Fixation device for fixing surgical instruments in holes in the skull and for assisting in the anterior placement of surgical instruments

Abstract

A surgical fixation device for attachment to bone is disclosed. The device achieves stability by applying force to the inner wall of the hole rather than utilizing screws, and is therefore more robust, easier to use, and less user-dependent. The device facilitates a quick and easy fixation system for use with other devices requiring rigid fixation to bone. The device provides intermittent attachment of tools, instruments, and / or accessories to cylindrical holes in bone for use in surgical applications without damaging the surrounding bone structure, as occurs with the use of bone screws. Rigid fixation to bone is a common requirement in surgical procedures for the placement of tools, monitoring systems, positioning systems, or for use as fiducial markers. The fixation device of the present invention is removably attached to bone without the disadvantages associated with bone screws and other fixation devices.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 413026, filed October 4, 2022, and U.S. Patent Application No. 18 / 200858, filed May 23, 2023, the disclosures of which are incorporated herein by reference.

[0002] The present disclosure relates to an intermittent fixture that can be placed within a bone or around a hole in the skull and used in surgical procedures and applications.

[0003] The present disclosure further relates to a removable attachment for rigid fixation of surgical instruments, tools, and / or accessories for purposes of alignment, guidance, and monitoring without the use of bone screws for rigid fixation. [Background technology]

[0004] The advent of modern neurosurgery, as well as other surgical and non-surgical procedures, has increased the need for attachment of devices to a patient's bony structures, such as the skull and other bony structures. A variety of biomedical and surgical instruments have been developed to utilize such attachments and better serve the necessary medical procedures. Most current techniques utilize bone screws and the like. However, these types of fixation devices have many drawbacks, including the potential for causing trauma to nearby hole sites and weakening the surrounding bone structures in which the holes are located.

[0005] While bone screws are functional and are often conventional, physicians continue to strive for more optimal devices that provide rigid fixation for intermittent use and ease of removal and insertion. Some problems encountered with prior art bone screws and other similar fixation devices include, for example, the difficulty medical professionals have in managing such small screws or the difficulty in removing the device when replacement is necessary.

[0006] In fact, if the device needs to be quickly removed, the physician must remove all screws inserted into the bone structure. If the device needs to be reinstalled, the bone may be damaged by previous holes created by previous screw insertion. There remains a need in the medical community for better devices that meet improved functional standards.

[0007] Many attempts have been made to overcome the problems associated with screw fixation in conditions of compromised bone quality. These attempts include modified designs such as conical screws, special thread profiles, expansion screws, bridged constructs, and screw coatings, as well as alternative screw materials such as composite screws or polymer-based screws. Alternatively, surgical techniques have been modified to avoid undesirable results, although this is not commonly done. However, these traditional attempts have still failed in the case of osteoporosis, where the bone surface is brittle, increasing the risk of bone fragility and fracture. Summary of the Invention [Problem to be solved by the invention]

[0008] Therefore, alternative fixation devices are of great importance. There is a need for improved devices that can be mounted on bony structures and eliminate the above-mentioned drawbacks. [Means for solving the problem]

[0009] In comparison with the above prior attempts, the present disclosure meets the above criteria and provides additional benefits not offered by prior art systems. A fastener is disclosed and described that secures within, around, or beneath a bone hole. Once an initial hole is formed in the bone for a medical procedure, no screws are required to secure the fastener onto the bone.

[0010] The fixture can be used to hold surgical instruments, imaging devices, tools, and other accessories, depending on the procedure. Furthermore, rigid fixation to bone allows for immediate alignment to the patient's anatomy for use with imaging devices, compared to other modern instruments that require complex and lengthy calibration processes. The novel retention mechanism, designed to hold the fixture inside a hole (e.g., a hole in the skull or bone), allows for easy and rapid fixation and removal.

[0011] The novel retention mechanism allows for intermittent retention or removal and subsequent reuse of the device without compromising the anchoring bone structure by threading and unthreading within the bone structure each time the device is repositioned on the bone structure.

[0012] Similar instruments are typically, and almost exclusively, fastened to holes or apertures by using bone screws within the outer plate. Inserting and removing small bone screws by hand can be tedious and time-consuming, especially in applications where the instrument is not used as an implant and is intended only for intraoperative use. The present invention and instrument do not utilize screws. The instrument of the present invention achieves stability by applying force to the interior walls of the bone hole and is therefore quicker, easier to use, and less user-dependent than prior art bone fasteners used to hold accessories and the like. The instrument of the present invention facilitates a quick and easy fixation system for use with other instruments, accessories, monitors, diagnostic devices, and the like that require rigid fixation to bone.

