Methods and apparatus for acute or chronic delivery of substances or apparatus to extravascular treatment sites

• US 7,606,615 B2
• Filed: 06/10/2003
• Issued: 10/20/2009
• Est. Priority Date: 01/17/2001
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Catanese, Joseph III, Flaherty, J. Christopher, Makower, Joshua, Lamson, Theodore C., Chang, John Y., Tholfsen, David R., Reggie, John A.
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): Luong; Peter
• Application Number:
  US10/458,153
• Publication Number:
  US 20050090748A1
• Time in Patent Office: 2,324 Days
• Field of Search: 600/407, 600/424, 600/431, 600/433, 600/435, 604 19- 21
• US Class Current: 600/435
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/065 Guide needles

Abstract

Methods and apparatus for delivery of substances or apparatus to target sites located outside blood vessels within the body of a human or animal patient. A vessel wall penetrating catheter is inserted into the vasculature, positioned and oriented within a blood vessel near the target extravascular site and a penetrator is advanced from the catheter so as to penetrate outwardly through the wall of the blood vessel in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site. In some applications, the penetrator may be retracted into the vessel wall penetrating catheter and the vessel wall penetrating catheter may be removed, leaving the delivery catheter in place for chronic or continuous delivery of substance(s) to and/or obtaining of information or samples from the target site. Alternatively, a delivery catheter having an occlusion member or balloon may be advanced into a vein or venule and the occlusion member or balloon may be used to occlude the lumen of the vein or venule during and after injection of a substance through the catheter, such that the substance will not be carried away by normal venous blood flow and will remain in the vein or venule for a sufficient period of time to have its intended effect (e.g. to enter adjacent tissues through capillary beds drained by that vein or venule).

Claims

1. A catheter device for delivering a substance or apparatus to a target site located within the body of a human or veterinary patient, said device comprising:

an elongate catheter body having a distal end, said catheter body being positionable in a blood vessel lumen;

a hollow penetrator member positioned within the catheter body and advanceable therefrom;

at least one imageable marker that indicates the rotational orientation of the catheter body within the blood vessel lumen, said marker being useable to enable an operator to rotationally orient the catheter body relative to the target site such that subsequent advancement of the penetrator will cause the penetrator to move to a first location that is within or near the target site; and

,

a delivery catheter that is advanceable through the hollow penetrator to the target site, the substance or apparatus being deliverable to the target site through said delivery catheter.

2. A device according to claim 1 wherein the said at least one marker comprises a radiopaque marker.

3. A device according to claim 1 wherein said at least one marker is positioned and configured to mark the location of the lumen.

4. A device according to claim 1 wherein said at least one marker is positioned and configured to mark the location of the lumen adjacent to an aperture through which the hollow penetrator exits the catheter body.

5. A device according to claim 1 further comprising a guidewire lumen.

6. A device according to claim 1 further comprising a distal tip member on the distal end of the catheter body.

7. A device according to claim 6 wherein the distal tip member is formed of soft, flexible material.

8. A catheter device according to claim 1 further comprising an imaging apparatus on the catheter body, said imaging apparatus being useable to image the at least one imageable marker, thereby providing an image to enable the operator to position and rotationally orient the catheter body within the blood vessel lumen such that subsequent advancement of the penetrator member will cause the penetrator member to enter the target site.

9. A system comprising a catheter device according to claim 1 further in combination with an imaging apparatus that is not located on the catheter body, said said imaging apparatus being useable to image the at least one imageable marker, thereby providing an image to enable the operator to position and rotationally orient the catheter body within the blood vessel lumen such that subsequent advancement of the penetrator member will cause the penetrator member to enter the target site.

10. A system according to claim 9 wherein the imaging device comprises a fluoroscope.

11. A system comprising a catheter device according to claim 1 further in combination with a delivery catheter that is advanceable through the hollow penetrator member of the catheter device to the target site, the substance being deliverable through the delivery catheter.

