US6443949B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method of drug delivery to interstitial regions of the myocardium
Assignee: Biocardia Inc
•
Filing: 1998-10-23
•
Granted: 2002-09-03
•
Expires: 2018-10-23
Abstract
Abstract A method of treating the heart and other body tissues by injecting a compound comprised of microsphere encapsulated macromolecule therapeutic agents into the myocardium, such that the microsphere size inhibits capillary transport of the compound but may permit lymphatic transport of the compound, and the compound releases therapeutic agents upon degradation of the microsphere.
Inventors
- 👤 Peter A. Altman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:55
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/056; A61N1/057; A61N1/0573; A61N1/0575; A61B; A61B18/00; A61B18/04; A61B18/12; A61B18/14; A61B18/1492; A61K; A61K9/00; A61K9/10; A61K9/127; A61K9/14; A61K9/16; A61K9/167; A61K9/1676; A61K9/48; A61K9/50; A61B17/00; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2018/00005; A61B2018/00011; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00392; A61B2018/00571; A61B2018/00577; A61B2018/00636; A61B2018/00773; A61B2018/00839; A61B2018/1405; A61B2018/1425; A61B2018/1435; A61B2218/00; A61B2218/001; A61B2218/002; A61K9/5084; A61M; A61M25/00; A61M25/0067; A61M25/0082; A61M25/0084; A61M2025/0089; Y; Y10; Y10S; Y10S977/00; Y10S977/70; Y10S977/773; Y10S977/775; Y10S977/902; Y10S977/904; Y10S977/906; Y10S977/907
Claims Analysis
Total Claims: 27
Claim 1
Independent Claim
54 words
A method of delivering a therapeutic molecule to myocardial interstitium to achieve local therapy to the heart muscle, said method comprising the steps of: encasing the therapeutic molecule within a liposome, the liposome having a half-life within mammal myocardial tissue of less than about thirty minutes; and injecting the liposome into the myocardial interstitium.
Claim 2
Independent Claim
54 words
A method of delivering a therapeutic molecule to myocardial interstitium to achieve local therapy to the heart muscle, said method comprising the steps of: encasing the therapeutic molecule within a liposome, the liposome having a half-life within mammal myocardial tissue of less than about thirty minutes; and injecting the liposome into the myocardial interstitium.
Claim 3
Dependent Claim
27 words
The method of claim 1 wherein the injecting step comprises providing a catheter system that delivers the stable liposomal preparation through an endocardial hollow penetrating delivery system.
Claim 4
Dependent Claim
13 words
The method of claim 1 wherein the injecting step comprises an epicardial injection.
Claim 5
Dependent Claim
22 words
The method of claim 1 wherein the therapeutic molecule is a small molecule with a molecular weight less than about 2000 daltons.
Claim 6
Dependent Claim
12 words
The method of claim 1 wherein the therapeutic molecule is a macromolecule.
Claim 7
Dependent Claim
14 words
The method of claim 1 wherein the therapeutic molecule is a gene therapy preparation.
Claim 8
Independent Claim
54 words
A method of delivering a therapeutic agent to myocardium comprising the steps of: providing a liposomal delivery catheter with a fluid lumen, the fluid lumen having a different physicochemical state than the mammal myocardium; and injecting liposomes into said myocardium, the liposomes being stable in the fluid lumen and unstable in the mammal myocardium.
Claim 9
Independent Claim
54 words
A method of delivering a therapeutic agent to myocardium comprising the steps of: providing a liposomal delivery catheter with a fluid lumen, the fluid lumen having a different physicochemical state than the mammal myocardium; and injecting liposomes into said myocardium, the liposomes being stable in the fluid lumen and unstable in the mammal myocardium.
Claim 10
Independent Claim
51 words
A method of delivering therapeutic macromolecules locally to the myocardial interstitium to achieve local therapy to the heart muscle, said method comprising the steps of: encasing the macromolecules within an intact controlled release particle between 15 and 150 micrometers in diameter; and injecting the controlled release particle into the myocardial interstitium.
Claim 11
Independent Claim
51 words
A method of delivering therapeutic macromolecules locally to the myocardial interstitium to achieve local therapy to the heart muscle, said method comprising the steps of: encasing the macromolecules within an intact controlled release particle between 15 and 150 micrometers in diameter; and injecting the controlled release particle into the myocardial interstitium.
Claim 12
Dependent Claim
27 words
The method of claim 8 wherein the injecting step comprises providing a catheter system that delivers the controlled release particle through an endocardial hollow penetrating delivery system.
Claim 13
Independent Claim
98 words
A method of treating the heart of a patient by injecting a therapeutic agent into the tissue of the heart, said method comprising the step of: forming a plurality of capsules by encapsulating molecules of the therapeutic agent within an encapsulating layer, said encapsulating layer being degradable within the heart tissue, said capsules being of sufficient size to prevent capillary transport of the capsules after injection into the heart tissue; injecting the capsules into the heart tissue; allowing the encapsulating layer to degrade within the heart tissue and thereby release molecules of therapeutic agent within the heart tissue.
