Patent Grant
12023017
Embodiments of the current disclosure are directed toward an apparatus, methods and systems for spine surgery, and more particularly, an apparatus, methods and systems for separating vertebra during anterior and lateral surgeries.
Surgical operations have been increasingly employed to deal with complications that arise from disc degenerations in patients. For example, fusion operations can be performed to treat such complications, resulting in an ossified connection of vertebrae. Alternatively, or in addition to fusion, disc implants can be used to replace the degenerated disc. In contrast to fusion, this approach has the advantage of preserving the movability of the vertebra adjacent to the defective disc.
Some embodiments of the current disclosure disclose a corpectomy method, comprising the steps of: providing a distractor unit comprising at least a first hydraulic cylinder configured to removably receive a piston of a predetermined length during a surgical procedure; providing the piston; providing a plurality of bone screws; affixing a first bone screw of the plurality of bone screws to a first vertebrae of a spine and a second bone screw of the plurality of bone screws to a second vertebrae of the spine; mounting the distractor unit onto the first bone screw and the second bone screw; and extending the hydraulic piston of the distractor unit to cause the first vertebrae and the second vertebrae to move away from each other.
Some embodiments of the current disclosure disclose a vertebral separation method comprising the steps of: notching at least one pair of vertebrae to mark at least two pairs of positions for inserting bone screws at a lateral distance apart from a center of an anterior spinal column; inserting the bone screws into the at least one pair of vertebrae at the notched positions, the insertion configured at an angle relative to a longitudinal axis of the spinal column so as to avoid penetrating a spinal canal, and such that the bone screws enter, but not go through, opposite cortical bone tissue; mounting a suitably sized spacer ring to each of the bone screws; attaching a distractor unit to each pair of the bone screws in a substantially vertical position at a desired angle relative to an anterior side of the spinal column; locking each distractor unit at the desired angle against each pair of the bone screws; and separating the at least one pair of vertebrae by extending a hydraulic piston within the distractor unit such that the bone screws are moved away from each other.
Such embodiments may include one and/or another (and also, a plurality of) of the following features, structures, functionalities, steps, and/or clarifications, yielding yet still other embodiments of the present disclosure:
Some embodiments of the current disclosure disclose a distractor system including a mostly non-disposable surgical system with some disposable components, configured to at least one of separate, hold apart, and reposition vertebrae during surgery. The distractor system provides a fine control of separation distance between vertebra, facilitating enhanced positioning of, for example, a prosthesis. In some embodiments, the distractor system includes a distractor unit, a hydraulic tube unit, a spanner handle, retractors and frame, measurement gauge, a plurality of hooks, a plurality of bone screws and additional tools such as screw drivers and the like.
Such embodiments may include one and/or another (and also, a plurality of) of the following features, structures, functionalities, steps, and/or clarifications, yielding yet still other embodiments of the present disclosure:
It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein. In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.
The skilled artisan will understand that the drawings primarily are for illustrative purposes and are not intended to limit the scope of the inventive subject matter described herein. The drawings are not necessarily to scale; in some instances, various aspects of the inventive subject matter disclosed herein may be shown exaggerated or enlarged in the drawings to facilitate an understanding of different features. In the drawings, like reference characters generally refer to like features (e.g., functionally similar and/or structurally similar elements).
In some embodiments, the disposable components of the vertebral separation system disclosed herein such as but not limited to the tube unit, the measurement gauge, hooks for attaching the retractor to the distractor unit, the bone screws, etc., may be packaged separately from the non-disposable components such as but not limited to the distractor unit, the spanner handle, the retractors, the frame, and the various tools (e.g., bone screw drivers, etc.). Some embodiments of the current disclosure are directed to a kit comprising the disposable components and the non-disposable components.
With reference to
In some embodiments, the second arm of one of the first jointed part 210 and the second jointed part 240 may include a hollow interior configured for receiving a bone screw for attachment with a vertebrae. For example, the first jointed part 210 and/or the second jointed part 240 may respectively include a second arm 220 and/or 250 that are configured to allow a bone screw to pass through their interiors for attachment with vertebra, thereby allowing the distractor unit 200 (which includes the first jointed part 210 and the second jointed part 240) to be coupled to the vertebrae.
