The present invention relates to a mixing container and methods of using. The mixing container has a mixing blade in a mixing chamber for uniformly blending dry compositions with fluids. Optionally, and more specifically, the mixing container forms a package container to be pre-filled with a dry composition upon assembly, stored and shipped for later use.
Mixing devices are well known and are commonly used in food preparation. Often a variety of dry ingredients like flour or cake mixes must be mixed with fluids such as water, milk, egg, etc. In such cases, the methods involve using handheld mixers with rotatable blades or mixing bowls. The objective is to quickly and easily blend the combination of ingredients into a uniformly dispersed batter, so the finished product is a perfectly baked cake.
In medical and scientific research applications, the constituents of the ingredients also involves a mixing of dry compositions with fluids. In many cases, the outcomes of this blending depends on uniform dispersion, avoidance of waste and in the case of incorporating viable cells or biological active cell components this mixing must avoid damage. In many medical applications, the surgical personnel are asked, in an aseptic and non-contaminating way, to mix these constituents in the operating room, often with no suitable way to do the task, let alone to make a uniform blend without damaging the components. The spillage, waste and damage means the material that is to be implanted or injected into the patient varies in quality and therefore effectiveness. This quality of mixed ingredients varies widely dependent on the skill of the personnel doing the blending.
The objective of the present invention is to create a mixing container that eliminates all these possible technique dependent variations and provides the medial or research staff a sterile self-contained mixing chamber isolated from any external contamination. These and other beneficial objectives are achieved by the present invention described herein.
A mixing container with an internal mixing blade has an extraction funnel, a main housing, a rotatable base cap, a mixing blade and a gear mechanism. The extraction funnel has a first end with a maximum diameter and narrowing to a second end of a minimum diameter at a neck portion. The main housing includes a mixing chamber. The rotatable base cap with an internal gear is attached to and is rotatable relative to the main housing. The mixing blade has a plurality of prongs extending from a shaft. The prongs are in the mixing chamber and the shaft extends through an opening in the main housing to inside the rotatable base cap. An end of the shaft has a gear. The gear mechanism has at least one gear, each of the at least one gears is connected to or intermeshed with the internal gear of the base cap and the gear of the shaft end. The gear mechanism is external of the main housing and is held in the rotatable base cap. Rotation of the rotatable base cap drives the gear mechanism to rotate the mixing blade.
The shaft of the mixing blade has an axis of rotation centered and aligned with the axis of rotation of the rotatable base cap. The base cap has the internal gear extending circumferentially and is coupled to the at least one gear to form a planetary gear system about the gear of the shaft of the mixing device. Each of the at least one drive gears are larger than the gear of the shaft and rotation of the rotatable base cap spins the mixing blade faster than the speed of the rotatable base cap, preferably at least four times faster, preferably about five times faster. The main housing is detachable from the rotatable base cap.
In one embodiment, the main housing is snap fit attached to a circumferentially continuous groove of the rotatable base cap and removably attached and rotatable about the groove of the rotatable base cap. The mixing blade is sealed at the shaft to the main housing by an “O” ring seal at the opening, optionally by two “O” ring seals.
The mixing container further has a sealed injection port affixed at the second end of the neck portion of the extraction funnel. The sealed injection port can be in a cap. The cap can be removably attached to the second end of the extraction funnel. The gear mechanism of the mixing container includes a 36 tooth rotatable base cap gear, a 36 tooth at least one gear and a 16 tooth gear at the end of the mixing shaft.
In one embodiment, the mixing chamber and extraction funnel are made of clear or transparent plastic. The rotatable base cap, mixing blade and gears are made of non-transparent plastic. The “O” ring seal or seals and injection port are made of an elastomeric material, the elastomeric material can be a natural or synthetic rubber.
In one embodiment, the rotatable base cap has an external grip surface to facilitate rotation and the main housing has an external grip surface to hold the main housing while the rotatable base cap is rotated. The extraction funnel is attached to the end of the main housing by a threaded fastening. The mixing chamber of the main housing has a conical bottom and the prongs of the mixing blade extend along the conical bottom and turn parallel to closely fit along an internal cylindrical surface of the mixing chamber.