[0013] An apparatus for intermittently attaching tools, instruments, and / or accessories to a cylindrical hole in bone for use in surgical applications has several embodiments, as further described herein. Rigid fixation to bone is a common requirement in surgical procedures for the placement of tools, monitoring systems, positioning systems, or used as fiducial markers, and the present invention achieves this fixation without any of the drawbacks of screws or other prior attempts to provide rigid fixation to bone.

[0014] In some embodiments, the fastener has a flexible structure that can be deformed by the user and then apply a set preload force to the bone hole, either inside the hole or on one of the surfaces, to hold the instrument in place by friction.

[0015] In some embodiments, the flexible structure is an hourglass-shaped bend that, when deformed, allows the legs of the fastener to fit inside the bone hole, and then, when released, the bend remains deformed but applies a force to the inside of the bone hole.

[0016] In some embodiments, the fastener deforms via a hinge and is actuated via a screw to hold the screw in a desired position.

[0017] In some embodiments, the fastener has raised features on the surface intended to contact the bone, which helps to better embed the fastener into the bone.

[0018] The accompanying drawings are set forth to assist those skilled in the art in making and using the disclosed compositions and methods. [Brief explanation of the drawings]

[0019] [Figure 1A-1B] 10A-10D show an embodiment of the present invention utilizing a dovetailed threaded slide and sliding teeth to mount the instrument inside a bone hole. [Figure 2A-2B] FIG. 10 shows an exemplary design of one embodiment of the present invention utilizing a retraction mechanism and four legs or prongs to attach the instrument inside the bone hole. [Figure 3A-3B] FIG. 1 shows an exemplary design of one embodiment of the present invention utilizing a set screw mechanism and two legs or prongs to attach the instrument inside the bone hole. [Figure 4] FIG. 10 shows an exemplary design of one embodiment of the present invention utilizing a notch feature and two legs or prongs to attach the instrument inside the bone hole. [Figure 5A-5B]1C is an additional view of the "dovetail" concept described in FIGS. 1A and 1B. FIG. [Figure 6] FIG. 1B is a side view of the device shown in FIG. 1A. [Figure 7] FIG. 10 is a view showing a modified hinge (120) that flexibly joins a first tooth body (110) and a second tooth body (113). [Figure 8] FIG. 10 shows a screw and cantilever embodiment utilizing the principles of the previous figures. [Figure 9] FIG. 10 shows a side-screw cantilever instrument utilizing the principles of the previous figures. [Figure 10] FIG. 8 shows a modified hinge (120) flexibly joining a first tooth (110) and a second tooth (113) as shown and described in FIG. 7. [Figures 11A-11C] 10A-10C show rotating tooth profiles intended to apply force to the wall of a bone hole for use in any of the embodiments described herein. [Figure 12] 1A-1C illustrate one embodiment of intermittent attachment of tools, instruments, and / or accessories to a cylindrical hole in bone for use in surgical applications. [Figure 13] FIG. 1 is a diagram of one embodiment showing a device or feature intended to guide other devices, such as, but not limited to, a catheter, biopsy needle, stent, endoscope, ultrasound probe, DBS lead, or other intraoperative device, into, through, or around bone or other anatomical structure. [Figure 14] 1A-1C illustrate an embodiment for placing temporary or permanent surveillance, measuring, or monitoring devices in, through, or around bone or other anatomical structures. [Figure 15] 15A-15C are views of the embodiment of FIG. 14 showing the use of the assembly with other anatomical structures having mounting features and accessories. [Figure 16] 16 is a cross-sectional view of FIG. 15 showing a locking screw moving the rotary tooth profile. DETAILED DESCRIPTION OF THE INVENTION

[0020] The present invention, according to certain embodiments, includes systems and processes relating to fixation devices used in medical procedures.

[0021] An apparatus is disclosed for intermittently attaching tools, instruments, and / or accessories to cylindrical holes in bone for use in surgical applications. Rigid fixation to bone is a common requirement in surgical procedures for the placement of tools, monitoring systems, positioning systems, or for use as fiducial markers.

[0022] Similar instruments are typically, and almost exclusively, fastened to holes or apertures by using bone screws within the outer plate. Inserting and removing small bone screws by hand can be tedious and time-consuming, especially in applications where the instrument is not used as an implant and is intended only for intraoperative use. This instrument achieves stability by applying force to the inner wall of the hole rather than utilizing screws, and is therefore more robust, easier to use, and less user-dependent. This instrument facilitates a quick and easy fixation system for use with other instruments requiring rigid fixation to bone.