Claim 14
Independent Claim
98 words
A method of treating the heart of a patient by injecting a therapeutic agent into the tissue of the heart, said method comprising the step of: forming a plurality of capsules by encapsulating molecules of the therapeutic agent within an encapsulating layer, said encapsulating layer being degradable within the heart tissue, said capsules being of sufficient size to prevent capillary transport of the capsules after injection into the heart tissue; injecting the capsules into the heart tissue; allowing the encapsulating layer to degrade within the heart tissue and thereby release molecules of therapeutic agent within the heart tissue.
Claim 15
Dependent Claim
43 words
The method of claim 10 further comprising the steps of: formulating the capsules so that they are stable in a storage environment and unstable in a physiological environment, and storing the capsules in the storage environment prior to injection into the heart tissue.
Claim 16
Dependent Claim
12 words
The method of claim 10 wherein: the encapsulating layer comprises a liposome.
Claim 17
Dependent Claim
12 words
The method of claim 10 wherein: the encapsulating layer comprises a micelle.
Claim 18
Dependent Claim
40 words
The method of claim 10 wherein: the encapsulating layer comprises a liposome having a diameter in the range of about 50 nm to about 400 nm the therapeutic agents comprise at least one of: macromolecules, gene therapy preparations, antiarrhythmic agents.
Claim 19
Dependent Claim
39 words
The method of claim 10 further comprising: determining a site of intended treatment within the heart tissue; injecting the capsules into the heart tissue at a point upstream in the lymphatic system relative to an area of intended treatment.
Claim 20
Dependent Claim
25 words
The method of claim 10 wherein the capsules are of sufficient size to prevent lymphatic transport of the capsule after injection into the heart tissue.
Claim 21
Dependent Claim
77 words
A substance for treatment of body tissue comprising: a plurality of capsules comprising an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue; the half life of said encapsulating layers being between five and sixty minutes; said capsules having an outer diameter less than about 400 nanometers; said therapeutic agent having a pharmacological effect on the body tissue upon degradation of the encapsulating layer.
Claim 22
Dependent Claim
77 words
A substance for treatment of body tissue comprising: a plurality of capsules comprising an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue; the half life of said encapsulating layers being between five and sixty minutes; said capsules having an outer diameter less than about 400 nanometers; said therapeutic agent having a pharmacological effect on the body tissue upon degradation of the encapsulating layer.
Claim 23
Dependent Claim
24 words
The substance of claim 17 wherein the capsules further comprise a core of about 7.5 μm diameter which is substantially devoid of therapeutic agent.
Claim 24
Dependent Claim
83 words
A substance for treatment of body tissue comprising: a plurality of capsules comprising an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue; said capsules having an outer diameter between about 15 and 150 microns, the capsules also having a core of about 7.5 μm diameter which is substantially devoid of therapeutic agent; said therapeutic agent having a pharmacological effect on the body tissue upon degradation of the encapsulating layer.
Claim 25
Dependent Claim
83 words
A substance for treatment of body tissue comprising: a plurality of capsules comprising an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue; said capsules having an outer diameter between about 15 and 150 microns, the capsules also having a core of about 7.5 μm diameter which is substantially devoid of therapeutic agent; said therapeutic agent having a pharmacological effect on the body tissue upon degradation of the encapsulating layer.
Claim 26
Dependent Claim
66 words
A substance for treatment of body tissue comprising: a plurality of microspheres comprising an outer layer and an inner core, the outer layer incorporating a therapeutic agent, the inner core comprising a substantially inert agent, the outer layer being degradable when injected into the body tissue thereby releasing the therapeutic agent to the body tissue; said therapeutic agent having a pharmacological effect on the body tissue.
Claim 27
Dependent Claim
66 words
A substance for treatment of body tissue comprising: a plurality of microspheres comprising an outer layer and an inner core, the outer layer incorporating a therapeutic agent, the inner core comprising a substantially inert agent, the outer layer being degradable when injected into the body tissue thereby releasing the therapeutic agent to the body tissue; said therapeutic agent having a pharmacological effect on the body tissue.
References Cited (Backward Citations)
US4146029A
Cited
US4797285A
Cited
US5190761A
Cited
US5324325A
Cited
US5634895A
Cited
US5681278A
Cited
US5527344A
Cited
US5662929A
Cited
US5551427A
Cited
US5690682A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2005-09-02 | 2006-03-04 | 2006-09-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-09-02 | 2010-03-04 | 2010-09-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-09-02 | 2014-03-04 | 2014-09-03 | $7700.00 | Window Closed / Lapsed |