Devices and methods for interstitial injection of biologic agents into tissue

• US 20050209564A1
• Filed: 11/30/2004
• Published: 09/22/2005
• Est. Priority Date: 01/13/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Usher, Raymond W., Rothstein, Paul T., Keogh, James R., Bonner, Matthew D., Hiniduma-Lokuge, Prasanga D., Chen, Victor T., Jahns, Scott Eric
• Granted Patent: US 7,628,780 B2
• Time in Patent Office: Days
• US Class Current: 604/173
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/2936 Pins in guiding slots
• 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: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Claims

1. A device for injecting cells into tissue, the device comprising:

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;

a plurality of hollow needles having a sharp distal end and at least one discharge port, the needles operably coupled to the elongate shaft distal region;

means for driving the sharp distal ends of the needles into the area of tissue grasped by the suction member; and

means for discharging cells from the needle discharge ports into the area of tissue grasped by the suction member.

6. A device as in claim 1, wherein the fluid discharge means includes a proximal pressure source and a lumen disposed along the length of the elongate shaft in fluid communication with both the hollow needles and the proximal pressure source.

7. A device as in claim 6, wherein the proximal pressure source includes a syringe.

9. A device as in claim 1, wherein the plurality of needles have substantially different lengths among the needles.

10. A device as in claim 1, wherein the plurality of needles have substantially same lengths among the needles.

11. A device as in claim 1, further comprising:

a needle trigger operably coupled to the needle driving means for initiating the needle driving means to drive the needles; and

a discharge trigger operably coupled to the cell discharge means for initiating the discharge of cells from the needles.

12. A device as in claim 1, wherein the needles have a plurality of side holes in at least two different positions along the needle length.

13. A device as in claim 1, wherein the device includes means for controllably varying the needle penetration depth into the tissue.

14. A device as in claim 1, wherein the suction member includes one or more sensors.

15. A device as in claim 14, wherein the one or more sensors are coupled to a controller.

16. A device as in claim 15, wherein the controller is coupled to a vacuum source.

17. A device as in claim 1, wherein the means for discharging cells comprises one or more syringes.

18. A device for injecting a biological substance into tissue, the device comprising:

an elongate shaft including a longitudinal axis, a proximal region, and a distal region;

a suction member coupled to the shaft distal region, the suction member having a surface sized and shaped for contacting the tissue;

one or more needles slidably disposed through the suction member for injecting the substance into the tissue; and

a needle driver for driving the one or more needles past the suction member and into the tissue.

19. A device as in claim 18, wherein the needle driver includes means for transferring a longitudinal force directed along the shaft to drive the one or more needles past the suction member and into the tissue.

20. A device as in claim 19, wherein the means for transferring force includes a substantially planar member, wherein the planar member has the one or more needles fixedly and transversely attached thereto.

21. A device as in claim 18, further comprising a first fluid lumen coupled to a first set of one or more needles.

22. A device as in claim 21, wherein the first fluid lumen is also coupled to a first reservoir.

23. A device as in claim 21, further comprising a second fluid lumen coupled to a second set of one or more needles.

24. A device as in claim 23, wherein the second fluid lumen is also coupled to a second reservoir.

25. A device as in claim 18, wherein the suction member comprises a plurality of vacuum pods disposed on the tissue-contacting surface.

26. A device as in claim 18, wherein the biological substance comprises cells.

2. A device as in claim 1, wherein the means for driving the needles along the needle axes includes a first body having the needles fixedly attached thereto and the suction member having the needles slidably disposed therethrough.

3. A device as in claim 2, wherein the first body includes a substantially planar portion substantially perpendicular to the needle axes.

4. A device as in claim 2, wherein the means for driving the needles along the needle axes includes means for driving the first body toward the suction member.

5. A device as in claim 2, wherein the means for discharging fluid includes the first body having a fluid manifold and the needles having fluid entry ports in communication with the fluid manifold.

8. A device as in claim 2, wherein the suction member includes a plurality of vacuum pods facing away from the first body.

27. A device as in claim 18, wherein the biological substance comprises platelet gel.

28. A method as in claim 26, wherein the making opening step includes making a xiphoid opening below the sternum.

29. A method as in claim 26, wherein the injecting the substance step includes injecting a substance selected from the group consisting of bone marrow cells, stem cells, embryonic stem cells, pluripotent stem cells, mesenchymal stem cells, and satellite muscle cells.

30. A method as in claim 26, wherein the injecting the substance step includes injecting a substance selected from the group consisting of growth factors, vascular endothelial growth factors, and angiogenesis promoting agents.

31. A method as in claim 26, wherein the making opening step includes making a sternotomy.

32. A method as in claim 26, further comprising the step of sensing contractions of the heart.

33. A method as in claim 32, wherein the injecting the substance step occurs between contractions of the heart.

34. A method as in claim 33, wherein the heart is temporarily stopped using vagal nerve stimulation.

35. A method as in claim 26, further comprising:

providing a suction assisted positioning device;

engaging the heart with the positioning device; and

,

positioning the heart into a non-physiological orientation.

36. A method as in claim 35, wherein the injecting the substance step occurs following the positioning of the heart in a non-physiological orientation step.

37. A method as in claim 26, wherein the injecting the substance step includes injecting a substance selected from the group consisting of platelet rich plasma, platelet poor plasma, fibrinogen and a clotting agent.

38. A method as in claim 37, wherein the clotting agent is thrombin.

26-1. A method for epicardially injecting a substance into an area of tissue of a heart having an epicardial surface and disposed within a torso, the method comprising:

providing a substance-injecting device including a suction member, a plurality of needles slidably coupled to the suction member, an elongate shaft having a longitudinal axis, a proximal region, a distal region, and a needle driver coupled to the elongate shaft distal region for driving the needles substantially parallel to the elongate shaft distal region longitudinal axis, through the suction member and into tissue;

making an opening into the torso;

advancing the injecting device through the opening to the epicardial surface of the heart;

grasping an area of tissue of the heart via the suction member;

driving the needles into the area of tissue grasped by the suction member; and

injecting the substance from the device into the area of tissue grasped by the suction member.

27-2. A method as in claim 26, wherein the making opening step includes making an intercostal opening.