In some embodiments, with the second arms 220 and 250 coupled to the bone screws affixed to vertebra, the distance between the vertebra may correspond at least substantially with the distance between the second arms 220 and 250 (as measured from the joints 270 and 280, for example). In such embodiments, the distance between the vertebra may be varied (for example, to access a damaged disc between the vertebra) by varying the distance between the second arms 220 and 250. In some embodiments, the distance between the second arms 220 and 250 may be varied based on the extent of the second arm 260's penetration into the hollow interior of the first arm 230. For example, the mating between the second arm 260 and the first arm 230 may be configured such that the distance the second arm 260 traverses within the hollow interior of the first arm 230 before being secured to the first arm 230 (and its motion within the first arm 230 ceased) may be variable, either continuously or step-wise. That is, the hydraulic piston system comprising the first arm 230 and the second arm 260 may change its length continuously or in a step-wise fashion based on the distance the first arm 230 traverses as it enters the second arm 260.
For example, as discussed above, in some embodiments, the first arm 230 and the second arm 260 may make up a hydraulic piston system, and the separation distance between the second arms 220 and 250 may correspond at least substantially to the length of the hydraulic piston system. In such embodiments, the separation distance can be controlled by selecting an appropriately sized piston and/or by controlling the extension of the piston (for example, by varying the pressure within the hydraulic tube units that deliver/withdraw pressure to the piston and cause/reduce its extension). In some embodiments, the second arm 260 (e.g., the piston) may be replaceable and the separation distance between the vertebra may be varied by using different length second arm 260 or pistons. For example, in some embodiments, the second arm 260 or the pistons may have a length ranging from about 30 mm to about 120 mm, from about 40 mm to about 100 mm, from about 50 mm to about 90 mm, from about 60 mm to about 80 mm, about 37 mm, about 47 mm, about 57 mm, about 77 mm, about 87 mm, about 100 mm, including values and subranges therebetween. By selecting a piston with desired length, in some embodiments, the length of the hydraulic piston system may be varied, facilitating the control of the vertebra separation distance. In some embodiments, the hydraulic piston system may be extended by increasing the pressure in the hydraulic tube of the distractor with the use of the spanner handle.
As an example illustration of the above embodiments, the second arms 220 and 250 may be coupled to adjacent vertebrae via bone screws, the adjacent vertebrae sandwiching a damaged disk. To access the damaged disc with ease, the distance between the second arms 220 and 250 may be increased by using a longer piston and/or extending the hydraulic piston system as discussed above, for example, thereby increasing the distance between the neighboring vertebrae and providing access to the damaged disc.
In some embodiments,
Upon securing the bone screws 310 and 320 to different vertebrae, in some embodiments, a hydraulic distractor unit 330 including a first hollow arm 340 and a second hollow arm 350 may be coupled to the bone screws 310 and 320 for controlling the separation distance between the vertebrae as well as positioning and stability of the vertebral body in general, which may lead to increased access to the discs and/or vertebrae therebetween. For example, the first hollow arm 340 and the second hollow arm 350 may be coupled to the bone screws 310 and 320 by allowing the bone screws 310 and 320 to pass through the hollow interiors of the first hollow arm 340 and the second hollow arm 350. In some embodiments, a plurality of pairs of bone screws and distractors may be used for additional control over separation distances and positioning of vertebra. As an example,
An example application of the apparatus, methods and systems disclosed herein is for discectomy, where a damaged or abnormal disc is surgically removed. In such embodiments, the bone screws and the distractor disclosed herein can be used to control the separation, positioning and stability of vertebra. For example, the bone screws and the distractor may be mounted into the vertebra to separate the vertebra to facilitate the removal of the damaged disc.
