KR20100024398A - Interspinous implants and methods for implanting same - Google Patents

Abstract

A spinal implant for treating lumbar spinal stenosis or as an adjunct to spinal fusion. The implant includes a body portion having an interior cavity. A plurality of locking wings are adapted and configured to move between a stowed position retracted within the interior cavity of the body portion and a deployed position extended from the interior cavity of the body portion. In the deployed position, the wings fix the implant in a selected interspinous space. A cable and wheel arrangement moves the plurality of locking wings from the stowed position to the deployed position and a ratchet/pawl assembly prevents backward movement of the wings.

Description

Interstitial implants and methods for inserting them {INTERSPINOUS IMPLANTS AND METHODS FOR IMPLANTING SAME}

The present invention relates to interstitial implants with deployable wings to treat spinal implants, in particular lumbar stenosis, methods for transdermal insertion of interstitial implants, and techniques for determining the appropriate size of interstitial implants.

The spine consists of columns of 24 vertebrae that extend from the skull to the buttocks. Discs of soft tissue are placed between adjacent vertebrae. The vertebra provides support for the head and body, and the disk acts as a buffer. In addition, the spine surrounds and protects the spinal cord, which is surrounded by a bony channel called the spinal canal. There is usually a space between the border of the spinal canal and the spinal cord so that the spinal cord and nerves associated with the spinal cord are not sandwiched and compressed.

Over time, the ligaments and bones surrounding the spinal canal become thicker and harder, narrowing the spinal canal and compressing the spinal cord. This condition is called spinal stenosis, which causes pain and numbness, weakness and / or loss of balance in the back and legs. These symptoms often increase after standing or walking for a period of time.

Numerous non-surgical stenosis treatments exist. These include nonsteroidal anti-inflammatory drugs that reduce swelling and pain, and corticosteroid injections to reduce swelling and treat acute pain. Some patients may experience relief of the symptoms of spinal stenosis at this procedure, but many patients turn to surgical treatment because they do not. The most common surgical procedure for treating spinal stenosis is decompressive laminectomy, which involves removing part of the vertebrae. The purpose of the procedure is to relieve pressure on the spinal cord and nerves by increasing the area of the spinal canal.

Interspinous process decompression (IPD) is a less invasive surgical procedure to treat spinal stenosis. In IPD surgery, bone or soft tissue is not removed. Instead, an implant or spacer is placed behind the spinal cord between the spinous processes protruding from the lower vertebrae. Known implants used to perform IPD surgery are those of St. Alameda, CA, USA. X-STOP® device first introduced by Francis Medical Technologies, Inc. However, insertion of the X-STOP® device still requires an incision for the spinal column approach to deploy the X-STOP® device.

It would be advantageous to provide an implant for performing an IPD procedure that can be transdermally inserted into the interstitial space and can effectively treat lumbar stenosis.

The present invention relates to a spinal implant mainly used in spinous process decompression procedures that can be introduced percutaneously into the interspace space. In the most basic configuration of such a spinal implant, the device is constructed and shaped to move between a body portion having an internal cavity and a deployed position extending from the internal cavity of the body and a retracted position retracted within the internal cavity of the body portion. Locking wings and means for moving the plurality of locking wings from the storage position to the deployment position.

The present invention also relates to a method for percutaneously placing a spinal implant during a spinous process decompression procedure, which method includes a plurality of deployables having dimensions and shapes that can be combined with the spinous process of the vertebrae adjacent to the disc level, in particular. Providing a spinal implant having a body portion comprising a locking wing, advancing the curved needle bar through the skin from one side of the spine into the spinous process between the symptomatic disc levels, and forming the curved needle bar Guiding the spinal implant from one side approach into the spinous process along the path, and subsequently deploying the locking wing to engage with the spinous process of the adjacent vertebrae.

The present invention also relates to a method for transdermal placement of a spinal implant, the method comprising: a body portion for receiving a plurality of deployable locking wings having dimensions and shapes that can engage the spinous processes of adjacent vertebrae at the symptomatic disk level; Providing a vertebral implant having a vertebral implant, and advancing the curved needle through the skin from one side of the spine downward into the spinous process between symptomatic disc levels to allow bilateral access to the spinous process and through the skin opposite the spine. Advancing the curved fine needle to the outside. The method further includes guiding the spinal implant from one side of the spine into the spinous process along the path formed by the curved needle bar, and subsequently deploying the locking wing to engage with the spinous process of the adjacent vertebrae.

Implants can be advantageously used in a variety of procedures including treatments to alleviate the symptoms of protruding lumbar discs, treatment of back pain and aids for fusion, and the like.

The invention also relates to an instrument kit for facilitating transdermal insertion of the device. The kit includes one or more of the components described below: A digestion assembly having an adjustable crosslinked portion having a curved guide sleeve for graduated positioning depressions, curved depressions and curved depressions. The kit may further comprise a set of curved tubular dilators of varying diameters and a plurality of implants of varying sizes.

The invention also relates to an apparatus for measuring the optimal size of an interstitial implant for treating lumbar stenosis. The device comprises distraction means having dimensions and structure capable of transdermal insertion into the interspinous spaces between adjacent spinous processes, wherein the distraction means are movable between a closed insertion position and an open distraction position. In addition, the apparatus further comprises deployment means for moving the stretching means between the closed insertion position and the open distraction position, the amount of movement of the deployment means being the optimal size of the interstitial implant for placement in the interpolar space between adjacent spinous processes. Corresponds to.

The present invention also relates to a method of measuring the optimal size of an interstitial implant for treating lumbar stenosis. The method includes transdermally inserting the distraction means into the interspinous space between adjacent spinous processes, wherein the distraction means is movable between a closed insertion position and an open distraction position. The method comprises the steps of moving the distraction means between a closed insertion position and an open distraction position and correlating the movement of the distraction means to an optimal size of the interspinous implant for subsequent placement in the interspinous space between adjacent spinous processes. It further includes.

In one embodiment, the present technology is directed to an interstitial implant for placement between symptomatic disc level spinous processes, the shell comprising a shell having a lower shell portion and an upper shell portion forming four internal grooves, wherein Two grooves terminate at the opening of the shell, and the shell includes a detent adjacent to each opening. The four deployable ratchet locking vanes are coupled in each groove so as to be slidable between i) a receiving position in which the wing is in the groove and ii) a deploying position in which the wing extends outwardly from the shell. Each wing has a set of ratchet teeth for engaging and locking each detent in the deployed position. A pair of coaxial locking wheels are rotatably mounted in the shell to selectively exert a force on each of the locking vanes to move the locking vanes from the stowed position to the deployed position, and the deployment cable couples to the wheels to rotate the wheels. Ring.

In addition, the implant may have a guide on the shell to receive the microneedle during the percutaneous placement procedure. In addition, the two wings may be located on a first plane of parallel spaced geometry, extending on the first side of the centerline of the shell, and the remaining two wings extending on the second side of the centerline of the shell, It is located on a second plane of parallel spaced geometry.

