Medical device

• US 4,782,841 A
• Filed: 11/30/1987
• Issued: 11/08/1988
• Est. Priority Date: 04/07/1987
• Status: Expired due to Term

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Lopez, George A.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/129,362
• Time in Patent Office: 344 Days
• Field of Search: 604/198, 604/263, 604/192, 604/187, 128/763, 128/764, 128/765
• US Class Current: 600/577
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150587 by friction fit
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: A61M 5/3243 being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel devices for protecting guide needles in combination with catheters A61M25/0612

Abstract

Disclosed is a vacuum tube type collection device for collecting blood or other body fluids from a patient. The device includes a conventional sealed vacuum tube received in a tube holder having a removable needle assembly connected to the tube holder. The characterizing feature of the device of this invention is that the needle assembly has a guard member which protects the exposed tip of the needle after withdrawal of the needle from the patient'"'"'s body. This member is movable between a first position where the tip of the needle is exposed and a second position where the guard member covers the tip of the needle and prevents needle sticks. A locking element is mounted along the needle shaft which permanently locks the guard member in the second position upon movement of the guard member into the second position.

Claims

1. In a device used to withdraw blood or other fluids from a patient, including (a) tube means having a seal in an open end adapted to be penetrated by a needle, with said seal then being self-sealing upon withdrawal of the needle penetrating said seal, (b) reusable tube holder means into which the tube means is received during use, said tube holder means having an open end which receives the sealed end of the tube means, (c) opposite the open end, a connector for a needle assembly, and (d) a disposable needle assembly adapted to be removably connected to the tube holder means,

the improvement wherein the needle assembly includes needle means having a first needle segment extending into the tube holder means upon connection with the tube holder means and a second needle segment extending outwardly from the tube holder means upon connection of the needle assembly to the tube holder means with the tip of the second needle segment being exposed prior to insertion of this second segment into the patient,

a guard member mounted on the shaft of the second needle segment and movable axially along the shaft of said second needle segment between a first position where the guard means is displaced inwardly from the tip to expose said tip to enable it to penetrate the body of a patient and a second position where the guard member covers said tip to prevent needle sticks, and

locking means mounted along said needle shaft which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.

2. The device of claim 1 wherein the needle assembly is a unitary structure having a body member with said first and second needle segments aligned along a common axis and extending outwardly from the body member.

3. The device of claim 1 wherein the needle assembly has two separate sections which are adapted to be detachably connected together, one of said sections carrying one needle segment and the other section carrying the other needle segment.

4. The device of claim 3 wherein said needle segments are aligned along a common axis upon connecting the two sections together.

5. A disposable needle assembly including

an elongated needle element terminating at first and second opposed pointed tips,

a connector member mounted between the opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a blood withdrawal device,

a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard means is displaced inwardly from the first pointed tip to expose said first tip to enable it to penetrate the body of a patient and a second position where the guard member covers said first tip to prevent needle sticks, and

locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.

6. The disposable needle assembly of claim 5 wherein the connector member has a threaded element extending therefrom towards the second tip to enable the needle assembly to be screwed into a threaded opening in the tube holder.

7. The disposable needle assembly of claim 6 wherein the connector member has on its exterior rib elements which coact with splines on a needle sheath to facilitate connecting and disconnecting the needle assembly to the tube holder.

8. The disposable needle assembly of claim 5 wherein a rubber cap is seated on the second tip of the needle.

9. A disposable needle assembly including

an elongated needle element terminating in first and second opposed pointed tips,

a connector member mounted along the needle element between said opposed tips of the needle element for removably connecting the needle assembly to a tube holder of a blood withdrawal device,

said connector member having a recessed guard holding section at one end and a threaded tube connection section at the other end,

a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard means is displaced inwardly from the first pointed tip to expose said first trip to enable it to penetrate the body of a patient and a second position where the guard member covers said first tip to prevent needle sticks, said guard member in the first position being seated in the recessed guard holding section, and

locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.

10. The needle assembly of claim 9 wherein the guard member and recessed guard holding section each including interactive elements which hold the guard member in said recessed section until the guard member is manually moved to the second position.

11. A needle assembly including

an elongated needle element terminating at one end in a pointed tip,

a connector member displaced inwardly from said pointed tip mounted on the needle element for removably connecting the needle assembly to a tube holder,

a guard member mounted on the needle element and movable axially along the needle element between a first position where the guard member is displaced inwardly from the tip to expose said tip to enable it to penetrate the body of a patient and a second position where the guard member covers said tip to prevent needle sticks, and

locking means mounted along said needle element between the connector means and said first tip which permanently locks the guard member in the second position upon movement of said guard member from the first position to the second position.

12. The needle assembly of claim 11 wherein the connector member has a tapered open end which receives a needle carried in a hollow tapered fitting.

13. A medical device comprising

a tube holding member which removable receives a vacuum tube having a sealed end,

a needle element having a first end extending into the tube holding member and adapted to penetrate the sealed end of the vacuum tube upon insertion of the tube into the tube holding member and a second end extending outwardly from the tube holding member and adapted to penetrate the body of a patient,

a guard member mounted to be moved between a retracted position exposing the second end of the needle and an extended position covering the second end of the needle, and

locking means for permanently locking the guard member in the extended position upon movement to said extended position.