Coupled directional bone drill and grafting system

Abstract

A system for creating multiple channels in bone and for delivery of graft material, such as in the treatment of bone necrosis, which includes a primary drill having a shaft with a cylindrical side, a proximal end, and a distal end; a flexible drill; and a system for harvesting bone graft for deep bone graft delivery. The primary drill has a first drill bit at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The flexible drill has a second drill bit configured to enter the longitudinal bore in the shaft of the primary drill so that the second drill bit extends toward the distal end of the shaft and extends from the opening in the cylindrical side of the shaft. A separate system for the harvest and delivery of bone graft is also described, which couples to the primary drill system via a tubular trocar guide, through which both systems function interchangeably allowing sequential drilling and grafting.

Description

Attorney Docket Number: HCL 3001-PCTCOUPLED DIRECTIONAL BONE DRILL AND GRAFTING SYSTEMTECHNICAL FIELD

[0001] Various exemplary embodiments disclosed herein relate generally to a system for drilling into a bone and delivering a bone graft or bone graft material. More particularly, a system for drilling multiple small holes into a bone from a single primary hole is disclosed. Additionally, a system for harvesting and implanting an autologous bone graft into a deep bony site is also disclosed.BACKGROUND

[0002] Avascular necrosis (AVN), also called osteonecrosis or bone infarction, is the death of bone tissue due to the interruption of the blood supply. Although it can occur in any bone, it most commonly affects the hip. There are no symptoms in the early stages, but it may eventually cause pain in the affected joint as the disease progresses. In the later stages, this disease can lead to the collapse of the femoral head and severe osteoarthritis. Total hip arthroplasty is currently the standard of care to treat femoral AVN with head collapse. Due to the limited product life of an artificial hip, there is a need to develop treatment options addressing the earlier stages of the disease to delay or prevent hip collapse, especially for younger patients.

[0003] For the earlier stages of the disease there are nonsurgical treatment options (e g. antiinflammatory medications and activity changes) to help relieve pain and slow the progression of the disease. But the most successful treatment options are surgical and include:Core Decompression (CD); andNon-Vascularized and Vascularized Bone Graft.

[0004] Core decompression is more commonly performed in early stages of the disease, and involves drilling one large hole or several smaller holes (multi-hole CD) into the necrotic areas of the femoral head to reduce pressure, increase blood flow, trigger creeping substitution of diseased bone, and potentially fill necrotic bony tissue with graft material. In later stages, it may be necessary to remove the necrotic bony tissue and replace it with a bone graft.Attorney Docket Number: HCL 3001-PCTSUMMARY

[0005] In light of the present need for improved tools for treating necrotic bone or other types of deep bony failure, a brief summary of various embodiments disclosed herein is presented. Some simplifications and omissions may be made in the following summary, which is intended to highlight and introduce some aspects of the various embodiments, but not to limit the scope of the invention. Detailed descriptions of a preferred embodiment adequate to allow those of ordinary skill in the art to make and use the inventive concepts will follow in later sections.

[0006] While the following discussion focuses on treating necrotic tissue within a bone, the drill and bone grafting system disclosed herein may be used to treat other conditions, including but not limited to, avascular necrosis of a bone, an impacted bone fracture whereby fracture reduction may be achieved by either direct or indirect augmentation by grafting, or conditions necessitating drilling to permit subsequent injection or ingress of cements, growth factors, cellular components, liquid or semi-solid allogeneic or autologous bone grafts or graft substitutes, radiopaque agents, or pharmaceutical agents (hereinafter referred to as inj ectants) in bone. The bone grafting system, in couple with the drill, also permits back-filling of the drill hole to prevent leakage of inj ectants. The bone grafting harvest tube permits deep bone grafting with precise bone graft placement. Also, while the following discussion describes use of the drill system in treating necrotic bone or other bone defects in the hip joint, this drill system can be used for other joints which experience subchondral bone disease, e g., the knee, shoulder, or ankle joint, or other regions of the bony anatomy not necessarily adjacent to a joint structure.

[0007] Various embodiments disclosed herein relate to a primary drill including a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending along an axis of the shaft from the proximal end toward the distal end. The drill bit on the primary drill may have variable drill tips permitting unidirectional or bidirectional drilling. The primary drill has an opening in the cylindrical side of the shaft. A passage extends from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The longitudinal bore in the primary drill is configured to receive a flexible drill having a proximal end and a distal end; and the opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough.Attorney Docket Number: HCL 3001-PCT

[0008] The primary drill may also include a connection means at the proximal end of the shaft in fluid communication with the longitudinal bore in the shaft. The connection means is configured to allow inj ectants to be transferred through the longitudinal bore.

[0009] Various embodiments disclosed herein relate to a system including: a primary drill with a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending from the proximal end toward the distal end; a first drill bit having a helical flute at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; and a flexible drill having a second drill bit.In various embodiments, the flexible drill is configured to enter the longitudinal bore in the shaft of the primary drill so that the second drill bit extends toward the distal end of the shaft; and the second drill bit on the flexible drill is configured to extend from the opening in the cylindrical side of the shaft.

[0010] The present application describes a method of creating multiple channels in necrotic bone, including a step of drilling into a bone containing necrotic tissue with a primary drill including a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending from the proximal end toward the distal end; a first drill bit having a helical flute at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The primary drill is used to drill into the bone. The primary drill may be used to drill into the bone without entering the necrotic tissue in the bone. In some cases, the drill may be used to drill through healthy bone tissue and then into necrotic tissue in the bone to purposefully create multiple passages.

[0011] After drilling into the bone, a flexible side drill is positioned in the longitudinal bore of the primary drill, and a distal end of the flexible drill is extended through the opening in the cylindrical side of the shaft of the primary drill. The flexible drill is used to create a first channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone. The flexible drill is then withdrawn into the longitudinal bore of the primary drill and the position of the primary drill is angularly and / or longitudinally adjusted. This may be done by rotating the primary drillAttorney Docket Number: HCL 3001-PCT around its axis and / or advancing or retracting the primary drill along its axis either manually or with the use of a power tool. The flexible drill is then used to create a further channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone, where the further channel is spaced from the first channel. The flexible drill is then withdrawn from the longitudinal bore and injectant is provided to the channels extending into the necrotic tissue through the longitudinal bore.

[0012] Various embodiments disclosed herein relate to a primary drill including a shaft having a cylindrical side, a proximal end, and a distal end, with a first longitudinal bore extending along an axis of the shaft from the proximal end to the distal end; and a second longitudinal bore extending from the proximal end of the shaft toward the distal end, the second longitudinal bore being offset from the axis of the shaft. The drill further includes a drill bit having a helical flute at the distal end of the shaft, wherein the first longitudinal bore extends through the drill bit; an opening in the cylindrical side of the shaft; and a passage extending from the second longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The first longitudinal bore is configured to allow a guidewire to pass therethrough; while the second longitudinal bore is configured to receive a flexible drill having a proximal end and a distal end. The opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough.

[0013] A system including a primary drill including a shaft with a first longitudinal bore, a second longitudinal bore, and a drill bit may also include a guidewire and a flexible drill having a second drill bit. The guidewire is configured to pass through the first longitudinal bore; and the flexible drill is configured to enter the second longitudinal bore in the shaft of the primary drill so that the second drill bit extends toward the distal end of the shaft. The second drill bit on the flexible drill is configured to extend from an opening leading from the second longitudinal bore to a cylindrical side of the shaft.

