Intravesical infuser

• US 6,171,298 B1
• Filed: 03/11/1998
• Issued: 01/09/2001
• Est. Priority Date: 05/03/1996
• Status: Expired due to Fees

• Current Assignee: Solace Therapeutics, Inc.
• Original Assignee: Situs, Inc.
• Inventors: Sirivong, Mikxay, Zupkas, Paul F., Parsons, Charles Lowell, Greelis, John Patrick, Matsuura, David G., Gillespie, Walter Dean
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/041,475
• Time in Patent Office: 1,035 Days
• Field of Search: 604/93, 604/891.1, 604/131, 604/132, 604/141, 604/134, 604/30
• US Class Current: 604/891.1
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61L 33/0094 Physical treatment, e.g. plasma treatment
• CPC Class Codes: A61L 33/08 Polysaccharides
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• 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 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00

Abstract

A drug-infusing device is implanted into a body cavity such as a bladder. The device is implanted in an uninflated, low profile state. After insertion into the body cavity, the device is filled with a substance, such as a drug, and assumes an increased profile. After the device is filled, it is allowed to float freely within the body cavity. Alternatively, the device can be tethered to a wall of the body cavity. The device delivers the drug at a controlled rate over an extended period of time. In order to deliver the drug at a controlled rate, the device preferably has a pressure-responsive valving member. The flow resistance of the valving member is responsive to the pressure at which the drug is stored within the infusing device. The resistance of the valving member decreases as the pressure within the infusing device decreases, thereby providing a resultant controlled flow rate.

Claims

1. An implantable infusion device, comprising:

a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second arcuate shape and to hold a pressurized substance;

a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and

a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.

2. The device of claim 1, further comprising a tethering means for tethering said device to a wall of the body cavity.

3. The device of claim 1, wherein said reservoir resumes substantially said first shape as said pressurized fluid substance is dispensed.

4. The device of claim 1, wherein said reservoir is coated so as to inhibit deposition of materials present in the urinary tract.

5. The device of claim 1, wherein said reservoir is coated so as increase the lubricity of the device.

6. The device of claim 1, wherein said flow-restricted exit port provides a means of rapidly purging said pressurized substance from said reservoir.

7. The device of claim 6, wherein said reservoir resumes substantially said first shape upon purging said pressurized substance.

8. The device of claim 1, wherein said reservoir is elongated, said valve assembly is disposed at a first end of said elongated reservoir and said flow-restricted exit port is disposed at a second end of said elongated reservoir opposite said first end.

9. The device of claim 8, wherein said second end has greater buoyancy than the overall buoyancy of said elongated reservoir.

10. The device of claim 8, wherein said second end is at least partially covered by a compliant bumper.

11. The device of claim 8, further comprising a capture member.

12. The device of claim 11, wherein said capture member is incorporated into a release mechanism which is configured to allow said flow-restricted exit port to purge said pressurized substance from said elongated reservoir.

13. The device of claim 8, further comprising a capture member protruding from the center of said second end.

14. The device of claim 1, further comprising a capture member coupled to said flow-restricted exit port, wherein if force is exerted upon said capture member while opposite pressure is maintained against said flow-restricted exit port, the flow restriction of said flow-restricted exit port is reduced such that said pressurized fluid substance is purged.

15. The device of claim 14, wherein said flow-restricted exit port is configured to mate with a sheath that is introduced into said body cavity such that said pressurized substance is purged through a channel of said sheath rather than into said body cavity.

16. The device of claim 1, wherein said flow-restricted exit port provides delivery of said pressurized substance over a period of at least 5 days.

17. The device of claim 1, wherein said flow-restricted exit port provides delivery of said pressurized fluid substance over a period of at least 15 days.

18. The device of claim 1, wherein said pressurized substance is in a liquid form and the device delivers said pressurized fluid substance at a rate of less than about 400 μ

l/hour.

19. The device of claim 1, wherein said second shape facilitates retention of said elongated reservoir in said body cavity.

20. The device of claim 1, wherein said second shape has a cross sectional shape of sufficient diameter to deter voiding of said elongated reservoir through a mammalian urethra.

21. The device of claim 1, wherein said second shape deters obstruction of mammalian bladder neck so as to allow urine to pass around the device.

22. The device of claim 1, wherein said reservoir is elastomeric.

23. The device of claim 1, wherein said pressured substance is a drug.

24. The device of claim 1, wherein said pressured substance is a diagnostic tool.

25. The device of claim 1, wherein said reservoir is elongated and a first end of said reservoir has greater buoyancy than the overall buoyancy of said reservoir.

