Title of Invention	"ORTHOPEDIC IMPLANT INSERTION HANDLE AND AIMING GUIDE"
Abstract	An ortnopaeaic impiaiu insertion instrument including an insertion handle and a radiolucent aiming guide and method of using same. The insertion handle may be formed of steel and is used for inserting an orthopaedic implant, such as an intramedullary nail or bone plate, into a patient. The radiolucent aiming guide is used to properly locate and guide a drill and/or other insertion instruments for installing fixation elements, such as screws, pins, nails, bolts, blades, etc., through the orthopaedic implant and into the affected bone to secure the implant in position and facilitate healing. The aiming gaide is substantially hollow and tubular and is preferably formed of a carbon fiber material.

Title of Invention

"ORTHOPEDIC IMPLANT INSERTION HANDLE AND AIMING GUIDE"

Abstract

An ortnopaeaic impiaiu insertion instrument including an insertion handle and a radiolucent aiming guide and method of using same. The insertion handle may be formed of steel and is used for inserting an orthopaedic implant, such as an intramedullary nail or bone plate, into a patient. The radiolucent aiming guide is used to properly locate and guide a drill and/or other insertion instruments for installing fixation elements, such as screws, pins, nails, bolts, blades, etc., through the orthopaedic implant and into the affected bone to secure the implant in position and facilitate healing. The aiming gaide is substantially hollow and tubular and is preferably formed of a carbon fiber material.