[0014] Various embodiments relate to a method of creating a channel in necrotic bone by: positioning a guidewire in a first longitudinal bore of a primary drill with a first longitudinal bore, a second longitudinal bore, and a drill bit; drilling into a bone containing necrotic tissue with the primary drill; positioning a flexible side drill in the second longitudinal bore of the primary drill afterAttorney Docket Number: HCL 3001-PCT removing the guidewire; extending a distal end of the flexible drill through an opening leading from the second longitudinal bore to a cylindrical side of the shaft; using the flexible drill to create a first channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone; withdrawing the flexible drill from the longitudinal bore; and optionally providing inj ectant to the first channel through the second longitudinal bore.

[0015] Various embodiments relate to a method of creating a channel in necrotic bone by: inserting a guidewire in a bone; positioning a primary drill over the guidewire so the guidewire passes through a first longitudinal bore of the primary drill; drilling into the bone with the primary drill; positioning a flexible side drill in a second longitudinal bore of the primary drill after removing the guidewire, where the first longitudinal bore and the second longitudinal bore may be the same or different; extending a distal end of the flexible drill through an opening leading from the second longitudinal bore to a cylindrical side of the shaft; using the flexible drill to create a first channel extending from the opening in the cylindrical side of the shaft into necrotic tissue in the bone; withdrawing the flexible drill from the longitudinal bore; and optionally providing inj ectant to the first channel through the second longitudinal bore.

[0016] The method of creating a channel in necrotic bone using a primary drill with a first longitudinal bore, a second longitudinal bore, and a drill bit may further include, prior to the step of providing injectant, at least one step of withdrawing the flexible drill into the second longitudinal bore of the primary drill and adjusting the position of the primary drill angularly around the axis of the shaft and / or along the length of the shaft, and using the flexible drill to create a further channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone, wherein the further channel is spaced from the first channel. The step of providing injectant may include providing injectant to the first channel and each further channelAttorney Docket Number: HCL 3001-PCT through the second longitudinal bore.

[0017] Various embodiments disclosed herein relate to a primary drill including a shaft having a cylindrical side, a proximal end, and a distal end, with a first longitudinal bore extending along the shaft to the distal end; and a second longitudinal bore extending along the shaft from the proximal end toward the distal end. In various embodiments, the primary drill includes a cutting surface or a cutting edge at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the second longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The cutting edge may be one or more helical flutes. The primary drill may be a bidirectional drill, and the cutting surface may be a grinding surface. The opening in the cylindrical side of the shaft is proximal to the drill bit. The second longitudinal bore is configured to receive a flexible drill having a proximal end and a distal end; and the first longitudinal bore is configured to receive a guidewire. The opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough. The first longitudinal bore and the second longitudinal bore are either coaxial with each other; or offset from each other. The first longitudinal bore and the second longitudinal bore may be coaxial with each other, where the first longitudinal bore is configured to allow a guidewire to pass through an opening at the distal end of the shaft, without permitting the flexible drill to pass therethrough; and the second longitudinal bore is configured to allow a guidewire to enter the first longitudinal bore and to allow a flexible drill to enter the passage extending from the second longitudinal bore to the opening in the cylindrical side of the shaft. The first longitudinal bore and the second longitudinal bore may be arranged so that the first longitudinal bore extends along an axis of the shaft of the primary drill, and the second longitudinal bore is radially offset from the first longitudinal bore.

[0018] Various embodiments disclosed herein relate to a method of treating necrotic tissue in a bone in a patient in need thereof, by positioning a tubular trocar guide within a patient and positioning a primary drill within the tubular trocar guide. The primary drill includes a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending along an axis of the shaft from the proximal end to the distal end. The drill further includes a drill bit having a helical flute at the distal end of the shaft, wherein the first longitudinal bore extends through the drill bit; an opening in the cylindrical side of the shaft; and a passage extending from the secondAttorney Docket Number: HCL 3001-PCT longitudinal bore in the shaft to the opening in the cylindrical side of the shaft. The drill is positioned so that the drill bit is near the bone of the patient. The method further includes drilling into the bone with the primary drill to create a drill hole in the bone, without entering the necrotic tissue or only a portion of it with the drill bit; and positioning a flexible side drill in the longitudinal bore of the primary drill. A distal end of the flexible drill extends from the bore through the opening in the cylindrical side of the shaft. The flexible drill is used to create a channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone. The flexible drill is withdrawn from the longitudinal bore and inj ectant is provided to the channel through the longitudinal bore. The primary drill is removed from the tubular trocar guide; and a bone graft deployment instrument is deployed through the tubular trocar guide in the drill hole in the bone.

[0019] The steps of positioning the tubular trocar guide within a patient and positioning the primary drill within the tubular trocar guide may include: inserting a guide wire within the patient so that a tip of the guide wire is near the desired location in the bone of the patient; positioning the tubular trocar guide over the guide wire with or without docking into the bone; and inserting the primary drill through the tubular trocar guide so that the guide wire passes through the longitudinal bore of the primary drill.

[0020] The steps of positioning the tubular trocar guide within a patient and positioning the primary drill within the tubular trocar guide may include, after drilling into the bone with the primary drill, inserting the tubular trocar guide over the primary drill within the patient so that the primary drill passes through the tubular trocar guide.

[0021] The steps of deploying the bone graft may include inserting a harvest tube containing a bone graft core through a grafting cannula into the drill hole in the bone and deploying the bone graft core in the drill hole.

[0022] The steps of deploying the bone graft may include inserting a grafting cannula into the drill hole in the bone and deploying the bone graft material in the drill hole, where the bone graft material may be autologous bone; a human bone allograft; synthetic bone graft or bone graft extenders; a bone xenograft; a bone cement; an inj ectant; or a mixture thereof.Attorney Docket Number: HCL 3001-PCT

[0023] The steps of deploying the bone graft may include inserting a harvest tube containing bone graft material into the drill hole in the bone through a grafting cannula positioned in a tubular trocar guide; and deploying the bone graft material in the drill hole, where the bone graft material may be autologous bone; a human bone allograft; synthetic bone graft or bone graft extenders; a bone xenograft; a bone cement; an inj ectant; or a mixture thereof. The steps of deploying the bone graft may include: inserting the grafting cannula through a tubular trocar guide after removing the primary drill; and inserting the harvest tube containing bone graft material through the grafting cannula into the drill hole in the bone and deploying the bone graft material in the drill hole.

[0024] Various embodiments disclosed herein relate to bone graft harvesting and delivery system comprising: a harvest tube with an outer surface, a distal end, a proximal end, and a bore along its longitudinal axis, wherein the harvest tube is configured to be inserted in a donor bone and temporarily store a bone graft in its longitudinal bore; a grafting cannula with an outer surface, a distal end, a proximal end, and a bore along its longitudinal axis, wherein the longitudinal bore of the cannula is configured to receive the harvest tube; a tubular trocar guide with an outer surface, a distal end, a proximal end, a beveled or stepped tip at one end, and a bore along its longitudinal axis, wherein the longitudinal bore of the tubular trocar guide is configured to receive the grafting cannula or harvest tube and provide directional control for insertion of the grafting cannula or harvest tube into a bone of a patient; and a plunger or obturator which is configured to push the bone graft from the harvest tube into a delivery site in the bone of the patient.