12. A system according to claim 11 wherein the catheter device is removable leaving the delivery catheter in position within the patient'"'"'s body.

13. A system according to claim 12 wherein the delivery catheter has a lumen and an outflow opening and wherein the system further comprises a matter blocking member that substantially deters unwanted matter from entering the outflow opening.

14. A system according to claim 13 wherein the matter blocking member comprises a selectively permeable barrier that allows a substance to be infused in the distal direction through the outflow opening and to the target location but prevents cellular ingrowth and other matter from entering the lumen of the delivery catheter through said outflow opening.

15. A system according to claim 14 wherein the selectively permeable barrier is a balloon attached to the delivery catheter such that a substance infused through the lumen of the delivery catheter will collect within the balloon and subsequently diffuse outwardly through the balloon.

16. A system according to claim 14 wherein the matter blocking member comprises a stylet that is insertable into the lumen of the delivery catheter to block the entry of matter into the lumen of the delivery catheter lumen.

17. A system according to claim 16 wherein the stylet is removable from the lumen of the delivery catheter to permit delivery of a substance or apparatus through the delivery catheter.

18. A system according to claim 11 wherein the delivery catheter comprises:

a first tube having a lumen and a sidewall in which an outflow aperture is formed; and

,

a second tube rotatably disposed in a coaxial position within the first tube, said second tube having a lumen, a closed distal end and a sidewall in which an opening is formed;

the second tube being rotatably moveable between i) a blocking position wherein the side wall of the second tube substantially blocks the outflow aperture of the first tube to prevent cellular ingrowth and other matter from entering the lumen of the second tube and ii) an infusion position wherein the opening of the second tube is aligned with the outflow opening of the first tube such that a substance that is injected into the lumen of the second tube will flow through the opening of the second tube and through the outflow opening of the first tube.

19. A system according to claim 18 wherein a plurality of outflow apertures are formed in the sidewall of the first tube.

20. A system according to claim 11 wherein the delivery catheter comprises:

a tube having a lumen and a sidewall in which an outflow aperture is formed; and

,

an obturator member disposed at least partially within the lumen of the tube, said obturator member being alternately disposable in i) a blocking position wherein the obturator substantially blocks the outflow aperture of the tube to prevent cellular ingrowth and other matter from entering the lumen of the tube and ii) an infusion position wherein the obturator does not substantially block the outflow apertures such that fluid may be injected through the lumen of the tube and out of the outflow aperture.

21. A system according to claim 20 wherein a plurality of outflow apertures are formed in the sidewall of the tube.

22. A system according to claim 20 wherein the obturator member is an inflatable balloon that assumes said blocking position when inflated and said infusion position when deflated.

23. A system according to claim 11 wherein the delivery catheter comprises an infusion lumen, a return lumen, an outflow aperture through which an infused substance may flow out of the infusion lumen and a flow diverter, said flow diverter that is alternately deployable in i) an infusion position whereby the substance infused through the infusion lumen will flow out of the outflow aperture and ii) a recirculation position whereby fluid infused through the infusion lumen will be recirculated back through the return lumen.

24. A system according to claim 11 wherein the delivery catheter comprises a pressure increasing outflow opening configured to cause an increase the pressure of fluids that are injected through the delivery catheter lumen and out of said pressure increasing outflow opening.

25. A system according to claim 24 wherein said pressure increasing outflow opening is formed in the side wall of the delivery catheter.

26. A system according to claim 25 wherein a plurality of pressure increasing outflow openings are formed in the side wall of the delivery catheter.

27. A system according to claim 1 wherein the delivery catheter further comprises an anchoring member for anchoring the catheter in a substantially fixed position within the patient'"'"'s body.

28. A system according to claim 27 wherein the anchoring member is selected from the group of anchoring members consisting of:

a hook;

a barb;

a permeable surface into which tissue may grow;

an adhesive; and

,

combinations thereof.

29. A system according to claim 1 wherein the delivery catheter further comprises a backflow deterrent member for blocking backflow of a substance that has been injected through the delivery catheter.

