Implant delivery catheter system and methods for its use

• US 6,478,776 B1
• Filed: 04/05/2000
• Issued: 11/12/2002
• Est. Priority Date: 04/05/2000
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Miller, Aaron J., Lovich, Mark A., Schwartz, Micheal A., Altman, Peter A., Rosenman, Daniel C.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/543,127
• Time in Patent Office: 951 Days
• Field of Search: 604/523, 604/508, 604/507, 604/164.01, 604/502, 607/119-120, 607/122, 607/126, 607/127, 607/128
• US Class Current: 604/164.01
• 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 catheter system for implantation of a helical drug delivery coil into the myocardium of the heart of a patient through the vasculature of the patient, said catheter system comprising:

an outer sheath having a distal end adapted for percutaneous entry into the vasculature of the patient and navigation through the vasculature into the heart and a proximal end having a first handle, said outer sheath having a lumen extending through the sheath from the proximal end to the distal end thereof;

an inner core disposed within the lumen of the outer sheath, said inner core being rotatable within the outer sheath and longitudinally slidable within the outer sheath, said inner core having a distal end adapted for percutaneous entry into the vasculature of the patient and navigation through the vasculature into the heart and a proximal end having a second handle;

a first helix securely fixed to the distal end of the inner core, said helix sized and dimensioned to fit within the lumen of the outer sheath and be slidable and rotatable within the lumen of the outer sheath;

a second helix nested within the first helix and thereby releasably secured to the inner core.

2. The device of claim 1 further comprising:

a boss disposed on the distal end of the inner core sized and dimensioned to prohibit proximal movement of the second helix beyond the boss.

3. The device of claim 1 wherein the inner core comprises:

a first tube disposed within the outer sheath and having a distal end;

a second tube disposed within the outer sheath, said second tube having a lumen extending therethrough, said second tube being disposed coaxially over the first tube and having a distal end which terminates a short distance proximal to the distal end of the first tube thereby defining a distally facing shoulder around the first tube; and

wherein the first helix is fixed to the distal end of the first tube and the second helix is nested in the coils of the first helix and proximal helical rotation of the second helix out of the first helix is prevented.

4. A catheter system for implantation of an implant into the myocardium of the heart of a patient through the vasculature of the patient, said catheter system comprising:

an outer sheath having a distal end adapted for percutaneous entry into the vasculature of the patient and navigation through the vasculature into the heart and a proximal end having a first handle, said outer sheath having a lumen extending through the sheath from the proximal end to the distal end;

an inner core disposed within the lumen of the outer sheath, said inner core being rotatable within the outer sheath and longitudinally slidable within the outer sheath, said inner core having a distal end adapted for percutaneous entry into the vasculature of the patient and navigation through the vasculature into the heart and a proximal end having a second handle;

a helix securely fixed to the distal end of the outer sheath; and

a dart-like implant nested within the helix and thereby releasably secured to the inner core.

5. The device of claim 4 further comprising:

an internally threaded segment disposed within the outer sheath; and

an externally threaded segment disposed on the inner core, said externally threaded segment matched to the internally threaded segment of the outer core.