WO2011049817A1

WO2011049817A1 - Connector assembly

Info

Publication number: WO2011049817A1
Application number: PCT/US2010/052770
Authority: WO
Inventors: William A. Karpovich; Thomas A. Einhorn
Original assignee: Smith & Nephew, Inc.
Priority date: 2009-10-20
Filing date: 2010-10-15
Publication date: 2011-04-28
Also published as: JP2013508081A; EP2490603A1; RU2012119245A; AU2010308389B2; RU2570965C2; CN102711633A; BR112012009498A2; CN102711633B; JP6038655B2; AU2010308389A1

Abstract

The present disclosure relates to a connector assembly (20,30) for use with a drill bit (10) in a surgical procedure. The connector assembly comprises first (20) and second (30) cannulated connectors, where the first connector is for coupling to the drill bit and the second connector is for coupling to a fluid delivery device or a fluid withdrawal device, such as a syringe. The diameter of the first connector can be larger than the diameter of the second connector, such that a drill fits over the second connector to couple with the first connector. The dislosure further relates to a drill bit assembly comprising a cannulated drill bit and first and second cannulated connectors. The drill bit may have threads or cutting teeth (18) and at least one fluid transfer slot (15), which might be located at an angle to the drill bit axis.

Description

CONNECTOR ASSEMBLY

CROSS-REFERENCE TO RELATED APPLICATIONS

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.

FIELD OF TECHNOLOGY

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.

BACKGROUND TO THE INVENTION

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 marrow. Therefore, the procedure, and the devices used within the procedure, need to be improved.

SUMMARY OF THE INVENTION

According to a first aspect of the invention there is provided 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.

According to a second aspect of the invention there is provided 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.

According to a third aspect of the invention there is provided a kit comprising at least one drill bit and at least one connector assembly according to the first aspect of the invention. According to a fourth aspect of the invention there is provided 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) 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.

According to 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) 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.

According to 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;

(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.

According to a further aspect of the invention there is provided 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 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. 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 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.

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 disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings:

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.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiments) 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 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 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.

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 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 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 fauna, such as living cells, preserved cells, dormant cells, and dead cells; and osteoconductive materials.

As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.

Claims

1. 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.

2. A connector assembly according to claim 1 , wherein the first connector can be removably coupled to the drill bit.

3. A connector assembly according to claim 1 or 2, wherein the second connector is a luer lock connector.

4. A connector assembly according to any preceding claim, wherein the diameter of the first connector is larger than the diameter of the second connector such that when in use a drill will fit over the second connector and couple with the first connector.

5. A connector assembly according to any preceding claim, wherein the cannulation of the first and second connector is of the same diameter.

6. A connector assembly according to any preceding claim, wherein the cannulation of the second connector is tapered.

7. A drill bit assembly comprising, when in use; 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.

8. A drill bit assembly according to claim 7, wherein the first connector is coupled at or near the proximal portion of the drill bit.

9. A drill bit assembly according to claim 7 or 8, wherein the first connector is removably coupled to the drill bit.

10. A drill bit assembly according to claim 9, wherein the removable coupling is a press-fit mechanism,

11. A drill bit assembly according to any preceding claim, wherein the first connector is configured for coupling to a drill.

12. A drill bit assembly according to any preceding claim, wherein the second connector is a leur lock connector.

13. A drill bit assembly according to any preceding claim, wherein the second connector is configured for coupling to a fluid delivery device or a fluid withdrawal device.

14. A drill bit assembly according to claim 13, wherein the fluid delivery device or the fluid withdrawal device is a syringe.

15. A drill bit assembly according to any preceding claim, wherein the cannulation of at least the second connector is tapered.

16. A drill bit assembly according to any preceding claim, wherein the cannulation of the drill bit, the first connector and the second connector is of the same diameter.

17. A drill bit assembly according to any preceding claim, wherein the drill bit is at least partially threaded or is provided with cutting teeth/blades at or near the distal end.

18. A drill bit according to any preceding claim, wherein the cannulation of the drill bit is blind at the distal end.

19. A drill bit assembly according to any preceding claim, wherein at least one fluid transfer slot is provided on the drill bit.

20. A drill bit assembly according to claim 19, where the at least one fluid transfer slot is provided on the distal portion of the drill bit.

21.A drill assembly according to claim 19 or 20, wherein a pair of fluid transfer slots are provided on the drill bit and wherein said slots are opposed.

22. A drill assembly according to any of claims 19 to 21 , wherein the at least one fluid transfer slot is located between the threads on the drill bit.

23. A drill assembly according to any of claims 19 to 22, wherein the drill bit has a longitudinal axis and the at least one fluid transfer slot is located at an angle relative to said axis.

24. A kit comprising at least one drill bit and at least one connector assembly according to any of claims 1 to 6.

25. A method of delivering a fluid into a tissue of a subject using the drill bit assembly according to any of claims 7 to 24, wherein the method comprises the steps of;

(c) removing the drill from the first connector;

(d) coupling the 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.

26. A method according to claim 25, wherein the tissue is bone.

27. A method according to claim 25 or 26, wherein the subject is a non-human animal.

28. A method according to any of claims 25 to 27, wherein the fluid delivery device is a syringe.

29. A method according to any of claims 25 to 28, wherein the fluid comprises a biological component and/or a pharmaceutical component.

30. A method according to any of claims 25 to 29, wherein the fluid is a bone cement.

31.A method of treating osteonecrosis in a subject in need thereof using the drill bit assembly according to any of claims 7 to 17 or 19 to 23, wherein the method comprises the steps of;

(a) inserting a guide wire into a bone;

(b) passing the drill bit over the guide wire, (c) coupling a drill via the first connector to the proximal end of the drill bit,

(e) removing the drill from the first connector;

(f) coupling the 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.

32. A method according to claim 31 , wherein the method comprises delivering a cellular component within a fluid carrier into the bone.

33. A method according to claim 32, wherein the cellular component comprises bone marrow cells.

34. A method of withdrawing a biological sample from the tissue of a subject using the drill bit assembly according to any of claims 7 to 23, wherein the method comprises the steps of;

(c) removing the drill from the first connector; (d) coupling the fluid withdrawal device to the second connector;

35. A method according to claim 34, wherein the fluid delivery device is or is connected to a suction device.

36. A method according to claim 34 or 35, wherein the tissue is bone and the biological sample is bone marrow aspirate.

37. A method according to any of claims 34 to 36, wherein the subject is a non- human animal.

38. 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.