Apparatus and method for producing augmentive products

An apparatus for shaping a Platelet Rich Fibrin component of patient whole blood includes a main body. The main body includes a substantially planar surface. The main body also has a reservoir positioned therein. The substantially planar surface includes a plurality of channels fluidly connecting the substantially planar surface and the reservoir. The apparatus also includes a lid which is positioned over the substantially planar surface. The lid is used to compress a Platelet Rich Fibrin component. Liquids that are expressed from the Platelet Rich Fibrin component flow to the reservoir. The apparatus also includes openings for forming plugs of Platelet Rich Fibrin material.

TECHNICAL FIELD

Various embodiments described herein relate to an apparatus for producing augmentive products and a method for making the augmentive product using the apparatus. More specifically, the apparatus and method are used for various types of dentistry.

BACKGROUND

Dental surgeries including tooth extractions, implant placement, bone grafting and others. More recently, dentists have started to rely on augmentative products and the methods for making these products as part of these surgeries. The use of augmentative products and methods help patients. Among the benefits is that the use of augmentative products and methods speed a patient's healing.

DETAILED DESCRIPTION

In the following paper, numerous specific details are set forth to provide a thorough understanding of the concepts underlying the described embodiments. It will be apparent, however, to one skilled in the art that the described embodiments may be practiced without some or all of these specific details. In other instances, well known process steps have not been described in detail in order to avoid unnecessarily obscuring the underlying concepts.

This apparatus is intended for use in the dental surgical industry in both surgical specialties and general practice. Applications include, but are not limited to, implants, apical surgeries, extractions, and bone and tissue grafting in support of general oral surgery. The apparatus fabricates products that aid in healing. The apparatus will be used for fashioning tissue membranes or cylindrical slugs derived via phlebotomy procedure from the patient's centrifuged whole blood.

Dental surgeries including tooth extractions, implant placement, bone grafting and others. Dentists have begun to rely on augmentative products to speed healing. In one embodiment, autologous blood (i.e., blood emanating from the patient himself) is placed in a centrifuge. The autologous blood is spun to separate components that effectuate better healing. That portion of the patient whole blood functioning in this capacity is the Platelet Rich Fibrin (“PRF”) component. This element contains platelets and fibrin, which initiate clot formation and promote maturation elements to enable stabilization. This portion also contains agents that actually recruit and promote healing cells and molecules from the blood and tissue. By using these PRF constituents, the practitioner can fabricate both membranes (to cover grafts) and plugs (to press into bony defects). This, in turn, both improves and accelerates the healing process once a surgical procedure is concluded.

FIG. 1is a perspective view of an apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, according to an example embodiment.FIG. 2is a perspective exploded view of an apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, according to an example embodiment. The apparatus100includes a main body110. The main body110includes a grooved surface120that is substantially planar absent the grooves121. The main body also includes a reservoir112at one end of the main body110. At least some of the grooves are connected or fluidly coupled t the reservoir112. The grooves are sized to allow fluids associated with a Platelet Rich Fibrin component to flow through the grooves121. The main body100also includes at least one cylindrical opening130. As shown inFIGS. 1 and 2, the main body includes four cylindrical openings130,132,134,136. The cylindrical openings130,132,134,136, may have the same diameter or different diameters. In some embodiments, one or more cylinders can be of equal diameter and size. In another embodiment, each of the cylinders130,132,134,136can have different diameters and be of different sizes. It should be noted that inFIGS. 1 and 2, there are four cylindrical openings but in other embodiments, there may be more openings or less openings.

At least some of the cylindrical openings130,132,134,136receive a cylinder or sleeve140,142,144,146. As shown inFIGS. 1 and 2, each cylindrical opening130,132,134,136receives a sleeve140,142,144,146. As shown inFIG. 2, the sleeves140,142,144,146each have a wall thickness that is about equal. It is contemplated that some of the cylindrical openings can have sleeves with the same outer diameter to fit within a cylindrical opening, but with different inner diameters. In this way a sleeve could be changed out to form a smaller diameter opening or space.