In addition, the interstitial implant may include a placement mechanism for introducing the shell into the spinous process. The deployment mechanism may comprise an elongated tubular stem having a straight distal portion and a curved proximal portion, which form a central lumen for receiving the deployment cable and coupling sleeve on the straight distal portion for selectively engaging with the shell. In other embodiments, the placement mechanism may be a long tubular stem that is curved.

In addition, the interstitial implant may comprise a needle needle assembly for transdermal insertion of the interstitial implant. The flat needle assembly has a long scaled positioning needle for positioning the needle needle assembly on the central axis of the spine, a curved needle needle for lateral access to the interstitial space, and a curved needle needle for positioning the needle needle. And an adjustable guide bridge having a central portion extending between the set needles and having a curved guide sleeve to guide the curved needles. The curved needle bar can have a size and shape for one or both insertions.

The interstitial implant further includes a long arcuate hollow cable attachment device having a tapered distal end having a radially inwardly extending flexible end forming a distal opening, and a proximal end having a ball captured by the flexible branch end. And a deploying cable having a distal end attached to the interstitial implant, and a second tube inserted into the cable attachment device to release the ball to facilitate the flexible branch end after deployment of the interstitial implant.

In another embodiment, the present invention is directed to a method of placing a spinal implant, the method comprising a plurality of deployable locking wings having dimensions and shapes that can engage the spinous processes of adjacent vertebrae at the symptomatic disk level. Providing a spinal implant having a body portion, advancing a curved needle bar through the skin from one side of the spine into the spinous process between the symptomatic disc levels, and a spinal implant along a path formed by the curved needle bar Guiding the to the spinous process from one side approach, and deploying the locking wing to engage with the spinous process of the adjacent vertebrae.

In another one or more embodiments, the present technology is directed to an apparatus for percutaneously measuring the optimal size of an interstitial implant. The metrology device includes a proximal deployment portion comprising a plunger tube supporting a rod, a distal metrology assembly comprising four connected arms pivotally connected to four coupling joints, and a rod of the plunger tube at the proximal end. And a central shaft coupled to the coupling joint at the distal end, the opposing configured to engage the spine when the rod and thus the central shaft are pulled proximally with the plunger tube fixed so that the connected arm extends from the proximal position to the metrology position. Two opposing concave pedestals in contact with the coupling joint. The metrology device may also include a strain gauge operatively coupled with the plunger tube and the rod to determine the force exerted by the interstitial implant.

In another embodiment, the metrology device comprises a long body portion having a pair of jaw members at the distal end for positioning within the interspinous space, and a pedestal on each jaw member constructed and configured to support the adjacent spinous process in cup form. And a plunger tube and a rod partially received within the plunger tube and attached to the jaw member to selectively move the jaw member from the closed position to an open position where the pedestal engages with the spinous process. The travel distance is correlated with the distance in which the interstitial space is stretched.

The technique also includes a method for measuring the optimal size of an interstitial implant for the treatment of lumbar stenosis, wherein the method includes an extension means between adjacent spinous processes that is movable between a closed insertion position and an open distraction position. Transdermal insertion into the interstitial space of the body, movement of the distraction means between the closed insertion position and the open distraction position, and movement of the distraction means for placement within the interspinous space between adjacent spinous processes. Correlating with size.

It will be appreciated that each feature of the disclosed implants and methods may be interchanged and coupled freely with various other features employing any combination thereof. These and other features of the interstitial implant and transdermal placement method of the present invention will be more readily understood to those skilled in the art from the following detailed description of the preferred embodiment taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Preferred embodiments of the present invention will be described in detail below with reference to specific drawings so that those skilled in the art can easily understand how to make and use the interstitial implant of the present invention without undue experimentation.

1 is a perspective view of an interstitial implant in accordance with the present invention comprising an insertion mechanism to facilitate transdermal introduction of an implant into the spine and a main shell portion having a plurality of locking wings.

FIG. 2 is a plan view of the interstitial implant of FIG. 1 showing the locking wing in the deployed position. FIG.

3 is a side view of the interstitial implant of FIG. 1.

4 is a cross-sectional view taken along line 4-4 of FIG. 3 showing a locking wheel disposed in the main shell of the interstitial implant for deploying a pair of opposite locking wings.

5A is a detailed perspective view of the lower portion of the main shell of the interstitial implant of FIG. 1.

5B is a plan view of the interior of the lower portion of the main shell of FIG. 5A.

5C is a side view of the interior of the lower portion of the main shell of FIG. 5A.

5D is a proximal end view of the lower portion of the main shell of FIG. 5A.

6A is a detailed perspective view of the upper portion of the main shell of the interstitial implant of FIG. 1.

6B is a plan view of the interior of the upper portion of the main shell of FIG. 6A.

6C is a side view of the interior of the upper portion of the main shell of FIG. 6A.

FIG. 6D is another side view of the interior of the upper portion of the main shell of FIG. 6A with the interior shown in hidden lines. FIG.

6E is a proximal end view of the upper portion of the main shell of FIG. 6A.

6F is a distal end view of the upper portion of the main shell of FIG. 6A.

FIG. 7A is a detailed perspective view of the locking wing of the interdental implant of FIG. 1. FIG.

7B is a side view of the locking wing of FIG. 7A.

7C is a top view of the locking wing of FIG. 7A.

7D is a bottom view of the locking wing of FIG. 7A.

7E is an end view of the locking wing of FIG. 7A.

8A is a detailed perspective view of the locking wheel of the interstitial implant of FIG. 1.

8B is a top view of the locking wheel of FIG. 8A.

8C is a side view of the locking wheel of FIG. 8A.

8D is an end view of the locking wheel of FIG. 8A.

8E is a detailed plan view of a locking wheel different from a portion of the actuation mechanism used for the interpolar implant of FIG.

9A is a detailed perspective view of the placement mechanism for use with the interstitial implant of FIG. 1.

9B is a side view of the exhaust mechanism of FIG. 9A.

9C is a plan view of the arrangement mechanism of FIG. 9A.

9D is a distal end view of the placement mechanism of FIG. 9A.

Fig. 10A is a perspective view of the interstitial implant of the present invention in cross section showing four locking vanes and two locking wheels in the stowed position.

1OB is a perspective view of the interstitial implant of the present invention showing, in cross section, four locking vanes and two locking wheels in the deployed position.

11 is a perspective view of the interstitial implant of the present invention with four locking vanes fully retracted and housed within the shell of the device.

Figure 12 illustrates a digestion assembly used to transdermally deploy the interspinous implant of the present invention.

Figures 13-16 illustrate transdermal introduction of the interstitial implant of the present invention through one-sided access from one side of the spine.

17-21 illustrate the transdermal introduction of the interstitial implant of the present invention through bilateral access from both sides of the spine.