Full Text	ORTHOPEDIC IMPLANT INSERTION HANDLE AND AIMING GUIDE TECHNICAL FIELD [0001] The present invention relates to an orthopedic implant insertion instrument, and more particularly, to an implant insertion handle and aiming guide that is radiolucent and may be exceedingly useful for the insertion of orthopaedic implants, such as intramedullary nails or bone plates, and for fixing an implant relative to a patient's bone with accurately placed bone fixation elements, e.g., screws. BACKGROUND OF THE INVENTION [0002] Fractured or deformed long bones, e.g., femur, tibia, are typically repaired, reconstructed and/or healed using an elongated rod, often referred to as a "nail," which is inserted into the intramedullary canal of the bone. Once inserted, there is a need to stabilize bone segments or parts relative to the nail or rod to enhance the healing, repair and/or reconstruction process. To this end, intramedullary nails may have one or more transverse holes, which may be formed perpendicular to the long axis of the nail and/or at an angle relative to the long axis of the nail, for the passage of bone screws, nails, bolts, pins or other fixation elements that traverse the lateral cortex of the femur and may pass through the femoral neck and into the femoral head. Other fixation elements may pass through the nail and the shaft of the femur to prevent unwanted rotation or translation of the nail. [0003] During such a surgical procedure, a surgeon will continually monitor the location of the implants within the bone by using a fluoroscope. Fluoroscopy allows the surgeon to see the locations of the femur, the nail in the femur, and any transverse fixation elements being installed. The surgeon is then able to aim a drill and to correctly insert the fixation elements, e.g., screws, into the nail holes at the desired femur locations. [0004] Existing targeting devices for orthopedic implants are frequently described as being radio-transparent or radiolucent, however, they are sufficiently dense or thick-walled to cause scattering of the radiation being used. Frequently this is caused by the material being used, but is also caused by the configuration of the structure of the device. X-ray scattering compromises accuracy by detracting from the clarity of the operative site, which may make the operative procedure longer and more difficult. SUMMARY OF THE INVENTION [0005] The present invention generally relates to an orthopaedic implant insertion tool, and, in particular, an implant insertion handle and aiming guide having improved radiolucent properties. The present invention also relates to a method for inserting and restraining an orthopedic implant, [0006] In one embodiment, the orthopedic implant insertion handle and aiming guide may comprise an insertion handle, which may be formed of steel, titanium, or other suitable material, and a thin walled, hollow aiming guide arm connected to the insertion handle where the guide arm may be formed of carbon fiber or other suitable radiolucent material and has at least one transverse bore extending therethrough. The guide arm may be formed as a tube of substantially circular or polygonal cross-section. Preferably, the guide arm is removably connected to said insertion handle, but the guide arm may be formed integral with the insertion handle. The aiming guide may further include a first end portion, a second end portion and a substantially linear middle portion located between the first and second end portions, and the first end portion may form an angle with respect to the middle portion. The first end portion of the aiming guide may have a wall thickness greater than the wall thickness of the middle portion. [0007] In another embodiment, the orthopedic implant insertion handle and aiming guide may comprise a coupling connected to the aiming guide arm and a threaded coupling nut mounted to the coupling enabling the guide arm to be removably connected to the insertion handle. [0008] In still another embodiment, a pin may be mounted to the coupling, and the insertion handle may include a notch such that when connecting the guide arm and the insertion handle, the guide arm. is precisely aligned and positioned in relation to an implanted intramedullary nail or plate. Drilling into a bone and inserting screws in the bone are thereby facilitated. [0009] In still another embodiment, the insertion handle may be used independently of the guide arm to install an intramedullary nail or plate and thereafter, the guide arm may be connected to the insertion handle to guide screws into the nail or plate and into the femur in which the nail or plate is implanted. BRIEF DESCRIPTION OF THE DRAWINGS [0010] To facilitate an understanding of and for the purpose of illustrating the present invention, exemplary and preferred features and embodiments are disclosed in the accompanying drawings, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, and wherein similar reference characters denote similar elements throughout the several views, and wherein: [0011] FIG. 1 is an isometric view of the radiolucent orthopedic implant insertion and aiming guide of the present invention. [0012] FIG. 2 is an isometric view of an insertion handle and a barrel of the inventive guide. to manipulate and to remove orthopedic implants, such as the nail, and to implant plates. The guide may include an insertion handle or base 12, a barrel 14, a guide arm. 16 and a connecting structure 18 that may include a coupling 20 and a threaded coupling nut 22. An intramedullary nail 24 is illustrated in phantom line connected to the barrel 14. [0019] Referring to FIGS. 2 and 3, the insertion handle 12 may have aproximal end portion 26, a distal end portion 28 and a middle portion 30. The proximal end portion 26 may include a bore 32 for receiving and securing the barrel 14. The barrel 14 may in turn support the intramedullary rod or nail 24 which may be used to stabilize and heal an injured or deformed bone, e.g., femur, tibia, etc. [0020] The distal end portion 28 may include a guide arm insertion section 34 having a notch 36, a collar section 38 and an annular threaded shoulder section 40. The insertion section 34, the collar section 38 and the shoulder section 40 may be part of the connecting structure 18 and operatively connect to the coupling 20 and the threaded coupling nut 22 to enable the insertion handle 12 to be removably secured to the guide arm 16. As will be explained hi more detail below, the notch 36 prevents rotation of the guide arm, and the collar section 38 acts as a positioning guide when mounting the guide arm. Shoulder section 40' thieadedly engages with the coupling nut 22 to position and secure the guide-arm to the insertion handle. The distal end portion 28 may also include two drill receiving holes 42,44 positioned close to the shoulder section 40. In some embodiments, either or both of holes 42, 44 may be threaded for receiving other insertion instruments (not shown). It should also be noted that, in alternate embodiments, the insertion handle and guide arm may be formed as a single unit. [0021] The middle portion 30 of the insertion handle is formed integral with the proximal and distal end portions 26,28 and may be configured with the proximal and distal end portions in a generalized "L" shape. An upper flat surface 45 may be used as a hammer strike surface to facilitate the insertion of the nail. Side and top grooves 46, 47 may be formed in the middle