# Patent

## Title
Spacer insertion instrument

## Abstract

A percutaneous and minimally invasive instrument for inserting an interspinous process spacer into a patient is disclosed. The insertion instrument includes a first assembly connected to a handle assembly. The first assembly includes an inner shaft located inside an outer shaft and configured for relative translational motion with respect to the outer shaft. The relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts wherein such deflection causes engagement with a juxtapositioned interspinous spacer. The instrument further includes a driving tool configured for removable insertion into a proximal end of a passageway of the instrument.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 12/338,793, now U.S. Pat. No. 8,613,747, filed Dec. 18, 2008, now allowed, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/008,418 entitled “Spacer Insertion Instrument” filed on Dec. 19, 2007, which also claims priority to and is a continuation-in-part of U.S. patent application Ser. No. 12/205,511, now U.S. Pat. No. 8,123,782, filed on Sep. 5, 2008, entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/967,805, filed on Sep. 7, 2007, and entitled “Interspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/220,427, now U.S. Pat. No. 8,277,488, filed Jul. 24, 2008 and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/961,741, filed Jul. 27, 2007, and entitled “Insterspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/217,662, now U.S. Pat. No. 8,273,108, filed Jul. 8, 2008, and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/958,876, filed Jul. 9, 2007, and entitled “Interspinous Spacer,” and is a continuation-in-part of U.S. patent application Ser. No. 12/148,104, now U.S. Pat. No. 8,292,922, filed Apr. 16, 2008, and entitled “Interspinous Spacer,” which is a non-provisional of U.S. Provisional Patent Application No. 60/923,971, filed on Apr. 17, 2007, and entitled “Interspinous Spacer,” and U.S. Provisional Patent Application No. 60/923,841, filed Apr. 16, 2007, entitled “Spacer Insertion Instrument,” all of which are hereby incorporated by reference in their entireties. Patent application Ser. No. 12/338,793 is also a continuation-in-part of U.S. Patent application Ser. No. 11/593,995, now U.S. Pat. No. 8,425,559, filed on Nov. 7, 2006, entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/582,874, now U.S. Pat. No. 8,128,662, filed on Oct. 18, 2006, and entitled “Minimally Invasive Tooling for Delivery of Interspinous Spacer” and a continuation-in-part of U.S. patent application Ser. No. 11/314,712, now U.S. Pat. No. 8,152,837, filed on Dec. 20, 2005 and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/190,496, now U.S. Pat. No. 8,409,282, filed Jul. 26, 2005, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” and a continuation-in-part of U.S. patent application Ser. No. 11/079,006, now U.S. Pat. No. 8,012,207, filed on Mar. 10, 2005, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” which is a continuation-in-part of U.S. patent application Ser. No. 11/052,002, now U.S. Pat. No. 8,317,864, filed Feb. 4, 2005, entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” which is a continuation-in-part of U.S. patent application Ser. No. 11/006,502, now U.S. Pat. No. 8,123,807, filed on Dec. 6, 2004, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine” which is a continuation-in-part of U.S. patent application Ser. No. 10/970,843, now U.S. Pat. No. 8,167,944, filed Oct. 20, 2004, and entitled “Systems and Methods for Posterior Dynamic Stabilization of the Spine,” all of which are hereby incorporated by reference in their entireties.


