Flexible Bone Tool

Abstract

A flexible bone tool, comprising: a plurality of links pivotally connected to each other and collectively defining a substantially tubular bendable body, the bendable body being: (a) connected at a proximal end to a hand-held portion, and (b) connected at a distal end to a bone tissue removal assembly. The plurality of links include: one or more proximal links having an engagement portion, a wall portion of the engagement portion including a first opening; and one or more distal links including a receiving portion, a wall portion of the receiving portion including one or more second openings, the receiving portion being sized and shaped to receive the engagement portion such that the first opening is aligned with the second opening; and at least one latch sized and adapted to be received by the aligned first opening and second opening and to pivotally connect the proximal link and the distal link.

Description

[0001] Related Applications

[0002] This application is a divisional application of application number 201780017866.5, application date January 17, 2017, and invention name “Flexible Bone Tool”.

[0003] Technical Field and Background Art

[0004] In some embodiments of the present invention, the present invention relates to a flexible bone tool, and more particularly, but not limited to, to a flexible bone tool configured to be advanced into a bone during an arthroscopic procedure.

[0005] U.S. Publication No. 6447518B1 discloses: "An improved flexible shaft for expanding the medullary cavity in multiple bones." The shaft is composed of a solid component with a longitudinal hole, the solid component has a longitudinal hole for the entire length and a suitably formed narrow slot, the narrow slot extends spirally around the shaft in a continuous or segmented manner. Attached to the multiple opposite ends of the shaft are a cutting head and a device for connecting the shaft to a drive mechanism. Additionally, an improved anthropomorphic spinal component and vertebral replacement implant are described, the anthropomorphic spinal component is composed of a solid component with a longitudinal hole and a suitably formed narrow slot, the narrow slot extends spirally around the shaft in a continuous or segmented manner, and is completely or partially filled with an elastomeric material. The vertebral replacement implant is composed of a suitable implant material, the implant material has a longitudinal hole for the entire length and a suitably formed narrow slot, the narrow slot extends spirally around the shaft in a continuous or segmented manner. Connected to the opposing ends of the central portion is a device for attachment to the adjacent vertebrae, allowing height and angle adjustment.”

[0006] U.S. Publication No. 4362520A discloses: "The present invention is a durable flexible shaft that accommodates misalignment between an input shaft and an output shaft. The flexible shaft includes a plurality of hollow, separately manufactured, cooperating members contained within a tubular flexible shaft. Each segment is tightly coupled, one segment within another, but the segments are designed to allow limited longitudinal movement while restricting circumferential movement between the segments during transmission of torsions from the input shaft to the output shaft." Summary of the invention

[0007] According to one aspect of some embodiments of the present invention, a flexible bone tool is provided, which includes a bone tissue removal component configured at a distal end of the tool; at least two links are proximally connected to the bone tissue removal component, and the multiple links are connected to each other by a radial interference connection, wherein at least one radially outwardly extending protrusion of a first link is accommodated in a groove of a subsequent link.

[0008] According to some embodiments of the present invention, each of the plurality of links comprises a coupling portion and a receiving portion, wherein the coupling portion is located at a distal side relative to the receiving portion.

[0009] According to some embodiments of the present invention, the receiving portion includes an inner cavity, the inner cavity opens at a proximal end of the link and leads to the groove, and the groove is large enough to accommodate at least one protrusion without compressing the protrusion inwardly.

[0010] According to some embodiments of the present invention, the connection is a snap-fit ​​connection, wherein at least one radial protrusion is compressed inwardly by the inner cavity of the successive link and advances distally until the protrusion is allowed to resiliently snap into the groove, locking the first link and the successive link to each other while allowing the links to flex relative to each other.

[0011] According to some embodiments of the present invention, the first link and the subsequent links include a plurality of matching geometries suitable for transmitting a torque between the plurality of links, the torque having a magnitude sufficient to advance the bone tissue removal assembly into a bone.

[0012] According to some embodiments of the invention, the plurality of mating geometric shapes include at least one surface shaped to interfere with axial rotation of the plurality of links relative to each other.

[0013] According to some embodiments of the present invention, the matching geometry includes a plurality of mutually flat surfaces that contact at least a portion of each other, wherein a first flat surface is configured on the engaging portion of the first link, and a second flat surface is configured in the inner cavity of the receiving portion of the subsequent link.

[0014] According to some embodiments of the present invention, the torque value ranges from 3 Newton centimeters (N*cm) to 30 Newton centimeters.

[0015] According to some embodiments of the present invention, the first link and the subsequent link each include a receiving groove, wherein the multiple grooves of the two links have substantially the same design and are configured to be rotationally oriented relative to each other, so that the receiving groove of the first link is configured to form an angle with the receiving groove of the subsequent link.

[0016] According to some embodiments of the invention, the angle is 90 degrees.

[0017] According to some embodiments of the present invention, a volume of the at least one radial protrusion occupies no more than 95% of a volume of the recess.

[0018] According to some embodiments of the present invention, the groove does not extend beyond an outer edge of the receiving portion, and the protrusion is received inside the receiving portion.

[0019] According to some embodiments of the present invention, the groove extends through an outer edge of the receiving portion, and the protrusion is long enough to extend through the groove.

[0020] According to some embodiments of the present invention, the engagement portion comprises at least one toothed extension / latch extending in a distal direction, and wherein the protrusion extends radially outwardly from the toothed extension / latch.

[0021] According to some embodiments of the invention, the plurality of links define a tubular body.

[0022] According to some embodiments of the invention, the tubular body is configured to be bent into a bend radius of 30 mm or greater.

[0023] According to some embodiments of the present invention, the tool is hollow, and wherein the shape and size of the hollow are designed to allow delivery of the tool over a guide wire.

[0024] According to some embodiments of the present invention, the bone tissue removal assembly is shaped and sized to form a hole in the bone.

[0025] According to some embodiments of the present invention, the bone tissue removal assembly is shaped and sized to enlarge an existing hole in the bone.

[0026] According to some embodiments of the present invention, the tool further comprises a hand-held portion located at a proximal end of the tool, the hand-held portion being engageable by a user or a tool.

[0027] According to some embodiments of the invention, the tool is a drill bit.

[0028] According to one aspect of some embodiments of the present invention, a method for advancing a flexible bone tool into a bone is provided, comprising providing a flexible bone tool, the flexible bone tool comprising a plurality of links which are locked to each other via a radial interference connection; introducing the flexible bone tool onto a guide wire to approach the bone; and rotating the tool to advance at least one distal end of the tool into the bone.

[0029] According to some embodiments of the invention, the plurality of links are rigid, and wherein the introducing comprises advancing the tool along a curved path defined by the guide wire such that the plurality of rigid links bend relative to each other.

[0030] According to some embodiments of the invention, during contacting the bone, an axial gap between adjacent ones of the plurality of links decreases.

[0031] According to some embodiments of the invention, the advancing comprises forming a hole in the bone.

[0032] According to some embodiments of the invention, the advancing comprises enlarging an existing hole in the bone.

[0033] According to some embodiments of the invention, the bone is the femur, and the rotating expands a tunnel in the femur to accommodate a graft.

[0034] According to some embodiments of the invention, the rotating includes connecting a drill bit to a proximal end of the bone tool.

[0035] According to one aspect of some embodiments of the present invention, a flexible bone tool is provided, which includes a bone tissue removal component configured at a distal end of the tool; at least two links are connected at the proximal end of the bone tissue removal component, and the multiple links are interconnected by a snap connection, wherein a first link includes at least one protrusion, and the protrusion is compressed inwardly by an inner cavity of a subsequent link until the at least one protrusion is allowed to elastically snap into a corresponding groove of the subsequent link to which the inner cavity leads.

[0036] According to some embodiments of the present invention, the inner cavity opens at a proximal end of the consecutive link and extends longitudinally within a receiving portion of the consecutive link, and the shape and size of the inner cavity are suitable for compressing at least one protrusion radially inwardly.

[0037] According to some embodiments of the invention, the snap connection locks the first link and the subsequent link to each other while allowing the plurality of links to flex relative to each other.

[0038] According to an aspect of some embodiments of the present invention, there is provided a set of tools for adjusting a flexible bone, comprising a plurality of interconnectable links configured to engage with each other via a snap connection to form an elongated, bendable body.

[0039] According to some embodiments of the invention, the tool comprises a proximal hand-held portion, and wherein at least one of the plurality of links is configured to engage the proximal hand-held portion.

[0040] According to some embodiments of the present invention, the kit further comprises a plurality of cutting heads, wherein a cutting head is selected and configured to engage a distal end of at least one of the plurality of links.

[0041] According to one aspect of some embodiments of the present invention, a method for adjusting a flexible bone tool is provided, comprising: providing a flexible bone tool, the flexible bone tool comprising a plurality of links connected to each other by a snap connection; attaching or removing one or more links to adjust a length of the bone tool.

[0042] According to some embodiments of the invention, the method further comprises selecting a cutting head having a particular shape or size, and connecting the cutting head to a distal-most link of the plurality of links.

[0043] According to some embodiments of the invention, the attaching or the removing provides at least one of audible, sensory or visual feedback to the user.

[0044] According to some embodiments of the invention, the audible feedback comprises a "click" type sound when the plurality of links are locked to one another.

[0045] According to one aspect of some embodiments of the present invention, a flexible bone tool is provided, comprising a bone tissue removal assembly configured at a distal end of the tool; at least two links are engaged at a proximal end of the bone tissue removal assembly, the multiple links being interconnected by a "click" type connection, wherein a sound indication is provided during the process of connecting the multiple links.

[0046] According to one aspect of some embodiments, there is provided a flexible reamer slidable on a guide pin, comprising:

[0047] a proximal hand-held portion;

[0048] a middle part;

[0049] A distal portion includes a plurality of interconnected links connected in an articulated manner, the plurality of interconnected links allowing force to be transmitted from one link to a succeeding link in a direction corresponding to the direction of the guide pin.

[0050] In some embodiments, the flexible reamer further comprises a distal drilling end.

[0051] In some embodiments, the guide pin is made of Nitinol.

[0052] In some embodiments, the plurality of links are non-detachably connected to each other.

[0053] In some embodiments, the plurality of links are connected to each other via a snap.

[0054] In some embodiments, a fulcrum of the distal portion is formed at a proximal-most link.

[0055] Therefore, according to one aspect of some embodiments of the present invention, a flexible bone tool is provided, which includes a hand-held portion, a bone tissue removal component and a plurality of links, which are pivotally connected to each other and together define a bendable curved body; the link: a) is connected to the hand-held portion at a proximal end; and b) is connected to the bone tissue removal component at a distal end, wherein the plurality of links include at least two links, each link having a coupling portion, a wall portion of the coupling portion including at least a first opening and a receiving portion, a wall portion of the receiving portion including at least a second opening, the size and shape of the receiving portion being suitable for receiving the coupling portion so that the first opening is aligned with the second opening; and at least one pin, the size and shape of which is adapted to be received by the aligned first opening and second opening, and is used to movably connect the proximal link and the distal link.

[0056] In some embodiments of the present invention, the plurality of links of the flexible bone tool include a coupling portion and a receiving portion, the coupling portion and the receiving portion each including at least one opening. In some embodiments, the plurality of links include a coupling portion and a receiving portion, the coupling portion and the receiving portion each including at least one pair of diametrically opposed openings, wherein a first imaginary line connecting a pair of diametrically opposed openings in a receiving portion is at an angle relative to a second imaginary line connecting a plurality of diametrically opposed openings in the coupling portion. In some embodiments, the angle is 90 degrees.

[0057] In some embodiments of the present invention, a first imaginary line connecting a pair of diametrically opposed openings in a receiving portion of a distal link is angled relative to a second imaginary line diametrically opposed openings in a forward successive link or a rearward successive receiving portion. In some embodiments, the angle is 90 degrees.

[0058] According to some embodiments of the present invention, at least one link is operable to pivot 2 to 10 degrees relative to at least one of a forward successive link or a rearward successive link. In some embodiments, the tool comprises a plurality of links, and the tool is configured to bend at a bending radius R between 20 and 80 millimeters (mm). In some embodiments, the tool comprises a plurality of links, and the tool is configured to follow a curve that is generally L-shaped. In some embodiments, the tool comprises a plurality of links, and the tool is configured to follow a curve that is generally U-shaped. In some embodiments, the tool comprises a plurality of links, and the tool is configured to bend at an angle between 0 and 180 degrees relative to the axis of rotation of the handheld portion. In some embodiments, a degree of pivoting accumulated along the plurality of links defines a bending radius of the tool.

[0059] Thus, according to one aspect of some embodiments of the present invention, there is provided a flexible bone tool, wherein the plurality of matching geometries of the engagement portion, when engaged with a corresponding lumen of a continuous receiving portion, are adapted to the corresponding lumen of the continuous receiving portion for transmitting a torque between the plurality of links having a value sufficient to advance the bone tissue removal assembly into a bone. In some embodiments, a plurality of successive links include a plurality of matching geometries adapted to transmit torque between the plurality of links within a range of between 3 Newton centimeters and 30 Newton centimeters. In some embodiments, the plurality of matching geometries of the engagement portion and the corresponding lumen of a continuous receiving portion allow axial rotation of the plurality of links relative to each other so as to only reach a degree sufficient to enable a sufficient torque to be transmitted between the plurality of links.

[0060] Thus, according to one aspect of some embodiments of the present invention, there is provided a flexible bone tool comprising a bone removal assembly shaped and sized to cut at least one of a plurality of bones, form a hole in the bone, and dilate an existing hole in the bone. At least a portion of the flexible tool is slidable over at least one of a guide pin and a guide wire. In some embodiments, the connection comprises a radial interference connection.

[0061] According to some embodiments of the present invention, at least one of the tubular body and the proximal hand-held portion is hollow. In some embodiments, at least one of the plurality of latches includes a cylindrical portion and an outwardly tapered portion, the outwardly tapered portion defining an outwardly facing surface, and at least one of the plurality of latches includes a cylindrical portion and a latch head, the latch head having a flat surface, the flat surface abutting an inner wall surface of an inner cavity facing the plurality of links. In some embodiments, at least one of the plurality of latches includes a cylindrical portion and a radially inwardly tapered latch head, so that at least one of the plurality of latches is adapted to be fitted in a groove on a circumference of the opening surrounding an inner wall surface of the plurality of links, and at least one of the plurality of openings is formed in an annular groove on an outer surface of the receiving portion.

