WO2011116096A1 - Method and device for tenting dura mater in spinal surgery - Google Patents

Method and device for tenting dura mater in spinal surgery Download PDF

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Publication number
WO2011116096A1
WO2011116096A1 PCT/US2011/028669 US2011028669W WO2011116096A1 WO 2011116096 A1 WO2011116096 A1 WO 2011116096A1 US 2011028669 W US2011028669 W US 2011028669W WO 2011116096 A1 WO2011116096 A1 WO 2011116096A1
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WO
WIPO (PCT)
Prior art keywords
dura mater
tenting
spinal cord
attachment member
spinal
Prior art date
Application number
PCT/US2011/028669
Other languages
French (fr)
Inventor
Scott P. Falci
Original Assignee
Falci Scott P
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Falci Scott P filed Critical Falci Scott P
Publication of WO2011116096A1 publication Critical patent/WO2011116096A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant

Definitions

  • the present disclosure relates to medical apparatus and methods. More specifically, the present disclosure relates to a device for tenting dura mater and methods and a kit for using such device.
  • Optional or necessary spinal surgery can be required following an accident, such as a motor vehicle accident or a diving accident, or to relieve pain associated with, for example, a bulging disc or a slipped disc. Such surgery does not always require access to, or is not a procedure involving, the spinal cord.
  • a surgeon may perform a procedure on or near the spinal cord.
  • an incision is made in the dura mater surrounding the spinal cord.
  • the incision is closed and the dura mater may come to rest on the spinal cord, resulting in the formation of scar tissue.
  • Scar tissue around the spinal cord can cause several problems, including progressive loss of function, pain, spasticity, disruption of fluid flow around the spinal cord and impedance of the normal motion of the spinal cord.
  • the present disclosure is directed to a tenting device for tenting dura mater above the spinal cord in the spinal column of a subject.
  • the device can include a support member with at least one connecting portion capable of attaching to a dura mater surface via an attachment member, wherein the support member is at least partially angled or conformable to be at least partially angled relative to the longitudinal surface of the member.
  • the present disclosure is directed to a kit for tenting dura mater above the spinal cord in the spinal column.
  • the kit can include an implantable dura mater tenting device and can also include instructions for attaching the implantable dura mater tenting device to a dura mater surface of the spinal column in order to elevate the dura mater above the spinal cord.
  • the present disclosure is directed to a method of suspending the dura mater above the spinal cord.
  • the method can include fastening the tenting device on at least one vertebra.
  • the method can also include connecting a first end of an attachment member to the connecting portion of the tenting device and a second end of the attachment member to the dura mater to elevate the dura mater above the spinal cord.
  • the present disclosure is directed to a method of reducing or preventing spinal scarring.
  • the method can include fastening the tenting device on at least one vertebra or skull.
  • the method can also include connecting a first end of an attachment member to the connecting portion of the tenting device and a second end of the attachment member to the dura mater to elevate the dura mater above the spinal cord.
  • the present disclosure is directed to a method for selling an implantable spinal dura mater tenting device.
  • the method includes offering the implantable spinal dura mater tenting device for sale.
  • the method can further include transferring the implantable tenting device to a second or third person.
  • FIG. 1 A is a top plan view of a vertebra and spinal cord, wherein a dura mater tenting device according to the present disclosure is shown implanted.
  • FIG. 1 B is an isometric view of the vertebra, spinal cord and tenting device of FIG. 1A, taken from a top, rear and lateral side view.
  • FIG. 2A depicts an embodiment of the device for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
  • FIG. 2B depicts an alternative embodiment of the device for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
  • FIG. 3A is an isometric view of a spinal cord and its surrounding membranes, wherein an incision has been made in a dura mater surface.
  • FIG. 3B is the spinal cord of FIG. 3A, wherein the dura mater has been opened for surgery.
  • FIG. 3C depicts the dura mater surface of FIG. 3B, after the incision in the dura mater has been closed.
  • the present disclosure provides a device, methods, and a kit for tenting dura mater in the spinal cord of a subject.
  • Embodiments of the disclosure provide a tenting device for tenting dura mater of the spinal cord, methods of tenting spinal dura mater and of selling such a device or kit, and a kit which can include
  • the present disclosure provides a device that elevates or "tents" the dura mater above the spinal cord, thus preventing or reducing the build-up of scar tissue around the spinal cord.
  • the tenting device can be connected to a vertebra and/or portion of the skull, and also attached to a dura mater surface. When the device is implanted and attached to the dura, the dura mater is elevated or “tented” above the spinal cord.
  • the terms “attached”, “fastened” and “connected” are used interchangeably. For purposes of the present disclosure, attached and connected are used to describe a direct connection, as well as attachment or association via two members via intervening parts
  • FIG. 1 A is a top plan view of a vertebra 110 and spinal cord 128, wherein a dura mater tenting device 100 according to the present disclosure is shown implanted.
  • FIG. 1B is an isometric view of the vertebra 1 0, spinal cord 28 and tenting device 100 of FIG. 1A, taken from a top, rear and lateral side view.
  • the spinal cord is housed in and protected by the spine in the spinal column or more specifically, the spinal canal.
  • the spine is a flexible column formed by a series of bones called vertebrae.
  • the spinal column is formed by the junction of these vertebrae.
  • the spinal canal which is formed by an opening generally in the center of each vertebra, follows the curvature of the spine and is largest where the spine moves more freely and is smaller where the spine is more limited in motion. While the movement permitted between any two individual pieces of the spinal column is small, there is a considerable range of movement for the whole without a significant diminution of strength.
  • the curvature of the spine also adds to its stability and lessens the liability of injury.
  • each vertebra 110 consists of two parts, the body 112 and the arch 114.
  • the arch 1 4 is formed by two pedicles 116 and two laminae 118 and supports seven processes, including one spinous process 120, four articular processes 122 and two transverse processes 124.
  • the arches 114 form a hollow cylinder behind the bodies 112 to protect the spinal cord 128.
  • the articular processes 122 and intervertebral discs connect the different vertebrae 110 together.