[0023] A device for the intermittent attachment of tools, instruments, and / or accessories to cylindrical holes in bone for use in surgical applications. Rigid fixation to bone is a common requirement in surgical procedures for the placement of tools, monitoring systems, positioning systems, or to be used as fiducial markers.

[0024] Similar instruments are typically, and almost exclusively, fastened to holes or apertures by using bone screws within the outer plate. Inserting and removing small bone screws by hand can be tedious and time-consuming, especially in applications where the instrument is not used as an implant and is intended only for intraoperative use. This instrument achieves stability by applying force to the inner wall of the hole rather than utilizing screws, and is therefore more robust, easier to use, and less user-dependent. This instrument facilitates a quick and easy fixation system for use with other instruments requiring rigid fixation to bone.

[0025] 1A and 1B are isometric and cross-sectional views of one embodiment of a so-called two- or multi-part rigid fastener, also referred to as the "dovetail concept." The tool (1') may include a dovetail profile that is part of a separate, distinct body, where the male profile may include the sliding teeth (2) and the female profile (7) includes the fixed teeth (3). The female profile (7) is also a recess in the tool that houses the movable detail base (1). The profile of the movable dovetail base (1) includes the sliding teeth (2) and moves laterally or horizontally. The movable dovetail base (1) of this dovetail profile includes threads for actuation via the screw (5). The drive guide (4) is a through-hole for positioning the driver (8) on the same axis "A" as the screw (5).

[0026] The screw (5) can be left-handed, such as counterclockwise (CCW), to provide the user with a consistent right-handed tightening. Turning the driver (8) right or clockwise (CW) through the screw (5) applies force to a bone hole or opening (2000) in the bone structure (9). The annulus (6) allows for versatile attachment of various accessories and tools onto any bone structure. Such accessories and tools may be for surgical use, monitoring, evaluation, etc. Again, a female dovetail feature or recess (7) holds a male dovetail feature or movable dovetail base (1). The recess (7) allows the screw (5) to align with the direction of the dovetail cut and axis "A."

[0027] Thus, tooth (2) moves horizontally relative to tooth (3), while tooth (3) remains stationary. Depending on the embodiment, the toothed feature may include a sharp (313) and an extender (1100) connected to the sharp and tooth. This threadless design causes less trauma to the bone structure surrounding the skull hole or any other bone hole. The fasteners of the present invention are more easily intermittently removed than prior art screw fasteners because only one locking thread (5) is required to secure the device, compared to the multiple screws required in prior art devices to secure the device. These multiple screws are also much more difficult to manage because they are smaller, compared to the single, large locking thread (5) of the present invention.

[0028] Within the movable dovetail (1), a left-handed or locking thread (5) is axially aligned with the cutting direction within the bone structure. The dovetail (1) includes a screw (5) that moves with a driver (8) when rotated, for example, clockwise. The driver (8) may or may not be threaded like the screw (5), depending on the embodiment. Because the movable dovetail base (1) is a dovetail, it extends horizontally away from a fixation foot that includes a fixation tooth (3). The sliding tooth (2) and the fixation tooth (3) apply equal and opposite forces to the interior wall of the hole. Turning the screw (5) counterclockwise reverses the direction of the sliding foot (2), releasing the instrument from the bone.

[0029] 2A and 2B are isometric and cross-sectional views, respectively, of an embodiment of a multi-part retractor-type fastener (2'). A main body including a tooth feature or base or tooth body A (100) and a separate body including a different tooth feature or different base or tooth body B (113) are positioned opposite each other. A set screw (110) is connected to the base (100). The set screw (110) controls the movement of the base (100) in a horizontal track so that the sharp (313) and teeth (111) and teeth (112) move in opposite directions and are fixed within the bone hole opening (2000).

[0030] When tightened, the set screw (110) applies a force to the spreader ring (106). The set screw (110) compresses the ring (106), applying a force to the ring (106) in the opposite direction to tooth A or base (110), applying a force to each of the teeth (100), (113) in an opposite direction. Depending on the embodiment, tooth A (100) and tooth B (113) may be connected via a non-plastically deforming hinge member (117), shown in hidden lines, and positioned below the annular body (109). The hinge member (117) allows the tooth bodies (100), (113) to expand and contract as the set screw (110) applies a force to the spreader ring (106). An alignment pin (107) or pins (107) are used to keep the spreader ring (106) aligned in the direction of the force applied to the ring by the screws (110). The annulus (109) defines a window (109') that allows 360° access to the interior of the bone hole (2000).