22 is a perspective view of an arrangement or cable actuation device for use with the interpolar implant of the present invention.

FIG. 23 is a distal cross-sectional view of the device of FIG. 22.

24 is a diagram of an apparatus for measuring the optimal size of an interstitial implant, shown at an initial metrology position.

25 is a view of the device shown in FIG. 24 in an open or distracted position.

FIG. 26 is a diagram of another device for measuring the optimal size of an interstitial implant, shown in the inserted or closed position.

FIG. 27 is a view of the apparatus shown in FIG. 26 in an open or distracted position.

FIG. 28 is a top view of an instrument kit for facilitating a scenic placement of a spinal implant.

The present invention overcomes many conventional problems associated with implants for alleviating spinal stenosis. The advantages and other features of the systems disclosed herein can be more readily understood by those skilled in the art by the following detailed description of certain preferred embodiments, taken in conjunction with the drawings, which illustrate exemplary embodiments of the invention, wherein like reference numerals refer to like structural elements. Indicates. Relative descriptions herein, such as horizontal, vertical, left, right, upper, lower, are related to the drawings and do not have a limiting meaning. For reference, the proximal is generally an area or portion adjacent or proximate to the surgeon, and the distal means a portion remote or remotely located at the surgeon.

Spinal implant

Referring now to FIG. 1, an interspinous implant formed in connection with a preferred embodiment of the present invention is shown generally indicated by reference numeral 10. The implant 10 is particularly suitable for use in minimally invasive surgical procedures to treat spinal stenosis, including, for example, spinous decompression (IPD).

However, the implant 10 of the present invention may be used in other spinal procedures that may include, but are not limited to, aids for spinal fusion procedures. Those skilled in the art will readily understand that the interstitial implant of the present invention is well suited for transdermal insertion, overcoming many of the deficiencies of existing devices currently used in IPD procedures. That is, the implant 10 has a size and configuration that allows for introduction and placement through a small stab skin incision.

1-4, the interstitial implant of the present invention comprises a main shell or body portion 12 having an upper shell 12a and a lower shell 12b. The shell portions 12a and 12b may have interference fits or may be secured together by fasteners (not shown) inserted into the screw holes 44. The shell portions 12a and 12b are preferably formed of a biocompatible polymer material having an elastic modulus substantially similar to that of bone, such as, for example, a polyetheretherketon thermoplastic (PEEK) material or similar material. The main shell 12 may also be made of a biocompatible metal, such as a material such as titanium alloy. The main shell 12 has a size and configuration that can be placed between the spinous processes of symptomatic disc level (see FIGS. 5A and 5B). Placing the implant in this manner limits expansion at the symptom level while preserving mobility and alignment. The shell 12 is in the form of a general bullet or truncated cone, but the curved end section can be truncated or provided in a flat orientation, such that the shell can take on a barrel structure among many other variations. The shell 12 has opposing depressions 13 that, when disposed, serve to mate with the profile of adjacent bones.

Lower shell portion 12b includes an optical guide 15 for receiving a stylet during a percutaneous placement procedure as best shown in FIGS. 5A-5D and described in detail below. The guide 15 has a bore 17 which can slide over the needle bar. The main shell 12 houses four deployable ratcheting locking wings 14a-14d that are constructed and configured to engage adjacent vertebral portions of the spinous process. The shell 12 has four openings 46a-46d that allow the locking vanes 14a-14b to extend outward from the shell 12. The locking vanes 14a-14b are preferably formed of a lightweight, high strength biocompatible material, such as titanium or similar material.

During deployment of the implant 10, the locking wings 14a-14b are housed in the shell 12 of the implant 10 to form a streamlined structure, as shown in FIGS. 10A-11. As best shown in FIGS. 4, 5A, 5B, 6A, 6B, 10A and 10B, two curved guide tracks 19 formed in the shell portions 12a and 12b are in the stowed position. It accommodates the wing parts 14a-14b.

Each locking wing 14a-14d includes a set of ratchet teeth 16 as best shown in FIGS. 7A-7C. The ratchet teeth 16 on each wing 14a to 14d are correspondingly formed adjacent the openings 46a to 46d on the shell 12 during deployment to lock the wing 14a to 14d at a predetermined position. It has a size and shape that engages the detent structure 18. Locking vanes 14a-14d hold adjacent spinous processes. The implant 10 is mainly used as a spacing between the spinous processes, but the implant 10 may also be used to distract the spinous processes due to the selectively deployable wings 14a-14d. Advantageously, movement of the implant 10 is prevented when the wings 14a-14d are deployed to secure the spinous process.

As best shown in FIG. 3, the two wings 14c, 14b on the side of the implant 10 are located in a plane of parallel spaced geometry extending on the side of the horizontal centerline of the implant shell 12. . That is, in the deployment position, the locking wing 14b is in a deployment plane parallel to the deployment plane of the locking wing 14c. Similarly, the locking wing 14a is in a plane parallel to the deployment plane of the locking wing 14d. Thus, the locking vanes 14a, 14c are in the common deployment plane, and the locking vanes 14b, 14d are in the common deployment plane. This orientation helps to maintain stability in the spinous process and to prevent movement of the device.

The movement or deployment of the locking vanes 14a-14d is controlled or implemented by a pair of coaxial locking wheels 20a, 20b as shown in FIGS. 4 and 8A-8D. The locking wheels 20a and 20b are provided with center openings 25a and 25b, respectively, for mounting on the center hub 21 in the shell 12. The locking wheel 20a is seated on the upper shell portion 12a to control the movement of the vanes 14a, 14c, and the locking wheel 20b is mounted on the lower shell portion (i) to control the movement of the vanes 14b, 14d. 12b). In particular, each of the opposite ends 23a, 23b of the locking wheels 20a, 20b is configured and formed to exert a force on the bearing surface 22 formed at each end of the locking vanes 14a-14d, This is best shown in Figures 10A and 10B.

According to a preferred embodiment of the present invention, the locking wheels 20a, 20b are controlled by the deployment cable 27 as shown in Fig. 10B and the locking vanes 14a-14d are controlled accordingly. One or more cables may be employed. The deployment cable 27 is a key-shaped opening formed in the locking wheels 20a and 20b to facilitate remote operation of the locking wheels 20a and 20b and corresponding movement of the ratcheting locking vanes 14a and 14b. 41). The cable 27 is separated at the distal end and terminated with two balls (not shown). Each ball may pass through its respective key shaped opening 41 and may optionally be trapped within the key shaped portion. Cable 27 exits shell 12 through passageway 90 for use by a surgeon. When deployed, the cable 27 may be cut or disengaged from the keyed opening 41 as described below.

