US20020066686A1

US20020066686A1 - Containment system for encapsulating a sharp medical instrument

Info

Publication number: US20020066686A1
Application number: US09/930,848
Authority: US
Inventors: Robert Montenieri; Brian Vakiener; Shabbir Attarwala
Original assignee: Henkel Loctite Corp
Current assignee: Henkel Loctite Corp
Priority date: 2000-08-17
Filing date: 2001-08-15
Publication date: 2002-06-06
Also published as: WO2002013889A1; AU2001286502A1

Abstract

A containment system encapsulates a sharp medical instrument. The containment system includes a container having an upper end for insertably accommodating the medical instrument. The container supports a pair of liquid components of a two-part hardenable compound which are separated by a rupturable divider. The components are mixed upon rupture of the divider caused by insertion of the medical instrument thereinto. The hardenable compound thereby hardens around the medical instrument, quickly and permanently encapsulating the inserted instrument.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to Provisional Application, Serial No. 60/225,874, filed on Aug. 17, 2000 and entitled “Containment System For Encapsulating A Sharp Medical Instrument”.[0001]

FIELD OF THE INVENTION

The present invention relates generally to a containment system for disposal of a sharp medical instrument such as a hypodermic needle. More particularly, the present invention relates to a containment device which quickly and permanently seals, plugs and encapsulates an inserted needle, making it unusable and allowing the safe disposal thereof.

DISCUSSION OF THE RELATED ART

The handling and disposal of used medical instruments, particularly sharp medical instruments such as hypodermic needles, suture needles, lancets, trocars, scalpel blades and the like is a major problem facing healthcare professionals. Blood-born pathogens can be easily transmitted by inadvertent contact with the used medical instrument such as by accidental needle sticks.

In order to avoid such accidental needle sticks, especially immediately after using the medical instrument, the healthcare professional will attempt to cover the needle with a protective cap or sheath so that the instrument can be safely transported for disposal. The provision for caps and sheaths affords some degree of protection, however many accidental needle sticks occur while trying to place the cap or sheath back on the needle in preparation for transport for disposal.

In the absence of re-capping or re-sheathing, quite often the used medical instrument is transported uncovered to a sharps container which ideally is located proximate to the site. The sharps container holds several used medical instruments in a hard puncture-resistant package which is subsequently collected for final disposal. However, this still requires the healthcare professional to handle and transport the unprotected needle after use. Also, the collected used instruments remain on site in the sharps container until collected for final disposal.

The art has seen many devices for capping, closing and sheathing used sharp medical instruments for disposal. Many of these devices simply enclose the entire medical instrument, or at least the sharp portion thereof in a protective enclosure. Other of these devices attempt to encapsulate or surround the used medical instrument with a composition which hardens around the sharp portion of the instrument, providing permanent containment and protection.

One such encapsulation system is shown in U.S. Pat. No. 5,322,165 where a two-part hardenable compound is provided in a container which accepts a sharp medical instrument such as a hypodermic needle. The container of the ′165 patent supports a hardenable resin such as a cyanoacrylate ester and a filler of particulate matter in spaced separation. The filler includes an accelerator which is used to speed up the hardening of the resin. The resin and the filler accelerator are separated by a rupturable partition such as thin glass. The used medical instrument, such as a needle, is inserted into the container, rupturing the glass membrane between the two components, thereby causing the components to come together and harden around the needle.

Another encapsulation system for a sharp object is depicted in U.S. Pat. No. 4,845,923 wherein a container holds a first liquid reactive agent and a porous foam impregnated with a second reactive agent. A pierceable membrane separates the porous impregnated foam from the first reactive agent. Upon piercing the membrane, the first reactive agent is absorbed by the foam which then, as a result of hardening, encapsulates the sharp object.

As may be appreciated, the length of time it takes for the resin and accelerator to react and harden around the needle is of particular importance. If, upon insertion of the needle into the container, the hardening process takes too long, there is risk that the needle can be removed from the container, thereby exposing the healthcare professional to an increased risk of accidental needle stick. Further, if the components in the container require some form of agitation to assure complete hardening, such as may be the case where one of the components is a particulate matter such as a filler, the subsequent mixing operation by the healthcare professional may present additional risks or, as significantly, if done improperly, may result in incomplete hardening around the inserted needle and failure to plug the needle itself.

It is, therefore, desirable to provide an improved containment system for supporting a two-part hardenable compound which is quickly mixed so that hardening can occur upon simple insertion of the sharp medical device into the container to harden around the needle as well as plug the needle making it unusable.

SUMMARY OF THE INVENTION

The present invention provides a containment system for encapsulating a sharp medical instrument. The containment system includes a container having an end for insertably receiving the sharp medical instrument. The container supports a pair of liquid components of a two-part hardenable resin material. The two liquid components include a hardenable resin first part and a resin hardener second part, each of which are separated by a rupturable divider which is ruptured upon instrument insertion. The components are mixed upon rupture of the divider and harden to encapsulate the inserted medical instrument.

