Dispensation and disposal container for medical devices

Details Dispensation and disposal container for medical devices Dispensation and disposal container for medical devices

2001-02-02

2003-03-04

Luong, Shian (Department: 3728)

Special receptacle or package

For a tool

Body treatment

C206S438000, C220S008000

Reexamination Certificate

active

06527115

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to a container for storage, dispensation, transport and disposal of a medical device. More particularly, this invention is directed to a container for storing a sterile ultrasonic surgical probe that allows its dispensation for use, and for its safe storage and disposal after use, thereby protecting the user from the hazards of accidental needle sticks and possible contamination from small-diameter probes. The container of the present invention also provides a mechanism for restricting access to the probe to prevent its reuse, and a method for its safe attachment to and detachment from an ultrasonic medical device.
BACKGROUND OF THE INVENTION
The increased utilization of disposable medical devices such as scalpels, syringes, lances needles, and the like, commonly referred to as “sharps” is raising concern with regard to the safe disposal of such devices. Improper handling of sharps by medical and healthcare personnel is attributed to being the leading cause of accidental skin puncture wounds. The consequences of such injuries can be life threatening, since used medical devices that are contaminated with blood and other biological media can result in transmission of dangerous infectious diseases such as hepatitis and AIDS. Furthermore, conventional disposal units for such devices do not normally allow for positive neutralization of the biological hazard at the site of the surgical procedure. Such devices, therefore, may contain contaminating bacterial and viral species that remain viable as the device is transported from the site through a waste hauling system to a decontamination facility. Additionally, a number of currently used disposal devices, especially sharps, do not affirmatively lock when closed, resulting in their being accidentally or intentionally reopened thereby exposing medical and waste disposal personnel to potentially dangerous biological contaminants.
Various devices have been proposed in the art for disposal of sharps. Sharps containers in the art typically include a valved opening, and a closure mechanism (see, e.g., model 5400 series available from Becton Dickinson and Company of Rutherford, N.J.) or non-valved openings (see, e.g., U.S. Pat. No. 4,569,554). The containers typically can be filled with multiple sharp objects. Other sharps containers (Model 8600, Becton Dickinson and Company of Rutherford, N.J.) include a mechanism to disable a sharp object being disposed of (e.g., a needle), but also invites filling with multiple sharp objects. A great majority of sharp containers disclosed in the art (for example in U.S. Pat. Nos. 4,666,538, 4,804,090, 4,842,138 and 5,281,391, 5,630,506) are limited to the disposal of needles, more particularly syringe needles, and are designed to be disposal containers capable of accepting and containing several units, after which the container is sealed and transported for disposal. Since these containers are designed for disposal only, they offer only a limited advantage, since they do not obviate the need for the healthcare professional to manipulate the needle manually to detach it from the syringe prior to discarding them in such containers. The aforementioned risks of accidental injury are, therefore, not precluded.
While many of the prior art devices have provided innovative and improved disposal methods for sharps, more particularly, needles, these devices suffer from some of the following disadvantages:
i) inadequate design for disposal of single use specialty devices such as probes, catheters, guide-wires and other non-permanent implants. Although such devices that have to be disposed of taking the same precautionary steps as needles to prevent accidental contamination, they are presently discarded using conventional disposal devices that require physical handling by the healthcare personnel.
ii) they require direct handling of sharps by medical personnel to remove them from manufacturers sterile packaging for attachment to ancillary devices such as a handle of a surgical device or a dispensing syringe, and for their subsequent detachment from said ancillary device for discarding into a disposal container. Such handling can result in inadvertent microbiological contamination of the sharp prior to use that can pose risk of infecting the patient, and pose concerns of health hazard to the healthcare provider arising from contact with contaminated biological materials such as blood or tissue from the used device during the process of detaching them from the ancillary device for their disposal.
iii) they do not offer efficient means to remove new sharps from sterile packaging, their attachment and detachment to device ancillary units, and disposal without substantial human contact, thereby eliminating inadvertent injury caused by handling the sharps and associated concerns such as contaminating unused sharps prior to use on a patient, or contracting contagious diseases from used contaminated sharps.
Due to the recent advent of disposable forms of devices such as endoscopes, ultrasonic tissue ablation probes, and the like, previously only being envisioned as reusable devices, there exists a significant need for an improved apparatus for containing devices (herein referred to as “container”) and methods for dispensation, storage and safe disposal of such devices, that allows their easy removal for use substantially without direct human contact, and subsequent placement of the device in the same container after its use again without requiring such direct contact. It is also desirable for the container to maintain used devices contained in them such that they are substantially isolated from further access during handling for disposal. There is also a need for the container to be able to preclude retrieval of used medical devices placed in them, thereby discouraging their unauthorized reuse. Additionally, it is desirable to have the ability to package new unused medical devices such as “sharps” in the multi-functional container that enables dispensation, storage and disposal of the device. Presently, new sharps are typically packaged and transported in one type of container and disposed in another container after use. Furthermore, it is generally recognized by those skilled in transport and delivery of medical instruments and devices that it is critically important to provide evidence of tampering for each user immediately prior to opening a container of new medical instruments and devices.
Ultrasonic surgical probes, especially those operating in transverse mode described in applicants co-pending provisional applications U.S. Ser. Nos. 60/178,901 and 60/225,060, have a plurality of regions of maximum energy referred to as nodes, along the length of the probe. This results in a plurality of regions of high stress, resulting in potential for degradation of structural integrity of the probe. Repetitive use of the probe can potentially worsen this problem, with inadequate means by the user to determine the residual life of the probe. Stress fractures may develop, creating a greater tendency for the probe to shatter with the potential of foreign bodies being induced into the patient, or resulting in microscopic irregularities in the surface that may render the probe difficult to decontaminate between uses. As such, ultrasonic probes should be treated as single use, single patient contact medical devices, and after each use be considered medical waste. Where a probe sheath is also used in conjunction with the probe, the small sheath lumen will incorporate blood and cellular debris during use, which due to their small diameter, render them extremely difficult to clean. For safety purposes they should be discarded.
Medical waste disposal devices also do not normally allow visual inspection and counting of enclosed sharps or other devices after the devices is closed, thereby precluding an accounting means to ensure the number and type of medical waste included in such sealed containers. Furthermore current medical-waste disposal methods typically require large treatme

Affiliated with

Also associated with

Rating

Dispensation and disposal container for medical devices does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Dispensation and disposal container for medical devices, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Dispensation and disposal container for medical devices will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-3013852