[0031] The set screw (104) tightens and loosens the retractor tooth A (101) and the retractor tooth B (108), and in conjunction with the forward and rearward forces applied to the ring (106) by the set screw (110), applies a lateral force to the hole (2000) and thus to the tooth bodies A (100) and B (113), respectively, on the bone tunnel. At least one tooth A (111) is disposed on the tooth body A (100). And at least one tooth B (112) is disposed on the tooth body B. Both tooth members (111), (112) contact the walls of the bone tunnel (2000) in the bony structure (9) to provide intermittent support for the instrument, thereby allowing for easy removal of the instrument, along with any accessories or other attachments on the instrument, without removing the bone screws attached to the bony structure (9). This feature allows it to be easily removed from and reattached to the bone structure (9) with minimal trauma to the bone structure (9) or weakening of the bone structure surrounding the hole (2000).

[0032] The set screw (104) is housed in the retractor A leg member (105) and the retractor B leg member (103), which together move the teeth A (101) and B (108) simultaneously apart or together depending on the direction of rotation of the set screw (104).

[0033] A retractor pivot pin or shoulder pin (102) is disposed adjacent to and within tooth body B (113). The pivot pin allows leg members (103) and (105), and thus retractor tooth member A (101) and retractor tooth member B (108), to pivot relative to one another in the same plane. Tooth body (113) may include threads for receiving a shoulder screw, pin, or cylindrical restraining feature (102). Additionally, pin (102) may function as a pivot point for the pair of retractor members (105), (103). Retractor member (103) may include an interlocking feature (104) for use with a fastener, ratchet feature, or mechanical locking feature to draw the distal ends of members (103) and (105) together. When the distal end of the retractor member is tightened, the retractor teeth (101) and retractor A tooth members (108) (the teeth are also known as feet, and each tooth is also known as a leg) extend into the wall of the bone hole. The force exerted by the retractor teeth (101), (108) can be perpendicular to the force of the teeth (111) and (112). Each tooth can have a sharp (313), a sharp edge, multiple teeth, or any combination thereof, depending on the embodiment.

[0034] FIG. 2B further illustrates the ring force application dimple (114) feature. The dimple (114) is provided to concentrate force on the sidewall of tooth body B (113). The angled undercut groove (115) allows tooth body A (100) and tooth body B (113) to be restrained along the direction of the force in "axis B" applied by ring (106). The groove (115) also provides rigidity to the annular body (109) so that when the system is under tension, for example, when a ring force is applied and teeth (111) and (112) apply pressure to bone structure (9), all components of the appliance (2') are fully restrained, providing rigid fixation. Also included within the appliance, depending on the embodiment, are stabilizing features (116) for either or both tooth body A (100) and / or tooth body B (113). Stabilizing features 116 may engage into grooves (115), for example, when instrument (2') is under tension and teeth (111) and teeth (112) are spread apart and / or retractor teeth (108) and retractor teeth (101) are spread apart.

[0035] Figures 3A and 3B illustrate the concept of instrument (3'). The features, structures, and reference numbers used above for instruments (1') and (2') apply to instrument (3'). In instrument (3'), retractor features (103) and (105) are eliminated. Set screws 110 are utilized to move tooth body A (100) and tooth body B (113) through forces applied to ring (106) by the set screws. As shown in Figure 2B, alignment pins (107) allow the force applied to ring (106) to be guided in a direction along axis B. Ring (106) may further include detents (301) and mating detent recesses (302) to assist in the mechanical movement of tooth body B (113) and / or tooth body A (100).

[0036] FIG. 4 shows an embodiment of a single-piece fastener (4') using mechanical notches (200) to impart predictable strain to the body material, causing teeth (208) and (206), teeth (also known as legs), and each tooth (also known as a leg) to expand and / or contract in opposite directions tangent to the depicted circular path or line of rotation or tooth extension path (210). The thickness ratio of the upper member (201) and the lower member (207) was determined to maximize the force exerted by teeth B (208) and A (206) while maintaining parallelism of the top surface of the annular portion of the upper member (201). Surprisingly, it was found that when the upper member (201) is thicker than the lower member (207), it exerts a greater maximum force than when the members are of equal thickness or when the thicknesses are reversed (e.g., when the lower member (207) is thicker than the upper member (201)). The vertical axis (202) indicates the axis parallel to the bone hole (2000) in the bone (9) shown in the figure. Depending on the embodiment, the bone hole can be approximately 14 mm, 11 mm, and 8 mm in diameter. However, the instruments described herein and the principles of the present invention are not limited to any particular diameter of the bone hole and can be utilized with any drill hole size or shape and any opening size in any bone structure.