portion. Another side groove, not shown, may be formed opposite the side groove 46, The grooves provide for a lighter instrument. [0022] As illustrated in FIG. 3, a central axis 48 of distal end portion 28 may be about 45 degrees away from a central axis 50 of the bore 32 of the proximal end portion 26. The central axis 50 is also coincident with an axis of the nail. A central axis 52 of the drill receiving opening 42 may be about 90 degrees from the center axis 48. A central axis 54 of the drill receiving opening 44 may be about 90 degrees from the distal end central axis 48. [0023] A measurement point 56, which is the center of a 6 mm circle placed in the notch 36 to represent a pin to be described below, is positioned to be tangent to two walls 58, 60 that meet at an angle of about 100 degrees. The vertex of the notch may be 3 mm from an end surface 62 of the distal end portion 28. The distance LI between the point 56 and the central axis 52 may be on the order of about 40 mm, and in one specific embodiment is about 42,9 mm/ The distance from the central axis 54 to the point 56 may be on the order of 65 mm, and the distance from the central axis 50 to the point 56 may be on the order of 135 mm. The outer diameter of the insertion section 34 of distal end portion 28 may be about 16 mm, the inner diameter of the insertion section 34 may be about 14 mm, the vertical distance (as shown in FIG. 3) from the point 56 to an end surface 64 of the proximal end portion 26 may be about 20 mm, the diameter of the drill receiving hole 44 may be about 12 mm, the . diameter of the drill receiving hole 42 may also be about 12 mm and the vertical distance L2 from the pobt 56 to an end surface 66 of the barrel 14 may be about 54 mm. The vertical distance L3 from a point 68 on the central axis 50 to the point 56 may be about 75 nym. These measurements are illustrated in FIG. 3. The angular relationship between the distal end central axis 48 and the flat surface 45 may be about 45°, the angle between the flat surface 45 and the surface 47 may be about 20° and the angle between the flat surface 45 and the surface 49 may be about 40°. [0024] The barrel 14 may have a tabular design including a slightly enlarged head portion 70 and a series of four circumstantial grooves 72,74, 76,78 at a base portion 80 of the barrel. The head portion 70 is constructed to fit within the proximal end portion bore 32 until an internal stop is reached. A laterally directed fastener receiving opening 82 may be formed in the barrel head portion 70 and a similar fastener receiving, laterally directed opening 84 may be formed in the proximal end portion 26 of the insertion handle 12 such that when the barrel is inserted into the proximal end portion 26 of the insertion handle and the openings 82 and 84 are aligned, a fastener, •which may be in the form of a pin 86, may be inserted to lock the aligned barrel hi place. The barrel 14 may also include a tab 86 for aligning the nail. [0025] • The material of the insertion handle may be steel or any other strong, suitable material. The length of the barrel 14 may be on the order of 90 mm, the outer diameter of the head .portion 70 may be on the order of 14 mm, the remainder of the barrel may have an outer diameter of about 13 mm and the barrel may have an inner diameter of about 8 mm. The grooves 72, 74, 76, 78 may be located 22.4,17.4, 12.4 and. 7.4 mm, respectively, from the end surface 66 of the barrel, and each may have a width of 0.8 mm and a depth of about 0.5 mm. [0026] Referring now to FIGS. 4-6, the guide arm 16 is shown in detail and may include an upper end portion 90, a middle portion 92 and a lower end portion 94. The upper end portion 90 and the lower end portion 94 are generally tubular with open centers 96, 98 and thin walls 100,102. The middle portion has a greatly reduced cross section formed by two lateral pass-through slots 104,106. The open center 96 of the upper end portion 90 may have a diameter of about 16,99 mm and a length of about 23 mm to receive the coupling 20. The open center 98 of the lower end portion may have a diameter of about 16 mm and a length of about 70 mm. The outer diameter of the upper end portion 90 may be about 25 mm forming a thin wall of about 4 mm in thickness. The lower end portion 94 may have a partial thin wall of about 4.5 mm and a thicken portion building to a little more than twice the thickness to facilitate aligning drills through the adjacent drill guide bores. The pass-through slots 104, 106 may be about 12 mm wide, with the slot 104 having a length of about 38 mm and the slot 106 having a length of about 54 mm. [0027] The middle portion 92 of the guide arm 16 may be offset from the upper portion 90 by an angle of approximately 28 to 32 degrees. The lower portion 94 may be offset from the upper portion 90 by angle of about 50 to 54 degrees, [0028] A first or upper pair of drill guide bores or openings 110,112 may be formed in the middle portion 92 of the guide arm 16 between the slots 104,106, and a second or lower pair of drill guide bores or openings 114,116 may be formed in the lower end portion 94. The first pair of drill guide bores 110,112 may have central axes, such as the central axis 117, located approximately 60 degrees from a central axis 118 of the upper end portion 90 of the guide arm. The second pair of drill guide bores 114,116 may have central axes, such as the central axis 119, at an angle of approximately 21 degrees from the central axis 118 of the upper end portion 90 of the guide arm. Shown hi phantom line in FIG. 5 is a nail axis 120 which may be at an angle of about 45 degrees from the central axis 118 of the upper end portion 90 and spaced from the axis 118 at a point 121 by a distance L4 on the order of 190 mm. The lower bores 114,116 may have diameters on the order of between 9 and 12 mm, and preferably 11.5 mm, and having axes spaced about 13 mm apart. The upper bores 110, 112 may have overlapping diameters of between about 9 and 13 mm, and preferably about 12 mm, and have axes spaced about 7 nrm apart. [0029] The material of the guide arm 16 is carbon fiber which has unproved radiolucent qualities especially when combined with the thin walls 100,102, the hollow open centers 96, 98 and the pass-through slots 104,106 disclosed above. [0030] The coupling 20 and the coupling nut 22 may be inserted hi the upper end portion 90 of the guide arm 16 as shown in FIG. 5. A first or lower fastener receiving opening 124 is formed in the coupling. A similar fastener receiving opening 126 may also be formed in the upper end portion 90 of the guide arm 16. The coupling 20 may be press fitted into the guide arm 16, and the fastener receiving openings 124,126 may be aligned to receive a pin 128 which locks the aligned coupling 20 to the upper end portion 90 of the guide arm 16. The coupling 20 may include a lower shoulder 130, and an upper shoulder 132. The lower shoulder abuts an end surface 134 of the guide arm 16 and the coupling upper shoulder 132 provides an abutment for the coupling nut 22. The coupling nut 22 is positioned around the coupling 20. The coupling nut engages the annular shoulder 40 of'the insertion handle 12. The coupling nut includes an outer ribbed surface 136 to facilitate rotation and tightening of the nut on the insertion arm annular shoulder 40. [0031] A second or upper fastener receiving opening 140 may be formed in the coupling. A pin 142 inserted in the upper pin