US5199951A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of drug application in a transporting medium to an arterial wall injured during angioplasty
Assignee: Wayne State University
•
Filing: 1991-09-13
•
Granted: 1993-04-06
•
Expires: 2011-09-13
Abstract
Abstract A method for treating a lesion (27) in an arterial wall (28) having plaque (52) thereon and a luminal surface (29). The arterial wall (28) has typically been mechanically injured during an angioplasty procedure. As a result of that procedure, the arterial wall (28) and the plaque (52) include fissures (24) defined therein. It has been found that those fissures (24) form excellent sites at which a bioprotective material (26) may become bonded upon application of thermal energy. The method comprising the steps of positioning an angioplasty catheter (20) adjacent to the lesion (27) being treated; delivering a soluble sleeve containing bioprotective material (26) between the arterial wall (28) and the angioplasty catheter (20) so that the bioprotective material (26) is entrapped therebetween applying thermal energy to the lesion (27), thereby liquifying the sleeve and bonding the bioprotective material (26) to the arterial wall (28) and within the fissures (24); removing the angioplasty catheter (20), the bioprotective material (26) remaining adherent to the arterial wall (28) and within the fissures (24); cooling the sleeve so that it becomes solidified; releasing and removing the angioplasty catheter (20) from the site being treated, whereupon the soluble sleeve is irrigated away by blood (50) flowing adjacent thereto, leaving an insoluble material semi- or permanently bonded to the fissures (24) of the arterial wall (28), despite contact with blood (50) flowing adjacent thereto.
Inventors
- 👤 James R. Spears
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 05:45
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/22; A61B17/00491; A61B17/22004; A61B18/00; A61B18/04; A61B18/08; A61B18/082; A61B18/18; A61B18/20; A61B18/22; A61B18/28; A61B2017/00831; A61B2017/22001; A61B2017/22002; A61B2017/22038; A61B2017/22051; A61B2017/22062; A61B2017/22064; A61B2017/22082; A61B2017/22084; A61B2017/22085; A61B2017/22087; A61M; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/105; A61M25/104; A61M37/00; A61M37/0092
Claims Analysis
Total Claims: 66
Claim 1
Independent Claim
221 words
A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: providing a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin, the layer of bioprotective material being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; positioning the angioplasty catheter adjacent to the lesion being treated so that the transporting medium and the bioprotective material are entrapped therebetween; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy, thereby liquefying the transporting medium under pressure and promoting contact of the bioprotective material with the fissures and the luminal surface, whereby the thermal energy bonds the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; and removing the angioplasty catheter, the bioprotective material remaining adherent to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, despite contact with blood flowing adjacent thereto, the blood dissolving and removing the transporting medium.
Claim 2
Independent Claim
221 words
A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: providing a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin, the layer of bioprotective material being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; positioning the angioplasty catheter adjacent to the lesion being treated so that the transporting medium and the bioprotective material are entrapped therebetween; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy, thereby liquefying the transporting medium under pressure and promoting contact of the bioprotective material with the fissures and the luminal surface, whereby the thermal energy bonds the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; and removing the angioplasty catheter, the bioprotective material remaining adherent to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, despite contact with blood flowing adjacent thereto, the blood dissolving and removing the transporting medium.
Claim 3
Dependent Claim
14 words
The method of claim 1 wherein the angioplasty catheter utilized includes an inflatable balloon.
Claim 4
Dependent Claim
42 words
The method of claim 2 wherein the inflatable balloon is at least partially inflated before delivering the transporting medium and bioprotective material between the arterial wall and the inflatable balloon, thereby promoting localized application of the bioprotective material to the arterial wall.
Claim 5
Dependent Claim
38 words
The method of claim 1 wherein the bioprotective material utilized is a macroaggregated albumin which bonds to the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 6
Dependent Claim
44 words
The method of claim 1 wherein the bioprotective material comprises platelets carried by the transporting medium, which become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 7
Dependent Claim
46 words
The method of claim 1 wherein the bioprotective material comprises red blood cells carried by the transporting medium, which become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 8
Dependent Claim
44 words
The method of claim 1 wherein the bioprotective material comprises liposomes carried by the transporting medium, which become adherent to the luminal surface and to tissues adjacent to fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 9
Dependent Claim
51 words
The method of claim 1 wherein the transporting medium comprises a gelatin which liquifies upon application of thermal energy, whereby the bioprotective material within the liquified transporting medium bonds to the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 10
Dependent Claim
33 words
The method of claim 1 wherein the bioprotective material utilized bonds to the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 11
Dependent Claim
44 words
The method of claim 1 wherein the bioprotective material comprises a high molecular weight carbohydrate which bonds to the luminal surface precipitates onto the luminal surface and within fissures and vessels of the arterial wall as a result of the application of thermal energy.
Claim 12
Dependent Claim
35 words
The method of claim 1 wherein the bioprotective material utilized entraps a useful pharmaceutical agent in order to provide local drug therapy directly to the luminal surface, and to fissures defined within the arterial wall.
