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

• US 8,090,430 B2
• Filed: 09/28/2009
• Issued: 01/03/2012
• 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: Makower, Joshua, Lamson, Theodore C., Flaherty, J. Christopher, Chang, John, Catanese, Joseph III, Tholfsen, David, Reggie, John
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Luong, Peter
• Application Number:
  US12/567,915
• Publication Number:
  US 20100016836A1
• Time in Patent Office: 827 Days
• Field of Search: 604/93.01, 604/288.01, 604/288.04, 600/424, 600/431, 600/433, 600/434
• US Class Current: 600/431
• 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 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 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.

Claims

1. A method for delivering a substance selected from i) substances comprising a therapeutic substance and ii) substances comprising cells, to a target location within the body of a human or animal subject, said method comprising the steps of:

(A) inserting into the subject'"'"'s vasculature a tissue penetrating catheter having a catheter body and a tissue penetrator that is advanceable from and retractable into the catheter body, said tissue penetrator having a lumen;

(B) positioning the tissue penetrating catheter in a blood vessel near the target location;

(C) advancing the tissue penetrator from the tissue penetrating catheter toward the target location;

(D) advancing a delivery catheter through the tissue penetrator lumen, said delivery catheter having an elongate delivery catheter body, a delivery catheter lumen and at least one outlet opening through which a substance may be delivered;

(E) positioning the delivery catheter such that delivery of said substance selected from i) substances comprising a therapeutic substance and ii) substances comprising cells through the delivery catheter and out of said at least one outlet opening will enter the target location;

(F) retracting the tissue penetrator and removing the tissue penetrating catheter, leaving the delivery catheter in place with the elongate delivery catheter body extends through the subject'"'"'s vasculature and subsequent delivery of said substance selected from i) substances comprising a therapeutic substance and ii) substances comprising cells through the delivery catheter and out of said at least one outlet opening will cause the substance to enter the target location;

(G) subcutaneously implanting a port or reservoir;

(H) connecting the delivery catheter lumen to the subcutaneously implanted port or reservoir; and

(I) injecting said substance selected from i) substances comprising a therapeutic substance and ii) substances comprising cells into the subcutaneously implanted port or reservoir causing the substance to flow through the delivery catheter lumen, out of said at least one outlet opening and to the target location.

2. A method according to claim 1 wherein the target location is located outside of the blood vessel lumen in which the tissue penetrating catheter is positioned.

3. A method according to claim 1 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, genetic material in combination with a vector for delivering the genetic material into locations within cells at which the genetic material will have a desired effect on the cells.

4. A method according to claim 1 wherein the method is carried out to improve perfusion of ischemic tissue and where the substance comprises is an angiogenic agent that increases vascularity of the target location.

5. A method according to claim 4 wherein the angiogenic agent 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.

6. A method according to claim 1 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.

7. A method according to claim 1 wherein the method is carried out to treat a condition characterized by a deficiency of a type of cell within the patient'"'"'s body and wherein the type of cell that is deficient matures in situ from stem cells, and wherein the therapeutic substance delivered in Step F comprises stem cells of a type that mature into the deficient cell type.

8. A method according to claim 1 wherein the method is carried out to treat a condition characterized by a lack of living myocytes in or near the target location and wherein the substance comprises myocytes.

9. A method according to claim 1 wherein the method is carried out to treat parkinsonism, the target location comprises the substantia nigra of the subject'"'"'s brain and the substance comprises dopamine or dopamine secreting cells which when implanted will increase dopamine in the substantia nigra.

10. A method according to claim 1 wherein the method is carried out to treat diabetes, the target location comprises the patient'"'"'s pancreas and the substance comprises insulin secreting cells which, when implanted, will increase insulin production by the patient'"'"'s pancreas.

11. A method according to claim 10 wherein the insulin secreting cells comprise pancreatic beta islet cells.

12. A method according to claim 1 wherein the method is carried out to treat a neurogenerative disorder and the substance comprises nerve cells.

13. A method according to claim 1 wherein the method is carried out to treat a neurogenerative disorder and the substance facilitates nerve growth.

14. A method according to claim 13 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.

15. A method according to claim 1 wherein the therapeutic 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.

16. A method according to claim 15 wherein the vector is a virus.

17. A method according to claim 1 wherein the target location is a tumor and wherein the substance is an antitumor agent.

18. A method according to claim 1 wherein Step I is repeated a plurality of times.

19. A method according to claim 1 wherein the delivery catheter further comprises at least one anchoring member and wherein the method further comprises causing said at least one anchoring member to anchor the delivery catheter.

20. A method according to claim 19 wherein said at least one anchoring member comprises at least one member selected from the group consisting of:

a hook;

a barb;

a permeable surface into which tissue may grow.

21. A method according to claim 1 wherein the delivery catheter further comprises anti-obstruction for maintaining patency of the delivery catheter.

22. A method according to claim 1 wherein the delivery catheter further comprises a backflow deterrent for blocking backflow of a substance that has been delivered through the delivery catheter lumen and out of said at least one outlet opening and wherein the method further comprises the step of:

causing the backflow deterrent to deter backflow of the substance.

23. A method according to claim 22 wherein the backflow deterrent comprises a backflow barrier rib formed on the delivery catheter and wherein the step of causing the backflow deterrent to deter backflow is carried out by positioning the backflow deterrent rib so that is acts as a barrier to the unwanted backflow.

24. A method according to claim 22 wherein said backflow barrier comprises an inflatable balloon on the delivery catheter and wherein the step causing the backflow deterrent to deter backflow is carried out by inflating the balloon.

25. A method according to claim 22 wherein said backflow deterrent comprises a raised projection formed on the delivery catheter and wherein the step of causing the backflow deterrent to deter backflow is carried out by positioning the raised projection so that is acts as a barrier to unwanted backflow.

26. A method according to claim 1 wherein at least a portion of the delivery catheter is coated with an adhesive and wherein the method further comprises the step of causing the adhesive to adhere to adjacent tissue thereby deterring unwanted movement of the delivery catheter.

27. A method according to claim 1 wherein an anti-microbial substance is disposed on at least a portion of the delivery catheter and wherein the method further comprises the step of causing the anti-microbail substance to deter microbial growth.

28. A method according to claim 1 wherein an anti-coagulant substance is disposed on at least a portion of the delivery catheter and wherein the method further comprises the step of causing the anti-coagulant substance to deter coagulative processes.

29. A method according to claim 1 wherein the delivery catheter further comprises an interactive member for sensing, sampling or receiving information from the target location and the method further comprises using the interactive member to obtain a sample or information from the target location.

30. A method according to claim 29 wherein the step of using the interactive member to obtain a sample or information from the target location comprises using the interactive member to measure a variable selected from the group consisting of:

electrocardiogram, contractility, force of contraction, pressure, electrocardiographic amplitude, protein level, antibody level, pO₂, pCO₂, oxygen saturation, blood flow rate, pH and lactate level.