[0025] Various embodiments disclosed herein relate to bone graft harvesting and delivery method including steps of: inserting a harvest tube with a longitudinal bore into a donor bone and temporarily storing a bone graft in the longitudinal bore of the harvest tube;Attorney Docket Number: HCL 3001-PCT inserting a grafting cannula with a longitudinal bore through the tubular trocar guide into the drill hole in the bone of the patient; inserting the harvest tube with the bone graft through the grafting cannula into the drill hole; and using a plunger or obturator to push the bone graft from the harvest tube into the drill hole in the bone of the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to better understand various exemplary embodiments, reference is made to the accompanying drawings, wherein:

[0027] FIG. 1A illustrates a first embodiment of a drill system for treating necrotic bony tissue, including a primary drill 1 and a flexible drill 2;

[0028] FIGS. IB and 1C illustrate a second embodiment of a primary drill for use in the system of FIG. 1A;

[0029] FIG. 2A illustrates a tip of a primary drill 1 in the system of FIG. 1A;

[0030] FIG. 2B illustrates a cross section of a primary drill 1 in the system of FIG. 1A, viewed in the direction of arrows A;

[0031] FIG. 3 A illustrates an alternate embodiment of a primary drill 1 for use in the system of FIG. 1A;

[0032] FIG. 3B illustrates a cross section of the primary drill 1 of FIG. 3A, viewed in the direction of arrows D in FIG. 3A;

[0033] FIG. 4A illustrates a second embodiment of a drill system for treating necrotic bony tissue, including a primary drill 1 (flexible drill 2 omitted for clarity);

[0034] FIG. 4B illustrates a third embodiment of a drill system for treating necrotic bony tissue, including a primary drill 1 (flexible drill 2 omitted for clarity);

[0035] FIG. 5 illustrates a cross section of a primary drill 1 in the system of FIG. 4A, viewed in the direction of arrows B;

[0036] FIG. 6 illustrates a femur with a drill hole and a channel in the bone prepared using the first embodiment of the drill system of FIG. 1A or the second embodiment of the drill system of FIG. 4A or the third embodiment of the drill system of FIG. 4B;Attorney Docket Number: HCL 3001-PCT

[0037] FIG. 7 illustrates a cross section of the femur of FIG. 6, viewed in the direction of arrows C;

[0038] FIG. 8 illustrates a cross section of the primary drill of FIG. 4A, showing a removable adaptor for insertion of inj ectant;

[0039] FIG. 9 illustrates a modified version of the drill system of FIG. 1A inside a tubular trocar guide;

[0040] FIGS. 10A and 10B illustrate a tubular trocar guide;

[0041] FIGS. 11A and 1 IB illustrate a harvest tube;

[0042] FIG. 12 illustrates a graft pusher;

[0043] FIG. 13 illustrates a system for harvesting and delivering bone graft material; and

[0044] FIG. 14 shows a means for deploying inj ectant or bone graft material.DETAILED DESCRIPTION

[0045] Referring now to the drawings, in which like numerals refer to like components or steps, there are disclosed broad aspects of various exemplary embodiments.

[0046] FIG. 1 A shows a first embodiment of a drill system, including a primary drill 1, a flexible drill 2, and a handle 3. The system of FIG. 1A may be used with a guidewire 201, shown in FIG. 2A.

[0047] Primary drill 1 includes a shaft 101 with a distal end and a proximal end. The distal end of the shaft 101 of the primary drill 1 includes a drill bit 107 having a length X, where the drill bit 107 may include at least one, preferably two or more, helical or non-helical flutes 104. Non-helical designs such as a bladed tip may permit rotationally bidirectional drilling. The shaft 101 of primary drill 1 has a radius Rl, as shown in FIGS. 2 A and 2B, which will be further described later. The shaft 101 has a bore with axis Al therethrough, where a proximal section 102 of the bore has a radius R3, and a distal section 103 of the bore, extending through the drill bit 107 defined by flutes 104, has a radius R2, where R2 is less than R3, as shown in FIG. 2B. At the distal end of proximal bore section 102, a passage 105 extends from the bore to an opening on a cylindrical outer surface of shaft 101. The opening of passage 105 has a proximal end and a distal end. The drill bit defined by flutes 104 extends from the distal tip of shaft 101 for a distance X. The distal end of the openingAttorney Docket Number: HCL 3001-PCT of passage 105 is separated from the distal tip of shaft 101 by a distance Y. In various embodiments, Y > X. In some embodiments, Y < X, so that opening of passage 105 extends to or past the proximal end of flutes 104.

[0048] Flexible drill 2 has a shaft 202 with an axis A2 and a drill bit 203. As used herein, drill bit 203 may be a drilling implement with a tip including helical flutes, or a piercing implement with a pointed tip or a blade shaped end with trocar tip. The diameter of shaft 202 of flexible drill 2 is small enough that flexible drill 2 can pass through the proximal section 102 of the bore in primary drill 1, but large enough that flexible drill 2 is unable to enter the distal section 103 of the bore in primary drill 1. Accordingly, the flexible drill 2 exits the bore of the primary drill 102 through passage 105 through the opening on the cylindrical outer surface of shaft 101. While the flexible drill is inside proximal section 102 of the bore, the axis Al of the bore and the axis A2 of flexible drill shaft 202 are substantially coaxial. After the flexible drill exits proximal section 102 of the bore through passage 105, the axis Al of the bore and the axis A2 of flexible drill shaft 202 may diverge by an angle a, where a may be 10° to 45°, 15° to 40°, 20° to 35°, 25° to 30°, 10° to 25°, or 15° to 20°. In various embodiments, an outer sleeve may be deployed over shaft 101 of primary drill 1. A distal end of the outer sleeve reaches passage 105. The position of the outer sleeve may be adjusted so as to increase or decrease the size of opening 105. By adjusting the size of opening 105, the user may control the angle between the axis Al of the bore and the axis A2 of flexible drill shaft 202.

[0049] Handle 3 includes a central section 301 with a bore that receives shaft 101 of primary drill 1, and two handles 302 connected to central section 301. Handles 302 may be removable handles which screw into threaded bores in central section 301 until shaft 101 is clamped in a fixed position between handles 302, and cannot rotate independently of section 301. Handles 302 may be permanently attached to central section 301, and shaft 101 may be clamped in a fixed position relative to section 301 by one or more set screws 304 which are screwed against shaft 102 using a threaded opening in central section 301.

[0050] In various embodiments, handle 3 may be connected to shaft 101 with a quick connect coupling. Such quick connect coupling are known in the art. For example, the proximal end of shaft 101 may include a male joint with a hexagonal cross section and a groove. Handle 3 mayAttorney Docket Number: HCL 3001-PCT include a hexagonal female joint configured to engage the hexagonal male joint on shaft 101. The hexagonal female joint may include a feature, e.g., a ridge or one or more balls, configured to engage the groove on the hexagonal male joint on shaft 101.

[0051] In various embodiments, handle 3 may be replaced with a powered drill. The shaft 101 may be connected to the powered drill using a quick connect coupling.

[0052] In various embodiments, a marker or guide 303 is positioned in one of handles 302, and shaft 101 may be clamped in a fixed position relative to section 301 so that the marker or guide 303 is aligned with the opening of passage 105 in primary drill 1. Although marker or guide 303 is shown as an extended pointer with a sharpened tip in FIG. 1 A, other embodiments may be used. For example, the marker may be a notch or a colored stripe on one of handles 302, where the notch or colored stripe is aligned with the opening of passage 105. Marker 303 may in some embodiments also indicate the position of the flexible drill tip 203 relative to axis Al of the primary drill. In some embodiments shaft 101 may include a notch or a colored stripe aligned with the opening of passage 105.

[0053] In various embodiments, an adapter 106 may be removably or permanently fitted to a proximal end of shaft 101 of primary drill 1. The purpose of adapter 106 will be described later in further detail.

