US5797870A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Pericardial delivery of therapeutic and diagnostic agents
Assignee: Indiana University Research and Technology Corp
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Filing: 1995-06-07
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Granted: 1998-08-25
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Expires: 2015-06-07
Abstract
Abstract A method for treating a patient's heart which comprising delivering a gene therapy agent into the pericardial sac around the patient's heart. The agent is introduced surgically or by transvascular means such as a catheter which has been introduced percutaneously or otherwise. Introducing the gene therapy agent into the pericardial sac contains the agent, allowing high concentration of the agent adjacent large regions of the epicardium and pericardium without spillage or systemic distribution to other organs or tissues. The gene therapy agents of this invention comprise vectors for transferring genetic information to the epicardial cells in vivo or harvested cells which have been genetically engineered in vitro. In a preferred embodiment, a catheter is percutaneously introduced, such as through the femoral artery, and guided upstream into the left ventricle. The distal end of the catheter advanced until it penetrates through the epicardium so that agent can be introduced into the pericardial space. Access to the pericardium may also be gained intraoperatively or through a thoracotomy. Additionally, the method may comprise employing a viscosity enhancer in conjunction with the gene therapy agent to affect the kinetics of the agent-host cell interaction and thus improve the rate and efficiency of transduction.
Inventors
- 👤 Keith L. March
- 👤 Douglas P. Zipes
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 06:27
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/0067; A61M25/0068; A61K; A61K48/00; A61M25/0082; C; C07; C07K; C07K14/00; C07K14/81; C07K14/8107; C07K14/811; C07K14/8121; C07K14/8125; A61B; A61B17/00; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B18/00; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00392; A61K38/00; A61M25/01; A61M25/09; A61M2025/09175; A61M2025/09183; A61M2210/00; A61M2210/10; A61M2210/12; A61M2210/122; A61M2210/125; C12; C12N; C12N2799/00; C12N2799/02; C12N2799/021; C12N2799/022
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
100 words
A method for delivering a gene therapy agent to epicardial and pericardial tissue of a patient's heart, comprising: providing an elongated intravascular device having a distal tip configured to pierce a wall of the patient's heart. guiding the distal tip of the device into the left ventricle of the patient's heart; piercing the endocardium, the myocardium and the epicardium with the distal tip of the device, said distal tip being located in the pericardial space; introducing the gene therapy agent through the distal tip; and maintaining the gene therapy agent within the pericardial space for a sufficient period of time.
Claim 2
Independent Claim
100 words
A method for delivering a gene therapy agent to epicardial and pericardial tissue of a patient's heart, comprising: providing an elongated intravascular device having a distal tip configured to pierce a wall of the patient's heart. guiding the distal tip of the device into the left ventricle of the patient's heart; piercing the endocardium, the myocardium and the epicardium with the distal tip of the device, said distal tip being located in the pericardial space; introducing the gene therapy agent through the distal tip; and maintaining the gene therapy agent within the pericardial space for a sufficient period of time.
Claim 3
Dependent Claim
29 words
The method of claim 1, wherein the step of maintaining the gene therapy agent within the pericardial space comprises providing the intravascular device with a helical hypotube distal tip.
Claim 4
Independent Claim
99 words
A method of delivering a gene therapy agent to epicardial and pericardial tissue of a patient's heart, comprising: providing a device configured to be introduced through the patient's chest having a distal tip configured to pierce the pericardium of the patient's heart; pulling the pericardium away from the epicardium; piercing the pericardium with the distal tip of the device; positioning the distal tip of the device in the pericardial space; introducing the gene therapy agent through the distal tip into the pericardial space; and maintaining the gene therapy agent within the pericardial space for a sufficient period of time.
Claim 5
Independent Claim
99 words
A method of delivering a gene therapy agent to epicardial and pericardial tissue of a patient's heart, comprising: providing a device configured to be introduced through the patient's chest having a distal tip configured to pierce the pericardium of the patient's heart; pulling the pericardium away from the epicardium; piercing the pericardium with the distal tip of the device; positioning the distal tip of the device in the pericardial space; introducing the gene therapy agent through the distal tip into the pericardial space; and maintaining the gene therapy agent within the pericardial space for a sufficient period of time.
