Blood sampling device

• US 5,086,783 A
• Filed: 10/31/1990
• Issued: 02/11/1992
• Est. Priority Date: 10/31/1990
• Status: Expired due to Term

• Current Assignee: Sherwood Services AG
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: Paulussen, Henricus F., Vos, Jellard, Macors, Paul P. M. G. J.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/607,410
• Time in Patent Office: 468 Days
• Field of Search: 128/760, 128/763, 128/764, 128/765, 604/256, 604/244, 604/413, 604/414, 604/415
• US Class Current: 600/578
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150244 Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence

Abstract

A blood sampling kit and the method of using the blood sampling kit are disclosed wherein an arterial blood gas syringe having a venting means associated therewith is used in combination with a blood collection tube holder having a double ended needle mounted therein and a stopper assembly consisting generally of a cylindrical member with a central opening and a flexible diaphragm member extending across the opening such that the stopper assembly and syringe assembly are inserted into the blood collection tube holder to obtain a blood sample from a patient in the syringe assembly and, once the blood sample is obtained, the syringe assembly and stopper assembly are removed from the blood collection tube holder and the stopper assembly protects the blood sample from exposure to the atmosphere.

Claims

1. A blood sampling kit for obtaining a blood sample from a patient, said kit comprising:

a syringe assembly having first outer diameter, an elongate barrel section with a reduced diameter distal end and a piston member movably positioned in said barrel section to form a sample chamber between said distal end of said barrel section and said piston member;

a stopper assembly having distal and proximal ends and a second outer diameter, said stopper assembly further including a needle piercable diaphragm member operatively associated therewith;

an elongate and generally cylindrical blood collection tube holder having distal and proximal ends and an inner diameter, said blood collection tube holder further including a needle with distal and proximal needle points thereon wherein said needle is operatively associated with said distal end of said blood collection tube holder; and

said stopper assembly is sized to be completely received in said blood collection tube holder and said second outer diameter of said stopper assembly is intermediate said first outer diameter of said syringe assembly and said inner diameter of said blood collection tube holder.

2. The blood sampling kit of claim 1 wherein said syringe assembly includes a means for venting said sample chamber operatively associated therewith to allow for the removal of air from said sample chamber while preventing the flow of the blood sample from the patient therethrough.

3. The blood sampling kit of claim 2 wherein said means for venting said sample chamber includes a filter member operatively associated with said piston member.

4. The blood sampling kit of claim 1 wherein said syringe assembly includes a plunger rod operatively associated with said piston member to allow for the manual adjustment of the size of said sample chamber.

5. The blood sampling kit of claim 1 wherein said stopper assembly includes a distal opening extending from said distal end thereof to receive said proximal needle point therethrough and wherein said proximal needle point is adapted to pierce said diaphragm member and is prevented from contacting said piston member of said syringe by contact between said distal end of said stopper assembly and said distal end of said inner diameter of said blood collection tube holder.

6. The blood sampling kit of claim 1 wherein said syringe assembly includes a luer extension extending distally from the distal end of said barrel section and said stopper assembly includes a proximal opening extending inwardly from said proximal end of said stopper assembly and wherein said proximal opening is adapted to receive said luer extension therein such that said diaphragm member is positioned distally of said luer extension.

7. The blood sampling kit of claim 1 wherein said stopper assembly includes a distal opening extending inwardly from said distal end thereof and a proximal opening extending inwardly from said proximal end thereof and wherein said diaphragm member is operatively positioned therebetween.

8. The blood sampling kit of claim 7 wherein said distal opening of said stopper assembly is larger than said proximal opening and said proximal section of said needle includes a proximal needle point thereon which is adapted to extend through said distal opening and said diaphragm member into said proximal opening of said stopper assembly and said distal opening is sized to receive a sleeve member on said proximal section of said needle therein.

9. The blood sampling kit of claim 1 wherein said stopper assembly is constructed of a first material with a central opening extending therethrough and said diaphragm member extends thereacross and is constructed of a second material which is more flexible than said first material.

