JP6038655B2 - Connector assembly - Google Patents

Description

This application claims the benefit of US Provisional Application No. 61 / 253,093, filed Oct. 20, 2009, which is incorporated herein by reference in its entirety. is there.

  The present invention relates to a drill bit connector assembly for use in fluid delivery and withdrawal. The present disclosure relates in particular to the repair of bone defects caused by osteonecrosis, and in particular to treatments and devices for use in repair.

  Osteonecrosis is a bone disease that occurs primarily in the joints of the body, such as the hip joint. This disease can lead to bone lesions or defects, which can be caused by the use of guide wires and cannulated drill bits, especially in bone defects. The hole can then be repaired by treatment by injecting pre-harvested bone marrow through a cannulated drill bit by use of a syringe.

  However, this procedure has several drawbacks. First, there is actually no suitable means for coupling the syringe to the drill bit so that there is no bone marrow leak around the drill bit. Secondly, the length of currently available drill bits and guide wires substantially reduces the possibility of performing this procedure on more patients. Thirdly, the bone marrow adheres exclusively into the hole through the end of the drill bit located in the hole, so that high bone penetration by the bone marrow cannot be expected. Therefore, this procedure and the devices used within the procedure need to be improved.

  In accordance with a first aspect of the present invention, a connector assembly for use with a drill bit is provided, the assembly being a first cannulated connector permanently coupled to a second cannulated connector. A connector is provided, wherein the first connector is configured to couple to the drill bit and the second connector is configured to couple to the fluid delivery device or fluid withdrawal device.

  According to a second aspect of the present invention there is provided a drill bit assembly comprising a cannulated drill bit having a distal portion and a proximal portion, and a connector assembly according to the first aspect of the present invention. One connector is coupled to the proximal portion of the drill bit.

  According to a third aspect of the invention, a kit is provided 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 present invention, there is provided a method of delivering fluid into a tissue of a subject using a drill bit assembly according to the second aspect of the present invention, comprising:
(A) coupling the drill to the proximal end of the drill bit via the first connector;
(B) actuating the drill to facilitate insertion of the distal end of the drill bit into the tissue;
(C) removing the drill from the first connector;
(D) coupling the fluid delivery device to the second connector;
(E) actuating the fluid delivery device to facilitate delivery of the fluid into the tissue.

According to a fifth aspect of the present invention there is provided a method of treating osteonecrosis in a subject in need of osteonecrosis treatment using a drill bit assembly according to the second aspect of the present invention, comprising:
(A) inserting a guide wire into the bone;
(B) passing a cannulated drill bit over the guide wire;
(C) coupling the drill to the proximal end of the drill bit via the first connector;
(D) actuating the drill to facilitate insertion of the distal end of the drill bit into the tissue;
(E) removing the drill from the first connector;
(F) coupling the fluid delivery device to the second connector;
(G) actuating the fluid delivery device to facilitate delivery of fluid into the tissue.

According to a sixth aspect of the present invention there is provided a method for extracting a biological sample from a tissue of interest using a drill bit assembly according to the second aspect of the present invention, comprising:
(A) coupling the drill to the proximal end of the drill bit via the first connector;
(B) actuating the drill to facilitate insertion of the distal end of the drill bit into the tissue;
(C) removing the drill from the first connector;
(D) coupling the fluid withdrawal device to the second connector;
(E) actuating a fluid withdrawal device to facilitate removal of the biological sample from the tissue.

  In accordance with further aspects of the present invention, a connector assembly, drill bit assembly, substantially as herein described with reference to the accompanying examples and FIGS. 1, 2, and / or 3. Solids, methods, or kits are provided.

  In an embodiment of the present invention, the first connector is coupled to 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 to couple to a drill. The first connector may be a Jacob's Quick Connect connector or a connector known to those skilled in the art.

  In an embodiment of the present invention, the second connector is a luer lock connector. Advantageously, the second connector is configured to couple to a fluid delivery device or fluid withdrawal device, such as a syringe. The fluid withdrawal device may be a suction device or may be associated with a suction device (eg, a vacuum pump) to facilitate the withdrawal of biological fluid.

  Advantageously, the diameter of the first connector is larger than the diameter of the second connector so that the drill will fit over and couple with the first connector. This allows the surgeon to move the drill bit in place, remove the drill, and then connect the syringe without requiring any other assembly.

  In embodiments of the present invention, for the purposes described below, at least the cannulation of the second connector is tapered. In a further embodiment of the invention, the shaft, the first connector, and the second connector cannulation are of the same diameter.

  In an embodiment of the invention, the drill bit cannulation has no outlet at the distal end. Alternatively, in embodiments of the invention in which a guide wire (eg, a Kirschner wire) is used with the drill bit, the cannulation portion is open so that the drill bit can pass over the guide wire.

