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WO1997016118A1 - Systeme de collecte de matieres et ses utilisations - Google Patents

Systeme de collecte de matieres et ses utilisations Download PDF

Info

Publication number
WO1997016118A1
WO1997016118A1 PCT/US1996/003875 US9603875W WO9716118A1 WO 1997016118 A1 WO1997016118 A1 WO 1997016118A1 US 9603875 W US9603875 W US 9603875W WO 9716118 A1 WO9716118 A1 WO 9716118A1
Authority
WO
WIPO (PCT)
Prior art keywords
instrument
cuttings
bone
tip
cutting tool
Prior art date
Application number
PCT/US1996/003875
Other languages
English (en)
Inventor
William Casey Fox
Bryan Phillip Brooks
Original Assignee
Biomedical Enterprises, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biomedical Enterprises, Inc. filed Critical Biomedical Enterprises, Inc.
Priority to AU54271/96A priority Critical patent/AU714657B2/en
Priority to JP9517294A priority patent/JPH11514905A/ja
Priority to NZ306102A priority patent/NZ306102A/en
Priority to KR1019980703173A priority patent/KR19990067216A/ko
Priority to BR9611373-1A priority patent/BR9611373A/pt
Priority to EP96911365A priority patent/EP0859570A4/fr
Priority to US08/799,122 priority patent/US6071284A/en
Publication of WO1997016118A1 publication Critical patent/WO1997016118A1/fr
Priority to NO981940A priority patent/NO981940L/no
Priority to US09/494,872 priority patent/US6325806B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/025—Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1635—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for grafts, harvesting or transplants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1637—Hollow drills or saws producing a curved cut, e.g. cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00969—Surgical instruments, devices or methods used for transplantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/063—Measuring instruments not otherwise provided for for measuring volume

Definitions

  • the present invention relates to fields of use where cuttings are collected from the action of a cutting tool. Instrumentation and methods are provided for industrial and medical applications.
  • the present invention relates to surgical instrumentation and a method of use that allows skeletal tissue collection.
  • collected skeletal tissue may be processed and transplanted, preferably within the donor subject to provide an autologous transplant.
  • the surgical harvest of bone, with or without marrow components, is a further example of the need for instrumentation for collection of cuttings.
  • Harvested bone material is used in treatment of bone defects and diseases.
  • the goal of therapeutic transplantation of bone and bone marrow products is the induction or augmentation of bone growth and repair at a defect site or around an implant site.
  • Autogenous bone grafts are the gold standard against which all graft materials are measured. Acquisition of fresh autogenous bone transplant material provides all naturally available mitogens and growth factors in physiologic concentrations, viable mesenchymal and progenitor cell populations, and natural bone matrix. Autograft bone has greater osteogenic capacity than either allograft (tissue from donors of the same species) or xenograft (tissue from donors of different species). In comparison to frozen allogenic and decalcified allogenic bone, fresh autogenic cancellous bone grafts lead to healing in most instances. Autogenous bone grafts avoid the potential immunologic and infectious complications associated with allograft materials.
  • Bonutti US Patent 5,269,785, US Patent 5,403,31
  • Thimsen et al. US Patent 4,649,919, US Patent 4,844,064 relate to orthoscopic tissue removal.
  • Existing methods and associated deficiencies include: 1) genetically foreign bone and bone matrix often elicit an inflammatory response and immunogenic rejection, 2) freeze-dried bone implants from human donors are slow to vascularize and pose unacceptable risks of postoperative complications including disease transmission, 3) second-site surgery in the patient to obtain autografts often result in high morbidity and complications, 4) cortical bone implants are difficult to shape and conform to a defect site, 5) present bone harvest instrumentation and equipment are limited to trephines and curettes and limit quantity and quality while requiring second-site surgery, and 6) a deficiency exists in present synthetic bone matrix materials, such as compositions of calcium phosphate and calcium carbonate, silica glass, copolymers of polylactic and polyglycolic acid, and sea coral.
  • the present invention provides an instrument and methods for the collection of cuttings that result from the cutting action of cutting tools.
  • the instrument comprises a tip adapted for use with a cutting tool, and a collection chamber attachable to the tip for collecting and holding cuttings.
  • the instrument acts independently from the cutting tool by allowing cutting tool rotation along its longitudinal axis and translation of the cutting tool in and out through the instrument.
  • cuttings accumulate in the collection chamber.
  • adapted for use with a cutting tool is meant that the tip serves as a cutting tool guide, and can further serve as a cutting tool bearing.
  • the tip has a bore for fitting to a cutting tool.
  • aspects of the invention that cause the accumulation of cuttings in the collection chamber include channeling from the action of a cutting tool, pulling due to translation of the cutting tool, and flinging due to centripetal forces caused by rotation of the cutting tool.
  • An embodiment of the instrument further comprises a cap attachable to the collection chamber, the cap adapted for use with a cutting tool.
  • the cap serves as a cutting tool guide, and further may serve as a cutting tool bearing.
  • a cap may have a bore for fitting to a cutting tool, it may have a further attachment for mixing contents of the attachment with cuttings in the collection chamber.
  • the instrument may further comprise a wiper for wiping a cutting tool.
  • the wiper may have a flexible or rigid protrusion, and may be fittable into a wiper bushing that is attachable to the collection chamber or to the cap.
  • the protrusion for wiping a cutting tool may be flexible so as to contour to the cutting tool surface, such as a wire, a bristle, or a brush; or the protrusion may be rigid and formed to matchingly fit or contour to a flute or cross-sectional outline of a drill bit.
  • the protrusion for wiping a cutting tool may further consist of a finger that runs against the outside of the cutting tool to clear material and may be located near the junction of the tip and collection chamber.