Also associated with the apparatus are a set of pistons150,152,154,156. Each of the pistons150,152,154,156has an outside diameter that is substantially equal to the inner diameter of the corresponding sleeve140,142,144,146. The pistons have piston rods151,153,155,157. The piston rods151,153,155,157are sized so that they can bear a doughnut-shaped weight. The piston rods151,153,155,157are also attached to the pistons150,152,154,156so that they can be pushed or pulled without separating from the pistons150,152,154,156. Doughnut shaped weights160,162,164are also shown inFIGS. 1 and 2. Weights160,162are placed on piston rod150. The apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes100also includes a lid170. The lid170covers at least the grooved surface120of the main housing110. The lid170is also a weight that is used to compress or express liquid from the Platelet Rich Fibrin component. The lid includes posts171,173,175which is on the exterior surface of the lid170. Weights, such as weight164can be placed on a post171,173,175to further load the lid and increase the force on the Platelet Rich Fibrin component. It should be noted that only three weights are shown inFIGS. 1 and 2and that there could be many more that are used to weight the plate170and the pistons150,152,152,156. In other words, it is contemplated that multiple weights could be placed on each post or each piston rod in some applications of this apparatus.

The apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes also includes a table stand180which lifts one edge of the body110and imparts a tilt to the surface120. The body110of the table assembly includes a slot or groove182sized to receive the edge of the table stand180. The table stand180, in this embodiment, is a thin piece of material, such as metal. The edge of the table stand180is placed into the groove182to impart a tilt on the entire table apparatus100. The tilt that results directs the flow of fluids expressed from the Platelet Rich Fibrin components to flow downhill in the grooves, such as groove121, of the surface120. The fluids flow to the reservoir112and collect there.

FIG. 3is a top view of the body110or table of the apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, according to an example embodiment.FIG. 4is an end view of the body110or table of the apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, according to an example embodiment. Now referring to bothFIGS. 3 and 4, the body110or table of the apparatus100will be further detailed. The grooved surface120and the area310surrounding the cylinders130,132,134,136are slightly recessed from the surface which forms the outer edge of the body110or table. The recesses120and310in the body form a first rail312, a second rail314and a third rail316. The first rail312and the third rail316correspond with the outer perimeter of the table or body110. The outer perimeter of the body110is bound on three sides. A side that is normally elevated while in use is not bound. The second rail314is located between the first rail312, and the third rail316. The first rail312, and the second rail314bound the grooved surface120. The grooved surface120has grooves that run to the reservoir112. The second rail314and the third rail316bound the area310surrounding the cylindrical openings130,132,134,136.

FIG. 5is cross sectional view of the body110or table of the apparatus for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, as viewed along line5-5inFIG. 4, according to an example embodiment. As shown in the cross-sectional view, the housing110includes a bored tunnel or bore380that fluidly couples the base of the cylindrical wells or cylindrical openings130,132,134,136and the sump or reservoir112. The cross-sectional view ofFIG. 5details the size and position of the bore380that fluidly connects these portions of the base110. The bore and the base of each of the cylindrical openings are positioned so as to minimize fluid from collecting in either the cylindrical openings130,132,134,136or the bore380.

In operation, the apparatus100is used to shape the harvested PRF component of patient whole blood after it is centrifuged into sheets and plugs of varying sizes. The sheets and plugs can then be used in dental surgery and potentially other surgery. Dental surgeries include tooth extractions, implant placement, bone grafting and others. Dentists rely on augmentative products, that is made from the patient's blood, and the methods for making these products as part of these surgeries. The use of augmentative products and methods speed a patient's healing because there are no rejection issues.

After centrifugation, the PRF portion will begin to clot and hold together and can then be removed in whole as an amorphous mass and manipulated. The apparatus100assists fabrication into either of two general shapes, a sheet (membrane) or a cylindrical form (plug). To form a sheet of material, the amorphous mass is placed on the surface112. The lid170is placed over the amorphous mass and compressed into a sheet. Weights, such as weight164, can be added to the sheet to produce additional force to be placed on the sheet during formation. The number of weights that can be used can be placed on posts171,173,175. The downward force of the lid170and any additional weight placed thereon, compresses the amorphous mass into a sheet. Portions of the amorphous mass can also be placed into the openings130,132,134,138. Pistons,150,152,154,158are placed onto the portions of amorphous mass. The pistons150,152,154,158have piston rods151,153,155,157sized to receive one or more weights. The piston, piston rod, and weight place a downward force on the amorphous mass in the cylindrical opening130,132,134,138to form a plug to be used in various sorts of operations.

