Patent Application
20180353225
The present invention relates to the field of orthopedic surgery, in particular to devices, systems and methods for stabilizing and/or fixing bones and/or joints in a patient. More particularly, the present invention relates to instruments, assemblies and methods for surgical procedures on the spine.
Bone may be subject to degeneration caused by trauma, disease, and/or aging. Degeneration may destabilize bone and affect surrounding structures. For example, destabilization of a spine may result in alteration of a natural spacing between adjacent vertebrae. Alteration of a natural spacing between adjacent vertebrae may subject nerves that pass between vertebral bodies to pressure. Pressure applied to the nerves may cause pain and/or nerve damage. Maintaining the natural spacing between vertebrae may reduce pressure applied to nerves that pass between vertebral bodies. A spinal stabilization procedure may be used to maintain the natural spacing between vertebrae and promote spinal stability.
The fixation and/or stabilization of bones and/or bone fragments is/are commonly required by orthopedic surgeons to treat injuries such as fractures or disease. To accomplish this, the bones/bone fragments can be joined by a rod, plate or the like, which is fixed to the bones/bone fragments via fasteners such as screws, pins or the like. The connection by the rod(s), plate(s) or the like maintains the bones/bone fragments in a desired orientation and/or at desired spacings, positions, etc.
In spinal surgery, it is often necessary to secure various implants to the vertebrae and interconnect the vertebrae by attaching one or more rods or plates to the implants. Procedures such as reduction, compression and/or distraction are commonly carried out in an effort to repair fractures or disease caused by trauma, disease, genetic abnormalities and/or aging.
Conventional stabilization systems may require a large incision and/or multiple incisions in the soft tissue to provide access to a portion of the spine to be stabilized. Conventional procedures may result in trauma to the soft tissue, for example, due to muscle stripping. Minimally invasive techniques are being developed to minimize the size of incisions/degree of opening of the patient required to perform surgical procedures on the spine.
There is a continuing need for instruments, assemblies and procedures to facilitate such minimally invasive procedures.
According to one aspect of the present invention, a sleeve for performing surgical procedures is provided that includes: an elongate main body; a channel extending within a length of the elongate main body; slots formed in the elongate main body and extending linearly along the length of the elongate main body the slots comprising distal end openings configured to slidably receive extended tabs that extend from a bone fastener therein; and a retainer configured and dimensioned to releasably retain a fixation member in the sleeve at a predetermined orientation and predetermined distance from a distal end of the sleeve.
In at least one embodiment, the retainer is resiliently deformable to receive the fixation member.
In at least one embodiment, the retainer comprises at least one leaf spring.
In at least one embodiment, the retainer comprises a pair of opposing leaf springs.
In at least one embodiment, the retainer comprises at least one prong to releasably capture the fixation member.
In at least one embodiment, a distal end portion of the sleeve is configured and dimensioned to attach to a tulip portion of a bone fastener.
In at least one embodiment, the sleeve further comprises a tool interface configured to mate with a working end of a counter-torque tool.
In at least one embodiment, a passage is formed through opposite walls of a distal end portion of the sleeve, the passage being configured to allow a rod or other connector to pass therethrough.
In at least one embodiment, the tool interface is on external, side surfaces of the sleeve.
In at least one embodiment, the slots comprise stops that are configured to mate lengthwise along sides of the extended tabs to prevent rotation of the sleeve relative to the extended tabs.
In at least one embodiment, an alignment feature is provided on an inner surface of a wall of the elongate main body, configured to properly align an orientation of the sleeve in a height direction relative to a bone fastener, when the sleeve is attached to the bone fastener.
In at least one embodiment, the alignment feature comprises a ledge or shoulder.
In at least one embodiment, the sleeve includes stays forming anti-splaying slots with a wall of the elongate main body, wherein the anti-splaying slots are configured to receive proximal end portions of the extended tabs such that the stays contact the proximal end portions on outsides of the proximal end portions, and the wall contacts the proximal end portions on insides of the proximal end portions and the stays are configured to prevent splaying of the extended tabs.
