The present disclosure relates to a device for spinal surgery and, more particularly, to a modular offset screw.
Spinal pathologies, whether the result of genetic or developmental irregularities, trauma, chronic stress, tumors, or disease can limit the spine's range of motion or threaten critical elements of the nervous system housed within the spine. A variety of systems to correct the alignment of the spinal vertebrae involving the implantation of artificial assemblies in or on the spine have been devised.
The mechanical hardware used to immobilize the spinal column typically involves a series of bone screws and metal spinal rods or plates. When the spine surgery is performed posteriorly, it is common practice to place bone screws into the vertebral bodies and then connect a metal rod between the screws, thus creating a rigid structure between adjacent vertebral bodies. In some cases, the use of these devices may be permanently implanted in the patient. In other cases, the devices may be implanted only as a temporary means of stabilizing or fixing the bones or bone fragments, with subsequent removal when no longer needed.
When using screws, the surgeon directs the screw into the vertebral body. Because different patients have different anatomies, there exists the potential that the screws may be inserted at different angles and at different heights relative to the operating field.
Therefore, a continuing need exists for an improved fixation member that could reduce the time and labor required by a user to insert the fixation member, such as a screw, into a vertebra, while also providing the ability to adjust the angle and the height to ensure proper placement of medical hardware, such as spinal rods and bands.
The present disclosure describes a modular screw that demonstrates a practical approach to meeting the performance requirements and overcoming usability challenges associated with spinal surgeries. In accordance with an embodiment of the present disclosure, a modular screw includes a first assembly and a second assembly. The first assembly includes a base portion having a head portion defining a slot dimensioned to receive a spinal rod, a securing portion defining a first bore and including a first set screw threadably received in the first bore, and a receiving portion defining a second bore. The second assembly is operatively associated with the first assembly. The second assembly includes a first post defining a cavity, a second post including an engaging portion rotatably received in the cavity of the first post, and an elongate screw threadably engageable with the second post. In particular, the second post is dimensioned to be received through the second bore of the receiving portion of the first assembly such that when the first set screw of the securing portion is received in the first bore of the securing portion, the first set screw secures the base portion of the first assembly to the second post. The elongate screw received in the second post causes radial expansion of the engaging portion of the second post, which, in turn, causes the engaging portion to be affixed to the cavity of the first post.
In an embodiment, the engaging portion of the second post and the cavity of the first post may have a ball and socket configuration.
In another embodiment, the engaging portion of the second post may define a slit configured to enable radial expansion of the engaging portion.
In yet another embodiment, the receiving portion of the first assembly may define an annular groove concentrically arranged with the second bore.
In still yet another embodiment, the second post may define internal threads configured to threadably engage the elongate screw.
In an embodiment, the receiving portion of the first assembly may include a ring defining a slit configured to provide radial contraction and expansion of the ring. In particular, the ring may be configured to contract when the first set screw is threadably received in the first bore of the securing portion.
In another embodiment, a first longitudinal axis defined by the first bore of the first assembly may define an acute angle with respect to a second longitudinal axis defined by the second bore.
In yet another embodiment, the first post of the second assembly may include external threads along a length of the first post.
In still yet another embodiment, at least a portion of the first post may be tapered along a length thereof.
In still yet another embodiment, the at least a portion of the first post may extend at least a quarter of the length of the first post.
In still yet another embodiment, the first post of the second assembly may include an inner surface having a keyed surface distal of the cavity.
In still yet another embodiment, the head portion of the first assembly may define a lateral opening configured to receive a band therethrough.
In an embodiment, the head portion of the first assembly may include inner walls defining internal threads configured to threadably engage a set screw configured to secure the spinal rod received in the slot.
In another embodiment, the second post may be configured for a polyaxial range of motion with respect to the first post. The polyaxial motion may define an angle with respect to a longitudinal axis defined by the first post in the range of about 15 degrees and about 60 degrees.
In accordance with another embodiment of the present disclosure, a modular screw includes a first assembly and a second assembly. The first assembly includes a base portion including a first set screw and a head portion configured to receive a spinal rod, the base portion defining a first bore configured to threadably receive the first set screw, and a second bore. The second assembly includes a first post configured to be at least partially received in tissue, a second post operatively associated with the first post, and an elongate screw operatively coupled with the second post to secure a relative orientation of the second post with respect to the first post. The second post is dimensioned to be received in the second bore of the first assembly, whereby a distance between the base portion of the first assembly and the first post is selectively adjustable.
