Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
  • A61B17/1642—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for producing a curved bore
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00526—Methods of manufacturing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00867—Material properties shape memory effect
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B2017/320056—Tunnelers

Definitions

• the subject matter described herein relates generally to systems, devices, and methods for creating bone tunnels.
• described herein are embodiments of bone tunneling devices configured to create curvilinear tunnels in bone, as well as methods and devices relating thereto.
• Joint arthropathies caused by soft tissue damage make up the majority of cases within the broader category of musculoskeletal conditions. Shoulder pain stands among the most common musculoskeletal complaints worldwide, with rotator cuff tears being the leading cause of shoulder disability.
• Other types of ligament, tendon, and fibrocartilage injuries such as labral tears, meniscus root tears, Achilles tendon avulsions, anterior cruciate ligament (ACL) ruptures, and lateral ankle ligament tears, among others, are somewhat less prevalent, but no less debilitating.
• the goal of such repairs is to re-establish the position and direction of force transmission in these tissues in order to restore stability and motion to their respective joints.
• this can be achieved by re-attaching the torn areas of soft tissue (e.g., tendon, ligament, and/or fibrocartilage) - which naturally pull away from their anatomic insertion site upon injury - using a fixation method to create a stable connection and close contact between tissue and bone so that the interface can heal over time.
• soft tissue e.g., tendon, ligament, and/or fibrocartilage
• a bone tunnel is required either for the insertion of an implant, suture, or tissue.
• ACL reconstructions often employ the use of straight bone tunnels for both femoral and tibial fixation of graft tissue using interference screws and/or bone plugs.
• rotator cuff repairs may utilize a transosseous approach involving the creation of curvilinear or piece-wise linear bone tunnels through which sutures are passed to pull the torn tendon back to the bone.
• a device for creating curvilinear tunnels in a bone comprising a housing having a distal end configured to interface with a surface of the bone; an impactor at least partially disposed within the housing, wherein the impactor is configured to be inserted into the bone and to create a curvilinear tunnel, and wherein the impactor comprises a rigid material and a curved geometry; an inner channel disposed within the housing and configured to guide the impactor into the bone; and an actuator comprising a propulsion mechanism configured to move the impactor.
• a device for creating curvilinear tunnels in a bone comprising a housing having a distal end configured to interface with a surface of the bone; one or more curved needles at least partially disposed within the housing, wherein the one or more curved needles are configured to be inserted into the bone and to create a curvilinear tunnel, and wherein the one or more curved needles comprise a superelastic material; one or more straight hollow punches configured to introduce the one or more curved needles at a predetermined depth under the surface of the bone; one or more inner channels disposed within the housing, wherein each of the one or more inner channels is configured to guide a corresponding curved needle into the bone; a first set of one or more drivers configured to move the one or more straight hollow punches; and a second set of one or more drivers configured to move the one or more curved needles.
• a device for creating curvilinear tunnels in a bone comprising a housing having a distal end configured to interface with a surface of the bone; a flexible hollow shaft configured to bend during insertion into bone and to guide a path of a curvilinear tunnel; a flexible drill bit including an exposed head, wherein the exposed head is located at a tip portion of the flexible hollow shaft, and wherein the flexible drill bit includes a drill shaft configured to rotate within the flexible hollow shaft; a first set of one or more drivers to steer and extend the flexible hollow shaft; and a second set of one or more drivers to spin and extend the flexible drill bit.
• FIG. 1 A is a perspective view of an example embodiment of a bone tunneling device with a curved impactor.
• FIG. IB is a side view of an example embodiment of a bone tunneling device with a curved impactor.
• FIGS. 2A and 2B are side views of another example embodiment of a bone tunneling device with a curved needle in various configurations.
• FIG. 2C is an exploded view of an example embodiment of a bone tunneling device with a curved needle.
• FIGS. 3A and 3B are side views of another example embodiment of a bone tunneling device with two curved needles in various configurations.
• FIGS. 4A and 4B are side views of another example embodiment of a bone tunneling device with a curved needle.
• FIGS. 5 A to 5F are side views of various example embodiments of curved needles.
• FIG. 6 is a perspective view of an example embodiment of a bone tunneling device with a steerable shaft and a flexible drill bit.