In one particular embodiment of the present invention, the container includes an open ended container base which accommodates one of the pair of liquid components, and an open ended container cap which insertably receives the medical instrument and accommodates the other of the pair of liquid components. The cap is positioned and secured over the open end of the base with the rupturable divider being positioned therebetween. The rupturable divider may be a glass wafer which is shatterable upon instrument insertion.

The compounds may include a hardenable resin and a resin hardener. The hardenable liquid resin may be selected from a variety of resins which can be cured rapidly (meth)acrylates, cyanoacrylates, vinyls, epoxies and combinations thereof. For example, anaerobically curable resins, polyurethane polyacrylate resins, epoxy resins, cyanoacrylates, vinyl resins, silicones, silicone-acrylate resins may be employed. The liquid resin hardener may be selected in accordance with the type of hardenable resin employed. For example, free radical initiators, metal catalysts, acidic or basic catalysts and/or accelerators may be employed. For purposes of this invention, the term “liquid resin hardener” will include any material, such as initiators, catalysts, accelerators, and promoters, which when mixed with the hardenable resin causes the resin to harden.

In further embodiments, the rupturable divider may include a break-away wall which is snap-fitted onto the container cap and is broken away by instrument insertion.

In a method aspect of the present invention, a method of encapsulating a sharp medical instrument is provided. The method includes inserting the instrument into a container supporting a pair of liquid components of a two-part hardenable compound. The components are separated by a rupturable divider. Upon inserting the instrument into container, the divider is ruptured and the components become mixed so as to cause the compound to harden around the instrument.

In a further particular aspect of the present invention, a container for enclosing a medical instrument having a sharp extent comprises a container housing having an upper chamber, a middle chamber and a lower chamber. The upper chamber has an upper end for insertably receiving the instrument and for accommodating a first component of a two-component hardenable compound. The middle chamber accommodates a second component of the two-component hardenable compound. A rupturable divider is disposed between the upper chamber and the middle chamber, the divider being rupturable upon instrument insertion to cause the first and second components to mix in the middle chamber and harden around a portion of the inserted instrument. A penetrable wall is disposed between the middle chamber and the lower chamber, the wall being penetrable by a sharp extent of the instrument, the lower chamber being configured to receive and accommodate the sharp extent of the inserted instrument.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an exploded vertical section of one embodiment of the containment system of the present invention. [0017]
FIG. 2 is a vertical sectional showing of the assembled containment system of FIG. 1. [0018]
FIGS. 3, 4 and [0019] 5 are sectional showings of containment system of FIG. 1, including two-part liquid encapsulate accommodated therein, with the figures showing progressively the insertion of a needle thereinto.
FIG. 6 is a vertical section of a further embodiment of the containment system of FIG. 1. [0020]
FIGS. [0021] 7-10 are vertical sections of additional embodiments of the containment system of the present invention.
FIG. 11 is a schematic showing of a tray used to support a plurality of containment devices shown in FIGS. [0022] 1-10.
FIG. 12 is a perspective view of a further particular form of a container for encapsulating a sharp medical instrument in accordance with the present invention. [0023]
FIG. 13 is a perspective vertical sectional view of the container of FIG. 12. [0024]
FIG. 14 is a vertical sectional view of the container of FIG. 12. [0025]
FIG. 15 is a perspective view of an upper cup component of the container of FIG. 14 for accommodating one component of a two-component hardenable compound. [0026]
FIGS. [0027] 15(a) and 15(b) are perspective views of variations of the upper cup component of FIG. 15.
FIG. 16 is a vertical sectional view of the container of FIG. 12 shown in encapsulating assembly with a hypodermic needle.[0028]