In an embodiment, the first bore of the base portion may define a first axis and the second bore of the base portion may define a second axis. The first and second axes may define an acute angle with respect to each other.
In another embodiment, the second post of the second assembly may include an engaging portion transitionable between a radially expanded state and a radially contracted state, wherein the engaging portion is configured to maintain the orientation of the second post with respect to the first post when the engaging portion is in the radially expanded state.
In yet another embodiment, the first post may include a tapered portion extending along a length of the first post.
In still yet another embodiment, the tapered portion may extend partially along the length of the first post.
In still yet another embodiment, the tapered portion may include external threads.
In accordance with another embodiment of the present disclosure, a post for use with a modular screw assembly includes a head including a keyed inner surface having a key feature for engagement with a driver, a tapered portion having external threads tapered along a length of the tapered portion, and a shank extending distally from the tapered portion. The tapered portion extends at least a quarter of a length of the post.
In an embodiment, the tapered portion may extend at least a half of a length of the post.
In another embodiment, a major diameter of the external threads of the tapered portion may be in the range of about 9 mm and about 13 mm.
In yet another embodiment, the major diameter of the external threads may be in the range of about 10 mm and about 12 mm.
In still yet another embodiment, the major diameter may taper along the length of the post at a ratio of a major diameter at a proximal portion of the tapered portion to a major diameter at a distal portion of the tapered portion in the range of about 1 and about 2.
In an embodiment, the ratio may be in the range of about 1.4 and about 1.7.
In another embodiment, an angle of taper of the tapered portion with respect to a longitudinal axis defined by the tapered portion may be in the range of about 10 degrees and about 60 degrees.
In yet another embodiment, the angle of taper of the tapered portion may be in the range of about 18 degrees and 56 degrees.
In still yet another embodiment, a diameter of the post may be in the range of about 2 mm and 5 mm.
In still yet another embodiment, the diameter of the post may be in the range of about 3 mm and 4 mm.
In still yet another embodiment, the shank may extend at least a half of a length of the post.
In still yet another embodiment, the shank may have a smooth surface.
In still yet another embodiment, the shank may include a gripping surface.
In still yet another embodiment, the gripping surface may include shallow helical threads.
In accordance with another embodiment of the present disclosure, a post for use with a modular screw assembly includes a housing assembly and a post. The housing assembly includes a base portion having a head portion defining a slot, a securing portion defining a first bore, and a receiving portion defining a second bore. The post includes a head, a tapered portion including threads, and a shaft extending distally from the tapered portion. A proximal portion of the head includes a multi-faceted surface configured to engage a tool. The head is configured to be slidably received in the second bore of the housing assembly.
In an embodiment, the securing portion of the housing assembly may include a first set screw configured to secure the base portion to the head of the post when the head of the post is inserted through the second bore of the housing assembly.
Various embodiments of the present disclosure are described hereinbelow with reference to the drawings, wherein:
Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal,” as is conventional, will refer to that portion of the instrument, apparatus, device or component thereof which is farther from the user while, the term “proximal,” will refer to that portion of the instrument, apparatus, device or component thereof which is closer to the user. In addition, the term “cephalad” is used in this application to indicate a direction toward a patient's head, while the term “caudad” indicates a direction toward the patient's feet. Further still, for the purposes of this application, the term “medial” indicates a direction toward the middle of the body of the patient, while the term “lateral” indicates a direction toward a side of the body of the patient, i.e., away from the middle of the body of the patient. The term “posterior” indicates a direction toward the patient's back, while the term “anterior” indicates a direction toward the patient's front. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
With reference to
With reference now to
With continued reference to
With continued reference to
With reference now to
With reference to
With brief reference to
With reference now to
With continued reference to
In this manner, the polyaxial post 54 and the elongate screw 56 may be positioned at various angles relative to a longitudinal axis “Y-Y” defined by the post 52, thereby enabling polyaxial range of motion. The angle may be in the range of about 0 degree and about 85 degrees. Alternatively, the angle may be in the range of about 5 degrees and about 75 degrees. Furthermore, the angle may be in the range of about 15 degrees and about 60 degrees. Under such a configuration, the clinician may selectively adjust the angle of the polyaxial post 54 relative to the longitudinal axis “Y-Y” of the post 52, which, in turn, adjusts a position of the first assembly 12. After a suitable angle has been selected, the clinician may threadably insert the elongate screw 56 into the channel 54c of the polyaxial post 54 in order to expand the engaging portion 58a of the polyaxial post 54 radially outward within the cavity 53 of the post 52 and thereby fixing or setting the angle through, e.g., a friction fit, between the engaging portion 58a and the cavity 53 of the post 52.