Claim 13
Dependent Claim
13 words
The method of claim 11 wherein the useful pharmaceutical agent is an anti-coagulant.
Claim 14
Dependent Claim
14 words
The method of claim 11 wherein the useful pharmaceutical agent is a fibrinolytic agent.
Claim 15
Dependent Claim
14 words
The method of claim 11 wherein the useful pharmaceutical agent is a thrombolytic agent.
Claim 16
Dependent Claim
14 words
The method of claim 11 wherein the useful pharmaceutical agent is an anti-inflammatory agent.
Claim 17
Dependent Claim
13 words
The method of claim 11 wherein the useful pharmaceutical is an anti-proliferative compound.
Claim 18
Dependent Claim
12 words
The method of claim 11 wherein the useful pharmaceutical is an immunosuppressant.
Claim 19
Dependent Claim
13 words
The method of claim 11 wherein the useful pharmaceutical is a collagen inhibitor.
Claim 20
Dependent Claim
15 words
The method of claim 11 wherein the useful pharmaceutical is an endothelial cell growth promotor.
Claim 21
Dependent Claim
13 words
The method of claim 11 wherein the useful pharmaceutical is a sulfated polysaccharide.
Claim 22
Dependent Claim
34 words
The method of claim 1 wherein the bioprotective material includes a drug which is bound to albumin prior to injection, so that the drug is permanently affixed thereto by application of the thermal energy.
Claim 23
Dependent Claim
24 words
The method of claim 1 wherein the bioprotective material includes a drug which is physically trapped within albumin during the application of thermal energy.
Claim 24
Dependent Claim
11 words
The method of claim 1 wherein the bioprotective material comprises microspheres.
Claim 25
Dependent Claim
17 words
The method of claim 1 wherein the bioprotective material includes a drug preparation having an encapsulating medium.
Claim 26
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises albumin.
Claim 27
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises carbohydrates.
Claim 28
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises platelets.
Claim 29
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises liposomes.
Claim 30
Dependent Claim
13 words
The method of claim 24 wherein the encapsulating medium comprises red blood cells.
Claim 31
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises gelatin.
Claim 32
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises hemoglobin.
Claim 33
Dependent Claim
13 words
The method of claim 24 wherein the encapsulating medium comprises a synthetic polymer.
Claim 34
Dependent Claim
13 words
The method of claim 24 wherein the encapsulating medium comprises a sulfated polysaccharide.
Claim 35
Dependent Claim
13 words
The method of claim 24 wherein the encapsulating medium comprises ghost red cells.
Claim 36
Dependent Claim
11 words
The method of claim 24 wherein the encapsulating medium comprises heparin.
Claim 37
Dependent Claim
23 words
The method of claim 1 wherein the bioprotective material is a confluent layer of microspheres impregnated on the surface of the transporting medium.
Claim 38
Dependent Claim
61 words
The method of claim 1 wherein the step of removing the angioplasty catheter is (followed) by the step of cooling the liquified transporting medium and tissues, thereby enhancing bonding of the bioprotective material to the lesion so that the bioprotective material remains adherent to the arterial wall, and fills cracks and recesses therewithin, thereby providing localized delivery of the bioprotective material.
Claim 39
Independent Claim
25 words
The method of claim wherein the transporting medium becomes re-solidified upon cooling, and is dissolved by blood flowing adjacent thereto after removal of the catheter.
Claim 40
Dependent Claim
36 words
The method of claim 1 wherein microspheres are formed in situ at the luminal surface and within the arterial wall as a result of the thermal energy applied to the transporting medium and the bioprotective material.
Claim 41
Dependent Claim
18 words
The method of claim 1 wherein a drug, simultaneously injected with the bioprotective material, is entrapped within microspheres.
Claim 42
Dependent Claim
25 words
The method of claim 1 wherein the bioprotective material functions as a physiologic glue, thereby enhancing thermal fusion of fissured tissues within the arterial wall.
Claim 43
Dependent Claim
18 words
The method of claim 1 wherein the bioprotective material includes a chromophore which enhances absorption of electromagnetic radiation.
Claim 44
Dependent Claim
18 words
The method of claim 24 wherein the encapsulating medium comprises a chromophore which enhances absorption of electromagnetic radiation.
Claim 45
Dependent Claim
13 words
The method of claim 1 wherein the angioplasty catheter is a metal probe.
Claim 46
Dependent Claim
13 words
The method of claim 1 wherein the applied thermal energy is electromagnetic radiation.
Claim 47
Dependent Claim
15 words
The method of claim 45 wherein the applied thermal energy is continuous wave electromagnetic radiation.
Claim 48
Dependent Claim
14 words
The method of claim 45 wherein the applied thermal energy is pulsed electromagnetic radiation.
Claim 49
Dependent Claim
12 words
The method of claim 45 wherein the electromagnetic radiation is laser radiation.
Claim 50
Dependent Claim
12 words
The method of claim 45 wherein the electromagnetic radiation is radio-frequency radiation.
Claim 51
Dependent Claim
12 words
The method of claim 45 wherein the electromagnetic radiation is microwave radiation.
