SPECIMEN CONTAINER FOR BIOLOGICAL MATERIALS

Abstract

A specimen container for use with biological specimens that includes at least one cylindrical housing, wherein the at least one cylindrical housing is open on one or both ends thereof; at least one cap for sealing the open ends of the at least one cylindrical housing; a syringe plunger adapted for insertion into the at least one cylindrical housing, wherein the syringe plunger is operative to move a biological specimen into the at least one cylindrical housing when the syringe plunger is depressed; and optionally, a linking cuff, wherein the linking cuff is operative to join multiple cylindrical housings to one another and permit mixing of the contents thereof.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. patent application Ser. No. 14/703,283, filed on May 5, 2015 and entitled Specimen Container for Biological Materials, which claimed the benefit of U.S. Provisional Patent Application Ser. No. 61/987,577 filed on May 2, 2014 and entitled “Specimen Container for Biological Materials,” the disclosures of which are hereby incorporated by reference herein in their entirety and made part of the present U.S. utility patent application for all purposes.

BACKGROUND OF THE INVENTION

The described invention relates in general to a containers for use with biological specimens and samples, and more specifically to a container for use with bone samples harvested from living patients. Proper collection and preparation of bone marrow is critical to the study of a variety of hematologic and neoplastic disorders. Dry bone core samples will desiccate and be useless for any study, including slides/morphology. Thus, there is an ongoing need for a container that may be used to effectively store and transport bone samples or other biological materials without damaging or otherwise rendering useless the sample.

SUMMARY OF THE INVENTION

The following provides a summary of certain exemplary embodiments of the present invention. This summary is not an extensive overview and is not intended to identify key or critical aspects or elements of the present invention or to delineate its scope. This invention provides various containers for use with biological specimens and other samples, and more specifically to a container for use with bone samples harvested from living patients which can be used with cryopreservative and kept at as low as negative 80 degrees for short or long term storage. These containers can then be used with additional parts to enable the bone samples to be mixed with other additives and then delivered to another target area.

Exemplary embodiments of this invention provide containers for storing and transporting biological specimens and samples, and more specifically to containers for storing, transporting, and preserving bone samples and/or other cell or tissue specimens which allows for collection in a sterile fashion as well as addition of cryopreservative in sterile fashion either immediately (in a first container) or in a delayed fashion (in a second container). Included is at least one smooth cylindrical housing, wherein the at least one smooth cylindrical housing is open on both ends and threaded thereon, wherein one end has thicker threading at its base thread; and at least one cap with ring for completely sealing the open ends of the at least one cylindrical housing. If only one cap is used, a plunger stopper with two valves with depressed threaded area and cap is used. Both valves can be removed and immediately sealed, if desired. One valve is typically longer than the other and includes a luer connection or similar connection to facilitate filling, and the other valve is shorter with an inline filter to serve as a relief valve. The first and second containers also have fill lines marked thereon. In the first container, the fill mark can be on either end. In the second container, the file line is placed on the end with the thicker bottom thread, which is the end which is designed to accept the plunger stopper.

After cryopreservation of a sample or specimen, the first and second containers may be used with separately packed mesh screen to simply rinse and decant specimen before use. Alternatively, separately packaged threaded cuff, ring with wings, and two plungers with plunger stoppers can be used with first container to permit gently mixing of the contents thereof with dimineralized bone matrix (DBM), bone marrow aspirate (BMA) or other materials and compositions, per the choice of the surgeon using the container. Separately packaged threaded cuff, ring with wings, one plunger with plunger stopper, and one plunger with threaded end can be used with the second container to permit gently mixing of the contents thereof.

The first and second containers, including cylindrical housings, caps with ring seals, plunger stoppers with valves and threaded depressions, may be manufactured using cryo-compatible materials such as silicone and EVA that can be sterilized. The third container including threaded cuff, ring with wings, plunger with plunger stopper, threaded plunger, and mesh screen may be manufactured from any variety of suitable materials that can be sterilized. All three containers may be provided in at least 5 and 10 cc sizes. The threaded cuffs have ridges on the outside surfaces thereof, approximately 10 mm apart and perpendicular to the inner threads to allow for ease in use to lock into other threads and be disassembled. The caps include similar outer ridges and O-rings placed inside the caps.

Additional features and aspects of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the exemplary embodiments. As will be appreciated by the skilled artisan, further embodiments of the invention are possible without departing from the scope and spirit of the invention. Accordingly, the drawings and associated descriptions are to be regarded as illustrative and not restrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and form a part of the specification, schematically illustrate one or more exemplary embodiments of the invention and, together with the general description given above and detailed description given below, serve to explain the principles of the invention, and wherein:

FIG. 1 and FIG. 2 are exploded, perspective views of a specimen container in accordance with an exemplary embodiment of the present invention, wherein the threaded cap present in FIG. 1 has been replaced with a plunger as shown in FIG. 2. FIGS. 3-5 are various views of alternate embodiments of this invention.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary embodiments of the present invention are now described with reference to the Figures. Although the following detailed description contains many specifics for purposes of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention.

