Ureteral and bladder catheters and methods of inducing negative pressure to increase renal perfusion

• US 10,307,564 B2
• Filed: 07/20/2016
• Issued: 06/04/2019
• Est. Priority Date: 07/20/2015
• Status: Active Grant

• Current Assignee: Roivios Limited
• Original Assignee: Strataca Systems Limited
• Inventors: Erbey, II, John R., Upperco, Jacob L., Fisher, Michael Allen, Strane, Patrick William, Black, Lance Michael
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/214,955
• Publication Number:
  US 20170021128A1
• Time in Patent Office: 1,049 Days
• CPC Class Codes: A61F 13/2002 characterised by the use
• CPC Class Codes: A61F 2013/15146 for urine collection
• CPC Class Codes: A61M 1/70 Gravity drainage systems drainage containers not being adapted for subjection to vacuum A61M1/69
• CPC Class Codes: A61M 1/73 comprising sensors or indicators for physical values
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0213 where the catheter is attached by means specifically adapted to a part of the human body
• CPC Class Codes: A61M 2202/0496 Urine
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/1092 Female
• CPC Class Codes: A61M 2210/1096 Male
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• 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 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1025 : Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 27/008 : pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 39/12 : for joining a flexible tube to a rigid attachment

Abstract

Ureteral catheters and assemblies are provided including: a drainage lumen including a proximal portion configured to be positioned in at least a portion of a patient'"'"'s urethra and a distal portion configured to be positioned in a patient'"'"'s ureter and/or kidney, the distal portion including a coiled retention portion including at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter; or wherein the retention portion extends radially outwardly from a portion of the distal end of the drainage lumen portion, the retention portion including a proximal end having a first diameter, a distal end having a second diameter, and a wall and/or surface extending therebetween, the retention portion having a second diameter is greater than the first diameter when deployed; or wherein the retention portion includes a plurality of drainage tubes.

Claims

1. A ureteral catheter, comprising:

a drainage lumen comprising a proximal portion and a distal portion configured to be positioned in a patient'"'"'s kidney, renal pelvis and/or in the ureter adjacent to the renal pelvis, the distal portion comprising a coiled retention portion, the coiled retention portion comprising;

at least a first coil having a first diameter;

at least a second coil having a second diameter, the first diameter being less than the second diameter, the second coil being closer to an end of the distal portion of the drainage lumen than the first coil; and

one or more perforations on a sidewall of the coiled retention portion of the distal portion of the drainage lumen for permitting fluid flow into the drainage lumen,

wherein the proximal portion of the drainage lumen is essentially free of or free of perforations.

2. The ureteral catheter of claim 1, wherein the first coil is proximal to the second coil.

3. The ureteral catheter of claim 1, wherein, prior to insertion into a patient'"'"'s urinary tract, a portion of the drainage lumen that is proximal to the retention portion defines a straight or curvilinear central axis, and wherein the first coil and the second coil of the retention portion extend about an axis that is at least partially coextensive with the straight or curvilinear central axis of the portion of the drainage lumen.

4. The ureteral catheter of claim 3, wherein the axis of the retention portion is curved relative to the central axis of the drainage lumen.

5. The ureteral catheter of claim 1, wherein, prior to insertion to the patient'"'"'s urinary tract, a portion of the drainage lumen that is proximal to the retention portion defines a straight or curvilinear central axis, and wherein the first coil and the second coil of the retention portion extend about an axis that is essentially coextensive with the straight or curvilinear central axis of the portion of the drainage lumen.

6. The ureteral catheter of claim 1, wherein a portion of the drainage lumen that is proximal to the retention portion defines a straight or curvilinear central axis, and wherein the first coil and the second coil of the retention portion extend about an axis of the retention portion, the axis of the retention portion being positioned at an angle from the central axis ranging from about 15 degrees to about 75 degrees.

7. The ureteral catheter of claim 1, wherein the catheter is transitionable between a contracted configuration for insertion into the patient'"'"'s ureter and a deployed configuration for deployment within the ureter.

8. The ureteral catheter of claim 1, wherein the retention portion further comprises a third coil, the third coil having a diameter greater than or equal to either the first diameter or the second diameter.

9. The ureteral catheter of claim 1, wherein the retention portion comprises a tube comprising perforations for permitting fluid to be received within the lumen of the tube.

