Apparatus and methods for transporting and discarding medical materials
First Claim
1. A container for use in transport and disposal of medical instruments, comprising:
- a container body having an opening and an internal volume;
a self-closing biased flap at an associated ingress site superiorly disposed as a part of the container to provide for selective deposit of used medical instruments into the volume, said flap being securely connected to the container body as part of a covering for the opening; and
a safety guard disposed within the internal volume which denies a direct pathway through the ingress site to medical instruments and waste disposed within the volume, said safety guard comprising an access hole through which medical products having a size which permits ingress through the alternate ingress aperture are passed into the internal volume.
1 Assignment
0 Petitions
Accused Products
Abstract
A container assembly for transport of new devices and for later disposal of sharps and other medical waste, the assembly comprising a secure closure for transport and tamper evidence upon its being opened for access to new devices is disclosed and claimed. The transport and disposal container assembly preferably has a container body with a device ingress and egress opening, a lid for use with multiple-sized container bodies and at least one apparatus which produces tamper evidence when accessing new devices stored for transport within the assembly. Evidence of tampering comprises at least one of (1) a collar which releasibly, but securely interconnects the container body and lid for transport of new devices, (2) a shrink wrap disposed over the entire container and (3) a seal over the container body opening. In one embodiment, the container assembly, when used for disposal, includes a lid having a self-closing biased flap and a cradle member and a safety guard disposed inside the assembly which restricts direct or line-of-sight access to sharps and medical waste previously deposited within the assembly. In addition a lid having a tube cutter and a lock which permanently restricts access to the assembly when the container is filled or retired from use is disclosed. Also, a unitary lid made by a single injection molding step is disclosed.
143 Citations
51 Claims
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1. A container for use in transport and disposal of medical instruments, comprising:
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a container body having an opening and an internal volume; a self-closing biased flap at an associated ingress site superiorly disposed as a part of the container to provide for selective deposit of used medical instruments into the volume, said flap being securely connected to the container body as part of a covering for the opening; and a safety guard disposed within the internal volume which denies a direct pathway through the ingress site to medical instruments and waste disposed within the volume, said safety guard comprising an access hole through which medical products having a size which permits ingress through the alternate ingress aperture are passed into the internal volume.
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2. A container for use in transport and disposal of medical instruments, comprising:
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a container body having an opening and an internal volume; a self-closing biased flap at an associated ingress site superiorly disposed as a part of the container to provide for selective deposit of used medical instruments into the volume, said flap being securely connected to the container body as part of a covering for the opening; and a safety guard disposed within the internal volume which denies a direct pathway through the ingress site to medical instruments and waste disposed within the volume, said safety guard comprising a first acute angle relative to the plane of the self-closing biased flap and substantially comprises only sufficient material strength to support its own weight and therefore yields under weight of an item introduced through the opening to bend to a second angle which is less acute relative to the plane of the flap and therefore to a horizontal plane.
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3. A method of transporting and storing and gaining access to unused medical materials by means of a container assembly comprising a lid body having an opening, a self-closing biased flap connected to the lid body for covering the opening, tamper evidence producing means for temporarily attaching the lid over an opening of an associated container, and a cradling means for insertion of medical materials into the container body through the opening, said cradling means having a floor disposed on the biased flap, comprising the steps of:
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a) placing unused medical materials inside the container body; and b) using the tamper evidence producing means to temporarily secure the lid body over the container opening; and c) gaining access to the unused medical materials by substantially irreversibly displacing at least a portion of the evidence producing means thereby providing tamper evidence. - View Dependent Claims (4, 5, 6, 7)
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8. A container apparatus for use in transport and disposal of medical instruments, comprising:
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a container body having an opening and an internal volume; a lid which comprises means for permanently being affixed to the container body in a first orientation and for releasably attaching to the container body in a second orientation, said lid comprising means for selectively providing access through the lid to the opening; and a tamper evidence producing device which securely interconnects the container body to the lid in the second orientation and provides a release of the lid from the container body by manual action which produces irreversible structural change to the tamper evidence producing device. - View Dependent Claims (9, 10)
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11. A method of disposing of used medical materials by means of a container assembly comprising a lid body having an opening, a self-closing biased flap connected to the lid body for covering the opening, means for permanently attaching the lid body over an opening of an associated container, means for permanently locking the biased flap closed, and a cradling means for insertion of medical materials into the container body through the opening, said cradling means having a floor disposed on the biased flap, comprising the steps of:
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a) permanently securing the lid body to the associated container; b) placing the used medical materials onto the floor of the cradling means; c) pushing downward against the biased flap in an area adjacent to the cradling means, thereby allowing the used medical materials to fall inside the container assembly without operator contact; and d) when the container is filled to a desired level, closing and locking the biased flap closed.
