Pre-slit injection site and tapered cannula

• US 5,135,489 A
• Filed: 04/10/1989
• Issued: 08/04/1992
• Est. Priority Date: 01/25/1988
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Shepherd, David J., Minailo, Michael, Noblitt, Brent, Jepson, Steven C., Gordon, Mark G., Dudar, Thomas E.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/335,927
• Time in Patent Office: 1,212 Days
• Field of Search: 604/80-86, 604/56, 604/57, 604/48, 604/192, 604/98, 604/93, 604/201, 604/263, 604/905, 128/760-766, 128/673
• US Class Current: 604/48
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/36 : with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: Y10S 604/905 : Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A pre-slit injection site (34) includes a housing (40) with a flow path therethrough. A first end (42) of the housing (40) carries a pre-slit septum (52). One form of a blunt cannula (98), usable with the injection site (34), carries a locking member (100). When the pre-slit injection site (34) slidably receives the blunt cannula (98), the locking member (100) latches to the injection site (34) and creates a mechanically coupled unit. Another form of the cannula (280) includes a tube having a tapered distal end region (298) and having elongate discharge slots (294) for reducing contact surface area and for directing the flow laterally out of the cannula. The cannula may also include a rounded lead post (330), an annular barb (394), and axially oriented grooves (268). A blood sampling system utilizing an in-line pre-slit injetion site (492) and a shielded blunt cannula (512). An adapter for transferring fluids from a syringe with a blunt cannula to an evacuated tube, including a pre-slit injection site (554) and a shroud covered needle (556) with a rubber sleeve.

Claims

1. A blood sampling system for withdrawing blood from a patient, comprising;

(a) tubing adapted to be connected at one end to the patient in fluid communication with the patient'"'"'s vascular system and at the other end to a fluid supply;

(b) a reservoir assembly connected in-line to said tubing between the patient end and the fluid supply end, comprising a flow through reservoir housing having inner walls defining an interior chamber of holding fluid, a first port in fluid communication with said interior chamber connected to said tubing leading to the fluid supply, a second port in fluid communication with said interior chamber connected to said tubing leading to the patient, a retractable plunger disposed within said reservoir housing, said plunger formed in a complementary configuration to said interior chamber and adapted to traverse said chamber, and a sealing member disposed about said plunger in slidable sealing engagement with said inner walls of said interior chamber, said plunger adapted to be slidably retracted within said interior chamber to create negative pressure within said chamber, said negative pressure being effective to draw fluid from said tubing into said chamber for temporarily storing said fluid in said chamber and to draw blood from said patient into said tubing, said plunger adapted to be slidably projected toward said ports for reintroducing said stored fluid into said tubing; and

(c) a sampling site connected in-line to the tubing between said patient end and said reservoir assembly, said sampling site, comprising a flow through sampling site housing having a first port connected to said tubing leading to said reservoir assembly and a second port connected to said tubing leading to the patient, thereby defining a fluid channel through said sampling site housing, means defining an access aperture in said sampling site housing in communication with said fluid channel, and flexible means carried by said sampling site housing for sealing said access aperture, said means having a resealable opening therein such that a blunt cannula can be sealingly inserted through said opening and placed in fluid flow communication with said channel to withdraw blood from said tubing and such that said blunt cannula can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening.

3. A blood sampling system according to claim 1 or 2, wherein said first port of said sampling site housing leading to said reservoir assembly is located at a lower portion of said sampling site housing and said second port of said sampling site housing leading to the patient is located at a higher portion of said sampling site housing, thereby providing for ease of debubbling during initial filling of said tubing with fluid from the fluid supply and ease of clearing fluid from said reservoir assembly when said plunger is projected toward said ports in said reservoir assembly.

6. A blood sampling system according to claim 1 or 2, further comprising an adapter for transferring fluid from said blunt cannula to an evacuated tube having a sealed end, comprising:

(a) an injection site having a substantially cylindrical injection site housing and flexible means carried by said injection site housing for sealing one end of said injection site housing, said flexible means having a resealable opening therein such that the blunt cannula can be sealingly inserted through said opening and can be removed therefrom with said flexible means interacting with said injection site housing so as to reseal said resealable opening;

(b) a needle attached to the other end of said injection site housing in fluid flow communication with said injection site housing;

(c) a shroud attached to said injection site housing, said shroud covering said needle and adapted to receive said evacuated tube such that said evacuated tube can be inserted into said shroud and pushed against said needle until said needle pierces said sealed end, thereby enabling transfer of fluid from said blunt cannula to said evacuated tube.

7. An adapter according to claim 6, further comprising an elastomeric sleeve covering said needle such that when said evacuated tube is pushed against said needle, said sleeve is pushed back exposing the needle as the needle pierces the sealed end of the evacuated tube and as the evacuated tube is removed from the needle, the sleeve slides back over the needle to cover the needle.

