Microcatheter Devices and Methods for Targeted Substance Delivery

• US 20060173440A1
• Filed: 04/14/2006
• Published: 08/03/2006
• Est. Priority Date: 01/17/2001
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Lamson, Theodore C., Macaulay, Patrick
• Granted Patent: US 8,979,801 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0092 Single injection needle protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: Y02E 50/30 Fuel from waste, e.g. synthetic alcohol or diesel

Abstract

Delivery catheters useable to deliver substances, articles or devices to target locations within the bodies of human or animal subjects. The delivery catheter generally comprises a catheter having a tissue penetrating distal tip member on the distal end and one or more delivery aperture(s) whereby a substance, article or device may be delivered through the lumen of the catheter body and out of the delivery aperture(s). In some applications, the substance delivery catheter is used in combination with a transluminal tissue penetrating catheter having a penetrator that is advanced to a first location. The delivery catheter is then advanced through (or over) the penetrator, through intervening tissue, to a desired target location.

Claims

1. A delivery catheter device useable to deliver a substance, article or device to a location within the body of human or animal subject, comprising:

a catheter body having a side wall, a lumen and a distal end;

a tissue penetrating distal tip member on the distal end of the catheter body; and

at least one aperture formed in the side wall of the catheter body such that substance delivered through the lumen of the catheter body will flow out of said at least one aperture.

2. A delivery catheter device according to claim 1 wherein the tissue penetrating distal tip member is formed substantially of radiopaque material.

3. A delivery catheter device according to claim 1 wherein the tissue penetrating distal tip member is radiographically distinguishable from the catheter body.

4. A delivery catheter device according to claim 1 wherein the tissue penetrating distal tip member is substantially formed of metal.

5. A delivery catheter device according to claim 4 wherein the catheter body is formed substantially of polymeric material.

6. A delivery catheter device according to claim 1 wherein at least a distal portion of the catheter body is formed of a first metal and the tissue penetrating distal tip member is formed of a second metal.

7. A delivery catheter device according to claim 6 wherein at least a distal portion of the catheter body is formed of a metal selected from steel and nickel-titanium alloy and the tissue penetrating distal tip member is formed substantially of platinum.

8. A delivery catheter device according to claim 1 wherein the tissue penetrating distal tip member comprises metal and additionally functions as an electrode.

9. A delivery catheter device according to claim 1 wherein substance from the lumen of the catheter body does not flow through the tissue penetrating distal tip member.

10. A delivery catheter device according to claim 9 wherein the tissue penetrating distal tip member has an opening through which substance from the lumen of the catheter body may flow through the tissue penetrating distal tip member.

11. A system comprising a substance delivery catheter device according to any of claims 1-10 in combination with a tissue penetrating catheter device that is positionable within a body lumen and has a tissue penetrating member that is advancable to a first location outside of that body lumen, said substance delivery catheter device being thereafter advanceable through or over the tissue penetrating member such that the tissue penetrating distal tip member of the substance delivery catheter device penetrates through further tissue to a second location.

12. A system according to claim 1 wherein the tissue penetrating member of the tissue penetrating catheter comprises a needle having a hollow lumen and wherein the substance delivery catheter device is advanceable though the lumen of the tissue penetrating member.

13. A system according to claim 12 wherein the tissue penetrating catheter device comprises apparatus that indicates the rotational orientation of the tissue penetrating catheter device within the body lumen relative to the target location such that the operator may adjust the rotational orientation of the tissue penetrating catheter device within the body lumen as needed to substantially ensure that subsequent advancement of the tissue penetrating member will cause the tissue penetrating member to travel to the desired first location rather than some other location.

14. A system according to claim 12 wherein the tissue penetrating catheter device comprises apparatus that indicates the path on which the tissue penetrating member will subsequently advance such that the operator may adjust the rotational orientation and position of the tissue penetrating catheter device within the body lumen as needed to substantially ensure that subsequent advancement of the tissue penetrating member will cause the tissue penetrating member to travel to the desired first location rather than some other location.

15. A method for delivering a substance, article or device to a target location within the body of a human or animal subject, said method comprising the steps of:

providing a tissue penetrating catheter that is positionable in a body lumen within the subject'"'"'s body and has a tissue penetrating member that is advancable to a first location outside of the body lumen;

providing a delivery catheter has a tissue penetrating distal tip and is advanceable through or over the tissue penetrating member of the tissue penetrating catheter device;

positioning the tissue penetrating catheter in a body lumen within the subject'"'"'s body;

advancing the tissue penetrating member from the tissue penetrating catheter to a first location outside of the body lumen in which the tissue penetrating catheter is positioned;

advancing the delivery catheter through or over the tissue penetrating member such that the tissue penetrating distal tip of the delivery catheter penetrates further through tissue to or through the target location; and

using the delivery catheter to deliver a substance, article or device to the target location.

16. A method according to claim 15 wherein the tissue penetrating distal tip of the delivery catheter is closed and at least side aperture is formed in the delivery catheter proximal to its distal tip and wherein:

Step E comprises advancing the tissue penetrating distal tip pf the delivery catheter through the target location; and

Step F comprises causing the substance, article or device to pass out of said at least one side aperture to the target location.

17. A method according to claim 15 wherein the tissue penetrating distal tip of the delivery catheter has an opening through which the substance, apparatus or device may pass and wherein:

Step E comprises advancing the tissue penetrating distal tip pf the delivery catheter into the target location; and

Step F comprises causing the substance, article or device to pass out of the opening in the distal tip pf the delivery catheter and into the target location.