• FIG. 7 is an example block diagram for controlling the operation of an actuator in a bone tunneling device.
• FIG. 8 is an example flow chart illustrating the method of use for the bone tunneling device in conjunction with or without bracing apparatuses for repairing the attachment of soft tissue to bone.
• FIG. 9 is an example flow chart illustrating a method of manufacture for a curved needle.
• a tunneling device for creating a curved bone tunnel.
• the tunneling device can include a curved channel or guide tube configured to guide a pointed impactor along a predetermined path.
• one or more ends of a curved track or guide tube abut a target area of a bone surface, wherein the target area comprises one or more predetermined entry and exit points of a tunnel to be created in the bone.
• a tunneling device can also include a means for propelling the impactor, for example, through the use of a pneumatic, magnetic, electrical, or mechanical mechanism, or a combination thereof, whether automated or manually operated.
• a tunneling device includes a sharp tipped needle that can be made of a superelastic material.
• a superelastic material is nickel -titanium alloy, also known as nitinol.
• the sharp tipped needle can be retracted into a curved or straight guide tube, and then extended from the guide tube either by a manual or automated mechanism within the tunneling device to enable the sharp tipped needle to extend out of the guide tube, thereby assuming its curved configuration, to create a curvilinear bone tunnel.
• a tunneling device in another embodiment, includes a steerable component and an extending component that enables the device to advance into the bone along a controllable path.
• FIG. 1A is a perspective view depicting an example embodiment of a tunneling device 100 for creating one or more curvilinear tunnels in a bone material.
• tunneling device 100 includes a housing 110 comprising a distal end having at least one surface 105 configured to interface with a bone material, a channel 120 disposed within housing 110, and a curved impactor 130 configured to travel within channel 120.
• Channel 120 is shown to be circular in cross-section, but those of skill in the art will appreciate that the cross- sectional shape of channel 120 and impactor 130, configured to travel therein, can be of any geometry.
• the path of channel 120 within tunneling device 100 can have an arcuate geometry. Furthermore, as seen in FIG.
• tunneling device 100 including housing 110 and channel 120 disposed therein, comprises a semi-circular shape subtending an angle of 180 degrees.
• tunneling device 100, housing 110, or channel 120 can comprise a circular arc subtending an angle of more or less than 180 degrees, or can have a non-circular shape.
• the length of curved impactor 130 can be either greater than or less than the length of channel 120 of tunneling device 100.
• an internal propulsion mechanism transfers energy to impactor 130 to generate bidirectional motion within channel 120.
• the internal propulsion mechanism can comprise technology used to generate motion including, but not limited to, an electromechanical actuator, a piezoelectric actuator, an electrical induction actuator, a magnetic propulsion actuator, a pneumatic propulsion actuator, a hydraulic propulsion actuator, a mechanical propulsion (e.g., linkages, gears, etc.) actuator, or any combination thereof.
• the internal propulsion mechanism can be fully automated, partially automated, or manually powered.
• FIG. 1A depicts a perspective partial cross-sectional view of an example embodiment of tunneling device 100 comprising a direct current (DC) motor 150 configured to move impactor 130.
• DC motor 150 drives a rotating shaft 155.
• Shaft 155 inserts into a coupler 160, which is coupled with drive shaft 165, which is configured to transmit torque from DC motor 150 to miter gear 170.
• FIG. IB is a perspective view depicting a distal end of tunneling device 100.
• miter gear 170 is operatively engaged with a second complementary miter gear 175.
• Rotation of second miter gear 175 turns shaft 180, as well as worm screw 185.
• the direction of rotation of worm screw 185 drives the forward or backward direction of motion of impactor 130, which possesses teeth 135 complementary to the worm screw 185 along its outer surface.
• impactor 130 includes one or more pointed ends 131 and 132, which are configured such that the energy upon striking or burrowing through a bone material can cause a bone tunnel to lengthen.
• FIG. IB the embodiment is depicted in FIG. IB as using a throated worm screw 185 and a non-throated impactor 130, those of skill in the art will recognize that worm screw 185 and impactor 130 can each be throated or non-throated, and such embodiments are within the scope of the present disclosure.
• impactor 130 can comprise a solid component including one or more solid conical tips 131 and 132 on each end with teeth 135 complementary to worm screw 185.
