US20190343112A1 - Cutting Apparatus for Bioprocessing Bone - Google Patents
Cutting Apparatus for Bioprocessing Bone Download PDFInfo
- Publication number
- US20190343112A1 US20190343112A1 US16/409,808 US201916409808A US2019343112A1 US 20190343112 A1 US20190343112 A1 US 20190343112A1 US 201916409808 A US201916409808 A US 201916409808A US 2019343112 A1 US2019343112 A1 US 2019343112A1
- Authority
- US
- United States
- Prior art keywords
- cutting
- bone
- cutting element
- blades
- cutting blades
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1604—Chisels; Rongeurs; Punches; Stamps
- A61B17/1606—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other
- A61B17/1608—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
- A61B17/1611—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other the two jaw elements being integral with respective elongate shaft elements
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0652—Cells of skeletal and connective tissues; Mesenchyme
- C12N5/0669—Bone marrow stromal cells; Whole bone marrow
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2509/00—Methods for the dissociation of cells, e.g. specific use of enzymes
- C12N2509/10—Mechanical dissociation
Definitions
- the present disclosure concerns an apparatus useful for recovering live bone marrow.
- Bone marrow for clinical purposes is harvested from HLA matched siblings or optimally matched unrelated donors (MUD). Other graft sources are mismatched haploidentical related or unrelated donors and umbilical cord blood (CB).
- HSCs hematopoietic stern cells
- Bone marrow is also a source for mesenchymal stromal/stem cells (MSCs) which are self-renewing, multipotent progenitor cells with multilineage potential to differentiate into cell types of mesodermal origin, such as adipocytes, osteocytes, and chondrocytes.
- MSCs mesenchymal stromal/stem cells
- adipocytes adipocytes
- osteocytes osteocytes
- chondrocytes chondrocytes.
- MSCs mesenchymal stromal/stem cells
- bone marrow is typically collected through a hole created in the outer bone with a trocar needle.
- a bone marrow aspiration needle is then introduced into the hole and a syringe is used to draw the marrow out of the bone.
- the syringes are then removed from the sterile field and connected to a collection bag containing anticoagulants.
- the marrow is pushed into the bag. This step is repeated many times, typically in both pelvic bones, and can often result in contamination of the aspirate.
- bone marrow can be cryopreserved and banked for future use.
- a cryoprotectant agent such as dimethyl sulfoxide (DMSO) with or without a carbohydrate, such as hydroxyethyl starch (HES), in a balanced electrolyte solution with or without a protein supplement, such as human or animal serum, platelet lysate, or albumin and with or without added growth factors.
- CPA cryoprotectant agent
- DMSO dimethyl sulfoxide
- HES hydroxyethyl starch
- a protein supplement such as human or animal serum, platelet lysate, or albumin and with or without added growth factors.
- Cells are cooled slowly ( ⁇ 1° C. to ⁇ 5° C./min) down to an intermediate, low sub-zero temperature and then transferred to final storage in vapor or liquid nitrogen.
- Optimal cryopreservation techniques for bone marrow should be effective when applied to the whole tissue, with the idea that stem cells would be isolated following thawing, assuming adequate permeation of the cells to the CPA. Immediate cryopreservation of tissues is more practical than direct primary isolation of stem cells, which requires further processing and expense.
- cryopreserved whole bone it is often optimal to cryopreserved whole bone to be subsequently processed for extraction of the bone marrow.
- the bone To adequately cryopreserve bone for subsequent post thaw processing, the bone must be cooled very slowly (with cryoprotective agents) e.g. with cooling rates of ⁇ 0.1° to ⁇ 4.0° C. per min.
- cryoprotective agents e.g. with cooling rates of ⁇ 0.1° to ⁇ 4.0° C. per min.
- rapid warming e.g. >50° C./min.
- cooling rates can readily be applied in a slow manner, warming large volumes of bone quickly is problematic. Consequently, there is a need for an apparatus that can reduce the whole cryopreserved bone to smaller pieces that can then be placed into a warming medium immediately to allow rapid thaw.
- an apparatus which can be used to process the bone and recover bone marrow to a cellular suspension prior to cryopreservation, or to enable the cryopreservation of whole bone to be subsequently processed.
- the apparatus allows either a fresh bone or a cryopreserved bone to be cut into pieces appropriately sized for further fresh processing or rapid thawing.
- the apparatus is manually operated with a linkage arrangement or a lever arm and rack and pinion arrangement providing a mechanical advantage or leverage sufficient to cut through bone with only manual effort.
- the present disclosure provides a bone cutting apparatus that comprises a lower cutting element configured to support a bone segment to be cut and an upper cutting element including a plurality of cutting blades facing the lower cutting element.
- a frame supports the upper cutting element above the lower cutting element for movement toward and away from the lower cutting element.
- the apparatus is provided with a manually operable handle and a force transmission mechanism connecting the handle to the upper cutting element to move the upper cutting element toward the lower cutting element with sufficient force to cut through the bone segment supported on the lower cutting element.
- the bone cutting apparatus includes upper and lower cutting elements, each with aligned cutting blades, in which the upper cutting element is pushed toward the stationary lower cutting element to cut through a bone segment positioned between the two elements.
- the upper cutting element is carried by a shaft that is connected to a linkage, that is in turn connected to a handle.
- the handle is pivotably mounted to the cutting apparatus so that pushing the handle downward pushes the upper cutting element downward with a mechanical advantage derived by the configuration of the handle and linkage.
- the upper cutting element is pushed by a handle applying force through a rack and pinion arrangement.
- a ratchet and pawl arrangement control the direction of movement of the rack that carries the upper cutting element.
- the upper cutting element includes replaceable blades and a stationary lower cutting tray that supports the bone segment to be cut.
- a collection container is disposed beneath the lower cutting tray to receive the bone fragments at the completion of the cutting operation.
- FIG. 1 is a perspective view of a bone cutting apparatus according to one embodiment of the present disclosure.
- FIG. 2 is a perspective view of the apparatus of FIG. 1 shown in one stage of operation.
- FIG. 3 is a perspective view of the apparatus of FIG. 1 shown in another stage of operation.
- FIG. 4 is a perspective view of the apparatus of FIG. 1 shown in a further stage of operation.
- FIG. 5 is an enlarged view of the apparatus shown in FIG. 4 .
- FIGS. 6A, 6B are side and top views of cutting elements for use in the apparatus of FIG. 1 .
- FIGS. 7A, 7B are side and top view of alternative cutting elements for use in the apparatus of FIG. 1 .
- FIGS. 8A, 8B are side and top view of further alternative cutting elements for use in the apparatus of FIG. 1 .
- FIGS. 9A, 9B, 9C and 9D are side, top and perspective views of another alternative cutting elements for use in the apparatus of FIG. 1 , with FIG. 9C showing the cutting elements in different stages of operation.
- FIG. 10 is a perspective view of a bone cutting apparatus according to another embodiment of the disclosure.
- FIG. 11 is a side partial cross-sectional view of the apparatus shown in FIG. 10 .
- FIG. 12 is an enlarged cross-sectional view of a portion of the apparatus shown in FIG. 10 .
- FIG. 13 is a top view of the apparatus shown in FIG. 10 .
- FIG. 14 is a side view of the apparatus shown in FIG. 10 .
- FIG. 15 is an enlarged view of a portion of the apparatus shown in FIG. 10 .
- FIG. 16 is an end view of the apparatus shown in FIG. 10 .
- FIG. 17 is an enlarged perspective view of a component of the apparatus shown in FIG. 10 .
- FIG. 18 is an enlarged side perspective view of an upper cutting element for use in the apparatus of FIG. 10 .
- FIG. 19 is a bottom perspective view of the upper cutting element shown in FIG. 18 .
