Apparatus and methods for treating the urinary bladder

• US 6,648,863 B2
• Filed: 09/20/2001
• Issued: 11/18/2003
• Est. Priority Date: 09/20/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Reever, Kenneth
• Primary Examiner(s): Lo, Weilun
• Assistant Examiner(s): BOGART, MICHAEL G
• Application Number:
  US09/957,206
• Publication Number:
  US 20020045868A1
• Time in Patent Office: 789 Days
• Field of Search: 128/885, 604/544, 604/325, 604/327, 604/329, 604/335, 604/258, 604/910, 623/23.64, 623/23.65, 623/12
• US Class Current: 604/327
• CPC Class Codes: A61F 2/042 Urinary bladders
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

Disclosed are devices and methods for treating disease in a urinary bladder. The devices include a bladder liner for insertion into the urinary bladder and catheters positioned within the urinary bladder to carry urine from the ureters to an outside collection container. The bladder liner and catheters are constructed of biocompatible materials and are configured to create a seal with the urethra and ureters. The bladder liner may be adapted to deliver medicinal agents to the urinary bladder. Methods of treating disease in the urinary bladder include isolating urine from the bladder wall to allow sufficient time for the bladder wall to heal e.g., by implanting the aforementioned devices. Healing or pain relief may be enhanced by instilling pharmaceutical agents between the liner and bladder wall without dilutional effects.

Claims

1. A medical device adapted to fit within a patient'"'"'s urinary bladder, the device comprising:

a liner comprising;

a reservoir;

a first inlet and a second inlet in fluidic communication with the reservoir, each inlet sealably connectable to a respective end of one of the patient'"'"'s two ureters to pass urine into the reservoir; and

an outlet in fluidic communication with the reservoir and extending into the patient'"'"'s urethra to permit voiding of urine from the reservoir, wherein the liner fits within the urinary bladder and substantially isolates urine from the urinary bladder.

2. The liner of claim 1, wherein the first and second inlets connect to inlet catheters that are adapted to sealably connect to the respective ends of the ureters.

3. The liner of claim 1, wherein the outlet is adapted to sealably connect to the urethra.

4. The liner of claim 1, wherein the outlet is adapted to extend through a urinary sphincter.

5. The liner of claim 1, wherein the outlet connects to an outlet catheter that is adapted to extend through a urinary sphincter.

6. The liner of claim 5, wherein the outlet catheter comprises a material sufficiently flexible to facilitate compression by the urinary sphincter.

7. The liner of claim 1, wherein the sealable connections comprise at least one biocompatible adhesive.

8. The liner of claim 2, wherein the sealable connections comprise an expandable wall at an end of each inlet catheter that contacts the ureters so as to fix the catheter ends in place and form a liquid-impermeable seal.

9. The liner of claim 2, wherein the inlet catheters are adapted to extend through the ureters and into the patient'"'"'s kidneys.

10. The liner of claim 1, wherein the liner is made of a pliant material.

11. The liner of claim 1, wherein the liner is made of a material selected from the group consisting of vinyl, polyethylene, PVC, EVA, silicone, latex, and polypropylene.

12. The liner of claim 1, wherein an outer surface of the liner is coated with at least one of heparin and a heparin-like drug.

13. The liner of claim 1, wherein the liner comprises a material that stretches and shrinks.

14. The liner of claim 1, wherein an outer surface of the liner is coated with a hydrogel.

15. The liner of claim 2, wherein the outlet connects to an outlet catheter that is adapted to extend through the urethra.

16. The liner of claim 9, wherein distal ends of the inlet catheters are coiled to fit in a kidney basin.

17. The liner of claim 16, wherein the inlet catheters include a plurality of fins mounted on exterior surfaces of the catheters and adapted to form a liquid-impermeable seal with a wall of each ureter.

18. An apparatus for isolating urine from a patient'"'"'s urinary bladder, the apparatus comprising:

a first catheter positionable in the patient'"'"'s first ureter, the first catheter including a proximal end and a distal end, the proximal end of the first catheter including a ureter to catheter seal, the distal end of the first catheter being capable of passing through the patient'"'"'s urinary sphincter; and

a second catheter positionable in the patient'"'"'s second ureter, the second catheter including a proximal end and a distal end, the proximal end of the second catheter including a ureter to catheter seal, the distal end of the second catheter being capable of passing through the patient'"'"'s urinary sphincter and the distal ends of the first and second catheters being capable of connection to an external urine collection container.