Apparatus and method for promoting angiogenesis in ischemic tissue

• US 10,610,669 B2
• Filed: 03/16/2016
• Issued: 04/07/2020
• Est. Priority Date: 03/16/2016
• Status: Active Grant

• Current Assignee: Krishna Martinez-Singh, Krishna Rocha-Singh
• Original Assignee: Krishna Martinez-Singh, Krishna Rocha-Singh
• Inventors: Rocha-Singh, M.D., Krishna, Martinez-Singh, Krishna
• Primary Examiner(s): Medway, Scott J
• Application Number:
  US15/072,249
• Publication Number:
  US 20170266414A1
• Time in Patent Office: 1,483 Days
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A biologics delivery device and method of use for promoting angiogenesis in occluded vessels and ischemic tissue of a patient are provided, wherein the biologics delivery device includes a catheter having a proximal end, a distal region having a distal end, a lumen extending there between, and a plurality of through-wall apertures distributed along the distal region, the plurality of through-wall apertures in fluid communication with the proximal end and the lumen, and an expandable member disposed in the distal region, the expandable member configured to transition between a collapsed state and an expanded state. Methods of using the inventive biologics delivery device also are provided to achieve substantially uniform distribution of the biologic into a subintimal space.

Claims

1. A method of promoting angiogenesis in an ischemic area of a patient body, comprising:

accessing a subintimal space between an adventitial layer and an intimal layer of a vascular wall of an occluded blood vessel having a vessel lumen, the subintimal space having a surface;

providing a biologics delivery device comprising a catheter having a proximal end, a distal region having a distal end, a lumen extending therebetween, a catheter shaft, and a plurality of through-wall apertures in the catheter shaft along a longitudinal axis of the distal region of the catheter in fluid communication with the proximal end and the lumen, and an expandable member disposed over the plurality of through-wall apertures and configured to transition between a collapsed state and an expanded state;

introducing the distal end of the biologics delivery device from the vessel lumen through the intimal layer and into the subintimal space such that the expandable member is positioned in the subintimal space in the collapsed state;

transitioning the expandable member positioned in the subintimal space from the collapsed state to the expanded state to contact and support the surface of the subintimal space; and

while the expandable member is positioned in the subintimal space, delivering a biologic through the plurality of through-wall apertures of the biologics delivery device between the catheter and the expandable member, so that the biologic is distributed substantially uniformly along the distal region.

2. The method of claim 1, wherein providing the biologics delivery device comprises providing the biologics delivery device having the catheter in which the plurality of through-wall apertures are directed towards the adventitial layer.

3. The method of claim 1, wherein transitioning the expandable member to the expanded state comprises compressing a plurality of strands until the plurality of strands expands radially outward.

4. The method of claim 1, wherein providing the biologics delivery device comprises providing the biologics delivery device having the expandable member comprising a plurality of mesh cells.

5. The method of claim 1, further comprising measuring an amount of stem cells delivered through the plurality of through-wall apertures.

6. The method of claim 1, wherein delivering the biologic comprises delivering the biologic comprising one or more hematopoietic stem cells, endothelial progenitor cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells, or growth factors, or any combination thereof.