodegradable polymeric material.
Claim 15
Dependent Claim
15 words
The method of claim 8 wherein the balloon is made of non-biodegradable, biocompatible polymeric material.
Claim 16
Dependent Claim
18 words
The method of claim 8 wherein the balloon and liquid solution include growth factors and other mitogenic agents.
Claim 17
Independent Claim
233 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said polymeric material being relatively soft and compliant in a first state, the plug being of a specific configuration which is adapted to fit securely into said defect upon being positioned therein and substantially close it, said polymeric material being capable of being cured and changed to a hardened second state in situ, said plug comprising a compressible polymeric foam made of a bioabsorbable material that reacts to heat, light, alterations in pH or chemical reactants, said plug having a first end and a second end; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; and iii) means for releasably securing the plug to the catheter the plug being directly introduced into the area of a septal defect; and iv) curing means; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; and e) releasing the plug from the catheter; and f) curing the polymeric material in situ, whereby the plug remains and the defect is permanently closed by said plug of cured polymeric material.
Claim 18
Independent Claim
233 words
A method for permanently closing a septal defect, comprising the steps of: a) providing an apparatus comprising: i) a plug comprising a polymeric material which is cured or hardened in situ, said polymeric material being relatively soft and compliant in a first state, the plug being of a specific configuration which is adapted to fit securely into said defect upon being positioned therein and substantially close it, said polymeric material being capable of being cured and changed to a hardened second state in situ, said plug comprising a compressible polymeric foam made of a bioabsorbable material that reacts to heat, light, alterations in pH or chemical reactants, said plug having a first end and a second end; ii) a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; and iii) means for releasably securing the plug to the catheter the plug being directly introduced into the area of a septal defect; and iv) curing means; and b) introducing the apparatus into a body and advancing the catheter to an area of a septal defect; c) delivering the plug to the defect area; d) placing the plug in the septal defect; and e) releasing the plug from the catheter; and f) curing the polymeric material in situ, whereby the plug remains and the defect is permanently closed by said plug of cured polymeric material.
Claim 19
Dependent Claim
16 words
The method of claim 14 wherein the polymeric material includes growth factors and other mitogenic agents.
References Cited (Backward Citations)
US3704711A
Cited
US3848602A
Cited
US3874388A
Cited
GB1509023A
Cited
US3952742A
Cited
US4000743A
Cited
US4090518A
Cited
US4180076A
Cited
SU676285A1
Cited
US4198981A
Cited
US4292976A
Cited
US4327736A
Cited
US4329993A
Cited
SU952234A1
Cited
US4351342A
Cited
US4484579A
Cited
US4672969A
Cited
US4854320A
Cited
US4860745A
Cited
SU1531995A1
Cited
US4836204A
Cited
US4917089A
Cited
US4985029A
Cited
US5192301A
Cited
US4997431A
Cited
US5065772A
Cited
US5171259A
Cited
US5071417A
Cited
US5139480A
Cited
US5258020A
Cited
US5591204A
Cited
US5391183A
Cited
US5601602A
Cited
US5108420A
Cited
EP0541063A2
Cited
EP0545091A2
Cited
US5258042A
Cited
WO1993013712A1
Cited
WO1993016738A1
Cited
US5630833A
Cited
US5486195A
Cited
US5634936A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-08-06 | 2005-02-05 | 2005-08-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-08-06 | 2009-02-05 | 2009-08-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-08-06 | 2013-02-05 | 2013-08-07 | $7700.00 | Window Closed / Lapsed |