  • the spinous and transverse processes 120, 124 act as levers for the attachment of muscles which move various parts of the spine. As shown in FIG. 1B, there are also apertures between each pair of vertebrae 110 through which the spinal nerves 136 extend from the spinal cord 128.
  • the spinal cord 128 is enveloped by three
  • the dura mater 130 is the most external membrane and forms a loose sheath around the spinal cord 128.
  • the dura mater 130 may be covered by loose areolar tissue and veins and surrounded by cerebrospinal fluid, both of which separate the dura mater 130 from the walls of the spinal canal.
  • Beneath the dura mater 130 is the arachnoid membrane 132.
  • the arachnoid membrane 32 is a delicate and thin tubular membrane that envelops the surface of the cord 128. Thin filaments of connective tissue connect it to the pia mater 134.
  • the inner surface of the dura mater 130 and the outer surface of the arachnoid membrane 132 are in contact with each other, and are only sparingly connected.
  • the pia mater 134 covers the entire surface of the spinal cord 128.
  • the pia mater 134 is tightly connected to the spinal cord 128 and forms its neurilemma (a plasma membrane.
  • FIG. 1A is a top plan view of a dura mater tenting device 100.
  • FIG. 1 B is an isometric view of the tenting device 100 of FIG. 1A, taken from a top, rear and lateral side view.
  • FIG. 2A depicts an embodiment of a device 100 for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
  • FIG. 2B depicts an alternative embodiment of the device 100 for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
  • the tenting device 100 is implanted.
  • the tenting device 100 includes a support member 102, a connecting portion 104, a fastening member 106 and an attachment member 108.
  • the device is implanted at a thoracic vertebra, wherein the spinous process and laminae are shown in phantom because they have been removed to permit access to the spinal cord. The removal is discussed in more detail below.
  • the support member 102 of tenting device 100 can be connected to a vertebra 1 10.
  • the term vertebra includes the sacrum.
  • the support member 02 can be, but does not have to be, the surface of the device 100 that contacts the vertebra 110.
  • the support member 102 of device 100 is connected to a vertebra in the thoracic region. It can be appreciated that the support member 102 of the device 100 can also be attached to a vertebra in the cervical or lumbar regions or any other region where the dura can contact the spinal cord following surgery.
  • the support member 102 of tenting device 100 can be connected to the transverse process 124 of a vertebra. It can be appreciated that the support member 102 of tenting device 100 can be connected to the pedicle 16, the articular process 122, or any other bony surface or other surface of a vertebra 0 or the skull.
  • the tending device can be connected to the skull as described for the vertebra in each embodiment described herein.
  • the support member 102 can have a single planar or longitudinal surface. In various other embodiments, the support member 102 can be at least partially angled or conformable to be at least partially angled relative to the longitudinal surface of the support member 102. That is, the support member 102 can be bent or angled relative to a longitudinal surface of the support member 102. The support member 102 can also be conformable to be bent or angled relative to a longitudinal surface of the support member 102. The bend or angle may be in the same plane as the surface of the support member. However, it can be appreciated that the bend or angle is or is conformable to be in a different plane depending on how and where the surgeon implants the device in order to position it to tent the dura mater.
  • the support member 102 can be constructed of titanium, or a titanium alloy, or plastic or etc.
  • the support member is connected to the dura mater surface by an attachment member. More specifically, the support member 102 has at least one connecting portion 104 capable of operably attaching to a dura mater surface 130 via an attachment member 08.
  • the connecting portion 104 can be a hole or aperture within or on the support member 102 or may be the portion of the support member where an adhesive is applied. That is, the connecting portion is the part of the support member that receives the dura mater attachment member and the attachment member may be received by the connecting portion by any method known in the art.
  • the attachment member is connected to the device at the connecting portion.
  • the connecting portion can receive the attachment member 108 and can aid in elevating the dura mater surface relative to the spinal cord.
  • the connecting portion 104 can be at a first end of the support member 102 or the connecting portion 104 can be located somewhere in between a first end and a second end of the support member 102.
  • the connecting portion 104 can be at a first and a second end of the support member 102 or the connecting portion 104 can be at a first, a second and a third end or other end, or located somewhere in between a first, second and/or third or other end of the support member 102.
  • the fastening member 106 operably connects the support member 102 of device 100 to a vertebra 110 or the skull. That is, the fastening member 106 is received on or in the support member 102 and operably attaches the support member 102 to the vertebra 1 0.
  • the tenting device 100 can be connected to the transverse process 124, but as explained above, the device 100 can be connected to any bony surface.
  • the fastening member 106 can be any fastening device, such as a screw or an adhesive.
  • a screw can be received in an aperture or hole on or in the support member 102.
  • the screw can be of any length known to those of skill in the art.
  • An adhesive can be received on the support member 102.
  • the adhesive can be glue, tape, or any other adhesive known in the art.
  • the tenting device 100 is implanted and can be attached to a vertebra 110.
  • the tenting device 100 can also be attached to the dura mater surface 130 with an attachment member 108.
  • the attachment member 108 will help elevate the dura mater 130 relative to the spinal cord 128.
  • the attachment member 108 has at least opposing ends. At least one opposing end of the attachment member 108 is received in or by the connecting portion 104 of device 100.
  • the dura mater attachment member 108 can include, but is not limited to surgical thread. Also, in various embodiments, there can be more than one attachment member 108.
  • the fastening member 106 operably attaches the support member 102 of the device to a vertebra 110.
  • a first end of attachment member 108 can be connected to the connecting portion 104 of support member 102.
  • a second end of the attachment member 108 can be connected to a dura mater surface 130.
  • the dura mater surface 130 can thereby be elevated or suspended relative to the spinal cord 128 by, for example, making the attachment member 108 substantially taut to elevate or "tent" the dura mater. This elevation or suspension can help reduce or prevent scar tissue such as that caused by the dura mater 130 contacting the spinal cord 128.
  • more than one tenting device 100 is used to elevate the dura mater 130 above the spinal cord 128.
  • a single tenting device 100 is used to elevate the dura mater 130 above the spinal cord 128.
  • FIGS. 2A and 2B depict various alternative embodiments of the tenting device in accordance with the present disclosure and are shown in a non-implanted state for clarity purposes.