26. The device of claim 1, wherein said first end is at least partially covered by a compliant bumper.

27. The device of claim 1, wherein said valve assembly comprises an opening for accepting a secure coupling fitting through which said pressurized substance is dispensed.

28. The device of claim 27, wherein said opening is further for securing the device to an introducer which is used to disposed the device within said body cavity.

29. The device of claim 1, wherein said valve assembly comprises a floating disc which is biased to occlude an input channel.

30. The device of claim 1, wherein a resistance of said flow-restricted exit port varies in proportion to a pressure level of said pressurized substance such that said flow-restricted exit port dispenses said pressurized fluid substance at a controlled rate.

31. The device of claim 30, wherein said flow-restricted exit port varies said resistance by varying an area of a flow channel of said flow-restricted exit port in inverse proportion to said pressure level of said pressurized fluid substance.

32. The device of claim 1, wherein said flow-restricted exit port comprises a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow-restricted exit port in a manner inversely related to a pressure level of said pressurized substance.

33. The device of claim 1, wherein said flow-restricted exit port is comprised of sintered metal.

34. An implantable infusion device, comprising:

a reservoir containing a drug;

a flow-restricted exit port in fluid communication with the drug in said reservoir; and

wherein said device assumes a first generally elongated shape when empty during implantation and a second arcuate shape when filled after implantation into a mammal.

35. The device of claim 34, further comprising:

a coating on said device adapted to provide lubricity or to inhibit deposition of material on said device when implanted in a body cavity of a mammal.

36. The device of claim 35, wherein said coating inhibits deposition of materials present in the urinary tract.

37. The device of claim 35, wherein said coating is a surface coating on surfaces of said device exposed to the body upon implantation.

38. The device of claim 35, wherein said coating covers only a portion of said device.

39. The device of claim 35, wherein said flow-restricted exit port provides delivery of said drug over a period of at least 5 days.

40. The device of claim 39 herein said flow-restricted exit port provides delivery of said drug over a period of at least 15 days.

41. The device of claim 39, wherein said drug is in a liquid form and said device delivers said drug at a rate of less than about 400 μ

l/hour.

42. The device of claim 35, wherein said drug is an incontinence-treating drug.

43. The device of claim 35, wherein said drug is used to treat urge incontinence.

44. The device of claim 35, wherein said drug is an anesthetic or analgesic.

45. The device of claim 35, wherein said drug is an antibiotic.

46. The device of claim 35, wherein said drug is used to treat cystitis.

47. The device of claim 35, wherein said drug is an anti-cancer drug.

48. The device of claim 35, wherein said drug is oxybutynin.

49. The device of claim 35, wherein said device has a first end and a second end, wherein at least one of said ends is buoyant.

50. The device of claim 49, wherein said first end and said second end are buoyant.

51. The device of claim 35, wherein said device is sized to fit through a urethra into a mammalian bladder.

52. An infusion device, comprising:

a housing;

a drug inside the housing;

a flow controller comprising a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow path in a manner inversely related to the pressure of said drug to control the rate at which said drug is released from the housing.

53. The device of claim 52, wherein said drug is pressurized and said flow controller is pressure-responsive.

54. The device of claim 52, wherein said flow controller further comprises a third pressure reducing element downstream of said first and second pressure reducing elements.

55. An implantable infusion device, comprising:

a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance;

a valve assembly comprising a floating disc which is biased to occlude an input channel, said valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and

a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity.

56. An implantable infusion device, comprising:

a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance;

a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and

a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein a resistance of said flow-restricted exit port varies in proportion to a pressure level of said pressurized substance by varying an area of a flow channel of said flow-restricted exit port in inverse proportion to said pressure level of said pressurized fluid substance, such that said flow-restricted exit port dispenses said pressurized fluid substance at a controlled rate.

57. An implantable infusion device, comprising:

a reservoir having a first shape wherein said first shape of said reservoir permits said reservoir to be passed into a body cavity, said reservoir configured to expand to a second shape and to hold a pressurized substance;

a valve assembly configured to admit the pressurized fluid substance into said reservoir while said reservoir is within the body cavity; and

a flow-restricted exit port configured to dispense the pressurized substance from said reservoir while said reservoir is within said body cavity, wherein said flow-restricted exit port comprises a first pressure reducing element, a second pressure reducing element, and a flow channel through said first and second pressure reducing elements, wherein said second pressure reducing element alters a cross-sectional area of said flow-restricted exit port in a manner inversely related to a pressure level of said pressurized substance.