WO2009044395A2

WO2009044395A2 - Orthopedic fastening device and kit for using the same

Info

Publication number: WO2009044395A2
Application number: PCT/IL2008/001297
Authority: WO
Inventors: Hamid Sharim; Shmuel Beck
Original assignee: Medilock Medical Solutions Ltd.
Priority date: 2007-10-01
Filing date: 2008-09-25
Publication date: 2009-04-09
Also published as: WO2009044395A3

Abstract

A self-locking fastening device comprising fastening elements is disclosed. The fastening elements are adapted to be inserted into a bone. The fastening elements are provided with a bore at a portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively interlocking in a body of said bone by means of inserting the fastening elements into the bone so that each successive element passes through said bore of each preceding element.

Description

ORTHOPEDIC FASTENING DEVICE AND KIT FOR USING THE SAME

FIELD OF THE INVENTION

The present invention relates to an orthopedic fastener, and, more specifically, to a self-locking fastening device.

BACKGROUND OF THE INVENTION

The human skeleton is composed of 206 individual bones that perform a variety of important functions, including support, movement, protection, storage of minerals, and formation of blood cells. To ensure that the skeleton retains its ability to perform these functions and to reduce pain and disfigurement, bones that become fractured should be repaired promptly and properly. Typically, fractured bones are treated using fixation devices, which reinforce the fractured bones and keep them aligned during healing. Fixation devices may take a variety of forms, including casts for external fixation, and bone plates and/or bone screws for internal fixation, among others.

Bone screws are threaded fasteners used to draw together and/or hold fragments of fractured bones. These screws may be used alone, for example, to span a fracture, and/or in combination with other fixation devices, for example, to secure a bone plate to a fractured bone on opposing sides of a fracture. To place a bone screw in bone, the bone screw is driven (e.g., turned) into a hole in bone, such that a thread of the bone screw engages the bone around the hole. The bone screw may be threaded along some or all of its length.

It is well known that in osteosynthesis holding systems in general, and in those systems used for stabilization of the spinal column in particular, a loosening of the bone screw which secures the clamping element to the bone segment occurs. When the bone screw becomes loose, the bone screw may move in an axial direction (i.e. a backing out of the screw may occur). This axial movement may result in a loosening of the entire system, as well as injury to the patient by the protruding screw. For example, injury of blood vessels and nerves in the cervical spine and esophagus are common. The US Patent 6450812 ('812) discloses a dental implant which contains a bi-cortical anchor apparatus for insertion into a jawbone, the anchor apparatus including a tool receptor for interacting with a tool which facilitates insertion of the apparatus. An implant member arranged for insertion into a jawbone, the member containing a cervix to secure a dental prosthesis and a through conduit to support an anchor apparatus. A complementary system includes an implant member and a template, the latter meshes with and helping align the implant member. Additionally, '812 teaches a method for inserting the implant member into a bore in the jawbone. The method includes drilling a channel in the jawbone through a drill-bit guide channel and inserting a bi-cortical anchor apparatus through the channel and through a conduit of an implant member, anchoring at least two portions of the anchor apparatus.

The tooth replacement has an implant member anchored with bi-cortical anchor apparatus which has been uniquely designed to provide bi-cortical retention. The jawbone defines a Z-axis along the vertical axis of the tooth, an X-axis, in the buccal to lingual direction," and a 7-axis, perpendicular to both. In the following description, the Z direction is regarded as a vertical direction, and the X-Y plane is regarded as a lateral plane. Near and far describe positions with respect to the operator along the Z-axis, while proximal and distal describe positions with respect to the operator along the X-axis.

The implant member constituting a solid cylinder is arranged for insertion into a bore drilled in the Z direction. The implant member is screwed into bore with some force. The bi-cortical anchor apparatus is formed as a screw, having proximal, mid, and distal portions. The distal portion is operable to bite into and engage with virgin tissue of lingual cortical plate. The mid portion is operable to support dental implant without locking it. The proximal portion is operable to bite into and engage with virgin tissue of buccal cortical plate.

It should be emphasized that '812 teaches the technical solution providing an dental implant inserted into jaw bone along the Z-axis anchored by the bi-cortical anchor parallel to the X-axis. Anatomical configuration of the jaw bone makes possible orthogonal interlocking the aforesaid dental implant and bi-cortical anchor. In other words, the dental implant is inserted into the jaw bone from above while the anchor is inserted into the cortical plate laterally. '812 does not however provide a solution for non orthogonal arrangements providing insertion of the implant and the anchor for less depth into the mandibular bone. Furthermore, laterally inserting the lateral screw involves high risk of damage of the mandibular nerve and the lingual artery.