[0062] Thus, according to an aspect of some embodiments of the present invention, there is provided a flexible bone tool comprising a fixture having an annular geometry. In some embodiments, the fixture has a semicircular geometry. In some embodiments, the fixture is elastic and defines an inwardly facing surface, an outwardly facing surface, and a slit that enables the fixture assembly to elastically deform when a stress is applied. In some embodiments, the fixture has a theoretical dome geometry that includes a plurality of mutually independent finger-like protrusions.

[0063] According to some embodiments, an outer surface of the receiving portion includes an annular groove, the plurality of pins are received by a plurality of openings formed in the groove, and the retainer is placed along the annular groove, the inward surface engages with an outward surface of at least one of the plurality of pins received in the plurality of openings, and the retainer includes a plurality of pins fixedly attached diametrically relative to each other.

[0064] Therefore, according to one aspect of some embodiments of the present invention, there is provided a flexible bone tool, the flexible bone tool comprising a bendable body, the bending radius of the bendable body being defined by the number of multiple links comprising the body. In some embodiments, the bending radius of the bendable body is defined by at least one dimension of the multiple links, the at least one dimension being selected from a group of dimensions consisting of an outer diameter of a joint portion of the multiple links, a length of a joint portion of the multiple links, and an inner diameter of a receiving portion of the links. In some embodiments, the tubular body comprises a flexible core.

[0065] According to some embodiments, at least one of the plurality of openings is elliptical in the axial direction, so that the flexible tool includes at least one axial gap between at least two consecutive links, the axial gap decreasing upon contacting the bone. In some embodiments, the plurality of links rotate relative to each other about the longitudinal axis of the plurality of links, for example: the links rotate 90 degrees relative to each other. In some embodiments, the bone tissue removal assembly is replaceable.

[0066] Thus, according to one aspect of some embodiments of the present invention, there is provided a method of drilling a hole in a bone, the method comprising: introducing at least a portion of a guide wire into a bone, sliding a flexible bone tool over the guide wire and upwardly against the bone, rotating the tool to advance at least one distal end of the tool into the bone; and advancing the tool along a curved path defined by the guide wire. The method further comprises: removing the flexible bone tool, disassembling the cutting head, and replacing the cutting head with a reamer head, sliding the flexible bone tool over the guide wire and into a bore hole in the bone, and expanding the hole.

[0067] Therefore, according to one aspect of some embodiments of the present invention, there is provided a set of flexible bone tools for drilling a curved hole in a bone, the set comprising: at least one flexible bone tool, the flexible bone tool comprising at least one proximal handheld portion, at least one first link connectable to the handheld portion from a distal end, at least one second link comprising a tissue removal assembly attachable to at least one of the handheld portion and the first link, a plurality of connecting pins and

[0068] At least one link removal tool. In some embodiments, the tissue removal assembly is configured to at least cut bone, form a hole in the bone, and dilate a hole in the bone. In some embodiments, the link removal tool is configured to remove multiple links, and / or remove the links comprising a tissue removal assembly, and the length of the initial base is in the range of 30 to 120 mm.

[0069] Unless otherwise specified, all technical terms and / or scientific terms used in this specification have the same meaning as those generally understood by those of ordinary skill in the art to which the invention belongs. Although embodiments of the invention may be implemented or tested by any method and material similar or equivalent to those described in the embodiments of the invention, embodiments of the invention, the methods and / or materials listed are described below. In the event of a conflict, the definitions included in this patent specification will control. In addition, materials, methods and embodiments are exemplary only and are not necessarily intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Some embodiments of the present invention are described herein by way of example only and with reference to a number of drawings. By describing in detail the specific references to the drawings, it should be emphasized that the details shown are only examples for the purpose of illustrating the embodiments of the present invention. Based on this, the drawings and description together enable those skilled in the art to clearly implement the embodiments of the present invention.

[0071] In the attached picture:

[0072] Figure 1 is a flow chart of a method of advancing a flexible bone tool including a plurality of links that lock into a bone via a snap connection according to some embodiments of the present invention.

[0073] Figure 2A , 2B and 2C is a simplified exploded illustration of a link structure of the flexible bone tool according to some embodiments of the present invention and a simplified side view illustration of multiple pin types;

[0074] Figure 3A and 3B are simplified illustrations of a side view of a flexible bone tool in a bent configuration and a straight configuration, respectively, according to some embodiments of the present invention;

[0075] Figure 4 is a simplified illustration of a side view of a flexible bone tool bent into an L-shaped curve in accordance with some embodiments of the present invention.

[0076] Figure 5 A simplified illustration of a perspective view and a cross-sectional view of a single link is shown in accordance with some embodiments of the present invention.

[0077] Fig. 6A and 6B according to some embodiments of the present invention Figure 5 A simplified illustration of a cross-sectional view of a single chain link, the cross section being along Figure 5 The straight line AA in is intercepted;

[0078] Figure 7 According to some embodiments of the present invention Figure 5 A simplified illustration of a cross-sectional view of a single link of the chain, a receiving successive link relative to Figure 5 The chain links are rotatably oriented, and the plurality of chain links are connected to each other, the cross section is along Figure 3B The straight line AA in is intercepted;

[0079] Fig. 8A and 8B is a simplified illustration of a perspective view of a portion of the plurality of joined links according to some embodiments of the present invention;

[0080] Figure 8C yes Fig. 8A A simplified illustration of a cross-sectional view of Fig. 8A The straight line CC in is intercepted.

[0081] Fig. 9 A simplified illustration showing a side view of a cutting head according to some embodiments of the present invention;

[0082] Fig.10 is a simplified illustration of one embodiment of an assembled flexible bone tool constructed and operative in accordance with some embodiments of the present invention.

[0083] Fig.11 yes Fig.10 A simplified partially exploded view of a link structure of an embodiment of a flexible bone tool.

[0084] Fig. 12A and 12B is based on Fig.10 A simplified illustration of a perspective view and a cross-sectional view of a shaft of an embodiment of the flexible bone tool, the cross section being taken along line BB;

[0085] Fig.13A and 13B yes Fig.10 A simplified illustration of a perspective view and a cross-sectional view of an embodiment of a single link of the flexible bone tool;

[0086] Fig.14A , 14B and 14C is a simplified illustration of perspective views of exemplary embodiments of a securing assembly of link components;

[0087] Fig.15 is along Fig.10 A simplified illustration of a partial cross-sectional view of multiple consecutive link components of an embodiment of the flexible bone tool.

[0088] Fig.16A , 16B And 16C is Fig.10 A simplified illustration of a perspective view and a cross-sectional view of an embodiment of a plurality of successive link components of the flexible bone tool, the cross section being along Fig.16A The straight line CC in is intercepted;

[0089] Fig.17 yes Fig.10 A simplified illustration of an embodiment of the flexible bone tool mounted on a guide pin.

[0090] Fig.18A and 18B yes Fig.10Simplified corresponding illustrations and cross-sectional views of one embodiment of the flexible bone tool mounted on a guide pin, shown in a curved orientation within a bone of a patient;

[0091] Fig.19 is a simplified illustration of an assembled flexible bone tool according to another embodiment of the present invention;

[0092] Fig. 20 yes Fig.19 A simplified partially exploded illustration of the link structure of an embodiment of the flexible bone tool.

[0093] Fig.21A and 21B is Fig.19 A simplified illustration of a perspective view and a cross-sectional view of an embodiment of a link of the flexible bone tool;

[0094] Fig.22A and 22B is Fig.19 A simplified illustration of a fixation assembly of the flexible bone tool;

[0095] Fig.23 is along Fig.19 A simplified illustration of a partial cross-sectional view of multiple consecutive links of the flexible bone tool.

[0096] Fig.24A , 24B And 24C is Fig.19 A simplified illustration of a perspective view and a cross-sectional view of a plurality of successive links of the flexible bone tool, the cross-sectional view being along the Fig.24A The straight line CC in is intercepted;

[0097] Fig.25 yes Fig.19 A simplified illustration of a perspective view of the flexible bone tool mounted on a guide pin in the bent orientation.

[0098] Fig.26A and 26B is mounted on a guide pin Fig.19 a simplified perspective view and a simplified illustration of a cross-sectional view of the flexible bone tool shown in the curved orientation within a bone of a patient;

[0099] Fig.27A and 27B, of which Fig.27A is a simplified illustration of a plan view and a side view of a link removal tool according to some embodiments of the present invention, and Fig.27B Is implemented Fig.27A a simplified illustration of a side view of the link removal tool depicted; and

[0100] Fig.28A flexible bone tool set is used to drill a curved hole in the bone.

[0101] Flowchart of the method. DETAILED DESCRIPTION

[0102] In some embodiments of the present invention, the present invention relates to a flexible bone tool, and more particularly, but not limited to, to a flexible bone tool configured to be advanced into a bone during an arthroscopic procedure or a biologic bone procedure for bone drilling.

[0103] One aspect of some embodiments of the present invention relates to a flexible bone tool comprising a plurality of links interconnected to one another by a radial interference connection. In some embodiments, the plurality of links are arranged along a common axis to form an elongated body. In some embodiments, the elongated body has a tubular geometry. In some embodiments, the tubular body comprises 10 to 50 links. In some embodiments, the tubular body comprises 20 to 40 links, less than 10, greater than 50, or any intermediate number.

[0104] In some embodiments, an outer diameter of the tubular body ranges from, for example, 2 to 10 mm, 4 to 6.5 mm, 5 to 20 mm, or intermediate, larger or smaller diameters. In some embodiments, the length of the flexible tubular body ranges from 30 to 120 mm, 40 to 100 mm, 60 to 80 mm, longer than 120 mm, shorter than 30 mm, or any intermediate length. In some embodiments, the diameter of a single link in multiple embodiments ranges from 2 to 6.5 mm, 3 to 4.5 mm, less than 3 mm, greater than 6.5 mm, or any intermediate diameter. In some embodiments, the length of a single link ranges from 2 to 8 mm, 4 to 6 mm, less than 2 mm, greater than 8 mm, or any intermediate length.

[0105] In some embodiments, the length of a link is defined by at least the outer dimension (e.g., diameter) of the engagement portion of the preceding link, the thickness of the wall of the link receiving portion (i.e., the inner diameter of the receiving portion), and the axial gap between two engaged links.

[0106] In some embodiments, the radial interference connection includes a plurality of latches that are inserted into a plurality of openings in a plurality of wall portions of the plurality of links. In some embodiments, the plurality of latches are inserted through a plurality of aligned openings of a first link and a plurality of openings of a second, preceding or consecutive link. In some embodiments, the plurality of latches are cylindrical. In some embodiments, the plurality of latches are inserted under pressure and are retained in the plurality of openings by friction. In some embodiments, the plurality of latches include a plurality of latch heads on an end that abut against an inner wall surface of an inner cavity facing at least one link and prevent the plurality of latches from falling out of position under centrifugation or other forces from being applied when the tool is rotated.

[0107] In some embodiments, the latch head includes a flat surface that abuts an inner wall surface of an inner cavity facing the plurality of chain links. In some embodiments, the latch head tapers radially inwardly so that the latch head fits into a groove around a circumference of a receiving opening in an inner wall surface of an inner cavity facing one or more chain links.

[0108] One aspect of some embodiments of the present invention relates to a flexible bone tool comprising a plurality of links. In some embodiments, a plurality of links comprising at least a portion of the bone tool are similar to each other. In some embodiments, the links are dissimilar to each other. In some embodiments, the plurality of links comprise a plurality of different lengths. In some embodiments, the plurality of links comprise a plurality of different diameters. In some embodiments, a pivot angle between a plurality of links varies along the length of the flexible tubular body. In some embodiments, the plurality of latches allow a plurality of engaged links to at least pivot relative to each other while maintaining the plurality of engaged links in a mutually locked configuration. In some embodiments, the plurality of links comprise similar links and dissimilar links. In some embodiments, each link comprises at least one receiving portion and at least one engaging portion. In some embodiments, the receiving portion of a first link is sized and fitted to accommodate the engaging portion of a second link. In some embodiments, the engaging portion of a first link is sized and fitted to be inserted into the receiving portion of a second link.

[0109] In some embodiments, the flexible tubular body comprises rotational symmetry. In some embodiments, the flexible tubular body comprises rotational asymmetry.

[0110] In some embodiments, the plurality of links are made of a hard material adapted to withstand and transmit torque along the body of the link and between the plurality of links having a magnitude sufficient to advance the bone tissue removal assembly into a bone.

[0111] In some embodiments, each of the receiving portion and the engaging portion includes a plurality of diametrically opposed radially facing openings. In some embodiments, a first imaginary line connecting a pair of diametrically opposed openings in a receiving portion is angled relative to a second imaginary line connecting a plurality of diametrically opposed openings in the engaging portion.

[0112] In some embodiments, the angle is 90 degrees. In some embodiments, the plurality of openings extend the entire thickness of the wall of the link. In some embodiments, the plurality of openings are sized to accommodate at least one latch. In some embodiments, the length of the latch is the thickness of the wall of at least two links measured at the level of the plurality of openings.

[0113] In some embodiments, at least a portion of the flexible bone tool includes at least a first proximal link and at least a second, consecutive distal link. In some embodiments, an engagement portion of the proximal link is movably received within a receiving portion of the distal link. In some embodiments, the proximal link and the distal link are engaged such that the plurality of openings in the engagement portion of the proximal link are aligned with the plurality of openings in the receiving portion of the distal link.

[0114] In some embodiments, the plurality of links are connected by a radial interference connection. In some embodiments, the radial interference connection comprises at least one latch formed by aligned openings of both the engagement portion of the proximal link and the receiving portion of the distal link, and the latch extends in a radial direction relative to a longitudinal axis of the elongated body, and the latch is received in the plurality of openings of the first link and a second, successive link.

[0115] In some embodiments, the connection between the multiple links provides movement of the multiple links relative to each other. In some embodiments, the movement is a downward movement. In some surgeries, it may be necessary to approach the bone by following a curved path (i.e., not directly approaching the bone), for example: due to the anatomical structure of the treatment area. In some surgeries, the target bone is approached at a certain angle. Due to the articulation of the tubular body, a flexible tool as described in this specification may be particularly useful in such surgeries. In some embodiments, the articulation between multiple adjacent links enables the tool to advance along a curved path, for example: when approaching the bone through the soft tissue and / or when advancing into the bone.