- FIG. 20 is an enlarged perspective view of a cutting blade for use in the upper cutting element shown in FIGS. 18-19 .
- FIG. 21 is a perspective view of a bottom cutting tray for use in the apparatus shown in FIG. 10
- FIG. 22 is a top view of the bottom cutting tray shown in FIG. 21 .
- FIG. 23 is an enlarged perspective view of a base component of the apparatus shown in FIG. 10 .
- FIG. 24 is an enlarged perspective view of a collection container for use with the apparatus shown in FIG. 10 .
- FIG. 25 is an enlarged perspective view of a blade assembly assist component for use with the apparatus shown in FIG. 10 and the upper cutting element and cutting blade shown in FIG. 18-20 .
- FIG. 26 is an enlarged end view of a portion of the apparatus of FIG. 10 shown with a blade assembly assist component.
- An apparatus 10 is provided, as shown in FIG. 1 , for cutting a bone segment recovered from organ and tissue donors for subsequent processing.
- the apparatus includes a frame formed by a base plate 11 supporting four vertical columns 12 .
- the frame also includes a top plate 14 is mounted on the four vertical columns and an intermediate plate 16 is mounted to the columns at a position between the base plate and top plate.
- a bone cutting assembly 20 is provided between the base plate 11 and the intermediate plate 16 .
- the assembly 20 includes a lower cutter element 22 mounted on the base plate 11 .
- the lower cutter element is surrounded by a shroud 23 arranged to contain fragments of a whole bone segment B ( FIG. 2 ) generated in a cutting process.
- the assembly further includes a movable upper cutting element 30 that is also surrounded by a shroud 32 .
- the two shrouds 23 , 32 combine to form a chamber C to contain the whole bone segment during the cutting process, as shown in FIG. 3 .
- the upper shroud 32 can be configured to slide downward toward the lower shroud 23 with the respective edges 24 , 33 contacting each other, thereby closing the chamber C with the bone segment B inside.
- the edges 24 , 33 can have complementary configurations so that one edge nests within the other edge to ensure proper alignment of the two shrouds.
- the upper shroud 32 can include a plurality of vertical slots 34 that can receive a projection 41 a on each of the cutting blades 41 of the upper cutting element 30 .
- the projections 41 a on the blades can thus guide the upper shroud 32 as it is moved from its uppermost position shown in FIG. 2 to its closed position shown in FIG. 3 .
- the vertical slots 34 can then serve as a guide for the cutting blades 41 as the upper cutting element is moved from its uppermost position shown in FIG. 3 to its cutting position shown in FIG. 4 .
- the two shrouds are preferably formed of a transparent material, such as glass or certain plastics, to enable viewing of the whole bone segment prior to cutting and of the bone fragments after the cutting process.
- the upper cutting element 30 is carried by a shaft 35 that extends through and is guided by a bore 36 in the intermediate plate 16 .
- the upper end of the shaft 35 is pivotably connected to a linkage 40 that is pivotably connected to a handle 42 .
- the handle 42 includes a hand grip portion 42 a that is mounted or affixed at a generally perpendicular angle to a plate 42 b, as best seen in FIG. 4 .
- the plate 42 b is pivotably mounted to the top plate 14 of the apparatus.
- the handle 42 is configured to be manually grasped and pivoted downward, which in turn pivots the linkage 40 about the end of the shaft in a direction opposite to the pivot direction of the handle, to thereby move the shaft 35 , and thus the upper cutter element 30 , downward toward the lower cutter element 22 .
- the offset of the pivot connection of the linkage 40 to the handle 42 relative to the pivot connection of the handle 42 to the plate 16 provides a mechanical advantage that enables cutting through the bone segment B using only manual force.
- the bone segment B is placed on top of the lower cutter element within the chamber C defined by the two shrouds 23 , 32 .
- the upper cutter element 30 is pressed into the bone segment to cut the segment into the shapes and dimensions set by the blades 40 , 41 of the two cutter elements 22 , 30 , as depicted in FIG. 4 .
- the upper cutting element 30 can include a piston body 44 ( FIG. 3 ) to which the cutting blades 41 are mounted.
- the cutting blades 41 can be separate blades mounted to the piston body or can be part of a cutting blade component.
- the piston body 44 can be engaged to the lower end of the shaft 35 in a conventional manner, such as by a threaded engagement.
- a bushing 46 ( FIG. 4 ) can be affixed or mounted to the underside of the intermediate plate 16 to provide a bearing or sliding interface for the shaft 35 .
- the shaft 35 may be provided with vertical splines 35 a along the length of the shaft that engage mating vertical grooves (not shown) within the inner circumference of the bushing 46 to prevent rotation of the piston body 44 and cutting blades 41 during a cutting operation.
- the lower cutter element 22 can include a base 47 onto which the cutting blades 40 are mounted or affixed. As with the cutting blades 41 , the cutting blades 40 can be individually mounted to the base 47 or can be part of a cutting blade component.
- the base 47 is configured to be seated within a cavity or recess 48 defined in the bottom plate 11 , as shown in FIG. 1 . In this way, the lower cutting element 22 can be interchangeable or replaceable.
- the base 47 and recess 48 can include an alignment feature, such as a notch and complementary projection (not shown) to ensure a particular orientation of the cutting blades 40 , and in particular to ensure that the cutting blades 40 are aligned with their counterpart cutting blades 41 in the upper cutting element 30 .
- the splines 35 a of the shaft 35 can include one spline that is larger than the others to mate with a correspondingly deeper groove in the bushing to align the upper cutter element 30 .
- the key in the alignment features is that the cutting edges of the upper blades 41 are in direct alignment with the cutting edges of the lower blades 40 to properly cut through the bone segment B as the upper cutter element 30 is pushed toward the lower cutter element 22 .
- FIGS. 6A, 6B show four blades defining a “+” configuration.
- the cutting edges of the lower and upper cutting blades can have the configuration of the cutting edge 40 a shown in FIG. 6A in which the blade is angled on both sides of the blade to a sharp edge and in which the edge 40 a is linear and generally perpendicular to the vertical cutting direction.
- FIGS. 7 a , 7 b show an embodiment with six cutting blades having the same cutting edge configuration as the cutting edge 40 a in FIG. 6A .
- FIGS. 8 a , 8 b show an embodiment with eight cutting blades having the same cutting edge configuration as the cutting edge 40 a in FIG. 6A .
- the lower cutting element 22 ′ only includes the base 47 ′ and does not include the cutting blades 40 of the previous embodiments.
- the upper cutting element 30 ′ includes cutting blades 41 ′ that have an angled cutting edge 41 a ′.
- the angled cutting edges 41 a ′ of all of the cutting blades 41 ′ converge at a central point 41 b ′ that can facilitate the initial entry of the upper cutter element 30 ′ into the bone segment, as depicted in FIG. 9C .
- the base 47 ′ of the lower cutter element 22 ′ includes a plurality of slots 47 a ′ that correspond with and are aligned with the cutting blades 41 ′ of the upper cutter element 30 .
- the blades 41 ′ penetrate the slots 47 a ′ so that the entire angled edge 41 a ′ ( FIG. 9A ) of the blades are within the slots, as in “Position 3 ” in FIG. 9C .
- the upper and lower cutter elements can have a combined cutting height of about 2.5-3.0 inches in order to cut through bone segments B of the same height.
- the cutting blades can have a thickness of about 0.12 inches, tapering to a sharp point.
- the angled cutting edges can be angled at about 15° relative to the horizontal.
- FIGS. 10-26 A bone cutting apparatus 50 according to another embodiment of the disclosure is shown in FIGS. 10-26 .
- the apparatus 50 includes a mounting plate 52 with handles 53 that allow the apparatus to be carried to different locations in a sterile bone processing facility.