In the field of orthopedics, in many cases there is a need to insert an anchorable orthopedic fastener on one side. As an illustration, one can give a case of holding of a limb fractured bone. A metal plate is fastened by means of a screw to both portions of the fractured bone. It stands to reason that the similar to '812 orthogonally anchoring the fastening screw is impossible. Thus, an unmet and long-felt need is to provide an orthopedic self-anchoring device adapted for inserting from one side so that the elements may be fastened at an acute angle. There is also an unmet long felt need for means and methods of providing orthopedic fasteners which afford the surgeon a greater range of tolerances for the insertion and interlocking procedures.

It is acknowledged that contacting screws made of different metals or alloys in environment of human body form a galvanic pair and generate difference of electrical potentials resulting in galvanic corrosion. Thus, a further unmet long-felt need is to prevent the inserted orthopedic self-anchoring device and surrounding tissues from galvanic corrosion effects.

SUMMARY OF THE INVENTION

It is hence one object of the invention to disclose a self locking fastening device comprising JV^" fastening elements where JA/> 2. The fastening elements are adapted to be inserted into a bone. It is a core purpose of the invention to provide JVsaid fastening elements provided with mechanical interlocking means at a portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively interlocking with each other in a body of the bone by means of interlocking the fastening elements in the bone so that each successive element mechanically interlocks with each preceding element.

Another object of the invention is to disclose the interlocking means chosen from the group consisting of tongue-and-groove joint, mortice-and-tenon joint, male-and-female threads, notch, spline, protuberance, slot, hook,.,bar.b, grapple, taper and any ,combination,.thereof.

A further object of the invention is to disclose fastening elements that are screws. A further object of the invention is to disclose the fastening device adapted for use chosen from the group consisting of dynamic hip screw, hip plating screw, hip fixation screw, Salame's fixation nail when treating pathology chosen from the group consisting of hip fractures, particularly, osteoporotic hip fracture, distal radius fracture (Colles' fracture) neck base fracture, and any combination thereof. Other embodiments of the invention may include other screws not mentioned here.

A further object of the invention is to disclose the fastening device adapted for treating Periarticular Fracture. It should be noted for some types of Periarticular Fractures a fastening device is herein disclosed wherein JV may equal 1

A further object of the invention is to disclose the fastening device adapted for use chosen from the group consisting of Pedicle Screw and Laminar Screw when treating pathology is chosen from the group consisting of Anterior Spine Fixation and Posterior Spine Fixation. It is herein acknowledged that the disclosed fastening device consisting of Pedicle Screw and Laminar Screw may be used for treating other pathologies when suitable.

A further object of the invention is to disclose the fastening device adapted for use in dental and oral surgery.

A further object of the invention is to disclose the fastening device adapted for use in osseointegration and dental implants.

A further object of the invention is to disclose the fastening device adapted for use in bone osteotomies such as high tibial osteotomy and joint fusion procedures such as but not limited to triple arthrodesis.

A further object of the invention is to disclose the number JV which is equal to 2.

A further object of the invention is to disclose the device comprising first and second screws. The first screw is provided with a bore at a portion thereof insertable into the bone. The second screw is provided with a distal portion thereof adapted for passing through the bore of the first screw. A further object of the invention is to disclose the bore in said first screw filled with a material adapted to be screwed by said second screw and fixate said second screw in said bore.

A further object of the invention is to disclose the first and second screws made of a material selected from the group consisting of stainless steel and titanium and any combination thereof.

A further object of the invention is to disclose a material of a filling disposed into a said bore selected from the group consisting of silicone, polyethylene, polypropylene, aluminum, and magnesium.

A further object of the invention is to disclose the filling adapted for electrically isolating the first and second screws from each other.

A further object of the invention is to disclose the bore of the first screw and the distal portion of the second screw provided with female and male threads, respectively, adapted for translating the second screw through the bore and interlocking the first and second-screws in the body.

A further object of the invention is to disclose the first screw provided with a mark at a proximal portion thereof such that the mark indicates a position of a plane defined by screw and bore axes. The mark is adapted for mutually orienting the first and second screws.

A further object of the invention is to disclose the self-locking fastening device implanted into the knee joint.

A further object of the invention is to disclose the self-locking fastening device implanted into the wrist.

A further object of the invention is to disclose the self-locking fastening device implanted into the vertebra.

A further object of the invention is to disclose the first and second screws interconnected by a flexible link adapted to resiliently couple said screws.

A further object of the invention is to disclose a guide element adapted for guiding a drilling tool. The guide element is connectable to the proximal portion of the first screw inserted into the bone such that an axis of the drilling tool coincides with the axis of the bore of the first screw.