  • the tenting device 100 can be comprised of a support member 102, a connecting portion 104, and a fastening member 106. It can be appreciated that, while not shown, the attachment member 108 may be present or connected to the device in a non-implanted state.
  • the support member 102 of tenting device 100 can have one angle relative to the longitudinal surface of the support member 102. As illustrated in FIG. 2B, in an alternative embodiment, the tenting device 100 can have more than one angle relative to the longitudinal surface of the support member 102. As discussed previously, the angle or bend can help to elevate the dura surface relative to the spinal cord.
  • the connecting portion 104 can be a hole or aperture within or on the support member 102. As illustrated in FIG. 2A, in one embodiment, the connecting portion 104 can be at a first end of the support member 102. As shown in FIG. 2B, in an alternative embodiment, the connecting portion 104 can be located somewhere in between a first end and a second end of the support member 102. In various other embodiments, the connecting portion 102 is located in another location conducive for aiding in the elevation of the dura mater when the device is implanted.
  • both FIGS. 2A and 2B include a fastening member 106.
  • the fastening member 106 operably connects the support member 102 of device 100 to a vertebra 110.
  • the fastening member can be any fastening device, such as a screw or an adhesive
  • a spinal cord injury may be caused by a contusion, hemorrhage, compression, tumor, infection, abrasion, disruption, or movement of the spinal cord.
  • Treatment of a spinal cord injury often requires surgical intervention to repair the injured spinal cord.
  • incisions can be made to the dura mater in order to reach the spinal cord.
  • the spinal cord is surrounded by three membranes: the pia mater, the arachnoid membrane, and the dura mater. Once an incision is made and subsequently closed after the surgical procedure, the dura mater may contact the spinal cord directly, thereby creating scar tissue.
  • Scar tissue around the spinal cord can cause several problems, including progressive loss of sensory and/or motor function, pain, and spasticity. Scar tissue may prevent the normal flow of spinal fluid around the spinal cord and impede the normal motion of the spinal cord.
  • FIG. 3A is an isometric view of the spinal cord 128, wherein an incision has been made.
  • FIG. 3B is the spinal cord 128 of FIG. 3A, wherein a dura mater surface 130 has been opened during surgery.
  • FIG. 3C depicts the dura mater surface 130 of FIG. 3B, after the incision has been tented.
  • the spinal cord 128 is housed within the spinal column.
  • the spinal canal can be exposed by separating the muscles from the vertebral grooves and thereby exposing the laminae 118 and spinous processes 120 of the vertebrae 1 10.
  • the laminae 118 can be sawed through on each side, removing the spinous process 120.
  • the vertebral arches 114 can be displaced and the separate fragments removed, thus exposing the external membrane 130 that surrounds and protects the spinal cord 128. It can be appreciated that the spinal canal, and subsequently the dura mater 130, can be exposed by any method known in the art.
  • an incision 302 can be made.
  • the dura mater 130 can be expanded in the directions A and B. It can be appreciated that an incision in the dura mater and the subsequent expansion can occur in any location and in any direction.
  • the dura mater 130 can be expanded at the incision site 302 and the spinal cord 128 can be exposed.
  • the spinal cord can then be accessed to treat spinal cord injuries and other problems, such as treatment for syringomyelia, posttraumatic tethered spinal cord, spinal cord tethering from any cause, tumor, vascular malformation, infection, hematoma, foreign body or for implantation of devices, pharmaceuticals, or cells.
  • spinal cord injuries and other problems such as treatment for syringomyelia, posttraumatic tethered spinal cord, spinal cord tethering from any cause, tumor, vascular malformation, infection, hematoma, foreign body or for implantation of devices, pharmaceuticals, or cells.
  • the incision 302 in the dura mater is closed.
  • the dura mater 130 may subsequently come to rest on the spinal cord 128, thereby creating scar tissue.
  • this scar tissue may cause pain and other problems and may interrupt the normal movement of the spinal cord 128 and the flow of fluids around it.
  • the tenting device 100 as described above, can be utilized to elevate or "tent" the dura 130 after the surgical incision 302 is closed.
  • the support member 102 of device 100 can be attached to a vertebra 110 before or after the surgical procedure to the cord 128.
  • An attachment member 108 such as surgical thread, can also be attached to the connecting member 104 of the device 100. After the incision 302 is closed, the attachment member 108 with at least opposing ends, is attached at a first end to the connecting member 104 of device 100 and at a second end to a dura mater surface 130. Once secured to the dura mater surface, the attachment member 108 is, for example, pulled taut, thereby elevating or tenting the dura 130 above the spinal cord 128.
  • the steps of the dura mater tenting can occur in any order.
  • the support member can be attached at any time, including before or after an incision made in the dura mater.
  • the dura mater tenting device can also be a part of a kit.
  • the kit can include, but is not limited to, a dura mater tenting device and instructions for implanting the device.
  • the kit includes at least one tenting device.
  • the kit can include more than one dura mater tenting device.
  • the kit can also include a fastening member, such as a screw or an adhesive.
  • the kit can also include at least one dura mater attachment member, such as, surgical thread.
  • the instructions can include a description attaching the dura mater tenting device to at least one vertebra.
  • the instructions can provide detail on where and how to attach the tenting device to bone, such as where to drill the holes in the bone.
  • the instructions can also include a description of operably attaching the tenting device to a dura mater surface to elevate the dura mater above the spinal cord.
  • the instructions can include details as to how and where to attach the tenting device to the dura mater, such as the location of the attachment member incision relative to the closed surgical incision in the dura mater.
  • the instructions can also include techniques for attaching the attachment member to the connecting portion, such as by tying a knot.
  • the instructions can also include techniques for attaching the attachment member to the dura mater surface, such as by screws or adhesives.
  • the instructions can also include steps for how to tent the dura mater. Methods of Use
  • a surgeon can perform surgery to repair a spinal cord injury or to alleviate problems associated with such an injury.
  • post-traumatic syringomyelia and post-traumatic tethered spinal cord are conditions that may occur after a spinal cord injury and can result in progressive deterioration of the spinal cord.
  • a spinal cord injury may cause pain and/or spasticity that requires surgical intervention.