FIELD
The present invention generally relates to medical devices for the spine. In particular, the present invention relates to minimally invasive instruments for delivery of an implant between adjacent spinous processes of a patient's spine.
BACKGROUND
With spinal stenosis, the spinal canal narrows and pinches the spinal cord and nerves, causing pain in the back and legs. Typically, with age, a person's ligaments may thicken, intervertebral discs may deteriorate and facet joints may break down all contributing to the condition of the spine characterized by a narrowing of the spinal canal. Injury, heredity, arthritis, changes in blood flow and other causes may also contribute to spinal stenosis.
Doctors have been at the forefront with various treatments of the spine including medications, surgical techniques and implantable devices that alleviate and substantially reduce debilitating pain associated with the back. In one surgical technique, a spacer is implanted between adjacent spinous processes of a patient's spine. The implanted spacer opens the spinal canal, maintains the desired distance between vertebral body segments, and as a result, avoids impingement of nerves and relieves pain. For suitable candidates, an implantable interspinous spacer may provide significant benefits in terms of pain relief.
Any surgery is an ordeal. However, the type of device and how it is implanted has an impact. For example, one consideration when performing surgery to implant an interspinous spacer is the size of the incision that is required to allow introduction of the device. Small incisions and minimally invasive techniques are generally preferred as they affect less tissue and result in speedier recovery times. As such, there is a need for interspinous process spacers and instruments that deliver them that work well with surgical techniques that are minimally invasive for the patient. The present invention sets forth such an instrument.
SUMMARY
According to one aspect of the invention, an instrument is provided. The instrument includes a handle connected to a first assembly. The first assembly comprises an outer shaft. An inner shaft is located inside the outer shaft and configured for relative translational motion with respect to the outer shaft. A control is configured to effect the relative translational motion wherein the relative translational motion causes one of the outer or inner shafts to move with respect to the other and thereby deflect at least one prong formed on one of the inner or outer shafts. Such deflection causes connection or engagement with a juxtapositioned spacer. A driver having a distal portion configured to reversibly arrange the spacer between and including at least one deployed configuration and at least one undeployed configuration.
According to another aspect of the invention, an instrument having a longitudinal axis and connectable to a spacer is provided. The instrument comprises a substantially radiolucent portion connected to a substantially non-radiolucent portion. The substantially non-radiolucent portion has a radiographic projection on a plane perpendicular to the longitudinal axis that is substantially coincident with a radiographic or non-radiographic projection of a connected undeployed spacer on said plane.
According to another aspect of the invention, a method is disclosed. The method includes the step of connecting an interspinous spacer to a distal end of an instrument. The connected interspinous spacer is inserted into an interspinous space of a patient's spine with the instrument. The interspinous spacer is arranged by the instrument into at least one deployed configuration while the interspinous spacer is inserted in the interspinous space. The interspinous spacer is disconnected from the instrument leaving the interspinous spacer located in the interspinous space.
According to another aspect of the invention, a method is disclosed. The method includes the step of inserting a distal end of an instrument into an interspinous space of a patient's spine. The distal end of the instrument is connected to an interspinous spacer implanted in the interspinous space. The interspinous spacer is arranged with said instrument into at least one undeployed configuration while said instrument is inserted in the interspinous space and connected to the interspinous spacer. The connected interspinous spacer is removed from the patient with the instrument.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.
FIG. 1 illustrates a perspective view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 2 illustrates a side view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 3 illustrates a front view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 4 illustrates an end view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 5 illustrates a top view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 6 illustrates a cross-sectional view of a spacer insertion instrument without a driving tool according to the present invention.
FIG. 7 illustrates a cross-sectional view of an inner shaft of a spacer insertion instrument according to the present invention.
FIG. 8a illustrates a perspective view of an outer shaft of a spacer insertion instrument according to the present invention.
FIG. 8b illustrates a side view of an outer shaft of a spacer insertion instrument according to the present invention.
FIG. 8c illustrates a side view of an outer shaft of a spacer insertion instrument according to the present invention.
FIG. 8d illustrates a cross-sectional view of an outer shaft of a spacer insertion instrument according to the present invention.
FIG. 9a illustrates a perspective view of a control of a spacer insertion instrument according to the present invention.
FIG. 9b illustrates a perspective view of a control of a spacer insertion instrument according to the present invention.
FIG. 9c illustrates a cross-sectional view of a control of a spacer insertion instrument according to the present invention.
FIG. 10a illustrates a perspective view of a proximal end cap of a spacer insertion instrument according to the present invention.
FIG. 10b illustrates a perspective view of a proximal end cap of a spacer insertion instrument according to the present invention.
FIG. 11 illustrates a perspective view of a distal end cap of a spacer insertion instrument according to the present invention.
FIG. 12a illustrates a perspective view of a spacer in an undeployed configuration.
FIG. 12b illustrates a perspective view of a spacer in a deployed configuration.
FIG. 13a illustrates a perspective view of a spacer in an undeployed configuration.
FIG. 13b illustrates a perspective view of a spacer in a deployed configuration.
FIG. 14a illustrates a perspective view of a spacer in an undeployed configuration.
FIG. 14b illustrates a perspective view of a spacer in a deployed configuration.
FIG. 15a illustrates a perspective view of a driving tool according to the present invention.
FIG. 15b illustrates a side view of a driving tool according to the present invention.
FIG. 15c illustrates a partial perspective view of a driving tool according to the present invention.
FIG. 16 illustrates a perspective view of a spacer insertion instrument and driving tool connected to a spacer in a deployed configuration according to the present invention.
FIG. 17 illustrates a cross-sectional view of a spacer insertion instrument and driving tool connected to a spacer in an undeployed configuration according to the present invention.
FIG. 18 illustrates a partial cross-sectional view of a spacer insertion instrument and driving tool connected to a spacer in an undeployed configuration according to the present invention.
FIG. 19 illustrates a cross-sectional view of a spacer insertion instrument and driving tool connected to a spacer in a deployed configuration according to the present invention.
FIG. 20 illustrates a partial cross-sectional view of a spacer insertion instrument and driving tool connected to a spacer in a deployed configuration according to the present invention.



