Ureteral catheters, bladder catheters, systems, kits and methods for inducing negative pressure to increase renal function

• US 10,493,232 B2
• Filed: 11/30/2018
• Issued: 12/03/2019
• 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., Orr, David E., Fisher, Michael Allen, Strane, Patrick William, Black, Lance Michael
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US16/205,987
• Publication Number:
  US 20190099584A1
• Time in Patent Office: 368 Days
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• 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 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2210/1085 Bladder
• CPC Class Codes: A61M 2210/1089 Urethra
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

Ureteral or bladder catheters are provided, including (a) a proximal portion; and (b) a distal portion, the distal portion including a retention portion that includes one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter. Systems, kits and methods for inducing negative pressure to increase renal function also are provided.

Claims

1. A ureteral catheter comprising (a) a proximal portion;

and (b) a distal portion, the distal portion comprising a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter, wherein the retention portion is configured into a funnel-shaped support having an outer surface and an inner surface, and wherein the outer periphery or protective surface area comprises the outer surface of the funnel-shaped support, and the one or more drainage holes, ports or perforations are disposed on the inner surface of the funnel-shaped support.

2. The ureteral catheter according to claim 1, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion, and wherein the outer periphery or protective surface area of the retention portion of the catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the ureteral catheter.

3. The ureteral catheter according to claim 1, wherein the retention portion comprises one or more helical coils, each coil having an outwardly facing side and an inwardly facing side, and wherein the outer periphery or protective surface area comprises the outwardly facing side(s) of the one or more helical coil(s), and the one or more protected drainage holes, ports or perforations are disposed on the inwardly facing side(s) of the one or more helical coil(s).

4. The ureteral catheter according to claim 1, wherein the retention portion is 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.

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

one or two ureteral catheters according to claim 1; and

a pump external to the patient'"'"'s body for application of negative pressure through the ureteral catheter, which in turn causes fluid from the kidney to be drawn into the ureteral catheter, through the ureteral catheter and then outside the patient'"'"'s body.

6. A bladder catheter comprising (a) a proximal portion;

and (b) a distal portion, the distal portion comprising a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter, wherein the retention portion is configured into a funnel-shaped support having an outer surface and an inner surface, and wherein the outer periphery or protective surface area comprises the outer surface of the funnel-shaped support, and the one or more drainage holes, ports or perforations are disposed on the inner surface of the funnel-shaped support.

7. The bladder catheter according to claim 6, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion, and wherein the outer periphery or protective surface area of the retention portion of the catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the bladder catheter.

8. The bladder catheter according to claim 6, wherein the retention portion comprises one or more helical coils, each coil having an outwardly facing side and an inwardly facing side, and wherein the outer periphery or protective surface area comprises the outwardly facing side(s) of the one or more helical coil(s), and the one or more protected drainage holes, ports or perforations are disposed on the inwardly facing side(s) of the one or more helical coil(s).

9. The bladder catheter according to claim 6, wherein the retention portion is 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.

10. A kit comprising:

a plurality of disposable bladder catheters according to claim 6;

instructions for deploying the bladder catheter; and

instructions for connecting the proximal end of the bladder catheter to a pump and for operating the pump to draw urine through the drainage lumen of the bladder catheter.

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

(a) at least one ureteral catheter, the at least one ureteral catheter comprising a distal portion configured for insertion within the patient'"'"'s kidney and a proximal portion;

(b) a bladder catheter comprising a distal portion configured for insertion within the patient'"'"'s bladder and a proximal portion for receiving negative pressure from a negative pressure source,

wherein at least one of the at least one ureteral catheter(s) or the bladder catheter comprises (a) a proximal portion; and

(b) a distal portion, the distal portion comprising a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter; and

(c) a negative pressure source for application of negative pressure through both the bladder catheter and the ureteral catheter(s), which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter(s), then through the bladder catheter, and then outside of the patient'"'"'s body.

12. The system according to claim 11, wherein the proximal portion of the at least one ureteral catheter(s) is in fluid communication with the distal portion of the bladder catheter.

13. The system according to claim 11, wherein the distal portion of the at least one ureteral catheter(s) comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of negative pressure from the negative pressure source.

14. The system according to claim 13, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the ureteral catheter, and wherein the outer periphery or protective surface area of the retention portion of the ureteral catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the ureteral catheter.

15. The system according to claim 11, wherein the distal portion of the bladder catheter comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of negative pressure from the negative pressure source.

16. The system according to claim 15, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the bladder catheter, and wherein the outer periphery or protective surface area of the retention portion of the bladder catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the bladder catheter.

17. The system according to claim 11, wherein the negative pressure source comprises a pump external to the patient'"'"'s body for application of negative pressure through both the bladder catheter and the ureteral catheter, which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter, then through the bladder catheter, and then outside of the patient'"'"'s body.

18. The system according to claim 17, wherein the pump provides an accuracy of about 10 mmHg or less.

19. The system according to claim 11, wherein the negative pressure source comprises a vacuum source external to the patient'"'"'s body for application and regulation of negative pressure through both the bladder catheter and the ureteral catheter, which in turn causes fluid from the kidney to be drawn into and through the ureteral catheter, then through the bladder catheter, and then outside of the patient'"'"'s body.

20. The system according to claim 11, wherein the negative pressure received from the negative pressure source is controlled manually, automatically, or combinations thereof.

21. The system according to claim 11, wherein a controller is used to regulate negative pressure from the negative pressure source.

22. The system according to claim 11, wherein the negative pressure is provided within a range of about 2 mm Hg to about 150 mm Hg.

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

(a) at least one ureteral catheter, the at least one ureteral catheter comprising a distal portion configured for insertion within the patient'"'"'s kidney and a proximal portion;

(b) a bladder catheter comprising a distal portion configured for insertion within the patient'"'"'s bladder and a proximal portion for receiving a negative pressure, wherein the negative pressure causes fluid from the kidney to be drawn into and through the ureteral catheter(s), then through the bladder catheter, and then outside of the patient'"'"'s body,

wherein at least one of the at least one ureteral catheter(s) or the bladder catheter comprises (a) a proximal portion; and

(b) a distal portion, the distal portion comprising a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of the negative pressure through the at least one ureteral catheter(s) or the bladder catheter.

24. The system according to claim 23, wherein the proximal portion of the at least one ureteral catheter(s) is in fluid communication with the distal portion of the bladder catheter.

25. The system according to claim 23, wherein the distal portion of the at least one ureteral catheter(s) comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of the pressure differential.

26. The system according to claim 25, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the ureteral catheter, and wherein the outer periphery or protective surface area of the retention portion of the ureteral catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the ureteral catheter.

27. The system according to claim 23, wherein the distal portion of the bladder catheter comprises a retention portion that comprises one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon the application of the pressure differential.

28. The system according to claim 27, wherein the one or more protected drainage holes, ports or perforations are disposed on a protected surface area or inner surface area of the retention portion of the bladder catheter, and wherein the outer periphery or protective surface area of the retention portion of the bladder catheter is configured to support the mucosal tissue and thereby prevent occlusion of the one or more of the protected drainage holes, ports or perforations upon application of negative pressure through the bladder catheter.