Catheter assembly and related method

• US 5,242,398 A
• Filed: 03/12/1992
• Issued: 09/07/1993
• Est. Priority Date: 03/12/1992
• Status: Expired due to Fees

• Current Assignee: Charles L. Knoll, Peter J. Wilk, Wexler, Eugene
• Original Assignee: Charles L. Knoll, Peter J. Wilk, Wexler, Eugene
• Inventors: Wexler, Eugene, Wilk, Peter J., Knoll, Charles L.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/850,433
• Time in Patent Office: 544 Days
• Field of Search: 604/101, 604/96, 604/171, 604/163, 604/275, 604/278, 604/250, 604/54, 604/49
• US Class Current: 604/103.05
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction coatings A61M2025/0046
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• 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

Abstract

A catheter assembly comprises a catheter and a sheath enclosing the catheter to preserve the sterility thereof, the sheath being provided with a plurality of fold lines which form accordion-like pleats to enable a collapse of the sheath at a point of insertion of the catheter into a patient. The sheath is provided at a distal end of the catheter with a flange for engaging a patient during an insertion of the catheter into the patient. A catheter assembly also comprises an anchor balloon attached to the catheter at a distal end thereof, an ancillary balloon attached to the catheter at a point spaced in a proximal direction from the anchor balloon, a tube connecting the ancillary balloon to the anchor balloon so as to enable communication therebetween, and a flow stop mounted to the catheter for preventing fluid from returning to the tube from the anchor balloon upon a pressurization of the anchor balloon with fluid forced from the tube by an application of pressure to the ancillary balloon. A hollow catheter plug defining a flash chamber and having a transparent wall is connected to the catheter at a proximal end thereof for communicating with the catheter. A valve is connected to the plug for preventing fluid flow from the flash chamber.

Claims

1. A catheter assembly comprising:

a catheter;

an anchor balloon attached to said catheter at a distal end thereof;

an ancillary balloon attached to said catheter at a point spaced in a proximal direction from said anchor balloon;

a tube connecting said ancillary balloon to said anchor balloon so as to enable communication therebetween, said anchor balloon, said tube and said ancillary balloon containing fluid in an essentially closed system to enable expansion of said anchor balloon by at least a partial collapse of said ancillary balloon; and

flow stoppage means mounted to said catheter for preventing said fluid from returning to said tube from said anchor balloon upon a pressurization of said anchor balloon with fluid forced from said tube by an application of pressure to said ancillary balloon.

2. The catheter assembly defined in claim 1 wherein said flow stoppage means includes locking means operatively connected to said tube for blocking communication between said anchor balloon and said ancillary balloon.

3. The catheter assembly defined in claim 2 wherein said locking means includes clamping means for closing off said tube.

4. The catheter assembly defined in claim 3 wherein said clamping means includes a clip.

5. The catheter assembly defined in claim 3 wherein said clamping means includes an elastic band.

6. The catheter assembly defined in claim 2 wherein said locking means includes a valve having an opened position and a closed position.

7. The catheter assembly defined in claim 1 wherein said flow stoppage means includes a substantially rigid sleeve movably attached to said catheter for sliding over said ancillary balloon and thereby preventing a reinflation thereof with fluid from said anchor balloon.

8. The catheter assembly defined in claim 1 wherein said anchor balloon is defined by a first wall and said ancillary balloon is defined by a second wall, said first wall being less stretchable than said second wall, whereby a pressurizing fluid in said anchor balloon, said ancillary balloon and said tube is at a higher pressure when said anchor balloon and said ancillary balloon are in an expanded state and a collapsed state, respectively, than when said anchor balloon and said ancillary balloon are in a collapsed state and an expanded state, respectively.

9. The catheter assembly defined in claim 1 wherein said ancillary balloon is connected to said catheter via said tube.

10. The catheter assembly defined in claim 1, further comprising:

a hollow catheter plug defining a flash chamber having a transparent wall, said plug being connected to said catheter at a proximal end thereof for communicating with said catheter; and

valve means connected to said plug for preventing fluid flow from said chamber.

11. The catheter assembly defined in claim 1, further comprising a sheath enclosing catheter, said anchor balloon, said ancillary balloon and said tube to preserve the sterility thereof, said sheath being provided with a plurality of fold lines to enable a collapse of said sheath at a point of insertion of said catheter into a patient.

