Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-02-04
2001-03-06
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S164010, C604S165030, C604S171000
Reexamination Certificate
active
06197007
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to safety products which generally pertain to hollow bore needle devices used in percutaneous medical procedures. Such products are aptly applied to conventional blood collection and other devices wherein a very small bore needle is shielded or otherwise secured, after being contaminated by use in the medical procedure, to minimize hazards of inadvertent injury and subsequent infection. Preferably, for further protection from contamination, the devices are limited to single-use and are disposable.
DESCRIPTION OF RELATED ART
Recognition of all too common occurrences of sickness which sometimes prove fatal due to diseases transmitted by inadvertent needle sticks has resulted in development of a wide variety of safety medical needle devices which are used in the areas of I.V. catheters, phlebotomy and syringe devices. Likely, due to the special size, market cost sensitivity and nature of specialized uses for small gauge needles and associated devices used in winged needle sets, the breadth of commercially available safety winged needle devices is more limited than for larger size needle devices. Examples of patents which protect currently commercially available winged needle safety devices are found in U.S. Pat. No. 5,174,655 issued Jan. 5, 1993 to McCormick et al. (McCormick '655) and in U.S. Pat. 5,120,320 issued Jan. 9, 1992 to Fayngold (Fayngold '320).
McCormick '655 discloses a disposable medical needle assembly comprising a guide which shields a needle withdrawn therein after use and limiting members which limit extraction of the needle from the guide as the needle is withdrawn into the guide. Further, a releasible abutment is disclosed in a winged version of a device which restricts movement of the needle during an insertion process. A spring biased blocking plate is taught to provide a restriction against distal extension of the needle from the guide after retraction and shielding. In another embodiment, a device having reduced wing size is disclosed wherein a proximally disposed manipulating member abuts but only restricts relative distal movement of the needle. Similar extraction limiting members are used in this version to restrict extraction of the needle from a shielding guide when the needle is retracted to a safety position.
Fayngold '320 discloses an intravenous infusion and/or blood collection assembly which incorporates a two-part shield which, when placed in cooperating relationship, allows accommodation of a conventional, unmodified blood collection needle and body, including wings associated with the blood collection needle and body. The wings are an inherent part of a needle retraction and locking mechanism for the assembly.
Generally, winged needle and small cannula size safety devices depend upon a stable first needle position where the needle is disposed for use and a second stable second needle position, within which the needle is safely disposed within the cover of a shield. In some cases, as in one embodiment of Fayngold '320, the stable first position is dependent upon formation of a needle movement restricting abutment provided by interaction between a needle hub and a portion of one or more wings, the one or more wings being required to be disposed in a predetermined position while the needle is extended to be used. In other cases, exemplified by McCormick '655, an interaction with one or more wings is integral to needle retraction into shielded state. It should be noted that, in some medical procedures (e.g. where angular articulation of a needle is necessary to facilely find entrance into a vessel), one or more wings on a device may be detrimental to successful accomplishment of a procedure. In such cases, inherent need for the one or more wings is counterproductive.
As it is generally considered prudent to leave one hand free to care for a patient, particularly to a wound site, from which a needle is being withdrawn, a natural consequence is a need for devices which are operable by a single hand. For this reason, devices which can be operated by a single hand or digit thereof are most often preferred over devices requiring more. Further, ease of manipulating the needle from the first position to the second position is an important characteristic of a safety device, requiring critical attention in conception and design. However, even though manipulation should be easy, needle retraction (when moving the needle from the first position to the second position) must not be inadvertent, especially when considering that use of such a needle may involve relatively long periods of time when the patient and needle insertion device are left unattended. As a consequence, a better device would more than likely be one which requires a deliberate action to change a state of a retraction mechanism from one stable state to another when the needle is retracted.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
In brief summary, this novel invention alleviates all of the known problems related to facile, single handed operation of winged and small cannula, safety hollow bore needle devices. The inventive concepts and processes inherent in the instant invention are basic to devices which comprise elongated, slender core structure for ease in maneuvering of the device to accomplish ready needle entry into difficult to access vessels, which retract needles into safe confines in line with long needle axes, which may have power assisted or powered retraction impelled by memory elements in which energy is stored during an initiation phase of needle retraction or is stored during needle extension in preparation for use in a particular medical procedure and which permit responsive, early visualization of a “blood flash” as the needle penetrates a blood vessel. For device cost containment and facile manufacture, all such inventive features may be incorporated through utilization of a single injection molded medical needle hub and another single injection molded body part. The body part acts as a handle used for facile percutaneous needle insertion and holds the hub in slideable confinement. Needle retraction actuation mechanisms are an inherent part of the body. The hub and associated needle may be proximally connected in communicating relationship with tubing and other items which are common to small cannula and winged needle apparatus.
Devices, which stem from the instant invention, may have or not have wings, as wings are not inherently required for function of the invention. Generally, such devices comprise a small diameter, hollow bore medical needle securely affixed in a needle hub. Preferably, for early determination of access to a blood vessel (seen as a flash of red), a flash chamber is provided as part of the needle hub and is closely disposed to the proximal end of the medical needle. Contents of the flash chamber are transmitted, to be seen by a practicing clinician, through a translucent portion of a surrounding elongated part of the body in which the hub resides. The flash chamber is so disposed to provide an early visualization of blood as near a needle puncture site as possible.
In all embodiments of the invention, the hub is slidably disposed, but securely contained within the elongated body. In unpowered and power assisted embodiments, the hub is securely, but hingeably affixed to an extendable member of the body which is further affixed to a needle retraction actuator. In powered retraction embodiments, the hub communicates with constraining body parts through a latch/catch mechanism and an energy storing component. In the various embodiments, devices may comprise unpowered needle retraction having all phases of needle retraction being the result of manual action against an actuator. Otherwise, devices may comprise power assisted retraction wherein approximately a latter half of needle retraction is compelled by energy stored in a part which is stressed during an initial portion of the actuation. In other embodiments, devices may comprise powered retraction resulting from energy
Barrus Roy L.
Thorne David L.
Thorne Gale H.
Thorne Kendall P.
Evans Paul S.
Thorne Gale H.
Yasko John D.
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