Apparatus and methods for performing percutaneous myocardial revascularization and stimulating angiogenesis using autologous materials

• US 6,432,119 B1
• Filed: 10/27/1999
• Issued: 08/13/2002
• Est. Priority Date: 03/17/1999
• Status: Expired due to Fees

• Current Assignee: Angiotrax, Inc.
• Original Assignee: Angiotrax, Inc.
• Inventors: Saadat, Vahid
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/428,698
• Time in Patent Office: 1,021 Days
• Field of Search: 606/1, 606/14, 606/45, 606/46, 606/108, 606/159, 606/170, 606/171, 606/180, 606/564, 606/565, 128/898
• US Class Current: 606/170
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration
• 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: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence

Abstract

Methods are provided for collecting and processing autologous biological materials to form autologous angiogenic agents. Apparatus and methods also are provided for performing percutaneous myocardial revascularization wherein an injection needle is disposed in spaced-apart relation to the channel-forming tool, so that a predetermined amount of the autologous angiogenic agent may be injected into the myocardium adjacent to the PMR channel.

Claims

1. A method of performing percutaneous myocardial revascularization of a patient comprising:

collecting autologous biological material from the patient;

preparing the autologous biological material to form an angiogenic agent;

providing a catheter adapted for insertion into the left ventricle comprising a hollow stabilizer element and a cutting head movable from a retracted position to an extended position;

advancing a distal region of the catheter transluminally to a position within the patient'"'"'s left ventricle;

deploying the stabilizer element to stabilize the distal region of the catheter in contact with an endocardial surface;

advancing the cutting head from the retracted to the extended position to bore a channel into the patient'"'"'s cardiac tissue; and

injecting an amount of the angiogenic agent through the hollow stabilizer element into a region of the patient'"'"'s cardiac tissue adjacent to the channel.

2. The method of claim 1 wherein the stabilizer element comprises a first retractable needle and deploying the stabilizer element comprises advancing the retractable needle to penetrate into the patient'"'"'s cardiac tissue.

3. The method of claim 1 wherein collecting autologous biological material from the patient comprises collecting a quantity of whole blood from the patient.

4. The method of claim 3 wherein preparing the autologous biological material comprises centrifuging the whole blood to form a platelet-rich plasma.

5. The method of claim 4 wherein preparing the autologous material further comprises activating the platelet rich plasma.

6. The method of claim 5 wherein activating the platelet rich plasma further comprises activating the platelet rich plasma with purified thrombin.

7. The method of claim 1 wherein collecting autologous biological material from the patient comprises harvesting cells from the patient'"'"'s cardiac tissue or bone marrow.

8. The method of claim 7 wherein preparing the autologous material further comprises culturing the harvested cells in vitro.

9. The method of claim 1 further comprising aspirating cardiac tissue severed by the cutting head.

10. The method of claim 1 further comprising, after the step of preparing an angiogenic agent, storing the angiogenic agent under refrigeration.

20. The method of claim 1 further comprising, after the step of preparing an angiogenic agent, storing the angiogenic agent under refrigeration.

11. A method of performing percutaneous revascularization of a patient'"'"'s cardiac tissue, the method comprising:

collecting autologous biological material from the patient;

preparing the autologous biological material to form an angiogenic agent;

providing a catheter adapted for insertion into the left ventricle comprising a hollow needle movable from a retracted position to an extended position and a cutting head movable from a retracted position to an extended position;

advancing a distal region of the catheter transluminally to a position within a patient'"'"'s left ventricle;

advancing the hollow needle to the extended position to penetrate and stabilize the distal region of the catheter in contact with an endocardial surface;

rotating the cutting head;

advancing the cutting head from the retracted to the extended position to bore a channel into the patient'"'"'s cardiac tissue; and

injecting an amount of the angiogenic agent through the hollow needle into a region of the patient'"'"'s cardiac tissue adjacent to the channel.

12. The method of claim 11 wherein injecting an amount of the angiogenic agent comprises injecting a predetermined bolus of angiogenic agent to form a pocket of angiogenic material adjacent to the channel.

13. The method of claim 11 wherein collecting autologous biological material from the patient comprises collecting a quantity of whole blood from the patient.

14. The method of claim 13 wherein preparing the autologous biological material comprises centrifuging the whole blood to form a platelet-rich plasma.

15. The method of claim 14 wherein preparing the autologous material further comprises activating the platelet rich plasma.

16. The method of claim 15 wherein activating the platelet rich plasma further comprises activating the platelet rich plasma with purified thrombin.

17. The method of claim 11 wherein collecting autologous biological material from the patient comprises harvesting cells from the patient'"'"'s cardiac tissue or bone marrow.

18. The method of claim 17 wherein preparing the autologous material further comprises culturing the harvested cells in vitro.

19. The method of claim 11 further comprising aspirating cardiac tissue severed by the cutting head.

21. A method of performing percutaneous myocardial revascularization of a patient comprising:

preparing biological material to form an angiogenic agent;

providing a catheter adapted for insertion into the left ventricle comprising a hollow stabilizer element;

advancing a distal region of the catheter transluminally to a position within the patient'"'"'s left ventricle;

deploying the stabilizer element to stabilize the distal region of the catheter in contact with an endocardial surface; and

injecting an amount of the angiogenic agent through the hollow stabilizer element into the patient'"'"'s cardiac tissue,

wherein the stabilizer element comprises a first retractable needle and deploying the stabilizer element comprises advancing the retractable needle to penetrate into the patient'"'"'s cardiac tissue.

22. The method of claim 21 further comprising, prior to preparing biological material, collecting the biological from the patient.

23. The method of claim 22, wherein the biological material comprises autologous biological material.

24. The method of claim 23 wherein collecting autologous biological material from the patient comprises collecting a quantity of whole blood from the patient.

25. The method of claim 24 wherein preparing the autologous biological material comprises centrifuging the whole blood to form a platelet-rich plasma.

26. The method of claim 25 wherein preparing the autologous material further comprises activating the platelet rich plasma.

27. The method of claim 26 wherein activating the platelet rich plasma further comprises activating the platelet rich plasma with purified thrombin.

28. The method of claim 23 wherein collecting autologous biological material from the patient comprises harvesting cells from the patient'"'"'s cardiac tissue or bone marrow.

29. The method of claim 28 wherein preparing the autologous material further comprises culturing the harvested cells in vitro.

30. The method of claim 21, wherein the catheter further comprises a cutting head movable from a retracted position to an extended position.

31. The method of claim 30 further comprising, after deploying the stabilizer element, advancing the cutting head from the retracted to the extended position to bore a channel into the patient'"'"'s cardiac tissue.

32. The method of claim 31, wherein injecting the angiogenic agent into the patient'"'"'s cardiac tissue adjacent injecting into a region of the patient'"'"'s cardiac tissue adjacent to the channel.

33. The method of claim 31 further comprising aspirating cardiac tissue severed by the cutting head.

34. The method of claim 21 further comprising, after the step of preparing an angiogenic agent, storing the angiogenic agent under refrigeration.