• impactor 130 can possess one or more tips 131 and 132 having a different geometry including, but not limited to, pyramidal, hollow cylindrical, hemispherical, or truncated conical tip, along with other tip features, such as flutes and tapers. Additionally, the cross sectional geometry of the impactor 130 is depicted as circular, but can be of any shape including, but not limited to, elliptical, polygonal, or an irregular shape. The impactor 130 can also be hollow or partially hollow. Some embodiments of tunneling device 100 may not include teeth 135, but can introduce other physical features or properties of impactor 130 in order to achieve motion by said means of propulsion. Certain embodiments of tunneling device 100 can use an impactor 130 of appropriate size, geometry, and properties to form a curved bone tunnel, and leave the impactor within the tunnel as an implantable device after the tunnel is formed.
• FIGS. 2A and 2B depict a side view of another embodiment of tunneling device 200 in retracted and fully deployed, extended configurations, respectively.
• FIG. 2C depicts an exploded view of tunneling device 200.
• tunneling device 200 can comprise a curved needle 260 configured to be driven into bone to create a curved bone tunnel.
• curved needle 260 can comprise a superelastic material, one of numerous examples of which include nickel -titanium alloy, also known as nitinol.
• tunneling device 200 can comprise a housing 210, which can include a distal end comprising at least one surface 215 configured to interface with a bone material, a shaft 220 containing a channel 225 through which the curved needle 260 is extended and retracted, and a main body 230.
• a first subassembly comprises first plunger 240 and hollow punch 245, both of which are mutually engaged.
• First plunger 240 is configured to slide freely through main body 230, and hollow punch 245, in turn, is configured to slide freely within channel 225 in shaft 220.
• first set of drivers pushes first plunger 240, whether by a screw mechanism or by impact, and whether by automation or by manual operation, hollow punch 245 will extend from an orifice on surface 215 to enable hollow punch 245 to enter the bone material.
• hollow punch 245 The extension of hollow punch 245 from the orifice is best seen in the inset of FIG. 2B showing a closeup of the region of tunneling device 200 that interfaces with bone.
• the extended length of hollow punch 245 can be zero (no extension) or any finite length that can be accommodated by the housing 210 and by the needle 260 within it.
• hollow punch 245 is depicted as circular in cross section, those of knowledge in the art will recognize that the cross section of hollow punch 245 can be of any geometry, including, but not limited to, elliptical, polygonal, or any irregular shape.
• a second subassembly comprises a second plunger 250 attached to a curved needle 260 via a connector 255.
• Second plunger 250 further comprises a plunger head 251 and plunger shaft 252.
• a second set of drivers pushes second plunger 250, whether by a screw mechanism or by impact, and whether by automation or by manual operation, through the first subassembly, this can cause curved needle 260 to extend through the hollow punch 245 in shaft 220 by way of connector 255.
• the tip 270 of curved needle 260 emerges from the end of hollow punch 245 at the surface of the bone if hollow punch has an extension of zero, or below the surface of bone if the hollow punch is extended a non-zero distance.
• curved needle 260 can comprise a superelastic material that enables it to be straightened with little or no permanent deformation when retracted within the hollow punch 245 in shaft 220 of the housing 210.
• curved needle 260 is shown to be circular in cross section, those of knowledge in the art will appreciate that the cross section of curved needle 260 can be of any geometry, including, but not limited to, elliptical, polygonal, or any irregular shape.
• this embodiment is depicted and described with connector 255, but those with skill in the art will appreciate that connector 255 can be omitted if curved needle 260 can be directly attached to plunger shaft 252.
• the tip 270 of curved needle 260 can be larger or smaller in diameter than the curved needle.
• the tip 270 of curved needle 260 can have any geometry including, but not limited to, conical, pyramidal, hollow cylindrical, hemispherical, or truncated conical tip, along with other tip features, such as flutes and tapers.
• hollow punch 245 in tunneling device 200 can occur after surface 215 has been placed in contact with bone.
• hollow punch 245 in tunneling device 200 can be extended before surface 215 comes into contact with bone, and then can be used to penetrate the surface of bone forcibly while already extended.
• the depth of which the hollow punch 245 enters bone can be user-adjustable or preset, and can be zero or any depth that can be accommodated by the design of tunneling device 200.
