Patent Publication Number: US-2022226789-A1

Title: Mixing container and method of use

Description:
RELATED APPLICATIONS 
     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”. 
    
    
     FIELD OF THE INVENTION 
     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. 
     BACKGROUND OF THE INVENTION 
     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. 
     SUMMARY OF THE INVENTION 
     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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be described by way of example and with reference to the accompanying drawings in which: 
         FIG. 1  is an upper perspective view of the mixing container of the present invention. 
         FIG. 2  is a lower perspective view of the mixing container of  FIG. 1 . 
         FIG. 3  is a top plan view of the mixing container of  FIG. 1 . 
         FIG. 4  is a side plan view of the mixing container of  FIG. 1 . 
         FIG. 5  is a cross sectional view of the mixing container taken along lines  5 - 5  of  FIG. 4 . 
         FIG. 6  is a partial cutaway view of the mixing container wherein an upper portion of the mixing container is removed exposing the mixing blade and gear mechanism. 
         FIG. 7  is an exploded upper perspective view of the mixing container of  FIG. 1 . 
         FIG. 8  is an exploded lower view of the mixing container of  FIG. 2 . 
         FIGS. 9A-9F  illustrate an exemplary method of how the mixing container is to be used with all the views shown in cross section. 
         FIG. 9A  shows a mixing container pre-filled with a dry micronized particle composition wherein a syringe holding a volume of a fluid has an attached needle inserted into an injection port and wetting the composition. 
         FIG. 9B  shows the wetted composition being mixed by the mixing blade moving in a clockwise and/or counterclockwise rotation by twisting a rotatable base cap until the fluid and composition are fully mixed. 
         FIG. 9C  shows a second syringe filled with cells or cell components being injected into the mixing container and the wetted composition. 
         FIG. 9D  shows the combination of cells or cell components being incorporated into the wetted composition by the movement of the mixing blade driven by the gear mechanism in the rotatable base cap. 
         FIG. 9E  illustrates the step of inverting the mixing container twisting the rotatable base cap to rotate the mixing blade moving the wetted composition with or without the cells or cell components into an extraction funnel with an empty syringe with needle shown for later extraction. 
         FIG. 9F  illustrates the syringe with a needle of  FIG. 9E  inserted into the injection port of the inverted mixing container as a withdrawal movement of the syringe plunger extracts the contents of the mixing container into the syringe. 
         FIG. 10  illustrates the contents of the mixing container after being transferred into the syringe ready for use by implantation or direct injection. 
         FIG. 11  shows a mixing container filled with a dry micronized particle composition at a point of use. 
         FIG. 12  shows the mixing container with the extraction funnel removed to allow removal of a wetted composition. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to  FIGS. 1-8 , illustrations of the mixing container of the present invention are shown. 
     With reference to  FIGS. 1-4 , the mixing container  10  of the present invention is illustrated.  FIG. 1  is an upper perspective view.  FIG. 2  is a lower perspective view. In these views, the lowest portion is a rotatable base  40 . The rotatable base  40  is attached to a main housing  20 , affixed to the main housing  20  is an extraction funnel  60 . The extraction funnel  60  has a maximum diameter at its connection to the main housing  20  and narrows to a second end, the second end having a cap  80  housing an injection port  90  as illustrated. The mixing container  10  is a unique device in that it is designed to be pre-filled with a dry component or composition. It is optimally filled at the manufacturing site or can be filled at the point of use with the dry component. One of its primary uses is to hold a micronized particle or other dry component. The dry component can be a bone based allograft material or a nucleus pulposus freeze-dried material, a neural tissue that has been freeze-dried and micronized into particles, or can even include demineralized bone particles or fibers in a dried form. In these forms, the dry component or composition is packaged in the mixing chamber best illustrated in  FIG. 9A . The mixing chamber  24  has a conical base and a cylindrical chamber with a threaded end and is part of the main housing  20 . The dry components are poured into this mixing chamber  24  when the extraction funnel  60  is removed as shown in  FIG. 11 . 