  • aspects of the further embodiments of the invention that contribute to accumulation of cuttings in the collection chamber include the use of a wiper as herein described and use of suction from a vacuum line, for example. These aspects add the actions of wiping and sucking to the previously described actions of channeling, pulling, and flinging as means by which the present invention provides for the collection of cuttings resulting from the use of cutting tools.
  • the tip of the instrument may further comprise a tooth or a plurality of teeth for eliminating slippage on a cutting surface.
  • the tip may be a spherical tip or a swivel tip.
  • the instrument further comprises a concentrically oriented cutting tool.
  • cutting tool is meant a tool having a flute such as a drill bit, bur, grinder, rasp, reamer, milling cutter, and the like; and tools not having a flute, such as a hole saw.
  • concentrically oriented is meant that the tool fits into the body of the instrument so as to be substantially centered within the instrument.
  • the cutting tool may be fitted with an adjustable stop, preferably with a calibrated adjustable stop.
  • the cutting tool is a drill bit.
  • the drill bit may have a standard tip, or a tip with a first side and a second side, the first side having a straight cutting edge, and the second side having a row of grinding teeth.
  • the cutting tool may be rotated manually, however, the instrument may further comprise means for rotating the cutting tool for optimizing the cutting action for hardened materials such as metal.
  • a preferred means is an external motor.
  • the instrument further comprises an attachment for pushing cuttings out of the collection chamber through the tip for application to a site.
  • the attachment may be a plunger that is inserted through the cap.
  • the attachment may be a dual plunger that is inserted into the collection chamber after the cap has been removed.
  • the collection chamber may further comprise a means for measuring volume.
  • the collection chamber has a transparent or translucent wall and the means for measuring volume includes a volumetric marking on the wall.
  • Such an instrument may further comprise a plunger for packing collected cuttings so that packed volume may be measured.
  • Certain of the parts of the instrument may be advantageously fabricated as one unit so as to provide a disposable unit, for example.
  • Such units may include the tip, the collection chamber, and a wiper bushing; the tip and the collection chamber; or the cap, a wiper, and a wiper bushing.
  • a drill bit having a tip with a first side and a second side, the first side having a straight cutting edge, and the second side having a row of grinding teeth is a further aspect of the present invention.
  • Cuttings obtained by a process of using the instrument fitted with a cutting tool having said drill bit is another aspect of the invention.
  • the collection chamber further comprises an opening for connection to a vacuum line to provide suction.
  • skeletal tissue is harvested using the instrument provided.
  • the harvesting is performed aseptically so as to provide material for transplant.
  • skeletal tissue is meant bony or more or less cartilaginous framework of an organism, bone, bone marrow, cartilage, ligaments, spongy bone tissue, or tendon, including intrinsic physiological factors thereof, such as growth factors, blood, biochemical or cellular components or constituents.
  • aseptic conditions is meant those sterile or near sterile conditions as operative in a surgical setting.
  • aseptic would include sterilization of instruments, surfaces, solutions, and the like; use of sterile garments, masks, and the like: and filtering of ambient air, for example. Sterilization may be achieved by heat, ultraviolet light, alcohol swabbing, or use of germicides, for example.
  • a materials transplant system is another embodiment of the present invention.
  • the system comprises an instrument of the present invention with or without a wiper, fitted with a cutting tool, and means for moving cuttings to an alternate site of use, such as a site of implantation.
  • the cuttings are bone cuttings and the system is a sterile tissue transplant system.
  • the materials transplant system may further comprise means for processing tissue, such as an encapsulation nozzle, for example.
  • means for moving cuttings to an alternate site of use is meant any means of transporting cuttings from the site of harvest to a different site.
  • a method or use of a materials transplant system as described herein for aseptically transplanting skeletal tissue from a first site to a second site is another embodiment of the invention.
  • the method includes the steps of removing skeletal tissue aseptically from the first site using the materials transplant system herein described, and implanting the skeletal tissue aseptically at the second site.
  • the skeletal tissue may be processed before implanting at the second site, and the processing may include washing, grinding, tissue separation, acid addition, base addition, encapsulant addition, or therapeutic agents including but not limited to pharmaceuticals and growth factor addition.
  • the first site and the second site are within one subject so that the implant is an autologous transplant.
  • the instrument of the present invention is useful in any field of use where cuttings are collected. Cuttings may be collected because the materials being cut are precious, i.e., rare, 7 expensive, or have a special property, and where loss is undesirable. On the other hand, cuttings may be toxic or hazardous, and collection of such cuttings is desirable to minimize any hazard. Toxicity may be due to volatility, flammability, radioactivity, or due to biohazardous aspects, such as having a virus like the HIV virus, for example.
  • the instrument and methods of the present invention provide enhanced safety. Materials that are easily oxidized and present a fire hazard such as titanium, magnesium, and sodium can be collected safely in the system since oxygen pressure can be controlled within the system.
  • the design of the instrument minimizes any fire hazard by having a reduced access to oxygen in a substantially closed system.
  • Vacuum can be used to remove powdered cuttings and further reduce collection chamber oxygen tension. Furthermore, the collection system may be flushed with an inert gas such as argon, for minimizing combustion hazard.
  • an inert gas such as argon
  • microgravity is meant any environment having a force of gravity less than that found on the surface of the earth, for example, the space station environment.
  • the collection of cuttings of skeletal tissue is particularly contemplated in orthopaedic or dental applications where bone and/or marrow is to be drilled or aseptically harvested for subsequent medical use.
  • Harvested skeletal tissue may be used for transplants, for facilitating healing of bone defects, or for assisting implant acceptance. If harvested tissue is a biohazard, the present collection system enhances the safety of handling such tissue by keeping it substantially contained, until disposal.
  • Ceramic is meant a material made of silica-based ceramic, silica glass, calcium carbonate, calcium phosphate, hydroxyapatite, porcelain, or an aerospace ceramic, for example.
