Method and associated instrumentation for installation of spinal dynamic stabilization system
In one embodiment, a spinal stabilization apparatus includes a vertebral anchor having a head portion and a bone attachment portion. An elongate, flexible guide is removably coupled to the head portion of the vertebral anchor and has a channel extending longitudinally thereof and communicating with a slot in the head portion of the anchor. An elongate cord may be received within the channel to facilitate inserting and securing a spacer between pairs of anchors installed into adjacent vertebrae of a person's spine.
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This application More than one application has been filed for the reissue of U.S. Pat. No. 8,632,572. The reissue applications are U.S. application Ser. No. 14/995,435 (the present application) and U.S. application Ser. No. 15/619,948, filed on Jun. 12, 2017, all of which are divisional reissues of U.S. Pat. No. 8,632,572. The present application is a reissue of U.S. application Ser. No. 13/048,447, filed on Mar. 15, 2011, now U.S. Pat. No. 8,632,572, which is a continuation of U.S. patent application Ser. No. 11/737,151, filed Apr. 19, 2007, now U.S. Pat. No. 7,922,725 B2, which is incorporated herein by reference.
TECHNICAL FIELDThis invention relates generally to spinal support devices, and more particularly to methods and devices that facilitate installing an implantable system for providing dynamic stability of a person's spine.
BACKGROUND OF THE INVENTIONThe treatment of acute and chronic spinal instabilities or deformities of the thoracic, lumbar, and sacral spine has traditionally involved the implantation of rigid rods to secure the vertebrae of a patient. More recently, flexible materials have been utilized in connection with securing elements, such as pedicle screws, to provide a dynamic stabilization of the spine. Such dynamic stabilization systems typically include a flexible spacer positioned between pedicle screws installed in adjacent vertebrae of a person's spine. Once the spacer is positioned between the pedicle screws, a flexible cord is threaded through eyelets formed in the pedicle screws and an aperture through the spacer. The flexible cord retains the spacer between the pedicle screws while cooperating with the spacer to permit mobility of the spine. Traditional implantation of such dynamic stabilization systems may require relatively large surgical sites to permit threading the cord through the screws and spacer once the spacer has been positioned between the screws.
While some dynamic stabilization systems have been proposed for permitting the top loading of a spacer and cord between pedicle screws, these systems also require added instrumentation and procedures to distract the pedicle screws for placement of the spacer.
A need therefore exists for a spinal dynamic stabilization system and associated installation tools and techniques that overcome these and other drawbacks of the prior art.
SUMMARY OF THE INVENTIONThis invention overcomes the foregoing and other short-comings and drawbacks of spinal stabilization systems heretofore known for use in suitable various commercial and industrial environments. While various embodiments will be described herein, the invention is not limited to these embodiments. On the contrary, the invention includes all alternatives, modifications and equivalents as may be included within the spirit and scope of this invention.
In one embodiment, a system for stabilizing a patient's spine includes a pair of vertebral anchors adapted to be anchored to first and second vertebrae, respectively. Each vertebral anchor has an upwardly open channel. A connecting element that may be in the form of a flexible cord extends between the vertebral anchors and is seated in the channels. An annular spacer is positioned between the channels of the vertebral anchors with the connecting element passing there through. A pair of fasteners is each mated with the one of the channels of the vertebral anchors to secure the connecting element thereto. A pair of access members in the form of sleeves is mounted on the vertebral anchors and each sleeve has a cannula to provide percutaneous access to the vertebral anchor when mounted thereon.
A slot in each of the sleeves is in communication with the associated channel when mounted on the vertebral anchor. The system includes one tool having a tubular member with a cannula extending there through and configured to fit over one of the sleeves when mounted on the associated vertebral anchor. The tool is used by the surgeon to advance the connecting member along the slot and into the channel of one of the vertebral anchors and to position the spacer between the vertebral anchors. In alternative embodiments, the tool may have an arcuate flange on its distal end to cradle the spacer for distraction during insertion between the vertebral anchors.
The system may include another tool also having a tubular member with a cannula extending there through and configured to fit over one of the sleeves when mounted on the associated vertebral anchor. This tool is adapted to advance the connecting member along the slot and into the channel of the vertebral anchors. This tool may include a mating feature proximate the distal end and complementary to a mating feature on either the vertebral anchor or the sleeve to thereby couple the tool thereto. The complementary mating features may include a recess on the distal end of the tool, a recess on the head of the pedicle screw, an outwardly directed protrusion proximate a distal end of the sleeve, and an inwardly directed protrusion proximate the distal end of the sleeve. The recesses are configured to mate with the protrusions to releasably secure the tool to the pedicle screw and allow the surgeon to use the tool to screw the pedicle screws into the vertebrae.
