Source: https://patents.google.com/patent/US20180071105A1/en
Timestamp: 2019-12-09 21:49:46
Document Index: 31131934

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61']

US20180071105A1 - Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis - Google Patents
Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis Download PDF
US20180071105A1
US20180071105A1 US15/816,714 US201715816714A US2018071105A1 US 20180071105 A1 US20180071105 A1 US 20180071105A1 US 201715816714 A US201715816714 A US 201715816714A US 2018071105 A1 US2018071105 A1 US 2018071105A1
US15/816,714
US10251757B2 (en
2008-09-17 Priority to US9761608P priority Critical
2009-09-02 Priority to US23927709P priority
2009-09-17 Priority to US12/561,805 priority patent/US9095440B2/en
2012-09-06 Priority to US13/604,931 priority patent/US20130245699A1/en
2013-04-24 Priority to US201361815634P priority
2014-04-24 Priority to US14/260,833 priority patent/US10188438B2/en
2015-07-31 Priority to US14/815,332 priority patent/US9820862B2/en
2017-11-17 Priority to US15/816,714 priority patent/US10251757B2/en
2017-11-17 Application filed by Skeletal Dynamics LLC filed Critical Skeletal Dynamics LLC
2018-03-15 Publication of US20180071105A1 publication Critical patent/US20180071105A1/en
2018-12-19 Assigned to SKELETAL DYNAMICS, LLC reassignment SKELETAL DYNAMICS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SALCEDO, JUAN, ORBAY, JORGE L., NORMAN, THOMAS, GIL, ALEXANDER
2019-04-09 Publication of US10251757B2 publication Critical patent/US10251757B2/en
210000000282 Nails Anatomy 0 description 187
210000000707 Wrist Anatomy 0 description 44
A grooved slot is provided in a bone fixation device for osteosynthesis that permits adjustment of the bone fixation device relative to the bone, before the bone fixation device is finally fixed to the bone. The grooves are formed on the two longitudinally extending, facing walls of the slot, with the grooves on a first side wall of the slot having a vertical displacement of exactly one-half pitch relative to the grooves on the second, opposite side wall of the slot
The present application is a Continuation-in-Part of co-pending U.S. patent application Ser. No. 14/815,332, filed on Jul. 31, 2015, issuing on Nov. 21, 2017 as U.S. Pat. No. 9,820,862, which application was a divisional of U.S. patent application Ser. No. 12/561,805, filed on Sep. 17, 2009, now U.S. Pat. No. 9,095,440, which claimed priority to: Provisional Patent Application No. 61/097,616, filed on Sep. 17, 2008 and Provisional Patent Application No. 61/239,277, filed on Sep. 2, 2009; the present application additionally claims priority to co-pending U.S. patent application Ser. No. 13/604,931, filed on Sep. 6, 2012, which claimed priority to U.S. patent application Ser. No. 13/366,886, now U.S. Pat. No. 8,814,918, which claimed priority to: Provisional Patent Application No. 61/531,485, filed on Sep. 6, 2011, Provisional Patent Application No. 61/536,316, filed on Sep. 19, 2011 and Provisional Patent Application No. 61/595,986, filed on Feb. 7, 2012; the present application further claims priority to co-pending U.S. patent application Ser. No. 14/260,833, filed on Apr. 24, 2014, which claimed priority to Provisional Patent Application No. 61/815,634, filed on Apr. 24, 2013; all of the above-named applications being incorporated herein, by reference, in their entireties.
The instant invention relates to a grooved slot for incorporation into a bone fixation device for osteosynthesis, which slot permits movement and adjustment of the bone fixation device, intraoperatively, prior to fixation, and to a bone fixation device including the described grooved slot.
Arthrodesis or joint fusion is a well known procedure for osteosynthesis often associated with the spine, the ankle or the wrist. In particular, the wrist or carpus is the complex joint between the forearm and the hand. It allows the hand three degrees of movement important to manual dexterity: flexion/extension in the palmar-dorsal plane; adduction/abduction, also referred to as radial or ulnar deviation, in the medial-lateral plane and circumduction, the combination of both movements. These degrees of movement combine with the degrees of movement provided by the forearm (pronation/supination), the elbow (flexion/extension) and those of the shoulder to give the hand a vast positional range.
Fracture fixation is another form of osteosynthesis, involving the reduction and internal fixation of a bone fracture with an implantable device. In contrast to arthrodesis of a joint, discussed above, fracture fixation unites the ends of a fractured bone by mechanical means, such as a bone plate.
