A compressor/distractor system for operating on a spine is disclosed. The system includes two rod reducers which each advance a spinal rod into the shoulder portion of a pedicle screw. Each rod reducer includes an inner member, an outer member, and a pair of gripping members. Each outer member receives and advances the spinal rod into the pedicle screw. The outer member also includes a through slot which receives the proximal end of each of the pair of gripping members which may limit the longitudinal translation of the outer member with respect to the inner member. The compressor/distractor system may include a compressor/distractor device which has a compressing, a distracting, and a neutral configuration. A method for using the minimally invasive rod reducers with the compressor/distractor system to secure at least two pedicle screws in desired positions on a spinal rod is also disclosed.
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7. A method for manipulating vertebrae comprising:
securing a first elongate member to a first pedicle screw that is secured in a first vertebra;
securing a second elongate member to a second pedicle screw that is secured in a second vertebra; and
manipulating the first and second elongate members with a force applying device until the first and second pedicle screws are in a desired position, the force applying device having first and second hook members, each hook member having a distracting hook and a compressing hook.
13. A method for manipulating vertebrae comprising:
securing a first elongate member to a first pedicle screw that is secured in a first vertebra;
securing a second elongate member to a second pedicle screw that is secured in a second vertebra; and
manipulating the first and second elongate members with a force applying device until the first and second pedicle screws are in a desired position, the force applying device having a compressing configuration, a distracting configuration, and a neutral configuration and including two hook members, at least one of the two hook members including switch assembly for selecting a respective one of the compressing, distracting, and neutral configurations, the switch assembly defining detents which each correspond to a respective one of the compressing, distracting, and neutral configurations of the force applying device.
0. 26. A method for manipulating vertebrae comprising:
securing a first elongate member to a first pedicle screw that is secured in a first vertebra;
securing a second elongate member to a second pedicle screw that is secured in a second vertebra;
selecting a selected spacing from a plurality of different possible spacings provided by a fulcrum having a plurality of receptacles configured to receive the first and second elongate members therein, the spacings each being characterized by a length dimension defined between any first one of the receptacles and any second one of the receptacles, such that the selected spacing is defined by the length dimension between a selected first one of the receptacles and a selected second one of the receptacles;
engaging the first and second elongate members with the fulcrum by receiving the first elongate member within the selected first one of the receptacles and receiving the second elongate member within the selected second one of the receptacles so as to fix a distance between the first and second elongate members at a fulcrum location along the first and second elongate members, the distance being the length dimension defined between the selected first one of the receptacles and the selected second one of the receptacles; and
applying compression and/or distraction forces to the first and second elongate members while the fulcrum fixes the distance between the first and second elongate members at the fulcrum location.
1. A method for manipulating vertebrae comprising:
accessing the spinal area of a patient having a pedicle screw secured to each of at least two vertebrae;
engaging each pedicle screw with an inner member having distal and proximal ends defining a longitudinal axis therebetween, the distal end of each inner member receiving a head of the pedicle screw;
advancing an outer member having distal and proximal ends distally along each of the inner members by rotating the proximal end of each of the outer members relative to each inner member, a pair of receiving slots on the distal end of each outer member receiving a portion of a spinal rod, each pair of receiving slots advancing the spinal rod into a saddle portion of the head of each pedicle screw;
attaching a force applying device and a fulcrum to an outer surface of each outer member, the force applying device including first and second hook members and having a compressing configuration when the first and second hook members are attached to each outer member with each of the outer members between the first and second hook members and a distracting configuration when the first and second hook members are attached to each outer member with the first and second hook members between each of the outer members;
manipulating each outer member with the force applying device until each of the pedicle screws is in a desired position with respect to the spinal rod; and
securing each pedicle screw to the spinal rod with a set screw.
2. The method of
3. The method of
4. The method of
5. The method of
6. The method of
8. The method according of to
9. The method according of to
10. The method according of to
11. The method according to
12. The method according of to
reducing a spinal rod into a head of the first pedicle screw with the first elongate member; and
reducing the spinal rod into a head of the second pedicle screw with the second elongate member.
0. 14. The method according to claim 10, wherein positioning the fulcrum over the proximal end of each of the first and second elongate members comprises positioning each of the first and second elongate members in a respective through hole of a plurality of through holes extending through the fulcrum.