[0054] FIGS. IB and 1C show a different embodiment of a primary drill for use in the system of FIG. 1 A. The drill of FIGS. IB and 1C has a bore extending toward the distal end of the drill, but unlike primary drill 1 in FIG. 1 A, the bore does not extend to the distal end of the drill. Referring to FIG. IB, the drill has a shaft 101 with a distal end and a proximal end. The distal end of the shaft 101 of the primary drill 1 includes a drill bit 107, where the drill bit 107 may include at least one helical or non-helical flute 104 (not shown in FIGS. IB and 1 C). Near the distal end of shaft 101, a passage 105 extends from an opening on a cylindrical outer surface of shaft 101 to the distal end of the bore extending toward the distal end of the drill.

[0055] FIG. 1C is a cross section of the primary drill of FIG. IB, viewed in the direction of arrows E. As seen in FIG. 1C, bore 102 extends along an axis of the primary drill, with opening 105 in the shaft 101 intersecting with the distal end of bore 102. Bore 102 extends toward the distal end of shaft 101, without reaching the distal end of shaft 101.Attorney Docket Number: HCL 3001-PCT

[0056] FIGS. IB and 1C illustrate a structure for connection of handle 3 of FIG. 1A or a power tool with the primary drill. The proximal end of the shaft 101 may include a male joint 112 with at least one flat surface which is configured to mate with a female joint in handle 3 (not shown in FIGS IB and 1 C), where the male joint 112 and the female joint have corresponding flat surfaces. The male joint 112 and the female joint may each be square, with four corresponding flat surfaces. The male joint 112 and the female joint may each be hexagonal, with six corresponding flat surfaces. The male joint 112 and the female joint may each be semicylindrical, with a single corresponding flat surface. The male joint may include a groove 111 for use with a female joint of a quick connect coupler, where groove I l l is configured to receive spring loaded balls from the female joint. If desired, the outer diameter of shaft 101 may be enlarged at the proximal end 110 of shaft 101 to better support the male joint 112 and a handle attached thereto. As seen in FIG. 1C, male joint 112 may include a hollow region 113 configured to connect with a tip of a syringe, so as to place the interior of the syringe in fluid communication with bore 102 and opening 105. This allows medications, inj ectant, or biological materials in the syringe to be administered to an interior of a bone.

[0057] FIG. 2A shows a view of the distal tip of primary drill 1, showing flutes 104 and the distal end of the distal section 103 of the bore through primary drill 1. The shaft 101 of drill 1 has a radius Rl. The distal section 103 of the bore through drill 1 has radius R2, where R2 < Rl. The distal section 103 of the bore through drill 1 is large enough to allow a guidewire 201 to pass therethrough, as shown in FIG. 2A.

[0058] FIG. 2B shows a cross section view of primary drill 1, viewed in the direction of arrows A of FIG. 1A. The cross section view of FIG. 2B shows the tips of flutes 104 and an opening to the distal end of the distal section 103 of the bore through primary drill 1. Note that in some embodiments, the tips of flutes 104 may not extend beyond the surface of shaft 101; in such embodiments, the tips of flutes 104 would not be visible in a cross section similar to FIG. 2B. The cross section view of FIG. 2B also shows the distal end of the proximal section 102 of the bore through primary drill 1, and the passage 105 leading from the distal end of the proximal section 102 to an opening on a cylindrical outer surface of shaft 101 of primary drill 1. The shaft 101 of drill 1 has a radius Rl. The distal section 103 of the bore through drill 1 has radius R2. TheAttorney Docket Number: HCL 3001-PCT proximal section 102 of the bore through primary drill 1 has radius R3, where R2 < R3 < Rl. The distal section 103 of the bore through primary drill 1 is large enough to allow a guidewire 201 to pass therethrough, as shown in FIG. 2A, but too small to allow the flexible drill 2 (shown in FIG. 1A) therethrough. The proximal section 102 of the bore through primary drill 1 is large enough to allow both the guidewire 201 and the flexible drill 2 to pass therethrough. As seen in FIG. 2B, the passage 105 leading from the distal end of the proximal section 102 of the bore to the opening on the outer surface of shaft 101 may have a width equal to a diameter of the proximal section 102 of the bore in the primary drill 1. In various embodiments, the passage 105 leading from the proximal section 102 of the bore to the opening on the outer surface of shaft 101 may have a width which is either greater than, or less than, a diameter of the proximal section 102 of the bore, as long as the passage 105 is large enough to allow flexible drill 2 therethrough.

[0059] In an alternate embodiment of a primary drill 1 shown in FIG. 3A, primary drill 1 includes a shaft 101 with a distal end and a proximal end. The distal end of the shaft 101 of the primary drill 1 includes a drill bit 107, where the drill bit 107 includes at least one, preferably two or more, flutes 104. The shaft 101 of primary drill 1 has a radius Rl, as shown in FIG. 3B, which will be further described later. The shaft 101 has a bore 102 with axis Al therethrough, where the bore 102 has a radius R3. At the distal end of bore 102, a passage 105 extends from the bore 102 to an opening on a cylindrical outer surface of shaft 101. Bore 102 terminates at passage 105; the distal end of shaft 101 is solid, with no bore passing therethrough. The primary drill 1 of FIG. 3A is used without a guidewire.

[0060] FIG. 3B shows a cross section view of primary drill 1 of FIG. 3 A. The cross section view of FIG. 2B shows the distal end of the bore 102 through primary drill 1, and the passage 105 leading from the distal end of bore 102 to an opening on a cylindrical outer surface of shaft 101 of primary drill 1. The shaft 101 of drill 1 has a radius Rl. Bore 102 through primary drill 1 has radius R3. Bore 102 is large enough to allow the flexible drill 2 to pass therethrough. The passage 105 may have a width equal to a diameter of the bore 102 in the primary drill 1. In various embodiments, the passage 105 leading from the proximal section 102 of the bore to the opening on the outer surface of shaft 101 may have a width which is either greater than, or less than, aAttorney Docket Number: HCL 3001-PCT diameter of bore 102, as long as the passage 105 is large enough to allow flexible drill 2 therethrough. Bore 102 terminates at passage 105; no bore extends to a tip of shaft 101.

[0061] FIG. 4A shows a second embodiment of a drill system for treating necrotic bony tissue, including a primary drill 4, a flexible drill 2 (not shown in FIG. 4A), and a handle 3. Flexible drill 2 and handle 3 are substantially similar to the flexible drill and handle of FIG. 1 A, and will not be further described except with relation to primary drill 4.

[0062] Primary drill 4 includes a shaft 101 with a distal end and a proximal end. The distal end of the shaft 101 of the primary drill 1 includes a drill bit 107 having a length X, where the drill bit 107 includes at least one, preferably two or more, helical flutes 104. The shaft 101 of primary drill 1 has a radius Rl, as shown in FIG. 5, which will be further described later. The shaft 101 has: a first bore 401 with axis A3 therethrough, where bore 401 has a radius R4, as shown in FIG. 5, extending from the proximal end of shaft 101 through the drill bit 107 defined by flutes 104, and a second bore 402 with axis A4 therethrough, where bore 402 has a radius R5, as shown in FIG. 5, and extends from the proximal end of shaft 101 toward the drill bit 107.The first bore 401 and the second bore 402 are parallel to each other. The first bore may be coaxial with an axis of shaft 101, with the second bore being radially offset from the first bore, as shown in FIG. 5. Alternatively, the first bore 401 and the second bore 402 may each be radially offset from an axis of shaft 101. At a distal end of second bore 402, bore 402 ends and a passage 403 extends from the end of bore 402 to an opening on a cylindrical outer surface of shaft 101. The drill bit defined by flutes 104 extends from the distal tip of shaft 101 for a distance X. The opening of passage 403 from bore 402 to the opening on the surface of shaft 101 is separated from the distal tip of shaft 101 by a distance Y. In various embodiments, Y > X. In some embodiments, Y < X, so that opening of passage 403 extends to or past the proximal end of flutes 104. Thus, as shown in FIG. 4A, the proximal end of shaft 101 in primary drill 4 has two parallel bores therethrough, and the distal end of shaft 101 has a single bore therethrough.