12. A catheter assembly comprising:

a catheter;

a hollow catheter plug defining a flash chamber having a transparent wall, said plug being connected to said catheter at a proximal end thereof for communicating with said catheter; and

valve means connected to said plug for preventing fluid flow from said chamber.

13. A catheter assembly comprising:

a catheter; and

a sheath collapsible in a longitudinal direction and enclosing said catheter to preserve the sterility thereof, said sheath being provided at a distal end of said catheter with a flange for engaging a patient during an insertion of said catheter into the patient, said sheath being provided with a score line distally of said flange to enable a tearing off of a distal end portion of said sheath to expose a distal tip of said catheter.

14. The catheter assembly defined in claim 13 wherein said sheath has a body portion containing said catheter, said flange being disposed at a distal end of said body portion, said sheath being provided distally of said flange with a chamber separable from said flange via said score line, an aliquot of an antibacterial agent being disposed in said chamber.

15. The catheter assembly defined in claim 14, further comprising a swab member disposed in said chamber.

16. The catheter assembly defined in claim 14 wherein said sheath is provided with an additional score line distally of said chamber to enable a tearing off of a distal tip of said sheath to expose said antibacterial agent to enable an application thereof to an insertion site on a patient.

17. The catheter assembly defined in claim 13 wherein said flange is cup shaped.

18. The catheter assembly defined in claim 13 wherein said flange is at least partially rigid.

19. The catheter assembly defined in claim 13, further comprising:

an anchor balloon attached to said catheter at a distal end thereof;

an ancillary balloon attached to said catheter at a point spaced in a proximal direction from said anchor balloon;

a tube connecting said ancillary balloon to said anchor balloon so as to enable communication therebetween; and

flow stoppage means mounted to said catheter for preventing fluid from returning to said tube from said anchor balloon upon a pressurization of said anchor balloon with fluid forced from said tube by an application of pressure to said ancillary balloon, said anchor balloon, said ancillary balloon and said tube being enclosed by said sheath.

20. The catheter assembly defined in claim 13, further comprising:

a hollow catheter plug defining a flash chamber having a transparent wall, said plug being connected to said catheter at a proximal end thereof for communicating with said catheter; and

valve means connected to said plug for preventing fluid flow from said chamber.

21. A catheter assembly comprising:

a catheter;

a sheath collapsible in longitudinal direction, said sheath having a body portion containing said catheter and, at a distal end of said body portion, a chamber separable from said body portion; and

an aliquot of an antibacterial agent disposed in said chamber.

22. The catheter assembly defined in claim 21 wherein said sheath is provided at a distal end of said catheter with a flange for engaging a patient during an insertion of said catheter into the patient.

23. The catheter assembly defined in claim 22 wherein said flange is cup-shaped.

24. The catheter assembly defined in claim 22 wherein said flange is substantially rigid.

25. The catheter assembly defined in claim 21, further comprising:

a hollow catheter plug defining a flash chamber having a transparent wall, said plug being connected to said catheter at a proximal end thereof for communicating with said catheter; and

valve means connected to said plug for preventing fluid flow from said chamber.

26. The catheter assembly defined in claim 25 further comprising a swab member disposed in said chamber.

27. The catheter assembly defined in claim 21 wherein

is provided with a score line distally of said chamber to enable a tearing off of a distal end portion of said sheath to expose said antibacterial agent to enable an application thereof to an insertion site on a patient.

28. The catheter assembly defined in claim 21 wherein said sheath is provided with a plurality of fold lines to enable a collapse of said sheath at a point of insertion of said catheter into a patient, said fold lines being circular and defining a plurality of collapsible pleats in said sheath.

29. The catheter assembly defined in claim 21, further comprising:

an anchor balloon attached to said catheter at a distal end thereof;

an ancillary balloon attached to said catheter at a point spaced in a proximal direction from said anchor balloon;

a tube connecting said ancillary balloon to said anchor balloon so as to enable communication therebetween; and

flow stoppage means mounted to said catheter for preventing fluid from returning to said tube from said anchor balloon upon a pressurization of said anchor balloon with fluid forced from said tube by an application of pressure to said ancillary balloon, said anchor balloon, said ancillary balloon and said tube being enclosed by said sheath.

