WO2006074224A2

WO2006074224A2 - Method and apparatus for monitoring distribution of safety syringes

Info

Publication number: WO2006074224A2
Application number: PCT/US2006/000177
Authority: WO
Inventors: Frazier Ross Sharp
Original assignee: Inviro Medical, Inc.
Priority date: 2005-01-05
Filing date: 2006-01-05
Publication date: 2006-07-13
Also published as: WO2006074224A3

Abstract

A method for monitoring the distribution of safety syringes of the type having a disabling mechanism preventing re-use of the syringe includes the steps of , a) after using each syringe, disabling the syringe by removing a part necessary to the operation of the syringe, and b) collecting the removed parts to evidence that the syringes have not been sold or redistributed by the user.

Description

METHOD AND APPARATUS FOR MONITORING DISTRIBUTION OF

SAFETY SYRINGES

[0001] This application is related and claims priority to U. S . Provisional Patent Application Serial No . 60/641 , 150 , filed January 5 , 2005 , the disclosure of which is incorporated by reference .

[0002] The present invention relates to methods and apparatus for monitoring the distribution of safety syringes of the type having a disabling mechanism preventing reuse of the syringe, and particularly relates to methods and apparatus to prevent the further distribution of safety syringes in the absence of proof of use and disablement of distributed syringes .

[0003] In many areas of the world, particularly in countries which are poor and underdeveloped, the distribution of medicines , medical devices and ancillary supplies is difficult, scanty and the demand for such services and devices typically exceeds the supply. For example, syringes are commonly used for percutaneous inj ections as well as for withdrawing fluid, e . g . , medicines from vials and inj ecting the fluid into IV lines or directly into individuals . In this modern era, safety syringes have been developed to preclude or minimize needle stick injuries among medical personnel such as health care workers to avoid the transmission of viruses such as HIV-I and Hepatitis B . These safety syringes frequently feature a disabling mechanism whereby after a single use of the syringe , the syringe can be disabled by the user to prevent subsequent use . One such disabling mechanism for a syringe includes an adapter carrying the metal needle and releasably secured to the distal end of the syringe barrel . Upon disablement, the adapter and needle are withdrawn into the barrel . Particularly, the distal end of the plunger is connected to the adapter and the adapter and needle are withdrawn into the barrel upon retracting the plunger relative to the barrel . The needle and adapter are thus located within the confines of the barrel and the plunger is broken off from its bung thereby preventing reuse of the syringe . An example of a syringe of this type is described and illustrated in U. S . Patent No . 6 , 344 , 031 of common assignee , the disclosure of which is incorporated herein by reference .

[0004] In those areas of the world, however, where the need for medical assistance is high and the supply of medical care personnel and devices is marginal , distributors of medical supplies such as syringes wish to be reassured that individuals to whom the syringes are distributed for use on a regular basis are being properly used and not sold for profit by the unscrupulous . While it is impractical to monitor each and every use of the syringe to insure that the syringe is used only once , subsequently disabled and not reused one or more times , the distribution of the syringes can be monitored and controlled by the party distributing the syringes . For example, a distributor may sell or distribute a predetermined number, i . e . a lot of syringes to a medical practitioner who will then utilize the syringes in an appropriate manner using each syringe only once and then disabling the syringe . To ensure that such practitioner, does not redistribute or sell the syringes for profit, the distributor may require proof that the practitioner has utilized the syringe properly and not further distributed or sold the syringes for profit before selling a new lot of syringes to the practitioner .

[0005] To accomplish the foregoing, a seller or distributor of safety syringes may require the purchaser to return to the seller or distributor a part from the used syringe . For example , in the previously noted safety syringe , the plunger stem is broken off from the syringe to permanently disable the syringe . The distributor may require from the purchaser evidence that the syringe has been properly used and not sold to a third party by requiring return of the broken off part , e . g. , the plunger stem. To facilitate this method of monitoring distribution and use of the syringes , the seller or distributor may also provide the purchaser with a holder in which may be placed or secured the broken off part, e . g . , the plunger stem. In this manner, when the purchaser of a lot of syringes returns to the distributor to purchase a second or further lot of syringes , the distributor may require return of the broken off syringe part, e . g . , the plunger stems in the holder so that a count of the returned plunger stems can be made . The count of the returned syringe parts should correspond to the count of originally provided safety syringes . In this manner, the distributor is assured that the purchaser has not sold for profit the syringes of the first lot since the distributor will have proof that the purchaser either personally disabled or controlled the disablement of the safety syringes .