Other embodiments of this invention involve the installation procedures for a spinal stabilization construct and include installing the vertebral anchors onto the vertebrae and mounting access members, which in one embodiment are sleeves, onto the vertebral anchors. Each sleeve has a cannula to provide percutaneous access to the channel of the respective vertebral anchor. The connecting element is inserted through a slot in one of the sleeves and is advanced from the slot into the channel in the associated vertebral anchor. The connecting element is secured to the channel of the vertebral anchor with a fastener and an annular spacer is positioned on the connecting element adjacent the vertebral anchor.
The connecting element is inserted through a slot in the other sleeve and advanced into the channel in the second vertebral anchor. The spacer distracts against the first vertebral anchor and positions the spacer between the vertebral anchors. The connecting element is secured to the channel of the second vertebral anchor with a second fastener. The connecting element may be a flexible cord that is tensioned between the vertebral anchors. The respective fasteners may be passed through the sleeves percutaneously to the respective channels in conjunction with the tensioning of the cord or connecting element.
These and other features, objects and advantages of the invention will become more readily apparent to those skilled in the art in view of the following detailed description, taken in conjunction with the accompanying drawings.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description given below, serve to explain the principles of the invention.
The spacer 20 and pedicle screws 12 are coupled together by a connecting element 22 which in one embodiment is a flexible member coupled to or passed through the spacer 20 and secured to the heads 24 of the screws 12. Such spacers 20 and flexible members 22 may be similar to those used in the Dynesys® Dynamic Stabilization System available from Zimmer Spine of Minneapolis, Minn. In one embodiment, the spacer 20 may be formed from polycarbonate urethane and the flexible member 22 is a cord that may be formed from polyethylene-terephthalate, although it will be recognized that various other materials suitable for implantation within the human body and for providing stabilization of the spine while maintaining flexibility may be used.
In one embodiment, the anchor 12 is a pedicle screw having a threaded shank 26 configured to be screwed into the pedicle area of a vertebra 14,16. The head 24 of the screw is configured to receive and secure the flexible member 22. In the embodiment shown, the head 24 includes an upwardly open channel 28 formed between upwardly directed arms 30 and extending generally transverse to the longitudinal axis of the shank 26 and having an open end opposite the shank 26 for receiving the flexible member 22 into the channel 28 of the head 24 in a top loading fashion. Accordingly, the channel 28 alleviates the need to thread the flexible member 22 through an eyelet of the head 24 of the anchor 12 after the anchor 12 has been installed into the vertebral body 14, 16 of a patient's spine. The head 24 may have a pair of spaced, generally flat faces 33 for juxtaposition to the spacer 20.
In this embodiment, the head 24 of the pedicle screw 12 has receiving channels, such as recesses 32, provided on oppositely disposed sides of the arms 30 of the head 24 to facilitate screwing the anchor 12 into a vertebra 14,16 of a patient's spine using a tool as described later herein. In one embodiment, the pedicle screw 12 is formed from a titanium alloy, but it will be recognized that various other materials suitable for implantation within the human body and having sufficient strength to be securely attached to the bone and to secure the flexible member 22 may be used. While a uniaxial pedicle screw is shown and described herein, it will be recognized that the anchor 12 may alternatively comprise a hook, a polyaxial pedicle screw, or various other structure suitable to be secured to a vertebral body.
An elongate access member 18 is removably secured to the head 24 of the pedicle screw 12 and is formed substantially from a resilient, flexible material that permits deformation or bending of the access member 18 along its length without transmitting significant force to the pedicle screw 12. For example, the access member 18 may be formed from polymeric material such as nylon, polyethylene, polyurethane, or various other polymeric materials that are biocompatible and provide sufficient flexibility to permit the guides to bend in flexure along their length without transmitting significant force to the pedicle screw 12. In other exemplary embodiments, the access members 18 may be configured as a rigid or a composite structure, comprising a portion formed from a substantially rigid material and a portion comprising a flexible material or wholly of a rigid material.