[0037] The pair of screws A (203) and B (204) can be rotated clockwise and / or counterclockwise to deform around the notch, and deformable bodies A (205) and B (209) move along a rotation line (210) toward or away from plane P (211) depending on whether the screws (203) and (204) are tightened or loosened. Deformable bodies A and B can be deformed in opposite or identical directions along path (210) depending on whether the screws are loosened or tightened. The thickness ratio of the upper member to the lower member ranges, for example, but is not limited to, 10:1 to 2:1, most preferably 3:1.

[0038] 5A and 5B are additional views of the "dovetail" concept described in FIGS. 1A and 1B. FIG. 5A is a cross-sectional view through the midline of the instrument shown in FIG. 1A. In one embodiment, when the driver (8) is rotated in a clockwise direction (1102), the left-handed shoulder screw (5) engages the sliding tooth (2), moving the sliding tooth (2) within the bone tunnel (2000) in a direction (1101) away from the fixed tooth (3) and against the mounting surface of the bony structure (9). This embodiment provides a spring action or movement in the direction of the arrow (2001) for the teeth (208) and (206), where there is a deflection of material within the instrument without deformation, exerting pressure on the inner wall of the burr hole or bone tunnel (2000). The instrument is removable and / or temporary, and removal does not cause associated damage to the bony structure (9) compared to state-of-the-art instruments that are attached to the bony structure.

[0039] Figure 5B is a top view of the fully extended instrument of Figure 5A. Depending on the embodiment, the tooth bodies (2), (3) may further include, individually or individually, sharps (313) and / or sharp edges (510) for contacting the walls of the bone hole (2000). It is also within the scope of the present invention to have multiple rows of teeth and / or multiple rows of sharps and / or sharp edges. Depending on the embodiment, the teeth may have textured features. Such textured features may include, but are not limited to, surface protrusions, sharp edges, rough edges, one or more sharps of triangular or pyramidal shape or any other geometric shape, surface texture, surface finish, deviation of the direction of the normal vector of the actual surface of the instrument that contacts the wall of the bone hole from its ideal shape, etc. The teeth and / or protrusions are intended to bite into and engage the side walls of the burr hole when the teeth of the instrument are extended. The teeth may have any contour and size. Depending on the embodiment, the teeth may be knurled, roughened, or tapered depending on the expected loads (withdrawal, rotation, torque). Additionally, the arc length within the burr hole is considered for the necessary interaction of items that need to enter or penetrate the burr hole. It is possible to have multiple rows of teeth depending on clinical need. A gap through the center of the instrument allows for access through the burr hole if clinically necessary. Additionally, lateral access is available through a space from the side of the instrument to visualize and access any implants, instruments, catheters, etc. that may enter the burr hole, including but not limited to.

[0040] FIG. 6 is a side view of the instrument shown in FIG. 1A. This instrument allows access to the bone hole from both sides of the engaged teeth (111), (112) inside the hole and below the mounting surface or bony structure (9). This is important for intermittent access and visibility of instruments used within the hole without interfering with the fixation of alignment instruments, guidance instruments, and / or monitoring devices. Depending on the embodiment, the instrument may or may not have a non-deforming and / or non-flexing surface, which, as previously described, serves as a reference surface for mating and / or attachment of other components. The instrument seats flush against the circular surface and therefore is flush (locally) against the circular surface of the bone or skull because the fixation of the instrument occurs within the bone hole or burr hole, rather than by fixing the instrument on the surface of the bone or skull as occurs with prior art instruments. This feature provided by the inventive instrument is an advantage over prior art instruments. The device of the present invention provides a flat surface for attaching any accessory onto bone structures of any geometry, with the anchoring mechanism being within the burr hole rather than on the surface of the bone.

[0041] Also shown in Figure 6 is a set screw (110) having similar properties and functionality to the set screws previously described herein. The set screw (110) moves at least one of the rotating teeth or feet (1110) along an axis (620) that represents the surface of the bone structure (9). Depending on the embodiment, the foot (1110) may have an extender (1100) that extends vertically into the interior of the bone hole along an axis (630) so that the teeth (111), (112) are mounted deep within the burr hole or bone tunnel of the bone structure. Access to the bone tunnel from the top of the instrument (600) and the side between teeth (111) and (112), as shown by the halo (610), allows the user full 360° access to the bone tunnel, at least in the planes represented by (610) and (610').