[0063] FIG. 4B shows a third embodiment of a drill system for treating necrotic bony tissue, including a primary drill 4, a flexible drill 2 (not shown in FIG. 4B), and a handle 3 (not shown inAttorney Docket Number: HCL 3001-PCTFIG. 4B). Flexible drill 2 and handle 3 are substantially similar to the flexible drill and handle of FIG. 1A, and will not be further described except with relation to primary drill 4.

[0064] Primary drill 4 includes a shaft 101 with a distal end and a proximal end. The distal end of the shaft 101 of the primary drill 1 includes a drill bit 107 with at least one, preferably two or more, helical or non-helical flutes 104. The shaft 101 has: a first bore 401 extending from the proximal end of shaft 101 through the drill bit 107 defined by flutes 104, and a second bore 402 extending from the proximal end of shaft 101 toward the drill bit 107.The first bore 401 and the second bore 402 are parallel to each other. The first bore may be coaxial with an axis of shaft 101, with the second bore being radially offset from the first bore, as shown in FIG. 4B. Alternatively, the first bore 401 and the second bore 402 may each be radially offset from an axis of shaft 101. At a distal end of second bore 402, bore 402 ends and a passage 403 extends from the end of bore 402 to an opening on a cylindrical outer surface of shaft 101. Thus, as shown in FIG. 4A, the proximal end of shaft 101 in primary drill 4 has two parallel bores therethrough, and the distal end of shaft 101 has a single bore therethrough. As shown in FIG. 4B, the opening on the cylindrical outer surface of shaft 101 and bore 402 may be on opposite sides of bore 401. Bore 401 is used to receive a guidewire used for directing primary drill 4. After a drill hole has been made with primary drill 4, the guidewire is removed from bore 401. A flexible drill is then positioned in bore 402. At the end of bore 402, the flexible drill passes through passage 403 to the opening on the cylindrical outer surface of shaft 101. As the opening on the outer surface of shaft 101 and bore 402 are on opposite sides of bore 401 in the embodiment of FIG. 4B, the flexible drill passes from one side of bore 401 to the opposite side of bore 401 as it passes through passage 403. In some embodiments, bore 402 is larger in diameter than bore 401 and the radial offset between both bores is such that bore 401 is located within bore 402 from the proximal end of shaft 101 to passage 403.

[0065] FIG. 5 shows a cross section view of the primary drill 4 of FIG. 4A, with a guidewire 201 and a flexible drill 2 positioned therein. The primary drill 4 is viewed in the direction of arrows B of FIG. 4A. The cross section view of FIG. 5 shows the tips of flutes 104, first bore 401, and the distal end of second bore 402, where passage 403 extends from bore 402 to an opening on the outerAttorney Docket Number: HCL 3001-PCT surface of shaft 101. Note that in some embodiments, the tips of flutes 104 may not extend beyond the surface of shaft 101; in such embodiments, the tips of flutes 104 would not be visible in a cross section similar to FIG. 5. The shaft 101 of primary drill 4 has a radius Rl. The first bore 401 through primary drill 4 has radius R4. The second 402 bore through primary drill 4 has radius R5. The first bore 401 through primary drill 4 is large enough to allow a guidewire 201 to pass therethrough, as shown in FIG. 5. The second bore 402 through primary drill 4 is large enough to allow flexible drill 2 to pass therethrough and out through opening 403, as shown in FIG. 5. The relative sizes and positions of first bore 401 and second bore 402 may vary, depending on the relative diameters of the flexible drill 2 and the guidewire 201. If, for example, the flexible drill 2 and the guidewire 201 have similar diameters, R4 may be equal to R5. If, for example, the flexible drill 2 is substantially larger than the guidewire 201, R4 may be less than R5.

[0066] As seen in FIG. 5, the passage 403 leading from the second bore 402 to the opening on the outer surface of shaft 101 may have a width equal to a diameter of second bore 402. In various embodiments, the passage 403 may have a width which is either greater than, or less than, a diameter of the second bore 402, as long as the passage 403 is large enough to allow flexible drill 2 to pass therethrough. In other embodiments, bore 402 may be laterally offset from passage 403. In some embodiments, bore 402 and passage 403 may intersect partially, e.g., the intersection of bore 402 and passage 403 occupies less than 100%, e.g., 90%, 80%, 75%, 65%, or less than 50%, of the width of passage 403. This connects passage 403 and bore 402, while still maintaining independent function of bore 402 and passage 403. The length of passage 403 along bore 402 may be adjusted so as to control the angle at which a flexible drill exits passage 403. As the length of passage 403 increases, the angle at which the flexible drill exits passage 403 decreases. As the length of passage 403 decreases, the angle at which the flexible drill exits passage 403 increases. Thus, the curvature of the flexible drill along passage 403 varies with the length of passage 403.

[0067] FIG. 6 shows a femur 6 with a head 601, a neck 602, and a region 603 with necrotic tissue in head 601. The femur may be treated with the drill system of FIG. 1A as follows, channels leading to necrotic bone 603 may be produced in the femur, by drilling into femur 6 with the primary drill 1 of FIG. 1 A, creating a passage 604 extending through the neck 602 of femur 6 into head 601. A guidewire 201 passing through bore 102, 103 may be used to direct drill 1 by knownAttorney Docket Number: HCL 3001-PCT methods. After passage 604 is completed, the guidewire is removed from the bore 102, 103. A flexible drill 2 is then positioned in longitudinal bore 102 of the primary drill. A distal end of the flexible drill passes from bore 102, and is extended through passage 105 and exits through the opening in the cylindrical side of the shaft 101. The flexible drill is used to create a first channel 605 extending from the opening in the cylindrical side of the shaft 101 into the necrotic tissue 603 in the bone. If desired, the proximal end of bore 103 may be sealed or plugged after removal of guidewire 201, and before insertion of flexible drill 2, to facilitate guiding the flexible drill 2 through the passage 105.

[0068] In various embodiments, the flexible drill 2 is withdrawn into the longitudinal bore 102 of the primary drill 1, which is then rotationally and / or axially adjusted, changing the position of the primary drill 1 around and / or along the axis of the shaft 101. The flexible drill creates a further channel extending from the opening in the cylindrical side of the shaft 101 into the necrotic tissue603 in the bone 6, wherein the further channel is spaced from the first channel. The steps of rotationally and / or axially adjusting the primary drill 1 and using the flexible drill 2 to create a further channel may be repeated one or more times to create multiple channels 605, as shown in FIG. 7. FIG. 7 is a cross section of the head 601 of femur 6 of FIG. 6, showing the position of necrotic tissue 603. The primary drill 1 in the drill system of FIG. 1 A has been used to drill passage604 extending through the neck 602 of femur 6 into head 601. The flexible drill 2 in the drill system of FIG. 1A has been used to drill channels 605a, 605b, and 605c into necrotic tissue 603. In FIG. 7, channels 605a, 605b, and 605c are angularly spaced from one another, due to rotation of primary drill 1 by a fractional number of rotations between creating each pair of channels. Channels 605a, 605b, and 605c may be longitudinally spaced from one another, if primary drill 1 is advanced or retracted along its axis, between creating each pair of channels.