  • Posttraumatic syringomyelia occurs when a cyst or fluid-filled cavity develops within the spinal cord following an injury to the spinal cord. If surgical intervention is needed, a procedure known as Cyst Shunting may be performed. In Cyst Shunting, if a cyst is present, a tube is placed inside the cyst cavity to drain the fluid from the cyst. The tenting device can be used following this procedure to tent the dura above the spinal cord.
  • Posttraumatic tethered spinal cord can occur following injury to the spinal cord wherein scar tissue forms and tethers, or holds, the spinal cord to the dura mater. This scar tissue prevents the normal flow of spinal fluid around the spinal cord and impedes the normal motion of the spinal cord.
  • Spinal Cord Untethering involves releasing the scar tissue around the spinal cord to restore spinal-fluid flow and the motion of the spinal cord.
  • an expansion graft is placed to enhance the dural space and decrease the risk of re-scarring.
  • the tenting device can also be used following this procedure to decrease the risk of re-scarring.
  • CA- DREZ Computer-Assisted Dorsal Root Entry Zone Microcoagulation
  • Spasticity or spasms are spontaneous, involuntary, uncoordinated reflex movements of muscles, which can occur following spinal cord injury. While some spasticity may be useful, spasms can become a problem and interfere with wheelchair positioning, transfers, and sleeping. Surgical intervention can be appropriate when medication does not work. Examples of surgical intervention for spasticity include Selective Sensory Microrootlet Section (SSMS), a surgical procedure which involves cutting selected sensory nerve rootlets entering the spinal cord. As above, the device can tent the dura above the spinal cord following these procedures.
  • SSMS Selective Sensory Microrootlet Section
  • the methods and devices can be used in any procedure in which the dura must be opened.
  • the methods and devices herein reduce the scarring that results from dural closure.
  • Various exemplary pathologies include, but are not limited to, tumors, vascular malformations, hematomas, and infections.
  • a method for selling an implantable spinal dura mater tenting device is also disclosed.
  • the implantable spinal dura mater tenting device is offered for sale.
  • An offer for sale can include, for example, the Uniform Commercial Code or the general body of contract law.
  • the implantable tenting device or kit can be sold, offered for sale or otherwise transferred and the tenting device can be implanted or intended to be implanted into a subject during or following a spinal surgical procedure.
  • the device or kit can be offered for sale and transferred to a second or third person or entity.
  • the device can be sold, offered for sale or otherwise transferred to, for example, a supplier, a distributor, a retailer, a hospital, a doctor or any other entity capable of using or otherwise selling, offering for sale or transferring for use, the tenting device.
  • Instructions, as described in more detail herein, can also be provided for attaching the implantable dura mater tenting device in the spinal column to elevate the dura mater above the spinal cord.

Abstract

Disclosed herein is a method, device, and kit for tenting dura mater. In one embodiment, the device is implanted to elevate the dura mater above the spinal cord to prevent or reduce scar tissue. The kit can include a dura mater tenting device and instructions for elevating a dura mater surface above the spinal cord.

Description

METHOD AND DEVICE FOR TENTING DURA MATER
IN SPINAL SURGERY
CROSS REFERENCE TO RELATED APPLICATIONS
[001] This application claims benefit under 35 U.S.C. §1 19(e) to USSN 61/314,404, filed March 16, 2010, which is incorporated herein by reference in its entirety.
TECHNICAL FIELD
[002] The present disclosure relates to medical apparatus and methods. More specifically, the present disclosure relates to a device for tenting dura mater and methods and a kit for using such device.
BACKGROUND
[003] Optional or necessary spinal surgery can be required following an accident, such as a motor vehicle accident or a diving accident, or to relieve pain associated with, for example, a bulging disc or a slipped disc. Such surgery does not always require access to, or is not a procedure involving, the spinal cord.
[004] In other instances, however, where a spinal cord injury has occurred, a surgeon may perform a procedure on or near the spinal cord. In such instances, after preparation of the surrounding areas, i.e. removal of certain portions of the vertebra, an incision is made in the dura mater surrounding the spinal cord. Upon completion of the procedure, the incision is closed and the dura mater may come to rest on the spinal cord, resulting in the formation of scar tissue. Scar tissue around the spinal cord can cause several problems, including progressive loss of function, pain, spasticity, disruption of fluid flow around the spinal cord and impedance of the normal motion of the spinal cord. Thus, there exists a need in the art for a device, methods and a kit for reducing or preventing the development of scar tissue in a patient following spinal surgery.
BRIEF SUMMARY
[005] In one aspect, the present disclosure is directed to a tenting device for tenting dura mater above the spinal cord in the spinal column of a subject. The device can include a support member with at least one connecting portion capable of attaching to a dura mater surface via an attachment member, wherein the support member is at least partially angled or conformable to be at least partially angled relative to the longitudinal surface of the member.
[006] In other aspects, the present disclosure is directed to a kit for tenting dura mater above the spinal cord in the spinal column. The kit can include an implantable dura mater tenting device and can also include instructions for attaching the implantable dura mater tenting device to a dura mater surface of the spinal column in order to elevate the dura mater above the spinal cord.
[007] In other aspects, the present disclosure is directed to a method of suspending the dura mater above the spinal cord. The method can include fastening the tenting device on at least one vertebra. The method can also include connecting a first end of an attachment member to the connecting portion of the tenting device and a second end of the attachment member to the dura mater to elevate the dura mater above the spinal cord.
[008] In other aspects, the present disclosure is directed to a method of reducing or preventing spinal scarring. The method can include fastening the tenting device on at least one vertebra or skull. The method can also include connecting a first end of an attachment member to the connecting portion of the tenting device and a second end of the attachment member to the dura mater to elevate the dura mater above the spinal cord.
[009] In other aspects, the present disclosure is directed to a method for selling an implantable spinal dura mater tenting device. The method includes offering the implantable spinal dura mater tenting device for sale. The method can further include transferring the implantable tenting device to a second or third person.
[010] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following Detailed Description, which shows and describes illustrative embodiments. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[011] FIG. 1 A is a top plan view of a vertebra and spinal cord, wherein a dura mater tenting device according to the present disclosure is shown implanted. [012] FIG. 1 B is an isometric view of the vertebra, spinal cord and tenting device of FIG. 1A, taken from a top, rear and lateral side view.