0. 15. The method according to claim 14, wherein the plurality of through holes extending through the fulcrum includes multiple through holes for each of the first and second elongate members, the through holes being spaced apart from one another such that each of the first and second elongate members can be selectively received within different ones of the multiple through holes, so as to thereby define a variable spacing between the first and second elongate members at a location where the fulcrum receives the first and second elongate members.
0. 16. The method according to claim 15, wherein the plurality of first and second through holes are aligned along an axis of the fulcrum, the through holes being spaced apart along the axis.
0. 17. The method according to claim 14, wherein each of the plurality of through holes includes a bearing ring received within the respective through hole.
0. 18. The method of claim 1, wherein the fulcrum includes a plurality of through holes configured to receive each of the outer members therein.
0. 19. The method of claim 18, wherein the plurality of through holes in the fulcrum includes multiple through holes for each of the outer members, the through holes being spaced apart from one another such that each outer member can be selectively received within different ones of the multiple through holes, so as to thereby define a variable spacing between the outer members at a location where the fulcrum receives the outer members.
0. 20. The method of claim 19, wherein the plurality of through holes are aligned along an axis of the fulcrum, the through holes being spaced apart along the axis.
0. 21. The method of claim 18, wherein each of the plurality of through holes includes a bearing ring received within the respective through hole.
0. 22. The method of claim 13, further comprising engaging the first and second elongate members with a fulcrum by positioning each of the first and second elongate members in a respective through hole of a plurality of through holes extending through the fulcrum.
0. 23. The method of claim 22, wherein the plurality of through holes extending through the fulcrum includes multiple through holes for each of the first and second elongate members, the through holes being spaced apart from one another such that each of the first and second elongate members can be selectively received within different ones of the multiple through holes, so as to thereby define a variable spacing between the first and second elongate members at a location where the fulcrum receives the first and second elongate members.
0. 24. The method of claim 23, wherein the plurality of first and second through holes are aligned along an axis of the fulcrum, the through holes being spaced apart along the axis.
0. 25. The method of claim 22, wherein each of the plurality of through holes includes a bearing ring received within the respective through hole.
0. 27. The method of claim 26, wherein the first and second receptacles are through holes extending through the fulcrum.
0. 28. The method of claim 26, wherein the plurality of first and second receptacles are aligned along an axis of the fulcrum, the receptacles being spaced apart along the axis.
0. 29. The method of claim 26, wherein each of the plurality of first and second receptacles includes a bearing ring received therein.
0. 30. The method of claim 26, wherein each of the first and second elongate members is a rod reducer.
0. 31. The method of claim 26, wherein each of the plurality of different possible spacings provided by the fulcrum corresponds to a different respective angle defined between the first and second elongate members when the first and second elongate members are secured to the respective first and second pedicle screws and when the first and second members are engaged with the fulcrum at the fulcrum location.
0. 32. The method of claim 26, wherein the step of applying compression and/or distraction forces to the first and second elongate members comprises engaging a force applying device to the first and second elongate members, the force applying device being engageable to a plurality of force applying locations on each of the first and second elongate members.
0. 33. The method of claim 32, wherein the step of engaging the force applying device to the first and second elongate members comprises engaging the force applying device to the first and second elongate members at a selected one of the force applying locations, the selected force applying location being between the fulcrum and the first and second pedicle screws.
0. 34. The method of claim 26, wherein the fulcrum is engageable with the first and second elongate members by receiving the first and second elongate members at a variety of different fulcrum locations along a respective portion of each of the first and second elongate members.
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The present application is an application for the reissue of U.S. Pat. No. 9,737,351, which is a divisional of U.S. patent application Ser. No. 13/741,934, filed Jun. Jan. 15, 2013, which claims the benefit of, and priority to, U.S. Provisional Application Ser. No. 61/586,928, filed on Jan. 16, 2012. The entire contents of each of the above applications are incorporated herein by reference.
Technical Field
The present disclosure relates to a system and method for operating on the spine. More particularly, the present disclosure relates to a minimally invasive rod reducer, compressor/distractor system, and a method for using the compressor/distractor system to deliver a spinal rod to the head of a pedicle screw.
Background of Related Art
The spinal column is a complex system of bones and connective tissues that provide support for the human body and protection for the spinal cord and nerves. The adult spine is comprised of an upper and lower portion. The upper portion contains 24 discrete bones, which are subdivided into three areas including 7 cervical vertebrae, 12 thoracic vertebrae and 5 lumbar vertebrae. The lower portion is comprised of the sacral and coccygeal bones. The cylindrical shaped bones, called vertebral bodies, progressively increase in size from the upper portion downwards to the lower portion.