[0006] In a preferred embodiment of the present invention, the distributor may provide a receptacle, e . g . , a notebook having multiple pages with pockets for receiving the disabled parts of the safety syringes , e . g . , the plunger . Preferably, the pages of the notebook may be formed of a plastic material with slits providing entryways into pockets within the notebook pages such that the disabled parts , e . g . , the plunger stems can be readily viewed and counted. The pages may have index markings adj acent the slits or pockets such that the slits or pockets may be filled in numerical sequence whereby the number of plunger stems can be readily ascertained by the distributor . In this manner, the distributor is assured that the first lot of syringes sold to the purchaser, e . g . a medical practitioner has been properly used and not sold for profit .

[0007] A mechanism by which the distribution of the syringes can be monitored is illustrated in the accompanying drawings in which :

[0008] FIGURES IA and IB illustrate a safety syringe of the type disclosed and illustrated in the aforementioned U. S . patent ; and

[0009] FIGURE 2 illustrates a notebook having pages containing slits and pockets in which the broken off parts of the safety syringe , i . e . , the plunger, can be inserted .

[0010] Referring to Figures IA and IB, there is illustrated a syringe designated 10 comprised of a syringe barrel 12 , an adapter 14 mounting a needle 16 and a plunger 18 having a plunger stem 19. It will be appreciated that the adapter 14 is releasably secured to the distal end of the barrel with the needle 16 projecting from the barrel end for use . To disable the syringe after use , various mechanisms may be employed to couple the distal end of the plunger 18 and the proximal end of the adapter to facilitate withdrawal of the adapter and the accompanying needle 16 into the syringe barrel . One such coupling device is illustrated in the aforementioned U. S . patent . In that patent, the adapter 14 is threaded into the distal end of the barrel 12. To disable the syringe, the plunger is advanced to engage and rotate the adapter in an unthreading direction and, with the plunger and adapter engaged to one another, withdrawal of the plunger relative to the barrel enables the adapter and accompanying needle to be withdrawn into the barrel . A weakened or frangible portion 20 between the plunger stem 19 and bung 22 of the plunger enables the plunger stem 19 to be broken from the distal end of the plunger and removed from the syringe as illustrated in Figure IB .

[0011] Referring now to Figure 2 , there is illustrated a holder, for example , a notebook 30 , having a plurality of sheets or pages 32. Each of the pages 32 may comprise a plurality of slits 31 forming entryways for pockets 34. For example , the sheets 32 may be formed of a two-ply plastic film material secured back to back with the pockets 34 formed with slits 31 at one end, enabling the stem 19 of the plunger stem 18 for insertion within the pocket . As illustrated, each sheet may be divided into sections , ten sections being illustrated. Each section 38 includes four pockets whereby forty plunger stems 19 may be received in the pockets on a single sheet . Once a single sheet is filled with the plunger stems 19 signifying disablement of the syringe, one or more additional sheets may likewise be filled with the disabled syringe parts .

[0012] It will be appreciated that when some or all of the sheets are filled with plunger stems , the practitioner may return the notebook to the distributor of the syringes . This signifies to the distributor that the practitioner has not sold the syringes of a first lot of syringes purchased from the distributor to another party. Once the distributor receives the notebook and recognizes that an equal or near equal number of broken plunger stems in the notebook corresponding to the number of syringes previously sold to the practitioner, the distributor is assured that the syringes have not been sold or otherwise placed out of the control of the user . Thus , the distribution of syringes lot by lot may be monitored by the distributor .

Claims

WHAT IS CLAIMED IS :

1. A method of inhibiting selling or redistribution of used syringes each operable to transmit a fluid through a needle carried by the syringe comprising the steps of :

a) after using each syringe to transmit fluid through the needle, disabling the syringe by removing a part necessary to the operation of the syringe ; and

b) collecting the removed parts to evidence that the syringes have not been sold or redistributed by the user.

2. A method according to claim 1 wherein the step b) disposing the collected parts in a receptacle .

3. A method according to claim 1 wherein step b) includes disposing the collected parts .

4. A method according to claim 1 wherein step includes a) withdrawing the needle into the barrel of the syringe and step b) includes breaking off a portion of the plunger of the syringe .

5. A method according to claim 4 wherein step b) includes disposing the collected plunger part in a receptacle .