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
  • A61B17/1613—Component parts
  • A61B17/1615—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
• • 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
  • A61B17/1637—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, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8897—Guide wires or guide pins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; 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
  • A61B2010/0258—Marrow samples

Definitions

• the present invention relates to a drill bit connector assembly for use in the delivery and withdrawal of fluids.
• the present disclosure particularly relates to the repair of bone defects caused by osteonecrosis and, specifically, a procedure and devices for use in the repair.
• Osteonecrosis is a bone disease that occurs mostly in the joint areas of the body, such as the hip joint. This disease can result in bone lesions or defects, which may be repaired via a procedure whereby a hole is drilled into the bone, particularly the defect of the bone, via the use of a guide wire and cannulated drill bit, and then previously harvested bone marrow is injected through the cannulated drill bit, via the use of a syringe.
• a syringe there are several drawbacks to this procedure. Firstly, there is really no adequate means for coupling the syringe to the drill bit so that leakage of the marrow around the drill bit does not occur.
• the lengths of currently available drill bits and guide wires substantially reduce the possibility of performing this procedure on larger patients.
• the marrow is solely deposited into the hole via the end of the drill bit that is located in the hole, thereby not allowing for a high amount of permeation of the bone by the marrow. Therefore, the procedure, and the devices used within the procedure, need to be improved.
• a connector assembly for use with a drill bit, wherein said assembly comprises a first cannulated connector permanently coupled to a second cannulated connector, wherein the first connector is configured for coupling to the drill bit and the second connector is configured for coupling to a fluid delivery device or a fluid withdrawal device.
• a drill bit assembly comprising; a cannulated drill bit having a distal portion and a proximal portion; and the connector assembly according to the first aspect of the invention, wherein the first connector is coupled to the proximal portion of the drill bit.
• a kit comprising at least one drill bit and at least one connector assembly according to the first aspect of the invention.
• a method of delivering a fluid into a tissue of a subject using the drill bit assembly according the second aspect of the invention wherein the method comprises the steps of;
• a fifth aspect of the invention there is provided a method of treating osteonecrosis in a subject in need thereof using the drill bit assembly according to the second aspect of the invention, wherein the method comprises the steps of;
• a sixth aspect of the invention there is provided a method of withdrawing a biological sample from a tissue of a subject using the drill bit assembly according to the second aspect of the invention, wherein the method comprises the steps of;
• connector assemblies, drill bit assemblies, methods or kits as substantially herein described with reference to the accompanying Examples and Figure 1 , 2 and/or 3.
• the first connector is coupled at or near the proximal portion of the shaft.
• the first connector may be removably coupled to the shaft, for example by a press-fit mechanism.
• the first connector may be permanently coupled to the shaft.
• the first connector is configured for coupling to a drill.
• the first connector may be a Jacob's Quick Connect connector, or connector known to one skilled in the art.
• the second connector is a leur lock connector.
• the second connector is configured for coupling to a fluid delivery device or a fluid withdrawal device, for example a syringe.
• the fluid withdrawal device may be a suction device or may be associated with a suction device (e.g a vacuum pump) in order to facilitate the withdrawal of the biological fluid.
• the diameter of the first connector is larger than the diameter of the second connector so that a drill will fit over the second connector and couple with the first connector. This enables the surgeon to power the drill bit into position, remove the drill and then connect the syringe without the requirement for any other assembly.
• the cannulation of at least the second connector is tapered, for purposes to be described later
• the cannulation of the shaft, the first connector and the second connector is of the same diameter
• the cannulation of the drill bit is blind at the distal end.
• a guide wire ⁇ e.g Kirschner wire
• the cannulation is open-ended so that the drill bit can pass over the guide wire.
• at least one fluid transfer slot is provided on the drill bit. This at least one fluid transfer slot may be provided on the distal portion of the drill bit. A pair of fluid transfer slots may be provided on the drill bit and these slots may be opposing each other.
• the at least one fluid transfer slot may be located between the threads.
• the drill bit has a longitudinal axis and in embodiments of the invention the at least one fluid transfer slot is either aligned with the longitudinal axis or orientated at an angle relative to the longitudinal axis.
• the fluid may comprise a biological and/or a pharmaceutical component.
• components that the fluid may include are isolated cells (e.g stem cells), biological fluids (e.g bone marrow aspirate); other blood borne elements, bone cements (e.g Poly(methyl methacry!ate) or calcium based cements), or medicaments/actives (e.g antimicrobials; bisphosphonates; growth factors; osteogenic agents (e.g bone morphogenetic proteins); angiogenic factors, anti-inflammatories, analgesics; monobutryin; thrombin; modified proteins; platelet rich plasma/solution, platelet poor plasma/solution; osteoconductive materials.
• isolated cells e.g stem cells
• biological fluids e.g bone marrow aspirate
• other blood borne elements e.g Poly(methyl methacry!ate) or calcium based cements
• medicaments/actives e.g antimicrobials; bisphosphonates; growth factors; osteogenic agents (e.g bone morph
• Fig. 1 shows a side view of the drill bit of the present disclosure.
• Fig. 1 A shows an enlarged view of the distal portion of the drill bit of Fig. 1.
• Fig. 2 shows an end view of a connector of the drill bit of Fig. 1.