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a containment system for the encapsulation of a sharp medical instrument such as a hypodermic needle. The containment system is easy to use and quickly encapsulates the needle after use, thus reducing the incident of accidental needle stick by making it non-reusable. [0029]
With reference to FIGS. 1 and 2, one embodiment of the present invention provides a containment assembly for supporting and separating two liquid components of a two-part hardenable compound. A first liquid component is supported in spaced separation from second liquid component. In the present invention, first component may be a liquid hardenable resin of the type selected from the group consisting of anaerobically curable resins, epoxy resins, cyanoacrylates, vinyl resins, silicones, silicone-acrylate resins and combinations thereof. A second component may include a liquid resin hardener selected from the group consisting of free radical initiators, metal catalysts, acidic or basic catalysts or combinations thereof. The two liquid components forming the liquid hardenable resin and the liquid resin hardener are miscible. Thus, upon mixing the liquid hardenable resin with the liquid resin hardener, the liquid components rapidly harden, and, as will be disclosed in further detail hereinbelow, completely encapsulate an inserted sharp medical instrument such as a hypodermic needle. [0030]
The [0031] containment assembly 10 preferably includes three assembled components. A base 16 supports a liquid resin hardener 12 while a cap 18 supports a liquid resin 14. A rupturable divider in the form of a membrane or wafer 20 is supported between cap 18 and base 16, so as to contain hardener 14 in the cap and to separate resin hardener 12 from liquid resin 14. As may be appreciated, alternatively, the base may support the resin while the cap supports the hardener.
While the components forming [0032] containment assembly 10 may take various shapes and configurations, base 16 is generally a cup-shape member having a closed bottom surface 22 and an opposed open end 24, with a circumferential sidewall 26 extending therebetween. Base 16 defines an interior 17 for accommodating liquid hardenable resin 12 at the lower end thereof. The distal extent of sidewall 26 defines a rim-like seat 30 for supporting rupturable wafer 20 thereon. Also, base 16 includes an outwardly extending lip 31, which as will be described in detail hereinbelow, provides for securement of cap 18 thereto.
[0033] Cap 18 is generally an elongate member having an enlarged lower open end 32 and an opposed upper end 34, closed by a transverse puncturable wall 36. An elongate circumferential sidewall 38 extends between lower end 32 and upper end 34 of cap 18.
[0034] Base 16 and cap 18 may be formed of any suitably rigid material, preferably molded plastic which, with the exception of transverse wall 36, is resistant to puncture by a sharp medical instrument such as a hypodermic needle. It is also preferable that base 16 and cap 18 be formed of a transparent or translucent material so as to permit viewing of the components of the two-part compound, as well as the insertion of the sharp medical instrument therein.
As shown in FIGS. 1 and 2, [0035] cap 18 is attachable to base 16, with wafer 20 being secured therebetween. The enlarged lower end 32 of cap 18 fits in a frictionally secured relationship with the extending lip 31 of the upper end of base 16. By such securement wafer 20, seated on rim 30, is captively secured between base 16 and cap 18. While frictional securement of cap 18 to base 16 is shown, other securement techniques such as interfitting snap rings and/or screw securement may also be employed. Wafer 20 with cap 18 defines a cap interior 19 for accommodating resin 14.
[0036] Wafer 20 is preferably formed of shatterable material, such as glass. As such, upon contact with the sharp medical instrument during insertion thereof, the glass wafer 20 will shatter. Shattering of wafer 20 assures that the interior 19 of cap 18 is placed in communication with the interior 17 of base 16 so as to cause the liquid resin 14 to flow from interior 19 into interior 17 and mix with resin hardener 12 in base 16. While shatterable glass is preferred, the present invention may be employed with any rupturable membrane supported between cap 18 and base 16.
[0037] Transverse wall 36, extending across and closing the upper end 34 of cap 18, may be integrally formed therewith or may be formed by a separate component placed therein. Transverse wall 36 is readily puncturable by the insertion of a hypodermic needle or other sharp medical instrument. The puncturability of transverse wall 36 is provided by the thinness of wall 36, where the wall is formed integrally with cap 18. Where wall 36 is formed separately from cap 18, the puncturability of wall 36 may be provided by its thinness or by the particular material from which it is formed, such as thin metal foil. Prior to puncturing, however, transverse wall 36 serves to enclose the interior 19 of cap 18, providing containment of liquid resin 14 therein.
Having described the components of [0038] containment assembly 10 of the present invention, its operation in encapsulating an inserted medical device may now be described with respect to FIGS. 3-5. In the description hereinbelow, the inserted sharp medical device is shown as a needle 40, such as a hypodermic needle. However, it may be appreciated that any other sharpened medical device may also be employed in combination with the containment assembly 10 of the present invention.
As shown in FIG. 3, after using [0039] needle 40, the needle may be inserted into the open upper end 34 of cap 18. The sharp point 42 of needle 40 punctures puncturable transverse wall 36. Due to the thinness and/or material forming wall 36, the wall is in close contact with needle 40 which may assist in providing a wiping action as the needle is inserted thereinto. The needle progresses until the sharpened tip 40 makes contact with glass wafer 20.
As shown in FIG. 4, upon the contacting of [0040] tip 42 with glass wafer 20 and upon continued insertion, the needle shatters glass wafer 20. The shattering of the glass wafer 20 causes an immediate opening of the passage between interior 19 of cap 18 and the interior 17 of base 16. This places the liquid resin hardener 12 in communication with the liquid resin 14. Once in contact, and with the liquid hardenable resin and the liquid resin hardener being miscible, immediate mixing and hardening of the combined materials takes place. The hardening occurs as the needle 40 is pushed fully into the base 16 until it approaches or is stopped by the bottom wall 22 thereof. The risk of puncturing the bottom wall is prevented by forming the base of a suitably rigid plastic.
Since the materials forming the compound are liquid, some of the combined [0041] material 50 will actually flow into the hollow interior channel of needle 40. This results in plugging the interior channel rendering the needle non-reusable. The admixing of the liquid hardened resin with the resin hardener causes encapsulation of the needle 40 within base 16 rapidly, and desirably in a matter of seconds. The needle 40 is thereby permanently encapsulated and contained within the containment assembly 10, preventing removal of the needle therefrom. Such containment prevents any occurrence of an accidental needle stick. The containment assembly 10 with the needle permanently encapsulated therein may now be safely transported for disposal.
