Method and apparatus for treating lumbar pain

Abstract

A method and tool are described for relieving lower back pain via destruction and removal of suprapedicular tissues, particularly via the destruction and removal of the peridural membrane. The tool comprises a narrow tubular body having one of a plurality of tip designs at one end and a handle at the other end. The tool is inserted through the suprapedicular canal, and mechanical manipulation of the tool effects the destruction of the target tissues responsible for chronic lower back pain.

Claims

1. A method for relieving lower back pain comprising destruction and removal of the peridural membrane forming the medial and superior boundary of the suprapedicular compartment.

2. A method for relieving lower back pain comprising insertion of a tool through the suprapedicular canal and using said tool to remove or denervate tissue located in said suprapedicular canal.

3. The method of claim 2, wherein said tool is inserted through said suprapedicular canal via a transforaminal approach.

4. The method of claim 2, wherein said tool is inserted through said suprapedicular canal via a caudal approach.

5. A method for relieving lower back pain comprising: a. insertion of a needle into the inferior neuroforamen; b. advancement of a guide wire through said needle into or through the suprapedicular canal; c. advancement of a dilator over said guide wire into or through said suprapedicular canal; d. advancement of a tool through said dilator into or through said suprapedicular canal; and e. retraction of said dilator and manipulation of said tool in said suprapedicular canal to remove, destruct, and/or denervate tissue in said suprapedicular canal.

6. The method of claim 5, further comprising advancement of flexible sheath approximately to said inferior neuroforamen after said advancement of said dilator but before said advancement of said tool.

7. The method of claim 6, wherein said tool further comprises an active surface, and wherein said active surface is advanced past said flexible sheath into the suprapedicular canal.

8. The method of claim 2, 3, 6, or 7, wherein said tissue further comprises the peridural membrane.

9. A tool for effecting the relief of lower back pain, comprising a tubular body made of a flexible material and sufficiently narrow for insertion into the suprapedicular canal, wherein said tubular body has a handle at its proximal end and a tip at its distal end.

10. The tool of claim 9, wherein said tip of said tool has a proximal portion and a distal portion, and wherein the exterior surface of said proximal portion has an active surface, and wherein the exterior surface of said distal portion is smooth, and wherein said handle may be rotatably locked to said tubular body such that torque may be transmitted to said tip by rotation of said handle about the long axis of said tool.

11. The tool of claim 10, wherein said distal portion of said tip further comprises a blunt end with rounded corners.

12. The tool of claim 10, wherein said distal portion further comprises a conical end, and wherein the vertex of said conical end is rounded.

13. The tool of claim 9, 10, 11, or 12, wherein said handle includes one or more fluid injection ports in fluid communication with the interior of said tubular body.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 Top view of a human vertebra

[0016] FIG. 2 Detailed anatomy of the suprapedicular compartment

[0017] FIG. 3 Cross-sectional view of basic tool separated into components

[0018] FIG. 4 Cross-sectional view of assembled basic PACIF tool

[0019] FIG. 5 Cross-sectional view of representative interchangeable tips

[0020] FIG. 6 Cross-sectional exploded view of tool with guide wire

[0021] FIG. 7 Fluoroscopy image of the PACIF procedure

[0022] FIG. 8 Anatomical dissection of the L4-L5 lumbar spinal canal, sagittal approach

[0023] FIG. 9 Anatomical dissection sagittal cut, cephalid left, anterior bottom, thoracic spinal canal

[0024] FIG. 10 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0025] FIG. 11 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0026] FIG. 12 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0027] FIG. 13 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0028] FIG. 14 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0029] FIG. 15 Anatomical dissection sagittal cut, cephalid right, anterior bottom, lumbar spinal canal

[0030] FIG. 16 Histology photo, segment of peridural membrane, stained with PGP 9.5 antibodies, showing nerve tissue in membrane

[0031] FIG. 20 Depictions of a subject undergoing the procedure including dorsal, ventral, and right side cross-sectional views

[0032] FIG. 21 Side view of the PACIF tool in the suprapedicular space as inserted during the PACIF procedure

[0033] FIG. 22 Posterior view of spinal column undergoing three different approaches of the PACIF procedure

[0034] FIG. 27A Variation of PACIF procedure, detailing PACIF tool assembly being inserted medial to pedicle before moving into suprapedicular space

[0035] FIG. 27B Variation of PACIF procedure, showing PACIF tool and guide wire along the medial insertion to pedicle