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12. A method of using a transport and disposal container assembly combination comprising the steps of:
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a) providing a container body having an accessible opening;
a lid body having a normally closed ingress site, a self-closing biased flap connected to the lid body for selectively covering and thereby closing the ingress site and for intermittent access to the opening at the site;
a lock associated with the lid for permanently locking the ingress site closed;
tamper evidence producing means for temporarily attaching the lid over the opening of the container; and
a cradling means for insertion of medical materials into the container body at the ingress site, said cradling means having a floor disposed on the biased flap;b) placing unused medical materials inside the container body; c) using the tamper evidence producing means to temporarily secure the lid body over the container opening; d) at a user site, noting whether or not the tamper evidence producing means shows evidence of tampering; e) if there is evidence of tampering, taking appropriate responsive action to a container assembly combination which shows evidence of tampering; f) if there is no evidence of tampering, gaining access to the unused medical materials by substantially irreversibly displacing at least a portion of the tamper evidence producing means; g) removing the unused medical materials; h) permanently affixing the lid to the container body to form the combination for use as a medical waste disposal container;
depositing used medical materials through the ingress site; andj) when the medical waste disposal container is filled to a desired level, locking the lid closed at the ingress site to preclude any further filling.
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13. A lid for a container apparatus for medical sharps and associated waste comprising:
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an ingress site normally closed by a biased flap; a tapered hole which permits direct insertion of medical needles and other tubing connected devices through the lid; slider means providing manual positioning to at least three positions comprising; an open position whereat the biased flap may be selectively opened and medical needles and other tubing connected devices may be delivered through the tapered hole; a closed position whereat the biased flap is maintained in a closed position and the tapered hole is covered; and a locked position whereat the biased flap and tapered hole are permanently closed to further access.
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14. A lid for a container apparatus for medical sharps and associated waste comprising:
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an ingress site normally closed by a biased flap; a tapered hole which permits direct insertion of medical needles and other tubing connected devices through the lid; slider means providing manual positioning to at least three positions comprising; an open position whereat the biased flap may be selectively opened and medical needles and other tubing connected devices may be delivered through the tapered hole; a closed position whereat the biased flap is maintained in a closed position and the tapered hole is covered; a locked position whereat the biased flap and tapered hole are permanently closed to further access; and the lid further comprising a tube cutter disposed at the tapered hole and activated by the slider.
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15. A method of transporting and storing unused medical materials from a point of assembly to a point of usage within a self-contained shipping container assembly and then using the same container assembly as a secure sharps container thereafter, comprising the steps of:
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a) providing, as a bottom portion of the container, a container body having a bottom and a plurality of sides defining a preselected volume for storing prescribed quantity of the unused medical materials, said sides having a top portion that defines a container body opening; b) providing a lid for releasibly closing off said container body opening during said storing and transporting, said lid being selectably removable from a temporarily attached position with respect to said container body opening so as to permit the bulk removal of all of said preselected quantity of unused medical materials; c) providing a means for reclosing said container including said lid and additional locking means for irreversibly securing said lid to said container body opening; d) providing a means for selectively disposing sharps into the container body after the lid is securely disposed upon the container body; e) placing unused medical materials inside the container body; f) temporarily securing the lid over the container body opening to close said opening and to form a self-contained shipping container in which said bottom, sides and lid enclose said unused medical materials in said shipping container; g) transporting the so-filled shipping container to a site where the materials are to be used; h) displacing the lid relative to the container body opening for access to the materials; i) replacing the lid such that the lid is irreversibly secured to the container body, thereby forming a sharps container; j) disposing used sharps and other biohazard materials into the sharps container for safe keeping. - View Dependent Claims (16, 17)
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18. A method of disposing of used medical materials by means of a container assembly comprising a lid body having an opening, a self-closing biased flap connected to the lid body for covering the opening, means for permanently attaching the lid body over an opening of an associated container, a cradling means for insertion of medical materials into the container body through the opening, said cradling means having a floor disposed on the biased flap, and a hinged cover having a releasable latch which is selectively closed and releasably latched to deny access to the cradling means, said method comprising the steps of:
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a) permanently securing the lid body to the associated container; b) placing the used medical materials onto the floor of the cradling means; c) pushing downwardly against the biased flap in an area adjacent to the cradling means, thereby allowing the used medical materials to fall inside the container assembly without operator contact; and d) closing the cover and engaging the releasable latch, thereby restricting access to the cradling means until the cover is purposefully opened. - View Dependent Claims (19, 20)