  • aerospace ceramic is meant materials such as fibrous refractory composite insulation, thermoplastic syntactic foam, ceramic matrix composite, or the like.
  • polymer is meant medical grade polymers such as polymethylmethacrylate, polycarbonate, polystyrene, polyvinylchloride, silicone elastomer, or the like.
  • the instrument of the present invention can be used by following the steps of an exemplary orthopaedic procedure as follows: 1) place the instrument on bone, to locate the cutting site, and provide a guide for the cutting tool, in this example, a drill bit, 2) place the drill bit into the instrument, 3) drill in a manner consistent with clinical practice, 4) withdraw the drill from the instrument, 5) hold the instrument at the drill site so as to align the bore of the tip and drill hole to allow ma ⁇ ow tissues including blood to well up into the tip and collection chamber, 6) remove the instrument from the site, 7) compact the harvested material within the instrument, 8) measure the volume of material collected, 9) extrude compacted material through the tip or withdraw it from the bore of the collection chamber, and 10) implant the material in a second site within the same patient.
  • the independence of the instrument from the drill bit is demonstrated in noting that the drill bit was used with the instrument in only three steps (2, 3 and 4), tissue was collected in three steps (3, 4 and 5) and tissue was manipulated within the device in 6 steps (3, 4, 5, 6, 7, 8 and 9).
  • the instrument was used to locate the site of drilling, brace the drill, guide the drill, control the depth of drilling through use of an adjustable stop, protect sunounding tissues from being caught by the edge of the drill, and to collect, protect, store and transport tissue in a sterile manner.
  • the instrument can be customized to specific cutting procedures and requirements, 2) the instrument facilitates rapid and easy volumetric quantitation of collected material, 3) the instrumentation facilitates the efficient utilization and placement of collected cuttings in an alternate site, 4) the invention eliminates the practice of discarding and waste of valuable materials, 5) the invention can be used with conventional drill motors and bits, 6) the invention efficiently combines three processes: channeling, pulling, and slinging to collect cuttings, 7) the invention is adaptable to numerous types of cutting tools, 8) the invention can be used to collect precious metal chips and dust, 9) the invention can be used to automatically collect radioactive material, 10) the invention can be used to reduce the likelihood of a fire when cutting oxidizable materials, 11) the invention can be used to locate and brace a cutting tool, 12) a flute wiper of the invention can rotate with the bit during rotation and translation, 13) the instrument can be held by hand, 14) the invention is independent from the cutting tool in many of its uses, and 15) efficient collection through the processes of
  • the invention allows harvest of cancellous and other bone and/or ma ⁇ ow material from multiple donor sites
  • the invention allows for optimal processing of viable collected skeletal tissue for transplantation by providing it in small pieces with a high surface area and washed in vital ma ⁇ ow elements
  • the invention minimizes biohazards associated with the disposal of human bone cuttings
  • the invention decreases patient morbidity by decreasing harvest time and allows the use of minimally invasive surgical procedures
  • the invention decreases mechanical stress concentration and probability of iatrogenic fracture and morbidity.
  • Fig. 1 shows a cross-sectional plane view of an embodiment of the instrument of the present invention having a drill bit placed therein.
  • Fig. 2 shows an exploded plane view with some components in cross-section of an embodiment of the invention.
  • Fig. 3a shows a cross-sectional plane view of a further embodiment of the invention adjacent to bone and prior to drilling.
  • Fig. 3b illustrates an embodiment of the invention during a harvesting operation.
  • the drill body (150) is being rotated at speed ( ⁇ ) in a clockwise direction.
  • Fig. 4a shows an exploded plane view with some components in cross-section of an embodiment of the invention.
  • Fig. 4b shows a plane view of a tip of an instrument with means to grip bone surface and pivot to provide a seal between the tip and bone.
  • Fig. 5a and 5b show a plane view of a fluted drill bit design that combines both grinding and cutting processes at the tip to optimize the mo ⁇ hology of cuttings and a large flute with low flute angle to facilitate movement of cuttings up the drill and within the tip (100).
  • Fig. 6 shows a schematic of an embodiment of the invention that provides for aseptic tissue transplantation from a first site to a second site using an instrument of the present invention.
  • Harvested tissue may be processed to further enhance its bone inductive potential.
  • Fig. 7 shows a dual plunger attachment within a collection chamber of an instrument of the present invention for extrusion of collected cuttings.
  • Fig. 8 shows a cross-sectional view of a dual plunger.
  • Fig. 9a shows a top view of a rotating drill flute wiper (600) with rigid flute protrusion (610) for drill bits with two conventional flutes.
  • Fig. 9b shows a top view of a rotating generic wiper (620) with flexible bristle-like protrusions (630) for use with a drill bit, tapered reamer, bur, rasp, or saw.
  • Fig. 9c shows a top view of a rotating reamer flute wiper (640) with rigid or flexible flute protrusions (650) for a multifluted reamer.
  • the present invention in one example of its prefe ⁇ ed embodiment, provides surgical instrumentation that acts as a cutting tool brace for efficient cutting and collection of skeletal tissue, including bone and cartilage tissue.
  • the invention further provides for transfer of harvested tissue to an implantation site.
  • the transplant is called an autologous transplant or an autograft.
  • This type of transplant is as close to ideal as can be achieved, since intrinsic growth factors and matrix material are provided, and the possibility of immune rejection is avoided.
  • the transplant is called an allogeneic transplant or allograft, and the possibility of immune rejection by the recipient subject exists.
  • An implantation site may be a structural defect or a site of an implant in a bone or cartilaginous site in a body, such as an orthopaedic implant or dental implant.
  • Freshly harvested bone or cartilage tissue can be described as being vital and having inductive potential. This means that freshly harvested tissue has growth factors and matrix material that, when implanted in the donor patient, stimulate bone or cartilage to heal.