In at least one embodiment, the sleeve further includes the fixation member releasably retained by the retainer at the predetermined orientation and predetermined distance from the distal end of the sleeve.
In at least one embodiment, the fixation member comprises a set screw.
According to another aspect of the present invention, a sleeve for performing surgical procedures is provided, including: an elongate main body; a channel extending within a length of the elongate main body; and elongated slots extending lengthwise in the elongate main body and having distal open ends configured and dimensioned to receive extended tabs that extend from a bone fastener, wherein the elongated slots are alignable with the extended tabs so that the extended tabs are slidable through the distal open ends and into the elongated slots; and an alignment feature provided on an inner surface of a wall of the elongate main body, configured to properly align an orientation of the sleeve in a height direction relative to a bone fastener, when the sleeve is attached to the bone fastener.
In at least one embodiment, the slots comprise stops that are configured to mate with sides of the extended tabs to prevent rotation of the sleeve relative to the extended tabs.
In at least one embodiment, the alignment feature comprises a ledge or shoulder.
In at least one embodiment, the sleeve further includes stays forming anti-splaying slots with the wall of the elongate main body, wherein the anti-splaying slots are configured to receive proximal end portions of the extended tabs and the stays are configured to prevent splaying of the extended tabs.
In another aspect of the present invention, an assembly for performing surgical procedures includes: a sleeve comprising: an elongate main body; and a channel extending within a length of the elongate main body; a fixation member having been preloaded in the sleeve; and a bone fastener comprising: a shaft configured to engage bone; a tulip configured to receive a rod; a retention feature; and extended tabs integral with and extending from the tulip; wherein a distal end portion of the sleeve is mounted over the tulip; wherein the extended tabs are received in slots in the sleeve by relative, linear sliding of the extended tabs relative to the slots; and wherein the fixation member is located at a predetermined orientation and distance from a distal end of the sleeve to approximate a proximal end of the retention feature.
In at least one embodiment, the sleeve further comprises a retainer that releasably retains the fixation member in the sleeve at the predetermined orientation and the predetermined distance from the distal end of the sleeve.
In at least one embodiment, the retainer is resiliently deformable to receive the fixation member.
In at least one embodiment, the sleeve further comprises a tool interface configured to mate with a working end of a counter-torque tool.
In at least one embodiment, the assembly further includes a counter-torque tool, the working end of the counter-torque tool engageable with the tool interface.
In at least one embodiment, the sleeve further comprises a passage formed through opposite walls of the distal end portion of the sleeve, the passage being configured to allow the rod or other connector to pass therethrough.
In at least one embodiment, the slots extend over a majority of a length of the elongate main body.
In at least one embodiment, the slots comprise stops that mate with sides of the extended tabs to prevent rotation of the sleeve relative to the extended tabs.
In at least one embodiment, the sleeve further comprises an alignment feature provided on an inner surface of a wall of the elongate main body, configured to properly align an orientation of the sleeve in a height direction relative to the bone fastener.
In at least one embodiment, the sleeve further comprises stays forming anti-splaying slots with a wall of the elongate main body, wherein the anti-splaying slots receive proximal end portions of the extended tabs and the stays prevent splaying of the extended tabs.
In at least one embodiment, the fixation member comprises a set screw.
In another aspect of the present invention, a method of performing a surgical procedure includes: providing an elongate sleeve having proximal and distal ends and a channel extending therethrough; releasably retaining a fixation member in the channel of the sleeve at a predetermined orientation and predetermined distance from the distal end of the sleeve; and assembling the sleeve on a bone fastener, wherein the assembling comprises aligning slots of the elongate sleeve with extended tabs of the bone fastener and linearly sliding the slots over the extended tabs.