• housing 210 is illustrated to comprise separate shaft 220 and main body 230 components.
• the housing 210 in tunneling device 200 can be manufactured with more or fewer components, or as a single component.
• the first subassembly of tunneling device 200 can be of any size and shape with fewer or more components, with its primary purpose being to interface with and move hollow punch 245.
• the second subassembly can be of any size and shape with fewer or more components, with its primary purpose being to interface with and move curved needle 260 in tunneling device 200.
• channels - shown to be straight within the shaft - can be curved, can have any cross- sectional geometry, and can extend into the main body.
• the curved needle 260 in tunneling device 200 can be of any length, curvature, and tortuosity, and can be of any cross-sectional shape and size.
• mechanisms for extension and retraction of the needle e.g., using a pneumatic, magnetic, electrical, or mechanical actuator, can be either external to or integral with the device, and moreover, can be automated or manually operated. Such a mechanism can be incorporated within or outside of the device, in conjunction with or in place of other components in each subassembly.
• FIGS. 3A and 3B depict side views of another embodiment of tunneling device 300 in retracted and fully deployed configurations, respectively.
• Tunneling device 300 utilizes similar principles as tunneling device 200, but employs two curved needles 360 and 361 that are configured to meet when fully extended to form a continuous curvilinear bone tunnel.
• curved needles 360 and 361 can comprise a superelastic material, one of numerous examples of which include nickel -titanium alloy, also known as nitinol.
• tunneling device 300 comprises a housing of unibody construction 310, in which the two shafts 320 and 321, together with main body 330, are regions within a single component.
• Main body 330 has two channels, one for each curved needle. Each channel continues from the main body 330 into one of the two shafts 320 and 321.
• a first subassembly comprises a first plunger 340 that includes two plunger shafts, each of which is directly engaged with one of the hollow punches 345 and 346.
• First plunger 340 is configured to slide freely through a corresponding channel within main body 330, and each of the hollow punches 345 and 346 are configured to slide freely within their respective channels 325 and 326 in corresponding shafts 320 and 321.
• hollow punches 345 and 346 when a first set of drivers pushes first plunger 340, whether by a screw mechanism or by impact, and whether by automation or by manual operation, hollow punches 345 and 346 will each extend from an orifice on respective surfaces 315 and 316 to enable hollow punches 345 and 346 to enter the bone material.
• the extension of hollow punches 345 and 346 from their respective orifices is best seen in the inset of FIG. 3B showing a closeup of the region of tunneling device 300 that interfaces with bone.
• the extended length of hollow punches 345 and 346 can be zero (no extension) or any finite length that can be accommodated by the housing and by the needle within it.
• hollow punches 345 and 346 are depicted as circular in cross section, those of knowledge in the art will recognize that the cross section of hollow punches 345 and 346 can be of any geometry, including, but not limited to, elliptical, polygonal, or any irregular shape. Also, although hollow punches 345 and 346 are depicted as extending the same length, those of knowledge in the art will recognize that the two hollow punches can extend to two different lengths.
• a second subassembly comprises a second plunger 350 attached to curved needles
• Second plunger 350 further comprises plunger head 351 and plunger shafts 353 and 354. According to one aspect of the embodiments, when a second set of drivers pushes second plunger 350, whether by a screw mechanism or by impact, and whether by automation or by manual operation, through main body 330, this causes curved needles 360 and
• curved needles 360 and 361 can comprise a superelastic material that enables the needles to be straightened with little or no permanent deformation when retracted within hollow punches 345 and 346 in shafts 320 and 321 of the housing 310.
• curved needles 360 and 361 are shown to be circular in cross section, those of knowledge in the art will appreciate that the cross sections of curved needles 360 and 361 can be of any geometry, including, but not limited to, elliptical, polygonal, or any irregular shape. Those of skill in the art will also recognize that the tips 370 and 371 of respective curved needles 360 and 361 can be larger or smaller in diameter than the curved needle. Those of skill in the art will further recognize that the tips 370 and 371 of respective curved needle 360 and 361 can have any geometry including, but not limited to, conical, pyramidal, hollow cylindrical, hemispherical, or truncated conical tip, along with other tip features, such as flutes and tapers.
