Ureteral bypass devices and procedures

1. A procedure for performing an internal urinary diversion that bypasses a ureter of a patient between a kidney and urinary bladder of the patient, the procedure comprising:

creating an incision in the skin of a patient;

implanting a nephrostomy catheter through the incision so that the nephrostomy catheter is entirely external of the ureter, and securing a first end of the nephrostomy catheter within the renal pelvis of a kidney of the patient;

implanting a cystostomy catheter through the incision so that the cystostomy catheter is entirely external of the ureter, and securing a first end of the cystostomy catheter within the urinary bladder of the patient;

removably assembling second ends of the nephrostomy and cystostomy catheters to an adaptor with connectors to yield a ureteral bypass device in which the nephrostomy and cystostomy catheters are fluidically connected together through the adaptor and the ureteral bypass device defines an internalized urinary diversion through which urinary drainage occurs from the kidney to the urinary bladder and entirely bypasses the ureter of the patient, the connectors enabling interchangeability of the nephrostomy and cystostomy catheters with additional nephrostomy and cystostomy catheters, the adaptor having an internal reservoir compartment and an entry site that comprises a self-sealing septum; and

implanting the adaptor and closing the incision so that the ureteral bypass device is entirely located internally of the patient, the entry site of the adaptor is subcutaneously located in proximity to skin of the patient, and the septum is accessible through the skin of the patient to enable performing diagnostic and therapeutic procedures including testing, sampling and flushing of the ureteral bypass device in its entirety while the ureteral bypass device is within the patient and without necessitating removal of the ureteral bypass device from the patient or surgical manipulation.

2. The procedure according to claim 1 , wherein the first end of the nephrostomy catheter is secured within the renal pelvis as a result of the first end being configured as a locking loop.

3. The procedure according to claim 1 , wherein the first end of the cystostomy catheter is secured within the urinary bladder as a result of the first end being configured as a locking loop.

4. The procedure according to claim 1 , wherein the first end of the nephrostomy catheter is secured within the renal pelvis with a cuff that is pexied to an external surface of the kidney with or without a locking loop.

5. The procedure according to claim 1 , wherein the first end of the cystostomy catheter is secured within the urinary bladder with a cuff that is pexied to an external surface of the urinary bladder with or without a locking loop.

6. The procedure according to claim 1 , further comprising:

inserting a needle through the skin of the patient and through the entry site; and then

performing at least one step chosen from the group consisting of testing, sampling and flushing the ureteral bypass device.

7. The procedure according to claim 6 , wherein the step comprises sampling fluid within the ureteral bypass device for infection and urinalysis while the ureteral bypass device remains implanted within the patient.

8. The procedure according to claim 6 , wherein the step comprises testing the ureteral bypass device while the ureteral bypass device remains implanted within the patient by injecting a contrast material into the ureteral bypass device so that the contrast material subsequently flows into the kidney and the urinary bladder to ensure patency and prevent occlusion.

9. The procedure according to claim 6 , wherein the step comprises:

determining whether an occlusion is present in the ureteral bypass device; and then

flushing the occlusion from the ureteral bypass device while the ureteral bypass device remains implanted within the patient.

10. The procedure according to claim 1 , further comprising:

implanting a second nephrostomy catheter through the incision and securing a first end of the second nephrostomy catheter within the renal pelvis of a second kidney of the patient; and then

fluidically connecting the second nephrostomy catheter to the adaptor so as to fluidically connect the second nephrostomy catheter to the cystostomy catheter.

11. The procedure according to claim 1 , wherein the patient is an animal.

12. The procedure according to claim 11 , wherein each of the nephrostomy and cystostomy catheters has a diameter within a range of about 5 to about 30 Fr.

13. The procedure according to claim 1 , wherein the patient is a child or adult human.

14. The procedure according to claim 13 , wherein each of the nephrostomy and cystostomy catheters has a diameter within a range of about 5 to about 8 Fr.

15. The procedure according to claim 1 , wherein the ureteral bypass device remains indwelling long-term within the patient.

16. The procedure according to claim 1 , further comprising:

creating a second incision in the skin of the patient;

disconnecting the adaptor from at least one of the nephrostomy and cystostomy catheters; and then

removing one or more of the adaptor and the nephrostomy and cystostomy catheters but not the ureteral bypass device in its entirety.

17. A ureteral bypass device adapted to provide an internal urinary diversion that bypasses a ureter of a patient between a kidney and urinary bladder of the patient, the ureteral bypass device comprising:

a nephrostomy catheter having oppositely-disposed first and second ends, means for adhering the nephrostomy catheter to an external surface of the kidney, and means for securing the first end within the renal pelvis of a kidney of a patient;

a cystostomy catheter having oppositely-disposed first and second ends, means for adhering the cystostomy catheter to an external surface of the urinary bladder, and means for securing the first end of the cystostomy catheter within the urinary bladder of the patient; and

an adaptor removably assembled with connectors to the second ends of the nephrostomy and cystostomy catheters so as to fluidically connect the nephrostomy and cystostomy catheters together through the adaptor and thereby form the ureteral bypass device that defines an internalized urinary diversion through which urinary drainage occurs from the kidney to the urinary bladder and bypasses the ureter of the patient, the connectors enabling interchangeability of the nephrostomy and cystostomy catheters with additional nephrostomy and cystostomy catheters, the adaptor having an internal reservoir compartment and an entry site that comprises a self-sealing septum, the adaptor being configured to subcutaneously locate the entry site in proximity to skin of a patient after implantation of the ureteral bypass device in the patient and to provide access to the entry site through the skin to enable performing diagnostic and therapeutic procedures including testing, sampling and flushing of the ureteral bypass device in its entirety while the ureteral bypass device is within the patient and without necessitating removal of the ureteral bypass device from the patient or surgical manipulation.