Useful hardenable resins include any liquid resin which when admixed with the liquid resin hardener cures in a sufficiently rapid time to be commercially acceptable for the device of the present invention. Usually, an acceptable hardening time is about 20 seconds to about 40 seconds. More desirably, the hardening time is about 20 seconds. Useful resins include anaerobically curable resins, polyurethane polyacrylate resins, epoxy resins, cyanoacrylates, vinyl resins, silicone resins, and silicone-acrylate resins. Combinations and copolymers of such resin materials are also useful. [0042]
More specifically, useful anaerobically curable resins include those based on mono- and poly(meth)acrylate monomers. Such resins are described, for example, as U.S. Pat. Nos. 3,043,820 and 3,046,262 to Loctite Corporation, which are incorporated herein by reference. [0043]
Resin hardeners particularly useful with anaerobic curing resins include solutions of metal salts. The use of salt solutions facilitates the mixing of the resin hardener with the hardenable resin to obtain rapid hardening. Virtually any transition metal salt solution may be employed, but salt solutions of copper, iron, nickel and zinc are most desirable. Examples of useful copper salts include copper octonate and the diketone salts of copper. Accelerators typically employed with anaerobic systems may also be incorporated in the resin hardener component. Amines are frequently used as accelerators in compatible organic carriers, such as tetraethylene glycol esters. Amines may be effectively combined with saccharin. Hydrazine derivatives and sulfonamides are also useful as accelerators. A description of various useful accelerators can be found in U.S. Pat. Nos. 3,203,941; 3,218,305; 4,180,640 and 4,287,330 to Loctite Corporation. [0044]
Useful cyanoacrylate resins include those described in U.S. Pat. Nos. 2,784,215 to Joyner and 3,742,018 to Loctite which are incorporated herein by reference. These resins typically employ amines, thiols, or benzothiazole sulfenamide derivatives as resin hardeners, as described in U.S. Pat. Nos. 3,742,018 and 3,836,377, also incorporated herein by reference. [0045]
Epoxy resins useful in the present invention includes those described in Epoxide Resins and Their Formulations, Plastics for Electronics, [0046] 2 ^ndEdition, Edited by Martin Gossey, Academic Publisher (1999). Typical resin hardeners for epoxies, such as amines or thiol compounds may be employed.
The relative proportions of the two parts of various curable compositions may be chosen to ensure rapid cure. For example, in cases where epoxy compositions are employed, generally the resin and hardener components are admixed in approximately equimolar proportions. In instances where anaerobic compositions or cyanoacrylate compositions are employed, amounts of about 0.05 to about 1 gram of resin is generally used for every 0.05 to about 0.025 grams of the resin hardener. Conventional proportions of resin to resin hardener may be employed, depending on the particular [0047]
Referring now to FIG. 6, further embodiment of the [0048] containment assembly 10 of the present invention is shown. Containment assembly 60 includes a base 62 which supports hardenable resin and a cap 64 which supports the liquid resin hardener. It should be understood that, in the alternative, base 62 may support the hardener and cap 64 may support the resin. Base 62 is generally a cup-shaped member having a closed bottom surface 66 and an open upper end 68 with a cylindrical side wall 70 extending therebetween. In the present embodiment, cap 64 is also generally cup-shaped, having an open upper end 72, a closed bottom wall 74, and a side wall 76 extending therebetween. In the present embodiment, bottom wall 74 may be formed by a shatterable material such as glass, or shatterable plastic which is easily shattered upon needle insertion as described above with respect to the embodiment of FIGS. 1-5.
Also, in order to assure that inserted needle contacts the shatterable [0049] bottom wall 74, side wall 76 includes a conical wall portion 76. The conical shape of wall portion 76 helps guide the inserted needle towards the shatterable bottom wall 74, which is generally positioned at the apex thereof. To further assure proper contact between bottom wall 74 and the inserted needle, the bottom wall includes an upwardly extending annular ridge 75. Ridge 75 accommodates the needle as it is inserted. Further, in order to prevent the needle from prematurely puncturing side wall 76, the cup-shaped cap 64 is formed of rigid plastic which resists needle puncture.
[0050] Cap 64 is inserted in position within the interior 71 of base 70, and includes a radially extending annular lip 78 which sits atop a rim-like seat 73 adjacent to the open upper end 68 of base 62. The securement of cap 64 to base 62 may be by frictional engagement or may be provided by other mechanical securement techniques such as a snap-fit. The engagement of lip 78 with seat 73 may be established such that a seal is provided therebetween.
The embodiment shown in FIG. 6 operates in a substantially similar manner to the embodiments shown in FIGS. [0051] 1-5 whereupon shattering of the bottom wall 74, the liquid resin hardener is placed in immediate communication with the hardenable resin. The extremely miscive nature of the components provides for hardening around the inserted instrument.
Referring now to FIG. 7, a further embodiment of the present invention is shown. [0052] Containment assembly 80, shown in FIG. 7, includes a base 82 referred to as a lower reservoir and a cap 84 referred to as an upper reservoir which are substantially identical to those shown and described with respect to FIG. 6. The bottom wall 86 of cap 84 is formed of a separate member which is attached to the conical portion 89 of side wall 88 by a releasable snap fit. In the present illustrative embodiment, bottom wall 86, which is itself conical in shape, includes an outwardly extending annular rib 90 which is snap-fitted into a corresponding groove 92 at the distal end of side wall 88. The rib and groove snap-fit arrangement between bottom wall 86 and side wall 88 provides for releasable securement thereof. Upon insertion of the medical instrument, bottom wall 86 is detached from side wall 88 so as to place the components respectively contained in base 82 and cap 84 in immediate communication. As with the embodiment of FIG. 6, the side wall 88 is formed of rigid plastic to assure that the inserted instrument is guided toward conical bottom wall 86 so as to effect detachment thereof.
As shown particularly in the embodiment of FIG. 7, cap [0053] 84 may include a puncturable transverse covering 95 which encloses the interior of cap 84. Covering 95 functions similar to transverse wall 36 of the embodiment of FIGS. 1-5.
FIG. 8 shows a further embodiment of the present invention which is substantially similar to the embodiment shown in FIG. 7 having a base [0054] 91 and cap 93. However, in the embodiment shown in FIG. 8, bottom wall 97 is a generally flat member having an internally directed annular groove 98 which is attachable to an outwardly extending annular rim 99 on the side wall 95 of cap 93. As with the embodiment of FIG. 7, insertion of the medical device serves to detach bottom wall 97 from the side wall so as to place the respective component in communication.
With respect to FIG. 9, an additional embodiment of the present invention is shown. This embodiment, which is substantially similar to the embodiments of FIGS. [0055] 6-8, includes a base 100 and a cap 102. Cap 102 has a sidewall 106 defining at the bottom thereof, and an opening 103. Opening 103 is fitted with a releasable plug 104, which may be attached to the circumferential inner edge of opening 103 by inwardly directed detents 108. The plug 104, which may be formed of impenetrable plastic, is dislodged from the sidewall 106 upon instrument insertion so as to allow communication between the respective materials held in the cap and the base.