The device of the present invention can be used by the following method. The method of mixing a composition has the steps of: providing a mixing container with a main housing with a mixing chamber with an internal mixing blade rotatable by a gear mechanism with a plurality of gears in a rotatable base of the mixing container, the mixing container having a quantity of dried micronized particles inside the mixing chamber, the mixing chamber having an end attached to an extraction funnel, the extraction funnel having a first end with a maximum diameter and narrowing to a minimum diameter at a neck portion at a second end, and the neck portion at the second end having a sealed injection port; injecting a volume of fluid using a needle with a syringe attached through the sealed injection port into the extraction funnel and mixing chamber containing the micronized particles; and rotating the base of the mixing container to move the plurality of gears of the gear mechanism to spin the internal mixing blade to incorporate the fluid into the micronized particles to the wet composition.
The method further has the steps of: inverting the mixing container; inserting a needle with an empty syringe attached into the injection port; and extracting the wet composition into the syringe.
The method further has the steps of: inserting a needle with a syringe attached into the injection port, the syringe having a quantity of cells or cell components; pushing the cells or cell components into the into the extraction funnel and mixing chamber with the wet composition; and rotating the base of the mixing container to move the plurality of gears of the gear mechanism to spin the internal mixing blade to disperse and incorporate the cells or cell components into the wet composition.
The method further has the steps of: inverting the mixing container; inserting a needle with an empty syringe attached into the injection port; and extracting the wet composition and cells or cell components into the syringe.
The method further has the step of: injecting or implanting the wet composition in the syringe into a patient.
The method further has the step of: injecting or implanting the wet composition with cells or cell components into a patient.
The dried composition can be shipped in the mixing container at the manufacture or can be added to an empty missing container by removing the extraction funnel, adding the dried composition into the mixing chamber and placing the extraction funnel back onto the main housing.
In an alternative method, the mixing container can be used to make a high viscosity material such as a bone gel, paste or putty, with or without cells or cell components, or a disc composition, or made from dried nucleus pulposus micronized particles with or without cells, or a neural composition made from dried neural tissue micronized particles. The mixing occurs similarly, but the container when inverted allowing the extraction funnel to be detached with the mixed composition or be directly removed with or without syringes if so desired. Alternatively, the extraction funnel can be removed without inverting the mixing container and the composition can be removed with or without syringes from the mixing chamber.
The invention will be described by way of example and with reference to the accompanying drawings in which:
With reference to
With reference to
As shown in
Alternatively, an empty mixing container 10 can be filled with the dry component at the point of use by removing the extraction funnel 60 and pouring the dry component 3D into the mixing chamber 24. Once filled, the extraction funnel 60 is replaced back onto the mixing chamber 24 and mixing can occur as shown in
In order for the container to be used at the surgical suite for preparation of an implantation to be prepared for use on a patient, the mixing container 10 has the base 40 rotatable relative to the main housing 20, the rotation of the base 40 drives a gear mechanism 30. The gear mechanism 30 has a plurality of gears driven by the rotatable base 40. Inside the rotatable base 40 is flat top 44 with a circumferentially extending continuously ring or an outer gear 42 above the top, this outer gear 42 drives a pair of inner gears 32 as illustrated, the inner gears 32 intermesh with the outer gear 42 and rotate driving a gear 52 connected to a shaft 51 holding the mixing blade 50. The gears 32 and 52 all rest on the top 44 as shown in
As further illustrated, the main housing 20 portion snap fits onto the rotatable base 40 at a groove 45. The groove 45 is connected to the main housing 20 via a projection 22 on a flexible tab. The flexible tab is adjacent an opening or slot 23 in the main housing 20 as illustrated in
Another important aspect of the present invention is that the mixing chamber 24, has a cylindrical column with a large cylindrical opening that extends to a conical bottom. The conical bottom has an opening 28 that is completely sealed from the external atmosphere by the seals 72, 74 of the shaft 51 and by the extraction funnel 60 which is threadingly engaged onto the top of the mixing chamber 24 of the main housing 20. Additionally, at the attachment, a plurality of projections are shown around the maximum diameter of the extraction funnel 60. These are provided so the user, if so desired, can simply unthread the extraction funnel 60 to open the mixing container 10. This feature is quite beneficial in certain aspects, as will be discussed. Additionally, the main housing 20 portion has a plurality of grips or depressions 21 molded into the main housing 20 structure. As illustrated all the components of the mixing container 10 can be made of plastic with the exception of an injection port 90 and the seals 72, 74 which can be made of a synthetic elastomer or natural rubber. The grips 21 around the periphery of the main housing 20 and the similar grips 41 around the rotatable base are provided so the user can hold onto these grips 21, 41 to easily move the rotatable base 40 relative to the main housing 20. The main housing 20 and all its components will remain stationary as the rotatable base 40 moves the gears which in turn moves the mixing blade 50 to stir the contents of the mixing chamber 24.