receiving opening 140 acts as a positioning stop to the insertion handle 12 by engaging the notch 36 of the distal end portion 28 of the insertion handle 12. The pin 142 also causes the proper alignment of the guide aim 16 and the insertion handle 12. The central axis of the pin 142 is coincident with the point 56, FIG. 3. [0032] In operation, an orthopedic implant, such as a femoral or tibial intramedullary nail 24, is installed using the insertion handle 12. Because the insertion handle is formed of a strong, durable material, e.g., stainless steel, titanium, etc., a large amount offeree, including hammer blows, may be used without any concern about damaging the insertion handle. Thereafter, the hollow guide arm 16, which may be relatively weak when compared to the insertion handle, may be connected to the insertion handle 12 by engaging the threaded coupling nut 22 with the annular shoulder portion 40 of the insertion handle. Because relative rotation of the guide arm 16 and coupling 20 may be prevented by use of the pin 128 in the fastener receiving openings 124,126, and because the notch 36 of the insertion handle may be seated on the pin 142, the drill guiding bores 110,112,114,116 in the guide arm 16 and the drill guide bores 42,44 in the insertion handle 12 may be aligned with openings (not shown) in the nail. Thereafter, a surgeon is in position to use the drill guiding bores to aim and insert fixation elements, such as screws, pins, nails, blades 01 bolts, so that an injured or deformed bone may be immobilized. [0033] To ensure that the drilling and/or insertion of fixation elements, such as a screw, is properly aligned, the limb of the patient may be subjected to x-rays thereby giving the surgeon a clear picture of the bone, the nail, the inserting drill bit and the fixation element. To keep radiation interference to a minimum, the guide arm 16 is formed of thin walled carbon fiber in the form of a thin walled tube in its upper and lower end portions and a substantially reduced cross sectional area in it middle portion. [0034] In embodiments where the insertion handle/aiming guide is configured as two cormectable and detachable pieces, rather than a one-piece design, a surgeon may be able to exert a larger insertion force on the mtramedullary nail or plate when using the insertion handle 12 separated from the aiming guide. When the nail or plate is in place, the guide arm 16 may be easily, quickly and accurately engaged to the insertion handle. Thereafter, the drilling or installation of fixation elements, e.g., screws, phis, nails, blades, bolts, etc., may be performed easily and accurately without the application of excessive force. Hence, a thin or small section of radiohicent carbon fiber may be conveniently used. As discussed above, in other embodiments, the insertion handle/aiming guide may be configured as a one piece design. [0035] It should be noted that there are various sizes and types of intramedullary nails used in orthopaedic surgery, e.g., solid, cannulated, femoral, humeral, tibial, etc. Therefore, the exact dimensions and angles disclosed above are not to be considered limiting in any way. Moreover, the present invention may be adapted for use with other orthopaedic implants and devices, such as bone plates, spinal implants, etc. [003 6] The present invention has been described in connection with the preferred embodiment. The embodiment, however, is merely for example and the invention is not restricted thereto or limited thereby. Thus, it will be understood by those skilled in the art that other variations and modifications can easily be made within the scope of the invention as defined by the appended claims, thus it is only intended float the present invention be limited by the following claims. CLAIMS 1. A radiolucent orthopedic implant insertion instrument comprising: an insertion handle; and an aiming guide adjacent to the insertion handle, the aiming guide formed of a substantially hollow structure of radiolucent material and having at least one transverse bore formed therethrough. 2. The instrument of claim 1, wherein the aiming guide is a tube of substantially circular cross-section. 3. The instrument of claim 1, wherein the Riming guide is a tube of polygonal cross section. 4. The instrument of claim 1, wherein the aiming guide has an open cross- section. 5. The instrument of claim 1, wherein the aiming guide s removably connectable to said insertion handle. 6. The instrument of claim 5, wherein the aiming guide is formed of carbon fiber. 7. The instrument of claim 5, further comprising a coupling and a threaded coupling nut configured and dimensioned to secure the insertion handle to the aiming guide, 8. The instrument of claim 7, wherein the coupling includes a fastener receiving opening; and the guide arm includes a fastener receiving opening, said coupling fastener receiving opening being alignable with said guide arm fastener receiving opening. 9. The instrument of claim 1, wherein the aiming guide has a first end portion, a second end portion and a substantially linear middle portion located between the first and second end portions, and the first end portion forms an angle with respect to the middle portion. 10. The instrument of claim 8, wherein the first end portion of the aiming guide has a first wall thickness and the middle portion of the aiming guide has a second wall thickness, and the first wall thickness is greater than the second wall thickness. 11. The instrument of claim 1, wherein the insertion handle includes at least one bore for aligning a drill. 12. The instrument of claim 1, wherein the insertion handle is formed of stainless steel, titanium, or titanium alloy. 13. A radiolucent orthopedic implant insertion instrument comprising: an insertion handle having a first end configured and dimensioned for removable connection to an orthopaedic implant and a second end configured and dimensioned for removable connection to an aiming guide; an aiming guide formed of a substantially hollow structure of radiolucent material and having at least one transverse bore formed therethrough, the aiming guide having a first end portion configured and dimensioned for connection to the insertion handle, a second end portion, and a substantially linear middle portion disposed between the first and second end portions, wherein the first and second end portions are substantially tubular. 14. The instrument of claim 13, wherein the aiming guide is formed of carbon fiber. 15. The instrument of claim 14, wherein the first end portion has a first wall thickness and the middle portion has a second wall thickness, and the first wall thickness is greater than the second wall thickness. 16. The instrument of claim 14, wherein the middle portion of the aiming guide has at least one linear slot formed therethrough. 17. The instrument of claim 14, wherein the insertion handle includes at least one transverse bore formed therethrough for locating and aligning a drill or implant insertion tool, 18. The instrument of claim 14, further comprising a coupling and a threaded coupling nut configured and dimensioned to secure the insertion handle to the aiming guide. 19. The instrument of claim 18, wherein the coupling includes a fastener receiving opening; and the first end portion of the aiming guide includes a fastener receiving opening, the coupling fastener receiving opening being alignable with said aiming guide fastener receiving opening.