  • Exemplary intrinsic growth factors and matrix material include, but are not limited to, transforming growth factor beta, fibroblast growth factor, bone mo ⁇ hogenetic proteins, biocompatible scaffolding, and natural matrix material to facilitate bone to bridge large fractures or fill defects. Growth factors, such as these and others, are contemplated as optionally being added to harvested material to further enhance bone healing at an implant site.
  • a surgical instrument of the present invention allows aseptic collection of bone and cartilage cuttings and comprises a tip (10, 100) that contacts bone and guides a cutting tool, a collection chamber (20, 110) that collects and holds bone cuttings, and a cap (30, 140) having a bore that acts as the upper cutting ton) (150) guide and bearing.
  • the tip (10, 100) and bearing cap (30, 140) center and allow a cutting tool (150) to be rotated and translated by hand, by using a handchuck, or by use of an external motor.
  • a cutting tool such as a drill bit (150)
  • the drill bit (150) inserts longitudinally through the body of the invention and serves to cut and grind bone cuttings (195) at its tip and translate the bone cuttings (195) up the tip into the tissue collection chamber (1 10).
  • sealing and “bearing” are used interchangeably herein to illustrate that the surface on which a cutting tool runs can be a simple bushing, or a roller bearing that turns with the cutting tool and has no sliding contact between the surface of the tool and the bearing.
  • the present invention efficiently combines three processes simultaneously to channel, pull, and fling cuttings resulting from the use of cutting tools into a collection chamber.
  • the instrument acts independently from the cutting tool by allowing cutting tool rotation along its longitudinal axis and translation of the cutting tool in and out of the entire instrument without being required to change the speed or translational characteristics of the drill and its motor.
  • cuttings are channeled through the action of flutes, pulled through translation of the bit, flung through centripetal forces caused by rotation of the bit, and may be withdrawn using a fourth process through evacuation of the collection chamber using suction.
  • a cutting tool may be a tool having a flute, such as for example, a drill bit, bur, grinder, rasp, reamer, milling cutter, or the like.
  • a wiper 130, 600, 620, 640 is provided for wiping cuttings (195) from a tool (170) causing the cuttings to be deposited into the collection chamber (110) when the cutting tool is removed from the instrument.
  • Use of a wiper adds a fifth process, that of wiping, to the herein described processes of channeling, pulling, flinging and sucking cuttings to more efficiently and completely clear all cuttings from the cutting tool.
  • the wiper (130, 600, 620, 640) may be designed so as to fit into the flutes (230) of the cutting tool.
  • the wiper (130, 600, 620, 640) is concentrically oriented with the cutting tool, and may have a protrusion (160, 610, 630, 650) in its bore that reaches into the flutes (230) of a cutting tool to wipe the flutes of cuttings when the cutting tool is pulled through the wiper.
  • the wiper (130, 600, 620, 640) is free to rotate within the collection chamber or an adjacent bearing housing, during cutting tool rotation or translation through the instrument.
  • a drill wiper (130, 600, 620, 640) turns with the drill bit (150) and allows drill bit (150) translation.
  • the drill wiper (130, 600, 620, 640) runs on an inner bore and is contained within a wiper bushing (120).
  • the drill flute wiper protrudes into the flutes of the drill bit to clear the flutes of bone cuttings and blood; the wiper rotates within the collection chamber during drill bit rotation and translation within the collection chamber.
  • Protrusions may be lobes (610, 650), hairs, wires, brushes (630), or threadlike projections (630).
  • a wiper (620) may be adapted to a tapered cutting tool.
  • the projections (630) are like the spokes on a wheel and flexible for adaptation to tapered reamers with one or more flutes. This wiper (620) turns in the housing so as to minimize rotational action of the bit against the spoke-like protrusions (630), while allowing translation and wiping of tapered fluted bits or reamers.
  • a reamer wiper (640) with i ⁇ egular flute-shaped protrusions (650) can be used with the instrument.
  • Cutting tools may also be tools lacking a flute, such as a hole saw.
  • Cylindrical saws having a bore and cutting teeth on one end are used to core material while cutting a round hole.
  • cut material moves up the bore of the saw until it enters a section of the saw bore that has a greater internal diameter than at the tip of the saw bore, where it accumulates in a collection chamber.
  • the collection chamber turns with the saw and inside a stationary housing.
  • the instrument would have a tip and a housing similar to the collection chamber of the prefe ⁇ ed embodiment through which the hole saw with collection chamber would rotate.
  • a cap fixed to the proximal end of the housing, would act as a bearing and end for the collection chamber within the saw.
  • the surgical instrument may further comprise an attachment that fits into the collection chamber that acts like a plunger (500, 510) to push bone cuttings (195) out of the collection chamber (20, 1 10) through the tip (10, 100) for application to a surgical site.
  • the plunger (500, 510) is translated through the bore of the collection chamber (20, 110) to force cuttings out the tip (10, 100).
  • the plunger face (530) is formed from pliable material and tapered at a more gentle angle than that of the collection chamber extrusion face (540) so that, upon contact, cuttings are first compressed at the periphery of the plunger face (530) to extrusion face (540) contact area.
  • the contact area grows in size and towards the tip (10, 100) bore. This action extrudes all materials into the tip (10, 100).
  • the tip is cleared with the tip plunger (500) once the collection chamber plunger (510) reaches full travel.
  • the instrument of the present invention may further comprise an attachment containing biocompatible materials, pharmaceuticals, or biologies for mixing with bone cuttings.
  • the attachment would fasten to the bore of the collection chamber (20, 1 10) and provide a means for mixing the contents of the attachment with the bone cuttings (195) within the collection chamber (20, 110).
  • the attachment may be configured with a screen for filtering cuttings by size, or a mixer to stir the contents of the attachment with bone cuttings (195).