In the embodiment shown in
In one embodiment, the access member 18 includes mating tabs 42 to mate with the receiving channels or recesses 32 on the head 24 of the pedicle screw 12. In the exemplary embodiment shown, the mating tabs 42 are inwardly directed protrusions. Mating surfaces between the pedicle screw and the access member 18 are configured to provide a mechanical interlock that is sufficient to withstand forces applied to the access member 18 during installation of the pedicle screws 12 into the vertebrae 14,16 and installation of the spacer 20 between adjacent pedicle screws 12. However, the access members 18 may be removed from the heads 24 of the pedicle screws 12, for example, by application of an appropriate force or by manipulating the access member 18 relative to the pedicle screw 12, to cause the mating tabs 42 on the access member 18 to dislodge from the recesses 32 on the head 24 of the pedicle screw 12. The access member 18 may be formed in a molding process in the form of a sleeve having a longitudinally extending cannula 44, and may thereafter be joined to the head 24 of the pedicle screw 12 by mechanically interlocking the sleeve 18 onto the head 24 of the pedicle screw 12 with the mating tabs 42 and receiving channels or recesses 32.
With continued reference to
Longitudinally extending and laterally oriented threads 52 are formed on the inwardly facing surfaces of the arms 30 in the channel 28 of the head 24. The threads 52 are sized for engagement with the fastener 50 when it is desired to secure the flexible member 22 to the head 24 of the pedicle screw 12. In one embodiment, a driver 54 (
While the fastener 50 has been shown and described herein as comprising a set screw, it will be recognized that various other types of securing members may alternatively be used to secure the flexible member 22 to the head 24 of the anchor 12. Likewise, the sleeve 18 may be configured to accommodate these various other types of fasteners and to percutaneously provide access for them to the anchor 12.
Referring now to
Referring to
The above-described description of the installation of the pedicle screw 12 may be performed on each of the pedicle screws 12 utilized in the stabilization system 10 as appropriate. In
With the flexible member 22 clamped by the forceps 80 and projecting through the slots 34 in the access member 18 as shown in
With the flexible member 22 seated in the channel 28 and secured therein by the forceps 80, the fastener or set screw 50 may be percutaneously introduced through the cannula 44 of the access member 18 for securing the flexible member 22 to the pedicle screw 12. A driver 54 or similar tool may be utilized to threadably secure the set screw 50 to the head 24 of the pedicle screw 12 thereby securing the flexible member 22 to the pedicle screw 12. The tubular member 62 and T-shaped tool 60 may continue to be mounted telescopically on the access member 18 and pedicle screw 12 or removed for easier access and installation of the set screw 50.
Referring to
The flexible member 22 is then inserted through the slots 34 of the access member 18 on the second pedicle screw 12b and a connecting element guide tool 92 can be slid over the access member 18 on the second pedicle screw 12b as shown in
Advantageously, this invention utilizes the tools and spacer to create distraction between the pedicle screw heads 24 and avoids threading the flexible member 22 through an eyelet in the head of the pedicle screw and any over distraction caused by the thickness of the flexible member when pulled into position.
Once the spacer 20 is positioned between the pedicle screw heads 24 and the flexible member 22 is seated in the channel 28 of the second pedicle screw 12b, the flexible member 22 may be tensioned utilizing a tensioning tool 96 as shown in
While this invention has been illustrated by the description of one or more embodiments thereof, and while the embodiments have been described in considerable detail, they are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and method and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept.
Claims
1. A method of installing a spinal stabilization construct, comprising:
- installing first and second vertebral anchors onto first and second vertebrae, respectively, each vertebral anchor having an upwardly open channel adapted to receive a flexible connecting element extending between the first and second vertebrae;
- mounting first and second access members onto the first and second vertebral anchors, respectively, each access member having a cannula to provide access to the channel of the respective vertebral anchor;
- inserting the connecting element through a slot in the first access member;
- advancing the flexible connecting element from the slot in the first access member into the channel of the first vertebral anchor;
- securing the flexible connecting element to within the channel of the first vertebral anchor with a first fastener;
- positioning a spacer on the connecting element adjacent the first vertebral anchor;
- inserting the flexible connecting element through a slot in the second access member;
- translating a tool along an exterior of the second access member without rotation to advance the flexible connecting element along the slot in the second access member into the channel in the second vertebral anchor;
- positioning the spacer between the vertebral anchors; and
- securing the flexible connecting element to within the channel of the second vertebral anchor with a second fastener.
2. The method of claim 1, wherein positioning the spacer between the vertebral anchors includes:
- pushing the spacer into position between the vertebral anchors with the tool.
3. The method of claim 2, wherein the tool includes a lateral portion extending transverse to a longitudinal axis of the tool for contacting the spacer.
4. The method of claim 3, wherein the lateral portion is a flange including an arcuate surface.
5. The method of claim 4, wherein the arcuate surface contacts an outer surface of the spacer.
6. The method of claim 1, wherein the tool is a tubular member slidably disposed around the second access member.
7. The method of claim 1, further comprising:
- tensioning the connecting element after securing the flexible connecting element to the channel of the first vertebral anchor and prior to securing the flexible connecting element to the channel of the second vertebral anchor.