DETAILED DESCRIPTION
Turning to FIGS. 1-6, there is shown a spacer insertion instrument 10 according to the present invention. The spacer insertion instrument 10 includes a first assembly 12 connected to a handle assembly 14 and retained by a distal end cap 16 and a proximal end cap 18. The instrument 10 also includes a driving tool 66 that is removably insertable into the central passageway of the instrument 10. FIGS. 15a, 15b and 15c illustrate the driving tool 66 and FIG. 16 shows the instrument 10 with the driving tool 66 inserted.
Still referencing FIGS. 1-6, the first assembly 12 of the insertion instrument 10 is configured to releasably clamp to a body of an interspinous process implant to be delivered into or removed from a patient using the instrument 10. The first assembly 12 includes an inner shaft 20, an outer shaft 22 and a control 24. The inner shaft 20 is connected to the handle assembly 14 and the outer shaft 22 is passed over the inner shaft 20 and allowed to translate with respect thereto by means of a control 24 that is threadingly engaged with the outer shaft 22. With rotation of the control 24 in either direction, the outer shaft 22 translates with respect to the stationary inner shaft 20. In another variation of the invention, the outer shaft 22 is connected to handle assembly 14 and the inner shaft 20 is threadingly engaged with the control 24 such that rotation of the control 24 moves the inner shaft 20 with respect to the outer shaft 22. Although rotation of the control 24 is used in one variation, other variations are within the scope of the present invention such as, for example, translation of the control 24 or movement of the outer shaft 22 relative to the inner shaft 20.
Turning now to FIG. 7, there is shown an inner shaft 20 according to the present invention. As seen in the drawings, the inner shaft 20 is substantially cylindrical in shape having a central bore 26 extending from end to end. The distal end of the inner shaft 20 includes a pair of prongs 28 with each prong being substantially oppositely located from each other. The finger-like prongs 28 are formed by openings 30 extending proximally from the distal end. The fingers are flexible and, when in a normal position, splay slightly outwardly from the longitudinal axis as shown in FIG. 7. The prongs 28 are configured to connect with a spacer 32 of the like shown in FIGS. 12-14 or other similar spacers. In particular, the prongs 28 include extensions 34 that extend inwardly toward the longitudinal axis in a hook-like fashion. These extensions 34 are configured to be inserted into prong-receiving portions 36 (see FIGS. 12-14) on the spacer 32 and securely clamp thereto. The prongs 28 also include conforming surfaces 38 configured to conform to the spacer 32 in a manner best suited for secure attachment thereto. The proximal end of the inner shaft 20 includes a proximal portion 40 having a larger cross section and configured for insertion into a conformingly shaped recess in the handle assembly 14.
Turning now to FIGS. 8a-8d, there is shown the outer shaft 22 of the first assembly 12. As seen in the drawings, the outer shaft 22 is substantially cylindrical in shape having a central bore 42 extending from end to end. The outer shaft 22 is sized such that the inner shaft 20 fits inside the outer shaft 22. The distal end includes a pair of flattened portions 44 located substantially opposite from each other. There is a middle portion 46 having a larger cross-section and a threaded proximal portion 48. The threaded proximal portion 48 is configured for threaded connection with the control 24. In one variation, the middle portion 46 includes features such as an octagonal shape as seen in FIG. 16 that serve to align the instrument 10 when inserted into a cannula positioned to an interspinous space of a patient. The features on the middle portion 46 are aligned with similar complementary features on a cannula so that insertion of the instrument into the cannula is limited by the alignment of the features with the result being proper orientation of the instrument relative to the cannula and in turn relative to the patient. The outer shaft 22 includes at least one aperture formed in the sidewall of the shaft to provide access to the inner shaft and the interior of the shaft construct for cleaning purposes.
Turning now to FIGS. 9a-9c, there is shown the control 24 of the first assembly 12. The control 24 includes a user interface such as a finger portion or grip 50. In the variation shown in FIGS. 9a-9c, the user interface 50 is an outer circular or disk shaped portion for easily effecting rotation of the control 24 with a thumb or index finger. The control 24 also includes a connecting portion 52 that connects the control 24 to effect relative translation of the inner shaft 20 with respect to the outer shaft 22. In particular, in the variation shown in the drawings, the connecting portion 52 is a cylindrical portion connected to the user interface 50. The cylindrical portion has a threaded inner surface for engaging the threaded proximal portion 48 of the outer shaft 22 wherein the outer shaft 22 is received inside a threaded bore 54 of the connecting portion 52.