[0116] In some embodiments, the flexible tool is introduced onto a guide wire. Optionally, in some embodiments, the guide wire defines a curved path for guiding the flexible bone tool to the bone. Alternatively, the guide wire defines a substantially linear path leading to the bone. In some embodiments, the flexible tool can be bent to closely follow the path defined by the guide wire. Optionally, in some embodiments, the elongated body can be bent to a bending radius as small as 50 mm, 30 mm, 60 mm, or intermediate, larger or smaller radii.

[0117] In some embodiments, the radial interference connection is configured to maintain the connection between the plurality of links, for example, by resisting pull-out forces acting on the tool during retraction from the body.

[0118] One aspect of some embodiments of the present invention relates to a flexible bone tool, the flexible bone tool comprising: a plurality of links and a fixture, the plurality of links being connected by a plurality of pins, the fixture holding the plurality of pins in place. In some embodiments, the fixture has an annular geometry. In some embodiments, the fixture has a semicircular geometry. In some embodiments, the fixture is elastic and defines an inwardly facing surface, an outwardly facing surface, and a slit, so that the fixture assembly can be elastically deformed when stress is applied. In some embodiments, an outer surface of the receiving portion includes an annular groove. In some embodiments, the plurality of pins are received by a plurality of openings formed in the groove, and the fixture is placed along the annular groove, the inwardly facing surface engaging an outwardly facing surface of at least one of the plurality of pins. In some embodiments, the fixture includes a plurality of pins fixedly attached diametrically opposite each other. In some embodiments, the fixture assembly includes a buckle, the buckle attached to a corresponding link. In some embodiments, the fixture has a theoretical dome geometry, the theoretical dome geometry including a plurality of mutually independent finger-like protrusions.

[0119] In some embodiments, when applied, the retainer covers at least a portion of a link at the level of the annular groove and a plurality of openings formed in the groove and blocks the plurality of pins from radially exiting the plurality of openings.

[0120] One aspect of some embodiments of the present invention relates to a flexible bone tool comprising a plurality of links interconnected to one another and allowing force to be transmitted from one to another. In some embodiments, the plurality of links have a matching geometry configured to allow force, such as torque, to be transmitted between the plurality of links. In some embodiments, the transmitted force comprises a value sufficient to advance at least a distal end of the tool into the bone. In some embodiments, the torque is applied to a proximal end of the tool, such as by a drill bit, and transmitted in a distal direction through the plurality of interconnected links. In some embodiments, a cutting head is configured at a distal end of the tool, and a value of torque sufficient to form a hole in the bone and / or for reaming an existing hole in the bone is transmitted to the cutting head through the plurality of links in the distal direction.

[0121] In some embodiments, the cutting and / or reaming head is replaceable. In some embodiments, the size and / or type of the cutting and / or reaming head is selected from a selection of a plurality of head types and sizes and is attached to a distal end of the flexible tubular portion prior to the medical procedure. In some embodiments, the cutting and / or reaming head is removed using a link removal tool.

[0122] In some embodiments, the plurality of matching geometries of the plurality of links include at least one surface sized to interfere with an axial rotation of a link relative to an adjacent link. In some embodiments, adjacent links are angularly rotated relative to each other. Optionally, the plurality of openings of a receiving link are disposed at an angle relative to the plurality of openings of the succeeding link, such as a 90 degree angle.

[0123] In some embodiments, the flexible bone tool can be configured to be disposable and then used during a single surgical procedure. An aspect of some embodiments of the present invention relates to a flexible bone tool, including a bone tissue removal assembly at a distal end of the tool. In some embodiments, the bone tissue removal assembly is configured to form a hole in the bone. In some embodiments, the bone tissue removal assembly is configured to expand an existing hole in the bone. In some embodiments, the bone tissue removal assembly is configured to form a hole in the bone and / or expand an existing hole in the bone.

[0124] In some embodiments, a specific cutting head, e.g., one having a specific shape and / or size and / or functionality (e.g., a head configured for drilling, a head configured for expansion) is selected and attached to a distal end of the tool, e.g., connected to the distal-most link.

[0125] One aspect of some embodiments of the present invention relates to a kit comprising one or more flexible bone tools and comprising one or more proximal hand-held portions and one or more links connected distal to the hand-held portions; a plurality of separate links for adding to the tool; and / or a plurality of cutting heads having various shapes and / or sizes and / or functions. In some embodiments, the kit may include an adjustment device configured to assemble the plurality of links and / or disassemble the plurality of links and / or assemble, replace or disassemble the cutting head.

[0126] In some embodiments of the present invention, a "bone tissue removal component" and / or "cutting head" refers to a component that is shaped and sized to be suitable for one or more of cutting bone, forming a hole in the bone, expanding an existing hole in a bone, penetrating bone tissue, crushing or breaking bone tissue, and grinding the bone.

[0127] As mentioned in this specification, the term "proximal" may refer to a direction of the user end of the tool, for example: an outer side of the body direction; the term "distal" may refer to a direction of the target bone away from the user end of the tool.

[0128] In some embodiments, a surgical tissue graft is inserted into a hole created in the knee to replace the damaged anterior cruciate ligament during various arthroscopic procedures, particularly anterior cruciate ligament reconstruction (ACL reconstruction). The injured ligament is removed from the knee prior to inserting the graft through the hole created by drilling. One possible challenge associated with the technique is approaching the knee joint at an angle. Several alternative methods have been developed for enabling angled engagement between the femur and the expander, an alternative exemplary method is to place a drill guide and guide pin on the femur and slide the expander over the guide pin to form a femoral tunnel.

[0129] Some embodiments of the present invention are directed to a flexible surgical dilator that provides for convenient orientation of the drill bit against the femur.

[0130] Some embodiments of the present invention are directed to flexible reamers for use in arthroscopic reconstructive procedures, particularly anterior cruciate ligament reconstruction (ACL) procedures.

[0131] Certain embodiments of the present invention seek to provide an improved flexible reamer for drilling a tunnel in a human femur.

[0132] Therefore, according to an embodiment of the present invention, there is provided a flexible reamer that can slide on a guide pin. In some embodiments, the reamer includes a proximal handheld portion, a middle portion, and a distal portion, the distal portion including a plurality of interconnected links. Optionally, the plurality of links are attached in an articulated manner, the plurality of links allowing force to be transmitted from one link to a subsequent link along a direction corresponding to the direction of the guide pin.

[0133] According to one embodiment of the present invention, the flexible reamer further comprises a distal drilling end.

[0134] Optionally, the guide pin is made of Nitinol.

[0135] Furthermore, according to an embodiment of the present invention, the plurality of chain links are non-detachably connected to each other.

[0136] In some embodiments, the plurality of links are connected to each other via a connecting pin.

[0137] In some embodiments, the plurality of links may be produced using a deep drawing process.

[0138] Some embodiments relate to a flexible reamer that can slide on a guide pin, including a proximal hand-held portion, an intermediate portion, and a distal portion, wherein the distal portion includes a plurality of interconnected links, the plurality of links being connected in an articulated manner, and the plurality of links allowing force to be transmitted from one link to a successive link along a direction corresponding to the direction of the guide pin.

[0139] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited to the details of the construction of the present invention, and the arrangement of components and / or methods described in the following description and / or the accompanying drawings and / or the embodiments. The present invention can be implemented or applied in other embodiments or in various ways.

[0140] Now please refer to Figure 1 , Figure 1 is a flow chart of a method for advancing a flexible bone tool including a plurality of links interconnected into a bone using a plurality of connection assemblies according to some embodiments of the present invention.

[0141] In some embodiments, a flexible bone tool is provided, comprising a plurality of links interconnected by a plurality of connecting assemblies, for example, as further described herein, provided as (100). In some embodiments, the plurality of links are arranged along a common longitudinal axis. In some embodiments, the plurality of chain links define a substantially tubular, bendable body. In some embodiments, the bone tool comprises a cutting head, the cutting head being configured at a distal end of the tubular body. Optionally, the shape and / or size of the cutting head is adapted to cut a hole in the bone, thereby allowing the tool to function as a drill. Additionally or alternatively, the shape and / or size of the cutting head is designed to widen an existing hole in the bone, for example, when rotational motion is applied to the tool, for example, to a proximal head of the tool, thereby allowing the tool to function as a reamer. In some embodiments, the bone tool comprises a handheld portion, the handheld portion being configured at a proximal side of the tubular body. The proximal handheld portion can be engaged by a user (e.g., a physician) and / or by an additional tool (e.g., a drill). In some embodiments, the tubular body and optionally the proximal handheld portion are hollow. Optionally, the tubular tool is delivered via a guide wire, guide pin, suture and / or other elongated component that can fit within and / or pass through the hollow portion.

[0142] In some embodiments, a guide wire is introduced into the bone of the target. Optionally, an initial hole is drilled into the bone, for example, by advancing the guide wire into the bone, for example, with the aid of a drill bit. In some embodiments, at least a portion of the guide wire is bent into an arch or other curved profile. Optionally, once at least a portion (e.g., a distal end) of the guide wire is anchored to the bone of the target, the guide wire is bent into a selected curvature.

[0143] In some embodiments, the flexible bone tool is introduced onto the guide wire (102). Optionally, the guide wire defines a curved path to guide the flexible bone tool to the bone. Alternatively, the guide wire defines a substantially linear path to the bone. In some surgeries, it is necessary or preferred to approach the bone by following a curved path (i.e., rather than approaching the bone directly), for example, due to the anatomical structure of the treatment area. In some surgeries, the target bone is approached at an angle. Due to the articulation ability of the tubular body, a flexible tool as described herein may be particularly useful in such a procedure.

[0144] In some embodiments, the flexible bone tool is advanced into the bone (104). In some embodiments, advancing the tool comprises: axially rotating the tubular body, for example: by attaching a drill bit to the proximal hand-held portion of the tool. Optionally, at least a portion of the tubular body of the tool is advanced into a pre-formed hole in the bone and widens a diameter of the hole as it advances. Alternatively, the tool creates the hole. In some embodiments, the snap connections between the multiple links of the tubular body are sufficiently strong to withstand multiple resistive forces of the bone while allowing transmission of forces, such as torque, from between the multiple links, such as: from the proximal hand-held portion to the distal head.

[0145] For example, a method as described herein may be particularly advantageous in multiple arthroscopic surgeries and is particularly suitable for multiple anterior cruciate ligament reconstruction surgeries in which a hole is formed in the femur. In some cases, the bone is approached at a certain angle to form the hole. Optionally, a flexible bone tool according to some embodiments is introduced into the femur. (Optionally, on a curved guide wire, the curved guide wire is used to form an initial hole in the bone) and used as a reamer to widen the initial hole to create a tunnel for accommodating a graft. Optionally, the tool is introduced along a curved path to meet the bone at a desired position.

[0146] In some embodiments, a user selects a cutting head suitable for performing a desired function (eg, penetrating a bone to create a hole, widening an existing hole, and / or other functions) and assembles the head onto the tool.

[0147] Now please refer to Figure 2A , 2B and 2C, Figure 2A , 2B and 2C is a simplified illustration of an exploded view of a link structure of the flexible bone tool according to some embodiments of the present invention and a simplified illustration of a side view of multiple pin types. As shown in FIG. 2, in some embodiments, each link includes one or more holes or one or more pairs of diametrically opposed openings, such as: 134 / 136, sized and shaped to accommodate one or more pins, such as: 124A / B and / or 128A / B, including a radial interference connection between each two subsequent links. In some embodiments, multiple pins are cylindrical, such as: 124A / B and / or 128A / B, and are inserted under pressure and retained in multiple openings, such as: 134 / 136 only by friction. In some embodiments, as Figure 2B and Figure 2CAs shown in , the latch 124 / 128 includes a plurality of latch heads 250 / 252, which are on one end of the latch and abut against an inner wall surface facing the plurality of links 120 and prevent the plurality of latches from falling and shifting under centrifugal force or other forces from being applied when the tool is rotated. Figure 2B As shown, the latch head 1250 includes a flat surface that abuts against a wall surface of an inner cavity facing the plurality of links 120. Figure 2C As shown, the latch head 1252 tapers radially inwardly so that the latch head 1252 fits into a groove around a circumference of a receiving opening 134 / 136 in an inner wall surface of an inner cavity facing one or more links 120. In some embodiments, a single latch is threaded through multiple openings 134 and / or 136. In some embodiments, each pair of latches, such as 124A / B and / or 128A / B, is threaded through corresponding openings 136 and / or 134.

[0148] In some embodiments and as shown in FIG. 2 , the connection of three links 120, 122, and 126 forms a flexible portion 110 of a flexible bone tool. In the depicted embodiment, a first link 120 is configured to be connected to a subsequent more distal link 122 by two connecting pins 124A and 124B, and another distal link 126 is connected to link 122 by connecting multiple pins 128A and 128B. In some embodiments, each link 120, 122, and 126 includes a receiving portion 130 and an engaging portion 132, such that each link (120 / 122 / 124) includes an engaging portion 132 configured to be received in a receiving portion 130 of the subsequent link. For example, a receiving portion 130 of a second link (e.g., 122) is sized and shaped to receive an engaging portion 132 of a first proximal link (e.g., 120).

[0149] In some embodiments, the engagement portion 132 comprises a cylindrical geometry and includes at least two diametrically opposed openings 134. Alternatively and optionally, in some embodiments, the engagement portion 132 defines a different cross-sectional circumferential geometry, outer contour, such as hexagonal, elliptical, and / or other outer contours, and the engagement portion 132 is configured to be received within the receiving portion 130 of the successive link.

[0150] In some embodiments, the receiving portion 130 includes a first substantially cylindrical proximal section and a second inwardly tapered distal section, and two diametrically opposed openings 136 located in a wall portion of the first proximal section of the receiving portion 130. In some embodiments, the openings 136 are circular. In some embodiments, the openings 136 and / or 134 are axially elliptical. Alternatively and optionally, the receiving portion 130 of a link (e.g., 122) defines a different internal profile, such as hexagonal, elliptical, and / or other external profile, and the receiving portion 130 is configured to be received within a corresponding engagement portion 132 of an adjacent proximal link (e.g., 120). In some embodiments, the plurality of openings 136 and / or 134 are axially elliptical and extend parallel to the axis 133. The elliptical openings 136 and / or 134 allow axial movement of a link relative to a preceding or trailing consecutive link.

[0151] In some embodiments, the plurality of links 120 , 122 , and 126 are generally disposed along a common longitudinal axis 133 when at rest.

