Patent Application
20110185834
1. Field of the Invention
The present invention relates generally to centrifuge devices and more particularly to a fully autoclavable, manually assembled and disassembled spinning apparatus for separating components in biological material wherein the spinning apparatus contains encapsulated, non-lubricated gears.
2. Discussion of Background information
Medical devices and implements used during surgery require full sterilization prior to entering an operating room. Typically, most surgical implements are sterilized in a high temperature steam driven autoclave device. Similarly medical devices designed for surgical use also require autoclaving. If a device comprises lubricated components, autoclaving is prohibited, and the device is therefore prohibited from entering the operating room.
One such device is a centrifuge for use with separating components in organic matter, such as, for example, human fat extracted for autologous grafting. Such devices centrifuge fat and separate out the adipocytes, or fat cells, from the serum and oil so that the concentrated fat may be grafted. Existing devices present a number of undesirable issues. High speed centrifuges, although efficient, may destroy fat cells. More slow, manually rotated devices exist for such separation procedures but internal gearing requires lubrication thereby precluding use in operating rooms.
Although successful with regard to achieving the desired end result, these existing manually rotated devices inherently create inefficiencies and pose potential risks to the patient because they preclude operating room usage. Once fat is extracted and bagged, the bags are carried outside the operating room, attached to a hanging turntable and manually spun until separation occurs. The bags are then reintroduced into the operating room by medical personnel who must scrub down again and manually transport the bags of separated tissue from a non-sterile environment back into the operating room, potentially transferring pathogens into that sterile space. These manual rotation devices are typically heavy metallic devices comprising lubricated components therein and crude attachment mechanisms for retaining the fat receptacles for spinning The attachment means, for example clips or carabiners, pose potential risk for puncturing or tearing fat receptacle bags, which are typically plastic bags similar or identical to intravenous (IV) fluid type bags.
A need therefore exists for a compact, easily assembled and disassembled spinning device comprising no lubricated components and adapted for easily and safely retaining standard surgical receptacles within a sterile operating room while rotating the tissue filled receptacles at least at 200-400 rpm and no more than 1000 rpm, thereby enabling efficient centrifugal separation of tissue components without catastrophic destruction of tissue.
The present invention solves the problems associated with existing surgical centrifuges and rotation devices intended to spin flexible receptacles for separation of components therein retained.
The present invention is directed to a modular spinning apparatus adapted for the separation of components in a biological sample. In one embodiment, the modular spinning apparatus comprises several elements which are designed and adapted for manual assembly within a sterile operating room: a gearbox, a rotatable riser shaft and a riser head fixedly engaged with the rotatable riser shaft. The modular spinning apparatus is designed to retain one or more receptacles each containing a biological sample requiring centrifugal separation of constituent components.
In one embodiment, the gearbox comprises a housing, a chamber defined by a hollow cavity within the housing and two bevel gears aligned and engaged within the cavity. The cavity is accessed through a removable cover selectively engaged with the housing, which comprises only 5 full walls when the removable cover is detached. Removing the cover completely exposes all components within the cavity, which contains therein no lubrication. The first of the two bevel gears has a horizontal axis of rotation and is disposed with the chamber adjacent the interior wall of a first side of the housing. The first bevel gear is mounted on a drive shaft extending through a first aperture extending through the first side of the housing.
In one embodiment, the rotatable riser shaft descends through a second aperture disposed in a second side of the housing that is perpendicular to the first side. The shaft then extends through the chamber and terminates at a proximal end within the chamber at a second bevel gear having a vertical axis of rotation such that the rotatable riser shaft rotates about its longitudinal axis. The teeth of the second bevel gear engage with the teeth of the first bevel gear so that rotating the drive shaft spins the first bevel gear which then rotates the second bevel gear and riser shaft therewith engaged. In certain embodiments, the distal end of the rotatable riser shaft has thereon an affixed riser head suspended apart from the gearbox, wherein the riser head comprises one or more retention members for securely and safely retaining receptacle bags.
The present invention further comprises a method for assembling the spinning apparatus. An embodiment of the method comprises providing a five walled housing wherein the five walls define a cavity accessed through a removable cover and wherein the housing comprises a first aperture extending though a first wall of the housing, a second aperture extending through a second wall of the housing, and a third aperture extending through a third wall of the housing that is oriented opposite the second wall so that the second and third aperture align. The embodiment of the assembly method also comprises inserting a rotatable drive shaft through the first aperture and mounting a first bevel gear onto the drive shaft so that the first bevel gear lies adjacent to and parallel with the interior surface of the first wall and so that the gear teeth of the first bevel gear face inward, into the cavity.