Turning now to FIGS. 10a and 10b, there is shown the proximal end cap 18 of the present invention. The end cap 18 is configured to cap the proximal end of the handle assembly 14. The handle assembly 14, if made of multiple parts, is held together, in part, by the end cap 18, capturing at least a portion of the first assembly 12 therein. The end cap 18 includes a central bore 56 providing a passage through the instrument 10 end to end. Also, apertures 58 are formed in the end cap 18 for receiving fasteners (not shown) therein for attachment to the handle assembly 14.
Turning now to FIG. 11, there is shown the distal end cap 16 of the present invention. The end cap 16 is configured to cap the distal end of the handle assembly 14. The handle assembly 14, if made of multiple parts, is held together, in part, by the distal end cap 16, capturing at least a portion of the first assembly 12 therein. The distal end cap 16 includes a central bore 60 sized to receive the outer shaft 22 therein. Also, apertures 62 are formed in the end cap 16 for receiving fasteners (not shown) therein for attachment to the handle assembly 14. In one variation, the distal end cap 16 has a directional indicator 64 in the shape of an arrow indicating, for example, a direction information such as “cephalad” as shown in FIG. 3 to help the surgeon to easily orientate the instrument 10.
The assembly of the spacer insertion instrument 10 will now be described. With particular reference back to FIG. 6, the control 24 is threaded onto the threaded proximal portion 48 of the outer shaft 22. The prongs 28 of the inner shaft 20 are compressed together slightly and the inner shaft 20 is inserted into the outer shaft 22. The first assembly 12 is then placed inside first assembly receiving portions of the handle assembly 14 and if more than one piece comprises the handle assembly 14 as, for example, in a clam shell construction, the handle assembly 14 is joined and secured together by the distal and proximal end caps 14, 16 fastened to the handle assembly 14. Additional fastening elements such as fasteners, screws, glue and the like may also be additionally or alternatively employed to capture at least a portion of and secure the first assembly 12 inside the handle assembly 14. With the instrument 10 assembled, there is a central passageway 67 clearly visible in the cross-sectional view of the instrument 10 shown in FIG. 6. The central passageway 67 extends from one end to the other end of the instrument 10. Through this central passageway 67, the driving tool 66 is removably inserted to deploy or undeploy the interspinous spacer. FIG. 16 illustrates a driving tool 66 inserted into the instrument 10 and engaged with a spacer 32 in a deployed configuration.
Jumping now to FIGS. 15a, 15b and 15c, there is shown a driving tool 66 according to the present invention. The driving tool 66 includes a handle 74 at the proximal end and a spacer engaging bit 76 at the distal end. The handle 74 and bit 76 are interconnected by a middle shaft portion 78. The driving tool 66 is configured and sized to be inserted into the central passageway 67 of the instrument 10 such that the bit 76 at the distal end operatively connects with a spacer loaded and locked into the prongs 28 of the instrument 10. The distal bit 78 includes features 80 for engaging with the operative portion of the spacer 32 in order to effect deployment or undeployment of the spacer 32. A driving tool 66 may have a different distal bit 76 in order to mate with a complementarily different member on the spacer. For example, the driving tool 66 shown in FIG. 15 includes features 80 comprising two oppositely located projections which are configured to mate with complementary features on the spacer. In another variation of the driving tool 66, the distal bit 66 may simply be a hexagonally shaped or other polygonal shaped member that fits inside a complementary member or hex socket on the spacer. In essence, different driving tools 66 having different distal bits 76 may be employed depending on the design of the spacer with which it is to be used. The instrument is advantageously configured such that torque placed on the handle 74 of the driving tool 66 while arranging the spacer is countered by grasping the handle assembly 14 to provide a counter-torque preventing twisting or misalignment of the instrument relative to the implantation site.
The spacer insertion instrument 10 functions to engage with, insert and deploy an interspinous spacer. Illustrative examples of interspinous spacers that are compatible with the insertion instrument are described in applicant's co-pending U.S. patent application Ser. No. 12/217,662 entitled “Interspinous spacer” filed on Jul. 8, 2008 incorporated herein by reference in its entirety, U.S. patent application Ser. No. 12/220,427 entitled “Interspinous spacer” filed on Jul. 24, 2008 incorporated herein by reference in its entirety, U.S. patent application Ser. No. 12/205,511 entitled “Interspinous spacer” filed on Sep. 5, 2008 incorporated herein by reference in its entirety, and U.S. Provisional Patent Application Ser. No. 61/011,199 entitled “Interspinous spacer” filed on Jan. 15, 2008 incorporated herein by reference in its entirety. Examples of such interspinous spacers 32 are shown in FIGS. 12-14 wherein like reference numerals are used to describe like parts. In general, each spacer 32 includes a body portion 68 with at least one prong receiving portion 36 for connecting with the instrument 10, at least one wing 70 rotatably connected to the body portion 68 and an actuator shaft 72 housed in the body portion 68 and configured to arrange the at least one wing 70 from at least one undeployed configuration (see FIGS. 12a, 13a and 14a) to at least one deployed configuration (see FIGS. 12b, 13b and 14b) and vice versa. The at least one wing serves as a body portion 68 stabilizer with respect to at least one adjacent spinous process of a patient's spine and is configured in one variation to cradle an adjacent spinous process on both sides and in another variation forming a seat for an adjacent spinous process.