A further object of the invention is to disclose a spinal stabilizing device comprising (a) a plurality of linking elements; and (b) a plurality of saddle devices. Each saddle device comprises a saddle body and JV fastening elements where JV > 2. The saddle body has JV holes for passing the fastening elements to be threaded into a vertebra and at least one member integral with the body for attaching the linking elements. The saddle body is provided with a contact surface adapted for mechanical contact with the curved surface of the vertebra. It is a core purpose of the invention to provide the fastening elements provided with a bore at a distal portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively fixating the fastening element in the bone by means of inserting the elements into the bone so that each successive element passes through the bore of each preceding element.

A further object of the invention is to disclose the linking elements which are flexible.

A further object of the invention is to disclose a bone fixating device comprising (a) at least two self-locking fastening devices; each self-locking device further comprises first and second screws; the first screw provided with a bore at a portion thereof insertable into the bone; the second screw is provided with a distal portion thereof adapted for passing through the bore of the first screw; and (b) at least one plate adapted to be fastened to the bone by means of the fastening devices.

A further object of the invention is to disclose a method of locking a fastening device. The method comprises the steps of (a) providing self-locking fastening device comprising JV fastening elements where JV> 2; the fastening elements are adapted to be inserted into an bone; JV- 1 fastening elements provided with a bore at a portion thereof to be inserted into the bone; the fastening elements are adapted for consecutively interlocking in a body of the bone by means of inserting the elements into the bone so that each successive element passes through the locking bore of each preceding element; and (b) consecutively interlocking said fastening elements in the bone by means of inserting the elements into the object so that each successive element passes through the locking bore of each preceding element.

A further object of the invention is to disclose the method of locking a fastening device further comprising the steps of providing a drilling tool and a guide element.

A further object of the invention is to disclose the step of interlocking further comprising drilling bores in the bone, inserting the fastening elements into the bores, inserting a distal portion of each successive element into a bore at a distal portion of each preceding element. The step of drilling further comprises guiding the drilling tool by means of the guiding element disposed at a proximal portion of the preceding element according to a mark indicating an orientation of the locking bore.

A further object of the invention is to disclose the step of inserting each successive element into a bore of each preceding element comprising threading each successive element into each preceding element.

A further object of the invention is to disclose a method of securing a saddle clamp device to a vertebra. The method comprises the steps of (a) providing the saddle clamp device comprising a saddle body and JV, screws where JSf≥ 2; the saddle body has J/Vholes for.passing the screws to be threaded into the vertebra and at least one member integral with the body for attaching the fixing member; the saddle body is provided with a contact surface adapted for mechanical contact with the curved surface of the vertebra; and (b) consecutively interlocking the screws in the vertebra by means of inserting the elements into the object so that each successive element is threaded into the bore of each preceding element.

A further object of the invention is to disclose a method of stabilizing a spine comprising the steps of (a) providing a plurality of linking elements and a plurality of saddle devices; (b) securing the saddle devices to vertebrae to be stabilized; (c) linking the secured saddle device by means of the linking elements.

It is a core purpose of the invention to provide the step of securing further comprising consecutively interlocking said screws in the vertebra by means of inserting the elements into the object so that each successive element is threaded into the bore of each preceding element.

A further object of the invention is to disclose a method of stabilizing a bone comprising the steps of (a) providing a bone fixating device further comprising (i) at least two selfrlocking fastening devices; each self locking device further comprises first and second screws; the first screw provided with a bore at a portion thereof insertable into the bone; the second screw is provided with a distal portion thereof adapted for passing through the bore of the first screw; and (ii) at least one plate adapted to be fastened to the bone by means of the fastening device; (b) attaching the plate to the bone of interest; and (c) consecutively interlocking the screws in the bone by means of inserting the elements into the bone so that each successive element is threaded into the bore of each preceding element. BRIEF DESCRIPTION OF THE DRAWINGS

In order- to understand the invention and to see -how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

Figs Ia and Ib are schematic views of the load-carrying screw;

Fig. Ic is a schematic view of the locking screw;

Figs Id and Ie are schematic views of the self-locking fastening device;

Fig. 2a is a schematic view of the integrated self-locking fastening device;

Fig. 2b is a schematic view of the self-locking fastening device with the one-way locking bar;

Fig. 3a is a schematic view of the bone fixating device with normal inserting the load-carrying screw;

Fig. 3b is a schematic view of the bone fixating device with angularly inserting the load-carrying screw;

Figs 4a - 4b are isometric views of the two-element fastening device locked by the gripper;

Fig. 4c is an isometric view of the three-element gripper fastening device;

Fig. 5 is a schematic view of the guiding device connected to the load-carrying screw;

Fig. 6 is a schematic view of the spinal stabilizing device;

Fig. 7 is a schematic view of the self-locking fastening device implanted into the knee joint;

Fig. 8 is a schematic view of the self-locking fastening device implanted into the wrist; and

Fig. 9 is a schematic view of the self-locking fastening device implanted into the vertebra.

