DEPLOYMENT SYSTEM FOR MYOCARDIAL CELLULAR MATERIAL

• US 20100137835A1
• Filed: 02/05/2010
• Published: 06/03/2010
• Est. Priority Date: 07/15/2003
• Status: Active Grant

• Current Assignee: Howard J. Leonhardt, Robert D. Lashinski
• Original Assignee: Howard J. Leonhardt, Robert D. Lashinski
• Inventors: Leonhardt, Howard J., Lashinski, Robert D.
• Granted Patent: US 8,308,708 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0086 the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

A catheter-based deployment system for deploying cellular material (22) into the heart muscle (25). The deployment system includes a guiding catheter (19) and a needle assembly (31) capable of sliding within the guiding catheter. The needle assembly (31) terminates in a tip (34) having at least one side with an opening (43) in communication with a lumen (20) disposed within the needle assembly (31). Once the guiding catheter (19) is positioned, the needle assembly (31) is advanced until the tip (34) penetrates the muscle wall (25). At a predetermined depth the cellular material (22) may be deployed into the muscle wall (25) via a push rod (46) disposed through the lumen of the needle assembly (31).

Claims

1. A deployment system for a myocardial cellular material, comprising:

a guiding catheter having at least one lumen defined therein and wherein a distal portion of the guiding catheter is articulatable;

a needle assembly capable of sliding through the lumen of the guiding catheter, the needle assembly having a lumen defined therein and terminating in a tip, the tip having at least one side which is proximal to the tip, the needle assembly having an opening in the at least one side of the tip disposed in communication with the lumen of the needle assembly so that the myocardial cellular material can be deployed into a myocardial wall from inside the lumen of the needle assembly, wherein the opening is proximal to the tip;

an anchor wire disposed axially through the tip and capable of engaging with a portion of the myocardial wall to position the needle assembly relative to the myocardial wall,

wherein the guiding catheter has an outer wall having a distal end, wherein the distal end forms an anchor extending frontwardly so as to hold the guiding catheter in a position against the myocardial wall; and

wherein the myocardial cellular material comprises stem cells.

2. The deployment system as in claim 1 wherein the stem cells are disposed in the lumen of the needle assembly and wherein the stem cells are differentiated to become cardiomyocyte-like.

3. The deployment system as in claim 2 wherein the stem cells have been transformed with a gene encoding nitric oxide synthase.

4. The deployment system as in claim 3 wherein the myocardial cellular material comprises vascular endothelium growth factors.

5. A deployment system for a myocardial cellular material, comprising:

a guiding catheter having at least one lumen defined therein and wherein a distal portion of the guiding catheter is articulatable;

a needle assembly capable of sliding through the lumen of the guiding catheter, the needle assembly having a lumen defined therein and terminating in a tip, the tip having at least one side which is proximal to the tip, the needle assembly having an opening in the at least one side of the tip disposed in communication with the lumen of the needle assembly, wherein the opening is proximal to the tip;

an anchor wire disposed axially through the tip and capable of engaging with a portion of a myocardial wall to position the needle assembly relative to the myocardial wall,

wherein the guiding catheter has an outer wall having a distal end, wherein the distal end forms an anchor extending frontwardly so as to hold the guiding catheter in a position against the myocardial wall; and

wherein the myocardial cellular material comprises cells and at least one growth factor.

6. The deployment system as in claim 5 wherein the cells comprise at least one of skeletal muscle cells and fetal endothelial cells, and wherein the cells are disposed in the lumen of the needle assembly.

7. The deployment system as in claim 6 wherein the myocardial cellular material comprises growth factors.

8. A method of deploying a myocardial cellular material, comprising:

providing a guiding catheter having at least one lumen defined therein and a needle assembly capable of sliding through the lumen of the guiding catheter, the needle assembly having a lumen defined therein and terminating in a tip, the tip having at least one side one side which is proximal to the tip, the needle assembly having an opening in the at least one side of the tip disposed in communication with the lumen of the needle assembly so that the myocardial cellular material can be deployed into a myocardial wall from inside the lumen of the needle assembly, wherein the opening is proximal to the tip;

advancing the guiding catheter through a patient'"'"'s body to the myocardial wall and utilizing an anchor wire disposed axially through the tip as a guidewire to engage the myocardial wall and position the needle assembly relative to the myocardial wall, wherein the guiding catheter has an outer wall having a distal end, wherein the distal end forms an anchor extending frontwardly so as to hold the guiding catheter in a position against the myocardial wall;

deploying the needle assembly by inserting the tip of the needle assembly into the myocardial wall; and

deploying the myocardial cellular material into the myocardial wall through the opening in the side of the tip, wherein the myocardial cellular material comprises at least one of stem cells and skeletal muscle cells and endothelial cells.

9. The method of claim 8, further comprising:

articulating a distal end of the guiding catheter to position the tip relative to the myocardial wall.

10. The method of claim 9, wherein the tip of the needle assembly has a point at its distal end.

11. The method of claim 8, wherein the needle assembly is capable of articulating.

12. The method of claim 9, wherein the guiding catheter further comprises a distal end having a sensor.

13. The method of claim 12, wherein the sensor is an opto-electric sensor.

14. The method of claim 12, wherein the needle assembly has a cradle for holding a charge of the myocardial cellular material, the cradle disposed between the lumen in the needle assembly and the opening in the side of the tip.