Alternatively, the key shaped opening 41 may be located further away from the pivot point of the locking wheel 20a 20b to provide more mechanical advantages. In addition, the cable 27 can be attached to two key-shaped openings 41 to form a loop. The loop may be a long loop exiting the shell through the passageway 90 or a simple loop at the distal end of the cable 27. A similar second loop of cable (not shown) may also be attached to two different key shaped openings on opposite ends of the locking wheels 20a and 20b to further increase the mechanical force during deployment. In addition, the second loop of cable will exit the implant 10 through a passage similar to the passage 90 except that it is formed at the distal end of the implant 10. When deployed, the cable loop can be delivered or left as part of the implant 10.

As best shown in FIGS. 1-3 and 9A-9D, the interstitial implant 10 is coupled with a placement mechanism 24 constructed and formed to facilitate transdermal insertion of the implant 10. The placement mechanism 24 includes an elongated tubular stem 26 having a straight distal portion 26a and a curved proximal portion 26b. In other embodiments, the tubular stem 26 may be curved without the straight portion. The tubular stem 26 has a central lumen 29 for receiving the proximal portion of the deployment cable 27. At the distal end, the placement mechanism 24 has a coupling sleeve 28 for selectively engaging the locking cuff 49 on the tail 10b of the shell 12. Sleeve 28 has a slot 92 and cuff 49 has one or more protrusions 94 that engage to form a twist lock to selectively place placement mechanism 24 in shell 12. Coupling In addition, the sleeve 28 may form a cutting surface 51 through which the cable 27 is routed for cutting, as best shown in FIGS. 10A and 10B. The protrusions 59 rotate as the sleeve 28 rotates so that the cutting surface 51 can cut the cable 27 after the locking vanes 14a-14d have been deployed by the locking wheels 20a, 20b. Lift the cable 27. When the cable 27 is a long loop, one end is simply released, while the other end of the cable 27 is pulled to remove the cable 27. In addition, each locking wheel 20a, 20b may have a loop or individual cable 27. In another embodiment, the cable 27 is relatively short and remains attached to the locking wheels 20a and 20b after deployment. To operate the locking wheels 20a, 20b, there is a longer secondary cable (not shown) that passes from the proximal end to the distal end of the placement mechanism 24 and loops around the cable 27. Thus, the secondary cable can again exit the proximal end of the placement mechanism 24. The ends of the secondary cable are pulled to pull the cable 27 to actuate the locking wheels 20a and 20b. Thereafter, one end of the secondary cable is simply released and the other end is pulled to remove the secondary cable.

Referring to FIG. 8E, another embodiment of a locking wheel 20 'is shown. The locking wheel 20 'has a spaced groove located on the center hub 21' that is constructed and configured to engage with the complementary spaced teeth on the actuation mechanism 27 '. The center hub 21 'is relatively thick near the center opening 25' such that the teeth on the conical head of the actuation mechanism 27 'effectively engage with the grooves to form the gear drive mechanism. In addition, various other shapes can form an effective gear drive mechanism. The actuation mechanism 27 ′ is preferably a rod extending along the long axis of the implant 10. The conical head of the actuating device 27 'may be arranged between the two actuating wheels 20' or each actuating wheel may have a separate actuating mechanism 27 '. On the other end (not shown), the actuation mechanism 27 'terminates near the end of the shell 12 to form a slot. A screwdriver type device (not shown) may be inserted downward into the placement mechanism 24 and coupled to the rod slot. By rotating a screwdriver type device, the actuating mechanism 27 'rotates so that one or both of the locking wheels 20' rotate in the opposite direction, so that the locking vanes 14a and 14b of the implant 10 are rotated. Perform the deployment.

Fine needle assembly

Referring now to FIG. 12, a digestion assembly 30 is shown and constructed and configured to facilitate transdermal insertion of the interstitial implant 10. The digest needle assembly 30 includes an elongated graduated positioning stylet 32 for positioning the assembly 30 over the central axis of the patient's spine. The graduated positioning needle 32 has a tip 31 constructed and configured to be inserted into the patient at the distal end. A knob 37 is provided at the proximal end of the calibrated positioning needle 32 to allow the surgeon to control the needle 32 more easily. The microneedle assembly 30 further includes an adjustable guide bridge 36 having a curved microneedle 34 for laterally accessing the interstices space and a curved guide sleeve 36a for the curved microneedle 34. . The adjustable guide bridge 36 also has a central portion 36b that acts as an insertion guide for the graduation positioning needle 32. The curved needle bar 34 has a proximal end with a distal end 33 and handle / movement stop 34a constructed and configured to be inserted into a patient. The relationship between the handle / movement stop 34a and the curved guide sleeve 36a sets the maximum insertion depth of the curved microneedle 34.

One side placement of implant

Referring to FIG. 13, a conventional graduated needle 32 is advanced through a small percutaneous incision such as a patient under fluoroscopy, such that the tip 31 reaches the interstitial space. Then, the distance D from the skin to the interstitial space is recognized based on the scale on the minute needle 32. Alternatively, the same distance can be measured from a preoperative CT scan. In each case, the central guide sleeve 36b of the adjustable guide bridge 36 is positioned above the needle 32 and the distance D is indicated in a direction perpendicular to the length of the spine. This distance D corresponds to the adjusted length of the adjustable guide bridge 36 of the digestion assembly 30. Thus, the curved needle bar 34 is advanced downward through the curved guide sleeve 36a of the adjustable guide bridge 36 to the interstitial space. The curved microneedle 34 has the same radius of curvature as D so that upon insertion the distal end 33 moves adjacent the tip 31 of the graduated microneedle 32 in the interstitial space. At the point of advancement of the curved needlepoint 34, the movement stop 34a at the end of the needlepoint 34 contacts the guide sleeve 36a to prevent further expansion. Thereafter, the movement stop 34a is decoupled from the end of the bent needle which is screwed or otherwise connected to the end of the bent needle 34, and the rest of the needle needle assembly 30 including the graduated needle 32 is included. The part is also removed. However, the curved needlepoint 34 remains in place as shown in FIG.

Then, as shown in FIGS. 14 and 15, continuous expanders 40, 42 are placed over the curved needlepoint 34 while observing the interstitial space under fluoroscopy. In addition, dilators 40 and 42 may have the same radius of curvature as D. FIG. The dilators 40 and 42 act to stretch the interstitial space. Although two expanders 40, 42 are shown, some expanders can be used to achieve the desired distraction of the interspace. Once the proper distraction of the interstitial space is observed, the implant 10 is percutaneously inserted through the lumen 43 formed in the final dilator 42. Although the implant 10 may also perform stretching, it is preferable that the dilators 40 and 42 stretch the spinous processes and the implant 10 merely maintains the stretching. Alternatively, the deployment of the implant 10 is carried out by stitching the implant 10 against a curved microneedle 34 which is a guide into the interspace space passing through the guide bore 15 on the lower shell portion 12b.

The implant 10 is adjusted down to the interstitial space. As shown in FIG. 16, the implant 10 has a knob 39 that is selectively attached to the placement mechanism 24 to help the surgeon adjust the implant 10. Knob 39 may include an extension that inserts into central lumen 29 to make stem 26 harder. Once the implant 10 is in place, the dilator 42 is removed while maintaining the position of the implant 10 for subsequent deployment of the locking wings 14a-14d.