[0152] In some embodiments, the outer diameter of the outer profile of the engagement portion 132 of the link 120 is generally smaller than an inner diameter of a receiving portion 130 of the subsequent link 122 , thereby fitting within the receiving portion 130 .

[0153] In some embodiments, the inner profile of the receiving portion 130 is formed by an inner diameter that is substantially larger than an outer diameter of the engagement portion 132 in the proximal link 120, thereby accommodating the engagement portion 132 in the receiving portion 130. For example, the engagement portion 132 of a first proximal link (e.g., 120) is sized and shaped to be inserted into and fit into the receiving portion 130 of a second, consecutive distal link (e.g., 122).

[0154] In some embodiments, when the links are axially aligned, for example, link 122 is axially rotated at an angle of approximately 90 degrees relative to the adjacent proximal link 120 , so that the openings 136 of link 122 are aligned with the openings 134 of link 120 .

[0155] In some embodiments, each link includes a plurality of openings 134 and 136, and a plurality of connecting pins 124 or 128, such as 2, 3, 4, 5, 6, 10 pins or intermediate, greater or lesser numbers. Optionally, multiple links of a single tool include different numbers of extensions / pins. Optionally, the number of extensions / pins determines the degree of movement of the multiple links relative to each other. For example, a single opening may provide a greater degree of freedom of movement, such as movement in the axial and / or radial directions, relative to a greater number of openings.

[0156] In some embodiments, the plurality of links are formed of metal, such as stainless steel. Additionally or alternatively and optionally, the plurality of links are formed of a biocompatible plastic, such as polycarbonate and / or thermoplastic polyurethane resin.

[0157] In some embodiments, at least one link and / or at least the tubular body and / or the cutting head are disposable.

[0158] In some embodiments, the value of the torque transmitted by the plurality of links is sufficient to drill into the bone tissue, for example, in a range of 3 Newton centimeters to 15 Newton centimeters. Optionally, the tubular body is configured to transmit a value of torque in a range of 1 Newton centimeter to 150 Newton centimeters, for example, 5 to 20 Newton centimeters, 10 to 40 Newton centimeters, and 50 to 100 Newton centimeters.

[0159] In some embodiments, the multiple matching non-circular geometries of the engaging portion and the size and shape of an inner cavity of the receiving portion are adapted to allow axial rotation of the multiple links relative to each other only to a degree of torque sufficient to maintain the functionality of the tool, and the torque can still be transmitted between the multiple links.

[0160] Reference now Figure 3A and 3B, Figure 3A and 3B are simplified illustrations of a side view of a flexible bone tool in a bent configuration and a straight configuration, respectively, according to some embodiments of the present invention;

[0161] Figure 3AAn embodiment of a flexible bone tool 150 is shown in a bent configuration. The tool 150 includes a tubular body 152, a distal portion of which includes an optional cutting head 154. Optionally, in some embodiments, the flexible bone tool 150 can be passed through a guide wire 156 (not shown) that protrudes from the distal end of the tool 150 when passed. The tool 150 includes a handheld portion 158 proximal to the tubular body 152. The handheld portion 158 proximally includes a proximal head 160 that is shaped and / or sized to engage with a drill and / or other tool.

[0162] In some embodiments, the tool 150 is configured to follow a path defined by the threaded guide wire 156, for example, a curved and / or straight path. In some embodiments, the tubular body 152 is configured to bend into a bend radius R. Optionally, the bend radius R can be as small as, for example, 50 mm, 30 mm, 20 mm, or intermediate, larger or smaller radii.

[0163] In some embodiments, the ability of the tubular body to bend to conform to the curvature of the guide pin is due to the relative angular orientation between the plurality of links 120 and 122 or 122 and 126. Optionally, during application of rotational motion to the tool (e.g., during drilling), the plurality of links become realigned with the path of the guide wire, with each portion of a turn being determined by the relative angular orientation between the plurality of links. In one example, at a 90 degree orientation between adjacent links, the plurality of links will "return" to the defined path every quarter turn. Optionally, the rotational orientation of the plurality of links reduces a discrete effect during rotation that may be caused by the plurality of rigid links, resulting in a discontinuous rotation. Optionally, reducing the angle between the plurality of adjacent links of the rotational orientation allows for smoother, substantially continuous rotation of the tubular body of the tool.

[0164] In some embodiments, the tubular body 152 has an outer diameter ranging from, for example, 2 to 10 mm, 4 to 6.5 mm, 5 to 20 mm, or intermediate, larger or smaller diameters. Optionally, the tool 150 is configured to form a hole or dilate an existing hole in a bone having multiple similar diameters.

[0165] Figure 3B The tool 150 is shown in an in-line configuration. In some embodiments, the tool 150 includes a cutting head 154 located at a distal end of a tubular body 152.

[0166] Reference now Figure 4, Figure 4 is a simplified illustration of a side view of a flexible bone tool bent into an L-shaped curve in accordance with some embodiments of the present invention.

[0167] In some embodiments, the tubular body 152 of the flexible bone tool 150 is configured to bend to a bend radius R, such as 30 mm, 40 mm, 60 mm or intermediate, larger or smaller radii. Optionally, the tubular body 152 is configured to bend to an L-shaped curve, such as such that the axis of rotation of the distal cutting head 154 is at an angle between 0 and 180 degrees relative to the axis of rotation of the handle 158. In some embodiments, the angle is 90 degrees. In configurations where the flexible bone is bent to an L-shaped or even a U-shaped curve, this facilitates a number of procedures that require access to the bone through a tortuous path, such as by bypassing a number of anatomical structures, such as during spinal surgery. In some embodiments, when the tool is bent to the U-shaped curve, the tool is rotated about the tool axis to provide drilling and / or widening of a hole in the bone while torque is applied from a substantially opposite direction, such as from a proximal portion of the tool 150 and transmitted to the distal cutting head 154 through the plurality of articulated links.

[0168] Reference now Figure 5 , Figure 5 is a simplified illustration of an illustrative diagram of a single link 120 according to some embodiments of the present invention. Fig. 6A and Figure 6B , Fig. 6A and Figure 6B yes Figure 5 1 is a simplified illustration of a cross-sectional view of an embodiment of a single link 120 taken along multiple lines AA.

[0169] In some embodiments, a single link 120, 122, and / or 126 is made of stainless steel and manufactured by deep drawing.

[0170] As described in detail elsewhere herein, a single link 120, 122, and / or 126 includes a proximal receiving portion 130 and a distal engagement portion 132. An engagement portion 132 is sized and shaped to be received within a receiving portion 130 of a successive distal link.

[0171] In some embodiments, the engagement portion 132 is generally cylindrical and has at least two diametrically opposed openings 134, with a diameter spanning between the plurality of openings 134 being oriented transversely relative to the longitudinal axis 133. Alternatively and optionally, the engagement portion 132 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, configured to be received within the receiving portion 130 of the successive link.

[0172] In some embodiments, the receiving portion 130 includes a generally cylindrical first proximal section and an inwardly tapered second distal section, and two diametrically opposed openings 136, the plurality of openings 136 being located in a wall portion of the first proximal section of the receiving portion and extending along an axis oriented transversely relative to the longitudinal axis 133. Alternatively and optionally, the receiving portion 130 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, configured to be received within the corresponding engagement portion 132 in the successive link.

[0173] The plurality of openings 134 are located on a plane that is substantially perpendicular to the plane where the plurality of openings 136 are located.

[0174] In some embodiments, the outer diameter of the outer profile of the engagement portion 132 of the link 120 is generally smaller than an inner diameter of a receiving portion 130 of the subsequent link 122 , thereby fitting within the receiving portion 130 .

[0175] In some embodiments, the inner diameter of the receiving portion 130 is substantially larger than an outer diameter of the engaging portion 132 in the proximal link 120 , so that the engaging portion 132 is accommodated in the receiving portion 130 .

[0176] In some embodiments, plurality of openings 136 are oriented at a generally 90 degree angle relative to plurality of openings 134 .

[0177] In some embodiments, each link includes a plurality of openings 134 and 136 and a plurality of corresponding connected pins 128 and / or 124, such as 2, 3, 4, 5, 6, 10 extensions / pins or intermediate, greater or lesser numbers. Optionally, multiple links of a single tool include different numbers of extensions / pins. Optionally, the number of extensions / pins determines the degree of movement of the multiple links relative to each other. For example, a single opening may provide a greater degree of freedom of movement, such as movement in the axial and / or radial directions, relative to a greater number of openings.

[0178] In some embodiments, the diameter of a single link (eg, 120, 122, and 126) is in the range of 2 to 6.5 mm, and the length of a single link (eg, 120, 122, and 126) is in the range of 4 to 8 mm.

[0179] exist Fig. 6A and 6B In the exemplary embodiments shown in FIG. 1 , the opening 136 may be circular ( Fig. 6A ) or oval ( Figure 6B In some embodiments, one or two of the plurality of openings 136 and / or 134 may be elliptical. The elliptical openings 136 / 134 provide limited movement of a first link 120 relative to a preceding or succeeding consecutive link 120 axially along an axis of rotation of the tool.

[0180] Reference now Figure 7 , Figure 7 is a simplified illustration of a cross-sectional view of the plurality of links of the flexible bone tool 150 according to some embodiments of the present invention.

[0181] like Figure 7 As shown in the exemplary embodiment of the present invention, multiple links 120, 122 and 126 are axially aligned, each link is engaged relative to a consecutive continuous distal continuous proximal link or a front continuous proximal link, and axially rotated (e.g., rotated about the longitudinal axis of the link). In some embodiments, the multiple links are engaged relative to each other and rotated at an angle of 90 degrees so that one of the multiple openings 136 is aligned with the multiple openings 134 in a front continuous proximal link. In some embodiments, when the distal cutting head 154 of the tool 150 contacts the bone, a circumferential contact area between the multiple links increases and the multiple links axially approach each other. An increased circumferential contact area can provide an advantage during drilling, for example, because the increased contact area helps to spread the load and thereby reduce the load acting on the toothed extension / pin that holds the multiple links together.

[0182] exist Figure 7 In the embodiment shown, the link 120 and a subsequent receiving link 122 are oriented rotationally perpendicularly relative to each other. The plurality of openings 136 of the link 120 are shown in a cross section extending in a plane perpendicular to the plane of the cross section of the plurality of openings 136 of the link 122.

[0183] In some embodiments, multiple links 120, 122, and 126 are coupled to each other using multiple connecting pins 124 and 128, as described in detail elsewhere in this specification. Figure 7 In the example of , the plurality of openings 136 of link 122 are aligned with the plurality of adjacent openings 134 of link 120, and the plurality of connecting pins 124 driven through openings 124 and 136 secure the two links together while providing a degree of rotational freedom, as described in more detail elsewhere in this specification.

[0184] In some embodiments, one or more dimensions of a link are selected to provide a specific bending radius range for a tubular body comprising a plurality of links. Optionally, the range of bending radius is determined by dimensions of the plurality of links, such as: dimensions of the contact area between each two consecutive links, a length of the engagement portion 132 of the link 120; an outer diameter of the engagement portion 132 of the link 120, and an inner diameter of the receiving portion 130 of the receiving link 122. In some embodiments, a more flexible tubular body configured to bend to a smaller bending radius may be provided by one or more of: increasing the length dimension; decreasing the outer diameter dimension and increasing the inner diameter dimension. Optionally, for example, selecting the dimensions of the plurality of links as described will result in a larger space between two consecutive links remaining unoccupied, allowing for freer rotation during bending of the plurality of links and allowing for a higher degree of bending of the tubular body 152.

[0185] Reference now Fig. 8A and 8B, showing a partial illustration and Figure 8C , Figure 8C A simplified illustration of a perspective view of a portion of the plurality of joined links of the flexible bone tool 150 is shown in accordance with some embodiments of the present invention. Fig. 8A , 8B As shown in FIG8C , a distal link 122 is shown connected to a proximal link 120 at a receiving front. Additionally and optionally, the distal link 122 is connected to the proximal link 120 and is rotated relative to the proximal link 120, for example, 90 degrees or a quarter turn. The multiple links are shown in a curved orientation. Additionally, reference is made to Figure 8C , Figure 8C Shows Fig. 8A A cross-sectional diagram of Fig. 8A It is intercepted by multiple straight lines CC in.

[0186] Optionally, there is an axial gap between at least a portion of the circumferences of the plurality of adjacent links 120 and 122, the axial gap extending over a distance L2. Optionally, the extension of L2 is affected by one or more of the following: the number of the plurality of openings 134 and 136 and the number of the plurality of corresponding connecting pins 124 connecting the links together. In some embodiments, a plurality of consecutive links 120 are connected by one or more pins 124 / 128, such that once connected, an engagement portion 132 is positioned within the receiving portion 130. A plurality of latches 124A and 124B connecting the engaging portion 132 in the engaging portion 130 prevent the engaging portion 132 from being fully inserted into the receiving portion 130, and a volume (e.g., a gap) not occupied by the engaging portion 132 is retained in the receiving portion 130 of the receiving link so that the engaging portion 132 can move (e.g., pivot) in the receiving cavity; the bending radius of the tubular body 152 or a section thereof, and the tension acting on the tubular body 152.

[0187] In some embodiments, the tool 150 advances along a curved path within the bone, optionally, the tool follows a path defined by the guide wire 156 as long as the curvature radius of the tubular body is compatible with the curvature radius of the guide wire, additionally or alternatively, the tool 150 advances along a straight path.

[0188] In some embodiments, the tubular body is advanced into the bone to a depth relative to the surface of the bone, for example, a depth ranging from 1 mm to 5 cm. Optionally, the tubular body is advanced to penetrate the bone, for example, such that the cutting head 154 leaves a surface of the bone opposite to the surface into which the tool is inserted.

[0189] In some embodiments, the tool is rotated about the axis of the tool to advance the tool into the bone. Optionally, the rotational motion is applied by attaching a drill bit to the head of the proximal clamping end 160. In some embodiments, the torque applied to a proximal end of the tool is transmitted to a distal end of the tool 150 through the plurality of connected links. In some embodiments, the tool is configured to transmit torque in the range of, for example, 3 Newton centimeters to 5 Newton centimeters, for example, 3.2, 4.5, 4.8 Newton centimeters or intermediate, higher or lower values.