     As shown in  FIG. 5 , the extraction funnel  60  is threaded onto the mixing chamber  24  column using the threads  25  of the column and the threads  65  of the extraction funnel  60 . When the dry component is placed into the mixing chamber  24 , it is placed onto a mixing blade  50  that is internally housed in the mixing chamber  24 . The mixing blade  50  has a plurality of prongs  58 . These prongs  58  extend from a central hub  59  and follow the contour of the internal surface of the mixing chamber  24  as clearly illustrated in  FIG. 5 . The mixing chamber  24  when filled has the extraction funnel  60  screwed back onto the top making a connection or seal. In one embodiment, this is done at the manufacturing site. The mixing container with the dry component 3D can then be placed in separate packaging for shipment and delivery that can be opened at the point of use or alternatively, can be packaged without any external covering, however, it is believe important the injection port at least be covered with some type of removable seal, not shown, if not placed in a sterile package. The purpose of sterility is that this mixing container  10  will be delivered to a surgical suite wherein the material in its dry form will be reconstituted into a flowable form as will be discussed in  FIGS. 9A-9F . 
     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  3 D 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  FIGS. 9A-9D . The thoroughly mixed composition  3 C can be withdrawn from the mixing container  10  as shown in  FIGS. 9E and 9F ; or alternatively, the gel composition  3 G can be removed as shown in  FIG. 12 . 
     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  FIG. 6 . In  FIGS. 7 and 8 , the entire gear mechanism  30  is shown in an exploded view. The pair of gears  32  are above the internal gear  42  and the gear  52  at an end of the shaft  51  above the pair of gears  32 . The shaft  51  has a pair of grooves  54 ,  56  about which a pair of “O” rings  72 ,  74  are attached. These “O” rings seal the shaft  51  relative to the main housing opening  28  through which the shaft  51  extends. The shaft  51  has a proximal end that is a hemispherical shape that has a flat portion  53 . The flat portion  53  fits into a complimentary opening of a central hub  59  of the mixing blade  50  in such a fashion that it provides a non-rotatable coupling between the shaft  51  and the mixing blade  50 . When the base  40  is rotated, the internal gear  42  moves and is intermeshed with the gears  32 , the gears  32  consequently rotate and drive the gear  52  on the shaft  51  to move the mixing blade  50  rotatingly. This movement can occur either clockwise or counterclockwise and can be done in a twisting action to gently agitate the contents inside the mixing chamber  24 . 
     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  FIG. 5 . It must be remembered that these attachments are such that the main housing  20  can be attached or detached from the rotatable base  40  by flexing the plurality of tabs around the circumference of the main housing  20 . As illustrated, there are four of these flexible tabs about the outer periphery of the main housing  20 . As further illustrated, the gears  32  each have a central opening, the central opening fits over posts  26 ,  27  projecting from the main housing  20 . The posts  26 ,  27  are circular in such a way that the gears  32  can rotate about these posts  26 ,  27  freely, as best illustrated in  FIG. 5 . 
     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  FIGS. 6-8 , the elastomeric injection port  90  has a center portion  92  that projects slightly upwardly about an external flange  91  that fits onto the neck end of the extraction funnel  60 . The cap  80  is then snap fit onto the neck end as shown in the illustration of  FIG. 6 . The neck end has an annular ring  62  that projects outwardly and the cap  80  is pressed over that ring  62  and has a plurality of projections  82  that engage and snap on the ring  62  making a sealed system. 
     With reference to  FIGS. 9A-9F  and  FIG. 10 , the mixing container  10  provides a unique way in which a dry micronized particle composition  3 D can be stowed in the mixing chamber  24  and, as shown in  FIG. 9A , a fluid filled syringe  100  with a needle  101  attached that can be inserted through the injection port  90  in such a way to transfer the fluid  2  from the syringe  100  into the mixing chamber  24  by pushing the plunger  104  inwardly filling the chamber  24  with a desired quantity of fluid  2  to achieve a desired viscosity of a wet composition  3 W. 