One side  Locking after insertion Wing  work

When the shell 12 rests between the spinous processes and contacts the bone at the indentation 13, the locking wings 14a to 14d are deployed. The surgeon uses the cable 27 to deploy the locking wings 14a to 14d and to fix the position of the implant 10. The distal ends 27a, 27b of the cable 27 are attached to the coaxial locking wheels 20a, 20b, respectively, so that when the cable 27 is pulled proximally, the locking wheels 20a, 20b are centered in the shell 12. It rotates about the hub 21.

Opposite ends 23a and 23b of the locking wheels 20a and 20b press the bearing surface 22 of each of the locking vanes 14a to 14d so that the locking vanes 14a to 14d guide the shell 12. It is pressurized outward in the track 19. When the ratchet teeth 16 of the locking vanes 14a-14d move outwards through the detent structure 18 of the shell 12, the detent 18 engages with the corresponding ratchet teeth 16. To prevent the locking vanes 14a-14b from moving inward back into the shell 12. As a result of this outward movement, the locking vanes 14a-14d engage the interproximal protrusion until the surgeon feels adequate resistance, such as deployment. When the locking vanes 14a to 14d are deployed, the cable 27 is released or cut off. Thus, the implant 10 is deployed and maintained between the interprotrusions. In one embodiment, a biasing element or elements, such as a spring, extends between the locking wheels 20a, 20b so that their movement does not occur before or after deployment.

In one embodiment, to release the cable 27, a second cable (not shown) extends under the placement mechanism 24. The second cable loops around the cable 27 and returns through the central lumen 29 of the placement mechanism 24. The surgeon can pull the cable 27 by pulling the second cable. Once the locking wing is deployed, the surgeon releases one end of the second cable loop and then pulls the second cable out of the placement instrument 24, leaving the cable 27 with the implant in the patient.

Placement of both sides of the implant

Referring to Figures 17-21, the surgical steps used for bilateral placement of the interstitial implant 10 of the present invention are shown. First, as shown in FIG. 17, the central portion 36b of the adjustable guide bridge 36 is disposed above the scale bar 32, and the scale bar 32 is inserted into the depth of the patient's spine. The measured distance D is used to determine the size of the adjustable guide bridge 36. Then, the second curved fine needle 34 ', which is similar to the curved fine needle 34, but is advanced downwards through the skin into the interstitial space through the curved guide sleeve 36a of the adjustable guide bridge 36. . In addition, the curved needlepoint 34 'is extendable, and the advancement of the curved needlepoint 34' continues until the distal end 33 of the curved needlepoint 34 'punctures the skin on the opposite side of the spine. .

As shown in Figs. 18 and 19, the adjustable guide bridge 36 and graduated roughening 32 are removed. Continuous tubular dilators 50, 52 are placed on the curved needle bar 34 ′ while observing the interstitial space under fluoroscopy. These dilators 50, 52 with increasingly larger diameters are provided along the same route as the curved needlepoint 34 ′ through the interstitial space until each of the distal ends 53, 55 exits the patient's body. .

Once the proper distraction of the interstitial space is observed, an interstitial implant 10 having a profile slightly smaller than the diameter of the larger dilator 52 is percutaneously inserted through the lumen 57 of the final dilator 55. The surgeon guides the implant 10 downward into the interstitial space by approaching from one or both sides of the spine, as shown in FIG. 20. Alternatively, when the interstitial space has been properly stretched by the dilators 50, 52, the immersion guide (not shown) may be reinserted after the final dilator 52 is removed. Thus, the implant 10 may be inserted into the interstitial space via the needle guide.

Locking after Both Sides Insertion Wing  work

As best shown in FIG. 20, in order to operate the locking vanes 14a-14d, the implant uses a placement mechanism 24a attached to the proximal tail 10b of the implant 10 to final dilator 52. Is inserted through). By pressing the second placement mechanism 24b into the dilator 52 in the opposite direction, the second placement mechanism 24b is attached to the distal nose portion 10a of the implant 10. Each of the positioning mechanisms 24a and 24b has knobs 39a and 39a corresponding to the proximal end. The final dilator 52 is optionally removed completely or partially by the positioning mechanism 24a or the positioning mechanisms 24a and 24b while maintaining the position of the implant 10.

The deployment cable (not shown) is pulled to operate the locking vanes 14a to 14d of the implant 10 in a state where the implant 10 is held in place by the arrangement mechanisms 24a and 24b. The distal end of the cable is attached to the coaxial locking wheels 20a and 20b so that when the cable is pulled, the locking wheels 20a and 20b rotate about the center hub 21 within the shell 12. Opposite ends 23a and 23b of the locking wheels 20a and 20b press the bearing surface 22 of each of the locking vanes 14a to 14d so that the locking vanes 14a to 14d guide the shell 12. Slide outward in track 19. When the ratchet teeth 16 of the locking vanes 14a-14d move outwards through the detent structure 18 of the shell, the detents 18 move the locking vanes 14a-14d into the shell 12. Engage with corresponding ratchet teeth 16 to prevent inward movement again. As a result of this outward movement, the locking vanes 14a-14d engage the spinous process until the surgeon feels adequate resistance, such as deployment, as shown in FIG. 21.

When the locking vanes 14a-14d are deployed, the cables are released and the placement mechanisms 24a, 24b are detached from the nose 10a and tail 10b of the implant 10. Thereafter, the implant 10 is deployed and maintained between the spinous processes as shown in FIG. Before the placement mechanism 24a is completely removed from the implant 10, the deployment cable is cut. To cut the cable, the placement mechanism 24a rotates the cutting surface 51, after which the cable is passed through and cut against the cutting surface 51.

Placement mechanisms 24a and 24b are respectively attached to interstitial implant 10 via an optional twist lock as described above. Alternatively, the placement mechanisms 24a and 24b are also designed to have a tapered end having a prong attached to the bulbous portion of the apex 10a and the tail 10b of the interstitial implant 10. Can be. Similarly, an unlocking rod can be inserted into the placement mechanism 24a, 24b or dilator 52 to disengage the placement mechanism 24a, 24b or dilator 52 from the shell 12.

Alternating  controller

Referring now to FIGS. 22 and 23, a control device 60 is shown. The control device 60 can be used to operate the cable (s) 27 or to position the implant 10. Thus, the size and shape may differ significantly from that shown, because the principle of operation is widely applicable. The control device 60 has an arcuate tube 61. The arcuate tube 61 preferably has a radius of curvature of D.