• hollow punches 345 and 346 in tunneling device 300 can occur after surfaces 315 and 316 have been placed in contact with bone.
• hollow punches 345 and 346 in tunneling device 300 can be extended before surfaces 315 and 316 come into contact with bone, and then can be used to penetrate the surface of bone forcibly while already extended.
• the depth of which the hollow punches 345 and 346 enter bone can be user-adjustable or preset, and can be zero or any depth that can be accommodated by the design of tunneling device 300.
• Housing 310 is shown to comprise a single component with two shafts 320 and 321 and a main body 330.
• the housing in tunneling device 300 can be manufactured with more components, or with a single shaft comprising multiple channels.
• the first subassembly of either tunneling device 300 can be of any size and shape with fewer or more components, with its primary purpose being to interface with and move hollow punches 345 and 346.
• the second subassembly can be of any size and shape with fewer or more components, with its primary purpose being to interface with and move curved needles 360 and 361 in tunneling device 300.
• channels - shown to be straight within the shaft - can be curved, can have any cross-sectional geometry, and can extend into the main body.
• the curved needles 360 and 361 in tunneling device 300 can be of any length, curvature, and tortuosity, and can be of any cross-sectional shape and size.
• mechanisms for extension and retraction of the needle e.g., using pneumatic, magnetic, electrical, or mechanical actuators, can be either external to or integral with the device and, moreover, can be automated or manually operated. Such a mechanism can be incorporated within or outside of the device, in conjunction with or in place of other components in each subassembly.
• FIG. 4A depicts a side view of another embodiment of tunneling device 400 in a fully deployed configuration.
• FIG. 4B depicts an exploded view of tunneling device 400.
• Tunneling device 400 utilizes similar principles as tunneling device 200, but additionally comprises several parts for the purposes of greater functionality of the device. Similar to tunneling device 200, according to one aspect of many embodiments, tunneling device 400 can comprise a housing 410, which can include a distal end comprising at least one surface 415 configured to interface with a bone material and a hollow punch 445 of fixed length configured to penetrate bone material. According to some embodiments, hollow punch 445 can be a component coupled with shaft 420.
• hollow punch 445 can be zero or any finite length that can be accommodated by the housing 410 and by the needle 460 within it.
• hollow punch 445 is depicted as circular in cross section, those of knowledge in the art will recognize that the cross section of hollow punch 445 can be of any geometry, including, but not limited to, elliptical, polygonal, or any irregular shape.
• a channel 425 which is continuous within the hollow punch 445 and the shaft 420, allows curved needle 460 to be extended and retracted.
• curved needle 460 can comprise a superelastic material, one of numerous examples of which include nickel -titanium alloy, also known as ni tinol.
• a subassembly comprises a plunger 450 directly coupled with a curved needle 460.
• a first window 430 can be made in housing 410 to provide access to the attachment point 453 between plunger 450 and curved needle 460.
• Plunger 450 further comprises a T-shaped plunger head 451 that is coupled with plunger shaft 452.
• the T-shaped plunger head 451 is T-shaped to assist in manual retraction of the plunger, in situations where manual retraction is used. Those of knowledge in the art, however, will appreciate that the plunger head can also have other geometries or mechanisms that can assist in manual retraction including, but not limited to, a ring-shaped puller to accommodate one or more fingers, or a trigger activated by squeezing of the hand.
• the plunger shaft 452 possesses a neck area 455 that is smaller in width relative to the plunger shaft.
• a U-shaped insert 457 with a gap between arms of the U that is larger than the width of the neck area 455 and smaller than the width of the plunger shaft 452 is placed into a second window 435 in housing 410 such that the arms of U-shaped insert 457 straddle either side of the neck area 455. This ensures that the travel distance of plunger 450 is constrained to the length of neck area 455, and that the plunger 450 cannot be removed while the U-shaped insert 457 is seated in the second window 435 of housing 410.
• the mechanism for limiting travel distance is depicted as a U-shaped insert 457 straddling either side of neck area 455 of plunger shaft 452, those of skill in the art will recognize that the travel distance can also be limited by other means, including, but not limited to, a pin, rod, or beam inserted through second window 435 of different shape in housing 410 and through a slot along the length of plunger shaft 452.
• Each of the example embodiments of tunneling device 200, 300, and 400 comprises one or more curved needles.