Additionally, plates and other bone fixation devices have been used in fracture fixation, as well as arthrodesis.
What is needed is a bone fixation device for osteosynthesis, the placement of which can be easily adjusted by a surgeon, intraoperatively, during fixation.
It is accordingly an object of this invention to provide a grooved slot in a bone fixation device for osteosynthesis that permits adjustment of the bone fixation device relative to the bone, before the bone fixation device is finally fixed to the bone.
In accordance with one particular embodiment of the invention, at least one slot disposed through the body of a bone fixation device includes grooves formed on the two longitudinally extending, facing walls of the slot, with the grooves on a first side wall of the slot having a vertical displacement of exactly one-half pitch relative to the grooves on the second, opposite side wall of the slot.
In one particular embodiment of the invention, the slotted bone fixation device is used to perform arthrodesis. In another embodiment of the invention, the slotted bone fixation device is used to perform fracture fixation.
Although the invention is illustrated and described herein as embodied in a grooved slot allowing adjustment of a position of a bone fixation device and/or a bone fixation device including such a grooved slot, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
FIGS. 19A and 19B are elevational views of the drill guide of FIGS. 18A and 18B in communication with, respectively, the distal nail portion and the proximal nail portion of the intramedullary arthrodesis nail of FIG. 15A.
FIG. 21 is a cross-sectional view of a bone fixation device including an elongated, grooved slot and a fastener engaged with the grooves of the slot in accordance with one embodiment of the invention.
FIG. 22 is a cross-sectional view of a bone fixation device including an elongated, grooved slot and a fastener engaged with the grooves of the slot in accordance with one embodiment of the invention.
FIG. 23A is a perspective view of a bone having a fracture on which a bone fixation device in accordance with one embodiment of the invention is loosely mounted in a first position.
FIG. 23B is a partial, enlarged perspective view of the bone and bone fixation device, in the first position, of FIG. 23A.
FIG. 23C is a partial, enlarged perspective view of the bone and bone fixation device of FIG. 23A, after the bone fixation device has been moved to a second position, in accordance with one particular embodiment of the invention.
FIG. 24 is a partial, enlarged, perspective view of a bone fixation device including an elongated, grooved slot in accordance with a particular embodiment of the invention.
FIG. 25 is a cross-sectional view of an elongated, grooved slot of a bone fixation device for slidably mating with a fastener in accordance with one embodiment of the present invention.
Referring now to FIGS. 1, 2, 3 and 13, the proximal nail portion 12, 22 includes an internally faceted (for example hexagonal or octagonal) socket 15, 25 intended to receive a matching externally faceted head portion 15 a of the distal nail portion 11. A thru-hole 15 d, 25 d extends through the outer wall of the socket 15, 25 and opens into the socket 15, 25. Thru-hole 15 d, 25 d is, in the present embodiment, unthreaded to allow the insertion of set screw 16 into threaded hole 15 b, when the head portion 15 a is mated with the socket 15, 25. It should be noted that when set screw 16 is fully tightened within threaded hole 15 b it engages the lower interior surface of socket 15, 25 in such a way that distal nail portion 11 becomes affixed to proximal nail portion 12, 22, impeding any movement along the longitudinal axis of the nail portions 12, 22. Furthermore, the external facets of head portion 15 a simultaneously engage internal facets 15 c, 25 c located in the sockets 15, 25, thus impeding any rotational motion between distal nail portion 11 and proximal nail portion 12, 22.
Referring now to FIGS. 16D-16F there is shown a particular embodiment of the splines 152 in head 150 of distal nail 110 and the corresponding splines 171 of a connector 170. In this particular embodiment there are shown twelve splines 152 in head 150 of distal nail portion 110 and twenty splines 171 in connector portion 170. This differentiation in the number of head splines relative to connector splines is advantageous as it provides more rotational adjustability. If the number of splines in both the head and the connector were identical, for example, twelve in each, the rotational adjustability of the connector relative to the head would be in steps of 30 degrees each. However from any initial position, as illustrated in FIG. 16E, the twenty splines 171 in the connector engage the twelve splines 152 in the head at points a, b, c, d, e, f, g and h. The rotational adjustability of the connector relative to the head is in steps of angle A (in this case, 6 degrees each, instead of 30 degrees) and the new points of engagement of splines 171 in the connector with splines 152 in the head would be at points a′, b′, c′, d′, e′, f, g′ and h′ (FIG. 16F). It should be noted that the particular number of splines 152 in the head and 171 in the connector illustrated herein is not intended to be limiting since different number of combinations exist that provide different degrees of rotational adjustment with a corresponding increase or reduction in the number of spline engagement points. The minimum number of splines is two in the head 150 and one in the connector 170 (or vice-versa), which provides engagement but eliminates the rotational adjustability.
