Catheter shield and test structure

• US 4,834,710 A
• Filed: 10/08/1987
• Issued: 05/30/1989
• Est. Priority Date: 10/08/1987
• Status: Expired due to Term

• Current Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Original Assignee: Arrow International Investment Corporation (Teleflex Incorporated)
• Inventors: Fleck, Philip B.
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/107,400
• Time in Patent Office: 600 Days
• Field of Search: 604/171, 604/172, 604/163, 206/365, 206/438
• US Class Current: 604/171
• 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

Equipment is disclosed for shielding a catheter such as a balloon-tipped vascular catheter from contamination during testing and insertion and for shielding a substantial reserve catheter section for use if catheter re-positioning is necessary. As shown, the structure includes two interconnecting envelopes which physically isolate the catheter. One envelope is designed to shield the distal end portion of the catheter during testing for luman patency and balloon inflation. The other envelope is extendible to cover the entire length of catheter intended for insertion into the patent upon completion of required tests. The second envelope thereafter provides a means for advancement or re-positioning of the catheter or withdrawal of the same without physical contact by the hands or exposure to airborne contaminants.

Claims

1. Equipment for shielding an elongated vascular catheter comprising a first impervious envelope for said catheter, said first envelope comprising a flexible, collapsible tubular sleeve, said sleeve being adapted to fit over the catheter in shielding relationship therewith and having a length relative to the length of said catheter to extend in shielding relationship therewith proximally from the distal tip of the catheter over all portions of the catheter subject to insertion into a vessel in the vascular system of a patient, said sleeve having a seal means at its proximal end for establishing a seal proximally of the portions of the catheter subject to insertion into the vessel, said sleeve being collapsible axially from the distal end thereof to allow for extension of the catheter beyond the distal end of the sleeve upon relative manual manipulation of the sleeve and of the catheter through the sleeve, a second impervious envelope for the distal end of the catheter, disconnectible means for connection of said second envelope to the distal end of the sleeve comprising said first envelope, said second envelope comprising a test chamber and a passage means extending from the said sleeve of said first envelope through said disconnectible means to said test chamber, said test chamber having a transparent end portion, said passage means allowing for positioning of the distal end of said catheter within the transparent end portion of the test chamber for visual inspection and testing when the sleeve is collapsed axially from said extended condition and for positioning of the distal end of the catheter within the first envelope when the sleeve is returned to said extended condition by relative manipulation of the sleeve and the catheter, said disconnectible means providing for removal of said second envelope when the sleeve is extended and for subsequent passage of the catheter from said first envelope into the vessel as the sleeve is collapsed from said extended condition.

2. Equipment according to claim 1 wherein said catheter is a multi-lumen flow directed catheter with an inflatable balloon adjacent the distal tip, and wherein said transparent end portion of the test chamber is sized to allow for clearance for the balloon when the balloon is within the test chamber and in the inflated state.

3. Equipment according to claim 2 wherein said catheter has an ejectate port spaced proximally of the balloon and wherein the test chamber is sized to simultaneously receive the balloon and the ejectate port.

4. Equipment according to claim 3 wherein said catheter is provided with a second ejectate port at the distal tip and wherein the transparent end portion of the test chamber comprises a receptacle of substantially rigid plastic material for accumulating liquid ejected through said ports.

5. Equipment according to claim 4 wherein said test chamber further comprises a tubular member formed of a relatively flexible, transparent material, said tubular member being connected to said passage means and said receptacle, said tubular member allowing clearance for said catheter and for the flow of liquid from the ejectate port which is spaced proximally of said balloon.

6. Equipment according to claim 5 further including a resilient wiper within said passage means, said wiper being in contact with said catheter at a point in said passageway spaced proximally of said balloon and said ejectate ports.

7. Equipment according to claim 1, said disconnectible means comprising means for freely suspending the second envelope from the distal end of the sleeve comprising said first envelope.