The spacer insertion instrument 10 utilizes a working channel accessing a patient's spine that is preferably created by the use of one or more tools such as a target needle, K-wire, dilators, mounting bracket, cannula, stabilizing arm, interspinous knife, interspinous reamer, and interspinous gage, all described in applicant's co-pending U.S. patent application Ser. No. 11/582,874 entitled “Minimally invasive tooling for delivery of interspinous spacer” filed on Oct. 18, 2006, incorporated herein by reference in its entirety. The spacer insertion instrument 10 is typically inserted through a cannula having a distal end positioned at the interspinous process space in a minimally invasive, percutaneous, mini-open or open surgical procedure. In some procedures, a cannula is not employed to deliver the instrument 10 and spacer 32 to the interspinous space.
In use, a spacer 32 is placed in juxtaposition to the distal end of the insertion instrument 10 such that the prongs 28 of the instrument 10 are adjacent to the prong receiving portions 36 on the spacer 32. The control 24 is then activated to clamp the prongs 28 of the inner shaft 20 onto the spacer 32. In particular, the control 24 is rotated in one direction which advances the outer shaft 22 over the inner shaft 20 to thereby inwardly deflect the outwardly extending prongs 28 at the distal end of the inner shaft 20. This inward deflection allows the prongs 28 to engage the spacer body and, in particular, allows the prong extensions 34 to be inserted into the prong receiving portions 36 and with further rotation of the control 24 to lock the instrument 10 securely onto the spacer 32. Reverse rotation of the control 24 translates the outer shaft 22 proximally to expose the prongs 28 allowing them to deflect outwardly to their pre-stressed normal position and thereby release the spacer 32 from the insertion instrument 10.
If a cannula is employed in the operative site, the insertion instrument 10 with the attached spacer 32 in an undeployed configuration is sized to fit through a cannula and is passed through the cannula to the interspinous process space. Once in position inside the patient, a driving tool 66 is inserted into the proximal opening of the central passageway 67 of the instrument and passed until the distal spacer engaging bit 76 of the driving tool 66 connects with the spacer 32. The connection of the driver 66 to the spacer is signaled via tactile feedback of the bit engaging the spacer. Depending on the spacer design, the connection of the driving tool 66 with the spacer 32, in particular the engaging features 80, 82, will be different. In general, however, the driving tool 66 connects to the spacer 32 such that movement, such as rotation and/or translation, of the driving tool 66 effects deployment of the at least one wing 70 of the spacer 32. Such deployment of the wings is continuous with the rotation and/or translation of the driving tool. As a result, the deployment may be stopped by stopping such rotation making the deployment incremental. Such incremental deployment allows the surgeon to observe incremental deployment progress via fluoroscopic observation inbetween rotations to help properly position the instrument. Hence, the spacer and instrument combination provides incremental and continous deployment unlike other spacer/installment combinations that only have one deployed configuration and one undeployed configuration with no intermediate configurations or means provided by the instrument to gradually arrange the spacer therebetween. In particular and with respect to the spacer embodiments shown in FIGS. 12-14, movement, such as rotation and/or translation, of the driving tool effects translation of the actuator shaft 72 which in turn is connected to the at least one wing 70 causing it to deploy into an expanded configuration.
With particular reference now to FIGS. 12a and 12b, the driving tool 66 that is configured to connect with the spacer shown in FIGS. 12a and 12b will have a spacer engaging bit 76 that has a hexagonally shaped member that is sized to fit inside the complementarily hexagonally shaped interior 84 of the actuator shaft 72. With the instrument 10 operatively positioned inside the patient and with the driving tool engaged to the actuator shaft 72, rotation of the driving tool 66 distally advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIG. 12b. Of course, any polygonal or other shape may be employed. Reverse rotation of the driving tool 66 will proximally retract the actuator shaft 72 to undeploy the wings 70.