- a base 55 is mounted to the mounting plate 52 by thumb screws 56 to permit ready disassembly and assembly of the apparatus.
- a post 57 is mounted to the base 55 to extend vertically above the plate 52 .
- the post 57 defines a shoulder 58 ( FIG. 11 ) on which is mounted a pinion mount 60 .
- the pinion mount 60 supports a rack 62 for vertical movement relative to the plate 52 . As shown in FIG.
- the rack 62 engages a pinion gear 64 that is formed on a pinion shaft 65 ( FIG. 17 ) so that rotation of the pinion gear 64 produces vertical movement of the rack 62 .
- a rack spring 75 and a rack bearing 76 provide a lateral force to hold the rack 62 in toothed engagement with the pinion gear 64 .
- the pinion shaft 65 includes a ratchet gear 70 that is engaged by a pawl 71 , as shown in FIGS. 12, 13, 15 .
- a torsion spring 72 biases the claw 71 a of the pawl 71 into engagement with the ratchet gear to hold the ratchet gear 70 and thus the pinion shaft 65 against rotation in one direction, while permitting rotation in the opposite direction.
- the ratchet gear and pawl are configured to permit rotation of the shaft 65 and the pinon gear 64 in the clockwise direction to drive the rack 62 downward.
- the claw 71 a of the pawl prevents counter-clockwise rotation of the pinion gear, which thereby prevents upward vertical movement of the rack 62 .
- the thumbwheel knob 77 ( FIGS. 12, 16 ) is mounted to the end of the pinion shaft 65 and can be manually rotated to rotate the pinion gear 64 in the counter-clockwise direction to raise the rack 62 .
- the ratchet gear 70 and thus the pinion shaft 65 , are manually rotated in the clockwise direction (as shown in FIG. 11 ) by way of a handle 74 fastened to a handle mount 73 , as shown in FIGS. 11-16 .
- the handle mount 73 is pivotably supported on the pinion shaft 65 , as best seen in FIG. 12 , and the pawl 71 is fixed to the handle mount 73 so that the pawl can be rotated relative to the pinion shaft.
- this rotation of the handle mount causes rotation of the ratchet gear 70 and thus rotation of the pinion shaft and pinion gear 64 .
- the handle 74 has a fulcrum length of 18-20 inches, which provides a leverage ratio of at least 27:1 between the force applied to push the handle down and the downward force applied by the vertical movement of the rack 62 when cutting through bone, as described in more detail herein.
- the pinion gear 64 can have an outer diameter of 1.375 inches with twelve gear teeth, while the rack can include 20 gear teeth configured to match the profile of the pinion gear teeth. The rack teeth thus span a length of 6.219 inches in the specific embodiment to thereby provide a rack travel distance of about six inches.
- the bone cutting assembly 50 is provided with an upper cutting assembly 80 and a lower cutting assembly 82 ( FIGS. 10-11 ).
- the upper cutting assembly is configured to be moved toward the lower cutting assembly to cut a bone segment B positioned between the two assemblies, as shown in FIG. 10 .
- the upper cutting assembly 80 includes an upper blade mounting plate 84 that is slidably mounted on two guide posts 86 that are themselves supported on the base 55 .
- the plate 84 can include a pair of bushings 85 to slidably receive the posts, as best seen in FIG. 11 .
- Each post includes concentrically mounted springs 87 disposed between the upper blade mounting plate 84 and the base 55 .
- the springs 87 help ensure uniform movement of the upper blade mounting plate 84 toward the base and provides a return force to lift the plate after the cutting operation is completed.
- the upper blade mounting plate 84 is fastened to the bottom of the rack 62 by a mounting bolt 90 so that the plate moves with the rack.
- this force is transmitted through the pawl, ratchet gear, pinion gear and rack to move the upper blade mounting plate 84 downward against the upward force of the springs 87 .
- the upper blade mounting plate 84 is configured to receive a removable and replaceable upper cutter base 92 , as shown in FIGS. 11, 18, 19 .
- the cutter base defines a channel 94 which receives the upper blade mounting plate 84 to fix the side-to-side position of the cutter base 92 relative to the mounting plate 84 .
- Bolt holes 94 receive mounting bolts 95 ( FIG. 11 ) that pass through aligned bolt holes in the mounting plate 84 to fasten the cutter base 92 to the mounting plate. It can thus be understood that different upper cutter bases may be provided with the bone cutting apparatus 50 of the present disclosure, each having the same channel 93 and bolt holes 94 for attachment to the upper blade mounting plate 84 .
- the cutter base 92 includes a fixed blade 96 projecting from the underside of the cutter base.
- the fixed blade incudes angled cutting edges 97 that converge to an apex 98 at the center of the cutter base 92 and that are configured to cut through bone.
- the cutter base 92 includes a plurality of T-shaped slots 99 extending radially from the center of the base to the outer perimeter of the base.
- the T-shaped slots are configured to receive replaceable cutter blades 88 , shown in FIG. 20 .
- the replaceable blades 88 include an upper rib 100 that is configured to be slidably received within a T-slot 99 of the cutter base 92 .
- Each cutter blade 88 defines a cutting edge 101 configured to cut through bone.
- the cutter blades 88 are configured so that the cutting edges 101 are angled upward toward the center of the cutter base, in contrast to the fixed blade 96 in which the cutting edges 97 are angled downward toward the center. Moreover, the cutting edges 101 of the replaceable blades 88 are offset upward from the apex 98 of the fixed cutter blade 96 , as shown in FIG. 11 .
- the fixed blade 96 contacts the bone segment first, followed by the replaceable blades 88 as the upper cutting assembly 80 is advanced downward toward the bone segment. It can be appreciated that the replaceable blades 88 can have cutting edges with different configurations from the cutting edge 101 shown in the illustrated embodiment.
- blades lots 99 can be provided in the upper cutter base 92 to receive different numbers of replaceable cutting blades 88 .
- four replaceable blades are provided along with the fixed blade 96 to provided six cutting edges 97 , 101 .
- the blade slots 99 in this embodiment are offset at 60° intervals, but other angular offsets are contemplated, including non-uniform angular offsets of the blades.
- the upper cutting assembly 80 is driven toward the lower cutting assembly 82 to cut a bone segment B positioned between the two assemblies.
- the lower cutting assembly includes a cutting tray 110 that is removably mounted in the base 55 , as illustrated in FIG. 11 .
- the base 55 defines aside opening cavity 113 with a ledge 112 for supporting the tray 110 above the cavity 113 .
- the cavity is sized to receive a removable collection container 115 ( FIG. 24 ) that can be placed below the tray and subsequently removed by a handle 116 .
- the ledge 112 more than 180°, and preferably about 240°, so that the cutting tray 110 is firmly retained within the base 55 during a cutting operation.
- the cutting tray 110 can include a circular rim 120 configured to be seated on the ledge 112 .
- the rim 120 can define one or more alignment recesses 121 that are configured to receive an alignment post 122 fastened to the base 55 ( FIGS. 10, 13 ).
- the alignment recesses and post fix the angular orientation of the cutting tray 110 relative to the upper cutting assembly 80 and upper cutting blades 88 , 96 .
- the cutting tray defines a plurality of slots 125 converging to a center opening 126 , as shown in FIG. 21 .
- the slots 125 are arranged to receive a corresponding cutting blade 88 , 96 as the upper cutting assembly 80 is pushed through the bone segment B.
- the slots thus ensure that the blades pass completely through the bone segment to produce the requisite bone fragments. It can be appreciated that the number and angular arrangement of the slots 125 must coincide with the number and angular arrangement of the cutting blades of the upper cutting assembly 80 .
- the cutting tray 110 defines a ledge 130 which supports a cutting guard 132 ( FIGS. 10, 11 ).