Positioning and Mounting Bone Screws. For ventral surgery, a plurality of screws (e.g., four) and two distractor units can be used (e.g., as shown in
Mounting of Distractor Units. In some embodiments, prior to mounting a distractor unit, any protective cages may be removed from the screws and spacer rings of suitable length may be mounted. Then, distractor units may be attached on bone screws, paired in the longitudinal direction of the vertebral column, as shown in
Separating Vertebrae. To separate vertebrae coupled to distractor units, in some embodiments, the handles of the distractor (such as handle 140 in
In some embodiments, a corpectomy may be performed using at least some of the steps discussed above with respect to a discectomy. In some embodiments, the same steps as in discectomy may be performed in the case of corpectomy, except for the use of longer distractor units to mount on vertebra that are farther apart from each other (compared to discectomy cases, for example). For example, longer distractor units may be used to remove some or all parts of a vertebral body.
In some embodiments, the expansion of the retractors 610 is facilitated by a sliding frame 620 that is coupled to the pair of retractors and pushes the retractors 610 away from each other as the frame slides. For example, the sliding frame 620 may be a rectangular frame where one of the opposite side pair is configured to slide along the other side pair when expanding the retractors 610 away from each other, e.g.,
In some embodiments, the vertebra 710 and 720 may not be neighboring vertebra, i.e., there may be a plurality of discs and one or more vertebra in between the vertebra 710 and 720. In such embodiments, the distractor units 740 control and manage the separation distance between the vertebra 710 and 720, providing access to the plurality of discs and the one or more vertebra. When replacing more than one disc, in some embodiments, the most inferior disc may be replaced first. In such embodiments, screws may be positioned in the superior vertebra to facilitate re-use of screw holes.
As an example application, the hydraulic spinal distractor disclosed herein can be used in treatments that include with corpectomy, vertebral body replacement and fusion to treat spondylodiscitis of vertebra L1 and L2 discovered with the use of an MRI scan. The MRI can show progressive vertebral body destruction, indicated by a high MRI signal for fluid in disc space. Using an anterior approach, bone screws may be inserted or implanted to separate the vertebra surrounding the damaged body and stabilize during debridement and decompression/resection. Initially, the cortical structures of vertebra Th12 and L3 may be opened using an awl. Further, the bone screws may be inserted, for example, bi-cortically. Upon the insertion of the bone screws, the distractors may be mounted and an increase in hydraulic power distraction causes the vertebra to move away from each other, i.e., separate and hold apparat vertebral bodies. Once the vertebra are distanced from each other, debridement may occur to remove damaged tissues in the vicinity as well as corpectormy of vertebra L1 and L2. For example, a titanium mesh cage with lordotic end-plates may be assembled and filled up with bone graft and the mesh cage may be inserted and aligned with an x-ray. To allow compression on the cage, pressure in the hydraulic system may be decreased. Further, the distractor and the bone screws may be withdrawn and the insertion points of the screws may be sealed with bone wax. As a check, the length of the thoraco-lumbar plate Th12-L3 may be measured and fixed if desired. A later scan (e.g., CT scan about 6 months later) may be performed to determine if bone material has grown into the previously damaged region.
While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, components and configurations described herein are meant to be an example and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure. Still further, some embodiments disclosed herein are distinguishable over prior art references by specifically lacking one or more features disclosed in the prior art; that is, claims to such embodiments may include negative limitations so as to be distinguished from the prior art.
Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
Any and all references to publications or other documents, including but not limited to, patents, patent applications, articles, webpages, books, etc., presented anywhere in the present application, are herein incorporated by reference in their entirety. Moreover, all definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.
The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of” or, when used in the claims, “consisting of” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of” “only one of” or “exactly one of” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.
