Catheter assembly having a fenestrated dilator

• US 6,726,659 B1
• Filed: 12/09/1999
• Issued: 04/27/2004
• Est. Priority Date: 12/09/1999
• Status: Expired due to Term

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Francis Duque, John E. Stocking
• Inventors: Duque, Francis, Stocking, John E.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thompson, Michael M.
• Application Number:
  US09/457,661
• Time in Patent Office: 1,601 Days
• Field of Search: 604/506-508, 604/510, 604/513, 604/158-163, 604/164.01, 604/164.02, 604/164.04, 604/164.05, 604/164.07, 604/164.09, 604/164.11, 604/164.12, 604/167.01, 604/167.02, 604/167.03, 604/167.05, 604/168.01, 604/171, 604/256, 604/264
• US Class Current: 604/164.09
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0693 Flashback chambers

Abstract

An improved catheter assembly featuring a hollow introducer needle, a hollow, flexible dilator containing at least one fenestration through a sidewall thereof, the dilator being slidably disposed over the needle, and a sheath slidably disposed over the dilator. A passageway is formed in the assembly to either show a rapid blood flashback along a lengthwise portion of the assembly or to conduct blood or other biological liquid from the patient to a sideport on the sheath for connection to blood pressure monitoring equipment, infusion/blood sampling equipment, or both, without the necessity of altering connections on or with the assembly after insertion of the needle into the patient.

Claims

1. A catheter assembly comprising:

an elongated hollow introducer needle adapted for insertion into a biological liquid containing region of a patient;

a flexible, hollow tubular dilator for forming a first stage dilation of an access opening in a patient, said dilator having a main lumen in which said needle is removably and operatively slidably disposed, said dilator defining a first dilator fenestration through a side wall thereof;

a flexible, hollow tubular sheath having a main lumen in which said dilator is removably and operatively, slidably disposed for forming a second stage dilation of the access opening in the patient which is larger than said first stage dilation, said sheath including at least one sideport which communicates with the main lumen of said sheath, and

means for conducting a biological liquid from said patient, as a result of insertion of said needle into said region, into said sideport through said first dilator fenestration said sideport communicating with the main lumen of said dilator at least under circumstances wherein said needle is retracted proximally beyond said first dilator fenestration.

2. The catheter assembly of claim 1 wherein said sheath further includes a hub defining an internal cavity therein which communicates with said sheath lumen at least when said sheath is not disposed over said dilator, said dilator being adapted to extend through said sheath into said cavity, said sideport being attached to said hub for communication with said cavity external to said dilator.

3. The catheter assembly of claim 1 wherein said sheath includes a hub formed on a proximal end portion thereof, said conducting means comprising a passageway formed within a sidewall of said sheath which extends from a first opening in said sheath lumen on a distal end thereof into said hub to a second opening on a proximal end thereof on a surface of said hub to form a sideport, the first opening communicating with said first dilator fenestration when said dilator and sheath are disposed in operative positions relative to one another for commencement of insertion of said needle, dilator and sheath into said region.

4. The catheter assembly of claim 2 wherein said conducting means comprises a passageway formed between lengthwise portions of said needle and dilator, a distal end of said passageway being proximally spaced from a distal end of said dilator, said needle containing a needle fenestration for conducting said liquid from a lumen of said needle into a distal end portion of said passageway at a position which is distally spaced from said hub when said needle and dilator are disposed in initial operative positions relative to each another for commencement of insertion of said needle into said region, said first dilator fenestration being located within said cavity for conducting said liquid from said passageway into said cavity and sideport, said passageway extending between and being in communication with said needle fenestration and said first dilator fenestration.

5. The catheter assembly of claim 2 wherein said conducting means comprises a passageway formed between lengthwise portions of said dilator and sheath which extends between a position which is proximally spaced from a distal end of said sheath and said hub cavity when said dilator and sheath are disposed in initial operative positions relative to each other for commencement of insertion of said needle into said region, said first dilator fenestration being positioned in communication with a distal end portion of said passageway which is distally spaced from said hub for introducing said liquid from said region through said dilator into said passageway upon insertion of said dilator into said region and upon withdrawal of said needle proximally through said dilator past said first dilator fenestration, a proximal end of said passageway communicating with said cavity for introduction of said liquid from said passageway into said cavity and sideport.

6. The catheter assembly of claim 2 wherein said conducting means comprises a passageway formed between lengthwise portions of said dilator and sheath which extends from a position which is proximally spaced from a distal end of said sheath into said cavity when said dilator and sheath are disposed in initial operative positions relative to each other for commencement of insertion of said needle into said region, said first dilator fenestration being located so as to communicate with a distal end portion of said passageway and which is distally spaced from said hub when said dilator and sheath are disposed in said initial operative positions, said needle containing a needle fenestration which communicates with said first dilator fenestration when said needle, dilator and sheath are disposed in said operative positions such that, when said needle is inserted into said region, said liquid can flow into a lumen of said needle, thence through said needle fenestration and said first dilator fenestration into and through said passageway and into said cavity and sideport.

