Myocardial Therapeutics, Inc.

Medivas, LLC

Michelle Fourmont

Kazuo Sasamine

Kenneth W Carpenter

Hong Li

E Thomas Malphus

The invention tissue injection catheters are designed to facilitate injection of a therapeutic or diagnostic agent to an interior body cavity, especially the myocardium or epicardium of the heart with precisely controlled depth penetration. The invention injection catheters, which include mechanisms for precisely controlling the length of needle tip exposed for tissue penetration, are designed to be used in an assemblage with a sterile container and delivery actuator for reinjection of autologous cell-containing fluids, such as autologous bone marrow aspirate. In preferred embodiments, the assemblage is designed to be hand-held. When used in such an assemblage, the invention catheters are particularly useful as a gene delivery device to effect angiogenesis of ischemic areas of the heart.

Flexible tissue injection catheters with controlled depth penetration

The invention provides systems containing a sterile container for aspiration, filtering, treating and reinjection into a subject of a bodily fluid in a sterile environment. The systems are particularly designed to facilitate transfection of cells within the sterile container by gene therapy molecules and reinjection of the transfected cells into the donor at controlled depth in precisely controlled volumes such as is useful for revascularization of ischemic cardiac tissue. For injection, a pressure actuator, preferably hand-held, applies force to liquids held within the sterile container in precisely controlled increments, thereby expressing liquids through a hollow needle or injection catheter in precisely controlled microvolumes. The invention systems include a hand-held injection device with audible cues that correspond to an operator-selected injection volume and/or audible cues that correspond to needle penetration depth selected by the operator.

Sterile aspiration/reinjection systems

A flexible stabilizer arm assembly is provided that can be positioned in a desired three-dimensional attitude and then fixed in place to forceably hold an object against an undulating surface. In one embodiment, the invention assembly comprises a mounting base for attachment of the arm to a stationary fixture, a flexible arm of multiple articulated elongate links rotatably joined to adjacent links, a freely rotatable turret joint at the distal end of the arm that is adapted to attach an appendage in freely rotatable fashion to the distal end of the arm. Once positioned, a tightening mechanism is actuated to fix the attitude of the arm with respect to the mounting base. Optionally, the appendage is a two-tined foot adapted for holding a surgical instrument, such as a suction body, against a beating heart. The flexible arm, which ranges up to 12 inches in length, can withstand an undulating force exerted against the distal end of up to 20 pounds while remaining in the fixed position. To stabilize the arm under these conditions, the arm preferably comprises multiple articulated elongate links and a joining piece that substantially increases the friction fit of the arm to the mounting base so as to withstand a counter-force of up to 150 pounds.

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Carlsbad, CA, United States of America

Michelle Fourmont