- the cutting guard can be formed of a transparent material so that the cutting operation can be observed.
- a blade assembly assist component 140 is provided for mounting the upper cutter base 92 to the blade mounting plate 84 , as shown in FIG. 26 .
- the assist component 140 includes a plurality of bosses 141 that define blade slots 142 between the bosses.
- the bosses 141 further define support surfaces 144 on which the upper cutter base 92 is placed with the cutting blades 88 , 96 extending into the slots 142 .
- Alignment posts 104 ( FIGS. 10, 26 ) are mounted in openings 103 in the cutter base 92 and are arranged to flank the sides of the upper blade mounting plate 84 . The alignment posts 104 ensure that the bolts 95 in the mounting plate 84 are aligned with the bolt holes 94 in the upper cutter base 92 .
- the upper cutter base 92 with the full complement of cutting blades is placed on the blade assembly assist component 140 with the cutting blades facing downward into the slots 142 .
- the assist component 140 is placed on the cutting tray 110 with the mounting face of the cutter base 92 facing the upper blade mounting plate 84 .
- the handle 74 is pushed downward to move the mounting plate 84 downward toward the assist component 140 until the bolts 95 contact the bolt holes 94 in the cutter base 92 .
- the bolts can then be tightened to draw the cutter base 92 into engagement with the mounting plate 84 .
- the pawl 71 is then depressed to release the rack and pinion, and the knob 77 is rotated counter-clockwise in FIG. 11 to raise the rack 62 and thus the upper blade mounting plate 84 with the cutter base 92 and cutting blades 88 , 96 mounted thereto.
- the blade assembly assist component 140 can then be removed from the cutting tray 110 .
- the bone cutting apparatus 50 can be used to cut a bone segment B into several fragments, even if the bone segment is frozen.
- the segment B is placed on the cutting tray 110 of the lower cutting assembly 82 , as shown in FIG. 11 .
- the bone segment is contained within the cutting guard 132 .
- the upper cutting assembly 80 is outfitted with the desired cutting blades. As explained above, manually pushing the handle 74 downward drives the upper cutting assembly 80 downward toward the cutting tray 110 .
- the cutting blades 88 , 96 contact the bone segment and cut through the bone segment as the handle is pushed further downward.
- the mechanical advantage or leverage provided by the length of the handle 74 and the gear ratio between the rack 62 and pinion gear 64 allows a frozen bone segment to be cut into discrete fragments with only manual force.
- the ratchet gear 70 and pawl 71 arrangement allows the operator to push the handle down in intervals, rather than having to cut through the bone in a single motion. Once the cutting blades have passed through the bone segment, the pawl can be depressed to release the ratchet and thus the pinion gear 64 . The springs 87 will push the upper blade mounting plate 84 upward somewhat, with the operator rotating the knob 77 to lift the rack 62 and upper cutting assembly 80 to its maximum upward position offset from the lower cutting assembly 82 . The pawl 71 can be re-engaged to the ratchet gear 70 to hold the upper cutting assembly at this uppermost position ready for another bone cutting operation.
- the cutting tray 110 can be configured so that the bone fragments fall into the collection container 115 positioned within the cavity 113 in the base 55 beneath the upper cutting assembly.
- the cutting tray can be configured like the base 47 ′ shown in FIG. 9D in which pie-shaped opening are defined between the parts of the base forming the slots 47 a ′ or receiving the upper cutting blades.
- the cutting tray 110 can be lifted from the base 55 and the bone fragments dumped into the collection container 115 .
- the bone cutting apparatuses 10 , 50 are configured to cut through a bone segment, such as the bones of the pelvis, the long bones and vertebral bodies.
- the force required to cut through such bone is typically 800-900 lbf.
- the apparatuses of the present disclosure provide a force transmission mechanism from the user-operated handles 42 , 74 to the upper cutting assemblies 20 , 80 .
- the force transmission mechanisms allow the typical operator to generate up to 1000 lbf by applying less than 50 lbf to the handle, which is well within the capability of most operators.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dentistry (AREA)
- Biotechnology (AREA)
- Chemical & Material Sciences (AREA)
- Transplantation (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Developmental Biology & Embryology (AREA)
- Hematology (AREA)
- Microbiology (AREA)
- Rheumatology (AREA)
- Immunology (AREA)
- Cell Biology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Physical Education & Sports Medicine (AREA)
- Mechanical Engineering (AREA)
- Environmental Sciences (AREA)
- Surgical Instruments (AREA)
Abstract
Description
- This application is a utility filing from and claims priority to co-pending application No. 62/670,283, filed on May 11, 2018, the entire disclosure of which is incorporated herein by reference.
- The present disclosure concerns an apparatus useful for recovering live bone marrow.
- Bone marrow for clinical purposes is harvested from HLA matched siblings or optimally matched unrelated donors (MUD). Other graft sources are mismatched haploidentical related or unrelated donors and umbilical cord blood (CB). When transplanted into patients with certain diseases, the hematopoietic stern cells (HSCs) in the donor bone marrow engraft in the patient and reconstitute immune and hematopoietic systems.
- Bone marrow is also a source for mesenchymal stromal/stem cells (MSCs) which are self-renewing, multipotent progenitor cells with multilineage potential to differentiate into cell types of mesodermal origin, such as adipocytes, osteocytes, and chondrocytes. In addition, MSCs can migrate to sites of inflammation and exert potent immunosuppressive and anti-inflammatory effects through interactions between lymphocytes associated with both the innate and adaptive immune system.
- Currently bone marrow is typically collected through a hole created in the outer bone with a trocar needle. A bone marrow aspiration needle is then introduced into the hole and a syringe is used to draw the marrow out of the bone. The syringes are then removed from the sterile field and connected to a collection bag containing anticoagulants. The marrow is pushed into the bag. This step is repeated many times, typically in both pelvic bones, and can often result in contamination of the aspirate.
- Once recovered, bone marrow can be cryopreserved and banked for future use. This is typically done using a cryoprotectant agent (CPA) such as dimethyl sulfoxide (DMSO) with or without a carbohydrate, such as hydroxyethyl starch (HES), in a balanced electrolyte solution with or without a protein supplement, such as human or animal serum, platelet lysate, or albumin and with or without added growth factors. Cells are cooled slowly (−1° C. to −5° C./min) down to an intermediate, low sub-zero temperature and then transferred to final storage in vapor or liquid nitrogen.
- Optimal cryopreservation techniques for bone marrow should be effective when applied to the whole tissue, with the idea that stem cells would be isolated following thawing, assuming adequate permeation of the cells to the CPA. Immediate cryopreservation of tissues is more practical than direct primary isolation of stem cells, which requires further processing and expense.
- It is often optimal to cryopreserved whole bone to be subsequently processed for extraction of the bone marrow. To adequately cryopreserve bone for subsequent post thaw processing, the bone must be cooled very slowly (with cryoprotective agents) e.g. with cooling rates of −0.1° to −4.0° C. per min. However, to successfully recover live cells rapid warming is required (e.g. >50° C./min). While cooling rates can readily be applied in a slow manner, warming large volumes of bone quickly is problematic. Consequently, there is a need for an apparatus that can reduce the whole cryopreserved bone to smaller pieces that can then be placed into a warming medium immediately to allow rapid thaw.
- To enable cryopreservation of whole bone and facilitate subsequent processing of the bone, an apparatus is provided which can be used to process the bone and recover bone marrow to a cellular suspension prior to cryopreservation, or to enable the cryopreservation of whole bone to be subsequently processed. The apparatus allows either a fresh bone or a cryopreserved bone to be cut into pieces appropriately sized for further fresh processing or rapid thawing. In one embodiment, the apparatus is manually operated with a linkage arrangement or a lever arm and rack and pinion arrangement providing a mechanical advantage or leverage sufficient to cut through bone with only manual effort.