In at least one embodiment, the fixation member is preloaded into the channel prior to the assembling.
In at least one embodiment, the fixation member is advanced against a retainer that resiliently deforms to allow the fixation member to pass by and resiliently returns to an unbiased configuration to releasably retain the fixation member.
In at least one embodiment, the retainer is spring loaded.
In at least one embodiment, the fixation member comprises a set screw.
In at least one embodiment, the fixation member is preloaded by: mounting the fixation member on a loading block; and advancing the fixation member and the loading block into the channel from the distal end of the sleeve.
In at least one embodiment, the method further includes mating the fixation member with a retention member of the bone fastener.
In at least one embodiment, the method further includes performing an operation on the bone fastener by manipulating the sleeve.
In at least one embodiment, the operation comprises at least one of reduction, distraction or compression.
In at least one embodiment, the method further includes finally fixing the fixation member in the retention member.
In at least one embodiment, the method further includes removing the sleeve from the bone fastener and breaking off the extended tabs.
In at least one embodiment, the elongate slots comprise stops that contact the extended tabs on opposite sides and prevent rotation of the elongate sleeve relative to the extended tabs.
These and other features of the invention will become apparent to those persons skilled in the art upon reading the details of the invention as more fully described below.
In the course of the detailed description to follow, reference will be made to the attached drawings. These drawings show different aspects of the present invention an, where appropriate, reference numerals illustrating like structures, components, materials and/or elements in different figures are labeled similarly. It is understood that various combinations of the structures, components, materials and/or elements, other than those specifically shown, are contemplated and are within the scope of the present invention.
Before the present instruments, apparatus and procedures are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a tab” includes a plurality of such tabs and reference to “the rod” includes reference to one or more rods and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. The dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
As used herein “RCDF” refers to retraction, compression, distraction and/or final fixation.
The present invention is provided for minimally invasive procedures on the spine, but may also be used in conventional open procedures, or in orthopedic procedures involving bones other than the bone of the spine.
It is known to use minimally invasive procedures for limiting an amount of trauma to soft tissue surrounding vertebrae to be stabilized, see, for example, US Patent Application Publication No. 2008/0077139 A1, which is hereby incorporated herein, in its entirety, by reference thereto.
A spinal stabilization system may be used to achieve rigid pedicle fixation while minimizing the amount of damage to surrounding tissue. In some embodiments, a spinal stabilization system may be used to provide stability to two adjacent vertebrae (i.e., one vertebral level). A spinal stabilization system may include two bone fastener assemblies. One bone fastener assembly may be positioned in each of the vertebrae to be stabilized. An elongated member may be coupled and secured to the bone fastener assemblies. As used herein, “coupled” components may directly contact each other or may be separated by one or more intervening members. In some embodiments, a single spinal stabilization system may be installed in a patient. Such a system may be referred to as a unilateral, single-level stabilization system or a single-level, two-point stabilization system. In some embodiments, two spinal stabilization systems may be installed in a patient on opposite sides of a spine. Such a system may be referred to as a bilateral, single-level stabilization system or a single-level, four-point stabilization system.
In some embodiments, a spinal stabilization system may provide stability to three or more vertebrae (i.e., two or more vertebral levels). In a two vertebral level spinal stabilization system, the spinal stabilization system may include three bone fastener assemblies. One bone fastener assembly may be positioned in each of the vertebrae to be stabilized. An elongated member may be coupled and secured to the three bone fastener assemblies. In some embodiments, a single two-level spinal stabilization system may be installed in a patient. Such a system may be referred to as a unilateral, two-level stabilization system or a two-level, three-point stabilization system. In some embodiments, two three-point spinal stabilization systems may be installed in a patient on opposite sides of a spine. Such a system may be referred to as a bilateral, two-level stabilization system or a two-level, six-point stabilization system.