[013] FIG. 2A depicts an embodiment of the device for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
[014] FIG. 2B depicts an alternative embodiment of the device for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
[015] FIG. 3A is an isometric view of a spinal cord and its surrounding membranes, wherein an incision has been made in a dura mater surface.
[016] FIG. 3B is the spinal cord of FIG. 3A, wherein the dura mater has been opened for surgery.
[017] FIG. 3C depicts the dura mater surface of FIG. 3B, after the incision in the dura mater has been closed.
DETAILED DESCRIPTION
[018] The present disclosure provides a device, methods, and a kit for tenting dura mater in the spinal cord of a subject. Embodiments of the disclosure provide a tenting device for tenting dura mater of the spinal cord, methods of tenting spinal dura mater and of selling such a device or kit, and a kit which can include
instructions for tenting spinal dura mater.
[019] An accident and other trauma may cause a spinal cord injury. Surgery to the spinal cord requires an incision in the dura mater, the external membranous layer surrounding the spinal cord. Upon closure of the incision, the dura mater may come to rest on the spinal cord. Contact between the spinal cord and the dura mater results in scar tissue that in turn can cause numerous additional undesired side effects. Scar tissue around the spinal cord can cause several problems, including progressive loss of sensory and/or motor function, pain, and spasticity. Scar tissue may prevent the normal flow of spinal fluid around the spinal cord and impede the normal motion of the spinal cord.
[020] The present disclosure provides a device that elevates or "tents" the dura mater above the spinal cord, thus preventing or reducing the build-up of scar tissue around the spinal cord. As described in more detail below, the tenting device can be connected to a vertebra and/or portion of the skull, and also attached to a dura mater surface. When the device is implanted and attached to the dura, the dura mater is elevated or "tented" above the spinal cord. [021] The terms "attached", "fastened" and "connected" are used interchangeably. For purposes of the present disclosure, attached and connected are used to describe a direct connection, as well as attachment or association via two members via intervening parts
[022] The devices, kits and methods are performed on the spinal cord. As such, and with reference to FIGS. 1A and 1 B, a description of the vertebral column, the vertebra and the membranes surrounding the spinal cord follows to provide context for the description of various embodiments of the device. FIG. 1 A is a top plan view of a vertebra 110 and spinal cord 128, wherein a dura mater tenting device 100 according to the present disclosure is shown implanted. FIG. 1B is an isometric view of the vertebra 1 0, spinal cord 28 and tenting device 100 of FIG. 1A, taken from a top, rear and lateral side view.
[023] Because variations of the present tenting device, methods, and kits depend on the anatomy of the spine and spinal cord, discussion of the anatomy related to the device disclosed herein follows.
The Vertebral Column
[024] The spinal cord is housed in and protected by the spine in the spinal column or more specifically, the spinal canal. The spine is a flexible column formed by a series of bones called vertebrae. The spinal column is formed by the junction of these vertebrae. The spinal canal, which is formed by an opening generally in the center of each vertebra, follows the curvature of the spine and is largest where the spine moves more freely and is smaller where the spine is more limited in motion. While the movement permitted between any two individual pieces of the spinal column is small, there is a considerable range of movement for the whole without a significant diminution of strength. The curvature of the spine also adds to its stability and lessens the liability of injury.
The Vertebra
[025] For a brief discussion of the general characteristics of vertebrae, reference is now made to FIG. 1 A. Generally, the vertebrae are stacked one on top of the other and form the support structure for the trunk and cranium of the human body. As shown in FIG. 1A, each vertebra 110 consists of two parts, the body 112 and the arch 114. The arch 1 4 is formed by two pedicles 116 and two laminae 118 and supports seven processes, including one spinous process 120, four articular processes 122 and two transverse processes 124. The arches 114 form a hollow cylinder behind the bodies 112 to protect the spinal cord 128. The articular processes 122 and intervertebral discs connect the different vertebrae 110 together. The spinous and transverse processes 120, 124 act as levers for the attachment of muscles which move various parts of the spine. As shown in FIG. 1B, there are also apertures between each pair of vertebrae 110 through which the spinal nerves 136 extend from the spinal cord 128.
The Membranes Surrounding the Spinal Cord
[026] As illustrated in FIG. 1B, the spinal cord 128 is enveloped by three
membranes: the dura mater 130, the arachnoid membrane 132 and the pia mater 134. The dura mater 130 is the most external membrane and forms a loose sheath around the spinal cord 128. The dura mater 130 may be covered by loose areolar tissue and veins and surrounded by cerebrospinal fluid, both of which separate the dura mater 130 from the walls of the spinal canal. Beneath the dura mater 130 is the arachnoid membrane 132. The arachnoid membrane 32 is a delicate and thin tubular membrane that envelops the surface of the cord 128. Thin filaments of connective tissue connect it to the pia mater 134. The inner surface of the dura mater 130 and the outer surface of the arachnoid membrane 132 are in contact with each other, and are only sparingly connected. The pia mater 134 covers the entire surface of the spinal cord 128. The pia mater 134 is tightly connected to the spinal cord 128 and forms its neurilemma (a plasma membrane.
Dura Mater Tenting Device
[027] For a discussion of a device for tenting and elevating the dura mater above the spinal cord to reduce or prevent contact between the spinal cord and dura mater, reference is now made to FIGS. 1A, 1 B, 2A and 2B. As discussed in more detail above, FIG. 1A is a top plan view of a dura mater tenting device 100. FIG. 1 B is an isometric view of the tenting device 100 of FIG. 1A, taken from a top, rear and lateral side view. FIG. 2A depicts an embodiment of a device 100 for tenting dura mater, wherein the device is shown not implanted for clarity purposes. FIG. 2B depicts an alternative embodiment of the device 100 for tenting dura mater, wherein the device is shown not implanted for clarity purposes.
[028] As indicated by FIGS. 1A and 1 B, in one embodiment, the tenting device 100 is implanted. The tenting device 100 includes a support member 102, a connecting portion 104, a fastening member 106 and an attachment member 108. In one embodiment, as illustrated by FIGS. 1A and 1 B, the device is implanted at a thoracic vertebra, wherein the spinous process and laminae are shown in phantom because they have been removed to permit access to the spinal cord. The removal is discussed in more detail below.
