Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-05-23
2004-04-13
Casler, Biran L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S092000, C604S191000, C604S411000, C604S416000
Reexamination Certificate
active
06719719
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to the field of liquid transfer. In particular, this invention relates to an improved spike or other needle, cannula, or penetrating member for facilitating the transfer of a liquid into a container such that little or no foaming occurs within the container, particularly when the liquid enters the container. This invention further relates to improved devices that utilize the spike. Such devices may include reconstitution, lyophilization, dilution, dissolution or drug transfer devices and injection or infusion combinations thereto as described and/or claimed, for example, in PCT Application No. PCT/US99/26751 (WO 00/29049), U.S. application Ser. No. 09/439,963, filed Nov. 12, 1999, U.S. Provisional Application No. 60/108,382, filed Nov. 13, 1998, U.S. Provisional Application No. 60/131,644, filed Apr. 29, 1999 and U.S. Provisional Application No. 60/234,118, filed Sep. 21, 2000, the disclosures of which are fully incorporated by reference herein.
Liquid transfer without foaming is very important, for example, in the field delivery of liquid medications for pharmaceutical and therapeutic use. Various devices have been developed for the percutaneous delivery of medications into living organisms. These devices include, for example, syringes, in which a liquid is delivered from a chamber using pressure asserted by a manual plunger through a needle inserted under the skin.
Of course, in the transfer of any other any liquids into and out of a container via a liquid jet or other liquid stream, even in fields unrelated to medicines, one may desire to minimize or prevent foaming. The present invention is directed to any conceivable transfer of liquid into a vial or other container that minimizes or eliminates such foaming during the transfer of the liquid.
In many fields, it is often necessary to lyophilize, reconstitute, dilute, dissolve, or mix a solid material, for example, a material in powdered form, or dilute or dissolve a liquid within a container. For purposes of the present invention, the terms reconstitution or reconstituting will be used to refer to any reconstitution, lyophilization, dilution, dissolution, mixing, or the like. This is accomplished by mixing the liquid or solid material with a suitable diluent, liquid, or solvent. Hereinafter, diluent will be used to refer to any diluent or other liquid or solvent used for reconstitution purposes in general. For example, such a diluent may be water or saline.
The reconstitution occurs when a diluent is transferred into a container having solid or liquid contents therein. The transfer of liquid into the container, especially under pressure, may cause considerable foaming. Where the ultimate solution is to be delivered to a mammal through a needle into the skin, such foaming must be avoided as the introduction of any gas into the tissue of mammal is not desirable and may be quite dangerous. Thus, it is desirable to have a simple, reliable system that facilitates preparation and safe reconstitution of a liquid or solid material within a container with minimal or no foaming. In addition, it may be desirable to provide a system that reconstitutes the liquid or solid material with minimal or no foaming while maintaining sterility throughout the process.
As indicated above, one element of such a system that must be taken into consideration is the need to prevent foaming. This may be accomplished by preventing the diluent fluid stream from directly hitting the liquid or solid material when it enters the container. Since some liquid or solid materials produce foam when a jet stream hits these materials, a fluid path that directs the liquid to directly impact the container contents is not desired. The present invention is directed to this shortcoming in the prior art.
An especially important area where minimization of foaming is desired is in the field of medicine. It is well known in the art that the storage life of certain injectable substances, for example, glucagon, which is used to dissolve blood clots, is increased when the substance is stored in a solid (e.g., powdered or lyophilized) or semisolid state. These powdered or lyophilized substances (i.e., drugs or compounds) are presently used for injection of materials that would otherwise be unstable. The resulting compound is typically stored in a glass container such as a vial, ampule, or cartridge, which is packaged under sterile conditions and enclosed within the container by securing a cap, such as a rubber stopper, membrane, or septum to the open end of the container.
As defined herein, powdered or lyophilized substances including drugs or other compounds will be designated generally as unreconstituted drugs.
In some cases, other drugs, although in a liquid state, must be diluted before use. As used herein, reconstitution with respect to medicines means to place a powdered or lyophilized drug or liquid drug into liquid form, as well as, to further dilute a liquid drug.
As indicated above, of particular interest at present are a wide range of medicaments produced by biochemical processes which are most stable when stored in a lyophilized form. Lyophilization is the rapid freezing of a material at a very low temperature followed by rapid dehydration by sublimation in a high vacuum. Lyophilization provides a product which is easily reconstitutable by the addition of a suitable solvent. Other medicaments may be provided as microparticles or nanoparticles which can be injected in a suspension formed by the addition of a suitable fluid thereto. Storage of medicaments in dry form can also be advantageous not only in terms of storage stability but also in terms of handling prior to use. Shipping costs and storage space can be reduced dramatically by employing a solid medicament form which is reconstituted, dissolved or diluted before use by, for example, the addition of water for injection. Moreover, sterility of the stored product may be better achieved is stored in such a solid form.
Prior to delivery, it is necessary to reconstitute the unreconstituted drugs. This is accomplished by mixing the solid compound with a suitable diluent, other liquid, or solvent. For example, diluents may be dextrose solution, saline solution, or water, as well as others. In the past, reconstitution of drugs typically involved the use of a syringe with a needle to withdraw a liquid such as a diluent from a separate vial by piercing a rubber septum into a separate the vial. The diluent is then injected through a rubber septum into a separate vial containing the unreconstituted, undiluted drug by piercing the rubber septum on the vial and injecting the diluent therein. The drug and diluent are then thoroughly mixed, typically by shaking the vial by hand. The desired amount of mixed solution is then withdrawn from the vial and injected into the patient.
Moreover, because the diluent and compound are in separate, sterilized containers, the manual withdrawal of diluent via a syringe and reinjection of the same into the container containing the unreconstituted drug may compromise sterility, health and safety due to the use of a syringe.
Additionally, many companies that manufacture a particular drug do not make the diluent and vice versa. Therefore, the unreconstituted drug and the diluent are sold separately. It is necessary for the doctor, pharmacist, nurse, or other medical person to mix the drug with diluent prior to use. Reconstituting the drug presents a number of problems.
Because of the use of such unreconstituted drugs, it is desirable to provide both professional and non-professional personnel with a drug delivery or mixing system to prepare and deliver the reconstituted drug. It is desirable to have a simple, reliable system that facilitates preparation and safe delivery of an accurate dosage of the reconstituted drug. In addition, it is desirable to provide a system that reconstitutes a drug while maintaining sterility throughout the process.
Of particular importance with drugs that require reconstitution is the need to prevent the di
Carmel Ehoud
Lavi Gilad
Tsals Izrail
Yigal Gil
Caesar Rivise Bernstein Cohen & Pokotilow Ltd.
Casler Biran L.
Elan Pharma International Limited
Williams Catherine S.
LandOfFree
Spike for liquid transfer device, liquid transfer device... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Spike for liquid transfer device, liquid transfer device..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Spike for liquid transfer device, liquid transfer device... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3245434