Delivery of biological compounds to ischemic and/or infarcted tissue

• US 8,137,333 B2
• Filed: 07/25/2007
• Issued: 03/20/2012
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Voyage Medical, Inc.
• Inventors: Saadat, Vahid, Rao, Sekhar A.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Bosques, Edelmira
• Application Number:
  US11/828,267
• Publication Number:
  US 20080033290A1
• Time in Patent Office: 1,700 Days
• Field of Search: 604/506, 604/104, 606/192, 606/194, 606/200
• US Class Current: 604/506
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/12 with cooling or rinsing arrangements
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

The delivery of biological compounds to ischemic and/or infarcted tissue are described herein where such a system may include a deployment catheter and an attached imaging hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. Additionally, any number of therapeutic tools can also be passed through the deployment catheter and into the imaging hood for performing any number of procedures on the tissue for identifying, locating, and/or accessing ischemic and/or infarcted tissue.

Claims

1. A method of identifying a tissue region of interest for treatment, comprising:

intravascularly advancing a deployment catheter towards the tissue region of interest through a vessel of a subject;

expanding a non-inflatable barrier or membrane defining an open area in fluid communication with an environment external to the barrier or membrane and projecting distally from the deployment catheter against the tissue region of interest;

urging a transparent fluid into the open area such that the fluid is retained within the open area when placed against or in proximity to the tissue region of interest and where the fluid is further displaced into the environment external to the barrier or membrane such that an opaque fluid is displaced from the open area;

visualizing the tissue region of interest via a visualization element through the transparent fluid; and

assessing at least one parameter of the tissue region.

2. The method of claim 1 wherein intravascularly advancing comprises advancing the deployment catheter into a chamber of a patient heart.

3. The method of claim 1 wherein expanding comprises self-expanding the barrier or membrane from a low-profile delivery configuration into an expanded deployed configuration.

4. The method of claim 1 wherein urging a transparent fluid comprises pumping the transparent fluid into the open area through a fluid delivery lumen defined through the deployment catheter.

5. The method of claim 4 wherein pumping the transparent fluid comprises urging saline, plasma, water, or perfluorinated liquid into the open area such that blood is displaced.

6. The method of claim 1 wherein visualizing comprises imaging the tissue region via an imaging element positioned within or adjacent to the expanded barrier or membrane.

7. The method of claim 1 wherein assessing comprises visually inspecting the tissue region for indications of ischemic and/or infarcted regions of tissue.

8. The method of claim 7 further comprising administering a fluorescent compound upon or into the tissue region prior to visually inspecting the tissue region.

9. The method of claim 8 wherein the fluorescent compound comprises indocyanin green.

10. The method of claim 1 wherein assessing comprises measuring a partial pressure of oxygen and/or carbon dioxide present in the tissue region.

11. The method of claim 1 wherein assessing comprises measuring a temperature of the tissue region.

12. The method of claim 1 wherein assessing comprises measuring for a presence of a biomarker indicative of tissue injury.

13. The method of claim 12 wherein the biomarker is selected from the group consisting of troponin T, troponin I, troponin C;

creatine phosphokinase, MB fraction (CKMB), myoglobin, lactate dehydrogenase (LDH), and combinations thereof.

14. The method of claim 1 wherein assessing comprises detecting differences in electrical current and/or electrical potential in the tissue region.

15. The method of claim 1 wherein assessing comprises measuring relative tissue hardness and/or deflection over the tissue region.

16. The method of claim 1 further comprising identifying injured tissue based upon an assessment of the at least one parameter.

17. The method of claim 16 further comprising treating the injured tissue with a bioactive agent.

18. The method of claim 17 wherein treating comprises injecting or infusing the bioactive agent upon or into the injured tissue.

19. The method of claim 17 wherein the bioactive agent is selected from the group consisting of stem cells, vascular endothelial growth factor, fibroblast growth factor, pro-angiogenic cytokines, tumor necrosis factor alpha, interleukin 8, SIKVAV, and neuropeptide Y.

20. The method of claim 16 further comprising treating the injured tissue with a chemical irritant.

21. The method of claim 1 further comprising ablating the tissue region of interest based upon an assessment of the at least one parameter.