The control device 60 can be used to operate the cable 27 so that cutting is not required by detachment from the cable 27 after deployment. For example, the arcuate tube 61 has a tapered distal end 62. The tapered end 62 has a flexible branch end 64 extending radially inwardly with a longitudinal slot 66 therebetween. Branch end 64 defines a distal opening 68. The proximal end of the deployment cable 27 may be attached to a small ball (not shown) on the proximal end of the cable 27. This ball will have a diameter slightly larger than the opening 68 to be trapped in the tapered distal end 62. In particular, the flexible branch end 64 of the cable attachment device 60 captures the cable ball. By capturing the cable balls, the control device 60 can be used to pull the cable 27 by pulling the control device 60.

When the cable 27 is pulled with the locking vanes 14a-14d of the implant 10 deployed, the ball of the cable 27 is released from the tapered distal end 62 of the arcuate tube 61. . As shown in FIG. 22, the release of the ball from the control device 60 is performed by inserting the second tube 67 into the arcuate tube 61. The second tube 67 will have a slightly smaller diameter than the arcuate tube 61. The tube 67 provides a suitable force to bias the branch end 64, increasing the diameter of the opening 68, thereby releasing the ball on the end of the deployment cable 27. Thus, a short amount of cable 27 can be kept inserted.

In addition, the implant 10 can be designed such that the deployment of the locking vanes 14a to 14d is achieved on both sides from the abutment 10a and tail 10b of the shell 12, thereby allowing two separate cables to be winged. It can be used to deploy parts 14a-14d, which doubles the mechanical advantages provided during one-sided access using a single deployment cable 27. The control device 60 can be used with one such cable or two cables.

In another embodiment, the control device 60 is used to position the implant 10. The flexible branch end 64 will be attached to an indentation on the implant 10. The two control devices 60 can be used with one control device attached to each end of the implant 10. Thus, the arcuate tube 61 can be used to position the implant 10. Upon deployment of the locking vanes 14a-14d, the second tube 67 will be used to release the control device 60 from the implant 10.

Newcomer  For locking Wing  use

In an alternative method, the locking vanes 14a-14d are used to stretch the spinous process. Rather than inserting dilators of increasing diameter, the implant 10 is placed in place. Thereafter, the cable 27 is used not only to deploy the locking vanes 14a to 14d, but the locking vanes 14a to 14d have a size and shape that can engage and stretch the spinous processes. For example, each locking wing 14a-14d may have a hook-shaped protrusion that is positioned to stretch the spine when the wing 14a-14d is deployed.

Implant at deployed position

When deployed, the interstitial implant 10 of the present invention is attached to an adjacent spinous process. Implant 10 limits the movement of the spine both in extension as well as in curvature. However, by slightly modifying the locking wings 14a to 14d, the locking wings 14a to 14d can alternatively be designed for simple contact with the spinous process, whereby the implant 10 is curved in the spine. Can be allowed.

The implant 10 may be permanently coupled to the spinous process. For example, the tips of the locking vanes 14a-14d may be sharp to create penetration of the spinous process. The tips of the locking wings 14a-14d can be deformed so that the edge forms a point on the opposing claw and the opposing wings can penetrate deeper or through the spinous process bones. In addition, the orientation of the points on the opposing claw may be reversed. Also, the tips of the wings 14a-14d may have one or more barbs to prevent disengagement. In addition, the tips of the wings 14a-14d may have perforations that enable bony ingrowth from the spinous process. In addition to being offset, the curves of the locking vanes 14a-14d are slightly different to allow the opposing claws not to meet, each of which can penetrate deeper through the bone.

Predetermination of Implant Size

Referring now to FIGS. 24 and 25, depending on the position of the implant 10 in the spinous process and the anatomical structure of the patient, measuring the optimal size of the interstitial implant 10, which may be from about 8 mm to about 14 mm in diameter, percutaneously An apparatus 100 and method are disclosed. Those skilled in the art will readily appreciate that the inter-pole measurement device disclosed herein may be used to measure or determine the optimal degree of force for inter-extension distraction.

Referring to FIG. 24, the metrology device 100 is shown in the closed position when the metrology device 100 is transdermally inserted into the interstitial space. The apparatus 100 includes a proximal deployment portion 110 that includes a plunger tube 102 that supports the rod 104. The rod 104 extends at approximately the same height at the distal end 106 of the plunger tube 102.

The apparatus 100 further includes a distal metrology assembly 112 consisting of four connected arms 114a-114d. Connected arms 114a through 114d are pivotally connected to four coupling joints 115a through 115d. The rod 104 of the plunger tube 102 extends on the distal end to be connected to the coupling joint 115c. Adjacent coupling joints 115b and 115d are configured and formed to support adjacent spinous processes in the form of a cup.

In order to percutaneously measure the optimal size of the interstitial implant 10, the device 100 is arranged such that opposing concave pedestals 116a, 116b, cradle are located between adjacent spinous processes. With the plunger tube 102 pressed in the distal direction, the rod 104 remains stationary. The connected arms 114a-14d are driven to extend in a trapezoidal shape as shown by the moving arrow "a" in FIG. 25. If not already stretched by the dilator, the spinous processes may be stretched due to the expansion of the connected arms 114a to l14d. The measurement of the travel distance of the rod 104 in the tube 102 will be correlated with the stretched length of the interpolar space, ie the size of the trapezoidal shape. Thus, the travel distance of the rod 104 can be used to determine the appropriate size of the interstitial implant 10. To facilitate travel distance measurement, rod 104 may be provided with a scale or indicator that may correspond to actual measurement or identify the appropriate size selection of implant 10.

Plunger tube 102 and / or rod 104 are operatively coupled with a strain gauge (not shown) to gauge the optimal degree of force for inter-extension distraction. As the device 100 is calibrated, appropriate laboratory tests may be performed to determine the optimum degree of distractive force. The adjusted device 100 can then be used to determine the appropriate implant 10 to apply the optimal force. To adjust the device 100, a clinical study may be conducted in which the amount of distraction is correlated with a radiological study indicating the extent of distraction. In addition, clinical studies can be conducted to observe prolonged clinical outcomes as well as possible subsidence of the implant 10 to spinous processes depending on varying degrees of force applied.

With reference to FIGS. 26 and 27, another device 200 is shown for percutaneously measuring the optimal size of the interstitial implant 10 in the closed and open positions, respectively. The metrology device 200 includes an elongated body portion 210 having a pair of jaw members 212a, 212b, jaw members at the distal end for positioning in the interspace space. The jaw members 212a and 212b have separate pedestals 214a and 214b that are constructed and formed to support adjacent spinous processes in the form of a cup.

The movement of the jaw member from the closed position of FIG. 26 to the open or metered position of FIG. 27 can be accomplished in a conventional manner (eg, by inclined cam slots, etc.) via a flexible rod 216 extending through the body portion 210. By way of example, similar to the plunger tube and rod shown in FIGS. 24 and 25. Again, the measurement of the moving distance of the rod 216 within the body portion 210 may be correlated with the distance between which the interstitial space is stretched or directly with the size of the appropriate implant 10. In addition, strain gauges may be used to determine the desired amount of force applied, such as by coupling strain gauges to plunger tube 102 or rod 216.