[029] When implanted, the support member 102 of tenting device 100 can be connected to a vertebra 1 10. As used herein, the term vertebra includes the sacrum. The support member 02 can be, but does not have to be, the surface of the device 100 that contacts the vertebra 110. In one embodiment, the support member 102 of device 100 is connected to a vertebra in the thoracic region. It can be appreciated that the support member 102 of the device 100 can also be attached to a vertebra in the cervical or lumbar regions or any other region where the dura can contact the spinal cord following surgery. In one embodiment, the support member 102 of tenting device 100 can be connected to the transverse process 124 of a vertebra. It can be appreciated that the support member 102 of tenting device 100 can be connected to the pedicle 16, the articular process 122, or any other bony surface or other surface of a vertebra 0 or the skull.
[030] It will be appreciated that the tending device can be connected to the skull as described for the vertebra in each embodiment described herein.
[031] In one embodiment, the support member 102 can have a single planar or longitudinal surface. In various other embodiments, the support member 102 can be at least partially angled or conformable to be at least partially angled relative to the longitudinal surface of the support member 102. That is, the support member 102 can be bent or angled relative to a longitudinal surface of the support member 102. The support member 102 can also be conformable to be bent or angled relative to a longitudinal surface of the support member 102. The bend or angle may be in the same plane as the surface of the support member. However, it can be appreciated that the bend or angle is or is conformable to be in a different plane depending on how and where the surgeon implants the device in order to position it to tent the dura mater. The support member 102 can be constructed of titanium, or a titanium alloy, or plastic or etc.
[032] As shown in FIGS. 1A-1 B, the support member is connected to the dura mater surface by an attachment member. More specifically, the support member 102 has at least one connecting portion 104 capable of operably attaching to a dura mater surface 130 via an attachment member 08. In various embodiments, the connecting portion 104 can be a hole or aperture within or on the support member 102 or may be the portion of the support member where an adhesive is applied. That is, the connecting portion is the part of the support member that receives the dura mater attachment member and the attachment member may be received by the connecting portion by any method known in the art. Thus, the attachment member is connected to the device at the connecting portion. As detailed below, the connecting portion can receive the attachment member 108 and can aid in elevating the dura mater surface relative to the spinal cord. In various embodiments, the connecting portion 104 can be at a first end of the support member 102 or the connecting portion 104 can be located somewhere in between a first end and a second end of the support member 102. In various other embodiments, the connecting portion 104 can be at a first and a second end of the support member 102 or the connecting portion 104 can be at a first, a second and a third end or other end, or located somewhere in between a first, second and/or third or other end of the support member 102.
[033] The fastening member 106 operably connects the support member 102 of device 100 to a vertebra 110 or the skull. That is, the fastening member 106 is received on or in the support member 102 and operably attaches the support member 102 to the vertebra 1 0. In one embodiment, the tenting device 100 can be connected to the transverse process 124, but as explained above, the device 100 can be connected to any bony surface. In one embodiment, there can be two fastening members 106. In various embodiments, there can be only one fastening member 106 or there can be more than two fastening members 106. The fastening member 106 can be any fastening device, such as a screw or an adhesive. A screw can be received in an aperture or hole on or in the support member 102. The screw can be of any length known to those of skill in the art. An adhesive can be received on the support member 102. The adhesive can be glue, tape, or any other adhesive known in the art.
[034] As indicated by FIGS. 1A and 1 B, and as described above, the tenting device 100 is implanted and can be attached to a vertebra 110. The tenting device 100 can also be attached to the dura mater surface 130 with an attachment member 108. The attachment member 108 will help elevate the dura mater 130 relative to the spinal cord 128. The attachment member 108 has at least opposing ends. At least one opposing end of the attachment member 108 is received in or by the connecting portion 104 of device 100. The dura mater attachment member 108 can include, but is not limited to surgical thread. Also, in various embodiments, there can be more than one attachment member 108.
[035] As can be understood from FIG. 1A, the fastening member 106 operably attaches the support member 102 of the device to a vertebra 110. A first end of attachment member 108 can be connected to the connecting portion 104 of support member 102. A second end of the attachment member 108 can be connected to a dura mater surface 130. Once connected, the dura mater surface 130 can thereby be elevated or suspended relative to the spinal cord 128 by, for example, making the attachment member 108 substantially taut to elevate or "tent" the dura mater. This elevation or suspension can help reduce or prevent scar tissue such as that caused by the dura mater 130 contacting the spinal cord 128.
[036] As illustrated by FIG. 1 A, in one embodiment, more than one tenting device 100 is used to elevate the dura mater 130 above the spinal cord 128. As illustrated in FIG. 1 B, in an alternative embodiment, a single tenting device 100 is used to elevate the dura mater 130 above the spinal cord 128.
[037] FIGS. 2A and 2B depict various alternative embodiments of the tenting device in accordance with the present disclosure and are shown in a non-implanted state for clarity purposes. As illustrated in FIGS. 2A and 2B, the tenting device 100 can be comprised of a support member 102, a connecting portion 104, and a fastening member 106. It can be appreciated that, while not shown, the attachment member 108 may be present or connected to the device in a non-implanted state.
[038] As discussed above and can be understood from FIG. 2A, in one
embodiment, the support member 102 of tenting device 100 can have one angle relative to the longitudinal surface of the support member 102. As illustrated in FIG. 2B, in an alternative embodiment, the tenting device 100 can have more than one angle relative to the longitudinal surface of the support member 102. As discussed previously, the angle or bend can help to elevate the dura surface relative to the spinal cord.
[039] The connecting portion 104 can be a hole or aperture within or on the support member 102. As illustrated in FIG. 2A, in one embodiment, the connecting portion 104 can be at a first end of the support member 102. As shown in FIG. 2B, in an alternative embodiment, the connecting portion 104 can be located somewhere in between a first end and a second end of the support member 102. In various other embodiments, the connecting portion 102 is located in another location conducive for aiding in the elevation of the dura mater when the device is implanted.