30. A system according to claim 29 wherein said backflow deterrent member comprises a backflow barrier rib formed on the delivery catheter.

31. A system according to claim 30 wherein said backflow barrier comprises an inflatable balloon on the delivery catheter.

32. A system according to claim 30 wherein said backflow barrier comprises a raised projection formed on the exterior of the delivery catheter.

33. A system according to claim 32 wherein the raised projection comprises an annular rib formed about the outer surface of the delivery catheter.

34. A system according to claim 30 wherein the backflow deterrent member comprises a sealant that is implanted prior to or concurrently with removal of the delivery catheter so as to prevent the injected substance from backflowing through the tract from which the delivery catheter is removed.

35. A system according to claim 34 wherein the sealant comprises a quantity of a flowable sealant injected into the tract upon removal of the delivery catheter.

36. A system according to claim 34 wherein the sealant comprises a detachable sealing member.

37. A system according to claim 36 wherein the detachable sealing member is formed of biodegradable material.

38. A system according to claim 36 wherein the detachable sealing member comprises a collagen sponge.

39. A system according to claim 36 wherein the detachable sealing member comprises a hydrogel sponge.

40. A system according to claim 1 wherein at least a portion of the delivery catheter is coated with an adhesive.

41. A system according to claim 1 wherein an anti-microbial substance is disposed on at least a portion of the delivery catheter.

42. A system according to claim 1 wherein an anti-coagulant substance is disposed on at least a portion of the delivery catheter.

43. A system according to claim 1 further comprising apparatus for creating a pocket within tissue adjacent to the delivery catheter such that when a substance or apparatus is introduced through the delivery catheter it will be received within said pocket.

44. A system according to claim 43 wherein the apparatus for creating a pocket comprises an energy emitting member that emits energy into adjacent tissue to create said pocket.

45. A system according to claim 44 wherein the energy emitting apparatus comprises a radiofrequency electrode.

46. A system according to claim 45 wherein the energy emitting apparatus comprises a laser.

47. A system according to claim 44 wherein the apparatus for creating a pocket comprises a nozzle through which a stream of fluid may be injected to create the pocket in adjacent tissue.

48. A system according to claim 44 wherein the apparatus for creating a pocket comprises an expandable cage which, when expanded, creates said pocket.

49. A system according to claim 1 further in combination with an infusion apparatus for infusing a substance through the delivery catheter.

50. A system according to claim 49 wherein said infusion apparatus comprises a syringe.

51. A system according to claim 49 wherein said infusion apparatus comprises a pump.

52. A system according to claim 49 wherein said infusion apparatus is a reservoir positioned for gravity drainage of the substance through the delivery catheter.

53. A system according to claim 49 wherein said infusion apparatus further comprises a quantity of a substance for infusion through the delivery catheter.

54. A system according to claim 53 wherein the substance comprises a drug.

55. A system according to claim 54 wherein the drug is selected from the group consisting of:

thrombolytics, platelet inhibitors, anti-restenotic agents, beta adrenergic blockers, ion channel antagonists, positive or negative ionotropic agents, anti-arrhythmics and combinations thereof.

56. A system according to claim 53 wherein the substance comprises a protein.

57. A system according to claim 53 wherein the substance comprises an angiogenic substance.

58. A system according to claim 57 wherein the angiogenic substance is selected from the group 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, and combinations thereof.

59. A system according to claim 53 wherein the substance comprises cells.

60. A system according to claim 59 wherein the substance comprises progenator cells for a type of cell that is desired to be formed at the target site.

61. A system according to claim 59 wherein said substance comprises myoblasts to form cardiac muscle cells.

62. A system according to claim 59 wherein said 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.

63. A system according to claim 53 wherein the substance is a gene.

64. A system according to claim 53 wherein the substance comprises a gene and a vector for facilitating entry of the gene into locations within cells at which the gene will have a desired effect on the cells.

65. A system according to claim 64 wherein the vector comprises a virus.