An allograft includes bone, tendon, skin, or other types of tissue that is transplanted from one person to another. Allografts are used in a variety of medical treatments, such as knee replacements, bone grafts, spinal fusions, eye surgery, and skin grafts for the severely burned. Allografts come from voluntarily donated human tissue obtained from cadaveric donor-derived, living-related, or living-unrelated donors and can help patients regain mobility, restore function, enjoy a better quality of life, and even save lives in the case of cardiovascular tissue or skin.
Currently, no efficient mechanisms or methods exist for the rapid harvesting of periosteum from human long bones or for processing the periosteum into individual fibers that may then be implemented within surgical allografts. Existing tools and methods present time, efficiency, efficacy, and repeatability challenges.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key aspects or essential aspects of the claimed subject matter. Moreover, this Summary is not intended for use as an aid in determining the scope of the claimed subject matter.
One embodiment provides a composition of periosteum fibers for use in strengthening a surgical allograft prepared by a method comprising the following steps: (1) providing a human long bone including a diaphysis extending between two epiphyses and having an outer layer of a periosteum tissue; (2) removing the epiphyses and securing the diaphysis between two rotating live centers; (3) removing, using one of a plurality of harvesting tools selected from a harvesting and processing kit, the periosteum tissue from the diaphysis; (4) executing a first wash cycle comprising washing the periosteum tissue in a hydrogen peroxide solution; (5) executing a second wash cycle comprising washing the periosteum tissue in an isopropyl alcohol solution; (6) executing a third wash cycle comprising washing the periosteum tissue in a phosphate buffered saline (PBS); (7) compressing the periosteum tissue; (8) cryofracturing the periosteum tissue into a quantity of fused periosteum fibers; and (9) separating the quantity of the fused periosteum fibers into a plurality of individual periosteum fibers.
Another embodiment provides a method of harvesting and processing bulk periosteum tissue. The method may include the following steps: (1) removing, using one or more harvesting tools, a quantity of bulk periosteum tissue from an outer surface of a human long bone; (2) first washing the quantity of the bulk periosteum tissue in a volume of hydrogen peroxide; (3) second washing the quantity of the bulk periosteum tissue in a volume of isopropyl alcohol; (4) third washing the quantity of the bulk periosteum tissue in a volume of phosphate buffered saline (PBS); (5) compressing the quantity of the bulk periosteum tissue; (6) cryofracturing the quantity of the bulk periosteum tissue until the quantity of the bulk periosteum tissue comprises a plurality of individual periosteum fibers; and (7) using a fiber separator tool to separate the plurality of the individual periosteum fibers from one another.
Yet another embodiment provides a method for harvesting and processing periosteum tissue, including the following: (1) providing a periosteum harvesting and processing kit comprising a plurality of periosteum harvesting tools configured for removing an outer layer of periosteum tissue from a human long bone, at least one sieve, at least one compression tool, and a periosteum fiber separator; (2) using at least one of the plurality of the periosteum harvesting tools, removing the periosteum tissue from the human long bone; (3) thrice repeating a first hydrogen peroxide wash cycle; (4) first drying the periosteum tissue; (5) twice repeating a second isopropyl alcohol wash cycle; (6) second drying the periosteum tissue; (7) performing a third phosphate buffered saline (PBS) wash cycle; (8) third drying the periosteum tissue; (9) compressing the periosteum tissue using the at least one compression tool; (10) cryofracturing the periosteum tissue into a plurality of fused periosteum fibers; and (11) separating the plurality of the fused periosteum fibers into a plurality of individual periosteum fibers using the periosteum fiber separator.
Other embodiments are also disclosed.
Additional objects, advantages and novel features of the technology will be set forth in part in the description which follows, and in part will become more apparent to those skilled in the art upon examination of the following, or may be learned from practice of the technology.
Non-limiting and non-exhaustive embodiments of the present invention, including the preferred embodiment, are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified. Illustrative embodiments of the invention are illustrated in the drawings, in which:
Embodiments are described more fully below in sufficient detail to enable those skilled in the art to practice the system and method. However, embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. The following detailed description is, therefore, not to be taken in a limiting sense.