The present invention relates generally to container for storing and transporting biological specimens and samples, and more specifically to a container for storing, transporting, and preserving bone samples (and/or other cell or tissue specimens) that includes at least one cylindrical housing, wherein the at least one cylindrical housing is open on one or both ends thereof; at least one cap for completely sealing the open ends of the at least one cylindrical housing; a syringe plunger adapted for insertion into the at least one cylindrical housing, wherein the syringe plunger is operative to move a biological specimen further into the at least one cylindrical housing when the syringe plunger is depressed; and optionally, a linking cuff, wherein the linking cuff is operative to join multiple cylindrical housings to one another and permit mixing of the contents thereof with demineralized bone matrix (DBM) or other materials and compositions, per the choice of the surgeon using the container.

FIG. 1 and FIG. 2 are exploded, perspective views view of a specimen container in accordance with an exemplary embodiment of the present invention. In FIG. 1, container 10 includes plunger 20, first housing section 30, which is threaded on both ends thereof; threaded linking cuff 40; second housing section 50, which is also threaded on both ends thereof; and threaded cap 60. In FIG. 2, threaded cap 60 has been replaced with plunger 20. Housing sections 30 and 50 also include wing structures 70, which provide gripping surfaces that facilitate depression of plunger 20, when in use. In some embodiments, only one housing section is used and cap 60 is threaded onto the end of housing section 30 opposite the end into which plunger 20 is inserted. In other embodiments, two or more housing sections are joined together for mixing the contents thereof or for simply increasing the volume thereof. When multiple housing sections are used, threaded linking cuff 40 is used to attach the sections to one another. O-rings, gaskets, or other rubberized components may be included to enhance the sealing properties of container 10 and to more effectively join the components thereof to one another.

Each cylindrical housing, as well as the caps and cuffs, may be manufactured from any variety of materials that are suitable for storing and transporting biological materials and each housing may be graduated for providing the user with an indication of the amount of material stored in each container. The container may be provided in 5 and 10 cc sizes, although other dimensions and volumes are possible. The containers of the present invention are typically provided as sterile devices and various stabilizers and/or preservatives may be pre-loaded into the containers, if appropriate and/or desirable.

Proper collection of bone samples in a sterile manner and the sterile preparation thereof with cryopreservative is important for its storage and repurposing and is important with regard to different orthopedic and neurosurgery procedures for patients and for additional study and use. Thus, in certain exemplary embodiments, this invention provides a container that may be effectively used to collect, store, transport, and deliver bone samples or other biological materials such as cell or tissue specimens without contaminating them or damaging them or otherwise rendering the samples useless.

In exemplary embodiments, there are multiple types of specimen containers usable for collection of a biological sample, addition of cryopreservative to the sample, and storage and ultimately delivery of the sample. One exemplary specimen container includes one smooth cylindrical housing, wherein the housing is open on both ends thereof and wherein both ends are threaded; and two caps for sealing the open ends of the cylindrical housing with rings in a sterile manner. This specimen container is for use when a cryopreservative can be added immediately at the time of aquisition of a bone sample or other biological specimen. The second specimen container includes one smooth cylindrical housing, wherein the housing is open on both ends thereof and wherein both ends are threaded; and one cap for sealing the open end of the cylindrical housing with a ring in a sterile manner. The other end includes a plunger stopper which fits in the end of the cylindrical housing; an attached fill and relief valve; and a threaded depression which can later be threaded into a plunger piece for use. The valves can be cut off and immediately sealed to preserve sterility of the contents of the container. Furthermore, the plunger stopper can seat within the cylindrical container such that when valves are removed, a sterile cap with ring for seal can be placed over the top of the cylindrical housing for sterile storage. Because cyropreservation is part of the purpose of cylindrical housing, the materials used to make the various parts of these devices include cryo-compatible materials such as, for example, silicone and EVA that can be sterilized.