As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
This application is a continuation of U.S. patent application Ser. No. 16/036,916, filed Jul. 16, 2018, entitled “Apparatus, Methods and Systems for Spine Surgery”, which claims priority to and the benefit of U.S. Provisional Patent Application No. 62/532,562, filed Jul. 14, 2017, entitled “Methods and Systems for Anterior Surgery”, which is incorporated by reference herein in its entirety.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2371519 | Haynes | Mar 1945 | A |
| 4386603 | Mayfield | Jun 1983 | A |
| 4611580 | Wu | Sep 1986 | A |
| 4658809 | Ulrich et al. | Apr 1987 | A |
| 4733657 | Kluger | Mar 1988 | A |
| 4854304 | Zielke | Aug 1989 | A |
| 4944743 | Gotzen et al. | Jul 1990 | A |
| 5219349 | Krag et al. | Jun 1993 | A |
| 5304179 | Wagner | Apr 1994 | A |
| 5431658 | Moskovich | Jul 1995 | A |
| 6139493 | Koros | Oct 2000 | A |
| 6342074 | Simpson | Jan 2002 | B1 |
| 6565568 | Rogozinski | May 2003 | B1 |
| 7387635 | Keller | Jun 2008 | B2 |
| 8764800 | Johansson et al. | Jul 2014 | B2 |
| 9049989 | Crenshaw | Jun 2015 | B2 |
| 9186132 | Nunley et al. | Nov 2015 | B2 |
| 9615938 | Frey | Apr 2017 | B2 |
| 9700425 | Smith et al. | Jul 2017 | B1 |
| 10159475 | Frey | Dec 2018 | B2 |
| 10368854 | Pell | Aug 2019 | B2 |
| 10405842 | Kim | Sep 2019 | B2 |
| 10952714 | Mikulowski | Mar 2021 | B1 |
| 20020161446 | Bryan et al. | Oct 2002 | A1 |
| 20030055427 | Graf | Mar 2003 | A1 |
| 20030181800 | Bonutti | Sep 2003 | A1 |
| 20030236472 | Van Hoeck | Dec 2003 | A1 |
| 20040002758 | Landry et al. | Jan 2004 | A1 |
| 20040059271 | Berry | Mar 2004 | A1 |
| 20040148028 | Ferree et al. | Jul 2004 | A1 |
| 20040220567 | Eisermann et al. | Nov 2004 | A1 |
| 20040220582 | Keller | Nov 2004 | A1 |
| 20040225295 | Zubok et al. | Nov 2004 | A1 |
| 20050159651 | Raymond et al. | Jul 2005 | A1 |
| 20050177156 | Timm et al. | Aug 2005 | A1 |
| 20050177240 | Blain | Aug 2005 | A1 |
| 20050203532 | Ferguson et al. | Sep 2005 | A1 |
| 20050245928 | Colleran | Nov 2005 | A1 |
| 20080077155 | Diederich | Mar 2008 | A1 |
| 20080172062 | Donahue et al. | Jul 2008 | A1 |
| 20080255567 | Accordino | Oct 2008 | A1 |
| 20080262501 | Chen et al. | Oct 2008 | A1 |
| 20090259107 | Crenshaw | Oct 2009 | A1 |
| 20090270873 | Fabian | Oct 2009 | A1 |
| 20110160866 | Laurence et al. | Jun 2011 | A1 |
| 20120130180 | Pell | May 2012 | A1 |
| 20120136355 | Wolfson | May 2012 | A1 |
| 20120184958 | Knuchel et al. | Jul 2012 | A1 |
| 20130225935 | Nunley et al. | Aug 2013 | A1 |
| 20140257313 | Frey | Sep 2014 | A1 |
| 20160007983 | Frey | Jan 2016 | A1 |
| 20160213500 | Beger | Jul 2016 | A1 |
| 20170209287 | Frey | Jul 2017 | A1 |
| 20180085105 | Kim | Mar 2018 | A1 |
| 20200093614 | Arramon | Mar 2020 | A1 |
| 20200113713 | LaMarca | Apr 2020 | A1 |
| Number | Date | Country |
|---|---|---|
| 0978258 | Feb 2000 | EP |
| WO-9002527 | Mar 1990 | WO |
| WO-2006130085 | Dec 2006 | WO |
| Entry |
|---|
| Extended European Search Report for European Application No. 09755134.5, dated Apr. 25, 2013, 6 pages. |
| International Preliminary Report on Patentability for International Application No. PCT/SE2009/000275, dated Aug. 11, 2010, 9 pages. |
| International Search Report for International Application No. PCT/SE2009/000275, dated Sep. 11, 2009, 6 pages. |
| Medtronic, “Cornerstone—SR Cervical Carbon Cage System”, Announcement Medtronic., Jan. 1, 1998, pp. 1-11, XP007916830. |
| Written Opinion of the International Searching Authority for International Application No. PCT/SE2009/000275, dated Sep. 11, 2009, 7 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 62532562 | Jul 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16036916 | Jul 2018 | US |
| Child | 17208789 | US |
