Surgery – Container for blood or body treating material – or means used... – Container with piercable closure
Reexamination Certificate
1997-12-19
2002-05-21
Casler, Brian L. (Department: 3763)
Surgery
Container for blood or body treating material, or means used...
Container with piercable closure
C604S411000, C604S239000, C604S272000, C604S274000
Reexamination Certificate
active
06391014
ABSTRACT:
BACKGROUND OF THE INVENTION
The present series of inventions was prompted by the need to decrease the exposure of healthcare workers to potentially harmful needle sticks which, as detailed in the inventors' recent disclosure (U.S. Pat. No. 5,478,328 in 1995), pose the risk of infection with diseases such as hepatitis and AIDS. All too commonly, inadvertent needle sticks occur with needles that are being used for, or have been used for, penetrating a diaphragm. The varied uses of such needle/diaphragm combinations include: (a) withdrawing from or injecting into a medication vial, collection tube, or fluid bag; (b) injecting or withdrawing medications or fluids via tubing attached to an intravenous catheter.
The common features of the present series of inventions include needle/diaphragm combinations wherein:
(a) “safe yet penetrating” needles, such as those illustrated, in part, in our prior patent (U.S. Pat. No. 5,478,328) and claimed herein, are designed to provide a compromise between “penetrating but dangerous” sharp needles of traditional systems and newer “safe but nonpenetrating” blunt cannulae of needleless blunt-cannula systems (described below). The inventive needles are designed to decrease the likelihood of harmful puncture of the skin of a healthcare worker (compared to that associated with a traditional needle) by one or both of the following:
1) lessening the pointedness of the tip;
2) providing one or more recessed orifices as opposed to an open tip;
(b) the “strong yet penetrable” diaphragms of the present disclosures are a compromise between the “strong but (relatively) impenetrable” and the “penetrable but weak” extremes described in the prior art (described below). They are designed to:
1) provide an intact covering or plug with a section that, at the time of clinical use, can be pierced with greater penetrability than a conventional diaphragm (which requires penetration by a traditional “penetrating but dangerous” sharp-tip needle);
2) have the integrity and long-term shelf-life approximate to that of a conventional diaphragm and thus maintain the sterility of the enclosed contents for months or years prior to the first clinical usage of the needle/diaphragm combination;
3) have the versatility of a conventional diaphragm (i.e., be able to cover openings with a wide range of diameters as may be found on injection ports, bottle tops, etc.);
4) provide a snug, secure fit for the needle or cannula which pierces it and thereby prevent leakage and dislodgement;
5) provide resealing properties after needle or cannula removal that enable the diaphragm to maintain its integrity and hence the sterility of the underlying contents for a satisfactory duration.
In addition, Disclosure #II of the three-part series introduces the concept of and means of a “converting” mechanism for modifying the diaphragm immediately prior to its first penetration for clinical use. This converts a strong diaphragm which otherwise would not be so readily penetrable by a given “safe” needle or cannula to a diaphragm which can be used in combination with said needle or cannula. The conversion may be accomplished by utilizing a device to puncture and/or slit the diaphragm (herein called a “convertor”).
In addition, Disclosure #III of the three-part series introduces the concept of and means of providing reversible compression of a prechannelled or preweakened diaphragm. This enables one to ensure effective closure of a preslit or preweakened region before a diaphragm has been penetrated by a needle or cannula and, in many embodiments, restoration of the ancillary pressure may secure effective closure even after penetration.
As alluded to above, prior to the present invention, two extremes of needle/diaphragm combinations have been available: 1) Strong Diaphragm/ Dangerous Needle; or 2) Weak Diaphragm/Safe Cannula. These are described below:
1. Strong Diaphragm/Dangerous Needle—It traditionally was felt that, in virtually all settings, needle insertion through a diaphragm necessitated the use of a sharp needle. Known hypodermic needles for use with penetrating diaphragms typically have:
(a) a sharp point;
(b) an open tip.
Such needles have cutting points, formed by a beveled cut typically at an angle of approximately 45° (or less) to the longitudinal axis of the needle shaft with an opening created at the junction of the beveled edge and the needle bore. Unfortunately, these features pose a threat to anyone who comes into contact with a used needle. The sharp point increases the likelihood of skin puncture; as evidenced by the large number of injuries, relatively little force is needed to penetrate the skin during an inadvertent stick with a sharp needle. The open tip can house infected fluid or tissue (herein called an inoculum); this increases the likelihood that a needle stick will result in disease transmission. The sharp-point, open-tip construction not only increases the risk of injury to a healthcare worker during usage but also increases the likelihood of accidental injury during recapping as a consequence of missing the cap or actually piercing the side of the cap.
2) Weak Diaphragm/Safe Cannula—The newly designed “needleless” blunt-cannula systems (e.g., the InterLink System, Baxter Healthcare Corp., Deerfield Ill. in collaboration with Becton-Dickinson Co., Franklin Lakes N.J.; and the Lifeshields system, Abbott Laboratories, Abbott Park Ill.) contain a diaphragm that is modified at the time of manufacture to such a degree that it is penetrable by an “absolutely” blunt-tipped cannula (with an end that typically is flat or hemispherical, and never with less than a 75° angle to the longitudinal axis of the cannula shaft). The manufacture of the diaphragm (herein called a “blunt-cannula diaphragm”) has been taught within the prior decade as follows:
(a) cutting a slit into the central portion of the diaphragm with a knife (“preslitting”) (Jepson, Dudaran, and Finley WO89/06553 & WO90/11108 in 1989/90—Baxter).
(b) reinforcing such a preslit diaphragm by covering the main plug with a thin diaphragm portion and using a metal ferrule which remains permanently in place for securing the inner and outer members of the stopper assembly together (Hook U.S. Pat. No. 5,328,041 in 1994—Abbott). In justifying the need for his more complex process (which includes two stopper members and a ferrule), the inventor stated that this was required to maintain sterility of the contents of vials covered with a preslit diaphragm: “the same prepierced construction used in prepierced reseals cannot be implemented for the stoppers on vials because of sterility and shelf-life degradation questions.”
(c) molding the diaphragm in two pieces which are joined by a penetrable hinged region (Grabenkort U.S. Pat. No. 5,403,293 in 1995—Abbott). Although Grabenkort claimed that his method of “compression molding allows the tolerances at the hinged region to be better controlled than the alternate method of cutting a slit into a rubber diaphragm (as originally described in a patent assigned to Baxter), the procedure to accomplish this appears to be more complicated as it involves the production of a stiff annular collar having a first and second annular flange.
(d) using ultrasonic heating to create a weakened portion that extends at least partially through the diaphragm's midsection. The horn and anvil of the mounting device conduct heat away from the outer surfaces, thereby allowing them to remain continuous and unbroken (Helgren U.S. Pat. No 5,403,525 in 1995—Abbott).
Review of the earlier prior art shows that the use of a more readily penetrable diaphragm was taught 30 years previously, but none of the inventions of the prior art was designed to facilitate passage of a “safe” needle as described in the present invention. Wimmer (U.S. Pat. No. 3,653,528) taught a means of creating an indentation in the outer surface to facilitate piercing without coring by a standard hypodermic needle. Sandhage (U.S. Pat. No. 2,906,423 in 1959) described a preslit diaphragm which was puncturable by a round-tip plastic
Casler Brian L.
Ostrolenk Faber Gerb & Soffen, LLP
Thissell Jeremy
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