• these curved needles 260, 360, 361, and 460 can comprise a superelastic material with cross-sectional geometries of any shape and size; with any length, curvature, and tortuosity; with respective tips 270, 370, 371, and 470 of any geometry and comprising other tip features.
• Curved needles 260, 360, 361, and 460 can further comprise features on the side(s) of the curved needle, along the length of the curved needle, and near or at the curved needle tip to enable additional functionality, including, but not limited to, the ability to capture objects extrinsic to the device.
• FIG. 5A depicts one example embodiment of a curved needle 560 comprising an angled slot feature 561, near the curved needle tip 570, forming a sharp hook-like feature that can capture a thin wire or suture.
• angled slot feature 561 can be disposed on a convex surface of curved needle 560.
• angled slot feature 561 can be disposed elsewhere on curved needle 560, such as, e.g., the concave surface of curved needle 560.
• angled slot feature 561 and curved needle tip 570 form an arc along the length of curved needle 560, and this arc subtends an angle of approximately 45 degrees.
• the angled slot feature 561 can be positioned anywhere along curved needle 560 to form a longer or shorter arc with curved needle tip 570.
• the centerline of the angled slot feature 561 is oriented 30° relative to the tangent of the curved needle at the centerline of the slot, pointed toward the needle tip, with a penetration depth of 33% of the curved needle diameter.
• the slot can instead be angled away from the tip, can be positioned anywhere along the length of curved needle 560, can be oriented at an angle of any value relative to the tangent of the curved needle, and can be of any depth.
• FIGS. 5B, 5C, and 5D respectively depict additional example embodiments of features 562, 563, and 564 on the side or surface of curved needle 560 that are intended to impart other functionalities to the device.
• FIG. 5B depicts an example embodiment of curved needle 560 comprising a boot-shaped feature 562 with the “toe” part of the feature pointing away from the needle tip 570.
• FIG. 5C depicts an example embodiment of curved needle 560 comprising a boot-shaped feature 563 with the “toe” part of the feature pointing toward the needle tip 570.
• FIG. 5D depicts an example embodiment of curved needle 560 comprising a T- or mushroomshaped feature 564.
• FIG. 5E depicts an example embodiment of curved needle 560 that comprises a simple slotted fork feature 565 at the needle tip 570.
• FIG. 5F depicts an example embodiment of curved needle 560 that comprises an orifice 566 that can be shaped like a diamond or a human eye.
• a tight space such as a tunnel or tube or channel
• the bowed out segments of curved needle that form orifice 566 will pinch together to enable the capture of objects extrinsic to the device.
• FIG. 9 depicts a flow diagram of an example embodiment of a method for manufacture.
• one example method for creating an orifice 566 is to obtain straight or coiled wire stock of the material (Step 902).
• a segment of superelastic wire can then be machined by various techniques including, but not limited to, electrical discharge machining (EDM) or laser cutting, to introduce a slit of desired length parallel to the length of superelastic wire (Step 904).
• EDM electrical discharge machining
• laser cutting to introduce a slit of desired length parallel to the length of superelastic wire
• the superelastic wire can then be placed into a mold that will hold the intended shape of the curved needle 560 (Step 906).
• the tip of a sharp instrument can be inserted into the slit to expand the slit to the desired width of orifice 566 (Step 908).
• the mold comprising the superelastic wire and the sharp instrument can then be subjected to heat treatment, in order to shape set the superelastic wire (Step 910).
• the resulting curved wire comprising the orifice can then be subjected to any additional processes to complete curved needle 560.
• the precise order of steps prior to heat treatment can vary, and that interspersing multiple heat treatment steps between different physical manipulations of superelastic wire can be performed, to achieve the same results.
• FIGS. 5 A to 5F All of these features shown in FIGS. 5 A to 5F are intended to illustrate general concepts of example embodiments and in no way should they serve to limit the types of features that can be comprised by the curved needle.
• features can be of any shape and size, can be located on any aspect of the curved needle crosssection, can be facing any direction and orientation, and can be at any position along the length of the curved needle, including any straight portions of the curved needle 560.
• features depicted in FIGS 5A to 5F can have parallel edges, non-parallel edges, curved or filleted or rounded edges, and wider or narrower openings.