[0190] In some embodiments, for example, when the flexible bone tool is used to drill a hole in the bone, the tubular body may include a flexible core, for example, made of nitinol, stainless steel. Optionally, the core is selected to be flexible enough to allow the tubular body to bend, but rigid enough to support the multiple links during drilling, when the tubular body needs to withstand multiple relatively strong forces from the bone tissue to penetrate the bone.

[0191] See especially Figures 8A to 8C In a bent orientation of the tool 150, the plurality of links 120 and 122 are disposed relative to one another at an angle "a" such that the proximal end of the receiving portion 130 of the link 122 is angularly displaced relative to the orientation of the proximal end at rest. Figure 7 As shown, in some embodiments, the angle "a" can be in the range of 2 to 10 degrees. In some embodiments, the rotation angle "a" between two consecutive links can be in the range of 5 to 8 degrees.

[0192] Reference now Fig. 9 , Fig. 9 A simplified illustration of a side view of a bone tissue removal link according to some embodiments of the present invention is shown; Fig. 9 In the example shown, the distal bone tissue removal link includes a cutting head 154. In some embodiments, the distal bone tissue removal link includes a bone expander. In some embodiments, the cutting head 154 is configured to engage the flexible bone tool 150.

[0193] In some embodiments, the cutting head 154 includes a proximal receiving portion 170 configured to receive an engagement portion of a forward link. Optionally, the receiving portion 170 includes an internal groove, for example, as described elsewhere herein. In some embodiments, the cutting head 154 includes a distal cutting portion 172 including one or more cutting edges 174 for penetrating the bone and / or for enlarging an existing hole in the bone.

[0194] In some embodiments, a cross-sectional area of ​​a cutting portion 172 is greater than a cross-sectional area of ​​the receiving portion 170 (and optionally the remainder of the tubular body of the tool). In one example, a maximum diameter of the cutting portion 172 is greater than a diameter of the receiving portion 170 by at least 5%, 10%, 20%, 40%, or intermediate, greater, or lesser percentages.

[0195] In some embodiments, a proximal portion of the tool is adjustable. Optionally, a structure of the proximal head is selected to engage a surgical tool, such as a drill, reamer, screwdriver and / or other tool. Optionally, the proximal head is adapted to be connected to a suitable tool for applying rotational motion to the flexible bone tool. For example, the proximal head may have a hexagonal profile, a square profile, a circular profile and / or any other profile, and the shape and size of the proximal head are suitable for engagement by the tool. In some embodiments, the dimensions of the proximal portion (e.g., an axial length and / or diameter) are selected according to the need.

[0196] In some embodiments, a set is provided. Optionally, the set includes a plurality of individual links; a plurality of cutting heads with different structures and / or sizes; a flexible bone tool including a proximal hand-held portion and a tubular body of an initial base length (e.g., a tubular body with a length ranging from 30 to 120 mm, such as 40 mm, 60 mm, 100 mm, or intermediate, longer or shorter tubular bodies).

[0197] Additionally or alternatively and optionally, attachment and / or removal of the plurality of links is performed manually, for example by a user using a dedicated tool, as described elsewhere herein.

[0198] A particular feature of an embodiment of the present invention is that the tubular tool 152 can be used as a disposable tool because the tool is manufactured using deep drawing and latching, thereby providing an inexpensive manufacturing process.

[0199] Reference now Fig.10 , is a simplified pictorial illustration of an assembled flexible bone tool constructed and operative in accordance with some embodiments of the present invention, and reference is made to Fig.11 , Fig.11 yes Fig.10 A simplified partially exploded illustration of the link structure of an embodiment of the link structure of the flexible bone tool.

[0200] exist Fig.10 An embodiment of a flexible bone tool 200 including a plurality of interconnected link assemblies 202 can be seen in FIG. The flexible bone tool 200 includes a shaft or proximal hand grip portion 204 at a proximal end of the flexible bone tool 200, a plurality of interconnected link assemblies 202 adapted to be pivotally displaced relative to each other, and a cutting head 206 at a distal end of the link assemblies 202.

[0201] In some embodiments, the plurality of link assemblies 202 are arranged along a common longitudinal axis 208 when stationary. In some embodiments, the plurality of interconnected link assemblies define a substantially tubular, bendable body. In some embodiments, the bone tool comprises a cutting head disposed at a distal end of the tubular body. Optionally, the shape and / or size of the cutting head is suitable for cutting a hole in the bone, thereby allowing the tool to be used as a drill. Additionally or alternatively and optionally, the shape and / or size of the cutting head is to widen an existing hole in the bone, for example: when rotational motion is applied to the tool, for example: when applied to a proximal hand-held portion of the tool, allowing the tool to be used as a reamer. In some embodiments, the bone tool comprises a hand-held portion, the hand-held portion being configured to be proximal to the tubular body. In some embodiments, the bone tool includes a proximal hand-held portion, the proximal hand-held portion is configured as the proximal end of the tubular body, and in some embodiments, the proximal hand-held portion can be engaged by a user (e.g., a physician) and / or by another tool (e.g., a drill). In some embodiments, optionally, the tubular body and the proximal hand-held portion are hollow. Optionally, the tubular tool is delivered over a guide wire, guide pin, suture and / or other elongated component, which can be assembled within and / or through the hollow portion.

[0202] In some embodiments, a guide wire is introduced into the bone of the target. Optionally, an initial hole is drilled in the bone, for example, by advancing the guide wire into the bone, for example, with the aid of a drill bit. In some embodiments, at least a portion of the guide wire is bent into an arch or other curved profile. Optionally, the guide wire is bent into a selected curvature after at least a portion of the guide wire (e.g., the distal end) has been anchored to the bone of the target.

[0203] In some embodiments, each of the assembled link assemblies 202 is configured to be connected to a subsequent more distal link assembly 202 via two connecting pins 210 and a retainer 212. Each link assembly 202 includes a link 220 having a receiving portion 230 and an engaging portion 240. In some embodiments, the plurality of links 220 of the link assembly 202 are configured such that an engaging portion 240 is received in a receiving portion 230 of a subsequent link 220.

[0204] In some embodiments, the engagement portion 240 is generally cylindrical and has two diametrically opposed openings 242. Alternatively, the engagement portion 240 defines a different outer contour, such as hexagonal, elliptical, and / or other outer contours, and the engagement portion 240 is configured to be received in a receiving portion 230 of the successive link having a corresponding geometry.

[0205] In some embodiments, the receiving portion 230 has a generally cylindrical outer profile, and has a circumferential annular groove 250 and two diametrically opposed openings 252 formed therein. Alternatively and optionally, the engaging portion 240 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, and the engaging portion 240 is configured to be received within the corresponding receiving portion 230 of the subsequent link having a corresponding geometry.

[0206] In some embodiments, the outer diameter of the engagement portion 240 of a link 220 is generally composed of having an outer diameter smaller than an inner diameter of a receiving portion 230 of the succeeding link 220 , thereby fitting within the receiving portion 230 .

[0207] In some embodiments, the inner diameter of the receiving portion 230 is generally larger than an outer diameter of the engaging portion 240 of the proximal link 220 , so that the engaging portion 240 is received in the receiving portion 230 .

[0208] In some embodiments, the plurality of openings 242 are disposed at an angle of substantially 90 degrees relative to the plurality of openings 252 .

[0209] In some embodiments, each successive link 220 is disposed at an angle of approximately 90 degrees relative to another link 220 such that the plurality of openings 242 of a first link 220 is adapted to align with the plurality of openings 252 in the second link 220 .

[0210] It should be noted that the plurality of connecting pins 210 include a generally cylindrical portion 260 and a generally outwardly tapered portion 262 defining an outwardly facing surface 264 .

[0211] In some embodiments, each link includes a plurality of openings 242 and 252 and a plurality of connecting pins 210, such as 2, 3, 4, 5, 6, 10 or intermediate, greater or lesser numbers of extensions / pins. Optionally, multiple links of a single tool include different numbers of extensions / pins. Optionally, the number of extensions / pins determines the degree of movement of the multiple links relative to each other. For example, a single opening may provide a greater degree of freedom of movement, such as movement in the axial and / or radial directions, relative to a greater number of openings.

[0212] In some embodiments, the plurality of links are formed of metal, such as stainless steel. Additionally or alternatively, the plurality of links are formed of a biocompatible plastic, such as polycarbonate and / or thermoplastic polyurethane resin.

[0213] In some embodiments, at least one link and / or at least the tubular body and / or the cutting head are disposable.

[0214] In some embodiments, the value of torque transmitted by the plurality of links is sufficient to drill into the bone tissue, for example, in a range between 3 Newton centimeters and 15 Newton centimeters. Optionally, the tubular body is configured to transmit a value of torque in a range between 1 Newton centimeter and 150 Newton centimeters, for example, 5 to 20 Newton centimeters, 10 to 40 Newton centimeters, and 50 to 100 Newton centimeters. In some embodiments, the plurality of matching non-circular geometries of the engagement portion and the size and shape of an inner cavity of the receiving portion are adapted to allow axial rotation of the components 202 of the plurality of links relative to each other only to a degree of torque sufficient to maintain the functionality of the tool, and the torque can still be transmitted between the plurality of links.

[0215] Reference now Fig. 12A and 12B, Fig. 12A and 12B are simplified illustrations of a perspective view and multiple cross-sectional views of the shaft 204 of the flexible bone tool 200 according to some embodiments of the present invention, the cross sections being taken along multiple lines BB.

[0216] In some embodiments, the shaft or proximal grip portion 204 is hollow. In some embodiments, the hollow shaft 204 includes a proximal gripping end 270, a middle generally cylindrical portion 272, and a proximal connecting portion 274. Fig. 12A As shown in the embodiment illustrated in FIG. 12B , two diametrically opposed openings 276 are formed in the proximal connecting portion 274 for attachment to the proximal-most link assembly 202 by way of a plurality of connecting pins 210 .

[0217] Reference now Fig.13A and 13B, Fig.13A 13B is a simplified illustration of a perspective view and a cross-sectional view of a single link 220 of the flexible bone tool 200. In some embodiments, the link 220 is made of, for example, stainless steel and is manufactured by deep drawing.

[0218] As described in detail above, in some embodiments, the link 220 has an engagement portion 240 that is sized and shaped to be received within a receiving portion 230 of the succeeding link 220 .

[0219] In some embodiments, the engagement portion 240 is generally cylindrical and has two diametrically opposed openings 242 extending along an axis that is transversely disposed relative to the longitudinal axis 208. Alternatively, the engagement portion 240 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, and the engagement portion 240 is configured to be received within the receiving portion 230 of the subsequent link.

[0220] In some embodiments, the receiving portion 230 has a generally cylindrical outer profile, the receiving portion 230 having a circumferential annular groove 250 formed on an outer surface of the receiving portion 230 and two diametrically opposed openings 252 formed in the groove 250 and extending along an axis oriented transversely relative to the longitudinal axis. Alternatively, the receiving portion 230 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, configured to be received in the corresponding engagement portion 240 of the subsequent link.

[0221] The plurality of openings 252 are located in a plane that is generally perpendicular to the plane in which the openings 242 are located.

[0222] The groove 250 defines an outwardly facing surface 290 and two shoulder edge surfaces 292 that bound the groove 250 .

[0223] In some embodiments, the outer diameter of the outer profile of the engagement portion 240 of a first link 220 is generally smaller than an inner diameter of a receiving portion 230 of a subsequent link 220 , thereby fitting within the receiving portion 230 .

[0224] In some embodiments, the inner diameter of the receiving portion 230 is substantially larger than an outer diameter of the engaging portion 240 in the proximal link 220 , so that the engaging portion 240 is accommodated in the receiving portion 230 .

[0225] In some embodiments, the plurality of openings 252 are oriented at a generally 90 degree angle relative to the plurality of openings 242 .

[0226] In some embodiments, the diameter of the single link 220 is in the range of 2 to 6.5 mm, and the length of the single link 220 is in the range of 4 to 8 mm.

[0227] Reference now Fig.14A , 14B 14C is a simplified illustration of multiple perspective views of multiple exemplary embodiments of a securing assembly of a link component. Fig.14AAs shown, a fixing component 212 is an integrally formed substantially annular ring component made of an elastic or semi-elastic material, such as stainless steel or any other biocompatible material. The fixing component 212 defines an inwardly facing surface 300, an outwardly facing surface 302, and a slit 304, wherein the slit 304 enables the fixing component 212 to elastically deform when stress is applied.

[0228] In some embodiments, when applied, the retainer 212 surrounds at least a portion of the link 220 at the level of the plurality of openings 252 and prevents the plurality of pins 210 from radially exiting the plurality of openings 252 .

[0229] In some embodiments and Fig. 14B As shown in FIGS. 14C and 14C , the fixing assembly 212 includes at least one latch 210 rigidly attached to the inwardly facing surface 300. Fig. 14B and 14C In the example of each fixing assembly, a pair of diametrically opposed pins 210 are included. In some embodiments, for example: Fig. 14B , the shape of the fixing component 212 is similar to Fig.14A In some embodiments, the fixing component 212 has a semicircular geometry, such as Fig. 14C In some embodiments, the fixing assembly 212 includes one or more latches 210, supporting the pivoting movement of a plurality of continuous links connected by the plurality of latches 210, for example; Fig. 14B and a plurality of latches 210 relative to each other as shown in FIG14C. In some embodiments, Figures 14A to 14C Each of the plurality of fixing assemblies 212 shown in FIG. 2 includes a snap-fit ​​attachment to a corresponding link 220 .

[0230] Reference now Fig.15 , Fig.15 is a simplified illustration of a partial cross-sectional view taken along a plurality of successive link components of the flexible bone tool 200, wherein Fig.15 In the illustrated embodiment, the plurality of link components 202 are connected to one another in a stationary, stress-free orientation.

[0231] exist Fig.15 In the illustrated embodiment, it can be seen that a proximal link 220 and a continuous distal receiving link 220 are oriented perpendicularly relative to each other. The plurality of openings 252 of the proximal link 220 are shown in a cross-section extending in a plane that is perpendicular to the plane of the cross-section of the plurality of openings 242 of the distal link 220.

[0232] The plurality of links 220 are coupled to each other using a plurality of connecting pins 210. The plurality of openings 242 of a proximal link 220 are aligned with the plurality of openings 252 of a distal link 220, and the plurality of connecting pins 210 are inserted through the two openings 242 and 252 and secure the two links together while providing rotational freedom, such as Figures 16A to 16C As further shown in .

