Systems and methods for inducing negative pressure in a portion of a urinary tract of a patient

• US 10,426,919 B2
• Filed: 01/25/2019
• Issued: 10/01/2019
• 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 Alan, Strane, Patrick William, Black, Lance Michael
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US16/257,791
• Publication Number:
  US 20190167944A1
• Time in Patent Office: 249 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 system for inducing negative pressure in a portion of a urinary tract of a patient, the system comprising:

(a) a 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 application of negative pressure, the proximal portion configured to extend outside of the patient'"'"'s body; and

(c) 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 the ureteral catheter, through both the ureteral catheter and the bladder catheter, and then outside of the patient'"'"'s body.

2. The system according to claim 1, wherein the proximal portion of the ureteral catheter is in fluid communication with the distal portion of the bladder catheter.

3. The system according to claim 1, wherein the distal portion of the ureteral 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 by the pump.

4. The system according to claim 3, 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, upon application of negative pressure, the mucosal tissue conforms or collapses onto the outer periphery or protective surface area of the retention portion of the ureteral catheter and is thereby prevented or inhibited from occluding the one or more of the protected drainage holes, ports or perforations.

5. The system according to claim 1, 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 by the pump.

6. The system according to claim 5, 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, upon application of negative pressure, the mucosal tissue conforms or collapses onto the outer periphery or protective surface area of the retention portion of the bladder catheter and is thereby prevented or inhibited from occluding the one or more of the protected drainage holes, ports or perforations.

7. The system according to claim 1, further comprising one or more physiological sensors configured to detect at least one physical parameter of the patient.

8. The system according to claim 7, wherein the at least one physical parameter comprises one or more of volume of urine collected, urine composition, urine protein concentration, blood composition or blood flow.

9. The system according to claim 8, wherein the at least one physical parameter of blood composition comprises one or more of hematocrit ratio, analyte concentration, protein concentration, or creatinine concentration.

10. The system according to claim 8, wherein the at least one physical parameter of blood flow comprises one or more of blood pressure or blood flow velocity.

11. The system according to claim 7, wherein the one or more physiological sensors comprise one or more of pulse oximetry sensor(s), blood pressure sensor(s), heart rate sensor(s), respiration sensor(s), capnography sensor(s), glucose sensor(s), blood velocity sensor(s), hemoglobin sensor(s), hematocrit sensor(s), protein sensor(s), creatinine sensor(s), analyte sensor(s), capacitance sensor(s), optical spectroscopy sensor(s) or combinations thereof.

12. The system according to claim 1, wherein the pump provides an accuracy of about 10 mmHg or less.

13. The system according to claim 1, wherein the negative pressure is provided within a range of about 2 mm Hg to about 150 mm Hg.

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

deploying a ureteral catheter into a ureter of a patient to maintain patency of fluid flow between a kidney and a bladder of the patient, the ureteral catheter comprising a distal portion for insertion within the patient'"'"'s kidney and a proximal portion;

deploying a bladder catheter into the bladder of the patient, wherein the bladder catheter comprises a distal portion for insertion within the patient'"'"'s bladder and a proximal portion for application of negative pressure, the proximal portion extending outside of the patient'"'"'s body; and

applying negative pressure to the proximal end of the bladder catheter to induce negative pressure in a portion of the urinary tract of the patient to remove fluid from the patient.

15. The method according to claim 14, wherein at least one of the ureteral catheter 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.

16. The method according to claim 14, wherein the ureteral catheter is deployed and remains in the patient'"'"'s body for at least 24 hours.

17. The method according to claim 14, wherein the ureteral catheter is deployed and remains in the patient'"'"'s body for at least 30 days or longer.

18. The method according to claim 14, wherein the bladder catheter is replaced more often that the ureteral catheter.

19. The method according to claim 14, wherein multiple bladder catheters are placed and removed during the indwell time for a single set of ureteral catheters.