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, are adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a self-locking fastening device comprising JV fastening elements where JV≥ 2. The fastening elements are adapted to be inserted into an bone. Methods of achieving and using same are herein described.

The term 'bones' hereinafter refers to rigid organs that form a part of the endoskeleton of the vertebrates. They function to move, support, and protect the various organs of the body, produce red and white blood cells and store minerals. Because bones come in a variety of .shapes and have a complex internal and external structure, they are lightweight, yet strong and hard, in addition to fulfilling their many other functions. One of the types of tissues that makes up bone is the mineralized osseous tissue, also called bone tissue, that gives it rigidity and honeycomb-like three-dimensional internal structure. Other types of tissue found in bones include marrow, endosteum and periosteum, nerves, blood vessels and cartilage. There are 206 bones in the adult body and about 300 bones in the infant body.

The term 'vertebral column (backbone or spine)' hereinafter refers to a column of 24 vertebrae, the sacrum, intervertebral discs, and the coccyx situated in the dorsal aspect of the torso, separated by spinal discs. It houses the spinal cord in its spinal canal.

The term 'Young's modulus' hereinafter refers to a measure of the stiffness of an isotropic elastic material. Young's modulus is defined as the ratio of the uniaxial stress over the uniaxial strain in the range of stress in which Hooke's Law holds. Young's modulus can be experimentally determined from the slope of a stress-strain curve created during tensile tests conducted on a sample of the material.

Reference is now made to Fig. Ia, showing a schematic view of a load-carrying screw 10. The aforesaid screw 10 constitutes an axisymmetric elongate member having a symmetry axis 60, a proximal portion 20, and a distal portion 30. The distal portion 30 is provided with a male thread 70 and a bore 40 drilled along to an axis 61. Both threaded and threadless bores 40 are in the scope of the current invention. The proximal portion 20 is provided with a slot 67 for a screwdriver and a mark 65 indicating an orientation of the bore 40.

Reference is now made to Fig. Ib, showing an alternative embodiment of a load-carrying screw 10a further comprising a filling 45 disposed into the bore 40. The aforesaid filling is made of a material having Young's modulus less than a material of the screw 10a. The smaller Young's modulus of the filling material relaxes tolerance on coincidence of the bore axis 61 and an axis 110 of anchoring screw 80 (not shown) during a process of anchoring. A number of polymers can be used as a filling material, for example, Silicone, Polyethylene, and Polypropylene having Young's modulus 20, 200, and 2000 MPa, respectively. Some metals with low Young's modulus such as aluminum and magnesium (59 and 45 GPa, respectively) are also applicable for this use. For comparison, stainless steel and titanium, the conventional materials used for manufacturing surgical screws are characterized by the following ranges of Young's modulus of about 180-200 GPa and about 105-120 GPa, respectively. It should be emphasized that the filling material should meet two requirements, specifically, to be sufficiently soft to be self-tapped by the anchoring screw 80 and to be sufficiently stiff to fixate the aforesaid screw 80 in the bore 40. Any materials that meet the aforesaid requirements are in the scope of the current invention. It is acknowledged that contacting screws made of different metals or alloys in the environment of the patient's body form a galvanic pair and generate difference of electrical potentials resulting in galvanic corrosion. In some embodiments of the invention the screws made of different material can be protected from the galvanic corrosion by an electrical isolation from each other. The filling 45 made of an electrically isolating material and disposed between them prevents the self-anchoring device 105a from galvanic corrosion.

Reference is now made to Fig. Ic, presenting a schematic view of a locking screw 80. A distal portion 90 is provided with a male thread 100. A symmetry axis of the screw 80 is indicated by a reference numeral 110.

Reference is now made to Fig. Id, showing a schematic view of a self-locking fastening anchoring device 105. The aforesaid device comprises the load-carrying screw 10 and the locking screw 80. When threaded into a bone, the load-carrying screw 10 is locked by means of the locking screw 80. The screw 80 is threaded into the bore 40 of the screw 10, thereby preventing the screw 10 from being pulled out. It should be emphasized that the screw 80 is inserted into the bore 40 such that the axes 60 and 110 make an angle a.