The concept of the funnel or conical shape may be practiced with an embodiment of the invention similar to that shown in FIGS. [0056] 1-6.
FIG. 10 shows a further embodiment of the invention where a [0057] base 116 and a cap 118 are separated by a glass wafer 120. The cap 118 may include a funnel or conically shaped interior cavity 117. Similarly, base 116 may include a conically shaped upper interior section 119 which serves to funnel the contents of cap 118 to the bottom of the base 116 after glass wafer 120 is shattered.
In a typical laboratory or other medical setting, it is often necessary to use multiple needles at one time. The present invention contemplates placing or arranging plural containment assembly of the types shown in FIGS. [0058] 1-9 in a mutually supported array.
As an example, the containment assemblies may be held in a 10×10 arrangement in a [0059] tray 150 shown in FIG. 11. Tray 150 includes compartments 152 which may each support one containment assembly. As may be appreciated, other number arrays may also be employed. Further, other techniques may also be used in supporting plural containment assemblies in a grid-like array.
Referring now to drawings FIGS. 12, 13 and [0060] 14, there is shown a particular arrangement of a container 200 for encapsulating a hypodermic needle. In this particular arrangement, container 200 is a three-component structure, comprising a container housing 202, a first cup 204 and second cup 206. While each of the housing 202, first cup 204 and second cup 206 is formed of molded plastic, it should be appreciated that other materials suitable for encapsulation purposes may be used.
[0061] Container housing 202 is of generally elongate, vial-like configuration having a closed lower end 208 and an open upper end 210 and an interior space 212. In one form of the housing configuration as shown particularly in FIGS. 12 and 13, the lower end of the housing 202 tapers downwardly to a narrowing interior space toward the closed end 208 while the upper end of the housing 202 flares outwardly to an expanding interior surface toward the upper end 210. Adjacent the upper end of the housing 202 a circumferential recess 214 is provided for receipt therein of the first cup 204, as will be described.
[0062] First cup 204 comprises sidewalls 216, a lower wall 218 and an open upper end 220. First cup 204 is particularly formed to have a tapering configuration narrowing toward the lower wall 218 and is adapted for insertion into the flared upper end of container housing 202 as shown. First cup 204 is formed to have an outwardly extending flange 222 that is particularly configured to be received in interference fit in housing recess 214.
In assembly with the [0063] housing 202, first cup 204 is disposed therein such that lower wall 218 is axially spaced from the closed end 208 defining thereby a lower chamber 224 for receipt therein of the sharp extent of a hypodermic needle as will be detailed. First cup 204 further defines in assembly with the container housing 202, a middle chamber 226. Middle chamber 226 is adapted to accommodate therein a first component of a two-component hardenable compound. In one arrangement, a liquid resin 14 of the type described herein is accommodated in middle chamber 226 of first cup 204. Lower wall 218 of first cup 204, while supporting the liquid resin 14 therein, is formed to be penetrable by the sharp extent of a hypodermic needle or other sharp object for receipt therethrough. While some seepage of compound may occur through the lower wall 218, it is intended that the hardenable compound be substantially retained in the middle chamber 226. First cup 204 is further formed at its upper end 220 to have a circumferential recess 228 for receipt therein of the second cup 206.
Referring now also to FIG. 15, the details of [0064] second cup 206 are described. Second cup 206 is of generally cylindrical configuration having circumferential side walls 230, a rupturable bottom wall 232 and an open upper end 234. Second cup 206 further includes an outwardly projecting circumferential flange 236 particularly configured for interference fit with recess 228 of first cup 204. It should be appreciated that while assembly of the first cup 204 in housing 202 and the assembly of the second cup 206 in the recess of the first cup 204 are described as being in interference fit, other suitable techniques for assembling these components may be used within the context of the invention. In assembly with the first cup 204 and the housing 202, the second cup 206 defines an upper chamber 238 that particularly accommodates a liquid resin hardener 12, of the type described herein. It should be appreciated that while a liquid resin 14 is shown and described as being accommodated in middle chamber 226 and a liquid resin hardener 12 is described as being contained in upper chamber 238, the resin 14 and hardener 12 may be reversed. A pierceable foil lid 240 is provided over the upper chamber 238 to hold the liquid resin hardener 12 therein.
In assembly, the [0065] bottom wall 232 of the second cup 206 is disposed above the middle chamber 226. In one particular aspect, the bottom wall 232 is formed to have a series of radially projecting weakened score lines 242 that are adapted to break upon the insertion of the sharp extent of an object to be encapsulated in the container 200.
In another form of the [0066] second cup 206 a as shown in FIG. 15(athe rupturable bottom wall 232 a formed to have a rupturable hinged door 244. Hinged door 244 in one particular arrangement, is rectangular and is defined by three weakened score lines 245 forming three edges of the hinged door 244 and one non-scored edge defining a hinge for door 244. Upon insertion of the sharp extent of an object such as a hypodermic needle to be encapsulated, the weakened score lines 245 are adapted to break open and the door 244 is rotatably openable about the non-scored edge which effectively provides a flexible hinge.
A further example of the second cup [0067] 206 b is illustrated with reference to FIG. 15(b). The bottom wall 232 b is provided with a plug 246 that is adapted to fully break and separate from the rupturable bottom wall 232 b upon insertion of the sharp extent of the object to be encapsulated. Having described three particular configurations of a rupturable bottom wall of the second cup 206, it should be appreciated that other variations may be made within the contemplated scope of the invention.
Turning now to FIG. 16, the encapsulation of a hypodermic needle by the container of the present invention is described. [0068] Hypodermic needle 248 comprises a hub 250 and an elongate sharp extent 252. After assembly of the first cup 204 and second cup 206 with container housing 202 as described herein, the hypodermic needle is protected as follows. The sharp extent 252 first pierces through foil lid 240 and then through the rupturable bottom wall 232 of the second cup 206. Upon rupturing of the bottom wall 232, the liquid resin hardener 12 flows under gravity completely out from the upper chamber 238 into the middle chamber 226 wherein it mixes with the liquid resin 14 to form hardenable compound 254. Insertion of the hypodermic needle 248 continues with the sharp extent 252 penetrating through the lower wall 218 of the first cup 204 until the hub 250 lies substantially within the middle chamber 226. Once the hub is fully disposed in middle chamber 226, the compound 254 hardens around the hub 250 for suitable encapsulation. The sharp extent 252, having penetrated through lower wall 218, projects into the lower chamber 224 wherein it is completely surrounded within the housing 202 and protected thereby. As described herein, the encapsulated syringes may be deposited in a tray or the like for suitable transport and disposal.