Specifically, the polyaxial post 54 and the elongate screw 56 may be fixed at a particular angle relative to the longitudinal axis “Y-Y” of the post 52 by first selecting a desired orientation of the polyaxial post 54 and threadably inserting the elongate screw 56 into the polyaxial post 54. At this time, the polyaxial post 54 may be received through the second bore 22 of the first assembly 12. In particular, the first assembly 12 is selectively positionable at any position along a length of the polyaxial post 54. In this manner, a relative distance between the first assembly 12 and the post 52 may be selectively adjustable. Upon positioning the first assembly 12 at a desired location along the length of the polyaxial post 54, the clinician may tighten the set screw 16 such that the set screw 16 engages the split ring 18, which, in turn, securely engages the polyaxial post 54.
As the slot 14a of the head portion 14 may be moved closer to or farther away from post 52 and may also be pivoted and/or rotated relative to longitudinal axis “Y-Y” of post 52, the modular screw 10 provides increased flexibility in assembling a rod and screw spinal construct. In particular, after the desired number of posts 52 is affixed to the vertebrae to define the number of levels of the construct, each first assembly 12 may be raised or lowered to a desired height for the construct. Additionally, each first assembly 12 may be rotated and/or pivoted into a desired orientation such that the slots 14a of the head portions 14 are the correct orientation for receiving a spinal rod. The ability of the head portions 14 to have rotational adjustment, pivotal adjustment, and height adjustment allows for greater flexibility in assembling a spinal rod and screw construct tailored to the procedure and the patient's anatomy In use, with reference to
The polyaxial post 54 is inserted into the cavity 53 of the post 52. The polyaxial post 54 is selectively adjusted to a desired orientation and/or angle relative to the post 52. At this time, the elongate screw 56 is threadably inserted into the channel 54c of the polyaxial post 54 to lock or securely fix the angle of the polyaxial post 54 relative to the post 52. Thereafter, the polyaxial post 54 is inserted through the second bore 22 of the first assembly 12. A relative distance between the first assembly 12 and the post 52 of the second assembly 50 is selectively adjusted. In particular, the base portion 15 is selectively displaced at a position along a length of the polyaxial post 54. Other spinal devices may be coupled to the modular screw 10. For example, a spinal rod (not shown) may be received in the slot 14a of the head portion 14 of the first assembly 12. It is also contemplated that a band (not shown) may be received through lateral openings 13 (
With reference to
With particular reference to
With continued reference to
In use, initially, an insertion hole is formed in osseous tissue by preparing the surface with a burr or other like instrument and then an awl to start the hole. After forming the insertion hole, the post 500 is inserted into the insertion hole. In particular, the post 500 is inserted into the insertion hole until the tapered portion 515 abuts the osseous tissue, such as, e.g., fitting with an isthmus of the osseous tissue. In this manner, the likelihood of breaching the pedicle is reduced and the need for navigation is eliminated. At this time the clinician may utilize a driver (not shown) to drive the head 512 of the post 500. In this manner, the post 500 is rotated about its longitudinal axis within the insertion hole such that the helical threads 515a of the tapered portion 515 engage the osseous tissue thereby fixing the post 500 to the osseous tissue.
With reference now to
With reference now to
With continued reference to
The post 200 includes a head 212 having a proximal portion 212a and a distal portion 212b. The proximal portion 212 includes a multi-faceted outer surface 213 configured to engage a tool (not shown). The proximal portion 212a is connected to the tapered portion 215. The tapered portion 215 and the shank 217 are substantially identical to the tapered portion 15 and the shank 17 of the post 500, and thus, will not be described herein. The method of use and operation of the post 200 is substantially identical to the method of use and operation of the post 500, and thus, will not be described herein.
With reference now to
With reference now to
Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure.