Reference is now made to Fig. Ie, showing a schematic view of a self-locking fastening anchoring device 105a. The anchoring screw 80 is self-tapped into the filling 45 and prevents the load-carrying screw 10a from being pulled out. In view of the lower Young's modulus characterizing the material of filling 45 in comparison with the screws' material, tolerance requirements for axis coincidence during the process of screw interlocking are relaxed. A greater range of angle deviation from the angle a is allowed

Reference is now made to Fig. 2a, presenting a schematic view of a self-locking fastening anchoring device 106 provided with a flexible link 120. The device 106 comprises the screws 10 and 80 interconnected by the link 120 adapted to resiliently couple the screws 10 and 80. The aforesaid screws 10 and 80 are connected together by the link 120 and have sufficient degree of spring-back to enable the surgeon to interlock screws 10 and 80 inside the bone.

Reference is now made to Fig. 2b, showing a schematic view of a self-locking fastening anchorable device 107. The aforesaid device 107 comprises the load-carrying screw 10, the link . 120 and a locking member 80a further comprising a one-way lock 82. When inserted into the bore 40, the member 80a is prevented from being pulled out of the aforesaid bore 40 by the lock 82, thereby blocking threading out the load-carrying screw 10. Optionally, the lock 82 is adapted to be destroyed in order to demount the fastening device 107.

Reference is now made to Figs 3a and 3b, showing schematic views of two embodiments 108a and 108b of a bone fixating device. Both devices 108a and 108b comprise two pairs of the load- carrying and locking screws 10 and 80 fastening a plate 180 to a fractured bone 130. The screws 10 and 80 are inserted into pre-drilled passages 170. According to Fig. 4a, the load-carrying screw 10 is normally inserted into a bone 130. The number 135 refers to a location of a bone fracture. Fig. 4b presents the device 108b. In accordance with the current embodiment, both screws 10 and 80 are inserted into the bone 130 at some angle to a normal to the plate 180.

Reference is now made to Fig. 4a, presenting an embodiment 105b of the current invention locked by means of a gripper 450. The device 105b comprises two screws 300 and 400. Both screws 300 and 400 are provided with heads 310 and 410, non-threaded portions 320 and 430, and threaded portions 330 and 440, respectively. After threading the screw 300 into the patient's bone (not shown), the screw 400 is threaded into the patient's bone at some angle to the screw 300 so that a gripper located at a distal terminal of the screw 400 is able to grip the screw 300, specifically, a groove 340 located in a mid portion thereof. The gripper 450 mechanically is controlled by the head 400. The aforesaid head 400 when manually rotated via an elongate member 415 tightens the gripper 400. A pair of jam nuts 420 stalls the member 415 after tightening the gripper 450 to fixate it. Thus, the screw 400 is an anchoring element preventing threading out and loosening the screw 300 in the patient's body. Any value of the angle a (in accordance with Figs Id and Ie) is in the scope of the current invention.

Reference is now made to Fig. 4b, illustrating an embodiment 105 c of the current invention. The device 105d is provided with alternative ratio of the screw sizes. In accordance with the current embodiment of the present invention, the anchoring screw 400a is of greater size in comparison with the load-carrying screw 300a.

Reference is now made to Fig. 4c, presenting an embodiment 105d- comprising two anchoring screws 400. The aforesaid screws 400 fixate the load-carrying screw 300b provided with two grooves 340b that are gripped by the grippers^O.

Reference is now made to Fig. 5, presenting a schematic view of a guide element 205 mechanically connected to the screw 10 inserted into a bone (for example, the bone 130). The screw 10 is threaded into the pre-drilled passage 170. The guiding device 205 comprises an arm 200 and a guiding passage 190 adapted for guiding a drilling tool. The guiding device 205 is adapted to be mounted on the screw 10 such that an axis of the guiding passage coincides with the axis 61 of the bore 40. Dashed lines 180 indicate a presumed trajectory of drill. The aforesaid coincidence of the axes of the passage 190 and the bore 40 is provided by co-sitting or aligning of marks 65 and 67 located at the screw 10 and the arm 200, respectively. The mark 65 indicates the orientation of the plane defined by the axes of the screw 10 and' the bore 40. The mark' 67 indicates the orientation of the plane defined by the axis of the guiding passage 190 and the arm 200. The aforesaid arm 200 is assumed to be connected to the screw 10 in coaxial relationship.

Reference is now made to Fig. 6, presenting a schematic view of a spinal stabilizing device 121. The device 121 comprises the saddles 150 attached to the pedicles of the vertebra arch 140 and linking elements 160 adapted to keep constant distances between the saddles 150. Because the saddles 150 are attached to the vertebrae 140, the device 121 provides stabilizing the vertebrae of the spine. Similar to said above, the saddles 150 are fastened to the vertebrae by means of the self-locked screw pair 10 and 80. Use of the screws of smaller size provides a less traumatic surgical procedure in comparison with the conventional procedure. .Resilient and non-resilient linking elements 160 are in the scope of the current invention.