In both instances, the weight compresses the amorphous mass that s either placed on the flat surface or in the cylindrical opening. During compression into either form, the tissue liquid that remains in the PRF is expressed out of the mass and drains either down the bored tunnel or bore380at the base of the cylindrical openings130,132,134,136or wells, or down the V-shaped grooves on the surface120of the table apparatus100. The table body110is inclined or tilted when the table stand180is placed into groove or slot182. The incline of the table body110is sufficient for gravity to pull the tissue fluids expressed from the process down-slope into the collection well or sump or reservoir112.

This apparatus differs in design from other apparatuses currently in use in that the apparatus100uses the slope of the inclined plane to drain the excess tissue fluids into a well or sump or reservoir112, away from the PRF membrane or plugs that are forming.

Advantageously, the apparatus100for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes includes many key functions in one station. Another apparatus utilizes a perforation tray through which the excess fluid drips into a pan below. The perforation tray must be removed to gain access to the fluid expressed from the Platelet Rich Fibrin component. In some operations, the fluid express from the Platelet Rich Fibrin component is mixed with other constituents to form other components that are used ins some operations. For example, bone chips may be ground into a powdery consistency. The fluid expressed from the Platelet Rich Fibrin component can be mixed with the powdery substance to form another useful component for various operations. This can be used to promote bone development where needed. This apparatus does not require the removal of various components to gain access to this fluid. The apparatus100delivers the fluid to the reservoir112so that it can be accessed at the reservoir. No need to tilt a separate pan to obtain some of the fluid expressed from the Platelet Rich Fibrin component. Still another advantage is to allow for several plug sizes. The apparatus100offers a choice of four (4) different diameters from which the practitioner can select depending on surgical needs. It is contemplated that the sleeves could be fashioned to provide still other sizes. In addition, the sleeves could also be provided to allow production of plugs of approximately the same size from the body110of the apparatus100.

For assembly, the table stand180is inserted into the slot or groove182on the bottom surface of the table body110. This provides a slope to the table body110, the surface120and the bore380to enable liquid from the Platelet Rich Fibrin component to run down the grooves on the table body surface120and into the well or sump or reservoir112at the down-slope edge of the table body110. The lid assembly170is then put in place with the pins176,178at an upper end of the lid170engaging with the machined pin slots196,198on the up-slope end of the table body110. Cylindrical weights, such as weight164, can be added to the shafts on the top side of the lid170to produce additional force on the lid170which in turn increases the pressure (force per unit area) on the Platelet Rich Fibrin component positioned between the grooved surface120and the lid170.

As shown inFIGS. 1 and 2, sized pistons fit within four similarly sized cylindrical openings. Four different diameter sizes are shown inFIGS. 1-3 and 5. It is contemplated that the number of different sized openings can be provided. In one embodiment, a sleeve140is inserted into the corresponding well or cylindrical opening130in the table body110. Next, the centrifuged clot is placed in the sleeve140, followed by the piston150for compression. Weights160,162can also be added to the piston150to increase pressure on the material within the walls of the sleeves or cylindrical opening130. The same can be done for the other cylindrical openings, sleeves and pistons already described, as desired by the operator. Machined into the base of the wells in the table body110is a bore-hole channel or bore380that runs from the up-slope end of the table body110, through the base of each of the wells or cylindrical bodies130,132,134,136and into the well/sump or reservoir112at the down-slope end of the table100. This provides a drainage channel for liquid that will be compressed out of the material in the piston/cylinder apparatus. SeeFIG. 5and the related description above for bore hole location and direction.

FIG. 6is a top view of the body or table of the apparatus for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, according to an example embodiment.

FIG. 7is cross sectional view of the body or table of the apparatus for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, as viewed along line7-7inFIG. 6, according to an example embodiment.