10. A stopper assembly for use with a syringe and a blood collection tube holder having a needle associated therewith to obtain a blood sampling from a patient, said stopper assembly comprising:

a housing assembly having distal and proximal ends and an outer circumference sized to be fully received in a blood collection tube holder, said housing assembly being constructed of a first material and including a central opening extending generally therethrough;

a flexible diaphragm member positioned across said central opening and constructed of a second material which is more flexible than said first material and said diaphragm member is positioned across said central opening such that a distal opening is formed adjacent to said distal end that is larger than a proximal opening formed adjacent said proximal end.

11. The stopper assembly of claim 10 further including a plurality of rib members extending outwardly from said outer circumference of said housing assembly to assist in aligning said distal opening with a portion of the needle on the blood collection tube holder.

12. The stopper assembly of claim 10 wherein said housing assembly includes distal and proximal housing sections both of which have a central opening extending therethrough and wherein said diaphragm member is fixedly retained between said distal and proximal housing sections.

13. The stopper assembly of claim 12 wherein said central opening in said proximal housing section has a first diameter and said central opening in said distal housing section has a second diameter wherein said second diameter is larger than said first diameter and said diaphragm member is positioned between said central opening on said distal housing section and said central opening on said proximal housing section.

14. A blood sampling kit comprising:

a syringe assembly having a first diameter and a generally tubular barrel section with an open proximal end and a reduced diameter distal end, a plunger rod and a piston member adapted to be movable in said barrel section to form a sample chamber between said piston member and said distal end of said barrel section;

a venting means operatively associated with said syringe assembly wherein said venting means is adapted to vent air from said sample chamber while retaining a collected blood sample therein;

a stopper assembly having a second diameter and distal and proximal ends, said stopper assembly including a housing section with a generally centrally located opening extending therethrough and a flexible diaphragm member wherein said diaphragm member is oriented to extend across said opening to form a distal opening distally thereof and a proximal opening proximally thereof;

a blood collection tube holder having a first inner diameter and an open proximal end adapted to receive said stopper assembly and said syringe assembly therethrough and a reduced diameter distal end with a needle associated therewith wherein said needle includes distal and proximal sections thereon and a hub means for operatively mounting said needle on said blood collection tube holder; and

wherein said second diameter of said stopper assembly is smaller than said inner diameter of said blood collection tube holder such that said stopper assembly is fully received therein and said distal end of said stopper assembly operatively contacts said reduced diameter distal end of said blood collection tube holder and wherein said proximal needle section extends through said distal opening and said diaphragm member in said stopper assembly to communicate with said sample chamber.

15. The blood sampling kit of claim 14 wherein said opening in said stopper assembly includes said distal opening and said proximal opening separated by said diaphragm member and said proximal opening is sized to receive a portion of said syringe assembly therein and wherein said distal opening is sized to receive a sleeve member on said proximal needle section and a portion of said proximal needle section therein.

16. The blood sampling kit of claim 14 wherein said first diameter of said syringe assembly is smaller than said second diameter of said stopper assembly.

17. The blood sampling kit of claim 14 wherein said stopper assembly includes a plurality of radially extending rib members thereon to assist in aligning the opening in the stopper assembly with the proximal needle section.

18. A method for obtaining a blood sample from a patient including the steps of

positioning a piston member in the elongate barrel section of a first syringe assembly having an open proximal end and a reduced diameter distal end to form a sample chamber between the piston member and the distal end of the barrel section;

placing a stopper assembly on the distal end of the first syringe assembly wherein the stopper assembly includes a generally cylindrical housing section and a flexible diaphragm member associated therewith;

inserting the distal end of a needle having proximal and distal ends into a blood vessel of a patient wherein the needle is operatively associate with a blood collection tube holder having an open proximal end;

inserting the first syringe assembly and stopper assembly combination into the open proximal end of a blood collection tube holder having a needle with distal and proximal ends thereon and wherein the distal end of the needle has previously been inserted into a blood vessel in a patient and containing insertion of the combination into the blood collection tube holder until the proximal end of the needle passes through the diaphragm member of the stopper assembly and into the distal end of the syringe assembly; and

collecting a blood sample from a patient in the sample chamber of the first syringe assembly.