[0069] In various embodiments, femur 6 may be treated with the drill system of FIG. 4A, where channels leading to necrotic bone 603 may be produced in the femur, by drilling into femur 6 with the primary drill 4 of FIG. 4A, creating a passage 604 extending through the neck 602 of femur 6 into head 601. A guidewire 201 passes through bore 401 and may be used to direct primary drill 4 by known methods. A flexible drill 2 passes through bore 402 of the primary drill. A distal end of the flexible drill passes from bore 402, and is extended through passage 403 and exits through theAttorney Docket Number: HCL 3001-PCT opening in the cylindrical side of the shaft 101. The flexible drill is used to create a first channel 605 extending from the opening in the cylindrical side of the shaft 101 into the necrotic tissue 603 in the bone. In general, the use of the drill system of FIG. 4A is similar to the operation of the drill system of FIG. 1A, except that the presence of two parallel longitudinal bores which are offset from each other means that there is no need to remove the guidewire 201 from the bore 401 prior to inserting flexible drill 2 into bore 402.

[0070] Returning to FIG. 1A, the use of adapter 106 after withdrawing the flexible drill from the longitudinal bore allows inj ectant to be provided to the further channel and the first channel through the longitudinal bore. Adapter 106 may be permanently or removably fixed to primary drill 1 or handle 3. Adapter 106 has a bore in fluid communication with bore 102 of primary drill 1. In various embodiments, adapter 106 may be a male fitting configured to receive a female fitting at the end of a tube, syringe or other inj ection device (not shown) for transferring inj ectant. Adapter 106 may be the female half of a Luer lock fitting, with tabs configured to screw into threads on a male Luer lock fitting at the end of the tube. Adapter 106 may be the male half of a Luer slip fitting, with a tapered outer surface configured to slide into a tapered inner surface of a female Luer slip fitting at the end of the tube. In various embodiments, a septum may be fitted over adapter 106, and a needle may be used to transfer inj ectant through the septum and adapter into bore 102.

[0071] Returning to FIGS. 1A and 6, injectant may be provided to a channel 605 through the longitudinal bore 102 of primary drill 1. If multiple channels 605 are present, injectant may be provided to each channel in succession by rotating drill 1 to successively bring passage 105 into fluid communication with each channel 605. A tube configured to be connected to drill 101 through an adapter 106 may be used to provide injectant, e.g., bone marrow, etc., to necrotic tissue in a bone by causing injectant to flow through bore 102 into channel 605.

[0072] In the system of FIG. 4A, the use of a removable adapter 801 may be preferred, so as to allow access to both bores 401 and 402 by the guidewire 201 and the flexible drill 2. For example, adapter 106 may include a tapered or threaded male joint 805 which fits into a corresponding female joint at the end of shaft 101, as shown in FIG. 8. The adapter 801 includes a bore 802. When adapter 801 is fitted to shaft 101, bore 802 is in fluid communication with bore 402, but not bore 401. Adapter 801 may include a means for maintaining proper alignment between adapterAttorney Docket Number: HCL 3001-PCT801 and shaft 101, so bores 802 and 402 remain in fluid communication. For example, a pin 803 on adapter 801 may fit into a corresponding hole 804 on shaft 101. In various embodiments, adapter 801 may be a female fitting configured to receive a male fitting at the end of a tube (not shown) for transferring inj ectant. In various embodiments, adapter 106 may include a tapered male joint 805 which fits into a corresponding female joint at the end of shaft 101, where a longitudinal rib on male joint 805 may fit into a corresponding groove on a female joint at the end of shaft 101, there by maintaining proper alignment between adaptor 106 and bore 402.

[0073] Returning to FIGS. 4A, 4B, and 6, injectant may be provided to a channel 605 through the longitudinal bore 402 of primary drill 4. If multiple channels 605 are present, injectant may be provided to each channel in succession by rotating primary drill 4 to successively bring passage 403 into fluid communication with each channel 605. A tube configured to be connected to drill 101 through an adapter as shown in FIG. 8 may be used to provide injectant, e.g., bone marrow, etc., to necrotic tissue in a bone by causing injectant to flow through bore 402 into channel 605.

[0074] FIG. 9 shows a modified version of the drill system of FIG. 1A. The system of FIG. 9 includes a guide wire 1101, a primary drill 1 as shown in FIG. 1A, a flexible drill 2 as shown in FIG. 1 A (not shown in FIG. 9), and a tubular trocar guide 1102. In use, a guide wire 1101 is inserted into a patient so that a tip of the guide wire is near the bone with necrotic tissue, or so that the tip of the guide wire penetrates the bone with necrotic tissue. In the case of necrotic tissue in the head of a femur, the axis of the guide wire 1 101 generally points through the neck of the femur into the head of the femur. The tubular trocar guide 1102 is positioned over the guidewire so that guide wire 1101 is positioned along an axis of tubular trocar guide 1102. The distal end of tubular trocar guide 1102 is positioned at or near the bone surface or inserted into the bone. Primary drill 1 is positioned in tubular trocar guide 1102 so that guide wire 1101 passes through the longitudinal bores 102, 103 of the primary drill 1. The primary drill 1 is then used to drill into the bone until the tip of the drill is near the necrotic tissue. The guidewire 1101 is then withdrawn from the primary drill, and flexible drill 2 is then positioned in the longitudinal bore 102 of the primary drill 1. Flexible drill 2 is then used to drill multiple channels into the necrotic tissue in the bone, generally as described above. Shaft 101 of primary drill 1 may include depth markings that indicate the position of the drill tip relative to the proximal end of the tubular trocar guide 1102.Attorney Docket Number: HCL 3001-PCT

[0075] If desired, the system of FIG. 9 may be used without guide wire 1101. In use, the primary drill 1 is used to drill into a bone with necrotic tissue until the tip of the drill is near the necrotic tissue. Tubular trocar guide 1102 is then positioned over primary drill 1, so the axis of primary drill 1 is generally coaxial with tubular trocar guide 1102. Flexible drill 2 is then positioned in bore 102 of primary drill 1 and used to drill one or more channels into the necrotic tissue in the bone, generally as described above. Alternatively, the tubular trocar guide 1102 can be positioned over primary drill 1, after primary drill 1 was used to drill into a bone guided by a guide wire as previously described.

[0076] A modified version of the drill system of FIG. 9 includes a guide wire 1101, a primary drill 4 as shown in FIG. 4A, a flexible drill 2 as shown in FIG. 4A (not shown in FIG. 9), and a tubular trocar guide 1102. In use, a guide wire 1101 is inserted into a patient. The tubular trocar guide 1102 is positioned over the guide wire 1101. Primary drill 4 of FIG. 4A is positioned in tubular trocar guide 1102 so that guide wire 1101 passes through the longitudinal bore 401 of the primary drill 4. The primary drill 4 is then used to drill into the bone until the tip of the drill is near the necrotic tissue. Flexible drill 2 is then positioned in the longitudinal bore 402 of the primary drill 1. Flexible drill 2 is then used to drill one or more channels into the necrotic tissue in the bone, generally as described above. Since the guide wire 1101 and the flexible drill pass through separate bores in the primary drill, there is no need to remove guidewire 1101 before positioning flexible drill 2 in bore 402.

[0077] The drill systems of FIG. 1A, FIG. 4A, or FIG. 9 may each be used as one element of a system for delivering bone graft material to a bone with necrotic tissue. Other elements in such a system for delivering bone graft material may include a tubular trocar guide, a harvest tube, a grafting cannula, and a graft pusher.