EXAMPLES

Example 1 is an example of an anaerobically curable two-part composition useful in the present invention. Part 1 and Part 2 of the compositions are set for the below in weight percent based on the total weight of each part. [0069]

Example 1



	Part 1 Components (Resin)	Wt %

	Poly(ethylene glycol)dimethacrylate	79.32
	Hydroxy methacrylate	10
	Acrylic acid	6
	1,4-Naphtaquinone	0.01
	Pentasodium diethylenetriamine pentaacetic acid (PTDA)	0.07
	Deionized water	0.2
	Propylene glycol	0.6
		100%

[0071]

Part 2 Components (Liquid Hardener) Wt %

2-Ethylhexonic acid 29.0

Copper carbonate 3.5

Poly (ethylene glycol) 200 Di (2-ethyl hexoate) 57.5

Tri butyl amine 10

100%
About 0.5 to about 1.0 grams of part 1 of the anaerobic composition were placed in the cap of the inventive device. About 0.05 to about 0.025 grams of part 2 (resin hardener) of the anaerobic composition were placed in the base. The barrier of the present device was then removed, permitting each of the parts to be combined and rapidly cure around the needle inserted therein. The curing time was within the range of about 20 to about 40 seconds. [0072]
Example 2 demonstrates a cyanoacrylate composition used in the present invention. The cyanoacrylate composition was formulated into a two-part composition, each of the parts being described in percent weight of the individual parts. [0073]

Example 2

[0074]

Part 1 Components (Resin) Wt %

Ethyl cyanoacrylate monomer 99.899

Boron trifluoride 0.001

Hydroquinone 0.100

100%
[0075]