An intervertebral disc along with two posterior facet joints cushion and dampen the various translational and rotational forces exerted upon the spinal column. The intervertebral disc is a spacer located between two vertebral bodies. The facets provide stability to the posterior portion of adjacent vertebrae. The spinal cord is housed in the canal of the vertebral bodies. It is protected posteriorly by the lamina. The lamina is a curved surface with three main protrusions. Two transverse processes extend laterally from the lamina, while the spinous process extends caudally and posteriorly. The vertebral bodies and lamina are connected by a bone bridge called the pedicle.
The spine is a flexible structure capable of a large range of motion. There are various disorders, diseases, and types of injury which restrict the range of motion of the spine or interfere with important elements of the nervous system. The problems include, but are not limited to scoliosis, kyphosis, excessive lordosis, spondylolisthesis, slipped or ruptured discs, degenerative disc disease, vertebral body fracture, and tumors. Persons suffering from any of the above conditions typically experience extreme or debilitating pain and often times diminished nerve function. These conditions and their treatments can be further complicated if the patient is suffering from osteoporosis, or bone tissue thinning and loss of bone density.
Spinal fixation apparatuses are widely employed in surgical processes for correcting spinal injuries and diseases. When the disc has degenerated to the point of requiring removal, there are a variety of interbody implants that are utilized to take the place of the disc. These include polyetheretherketone (“PEEK”) interbody spacers, metal cages, and cadaver and human bone implants. In order to facilitate stabilizing the spine and keeping the interbody in position, other implants are commonly employed, including longitudinally linked rods secured to coupling elements, which in turn are secured to the bone by spinal bone fixation fasteners such as pedicle screws, hooks, and others. The opposing pair of longitudinally linked rods is commonly disposed along the long axis of the spine via a posterior approach. Pedicle screws are utilized to capture these rods and can be manufactured from any biocompatible material, including cobalt chrome, stainless steel, titanium, and PEEK. It is desired to perform these procedures in a minimally invasive manner to minimize pain and reduce recovery time for the patient. Therefore, a need exists for a minimally invasive rod reducer, compressor, distractor system that can deliver the rod into the head of the pedicle screw or bone anchor while maintaining the proper screw and rod construct alignment.
A rod reducer that is small enough in diameter to work with a minimally invasive retractor, such as the rod reducer disclosed in U.S. Patent Publication No. 2013/0046345, the contents of which are hereby incorporated by reference in their entirety and a minimally invasive retractor, such as the minimally invasive retractor disclosed in U.S. Pat. No. 7,846,093, the contents of which are hereby incorporated by reference in their entirety, are also disclosed.
The present disclosure is directed towards a system for operating on the spine. The system includes pedicle screws, rod reducers, and a force applying device.
According to one aspect, the rod reducers include a proximal end and a distal end and define a longitudinal axis between the proximal and distal ends. The rod reducer includes an outer member and an inner member. The inner member is selectively attachable to the housing of the pedicle screw. The outer member is axially movable relative to the inner member when the inner member is secured to the housing of the pedicle screw to secure the spinal rod within the saddle of the housing of the pedicle screw. The outer member includes a proximal segment and a distal segment. The proximal segment is rotatable for axially translating the distal segment. The distal segment is engageable with the spinal rod to secure the spinal rod within the saddle upon the axial translation of the distal segment. The proximal segment independently rotates relative to the distal segment. The rod reducer includes a pair of gripping members configured to engage the housing of the pedicle screw. The pair of gripping members is positioned between the inner and outer members of the rod reducer.
The handle assembly is selectively engageable with the rod reducer to move the outer member of the rod reducer axially relative to the inner member of the rod reducer. The handle assembly is configured to rotate the outer member so that the rotational movement of the outer member axially moves the outer member relative to the inner member. The handle assembly includes a turning handle and an anti-torque handle. The anti-torque handle is selectively engageable with the proximal end of the rod reducer and the turning handle is selectively engageable with a proximal end of the anti-torque handle.
In another aspect, an embodiment of the system includes two rod reducers, a force applying device, and a fulcrum. The force applying device is configured for selectively engaging each rod reducer. The system may also include at least one minimally invasive retraction device.