[0233] A particular feature of an embodiment of the present invention is that the connecting pins 210 cannot be fully inserted into the interior of a link 220 due to the outwardly tapered portion 262 of the connecting pins 210. Another particular feature of an embodiment of the present invention is that the fixing assembly 212 is mounted in the groove 250 of each link 220 and is restrained by the shoulder edges 292 of the link 220. The inwardly facing surface 300 of the fixing assembly 212 engages the outwardly facing surfaces 264 of the connecting pins, thereby preventing the connecting pins 210 from falling out of the openings 242 and 252, so that the connecting pins 210 are firmly held in the links 220 and the links 220 are firmly held together. It should be noted that the fixing assembly 212 can be mounted on the link 220 due to the spring characteristics provided by the slits 304 formed in the fixing assembly 212.

[0234] Reference now Fig.16A , 16B and 16C, Fig.16A , 16B 16C is a simplified illustration of perspective and cross-sectional views of multiple embodiments of a plurality of successive link components 202 of the flexible bone tool 200, the plurality of successive link components 202 being connected to one another. The plurality of link components 202 are oriented in a curved manner. Figures 16A to 16C As shown in the figure, the cross section is along Fig.16A Multiple straight lines CC intercept in.

[0235] Figures 16A to 16C The embodiment shown in FIG. 1 is depicted in a curved orientation, with the plurality of link components 202 oriented at an angle “a” relative to one another, such that the proximal end of the receiving portion 230 of a distal link 220 is angularly displaced relative to the stationary orientation of the receiving portion 230, as shown in FIG. Fig.15 In some embodiments, the angle "a" may be in the range of 2 to 10 degrees, and in particular, the rotation angle "a" between two consecutive links may be in the range of 5 to 8 degrees.

[0236] When the array of the plurality of link components 202 is bent, an axial gap extending over a distance L is created between at least a portion of the circumference of the plurality of adjacent link components 202. Optionally, the extension of the distance L is affected by one or more of the following: the number of the plurality of openings 242 and 252 and the plurality of corresponding connecting pins 210 connecting the plurality of links together; a volume within the receiving link remains unoccupied by the engagement portion 240, allowing the engagement portion 240 to move within the receiving groove.

[0237] In some embodiments, one or more dimensions of a link are selected to provide a specific range of bend radii for a tubular body comprising the plurality of links. Optionally, the extension of the bend radius is determined by dimensions of the plurality of links, such as: a length of the engagement portion 240 of the link 220; an outer diameter of the engagement portion 240 of the link 220 and the inner diameter of the receiving portion 230 of the received link 220. In some embodiments, a more flexible tubular body configured to bend to a smaller bend radius may be provided by one or more of: increasing the length dimension; decreasing the outer diameter dimension and increasing the inner diameter dimension. Optionally, for example, selecting the dimensions of the plurality of links as described will result in a larger space between two consecutive links remaining unoccupied, allowing for freer rotation during bending of the plurality of links.

[0238] Reference now Fig.17 , Fig.17 is a simplified illustration of a side view of an embodiment of the flexible bone tool 200 mounted on a guide pin, shown in the bent orientation, and Fig.18A and Fig.18B Simplified illustrations of perspective and cross-sectional views of one embodiment of the flexible bone tool 200 mounted on a guide pin are shown in a curved orientation within a bone of a patient.

[0239] like Fig.17 The illustrated embodiment shows an array of multiple link members 202 securely held together to form the flexible bone tool 200 having a tubular body 320, a distal portion of which includes the cutting head 206, and a proximal portion of which includes the shaft 204. The flexible bone tool 200 may extend through a guide pin 350 protruding from the distal end of the tool 200. The shaft or proximal hand-held portion 204 includes a proximal gripping end 270 that is shaped and / or sized to engage a drill and / or other tool.

[0240] In some embodiments, the tool 200 is configured to follow a path, such as a curved and / or straight path, defined by the guide pin 350. In some embodiments, the tubular body 320 is configured to bend to a bend radius R. Optionally, the bend radius R can be as small as, for example, 50 mm, 30 mm, 20 mm, or intermediate, larger, or smaller radii.

[0241] In some embodiments, the ability of the tubular body to bend to conform to the curvature of the guide pin is due to the relative angular orientation between the plurality of link components 202. Optionally, in some embodiments, during rotational motion applied to the tool (e.g., during drilling), the plurality of links will "return" to align with the path of the guide pin, with each portion of a turn being determined by the angular orientation between a plurality of consecutive link components 202. For example, at a 90 degree angle between adjacent links, the plurality of links will "return" to the defined path every quarter turn. Optionally, the rotational orientation of the plurality of links reduces a discrete effect during rotation that may be caused by the plurality of rigid links, resulting in a discontinuous rotation. Optionally, reducing the angle between adjacent links of the rotational orientation allows for smoother, substantially continuous rotation of the tubular body of the tool.

[0242] In some embodiments, the tubular body 152 has an outer diameter ranging from, for example, 2 to 10 mm, 4 to 6.5 mm, 5 to 20 mm, or intermediate, larger or smaller diameters. Optionally, the tool 150 is configured to form a hole or dilate an existing hole in a bone having multiple similar diameters.

[0243] In some embodiments, the tool 200 is advanced along a curved path within the bone. Alternatively, the tool follows a path defined by a guide pin 350, as long as the curvature radius of the tubular body is compatible with the curvature radius of the guide wire.

[0244] Additionally or alternatively, the tool 200 advances along a linear path.

[0245] In some embodiments, the tubular body is advanced into the bone to a depth relative to the surface of the bone, for example, a depth ranging from 1 mm to 5 cm. Optionally, the tubular body is advanced to penetrate the bone, for example, such that the cutting head 206 leaves a surface of the bone opposite to the surface into which the tool is inserted.

[0246] In some embodiments, the tool is rotated about the tool axis to advance the tool into the bone. Optionally, the rotational motion is applied by attaching a drill bit to the head of the proximal clamping end 270. In some embodiments, the torque applied to a proximal end of the tool is transmitted to a distal end of the tool 200 through the plurality of connected link components. In some embodiments, the tool is configured to transmit a torque in the range of, for example, 3 Newton centimeters to 5 Newton centimeters, for example, 3.2, 4.5, 4.8 Newton centimeters, or intermediate, higher or lower values.

[0247] In some embodiments, for example, when the flexible bone tool is used to drill a hole in the bone, the tubular body may include a flexible core, such as made of nitinol, stainless steel, etc. Optionally, the core is selected to be flexible enough to allow bending of the tubular body, but rigid enough to support the plurality of links during drilling, when the tubular body needs to withstand relatively strong forces from the bone tissue to penetrate the bone.

[0248] In some embodiments, the flexible bone tool is introduced onto the guide pin 350. Optionally, the guide pin 350 defines a curved path that guides the flexible bone tool to the bone. Alternatively, the guide pin defines a substantially linear path leading to the bone. In some procedures, it is necessary or preferred to approach the bone by following a curved path (i.e., not directly approaching the bone), for example, due to the anatomical structure of the treatment area, in some procedures, the target bone is approached at a certain angle. Due to the articulation ability of the tubular body, a flexible tool 200 as described herein may be particularly useful in such procedures.

[0249] In some embodiments, each link is configured to have a degree of freedom to move or pivot relative to an engaged front or rear link. In some embodiments, the degree of freedom of the joint is limited to pivoting at least one of the contacting links relative to a front or rear, the pivoting being between 2 and 10 degrees. However, although the maximum pivot angle in some embodiments can remain constant between multiple links, the cumulative effect along the length of multiple links results in a bending radius R of the flexible tubular portion 152 of the flexible bone tool 150, the bending radius R being between 20 and 80 mm.

[0250] In some embodiments, a variation in the pivotal degree of freedom between consecutive links results in a cumulative bending effect along the entire length of the flexible portion of flexible tool 150 that affects the overall bend radius of the tool.

[0251] In some cases, when the distal cutting head 206 of the tool 200 contacts the bone, the circumferential contact area between the link components increases and the links axially move toward each other. An increased circumferential contact area can provide an advantage during drilling, for example, because the increased contact will help spread the load, thereby reducing the load on the connecting pins 210 that hold the links together.

[0252] In some embodiments, the flexible bone tool is advanced into the bone of a patient. In some embodiments, advancing the tool comprises axially rotating the tubular body, such as by connecting a drill bit to the proximal hand-held portion of the tool. Optionally, at least a portion of the tubular body of the tool is advanced into a pre-formed hole in the bone and widens a diameter of the hole as it is advanced. Alternatively, the tool creates the hole. In some embodiments, the snap connections between multiple links of the tubular body are sufficiently strong to withstand multiple resistive forces of the bone while allowing the transmission of forces such as torque between the multiple links, for example: from the proximal hand-held portion to the distal head.

[0253] For example, a method as described herein may be particularly advantageous in multiple arthroscopic surgeries and is particularly suitable for multiple anterior cruciate ligament reconstruction surgeries in which a hole is formed in the femur. In some cases, the bone is approached at a certain angle to form the hole. Optionally, a flexible bone tool according to some embodiments is introduced into the femur. (Optionally, on a curved guide wire, the curved guide wire is used to form an initial hole in the bone) and used as a reamer to widen the initial hole to create a tunnel for accommodating a graft. Optionally, the tool is introduced along a curved path to meet the bone at a desired position.

[0254] In some embodiments, a user selects a cutting head suitable for performing a desired function (eg, penetrating a bone to create a hole, widening an existing hole, and / or other functions) and assembles the head onto the tool 200 .

[0255] Reference now Fig.19 , Fig.19 is a simplified illustration of a perspective view of an assembled flexible bone tool constructed and operative in accordance with an embodiment of the present invention. Fig. 20 , Fig. 20 yes Fig.19 A simplified partial exploded view of the chain link structure of the flexible bone tool.

[0256] like Fig.19 As shown, a flexible bone tool 400 includes a plurality of interconnected link assemblies 402. In some embodiments, the flexible bone tool 400 includes a shaft or proximal handheld portion 404 at the proximal end of the flexible bone tool 400, a plurality of interconnected link components 402, adapted to be pivotally displaced relative to each other, and a cutting head 406 at the distal end of the flexible bone tool 400.

[0257] In some embodiments, the plurality of link members 402 are arranged along a common longitudinal axis 408 when stationary. In some embodiments, the interconnected link members define a substantially tubular, bendable body. In some embodiments, the bone tool comprises a cutting head disposed at a distal end of the tubular body. Optionally, the shape and / or size of the cutting head is adapted to cut a hole in the bone, thereby allowing the tool to function as a drill. Additionally or alternatively, the shape and / or size of the cutting head is adapted to widen an existing hole in the bone, for example when a rotational motion is applied to the tool, for example to a proximal head of the tool, thereby allowing the tool to function as a reamer. In some embodiments, the bone tool comprises a handheld portion, the handheld portion being disposed proximal to the tubular body. The proximal handheld portion can be engaged by a user (e.g., a physician) and / or by an additional tool (e.g., a drill). In some embodiments, the tubular body and optionally the proximal handheld portion are hollow. Optionally, the tubular tool is delivered over a guide wire, guide pin, suture, and / or other elongated component that can fit within and / or be inserted through the hollow portion.

[0258] In some embodiments, a guide wire is introduced into the bone of the target. Optionally, an initial hole is drilled in the bone, such as by advancing the guide wire into the bone, such as with the aid of a drill. In some embodiments, at least a portion of the guide wire is bent into an arch or other curved profile. Optionally, once at least a portion of the guide wire (e.g., a distal end) is anchored into the bone of the target, the guide wire is bent into a selected curvature.

[0259] Each link assembly 402 is configured to be connected to a subsequent, more distal link component 402 by means of one or more connecting pins 410 and one or more retainers 412. Each link component 402 includes a link 420 having a receiving portion 430 and an engaging portion 440, wherein the engaging portion 440 is configured distally of the receiving portion 430 to be received in a receiving portion 430 of the subsequent link 420.

[0260] In some embodiments, the engagement portion 440 is generally cylindrical and has two diametrically opposed openings 442. Alternatively and optionally, the engagement portion 440 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, configured to be received within the receiving portion 430 of the successive link.

[0261] In some embodiments, the receiving portion 430 includes a generally cylindrical outer profile having a generally circular inwardly curved distal end 448 and an annular circumferential neck 450 between the receiving portion 430 and the engagement portion 440 of the link 420. In some embodiments, a wall of the receiving portion 430 and / or the engagement portion 440 includes two diametrically opposed openings 452 formed in a wall of the receiving portion 430 and / or the engagement portion 440. Alternatively and optionally, the receiving portion 430 defines a different outer profile, such as a hexagonal, elliptical, and / or other outer profile, configured to be received within the corresponding engagement portion 440 of the succeeding link.

[0262] In some embodiments, the outer diameter of the outer profile of the engagement portion 440 of a first link 420 is generally smaller than an inner diameter of a receiving portion 430 of a subsequent link 420 , thereby fitting within the receiving portion 430 .

[0263] In some embodiments, the inner diameter of the receiving portion 430 is substantially larger than an outer diameter of the engaging portion 440 in the proximal link 420 , so that the engaging portion 440 is accommodated in the receiving portion 430 .

[0264] In some embodiments, plurality of openings 442 are oriented at a generally 90 degree angle relative to plurality of openings 452 .

[0265] In some embodiments, each successive link 420 is oriented and rotated at an angle, such as 90 degrees, relative to the preceding or succeeding consecutive link 420 such that the plurality of openings 442 of a first link 420 is aligned with the plurality of openings 452 of the second link 420 .

[0266] In some embodiments, the plurality of connecting pins 410 include a generally cylindrical portion 460 and a generally outwardly tapered portion 462 defining an outwardly facing surface 464 .

[0267] In some embodiments, each link includes a plurality of openings 442 and 452 and a plurality of connecting pins 410, such as 2, 3, 4, 5, 6, 10 or intermediate, greater or lesser numbers of extensions / pins. Optionally, multiple links of a single tool include different numbers of extensions / pins. Optionally, the number of extensions / pins determines the degree of movement of the multiple links relative to each other. For example, a single opening may provide a greater degree of freedom of movement, such as movement in the axial and / or radial directions, relative to a greater number of openings.

[0268] In some embodiments, the plurality of links are formed of metal, such as stainless steel. Additionally or alternatively, the plurality of links are formed of a biocompatible plastic, such as polycarbonate and / or thermoplastic polyurethane resin.