[0042] Figure 7 illustrates a modified hinge (120) that flexibly joins the first tooth (100) and the second tooth (113) of the appliance (700). The set screw (110) can be turned clockwise to apply force to the annulus (106), which in turn applies force to the opposing tooth (113). Depending on the embodiment, the appliance (700) can have a stabilizing feature (116) for multiple teeth or a single tooth, as illustrated in Figures 2A and 2B. This stabilizing feature mates with the angled undercut groove (115) previously shown and described in Figure 2B. The annulus (106) can be maintained in alignment by alignment pins (107), (114). Again, the tooth bodies (110), (113), individually or in combination, may include stabilizing features (116) of the same structure and function that mate with identically shaped cavities or angled undercut grooves (115) in the annulus (109). The stabilizing features (116), mating with the grooves (115), constrain the tooth bodies (100), (113) so that the force applied by the set screw (110) can be efficiently transferred to the teeth (111), (112) in the burr hole. The stabilizing features (116) also provide rigidity to the annulus so that when the system is under tension (ring force is applied and the teeth exert pressure on the bone), all components are fully constrained, providing rigid fixation. This stabilizing and rigid fixation effect is the same as that provided and described in the device of Figures 2A and 2B.

[0043] FIG. 8 illustrates a screw-cantilever instrument (800) utilizing the principles of the present invention. A set screw (810) is shown that, when tightened and / or loosened, contacts a surface (820) and cantilevers the surface around an intersection (830) with an upward or downward movement, as indicated by arrow (A). This upward or downward movement (A) then causes a tooth (840) to move leftward or rightward, as indicated by arrow (B). Again, the rotating tooth (1110) may include an extender (1100) that is inserted inside a burr hole or bone tunnel to secure the instrument and allow the tooth (840) to reach deeper into the burr hole or bone tunnel.

[0044] 9 shows a lateral screw cantilever instrument (900). A lateral screw (960) is shown that can be tightened or loosened. Tightening and loosening moves the legs (910) in a generally right- and left-hand movement indicated by arrow C. The generally right- and left-hand movement moves the tooth (920) in a movement indicated by arrow D.

[0045] Figure 10 shows a modified hinge (120) having the same function and structure as described above for the modified hinge (117) flexibly joining the first tooth (100) and the second tooth (113) as shown and described in Figure 7. Like reference numerals identify like elements having the same structure and function as previously described herein, which are reproduced and shown herein as merely an exemplary embodiment of the tooth profile shown and described in more detail in Figures 11A, 11B, and 11C.

[0046] 11A, 11B, and 11C show rotating tooth features intended to apply force to the wall of a bone hole for use in any of the embodiments described herein.

[0047] 11A, 11B, and 11C illustrate features of a rotating tooth or foot (1110) intended to apply force to the wall of a bone hole for use in any of the described embodiments. Each foot (1110) may have one or more of the following features, depending on the embodiment: An extender (1100) is positioned to extend from the base (100) and may or may not be part of the rotating tooth (1110). A sharp (310) can initially contact and penetrate the hole wall to prevent rotation about the hole axis. Depending on the embodiment, the sharp (310) may have a triangular shape with a sharp tip. The sharp (310) may also be shaped into a circular or sawtooth geometric shape containing two or more sharp points, or any other geometric shape, including, but not limited to, cylindrical, circular, oval, polygonal, etc. Additionally, the sharp may or may not include a roughened surface or texture and / or may or may not be replaced with a roughened surface, texture, etc., as described above. The leading edge angle (319) θ of FIG. 11A includes, but is not limited to, angles between 0 and 90°, and the trailing edge angle (318) β has an angle between 0 and 120°. The trailing edge (311) may or may not include a sharp edge for added safety. The inventors have found that both the leading and trailing edge angles have a synergistic effect on the function of the sharp (310) to enable initial, secure retention into bone structure without causing significant bone damage compared to that of typical prior art bone screws.

[0048] Depending on the embodiment, the rotating sharp (312) may be coaxial with the hole, as shown in FIG. 11A, or may follow a circular shape with the circle lying on the same line or axis as the center of the hole. The rotating sharp may include any of the described surface roughnesses, surface textures, teeth, sharps, geometric shapes, edges, etc. A spacer (314) may also separate the sharp edge (313) from the rotating sharp (312) in any of the described embodiments. As shown in FIG. 11B, tooth body A (100) and tooth body B (113) may include one or more rotating sharp edges (315) resembling knife edges, for example, parallel to any other tooth in any other combination of teeth described. A cross-section of the rotating sharp (315) is shown in FIG. 11C and is defined by the tooth length distance (317) and tooth angle (316) of 1 to 80 degrees. Depending on the embodiment, the tooth length distance (317) may include distances from about 0.0001 mm to about 100.0 mm, and any other distance that may be required for a particular application of the appliance.

