Method of drug delivery to interstitial regions of the myocardium

• US 20060020158A1
• Filed: 09/06/2005
• Published: 01/26/2006
• Est. Priority Date: 03/13/1997
• Status: Abandoned Application

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Altman, Peter A.
• Application Number:
  US11/220,794
• Publication Number:
  US 20060020158A1
• Time in Patent Office: Days
• US Class Current: 600/7
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/50 Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: Y10S 977/775 Nanosized powder or flake, e.g. nanosized catalyst
• CPC Class Codes: Y10S 977/907 Liposome

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.

Claims

1. A method for interventional treatment of a patient having a lymphatic system and heart with a myocardium comprising:

providing a catheter having a tissue penetrating element disposed on its distal end and an inner lumen extending from its proximal end to its distal end;

providing a microdrug fluidic delivery system comprising a plurality of microspheres, said microsperes having an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue;

said microspeheres sized and dimensioned to prevent take up by the lymphatic system for a first time period;

said therapeutic agent comprising a genetic material;

injecting said microdrug interstitially to a depth within the myocardium to a first treatment site using the catheter;

treating the first treatment site for the first time period;

transporting the microdrug delivery system through a lymphatic system to a second treament site after the first time period;

treating a second treatment site within the patient with the microdrug delivery system.

2. The method of claim 1 wherein the microspheres are less than 400 nm in size.

3. The method of claim 1 wherein the microspheres are between about 220 nm to about 250 nm in size.

4. The method of claim 1 wherein the first time period is between about 5 minutes to about 60 minutes.

5. The method of claim 1 wherin the therapeutic agent is an angiogenic protein.

6. The method of claim 1 wherein the therpeutic agent is an antiarrythmic agent.

7. The method of claim 1 wherein the therpeutic agent is an antirestenosis agent.

8. The method of claim 1 wherein the first treament site it the ventrical wall and the second treatment site is the atrium wall.

9. A system for interventional treatment of a patient having a lymphatic system and a heart with a myocardium comprising:

a catheter having a tissue penetrating element disposed on its distal end and an inner lumen extending from its proximal end to its distal end, said tissue penetrating element adapted to penetrate the endocardium of a chamber of a heart to a depth withing the myocardium; and

a microdrug fluidic delivery system disposed within the catheter comprising a plurality of microspheres, said microsperes having an encapsulating layer and a therapeutic agent within the encapsulating layer, wherein said encapsulating layer is degradable when injected into the body tissue;

said therapeutic agent comprising a genetic material;

said microspeheres sized and dimensioned to prevent take up by the lymphatic system for a first time period.

10. The system of claim 9 wherein the microspheres are less than 400 nm in size.

11. The system of claim 9 wherein the microspheres are between about 220 nm to about 250 nm in size.

12. The system of claim 9 wherein the first time period is between about 5 minutes to about 60 minutes.

13. The system of claim 9 wherein the therapeutic agent is an angiogenic protein.

14. The system of claim 9 wherein the therpeutic agent is an antiarrythmic agent.

15. The system of claim 9 wherein the therpeutic agent is an antirestenosis agent.