In another embodiment of this invention, the specimen container includes an additional (third) cylindrical housing section, wherein this section further includes wing structures formed thereon near one end thereof. Both ends of this specimen container are open and both ends are threaded. A plunger with a plunger stopper adapted for insertion into the housing section through the end with the winged structure is also included, as is a threaded linking cuff for connecting the third specimen container to either the first or second containers after removal of the cap. If the first container is used, another plunger with plunger stopper may be placed on the end thereof. If the second container is used, a threaded plunger which can be received by the threaded depression in the plunger stopper can be placed on the end of the container after the cap is removed. A separate threaded cuff with wings may be used, and this winged cuff fits over the first or second containers once the cap is removed. This cuff slides up to and stops at the thicker bottom ring of the threads at the other end of the container. The plunger at either end then cooperates with the wings on the cuff to move a biological specimen from the first or second container into the third container when depressed on the first or second container and then back when depressed on the third container. This mechanism allows for gentle mixing of contents with any chosen additive such as dimineralized bone matrix (DBM), bone marrow aspirate (BMA) or other materials and compositions. Because the third container is not typically used for cryopreservation, it can be made of any suitable material. A separately packaged flat mesh screen may be used with either the first or second container for rinsing and decanting the contents of a container by removing a cap from one end thereof.

While the present invention has been illustrated by the description of exemplary embodiments thereof, and while the embodiments have been described in certain detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the invention in its broader aspects is not limited to any of the specific details, representative devices and methods, and/or illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the applicant's general inventive concept.

Claims

1) A specimen container for use with biological specimens, comprising:

(a) at least one cylindrical housing, wherein the at least one cylindrical housing is open on one or both ends thereof;

(b) at least one cap for sealing the open ends of the at least one cylindrical housing;

(c) a syringe plunger adapted for insertion into the at least one cylindrical housing, wherein the syringe plunger is operative to move a biological specimen into the at least one cylindrical housing when the syringe plunger is depressed; and

(d) optionally, a linking cuff, wherein the linking cuff is operative to join multiple cylindrical housings to one another and permit mixing of the contents thereof.

2) The specimen container of claim 1, wherein the at least one cylindrical housing is graduated.

3) The specimen container of claim 1, wherein the at least one cylindrical housing further includes wing structures formed thereon, and wherein the wing structures provide gripping surfaces for facilitating the depression of the syringe plunger.

4) The specimen container of claim 1, wherein the end portions of the at least one cylindrical housing are threaded.

5) The specimen container of claim 1, wherein the volume of the at least one cylindrical housing is about 5 cc to 10 cc.

6) A specimen container for use with biological specimens, comprising:

(a) a first cylindrical housing section, wherein the first cylindrical housing is adapted to receive a plunger, and wherein the first cylindrical housing section is threaded on one or both ends thereof;

(b) a second cylindrical housing section, wherein the second cylindrical housing section is threaded on both ends thereof;

(c) a threaded linking cuff for connecting the first and second cylindrical housing sections to one another;

(d) a plunger adapted for insertion into the first cylindrical housing section, wherein the plunger is operative to move a biological specimen into the first cylindrical housing section when the syringe plunger is depressed; and

(e) a cap for sealing the end of the second cylindrical housing section opposite the end attached to the first cylindrical housing section.

7) The specimen container of claim 6, wherein at least one of the cylindrical housing sections is graduated.

8) The specimen container of claim 6, wherein at least one of the cylindrical housing sections further includes wing structures formed thereon, and wherein the wing structures provide gripping surfaces for facilitating the depression of the syringe plunger.

9) The specimen container of claim 6, wherein the volume of each cylindrical housing section is about 5 cc to 10 cc.

10) The specimen container of claim 6, wherein the plunger is a syringe plunger.

11) A specimen container for use with biological specimens, comprising:

(a) a first cylindrical housing section, wherein the first cylindrical housing is adapted to receive a plunger, wherein the first cylindrical housing section is threaded on both ends thereof, and wherein the first cylindrical housing section further includes wing structures formed thereon;

(b) a second cylindrical housing section, wherein the second cylindrical housing is adapted to receive a plunger, wherein the second cylindrical housing section is threaded on both ends thereof, and wherein the second cylindrical housing section further includes wing structures formed thereon;

(c) a threaded linking cuff for connecting the first and second cylindrical housing sections to one another;

(d) at least one plunger adapted for insertion into either the first or second cylindrical housing section, wherein the at least one plunger is operative to move a biological specimen into the first or second cylindrical housing section when the at least one plunger is depressed; and

(e) at least one cap for closing and sealing the open end of either of the cylindrical housing sections.

12) The specimen container of claim 11, wherein both of the cylindrical housing sections are graduated.

13) The specimen container of claim 11, wherein the volume of each cylindrical housing section is about 5 cc to 10 cc.

14) The specimen container of claim 11, wherein the plunger is a syringe plunger.

15) The specimen container of claim 11, further comprising at least one O-ring for providing a seal between the components of the container.

16) The specimen container of claim 11, further comprising a plurality of O-rings for providing seals between the components of the container.