       FIG. 9B  shows the fluid  2  after being added to the previously dry composition  3 D is blended or mixed uniformly by rotation of the rotatable base  40  relative to the main housing  20  to form the wetted composition  3 W. This rotation of the rotatable base  40  drives the gear mechanism  30  which causes the mixing blade  50  to rotate internal of the mixing chamber  24 . This rotation is illustrated by the directional arrows that shows the rotation can be a twisting action back and forth such that agitation occurs that uniformly disperses the fluid  2  within the mixing container  10 . 
     At this point, if the wetted composition  3 W is ready for use and is such that a paste or bone gel or some other viscous material composition  3 G is created, then as shown in  FIG. 12 , the contents of this gel of viscous composition  3 G can be taken from either the extraction funnel  60  by inverting the entire assembly mixing container  10  or by rotating the mixing blade  50  such that all the paste and gel like material falls into the extraction funnel  60 . Once all the material is in the extraction funnel  60 , the extraction funnel  60  can be unscrewed from the mixing container  10  and the material can be removed with a spatula or other means  110 , or as shown in  FIG. 12 , the paste or gel composition  3 G can be left in the mixing chamber  24  and removed with a spatula  110  once the extraction funnel  60  is detached. This is particularly useful in bone cements or other material where the paste or gel like material needs to be taken out using the spatula  110  or other means so it can be used to fill a bone defect. This is important in that many materials are of such viscosity that they will not easily pass through a needle. However, in many cases in the operating room, there is a need for a composition such that the dried components  3 D when mixed with the fluid  2  are sufficiently small enough that they will easily pass through a needle into a syringe. As illustrated in  FIGS. 9B-9F and 10 , once the composition is wetted sufficiently with fluid  2  from a first syringe  100 , as shown in the procedures of  9 A and  9 B, then a second syringe  100  filled with cells  4  or cell components  4 C can be injected into the wetted composition  3 W in the mixing chamber  24 , as shown in  FIG. 9C . As shown in  FIG. 9C , cells  4  or cell components  4 C housed in a syringe body  102 , are injected through the needle  101  inserted in the injection port  90  into the mixture  3 W in the mixing chamber  24  of the mixing container  10  as the plunger  104  is pushed to add the cells  4  or cell components  4 C in liquid form to the wetted composition  3 W. As shown in  FIG. 9D , the wetted composition  3 W and cells  4  or cell components  4 C are uniformly mixed in the mixing container  10  forming a mixture or composition with cells  3 C using rotation of the rotatable base  40  as previously discussed. At this point, the mixing container  10  is inverted so the thoroughly mixed contents  3 C flow to the extraction funnel  60 . An empty syringe  100  is then inserted into the injection port  90  and the plunger  104  is pulled back, as illustrated in  FIGS. 9E and 9F , transferring the contents of the mixing container  10  to the syringe  100  as shown in  FIG. 10 . At this point, the mixture  3 C with cells  4  or cell components  4 C thoroughly dispersed in mixing container  10  and transferred to the syringe and can be used for direct injection into a patient or for implantation into a patient using the filled syringe  100 . 
     Uniquely, the mixing blade  50  by being contoured to the internal surface of the mixing chamber  24  allows the cells  4  or cell components  4 C to be gently agitated so the composition  3 W is uniformly dispersed with the cells  4  or cell components  4 C. 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  3 D that can be made at the manufacturing plant. These dry materials  3 D 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  FIGS. 11 and 12 . With that possibility, other variations can be made, for example, the injection port can be removable, if so desired, and can be threadingly engaged onto the narrow end of the extraction funnel. In such a case, a large diameter syringe could be inserted through the opening and material could be inserted or withdrawn with or without a very large gauge large diameter lumen needle. Other variations are possible with the present invention making it very useful piece of equipment to be used at the surgical site. 
     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.