With particular reference now to FIGS. 13a, 13b and FIGS. 17-20, the driving tool 66 that is configured to connect with the spacer 32 shown in FIGS. 13a and 13b will have a configuration of the like shown in FIGS. 15a, 15b and 15c wherein the spacer engaging bit 76 includes two projecting features 80. The two projecting features 80 engage complementary features 88 on a spindle 86 located inside the body portion 68 of the spacer 32 as shown in FIG. 18. Once engaged to the spindle 86 (see FIG. 17), rotation of the driving tool 66 rotates the spindle 86 which in turn advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIGS. 13b, 19 and 20. As can be seen in these figures, when in the deployed configuration, the actuator shaft 72 is distally translated with rotation of the driving tool. Reverse rotation of the driving tool 66 will turn the spindle 86 in an opposite direction and proximally translate the actuator shaft 72 to undeploy the wings 70 into position shown in FIGS. 13a and 17.
With particular reference now to FIGS. 14a and 14b, the driving tool 66 that is configured to connect with the spacer shown in FIGS. 14a and 14b will have a spacer engaging bit 76 that has a hexagonally shaped member that is sized to fit inside the complementarily hexagonally shaped interior 84 of the actuator shaft 72. With the instrument 10 operatively positioned inside the patient and with the driving tool engaged to the actuator shaft 72, rotation of the driving tool 66 proximally advances the actuator shaft 72 to deploy the wings 70 into the configuration shown in FIG. 14b. Of course, any polygonal or other shape may be employed and reverse rotation of the driving tool 66 will distally advance the actuator shaft 72 to undeploy the wings 70.
For all of the spacer embodiments described above with which the insertion instrument 10 may be used, the driving tool 66 is activated by rotation. However, the driving tool may be activated by translation to deploy a spacer of the like described in applicant's co-pending U.S. patent application Ser. No. 11/314,712 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Dec. 20, 2005 and U.S. patent application Ser. No. 11/593,995 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Nov. 7, 2006, both of which are incorporated herein by reference in their entireties. Other examples of spacers with which the insertion instrument or modified version thereof may be employed are disclosed in U.S. patent application Ser. No. 11/079,006 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Mar. 10, 2005 and U.S. patent application Ser. No. 11/190,496 entitled “Systems and methods for posterior dynamic stabilization of the spine” filed on Jul. 26, 2005 both of which are incorporated herein by reference in their entireties.
Furthermore, the driving tool may be activated by rotation and translation of the driving tool to deploy the spacers of the like shown in FIGS. 12a, 12b, 14a and 14b. Activation of the driving tool to deploy the spacer that involves translation of the driving tool advantageously provides the user with a degree of deployment information. This feature is particularly important because positioning and deployment of the instrument and spacer may result in the wings 70 abutting tissue, bone or other obstructions within the patient that would signal to the user to either reposition the instrument and spacer or clear any obstructions. An example of a degree of deployment information feature includes translation of the driving tool. For example, if translation of the driving tool is less than a specific marker or distance, the user will know that the spacer is not fully deployed or that there is some obstruction and further movement of the driving tool, repositioning or removal of an obstruction is required for full deployment. In one variation, the handle 74 of the driving tool 66 rests a certain distance from the proximal end of the handle assembly 14 and with rotation, the driving tool 66 advances until the handle 74 of the driving tool contacts the proximal end of the handle assembly 14. In another variation, the middle shaft 78 of the driving tool 66 includes markings that indicate to the user the distance that the driving tool has moved distally or proximally to provide a degree of deployment information.
Of course, the spacer may have more than one deployed configuration as well as more than one undeployed configuration as the system permits varying degrees of deployment according to surgeon preference. Also, the deployment is reversible such that along any stage of deployment the driving tool can change the direction of translation of the actuator shaft of the spacer and hence, reverse deployment of the wings. The degree of translation of the actuator shaft and hence deployment of the spacer is variable. This variability advantageously permits the spacer to have multiple deployment configurations. Also, at intermediate levels of deployment, the spacer in conjunction with the instrument serves as a customized distractor. Once the spacer is in position and in the desired deployed configuration between adjacent interspinous processes of a patient's spine, the control 24 is activated in an opposite direction to release the prongs 28 and disconnect the spacer from the instrument. The insertion instrument is then removed from the patient leaving the spacer in place. With the spacer in place, the wings cradle the spinous processes. If two wings are employed, they cradle both of the adjacent spinous processes for a given interspinous process space. The spacer body alone, the wings alone, or the body in conjunction with one or more of the wings space apart the adjacent spinous processes and as a result, the implanted spacer opens the spinal canal, maintains the desired distance between vertebral body segments, and as a result, avoids impingement of nerves and relieves pain.