- The present disclosure provides a bone cutting apparatus that comprises a lower cutting element configured to support a bone segment to be cut and an upper cutting element including a plurality of cutting blades facing the lower cutting element. A frame supports the upper cutting element above the lower cutting element for movement toward and away from the lower cutting element. The apparatus is provided with a manually operable handle and a force transmission mechanism connecting the handle to the upper cutting element to move the upper cutting element toward the lower cutting element with sufficient force to cut through the bone segment supported on the lower cutting element.
- In one embodiment, the bone cutting apparatus includes upper and lower cutting elements, each with aligned cutting blades, in which the upper cutting element is pushed toward the stationary lower cutting element to cut through a bone segment positioned between the two elements. The upper cutting element is carried by a shaft that is connected to a linkage, that is in turn connected to a handle. The handle is pivotably mounted to the cutting apparatus so that pushing the handle downward pushes the upper cutting element downward with a mechanical advantage derived by the configuration of the handle and linkage.
- In another embodiment, the upper cutting element is pushed by a handle applying force through a rack and pinion arrangement. A ratchet and pawl arrangement control the direction of movement of the rack that carries the upper cutting element. In this embodiment, the upper cutting element includes replaceable blades and a stationary lower cutting tray that supports the bone segment to be cut. A collection container is disposed beneath the lower cutting tray to receive the bone fragments at the completion of the cutting operation.
-
FIG. 1 is a perspective view of a bone cutting apparatus according to one embodiment of the present disclosure. -
FIG. 2 is a perspective view of the apparatus ofFIG. 1 shown in one stage of operation. -
FIG. 3 is a perspective view of the apparatus ofFIG. 1 shown in another stage of operation. -
FIG. 4 is a perspective view of the apparatus ofFIG. 1 shown in a further stage of operation. -
FIG. 5 is an enlarged view of the apparatus shown inFIG. 4 . -
FIGS. 6A, 6B are side and top views of cutting elements for use in the apparatus ofFIG. 1 . -
FIGS. 7A, 7B are side and top view of alternative cutting elements for use in the apparatus ofFIG. 1 . -
FIGS. 8A, 8B are side and top view of further alternative cutting elements for use in the apparatus ofFIG. 1 . -
FIGS. 9A, 9B, 9C and 9D are side, top and perspective views of another alternative cutting elements for use in the apparatus ofFIG. 1 , withFIG. 9C showing the cutting elements in different stages of operation. -
FIG. 10 is a perspective view of a bone cutting apparatus according to another embodiment of the disclosure. -
FIG. 11 is a side partial cross-sectional view of the apparatus shown inFIG. 10 . -
FIG. 12 is an enlarged cross-sectional view of a portion of the apparatus shown inFIG. 10 . -
FIG. 13 is a top view of the apparatus shown inFIG. 10 . -
FIG. 14 is a side view of the apparatus shown inFIG. 10 . -
FIG. 15 is an enlarged view of a portion of the apparatus shown inFIG. 10 . -
FIG. 16 is an end view of the apparatus shown inFIG. 10 . -
FIG. 17 is an enlarged perspective view of a component of the apparatus shown inFIG. 10 . -
FIG. 18 is an enlarged side perspective view of an upper cutting element for use in the apparatus ofFIG. 10 . -
FIG. 19 is a bottom perspective view of the upper cutting element shown inFIG. 18 . -
FIG. 20 is an enlarged perspective view of a cutting blade for use in the upper cutting element shown inFIGS. 18-19 . -
FIG. 21 is a perspective view of a bottom cutting tray for use in the apparatus shown inFIG. 10 -
FIG. 22 is a top view of the bottom cutting tray shown inFIG. 21 . -
FIG. 23 is an enlarged perspective view of a base component of the apparatus shown inFIG. 10 . -
FIG. 24 is an enlarged perspective view of a collection container for use with the apparatus shown inFIG. 10 . -
FIG. 25 is an enlarged perspective view of a blade assembly assist component for use with the apparatus shown inFIG. 10 and the upper cutting element and cutting blade shown inFIG. 18-20 . -
FIG. 26 is an enlarged end view of a portion of the apparatus ofFIG. 10 shown with a blade assembly assist component. - For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the disclosure is thereby intended. It is further understood that the present disclosure includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles disclosed herein as would normally occur to one skilled in the art to which this disclosure pertains
- An
apparatus 10 is provided, as shown inFIG. 1 , for cutting a bone segment recovered from organ and tissue donors for subsequent processing. The apparatus includes a frame formed by abase plate 11 supporting fourvertical columns 12. The frame also includes atop plate 14 is mounted on the four vertical columns and anintermediate plate 16 is mounted to the columns at a position between the base plate and top plate. Abone cutting assembly 20 is provided between thebase plate 11 and theintermediate plate 16. Theassembly 20 includes alower cutter element 22 mounted on thebase plate 11. The lower cutter element is surrounded by ashroud 23 arranged to contain fragments of a whole bone segment B (FIG. 2 ) generated in a cutting process. The assembly further includes a movableupper cutting element 30 that is also surrounded by ashroud 32. The twoshrouds FIG. 3 . In particular, theupper shroud 32 can be configured to slide downward toward thelower shroud 23 with therespective edges edges - The
upper shroud 32 can include a plurality ofvertical slots 34 that can receive aprojection 41 a on each of thecutting blades 41 of theupper cutting element 30. Theprojections 41 a on the blades can thus guide theupper shroud 32 as it is moved from its uppermost position shown inFIG. 2 to its closed position shown inFIG. 3 . In the closed position, thevertical slots 34 can then serve as a guide for thecutting blades 41 as the upper cutting element is moved from its uppermost position shown inFIG. 3 to its cutting position shown inFIG. 4 . In one feature, the two shrouds are preferably formed of a transparent material, such as glass or certain plastics, to enable viewing of the whole bone segment prior to cutting and of the bone fragments after the cutting process. - The
upper cutting element 30 is carried by ashaft 35 that extends through and is guided by abore 36 in theintermediate plate 16. The upper end of theshaft 35 is pivotably connected to alinkage 40 that is pivotably connected to ahandle 42. Thehandle 42 includes ahand grip portion 42 a that is mounted or affixed at a generally perpendicular angle to aplate 42 b, as best seen inFIG. 4 . Theplate 42 b is pivotably mounted to thetop plate 14 of the apparatus. Thehandle 42 is configured to be manually grasped and pivoted downward, which in turn pivots thelinkage 40 about the end of the shaft in a direction opposite to the pivot direction of the handle, to thereby move theshaft 35, and thus theupper cutter element 30, downward toward thelower cutter element 22. The offset of the pivot connection of thelinkage 40 to thehandle 42 relative to the pivot connection of thehandle 42 to theplate 16 provides a mechanical advantage that enables cutting through the bone segment B using only manual force. As shown inFIG. 2 , the bone segment B is placed on top of the lower cutter element within the chamber C defined by the twoshrouds upper cutter element 30 is pressed into the bone segment to cut the segment into the shapes and dimensions set by theblades cutter elements FIG. 4 . - The
upper cutting element 30 can include a piston body 44 (FIG. 3 ) to which thecutting blades 41 are mounted. Thecutting blades 41 can be separate blades mounted to the piston body or can be part of a cutting blade component. Thepiston body 44 can be engaged to the lower end of theshaft 35 in a conventional manner, such as by a threaded engagement. A bushing 46 (FIG. 4 ) can be affixed or mounted to the underside of theintermediate plate 16 to provide a bearing or sliding interface for theshaft 35. Theshaft 35 may be provided withvertical splines 35 a along the length of the shaft that engage mating vertical grooves (not shown) within the inner circumference of thebushing 46 to prevent rotation of thepiston body 44 and cuttingblades 41 during a cutting operation. - The