8. The method of claim 1, further comprising:
- distracting the first and second vertebrae during positioning of the spacer between the vertebral anchors.
9. The method of claim 1, wherein securing the flexible connecting element to the channel of the first vertebral anchor with the first fastener includes passing the first fastener through the first access member percutaneously to the first vertebral anchor, and securing the flexible connecting element to the channel of the second vertebral anchor with the second fastener includes passing the second fastener through the second access member percutaneously to the second vertebral anchor.
10. A method for performing spinal stabilization surgery, comprising:
- creating at least one access opening in a patient;
- implanting, through the at least one access opening, a plurality of vertebral anchors into a plurality of corresponding vertebrae, each vertebral anchor having an upwardly open channel defined between upwardly directed arms, the channel configured to receive a flexible cord in a top loading manner;
- top loading the cord into the channel of a first vertebral anchor of the plurality of vertebral anchors using a cord guide tool having a cord guide feature and a vertebral anchor feature;
- securing a first end portion of the cord to the first vertebral anchor;
- engaging a second vertebral anchor of the plurality of vertebral anchors with the cord guide tool through the at least one access opening;
- using the cord guide tool to advance the cord distally into the channel of the second vertebral anchor subsequent to engagement with the second vertebral anchor and prior to fixation of the cord in the second vertebral anchor;
- engaging a tensioning tool to the cord guide tool;
- translating the second vertebral anchor implanted into a second vertebra relative to the first vertebral anchor implanted into a first vertebra using vertebral anchor feature of the cord guide tool;
- applying a tension to the cord using the tensioning tool; and
- securing the cord to the second vertebral anchor by rotating a set screw into securement in the channel of the second vertebral anchor with a driver;
- wherein the securing step is performed while the cord guide tool is engaged with the second vertebral anchor at the vertebral anchor feature after being slid over an access tool coupled to the second vertebral anchor.
11. The method of claim 10, further comprising:
- positioning the driver through a lumen of the cord guide tool to rotate the set screw.
12. The method of claim 11, wherein the tensioning tool is engaged at a proximal end region of the cord guide tool and the cord passes through an opening in the cord guide tool at least partially defining the cord guide feature to reach the tensioning tool.
13. The method of claim 12, wherein the driver is positioned in the lumen of the cord guide tool while the tensioning tool is engaged at a proximal end region of the cord guide tool.
14. The method of claim 13, wherein the tensioning tool is offset from the lumen of the cord guide.
15. The method of claim 10, wherein a portion of the cord extends from the second vertebral anchor to the tensioning tool.
16. A method for performing spinal stabilization surgery, comprising:
- implanting first and second vertebral anchors into first and second vertebral bodies, respectively, each vertebral anchor having an upwardly open channel defined between upwardly directed arms, the channel configured to receive a flexible cord in a top loading manner;
- advancing the cord distally into the channel the first vertebral anchor;
- securing a first end portion of the cord to the first vertebral anchor;
- engaging the second vertebral anchor with a cord guide tool;
- using the cord guide tool to both advance the cord distally into the channel of the second vertebral anchor with a cord guide feature and translate the second vertebral anchor relative to the first vertebral anchor with a vertebral anchor feature prior to fixation of the cord in the second vertebral anchor, wherein translating the second vertebral anchor involves application of force to the cord guide tool to manipulate the position of the second vertebral body;
- engaging a tensioning tool to a proximal end of the cord guide tool;
- applying a tension to the cord using the tensioning tool;
- positioning a driver through a lumen of the cord guide tool; and
- securing the cord to the second vertebral anchor while the cord guide tool is engaged with the second vertebral anchor at the vertebral anchor feature after being slid over an access tool coupled to the second vertebral anchor.
17. The method of claim 16, wherein the driver is positioned in the lumen of the cord guide tool while the tensioning tool is engaged with the cord guide tool.
18. The method of claim 17, wherein the tensioning tool is offset from the lumen of the cord guide tool.
19. The method of claim 18, wherein a portion of the cord extends from the second vertebral anchor to the tensioning tool.
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Type: Grant
Filed: Jan 14, 2016
Date of Patent: May 7, 2019
Assignee: Zimmer Spine, Inc. (Edina, MN)
Inventors: Mark W. Rice (Minneapolis, MN), Thomas J Gisel (Chaska, MN), Hugh D Hestad (Edina, MN), Mark J Kroll (St. Paul, MN)
Primary Examiner: Beverly M Flanagan
Application Number: 14/995,435
International Classification: A61B 17/70 (20060101);