Full Text

ORTHOPEDIC IMPLANT INSERTION HANDLE AND AIMING GUIDE
TECHNICAL FIELD
[0001] The present invention relates to an orthopedic implant insertion instrument, and more particularly, to an implant insertion handle and aiming guide that is radiolucent and may be exceedingly useful for the insertion of orthopaedic implants, such as intramedullary nails or bone plates, and for fixing an implant relative to a patient's bone with accurately placed bone fixation elements, e.g., screws.
BACKGROUND OF THE INVENTION
[0002] Fractured or deformed long bones, e.g., femur, tibia, are typically repaired, reconstructed and/or healed using an elongated rod, often referred to as a "nail," which is inserted into the intramedullary canal of the bone. Once inserted, there is a need to stabilize bone segments or parts relative to the nail or rod to enhance the healing, repair and/or reconstruction process. To this end, intramedullary nails may have one or more transverse holes, which may be formed perpendicular to the long axis of the nail and/or at an angle relative to the long axis of the nail, for the passage of bone screws, nails, bolts, pins or other fixation elements that traverse the lateral cortex of the femur and may pass through the femoral neck and into the femoral head. Other fixation elements may pass through the nail and the shaft of the femur to prevent unwanted rotation or translation of the nail.
[0003] During such a surgical procedure, a surgeon will continually monitor the location of the implants within the bone by using a fluoroscope. Fluoroscopy allows the surgeon to see the locations of the femur, the nail in the femur, and any transverse fixation elements being installed. The surgeon is then able to aim a drill and to correctly insert the fixation elements, e.g., screws, into the nail holes at the desired femur locations.

[0004] Existing targeting devices for orthopedic implants are frequently described as being radio-transparent or radiolucent, however, they are sufficiently dense or thick-walled to cause scattering of the radiation being used. Frequently this is caused by the material being used, but is also caused by the configuration of the structure of the device. X-ray scattering compromises accuracy by detracting from the clarity of the operative site, which may make the operative procedure longer and more difficult.
SUMMARY OF THE INVENTION
[0005] The present invention generally relates to an orthopaedic implant insertion tool, and, in particular, an implant insertion handle and aiming guide having improved radiolucent properties. The present invention also relates to a method for inserting and restraining an orthopedic implant,
[0006] In one embodiment, the orthopedic implant insertion handle and aiming guide may comprise an insertion handle, which may be formed of steel, titanium, or other suitable material, and a thin walled, hollow aiming guide arm connected to the insertion handle where the guide arm may be formed of carbon fiber or other suitable radiolucent material and has at least one transverse bore extending therethrough. The guide arm may be formed as a tube of substantially circular or polygonal cross-section. Preferably, the guide arm is removably connected to said insertion handle, but the guide arm may be formed integral with the insertion handle. The aiming guide may further include a first end portion, a second end portion and a substantially linear middle portion located between the first and second end portions, and the first end portion may form an angle with respect to the middle portion. The first end portion of the aiming guide may have a wall thickness greater than the wall thickness of the middle portion.

[0007] In another embodiment, the orthopedic implant insertion handle and aiming guide may comprise a coupling connected to the aiming guide arm and a threaded coupling nut mounted to the coupling enabling the guide arm to be removably connected to the insertion handle.
[0008] In still another embodiment, a pin may be mounted to the coupling, and the insertion handle may include a notch such that when connecting the guide arm and the insertion handle, the guide arm. is precisely aligned and positioned in relation to an implanted intramedullary nail or plate. Drilling into a bone and inserting screws in the bone are thereby facilitated.
[0009] In still another embodiment, the insertion handle may be used independently of the guide arm to install an intramedullary nail or plate and thereafter, the guide arm may be connected to the insertion handle to guide screws into the nail or plate and into the femur in which the nail or plate is implanted.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] To facilitate an understanding of and for the purpose of illustrating the present invention, exemplary and preferred features and embodiments are disclosed in the accompanying drawings, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, and wherein similar reference characters denote similar elements throughout the several views, and wherein:
[0011] FIG. 1 is an isometric view of the radiolucent orthopedic implant insertion and aiming guide of the present invention.
[0012] FIG. 2 is an isometric view of an insertion handle and a barrel of the inventive guide.