lower cutter element 22 can include a base 47 onto which thecutting blades 40 are mounted or affixed. As with thecutting blades 41, thecutting blades 40 can be individually mounted to the base 47 or can be part of a cutting blade component. Thebase 47 is configured to be seated within a cavity orrecess 48 defined in thebottom plate 11, as shown inFIG. 1 . In this way, thelower cutting element 22 can be interchangeable or replaceable. Thebase 47 andrecess 48 can include an alignment feature, such as a notch and complementary projection (not shown) to ensure a particular orientation of thecutting blades 40, and in particular to ensure that thecutting blades 40 are aligned with theircounterpart cutting blades 41 in theupper cutting element 30. Thesplines 35 a of theshaft 35 can include one spline that is larger than the others to mate with a correspondingly deeper groove in the bushing to align theupper cutter element 30. The key in the alignment features is that the cutting edges of theupper blades 41 are in direct alignment with the cutting edges of thelower blades 40 to properly cut through the bone segment B as theupper cutter element 30 is pushed toward thelower cutter element 22. - Several different configurations of cutting
blades upper cutter elements FIGS. 6A, 6B . The cutting edges of the lower and upper cutting blades can have the configuration of thecutting edge 40 a shown inFIG. 6A in which the blade is angled on both sides of the blade to a sharp edge and in which theedge 40 a is linear and generally perpendicular to the vertical cutting direction.FIGS. 7a, 7b show an embodiment with six cutting blades having the same cutting edge configuration as thecutting edge 40 a inFIG. 6A .FIGS. 8a, 8b show an embodiment with eight cutting blades having the same cutting edge configuration as thecutting edge 40 a inFIG. 6A . - In an alternative embodiment shown in
FIGS. 9A-9E , thelower cutting element 22′ only includes the base 47′ and does not include thecutting blades 40 of the previous embodiments. In this alternative embodiment, theupper cutting element 30′ includes cuttingblades 41′ that have an angledcutting edge 41 a′. The angled cutting edges 41 a′ of all of thecutting blades 41′ converge at acentral point 41 b′ that can facilitate the initial entry of theupper cutter element 30′ into the bone segment, as depicted inFIG. 9C . In order to ensure a solid cut completely through the bone segment B, the base 47′ of thelower cutter element 22′ includes a plurality ofslots 47 a′ that correspond with and are aligned with thecutting blades 41′ of theupper cutter element 30. When the upper cutter element has been pushed through the bone segment B, theblades 41′ penetrate theslots 47 a′ so that the entireangled edge 41 a′ (FIG. 9A ) of the blades are within the slots, as in “Position 3” inFIG. 9C . - In specific embodiments, the upper and lower cutter elements can have a combined cutting height of about 2.5-3.0 inches in order to cut through bone segments B of the same height. The cutting blades can have a thickness of about 0.12 inches, tapering to a sharp point. In the embodiment of
FIGS. 9A-9E , the angled cutting edges can be angled at about 15° relative to the horizontal. - A
bone cutting apparatus 50 according to another embodiment of the disclosure is shown inFIGS. 10-26 . As shown inFIG. 10 , theapparatus 50 includes a mountingplate 52 withhandles 53 that allow the apparatus to be carried to different locations in a sterile bone processing facility. Abase 55 is mounted to the mountingplate 52 bythumb screws 56 to permit ready disassembly and assembly of the apparatus. Apost 57 is mounted to the base 55 to extend vertically above theplate 52. Thepost 57 defines a shoulder 58 (FIG. 11 ) on which is mounted apinion mount 60. Thepinion mount 60 supports arack 62 for vertical movement relative to theplate 52. As shown inFIG. 11 , therack 62 engages apinion gear 64 that is formed on a pinion shaft 65 (FIG. 17 ) so that rotation of thepinion gear 64 produces vertical movement of therack 62. Arack spring 75 and arack bearing 76 provide a lateral force to hold therack 62 in toothed engagement with thepinion gear 64. - The
pinion shaft 65 includes aratchet gear 70 that is engaged by apawl 71, as shown inFIGS. 12, 13, 15 . Atorsion spring 72 biases the claw 71 a of thepawl 71 into engagement with the ratchet gear to hold theratchet gear 70 and thus thepinion shaft 65 against rotation in one direction, while permitting rotation in the opposite direction. Thus, as viewed inFIG. 11 , the ratchet gear and pawl are configured to permit rotation of theshaft 65 and thepinon gear 64 in the clockwise direction to drive therack 62 downward. The claw 71 a of the pawl prevents counter-clockwise rotation of the pinion gear, which thereby prevents upward vertical movement of therack 62. Counter-clockwise rotation of thepinion gear 64, and thus upward movement of therack 62, can be permitted by depressing thepawl 71 against thetorsion spring 72 to release the claw from theratchet gear 70. The thumbwheel knob 77 (FIGS. 12, 16 ) is mounted to the end of thepinion shaft 65 and can be manually rotated to rotate thepinion gear 64 in the counter-clockwise direction to raise therack 62. - The
ratchet gear 70, and thus thepinion shaft 65, are manually rotated in the clockwise direction (as shown inFIG. 11 ) by way of ahandle 74 fastened to ahandle mount 73, as shown inFIGS. 11-16 . Thehandle mount 73 is pivotably supported on thepinion shaft 65, as best seen inFIG. 12 , and thepawl 71 is fixed to thehandle mount 73 so that the pawl can be rotated relative to the pinion shaft. However, when the claw 71 a of the pawl is engaged to theratchet gear 70, this rotation of the handle mount causes rotation of theratchet gear 70 and thus rotation of the pinion shaft andpinion gear 64. In particular pushing thehandle 74 downward toward the mountingplate 52 produces the clockwise rotation of thepinion gear 64, leading to the downward movement of therack 62. In one specific embodiment, thehandle 74 has a fulcrum length of 18-20 inches, which provides a leverage ratio of at least 27:1 between the force applied to push the handle down and the downward force applied by the vertical movement of therack 62 when cutting through bone, as described in more detail herein. Thepinion gear 64 can have an outer diameter of 1.375 inches with twelve gear teeth, while the rack can include 20 gear teeth configured to match the profile of the pinion gear teeth. The rack teeth thus span a length of 6.219 inches in the specific embodiment to thereby provide a rack travel distance of about six inches. - In accordance with this embodiment, the
bone cutting assembly 50 is provided with anupper cutting assembly 80 and a lower cutting assembly 82 (FIGS. 10-11 ). The upper cutting assembly is configured to be moved toward the lower cutting assembly to cut a bone segment B positioned between the two assemblies, as shown inFIG. 10 . Theupper cutting assembly 80 includes an upperblade mounting plate 84 that is slidably mounted on twoguide posts 86 that are themselves supported on thebase 55. Theplate 84 can include a pair ofbushings 85 to slidably receive the posts, as best seen inFIG. 11 . Each post includes concentrically mountedsprings 87 disposed between the upperblade mounting plate 84 and thebase 55. Thesprings 87 help ensure uniform movement of the upperblade mounting plate 84 toward the base and provides a return force to lift the plate after the cutting operation is completed. The upperblade mounting plate 84 is fastened to the bottom of therack 62 by a mountingbolt 90 so that the plate moves with the rack. Thus, when the operator pushes thehandle 74 downward, this force is transmitted through the pawl, ratchet gear, pinion gear and rack to move the upperblade mounting plate 84 downward against the upward force of thesprings 87. - The upper