  In an embodiment of the invention, at least one fluid transfer slot is provided in the drill bit. The at least one fluid transfer slot may be provided at the distal portion of the drill bit. A pair of fluid transfer slots may be provided in the drill bit, and these slots may face 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 an embodiment of the invention, the at least one fluid transfer slot is aligned immediately above the longitudinal axis or is oriented at an angle relative to the longitudinal axis Either.

  In embodiments of the invention in which fluid is delivered using the device, the fluid can include biological and / or pharmaceutical components. Non-limiting examples of components that the fluid can include include isolated cells (eg, stem cells), biological fluids (eg, bone marrow aspirate), other blood-borne elements, bone cements (eg, poly ( Methyl methacrylate) or calcium-based cements), or drugs / active agents (eg antibacterial agents, bisphosphonates, growth factors, osteogenic agents (eg bone morphogenetic proteins)), angiogenic factors, anti-inflammatory Agents, analgesics, monobutyrin, thrombin, denatured protein, platelet rich plasma / solution, platelet poor plasma / solution, osteoconductive material.

  Further areas of applicability of the present disclosure will become apparent from the detailed description provided below. While preferred embodiments of the present disclosure are shown, it is to be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

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

It is a side view of the drill bit of this indication. FIG. 2 is an enlarged view of a distal portion of the drill bit of FIG. 1. It is an end view of the connector of the drill bit of FIG. FIG. 2 is an end view of a distal portion of the drill bit of FIG. 1.

  The following description of the preferred embodiments is merely exemplary in nature and is in no way intended to limit the present disclosure, its application, or uses.

  FIG. 1 illustrates a drill bit 10 of the present disclosure. The drill bit 10 includes a threaded shaft 11 that has a distal portion 12, a proximal portion 13, and a cannulation portion 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, the same slot (not shown) is located opposite the slot 15 shown in FIGS. 1 and 1A. Nevertheless, having less than two or more than two slots is also within the scope of the present disclosure. In addition, the slot 15 is located in the land 19 or in the region between the threads 18 and is at an angle with respect to the longitudinal axis L of the shaft 11. However, it is also within the scope of the present disclosure to have the slots 15 located in line with the longitudinal axis L. FIG. 3 shows an end view of the distal portion 12 including the opening 16 of the cannulation portion 14. The thread 18 is located along the length of at least a part of the shaft 11. However, it is also within the scope of the present disclosure to have a thread along the entire length of the shaft 11.

  The 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 those skilled in the art, may be coupled to the proximal end 13 by methods such as press fitting and optionally soldering. Jacob's Quick Connect is sold by Jacob Tubing, Memphis, Tennessee. The connector 20 includes a cannulation part 21, and the cannulation part 21 is aligned with the cannulation part 14 when the connector 20 is coupled to the shaft 11. Another connector 30 is coupled to the connector 20. For purposes of this disclosure, connector 30 is a luer lock connector and is coupled to connector 20 by machining. Similar to the connector 20, the connector 30 also includes a cannula 31 so that the cannula 31 is aligned with the cannula 14 and 21. Other connectors may be used for connector 30.

  FIG. 2 shows an end view of the connector 30 and shows that the opening 32 to the cannulation portion 31 is tapered for purposes described below. However, it is also within the scope of the present disclosure to have an opening that is not tapered. For purposes of this disclosure, the cannulation portions 14, 21, 31 are the same diameter. However, it is also within the scope of the present disclosure to have cannulation portions of different diameters.

  During the repair procedure, a guide wire is inserted into the bone, particularly into the affected area of the bone, by use of means such as fluoroscopy or C-Arm image intensification visualization. Other means are also possible. The drill bit 10 is then threaded over the guide wire so that the guide wire is placed inside the cannula 14, 21, 31. The drill is then coupled to the drill bit 10 via the connector 20 and the drill is manipulated to pass the drill bit 10 through the bone, thereby forming a hole in the bone. When the drill bit 10 is in place, the drill and guide wire are removed from the drill bit 10. Next, a delivery instrument such as a syringe containing bone marrow cells is coupled to the drill bit 10 by placing the end of the syringe through the opening 32 of the cannulation section 31. The syringe is then actuated to transfer cells from the syringe to the drill bit 10. Cells exit the drill bit 10 through the slot 15 and opening 16 in the distal portion 12 of the shaft 11 and subsequently adhere into the bone. When cell attachment is complete, the syringe and drill bit 10 are removed from the body.

  By having an integral drill bit that includes connectors for both the drill and syringe, the user can couple the drill and syringe to the drill bit without using a separate adapter. Further, for the purposes of this disclosure, the end of the syringe is tapered to accommodate the tapered opening of the luer lock connector, thereby providing an efficient seal between the luer lock connector and the syringe. Substantially reducing the possibility of bone marrow cells leaking out of the drill bit through the opening of the luer lock connector. However, syringes or other delivery devices that do not have a tapered end and connectors that do not have a non-tapered opening are also within the scope of the present disclosure. In addition, the drill connector allows the drill to be quickly and easily removed from the drill bit.