Reference is now made to Fig. 7, showing a schematic view of the self-locking fastening device 105 implanted into the tibia according to another embodiment of the invention. The device 105 fixates a fragment 250a. 135, 260, and 270 indicate the fracture line, fibula, and femur, respectively. The screw 10 fastens the fragment 250a to the bone 250. The screw 80 prevents the screw 10 from being pulled out.

Reference is now made to Fig. 8, showing a schematic view of the self-locking fastening device 105 implanted into the wrist. The screw 80 prevents the screw 10 from being pulled out. The purpose of the peri-subchondral construct is to support cartilage tissue and prevent sinking of subchondral bone with formation of an uneven articular surface. To this end, the use of a thick screw that is bolted diagonally is envisioned. Such a screw can prevent subchondral collapse in many joints, and is stabilized using the thinner penetrating screw.

According to the conventional prior art surgical procedure, the fastener (screw) is screwed into the pedicle so as to penetrate the first and second cortical walls (141 and 142) in fig. 9. The load is localised at the portion of the screw on the surface of the bone which has been screwed.

In the present invention, embodiments are provided with distributed load due to interlocking. Reference is now made to Fig. 9, presenting a schematic view of the present invention which is a novel embodiment of a self-locking fastening device 105 implanted into the vertebra which the following explanation will distinguish from the prior art: The screws 10 and 80 function similarly. In accordance with the current invention, the load-carrying screw 10 when inserted for a shorter depth provides the required fastening due to anchoring the screw 10 by means of the anchor 80. Furthermore the self- locking fastening device 105 distributes the fastened load without having to penetrate the second cortical wall 142. It should be stressed that the crossed screws 10 and 80 will also be more effectively osseointegrated with neighboring bone tissues due to less loosening of the foreign implant (screws) around the tissue. Reliably fastening the fractured parts of the vertebra 140 (for example, a pedicle) is hence achieved due to more effective osseointegration with the neighboring bone tissues and optimal volume distribution of the fastened load. In accordance with the current invention, a self-locking fastening device comprising JV fastening elements where JV≥ 2 is disclosed. The fastening elements are adapted to be inserted into a bone.

The core innovation constitutes the JV- 1 fastening elements provided with a bore at a portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively interlocking in a body of the bone by means of inserting the elements into the bone so that each successive element passes through the bore of each preceding element.

In accordance with one embodiment of the current invention, the self-locking fastening device comprises first and second screws. The first screw is provided with a bore at a portion thereof insertable into the bone. The second screw is provided with a distal portion thereof adapted for passing through the bore of the first screw.

In accordance with another embodiment of the current invention, the bore of the first screw and the distal portion of the second screw are provided with female and male threads, respectively, adapted for translating the second screw through the bore and interlocking the first and second screws in the body.

In accordance with a further embodiment of the current invention, the first screw is provided with a mark at a proximal portion thereof such. that .the mark indicates a position of a plane defined by screw and bore axes. The mark is adapted for mutually orienting the first and second screws.

In accordance with a further embodiment of the current invention, first and second screws are interconnected by a flexible link adapted to resiliently couple screws.

In accordance with a further embodiment of the current invention, fastening device is adapted for use in medial high tibial osteotomy and triple arthrodesis.

In accordance with a further embodiment of the current invention, a guiding device adapted for guiding a drilling tool is disclosed. The device is connectable to the proximal portion of the first screw inserted into the bone such that an axis of said drilling tool coincides with axis of the bore of the first screw. In accordance with a further embodiment of the current invention, a saddle clamp device securable to a curved surface of a bone for carrying a fixing member is disclosed. The device comprises a saddle body and JV fastening elements where JV ≥ 2. The saddle body has JV holes for passing said fastening elements to be threaded into the bone and at least one member integral with the body for attaching the fixing member. The saddle body is provided with a contact surface adapted for mechanical contact with the bone curved surface.

The core innovation constitutes the fastening elements provided with a bore at a portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively fixating the fastening element in the bone by means of inserting the elements into the bone so that each successive element passes through the bore of each preceding element.

In accordance with a further embodiment of the current invention, a spinal stabilizing device comprises (a) a plurality of linking elements; and (b) a plurality of saddle devices. Each saddle device comprises a saddle body and JV fastening elements where JV≥ 2. The saddle body has

JV holes for passing the fastening elements to be threaded into a vertebra and at least one member integral with the body for attaching the linking elements. The saddle body is provided with a contact surface adapted for mechanical contact with the curved surface of the vertebra. The core innovation constitutes the fastening elements provided with a bore at a distal portion thereof to be inserted into the bone. The fastening elements are adapted for consecutively fixating the fastening element in the bone by means of inserting the elements into the bone so that each successive element passes through the bore of each preceding element.