In addition, a temporary balloon may be inserted in the interstitial space to determine the appropriate size of the implant 10 to be used, which is within the scope of the present invention. In addition, the optimal force required for interstretch distraction can be correlated with the amount of pressure required to rupture the balloon. Thus, the optimal force and the size of the implant will be determined by how much the balloon is inflated to obtain the optimal pressure.

Implants Transdermal  Mechanism for placement Kit

Referring to FIG. 28, an instrument kit 400 is shown that facilitates transdermal insertion of the implant 10. The instrument kit 400 includes, in particular, a long graduated positioning needle 32, a curved needle 34, And an enclosure 410 comprising an extinction assembly 30 comprising an adjustable crosslinked portion 36 having a curved guide sleeve 36a. Instrument kit 400 includes a curved needlepoint 34 (see FIG. 13) configured to access the spinous process to one side, or a curved needlepoint 34 '(FIG. 18) configured and formed to access both sides of the spinous process Or both types of curved depressions.

Instrument kit 400 may also include one or more implants 10 that vary in size. The instrument kit 400 also preferably includes a set of tubular dilators of variable diameter (eg, dilators 42, 50, 52) corresponding to the variable implant 10. The dilators may have two different lengths, depending on whether the dilators 42, 50, 52 are used for the bilateral approach procedure or for the unilateral approach procedure. The tubular dilators 42, 50, 52 may range from about 8 mm to about 14 mm. In addition, the dilators, curved sweeps and placement mechanisms will have varying radii of curvature to suit the body shape of various patients. Of course, the implant 10 can be individually packaged for use with an insertion kit that is sized by the placement tool, the curved needle and the radius of curvature of the dilator.

Although the apparatus and method of the present invention have been shown and described with reference to the preferred embodiments, those skilled in the art will readily appreciate that changes and / or modifications may be made within the spirit and scope of the invention.

Claims (56)