The insertion instrument can also be used to remove a spacer from the patient or to adjust its position following deployment. In such a case, the insertion instrument is inserted into a cannula, if one is employed, the cannula being accessed to an interspinous process space of a patient and positioned proximate to the spacer located in the interspinous space. Then the control 24 is activated to connect the instrument to the body with tactile feedback of the connection provided by the instrument configuration. A driving tool 66 is also inserted and connected to the spacer to undeploy the spacer wings. With the wings in at least one undeployed configuration, the spacer can then be removed or repositioned and redeployed.
In typical applications, the insertion instrument includes a variety of markings, for example, to indicate various status conditions of the tool and the associate interspinous spacer. In an alterative arrangement, the markings are selected as conventional visible markings or may be radio-opaque. The insertion instrument may also be optionally arranged with one or more markers selected, for example, from ultrasonic, magnetic markers or other marker types to advantageously avoid the need for fluoroscopy.
The disclosed devices or any of their components can be made of any biologically adaptable or compatible materials including PEEK, PEK, PAEK, PEKEKK or other polyetherketones. Materials considered acceptable for biological implantation are well known and include, but are not limited to, stainless steel, titanium, tantalum, combination metallic alloys, various plastics, polymers, resins, ceramics, biologically absorbable materials and the like. In one variation, the instrument includes a substantially radiolucent portion connected to a substantially non-radiolucent portion. For example, the non-radiolucent portion may be comprised of at least a portion of the first assembly 12 and the radiolucent portion may be comprised of at least a portion of the handle assembly 14. The substantially non-radiolucent portion is a substantial portion of radiolucent material that is exclusive of small fasteners or other features found scattered in a radiographic projection. The substantially non-radiolucent portion has a radiographic projection on a plane perpendicular to the longitudinal axis that is substantially coincident with a radiographic projection of a connected spacer on said plane when in at least one undeployed configuration. This feature is advantageous for minimilly invasive surgical procedures wherein fluoroscopic observations assist the surgeon in correct placement of an implant while providing the patient with less tissue intrusion that would otherwise be the case in larger incisions or open surgical procedures because the substantial radiolucent portions of the instrument do not obstruct fluoroscopic imaging of the implantation site for positioning and guiding the implant. This is the case when the instrument is connected to a spacer, inserted posteriorly with radiographic projections taken along a substantially anterior-posterior view of the patient's body. This is also the case when the instrument is used to deploy the spacer into at least one deployed configuration wherein the radiographic or non-radiographic projection of the spacer on a plane perpendicular to the longitudinal axis is substantially coincident with a radiographic projection of a substantial portion of the instrument made of substantially non-radiolucent material. However, the instrument and spacer are configured such that when the wings are arranged in at least one deployed configuration, the projection of the deployed wings on said plane extend beyond the perimeter of the projection of non-radiolucent portions such that the wings and their position can be observed under fluoroscopic observation, thereby, the physician can see the deployment of the wings without obstruction from the rest of the instrument and then undeploy and redeploy the wings as necessary or reposition the instrument for proper placement of the spacer and improve implantation according to patient anatomy. Therefore, this instrument and spacer system greatly improves ease of implantation for the surgeon, reduces surgery time, increases patient recovery and significantly improves upon minimally invasive techniques. In one variation, the non-radiolucent portion substantially comprises a spacer connecting shaft. In one variation, non-radiolucent portions include the shaft 78 of the driving tool 66 and radiolucent portion include the handle 74 of the driver 66.
The preceding merely illustrates the principles of the invention. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the present invention, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present invention is embodied by the appended claims.