to manipulate and to remove orthopedic implants, such as the nail, and to implant plates. The guide may include an insertion handle or base 12, a barrel 14, a guide arm. 16 and a connecting structure 18 that may include a coupling 20 and a threaded coupling nut 22. An intramedullary nail 24 is illustrated in phantom line connected to the barrel 14.
[0019] Referring to FIGS. 2 and 3, the insertion handle 12 may have aproximal end portion 26, a distal end portion 28 and a middle portion 30. The proximal end portion 26 may include a bore 32 for receiving and securing the barrel 14. The barrel 14 may in turn support the intramedullary rod or nail 24 which may be used to stabilize and heal an injured or deformed bone, e.g., femur, tibia, etc.
[0020] The distal end portion 28 may include a guide arm insertion section 34 having a notch 36, a collar section 38 and an annular threaded shoulder section 40. The insertion section 34, the collar section 38 and the shoulder section 40 may be part of the connecting structure 18 and operatively connect to the coupling 20 and the threaded coupling nut 22 to enable the insertion handle 12 to be removably secured to the guide arm 16. As will be explained hi more detail below, the notch 36 prevents rotation of the guide arm, and the collar section 38 acts as a positioning guide when mounting the guide arm. Shoulder section 40' thieadedly engages with the coupling nut 22 to position and secure the guide-arm to the insertion handle. The distal end portion 28 may also include two drill receiving holes 42,44 positioned close to the shoulder section 40. In some embodiments, either or both of holes 42, 44 may be threaded for receiving other insertion instruments (not shown). It should also be noted that, in alternate embodiments, the insertion handle and guide arm may be formed as a single unit.
[0021] The middle portion 30 of the insertion handle is formed integral with the proximal and distal end portions 26,28 and may be configured with the proximal and distal end

portions in a generalized "L" shape. An upper flat surface 45 may be used as a hammer strike surface to facilitate the insertion of the nail. Side and top grooves 46, 47 may be formed in the middle portion. Another side groove, not shown, may be formed opposite the side groove 46, The grooves provide for a lighter instrument.
[0022] As illustrated in FIG. 3, a central axis 48 of distal end portion 28 may be about 45 degrees away from a central axis 50 of the bore 32 of the proximal end portion 26. The central axis 50 is also coincident with an axis of the nail. A central axis 52 of the drill receiving opening 42 may be about 90 degrees from the center axis 48. A central axis 54 of the drill receiving opening 44 may be about 90 degrees from the distal end central axis 48.
[0023] A measurement point 56, which is the center of a 6 mm circle placed in the notch 36 to represent a pin to be described below, is positioned to be tangent to two walls 58, 60 that meet at an angle of about 100 degrees. The vertex of the notch may be 3 mm from an end surface 62 of the distal end portion 28. The distance LI between the point 56 and the central axis 52 may be on the order of about 40 mm, and in one specific embodiment is about 42,9 mm/ The distance from the central axis 54 to the point 56 may be on the order of 65 mm, and the distance from the central axis 50 to the point 56 may be on the order of 135 mm. The outer diameter of the insertion section 34 of distal end portion 28 may be about 16 mm, the inner diameter of the insertion section 34 may be about 14 mm, the vertical distance (as shown in FIG. 3) from the point 56 to an end surface 64 of the proximal end portion 26 may be about 20 mm, the diameter of the drill receiving hole 44 may be about 12 mm, the . diameter of the drill receiving hole 42 may also be about 12 mm and the vertical distance L2 from the pobt 56 to an end surface 66 of the barrel 14 may be about 54 mm. The vertical distance L3 from a point 68 on the central axis 50 to the point 56 may be about 75 nym. These measurements are illustrated in FIG. 3. The angular relationship between the distal

end central axis 48 and the flat surface 45 may be about 45°, the angle between the flat surface 45 and the surface 47 may be about 20° and the angle between the flat surface 45 and the surface 49 may be about 40°.
[0024] The barrel 14 may have a tabular design including a slightly enlarged head portion 70 and a series of four circumstantial grooves 72,74, 76,78 at a base portion 80 of the barrel. The head portion 70 is constructed to fit within the proximal end portion bore 32 until an internal stop is reached. A laterally directed fastener receiving opening 82 may be formed in the barrel head portion 70 and a similar fastener receiving, laterally directed opening 84 may be formed in the proximal end portion 26 of the insertion handle 12 such that when the barrel is inserted into the proximal end portion 26 of the insertion handle and the openings 82 and 84 are aligned, a fastener, •which may be in the form of a pin 86, may be inserted to lock the aligned barrel hi place. The barrel 14 may also include a tab 86 for aligning the nail.
[0025] • The material of the insertion handle may be steel or any other strong, suitable material. The length of the barrel 14 may be on the order of 90 mm, the outer diameter of the head .portion 70 may be on the order of 14 mm, the remainder of the barrel may have an outer diameter of about 13 mm and the barrel may have an inner diameter of about 8 mm. The grooves 72, 74, 76, 78 may be located 22.4,17.4, 12.4 and. 7.4 mm, respectively, from the end surface 66 of the barrel, and each may have a width of 0.8 mm and a depth of about 0.5 mm.
[0026] Referring now to FIGS. 4-6, the guide arm 16 is shown in detail and may include an upper end portion 90, a middle portion 92 and a lower end portion 94. The upper end portion 90 and the lower end portion 94 are generally tubular with open centers 96, 98 and thin walls 100,102. The middle portion has a greatly reduced cross section formed by two lateral pass-through slots 104,106. The open center 96 of the upper end portion 90 may have a diameter

