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 A 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. No. 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 treatment systems involving complex operation that are non-portable and highly expensive. Such systems include autoclaving, incineration and bulk chemical treatment of the medical device waste. It is therefore, desirable to provide an improved portable disinfecting and disposal device for such medical device waste.
Based on the aforementioned limitations in the current disposal containers for medical devices disclosed in the art, and a lack of an efficient container that functions both as a dispensing as well as a disposal container for a disposable surgical device in the art. There is a need for such a dispensing and disposal container for sharp disposable medical devices, such as a small diameter ultrasonic probe used for tissue ablation. Such probes are described in the Applicant's co-pending provisional applications U.S. Serial Nos. 60/178,901, and 60/225,060 which further describe the design parameters for an ultrasonic probe operating in a transverse mode and the use of such a probe to remodel tissues, as well as the Applicants co-pending utility application entitled “Ultrasonic medical device operating in a transverse mode for removing occlusions” (Attorney Docket No. 20563/1010) which describes the use of such probes combined with probe sheath assemblies that modulate the cavitation energy emitted by the probe, and catheter balloon assemblies for removing blood vessel occlusions. The entirety of these applications are herein incorporated by reference.
SUMMARY OF INVENTION
It is therefore an object of the present invention to provide a tamper-resistant light-weight container for safely holding a medical-surgical device, allowing its dispensation of the device from the container for use, and for it's disposal after use, without requiring direct touching or handling of the probe itself The device containment segment of the container may be rigid, or flexible with rigid ends to accommodate devices that are flexible.
It is yet another object of the present invention to provide such a container to hold, dispense and dispose of medical sharps safely, particularly thin ultrasonic probes utilized for tissue ablation and removal of occlusion materials from vascular occlusions in blood vessels.
It is yet a further object of the invention to provide a container for an ultrasonic probe that is capable of dispensing a new probe or probe assembly for attachment to an ultrasonic surgical device, and for detaching the probe from the said device, without requiring direct handling of the probe or probe assembly.
It is another object of the present invention to provide a container for a medical device such as an ultrasonic probe, consisting of a tamper resistant locking mechanism that prevents reuse of a used device disposed within by precluding access to said device.
It is yet another object of the invention to provide a container for a medical device such as an ultrasonic probe which may be disposed of simultaneously with the disposal of the used medical-surgical device, thereby obviating the need for sterilizing the container itself.
Briefly summarized, the foregoing objects are achieved by a container assembly which is utilized for both storing and dispensing new sharps such as a small diameter ultrasonic probes and accompanying accessories, if any, such as sheath assemblies, balloon catheters, etc. prior to use, and receiving such contaminated or used devices for storage, transport and disposal.
The preferred embodiment comprises a container for an ultrasonic probe which prevents the probe's reuse and provides a method for dispensing and disposing an ultrasonic probe. The container is designed for containing a probe or probe assembly, a means for attaching the probe to an ultrasonic medical device, a means for simultaneously containing the used probe while detaching the probe from the ultrasonic medical device, without requiring direct handling of the probe.
The container comprises a hollow cylindrical tube having two collar assemblies (herein referred to as “Collar”) at the open ends that function as lids. The inner diameter and length of the cylinder with an inner dimension defining a space for the probe and its accompanying accessories, if any. The collars are designed to be adaptable to cylinders with varied lengths and diameters to accommodate probes and probe assemblies of different dimensions. Each collar comprises of two segments, both of which have apertures centrally located, having diameters that correspond to the dimension of the probe or probe assembly for which the container is adapted. The said apertures in the collars permit access to the cylindrical segment of the container. The collars are also designed such that they are securely affixed to the container body in a manner that provides evidence of tampering when removed. A complement of tamper resistant mechanisms, including locking assemblies in the collars, are provided that render opening of the container relatively restricted. The locking mechanism within the collars are configured to function in a manner complementary with respect to each other, thereby enabling the collar at the dispensing end to permit a one-time dispensation of a new, unused device, whereas the collar at the disposal end permits receipt of used or contaminated device. The said locking mechanisms in the collar assemblies prevent the reuse of the container by substantially preventing the removal or re-dispensation of a previously disposed device in the associated container. The collar at the disposal end includes an area for placement of a used or contaminated device, wherein a person may then deposit the article into the container body without directly touching the device being disposed of. Additionally, the collar assembly prevents further handling of the used devices by medical personnel subsequent to disposal.
In a preferred embodiment, the collar assemblies have a larger diameter than the cylindrical tube section of the container. The interior surface of the collar assemblies are arcuate or conical shaped, tapering from a larger diameter at the end distal to the cylindrical section to a smaller diameter approaching the aperture, thereby providing a means of guiding or directing the used probe into the device, and also providing clearance for attaching or detaching the probe to or from the transducer. In another embodiment of the invention, an extended rigid or semi-rigid structure located around the collar provides a means of shielding the hand of the operator that holds the container while the probe is inserted.