10. The ureteral catheter of claim 9, wherein, in the retention portion, the tube comprises a radially inwardly facing side and a radially outwardly facing side, and wherein a total surface area for perforations on the radially inwardly facing side is greater than a total surface area of perforations on the radially outwardly facing side.

11. The ureteral catheter of claim 9, wherein, in the retention portion, the tube comprises a radially inwardly facing side and a radially outwardly facing side, and wherein the perforations are disposed on the radially inwardly facing side, and wherein the radially outwardly facing side of the tube is essentially free of perforations.

12. The ureteral catheter of claim 11, wherein the radially outwardly facing side of the tube is free of perforations.

13. The ureteral catheter of claim 1, wherein the tube is formed, at least in part, from one or more of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone.

14. A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

the ureteral catheter according to claim 1; and

a pump in fluid communication with the drainage lumen of the ureteral catheter, the pump being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the ureteral catheter.

15. A urine collection assembly comprising:

at least one ureteral catheter comprising a drainage lumen comprising a proximal portion configured to be positioned in at least a portion of a patient'"'"'s urethra and a distal portion configured to be positioned in a patient'"'"'s ureter and/or kidney, the distal portion comprising a coiled retention portion, wherein the retention portion comprises at least a first coil having a first diameter and a second coil having a second diameter, the first diameter being less than the second diameter; and

a bladder catheter for deployment within the patient'"'"'s bladder, the bladder catheter comprising;

a drainage lumen comprising a proximal end and a distal end configured to be positioned in the patient'"'"'s bladder, and

a sidewall extending between the proximal end and the distal end of the drainage lumen; and

a deployable anchor portion comprising a seal configured to contact a proximal portion of the bladder wall to essentially or fully seal the urethral opening of the bladder,

wherein the drainage lumen portion or the anchor portion comprises at least one drainage port for permitting fluid flow into the drainage lumen.

16. The assembly of claim 15, wherein the drainage lumen portion of the at least one ureteral catheter is removably received through the drainage port of the bladder catheter, such that the proximal end of the at least one ureteral catheter is disposed within the drainage lumen of the bladder catheter.

17. The assembly of claim 15, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the drainage lumen portion of the bladder catheter.

18. The assembly of claim 15, wherein the at least one drainage port is disposed on a sidewall of the bladder catheter at a position proximal to the deployable anchor portion.

19. The assembly of claim 15, wherein the deployable anchor portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter.

20. The assembly of claim 19, wherein the deployable anchor further comprises a flexible cover extending about an upper portion of the cage.

21. The assembly of claim 20, wherein the cover extends over at least about the upper half of the cage.

22. The assembly of claim 15, wherein the deployable anchor portion comprises a plurality of longitudinally extending members that, in a deployed position, extend radially and longitudinally outwardly from a portion of the distal end of the bladder catheter, thereby forming a cage.

23. The assembly of claim 15, wherein the drainage lumen of the at least one ureteral catheter is a separate tube from a tube of the drainage lumen of the bladder catheter along an entire length of the tubes.

24. The urine collection assembly of claim 15, wherein the deployable anchor portion comprises an inflatable element or balloon in fluid communication with an inflation lumen of the drainage lumen portion of the bladder catheter.

25. The urine collection assembly of claim 24, wherein the inflatable element or balloon comprises an upper portion configured to be positioned in the patient'"'"'s bladder and a lower portion configured to be positioned in the patient'"'"'s urethra.

26. The urine collection assembly of claim 15, wherein the at least one drainage port is disposed on a sidewall of the bladder catheter at a position proximal to the anchor portion.

27. The bladder catheter of claim 15, wherein the deployable anchor portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter and a cover enclosing at least a portion of the cage.

28. The bladder catheter of claim 27, wherein the deployable anchor portion further comprises a flexible cover extending about an upper portion of the cage.

29. The bladder catheter of claim 28, wherein the cover extends over at least about the upper half of the cage.

30. A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

the urine collection assembly according to claim 15; and

a pump in fluid communication with the drainage lumen of the bladder catheter, the pump being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the bladder catheter and the drainage lumen of the ureteral catheter.

31. A ureteral catheter comprising:

a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a patient'"'"'s ureter and/or kidney, and a sidewall extending therebetween; and

a retention portion extending radially outwardly from a portion of the distal end of the drainage lumen portion, the retention portion comprising a proximal end having a first diameter, a distal end having a second diameter, and a wall and/or surface extending therebetween, the retention portion being configured to be extended into a deployed position in which the second diameter is greater than the first diameter.

