Dual-Lumen Drug Reservoir Fill and Withdrawal Devices and Methods

• US 20190308000A1
• Filed: 04/03/2019
• Published: 10/10/2019
• Est. Priority Date: 04/04/2018
• Status: Abandoned Application

• Current Assignee: Cylerus, Inc.
• Original Assignee: Cylerus, Inc.
• Inventors: HANSON, Stephen R.
• Application Number:
  US16/373,977
• Publication Number:
  US 20190308000A1
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2039/0202 for taking samples
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0217 at least some chambers being stacked separated by another septum
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1582 Double lumen needles

Abstract

Dual-lumen devices for delivery of drugs to a drug reservoir, blood vessel or vascular graft and methods of using the same are provided. In one aspect, devices comprising a dual-lumen needle and dual-lumen catheter are provided for filling and removing drug formulations from a drug reservoir are provided. The drug reservoir can optionally be connected to or associated with a vascular graft or blood vessel for controlled delivery of the drug.

Claims

1. A drug delivery device comprising an external casing, a first chamber having a first diaphragm, a second chamber having a second diaphragm and a needle stop, a dual-lumen needle, and a dual-lumen catheter.

2. The device of claim 1, wherein dual-lumen needle comprises a needle drug-fill lumen and a needle drug-withdrawal lumen.

3. The device of claim 2, wherein the needle drug-fill lumen of the dual-lumen needle is configured to puncture the second diaphragm and operatively connect to the second chamber.

4. The device of claim 2, wherein the needle drug-withdrawal lumen of the dual-lumen needle is configured to puncture the first diaphragm and operatively connect to the first chamber.

5. The device of claim 1, wherein the dual-lumen catheter comprises a catheter drug-fill lumen and a catheter drug-withdrawal lumen.

6. The device of claim 5, wherein the catheter drug-fill lumen is configured to operatively connect to the second chamber.

7. The device of claim 5, wherein the catheter drug-withdrawal lumen is configured to operatively connect to the first chamber.

8. The device of claim 5, wherein the catheter drug-fill lumen and the catheter drug-withdrawal lumen are configured to operatively connect to a drug reservoir.

9. The device of claim 8, wherein the drug reservoir further comprises a barrier configured to divide the drug reservoir into a first part and second part, wherein material in the first part can move to the second part in one direction.

10. The device of claim 9, wherein the catheter drug-fill lumen and the catheter drug-withdrawal lumen of the dual-lumen catheter are operatively connected to opposite sides of a drug reservoir formed by placing a barrier in the drug reservoir, wherein the barrier causes a material in the drug reservoir to move circumferentially when the drug reservoir is filled, refilled, or emptied.

11. The device of claim 10, further comprising a cuff surrounding the drug reservoir and a graft surrounded by the drug reservoir.

12. The device of claim 11, wherein the cuff is made of a material comprising silicone.

13. The device of claim 11, wherein the graft is made of a material comprising ePTFE.

14. The device of claim 11, wherein the graft further comprises a rate-limiting membrane.

15. The device of claim 14, wherein the rate-limiting membrane is made of a material comprising at least one of polytetrafluoroethylene, polyvinylidinefluoride, polyethersulfone, polycarbonate, and cellulose esters.

16. The device of claim 11, wherein the drug reservoir contains a first drug.

17. The device of claim 16, wherein the first drug is an olimus drug.

18. The device of claim 16, wherein the first drug is selected from the group consisting of at least one of actimmune, paclitaxel, brentuximab, vedotin, pemetrexed, bevacizumab, pegylated liposomal, doxorubicin, carboplatin, cisplatin, oxaliplatin, cetuximab, gemcitabine, eribulin, mesylate, trastuzumab, cabazitaxel, emtansine, pembrolizumab, carfilzomib, nivolumab, pertuzumab, rituximab, paclitaxel, docetaxel, temsirolimus, bedamustine, panitumumab, bortezomib, venofer, zoledronic acid, thiazolidinediones, glipizide, glimepiride, metformin, victoza, or jardiance.