In accordance with a further embodiment of the current invention, the linking elements are flexible.

In accordance with a further embodiment of the current invention, a bone fixating device comprises (a) at least two self-locking fastening devices; each self-locking device further comprises first and second screws; the first screw provided with a bore at a portion thereof insertable into the bone; the second screw is provided with a distal portion thereof adapted for passing through the bore of the first screw; and (b) at least one plate adapted to be fastened to the bone by means of the fastening devices. ^• In accordance with a further embodiment of the current invention, a method of locking a fastening device is disclosed. The method comprises the steps of (a) providing self-locking fastening device and (b) consecutively interlocking the fastening elements in the bone by means of inserting the elements into the object so that each successive element passes through the locking bore of each preceding element.

In accordance with a further embodiment of the current invention, the method further comprises the steps of providing a drilling tool and a guide element.

In accordance with a further embodiment of the current invention, the step of interlocking further comprises drilling bores in the bone, inserting the fastening elements into the bores, inserting a distal portion of each successive element into a bore at a distal portion of each preceding element; said step of drilling further comprises guiding said drilling tool by means of the guiding element disposed at a proximal portion of the preceding element according to a mark indicating an orientation of the locking bore.

In accordance with a further embodiment of the current invention, the step of inserting each successive element into a bore of each preceding element comprises threading each said successive element into each said preceding element.

In accordance with a further embodiment of the current invention, a method of securing a saddle clamp device to a vertebra is disclosed. The method comprises the steps of (a) providing the saddle clamp device; and (b) consecutively interlocking the screws in the vertebra by means of inserting the elements into the object so that each successive element is threaded into the bore of each preceding element.

In accordance with a further embodiment of the current invention, a method of stabilizing a spine comprises the steps of (a) providing a plurality of linking elements and a plurality of saddle devices; (b) securing the saddle devices to vertebrae to be stabilized; and (c) linking the secured saddle device by means of the linking elements;

The core innovation constitutes the step of securing further comprising consecutively interlocking the screws in the vertebra by means of inserting the elements into the object so that each successive element is threaded into the bore of each preceding element.

In accordance with a further embodiment of the current invention, a method of stabilizing a bone comprises the steps of (a) providing a bone fixating device; (b) attaching the plate to the bone of interest; and (c) consecutively interlocking the screws in the bone by means of inserting the elements into the bone so that each successive element is threaded into the bore of each preceding element.

Claims

1. A self locking fastening device comprising JV fastening elements where JV > 2; said elements-are adapted to be inserted "into a- bone wherein JV said fastening elements are provided with mechanical interlocking means at a portion thereof to be inserted into said bone; said fastening elements are adapted for consecutively interlocking with each other in a body of said bone by means of interlocking said elements in said bone so that each successive element mechanically interlocks with each preceding element.

2. A self-locking fastening device according to claim 1, wherein said interlocking means is chosen from the group consisting of tongue-and-groove connection, mortice-and-tenon connection , male-and-female threads, notch, spline, protuberance, slot, hook, barb, grapple, fossette, taper, and any combination thereof.

3. The device according to claim 1, wherein said fastening elements are screws.

4. The device according to claim 1, wherein said fastening device is adapted for use chosen from the group consisting of dynamic hip screw, hip plating screw, hip fixation screw, Salame's fixation nail when treating pathology chosen from the group consisting- of hip fractures, particularly, osteoporotic hip fracture, Distal Radius Fracture (Colles' fracture) neck base fracture, and any combination thereof.

5. The device according to claim 1, wherein said fastening device is adapted for treating Periarticular Fracture.

6. The device according to claim 1, wherein said fastening device is adapted for use chosen from the group consisting of Pedicle Screw and Laminar Screw when treating pathology chosen from the group consisting of Anterior Spine Fixation and Posterior Spine Fixation

7. The device according to claim 1, wherein said fastening device is adapted for use in dental and oral surgery.

8. The device according to claim 1, wherein said fastening device is adapted for use in osseointegration and dental implants.

9. The device according to claim 1, wherein said fastening device is adapted for use in medial high tibial osteotomy and triple arthrodesis.

10. The device according to claim 1, wherein said number JV is equal to 2.

11. The device according to claim 9, wherein said device comprises first and second screws; said first screw is provided with a bore .at, a portion thereof .insertable into, said bone; said second screw is provided with a distal portion thereof adapted for passing through said bore of said first screw.

12. The device according to claim 11, wherein said bore in said first screw is filled with a material adapted to be screwed by said second screw and fixate said second screw in said bore.

13. The device according to claim 11, wherein said filling is adapted for electrically isolating said first and second screws from each other.