32. The ureteral catheter of claim 31, wherein the retention portion comprises an expandable element or balloon in fluid communication with an inflation lumen extending along the drainage lumen portion.

33. The ureteral catheter of claim 31, wherein the retention portion comprises a coiled tube extending from the distal end of the drainage lumen portion, the tube defining a lumen in fluid communication with the drainage lumen defined by the drainage lumen portion.

34. The ureteral catheter of claim 31, wherein the coiled tube comprises perforations extending through a sidewall of the tube for permitting fluid to be received within the lumen.

35. The ureteral catheter of claim 34, wherein the perforations are disposed on a radially inwardly facing portion of the tube, and wherein an opposing radially outwardly facing portion of the tube is essentially free of perforations.

36. The ureteral catheter of claim 35, wherein the opposing radially outwardly facing portion of the tube is free of perforations.

37. The ureteral catheter of claim 31, wherein the drainage lumen portion and the retention portion are formed, at least in part, from one or more of copper, silver, gold, nickel-titanium alloy, stainless steel, titanium, polyurethane, polyvinyl chloride, polytetrafluoroethylene (PTFE), latex, and silicone.

38. The ureteral catheter of claim 31, wherein the retention portion comprises a wedge or funnel-shaped extension formed from a compressible and/or porous material.

39. The ureteral catheter of claim 31, wherein the retention portion is integrally formed with the drainage lumen portion.

40. The ureteral catheter of claim 31, wherein the retention portion further comprises a tapered inner surface configured to direct fluid towards the drainage lumen defined by the drainage lumen portion.

41. The ureteral catheter of claim 31, wherein negative pressure is applied to the drainage lumen of the catheter to facilitate fluid collection from the ureter and/or kidney.

42. A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

the ureteral catheter according to claim 31; and

a pump in fluid communication with the drainage lumen of the ureteral catheter, the pump being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the ureteral catheter.

43. A urine collection assembly comprising:

at least one ureteral catheter comprising;

a drainage lumen portion comprising a proximal end, a distal end configured to be positioned in a patient'"'"'s ureter and/or kidney, and a sidewall extending therebetween; and

a retention portion extending radially outwardly from a portion of the distal end of the drainage lumen portion, the retention portion comprising a proximal end having a first diameter, a distal end having a second diameter, and a wall and/or surface extending therebetween, the retention portion being configured to be extended into a deployed position in which the second diameter is greater than the first diameter; and

a bladder catheter for deployment within the patient'"'"'s bladder, the bladder catheter comprising;

a drainage lumen comprising a proximal end and a distal end configured to be positioned in the patient'"'"'s bladder, and a sidewall extending between the proximal end and the distal end of the drainage lumen; and

a deployable anchor portion comprising a seal configured to contact a proximal portion of the bladder wall to seal the urethral opening of the bladder,

wherein the drainage lumen portion or the anchor portion comprises at least one drainage port for permitting fluid flow into the drainage lumen.

44. The assembly of claim 43, wherein the drainage lumen portion of the at least one ureteral catheter is removably received through the drainage port of the bladder catheter, such that the proximal end of the at least one ureteral catheter is disposed within the drainage lumen of the bladder catheter.

45. The assembly of claim 43, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the drainage lumen portion of the bladder catheter.

46. The assembly of claim 43, wherein the at least one drainage port is disposed on a sidewall of the bladder catheter at a position proximal to the deployable anchor portion.

47. The assembly of claim 43, wherein the deployable anchor portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter.

48. The assembly of claim 47, wherein the deployable anchor further comprises a flexible cover extending about an upper portion of the cage.

49. The assembly of claim 48, wherein the cover extends over at least about the upper half of the cage.

50. The assembly of claim 43, wherein the deployable anchor portion comprises a plurality of longitudinally extending members that, in a deployed position, extend radially and longitudinally outward from a portion of the distal end of the bladder catheter, thereby forming a cage.

51. The urine collection assembly of claim 43, wherein the deployable anchor portion comprises an inflatable element or balloon in fluid communication with an inflation lumen of the drainage lumen portion of the bladder catheter.