The surgeon then selects the desired deviation for the arthrodesis in both the medial-lateral plane and the dorsal-palmar plane. The formable body portion 19 of the distal nail portion 11 is then bent into the proper angles using a bending tool (not shown). Finally, the faceted head 15 a of the distal nail portion 11 is inserted into the correspondingly faceted socket 15, 25, 35 of the proximal nail portion 12, 22, 32 and the two nail portions are lockingly affixed to each other by inserting and tightening the set screw 16, thus forming a unitary rigid body of the distal and proximal nail portions. Alternatively, the two nail portions can be affixed with a clip 36, as discussed in connection with FIG. 14. After locking the nail portions together, the incisions are closed by the surgeon in the standard fashion.
The connector 170, 175 is reinstalled into the distal nail 110 and secured using one of the set screws 160. Pronation and supination may be adjusted by incrementally repositioning the connector around its axes with the distal and proximal nails, using the spline features 151, 172. If using a straight connector, no repositioning is necessary. The connector is then attached to the proximal nail and the correct pronation and supination is reassessed. Once the desired position is achieved, the surgeon applies distal to proximal compression on the connector and installs the other set screw 160 to fix the connector to the proximal nail 120. Both set screws 160 are tightened to firmly affix the connector to the distal nail and the proximal nail, thus forming a unitary rigid body of the connector, distal nail and proximal nail.
The longitudinal slots 13, 130 discussed above, can be used in connection with other types of bone fixation devices, in order to provide ease of installation intraoperatively. For example, referring now to FIGS. 21 and 22, there are illustrated bone fixation devices 320, 320′ including a grooved, elongated slot 330 in accordance with the embodiments of the present invention.
More particularly, in the present preferred embodiment, the grooved, elongated slot 330 includes two opposing, grooved parallel side walls which interlock with threads 345 of a fastener 340, which is, in the present embodiment, a bone screw. In the present embodiment, at least two grooves 335 on each of the two parallel side walls of elongated slot 330 are disposed parallel to a longitudinal axis of the bone fixation device 320 and are configured to match the shape and the pitch of the threads 345 of screws 340. Note that, the longitudinal axis of the bone fixation device 320 may be a straight or curved longitudinal axis, depending on the geometry of the bone fixation device 320.
Additionally, in one particular embodiment of the instant invention, the grooves 335 on a first side wall 330 a of the elongated slot 330 have a vertical displacement of exactly one-half pitch relative to the grooves 335 on the second, opposite side wall 330 b of the slot 330. This relative displacement of opposite side grooves 335 permits the stable engagement of the threads 345 of screws 340 into the side wall grooves 335 of slot 330 at the tangential contact points of the aforementioned threads 345 with the grooves 335, while still permitting the loosely engaged screws 340 to be displaced horizontally to any desired position along the length the slot 330. Complementarily, once the screws are held in a fixed position (for example, by having been inserted into holes drilled in a bone cortex) the slot 330 (and consequently, the totality of the bone fixation device 320, 320′) may be displaced longitudinally through a wide range of positions along the slot 330, until such time as the surgeon wishes to fix it at a final desired location by further tightening of the screws.
Referring now to FIGS. 23A-25, there will be described another embodiment of the invention, wherein one or more grooved, elongated slots 430 are used in connection with a bone fixation device for performing osteosynthesis of a fracture of the bone B. In the present embodiment described, bone fixation device 420 is a bone plate made of biocompatible metal (such as titanium, cobalt chrome or stainless steel), PEEK or bio-absorbable material (such as PLA or PGA) or a combination of metal, PEEK and/or bio-absorbable material, and configured to be mounted to the outside surface of a bone B.