In some embodiments, combination systems may be installed. For example, a two-point stabilization system may be installed on one side of a spine, and a three-point stabilization system may be installed on the opposite side of the spine. The composite system may be referred to a five-point stabilization system.
Minimally invasive procedures may reduce trauma to soft tissue surrounding vertebrae that are to be stabilized. Only a small opening may need to be made in a patient. For example, for a single-level stabilization procedure on one side of the spine, the surgical procedure may be performed through a 2 cm to 4 cm incision formed in the skin of the patient. In some embodiments, the incision may be above and substantially between the vertebrae to be stabilized. In some embodiments, the incision may be above and between the vertebrae to be stabilized. In some embodiments, the incision may be above and substantially halfway between the vertebrae to be stabilized. Dilators, a targeting needle, and/or a tissue wedge may be used to provide access to the vertebrae to be stabilized without the need to form an incision with a scalpel through muscle and other tissue between the vertebrae to be stabilized. A minimally invasive procedure may reduce an amount of post-operative pain felt by a patient as compared to invasive spinal stabilization procedures. A minimally invasive procedure may reduce recovery time for the patient as compared to invasive spinal procedures.
Components of spinal stabilization systems may be made of materials including, but not limited to, titanium, titanium alloys, stainless steel, ceramics, and/or polymers. Some components of a spinal stabilization system may be autoclaved and/or chemically sterilized. Components that may not be autoclaved and/or chemically sterilized may be made of sterile materials. Components made of sterile materials may be placed in working relation to other sterile components during assembly of a spinal stabilization system.
Spinal stabilization systems may be used to correct problems in lumbar, thoracic, and/or cervical portions of a spine. Various embodiments of a spinal stabilization system may be used from the C1 vertebra to the sacrum. For example, a spinal stabilization system may be implanted posterior to the spine to maintain distraction between adjacent vertebral bodies in a lumbar portion of the spine.
Upon establishing the implantation of bone fastener assemblies to the vertebrae to be stabilized, various procedures are performed to place the vertebrae in the desired positions and orientations to be held under stabilization. Such procedures may include, but are not limited to reduction, compression and distraction. The present invention facilitates such procedures, and thus improves the ease of performing and success rates of minimally invasive procedure.
Sleeve 10 includes at least one channel 14 (the embodiment of
A passage 22 is formed through opposite walls of the distal end portion that is configured to allow a rod or other connector to pass therethrough so that it can be connected to adjacent bone fasteners.
Retainer 24 is provided adjacent distal end portion 10D and is configured to releasably retain a fixation member at the proper height and orientation to mate with a retention feature on the tulip of the bone fastener.
Upon completion of assembly, the proximal end portions of extended tabs 206 are received in slots 28 formed between stays 30 and the wall 16 of the sleeve 10. A detailed view of these features is shown in
Removal/disconnection of the sleeve 10 from the bone fastener 200 can be achieved by simply pulling on the sleeve 10 in the direction shown in
Retainer 24, as noted above, is provided adjacent distal end portion 10D and is configured to releasably retain a fixation member at the proper height and orientation to mate with a retention feature on the tulip 204 (or on extended tabs 206 and extending into tulip 204) of the bone fastener 200.
Once the fixation member 32 has been properly positioned (both height wise and in alignment with the longitudinal axis of the sleeve 10), the retainer 24 resiliently returns to its unbiased position and prongs 24P retain the fixation member 32 at the desired relative height and orientation relative to the sleeve 10, as shown in
As shown in the longitudinal sectional view of
As known conventionally, the fixation member 32 can then be used to be torqued own on a rod or the like for fixation thereof (final fixation). Prior to such final fixation, sleeve 10 can be used to facilitate the performance of manipulation of the bone fastener 200, such as in the performance of reduction, distraction and/or compression, or other manipulations.