[0269] In some embodiments, at least one link and / or at least the tubular body and / or the cutting head are disposable.

[0270] In some embodiments, the value of the torque transmitted by the plurality of links is sufficient to drill into the bone tissue, for example, in a range between 3 Newton centimeters and 15 Newton centimeters. Optionally, the tubular body is configured to transmit a value of torque in a range between 1 Newton centimeter and 150 Newton centimeters, for example, 5 to 20 Newton centimeters, 10 to 40 Newton centimeters, and 50 to 100 Newton centimeters. In some embodiments, the plurality of matching non-circular geometries of the engaging portion and the size and shape of an inner cavity of the receiving portion are adapted to allow axial rotation of the components 402 of the plurality of links relative to each other only to a degree of torque sufficient to maintain the functionality of the tool, and the torque can still be transmitted between the plurality of links. In some embodiments, the shaft 404 of the flexible bone tool 400 is substantially aligned with the shaft 404 of the flexible bone tool 400. Fig.10 In some embodiments, the shaft 404 of the flexible bone tool 400 is similar to Fig.10 The shaft 204 is shown in FIG.

[0271] Reference now Fig.21A and 21B, Fig.21A and 21B are simplified illustrations of a perspective view and a cross-sectional view of a single link 420 of the flexible bone tool 400.

[0272] In some embodiments, a link 420 is made of metal material, such as stainless steel, and is manufactured by deep drawing.

[0273] As described in detail herein, the link 420 includes a receiving portion 430 , which is sized and shaped to receive an engagement portion 440 of a subsequent link 420 .

[0274] In some embodiments, the engagement portion 440 is generally cylindrical and has two diametrically opposed openings 442 extending along an axis disposed transversely relative to the longitudinal axis 408. Alternatively, the engagement portion 440 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, configured to be received within the receiving portion 430 of the successive link.

[0275] In some embodiments, the receiving portion 430 has a generally cylindrical outer profile and has a rounded distal end 448 and forms an annular neck 450 between the receiving portion 430 and the engaging portion 440. Typically, two diametrically opposed openings 452 are formed in the receiving portion 430 and extend along an axis that is oriented transversely relative to the longitudinal axis 408. Alternatively, the receiving portion 430 defines a different outer profile, such as hexagonal, elliptical, and / or other outer profiles, and the receiving portion 430 is configured to be received within a corresponding engaging portion 440 of the subsequent link.

[0276] The plurality of openings 452 are located in a plane that is generally perpendicular to the plane in which the plurality of openings 442 are located.

[0277] In some embodiments, the outer profile of the engagement portion 440 of a first link 420 is generally smaller than the inner diameter of a receiving portion 430 of a subsequent link 420 , and is thus adapted to fit within the receiving portion 430 .

[0278] In some embodiments, the inner diameter of the receiving portion 430 is generally larger than an outer diameter of the engaging portion 440 of the proximal link 420 , so that the engaging portion 440 is accommodated in the receiving portion 430 .

[0279] In some embodiments, the plurality of openings 452 are disposed at an angle of approximately 90 degrees relative to the plurality of openings 442 .

[0280] In some embodiments, the diameter of the single link 420 is in the range of 2 to 6.5 mm, and the length of the single link 420 is in the range of 4 to 8 mm.

[0281] Reference now Fig.22A and Fig. 22B , Fig.22A and Fig. 22B 4 is a simplified illustration of several exemplary embodiments of a fixation assembly 412 of the flexible bone tool 400.

[0282] In some embodiments, the fixing component 412 / 414 is an integrally formed component having a cylindrical or semicircular proximal portion 490 and a theoretical dome geometry or extended distal portion 492, wherein the theoretical dome geometry is generally circular and inwardly curved, and the distal portion 492 has a plurality of mutually independent finger-like protrusions 494 defining a plurality of gaps 496 therebetween, and the plurality of gaps 496 enable the fixing component 412 to elastically deform when stress is applied.

[0283] like Fig. 22B As shown in the embodiment of FIG. 4 , the fixing assembly 414 has a semicircular geometry that includes a gap 450 and is integrally connected to one or more pins 410. Due to the elastic nature of the multiple gaps, the fixing assembly 412 / 414 includes a snap-on attachment corresponding to a link 420.

[0284] Reference now Fig.23 , Fig.23 is a partial cross-sectional view of a flexible section of the flexible bone tool according to some embodiments of the present invention, taken along a plurality of successive link assemblies 402 of the flexible bone tool 400, the plurality of successive link assemblies 402 being coupled to one another in a stationary orientation.

[0285] like Fig.23 As shown in the exemplary embodiment of the embodiment, a proximal link 420 and a subsequent distal receiving link 420 are axially rotated perpendicularly relative to each other. The cross-section of the plurality of openings 452 of the proximal link 420 is shown extending on a plane, which is perpendicular to the plane of the cross-section of the plurality of openings 442 of the distal link 420.

[0286] The plurality of links 420 are connected to each other using a plurality of connecting pins 410. The plurality of openings 442 of a proximal link 420 are aligned with the plurality of openings 452 of a distal link 420, and the connecting pins 410 are inserted through both openings 442 and 452 and secure the two links together while providing at least a rotational degree of freedom or a pivoting degree of freedom, such as particularly Figures 24A to 24C See further in.

[0287] A particular feature of an embodiment of the present invention is that the connecting pin 410 cannot be fully inserted into the interior of a link 420 due to the fact that the connecting pin 410 has an outwardly tapered portion 462. Another particular feature of an embodiment of the present invention is that the fixing assembly 412 is mounted on the receiving portion 430 of each link 420 so that the inwardly extending distal portion 492 is retained on the neck 450 of each link 420. The fixing assembly 412 engages the outwardly facing surfaces 464 of the plurality of connecting pins, thereby preventing the plurality of connecting pins 410 from falling out of the plurality of openings 442 and 452, and thus the plurality of connecting pins 410 are securely retained within the plurality of links 420 and securely retain the plurality of links 420 together. It should be noted that mounting the fixing assembly 412 to the links 420 is possible due to the spring characteristics provided by the plurality of gaps 496.

[0288] Reference now Figures 24A to 24C , Figures 24A to 24C Simplified Fig.19 Two different illustrations and a cross-sectional view of a plurality of successive link components 402 of the flexible bone tool 400, wherein the plurality of successive link components 402 are connected to each other, the link components 402 are shown in a curved orientation, and the cross section is along Fig.24A The straight line CC in is intercepted.

[0289] See especially Figures 24A to 24C In a bent orientation, the plurality of link components 402 are disposed at an angle "a" relative to one another, such that the proximal end of the receiving portion 430 of a distal link 420 is angularly displaced relative to the stationary orientation of the proximal end, such as Fig.23 In some embodiments, the angle "a" may be in the range of 2 to 10 degrees, and in particular, the rotation angle "a" between two consecutive links may be in the range of 5 to 8 degrees.

[0290] When the array of the plurality of link components 402 is bent, an axial gap is created between at least a portion of the plurality of circumferences of the adjacent link components 402, the axial gap extending over a distance L. Optionally, the extension of the distance L is affected by one or more of the following: the number of the plurality of openings 442 and 452 and the plurality of corresponding connecting pins 410 connecting the plurality of links together; a volume within the received link remains unoccupied by the engagement portion 440, allowing the engagement portion 440 to move within the receiving groove.

[0291] In some embodiments, one or more dimensions of a link are selected to provide a specific range of bend radii for a tubular body comprising the plurality of links. Optionally, the extension of the bend radius is determined by dimensions of the plurality of links, such as: a length of the engagement portion 440 of link 420; an outer diameter of the engagement portion 440 of link 420 and the inner diameter of the receiving portion 430 of the received link 420. In some embodiments, a more flexible tubular body configured to bend to a smaller bend radius may be provided by one or more of: increasing the length dimension; decreasing the outer diameter dimension and increasing the inner diameter dimension. Optionally, for example, selecting the dimensions of the plurality of links as described will result in a larger space between two consecutive links remaining unoccupied, allowing for freer rotation during bending of the plurality of links.

[0292] Reference now Fig.25 , Fig.25 is a simplified illustration of a side view of the flexible bone tool 400 mounted on a guide pin, the flexible bone tool 400 being shown in the bent orientation described, and Fig.26A and Fig.26B Simplified illustrations of perspective views and cross-sectional views of various embodiments of the flexible bone tool 400 are shown mounted on a guide pin, shown in the curved orientation within a bone of a patient.

[0293] like Fig.25 As shown in the exemplary embodiment shown, the array of multiple link components 402 are securely held together to form the flexible bone tool 400 having a tubular body 520 having a distal portion including the cutting head 406 and a proximal portion including a shaft 404. The flexible bone tool 400 can pass through a guide pin 500 and protrude from the distal end of the tool 400. The shaft 404 includes a proximal clamping end 270 that is shaped and / or sized to engage with a drill and / or other tool.

[0294] In some embodiments, the tool 400 is configured to follow a path 500 defined by the guide pin, for example, a curved and / or straight path. In some embodiments, the tubular body 520 is configured to bend to a bend radius R. Optionally, the bend radius R can be as small as, for example, 50 mm, 30 mm, 20 mm, or intermediate, larger or smaller radii.

[0295] In some embodiments, the ability of the tubular body to bend to conform to the curvature of the guide pin is due to the relative angular orientation between the plurality of link components 402. Optionally, in some embodiments, during rotational motion applied to the tool (e.g., during drilling), the plurality of links will "return" to align with the path of the guide pin, with each portion of a turn being determined by the orientation of the angle between a plurality of consecutive link components 202. For example, at a 90 degree angle between adjacent links, the plurality of links will "return" to the defined path every quarter turn. Optionally, the rotational orientation of the plurality of links reduces a discrete effect during rotation that may be caused by the plurality of rigid links, resulting in a discontinuous rotation. Optionally, reducing the angle between adjacent links of the rotational orientation allows for smoother, substantially continuous rotation of the tubular body of the tool.

[0296] In some embodiments, the tubular body 520 has an outer diameter ranging from, for example, 2 to 10 mm, 4 to 6.5 mm, 5 to 20 mm, or intermediate, larger or smaller diameters. Optionally, the tool 400 is configured to form a hole or dilate an existing hole in a bone having multiple similar diameters.

[0297] In some embodiments, the tool 400 is advanced along a curved path within the bone. Alternatively, the tool follows a path defined by the guide pin 500, as long as the curvature radius of the tubular body is compatible with the curvature radius of the guide wire.

[0298] Additionally or alternatively, the tool 400 advances along a linear path.

[0299] In some embodiments, the tubular body is advanced into the bone to a depth relative to the surface of the bone, for example, a depth ranging from 1 mm to 5 cm. Optionally, the tubular body is advanced to penetrate the bone, for example, such that the cutting head 406 leaves a surface of the bone opposite to the surface into which the tool is inserted.

[0300] In some embodiments, the tool is rotated about the tool axis to advance the tool into the bone. Optionally, the rotational motion is applied by attaching a drill bit to the head of the proximal clamping end 270. In some embodiments, the torque applied to a proximal end of the tool is transmitted to a distal end of the tool 400 through the plurality of connected link components. In some embodiments, the tool is configured to transmit torque in the range of, for example, 3 Newton centimeters to 5 Newton centimeters, for example, 3.2, 4.5, 4.8 Newton centimeters or intermediate, higher or lower values.

[0301] In some embodiments, for example, when the flexible bone tool is used to drill a hole in the bone, the tubular body may include a flexible core, for example, made of nitinol, stainless steel. Optionally, the core is selected to be flexible enough to allow the tubular body to bend, but rigid enough to support the multiple links during drilling, when the tubular body needs to withstand multiple relatively strong forces from the bone tissue to penetrate the bone.

[0302] In some embodiments, the flexible bone tool is introduced onto the guide pin 500. Optionally, the guide pin 500 defines a curved path to guide the flexible bone tool to the bone. Alternatively, the guide pin defines a substantially linear path to the bone. In some surgeries, it is necessary or preferred to approach the bone by following a curved path (i.e., rather than approaching the bone directly), for example, due to the anatomical structure of the treatment area. In some surgeries, the target bone is approached at an angle. Due to the articulation ability of the tubular body, the flexible tool 400 as described herein may be particularly useful in such procedures.

[0303] In some cases, when the distal cutting head 406 of the tool 400 contacts the bone, the circumferential contact area between the multiple links increases and the multiple links axially approach each other. An increased circumferential contact area can provide an advantage during drilling, for example: because the increased contact area helps to spread the load and thereby reduce the load acting on the toothed extension / pin holding the multiple connected links 410 together.

[0304] In some embodiments, the flexible bone tool is advanced into the bone of a patient. In some embodiments, advancing the tool comprises axially rotating the tubular body, such as by connecting a drill bit to the proximal hand-held portion of the tool. Optionally, at least a portion of the tubular body of the tool is advanced into a pre-formed hole in the bone and widens a diameter of the hole as it is advanced. Alternatively, the tool creates the hole. In some embodiments, the snap connections between multiple links of the tubular body are sufficiently strong to withstand multiple resistive forces of the bone while allowing the transmission of forces such as torque between the multiple links, for example: from the proximal hand-held portion to the distal head.

[0305] For example, a method as described in the present specification may be particularly advantageous in multiple arthroscopic surgeries and is particularly suitable for multiple anterior cruciate ligament reconstruction surgeries in which a hole is formed in the femur. In some cases, the bone is approached at a certain angle to form the hole. Optionally, a flexible bone tool according to some embodiments is introduced into the femur. (Optionally, on a curved guide wire, the curved guide wire is used to form an initial hole in the bone) and used as a reamer to widen the initial hole to create a tunnel for accommodating a graft. Optionally, the tool is introduced along a curved path to meet the bone at a desired position.

[0306] In some embodiments, a user selects a cutting head suitable for performing a desired function (eg, penetrating a bone to create a hole, widening an existing hole, and / or other functions) and assembles the head onto the tool 400 .

[0307] Reference now Fig.27A and 27B ,in Fig.27A is a simplified illustration of a plan view and a side view of a link removal tool according to some embodiments of the present invention, Fig.27B Is implemented Fig.27A A simplified illustration of a side view of the chain link removal tool is depicted. Fig.27A As shown in the exemplary embodiment shown, the link removal tool 2700 includes a shaft 2702 connected to a handle 2704 at a first end and to a removal end 2706 at a second end. In some embodiments, the removal end 2706 is bifurcated and includes one or more prongs sized and shaped to be inserted between any two consecutive links 120 and / or multiple link components 220 of the flexible bone tool 150. In some embodiments, the removal end 2706 includes two or more prongs 2708 sized and shaped to be inserted between any two consecutive links 120 along at least a portion of a circumference of the flexible bone tool 150.