Additionally, the elements and features shown or described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variations are also included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.
This application is a national phase entry under 35 U.S.C. § 371 of International Application No. PCT/US2018/024829, filed Mar. 28, 2018, which claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. Nos. 62/478,686, filed on Mar. 30, 2017, and 62/478,698, filed on Mar. 30, 2017, the entire contents of each of which are incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2018/024829 | 3/28/2018 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2018/183486 | 10/4/2018 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5382248 | Jacobson et al. | Jan 1995 | A |
5487744 | Howland | Jan 1996 | A |
5609592 | Brumfield | Mar 1997 | A |
5725528 | Errico et al. | Mar 1998 | A |
5735851 | Errico et al. | Apr 1998 | A |
5800435 | Errico et al. | Sep 1998 | A |
6004322 | Bernstein | Dec 1999 | A |
6050997 | Mullane | Apr 2000 | A |
6146383 | Studer et al. | Nov 2000 | A |
6482207 | Errico | Nov 2002 | B1 |
6623485 | Doubler et al. | Sep 2003 | B2 |
6669697 | Pisharodi | Dec 2003 | B1 |
6887242 | Doubler | May 2005 | B2 |
7163538 | Altarac | Jan 2007 | B2 |
7186255 | Baynham et al. | Mar 2007 | B2 |
7314467 | Howland | Jan 2008 | B2 |
7722645 | Bryan | May 2010 | B2 |
7766943 | Fallin et al. | Aug 2010 | B1 |
8007518 | Winslow et al. | Aug 2011 | B2 |
8012181 | Winslow et al. | Sep 2011 | B2 |
8016861 | Mitchell et al. | Sep 2011 | B2 |
8048115 | Winslow et al. | Nov 2011 | B2 |
8048126 | Altarac et al. | Nov 2011 | B2 |
8057515 | Flynn et al. | Nov 2011 | B2 |
8075603 | Hammill, Sr. et al. | Dec 2011 | B2 |
8083772 | Winslow et al. | Dec 2011 | B2 |
8083775 | Winslow et al. | Dec 2011 | B2 |
8083777 | Butters et al. | Dec 2011 | B2 |
8092501 | Mitchell et al. | Jan 2012 | B2 |
8097024 | Winslow et al. | Jan 2012 | B2 |
8114134 | Winslow et al. | Feb 2012 | B2 |
8137384 | Heiges et al. | Mar 2012 | B2 |
8192468 | Biedermann et al. | Jun 2012 | B2 |
8192470 | Biedermann et al. | Jun 2012 | B2 |
8197518 | Hammill, Sr. et al. | Jun 2012 | B2 |
8211155 | Winslow et al. | Jul 2012 | B2 |
8257397 | Winslow et al. | Sep 2012 | B2 |
8333792 | Winslow et al. | Dec 2012 | B2 |
8337530 | Hestad et al. | Dec 2012 | B2 |
8337536 | Mitchell et al. | Dec 2012 | B2 |
8430916 | Winslow et al. | Apr 2013 | B1 |
8506609 | Biedermann et al. | Aug 2013 | B2 |
8518085 | Winslow et al. | Aug 2013 | B2 |
8636781 | Biedermann et al. | Jan 2014 | B2 |
8636782 | Biedermann et al. | Jan 2014 | B2 |
8663290 | Doubler et al. | Mar 2014 | B2 |
8663291 | Doubler et al. | Mar 2014 | B2 |
8881358 | Biedermann et al. | Nov 2014 | B2 |
8900270 | Fauth et al. | Dec 2014 | B2 |
8926671 | Biedermann et al. | Jan 2015 | B2 |
8961568 | McKinley et al. | Feb 2015 | B2 |
8979904 | Jackson et al. | Mar 2015 | B2 |
8986349 | German et al. | Mar 2015 | B1 |
8992579 | Gustine et al. | Mar 2015 | B1 |
8998958 | Dauster et al. | Apr 2015 | B2 |
9017390 | Biedermann et al. | Apr 2015 | B2 |
9044273 | Richelsoph et al. | Jun 2015 | B2 |