14. The device according to claim 9, wherein said first and second screws are made of a material selected from the group consisting of stainless steel and titanium and any combination thereof.

15. The device according to claim 12, wherein a material of a filling disposed into a said bore is selected from the group consisting of silicone, polyethylene, polypropylene, aluminum, and magnesium.

16. The device according to claim 9, wherein said bore of said first screw and said distal portion of said second screw are provided with female and male threads, respectively, adapted for translating said second screw through said bore and interlocking said first and second screws in said body.

17. The device according to claim 11, wherein said first screw is provided with a mark at a proximal portion thereof such that said mark indicates a position of a plane defined by screw and bore axes; said mark is adapted for mutually orienting said first and second screws.

18. The device according to claim 9, wherein said device is implanted into a long bone.

19. The device according to claim 3, wherein said device is implanted into a bone or bones of the wrist.

20. The device according to claim 9, wherein said device is implanted into a vertebra.

21. The device according to claim 9, wherein said first and second screws are interconnected by a flexible link adapted to resiliently couple said screws.

22. A guiding device adapted for guiding a drilling tool; said element is connectable to said proximal portion of said first screw inserted into the bone such that an axis of said drilling tool coincides with said axis of said bore of said first screw.

23. A spinal stabilizing device comprising

(a) a plurality of linking elements;

(b) a plurality of saddle devices; each said saddle device comprises a saddle body and JV fastening elements where JY^"> 2; said saddle body has J^Vholes for passing said fastening elements to be threaded into a vertebra and at least one member integral with said body for attaching said linking elements; said saddle body is provided with a contact surface adapted for mechanical contact with said curved surface of said vertebra; wherein said fastening elements are provided with a bore at a distal portion thereof to be inserted into said bone; said fastening elements are adapted for consecutively fixating said fastening element in said bone by means of inserting said elements into said bone so that each successive element passes through said bore of each preceding element.

24. The spinal stabilizing device according to claim 23, wherein said linking elements are flexible.

25. A bone fixating device comprising

(a) at least two self-locking fastening devices; each self-locking device further comprises first and second screws; said first screw provided with a bore at a portion thereof insertable into said bone; said second screw is provided with a distal portion thereof adapted for passing through said bore of said first screw; and

(b) at least one plate adapted to be fastened to said bone by means of said fastening devices.

26. A method of locking a fastening device; said method comprises the steps of (a) providing self-locking fastening device comprising JV fastening elements where JV > 2; said elements are adapted to be inserted into an bone; JV- 1 said fastening elements are provided with a bore at a portion thereof to be inserted into said bone; said fastening elements are adapted for consecutively interlocking in a body of said bone by means of inserting said elements into said bone so that each successive element passes through said locking bore of each preceding element; and

(b) consecutively interlocking said fastening elements in said bone by means of inserting said elements into said object so that each successive element passes through said locking bore of each preceding element.

27. The method of locking a fastening device according to claim 26, wherein said method further comprises the steps of providing a drilling tool and a guide element.

28. The method of locking a fastening device according to claim 27, said step of interlocking further comprises drilling bores in said bone, inserting said fastening elements into said bores, inserting a distal portion of each successive element into a bore at a distal portion of each preceding element; said step of drilling further comprises guiding said drilling tool by means of said guiding element disposed at a proximal portion of said preceding element according to a mark indicating an orientation of said locking bore.

29. The method of locking a fastening device according to claim 26, wherein said step of inserting each said successive element into a bore of each said preceding element comprises threading each said successive element into each said preceding element.

30. The method of locking a fastening device according to claim 26, wherein said method comprises providing a first screw and a second screw.

31. The method of locking a fastening device according to claim 25, wherein said step of inserting comprises screwing said second screw into a filling disposed in a bore of said first screw;

32. A method of stabilizing a spine comprising the steps of

(a) providing a plurality of linking elements and a plurality of saddle devices;

(b) securing said saddle devices to vertebrae to be stabilized; (c) linking said secured saddle device by means of said linking elements; wherein said step of securing further comprising consecutively interlocking said screws in said vertebra by means of inserting said elements into said object so that each successive element is threaded into said bore of each preceding element.

33. A method of stabilizing a bone comprising the steps of

(a) providing a bone fixating device further comprising

(i) at least two self-locking fastening devices; -each self locking device further comprises first and second screws; said first screw provided with a bore_e at a portion thereof insertable into said bone; said second screw is provided with a distal portion thereof adapted for passing through said bore of said first screw; and

(ii) at least one plate adapted to be fastened to said bone by means of said fastening device;

(b) attaching said plate to said bone of interest; and

(c) consecutively interlocking said screws in said -bone by means of inserting said elements into said bone so that each successive element is threaded into said tiore of each preceding element.