8. Means for physically isolating a balloon-tipped vascular catheter from contaminants, said catheter having a distal end with a distal tip and a port at the distal tip, an inflatable balloon adjacent said tip and independent lumens within the catheter connected to and extending lengthwise respectively from the port at the distal tip and from said inflatable balloon to the proximal end of the catheter, said catheter further having an insertion zone extending from said distal tip lengthwise thereof to a point adjacent the proximal end, said zone being adapted to be inserted into a blood vessel of a patient, a flexible sleeve having a length at least as long as the insertion zone, said sleeve being collapsible to cover that portion of the zone not inserted within the patient'"'"'s blood vessel, the proximal end of the sleeve being fixedly secured to the catheter at the proximal end of the insertion zone in sealing relationship therewith, a hub slidably mounted on said catheter, means sealing the distal end of the sleeve to the hub, said sleeve allowing for manual manipulation of the catheter by pressure contact through the sleeve with the users'"'"' fingers for axial movement of the catheter, an enclosed test chamber for testing the integrity of the balloon when the balloon is in an inflated state and having a transparent wall portion for viewing of the balloon, a passageway connecting the test chamber with the sleeve, said passageway providing for placement of the distal tip of the catheter from a position adjacent the hub to a position within the test chamber, for retraction of the catheter to a position within the sleeve when the sleeve is extended, and disconnectible coupling means for disconnecting the hub from the test chamber when the distal end of the catheter is moved to a position within said sleeve, said catheter being axially moveable into a blood vessel by manipulation through said sleeve when the hub is disconnected from said test chamber.

9. Apparatus according to claim 8 wherein said test chamber is adapted to accumulate liquid discharged through said distal catheter port.

10. Apparatus according to claim 9 wherein said catheter has an ejectate port spaced proximally of the balloon and wherein said test chamber includes a tubular conduit through which said catheter extends, said conduit extending in a lengthwise direction proximally of said ejectate port when the distal catheter tip is within the test chamber whereby liquid discharged through said ejectate port accumulates in said test chamber.

11. Apparatus according to claim 9 wherein said tubular conduit is formed of a transparent material.

12. Apparatus according to claim 11 wherein said tubular conduit is formed of a flexible material.

13. Apparatus according to claim 9 further including a vent for said test chamber.

14. In combination with a vascular catheter having an elongated body portion and a distal tip and at least one lumen extending lengthwise of the catheter and exiting in the region of the distal tip, said catheter having an insertion zone for insertion into a blood vessel of a patient, said zone extending from the distal tip lengthwise of the body portion, a flexible and axially collapsible and extendable sleeve having a length at least equal to the length of the insertion zone, said sleeve being adapted to fit over the catheter so as to shield the catheter from contamination, means fixedly securing the proximal end of the sleeve to the catheter body portion at the proximal end of the insertion zone and in sealing relationship with said body portion, a hub slidably mounted on said catheter, means fixing the distal end of the sleeve to the hub in sealing relationship therewith, a test envelope adapted to receive the distal end of said catheter including said distal tip and a portion of said insertion zone, said test envelope having a transparent wall portion for viewing of the distal tip region of the catheter, disconnectible coupling means for connecting said hub to said test envelope, a passageway extending from the sleeve interior through said coupling means into the test envelope, said passageway being sized to pass the distal end of the catheter from the sleeve into the test envelope, said catheter being movable by manual manipulation through the sleeve from the test envelope into the sleeve and for subsequent advancement of the catheter from the sleeve into a blood vessel of the patient when the test envelope is disconnected.

15. Equipment according to claim 14 wherein the sleeve length relative to the length of the insertion zone is such that the distal tip of the catheter is withdrawn out of the test envelope into shielding relation with said sleeve when the sleeve is fully extended.

16. Equipment according to claim 15 wherein said test envelope comprises a flexible transparent tubing portion extending from said coupling means and a rigid walled receptacle at the distal end of said tubing portion in communication therewith, said rigid walled receptacle incorporating said transparent wall portion for viewing of the distal tip region of the catheter and the passageway extending through the tubing portion into the receptacle.

17. Equipment according to claim 16 wherein said test envelope is connected to said sleeve solely through said coupling means whereby the test envelope may be separated from the catheter and the sleeve and discarded when the catheter is advanced from the sleeve into a blood vessel.