US5634936A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device for closing a septal defect
Assignee: Boston Scientific Scimed Inc
•
Filing: 1995-02-06
•
Granted: 1997-06-03
•
Expires: 2015-02-06
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 device 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
2026-10-23 13:12
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: 56
Claim 1
Independent Claim
119 words
An apparatus for permanently closing off a septal defect, the apparatus comprising: a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.
Claim 2
Independent Claim
119 words
An apparatus for permanently closing off a septal defect, the apparatus comprising: a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.
Claim 3
Dependent Claim
26 words
The apparatus of claim 1 wherein the plug is made of a bioabsorbable polymeric material that reacts to heat, light, alterations in pH or chemical reactants.
Claim 4
Dependent Claim
16 words
The apparatus of claim 2 wherein the polymeric material includes growth factors and other mitogenic agents.
Claim 5
Dependent Claim
53 words
The apparatus of claim 1 wherein the catheter includes a balloon at its second end, said balloon being unitary in construction and having a specific conformation which is adapted to fit securely into the defect upon being positioned therein and substantially close it, and the plug comprises a sleeve which encases the balloon.
Claim 6
Dependent Claim
18 words
The apparatus of claim 4 wherein the plug is released from the catheter by deflation of the balloon.
Claim 7
Dependent Claim
75 words
The apparatus of claim 1 wherein the plug comprises a polymeric material which is relatively soft and compliant in a first state, the plug being of a specific configuration which is adapted to fit securely into the 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, whereby the defect is permanently closed by said plug of cured polymeric material.
Claim 8
Independent Claim
100 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect; and b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter including a corkscrew at its second end whereby the plug is releasably secured thereto; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 9
Independent Claim
100 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect; and b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter including a corkscrew at its second end whereby the plug is releasably secured thereto; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 10
Independent Claim
118 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter further comprising a threaded protrusion at its second end adapted to mate with a threaded bore located at the first end of the plug, whereby the plug is releasably secured to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 11
Independent Claim
118 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug, said catheter further comprising a threaded protrusion at its second end adapted to mate with a threaded bore located at the first end of the plug, whereby the plug is releasably secured to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 12
Independent Claim
102 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug comprising a balloon filled with polymeric foam, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 13
Independent Claim
102 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug comprising a balloon filled with polymeric foam, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 14
Dependent Claim
29 words
The apparatus of claim 9 wherein the catheter includes a fluid delivery lumen by means of which the polymeric foam is hardened after delivery to the area of defect.
Claim 15
Dependent Claim
13 words
The apparatus of claim 9 wherein the balloon is made of bioabsorbable material.
Claim 16
Dependent Claim
18 words
The apparatus of claim 9 wherein the balloon and polymeric material include growth factors and other mitogenic agents.
Claim 17
Independent Claim
131 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, said plug further comprising: i. a dual-lobed balloon made of polymeric material; and ii. 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; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 18
Independent Claim
131 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, said plug further comprising: i. a dual-lobed balloon made of polymeric material; and ii. 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; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 19
Dependent Claim
31 words
The apparatus of claim 13 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 20
Dependent Claim
32 words
The apparatus of claim 14 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 21
Dependent Claim
14 words
The apparatus of claim 3 wherein the balloon is made of biodegradable polymeric material.
Claim 22
Dependent Claim
15 words
The apparatus of claim 13 wherein the balloon is made of non-biodegradable, biocompatible polymeric material.
Claim 23
Dependent Claim
18 words
The apparatus of claim 13 wherein the balloon and liquid solution include growth factors and other mitogenic agents.
Claim 24
Independent Claim
159 words
An apparatus for closing off a septal defect, the apparatus comprising; a. a catheter having a first end and a second end, the catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it, b. a plug having a first end and a second end, the plug comprising a sleeve which encases the balloon, said catheter being adapted to carry and release the plug, said plug being directly introduced into the area of a septal defect, said sleeve further being made of a deformable polymeric material, said sleeve being permanently deformed by the balloon within the defect in the shape of a plug, leaving the defect substantially plugged after deflation and removal of the balloon; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 25
Independent Claim
159 words
An apparatus for closing off a septal defect, the apparatus comprising; a. a catheter having a first end and a second end, the catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it, b. a plug having a first end and a second end, the plug comprising a sleeve which encases the balloon, said catheter being adapted to carry and release the plug, said plug being directly introduced into the area of a septal defect, said sleeve further being made of a deformable polymeric material, said sleeve being permanently deformed by the balloon within the defect in the shape of a plug, leaving the defect substantially plugged after deflation and removal of the balloon; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 26
Dependent Claim
11 words
The apparatus of claim 19 wherein the balloon is dumbbell shaped.
Claim 27
Dependent Claim
16 words
The apparatus of claim 19 wherein the polymeric material includes growth factors and other mitogenic agents.
Claim 28
Dependent Claim
26 words
The apparatus of claim 19 wherein the polymeric material is made of a bioabsorbable material tilt reacts to heat, light, alterations in pH, or organic solvents.
Claim 29
Dependent Claim
20 words
The apparatus of claim 19 wherein the polymeric material reacts to electromagnetic energy, infrared light, visible light or ultraviolet light.
Claim 30
Independent Claim
152 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a catheter having a first end and a second end, said catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it; b. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, the catheter being adapted to carry and release the plug, the plug comprising a deformable sleeve-like mesh of a bioabsorbable polymeric material, the mesh contacting the surrounding surface area of the septal defect when the balloon is inserted therein and inflated, said sleeve-like mesh encasing the balloon for delivery thereof, whereby the sleeve-like mesh may be delivered to the defect and permanently deployed by the balloon, leaving a mesh across the defect after deflation and removal of the balloon.