[0078] The tubular trocar guide is shown in FIGS. 10A and 10B. The tubular trocar guide includes a tubular shaft 906, with a bore 910 extending through shaft 906 and a shoulder 907 near the distal end of tubular shaft 906. A narrowed portion of tubular shaft 906 extends from the shoulder to the distal end of shaft 906. The narrowed portion of tubular shaft 906 may terminate in a circular cutting edge 908. The proximal end of the tubular shaft 906 may include an enlarged gripping surface 909.Attorney Docket Number: HCL 3001-PCT

[0079] The harvest tube is shown in FIGS. 11 A and 1 IB. The harvest tube includes a tubular shaft 901, with a bore 902 extending through shaft 901. A distal end of tubular shaft 901 may terminate in a circular cutting edge 903. The proximal end of the tubular shaft 901 may include an enlarged gripping surface 911. The harvest tube of FIG. 11A is configured to pass through the bore 910 of the tubular trocar guide of FIG. 10B.

[0080] The graft pusher is shown in FIG. 12. The graft pusher includes an elongated shaft 1201, a generally flat tip 1202 which may have a slightly greater diameter than shaft 1201, and a handle 1203. The graft pusher of FIG. 12 is configured to pass through the bore 902 of the harvest tube of FIG. 11B.

[0081] In various embodiments, the system for harvesting and delivering bone graft material includes a harvest tube 901 with a longitudinal bore 902 therethrough, as shown in FIG. 13. Harvest tube 901 may have a beveled tip 903. A trocar tube 906 may be positioned against a donor bone 904, with a shoulder 907 on tube 906 being positioned against a donor bone surface and / or circular cutting edge 908 on tube 906 being inserted into the bone. Harvest tube 901 is inserted through trocar tube 906 into bone 904, and a shaped bone core 905, e.g., a cylindrical bone core, is cut from bone 904 using the harvest tube. Harvest tube 901 is then withdrawn from trocar tube 906 with bone core 905. If multiple bone cores are needed from donor bone 904, trocar tube 906 may be repositioned on bone 904, e.g., by moving trocar tube 906 to a different position along the bone or tilting trocar tube 906 relative to the bone, and new bone cores may be obtained using additional harvest tubes. The bone 904 may be an autologous bone; a human bone from a compatible donor; a bovine bone; or a porcine bone. Thus, the bone cores may be graft material selected from autologous bone; a human bone allograft; a bovine bone xenograft; and a porcine bone xenograft. In various embodiments where only a single bone core is required, the bone core may be obtained using harvest tube 901 without requiring a trocar tube 906.

[0082] As discussed above, inj ectant may be deployed through the bore of primary drill 1 to necrotic tissue in a bone. FIG. 14 shows an alternative means for deploying injectant. After using primary drill 1 of FIG. 1 A or primary drill 4 of FIG. 4 A to drill passage 604 through the neck 602 of femur 6 into head 601, and using flexible drill 2 to drill channel(s) 605 into necrotic tissue 603, primary drill 1 or 4 and flexible drill 2 are withdrawn from the bone, while leaving a tubular trocarAttorney Docket Number: HCL 3001-PCT guide 1102, as shown in FIG. 9 (not shown in FIG. 14), positioned at or near or in the bone. A grafting cannula 1002 is inserted through the tubular trocar guide 1102 into passage 604 in the bone. A harvest tube 901 containing bone core 905 is inserted through grafting cannula 1002 into passage 604, and the bone core 905 is deployed as a bone graft in passage 604. Alternatively, the harvest tube 901 is inserted directly through the tubular trocar guide 1102 without the use of grafting cannula 1002. The graft pusher of FIG. 12 may be used to push the bone core 905 out of harvest tube 901 into the hole drilled into the bone. If desired, before using harvest tube 901 to deploy bone core 905, a grafting cannula 1002 may be used to provide a paste of bone graft material to channel(s) 605 and necrotic tissue 603. The paste may contain natural or artificial bone graft material, such as autologous bone; a human bone allograft; a bovine bone xenograft; a porcine bone xenograft; hydroxyapatite, calcium carbonate, tricalcium phosphate; or a mixture thereof. The paste may be used to fill the channels, and bone cores 905 may be used to fill passage 604. Other bone graft materials known in the art may be deployed through grafting cannula 1002 by known methods.

[0083] The systems and methods disclosed herein allow: graft harvesting, creating a passage with branching channels in bone, and graft delivery to the passage in the bone, where creating the passage and deploying the graft may be carried out with directional control.

[0084] A bone graft core may be harvested from a donor bone using a harvest tube, and the harvest tube may be used to deploy the bone graft core in a passage drilled into a bone without first removing the bone graft core from the harvest tube, thereby simplifying graft delivery to a bone. Direct delivery of a shaped bone graft into a deep site within a bone may be carried out through a passage drilled using a drill system disclosed herein. Various systems disclosed herein couple graft harvesting from a donor bone and graft delivery to a bone with necrotic tissue.

[0085] Although the various disclosed embodiments have been described in detail with particular reference to certain features and / or uses thereof, it should be understood that the invention is capable of other embodiments and its details are capable of modifications in various obviousAttorney Docket Number: HCL 3001-PCT respects. As is readily apparent to those skilled in the art, variations and modifications can be affected while remaining within the spirit and scope of the invention. Accordingly, the foregoing disclosure, description, and figures are for illustrative purposes only and do not in any way limit the invention, which is defined only by the claims.

Claims

1. Attorney Docket Number: HCL 3001-PCTCLAIMSWhat is claimed is:

1. A primary drill comprising: a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending along an axis of the shaft from the proximal end toward the distal end; a drill bit with a cutting edge or a cutting surface at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; wherein: the longitudinal bore is configured to receive a flexible drill having a proximal end and a distal end; and the opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough.

2. The primary drill of claim 1, wherein the longitudinal bore extends from an opening at the proximal end of the shaft to the passage extending to the opening in the cylindrical side of the shaft, without reaching the distal end of the shaft.

3. The primary drill of claim 1, wherein the longitudinal bore has: a proximal section extending to the passage extending to the opening in the cylindrical side of the shaft, and a distal section extending to an opening at a distal end of the shaft; wherein: the proximal section is configured to allow the flexible drill to pass therethrough, and the distal section is configured to allow a guidewire to pass therethrough without allowing the flexible drill to pass therethrough.Attorney Docket Number: HCL 3001-PCT4. The primary drill of claim 1, further comprising a connection means at the proximal end of the shaft in fluid communication with the longitudinal bore in the shaft; wherein the connection means is configured to allow inj ectant to be transferred through the longitudinal bore.

5. A system comprising: a primary drill comprising: a shaft having a cylindrical side, a proximal end, and a distal end, with a longitudinal bore extending from the proximal end toward the distal end; a first drill bit at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; and a flexible drill having a second drill bit, wherein: the flexible drill is configured to enter the longitudinal bore in the shaft of the primary drill so that the second drill bit extends toward the distal end of the shaft; and the second drill bit on the flexible drill is configured to extend from the opening in the cylindrical side of the shaft.

6. A method of creating multiple channels in necrotic bone, comprising: drilling into a bone containing necrotic tissue with the primary drill of claim 1; positioning a flexible side drill in the longitudinal bore of the primary drill; extending a distal end of the flexible drill through the opening in the cylindrical side of the shaft; using the flexible drill to create a first channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone; withdrawing the flexible drill from the first channel and adjusting the position of the primary drill around and / or along the axis of the shaft,Attorney Docket Number: HCL 3001-PCT using the flexible drill to create a further channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone, wherein the further channel is spaced from the first channel; and withdrawing the flexible drill from the longitudinal bore and optionally providing inj ectant to the further channel and the first channel through the longitudinal bore.