18. A method according to claim 15 wherein the tissue penetrating catheter device comprises apparatus that provides an indication the rotational orientation of the tissue penetrating catheter device within the body lumen relative to the target location and wherein:

Step C further comprises using said indication the rotational orientation to adjust the rotational orientation of the tissue penetrating catheter device within the body lumen as needed to substantially ensure that subsequent advancement of the tissue penetrating member will cause the tissue penetrating member to travel to the desired first location rather than some other location.

19. A method according to claim 15 wherein the tissue penetrating catheter device comprises apparatus that provides an indication of the path on which the tissue penetrating member will subsequently advance and wherein:

Step C further comprises using said indication of the path on which the tissue penetrating member will subsequently advance to adjust the rotational orientation and/or position of the tissue penetrating catheter within the body lumen as needed to substantially ensure that subsequent advancement of the tissue penetrating member will cause the tissue penetrating member to travel to the desired first location rather than some other location.

20. A method according to claim 15 wherein the tissue penetrating distal tip of the delivery catheter is radiopaque and wherein:

Step E further comprises radiographically determining the location of the tissue penetrating distal tip of the delivery catheter.

21. A method according to claim 15 wherein the target location is within a mass of anatomic or pathologic tissue.

22. A method according to claim 15 wherein the target location is within the myocardium.

23. A method according to claim 15 wherein the target location is within an organ.

24. A method according to claim 15 wherein the target location is within a pathological lesion.

25. A method according to claim 24 wherein the pathological lesion comprises a tumor.

26. A method according to claim 15 wherein the target location is within another body lumen.

27. A method according to claim 15 further comprising the steps of:

retracting the tissue penetrating member into the tissue penetrating catheter; and

removing the tissue penetrating catheter from the body lumen, leaving the delivery catheter in place.

28. A method according to claim 15 wherein a substance is delivered through the delivery catheter.

29. A method according to claim 28 wherein the substance is a therapeutic substance.

30. A method according to claim 28 wherein the substance delivered in Step F is a agent that provides an enhanced image of the target site.

31. A method according to claim 28 wherein the substance delivered in Step F is a traceable substance that may be used to determine the rate at which the substance distributes away from or is otherwise inactivated at the target site or other pharmacokinetic or biodistributive parameters or variables.

32. A method according to claim 28 wherein the substance is selected from the group consisting of:

a drug, a protein, cells, an angiogenic substance, a myogenic substance, a neurogenic substance, a gene, a gene therapy composition and genetic material in combination with a vector for delivering the genetic material into locations within cells.

33. A method according to claim 28 wherein the method is carried out to improve perfusion of an ischemic target site and where the substance delivered in Step F comprises is an angiogenic agent that increases vascularity of the ischemic target site.

34. A method according to claim 33 wherein the angiogenic agent delivered in Step F is selected from the group of angiogenic agents consisting of vascular endothelial growth factor (VEGF), fibroblast growth factors (FGF), epidermal growth factor (EGF), platelet-derived growth factor (PDGF), hepatocyte growth factor (HGF)or scatter factor, heparin combined with an adenosine receptor agonist, nerve cell growth factor (NGF), and combinations thereof.

35. A method according to claim 28 wherein the substance delivered in Step F comprises cells.

36. A method according to claim 35 wherein the cells are selected from the group consisting of stem cells, progenator cells, myoblasts, myocytes, secretory cells, pancreatic islet cells, dopamine secreting cells, endothelial cells, hepatocytes, cloned cells, cells grown in cell culture, genetically modified cells, and combinations thereof.

37. A method according to claim 35 wherein the method is carried out to treat a condition characterized by a deficiency of a type of cell that normally matures in situ from stem cells, and wherein the therapeutic substance delivered in Step F comprises stem cells of a type that will mature into the deficient cell type.

38. A method according to claim 28 wherein the method is carried out to treat a condition characterized by a lack of living myocytes and wherein the substance delivered in Step F comprises or promotes the growth of myocytes.

39. A method according to claim 35 wherein the method is carried out to treat parkinsonism and wherein the substance delivered in Step F comprises dopamine secreting cells.

40. A method according to claim 39 wherein the dopamine secreting cells comprise fetal dopamine secreting cells.

41. A method according to claim 35 wherein the method is carried out to treat diabetes and the substance delivered in Step F comprises insulin secreting cells.

42. A method according to claim 41 wherein the insulin secreting cells comprise pancreatic β

islet cells.

43. A method according to claim 35 wherein the method is carried out to treat a neurogenerative or nerve disorder and wherein the substance delivered in Step F comprises nerve cells.

44. A method according to claim 28 wherein the method is carried out to treat a neurogenerative or nerve disorder and wherein the substance delivered in Step F comprises a substance that facilitates nerve growth.

45. A method according to claim 44 wherein the substance is selected from the group consisting of:

glial cell line-derived neurotropic factor (GDNF), nerve growth factor, neuro-immunophilin ligand, poly ADP-Ribose polymerase, and combinations thereof.

46. A method according to claim 15 wherein the substance comprises a gene in combination with a vector for facilitating entry of the gene into locations within cells in which the gene will have a desired therapeutic effect.

47. A method according to claim 46 wherein the vector is a virus.

48. A method according to claim 15 wherein an article is delivered through the delivery catheter in Step F.

49. A method according to claim 48 wherein the article is selected from the group consisting of:

substance eluting implants, radioactive implants, embolic members, markers, radiopaque markers.

50. A method according to claim 15 wherein a device is delivered through the delivery catheter in step F.

51. A method according to claim 50 wherein the device delivered through the delivery catheter is selected from the group consisting of:

catheters, cannulae, guidewires, wires, electrodes, sensors, implants and substance delivery implants.