  • the attachment can be used with a plunger to combine the features of facile and accurate delivery with the treatment of bone cuttings to enhance efficacy in facilitating bone healing.
  • the surgical instrument is preferably of a generally cylindrical shape, although the instrument is not limited thereto. Altemative general shapes may be elongated and shaped for ease of use such as having a grip, preferably a grip that is ergonometrically shaped.
  • An embodiment that has been fabricated and used in surgery is a cylinder of about 1.25 inches in diameter and 4.0 inches in length. Cylinders of about 3/8 to 1/2 inch in diameter, and about 1 inch in length are contemplated for use with small bones; for use in industrial settings, a cylinder having a diameter of up to about 1 foot and a length of up to about 1 foot is envisioned.
  • Materials suitable to fabricate the instrument include, but are not limited to, stainless steel, delrin, polymethylmethacrylate, and polyethylene, for example.
  • the tip, flute wiper, and bushing may be fabricated of metal, and is preferably made from surgical stainless steel. Alternative materials could be used, such as titanium, cobalt, or titanium nitrate coated steel.
  • the cap, collection chamber, and wiper housing are preferably fabricated from injection- molded high density polyethylene but can be formed from polymers including but not limited to delrin, nylon, polymethylmethacrylate, polyester, polyvinylchloride, and polycarbonate.
  • metal parts should be resistant from cutting tool wear and selected from a family of metals that is biocompatible so that a little wear debris will not adversely contaminate collected tissue.
  • the polymer parts can be formed of any material that can be easily formed and sufficiently strong for the application.
  • the tip (10, 100, 103) contacts a cutting surface without penetrating into it, and serves as a cutting tool (100) guide or brace and bearing, while channeling harvested tissue into the collection chamber (20, 110).
  • the instrument's tip (10, 100) forms the lower portion of the tissue collection chamber (20, 1 10) and may have a lip to enhance stability and retention in the collection chamber.
  • the tip provides a pathway and means to move cuttings into the collection chamber (20, 110).
  • the tip (10, 100) has means to eliminate slippage on bone and trap bone cuttings (195) in the cutting tool flute (170) to channel the bone cuttings up the tip (10, 100) and into the collection chamber (20, 110).
  • a se ⁇ ated edge or sha ⁇ tip teeth (15, 106) located directly on the cylindrical portion of the tip (10, 100) or on a swivel tip (180) held with elastic tip fixation prongs (183) can be used to eliminate slippage and channel bone cuttings (195).
  • a swivel tip (180) rotates about the lower end of an optional spherically ended tip (103) so as to provide good cortical bone (193) contact.
  • the collection chamber body (20, 110) may attach to a cap (30, 140) or to a wiper bushing (120). When fabricated to attach to a cap (30), the open end of the collection chamber (20, 110) may have a positive lip on the intemal diameter to lock with the cap.
  • the collection chamber (20, 110) requires no moving parts and takes advantage of the movement of cuttings up cutting tool flutes, pulling of tissue through the tip and slinging of cuttings to deposit cuttings in the collection chamber.
  • the collection chamber (20, 1 10) can be further enhanced by having an opening for connection to suction (401) to facilitate the collection of cuttings and to facilitate collection of blood.
  • the collection chamber (20, 1 10, 401) may have a means of measuring collected tissue volume not limited to a volumetric marking, or transparent or translucent outer walls which together with a volumetric marking, can be used to measure unpacked volume.
  • a plunger (500, 510) may be used to compress said bone cuttings for the measurement of packed volume.
  • the cap (30, 140) may attach to the collection chamber (20, 110) or to a wiper bushing (120).
  • the cap (30, 140) may have a groove on the outside diameter near one end to lock with a lip in the bore of the collection chamber (20, 110); other types of connections may be threads, o-rings or a quick disconnect member.
  • the cap (140) may house a flute wiper (130) that is held in through the use of a press-fit cylindrical bearing.
  • FIG. 3a An embodiment of the invention is shown in Fig. 3a in contact with cortical bone
  • the invention is shown in operation in Fig. 3b with cortical bone (193) and cancellous bone (190) being drilled and bone cuttings (195) moving up the drill flutes (170) and being deposited in the collection chamber (110).
  • the surgical instrument is designed for use with a drill bit.
  • a drill bit having a tip that both grinds and cuts bone (200, 210) to optimize the size of bone particles for specific transplantation purposes is an aspect of the invention (Fig. 5a and 5b).
  • the bit tip has teeth (210) and a cutting edge (200) at the entry to its flutes to grind and cut bone while creating a bore in bone.
  • the teeth and cutter geometry can be chosen to adjust the particle size of bone cuttings.
  • the drill may have a large flute volume and low flute angle to facilitate bone cutting movement into the tissue collection chamber.
  • Drill bits of most any design may be used, and the quality of the bone cuttings (195) can be optimized through the use of a specialty bit in one embodiment.
  • the cutting edge of a specialty drill bit tip has a straight cutting edge (200) on one side, and has a row of grinding teeth (210) on the other side.
  • the grinding teeth (210) protrude from the tip of the drill beyond the cutting edge (200) and serve to grind and loosen material for the cutting edge (200) to sever and scrape into the entry to the flute (230).
  • Further aspects of a drill bit that are contemplated as part of the present invention include the following.
  • a land (220) can be optimized for different applications using different flute volumes and angles to translate bone cuttings (195) or ma ⁇ ow tissue.
  • a drill shank (240) without fluted section attaches to a drill motor and serves to stop translation of the drill through the drill wiper (130) through interference between the flute wiper (160) and unfluted section of the drill shank (240).
  • the drill shank (240) can be fitted with a calibrated adjustable stop to allow precise control of drill penetration depth.
  • the surgical instrument may be a single use device, i.e., a disposable unit that is provided in a sterile package to a user.
  • a single use device i.e., a disposable unit that is provided in a sterile package to a user.
