Implant delivery catheter system and methods for its use

• US 20060084943A1
• Filed: 12/06/2005
• Published: 04/20/2006
• Est. Priority Date: 04/05/2000
• Status: Active Grant

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Altman, Peter A., Rosenman, Daniel C., Miller, Aaron J., Schwartz, Michael A., Lovich, Mark A.
• Granted Patent: US 8,529,550 B2
• Time in Patent Office: Days
• US Class Current: 604/890.100
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• 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: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

Catheter systems and methods for implanting helical or dart-like implants into the myocardium or other body tissue. The catheter system includes a helix for fixing the distal end of the catheter to the myocardium, an implant held by the helix, mechanisms for driving the fixation helix into the myocardium, and mechanisms for driving the implant into the myocardium, removing the fixation helix and leaving the implant behind. The implant may be coated, filled, or made of a drug or drug eluting compound, or drug delivery matrix of any composition.

Claims

1. A method of delivery of a therapeutic agent to a depth within the myocardium including the steps of:

providing a helical shaped controlled release structure having a therapeutic agent selected from the set of agents consisting of macromolecules, gene therapy preparation, microspheres and micelles;

penetrating the endocardium of the heart with the helical shaped controlled release structure attached to a tube or catheter;

implanting the helical shaped controlled release structure to a depth within the myocardium; and

delivering therapeutic agents to the heart tissue over time by diffusion, elution, osmosis, or hydrolysis from the implanted controlled release structure;

2. The method of claim 1 in which the therapeutic includes one or more agents selected from the set of angiogenic agents consisting of:

VEGF-165, VEGF-121, VEGF-145, FGF-1, FGF-2, Transforming Growth Factor (TGF-B), Tumor Necrosis Factor a (TNF-a), Tumor Necrosis Factor B (TNF-B), Angiogenin, Interleukin-8, Proliferin, Prostaglandins (PGE), Placental Growth factor, Granulocyte Growth Factor, Platelet Derived Endothelial Cell Growth Factor, Hepatocyte Growth Factor, DEL-1, Angiostatin-1 and Pleiotrophin.

3. A method of delivery of a therapeutic agent selected from the set consisting of macromolecule, gene therapy preparation, microspheres, or micelles to a region surrounding a tumor including the steps of:

penetrating the interstitium around the tumor with a helical structure attached to a tube or catheter;

implanting a helical shaped controlled release structure to a depth within the body tissue; and

delivering therapeutic agents to the heart tissue over time by diffusion, elution, osmosis, or hydrolysis from the implanted controlled release structure.

4. The method of claim 3 in which the therapeutic includes one or more agents selected from the set of cytotherapeutic agents consisting of:

cytotoxic agents, chemotherapeutic agents, growth inhibitory agents, apoptotic agents, anti-HER-2, anti CD20, paclitaxel and cisplatin.

5. A catheter system comprising:

an elongate flexible body having a proximal end and a distal end;

a disengageable distally located drug delivery depot, where the depot is a hollow structure with one or more apertures containing a therapeutic agent within its hollow structure;

a mechanism at the proximal end of the flexible body for disengaging said disengageable distally located drug depot; and

a fixation means on said disengageable distally located drug delivery depot that may be used within the body ducts and vasculature to implant drug delivery depots reservoir to a depth within an intended tissue, so that the depot is below the surface of the tissue.

6. The system of claim 5 wherein the drug delivery depot is a helical structure.

7. The system of claim 5 wherein the drug delivery depot is a dart structure.

8. The system of claim 5 wherein the apertures comprises slots or circular holes sized and positioned to control a rate of therapeutic diffusion from the hollow structure.

9. The system of claim 5 wherein the therapeutic agent is an agent selected from the group consisting of angiogenic agents, endothelial agents, antibodies and tumor necrosis factors.

10. The system of claim 5 wherein the drug delivery depot comprises a porous construction capable of wicking up the therapeutic fluid through capillary action.