• FIG. 6 is a perspective view depicting another example embodiment of tunneling device 600 for creating one or more curvilinear tunnels in a bone material.
• numerous sets of drivers can control the formation of the curved tunnel to be created.
• a flexible hollow shaft 610 that contains a flexible drill bit 620 can be induced by a first set of one or more drivers to curve along part of or the entirety of its length by subjecting the hollow shaft to a pulling, pushing, or bending force applied lengthwise to one or more regions 630 on or near the circumference of the hollow shaft cross-section, in order to produce bending of the flexible, hollow shaft 610.
• This first set of one or more drivers can apply pulling, pushing, or bending force by any element either attached, affixed, or separate from the hollow shaft, or can be an integral property of the hollow shaft triggered by an external signal or stimulus.
• the flexible hollow shaft can, based on its properties, intrinsically produce a curved configuration when extended from a rigid straight shaft 640 within which it is nested.
• a second set of drivers can extend and retract flexible hollow shaft 610.
• the head of the flexible drill bit 620 is exposed and outside the tip of the flexible hollow shaft 610.
• the shaft of flexible drill bit 620 rotates within flexible hollow shaft 610 and is constrained to follow any bending and curvature that is induced or generated by flexible hollow shaft 610.
• a third set of one or more drivers can extend or retract flexible drill bit 620, either independent of or in concert with any extension or retraction of flexible hollow shaft 610.
• Device body 650 can include any mechanisms to enable the operation of device 600, and can contain any connections from external mechanisms that are necessary to operate device 600.
• tunneling is produced by the advancement of the flexible drill bit 620 either independent of, or in conjunction with the flexible hollow shaft.
• a motorized actuator spins flexible drill bit 620 within flexible hollow shaft 610.
• flexible hollow shaft 610 and rigid straight shaft 640 are depicted as tubes of circular cross-section with circular lumens, having mutually coincident centers, those of knowledge in the art will recognize that flexible hollow shaft 610, rigid straight shaft 640, and both their respective lumens can be of any cross-sectional shape including, but not limited to, elliptical, polygonal, or any irregular shape, and that their lumens can be positioned off-center in any location with respect to the shaft cross-section.
• hollow flexible shaft 610, flexible drill bit 620, and rigid straight shaft 640 can each be of unibody construction or can each consist of multiple parts and/or exhibit variations in material or material properties along the length or over cross-section of each part in order to allow for optimal bending properties of the flexible hollow shaft 610 and flexible drill bit 620.
• FIG. 7 shows an example block diagram for controlling the operation of an actuator in a bone tunneling device.
• Controller 700 comprises a power supply or battery pack 705, input module 710, actuator 720, output module 730, and sensors 740.
• Input module 710 enables the user to initiate the operation of actuator 720 and to adjust various parameters for the actuator’s operation. These parameters can include, but are not limited to, speed and power.
• the actuator 720 engages the mechanism for creation of the bone tunnel.
• Output module 730 captures the current state of the actuator during operation.
• One or more sensors 740 can be used to detect changes in one or more states of the device that can require automated changes to the input module 710 in order to affect the operation of actuator 720. These sensors 740 can include, but are not limited to, temperature, position, and force.
• FIG. 8 illustrates an example flow chart for the method of use for the bone tunneling device in conjunction with bracing apparatuses for repairing the attachment of soft tissue to bone.
• bracing apparatuses Although the insertion of bracing apparatuses is shown as a subsequent step to creating the bone tunnel, those of skill in the art will appreciate that certain embodiments of the bone tunneling device and of the bracing apparatus can enable these two steps into a single step. Likewise, although insertion of sutures through bracing apparatuses is shown as a subsequent step to insertion of the bracing apparatus into a bone tunnel, those of skill in the art will understand that certain embodiments of the tunneling device will allow for the suture to be pre- loaded into the bracing apparatus before the bracing apparatus is inserted into the bone tunnel.
• a bracing apparatus can be omitted from the method of use, wherein sutures can be directly inserted through the bone tunnel in the absence of a bracing apparatus and subsequently used to tie down the soft tissue, or wherein the bone tunnel can be used for any other purpose.

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• 2021
  • 2021-12-10 WO PCT/US2021/062776 patent/WO2022125875A1/en not_active Ceased
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• 2023
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