As shown in
With reference to
At this point, if the wetted composition 3W is ready for use and is such that a paste or bone gel or some other viscous material composition 3G is created, then as shown in
Uniquely, the mixing blade 50 by being contoured to the internal surface of the mixing chamber 24 allows the cells 4 or cell components 4C to be gently agitated so the composition 3W is uniformly dispersed with the cells 4 or cell components 4C. This is particularly important when handling viable cells or biologically active materials in such a fashion that very little damage occurs and maximum dispersion and uniformity can be achieved. Historically, the surgical team when preparing these components will take cells that may have been cryogenically frozen, warm the container so the cells are now in a fluid form and then try to handle the material in such way that it can be transferred for use with the patient. This can be tedious and difficult to mix dry compositions with viable cells in a fluid and not damage or cause harm or contamination of the material to be injected in the patient. These problems are fundamentally eliminated with the use of a sterile syringe and needle assembly and the mixing container with injection port. These features make it easy for the practitioners to, in a self-contained way, mix the contents without allowing the contents to ever be exposed to the external atmosphere. Preferably, before insertion into the injection port occurs, one will swab the external surface of the injection port to ensure it is sterile upon entry of the sterile needle 101. Once the fluids are added to the mixing container and the composition is thoroughly mixed and dispersed, the composition can be withdrawn safely and aseptically into a sterile syringe for direct implantation or injection into a patient.
Heretofore, the ability of cells to be handled in a uniform and consistent way has not been possible, therefore, often the use of cells has varying degrees of success depending on the experience of the surgical team in their preparation of the material for injection or implantation into the patient. With the present invention, these variables are virtually eliminated in that everything can be done in a self-contained way. Simply by twisting the rotatable base one can achieve a uniform dispersion of the materials after they have been inserted into the mixing container 10 in such a way that is difficult to not effectively achieve the desired uniformity and dispersion. A simple few twists of the rotatable base 40 causes the mixing blade 50 to move rapidly due to a preferential gear ratio arrangement such that movement of the outer ring in short rotation caused a more rapid movement of the blade substantially quicker allowing the material to be mixed gently and uniformly. The movement of the blade is sufficiently fast to cause a dispersion and yet sufficiently gentle so it does not damage the cells.
The current invention can be used with a variety of either natural or synthetic materials for the dry components 3D that can be made at the manufacturing plant. These dry materials 3D can include by way of example, a variety of ether synthetic compositions, microbeads or calcium triphosphate or other materials used in bone repair, or bone allografts that can be fibers, micronized or particularized, micronized nucleus pulposus or micronized neural tissue. All of these components heretofore have been provided in separate packages and must be manipulated and assembled at the surgical suite. Such products, while very beneficial to the patient, need to be uniformly and consistently prepared. The present invention achieves this result in a way that is both sterile, aseptic and minimizes any loss or risk of loss.
It is important to note that while the extraction funnel is shown with an injection port, in certain cases where bone gels or paste is being made, the injection port may be unnecessary, in such a case, the extraction can have a closed end, not shown, so that the funnel is a one piece structure that can be threaded onto the mixing chamber 24. In these cases, the dry components can be reconstituted to the desired viscosity level and used in that fashion, as illustrated in
As illustrated all the components can be made of a synthetic plastic, injection molded in such a way that one use, the entire mixing container assembly can be discarded and not reused. Alternatively, the mixing container could be made of materials that can be sterilized and reused such as stainless steel, however, the objective of the present invention is to have the mixing container disposable. These and other variations can be achieved without altering from the spirit and scope of the present invention.
Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.
The present invention is a division of U.S. application Ser. No. 16/506,574 filed on Jul. 9, 2019 entitled, “Mixing Container And Method Of Use”.
Number | Date | Country | |
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Parent | 16506574 | Jul 2019 | US |
Child | 17714378 | US |