19. The method of claim 18 wherein as the blood sample is collected in the sample chamber of the first syringe assembly, air is allowed to pass from the sample chamber to the atmosphere through a venting means associated with the first syringe assembly.

20. The method of claim 18 wherein the first syringe assembly is replaced with a second syringe assembly having a piston member positioned adjacent to the distal end of the barrel section and the piston member in the barrel section to is withdrawn aspirate a blood sample from the patient into the second syringe assembly.

21. A stopper assembly and blood collection tube holder for use in a blood sampling kit, said stopper assembly and tube holder comprising:

an elongate tubular member having an open proximal end and a reduced diameter distal end,

a housing assembly having an outer circumference, distal and proximal ends and an opening extending generally therethrough between said distal and proximal ends said housing assembly being sized to be fully received in said tubular member,

a flexible diaphragm member fixedly attached to said housing assembly and extending across said opening in said housing assembly such that the distance between said distal end of said housing assembly and said diaphragm member is greater than the distance between said proximal end of said housing assembly and said diaphragm member.

22. The medical device of claim 21 wherein said housing assembly is constructed of a first material and said diaphragm member is constructed of a second material and wherein said second material is less rigid than said first material.

23. The medical device of claim 21 wherein said outer circumference of said housing assembly includes a plurality of positioning members thereon to operatively contact said tubular member when said housing assembly is inserted therein.

24. A blood sampling kit comprising:

a syringe assembly including an elongate barrel section having an open proximal end and a reduced diameter distal end and a piston member having distal and proximal ends and said piston member is adapted to be movably positioned in said barrel section,

means for venting air operatively associated with said syringe assembly to allow air to selectively flow between said distal end of said piston member and said proximal end of said barrel section,

a stopper assembly including a needle piercable diaphragm member operatively associated therewith, said stopper assembly including a distal opening thereon and a proximal end adapted to be operatively associated with said distal end of said barrel section,

an elongate and generally cylindrical member having an open proximal end and a reduced diameter distal end wherein said stopper assembly and said distal end of said barrel section are adapted to be fully received therein, and

an elongate needle means operatively associated with said distal end of said cylindrical member, said needle means including a proximal needle point thereon to pierce said diaphragm member and includes a sleeve member thereon which is received in said distal opening of said stopper assembly.

25. The blood sampling kit of claim 24 wherein said stopper assembly includes a distal end surrounding said distal opening and said distal end operatively contacts said distal end of said cylindrical member to prevent said proximal needle point from contacting said distal end of said piston member.

26. A blood sampling kit comprising:

a syringe assembly including an elongate barrel section having an inner diameter, an open proximal end and a reduced diameter distal end and a plunger member including a piston member thereon, said piston member including distal and proximal ends thereon and said piston member is operatively movable in said barrel section between said distal and proximal ends of said barrel section,

means for venting on said piston member to allow air to selectively flow between said distal end of said plunger member and said proximal end of said barrel section,

a stopper assembly including an outer diameter, distal and proximal ends thereon and a diaphragm member operatively associated therewith to form a distal opening between said distal end and said diaphragm member and a proximal opening between said proximal end and said diaphragm wherein said proximal opening between said proximal end and said diaphragm wherein said proximal opening is smaller than said distal opening and said proximal opening is sized to receive a portion of said syringe assembly therein,

an elongate and generally cylindrical member having an inner diameter sized to receive the entire stopper assembly therein, an open proximal end and a reduced diameter distal end,

an elongate needle member having distal and proximal needle sections with a hub means therebetween wherein said hub means is operatively associated with said distal end of said cylindrical member such that said distal needle section extends distally thereof and said proximal needle section extends into said inner diameter of said cylindrical member, said proximal needle section including a sleeve member thereon, and

wherein said stopper assembly is sized such that said distal end of said stopper assembly operatively contacts said distal end of said cylindrical member along said inner diameter thereof, said sleeve member is received in said distal opening of said stopper assembly and said proximal needle section extends through said distal opening and diaphragm member to a position distally of said distal end of said piston member.