blade mounting plate 84 is configured to receive a removable and replaceableupper cutter base 92, as shown inFIGS. 11, 18, 19 . The cutter base defines achannel 94 which receives the upperblade mounting plate 84 to fix the side-to-side position of thecutter base 92 relative to the mountingplate 84. Bolt holes 94 receive mounting bolts 95 (FIG. 11 ) that pass through aligned bolt holes in the mountingplate 84 to fasten thecutter base 92 to the mounting plate. It can thus be understood that different upper cutter bases may be provided with thebone cutting apparatus 50 of the present disclosure, each having thesame channel 93 and bolt holes 94 for attachment to the upperblade mounting plate 84. - As shown in
FIGS. 18, 19 , thecutter base 92 includes a fixedblade 96 projecting from the underside of the cutter base. The fixed blade incudes angled cuttingedges 97 that converge to an apex 98 at the center of thecutter base 92 and that are configured to cut through bone. Thecutter base 92 includes a plurality of T-shapedslots 99 extending radially from the center of the base to the outer perimeter of the base. The T-shaped slots are configured to receivereplaceable cutter blades 88, shown inFIG. 20 . Thereplaceable blades 88 include anupper rib 100 that is configured to be slidably received within a T-slot 99 of thecutter base 92. Eachcutter blade 88 defines acutting edge 101 configured to cut through bone. In the illustrated embodiment, thecutter blades 88 are configured so that the cuttingedges 101 are angled upward toward the center of the cutter base, in contrast to the fixedblade 96 in which the cutting edges 97 are angled downward toward the center. Moreover, the cuttingedges 101 of thereplaceable blades 88 are offset upward from the apex 98 of the fixedcutter blade 96, as shown inFIG. 11 . In a bone cutting operation, the fixedblade 96 contacts the bone segment first, followed by thereplaceable blades 88 as theupper cutting assembly 80 is advanced downward toward the bone segment. It can be appreciated that thereplaceable blades 88 can have cutting edges with different configurations from thecutting edge 101 shown in the illustrated embodiment. It can also be appreciated that different numbers ofblades lots 99 can be provided in theupper cutter base 92 to receive different numbers ofreplaceable cutting blades 88. In the illustrated embodiment, four replaceable blades are provided along with the fixedblade 96 to provided sixcutting edges blade slots 99 in this embodiment are offset at 60° intervals, but other angular offsets are contemplated, including non-uniform angular offsets of the blades. - The
upper cutting assembly 80 is driven toward thelower cutting assembly 82 to cut a bone segment B positioned between the two assemblies. The lower cutting assembly includes a cuttingtray 110 that is removably mounted in thebase 55, as illustrated inFIG. 11 . Thebase 55 defines aside openingcavity 113 with aledge 112 for supporting thetray 110 above thecavity 113. The cavity is sized to receive a removable collection container 115 (FIG. 24 ) that can be placed below the tray and subsequently removed by ahandle 116. As shown inFIG. 23 , theledge 112 more than 180°, and preferably about 240°, so that the cuttingtray 110 is firmly retained within thebase 55 during a cutting operation. The cuttingtray 110 can include acircular rim 120 configured to be seated on theledge 112. Therim 120 can define one or more alignment recesses 121 that are configured to receive analignment post 122 fastened to the base 55 (FIGS. 10, 13 ). The alignment recesses and post fix the angular orientation of the cuttingtray 110 relative to theupper cutting assembly 80 andupper cutting blades slots 125 converging to acenter opening 126, as shown inFIG. 21 . Theslots 125 are arranged to receive acorresponding cutting blade upper cutting assembly 80 is pushed through the bone segment B. The slots thus ensure that the blades pass completely through the bone segment to produce the requisite bone fragments. It can be appreciated that the number and angular arrangement of theslots 125 must coincide with the number and angular arrangement of the cutting blades of theupper cutting assembly 80. The cuttingtray 110 defines aledge 130 which supports a cutting guard 132 (FIGS. 10, 11 ). The cutting guard can be formed of a transparent material so that the cutting operation can be observed. - A blade assembly assist
component 140 is provided for mounting theupper cutter base 92 to theblade mounting plate 84, as shown inFIG. 26 . As shown inFIG. 25 , theassist component 140 includes a plurality ofbosses 141 that defineblade slots 142 between the bosses. Thebosses 141 further define support surfaces 144 on which theupper cutter base 92 is placed with thecutting blades slots 142. Alignment posts 104 (FIGS. 10, 26 ) are mounted inopenings 103 in thecutter base 92 and are arranged to flank the sides of the upperblade mounting plate 84. The alignment posts 104 ensure that thebolts 95 in the mountingplate 84 are aligned with the bolt holes 94 in theupper cutter base 92. As shown inFIG. 26 , theupper cutter base 92 with the full complement of cutting blades is placed on the blade assembly assistcomponent 140 with the cutting blades facing downward into theslots 142. Theassist component 140 is placed on the cuttingtray 110 with the mounting face of thecutter base 92 facing the upperblade mounting plate 84. Thehandle 74 is pushed downward to move the mountingplate 84 downward toward theassist component 140 until thebolts 95 contact the bolt holes 94 in thecutter base 92. The bolts can then be tightened to draw thecutter base 92 into engagement with the mountingplate 84. Thepawl 71 is then depressed to release the rack and pinion, and the knob 77 is rotated counter-clockwise inFIG. 11 to raise therack 62 and thus the upperblade mounting plate 84 with thecutter base 92 and cuttingblades component 140 can then be removed from the cuttingtray 110. - The
bone cutting apparatus 50 can be used to cut a bone segment B into several fragments, even if the bone segment is frozen. The segment B is placed on the cuttingtray 110 of thelower cutting assembly 82, as shown inFIG. 11 . The bone segment is contained within the cuttingguard 132. Theupper cutting assembly 80 is outfitted with the desired cutting blades. As explained above, manually pushing thehandle 74 downward drives theupper cutting assembly 80 downward toward the cuttingtray 110. Thecutting blades handle 74 and the gear ratio between therack 62 andpinion gear 64 allows a frozen bone segment to be cut into discrete fragments with only manual force. Theratchet gear 70 andpawl 71 arrangement allows the operator to push the handle down in intervals, rather than having to cut through the bone in a single motion. Once the cutting blades have passed through the bone segment, the pawl can be depressed to release the ratchet and thus thepinion gear 64. Thesprings 87 will push the upperblade mounting plate 84 upward somewhat, with the operator rotating the knob 77 to lift therack 62 andupper cutting assembly 80 to its maximum upward position offset from thelower cutting assembly 82. Thepawl 71 can be re-engaged to theratchet gear 70 to hold the upper cutting assembly at this uppermost position ready for another bone cutting operation. - The cutting
tray 110 can be configured so that the bone fragments fall into thecollection container 115 positioned within thecavity 113 in thebase 55 beneath the upper cutting assembly. For instance, the cutting tray can be configured like the base 47′ shown inFIG. 9D in which pie-shaped opening are defined between the parts of the base forming theslots 47 a′ or receiving the upper cutting blades. Alternatively, the cuttingtray 110 can be lifted from thebase 55 and the bone fragments dumped into thecollection container 115. - The
bone cutting apparatuses handles upper cutting assemblies - The present disclosure should be considered as illustrative and not restrictive in character. It is understood that only certain embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the disclosure are desired to be protected.
