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

• US 9,744,331 B2
• Filed: 07/20/2016
• Issued: 08/29/2017
• Est. Priority Date: 07/20/2015
• Status: Active Grant

• Current Assignee: Roivios Limited
• Original Assignee: Strataca Systems, LLC
• Inventors: Erbey, II, John R., Upperco, Jacob L., Fisher, Michael Allen, Strane, Patrick William, Black, Lance Michael
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/215,081
• Publication Number:
  US 20170021129A1
• Time in Patent Office: 405 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 configured to extend outside of the patient'"'"'s body by transiting through the patient'"'"'s urethra, 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,

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, when deployed, the first coil and the second coil of the retention portion extend about an axis of the retention portion that is at least partially coextensive with the straight or curvilinear central axis of the portion of the drainage lumen.

2. The ureteral catheter of claim 1, wherein the axis of the retention portion is curved relative to the central axis of the drainage lumen.

3. The ureteral catheter of claim 1, wherein at least a portion of the axis of the retention portion extends at an angle from the central axis of up to about 75 degrees.

4. 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.

5. The ureteral catheter of claim 1, wherein the retention portion further comprises a third coil extending about the axis of the retention portion, the third coil having a diameter greater than or equal to either the first coil diameter or the second coil diameter, the third coil being closer to an end of the distal portion of the drainage lumen than the second coil.

6. The ureteral catheter of claim 1, wherein the retention portion of the drainage lumen comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, and wherein a total surface area of perforations on the radially inwardly facing side is greater than a total surface area of perforations on the radially outwardly facing side.

7. The ureteral catheter of claim 1, wherein, the retention portion of the drainage lumen comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, and wherein the one or more perforations are disposed on the radially inwardly facing side, and wherein the radially outwardly facing side is essentially free of perforations.

8. The ureteral catheter of claim 1, wherein the drainage lumen 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.

9. The ureteral catheter of claim 1, wherein the retention portion of the drainage lumen further comprises an open distal end for permitting fluid flow into the drainage lumen.

10. The ureteral catheter of claim 1, wherein each of the one or more perforations has a diameter of about 0.7 to 0.9 mm.

11. The ureteral catheter of claim 1, wherein the first diameter of the first coil is about 8 mm to 10 mm and the second diameter of the second coil is about 16 mm to 20 mm.

12. The ureteral catheter of claim 1, wherein the first coil comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, the radially inwardly facing side of the first coil comprising one or more perforations for permitting fluid flow into the drainage lumen.

13. The ureteral catheter of claim 1, wherein the first coil comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, the radially inwardly facing side of the first coil comprising at least two perforations for permitting fluid flow into the drainage lumen.

14. The ureteral catheter of claim 1, wherein the first coil comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, the radially outwardly facing side of the first coil being essentially free of or free of one or more perforations.

15. The ureteral catheter of claim 1, wherein the first coil comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, the radially inwardly facing side of the first coil comprising one or more perforations for permitting fluid flow into the drainage lumen and the radially outwardly facing side being essentially free of or free of one or more perforations.

16. The ureteral catheter of claim 1, wherein the one or more perforations on the sidewall of the drainage lumen permit fluid flow by negative pressure into the drainage lumen.

17. The ureteral catheter of claim 1, wherein the diameter of the coils increases toward a distal end of the drainage lumen, resulting in a helical structure having a tapered or partially tapered configuration.

18. The ureteral catheter of claim 1, wherein one or more perforations are circular.

19. The ureteral catheter of claim 1, wherein one or more perforations are non-circular.

20. The ureteral catheter of claim 1, wherein when deployed, the first coil and the second coil of the retention portion extend about an axis of the retention portion that is coextensive with the straight or curvilinear central axis of the distal portion of the drainage lumen.

21. A ureteral catheter, comprising:

a drainage lumen comprising a proximal portion configured to extend outside of the patient'"'"'s body by transiting through the patient'"'"'s urethra, 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 drainage lumen for permitting fluid flow into the drainage lumen, wherein the sidewall comprises a radially inwardly facing side and a radially outwardly facing side, and wherein a total surface area of perforations on the radially inwardly facing side is greater than a total surface area of perforations on the radially outwardly facing side,

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, when deployed, the first coil and the second coil of the retention portion extend about an axis of the retention portion that is at least partially coextensive with the straight or curvilinear central axis of the portion of the drainage lumen.

22. The ureteral catheter of claim 21, wherein the axis of the retention portion is curved relative to the central axis of the drainage lumen.

23. The ureteral catheter of claim 21, wherein at least a portion of the axis of the retention portion extends at an angle from the central axis of up to about 75 degrees.

24. The ureteral catheter of claim 21, 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.

25. The ureteral catheter of claim 21, wherein the retention portion further comprises a third coil extending about the axis of the retention portion, the third coil having a diameter greater than or equal to either the first coil diameter or the second coil diameter, the third coil being closer to an end of the distal portion of the drainage lumen than the second coil.

26. The ureteral catheter of claim 21, wherein the first coil comprises a sidewall comprising a radially inwardly facing side and a radially outwardly facing side, the radially inwardly facing side of the first coil comprising one or more perforations for permitting fluid flow into the drainage lumen.

27. A ureteral catheter, comprising:

a drainage lumen comprising a proximal portion configured to extend outside of the patient'"'"'s body by transiting through the patient'"'"'s urethra, 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,

at least a third coil extending about the axis of the retention portion, the third coil having a diameter greater than or equal to either the first coil diameter or the second coil diameter, the third coil being closer to an end of the distal portion of the drainage lumen than the second coil,

one or more perforations on a sidewall of the coiled retention portion of the drainage lumen for permitting fluid flow into the drainage lumen and wherein the proximal portion of the drainage lumen is essentially free of or free of perforations,

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, when deployed, the first coil and the second coil of the retention portion extend about an axis of the retention portion that is at least partially coextensive with the straight or curvilinear central axis of the portion of the drainage lumen.

28. The ureteral catheter of claim 27, wherein the axis of the retention portion is curved relative to the central axis of the drainage lumen.

29. The ureteral catheter of claim 27, wherein at least a portion of the axis of the retention portion extends at an angle from the central axis of up to about 75 degrees.

30. The ureteral catheter of claim 27, 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.