|Publication number||USRE38996 E1|
|Application number||US 09/249,301|
|Publication date||Feb 28, 2006|
|Filing date||Feb 11, 1999|
|Priority date||Apr 20, 1990|
|Publication number||09249301, 249301, US RE38996 E1, US RE38996E1, US-E1-RE38996, USRE38996 E1, USRE38996E1|
|Inventors||Mark A. Crawford, Timothy J. Erskine, Gerald H. Peterson|
|Original Assignee||Becton, Dickinson And Company|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (72), Referenced by (12), Classifications (9), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a division of patent application Ser. No. 08/364,071 filed Dec. 27, 1994, now U.S. Pat. No. 5,558,691, which is a continuation of patent application Ser. No. 08/114,988 filed Aug. 12, 1993, now abandoned, which is a continuation of patent application Ser. No. 07/512,284 filed Apr. 20, 1990, now abandoned.
This invention relates to a needle tip cover to prevent transmission of infection and more particularly, relates to a tip cover for locking about the tip of a disposable needle after use to prevent accidental delivery of infectious organisms by penetration of the used needle tip into an animal.
With concern about infection, transmission of AIDS, hepatitis and similar incurable diseases of the blood, methods and devices to enclose the used disposable needle tip have become very important and in great demand. Many approaches to guard the needle, protect users and/or otherwise prevent injury have been proposed. All of them are cumbersome, expensive and interfere with the normal and accepted procedure for the insertion of an over the needle catheter. Typical of such introducers is U.S. Pat. No. 4,846,805 wherein the shield slides over the flash chamber body to engage the catheter and lock about the used needle tip.
Specifically, after the catheter has been inserted by an over the needle procedure and blood flashback has been observed, the catheter is advanced and/or the needle is withdrawn. After the catheter is inserted into the vessel as desired and the needle is withdrawn and discarded, protection of the used needle tip becomes important. Needle guards are of three types which either hide the withdrawn needle within the needle carrying hub, require replacement of a separate needle guard or include a sliding shield which can be positioned distally over the used needle. Some of these types of guards lock to secure the guard in the needle protecting position thereby preventing injury.
Those needle guards are cumbersome and interfere with the single hand over the needle catheter placement procedure as disclosed in Stanley, U.S. Pat. No. 3,714,945. The needle tip cover disclosed herein does not interfere with or require any additional steps, procedures or cumbersome mechanisms which interfere with the accepted over the needle technique.
U.S. Pat. No. 3,134,380 has a needle shield for a hypodermic needle and that needle shield is not provided to prevent infection but is included to preserve sterility and to hide the needle prior to use. The device therein includes a compressible resilient sleeve which is carried on the distal end of a syringe barrel to extend outwardly therefrom over the needle and its tip. The sleeve is axially collapsible during placement of the needle in the vessel and reextends due to the resilience of the sleeve as the needle is extracted from the vessel. The distal end of the sleeve is arranged to be carried about the needle and in its extended position rests beyond the tip. No means of locking the sleeve in the extended position is disclosed.
U.S. Pat. No. 4,846,804 has a needle tip protector with a collapsible sleeve disposed about the shank of the needle and a protective cap located at the distal end thereof. The cap surrounds and encloses the tip of the needle. A sealing member is located within the cap to enclose the tip until the needle is pushed through the sealing member. Similarly, U.S. Pat. No. 3,354,881 has a compressible device extending over the needle shank. Rubber septa are provided at the opposite ends of the compressible device so as to surround the needle.
U.S. Pat. No. 4,139,009 has a needle tip protector with a permanently attached cover surrounding the needle and a number of elastic arms which extend along the length of the needle. The arms are constructed so as to bow outwardly from the needle shank when the needle is pressed against and into the patient. U.S. Pat. No. 4,660,570 shows a needle tip protector with a membrane extending over the sharp point of the needle whereby penetration causes the needle to extend through the membrane and the skin of the patient.
U.S. Pat. No. 4,650,468 has a device with a sleeve concentrically placed about the needle shank. A safety shield at one end has a rubber membrane extending across an opening in the shield. The membrane is adapted to be pierced by the needle tip for use.
The invention most preferably is a needle and cover for use with a needle having an elongate shank relative to an axis thereof. The needle has a tip at one axial end with a sharpened point. The cover is coaxially associated with the elongate shank for sliding movement therealong toward the tip. The cover includes a part for extending along the axis beyond the sharpened point when the cover is positioned near the tip. A lock associated with the needle and the cover cooperates and holds the cover to prevent axial movement of the cover relative to the needle tip after the cover is positioned distally along the elongate shank near the tip with the part that extends over the sharpened point.