18. The ureteral bypass device according to claim 17 , wherein the securing means of the nephrostomy and cystostomy catheters are chosen from the group consisting of multi-fenestrated locking loops and cuffs adapted to be organ pexied.

19. The ureteral bypass device according to claim 17 , wherein the first end of at least one of the nephrostomy and cystostomy catheters is straight and multi-fenestrated.

20. The ureteral bypass device according to claim 17 , wherein each of the nephrostomy and cystostomy catheters has a diameter within a range of about 5 to about 30 Fr.

21. The ureteral bypass device according to claim 17 , wherein each of the nephrostomy and cystostomy catheters has a diameter within a range of about 5 to about 8 Fr.

22. The ureteral bypass device according to claim 17 , wherein each of the nephrostomy and cystostomy catheters has a diameter within a range of about 5 to about 6 Fr.

23. The ureteral bypass device according to claim 17 , further comprising a second nephrostomy catheter having oppositely-disposed first and second ends, and means for securing the first end of the second nephrostomy catheter within the renal pelvis of a second kidney of a patient, the adaptor being fluidically connected to the second end of the second nephrostomy catheter so as to fluidically connect the second nephrostomy catheter to the cystostomy catheter through the adaptor.

24. A procedure for performing an intra-abdominal urinary diversion with an implanted ureteral bypass device that bypasses a ureter of a patient between a kidney and urinary bladder of the patient, the procedure comprising:

creating an incision in the skin of a patient;

implanting a nephrostomy catheter through the incision so that the nephrostomy catheter is entirely external of the ureter, and securing a first end thereof within the renal pelvis of a kidney of the patient;

implanting a cystostomy catheter through the incision so that the cystostomy catheter is entirely external of the ureter, and securing a first end thereof within the urinary bladder of the patient;

removably assembling second ends of the nephrostomy and cystostomy catheters to an adaptor with connectors to fluidically connect the nephrostomy and cystostomy catheters together and thereby form a ureteral bypass device that defines an internalized urinary diversion through which urinary drainage occurs from the kidney to the urinary bladder and entirely bypasses the ureter of the patient, the connectors enabling interchangeability of the nephrostomy and cystostomy catheters with additional nephrostomy and cystostomy catheters, the adaptor having an internal reservoir compartment and an entry site that comprises a self-sealing septum; and

implanting the adaptor and closing the incision so that the ureteral bypass device is entirely located internally of the patient, the entry site of the adaptor being subcutaneously located in proximity to skin of the patient to provide access to the entry site through the skin to enable performing diagnostic and therapeutic procedures including testing, sampling and flushing of the ureteral bypass device in its entirety while the ureteral bypass device is within the patient and without necessitating removal of the ureteral bypass device from the patient or surgical manipulation.

25. The procedure according to claim 24 , further comprising:

inserting a needle through the skin of the patient and through an entry site of the adaptor; and then

performing at least one step chosen from the group consisting of testing, sampling and flushing the ureteral bypass device.

26. The procedure according to claim 25 , wherein the step comprises sampling fluid within the ureteral bypass device for infection and urinalysis while the ureteral bypass device remains implanted within the patient.

27. The procedure according to claim 25 , wherein the step comprises testing the ureteral bypass device while the ureteral bypass device remains implanted within the patient by injecting a contrast material into the ureteral bypass device so that the contrast material subsequently flows into the kidney and the urinary bladder.

28. The procedure according to claim 25 , wherein the step further comprises:

determining whether an occlusion is present in the ureteral bypass device; and then

flushing the occlusion from the ureteral bypass device while the ureteral bypass device remains implanted within the patient.

29. The procedure according to claim 24 , further comprising:

implanting a second nephrostomy catheter through the incision and securing a first end of the second nephrostomy catheter within the renal pelvis of a second kidney of the patient; and then

fluidically connecting the second nephrostomy catheter to the adaptor so as to fluidically connect the second nephrostomy catheter to the cystostomy catheter.

30. The procedure according to claim 24 , wherein the ureteral bypass device remains indwelling long-term within the patient.

31. The procedure according to claim 24 , further comprising:

creating a second incision in the skin of the patient;

disconnecting the adaptor from at least one of the nephrostomy and cystostomy catheters; and then

removing one or more of the adaptor and the nephrostomy and cystostomy catheters but not the ureteral bypass device in its entirety.