Claim 52
Dependent Claim
14 words
The method of claim 45 wherein the electromagnetic radiation is generated from electrical resistance.
Claim 53
Independent Claim
214 words
A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: performing angioplasty; providing a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin, the layer of bioprotective material being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; positioning the angioplasty catheter adjacent to the lesion being treated so that the transporting medium and the bioprotective material are entrapped therebetween; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy, thereby liquefying the transporting medium under pressure and promoting contact of the bioprotective material with the fissures and the luminal surface, whereby the thermal energy bonds the bioprotective mate rail to the arterial wall and within the fissures and vessels of the arterial wall; and removing the angioplasty catheter, the bioprotective material remaining adherent to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, despite contact with blood flowing adjacent thereto, the blood dissolving and removing the transporting medium.
Claim 54
Independent Claim
214 words
A method for treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: performing angioplasty; providing a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin, the layer of bioprotective material being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; positioning the angioplasty catheter adjacent to the lesion being treated so that the transporting medium and the bioprotective material are entrapped therebetween; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy, thereby liquefying the transporting medium under pressure and promoting contact of the bioprotective material with the fissures and the luminal surface, whereby the thermal energy bonds the bioprotective mate rail to the arterial wall and within the fissures and vessels of the arterial wall; and removing the angioplasty catheter, the bioprotective material remaining adherent to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, despite contact with blood flowing adjacent thereto, the blood dissolving and removing the transporting medium.
Claim 55
Dependent Claim
26 words
The method of claim 1 wherein the step of applying thermal energy to the lesion comprises applying the thermal energy from the angioplasty catheter radially outwardly.
Claim 56
Dependent Claim
37 words
The method of claim 1 wherein the step of applying thermal energy to the lesion comprises the step of applying thermal energy so that the temperature within the bioprotective material is raised to at least 40° C.
Claim 57
Dependent Claim
14 words
The method of claim 1 wherein the transporting medium is a soluble gelatin film.
Claim 58
Dependent Claim
27 words
The method of claim 55 wherein the gelatin is removed from the luminal surface of the tissue by ambient blood flow upon removal of the angioplasty catheter.
Claim 59
Dependent Claim
19 words
The method of claim 1 wherein the layer of a transporting medium has a thickness between about 5-200 microns.
Claim 60
Dependent Claim
16 words
The method of claim 11 wherein the useful pharmaceutical agent is an inhibitor of collagen cross-linking.
Claim 61
Dependent Claim
16 words
The method of claim 11 wherein the useful pharmaceutical agent is an inhibitor of elastin cross-linking.
Claim 62
Dependent Claim
13 words
The method of claim 11 wherein the useful pharmaceutical agent comprises deoxyribonucleic acid.
Claim 63
Dependent Claim
14 words
The method of claim 11 wherein the useful pharmaceutical agent material comprises ribonucleic acid.
Claim 64
Dependent Claim
15 words
The method of claim 11 wherein the useful pharmaceutical agent comprises one or more genes.
Claim 65
Independent Claim
220 words
A method of treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: positioning a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin upon a balloon angioplasty catheter adjacent to the lesion being treated, the layer being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy to the lesion and inflating the balloon, thereby liquefying the transporting medium and promoting contact of the bioprotective material with the fissures and luminal surface, whereby the thermal energy bonds the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; allowing the transporting medium to cool, thereby enabling it to become re-solidified; removing the angioplasty catheter, the bioprotective material remaining bonded to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, the blood flowing adjacent thereto, thereby dissolving and removing the resolidified transporting medium.
Claim 66
Independent Claim
220 words
A method of treating a lesion in an arterial wall having plaque thereon and a luminal surface, the arterial wall having been injured during an angioplasty procedure, the arterial wall and the plaque defining therewithin fissures resulting therefrom, the method comprising the steps of: positioning a layer of a transporting medium disposed about an angioplasty catheter balloon, said transporting medium having a bioprotective material distributed therewithin upon a balloon angioplasty catheter adjacent to the lesion being treated, the layer being surrounded by a removable sheath to prevent premature dissolution of the bioprotective material; removing the sheath so that the lesion is exposed to the bioprotective material; applying thermal energy to the lesion and inflating the balloon, thereby liquefying the transporting medium and promoting contact of the bioprotective material with the fissures and luminal surface, whereby the thermal energy bonds the bioprotective material to the arterial wall and within the fissures and vessels of the arterial wall; allowing the transporting medium to cool, thereby enabling it to become re-solidified; removing the angioplasty catheter, the bioprotective material remaining bonded to the fissures and vessels within the arterial wall, thereby treating the injured luminal surface with the bioprotective material, whereby at least semi-permanent protection to the arterial wall is provided, the blood flowing adjacent thereto, thereby dissolving and removing the resolidified transporting medium.
References Cited (Backward Citations)
US5092841A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-04-05 | 1996-10-05 | 1997-04-06 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-04-05 | 2000-10-05 | 2001-04-06 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-04-05 | 2004-10-05 | 2005-04-06 | $7700.00 | Window Closed / Lapsed |