  • models adapted to fit drill bit diameters of 2-4 mm, 4-6 mm, 6-8 mm, 8-10 mm, and 10-12 mm are contemplated.
  • Another embodiment of the invention includes the surgical instrument described herein and further includes means for transfe ⁇ ing harvested tissue to a second site with optional processing of the harvested tissue.
  • the collection chamber (401) is connected to a suction line (402) to move bone cuttings (405) and fluid collected from a surgical site, such as the iliac crest (414), so that it can be stored in a tissue reservoir (403).
  • Vacuum is supplied to the system by a vacuum pump (404) connected to the tissue reservoir (403).
  • Collected material in the tissue reservoir (403) is moved using a roller pump (406) to a tissue separator (407).
  • the tissue separator (407) can contain screens, filters, centrifuge units or other cell and tissue separating devices as well as acid and basic solutions to modify the collected tissue.
  • the tissue transplant system may comprise a pump, filter, centrifuge, mixing chamber, settling chamber, conduit, and the like.
  • the system may have an applicator for the implantation of collected skeletal tissue.
  • Skeletal tissue may be harvested from a variety of sites, such as rib, fibula, iliac bone, cranium, sternum, tibia, or the like.
  • a centrifuge may be used to fractionate the harvested tissue and remove red and/or white blood cells; or harvested tissue may be chemically washed so as to increase the bone inductive potential of various proteins and cells while maintaining their viability.
  • Processing may include steps to enhance the bone forming potential of said bone cuttings not limited to filtering, rinsing with water, grinding of said bone cuttings, washing with acid solutions, and washing with basic solutions.
  • Processed tissue components can be combined or sent separately to the site of implantation through a valve (408) to an encapsulation nozzle (410) where an encapsulant such as algin, poly-L-lysine, collagen, polylactic acid, polyglycolic acid, methylcellulose, glycerol, saline, calcium phosphate, or calcium carbonate from an encapsulant reservoir (409) can be combined with the tissue.
  • an encapsulant such as algin, poly-L-lysine, collagen, polylactic acid, polyglycolic acid, methylcellulose, glycerol, saline, calcium phosphate, or calcium carbonate from an encapsulant reservoir (409) can be combined with the tissue.
  • Encapsulant with tissue (412) or tissue alone can then be applied at a bone (413) defect site with an applicator (411).
  • a positive displacement pump (406) provides the positive pressure to move the material through the processing stage and to the implant site.
  • Cancellous bone is cell rich and integrates rapidly with recipient bone and is resistant to infection.
  • particulate or paste-like bony materials offer considerable advantages.
  • Further advantages of fresh autograft bone chips or particles include; high graft surface area facilitating vascularization and remodeling, healing would occur as a "field phenomenon" occurring simultaneously throughout the entire defect, i ⁇ egularly shaped defects can be filled more completely with contact between host site and graft tissues closer and more extensive, and only a small surgical access is necessary to fill a large bone cavity defect.
  • An aspect of the invention is the use of the herein described tissue transplant system combined with the addition of growth factors and matrix material to enhance bone wound healing. Addition of such factors and material is expected to optimize the state of the harvested skeletal tissue.
  • factors and material include, for example, transforming growth factor beta and alpha, bone mo ⁇ hogenetic protein, platelet derived growth factor, epithelial growth factor, fibroblast growth factor, vascular permeability factor, mitogens, mesenchymal cells, progenitor cells, and natural bone matrix.
  • Procurement of tissue may be separated in time by implantation into the donor or into a different recipient.
  • One of skill in the art would realize, in light of this disclosure, how to use the instrumentation of the present invention when tissue is harvested from one patient and implanted into a different patient.
  • drilling of skeletal tissue for reconstructive surgery, or for placement of orthopaedic, dental, oral, or maxillofacial implants such as plates, screws, or rods is performed using aseptic technique.
  • the drill cuttings are commonly discarded; with use of the present invention, the drill cuttings are collected and can be placed around the implant to further anchor the implant and facilitate healing.
  • the invention is used in conjunction with common drill bits and drill motors.
  • the method involves aseptic collection and transfer of bone cuttings and/or ma ⁇ ow constituents for immediate transplantation.
  • Tissue collected from use of the surgical instrument provided by the present invention is cortical and cancellous bone combined with ma ⁇ ow tissues and blood that form a paste-like graft material.
  • This material has paste-like handling properties, high surface area, and a generally open stmcture.
  • a drill bit (150) is inserted through the cap (140), wiper bushing (120), drill wiper (130), collection chamber (110) and tip (100). Rotation of the drill bit (150) cuts bone. Bone cuttings (195) are confined within the drill flute (170) by the tip (100). Continued rotation of the drill bit (150) causes translation of the bone cuttings (195) up the inner bore of the tip (100). Bone cuttings (195) that have moved up the tip (100) and into the collection chamber (110) fall from the drill flutes (170) and collect in the collection chamber (1 10).
  • Bone cuttings remaining in the drill tip (10, 100) can be pulled into the collection chamber (20, 110) through drill bit translation and cuttings remaining in the drill flutes (170) are removed from the drill flutes (170) by centripetal force, suction, or the drill wiper (130).
  • the drill wiper (130) is free to rotate in the wiper bushing (120) along its common axis with the drill bit (150).
  • the flute wiper (160) of the drill wiper (130) extends into the drill flute (170) to wipe any residual bone cuttings that have not collected in the collection chamber (110).
  • the drill wiper (130) turns with the drill bit when it is rotated along its long axis or when the drill bit is translated through the tip (100), collection chamber (110) and drill wiper (130).
  • the tip (100) is connected to the tissue collection chamber body (110).
  • the collection chamber (1 10) connects to the wiper bushing (120) which serves as a bearing surface and guide for the drill wiper (130).