The method further comprises mounting a rotatable riser shaft through the second aperture so that the shaft extends through the cavity. The rotatable riser shaft mounts co-axially to a second bevel gear having a stem seated within the third aperture extending through the third wall of the housing. The method comprises mating the riser shaft coaxially with the second bevel gear such that the axis of rotation of the second bevel gear is perpendicular to the axis of rotation of the first bevel gear and so that the teeth of the second bevel gear enmesh with the teeth of the first bevel gear.
The method further comprises engaging a removable cover with a retention means to form a sealed chamber within the housing. In one embodiment, the retention means comprises a pair of retention lips formed along the opening of the cavity for retaining the slidably engaged removable cover therein so that the cavity and components therein are enclosed securely. The embodiment of the method further comprises fixedly engaging a riser head with the distal end of the riser shaft and affixing retention members thereon for supporting and retaining filled receptacles during use of the apparatus.
One will better understand these and other features, aspects, and advantages of the present invention following a review of the description, appended claims, and accompanying drawings in which:
The present invention solves the problems associated with existing surgical centrifuges and spinners and provides a reliable, portable, modular spinner for use in sterile operating rooms.
The present invention is directed to a modular spinning apparatus 10 adapted for the separation of components in a biological sample, such as, for example human fat. In one embodiment, the modular spinning apparatus 10 comprises several elements which are designed and adapted for manual assembly within a sterile operating room. As
In one embodiment, the gearbox 100 comprises a housing 110 manufactured of an autoclavable metal material and manifesting dimensions equal to or smaller than sixteen inches by sixteen inches by twenty-four inches. Such sizing enables the housing 110 to fit with the confines of a standard surgical autoclave and enables comfortable portage and assembly with little or no exertion by hospital personnel. In one embodiment, the housing 110 comprises a chamber defined by a hollow cavity 115 bounded and defined by the five walls of the housing 110. A first bevel gear 120 and a second bevel gear 125 are aligned and engaged within the cavity 115, which is selectively enclosed by a removable cover 130. Opening or removing the cover 130 completely exposes all components within the cavity 115, which contains therein no lubrication. The first bevel gear 120 has a horizontal axis of rotation 135 and is disposed with the cavity 115 adjacent the interior surface of a first wall 140 of the housing. The first bevel gear 120 is mounted on a drive shaft 145 extending through a first aperture 150 extending through the first wall 140 of the housing. In the embodiment depicted in
In one embodiment, the rotatable riser shaft 200 extends through a second aperture 155 extending through a second wall 160 of the housing 110. In the embodiment of
As depicted in
In certain embodiments, the distal end 215 of the rotatable riser shaft has thereon an affixed riser head 300 suspended apart from the gearbox by the length of the riser shaft 200 therebetween. In the embodiment of
As indicated in
Furthermore, in one embodiment, the riser shaft 200, riser head 300, retention members 305, and flanges 310 may be separately manufactured components affixed to one another via mechanical permanent and/or semi-permanent affixation means such as but not limited to screws, welds, rivets, pins, spring loaded locking pins, glue, epoxy, magnets, slip fit interfaces, and press fit interfaces between components. In another embodiment, one or more of these components may be manufactured from a single machined piece or may be cast as a unified assembly in a metal die casting process or plastics molding process, for example. In all embodiments intended for use in a surgical setting, the rotatable riser shaft 200, riser head 300 and retention members 305 extending therefrom are manufactured of materials capable of adequate sterilization for introduction into an operating room during surgery. In certain embodiments, the materials of manufacture for the rotatable riser shaft 200 and riser head 300 are capable of withstanding sterilization environments of at least 250 degrees Celsius without degradation. These materials may be for example, but are not limited to, Teflon® coated anodized aluminum, stainless steel, polyetheretherketone (PEEK), polythermide (Ultem), polysulfone, polyphenylsulfone, acetal copolymer (Celcon), ultra-high molecule weight polyethylene (UHMW) and other medical grade plastics.
Similarly, the first bevel gear 120 and second bevel gear 125 require no lubrication therebetween and therefore qualify for full sterilization in an autoclave or other sterilization process. To preclude the requirement for lubrication, the first bevel gear 120 and second bevel gear 125 are manufactured from dissimilar materials manifesting dissimilar surface treatments and capable of withstanding at least 250 degrees Celsius without degradation. For example, in one embodiment, the first bevel gear 120 is manufactured from hard anodized Teflon® dipped aluminum and the second bevel gear is manufactured from stainless steel. Alternatively, in another embodiment, the first bevel gear 120 may be manufactured from stainless steel and the second bevel gear 125 may be manufactured from hard anodized Teflon® dipped aluminum. Any number of material combinations are suitable for manufacturing the first bevel gear 120 and second bevel gear 125 such as but not limited to anodized aluminum, stainless steel, polyetheretherketone (PEEK), polythermide (Ultem), polysulfone, polyphenylsulfone, acetal copolymer (Celcon), ultra-high molecule weight polyethylene (UHMW) and other medical grade plastics.