FIG. 8is cross sectional view of the body or table of the apparatus for shaping a Platelet Rich Fibrin component of patient whole blood into sheets and plugs of varying sizes, as viewed along line8-8inFIG. 6, according to an example embodiment.

Now referring toFIGS. 6-8, it can be seen that at least one of the channels and the bore380is sloped with respect to the substantially top planar surface of the body110of the apparatus100.

In summary, PRF clots are removed from a centrifuge and placed either on the table or surface120or in any of the cylindrical openings130,132,134,136or wells having the sleeves140,142,144,146already inserted. PRF is placed on the surface120if a sheet of augmentive material is required and in a cylindrical opening130,132,134,136or well if a plug is required. The cylindrical opening130,132,134,136or well selected depends on the size and shape of the desired tissue product. The lid170or piston associated with a cylindrical opening is then applied. Gravity compresses the portion of PRF material to form a cylindrical mass of a certain size (in the case of the cylinders) or a flat sheet (in the case of the grooved table). The apparatus100is inclined when the table stand180is inserted or engaged with the groove182in the body110of the apparatus100. The resulting sloped plane aids with drainage channels (in the case of the grooved table) or a drainage tunnel (in the case of cylindrical slugs) that permits the fluid supernatant from either product (sheet or cylinder) to flow downward into the collection sump or reservoir112. Fluid collected in this way can be reserved in any fashion for further use in preserving, rehydrating or maintaining hydration of the fabricated products. The table stand180supplied with the table110, when placed in the receiver position on the back of the table110provides the slope for the inclined plane. After compression by the lid on the table or by the pistons in the sleeves/wells the membrane or cylindrical plug is ready for use in the surgical site. It may be either removed and immediately delivered to the surgical site or retained in the collection well/sump where the fluid collects.

The four cylindrical openings130,132,134,136or wells, along with their sleeves and pistons, provide options for alternate plug product diameters depending on surgical needs. These vary upward from a 1-to-4.8 ratio (0.625 ranging up to 3.000). The sleeve and cylinder system is designed such that the height of the sleeve is situated sufficiently above the level of the table that it can be easily removed with the piston and product remaining in the sleeve. The product can then be expressed into the desired location by simply pushing on the stem of the piston and driving it through the sleeve to force out the PRF plug. This feature of this apparatus allows the formed product or products to be taken from the forming chamber and delivered directly to the surgical site or any other site.

The apparatus is also equipped with weights that fit onto stems mounted on the lid or on the piston stems themselves. This enables the user to vary the force applied to the PRE in order to influence desired thickness and density of the final product. This apparatus100is designed to have an inclined plane drainage system for fabricating PRF autogenous membranes and cylindrical slugs for use in dental implants and grafting. The design also acts as a delivery system for the formed cylindrical plugs using sleeves as carriers and pistons to express the product at the desired site.

An apparatus for shaping a Platelet Rich Fibrin component of patient whole blood includes a main body having a substantially planar surface. The main body has a reservoir positioned in the main body, and a plurality of channels fluidly connecting the substantially planar surface and the reservoir. In one embodiment, the substantially planar surface is inclined toward the reservoir. The apparatus further includes a table stand. The main body has a receiver for the table stand. When the table stand is placed in the receiver the main body inclines toward the reservoir. In one embodiment, the receiver is a groove within the main body and the table stand is a plate of material. It should be understood that the table stand could be of any geometric shape and the receiver could have a corresponding shape to receive the table stand. It is further contemplated that the table stand could be a block or even a plastic pad that could be placed under the main body at a point which would cause the main body to incline with the reservoir being the low point. The plurality of channels fluidly connect the substantially planar surface and the reservoir. In some embodiments, the floors of the plurality of channels can be inclined with respect to the substantially planar surface. The incline of the channels or channel floors is toward the reservoir to facilitate flow to the reservoir. The apparatus for shaping a Platelet Rich Fibrin component of patient can also include a lid. The lid covers at least a portion of the substantially planar surface. The lid places a load on a Platelet Rich Fibrin material. The lid is for forming a membrane of Platelet Rich Fibrin material. The amount of load can be altered. The apparatus also includes one or more lid weights. The lid includes a place for temporarily holding one or more lid weights. Thus, the load can be varied. The load may also be varied to vary the rate liquid is expressed from a sheet of Platelet Rich Fibrin material.