Claims (19)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US16/409,808 US20190343112A1 (en) | 2018-05-11 | 2019-05-11 | Cutting Apparatus for Bioprocessing Bone |
US17/079,309 US10980547B2 (en) | 2018-05-11 | 2020-10-23 | Cutting apparatus for bioprocessing bone |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201862670283P | 2018-05-11 | 2018-05-11 | |
US16/409,808 US20190343112A1 (en) | 2018-05-11 | 2019-05-11 | Cutting Apparatus for Bioprocessing Bone |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/079,309 Continuation US10980547B2 (en) | 2018-05-11 | 2020-10-23 | Cutting apparatus for bioprocessing bone |
Publications (1)
Publication Number | Publication Date |
---|---|
US20190343112A1 true US20190343112A1 (en) | 2019-11-14 |
Family
ID=68465162
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US16/409,808 Abandoned US20190343112A1 (en) | 2018-05-11 | 2019-05-11 | Cutting Apparatus for Bioprocessing Bone |
US17/079,309 Active US10980547B2 (en) | 2018-05-11 | 2020-10-23 | Cutting apparatus for bioprocessing bone |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US17/079,309 Active US10980547B2 (en) | 2018-05-11 | 2020-10-23 | Cutting apparatus for bioprocessing bone |
Country Status (1)
Country | Link |
---|---|
US (2) | US20190343112A1 (en) |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10980547B2 (en) | 2018-05-11 | 2021-04-20 | Ossium Health, Inc. | Cutting apparatus for bioprocessing bone |
US10995318B2 (en) | 2019-04-15 | 2021-05-04 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
CN114128823A (en) * | 2021-12-08 | 2022-03-04 | 玉树州治多阿米雪乳业发展有限公司 | Yak bone processing disinfection device and disinfection process |
CN114258938A (en) * | 2021-12-27 | 2022-04-01 | 天长市海旺食品有限公司 | Meat processing is with supplementary saw bone device |
US11744243B2 (en) | 2020-10-14 | 2023-09-05 | Ossium Health, Inc. | Systems and methods for extraction and cryopreservation of bone marrow |
US11786558B2 (en) | 2020-12-18 | 2023-10-17 | Ossium Health, Inc. | Methods of cell therapies |
US11896005B2 (en) | 2020-07-18 | 2024-02-13 | Ossium Health, Inc. | Warming cryopreserved bone |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US1002826A (en) | 1911-04-06 | 1911-09-12 | Allen De Vilbiss | Bone-forceps. |
US1604695A (en) * | 1925-05-04 | 1926-10-26 | George N Hein | Surgical instrument |
US2472103A (en) * | 1945-03-13 | 1949-06-07 | Josef H Giesen | Modified bone screw holder for surgical drills |
US3507284A (en) * | 1967-08-17 | 1970-04-21 | Leonard Simmons | Surgical bone cutter |
DE3673996D1 (en) | 1986-04-29 | 1990-10-11 | Link Waldemar Gmbh Co | MEDICAL BONE REMOVAL INSTRUMENT. |
US5496324A (en) * | 1994-06-20 | 1996-03-05 | Zimmer, Inc. | Proximal body milling apparatus |
US5766177A (en) * | 1996-04-02 | 1998-06-16 | Oceaneering International, Inc. | Rongeur |
US20100063500A1 (en) * | 2008-09-05 | 2010-03-11 | Tyco Healthcare Group Lp | Apparatus, System and Method for Performing an Electrosurgical Procedure |
US9265565B2 (en) * | 2011-11-29 | 2016-02-23 | Covidien Lp | Open vessel sealing instrument and method of manufacturing the same |
US20190343112A1 (en) | 2018-05-11 | 2019-11-14 | Ossium Health, Inc. | Cutting Apparatus for Bioprocessing Bone |
-
2019
- 2019-05-11 US US16/409,808 patent/US20190343112A1/en not_active Abandoned
-
2020
- 2020-10-23 US US17/079,309 patent/US10980547B2/en active Active
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10980547B2 (en) | 2018-05-11 | 2021-04-20 | Ossium Health, Inc. | Cutting apparatus for bioprocessing bone |
US10995318B2 (en) | 2019-04-15 | 2021-05-04 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11085024B2 (en) | 2019-04-15 | 2021-08-10 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11104882B2 (en) | 2019-04-15 | 2021-08-31 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11447750B2 (en) | 2019-04-15 | 2022-09-20 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11697799B2 (en) | 2019-04-15 | 2023-07-11 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11702637B2 (en) | 2019-04-15 | 2023-07-18 | Ossium Health, Inc. | System and method for extraction and cryopreservation of bone marrow |
US11896005B2 (en) | 2020-07-18 | 2024-02-13 | Ossium Health, Inc. | Warming cryopreserved bone |
US11744243B2 (en) | 2020-10-14 | 2023-09-05 | Ossium Health, Inc. | Systems and methods for extraction and cryopreservation of bone marrow |
US11786558B2 (en) | 2020-12-18 | 2023-10-17 | Ossium Health, Inc. | Methods of cell therapies |
CN114128823A (en) * | 2021-12-08 | 2022-03-04 | 玉树州治多阿米雪乳业发展有限公司 | Yak bone processing disinfection device and disinfection process |
CN114258938A (en) * | 2021-12-27 | 2022-04-01 | 天长市海旺食品有限公司 | Meat processing is with supplementary saw bone device |
Also Published As
Publication number | Publication date |
---|---|
US10980547B2 (en) | 2021-04-20 |
US20210037810A1 (en) | 2021-02-11 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10980547B2 (en) | Cutting apparatus for bioprocessing bone | |
US8967513B1 (en) | Systems and methods for processing cells | |
US6767740B2 (en) | Stem cell and dental pulp harvesting method and apparatus | |
US11697799B2 (en) | System and method for extraction and cryopreservation of bone marrow | |
CN105269615B (en) | Automatic umbilical cord Huatong glue dicer | |
US20140053664A1 (en) | Apparatus and methods for aliquotting frozen samples | |
CRABBÉ et al. | Freezing of testicular tissue as a minced suspension preserves sperm quality better than whole‐biopsy freezing when glycerol is used as cryoprotectant | |
Walmsley et al. | The first births and ongoing pregnancies associated with sperm cryopreservation within evacuated egg zonae | |
US20120273526A1 (en) | Dispenser device | |
US20090202976A1 (en) | Amniopunch and uses thereof | |
US20100199863A1 (en) | Cherry pitter | |
WO2015161057A1 (en) | Systems and methods for processing cells | |
Esteves | Microdissection TESE versus conventional TESE for men with nonobstructive azoospermia undergoing sperm retrieval | |
Aoki et al. | Improved in vitro fertilization embryo quality and pregnancy rates with intracytoplasmic sperm injection of sperm from fresh testicular biopsy samples vs. frozen biopsy samples | |
CN104703572B (en) | Tissue for obtaining stem cell is reclaimed, stored and explant culture apparatus | |
US7753927B2 (en) | Corneal punch | |
CN212589915U (en) | Intervertebral disc organ cryopreservation box | |
Ladinsky | Micromanipulator-assisted vitreous cryosectioning and sample preparation by high-pressure freezing | |
US20170191906A1 (en) | Biological tissue cutting device and use thereof | |
David et al. | Fertility Preservation in 2016: Where Are We? | |
CN205514832U (en) | Bone is transplanted to get and is planted ware | |
CN220568263U (en) | Adjustable weighing device for weighing biological materials | |
CN111602649A (en) | Intervertebral disc organ cryopreservation box | |
Boone et al. | Freezing of mammalian embryos without the aid of a programmable freezer | |
Uzay et al. | Comparison of Single Day Versus Two and Three Day Fractionated Infusion of Peripheral Stem Cells in Autologous Transplantation |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: OSSIUM HEALTH, INC, CALIFORNIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:WOODS, ERIK J.;JOHNSTONE, BRIAN;INGALLS, JOSEPH;REEL/FRAME:049181/0629 Effective date: 20190513 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |
|
AS | Assignment |
Owner name: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT, MARYLAND Free format text: CONFIRMATORY LICENSE;ASSIGNOR:OSSIUM HEALTH INC;REEL/FRAME:064548/0833 Effective date: 20210325 |