## Claims

1. A method for implanting an interspinous device having a spacer body and first and second wings, the method comprising:
inserting the interspinous device between a first spinous process and a second spinous process of a subject's spine while an instrument is connected to the interspinous device;
deploying the interspinous device by rotating a driving tool of the instrument to rotate the first and second wings relative to the spacer body such that the first and second wings are positioned to hold the first and second spinous processes; and
disconnecting the interspinous device from the instrument by rotating a control of the instrument while the first and second wings are positioned to hold the first and second spinous processes and the control is located outside of the subject.

2. The method of claim 1 wherein deploying the interspinous device includes rotating the driving tool while a prong of the instrument is positioned within a prong receiving portion of the interspinous device such that the prong limits rotation of the spacer body.

3. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving prongs of the instrument from a clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device.

4. The method of claim 1 wherein the instrument includes a clamping assembly and a handle, and wherein rotating the driving tool includes
rotating the driving tool about an axis of rotation defined by the clamping assembly while the driving tool extends through the clamping assembly and extends through the handle positioned outside of the subject.

5. The method of claim 1 wherein the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and wherein deploying the interspinous device includes
manually rotating the driver handle positioned proximally of a clamping tool of the instrument while the clamping tool of the instrument holds the spacer body and the engaging bit engages an actuation mechanism of the interspinous device, wherein the actuation mechanism is configured to rotate the first and second wings as the control rotates.

6. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes moving a clamping assembly of the instrument from a clamping configuration for holding the interspinous device to a release configuration for releasing the interspinous device.

7. The method of claim 1 wherein
the instrument includes
a handle, and
a clamping assembly coupleable to the handle, wherein the clamping assembly includes at least one prong, an outer shaft, and an inner shaft with a passageway for receiving the driving tool; and

disconnecting the interspinous device from the instrument includes moving the at least one prong out of a prong receiving portion of the interspinous device by moving one of the outer and inner shafts.

8. The method of claim 7 wherein disconnecting the interspinous device includes rotating the control to move one of the outer and inner shafts with respect to the other to cause the at least one prong to move toward and/or away from a longitudinal axis of the instrument.

9. The method of claim 1 wherein disconnecting the interspinous device from the instrument includes opening a clamping assembly of the instrument configured to hold the interspinous device.

10. The method of claim 1 wherein the instrument has a distal end that clamps onto the interspinous device, wherein rotation of the control causes the distal end to open and release the interspinous device.

11. A method for implanting an interspinous device having a spacer body and first and second wings using an instrument, the method comprising:
positioning the interspinous device at an interspinous space between a first spinous process and a second spinous process of a subject's spine while the interspinous device is connected to the instrument, wherein the instrument includes a handle, an assembly, a driving tool, and a control;
moving the driving tool relative to the spacer body releasably held by the assembly to cause an actuator mechanism of the interspinous device to drive the first and second wings toward a deployed configuration for holding the first and second spinous process;
after deploying the first and second wings, rotating the control positioned external to the subject to cause the assembly to release the interspinous device; and
after releasing the interspinous device, removing the instrument from the subject while the first spinous process is between elongate arms of the first wing and the second spinous process is between elongate arms of the second wing.

12. The method of claim 11 wherein the driving tool is configured to be rotated independent of rotation of the control to rotate the first and second wings independently of the release of the interspinous device.

13. The method of claim 11 wherein rotating the control of the instrument includes rotating the control a sufficient amount to move prongs of the instrument out of respective prong receiving portions of the interspinous device and thereby release the interspinous device.

14. The method of claim 11 wherein
the instrument includes a clamping assembly movable from clamping configuration for holding the interspinous device to an open configuration for releasing the interspinous device, and
rotating the control of the instrument includes rotating the control a sufficient amount to move the clamping assembly toward the open configuration so as to release the interspinous device.

15. The method of claim 11 wherein moving the driving tool includes rotating the driving tool about an axis of rotation defined by a clamping assembly of the instrument while the driving tool is positioned within a passageway of the clamping assembly.

16. The method of claim 11 wherein
the driving tool includes a proximal end with a driver handle and a distal end with an engaging bit, and
moving the driving tool includes manually rotating the driver handle positioned proximally of a clamping assembly of the instrument while the engaging bit engages the interspinous device held by the clamping assembly.

17. The method of claim 11 wherein rotating the control of the instrument causes a clamping assembly of the instrument to move from an clamping configuration for holding the interspinous device to a release configuration for disconnecting from the interspinous device.

18. The method of claim 11 wherein
the instrument includes a handle and a clamping assembly coupleable to the handle, wherein the clamping assembly includes an outer shaft and an inner shaft with a passageway for receiving the driving tool, and
rotating the control includes moving the control a sufficient amount to move at least one prong out of a prong receiving portion of the interspinous device.

19. The method of claim 18 wherein rotation of the control causes one of the outer and inner shafts to move with respect to the other to cause the at least one prong to move toward or away from a longitudinal axis of the instrument.

20. The method of claim 11 wherein the instrument includes an assembly having a distal end with a clamping assembly, wherein rotation of the control includes moving the clamping assembly between a clamping configuration for holding the interspinous device and an open configuration for releasing the interspinous device independent of rotation of the driving tool.

21. The method of claim 11, further comprising moving the interspinous device along a midline approach to position the interspinous device at the interspinous space.