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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to an exemplary, non-limiting embodiment illustrated in the figures and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is hereby intended, such alterations and further modifications, and such further applications of the principles of the invention as illustrated herein being contemplated as would normally occur to one skilled in the art to which the invention relates. In this regard, exemplary features may be shown and described which are not required to carry out the invention and thus it is intended that the invention only be limited by the claims.
As shown in
Referring to
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 in 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 threadedly 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.
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.
As illustrated in
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 L1 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
The barrel 14 may have a tubular 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 in place. The barrel 14 may also include a tab for aligning the nail.
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.
Referring now to
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.
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 in phantom line in
The material of the guide arm 16 is carbon fiber which has improved 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.
The coupling 20 and the coupling nut 22 may be inserted in the upper end portion 90 of the guide arm 16 as shown in
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 arm 16 and the insertion handle 12. The central axis of the pin 142 is coincident with the point 56,
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 of force, 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 or bolts, so that an injured or deformed bone may be immobilized.
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.
In embodiments where the insertion handle/aiming guide is configured as two connectable and detachable pieces, rather than a one-piece design, a surgeon may be able to exert a larger insertion force on the intramedullary 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, pins, nails, blades, bolts, etc., may be performed easily and accurately without the application of excessive force. Hence, a thin or small section of radiolucent 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.
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.
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 that the present invention be limited by the following claims.
Number | Name | Date | Kind |
---|---|---|---|
2531734 | Hopkins | Nov 1950 | A |
3613684 | Sheridan | Oct 1971 | A |
3704707 | Halloran | Dec 1972 | A |
4037592 | Kronner | Jul 1977 | A |
4418422 | Richter et al. | Nov 1983 | A |
4485815 | Amplatz et al. | Dec 1984 | A |
4541424 | Grosse et al. | Sep 1985 | A |
4621628 | Brudermann | Nov 1986 | A |
4625718 | Olerud et al. | Dec 1986 | A |
4722336 | Kim et al. | Feb 1988 | A |
4803976 | Frigg et al. | Feb 1989 | A |
4848327 | Perdue | Jul 1989 | A |
4850344 | Olerud et al. | Jul 1989 | A |
4865025 | Buzzi et al. | Sep 1989 | A |
4877019 | Vives | Oct 1989 | A |
4881535 | Sohngen | Nov 1989 | A |
4917111 | Pennig et al. | Apr 1990 | A |
4969889 | Greig | Nov 1990 | A |
4976713 | Landanger et al. | Dec 1990 | A |
5013317 | Cole et al. | May 1991 | A |
5031203 | Trecha | Jul 1991 | A |
5070861 | Einars et al. | Dec 1991 | A |
5112336 | Krevolin et al. | May 1992 | A |
5127913 | Thomas, Jr. | Jul 1992 | A |
5141513 | Fortune et al. | Aug 1992 | A |
5178621 | Cook et al. | Jan 1993 | A |
5278128 | Hotta et al. | Jan 1994 | A |
5283808 | Cramer et al. | Feb 1994 | A |
5334192 | Behrens | Aug 1994 | A |
5352228 | Kummer et al. | Oct 1994 | A |
5403321 | DiMarco | Apr 1995 | A |
5403322 | Herzenberg et al. | Apr 1995 | A |
5411503 | Hollstien et al. | May 1995 | A |
5417688 | Elstrom et al. | May 1995 | A |
5426687 | Goodall et al. | Jun 1995 | A |
5433720 | Faccioli et al. | Jul 1995 | A |
5458599 | Adobbati | Oct 1995 | A |
5478329 | Ternamian | Dec 1995 | A |
5478343 | Ritter | Dec 1995 | A |
5513240 | Hausmann et al. | Apr 1996 | A |
5514145 | Durham et al. | May 1996 | A |
5540691 | Elstrom et al. | Jul 1996 | A |
5540695 | Levy | Jul 1996 | A |
5584838 | Rona et al. | Dec 1996 | A |
5620449 | Faccioli et al. | Apr 1997 | A |
5630805 | Ternamian | May 1997 | A |
5658283 | Huebner | Aug 1997 | A |
5665086 | Itoman et al. | Sep 1997 | A |
5707375 | Durham et al. | Jan 1998 | A |
5722978 | Jenkins, Jr. | Mar 1998 | A |
5728128 | Crickenberger et al. | Mar 1998 | A |
5766179 | Faccioli et al. | Jun 1998 | A |
5772594 | Barrick | Jun 1998 | A |
5891158 | Manwaring et al. | Apr 1999 | A |
5976134 | Huebner | Nov 1999 | A |
6001097 | Campopiano et al. | Dec 1999 | A |
6036657 | Milliman et al. | Mar 2000 | A |
6036696 | Lambrecht et al. | Mar 2000 | A |
6106528 | Durham et al. | Aug 2000 | A |
6129729 | Snyder | Oct 2000 | A |
6168595 | Durham et al. | Jan 2001 | B1 |
6214013 | Lambrecht et al. | Apr 2001 | B1 |
6371959 | Trice | Apr 2002 | B1 |
6635061 | Snyder | Oct 2003 | B1 |
6656189 | Wilson et al. | Dec 2003 | B1 |
6869434 | Choi | Mar 2005 | B2 |
20020058948 | Arlettaz | May 2002 | A1 |
20020151897 | Zirkle, Jr. | Oct 2002 | A1 |
20030220651 | Pusnik et al. | Nov 2003 | A1 |
20040059329 | Zander | Mar 2004 | A1 |
20040082959 | Hayes et al. | Apr 2004 | A1 |
20040167533 | Wilson et al. | Aug 2004 | A1 |
20040215204 | Davison et al. | Oct 2004 | A1 |
20050015092 | Rathbun et al. | Jan 2005 | A1 |
20050065532 | Honl et al. | Mar 2005 | A1 |
20050070903 | Roth et al. | Mar 2005 | A1 |
20050075562 | Szakelyhidi, Jr. et al. | Apr 2005 | A1 |
20060200160 | Border et al. | Sep 2006 | A1 |
Number | Date | Country |
---|---|---|
0 281 763 | Sep 1988 | EP |
0 495 488 | Jul 1992 | EP |
1 344 494 | Sep 2003 | EP |
1 449 484 | Aug 2004 | EP |
1 486 176 | Dec 2004 | EP |
2 713 914 | Jun 1995 | FR |
WO 9530378 | Nov 1995 | WO |
WO 03092515 | Nov 2003 | WO |
Entry |
---|
International Search Report for International Application No. PCT/US06/036546, mailed Feb. 6, 2007. |
Written Opinion of the International Search Authority for International Application No. PCT/US06/036546. |
Number | Date | Country | |
---|---|---|---|
20070083213 A1 | Apr 2007 | US |