[040] As can be understood with reference to FIGS. 1A and 1 B, both FIGS. 2A and 2B include a fastening member 106. As discussed previously, the fastening member 106 operably connects the support member 102 of device 100 to a vertebra 110. The fastening member can be any fastening device, such as a screw or an adhesive
Spinal Surgery
[041] Following spinal surgery to treat a spinal cord injury, the tenting device discussed above can be used. A spinal cord injury may be caused by a contusion, hemorrhage, compression, tumor, infection, abrasion, disruption, or movement of the spinal cord. Treatment of a spinal cord injury often requires surgical intervention to repair the injured spinal cord. Upon removal of the surrounding bone, incisions can be made to the dura mater in order to reach the spinal cord. As discussed above, the spinal cord is surrounded by three membranes: the pia mater, the arachnoid membrane, and the dura mater. Once an incision is made and subsequently closed after the surgical procedure, the dura mater may contact the spinal cord directly, thereby creating scar tissue. Scar tissue around the spinal cord can cause several problems, including progressive loss of sensory and/or motor function, pain, and spasticity. Scar tissue may prevent the normal flow of spinal fluid around the spinal cord and impede the normal motion of the spinal cord.
[042] For a brief discussion of spinal surgery, as it relates to making an incision in the dura mater, reference is now made to FIGS. 3A-3C. FIG. 3A is an isometric view of the spinal cord 128, wherein an incision has been made. FIG. 3B is the spinal cord 128 of FIG. 3A, wherein a dura mater surface 130 has been opened during surgery. FIG. 3C depicts the dura mater surface 130 of FIG. 3B, after the incision has been tented.
[043] As discussed previously, and as can be understood with reference to FIG. 1A and 1 B, the spinal cord 128 is housed within the spinal column. In order to reach the spinal cord 128, the spinal canal can be exposed by separating the muscles from the vertebral grooves and thereby exposing the laminae 118 and spinous processes 120 of the vertebrae 1 10. The laminae 118 can be sawed through on each side, removing the spinous process 120. The vertebral arches 114 can be displaced and the separate fragments removed, thus exposing the external membrane 130 that surrounds and protects the spinal cord 128. It can be appreciated that the spinal canal, and subsequently the dura mater 130, can be exposed by any method known in the art.
[044] As illustrated by FIG. 3A, once the dura mater 130 is exposed, an incision 302 can be made. At the incision 302, the dura mater 130 can be expanded in the directions A and B. It can be appreciated that an incision in the dura mater and the subsequent expansion can occur in any location and in any direction. As shown in FIG. 3B, the dura mater 130 can be expanded at the incision site 302 and the spinal cord 128 can be exposed. The spinal cord can then be accessed to treat spinal cord injuries and other problems, such as treatment for syringomyelia, posttraumatic tethered spinal cord, spinal cord tethering from any cause, tumor, vascular malformation, infection, hematoma, foreign body or for implantation of devices, pharmaceuticals, or cells.
[045] Following surgery, the incision 302 in the dura mater is closed. As can be understood from FIG. 3C, the dura mater 130 may subsequently come to rest on the spinal cord 128, thereby creating scar tissue. As mentioned previously, this scar tissue may cause pain and other problems and may interrupt the normal movement of the spinal cord 128 and the flow of fluids around it. Thus, to elevate the dura mater 130 can be elevated above the spinal cord 128. [046] As can be understood with reference to FIGS. 1A, 1 B and 3C, the tenting device 100, as described above, can be utilized to elevate or "tent" the dura 130 after the surgical incision 302 is closed. The support member 102 of device 100 can be attached to a vertebra 110 before or after the surgical procedure to the cord 128. An attachment member 108, such as surgical thread, can also be attached to the connecting member 104 of the device 100. After the incision 302 is closed, the attachment member 108 with at least opposing ends, is attached at a first end to the connecting member 104 of device 100 and at a second end to a dura mater surface 130. Once secured to the dura mater surface, the attachment member 108 is, for example, pulled taut, thereby elevating or tenting the dura 130 above the spinal cord 128.
[047] Those of skill in the art will recognize that the steps of the dura mater tenting can occur in any order. For example, the support member can be attached at any time, including before or after an incision made in the dura mater.
Kits
[048] The dura mater tenting device can also be a part of a kit. The kit can include, but is not limited to, a dura mater tenting device and instructions for implanting the device. The kit includes at least one tenting device. The kit can include more than one dura mater tenting device. The kit can also include a fastening member, such as a screw or an adhesive. The kit can also include at least one dura mater attachment member, such as, surgical thread.
[049] The instructions can include a description attaching the dura mater tenting device to at least one vertebra. The instructions can provide detail on where and how to attach the tenting device to bone, such as where to drill the holes in the bone. The instructions can also include a description of operably attaching the tenting device to a dura mater surface to elevate the dura mater above the spinal cord. The instructions can include details as to how and where to attach the tenting device to the dura mater, such as the location of the attachment member incision relative to the closed surgical incision in the dura mater. The instructions can also include techniques for attaching the attachment member to the connecting portion, such as by tying a knot. The instructions can also include techniques for attaching the attachment member to the dura mater surface, such as by screws or adhesives. The instructions can also include steps for how to tent the dura mater. Methods of Use
[050] In various embodiments, a surgeon can perform surgery to repair a spinal cord injury or to alleviate problems associated with such an injury. For example, post-traumatic syringomyelia and post-traumatic tethered spinal cord are conditions that may occur after a spinal cord injury and can result in progressive deterioration of the spinal cord. Additionally, a spinal cord injury may cause pain and/or spasticity that requires surgical intervention. These surgeries offer various examples of when the dura mater tenting device can be used to elevate the dura after surgery to prevent or lessen contact with the spinal cord. These examples are for illustrative purposes only and are not intended to be limiting.
[051] Posttraumatic syringomyelia occurs when a cyst or fluid-filled cavity develops within the spinal cord following an injury to the spinal cord. If surgical intervention is needed, a procedure known as Cyst Shunting may be performed. In Cyst Shunting, if a cyst is present, a tube is placed inside the cyst cavity to drain the fluid from the cyst. The tenting device can be used following this procedure to tent the dura above the spinal cord.