2. A blood sampling system for withdrawing blood from a patient, comprising:

(a) tubing adapted to be connected at one end to the patient in fluid communication with the patient'"'"'s vascular system and at the other end to a fluid supply;

(b) a reservoir assembly connected in-line to said tubing between the patient end and the fluid supply end, comprising a flow through reservoir housing having inner walls defining an interior chamber for holding fluid, a first port in fluid communication with said interior chamber connected to said tubing leading to the fluid supply, a second port in fluid communication with said interior chamber connected to said tubing leading to the patient, a retractable plunger disposed within said reservoir housing, said plunger formed in a complementary configuration to said interior chamber and adapted to traverse said chamber, and a sealing member disposed about said plunger in slidable sealing engagement with said inner walls of said interior chamber, said plunger adapted to be slidably retracted within said interior chamber to create negative pressure within said chamber, said negative pressure being effective to draw fluid from said tubing into said chamber for temporarily storing said fluid in said chamber and to draw blood from said patient into said tubing, said plunger adapted to be slidably projected toward said ports for reintroducing said stored fluid into said tubing; and

(c) a sampling site connected in-line to said tubing between the patient end and said reservoir assembly, said sampling site comprising a flow through sampling site housing having a first port connected to said tubing leading to the reservoir assembly and a second port connected to said tubing leading to the patient, thereby defining a fluid channel through said sampling site housing, means defining an access aperture in said sampling site housing in communication with said fluid channel, and flexible means carried by said sampling site housing for sealing said access aperture, said means having a resealable opening therein such that a blunt cannula can be sealingly inserted through said opening and placed in fluid flow communication with said channel to withdraw blood from said tubing and such that said blunt cannula can be removed therefrom with said flexible means interacting with said sampling site housing so as to reseal said resealable opening;

(d) said blunt cannula comprising an elongated member with a fluid flow channel extending generally axially therewithin and through a distal end of said member, said elongated member being generally cylindrically along a substantial portion of its length and terminating in a generally tapered distal end portion having a blunt end edge.

4. A blood sampling system according to claim 2, wherein said blunt cannula further comprises a substantially cylindrical sheath surrounding said elongated member and being at least coextensive with and spaced apart from said elongated member to protect said member from inadvertent touch contamination.

5. A blood sampling system according to claim 4, wherein said sheath has two slots formed therein at its distal end, said slots disposed opposite each other in said sheath, said slots being adapted to fit over said first and second ports of said sampling site housing to aid in aligning said blunt cannula with said sampling site.

8. A method for withdrawing a blood sample from a patient line which is in communication with the patient'"'"'s vascular system at one end and connected to a fluid supply at the other end, comprising the steps of:

(a) disposing a reservoir assembly in said patient line between said fluid supply end and the patient end of said line;

(b) disposing a sampling site in said patient line between said reservoir assembly and the patient end of said line, said sampling site comprising a flow through housing having a first port leading to the reservoir assembly and a second port leading to the patient, thereby defining a fluid channel through said housing, means defining an access aperture in said housing in communication with said fluid channel, and flexible means carried by said housing for sealing said access aperture, said means having a resealable opening therein such that a blunt cannula can be sealingly inserted through said opening and placed in fluid flow communication with said channel and can be removed therefrom with said flexible means interacting with said housing so as to reseal said resealable opening;

(c) disabling fluid flow from the fluid supply to said reservoir assembly;

(d) drawing fluid contained in said patient line into said reservoir assembly, said drawing being effective to draw blood from the patient into said patient line;

(e) inserting said blunt cannula through said resealable opening of said sampling site to withdraw blood from said patient line; and

(f) removing said blunt cannula from said sampling site, said flexible means of said sampling site thereby interacting with said sampling site housing so as to reseal said resealable opening.

9. A method according to claim 8, further comprising the step of:

(g) transferring said blood withdrawn from said sampling site to an evacuated tube having a sealed end, through an adapter comprising an injection site having a substantially cylindrical injection site housing and flexible means carried by said injection site housing for sealing one end of said injection site housing, said flexible means having a resealable opening therein such that the blunt cannula can be sealingly inserted through said opening and can be removed therefrom with said flexible means interacting with said injection site housing so as to reseal said resealable opening, and a needle connected to the other end of said injection site housing in fluid communication with said injection site housing, a shroud connected to said injection site housing and surrounding said needle, said shroud adapted to receive said evacuated tube such that said evacuated tube can be inserted into said shroud and pushed against said needle until said needle pierces said sealed end, thereby enabling transfer of said blood from said blunt cannula to said evacuated tube.