• Fig. 3 shows an end view of the distal portion of the drill bit of Fig.
• Fig. 1 shows the drill bit 10 of the present disclosure.
• the drill bit 10 includes a threaded shaft 11 having a distal portion 12, a proximal portion 13, and a cannulation 14 that extends the entire length of the shaft 11.
• the distal portion 12 includes at least one slot 15.
• an identical slot (not shown) is located opposite the slot 15 shown in Figs. 1 and 1A.
• the slots 15 are located in the land 19 or the area between the threads 18 and at an angle relative to the longitudinal axis L of the shaft 11.
• Fig. 3 shows an end view of the distal portion 12 including an opening 16 of the cannulation 14. Threads 18 are located along at least a partial length of the shaft 11. However, having threads along the entire length of the shaft 11 is also within the scope of this disclosure.
• a connector 20 is coupled to the proximal end 13 of the shaft 11.
• the connector 20, which may be a Jacob's Quick Connect connector, or any other connector known to one of skill in the art, may be coupled to the proximal end 13 via a method, such as press-fit and, optionally, soldering.
• a Jacob's Quick Connect is sold by Jacob Tubing in Memphis, Tennessee.
• the connector 20 includes a cannulation 21 , such that cannulation 21 is in-line with cannulation 14 when connector 20 is coupled to the shaft 11.
• Another connector 30 is coupled to connector 20.
• connector 30 is a luer lock connector and is coupled to connector 20 via a machining process. Similar to connector 20, connector 30 also includes a cannulation 31 , such that cannulation 31 is in-line with cannulations 14 and 21. Other connectors may be used for connectors 30.
• Fig. 2 shows an end view of connector 30, which shows that the opening 32 to cannulation 31 is tapered, for purposes to be described later. However, having a non- tapered opening is also within the scope of this disclosure.
• cannu!ations 14, 21 , 31 are of the same diameter. However, having cannulations of different diameter are also within the scope of this disclosure.
• a guide wire is inserted into the bone, particularly at the affected area of the bone, via the use of means, such as fluoroscopy or C-Arm image intensification visualization. Other means are also possible.
• the drill bit 10 is then passed over the guide wire, such that the guide wire is disposed within cannulations 14, 21, 31.
• a drill is then coupled to the drill bit 10 via the connector 20 and the drill is operated to pass the drill bit 10 into the bone, thereby creating a hole in the bone. Once the drill bit 10 is in position, the drill and guide wire are removed from the drill bit 10.
• a delivery instrument such as a syringe, including bone marrow cells
• a delivery instrument is coupled to the drill 10 by placing an end of the syringe through the opening 32 of cannulation 31.
• the syringe is then activated to transfer the cells from the syringe to the drill bit 10.
• the cells exit the drill bit 10 via the slots 15 and the opening 16 at the distal portion 12 of the shaft 11 and are subsequently deposited into the bone. Once deposition of the cells is complete, the syringe and drill bit 10 are removed from the body.
• Having a one-piece drill bit that includes connectors for both the drill and the syringe provides the user with the ability to couple the drill and the syringe to the drill bit without the use of separate adaptors.
• the end of the syringe is tapered to correspond with the tapered opening of the luer lock connector, thereby providing an efficient seal between the luer lock connector and the syringe and substantially reducing the possibility of the marrow cells leaking out of the drill bit via the opening of the luer lock connector.
• a syringe, or other delivery instrument not having a tapered end, as well as a connector not having a non-tapered opening are also within the scope of this disclosure.
• the drill connector allows for quick and easy removal of the drill from the drill bit.
• the slots being located in the land, or the area between the threads, and at an angle relative to the longitudinal axis of the drill bit, reduces the possibility of bone debris entering into the cannulation of the shaft during drilling and clogging the cannulation.
• the drill bit is between about 6.5 inches (1.52mm) long through to about 24 inches (610mm) long, thereby enabling treatment of both large and small patients, thereby averting one of the drawbacks of current drill bits, as stated above.
• the drill bit is used for the delivery of bone marrow.
• other materials for possible use in the repair of tissue may be delivered to the repair site via the drill bit, including, but not limited to, growth factors; scaffolds; active agents, such as bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma/solution, platelet poor plasma/solution, and any cells sourced from flora or fauna, such as living cells, preserved cells, dormant cells, and dead cells; and osteoconductive materials.
• growth factors including, but not limited to, growth factors; scaffolds; active agents, such as bone morphogenic proteins, antibiotics, anti-inflammatories, angiogenic factors, osteogenic factors, monobutyrin, thrombin, modified proteins, platelet rich plasma/solution, platelet poor plasma/solution, and any cells sourced from flora or fauna, such as living cells, preserved cells, dormant cells, and dead cells; and

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• General Health & Medical Sciences (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• Immunology (AREA)
• Pathology (AREA)
• Hematology (AREA)
• Rheumatology (AREA)
• Dentistry (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Surgical Instruments (AREA)
• Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

Applications Claiming Priority (2)

Publications (1)

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• 2010
  • 2010-10-15 CN CN201080058213.XA patent/CN102711633B/zh not_active Expired - Fee Related
  • 2010-10-15 RU RU2012119245/14A patent/RU2570965C2/ru not_active IP Right Cessation
  • 2010-10-15 EP EP10774053A patent/EP2490603A1/en not_active Withdrawn
  • 2010-10-15 JP JP2012535251A patent/JP6038655B2/ja not_active Expired - Fee Related
  • 2010-10-15 BR BR112012009498A patent/BR112012009498A2/pt not_active IP Right Cessation
  • 2010-10-15 AU AU2010308389A patent/AU2010308389B2/en not_active Expired - Fee Related
  • 2010-10-15 WO PCT/US2010/052770 patent/WO2011049817A1/en active Application Filing

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