Referring again to FIGS. 23A-25, the bone fixation device 420 includes one or more elongated slot 430 with two opposing, grooved parallel side walls 430 a and 430 b. In a preferred embodiment, at least two grooves 435 on each of the two parallel side walls of elongated slot 430 are disposed in alignment with the longitudinal axis L (which may be straight or curved, based on the geometry of the bone fixation device 420) and are configured to match the shape and the pitch of the threads 445 of screws 440. As shown more particularly in FIG. 25, in one particular embodiment of the instant invention, the grooves 435 on a first side wall 430 a of the slot 430 have a vertical displacement of exactly one-half pitch relative to the grooves 435 on the second, opposite side wall 430 b of the slot 430. This relative displacement of opposite side grooves 435 permits the stable engagement of the threads 445 of screws 440 into the side wall grooves 435 of slot 430 at the tangential contact points of the aforementioned threads 445 with the grooves 435, while still permitting the loosely engaged screws 440 to be displaced horizontally to any desired position along the length the slot 430. Complementarily, once the screws are held in a fixed position (for example, by having been inserted into holes drilled in a bone cortex) the slot 430 (and consequently, the totality of the bone fixation device 420) may be displaced longitudinally through a wide range of positions along the slot 430, until such time as the surgeon wishes to fix it at a final desired location by further tightening of the screws. Compare, for example, FIGS. 23B, 23C and 24.
More particularly, as illustrated in FIGS. 23A and 23B, the screw 440 is engaged in the bone B, through the slot 430 at a first position in which the screw is disposed at a first end of the slot, with at least some of the threads 445 engaged with two or more grooves 435 on each sidewall 430 a of the elongated slot 430. It should be noted that the ends of each elongated slot 430 are not threaded or grooved in the present embodiment. With the screws 440 fixed to the bone, but loosely engaged within the elongated slot, the bone fixation device 420 can be slid along its longitudinal axis L, to translate the device 420 to another position. In the example illustrated in FIGS. 23A-23C, the bone fixation device 420 is disposed initially with the screw 440 disposed at a first position in the slot 430, but moving the plate in the direction of arrow A displaces the device 420, and correspondingly the slot 430, relative to the fixed screws 440. See also, for example, FIG. 24, wherein the screw is illustrated as being disposed at yet another desired position in the slot 430. Optionally, a scale 405 may be provided on the bone fixation device 420, adjacent the slot 430, to assist the surgeon in positioning the device.
Once the bone fixation device 420 is displaced along the screws 440 to a desired location, the screws can be tightened to lock the head 447 of the screw to the bone fixation device 420, thus preventing further displacement and, consequently, fixing the bone fixation device 420 to the bone at that location. In the embodiments shown, slot 430 is provided with a beveled portion 432 in which the head 447 of the screw can seat (i.e., countersink). More particularly, the device 420 can include a recess 432 at the top edge of the slot 430 so that, once tightened, the head 447 of the screw does not protrude much above the bone fixation device 420.
Additionally, in one embodiment of the invention illustrated in FIGS. 24 and 25, to ensure that the head 447 of the screw 440 sits in the recess 432, the head portion is additionally threaded to lock into the parallel grooves of the slot, in order to bring the head 447 into the recess 437. Although the device 420 includes a plurality of apertures therethrough for receiving fasters, as few as one of those apertures, or as many as all of those apertures, may be grooved, and still fall within the scope and spirit of the present invention. Furthermore, some apertures may be circular threaded apertures (not shown) adapted to accept additional screws 440 to be inserted and locked into the bone fixation device after it has been placed in a desired location, to further secure the construct.
Although a particular example of an elongated slot in a bone fixation device has been described above, this is not intended to be limited to only these details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
1. An elongated bone fixation device for osteosynthesis, defining a longitudinal axis and configured to receive one or more fasteners in apertures therethrough for positioning the device relative to a bone, at least one fastener having a thread defining a shape and a pitch, the elongated bone fixation device, comprising:
at least one aperture configured as an elongated slot extending through the bone fixation device, said elongated slot configured to receive the at least one fastener from a top of the slot;
said elongated slot including two opposing, grooved parallel side walls and two ungrooved walls enclosing said slot at each end, the grooves on each of said parallel side walls having a shape and a pitch configured to match the shape and pitch of the thread of the fastener, all of said grooves being disposed parallel to each other; and
wherein the grooves on a first of said parallel side walls are vertically displaced one-half of said pitch relative to the grooves on the second, opposite, side wall to permit the bone fixation device to be displaced longitudinally along said slot when the at least one threaded fastener is first engaged into a cortex of a bone through the top of said slot, and to fix the bone fixation device relative to the bone when the fastener is further tightened such that the threads of the fastener are fully engaged with said grooves.