Various embodiments of the systems and methods described herein relate to efficiently and rapidly harvesting the periosteum 16 from human long bones 10 (
Turning to the exemplary embodiments shown in the figures,
In this regard,
Returning to
Next, the periosteum tissue 16 may undergo a second wash cycle (114) involving two repetitions of a second wash (116), each time with a 200 ml volume of 70% Isopropyl alcohol for 5 minutes with agitation. After each second wash (116), the periosteum 116 may be isolated or recovered with the 125-micron sieve 40 (118). Following the second repetition of the second wash (116) and the second sieve isolation (118), the periosteum tissue 16 may again be dried using pressure applied through one or more of the sterile absorbent wipes 36 (120).
After the second wash cycle (114), the periosteum tissue 16 undergoes a third wash cycle (122) involving a single third wash (124) with a 200 ml volume of phosphate buffered saline (PBS) for 5 minutes. After this third wash (124), the periosteum tissue 16 is isolated (126) using the 125-micron sieve 40 to remove the excess PBS. The periosteum tissue 16 is then dried using pressure (e.g., manual pressure) applied through one or more of the sterile absorbent wipes 36 (128).
After completing the first, second, and third wash cycles (106, 114, 122), the periosteum tissue 16 may be laid upon a clean sterile absorbent wipe 36 in a manner that results in the tissue having a consistent thickness (130). In one embodiment, the wipe 36 may folded or wrapped around the periosteum tissue 16 (132) before the wipe 36, containing the periosteum tissue 16 therein, is rolled through a space between two adjacent rollers 38 or other compression tools (134), thereby compressing the periosteum/wipe configuration and removing any excess fluids from the periosteum tissue 16. In one embodiment, the periosteum/wipe configuration is rolled at least five times through the rollers 38. After each pass, the rollers may be moved incrementally closer together to incrementally decrease the space between the rollers and provide a resulting incremental increase in periosteum tissue compression (136).
Once the periosteum tissue 16 has been rolled/compressed (134, 136), it may be removed from the sterile absorbent wipe 36 (138) using the sterile forceps 34 before being freeze fractured, or cryofractured (140), utilizing, in one embodiment, the cryofracturing method or a modification of the cryofracturing method disclosed in issued U.S. Pat. No. 9,801,976B2. With a limited volume of crushed dry ice added to a cryofracturing chamber, two-second pulses of cryofracturing may be applied until a desired fiber size of the periosteum tissue 16 is achieved. The crushed dry ice and periosteum fiber mixture are then removed from the cryofracturing chamber and laid on a clean sterile wipe 36 to allow for the dry ice to evaporate (142).
After complete evaporation of the dry ice (142), the clumps of bulk periosteum tissue 16, each formed of a plurality of fused periosteum fibers, may be separated into individual periosteum fibers (144) by processing the bulk tissue through a separation tool or separator that may be included in the periosteum harvesting and processing kit 30 of
As the bulk periosteum tissue 16 is passed into contact with an overlapping portion 53 of the first and the second blade sets 46a, 46b, the blades 46a, 46b impinge upon the clumps of periosteum tissue 16 such that a number of blade teeth 50 separate the tissue 16 into its individual fibers 21 as the blades 46a, 46b travel from a first end 17 to a second end 19 of the bulk periosteum tissue 16, as shown in
In another embodiment shown in
Using the systems and associated tools and methods of use described above, a technician or other allograft preparation professional may harvest periosteum tissue 16 from a human long bone 10 and process the tissue into individual periosteum fibers for later use in strengthening surgical allograft products in a manner that is quick, efficient, reliable, and repeatable.
Although the above embodiments have been described in language that is specific to certain structures, elements, compositions, and methodological steps, it is to be understood that the technology defined in the appended claims is not necessarily limited to the specific structures, elements, compositions and/or steps described. Rather, the specific aspects and steps are described as forms of implementing the claimed technology. Since many embodiments of the technology can be practiced without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended.
This application claims the benefit under 35 U.S.C. 119 (e) of U.S. Provisional Patent Application No. 62/732,210, filed Sep. 17, 2018 by Megan Maccagnan, Cameron Mattson, Cole Watkins, Adrian C. Samaniego, and William Maslanik for “SYSTEM AND METHODS FOR HARVESTING AND PROCESSING PERIOSTEUM FIBERS,” all of which patent application is hereby incorporated herein by reference.
Number | Date | Country | |
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62732210 | Sep 2018 | US |