Claim 6
Dependent Claim
27 words
The method of claim 3, wherein the step of maintaining the gene therapy agent within the pericardial space comprises suturing the pericardium after removing the distal tip.
Claim 7
Dependent Claim
29 words
The method of claim 4, wherein the step of maintaining the gene therapy agent within the pericardial space comprises mixing the gene therapy agent with a viscosity modifying component.
Claim 8
Dependent Claim
29 words
The method of claim 5, wherein the step of maintaining the gene therapy agent within the pericardial space comprises mixing the gene therapy agent with a viscous biocompatible polyol.
Claim 9
Independent Claim
47 words
A method for genetically modifying cells lining the pericardial space of a patient's heart, comprising delivering a gene therapy agent into the pericardial space defined by the epicardium and the pericardium surrounding the patient's heart thereby transferring DNA to cells lining the pericardial space with the agent.
Claim 10
Independent Claim
47 words
A method for genetically modifying cells lining the pericardial space of a patient's heart, comprising delivering a gene therapy agent into the pericardial space defined by the epicardium and the pericardium surrounding the patient's heart thereby transferring DNA to cells lining the pericardial space with the agent.
Claim 11
Dependent Claim
32 words
The method of claim 7, wherein the step of delivering the gene therapy agent comprises delivering an agent comprising a vector containing DNA capable of expressing a therapeutically or diagnostically useful protein.
Claim 12
Dependent Claim
43 words
The method of claim 8, wherein the step of delivering the gene therapy agent comprises delivering a vector selected from the group consisting of retroviral vectors, adenovirus vectors, adeno-associated virus vectors, herpes simplex virus vectors, semliki forest virus vectors, and sindbis virus vectors.
Claim 13
Dependent Claim
63 words
The method of claim 9, wherein the step of delivering the gene therapy agent comprises delivering a vector containing DNA capable of expressing proteins selected from the group consisting of vascular endothelial growth factor, acidic and basic fibroblast growth factors, angiogenin, other angiogenic and vasculogenic factors, nitric oxide synthase, prostaglandin synthase and other prostaglandin synthetic enzymes and superoxide dismutase and other antioxidant proteins.
Claim 14
Dependent Claim
85 words
The method of claim 8, wherein the step of delivering the gene therapy agent comprises: a) providing an elongated intravascular device having a distal tip configured to pierce a wall of the patient's heart; b) guiding the distal tip of the device into a chamber of the patient's heart; c) piercing the endocardium, the myocardium and the epicardium with the distal tip of the device the distal tip is located in the pericardial space; and d) introducing the gene therapy agent through the distal tip.
Claim 15
Dependent Claim
49 words
A gene therapy method for cells lining the pericardial space of a patient's heart comprising: a) harvesting epicardial or pericardial cells from the heart of a patient; b) genetically modifying the cells; c) selecting cells which have been successfully modified; d) delivering the selected cells into the pericardial space.
Claim 16
Dependent Claim
49 words
A gene therapy method for cells lining the pericardial space of a patient's heart comprising: a) harvesting epicardial or pericardial cells from the heart of a patient; b) genetically modifying the cells; c) selecting cells which have been successfully modified; d) delivering the selected cells into the pericardial space.
Claim 17
Dependent Claim
32 words
The method of claim 12 wherein step (b) comprises genetically modifying said cells by introducing into said cells an agent comprising a vector including DNA encoding a therapeutically or diagnostically useful protein.
Claim 18
Dependent Claim
31 words
The method of claim 13 wherein said vector is selected from the group consisting of retroviral vectors, adenovirus vectors, Herpes Simplex Virus vectors, Semliki Forest Virus vectors, and Sindbis virus vectors.