  The exit of bone marrow cells from both the slot and opening at the distal portion of the shaft results in increased bone penetration by the bone marrow cells as opposed to exiting only from the opening. Due to the idea that bone marrow cells will differentiate into bone cells, the penetration of more bone marrow cells into the bone leads to better repair of the lesion or defect, which in turn grows healthy bone tissue and reduces the defect. It is thought to be blocked. Slots located in the area between the lands or threads and at an angle with respect to the longitudinal axis of the drill bit are used for bone debris to be inserted into the cannula of the shaft during drilling and closure of the cannula. Reduce the chances of getting inside. The drill bit is from about 6.5 inches (165 mm) long to about 24 inches (610 mm) long, thereby allowing treatment of both large and small patients, thereby Avoid one of the shortcomings of the current drill bits mentioned.

  For the purposes of this disclosure, drill bits are used for bone marrow delivery. However, other materials that can be used for tissue repair may be delivered via a drill bit to the repair site, including growth factors, scaffolds, bone morphogenetic proteins, antibiotics, anti-inflammatory agents , Angiogenic factor, bone morphogenetic factor, monobutyrin, thrombin, denatured protein, platelet-rich plasma / solution, platelet poor plasma / solution, and other active agents and plants or animals such as living cells, preserved cells, dormant cells, and dead cells Any cell of origin, as well as osteoconductive material, is included, but is not limited to these.

  Since various modifications may be made to the exemplary embodiments as described above with reference to corresponding examples without departing from the scope of the present disclosure, they are included in the above description and attached. All matters shown in the drawings are intended to be interpreted as illustrative rather than limiting. Accordingly, the breadth and scope of the present disclosure should not be limited by any of the exemplary embodiments described above, but the following claims appended hereto and their equivalents: Should be defined only according to things.

DESCRIPTION OF SYMBOLS 10 Drill bit 11 Shaft 12 Distal part 13 Proximal part / proximal end 14 Cannulation part 15 Slot 16 Opening 18 Thread 19 Land 20 Connector 21 Cannulation part 30 Connector 31 Cannulation part 32 Opening

Claims (17)

A connector assembly for use with a cannulated drill bit, the assembly comprising a first cannulated connector permanently coupled to a second cannulated connector; A connector is configured to couple to the drill bit, and the second connector is configured to couple to a fluid delivery device or a fluid withdrawal device;
In use, a guide wire may be placed through the cannulation portion of the drill bit, the first cannulated connector, and the second cannulated connector ;
A connector assembly wherein the diameter of the first connector is greater than the diameter of the second connector so that, in use, a drill couples with the drill bit via the first connector .   The connector assembly of claim 1, wherein the first connector can be removably coupled to the drill bit.   The connector assembly according to claim 1, wherein the second connector is a luer lock connector. The connector assembly according to any one of claims 1 to 3 , wherein the cannulated portions of the first connector and the second connector have the same diameter. The connector assembly according to any one of claims 1 to 4 , wherein a cannulation portion of the second connector is tapered. In use, a cannulated drill bit having a distal portion and a proximal portion, a first cannulated connector coupled to the proximal portion, and permanently coupled to the first connector A second cannulated connector;
A guide wire may be placed through the cannulation portion of the drill bit, the first cannulated connector, and the second cannulated connector ;
A drill bit assembly , wherein in use, the diameter of the first connector is greater than the diameter of the second connector so that a drill couples with the drill bit via the first connector . The drill bit assembly of claim 6 , wherein the first connector is coupled to the proximal portion of the drill bit or near the proximal portion of the drill bit. The drill bit assembly according to claim 6 or 7, wherein the first connector is removably coupled to the drill bit. The drill bit assembly according to any one of claims 6 to 8 , wherein the first connector is configured to couple to a drill. The drill bit assembly according to any one of claims 6 to 9 , wherein the second connector is a luer lock connector. The drill bit assembly according to any one of claims 6 to 10 , wherein the second connector is configured to couple to a fluid delivery device or a fluid withdrawal device. The drill bit assembly according to any one of claims 6 to 11 , wherein at least the cannulation portion of the second connector is tapered. The drill bit assembly according to any one of claims 6 to 12 , wherein the cantilever portions of the drill bit, the first connector, and the second connector have the same diameter. 14. A drill bit according to any one of claims 6 to 13 , wherein the drill bit is at least partially threaded or comprises an incisor / blade at or near the distal end. Assembly. 15. A drill bit assembly according to any one of claims 6 to 14 , wherein the cantilever portion of the drill bit has no outlet at the distal end. 16. A drill bit assembly according to any one of claims 6 to 15 , wherein at least one fluid transfer slot is provided in the drill bit. A kit comprising at least one drill bit and at least one connector assembly according to any one of claims 1-5 .

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