[0036] FIG. 28A Variation of PACIF procedure, detailing PACIF tool inserted into suprapedicular space from a lateral (direct) approach

[0037] FIG. 28B Variation of PACIF procedure, showing PACIF toolhead engaged with peridural membrane

[0038] FIG. 29 Superior view of PACIF procedure, showing PACIF tool inserted into suprapedicular space and against the dura, with guide wire inserted into spinal canal between spinal cord/nerve root bundle and vertebral body

[0039] FIG. 30. Superior view of PACIF procedure, showing PACIF tool inserted into suprapedicular space and between the spinal cord/nerve root bundle and vertebral body, and with guide wire inserted through spinal canal

[0040] FIG. 31. Detailed superior view of PACIF procedure, showing PACIF tool inserted through suprapedicular space and with guide wire running through spinal canal posterior to spinal cord/nerve root bundle

[0041] FIG. 32. Detailed superior view of PACIF procedure, showing variant of PACIF tool inserted through suprapedicular space and with blunt tip projecting into spinal canal between dura and the posterior aspect of the vertebral body

[0042] FIG. 33. Detailed superior view of PACIF procedure, showing variant of PACIF tool inserted through suprapedicular space and with blunt tip projecting into spinal canal between dura and the posterior aspect of the vertebral body

[0043] FIG. 34. Detailed superior view of PACIF procedure, showing variant of PACIF tool inserted through suprapedicular space and with blunt tip pressing against dura mater

[0044] FIG. 35 a, b, c, d. Detailed view of several variations of surfaces of tip of PACIF tool

[0045] FIG. 36 Detailed view of variation of tip of PACIF tool

[0046] FIG. 37 Detailed view of variation of tip of PACIF tool

[0047] FIG. 38 Detailed view of variation of tip of PACIF tool

[0048] FIG. 39 Overall view of PACIF tool and major components

CATALOG OF ELEMENTS

[0049] 10 Lumbar vertebra [0050] 12 Vertebral body [0051] 14 Pedicles [0052] 16 Laminae [0053] 18 Articular processes [0054] 20 Transverse processes [0055] 22 Spinular process [0056] 28 Intervertebral disc [0057] 30 Neuroforamen (or “neural foramen”) [0058] 32 Vertebral foramen/spinal canal [0059] 34 Suprapedicular space [0060] 36 Suprapedicular canal [0061] 38 Suprapedicular compartment [0062] 40 Spinal cord/nerve root bundle [0063] 42 Spinal nerve root [0064] 46 Posterior Ramus [0065] 48 Nerve branch to peridural membrane [0066] 50 Peridural membrane [0067] 52 Vagination of peridural membrane [0068] 55 Dura mater [0069] 62 Ligamentum flavum [0070] 64 Batson's plexus [0071] 66 Posterior longitudinal ligament [0072] 68 Venous epidural plexus [0073] 70 Epidural fat tissue [0074] 200 Tool [0075] 220 Tip [0076] 220a, 220b, 220c Alternative tips [0077] 222 Channel through tip [0078] 224 Tip tubular body socket [0079] 226 Active surface [0080] 230 Tubular body [0081] 232 Channel through tubular body [0082] 234 Tip end tubular body recess [0083] 236 Handle end tubular body recess [0084] 240 Handle connector [0085] 242 Handle tubular body socket [0086] 244 Injection port [0087] 246 Injection port divider [0088] 248 Handle [0089] 250 Guide wire [0090] 252 Flexible sheath [0091] 254 Dilator