  • the drill wiper (130) rotates freely in the wiper bushing
  • the tip (100), collection chamber (110) and wiper bushing (120) can be combined into one part and fabricated as a disposable instrument.
  • the surgical instrument is used with conventional surgical drill bits.
  • a drill bit of the appropriate diameter, flute length and overall length is inserted into the appropriate model of the surgical instrument from the cap end.
  • the instrument is held in one hand and the tip positioned on bone at the point of drilling.
  • bone and /or ma ⁇ ow tissue fragments are ca ⁇ ied up the flutes of the drill bit, through the tip and passively fall from the flutes into the collection chamber.
  • the drill bit can extend beyond the tip of the instrument up to about 3-5 inches, and the instrument may be moved in an arc motion so as to harvest tissue from a cone-shaped area of the bone.
  • rotating action further acts to displace material from flutes into the collection chamber, and in an embodiment having a wiper, movement of the drill bit through the wiper serves to displace material into the collection chamber.
  • a surgical instrument according to the present invention was built and tested in a cadaver and in living animals.
  • the device was used with a conventional drill bit in fresh cadaver femoral bones. Bone cuttings were collected following a few revolutions of the drill bit. Cuttings moved up the flute within the confines of the tip. Cuttings exited the flute once they passed the tip and entered the collection chamber. The white color of cortical bone was seen through the collection chamber window and cancellous chips were coated with a small quantity of blood. Six 0.272 inch holes of approximately 2 cm depth were made. With each new hole the collection chamber continued to fill. The large quantity of osseous tissue collected in the chamber quickly obscured the view of the drill.
  • the flutes were noted to retain some of the cuttings.
  • the drill bit was withdrawn. When removed from the device, the flutes were noted to be clear of cuttings and the cuttings were seen to fall into the collection chamber. The action of the rotating wiper was smooth and did not cause the bit to bind during drilling or withdrawal. At the desired drill depth, the bit could be quickly pushed in and pulled out to collect additional osseous tissue from the margins of the drill hole, or to pump blood into the collection chamber that was hemo ⁇ haging into the site. Use of a vacuum in conjunction with the device could facilitate collection of more blood if clinically advantageous. Once drilling was completed, the drill bit was withdrawn for the final time.
  • the cap and wiper bearing are fabricated as one unit, and this unit may be removed together with the rotating flute wiper.
  • the collection chamber and tip also may be fabricated as one piece.
  • a plunger assembly will connect to the collection chamber and facilitate clearing of the harvested osseous tissue from the device. This plunger assembly would allow harvested osseous tissue to be forced from the collection chamber through the tip to facilitate application to a site of injury, fusion, or implantation. With plunger assembly attached, the device allows placement of collected osseous tissue and blood.
  • the collection chamber was emptied of osseous tissue.
  • the osseous tissue was noted to consist of coarse cuttings with varied dimensions of approximately 0.5 mm X 4 mm X 8 mm. Blood coated the cuttings, however, no free liquid was present in the collection chamber.
  • Tissue was evaluated for volume and the values were compared to theoretical values based on the dimensions of the drill hole; tissue was also evaluated for weight and those values were compared to theoretical weight which was calculated using the density of the bone segment multiplied by the volume of the drill hole.
  • the tissue collection data are provided for volume comparisons in Table 1, and for weight comparisons in Table 2.
  • the surgical instrument was used in a living animal in both iliac crest and proximal tibial metaphysis sites. Two holes were drilled in each location. The observations made during the drilling of fresh cadaver bone and the sites in the live animal were consistent. Osseous tissue collection was achieved with the bone cuttings having a light coating of blood. Blood in the collection chamber was not of sufficient quantity to form free liquid.
  • the two drill holes in the tibia produced 0.45 cc or 0.48 grams of bone.
  • the two drill holes in the iliac crest produced 0.91 cc or 1.09 grams of bone.
  • a hole drilled in bone to fasten an implant or place a screw can be a source of highly inductive tissue capable of enhancing the healing response of bone, filling large bone defects, or facilitating fusion of unstable or diseased joints.
  • compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions and methods of this invention have been described in terms of prefe ⁇ ed embodiments, it will be apparent to those of skill in the art that variations may be applied to the composition, methods and in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. More specifically, it will be apparent that certain agents which are both chemically and physiologically related may be substituted for the agents described herein while the same or similar results would be achieved. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

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Abstract

La présente invention porte sur un instrument de collecte des débris provenant d'outils tranchants, ainsi que sur ses utilisations. Ces débris peuvent provenir de métaux précieux, de substances toxiques ou dangereuses, ou d'un tissu vivant, par exemple un os. Dans une forme de réalisation particulière concernant la collecte de débris d'os, la présente invention comporte un instrument accompagné d'un perçoir, de sorte que les débris d'os (195) sont recueillis de façon à être aseptisés dans une chambre de collecte (110) afin d'être ensuite transplantés. En cours d'utilisation de l'instrument, les débris de moelle et d'os (195) rentrent dans les rainures (170) d'un perçoir (150). Ils sont ensuite conduits jusqu'au trou situé à l'extrémité de l'instrument (100), puis recueillis dans la chambre de collecte (110). On peut ôter les résidus de tissu se trouvant dans les rainures du perçoir (150) en utilisant un dispositif rotatif de nettoyage des rainures (160), qui tourne en rotation avec le perçoir (150) en cours de percée ou lorsque le perçoir (150) est séparé de l'instrument. Dans cette forme de réalisation, l'utilisation de ce dispositif permet de recueillir tout tissu osseux important en vue d'une reconstitution d'os défectueux, ou en cas de fracture ou de fixation d'implants orthopédiques ou dentaires en contact avec l'os.