of about 16,99 mm and a length of about 23 mm to receive the coupling 20. The open center 98 of the lower end portion may have a diameter of about 16 mm and a length of about 70 mm. The outer diameter of the upper end portion 90 may be about 25 mm forming a thin wall of about 4 mm in thickness. The lower end portion 94 may have a partial thin wall of about 4.5 mm and a thicken portion building to a little more than twice the thickness to facilitate aligning drills through the adjacent drill guide bores. The pass-through slots 104, 106 may be about 12 mm wide, with the slot 104 having a length of about 38 mm and the slot 106 having a length of about 54 mm.
[0027] The middle portion 92 of the guide arm 16 may be offset from the upper portion 90 by an angle of approximately 28 to 32 degrees. The lower portion 94 may be offset from the upper portion 90 by angle of about 50 to 54 degrees,
[0028] A first or upper pair of drill guide bores or openings 110,112 may be formed in the middle portion 92 of the guide arm 16 between the slots 104,106, and a second or lower pair of drill guide bores or openings 114,116 may be formed in the lower end portion 94. The first pair of drill guide bores 110,112 may have central axes, such as the central axis 117, located approximately 60 degrees from a central axis 118 of the upper end portion 90 of the guide arm. The second pair of drill guide bores 114,116 may have central axes, such as the central axis 119, at an angle of approximately 21 degrees from the central axis 118 of the upper end portion 90 of the guide arm. Shown hi phantom line in FIG. 5 is a nail axis 120 which may be at an angle of about 45 degrees from the central axis 118 of the upper end portion 90 and spaced from the axis 118 at a point 121 by a distance L4 on the order of 190 mm. The lower bores 114,116 may have diameters on the order of between 9 and 12 mm, and preferably 11.5 mm, and having axes spaced about 13 mm apart. The upper bores 110,

112 may have overlapping diameters of between about 9 and 13 mm, and preferably about 12 mm, and have axes spaced about 7 nrm apart.
[0029] The material of the guide arm 16 is carbon fiber which has unproved radiolucent qualities especially when combined with the thin walls 100,102, the hollow open centers 96, 98 and the pass-through slots 104,106 disclosed above.
[0030] The coupling 20 and the coupling nut 22 may be inserted hi the upper end portion 90 of the guide arm 16 as shown in FIG. 5. A first or lower fastener receiving opening 124 is formed in the coupling. A similar fastener receiving opening 126 may also be formed in the upper end portion 90 of the guide arm 16. The coupling 20 may be press fitted into the guide arm 16, and the fastener receiving openings 124,126 may be aligned to receive a pin 128 which locks the aligned coupling 20 to the upper end portion 90 of the guide arm 16. The coupling 20 may include a lower shoulder 130, and an upper shoulder 132. The lower shoulder abuts an end surface 134 of the guide arm 16 and the coupling upper shoulder 132 provides an abutment for the coupling nut 22. The coupling nut 22 is positioned around the coupling 20. The coupling nut engages the annular shoulder 40 of'the insertion handle 12. The coupling nut includes an outer ribbed surface 136 to facilitate rotation and tightening of the nut on the insertion arm annular shoulder 40.
[0031] A second or upper fastener receiving opening 140 may be formed in the coupling. A pin 142 inserted in the upper pin receiving opening 140 acts as a positioning stop to the insertion handle 12 by engaging the notch 36 of the distal end portion 28 of the insertion handle 12. The pin 142 also causes the proper alignment of the guide aim 16 and the insertion handle 12. The central axis of the pin 142 is coincident with the point 56, FIG. 3.
[0032] In operation, an orthopedic implant, such as a femoral or tibial intramedullary nail 24, is installed using the insertion handle 12. Because the insertion handle is formed of a

strong, durable material, e.g., stainless steel, titanium, etc., a large amount offeree, including hammer blows, may be used without any concern about damaging the insertion handle. Thereafter, the hollow guide arm 16, which may be relatively weak when compared to the insertion handle, may be connected to the insertion handle 12 by engaging the threaded coupling nut 22 with the annular shoulder portion 40 of the insertion handle. Because relative rotation of the guide arm 16 and coupling 20 may be prevented by use of the pin 128 in the fastener receiving openings 124,126, and because the notch 36 of the insertion handle may be seated on the pin 142, the drill guiding bores 110,112,114,116 in the guide arm 16 and the drill guide bores 42,44 in the insertion handle 12 may be aligned with openings (not shown) in the nail. Thereafter, a surgeon is in position to use the drill guiding bores to aim and insert fixation elements, such as screws, pins, nails, blades 01 bolts, so that an injured or deformed bone may be immobilized.
[0033] To ensure that the drilling and/or insertion of fixation elements, such as a screw, is properly aligned, the limb of the patient may be subjected to x-rays thereby giving the surgeon a clear picture of the bone, the nail, the inserting drill bit and the fixation element. To keep radiation interference to a minimum, the guide arm 16 is formed of thin walled carbon fiber in the form of a thin walled tube in its upper and lower end portions and a substantially reduced cross sectional area in it middle portion.
[0034] In embodiments where the insertion handle/aiming guide is configured as two cormectable and detachable pieces, rather than a one-piece design, a surgeon may be able to exert a larger insertion force on the mtramedullary nail or plate when using the insertion handle 12 separated from the aiming guide. When the nail or plate is in place, the guide arm 16 may be easily, quickly and accurately engaged to the insertion handle. Thereafter, the drilling or installation of fixation elements, e.g., screws, phis, nails, blades, bolts, etc., may be