In one embodiment of use in a minimally invasive surgical procedure, a patient is prepared for a spinal procedure. A skin incision (e.g., stab wound) is made through the back of the patient and a needle is inserted through fascia to contact a pedicle of a vertebra. The inner stylet of needle is removed and a guidewire is inserted through the needle. A bone awl may optionally be used to penetrate cortical bone of pedicle. A tap may be used to tap threads into the pedicle.
Progressively larger dilators can be inserted over the guidewire to dilate the opening. The dilator(s) is removed and the bone fastener 200 is fastened to the pedicle using a minimally-invasive torquing tool. The tool is removed and the guidewire is removed. A rod may be installed through passage 22 either before or after assembling sleeve 10 on the bone fastener 200.
Prior to assembling the sleeve 10 on the bone fastener 200, a fixation member 32 is loaded into sleeve 10 to be releasably retained by retainer 24, as described above. Once the fixation member 32 has been releasably retained by retainer 24 at the proper orientation and height, sleeve 10 is next installed over the extended tabs 206 and tulip 204 of the bone fastener 200 in a manner as described above. This positions fixation member 32 at the proper height and orientation to readily engage and mate with retention feature 208.
Once assembled, the assembly 100 can be used to perform reduction, distraction and/or compression, as well as other manipulations of the bone fastener as needed utilizing the sleeve 10. The fixation member 32 and retention feature 208 can be used to facilitate reduction.
A counter torque wrench 400 can be used to prevent rotation of the sleeve 10/bone fastener 200 while the fixation member 32 is being torqued into the retention feature 208. The fixation member 32 can be torqued by inserting a driving tool 500 through the channel 14 to engage with a tool receiving feature 32R in the proximal end of the fixation member 32 that is configured to mate with a working end of the tool 500, and rotating the tool 500 relative to the sleeve 10. Counter-torque wrench 400 includes a working end 402 configured to mate with tool interface 18 of sleeve 10, and an elongate handle 404 designed to be grasped by the user and to provide a mechanical advantage (leverage) to the interface between working end 402 and tool interface 18.
Once all manipulations of the bone fastener 204 using sleeve 10 have been performed satisfactorily, a final tightening (final fixation) of the fixation member 32 against the rod is performed, while providing counter-torque with tool 400.
The sleeve 10 can then be removed from the patient and the bone fastener 200. The fixation member 32 having mated with the portion of the retention feature in tulip 204, extended tabs 206 can then be broken off and removed from the patient.
The length 12 of sleeve 10 may vary depending upon multiple factors, including, but not limited to: location of the vertebrae that are being operated on; size of the patient; level of obesity of the patient, etc. Typical lengths 12 of sleeve 10 are within a range of from about 100 mm to about 220 mm, typically from about 140 mm to about 185 mm. The embodiment shown in
The slots 20′ of sleeve 10′ are relatively shorter than slots 20 of sleeve 10 and extend only along the distal end portion of the sleeve, as shown. Slots 20′ are formed are configured to receive extended tabs of the tulip of the bone fastener when sleeve 10′ attaches to the bone fastener. The length 21′ of slots 20′ may vary. Typical lengths 21′ of slots 20′ are within a range of from about 5 mm to about 60 mm, typically from about 15 mm to about 35 mm. The embodiment shown in
To reduce the manufacturing costs, the proximal end portion 10P′ of the sleeve 10′ is manufactured separately from the remainder of the sleeve 10′ and subsequently integrated therewith, such as by welding, adhesives or other integrating techniques or agents. However, this embodiment could alternatively be manufactured all as an integral unit, the same as that which is done for the sleeve 10. Further alternatively, the proximal end portion 10P of sleeve 10 could be manufactured separately from the remainder of the sleeve 10 and then subsequently integrated therewith.
While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.
This application is a continuation-in-part application of U.S. application Ser. No. 15/170,865, filed Jun. 1, 2016, which is incorporated herein, in its entirety, by reference thereto, and to which application we claim priority under 35 USC § 120.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15170865 | Jun 2016 | US |
| Child | 16108489 | US |
