H ~ iphernovenq4RPotbIhDCCVLLuoS65j5 doc-5/30r20tS CONNECTOR ASSEMBLY The present application claims the benefit of US provisional application Serial No. 61/253,093, filed on October 20 2009, which is hereby incorporated by reference in its entirety. 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. However, 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. Secondly, the lengths of currently available drill bits and guide wires substantially reduce the possibility of performing this procedure on larger patients. Thirdly, 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 1 marrow. Therefore, the procedure, and the devices used within the procedure, need to be improved. In accordance with the present invention there is provided a system for the repair of bone defects, the system comprising: a drill bit having an open-ended Cannulation; a guide wire; a fluid delivery and/or withdrawal device: a first cannulated connector configured for coupling to the dril bit and via which a drill can be coupled to the drill bit: and a second cannuilated connector permanently coupled to the first connector and configured for coupling to the fluid device, wherein when the drill bit and connectors are so coupled, the cannulations thereof align to form a continuous cannulation in which the guide wire can be disposed, and in which fluid can travel under the influence of the fluid device. Disclosed herein is a drill bit assembly for repair of bone defects comprising a cannulated drill bit having a distal portion and a proximal portion; a first cannulated connector coupled to the proximal portion and a second cannulated connector permanently coupled to the first connector, wherein a guide wire is disposable in cannulations of the drill bit, the first cannulated connector and the second cannulated connector. Disclosed herein is a kit for repair of bone defects comprising at least one drill bit and at least one connector assembly according to the first aspect of the invention.
I1 kg. -C "Itic~~ r o hrI, KCG\912 I 1-2HD II21~ Disclosed herein is a method of delivering a fluid into a tissue of a subject using the drill bit assembly, wherein the method comprises the steps of; 2A l gaiem enR~ttDCsG 31913 I doBw2Wildl (a) coupling a drill via the first connector to the proximal end of the drill bit; (b) activating the drill to facilitate the insertion of the distal end of the drill bit into the tissue; (c) removing the drill from the first connector; (d) coupling a fluid delivery device to the second connector; (e) activating the fluid delivery device so as to facilitate the delivery of the fluid into the tissue. Disclosed herein is a method of treating osteonecrosis in a subject in need thereof using the drill bit assembly, wherein the method comprises the steps of; (a) inserting a guide wire into a bone; (b) passing a cannulated drill bit over the guide wire, (c) coupling a drill via the first connector to the proximal end of the drill bit, (d) activating the drill to facilitate the insertion of the distal end of the drill bit into the tissue; (e) removing the drill from the first connector; (f) coupling a fluid delivery device to the second connector; (g) activating the fluid delivery device so as to facilitate the delivery of the fluid into the tissue. Disclosed herein is a method of withdrawing a biological sample from a tissue of a subject using the drill bit assembly, wherein the method comprises the steps of; (a) coupling a drill via the first connector to the proximal end of the drill bit; ji .gr.IieI nNRVoi nl1I.DCCtG 9QW 1 I de-N 0I: 2016 (b) activating the drill to facilitate the insertion of the distal end of the drill bit into the tissue; (c) removing the drill from the first connector; (d) coupling a fluid withdrawal device to the second connector; (e) activating the fluid withdrawal device so as to facilitate the removal of the biological sample from the tissue. Disclosures herein also relate to 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. In embodiments of the invention 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. Alternatively the first connector may be permanently coupled to the shaft. Advantageously the first connector is configured for coupling to a 4 WO 2011/049817 PCT/US2010/052770 drill. The first connector may be a Jacob's Quick Connect connector, or connector known to one skilled in the art. In embodiments of the invention the second connector is a leur lock connector. Advantageously 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. Advantageously 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. In embodiments of the invention the cannulation of at least the second connector is tapered, for purposes to be described later In further embodiments of the invention the cannulation of the shaft, the first connector and the second connector is of the same diameter. In embodiments of the invention the cannulation of the drill bit is blind at the distal end. Alternatively in embodiments of the invention in which a guide wire (e.g Kirschner wire) is used in conjunction with the drill bit the cannulation is open-ended so that the drill bit can pass over the guide wire. 5 WO 2011/049817 PCT/US2010/052770 In embodiments of the invention 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. In embodiments of the invention in which the drill bit is at least partially threaded 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. In embodiments of the invention in which a fluid is delivered using the apparatus, the fluid may comprise a biological and/or a pharmaceutical component. None limiting examples of 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 methacrylate) 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. Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the 6 I 2IilgW ci 'N,RPolN CC 61- ,- ( I 1. 2.Ii, disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present teachings. Fig. 1 shows a side view of the drill bit of the present disclosure. Fig. 1A 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 1. The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. 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. As shown in both Figs. 1 and 1A, the distal portion 12 includes at least one slot 15. However, an identical slot (not shown) is located opposite the slot 15 shown in Figs. 1 and 1A. Although, having less than or 7 WO 2011/049817 PCT/US2010/052770 more than two slots is also within the scope of this disclosure. Additionally, 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. However, having slots 15 that are located in-line with the longitudinal axis L are also within the scope of this disclosure. 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. For the purposes of this disclosure, 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. For the purposes of this 8 I t' , DCem ewNRPontD XCG% 9$91 i1 I d 21' It disclosure, cannulations 14, 21, 31 are of the same diameter. However, having cannulations of different diameter are also within the scope of this disclosure. During a repair procedure, 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. Next, a delivery instrument, such as a syringe, including bone marrow cells, is coupled to the drill bit 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. Additionally, for the purposes of this disclosure, 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 9 WO 2011/049817 PCT/US2010/052770 drill bit via the opening of the luer lock connector. However, 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. Also, the drill connector allows for quick and easy removal of the drill from the drill bit. Due to the bone marrow cells exiting both the slots and the opening at the distal portion of the shaft, as opposed to only exiting the opening, an increased permeation of the bone by the marrow cells is caused. It is believed that more marrow cells permeating the bone will lead to a better repair of the lesion or defect due to the belief that the cells will differentiate into bone cells, which in turn, will develop into healthy bone tissue and fill the defect. 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. For the purposes of this disclosure, the drill bit is used for the delivery of bone marrow. However, 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 10 H jlliiicnvo-nNRPorblDCCULL 650 165_ docx-1 5110/015 fauna, such as living cells, preserved cells, dormant cells, and dead cells; and osteoconductive materials. The invention has been described by way of non-limiting example only and many modifications and variations may be made thereto without departing from the spirit and scope of the invention. Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. 11