52. The urine collection assembly of claim 51, wherein the inflatable element or balloon comprises an upper portion configured to be positioned in the patient'"'"'s bladder and a lower portion configured to be positioned in the patient'"'"'s urethra.

53. The urine collection assembly of claim 43, wherein the at least one drainage port is disposed on a sidewall of the bladder catheter at a position proximal to the anchor portion.

54. A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

the urine collection assembly according to claim 43; and

a pump in fluid communication with the drainage lumen of the bladder catheter, the pump being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the bladder catheter and the drainage lumen of the ureteral catheter.

55. A urine collection assembly comprising:

a first ureteral catheter configured to be positioned in a patient'"'"'s ureter and/or kidney and a second ureteral catheter configured to be positioned in the patient'"'"'s other ureter and/or kidney, the ureteral catheters each comprising;

a drainage lumen portion defining a drainage lumen and comprising a proximal end, a distal end configured to be positioned in a patient'"'"'s ureter and/or kidney, and a sidewall extending therebetween; and

a retention portion extending radially outward from a portion of the distal end of the drainage lumen portion, and being configured to be extended into a deployed position in which a diameter of the retention portion is greater than a diameter of the drainage lumen portion, wherein at least one of the drainage lumen portion or the retention portion comprises at least one drainage port to permit fluid flow into the drainage lumen; and

a bladder catheter for deployment within the patient'"'"'s bladder, the bladder catheter comprising;

a drainage lumen portion defining a drainage lumen and comprising a proximal end, a distal end configured to be positioned in the patient'"'"'s bladder, and a sidewall extending therebetween; and

a deployable anchor portion comprising a seal configured to contact a proximal portion of the bladder wall to seal the urethral opening, wherein at least one of the drainage lumen portion or the anchor portion comprises at least one drainage port for permitting fluid flow into the drainage lumen.

56. The assembly of claim 55, further comprising a connector for connecting proximal ends of the ureteral catheters to a vacuum source and for connecting the proximal end of the bladder catheter to a fluid collection container for fluid collection by gravity drainage.

57. The assembly of claim 56, wherein the connector comprises:

at least two ureteral catheter inflow ports for connection to the respective proximal ends of the first ureteral catheter and the second ureteral catheter;

a ureteral catheter outflow port in fluid communication with each inflow port and being configured to be connected to a pump for inducing negative pressure in the respective ureteral catheters;

a gravity drainage inflow port configured to be connected to the proximal end of the bladder catheter; and

an outflow port in fluid communication with the bladder catheter inflow port and being configured to be connected to a fluid collection container.

58. The assembly of claim 57, wherein the connector further comprises conduit extending from the at least two ureteral catheter inflow ports to the single ureteral catheter outflow port.

59. The assembly of claim 57, wherein the proximal ends of the respective catheters are removably connected to their respective inflow ports.

60. The assembly of claim 55, wherein the deployable anchor portion of the bladder catheter comprises an inflatable element or balloon in fluid communication with an inflation lumen defined by the drainage lumen portion of the bladder catheter.

61. The assembly of claim 60, wherein the deployable anchor further comprises a flexible cover extending about an upper portion of the cage.

62. The assembly of claim 61, wherein the cover extends over at least about the upper half of the cage.

63. The assembly of claim 55, wherein the deployable anchor portion comprises an expandable cage comprising a plurality of flexible members extending radially and longitudinally from the drainage lumen portion of the bladder catheter and a cover enclosing at least a portion of the cage.

64. The urine collection assembly of claim 55, wherein the deployable anchor portion comprises an inflatable element or balloon in fluid communication with an inflation lumen of the drainage lumen portion of the bladder catheter.

65. The urine collection assembly of claim 64, wherein the inflatable element or balloon comprises an upper portion configured to be positioned in the patient'"'"'s bladder and a lower portion configured to be positioned in the patient'"'"'s urethra.

66. The urine collection assembly of claim 55, wherein the at least one drainage port is disposed on a sidewall of the bladder catheter at a position proximal to the anchor portion.

67. A system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

the urine collection assembly according to claim 55; and

a pump in fluid communication with the drainage lumen of the bladder catheter, the pump being configured for inducing a negative pressure in a portion of the urinary tract of the patient to draw fluid through the drainage lumen of the bladder catheter and the drainage lumen(s) of at least one of the first ureteral catheter or the second ureteral catheter.