In yet another aspect, the force applying device is a compressor/distractor device including a first hook member, a second hook member, and a body portion. The body portion has a first end and a track extending from the first end. The first end includes the first hook member in a fixed position. The first end may slidably receive the first hook member in a fixed position. The track includes a set of teeth and is configured for slidably receiving the second hook member.
The second hook member includes a switch assembly and a gear assembly. The second hook member traverses the track when the gear assembly is rotated. The gear assembly may also retain the second hook member within the track. The switch assembly permits the second hook member to traverse the track in a desired direction, towards the first hook member or away from the first hook member. The switch assembly may also restrain the second hook member from traversing the track in an undesired direction.
The first and second hook members may be configured in a compressing configuration to engage the two rod reducers such that rod reducers are between the hook members. The first and second hook members may also be configured in a distracting configuration to engage the rod reducers such that the hook members are between the rod reducers.
The fulcrum is configured to receive the proximal segment of the outer member of each rod reducer and remain in a fixed position on the longitudinal axis of each rod reducer.
According to still another aspect, a method for compressing or distracting vertebrae including two minimally invasive rod reducers, a compressor/distractor system, a spinal rod, and two pedicle screws. The method includes the steps of accessing the spinal area of a patient having at least two pedicle screws secured to respective vertebrae, engaging each pedicle screw with a rod reducer, advancing the spinal rod into the head of each pedicle screw, attaching a compressor/distractor device to each rod reducer, inserting a set screw through each rod reducer, manipulating the compressor/distractor device, and securing the spinal rod to each pedicle screw.
The method may also include the step of attaching a fulcrum to the proximal segment of each outer member before rotating the gear assembly.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure, wherein:
Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the terms “proximal” and “trailing” may be employed interchangeably, and should be understood as referring to the portion of a structure that is closer to a clinician during proper use. The terms “distal” and “leading” may also be employed interchangeably, and should be understood as referring to the portion of a structure that is farther from the clinician during proper use. In addition, the term “cephalad” or “cranial” is used in this application to indicate a direction toward a patient's head, whereas the term “caudad” indicates a direction toward the patient's feet. Further still, the term “medial” indicates a direction toward the middle of the body of the patient, whilst 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, and 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.
Turning now to
Inner member 30 includes an elongate body member 39 that defines an annular recess 33 configured to receive the pair of gripping members 40 so that the gripping members 40 are disposed in opposition on the elongate body member 39. Inner member 30 includes a pair of arms 32 supported on a distal end of elongate body member 39. A proximal end of elongate body member 39 has a threaded arrangement 38 that mates with threaded inner surface 28 of proximal segment 21 of outer member 20 to axially advance outer member 20 relative to inner member 30 as will be described in greater detail below.
Each gripping member 40 includes a body 47 having a supporting member 43, a proximal finger 46, and a distal finger 45. Supporting member 43 is configured to engage annular recess 33 of inner member 30 to support body 47 of each gripping member 40 on inner member 30. Proximal finger 46 extends proximally from supporting member 43 and is slidably positionable within slot 26 of outer member 20. Distal finger 45 extends distally from supporting member 43 and is positionable between an arm 32 of inner member 30 and reducing portion 22a of outer member 20 so that distal finger 45 is substantially aligned with a gripping member receiving slot 24 of reducing portion 22a.
As illustrated in
Turning now to
Thus, if needed, either or both the turning handle 600 and the anti-torque handle 700 may be used to facilitate the rotational movement of outer member 20 relative to inner member 30. In particular, rotation of turning handle 600 imparts rotational movement to proximal segment 21 of outer member 20 and anti-torque handle 700 imparts counter rotational movement to distal segment 22 of outer member 20 so that proximal segment 21 rotates and distal segment 22 axially translates without rotating. As appreciated, anti-torque handle 700 is configured to limit the amount of torque imparted from the rotational movement imparted by turning handle 600 to prevent undesirable torquing of the outer member 20. More particularly, anti-torque handle 700 slides down over the outer surface of outer member 20 of rod reducer 10 so that a distal end of anti-torque handle 700 engages distal segment 22 of outer member 20 and a proximal end of proximal segment 21 of outer member 20 is exposed for engagement with turning handle 600. Meanwhile, since gripping member 40 is secured within annular recess 33 of inner member 30 such that proximal finger 46 of gripping member 40 is supported in slot 26 of distal segment 22 of outer member 20, the engagement of anti-torque handle 700 with gripping feature 22c of distal segment 22 of outer member 20 prevents rotation of both distal segment 22 of outer member 20 and inner member 30 as proximal segment 21 of outer member 20 is rotated with turning handle 600. After spinal rod 800 is fully reduced into the saddle 910 of pedicle screw 900, turning handle 600 and anti-torque handle 700 may be removed and a set screw (not shown) may be inserted down an inner diameter of rod reducer 10 to lock spinal rod 800 into place. Alternatively, anti-torque handle 700 may also be used to prevent rotation when tightening the set screw after spinal rod 800 has been fully reduced. Rod reducer 10 may then be removed.