19. The device of claim 16, wherein the first drug is selected from the group consisting of at least one of antiplatelets, antithrombins, anticoagulants, cytostatic agents, cytotoxic agents, antiproliferative agents, vasodilators, alkylating agents, antimicrobials, antibiotics, antimitotics, anti-infective agents, antisecretory agents, anti-inflammatory agents, immunosuppressive agents, antimetabolite agents, growth factor antagonists, free radical scavengers, antioxidants, radiotherapy agents, anesthetics, radiopaque agents, radiolabeled agents, nucleotides, cells, proteins, glycoproteins, hormones, anti-stenosis agents, anti-fibrotic agents, isolates, enzymes, monoclonal antibodies, and ribonucleases.

20. The device of claim 17, wherein the olimus drug is selected from the group consisting of at least one of sirolimus, everolimus, zotarolimus, tacrolimus, pimecrolimus, temsirolimus, ridaforolimus or biolimus.

21. The device of claim 16, wherein the drug reservoir contains a second drug.

22. The device of claim 16, further comprising a drug formulation containing the first drug.

23. The device of claim 22, wherein the drug formulation is selected from the group consisting of a drug depot formulation, a controlled release formulation, an extended release formulation, and a simple drug solution.

24. The device of claim 23, wherein the controlled release formulation is selected from the group consisting of microbeads and microspheres.

25. The device of claim 24, wherein the microbeads or microspheres comprise one or more materials selected from the group consisting of polyanhydride, PLG poly (D,L-lactide)-co-glycolide, poly DL lactide co-poly ethylene glycol (PELA) diblock copolymers, PLA-PEG-PLA triblocks, and PEG hydrophilic.

26. The device of claim 21, wherein the second drug is selected from the group consisting of one or more of actimmune, paclitaxel, brentuximab, vedotin, pemetrexed, bevacizumab, pegylated liposomal, doxorubicin, carboplatin, cisplatin, oxaliplatin, cetuximab, gemcitabine, eribulin, mesylate, trastuzumab, cabazitaxel, emtansine, pembrolizumab, carfilzomib, nivolumab, pertuzumab, rituximab, paclitaxel, docetaxel, temsirolimus, bedamustine, panitumumab, bortezomib, venofer, zoledronic acid, thiazolidinediones, glipizide, glimepiride, metformin, victoza, and jardiance.

27. The device of claim 26, wherein the second drug is selected from the group consisting of at least one a chemotherapy drug, pain reliever, nutrient, or at least one agent to treat at least one of diabetes, arthritis, cancer, dehydration, or a migraine.

28. The device of claim 26, wherein the second drug is selected from the group consisting of at least one of antiplatelets, antithrombins, anticoagulants, cytostatic agents, cytotoxic agents, antiproliferative agents, vasodilators, alkylating agents, antimicrobials, antibiotics, antimitotics, anti-infective agents, antisecretory agents, anti-inflammatory agents, immunosuppressive agents, antimetabolite agents, growth factor antagonists, free radical scavengers, antioxidants, radiotherapy agents, anesthetics, radiopaque agents, radiolabeled agents, nucleotides, cells, proteins, glycoproteins, hormones, anti-stenosis agents, anti-fibrotic agents, isolates, enzymes, monoclonal antibodies, and ribonucleases.

29. A method of filling a drug reservoir with new drug and withdrawing old drug from a drug reservoir comprising:

filling a drug reservoir with new drug and withdrawing old drug from a drug reservoir by infusing and withdrawing drug through a dual-lumen needle comprising a needle drug-fill lumen and a needle drug-withdrawal lumen wherein the needle drug-fill lumen is operatively connected to a first chamber and the needle drug-withdrawal lumen is operatively connected to a second chamber;

filling the first chamber with new drug wherein the new drug flows through a catheter drug-fill lumen of a dual-lumen catheter operatively connected to the first chamber;

filling the drug reservoir with new drug from the catheter drug-fill lumen of the dual-lumen catheter wherein the old drug flows into a catheter drug-withdrawal lumen of the dual-lumen catheter, wherein the catheter drug-withdrawal lumen of the dual-lumen catheter is operatively connected to a second chamber;

filling the second chamber with the old drug flowing through the catheter drug-withdrawal lumen of the dual-lumen catheter; and

withdrawing the old drug from the second chamber through the needle drug-withdrawal lumen of the dual-lumen needle.

30. The method of claim 29, wherein the drug reservoir is filled with new drug and old drug is withdrawn from the drug reservoir simultaneously.

31. The method of claim 29, wherein the drug reservoir further comprises a barrier dividing the drug reservoir into a first part and second part, wherein new drug in the first part can move to the second part in one direction.