7. The catheter assembly of claim 4 wherein said needle contains a second fenestration located within said cavity in registry with said first dilator fenestration when said needle, dilator and sheath are disposed in initial operative positions relative to one another for commencement of insertion of said needle into said region, whereby said liquid can flow from said region, through a lumen of said needle, thence through said second needle fenestration and first dilator fenestration into said cavity and sideport.

8. The catheter assembly of claim 4 wherein at least a portion of the length of said dilator which overlies said passageway and at least a portion of the length of said sheath which overlies said portion of said dilator when said dilator and sheath are disposed in said initial operative positions are constructed of a material which will permit visual recognition of the presence of said liquid in said passageway external to said hub.

9. The catheter assembly of claim 4 further comprising a resilient diaphragm disposed in a proximal end portion of said sheath hub for sealing a proximal end portion of said cavity in a liquid tight manner.

10. The catheter assembly of claim 5 wherein at least a portion of the length of said sheath which overlies said passageway external to said hub when said dilator and sheath are disposed in said initial operative positions is constructed of a material which will permit visual recognition of the presence of said liquid in said passageway external to said hub.

11. The catheter assembly of claim 5 further comprising a first needle fenestration formed in said needle for disposition in registry with a second dilator fenestration within said cavity when said needle, dilator and sheath are disposed in said initial operative positions relative to each other.

12. The catheter assembly of claim 5 further comprising a resilient diaphragm disposed in a proximal end portion of said sheath hub for sealing a proximal end portion of said cavity in a liquid tight manner.

13. The catheter assembly of claim 6 further comprising a resilient diaphragm disposed in a proximal end portion of said sheath hub for sealing a proximal end portion of said cavity in a liquid tight manner.

14. A catheter assembly comprising:

an elongated, hollow introducer needle having a sharp tip on a distal end for insertion into a liquid containing region of a biological organism;

an elongated, hollow, flexible tubular dilator having a main lumen in which said needle is operatively and removably slidably disposed, said dilator being adapted to form a first stage dilation of an access opening in a patient, said dilator defining at least one fenestration through a sidewall thereof which is spaced proximally from an open distal end of said dilator;

an elongated, hollow flexible tubular sheath having a main lumen in which said dilator is operatively and removably slidably disposed for forming a second stage dilation of the access opening in the patient which is larger than said first stage dilation, an open distal end of said sheath being proximally spaced from said distal end of said dilator when said dilator and sheath are disposed in position for insertion into said organism, a distal end portion of said sheath being in close fitting, liquid tight relationship with said dilator, a portion of said sheath extending proximally from said sheath distal end portion having an inside diameter which is greater than an outside diameter of said dilator to form a passageway between said dilator and sheath, said at least one fenestration being located so as to open into a distal end portion of said passageway when said dilator and sheath are operatively disposed on said needle for commencement of said insertion such that a biological liquid can flow into a distal end of said dilator, thence through said fenestration and into and along said passageway as said dilator enters a liquid containing region of said organism, and as said needle is withdrawn proximally from said region through said dilator and proximally past said fenestration.

15. A catheter assembly comprising:

an elongated, hollow, introducer needle defining a fenestration which is proximally spaced from a distal end thereof;

an elongated, hollow, flexible tubular dilator removably, slidably disposed over said needle, said dilator defining a fenestration which is proximally spaced from a distal end of said dilator, said dilator distal end being proximally spaced from said needle distal end when said dilator is operatively positioned over said needle for commencement of an insertion of said needle and dilator into a liquid containing region of a biological organism such that said needle fenestration communicates with said dilator fenestration;

an elongated, hollow, flexible tubular sheath removably slidably disposed over said dilator, a distal end of said sheath being proximally spaced from said dilator distal end when said sheath is operatively positioned over said dilator for commencement of an insertion of said needle, dilator and sheath into said region, such that a distal end portion of said sheath, extending from said sheath distal end to a position distally spaced from said dilator fenestration, fits over said dilator in a liquid tight manner; and

means for viewing the presence of a liquid flowing through said needle and dilator fenestrations from said region by way of a lumen in said needle.

16. The assembly of claim 15 wherein said viewing means comprises at least a portion of a remaining length of said sheath extending proximally from said sheath distal end portion being loosely fitting over said dilator to form a passageway for a biological liquid between said sheath and dilator, which passageway communicates with said needle and dilator fenestrations, said portion of said remaining length of said sheath comprising a translucent material for darkening in response to the flow of said liquid in said passageway.

17. The assembly of claim 16 wherein said viewing means comprises at least a portion of a remaining length of said sheath extending proximally from said sheath distal end portion being loosely fitting over said dilator to form a passageway for a biological liquid between said sheath and dilator, which passageway communicates with said needle and dilator fenestrations, said portion of said remaining length of said sheath comprising a transparent material for permitting the viewing of said liquid flowing in said passageway.