2: The elongated bone fixation device of claim 1, wherein the bone fixation device is an intramedullary nail.
3: The elongated bone fixation device of claim 1, wherein the bone fixation device is a bone plate.
4: The elongated bone fixation device of claim 1, wherein the at least one elongated slot is at least two elongated slots.
5: The elongated bone fixation device of claim 1, wherein at least one elongated slot is aligned with the longitudinal axis of the bone fixation device.
6: The elongated bone fixation device of claim 1, wherein at least one aperture is configured as a circular threaded aperture.
7: A method for performing osteosynthesis, comprising the steps of:
providing a bone fixation device according to claim 1;
placing the bone fixation device into an initial position relative to a bone;
inserting a threaded fastener through the elongated slot into a cortex of a bone;
adjusting the position of the bone fixation device relative to the bone after the inserting step; and
after the adjusting step, tightening the threaded fastener into a locked position relative to the elongated slot to fix the bone fixation device relative to the bone.
8. An elongated slot formed in a bone fixation device for osteosynthesis, and configured to receive one or more fasteners from a top of the elongated slot therethrough for positioning the bone fixation device relative to a bone, at least one fastener having a thread defining a shape and a pitch, the elongated slot, comprising:
two opposing, grooved parallel side walls, the grooves on each of said parallel side walls having a shape and a pitch configured to match the shape and pitch of the thread of the fastener, all of said grooves being disposed parallel to each other; and
9. The elongated slot according to claim 8, further including two ungrooved walls enclosing said slot at each end, wherein said two grooved side walls are longer than the two ungrooved end walls.
10: The elongated slot of claim 8, wherein the bone fixation device is an intramedullary nail.
11: The elongated slot of claim 8, wherein the bone fixation device is a bone plate.
12. The elongated bone fixation device of claim 1, wherein at least one elongated slot is aligned with the longitudinal axis of the bone fixation device.
13. The elongated slot according to claim 12, wherein all of said grooves are disposed parallel to the longitudinal axis of the bone fixation device.
US15/816,714 2008-09-17 2017-11-17 Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis Active US10251757B2 (en)
US9761608P true 2008-09-17 2008-09-17
US23927709P true 2009-09-02 2009-09-02
US12/561,805 US9095440B2 (en) 2008-09-17 2009-09-17 Intramedullary arthrodesis nail and method of use
US201361815634P true 2013-04-24 2013-04-24
US14/260,833 US10188438B2 (en) 2013-04-24 2014-04-24 Bone plate with transversal slots for receiving a fastener
US14/815,332 US9820862B2 (en) 2008-09-17 2015-07-31 Intramedullary nail and method of use
US14/260,833 Continuation-In-Part US10188438B2 (en) 2013-04-24 2014-04-24 Bone plate with transversal slots for receiving a fastener
US14/815,332 Continuation-In-Part US9820862B2 (en) 2008-09-17 2015-07-31 Intramedullary nail and method of use
US14/815,332 Division US9820862B2 (en) 2008-09-17 2015-07-31 Intramedullary nail and method of use
US16/360,618 Continuation US20190216611A1 (en) 2008-09-17 2019-03-21 Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis
US20180071105A1 true US20180071105A1 (en) 2018-03-15
US10251757B2 US10251757B2 (en) 2019-04-09
ID=61559362
US15/816,714 Active US10251757B2 (en) 2008-09-17 2017-11-17 Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis
US16/360,618 Pending US20190216611A1 (en) 2008-09-17 2019-03-21 Grooved slot allowing adjustment of the position of a bone fixation device for osteosynthesis
US (2) US10251757B2 (en)
US781571A (en) * 1904-04-12 1905-01-31 George P Thomas Temporary fastening.
US526580A (en) 1894-09-25 osyor
2017-11-17 US US15/816,714 patent/US10251757B2/en active Active
2019-03-21 US US16/360,618 patent/US20190216611A1/en active Pending
US20190216611A1 (en) 2019-07-18
US10251757B2 (en) 2019-04-09
JP2010142657A (en) 2010-07-01 Plate and laminoplasty bridging device
Owner name: SKELETAL DYNAMICS, LLC, FLORIDA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ORBAY, JORGE L.;NORMAN, THOMAS;SALCEDO, JUAN;AND OTHERS;SIGNING DATES FROM 20181205 TO 20181218;REEL/FRAME:047812/0650