Claim 19
Dependent Claim
42 words
The method of claim 13 wherein said therapeutically useful protein is selected from the group consisting of vascular endothelial growth factor, acidic fibroblast growth factors, basic fibroblast growth factors, angiogenic factors, vasculogenic factors, nitric oxide synthase, prostaglandin synthetic enzymes, and antioxidant proteins.
Claim 20
Independent Claim
84 words
A method for treating a patient's heart, comprising: combining a gene therapy agent with a first compound, said first compound being a pharmaceutically acceptable carrier, to form thereby a mixture of said gene therapy agent and said first compound; injecting said mixture of said gene therapy agent and said first compound into the pericardial space of the patient's heart; and injecting into the pericardial space a second compound to enhance the viscosity of said mixture of said gene therapy agent and said first compound.
Claim 21
Independent Claim
84 words
A method for treating a patient's heart, comprising: combining a gene therapy agent with a first compound, said first compound being a pharmaceutically acceptable carrier, to form thereby a mixture of said gene therapy agent and said first compound; injecting said mixture of said gene therapy agent and said first compound into the pericardial space of the patient's heart; and injecting into the pericardial space a second compound to enhance the viscosity of said mixture of said gene therapy agent and said first compound.
Claim 22
Dependent Claim
20 words
The method of claim 16 wherein said gene therapy agent comprises a vector including DNA encoding a therapeutically useful protein.
Claim 23
Dependent Claim
31 words
The method of claim 17 wherein said vector is selected from the group consisting of retroviral vectors, adenovirus vectors, Herpes Simplex Virus vectors, Semliki Forest Virus vectors, and Sindbis virus vectors.
Claim 24
Dependent Claim
42 words
The method of claim 17 wherein said therapeutically useful protein is selected from the group consisting of vascular endothelial growth factor, acidic fibroblast growth factors, basic fibroblast growth factors, angiogenic factors, vasculogenic factors, nitric oxide synthase, prostaglandin synthetic enzymes, and anti-oxidant proteins.
Claim 25
Dependent Claim
15 words
The method of claim 16 wherein said second compound is injected simultaneously with said mixture.
Claim 26
Dependent Claim
17 words
The method of claim 16 wherein said second compound is injected after the injection of said mixture.
Claim 27
Independent Claim
80 words
A method of treating a patient's heart, comprising: combining a gene therapy agent with (i) a first compound, said first compound being a pharmaceutically acceptable carrier, and (ii) a second compound, said second compound being a viscosity enhancing agent, to form thereby a mixture of said gene therapy agent, said first compound, and said second compound; and injecting said mixture of said gene therapy agent, said first compound, and said second compound into the pericardial space of the patient's heart.
Claim 28
Independent Claim
80 words
A method of treating a patient's heart, comprising: combining a gene therapy agent with (i) a first compound, said first compound being a pharmaceutically acceptable carrier, and (ii) a second compound, said second compound being a viscosity enhancing agent, to form thereby a mixture of said gene therapy agent, said first compound, and said second compound; and injecting said mixture of said gene therapy agent, said first compound, and said second compound into the pericardial space of the patient's heart.
Claim 29
Dependent Claim
20 words
The method of claim 22 wherein said gene therapy agent comprises a vector including DNA encoding a therapeutically useful protein.
Claim 30
Dependent Claim
31 words
The method of claim 23 wherein said vector is selected from the group consisting of retroviral vectors, adenovirus vectors, Herpes Simplex Virus vectors, Semliki Forest Virus vectors, and Sindbis virus vectors.
Claim 31
Dependent Claim
42 words
The method of claim 23 wherein said therapeutically useful protein is selected from the group consisting of vascular endothelial growth factor, acidic fibroblast growth factors, basic fibroblast growth factors, angiogenic factors, vasculogenic factors, nitric oxide synthase, prostaglandin synthetic enzymes, and anti-oxidant proteins.
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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) | 2001-08-24 | 2002-02-23 | 2002-08-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-08-24 | 2006-02-23 | 2006-08-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-08-24 | 2010-02-23 | 2010-08-25 | $7700.00 | Window Closed / Lapsed |