Implant delivery catheter system and methods for its use

• US 6,971,998 B2
• Filed: 11/12/2002
• Issued: 12/06/2005
• Est. Priority Date: 04/05/2000
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Schwartz, Micheal A., Miller, Aaron J., Altman, Peter A., Rosenman, Daniel C., Lovich, Mark A.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Virdi, Sundeep
• Application Number:
  US10/292,667
• Publication Number:
  US 20030073972A1
• Time in Patent Office: 1,120 Days
• Field of Search: 604/164.01, 604/523, 604/500, 604/502, 604/508, 604/164.1, 604/57, 604/93.01, 607119-120, 607/122, 607/126, 607/127, 607/128
• US Class Current: 604/57
• 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 delivering a therapeutic agent to a depth within the myocardium, said method comprising steps of:

providing a tube;

filling the lumen of the tube with a therapeutic agent by tamping an open end of the tube into a reservoir of therapeutic agent;

forming the tube into a helical coil;

covering the tube with a sleeve;

twisting the helical coil so that it penetrates the endocardium, thereby driving the helical tube into the endocardium; and

leaving the helical tube implanted in the endocardium and permitting the therapeutic agent to transit from lumen of the helical tube to the endocardium over time.

2. The method of claim 1 further comprising the step of:

providing the therapeutic agent in the form of lyophilized protein powder, macromolecules, gene therapy preparations, microspheres, or micelles.

3. The method of claim 1 further comprising the step of:

filling the lumen of the tube with a biodegradable polymer loaded with the therapeutic agent.