32. The method of claim 29, wherein the first chamber further comprises a first diaphragm and the second chamber further comprises a second diaphragm.

33. The method of claim 32, wherein the needle drug-withdrawal lumen of the dual-lumen needle punctures the first diaphragm.

34. The method of claim 32, wherein the needle drug-fill lumen of the dual-lumen needle punctures the second diaphragm.

35. The method of claim 29, wherein the new drug comprises a first drug.

36. The method of claim 35, wherein the first drug is an olimus drug.

37. The method of claim 35, wherein the first drug is selected from the group consisting of one or more of actimmune, paclitaxel, brentuximab, vedotin, pemetrexed, bevacizumab, pegylated liposomal, doxorubicin, carboplatin, cisplatin, oxaliplatin, cetuximab, gemcitabine, eribulin, mesylate, trastuzumab, cabazitaxel, emtansine, pembrolizumab, carfilzomib, nivolumab, pertuzumab, rituximab, paclitaxel, docetaxel, temsirolimus, bedamustine, panitumumab, bortezomib, venofer, zoledronic acid, thiazolidinediones, glipizide, glimepiride, metformin, victoza, and jardiance.

38. The method of claim 35, wherein the first drug is selected from the group consisting of one or more of antiplatelets, antithrombins, anticoagulants, cytostatic agents, cytotoxic agents, antiproliferative agents, vasodilators, alkylating agents, antimicrobials, antibiotics, antimitotics, anti-infective agents, antisecretory agents, anti-inflammatory agents, immunosuppressive agents, antimetabolite agents, growth factor antagonists, free radical scavengers, antioxidants, radiotherapy agents, anesthetics, radiopaque agents, radiolabeled agents, nucleotides, cells, proteins, glycoproteins, hormones, anti-stenosis agents, anti-fibrotic agents, isolates, enzymes, monoclonal antibodies, and ribonucleases.

39. The method of claim 36, wherein the olimus drug is selected from the group consisting of at least one of sirolimus, everolimus, zotarolimus, tacrolimus, pimecrolimus, temsirolimus, ridaforolimus or biolimus.

40. The method of claim 35, wherein the new drug further comprises a second drug.

41. The method of claim 35, further comprising a drug formulation containing the first drug.

42. The method of claim 41, wherein the drug formulation is selected from the group consisting of a drug depot formulation, a controlled release formulation, an extended release formulation, and a simple drug solution.

43. The method of claim 42, wherein the controlled release formulation is selected from the group consisting of microbeads and microspheres.

44. The method of claim 43, wherein the microbeads or microspheres comprise one or more materials selected from the group consisting of polyanhydride, PLG poly (D,L-lactide)-co-glycolide, poly DL lactide co-poly ethylene glycol (PELA) diblock copolymers, PLA-PEG-PLA triblocks, and PEG hydrophilic.

45. The method of claim 40, wherein the second drug is selected from the group consisting of actimmune, paclitaxel, brentuximab, vedotin, pemetrexed, bevacizumab, pegylated liposomal, doxorubicin, carboplatin, cisplatin, oxaliplatin, cetuximab, gemcitabine, eribulin, mesylate, trastuzumab, cabazitaxel, emtansine, pembrolizumab, carfilzomib, nivolumab, pertuzumab, rituximab, paclitaxel, docetaxel, temsirolimus, bedamustine, panitumumab, bortezomib, venofer, zoledronic acid, thiazolidinediones, glipizide, glimepiride, metformin, victoza, and jardiance.

46. The method of claim 40, wherein the second drug is selected from the group consisting of at least one chemotherapy drug, pain reliever, nutrient, or at least one agent to treat at least one of diabetes, arthritis, cancer, dehydration, or a migraine.

47. The method of claim 40, wherein the second drug is selected from the group consisting of antiplatelets, antithrombins, anticoagulants, cytostatic agents, cytotoxic agents, antiproliferative agents, vasodilators, alkylating agents, antimicrobials, antibiotics, antimitotics, anti-infective agents, antisecretory agents, anti-inflammatory agents, immunosuppressive agents, antimetabolite agents, growth factor antagonists, free radical scavengers, antioxidants, radiotherapy agents, anesthetics, radiopaque agents, radiolabeled agents, nucleotides, cells, proteins, glycoproteins, hormones, anti-stenosis agents, anti-fibrotic agents, isolates, enzymes, monoclonal antibodies, and ribonucleases.