Part 2 Components (Liquid Hardener) Wt %

N,N′-Dimethyl p-toluidine 5.0

Poly(ethylene glycol)dimethacrylate 95.0

100%
Part 1 was placed in the cap of the inventive device in an amount of about 0.5 grams. Part 2 was placed in the base of the device in amounts of about 0.025 grams. The barrier was removed, permitting combination of Part 1 and Part 2 and subsequent curing to fully encapsulate the needle therein. [0076]
Example 3 demonstrates a cyanoacrylate composition used in the present invention. The cyanoacrylate composition was formulated into a two-part composition, each of the parts being described in percent weight of the individual parts. [0077]

Example 3

[0078]

Part 1 Components (Resin) Wt %

Ethyl cyanoacrylate monomer 94.898

Polymethyl Methacrylate 5.000

Boron trifluoride 0.002

Hydroquinone 0.100

100%
[0079]

Part 2 Components (Liquid Hardener) Wt %

Glycerol Triacetate 93.0

N-Oxydiethylene Benzothiazole-2-Sulfenamide 7.0

100%
Part 1 was placed in the cap of the inventive device in an amount of about 0.5 grams. Part 2 was placed in the base of the device in amounts of about 0.025 grams. The barrier was removed, permitting combination of Part 1 and Part 2 and subsequent curing to fully encapsulate the needle therein. [0080]
In any of the Examples 1-3 set forth herein, the Part 1 (Resin) and the Part 2 (Liquid Hardener) may be placed in either the cap or the base of the encapsulant container. [0081]
The invention being thus described, it will be evident to those skilled in the art that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention and all such modifications are intended to be included within the scope of the claims. [0082]

Claims

What is claimed is:

1. A containment system for encapsulating a sharp medical instrument comprising:

a container having an end for insertably receiving said medical instrument, said container supporting a pair of liquid components of a two-part hardenable compound separated by a rupturable divider, said components being mixed upon rupture of said divider by said insertion of said medical instrument thereinto.

2. A containment system of claim 1, wherein said container further includes an open ended container base containing one of said pair of liquid components, and an open ended container cap for insertably receiving said medical instrument and containing the other of said pair of liquid components, said cap being positioned over said open end of said base with said rupturable divider positioned therebetween.

3. A containment system of claim 2, wherein said container cap further includes a puncturable cover closing said open end thereof for receiving said medical instrument upon said insertion.

4. A containment system of claim 3, wherein said base contains a hardenable resin and wherein said cap contains a resin hardener.

5. A containment system of claim 3, wherein container cap is cup-shaped and is inserted within said container base.

6. A containment system of claim 5, wherein said cup-shaped cap includes a side wall and a breakaway bottom wall forming said rupturable divider, said side wall having a wall thickness resisting puncture by said inserted instrument.

7. A containment system of claim 3, wherein said rupturable divider includes said bottom wall being detachable from said side wall upon instrument insertion.

8. A containment system of claim 3, wherein said rupturable divider is shatterable glass.

9. A containment system of claim 4, wherein said hardenable resin is selected from the group consisting of anaerobically curable resins, cyanoacrylates, vinyl resins, epoxy resins, silicone resins, silicone-acrylate resins and combinations thereof.

10. A containment system of claim 9, wherein said resin hardener is selected from the group consisting of initiators, metal catalysts, acidic catalysts, basic catalysts and accelerators and combinations thereof.

11. A container for enclosing a sharp medical instrument comprising:

a container base having an open upper end for accommodating a first component of a two component hardenable compound;

a container cap positioned over said open upper end of said base and insertably receiving said instrument, and for accommodating a second component of said two component hardenable compound; and

a rupturable divider positioned between said cap and said base for maintaining separation between said first and second components, said divider being rupturable upon said instrument insertion to cause said first and second components to mix and harden around said inserted instrument.

12. A container of claim 11, wherein said cap has an opposed open lower end closed by said rupturable divider.

13. A container of claim 11, wherein said cap is snap fitted over said base.

14. A container of claim 13, wherein said container cap is a generally cup-shaped member insertable into said container base, said cup-shaped member having a side wall and a breakaway bottom wall forming said rupturable divider, said side wall having a wall thickness resisting puncture by said inserted medical instrument.

15. A container of claim 14, wherein said base is attached to said side wall by a releasable snap fit.

16. A container of claim 13, wherein said rupturable divider is a glass wafer supported between said cap and said base.

17. A container of claim 11, wherein said components of said two component hardenable compound are mutually miscive liquids.

18. A container of claim 11, wherein said first component is a hardenable resin selected from the group consisting of anaerobically curable resins, cyanoacrylates, epoxy resins, vinyl resins, silicone resins, silicone-acrylate resins and combinations thereof.

19. A container of claim 18, wherein said second component is a resin hardener selected from the group consisting of radical initiators, metal catalysts, acid catalysts, basic catalysts and accelerators and combinations thereof.