performed easily and accurately without the application of excessive force. Hence, a thin or small section of radiohicent carbon fiber may be conveniently used. As discussed above, in other embodiments, the insertion handle/aiming guide may be configured as a one piece design.
[0035] It should be noted that there are various sizes and types of intramedullary nails used in orthopaedic surgery, e.g., solid, cannulated, femoral, humeral, tibial, etc. Therefore, the exact dimensions and angles disclosed above are not to be considered limiting in any way. Moreover, the present invention may be adapted for use with other orthopaedic implants and devices, such as bone plates, spinal implants, etc.
[003 6] The present invention has been described in connection with the preferred embodiment. The embodiment, however, is merely for example and the invention is not restricted thereto or limited thereby. Thus, it will be understood by those skilled in the art that other variations and modifications can easily be made within the scope of the invention as defined by the appended claims, thus it is only intended float the present invention be limited by the following claims.

CLAIMS
1. A radiolucent orthopedic implant insertion instrument comprising:
an insertion handle; and
an aiming guide adjacent to the insertion handle, the aiming guide formed of a substantially hollow structure of radiolucent material and having at least one transverse bore formed therethrough.
2. The instrument of claim 1, wherein the aiming guide is a tube of substantially
circular cross-section.
3. The instrument of claim 1, wherein the Riming guide is a tube of polygonal
cross section.
4. The instrument of claim 1, wherein the aiming guide has an open cross-
section.
5. The instrument of claim 1, wherein the aiming guide s removably connectable
to said insertion handle.
6. The instrument of claim 5, wherein the aiming guide is formed of carbon fiber.
7. The instrument of claim 5, further comprising a coupling and a threaded
coupling nut configured and dimensioned to secure the insertion handle to the aiming guide,
8. The instrument of claim 7, wherein the coupling includes a fastener receiving
opening; and the guide arm includes a fastener receiving opening, said coupling fastener
receiving opening being alignable with said guide arm fastener receiving opening.
9. The instrument of claim 1, wherein the aiming guide has a first end portion, a
second end portion and a substantially linear middle portion located between the first and
second end portions, and the first end portion forms an angle with respect to the middle
portion.

10. The instrument of claim 8, wherein the first end portion of the aiming guide
has a first wall thickness and the middle portion of the aiming guide has a second wall
thickness, and the first wall thickness is greater than the second wall thickness.
11. The instrument of claim 1, wherein the insertion handle includes at least one
bore for aligning a drill.
12. The instrument of claim 1, wherein the insertion handle is formed of stainless
steel, titanium, or titanium alloy.
13. A radiolucent orthopedic implant insertion instrument comprising:
an insertion handle having a first end configured and dimensioned for
removable connection to an orthopaedic implant and a second end configured and dimensioned for removable connection to an aiming guide;
an aiming guide formed of a substantially hollow structure of radiolucent material and having at least one transverse bore formed therethrough, the aiming guide having a first end portion configured and dimensioned for connection to the insertion handle, a second end portion, and a substantially linear middle portion disposed between the first and second end portions, wherein the first and second end portions are substantially tubular.
14. The instrument of claim 13, wherein the aiming guide is formed of carbon
fiber.
15. The instrument of claim 14, wherein the first end portion has a first wall
thickness and the middle portion has a second wall thickness, and the first wall thickness is
greater than the second wall thickness.
16. The instrument of claim 14, wherein the middle portion of the aiming guide
has at least one linear slot formed therethrough.

17. The instrument of claim 14, wherein the insertion handle includes at least one
transverse bore formed therethrough for locating and aligning a drill or implant insertion tool,
18. The instrument of claim 14, further comprising a coupling and a threaded
coupling nut configured and dimensioned to secure the insertion handle to the aiming guide.
19. The instrument of claim 18, wherein the coupling includes a fastener receiving
opening; and the first end portion of the aiming guide includes a fastener receiving opening,
the coupling fastener receiving opening being alignable with said aiming guide fastener
receiving opening.

Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=9kDxaiuzZ1RIuuo+6kUWsw==&loc=+mN2fYxnTC4l0fUd8W4CAA==

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Patent Number

280067

Indian Patent Application Number

2233/DELNP/2008

PG Journal Number

06/2017

Publication Date

10-Feb-2017

Grant Date

08-Feb-2017

Date of Filing

17-Mar-2008

Name of Patentee

SYNTHES GMBH

Applicant Address

EIMATTSTRASSE 3, CH-4436 OBERDORF, SWITZERLAND

Inventors:

#	Inventor's Name	Inventor's Address
1	MARK SIRAVO	2917 SUNSET AVENUE, EAST NORRITON, PA 19403, U.S.A
2	GLEN PIERSON	201 MAPLEFLOWER ROAD, GLENMORE, PA 19343, U.S.A

PCT International Classification Number

A61B 17/17

PCT International Application Number

PCT/US2006/036546

PCT International Filing date

2006-09-19

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	11/231,099	2005-09-19	U.S.A.