Between the first and second segments of the collar is a locking mechanism capable of manipulation by the user. The first locking mechanism can be, for example a plate that slides along a groove in a direction perpendicular to the longitudinal axis of the container. Alternatively the locking mechanism can be a rod or an extrusion. The locking means is adapted for engaging the medical article or device stored or disposed within the container. In a preferred embodiment, the locking mechanism is capable of engaging the proximal end an ultrasonic probe at one or more grooves or threads located at proximal end of said probe or at a depression, aperture, or a raised surface designed on the probe at its proximal end. At one end of the container (herein referred to as “dispensing end”), articulation of the locking means by the operator, disengages the locking mechanism from the probe, thereby allowing its release from within the container for dispensation. At the end opposite from the dispensing end of the container (herein referred to as “disposal end”), articulation of the locking mechanism by the operator engages the probe thereby securing the probe irreversibly within the container, thereby preventing further access. The locking mechanisms are capable of securing the probe immovably within the container, thereby providing a mechanism for communicating torsional forces applied to the probe, for example, when the probe is affixed to or detached from an ultrasonic medical device. The attachment the probe and its detachment from the medical device can be accomplished for example, by screwing the probe on to, or off of the device, by rotating the device handle after affixing it to the proximal end of the probe. In other embodiments of the invention the locking mechanism can be threaded, or a ratcheting means, or other such ways of constraining the probe in a unidirectional manner while torsional forces are applied to the container to effectuate attachment or detachment of the probe from the ultrasonic medical device.
In another embodiment, the container of the invention comprises a single open end having a plurality of locking assemblies, thereby enabling the dispensation and disposal of a medical device from the same end of said container. In a further embodiment, the container of the invention comprises of a single open end having a single locking assembly, thereby enabling its utilization exclusively for safe disposal of used medical devices and articles.
In one aspect, the container of the present invention is provided together with an ultrasonic probe contained therein in the form of a kit. In another aspect, container of the present invention is provided together with a probe comprising accessories such as a sheath assembly, balloon catheter, and the like contained therein, as required for specific surgical procedures. In yet another aspect of the invention, the container within the kit with the probe and accessories, if any contained therein, further comprises packaging, whereby said container and its contents are pre-sterilized, and sealed against environmental contaminants. In another aspect, the container comprising the probe and accessories are provided in a manner complying with regulations governing packaging, storage, handling, transport and disposal of sharp medical devices.
In a preferred embodiment, the container provides a means of attaching the ultrasonic probe together with its accessories to an ultrasonic medical device, and further provides a means for detaching them from the said device, without necessitating direct manipulation or handling of the probe (and its accessories if any), and a means for removing the said probe and assembly from the ultrasonic medical device after use. In one aspect, container having a probe contained within provided a sterile kit, comprises single use locking mechanisms located at the dispensing and disposal ends of said container, wherein said locking mechanism at the dispensing end enables attachment of the probe to an ultrasonic medical device solely through the said container, thereby allowing its dispensation from within the container, and wherein the said locking mechanism at the disposal end allows its disposal into the container in a manner preventing re-insertion of the probe through the dispensing end and re-extracting the used probe from the disposal end.
The foregoing specific objects and advantages of the invention are illustrative of those that can be achieved by the present invention, and are not intended to be exhaustive of the possible advantages that can be realized. Thus these, and other objects and advantages of the invention will be apparent from the specifications and drawings, herein or can be learned by practicing the invention, both as embodied herein or as modified in the view of any variations which may be apparent to those skilled in the art. Accordingly, the present invention resides in the novel parts, construction, configurations, improvements and utility herein shown and described.
Materials useful for the present invention include any material rigid or semi-rigid materials that are substantially resistant to puncture from a sharp medical instrument, and capable of being sterilized by, for example, gamma irradiation or ethylene oxide gas (ETO), without losing their structural integrity. Such materials include but are not limited to, rubber, or plastics such as polytetrafluoroethylene (PTFE), polyethylene, polypropylene, silicone, polyetherimide or other similar plastics. Ceramic, metallic, and glassy materials can also be used, and have the added benefit being sterilizable by autoclaving. Where sterilization by ultraviolet irradiation is contemplated the materials for construction of the container must be substantially UV-transmissible. Combinations of the aforementioned materials can be used. The proportions of the device depend on the probe that will be contained within the device. A container that is designed to accommodate a probe of for example, eight inches long, would utilize a tube approximately the same length. The diameter of the tube must be sufficient to accommodate the probe, which will vary depending on the shape of the probe tip, for example, straight, rounded, curved, crescent, or “U” shaped, or the presence of a probe sheath. Glass or clear high-density plastic is preferred as the probe itself can be visualized in the container. The collar assembly has an inside diameter at least as wide as the tube, with an outside diameter greater than the inside diameter. In the preferred embodiment, the outside diameter of the collar is at least two to five times the inside diameter, and the inside surface tapers in width from the widest point at the terminus of the collar, and narrows proximally to the cylindrical section of the container. This taper provides a means to guide the probe into the tube, and it also provides clearance between the inside surface of the collar, allowing attachment to the ultrasonic medical device. A large outer diameter for the collar provides greater shielding capability to protect the hand of the operator from accidental pricks when a used probe is inserted into the container. The collar assembly may be manufactured out of any substantially rigid material that will not deform, crack, or shatter under the torsional forces generated from attaching or detaching the probe to the ultrasonic medical device, for example, high density plastic, metal, ceramic, or hard rubber, and the like.