Referring now to
Now referring to
Referring now to
First and second hook members 220, 230 may each include hook portions 224, 234 for engaging rod reducers 10. Hook portions 224, 234 have respective distracting hooks 225, 235 and compressing hooks 226, 236. When rod reducers 10 are between first and second hook members 220, 230, each compressing hook 226, 236 engages a rod reducer 10 in a compressing configuration of compressor/distractor device 210 (
Second hook member 230 may include a switch assembly 250 and a gear assembly 240. Switch assembly 250 may include a pawl 251, a pawl switch pin 252, a switch cap 253, a spring 254, a ball 255, ball detents 258, a switch 256, and a switch shaft 257. Switch assembly 250 is selectable amongst a first condition, a second condition, and a third condition. Each condition may correspond to a configuration of the compressor/distractor device 210. In the first condition, switch assembly 250 restrains second hook member 230 from traversing track 262 towards the first hook member 220, while permitting second hook member 230 to traverse track 262 away from the first hook member 220 (i.e., a distracting configuration). In the second condition, switch assembly 250 restrains second hook member 230 from traversing track 262 away from the first hook member 220, while permitting second hook member 230 to traverse track 262 towards the first hook member 220 (i.e., a compressing configuration). In the third condition, switch assembly 250 allows the second hook member 230 to freely move along track 262 in either direction (i.e., a neutral configuration), which allows for quick adjustment of compressor/distractor device 210.
Switch 256 rotates about switch shaft 257 causing pawl pivot pin 252 to rotate pawl 251 about switch shaft 257. Pawl pivot pin 252 acts on pawl 251 causing pawl 251 to engage set of teeth 263 which restrains second hook member from traversing in the undesired direction.
Second hook member 230 may include ball detents 258. Each ball detent 258 corresponds to a position of switch 256. Switch 256 may be retained in each position by spring 254 pressing ball 255 into a corresponding ball detent 258. Ball 255 selectively engages each ball detent 258 when the switch is in one of the positions corresponding to the compressing, distracting, and neutral configurations of the compressor/distractor device 210.
Gear assembly 240 engages set of teeth 263 causing second hook member 230 to traverse track 262. Rotation of traversing screw 244 rotates pinion 242. The cooperation of pinion 242 with set of teeth 263 induces the second hook member 230 to traverse track 262. A drive tool (not shown) may engage and rotate traversing screw 244.
A method for using system 200 to manipulate a vertebra into a desired position with respect to a second vertebra is discussed below. First, a surgeon accesses the spinal area of a patient having at least two pedicle screws 900 secured to adjacent vertebrae (not shown). Each pedicle screw 900 may be engaged by a minimally invasive retraction device 950. The surgeon then engages each pedicle screw 900 with a rod reducer 10 by attaching inner member 30 to pedicle screw head 910 as shown in
Rod engaging slots 25 of proximal segment 22 of each outer member 20 receives a portion of rod 800 and advances rod 800 into saddle portion 912 of each pedicle screw 900 as shown in
Then the surgeon manipulates gear assembly 240 until each pedicle screw 900 is in a desired position on rod 800. Manipulation of gear assembly 240 may include rotating traversing screw 244. The surgeon may use a drive tool to manipulate gear assembly 240.
Then the surgeon rotates each set screw to fully secure rod 800 to each pedicle screw 900 in the desired position. Then the surgeon may remove compressor/distractor device 210 and each rod reducer 10.
The surgeon may also attach fulcrum 300 to gripping portion 21b of proximal segment 21 of each outer member 20 before manipulating gear assembly 240. Fulcrum 300 may then be removed with the compressor/distractor device 210 and each of the rod reducers 10.
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
Boyd, Clint, McClintock, Larry E.
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