PCT/US1996/003875 1995-10-30 1996-03-22 Systeme de collecte de matieres et ses utilisations WO1997016118A1 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
AU54271/96A AU714657B2 (en) 1995-10-30 1996-03-22 Materials collection system and uses thereof
JP9517294A JPH11514905A (ja) 1995-10-30 1996-03-22 材料収集システムおよびその使用
NZ306102A NZ306102A (en) 1995-10-30 1996-03-22 Drill tip with collection chamber for holding cuttings, typically for precious metals, toxic substances or bone material
KR1019980703173A KR19990067216A (ko) 1995-10-30 1996-03-22 물질 수집용 장치 및 그것의 용도
BR9611373-1A BR9611373A (pt) 1995-10-30 1996-03-22 Sistema de coleta de materiais e usos do mesmo.
EP96911365A EP0859570A4 (fr) 1995-10-30 1996-03-22 Systeme de collecte de matieres et ses utilisations
US08/799,122 US6071284A (en) 1995-10-30 1997-02-11 Materials collection system and uses thereof
NO981940A NO981940L (no) 1995-10-30 1998-04-29 Oppsamlingssystem for materialer og anvendelse av dette
US09/494,872 US6325806B1 (en) 1995-10-30 2000-01-31 Materials collection system and uses thereof

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US55029795A 1995-10-30 1995-10-30
US08/550,297 1995-10-30

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JP (1) JPH11514905A (fr)
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AU (1) AU714657B2 (fr)
BR (1) BR9611373A (fr)
CA (1) CA2235483A1 (fr)
MX (1) MX9803470A (fr)
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NZ (1) NZ306102A (fr)
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Cited By (25)

* Cited by examiner, † Cited by third party
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US6325806B1 (en) 1995-10-30 2001-12-04 Biomedical Enterprises, Inc. Materials collection system and uses thereof
JP2002502282A (ja) * 1997-05-29 2002-01-22 ジンテーズ アクチエンゲゼルシャフト クール 穴あけガイドおよび測定器械
EP0992218A1 (fr) * 1998-10-09 2000-04-12 Gallini S.R.L Dispositif de biopsie
WO2000045712A1 (fr) * 1999-02-02 2000-08-10 Synthes Ag Chur Dispositif pour prelever des copeaux d'os
US6783532B2 (en) 1999-02-02 2004-08-31 Synthes (Usa) Device for removing bone tissue
US6332886B1 (en) 1999-02-03 2001-12-25 Synthes (Usa) Surgical reamer and method of using same
WO2004082484A1 (fr) * 2003-03-18 2004-09-30 Carlo Bianchini Dispositif pour biopsie medullaire
KR100833249B1 (ko) 2008-02-27 2008-05-29 (주)북부덴탈 초음파 골편 채취기용 끌팁
US9237906B2 (en) 2011-07-05 2016-01-19 Johan Janssens Combination of a bone drill and a sleeve
EP2543321B1 (fr) * 2011-07-05 2016-03-23 Johan Janssens Combinaison d'un foret à os et manchon
US9888929B2 (en) 2011-08-11 2018-02-13 Osstemimplant Co., Ltd. Drill, drill cover, and surgical instrument for collecting autologous bone employing same
US20150196287A1 (en) * 2012-09-27 2015-07-16 Terumo Kabushiki Kaisha Biopsy device
US10426447B2 (en) * 2012-09-27 2019-10-01 Terumo Kabushiki Kaisha Biopsy device
US11896242B2 (en) 2014-10-19 2024-02-13 T.A.G. Medical Products Corporation Ltd. Kit including a guiding system and a bone material removal device
US11779353B2 (en) 2015-04-09 2023-10-10 T.A.G. Medical Products Corporation Ltd. Bone material removal device and a method for use thereof
EP3291738A4 (fr) * 2015-05-07 2019-03-06 Avitus Orthopaedics Inc. Systèmes et procédés pour collecte d'os et de tissu
US11801060B2 (en) 2015-05-07 2023-10-31 Avitus Orthopaedics, Inc. Systems and methods for bone and tissue harvesting
US12102337B2 (en) 2016-02-11 2024-10-01 T.A.G. Medical Products Corporation Ltd. Bone material removal device and a method for use thereof
US11844537B2 (en) 2016-04-24 2023-12-19 T.A.G. Medical Products Corporation Ltd. Guiding device and method of using thereof
US11655454B1 (en) * 2017-03-23 2023-05-23 Elite IP, LLC Method and apparatus for improved mesenchymal stem cell harvesting
EP3781048A4 (fr) * 2018-04-18 2021-06-16 Michael J. Scianamblo Appareils de collecte de matière osseuse
US11690635B2 (en) 2018-08-01 2023-07-04 T.A.G. Medical Products Corporation Ltd. Adjustable drilling device and a method for use thereof
EP4238512A1 (fr) * 2022-03-01 2023-09-06 PMU Innovations GmbH Kit médical comprenant un foret et collecteur de débris
WO2023165755A1 (fr) * 2022-03-01 2023-09-07 Pmu Innovations Gmbh Kit médical comprenant un foret et un collecteur de débris
US12310601B2 (en) 2024-02-05 2025-05-27 T.A.G. Medical Products Corporation Ltd. Kit including a guiding system and a bone material removal device

Also Published As

Publication number Publication date
BR9611373A (pt) 1999-12-28
NO981940D0 (no) 1998-04-29
JPH11514905A (ja) 1999-12-21
NZ306102A (en) 1998-11-25
KR19990067216A (ko) 1999-08-16
EP0859570A1 (fr) 1998-08-26
AU5427196A (en) 1997-05-22
NO981940L (no) 1998-06-29
CA2235483A1 (fr) 1997-05-09
CN1203518A (zh) 1998-12-30
AU714657B2 (en) 2000-01-06
RU2169532C2 (ru) 2001-06-27
EP0859570A4 (fr) 2000-03-15
MX9803470A (es) 1998-11-29

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