Systems and methods for correcting and preventing occlusion in a catheter

• US 10,322,230 B2
• Filed: 06/09/2017
• Issued: 06/18/2019
• Est. Priority Date: 06/09/2016
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ofek, Gidon, Muse, Jay A., Hamatake, Bret, Smith, Garrick T.
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US15/619,219
• Publication Number:
  US 20170354777A1
• Time in Patent Office: 739 Days
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/772 operating alternately
• CPC Class Codes: A61M 1/80 Suction pumps A61M1/64, A61M1/71, A61M60/00 take precedence
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/1588 having means for monitoring, controlling or visual inspection, e.g. for patency check, avoiding extravasation
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 39/225 Flush valves, i.e. bypass valves for flushing line
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons

Abstract

A patency device for catheter assemblies and other elongate tubular devices used for establishing access to an interior body portion of a patient is disclosed. The patency device establishes and preserves patency of one or more lumens defined by the catheter assembly by providing impulses of positive pressure to fluid disposed in the lumen of the catheter assembly. In one embodiment, the patency device comprises a fluid reservoir configured to provide a fluid path to at least one lumen of the catheter assembly, and a pressure input portion. The pressure input portion is configured to provide pressure for one or more impulses of positive pressure to a fluid disposed within the lumen. The impulses are configured to dislodge occlusions that may have formed in the lumen. A negative pressure can then be provided to the lumen to aspirate the occlusion.

Claims

1. A patency device for providing patency to at least one lumen of a catheter assembly, the patency device comprising:

a fluid reservoir configured to provide a fluid path to the at least one lumen of the catheter assembly;

a pressure input portion having a distal end connected to the fluid reservoir, the pressure input portion configured to provide pressure for at least one impulse of positive pressure to a fluid disposed within the at least one lumen; and

an interface portion having a proximal end connected to the fluid reservoir, and a distal end connected to the at least one lumen.

2. The device as defined in claim 1, wherein the at least one impulse is configured to dislodge an occlusion disposed in the at least one lumen.

3. The device as defined in claim 1, wherein the patency device is further configured to provide a temporary negative pressure to the fluid disposed in the at least one lumen.

4. The device as defined in claim 3, wherein the temporary negative pressure is provided by a vacuum input portion of the patency device.

5. The device as defined in claim 4, wherein the vacuum input portion includes at least one of a syringe pump and a vacuum pump.

6. The device as defined in claim 4, wherein a normally open valve is included with the vacuum input portion.

7. The device as defined in claim 6, wherein a normally closed valve is included with the pressure input portion.

8. The device as defined in claim 7, wherein the normally open valve is configured to provide the temporary negative pressure to the fluid disposed in the at least one lumen, the normally open valve configured to close upon opening of the normally closed valve, the normally closed valve configured to provide the at least one impulse to the fluid disposed in the at least one lumen.

9. The device as defined in claim 1, wherein the at least one impulse includes a series of impulses at a predetermined impulse frequency and wherein the interface portion is disposable and provides a sterile barrier between the catheter assembly and the patency device.

10. The device as defined in claim 9, wherein the predetermined impulse frequency is at least 20 KHz.

11. The device as defined in claim 1, wherein the pressure input portion provides multiple series of the impulses in a predetermined impulse pattern, each series including at least one impulse.

12. The device as defined in claim 11, wherein each of the series of the impulses is separated by a rest period.

13. The device as defined in claim 12, wherein the patency device is configured to provide a negative pressure to the fluid disposed within the at least one lumen during each rest period.

14. The device as defined in claim 1, wherein the patency device is configured to provide the at least one impulse at a pressure of at least 30 psi.

15. The device as defined in claim 1, wherein the patency device is configured to provide the at least one impulse at a pressure that exceeds a burst pressure strength rating of a catheter tube of the catheter assembly.

16. The device as defined in claim 1, further comprising a pressure transducer configured to provide data relating to a pressure within a fluid line of the patency device.

17. The device as defined in claim 1, further comprising a controller configured to govern operation of the patency device, the controller including a processor.

18. The device as defined in claim 1, wherein the pressure input portion includes at least one of a hydrostatic pump, an actuator, and a wave generator.

19. The device as defined in claim 1, wherein the fluid reservoir includes at least one of a hydraulic accumulator and a syringe.

20. The device as defined in claim 1, wherein the at least one impulse includes a rise-time phase of about 30 milliseconds, a holding high-pressure phase of about 200 milliseconds, and a pressure reduction phase of about 40 milliseconds.

21. A patency device for providing patency to at least one lumen of a catheter assembly, the patency device comprising:

a fluid path to the at least one lumen of the catheter assembly;

a pressure input portion configured to provide pressure for at least one impulse of positive pressure to a fluid disposed within the at least one lumen; and

a vacuum input portion configured to provide a temporary negative pressure to the fluid disposed in the at least one lumen.

22. The device as defined in claim 21, wherein the vacuum input portion includes at least one of a syringe pump and a vacuum pump.

23. The device as defined in claim 21, wherein a normally open valve is included with the vacuum input portion.

24. The device as defined in claim 23, wherein a normally closed valve is included with the pressure input portion.

25. The device as defined in claim 24, wherein the normally open valve is configured to provide the temporary negative pressure to the fluid disposed in the at least one lumen, the normally open valve configured to close upon opening of the normally closed valve, the normally closed valve configured to provide the at least one impulse to the fluid disposed in the at least one lumen.

26. The device as defined in claim 21, wherein the pressure input portion includes one of a hydrostatic pump and an actuator, and wherein the fluid path includes a hydraulic accumulator operably connected to the hydrostatic pump.

27. The device as defined in claim 21, wherein the at least one impulse includes a series of impulses at a predetermined impulse frequency.

28. A method for providing patency to at least one lumen of a catheter assembly, the method comprising:

disposing a fluid in the at least one lumen of a catheter tube of the catheter assembly; and

propagating a plurality of impulses of positive pressure through the fluid disposed in the at least one lumen, the plurality of impulses propagated in a predetermined pattern.

29. The method as defined in claim 28, wherein propagating the plurality of impulses comprises propagating at least one series of impulses at a predetermined impulse frequency.

30. The method as defined in claim 29, further comprising propagating a first series of impulses followed by a rest period, and propagating a subsequent series of impulses.

31. The method as defined in claim 28, wherein propagating the plurality of impulses further comprises propagating the plurality of impulses at a pulse frequency of at least about 20 KHz.

32. The method as defined in claim 28, further comprising providing a negative pressure to the fluid disposed in the at least one lumen to aspirate occlusions dislodged by the plurality of impulses.

33. The method as defined in claim 28, further comprising providing a negative pressure to the fluid disposed in the at least one lumen between impulses of positive pressure to aspirate occlusions dislodged by the plurality of impulses.

34. The method as defined in claim 28, wherein propagating the plurality of impulses includes propagating the plurality of impulses in a distal direction with respect to the at least one lumen of the catheter tube.

35. The method as defined in claim 28, wherein propagating the plurality of impulses comprises propagating at least one series of impulses at a predetermined impulse frequency, the predetermined impulse frequency substantially matching a resonant frequency of the catheter assembly.