Claim 31
Independent Claim
152 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a catheter having a first end and a second end, said catheter including at its second end a balloon having a specific conformation adapted to fit securely into the defect upon being positioned therein and substantially close it; b. a plug having a first end and a second end, the plug being directly introduced into the area of a septal defect, the catheter being adapted to carry and release the plug, the plug comprising a deformable sleeve-like mesh of a bioabsorbable polymeric material, the mesh contacting the surrounding surface area of the septal defect when the balloon is inserted therein and inflated, said sleeve-like mesh encasing the balloon for delivery thereof, whereby the sleeve-like mesh may be delivered to the defect and permanently deployed by the balloon, leaving a mesh across the defect after deflation and removal of the balloon.
Claim 32
Dependent Claim
11 words
The apparatus of claim 24 wherein the balloon is bell shaped.
Claim 33
Dependent Claim
16 words
The apparatus of claim 24 wherein the polymeric material includes growth factors and other mitogenic agents.
Claim 34
Dependent Claim
32 words
The apparatus of claim 24 wherein the sleeve-like mesh is delivered to an area of defect through a catheter and secured to the area surrounding the detect by physical or chemical means.
Claim 35
Dependent Claim
26 words
The apparatus of claim 24 wherein the polymeric material is made of a bioabsorbable material that reacts to head, light, alterations in pH, or organic solvents.
Claim 36
Dependent Claim
12 words
The apparatus of claim 24 wherein the mesh is made of PET.
Claim 37
Dependent Claim
12 words
The apparatus of claim 24 wherein the mesh is made of PTFE.
Claim 38
Dependent Claim
25 words
The apparatus of claim 24 wherein the mesh is comprised of a material selected from the group consisting of caprolactone, polylactic acid and mixtures thereof.
Claim 39
Dependent Claim
26 words
The apparatus of claim 24 wherein the mesh further includes a bioactive material selected from the group consisting or fibronectin, vitronectin, collagen, fibrin and mixtures thereof.
Claim 40
Dependent Claim
26 words
The apparatus of claim 32 wherein the bioactive material is in fibrous form and is woven into the meshwork as a member of a composite fiber.
Claim 41
Dependent Claim
20 words
The apparatus of claim 32 wherein the bioactive material is deposited onto the surface of the fibers by chemical means.
Claim 42
Independent Claim
116 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug comprising a compressible polymeric foam made of a bioabsorbable material that reacts to heat, light, alterations in pH or chemical reactants, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 43
Independent Claim
116 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug comprising a compressible polymeric foam made of a bioabsorbable material that reacts to heat, light, alterations in pH or chemical reactants, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 44
Dependent Claim
16 words
The apparatus of claim 35 wherein the polymeric material includes growth factors and other mitogenic agents.
Claim 45
Dependent Claim
25 words
The apparatus of claim 36 wherein the polymeric foam is presoaked in an organic or aqueous solution of a specific pH to retain its compressibility.
Claim 46
Dependent Claim
50 words
The apparatus of claim 31 wherein the catheter includes a fluid delivering lumen by means of which the polymeric foam is hardened after delivery to the area of defect by infusion through the catheter of a solution of a different pH than the solution in which the apparatus was presoaked.
Claim 47
Dependent Claim
48 words
The apparatus of claim 37 wherein the polymeric material is presoaked in an organic solution, and the catheter includes a fluid delivering Iumen by means of which the polymeric foam is hardened after delivery to the area of defect by the removal of the organic solution by dilution.
Claim 48
Dependent Claim
26 words
The apparatus of claim 35 wherein the polymeric foam is hardened by the permeation therein or a second material which precipitates with a change in pH.
Claim 49
Dependent Claim
12 words
The apparatus of claim 40 wherein the second material is a gel.
Claim 50
Dependent Claim
12 words
The apparatus of claim 40 wherein the second material is a solution.
Claim 51
Dependent Claim
28 words
The apparatus of claim 40 wherein the alteration of the first state is effected in the presence of blood through a cooperative effect of coagulation, precipitation or ionization.
Claim 52
Independent Claim
111 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug being made of a bioabsorbable polymeric material that reacts to light and is hardened by photopolymerization, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 53
Independent Claim
111 words
An apparatus for closing off a septal defect, the apparatus comprising: a. a plug having a first end and a second end, said plug being made of a bioabsorbable polymeric material that reacts to light and is hardened by photopolymerization, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect and released from the catheter so it remains, plugging the defect.
Claim 54
Independent Claim
119 words
An apparatus for permanently closing off a septal defect, the apparatus comprising: a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.
Claim 55
Independent Claim
119 words
An apparatus for permanently closing off a septal defect, the apparatus comprising: a. a plug comprising a polymeric material which is cured or hardened in situ, said plug being unitary in construction and having a first end and a second end, the plug being directly introduced into the area of a septal defect; b. a catheter having a first end and a second end, the catheter being adapted to carry and release the plug; c. means for releasably securing the plug to the catheter; whereby the plug is delivered to the defect area by the catheter, placed in the septal defect, released from the catheter and cured or hardened in situ, whereby the hardened plug remains, plugging the defect.
Claim 56
Dependent Claim
53 words
The apparatus of claim 45 wherein the catheter includes a balloon at its second end, said balloon being unitary in construction and having a specific conformation which is adapted to fit securely into the defect upon being positioned therein and substantially close it, and the plug comprises a sleeve which encases the balloon.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2000-06-02 | 2000-12-02 | 2001-06-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-06-02 | 2004-12-02 | 2005-06-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-06-02 | 2008-12-02 | 2009-06-03 | $7700.00 | Window Closed / Lapsed |