Furthermore, using two bevel gears rather than, for example, a spiral and worm gear, prevents seizing or gear stripping caused by increased torque resulting from too great a gear tooth pitch angle. For example, in one embodiment, the first bevel gear 120 and the second bevel gear 125 present teeth oriented at a standard pitch angle of twenty degrees, which further assists with eliminating a need for lubrication. The present invention also addresses the challenge of selecting an appropriate gear ratio for achieving sufficient rotation speed without stripping the bevel gears 120, 125 or requiring the inclusion of additional moving parts. In certain embodiments, the gear ratio of the first bevel gear 120 to the second bevel gear 125 is between 1:3 and 1:7 and more preferably is 1:5. Such a gear ratio enables sufficient rotational speeds, for example up to 1000 rpm and more preferably between 300 and 700 rpm, to force separation between tissue components without introducing undue stresses on the non-lubricated moving components within the gearbox 100. The spinning apparatus 10 of the present invention therefore combines an optimal gear ratio with an optimal materials combination to enable centrifuging a biological sample at a desired rate of revolution to reduce the sample to its constituent components. These key design characteristics further enable sterilization of components of the spinning apparatus 10 so that the spinning apparatus 10 may be assembled quickly, employed and disassembled quickly and all within a sterile operating room.
The ability to assemble and disassemble the spinning apparatus 10 easily and quickly at the point of surgery addresses a major shortcoming presented by prior art centrifuges and spinners incapable of processing similar volumes of tissue safely and effectively within a sterile operating room. The present invention therefore comprises an assembly method 400 for efficiently manually assembling and disassembling the spinning apparatus 10 without requiring any tools or complex instructions for completion. The spinning apparatus 10 comprises a finite number of non-interchangeable parts so that component interactions are readily apparent to a user constructing the spinning apparatus 10 according to at least the following embodiment of the assembly method 400 of the present invention.
In one embodiment, depicted in
The assembly method 400 further comprises a step S420 of mounting a rotatable riser shaft 200 through the first aperture 150 so that the shaft 200 extends into and through the cavity 115. At a step S425, the rotatable riser shaft 200 mounts co-axially to a second bevel gear 125 having a stem 127 seated within the second aperture 155 extending through the second wall 160 of the housing 110. The method comprises mating a proximal end 210 of the riser shaft 200 coaxially with the second bevel gear 125 such that the axis of rotation of the second bevel gear 125 is perpendicular to the axis of rotation 135 of the second first bevel gear 120 and so that the teeth of the second bevel gear 125 enmesh with the teeth of the first bevel gear 125. In other embodiments, the rotatable riser shaft 200 may mount to the second bevel gear 125 so that their axes are not coaxial, but for simplicity of the gearing mechanism for rotating the shaft 200, the riser shaft 200 and second bevel gear 125 are preferably coaxial.
The embodiment of the method of assembly 400 of
Returning to
Although the second aperture 155 is described in this embodiment as extending through the second wall 160, in other embodiments, the second aperture 155 may comprise a recess in the second wall 160 without extending therethrough all the way to create an open ended tunnel. In embodiments, the method may further comprise a step of lining the second aperture 155 with a gear bushing 180 and lining the first aperture 150 with a distal shaft bushing 185. Additionally, embodiments of the assembly method further comprise disposing a coaxial riser head bearing 315 and/or a clutch 320 atop the riser shaft 200 and between the riser shaft 200 and the riser head 300. Additionally, embodiments of the assembly method further comprise disposing a large gear bushing 190 in the first aperture 150. In one embodiment, all of the bushings 180, 185, 190 are sized such that each bushing only fits in a specific aperture 150,155, 165. In other embodiments, the apertures 150, 155, 165 may be identically sized so that the bushings 180, 185, 190 are interchangeable. In some embodiments, the bushings 180, 185, 190 are manufactured of a surgical plastic capable of sterilization, such as, but not limited to, polyetheretherketone (PEEK), polythermide (Ultem), polysulfone, polyphenylsulfone, acetal copolymer (Celcon), ultra-high molecule weight polyethylene (UHMW) and other medical grade plastics.
Although steps S405-S420 are recited in a particular order, other embodiments of the method of assembly 400 may comprise an alternate ordering of some or all of the method steps.
Returning now to embodiments of the modular spinning apparatus 10 of present invention, in one embodiment, the drive shaft 145 may extend outward to include a handle 195 thereon or fixedly engaged therewith for manual rotation by hospital personnel. The handle 195 may be modular in some embodiments, such as the embodiment of
Embodiments of the spinning apparatus 10 further comprise means for selectively attaching the apparatus 10 to a solid support surface during use to prevent the apparatus 10 from tipping during the centrifuging process. In one embodiment, the attachment means comprises a slot 500 in the second wall 160 of the housing 100 that accommodates an attachment clamp 510 best depicted in
It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words, which have been used herein, are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.