The cover may have a bearing for circumscribing and guiding during coaxial sliding on the elongate shank. The part which extends hangs cantilever off the bearing to extend beyond the sharpened point preventing accidental injury. The lock may have a change in contour of the needle near where the elongate shank joins the tip so when the cover interengages with the change in contour it becomes locked relative to the needle preventing further axial movement.
The bearing has an inside diameter which most preferably rides upon the shank for axial movement therealong and the bearing is such that engagement with the change in contour prevents distal travel. The part which extends controls the proximal axial movement of the cover up the elongate shank away from the tip after thus locking the cover near the tip.
The change of contour may be a transition between a reduced diameter of the elongate shank and an enlarged diameter of the tip, a roughened surface on the needle, a change in cross section from a circular cross section for the elongate shank to a non-circular cross section near the tip or a notch which extends into the needle providing a latch face for a pawl on the cover.
The invention may be a part of a catheter assembly having a catheter and an adapter connected to one another for fluid communication and carried coaxially about a needle and hub. The catheter has a bore therethrough sized to surround the elongate shank of the needle for movement therewith during insertion and therealong during placement. A retaining means on the adapter and on the cover may releasably attach the cover to the adapter while the catheter and adapter are on the elongate shank of the needle. The retaining means permit the needle and cover to be disengaged from the catheter and adapter after placement of the catheter in the vessel. The lock cooperates and secures the cover to prevent the cover from axial movement relative to the needle tip after the cover is positioned near the tip.
The invention further includes a method of assembly of the hub and cover to the needle. The steps of placing the cover coaxially about the elongate shank with the bearing thereof axially slidable therealong toward the tip and securing the hub to the end of the elongate shank over which the bearing was placed thereby capturing the cover between the tip and the hub.
A method of inserting the over the needle catheter assembly is a part of the invention. The preferred method has the steps of applying pressure to the catheter assembly to penetrate the skin of the animal with the tip of the needle and carry the distal part of the coaxially positioned catheter into the body, inserting the catheter further with an over the needle procedure by holding the hub thereof between a finger and the thumb of the user and moving the cover axially along the needle from the hub to the tip with another finger while withdrawing the hub and needle from the inserted catheter and adapter with the other finger and thumb.
While this invention is satisfied by embodiments in many different forms, there is shown in the drawings and will herein be described in detail, a preferred embodiment and alternate embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the invention to any one of the embodiments illustrated. The scope of the invention will be measured by the appended claims and their equivalents.
A lock 20 is operatively associated with the needle 12 and the cover 11 for cooperation therebetween to hold the cover 11 in position over the tip in ways to be described. Specifically, the lock 20 is for securing the cover 11 to prevent the cover 11 from axial movement relative to the needle tip 15 after positioning the cover 11 near the tip 15. In particular, the lock 20 prevents the cover 11 from being removed from the elongate shank 14.
The cover 11 has a bearing 21 for circumscribing and coaxial sliding on the elongate shank 14 and the part which extends 18 hangs cantilever from the bearing 21. Depending upon whether the cover 11, as shown in
Alternatively, the part which extends 18 may be primarily distal and the bearing 21 can be proximal, as shown in
The needle tip cover 11 of
To avoid problems of permanent set or distortion of a polymeric cover 11 due to maintenance in that ready to close position of the part which extends 18, an alternate approach is disclosed in
The catheter assembly 10 is of an over the needle type wherein a catheter 13 is inserted into a vessel by a single hand technique as described in U.S. Pat. No. 3,714,945. The catheter assembly 10, shown in
There is a lug 41 on the proximal end of the cover 11 as shown in
A method of assembly of the needle hub 40 and the cover 11 to an end 43 opposite the tip 15 of the needle 12 and the needle 12 having the change in contour 22 and the cover 11 having the bearing 21 for circumscribing and coaxial sliding on the elongate shank 14, includes the following steps:
A method of inserting the catheter assembly 10 by an over the needle technique requires the needle 12 and the cover 11 carried about the needle 12 on the elongate shank 14 thereof for movement therealong from the hub 38 40 to the tip 15, includes the following steps:
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|U.S. Classification||604/263, 604/166.01, 604/198|
|International Classification||A61M25/06, A61M5/00|
|Cooperative Classification||A61M2005/325, A61M25/0618, A61M5/3273|
|Aug 18, 2008||REMI||Maintenance fee reminder mailed|
|Sep 4, 2008||SULP||Surcharge for late payment|
Year of fee payment: 11
|Sep 4, 2008||FPAY||Fee payment|
Year of fee payment: 12