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21. A container apparatus for use in disposal of medical instruments, comprising:
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a container body having an opening and an internal volume; a lid for said container apparatus comprising means for permanently attaching the lid to said container and which is molded as a single part, said lid comprising; a frame section comprising the attaching means; a safety cradle section disposed within the bounds of the frame section which comprises a biased hinge attachment to the frame section, the bias of the hinge maintaining the safety cradle in a normally closed position; and a cover section, hingedly affixed to the frame section, which, in a closed position, covers and protects the safety cradle and which comprises at least one actuator which when moved into operative engagement of the safety cradle operates to open the safety cradle in opposition to the bias of the hinge as the cover is being closed and which disengages from the safety cradle when the cover is closed, thereby permitting the biased hinge of the safety cradle to return to the normally closed position without actuator opposition. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. A lid body for use in disposal of medical instruments, comprising means for permanently attaching the lid body to a container for use as a container assembly used in disposal of medical sharps and other waste, said lid being molded as a single part comprising:
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a frame section comprising the attaching means; a safety cradle section disposed within the bounds of the frame section which comprises a biased hinge attachment to the frame section, the bias of the hinge maintaining the safety cradle in a normally closed position; and a cover section, hingedly affixed to the frame section, which, in a closed position, covers and protects the safety cradle and which comprises at least one actuator which when moved into operative engagement of the safety cradle operates to open the safety cradle in opposition to bias of the hinge as the cover is being closed and which disengages from the safety cradle when the cover is closed, thereby permitting the biased hinge of the safety cradle to return to the normally closed position without actuator opposition. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A method for making a lid for use with a container for medical sharps and other medical waste comprising the steps of:
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molding the lid as a single part comprising a frame section comprising means for attaching the lid to the container;
a safety cradle section disposed within the bounds of the frame section which comprises a biased hinge attachment to the frame section, the bias of the hinge maintaining the safety cradle in a normally closed position; and
a cover section, hingedly attached to the frame section, which, in a closed position, covers and protects the safety cradle and which comprises at least one actuator which when moved into operative engagement of the safety cradle operates to open the safety cradle in opposition to bias of the hinge as the cover is being closed and which disengages from the safety cradle when the cover is closed, thereby permitting the biased hinge of the safety cradle to return to the normally closed position without actuator opposition;folding the biased hinge into biased engagement with the frame section; folding the at least one actuator to an angle which permits operative engagement with the safety cradle; and closing the lid.
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44. A method of transporting or disposing of medical materials by means of a container assembly comprising a lid body having an opening, a self-closing biased flap connected to the lid body for covering the opening, means in a first used position capable of temporarily attaching the lid over an opening of an associated container and in a second used position capable of permanently attaching the lid over the opening of the associated container, and a cradling means for insertion of medical materials into the container body through the opening, said cradling means having a floor disposed on the biased flap, comprising the steps of:
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a) placing unused medical materials inside the container body when transporting medical materials; b) temporarily securing the lid body over the container opening when transporting medical materials; c) permanently securing the lid body to the associated container when disposing of medical materials; d) placing the used medical materials onto the floor of the cradling means when disposing of medical materials; and e) pushing downward against the biased flap in an area adjacent to the cradling means, thereby causing the used medical materials to fall inside the container assembly without operator contact when disposing of medical materials. - View Dependent Claims (45)
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46. A self-contained shipping and sharps container for transporting unused medical products after product manufacture to a point of product usage (whereat all such unused products are removed from said container), said container then being usable for safe storage of used sharp medical instruments, said container comprising:
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a) a container body having a bottom and a plurality of sides integral with said bottom and sides defining a preselected volume having an opening for storing of a prescribed quantity of unused medical products; b) a lid body comprising at least one biased opening covering flap, said lid body releasibly closing off said container body during said storage and having a first relative configuration of said lid body being selectably movable with respect to said container so as to permit the bulk removal of all of said preselected quantity of unused medical products; c) means for reclosing said container including said lid body, said lid body having a second relative configuration wherein an additional locking means irreversibly secures said lid body to said container body when rotated about an axis transverse to a plane of said opening and with respect to said first relative configuration; and d) means for serially disposing of the used sharp medical instruments and other medical waste into said closed container having said lid body irreversibly secured to said container body. - View Dependent Claims (47, 48, 49, 50, 51)
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Specification