30. A method for inserting a catheter into a body organ of a patient, comprising the steps of:

inserting a catheter into a patient, said catheter having an anchor balloon at a distal end and further having an ancillary balloon communicating with said anchor balloon and disposed proximally thereof, said anchor balloon and said ancillary balloon containing fluid in an essentially closed system, whereby collapse of said ancillary balloon results in an expansion of said anchor balloon;

applying pressure to said ancillary balloon to at least partially collapse said ancillary balloon and thereby squeeze a pressurizing fluid from said ancillary balloon towards said anchor balloon; and

upon an expansion of said anchor balloon in response to the application of pressure to said ancillary balloon, preventing fluid from flowing back from said anchor balloon towards said ancillary balloon.

31. The method defined in claim 30 wherein said step of preventing includes the step of closing communication between said anchor balloon and said ancillary balloon.

32. The method defined in claim 31 wherein said step of closing includes the step of clamping a tube extending between said anchor balloon and said ancillary balloon.

33. The method defined in claim 31 wherein said step of closing includes the step of actuating a valve to block communication between said anchor balloon and said ancillary balloon.

34. The method defined in claim 30 wherein said step of preventing includes the step of sliding a sleeve over said ancillary balloon to prevent a reinflation thereof with fluid.

35. The method defined in claim 30, further comprising the step of tearing off a distal end portion of a sheath enclosing said catheter, said step of tearing being executed prior to said step of inserting, said step of inserting including the step of collapsing said sheath into a folded accordion-like configuration about said catheter at a point of insertion of said catheter into the patient.

36. The method defined in claim 30 wherein said catheter is provided at a proximal end with a hollow catheter plug defining a flash chamber having a transparent wall, further comprising the step of actuating a valve connected to said plug for preventing fluid flow from said chamber.

37. A method for inserting a catheter into a body organ of a patient, comprising the steps of:

providing a catheter enclosed by an internally sterile sheath;

removing a distal end portion of said sheath so as to expose a distal end only of said catheter;

inserting said distal end into a patient; and

manipulating said catheter through said sheath to push said catheter into the patient while simultaneously collapsing said sheath into a shorted according-like configuration at a point of insertion of said catheter into the patient;

during said step of inserting and manipulating, engaging said patient about said point of insertion with a flange provided at a distal end of said sheath, said sheath being provided with a score line distally of said flange, said step of removing including the step of tearing off said distal end portion of said sheath at said score line.

38. The method defined in claim 37 wherein said sheath has a body portion containing said catheter and, at a distal end of said body portion, a chamber separable from said body portion, an aliquot of an antibacterial agent being disposed in said chamber, further comprising the steps of (a) tearing off a tip of said sheath to expose said antibacterial agent and (b) applying said antibacterial agent to the patient about said point of insertion prior to said step of removing.

39. The method defined in claim 37 wherein said catheter has an anchor balloon at a distal end, further comprising the steps of:

applying pressure to an ancillary balloon at a proximal end of said catheter to squeeze a pressurizing fluid from said ancillary balloon towards said anchor balloon, upon substantial completion of said steps of inserting and manipulating; and

upon an expansion of said anchor balloon in response to the application of pressure to said ancillary balloon, preventing fluid from flow back from said anchor balloon towards said ancillary balloon.

40. The method defined in claim 37 wherein said catheter is provided at a proximal end with a hollow catheter plug defining a flash chamber having a transparent wall, further comprising the step of actuating a valve connected to said plug for preventing fluid flow from said chamber.

41. A method for inserting a catheter into a body organ of a patient, comprising the steps of:

providing a catheter enclosed by an internally sterile sheath, said sheath having a body portion containing said catheter and further having a chamber separable from said body portion and containing an aliquot of an antibacterial agent;

tearing said sheath to expose said antibacterial agent;

applying said antibacterial agent to a patient about a point of insertion of said catheter into the patient;

acting on said sheath to expose a distal end only of said catheter;

inserting said distal end of said catheter into the patient at said point of insertion upon the application of said antibacterial agent to a patient about said point of insertion; and

manipulating said catheter through said sheath to push said catheter into the patient while simultaneously collapsing said sheath into a shortened accordion-like configuration at said point of insertion.

42. The method defined in claim 41 wherein said step of acting includes the step of removing a distal end portion of said sheath to expose the distal end of said catheter.

43. The method defined in claim 42 wherein said chamber is disposed in said distal end portion portion, said step of tearing including the step of separating a distal tip of said sheath along a preformed score line, said step of removing including the step of removing said chamber from said body portion

44. The method defined in claim 43 wherein said step of removing said chamber from said body portion includes the step of separating said chamber from said body portion along an additional preformed score line.

45. The method defined in claim 43 wherein said steps of separating and applying are performed prior to the removal of said distal end portion of said sheath.