9060814 | Doubler et al. | Jun 2015 | B2 |
9066759 | Biedermann et al. | Jun 2015 | B2 |
9119674 | Matthis et al. | Sep 2015 | B2 |
9131971 | Biedermann et al. | Sep 2015 | B2 |
9173684 | Biedermann et al. | Nov 2015 | B2 |
9186187 | Mishra | Nov 2015 | B2 |
9198694 | Mishra et al. | Dec 2015 | B2 |
9247965 | Biedermann et al. | Feb 2016 | B2 |
9254150 | Biedermann et al. | Feb 2016 | B2 |
9277938 | Biedermann et al. | Mar 2016 | B2 |
9277941 | Biedermann et al. | Mar 2016 | B2 |
9277942 | Biedermann et al. | Mar 2016 | B2 |
9333016 | Biedermann et al. | May 2016 | B2 |
9339304 | Biedermann et al. | May 2016 | B2 |
9358047 | Mishra et al. | Jun 2016 | B2 |
9364266 | Biedermann et al. | Jun 2016 | B2 |
9439680 | Biedermann et al. | Sep 2016 | B2 |
9451990 | Fauth et al. | Sep 2016 | B2 |
9452006 | Biedermann et al. | Sep 2016 | B2 |
9486246 | Biedermann et al. | Nov 2016 | B2 |
9492204 | Biedermann et al. | Nov 2016 | B2 |
9517089 | Casey | Dec 2016 | B1 |
9579125 | Raju et al. | Feb 2017 | B2 |
9603635 | Leff et al. | Mar 2017 | B2 |
9615858 | Doubler et al. | Apr 2017 | B2 |
9649142 | Doubler et al. | May 2017 | B2 |
9693808 | Fauth et al. | Jul 2017 | B2 |
9707013 | Rezach et al. | Jul 2017 | B2 |
9820780 | Duncan et al. | Nov 2017 | B2 |
9883892 | Jackson et al. | Feb 2018 | B2 |
9895170 | Biedermann et al. | Feb 2018 | B2 |
9895171 | Webb | Feb 2018 | B2 |
9907574 | Jackson et al. | Mar 2018 | B2 |
9918745 | Jackson et al. | Mar 2018 | B2 |
9936983 | Mesiwala et al. | Apr 2018 | B2 |
9980753 | Jackson et al. | May 2018 | B2 |
20030060823 | Bryan | Mar 2003 | A1 |
20100057135 | Heiges et al. | Mar 2010 | A1 |
20110118783 | Winslow et al. | May 2011 | A1 |
20110245876 | Brumfield | Oct 2011 | A1 |
20110307018 | Zucherman et al. | Dec 2011 | A1 |
20120041490 | Jacob et al. | Feb 2012 | A1 |
20140243900 | Ark et al. | Aug 2014 | A1 |
20150196338 | Biedermann et al. | Jul 2015 | A1 |
20160030086 | Mishra | Feb 2016 | A1 |
20160030090 | Webb | Feb 2016 | A1 |
20160220277 | Rezach et al. | Aug 2016 | A1 |
20160302833 | Baynham | Oct 2016 | A9 |
20170020574 | Biedermann et al. | Jan 2017 | A1 |
20170049482 | Campbell et al. | Feb 2017 | A1 |
20170049484 | Leff et al. | Feb 2017 | A1 |
20170065306 | Fauth et al. | Mar 2017 | A1 |
20170112542 | Biedermann et al. | Apr 2017 | A1 |
20170172630 | Biedermann et al. | Jun 2017 | A1 |
20170224386 | Leff et al. | Aug 2017 | A1 |
20170245898 | May et al. | Aug 2017 | A1 |
20170333085 | Jackson et al. | Nov 2017 | A1 |
20180014858 | Biester et al. | Jan 2018 | A1 |
20180014862 | Raina et al. | Jan 2018 | A1 |
20180014863 | Biester et al. | Jan 2018 | A1 |
20180036039 | Biedermann et al. | Feb 2018 | A1 |
20180055545 | Biedermann et al. | Mar 2018 | A1 |
20180092679 | Toon et al. | Apr 2018 | A1 |
20180110548 | May et al. | Apr 2018 | A1 |
Entry |
---|
International Search Report for PCT/US2018/024829 dated Aug. 3, 2018. |
Number | Date | Country | |
---|---|---|---|
20200038067 A1 | Feb 2020 | US |
Number | Date | Country | |
---|---|---|---|
62478698 | Mar 2017 | US | |
62478686 | Mar 2017 | US |