[0308] In some embodiments, the tool 2700 includes a cantilever 2710 that extends from the shaft 2702 at an angle relative to a longitudinal axis of the shaft 2702 .

[0309] exist Fig.27BIn the example shown, the link removal tool 2700 is applied to the flexible bone tool 150 between a bone tissue removal component 154 and a front engagement link 120. In some embodiments, an end surface 2712 of the cantilever 2710 rests on an outer surface of one or more front links 120, and the end surface 2712 provides leverage when the handle 2704 of the removal tool 2700 is pushed in a direction indicated by arrow 2750. Now refer to Fig.28 , Fig.28 is a simplified flow chart of a method of using the Flexible Bone Tool Kit.

[0310] In some embodiments, a flexible bone tool kit includes at least one of the flexible bone tools having a hand-held portion, at least one first link attachable to the distal side of the hand-held portion, at least one second link including an attachment to at least one tissue removal component, a plurality of connected pins, and at least one link removal tool, wherein the tissue removal component is attached to at least the hand-held portion and at least one of the first links.

[0311] In some embodiments and Fig.28 28. A method of using a set of tools is shown, comprising: selecting a flexible bone tool in step 2802, the flexible bone tool comprising a suitable number of links that provide a desired length according to the procedure to be performed (e.g., arthroscopy) surgery. In some embodiments, selecting a suitable bone tissue removal component at 2804, such as a bone cutting component, a reamer, a drill bit, and any other bone tissue removal and manipulation device, and attaching the component to the distal-most link (2806) of the flexible bone tool using a plurality of connecting pins. At 2808, once the procedure is terminated, the surgical procedure is performed and the flexible bone tool (2810) is removed. In some embodiments, the flexible bone tool (2814) is discarded at this time. In some embodiments, the bone tissue removal component is removed from the distal link 2812 using a link removal tool, and an identical or different bone tissue removal component (2804) is attached.

[0312] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes both the combination and sub-combination of the various features described above and variations and modifications of the combinations and sub-combinations that are not in the prior art.

[0313] The terms "comprises", "comprising", "includes", "including", "having" and their conjugations mean "including but not limited to"

[0314] The term "consisting of" means "including and not limited to".

[0315] The term "consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or components, but only when the additional ingredients, steps and / or components do not substantially change the basic and novel characteristics of the claimed composition, method or structure.

[0316] As used herein, the singular forms "a", "an" and "the" may include plural references unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0317] Throughout this application, various embodiments of the present invention may be presented in a range format in conjunction with references. It should be understood that the description in range format is merely for convenience and brevity and should not be interpreted as a strict limitation on the scope of the present invention. Therefore, the description of a range should be considered to specifically disclose all possible sub-ranges and each numerical value within the range, for example: describing a range such as "from 1 to 6" should be understood to disclose multiple sub-ranges, such as: from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc.; also disclose each number within this range, such as: 1, 2, 3, 4, 5 and 6, regardless of the width of the range.

[0318] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integer) within the indicated range. The terms "range between" a first indicated numeral and a second indicated numeral and "range from" a first indicated numeral to a second indicated numeral are interchangeable herein and are meant to include the first and second indicated numerals, and all fractions and integers therebetween.

[0319] The term "method" as used herein refers to manner, means, technique and procedures for accomplishing a particular task, wherein the given task includes but is not limited to those manners, means, techniques and procedures that are known or are readily developed by practitioners in the chemical, pharmacological, biological, biochemical and medical fields from known manners, means, techniques or procedures.

[0320] As used herein, the term "treating" includes halting, substantially inhibiting, slowing or reversing the progression of a disorder, substantially ameliorating the clinical or psychological symptoms of a disorder or substantially preventing the appearance of the clinical or psychological symptoms of a disorder.

[0321] It will be appreciated that certain features of the invention, which for the sake of clarity are described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which for the sake of clarity are described in the context of a single embodiment, may also be provided individually or in any suitable subcombination or in any other described implementation suitable for the invention. Some features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment does not function without those components.

Claims

1. A flexible bone tool, characterized in that: The flexible bone tool comprises: a plurality of links, each link having a receiving portion, the wall of the receiving portion including at least one first hole, wherein each of the at least plurality of links has an engaging portion, the wall of the engaging portion including at least one second hole, wherein the receiving portion has an inner diameter, and the engaging portion has an outer diameter, wherein an inner profile of the receiving portion of a distal link of the plurality of links has a larger diameter than the outer diameter of the engaging portion of a proximal link of the plurality of links, The receiving portion of the distal one of the plurality of links is sized and configured to receive the engaging portion of the proximal one of the plurality of links such that the first aperture of the distal one of the plurality of links is aligned with the second aperture of the proximal one of the plurality of links; and at least one latch sized and configured to be received by the aligned first and second apertures and to removably connect the distal one of the plurality of links with the proximal one of the plurality of links; wherein the plurality of links comprises at least three links, wherein a first link of the at least three links is connected to a second link of the at least three links, and wherein the second link of the at least three links is connected to a third link of the at least third links; wherein the movable connection of adjacent links of the plurality of links includes a movable connection of the first link and the second link of the at least three links to allow the flexible bone tool to have a first pivotal movement in a first plane, and includes a movable connection of the second link and the third link of the at least three links to allow the flexible bone tool to have a second pivotal movement in a second plane, the second plane being rotationally oriented relative to the first plane; The first pivotal movement in the first plane and the second pivotal movement in the second plane have a cumulative bending effect that allows the plurality of links to move in the first plane and the second plane, wherein the first plane and the second plane are rotationally oriented relative to each other.

2. The flexible bone tool according to claim 1, characterized in that: The flexible bone tool further includes a bone tissue removal component, the plurality of links having a distal end, and the distal ends of the plurality of links are connected to the bone tissue removal component.

3. The flexible bone tool according to claim 2, characterized in that: The plurality of links are movably connected to the bone tissue removal assembly and together define a bendable body.

4. The flexible bone tool according to claim 2, characterized in that: The bone tissue removal assembly comprises: a receiving portion, wherein a wall of the receiving portion of the bone tissue removal assembly includes at least a third aperture, the receiving portion of the bone tissue removal assembly being sized and configured to receive the engagement portion such that the first aperture and the third aperture are aligned; and At least one additional latch is sized and configured to be received by the aligned first and third apertures and is configured to removably couple the bone tissue removal assembly and the plurality of links.

5. The flexible bone tool according to claim 1, characterized in that: The flexible bone tool further comprises: a hand-held portion; wherein the plurality of links collectively have a proximal end, the proximal ends of the plurality of links being connected to the hand-held portion.

6. The flexible bone tool according to claim 5, characterized in that: The plurality of links define a tubular body that is distally attachable to the handheld portion and proximally attachable to a bone tissue removal assembly; and The plurality of chain links are movably connected to each other and together define a bendable body.

7. The flexible bone tool according to claim 1, characterized in that: The engagement portions each include at least one pair of diametrically opposed apertures.

8. The flexible bone tool according to claim 7, characterized in that: A first imaginary line connecting a pair of diametrically opposed holes in the receiving portion is angled relative to a second imaginary line connecting a plurality of diametrically opposed holes in the engaging portion.

9. The flexible bone tool according to claim 1, characterized in that: The at least one latch prevents the engaging portion from being fully inserted into the receiving portion and forms a gap between an outer surface of the engaging portion and an inner surface of the receiving portion.

10. The flexible bone tool according to any one of the preceding claims, characterized in that: The tool is configured to bend with a bend radius R between 20 and 80 millimeters.

11. The flexible bone tool according to any one of claims 1 to 9, characterized in that: The extent of pivoting along the plurality of links collectively define a bend radius of the tool.

12. The flexible bone tool according to any one of claims 1 to 9, characterized in that: The mating geometries of the engagement portion are adapted to transmit a torque between the adjacent links having a magnitude sufficient to advance the flexible bone tool into a bone when the mating geometries of the engagement portion engage a corresponding lumen of a continuous receiving portion.

13. The flexible bone tool according to any one of claims 1 to 9, characterized in that: Mating geometries of the engagement portion and a corresponding interior cavity of a continuous receiving portion permit axial rotation of the adjacent links relative to one another only to an extent sufficient to enable transmission of a sufficient torque between the links.

14. The flexible bone tool according to any one of claims 2 to 4 and 6, characterized in that: The bone tissue removal assembly is shaped and sized to at least one of cut a bone, form a hole in the bone, and dilate an existing hole in the bone.

15. The flexible bone tool according to any one of claims 1 to 9, characterized in that: At least a portion of the flexible bone tool is slidable over at least one of a guide pin and a guide wire.

16. The flexible bone tool according to any one of claims 1 to 9, characterized in that: The flexible bone tool includes a radial interference joint in which at least one pin is received in a plurality of aligned holes in two consecutive links.

17. The flexible bone tool according to claim 6, characterized in that: At least one of the tubular body and the hand-held portion is hollow.

18. The flexible bone tool according to claim 3, characterized in that: The bending radius of the bendable body is defined by the number of the plurality of links comprising the bendable body.

19. The flexible bone tool according to claim 3, characterized in that: A bending radius of the bendable body is defined by at least one dimension of the multiple links, and the at least one dimension is selected from a group of dimensions consisting of outer diameters of the joint portions of the multiple links, lengths of the joint portions of the multiple links, and inner diameters of the receiving portions of the links.

20. The flexible bone tool according to claim 2, characterized in that: The bone tissue removal assembly is replaceable.

21. The flexible bone tool according to claim 1, characterized in that: The flexible bone tool further includes a bone tissue removal assembly connected to the plurality of links; the bone tissue removal assembly is configured to at least cut bone, form a hole in the bone, and expand a hole in the bone.

22. The flexible bone tool according to claim 4, characterized in that: The receiving portion of the bone tissue removal assembly comprises: a cylindrical first proximal portion and an inwardly tapered second distal portion, wherein the wall of the proximal portion comprises the at least one third hole; wherein the engagement portion of one of the plurality of links comprises a proximal portion having a cylindrical outer contour, and a wall of the proximal portion comprises the at least one second hole; wherein the receiving portion of the bone tissue removal assembly is sized and configured to receive the engagement portion of one of the plurality of links such that the second aperture is aligned with the third aperture, wherein the one of the plurality of links and the bone tissue removal assembly are rotationally oriented relative to each other; and Wherein the movable connection between the bone tissue removal assembly and one of the plurality of links allows a first pivotal movement in a first plane.

23. The flexible bone tool according to any one of claims 1 to 22, characterized in that: Each of the plurality of links has a receiving portion, the receiving portion comprising: a proximal portion and an inwardly tapered portion; the proximal portion has a cylindrical outer contour, and the inwardly tapered portion is away from the proximal portion, wherein the wall of the proximal portion comprises at least one second hole, each of the plurality of links has a coupling portion, the coupling portion has a cylindrical outer contour, and its wall comprises at least one first hole, each of the receiving portions of each of the plurality of links is sized and configured to receive an engagement portion of each of the plurality of links such that the first aperture and the second aperture are aligned, wherein adjacent links of the plurality of links are rotationally oriented relative to each other; and The at least one latch is sized and configured to be received by each of the aligned first and second apertures and to movably connect adjacent links of the plurality of links.

24. The flexible bone tool according to claim 23, characterized in that: The receiving portion of the plurality of links includes a proximal section having a cylindrical outer contour with a circumferential annular groove.

25. A set of flexible bone tools for drilling holes in bones, characterized in that: The kit includes: A flexible bone tool according to any one of claims 1 to 24; and At least one chain link removal tool.

26. The kit according to claim 25, characterized in that: The kit further includes: a fixer.

27. The kit according to claim 25, characterized in that: The link removal tool is configured to remove adjacent links among the plurality of links.

28. The kit according to claim 25, characterized in that: The plurality of links are substantially tubular and bendable relative to each other, and wherein the plurality of links are at least 7 centimeters long.

29. The kit according to claim 25, characterized in that: The kit further includes: a plurality of bone tissue removal components.

30. A flexible bone tool, characterized in that: The flexible bone tool comprises: One hand-held part; A first link, comprising a bone tissue removal assembly, wherein the first link has a receiving portion, the receiving portion having an inner diameter and at least one hole; a tubular body including a second link and at least one third link, the second link being distally attachable to the handheld portion and proximally attachable to the first link; The first link, the second link and the at least one third link are movably connected to each other and together define a bendable body; wherein the second link comprises an engagement portion and a receiving portion, the engagement portion having an outer diameter, wherein an inner contour of the receiving portion of the first link has a diameter greater than the outer diameter of the engagement portion of the second link, wherein a wall of the engagement portion of the second link comprises at least one hole, and a wall of the receiving portion comprises at least one hole; The receiving portion of the first link is sized and configured to receive the engaging portion of the second link such that at least one aperture of the engaging portion of the second link is aligned with at least one aperture of the receiving portion of the first link; and at least one latch sized and configured to be received by one of the at least one aperture in the engagement portion of the second link aligned with one of the at least one aperture in the receiving portion of the first link, wherein the at least one latch movably connects the first link and the second link; The third link comprises: an engaging portion having an outer diameter, an inner profile of the receiving portion of the second link having a diameter greater than the outer diameter of the engaging portion of the third link, a wall of the engaging portion of the third link including at least one hole, the receiving portion of the second link being sized and configured to receive the engaging portion of the third link such that the at least one hole of the engaging portion of the third link is aligned with the at least one hole of the receiving portion of the second link; at least one latch being sized and configured to be received by one of the at least one holes in the engaging portion of the third link that is aligned with one of the at least one holes in the receiving portion of the second link, wherein the at least one latch movably connects the second link and the third link; wherein the movable connection of the first link, the second link, and the third link comprises a movable connection of the first link and the second link to allow a first pivotal movement of the flexible bone tool in a first plane, and a movable connection of the second link and the third link to allow a second pivotal movement of the flexible bone tool in a second plane, wherein the second plane is rotationally oriented relative to the first plane; Wherein the first pivotal movement in the first plane and the second pivotal movement in the second plane have a cumulative bending effect that allows the plurality of links to move in the first and second planes rotationally oriented relative to each other.

Images