The main body and the lid can be hingedly connected. A hinge is located between the main body and the lid. In some embodiments, the lid is used to control the thickness of the platelet rich fibrin sheet. In such an embodiment, the hinge holds the lid at a distance from the substantially planar surface of the main body. The hinge can have a first hinge position for forming a membrane of a first thickness, and a second hinge position for forming a membrane of a second thickness. Basically, the hinge position and the load on the lid can be used to form membranes of varying thicknesses. It is contemplated, in one embodiment, that the main body of the apparatus could have a bracket with a plurality of spaced openings for receiving cylindrical pins attached to one end of the lid. In this way, the lid could be placed at any height with respect to the substantially planar surface. In still another embodiment, a bar with two hinge openings could be mechanically attached to the main body and the height of the bar could be adjusted to a range of desired heights.

The main body of the apparatus for shaping a Platelet Rich Fibrin can also include one or more openings for forming plugs of Platelet Rich Fibrin material. The apparatus also can one or more plug weights which fit within the one or more openings for forming plugs. In one embodiment, the one or more plug weights is piston-shaped with a cylindrical piston portion and a rod portion. The cylindrical piston portion fits within at least one of the one or more openings. The rod portion is sized to receive supplemental weights. The plug weights would be doughnut shaped so they could easily slip on the rod portion to add to the load on the material in one of the openings. In one embodiment, the apparatus also includes one or more sleeves sized to fit within the one or more openings for forming plugs. A plug of a first dimension can be formed in the opening when a first sleeve is positioned in the opening. A plug of a second, smaller dimension can be formed within a sleeve within an opening when a second sleeve is positioned within the opening. A plug of a third dimension could be formed in the opening without any sleeve. In another embodiment, the main body includes a plurality of different-sized openings for forming plugs of Platelet Rich Fibrin material having different dimensions. The apparatus for shaping a. Platelet Rich Fibrin component of patient whole blood wherein the main body includes one or more bores for the one or more openings for forming plugs of Platelet Rich Fibrin material. The one or more bores fluidly couple the one or more openings for forming plugs to the reservoir within the main body.

The reservoir of the apparatus for shaping a Platelet Rich Fibrin component of patient whole blood of is positioned so that fluid in the reservoir is accessible without having to move another portion of the apparatus. In other words, fluids expressed from the Platelet Rich Fibrin material can be accessed without having to remove components of the apparatus. More importantly, the membrane of Platelet Rich Fibrin can remain in place while the reservoir is accesses. Similarly, a plug or plugs do not have to be moved to access or remove fluid from the reservoir.

An apparatus for shaping a Platelet Rich Fibrin component of patient whole blood includes a main body with a substantially planar surface, a lid positionable above the main body, a lid weighting apparatus, at least one piston-shaped weight, and a supplement piston weight for temporarily adding weight to the piston-shaped weight. The main body has a fluid reservoir therein, a plurality of channels therein, at least one cylindrical opening therein and at least on bore therein for connecting the at least one cylindrical opening to the reservoir.

The plurality of channels fluidly connects the substantially planar surface and the reservoir. The piston-shaped weight has a cylindrical end sized to fit within the cylindrical opening in the main body. The lid is positionable above the plurality of channels in the main body. The apparatus also includes a supplemental piston weight for temporarily adding weight to the piston-shaped weight. Other weights can be added to the lid. In one embodiment, the lid can be positioned above the main body at a plurality of distances. In still another embodiment, the channels in the main body and the bores in the main body are in fluid communication with each other. The apparatus can also include a table stand removably attached to the main body. The table stand positioned to incline the main body and the channels and bores therein toward the reservoir in the main body.

The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.

While the embodiments have been described in terms of several particular embodiments, there are alterations, permutations, and equivalents, which fall within the scope of these general concepts. It should also be noted that there are many alternative ways of implementing the methods and apparatuses of the present embodiments. It is therefore intended that the following appended claims be interpreted as including all such alterations, permutations, and equivalents as fall within the true spirit and scope of the described embodiments.