7. A primary drill comprising: a shaft having a cylindrical side, a proximal end, and a distal end, with: a first longitudinal bore extending along an axis of the shaft from the proximal end to the distal end; and a second longitudinal bore extending from the proximal end of the shaft toward the distal end, the second longitudinal bore being offset from the axis of the shaft; a drill bit having a helical flute at the distal end of the shaft, wherein the first longitudinal bore extends through the drill bit; an opening in the cylindrical side of the shaft; and a passage extending from the second longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; wherein: the first longitudinal bore is configured to allow a guidewire to pass therethrough; the second longitudinal bore is configured to receive a flexible drill having a proximal end and a distal end; and the opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough.

8. A system comprising: a primary drill comprising: a shaft having a cylindrical side, a proximal end, and a distal end, with:Attorney Docket Number: HCL 3001-PCT a first longitudinal bore extending along an axis of the shaft from the proximal end to the distal end; and a second longitudinal bore extending from the proximal end of the shaft toward the distal end, the second longitudinal bore being offset from the axis of the shaft; a drill bit distal end of the shaft, wherein the first longitudinal bore extends through the drill bit; an opening in the cylindrical side of the shaft; and a passage extending from the second longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; a guidewire; and a flexible drill having a second drill bit, wherein: the guidewire configured to pass through the first longitudinal bore; the flexible drill is configured to enter the second longitudinal bore in the shaft of the primary drill so that the second drill bit extends toward the distal end of the shaft; and the second drill bit on the flexible drill is configured to extend from the opening in the cylindrical side of the shaft.

9. A method of creating a channel in necrotic bone, comprising: positioning a guidewire in the first longitudinal bore of the primary drill of claim 7; drilling into a bone containing necrotic tissue with the primary drill; positioning a flexible side drill in the second longitudinal bore of the primary drill after removing the guidewire; extending a distal end of the flexible drill through the opening in the cylindrical side of the shaft; using the flexible drill to create a first channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone; and withdrawing the flexible drill from the longitudinal bore; and optionally providing inj ectant to the first channel through the second longitudinal bore.Attorney Docket Number: HCL 3001-PCT10. The method of claim 9, wherein the step of positioning the guidewire comprises positioning the guidewire in the bone, and positioning the primary drill over the guidewire so that the guidewire passes through the first longitudinal bore of the primary drill.

11. The method of claim 9, further comprising, prior to the step of providing inj ectant, at least one step of withdrawing the flexible drill from the first channel and adjusting the position of the primary drill around and / or along the axis of the shaft, and using the flexible drill to create a further channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone, wherein the further channel is different from the first channel.

12. The method of claim 11, wherein the step of providing injectant comprises providing inj ectant to the first channel and each further channel through the second longitudinal bore.

13. A primary drill comprising: a shaft having a cylindrical side, a proximal end, and a distal end, with a first longitudinal bore extending along the shaft to the distal end; a second longitudinal bore extending along the shaft from the proximal end toward the distal end; and a drill bit at the distal end of the shaft; an opening in the cylindrical side of the shaft; and a passage extending from the second longitudinal bore in the shaft to the opening in the cylindrical side of the shaft; wherein: the opening in the cylindrical side of the shaft is proximal to the drill bit; the second longitudinal bore is configured to receive a flexible drill having a proximal end and a distal end;Attorney Docket Number: HCL 3001-PCT the first longitudinal bore is configured to receive a guidewire; the opening in the cylindrical side of the shaft is configured to allow the distal end of the flexible drill to pass therethrough; and the first longitudinal bore and the second longitudinal bore are either: coaxial with each other; or offset from each other.

14. The primary drill of claim 13, wherein the first longitudinal bore and the second longitudinal bore are coaxial with each other, the first longitudinal bore is configured to allow a guidewire to pass through an opening at the distal end of the shaft, without permitting the flexible drill to pass therethrough; and the second longitudinal bore is configured to allow a guidewire to enter from the first longitudinal bore and to allow a flexible drill to enter the passage extending from the second longitudinal bore to the opening in the cylindrical side of the shaft.

15. The primary drill of claim 13, wherein: the first longitudinal bore extends along an axis of the shaft, and the second longitudinal bore is radially offset from the first longitudinal bore.

16. A method of treating bone defects, comprising: positioning a tubular trocar guide within a patient and positioning the primary drill of claim 1 within the tubular trocar guide so that the drill bit is near a bone of the patient; drilling into the bone with the primary drill to create a drill hole in the bone; positioning a flexible side drill in the longitudinal bore of the primary drill; extending a distal end of the flexible drill through the opening in the cylindrical side of the shaft; using the flexible drill to create a channel extending from the opening in the cylindrical side of the shaft into the necrotic tissue in the bone; withdrawing the flexible drill from the longitudinal bore and optionally providing inj ectantAttorney Docket Number: HCL 3001-PCT to the channel through the longitudinal bore; removing the primary drill from the tubular trocar guide; and deploying a bone graft in the drill hole in the bone and / or channel.

17. The method of claim 16, wherein positioning the tubular trocar guide within a patient and positioning the primary drill within the tubular trocar guide comprises: inserting a guide wire within the patient so that a tip of the guide wire is near the desired location in the bone of the patient; positioning the tubular trocar guide over the guide wire; and inserting the primary drill through the tubular trocar guide so that the guide wire passes through the longitudinal bore of the primary drill.

18. The method of claim 16, wherein positioning the tubular trocar guide within a patient and positioning the primary drill within the tubular trocar guide comprises, after drilling into the bone with the primary drill: inserting the tubular trocar guide within the patient so that the primary drill passes through the tubular trocar guide.

19. The method of claim 16, wherein deploying the bone graft comprises inserting a harvest tube containing a bone graft core through a grafting cannula into the drill hole in the bone and deploying the bone graft core in the drill hole.

20. The method of claim 16, wherein deploying the bone graft comprises inserting a harvest tube containing bone graft material through a grafting cannula into the drill hole in the bone and deploying the bone graft material in the drill hole wherein the bone graft material is selected from the group consisting of autologous bone; a human bone allograft; bone marrow aspirate; growth factors; synthetic bone graft material; hydroxyapatite; calcium carbonate; tricalcium phosphate; or a mixture thereof.Attorney Docket Number: HCL 3001-PCT21. The method of claim 16, wherein deploying the bone graft comprises: inserting the grafting cannula through the tubular trocar guide after removing the primary drill; and inserting the harvest tube containing bone graft material through the grafting cannula into the drill hole in the bone and deploying the bone graft material in the drill hole.

22. A bone graft harvesting and delivery system comprising: a harvest tube with an outer surface, a distal end, a proximal end, and a bore along its longitudinal axis, wherein the harvest tube is configured to be inserted in a donor bone and temporarily store a bone graft in its longitudinal bore; a grafting cannula with an outer surface, a distal end, a proximal end, and a bore along its longitudinal axis, wherein the longitudinal bore of the grafting cannula is configured to receive the harvest tube; a trocar guide with an outer surface, a distal end, a proximal end, a beveled or stepped tip at one end, and a bore along its longitudinal axis, wherein the longitudinal bore of the trocar guide is configured to receive the grafting cannula and provide directional control for insertion of the cannula into a bone of a patient; and a plunger which is configured to push the bone graft from the harvest tube into a delivery site in the bone of the patient.

23. The method of claim 16, wherein deploying the bone graft comprises inserting a harvest tube with a longitudinal bore into a donor bone and temporarily storing a bone graft in the longitudinal bore of the harvest tube; inserting a grafting cannula with a longitudinal bore through the tubular trocar guide into the drill hole in the bone of the patient; inserting the harvest tube with the bone graft through the cannula into the drill hole; and using a plunger to push the bone graft from the harvest tube into the drill hole in the bone of the patient; and optionally repeating additional deployments of bone graft using one or multiple harvestAttorney Docket Number: HCL 3001-PCT tubes.

Images