[0049] FIG. 12 illustrates one embodiment for intermittent or temporary attachment of tools, instruments, and / or accessories to a cylindrical hole in bone for use in surgical applications, etc. In fact, with prior art instruments, if a surgeon needs to quickly remove the prior art instrument and associated attachments and accessories attached to the prior art instrument, the surgeon must remove all inserted screws within the bone structure. If the prior art instrument needs to be reattached, the bone may be damaged by previous holes created by previous screw insertions. The principles of the present invention provide an instrument that meets improved functional criteria, namely, intermittent or temporary attachment of tools, instruments, and / or accessories to a cylindrical hole in bone. Unlike prior art instruments that are attached to the bone structure, the present invention is attached within the burr hole or hole itself, reducing trauma when the instrument and associated tools, instruments, and / or accessories need to be quickly removed and replaced in place.

[0050] 12 shows one embodiment of the bone fastener of the present invention with various accessories. It is understood that the bone fastener of the present invention is intended for use with any of a variety of accessories used in the medical field. The following is provided by way of example only, and the fastener is not limited to a particular attachment and / or any accessory, but may be used with any attachment and / or any accessory. As an example, attachment (2500) is seated on the bone fastener using the described concepts. Attachment (2500), in one embodiment, is fastened by attachment screw (2501).

[0051] The mounting extender (2502), which may or may not be used with the fixture (2500), is a standoff to allow use with several accessories, such as the placement of tools, monitoring systems, positioning systems, or as a fiducial marker. It may also be used as a guide for the placement of devices, including, but not limited to, catheters, biopsy needles, stents, endoscopes, ultrasound probes, Deep Brain Stimulation (DBS) leads, or other intraoperative devices, or for the placement of temporary or permanent monitoring, measuring, or diagnostic devices in, through, or around bone or other anatomical structures. The guide wire (2503) is a track made available by the mounting extender (2502) for use with various accessories. The mounting extender (2502) can articulate to align with the guide wire (2503) and / or to provide various angles for the guide wire (2503). For example, the extender (2502) may be rotated anywhere from 0 to 180 degrees to alter the placement of tools, monitoring systems, positioning systems, etc., or may be used as a fiducial marker for the placement of temporary or permanent monitoring, measuring, or diagnostic devices in, through, or around bone or other anatomical structures for use with accessories such as, but not limited to, catheters, biopsy needles, stents, endoscopes, ultrasound probes, DBS (Deep Brian Stimulation) leads, or other intraoperative instruments.

[0052] 13 is a diagram of one embodiment showing an attachment device (2500) without an extender (2502) that is intended to guide other devices, such as catheters, biopsy needles, stents, endoscopes, ultrasound probes, DBS leads, or other intraoperative devices, into, through, or around bone or other anatomical structures. Again, any of the devices described herein or utilizing the principles of the present invention may be used with any attachment system and / or accessories.

[0053] FIG. 14 is a top view of one embodiment shown in FIG. 12 for placing temporary or permanent monitoring, measuring, or diagnostic devices in, through, or around a bone or other anatomical structure. While the present invention provides intermittent or temporary fixation to a bone structure, it is understood that the device may also be used for permanent fixation for purposes such as, but not limited to, monitoring procedures, diagnostic procedures, and the like. Shown in FIG. 14 is a mounting extender (2502) attached to a fitting or retaining ring (2500). While the illustrated mounting extender (2502) is provided for a circular or concentric holder, such holders are not limited to use with the bone fasteners of the present invention. Also shown is a mounting screw (2501) that, when tightened, attaches the mount (2500) to the bone fasteners of the present invention.

[0054] 15 is a cross-sectional view of one embodiment of the present invention having a mounting feature 2500, an accessory 1510, and a mounting extender feature 2502. Again, accessory 1510 can be any item including, but not limited to, a catheter, biopsy needle, stent, endoscope, ultrasound probe, DBS (Deep Brian Stimulation) lead, or other intraoperative instrumentation, temporary or permanent monitoring, measuring, or diagnostic device placement in, through, or around bone or other anatomical structure. Accessory 1510 is not limited to only one accessory, but can include several accessories attached to or used with the bone fixation devices of the present invention.