[052] Posttraumatic tethered spinal cord can occur following injury to the spinal cord wherein scar tissue forms and tethers, or holds, the spinal cord to the dura mater. This scar tissue prevents the normal flow of spinal fluid around the spinal cord and impedes the normal motion of the spinal cord. Spinal Cord Untethering (SCU) involves releasing the scar tissue around the spinal cord to restore spinal-fluid flow and the motion of the spinal cord. In addition, an expansion graft is placed to enhance the dural space and decrease the risk of re-scarring. The tenting device can also be used following this procedure to decrease the risk of re-scarring.
[053] In addition, following spinal cord injury, patients can experience pain in areas of the body where they do not have normal sensation. These pains can occur anywhere at or below the level of injury. These pains can present at or very near the time of the injury or can occur much later- one to many years after the injury. The first line of treatment for these kinds of pains is medication, typically, antidepressants or antiseizure medications. However, if medication is not successful, neurosurgical intervention may be appropriate. For example, Computer-Assisted Dorsal Root Entry Zone Microcoagulation (CA- DREZ) may be utilized. This surgery is performed on the paraplegic population. It involves electrical recording inside the spinal cord at the time of surgery to identify regions of abnormally active pain-producing nerve cells. These abnormal nerve cells are then destroyed with radio frequency heat lesions. SCU and/or Cyst Shunting can also be used to treat pain. Again, the tenting device can be used following such procedures.
[054] Spasticity or spasms are spontaneous, involuntary, uncoordinated reflex movements of muscles, which can occur following spinal cord injury. While some spasticity may be useful, spasms can become a problem and interfere with wheelchair positioning, transfers, and sleeping. Surgical intervention can be appropriate when medication does not work. Examples of surgical intervention for spasticity include Selective Sensory Microrootlet Section (SSMS), a surgical procedure which involves cutting selected sensory nerve rootlets entering the spinal cord. As above, the device can tent the dura above the spinal cord following these procedures.
[055] The methods and devices can be used in any procedure in which the dura must be opened. The methods and devices herein reduce the scarring that results from dural closure. Various exemplary pathologies include, but are not limited to, tumors, vascular malformations, hematomas, and infections.
Methods of Selling
[056] A method for selling an implantable spinal dura mater tenting device is also disclosed. In one embodiment, the implantable spinal dura mater tenting device is offered for sale. An offer for sale can include, for example, the Uniform Commercial Code or the general body of contract law. The implantable tenting device or kit can be sold, offered for sale or otherwise transferred and the tenting device can be implanted or intended to be implanted into a subject during or following a spinal surgical procedure. Alternatively, the device or kit can be offered for sale and transferred to a second or third person or entity. The device can be sold, offered for sale or otherwise transferred to, for example, a supplier, a distributor, a retailer, a hospital, a doctor or any other entity capable of using or otherwise selling, offering for sale or transferring for use, the tenting device. Instructions, as described in more detail herein, can also be provided for attaching the implantable dura mater tenting device in the spinal column to elevate the dura mater above the spinal cord.
[057] Although the present invention has been described with reference to preferred embodiments, persons skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

CLAIMS What is claimed is:
1. A tenting device for tenting dura mater above the spinal cord of a subject comprising:
a support member comprising at least one connecting portion configured to a dura mater surface via an attachment member, wherein said support member is at least partially angled or conformable to be at least partially angled relative to the longitudinal surface of the member.
2. The tenting device of claim 1 , wherein said support member is constructed of titanium, a titanium alloy, or plastic.
3. The tenting device of one of claims 1 or 2, wherein said connecting portion comprises a hole in said support member.
4. The tenting device of one of claims 1-3, wherein said attachment member is surgical thread.
5. The tenting device of one of claims 1-3 further comprising a fastening member configured to operably connect said support member to a vertebra.
6. The tenting device of claim 5, wherein said fastening member is a screw.
7. The tenting device of claim 5, wherein said fastening member is an adhesive.
8. The tenting device of claim 1 further comprising said dura mater attachment member having at least opposing ends, wherein a first end of said attachment member is connected to said connecting portion of said support member.
9. The tenting device of claim 8 wherein a second end of said dura mater attachment member is connected to a dura mater surface to elevate said dura mater surface relative to the spinal cord.
10. The tenting device of claim 8, wherein said dura mater attachment member is surgical thread.
11. A kit for tenting dura mater above the spinal cord in the spinal column comprising:
an implantable dura mater tenting device according to claim 1 ; and instructions for attaching said implantable dura mater tenting device to a dura mater surface of the spinal column to elevate said dura mater above the spinal cord.
12. The kit of claim 11 , further comprising a dura mater attachment member.
13. The kit of claim 12, wherein said dura mater attachment member is surgical thread.
14. A method of suspending the dura mater above the spinal cord comprising:
fastening the tenting device of claim 1 on at least one vertebra; and connecting a first end of said attachment member to the connecting portion of the tenting device and a second end of said attachment member to the dura mater to elevate said dura mater above the spinal cord.
15. The method of claim 14, wherein the tenting device is titanium.
16. The method of claim 14, wherein the connecting portion is a hole in said tenting device.
17. The method of claim 14, wherein the attachment member is surgical thread.
18. A method of reducing or preventing spinal scarring comprising:
fastening the tenting device of claim 1 on at least one vertebra; and connecting a first end of said attachment member to the connecting portion of the tenting device and a second end of said attachment member to the dura mater to elevate said dura mater above the spinal cord.
19. The method of claim 18, wherein the support member of the tenting device is titanium.
20. The method of claim 18, wherein the connecting portion is a hole in said tenting device.
21. The method of claim 18, wherein the attachment member is surgical thread.
22. A method for selling an implantable spinal dura mater tenting device comprising:
offering the implantable spinal dura mater tenting device of claim 1 for sale; and
transferring said implantable tenting device to a second or third person.
23. The method of claim 22 further comprising providing instructions for attaching said implantable dura mater tenting device to a dura mater surface of the spinal column to elevate said dura mater above the spinal cord.
PCT/US2011/028669 2010-03-16 2011-03-16 Method and device for tenting dura mater in spinal surgery WO2011116096A1 (en)

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