Indwelling bladder catheter

• US 10,376,137 B2
• Filed: 08/25/2015
• Issued: 08/13/2019
• Est. Priority Date: 09/13/2012
• Status: Active Grant

• Current Assignee: Emmy Medical, LLC
• Original Assignee: Emmy Medical, LLC
• Inventors: Greenberg, James Adam, Adams, Ronald D., Kohli, Neeraj, Harari, David
• Primary Examiner(s): Carpenter, William R
• Application Number:
  US14/835,382
• Publication Number:
  US 20160051135A1
• Time in Patent Office: 1,449 Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00091 Nozzles
• CPC Class Codes: A61B 1/00128 mechanical, e.g. for tubes or pipes
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00137 End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Systems and methods of cannulating a body orifice such as a bladder are disclosed. An indwelling bladder catheter having reduced trauma risk can include a proximal end, a distal end, and a flexible elongate tubular body therebetween, the distal end having at least one distal port in fluid communication with a lumen extending within the tubular body, the distal end further having a distal tip comprising a blunt shape; a first proximal port for at least one of fluid inflow or outflow, the first proximal port in fluid communication with the lumen extending within the tubular body; an inflatable balloon near the distal end of the catheter, the balloon transformable from an unexpanded to an expanded configuration, wherein the balloon in its expanded configuration comprises a low profile oblong shape suitable for anchoring within a human bladder; and a second proximal port balloon inflation, in fluid connection with the balloon.

Claims

1. An indwelling transurethral bladder catheter having reduced trauma risk, the catheter comprising:

a proximal end, a distal end, and a flexible elongate tubular body therebetween, the distal end having at least one distal port in fluid communication with a lumen extending within the elongate tubular body, the distal end further having a distal tip comprising a blunt shape;

a first proximal port for at least one of fluid inflow or outflow, the first proximal port in fluid communication with the lumen extending within the elongate tubular body;

an inflatable balloon near the distal end of the catheter, the balloon transformable from an unexpanded to an expanded configuration,

wherein the balloon in its expanded configuration comprises a low profile oblong shape suitable for anchoring within a human bladder and providing a seal proximate an internal urethral orifice, the low profile oblong shape comprising a first dimension in a radial direction that is at least about 1.5×

of a second dimension in an axial direction, and

wherein the balloon is sized and positioned sufficiently close to a distal tip of the distal end of the catheter to enable a cystoscope protruding from the distal tip to view ureter openings of the bladder, the balloon positioned such that an axial length from a distal end of the balloon in its expanded configuration to the distal tip of the distal end of the catheter is no greater than ⅕

of an axial length from a proximal end of the balloon in its expanded configuration to the distal tip of the distal end of the catheter, wherein a proximal most edge of the balloon in its expanded configuration is aligned with a point at which the balloon attaches to the elongate tubular body, the distal end of the catheter extending distally beyond the distal end of the balloon and into the bladder in an axial direction, wherein the balloon and the distal end of the catheter are coupled distinct elements;

a second proximal port for balloon inflation, in fluid connection with the balloon; and

a third proximal port for insertion of a cystoscope therethrough, the third proximal port being fluidly connected to the lumen extending within the elongate tubular body.

2. The catheter of claim 1, wherein the first proximal port comprises a multifunction connector, the multifunction connector comprising a threaded portion, a tapered portion, and an annular region therebetween, wherein the annular region comprises a smaller outer diameter than the threaded portion.

3. The catheter of claim 1, further comprising a tethered cap comprising threads to couple with the threaded portion of the multifunction connector.

4. The catheter of claim 1, further comprising a tethered cap configured to seal the first proximal port.

5. The catheter of claim 4, wherein the tethered cap is integrally molded to the catheter.

6. The catheter of claim 4, further comprising a clamp that provides an alternative method of sealing the first proximal port, the clamp configured to pinch a section of tubing to limit fluid communication between the first proximal port and the lumen extending through the elongate tubular body.

7. The catheter of claim 1, further comprising a tapered portion extending about the third proximal port.

8. The catheter of claim 1, wherein the elongate tubular body comprises a plurality of markings regularly-spaced in an axial direction.

9. The catheter of claim 1, wherein the distal tip of the distal end of the catheter extends in an axial direction no more than 1 millimeter beyond the distal end of the balloon in its expanded configuration.

10. The catheter of claim 1, wherein the distal tip of the distal end of the catheter extends in an axial direction no more than 5 millimeters beyond the distal end of the balloon in its expanded configuration.

11. The catheter of claim 1, wherein the distal tip of the distal end of the catheter extends in an axial direction no more than 10 millimeters beyond the distal end of the balloon in its expanded configuration.

12. The catheter of claim 1, wherein an expanded axial length of the balloon is no greater than about 25 millimeters.

13. The catheter of claim 1, wherein the balloon in its expanded configuration has a volume of no more than about 5 cc.

14. The catheter of claim 1, wherein the balloon in its expanded configuration has a volume of no more than about 3 cc.

15. The catheter of claim 1, wherein the distal end comprises a rounded distal tip.

16. The catheter of claim 1, wherein the distal end comprises an end cap having a slot therein.

17. The catheter of claim 1, wherein the distal end comprises at least two distal ports, wherein at least one distal port is positioned on a distal surface of the distal end and at least one distal port is positioned on a side surface of the distal end.

18. The catheter of claim 1, wherein the balloon in its unexpanded configuration is positioned such that an axial length from the distal end of the balloon to the distal tip of the distal end of the catheter comprises a first value, wherein the balloon is configured to expand in both a transverse and an axial direction when changing from the unexpanded to the expanded configuration, such that in the expanded configuration the axial length from the distal end of the balloon to the distal tip of the distal end of the catheter comprises a second value that is smaller than the first value.

19. The catheter of claim 1, wherein the balloon in its expanded configuration comprises a longitudinally symmetric shape.