20. A container of claim 11, wherein said upper end of said container cap is closed by a puncturable cover.

21. A method of encapsulating a sharp medical instrument comprising the steps of:

inserting said instrument into a container supporting a pair of liquid components of a two-part hardenable compound separated by a rupturable divider, said components being mixed upon rupture of said divider during insertion of said instrument to cause said compound to harden around said instrument.

22. A method of claim 21, further including the step of shattering a glass wafer forming said rupturable divider upon said inserting step.

23. A method of claim 21, further including the step of breaking away a portion of a wall defining said divider.

24. A method of claim 21, wherein one part of said two-part hardenable compound is a hardenable resin and the other part as a resin hardener.

25. A container for enclosing a medical instrument having a sharp extent, comprising a container housing having an upper chamber, a middle chamber and a lower chamber, said upper chamber having an upper end for insertably receiving said instrument and for accommodating a first component of a two-component hardenable compound, said middle chamber accommodating a second component of said two-component hardenable compound, a rupturable divider disposed between said upper chamber and said middle chamber, said divider being rupturable upon said instrument insertion to cause said first and second components to mix in said middle chamber and harden around a portion of said inserted instrument, a penetrable wall disposed between said middle chamber and said lower chamber, said wall being penetrable by a sharp extent of said instrument, said lower chamber being configured to receive and accommodate the sharp extent of said inserted instrument.

26. A container according to claim 25, wherein said middle chamber is defined by a first cup received in said container housing, said first cup having side walls and a lower wall, and an open upper end, said lower wall defining said penetrable wall.

27. A container according to claim 26, wherein said container housing is generally elongate and includes a closed lower end opposite said open upper end, said first cup being disposed in said container housing such that said lower wall and said housing closed end bound said lower chamber.

28. A container according to claim 27, wherein said container housing tapers toward said lower closed end and flares outwardly toward said upper open end.

29. A container according to claim 28, wherein said first cup tapers toward said lower wall and is received in said housing flared portion.

30. A container according to claim 27, wherein said upper chamber is defined by a second cup received in said container housing, said second cup having side walls and a bottom wall, and an open upper end, said bottom wall defining said rupturable wall.

31. A container according to claim 30, wherein said second cup is disposed relative to said first cup such that said bottom wall of said second cup and said lower wall of said first cup bound said middle chamber.

32. A container according to claim 30, wherein said rupturable wall comprises a plurality of weakened score lines in said bottom wall that are adapted to break open upon insertion of said sharp extent of said instrument.

33. A container according to claim 30, wherein said rupturable wall comprises a breakable hinged floor in said bottom wall including a plurality of weakened score lines and a flexible hinged portion, said score lines being adapted to break upon insertion of said sharp extent of said instrument, with said floor being hingedly openable as a result thereof.

34. A container according to claim 30, wherein said rupturable wall comprises a plug that is separable from said bottom wall upon insertion of said sharp extent of said instrument.

35. A container according to claim 30, wherein said first cup, said second cup and said container housing are assembled in interference fit.

36. A container according to claim 30, wherein said second cup comprises a pierceable foil sealing lid disposed over said upper chamber.

37. A container for enclosing a hypodermic needle supported by a hub, comprising:

an elongate container housing having an interior space, a lower closed end and an upper open end, said interior space adjacent said closed end of said housing defining a first chamber;

a first cup having side walls, a bottom wall and an upper opening and defining a second chamber therein, said first cup being received in said upper open end of said housing with said bottom wall communicating with said first chamber, said second chamber configured to accommodate a first component of a two-component hardenable compound;

a second cup having side walls, a lower wall and an upper opening and defining a third chamber therein, said second cup being received in said upper open end of said housing adjacent said first cup, the lower wall of said second cup communicating with said second chamber, said third chamber configured to accommodate a second component of said two-component hardenable compound;

said lower wall of said second cup being rupturable upon insertion of said hypodermic needle into said housing to cause said first and second components to mix and harden substantially in said second chamber; and

said bottom wall of said first cup being penetrable upon insertion of said hypodermic needle to allow said needle to pass therethrough and be accommodated within said first chamber, with said hub being accommodated in said second chamber for encapsulation by the hardening of said compound therearound.

38. A container according to claim 37, further including a cover disposed over said third chamber.

39. A container according to claim 38, wherein said cover comprises a pierceable foil sealing lid.

40. A containment system for encapsulating a sharp medical instrument comprising:

means for separably containing two liquid components of a two-part hardenable compound and for insertably receiving a sharp medical instrument to be encapsulated; and

means supported by said containing means for separating said two liquid components being and responsive to said insertable receipt of said sharp medical instrument for rupturing, thereby causing mixture of said two components into a hardenable compound that hardens around and thereby encapsulates said sharp medical instrument.

41. An apparatus for enclosing a medical instrument having a sharp extent, comprising:

means for holding a first component of a two-part hardenable compound;

means for separably holding a second component of a two-part hardenable compound;

means between said first component and said second component for rupturing upon engagement by said sharp extent of said medical instrument to thereby allow said first component and said second component to mix and thereby harden around a portion of said medical instrument; and

means separate from said means for holding said first component and said means for holding said second component for enclosably accommodating said sharp extent of said medical instrument.