Spinal implants, A body portion having an internal cavity, A plurality of locking vanes configured and formed to move between the deployed position extending from the inner cavity of the body and the retracted position retracted into the inner cavity of the body portion; Means for moving the plurality of locking vanes from the stowed position to the deployed position; Spinal implant. The method of claim 1, Spinal implants are used to treat lumbar stenosis Spinal implant. The method of claim 2, When in the deployment position, the wing secures the implant within the selected interpolar space. Spinal implant. The method of claim 1, The means comprises a wheel arrangement for deploying the locking wing. Spinal implant. Interstitial implant for placement between symptomatic disc-level spinous processes, A shell having an upper shell portion and a lower shell portion forming four inner grooves, wherein the four inner grooves terminate in an opening of the shell, the shell having a detent adjacent each opening; a set of couplings for engaging and locking each detent in the unfolded position, i. Four deployable ratcheting locking wings, each having a ratchet tooth, A pair of coaxial locking wheels rotatably mounted in the shell to selectively exert a force on each locking wing to move the locking wing from the stowed position to the deployed position; A deployment cable coupled to the wheel to rotate the wheel. Interstitial Implants. The method of claim 5, The shell is formed of a biocompatible polymer material having an elastic modulus substantially similar to that of bone Interstitial Implants. The method of claim 5, The shell has a general truncated cone shape with opposing indentations. Interstitial Implants. The method of claim 5, The lower shell portion includes a guide for receiving a needle during transdermal placement procedure Interstitial Implants. The method of claim 5, The locking wing is formed of a lightweight, high strength biocompatible material Interstitial Implants. The method of claim 5, The deployment cable is attached to a key shaped opening formed in the locking wheel. Interstitial Implants. The method of claim 5, The first and second wings of the four wings are located on parallel spaced geometric first planes extending on the first side of the centerline of the shell, The third and fourth wings of the four wings are located on parallel spaced geometric second planes extending on the second side of the centerline of the shell. Interstitial Implants. The method of claim 5, Further comprising a placement mechanism for introducing the shell into the spinous process, The placement mechanism is A long tubular stem forming a central lumen for receiving deployment cables, A coupling sleeve on the straight distal portion for selectively engaging with the shell Interstitial Implants. The method of claim 12, The long tubular stem is curved and the coupling sleeve forms a cutting surface for cutting the deployment cable. Interstitial Implants. The method of claim 5, Further comprising an instrument for positioning the interstitial implant, The apparatus A first tube having a tapered distal end having a flexible branched end extending radially inward for engaging the shell; A second tube inserted into the first tube to bias the flexible branch after deployment of the interstitial implant, to separate the shell from the branch. Interstitial Implants. The method of claim 5, Further comprising a needle needle assembly for transdermal insertion of the interstitial implant Interstitial Implants. The method of claim 15, Burnout assembly A long graduation positioning needle to position the needle assembly relative to the central axis of the spine, A curved needle bar for laterally approaching the interstitial space, An adjustable guide bridge having a central portion extending between the curved needle and the positioning needle to guide the positioning needle and having a curved guide sleeve to guide the curved needle needle Interstitial Implants. Microneedle assembly for transdermal insertion of interstitial implants, A long graduation positioning needle to position the needle assembly relative to the central axis of the spine, A curved needle bar for laterally approaching the interstitial space, An adjustable guide bridge having a central portion extending between the curved needle and the positioning needle to guide the positioning needle and having a curved guide sleeve for guiding the curved needle needle Digestion assembly. The method of claim 17, Further comprising a movement stop coupled to the curved guide sleeve Digestion assembly. The method of claim 17, Curved needles have size and shape for one-sided insertion Digestion assembly. The method of claim 17, Curved needles are sized and shaped for bilateral insertion Digestion assembly. The method of claim 17, And further comprising one or more dilator tubes disposed over the curved needle tip to extend the interstitial space. Digestion assembly. The method of claim 17, Further includes an actuating mechanism for the interstitial implant, The apparatus An elongated arcuate hollow cable attachment device having a tapered distal end having a flexible branch end extending radially inwardly defining a distal opening; A deployment cable having a proximal end having a ball captured by the flexible branch end and a distal end attached to the interstitial implant, A second tube inserted into the cable attachment device to bias the flexible branch end after deployment of the interstitial implant and to separate the ball from the flexible branch end. Digestion assembly. For the placement of one side of the implant, Using the graduated needle to advance the implant through a small percutaneous incision of the patient's back skin under a fluoroscopic examination so that the tip of the graduated needle has reached the interstitial space; Measuring the distance from the skin to the interstitial space based on the graduation on the graduated minute needle, Adjusting the guide bridge extending from the central guide sleeve retaining the graduated needle at the distance such that the curved guide sleeve keeps the tip of the curved needle needle at the distance away from the incision of the skin; Advancing the curved fine needle through the curved guide sleeve of the adjustable guide bridge downwardly so that the distal end of the curved fine needle moves adjacent the tip in the interspace space; Removing the guide bridge and the graduations, Continually placing larger dilators on the curved sweep while observing the interspace under fluoroscopy to expand the interspace; Transdermal insertion of the implant through the lumen formed in the final dilator when sufficient distraction of the interstitial space is observed, Deploying the implant within the interstitial space Implant placement on one side. The method of claim 23, wherein Deploying the implant includes moving the locking wing to keep the implant distracted. Implant placement on one side. The method of claim 23, wherein Using a movement stop to block advancing of the distal end of the curved needlepoint passing through the interstitial space; Implant placement on one side. The method of claim 23, wherein Advancing the curved needlepoint until the distal end punctures the skin at the opposite side of the spine; Implant placement on one side. The method of claim 26, Using first and second stabilizing rods to position the implant, pulling a cable attached to the wing for deployment, and releasing at least a portion of the cable from the implant. Implant placement on one side. The method of claim 23, wherein The implant is used for treatment selected from the group consisting of treatment to alleviate the symptoms of protruding lumbar discs, treatment of back pain, and fixation devices that aid in fusion. Implant placement on one side. How to place a spinal implant, Providing a spinal implant having a body portion comprising a plurality of deployable locking wings having dimensions and shapes that can engage with the spinous process of the adjacent vertebrae at the symptomed disc level; Advancing the curved needle bar downward through the skin from one side of the spine into the spinous processes between symptomatic disc levels, Guiding the spinal implant from one side into the spinous process along the path formed by the curved needle bar; A method of positioning a spinal implant comprising deploying a locking wing to engage with the spinous process of an adjacent vertebra. Method of transdermal placement of spinal implants, Providing a spinal implant having a body portion for receiving a plurality of deployable locking wings having dimensions and shapes that can engage with the spinous process of the adjacent vertebrae at the symptomatic disc level; Advancing the curved fine needle down from one side of the spine into the spinous process between the symptomatic disc levels to allow bilateral access to the spinous process, and forwarding the curved fine needle out through the skin on the opposite side of the spine Wow, Guiding a spinal implant from both sides of the spine into the spinous process along a path formed by the curved needle bar, Deploying the locking wing to engage with the spinous process of the adjacent vertebrae; Spine implant transdermal placement method. It is a device for percutaneously measuring the optimal size of the interstitial implant, A proximal deployment portion comprising a plunger tube supporting a rod, A distal metrology assembly comprising four connected arms pivotally connected to four coupling joints, A central shaft connected to the rod of the plunger tube at the proximal end and to the coupling joint at the distal end, Includes two opposing concave supports in contact with the opposing coupling joint configured to engage the vertebrae when the rod and thus the central shaft are pulled proximally with the plunger tube secured so that the connected arm extends from the proximal position to the metrology position. doing Instrumentation device. The method of claim 31, wherein The interstitial space is stretched within the measurement position Instrumentation device. The method of claim 31, wherein The travel distance of the rod in the tube correlates with the length of the space between the gaps Instrumentation device. 32. The method of claim 31 wherein the measurement of the measurement of travel distance is correlated with the appropriate size of the interstitial implant. Instrumentation device. The method of claim 34, wherein The rod has a display for checking the moving distance Instrumentation device. The method of claim 31, wherein And further comprising a strain gauge operatively coupled to the plunger tube and rod to determine the force exerted by the interstitial implant. Instrumentation device. The method of claim 31, wherein The interstitial implant diameter ranges from about 8 mm to about 14 mm. Instrumentation device. It is a device to percutaneously measure the optimal size of the interstitial implant, An elongated body portion having a pair of jaw members at the distal end for positioning within the interpolar space, Pedestals on each jaw member, constructed and configured to support adjacent spinous processes in the form of a cup, With plunger tube, A rod partially received within the plunger tube, the rod being attached to the jaw member to selectively move the jaw member from the closed position to the open position where the pedestal engages with the spinous process, The travel distance of the rod in the plunger tube is correlated with the distance between the gaps Instrumentation device. It is a device for measuring the optimal size of the interstitial implant for the treatment of lumbar stenosis. Stretching means having a size and shape capable of transdermal insertion into the interspinous space between adjacent spinous processes, and movable between a closed insertion position and an open distraction position, A deployment means for moving the distraction means between the closed insertion position and the open distraction position, The amount of movement of the deployment means corresponds to the optimal size of the interstitial implant for placement in the interspinous space between adjacent spinous processes. Instrumentation device. The method of claim 39, The deployment means are capable of moving the stretching means into the interstitial space. Instrumentation device. The method of claim 39, Distraction means Four connected arms pivotally connected by four coupling joints, A rod to the coupling joint for expanding and contracting the shape formed by the four arms. Measuring device. The method of claim 41, wherein The rod has a scale that identifies the appropriate implant Instrumentation device. The method of claim 39, The deployment means is a plunger tube that supports the rod Instrumentation device. The method of claim 39, Distraction means An elongated body portion having a pair of jaw members, An opposing pedestal mounted on each jaw member, The pedestal is constructed and formed to support the adjacent spinous process in the form of a cup Instrumentation device. It is a method to measure the optimal size of the interstitial implant for the treatment of lumbar stenosis. Transdermally inserting a distraction means movable between a closed insertion position and an open distraction position into the interspinous space between adjacent spinous processes, Moving the distraction means between the closed insertion position and the open distraction position; Correlating the movement of the distraction means to the optimal size of the interspinous implant for placement in the interspinous spaces between adjacent spinous processes. Measurement method. Instrument kit for facilitating transdermal placement of spinal implants, A digestive assembly comprising: a digestive assembly having a long positioning digester for positioning the assembly over a central axis of the spine, a curved digester that is operatively coupled with the positioning digester to laterally access the interstitial space; One or more tubular expanders for distracting the interpolar space, having a predetermined outer diameter, An enclosure for providing the microneedle assembly and one or more tubular expanders Instrument kit. 47. The method of claim 46 wherein Curved needles are constructed and formed for one-sided access to spinous processes Instrument kit. 47. The method of claim 46 wherein Curved needles are constructed and formed for bilateral access to spinous processes Instrument kit. 47. The method of claim 46 wherein Further comprising a plurality of tubular expanders Instrument kit. 47. The method of claim 46 wherein Each tubular dilator has a different outer diameter Instrument kit. 47. The method of claim 46 wherein Each tubular expander has a different radius of curvature Instrument kit. Instrument kit for facilitating transdermal insertion of implants, i) a digester assembly having a long graduation positioning needle connected to a curved needlepoint by an adjustable crosslinking portion having a curved guide sleeve, and ii) an enclosure comprising a set of tubular expanders of varying diameters; Instrument kit. The method of claim 52, wherein The set of tubular expanders have different lengths Instrument kit. The method of claim 52, wherein Further comprising one or more implants Instrument kit. The method of claim 52, wherein Curved needles are configured for one side access Instrument kit. The method of claim 52, wherein Curved needles are configured for bilateral access Instrument kit.

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