Devices and methods for interstitial injection of biologic agents into tissue

• US 20060041243A1
• Filed: 06/23/2005
• Published: 02/23/2006
• Est. Priority Date: 01/13/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul T., Keogh, James R., Jahns, Scott E., Bonner, Matthew D., Hiniduma-Lokuge, Prasanga D., Chen, Victor T., Nayak, Asha S., Usher, Raymond W.
• Granted Patent: US 7,740,623 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/2936 Pins in guiding slots
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001

Abstract

The current invention discloses a method for treating infracted/ischemic injury to a myocardium by injecting a substance into the myocardium. The injected substance helps to prevent negative adaptive remodeling by providing mechanical reinforcement or mechanical reinforcement combined with biological therapy. A number of substances for injection are disclosed, including multi component substances such as platelet gel, and other substances. The substances disclosed may contain additives to augment/enhance the desired effects of the injection. The invention also discloses devices used to inject the substances. The devices can include means for ensuring needles do not penetrate beyond a desired depth into the myocardium. The devices can also include needles having multiple lumens such that the components of the platelet gel will be combined at the injection site and begin polymerization in the myocardium.

Claims

1. A method for injecting platelet gel into ischemic tissue of a heart of a patient, the method comprising:

providing a source of platelet plasma;

providing a source of thrombin;

providing an injection device fluidly coupled to the source of platelet plasma and the source of thrombin and including a first needle for separately injecting platelet plasma into tissue and a second needle for separately injecting thrombin into tissue;

making an opening into the patient;

advancing the first and second needles of the injection device through the opening to the heart;

identifying ischemic tissue of the heart;

driving the first and second needles of the injection device into the ischemic tissue; and

injecting the platelet plasma and the thrombin separately into the ischemic tissue, wherein the platelet plasma and the thrombin combine within the ischemic tissue to form a platelet gel.

2. A method as in claim 1, wherein the making an opening step includes making an intercostal opening.

3. A method as in claim 1, wherein the making an opening step includes making a xiphoid opening below the sternum.

4. A method as in claim 1, wherein the making an opening step includes making a sternotomy.

5. A method as in claim 1, wherein the making an opening step includes making a percutaneous opening.

6. A method as in claim 1, wherein the platelet plasma is autologous.

7. A method as in claim 1, wherein the platelet plasma is non-autologous.

8. A method as in claim 1, wherein the thrombin is autologous.

9. A method as in claim 1, wherein the thrombin is non-autologous.

10. A method as in claim 1, wherein the platelet plasma is platelet rich plasma.

11. A method as in claim 1, wherein the platelet plasma is platelet poor plasma.

12. A method as in claim 1, wherein the injecting step occurs between contractions of the heart.

13. A method as in claim 1, wherein the heart is temporarily stopped using vagal nerve stimulation.

14. A method as in claim 1, further comprising:

providing a positioning device;

engaging the heart with the positioning device; and

,

positioning the heart into a non-physiological orientation.

15. A method as in claim 14, wherein the injecting step occurs following the positioning of the heart in a non-physiological orientation step.

16. A method as in claim 1, wherein the identifying ischemic tissue step includes the use of one or more sensors.

17. A method as in claim 1, wherein the injecting step occurs following a myocardial infarction.

18. A method as in claim 1, wherein the first and second needles each include a sharp distal end and at least one discharge port.

19. A method as in claim 18, wherein the injection device further includes:

a suction member for grasping an area of tissue;

an elongate shaft having a longitudinal axis, a proximal region and a distal region, the distal region coupled to the suction member and operably coupled to the first and second needles; and

a mechanism for driving the sharp distal ends of the first and second needles into the area of tissue grasped by the suction member.

20. A method as in claim 19, wherein the injection device includes a mechanism for controllably varying the needle penetration depth of the first and second needles into the tissue.

21. A method as in claim 19, wherein the suction member includes one or more sensors.

22. A method as in claim 18, wherein the first and second needles each include a distal discharge port.

23. A method as in claim 18, wherein the first and second needles each include a discharge port proximal the sharp distal end of the first and second needles.

24. A method as in claim 1, wherein the platelet plasma and the thrombin are injected multiple times into the ischemic tissue.

25. A method as in claim 24, wherein each injection of the platelet plasma and the thrombin into the ischemic tissue is at a different location.