[0055] Figure 16 is a cross-sectional view of the mounting feature shown in Figure 15 without the mounting extender feature (2502) and accessory (1510). As shown, a mounting screw (2501) or locking screw contacts the bone fastener of the present invention to lock the mounting feature (2500) to the bone fastener. Again, no specific mounting mechanism is required for the present invention, as the bone fastener of the present invention can be utilized with a variety of mounting features and configurations, as well as a variety of accessories.

[0056] The headings and sub-headings used herein do not limit the embodiments described thereunder, and features of the various embodiments described herein may be utilized with other embodiments even if not listed under a particular heading for that embodiment.

[0057] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and other arrangements can be devised without departing from the spirit and scope of the invention as defined by the appended claims.

[0058] It is to be expressly noted that while exemplary embodiments have been described herein, these embodiments should not be construed as limiting; rather, additions and modifications to those explicitly described herein are also included within the scope of the present invention. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and that various combinations and permutations may exist in combinations and permutations not explicitly described herein without departing from the spirit and scope of the present invention.

Claims

1. A bone fixation device, a base having a geometric or ring shape and disposed above a bone structure having a bone burr hole or a bone hole with an inner wall; a plurality of protrusions or feet connected to the base and inserted into the bone burr hole; Equipped with the foot contacts and applies pressure to the inner wall of the bone hole, regardless of the diameter of the bone burr hole, to hold the bone fastener on a bone structure having a bone surface; the bone anchor is snugly fixed onto the bone structure without screws or other fixation accessories into the bone surface of the bone structure; and A bone anchor, wherein the feet only contact the interior walls of the bone hole to retain the bone anchor.

2. 10. The device of claim 1, wherein the number of feet is between two and four, and the feet are designed to penetrate bone without requiring rotation of the portion of the foot that contacts the bone.

3. The instrument of claim 2 , wherein the bone hole has a diameter of 14 mm, 11 mm, or 8 mm.

4. The device of claim 1 further comprising a spring-loaded member or hinge having material deflection without deformation to apply pressure to the interior wall of the burr hole.

5. 10. The device of claim 1, further comprising a removable or temporary feature, wherein the device is not intended for permanent fixation and removal of the device does not cause clinically relevant damage to the bone.

6. The device of claim 1 , wherein the foot further includes a roughened portion for contacting the interior wall of the burr hole.

7. The device of claim 6 , further comprising protrusions or sharps for biting into or engaging the side walls of the burr hole as the device is extended.

8. 7. The instrument of claim 6, wherein the teeth have a triangular profile or a surface selected from the group consisting of knurled, roughened, textured, ridged, tapered, knife-edge, and any combination thereof, the profile being dependent on expected loads of the fastener, the expected loads including pull-out, rotation, and torque.

9. The tool of claim 8 , wherein the arc length of the profile is within the burr hole and at least one accessory is used to enter or penetrate the burr hole.

10. The appliance of claim 6 , wherein the teeth are multiple rows of teeth and depend on clinical need.

11. The apparatus of claim 1 , wherein the fastener further defines a gap through a center of the fastener to allow access to and / or through the burr hole.

12. 12. The apparatus of claim 11, wherein the gap further includes a lateral access defined by the fixture, the lateral access providing space available from a side of the fixture for visualizing and accessing at least one accessory.

13. 12. The device of claim 11, wherein the at least one accessory is selected from the group consisting of an implant, an instrument, a catheter, a needle, a biopsy needle, a stent, an endoscope, an ultrasound probe, a DBS lead, an intraoperative tool, a sensor, an alignment tool, a fiducial marker, a diagnostic device, a guide, a surgical instrument, a device, and any combination thereof.

14. The device of claim 1 further comprising a flat surface that is free of deformation or deflection, said flat surface being a reference surface for joining with another component.

15. The device of claim 1 , wherein the fastener is snugly seated regardless of curvature of the bony structure.

16. The device of claim 1 further comprising an extensible hinge for extension of the fastener, wherein extension of the fastener is accomplished without an external instrument.

17. 17. The device of claim 16, wherein the hinge is made of a different material than the fastener to accommodate distortion during use of the fastener.

18. The device of claim 1 , wherein the teeth provide normal axis tension when the teeth are extended radially and / or tangentially relative to a surface of the bone structure.

19. The instrument of claim 1 , further comprising a bone retractor that applies pressure to the interior wall of the burr hole for attaching an accessory.

20. The apparatus of claim 1 further comprising a mount attached to an exterior surface of the fixture, the mount for holding an accessory.

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