DESCRIPTION OF THE PREFERRED EMBODIMENT

[0092] Understanding of the present invention requires first discussion of the relevant anatomical structures of the human vertebral column, especially regarding fine structures not heretofore generally recognized. Referring to FIG. 1, the basic features of a typical human vertebra are well-known in the art, and include a vertebral body 12 which forms the main part of the vertebra, with a vertebral foramen 32 anterior to the vertebral body 12 formed by two pedicles 14, two laminae 16, four atricular processes 18, and the spinular process 22. Additionally, there are two transverse processes 20 attached to the lateral aspects of the pedicles 14. The spinal cord 40 (or nerve root bundle 40, for those levels below about L1-L2) runs through the vertebral foramen at each level, and is surrounded by a protective membrane including the dura mater 55. At each vertebral level, nerve roots 42 exit the spinal cord 40 through the neuroforamen 30, which is a lateral opening to the vertebral foramen 32 formed by the pedicles 14 of the adjacent vertebrae 10 above and below, the laminae 16 and the articular processes 18 of the vertebra 10 below, and the vertebral body 12 of the vertebra 10 below, and the intervertebral disc 28 between the adjacent vertebrae 10 above and below. Referring particularly to FIG. 2, which is a coronal cross section through the vertebral foramen 32, one can see the spinal cord 40 running vertically, with nerve roots 42 departing laterally. Inferior to the nerve roots 42 are various soft tissues, including various connective tissues and including epidural fat pockets 70, but particularly including a peridural membrane 50 which is located in and partially defines a suprapedicular compartment 38 immediately superior to the pedicles 14. The suprapedicular compartment 38 is a subset of the inferior portion of the neuroforamen 30 as well as of the suprapedicular space 34 and the suprapedicular canal 36. The inferior portion of the neuroforamen 30 is that portion below an arbitrary transverse plane at the junction of the nerve root 42 and the outer border of the neuroforamen 30. This is further divided into the suprapedicular space 34 (that portion of the inferior neuroforamen 30 inferior to a transverse plane at the inferior aspect of the intervertebral disc 28), the suprapedicular canal 36 (that portion of the suprapedicular space 34 formed by a disc bulge/herniation, ligamentum flavum hypertrophy, and/or facet joint hypertrophy), and the suprapedicular compartment 38 (that portion of the suprapedicular canal 36 bounded laterally by the psoas fascia and cribiform fascia and medially and on the superior side by the peridural membrane 50 and epidural fat tissue 70). Not generally recognized previously, the peridural membrane 50 is innervated by a peridural membrane nerve branch 48 which branches from the posterior ramus 44 as the nerve root 42 exits the neuroforamen 30. These anatomical features can be further seen in detail in FIGS. 9-15. The fact that the peridural membrane 50 is innervated can be seen in detail in FIG. 16, which is a tissue sample of the peridural membrane 50 stained using PGP 9.5 antibodies to reveal nerve tissue.

[0093] As noted supra, the instant approach to treating low back pain is based on recognition of the premise that pain derives from an accumulation of inflammatory mediators within the suprapedicular compartment 38. These mediators “leak” from the intervertebral disc 28 when damaged, as well as through disruptions in the facet joints or ligamentum flavum, with these disruptions or damage occurring in the direct neighborhood of the affected suprapedicular canal 36, or at a distal site with mediators accumulating through gravitational and capillary forces. As inflammatory mediators build up, membranes such as the suprapedicular membrane 50 and the periosteum (the membrane on the bone surface) become sensitized. Additionally, prolonged exposure to these mediators results in a changing inflammatory response, with fibrosis setting, further affecting blood flow and possibly enhancing the buildup of mediators. The instant route of treatment includes, but is not limited to, the removal of these sensitized tissues. It is the particular objective of this method to relieve low back pain through rupture and removal of the peridural membrane 50 forming the medial and superior boundary of the suprapedicular compartment 38 and via removing inflammatory tissue from the suprapedicular canal 36; reduction of sensistization of the periosteum within the suprapedicular canal 36; removal of inflammatory tissue associated with the peridural membrane 50; removal of inflammation associated with the cribiform fascia and psoas fascia; partial removal of the periosteum, particularly in the suprapedicular space 34; denervation of the periosteum, peridural membrane 50, and other spinal anatomical structures via interrupting nerve pathways in the suprapedicular canal 36; and opening the suprapedicular canal 36 by removal of fibrous tissue, ligaments, and fascia from the suprapedicular canal 36 to create egress for inflammatory mediators and to prevent accumulation of these substances in the suprapedicular space 34.

[0094] These objectives are achieved through the instant method, referred to as percutaneous ablation curettage and inferior foraminotomy, or “PACIF”. It will be understood by those of skill in the art that the specific embodiment described infra is typical, and that other variations may be preferred for a particular patient. Initially, a needle with curved tip is guided into the inferior aspect of the neuroforamen 30 under fluoroscopy by one of a variety of approaches. As an exemplar of a preferred approach, the skin is anaesthetized one to two vertebral segments cephalad to the target pedicle 14 and approximately 15 cm lateral to the target area using AP fluoroscopy, with the needle tip directed medially and caudally towards the inferior aspect of the neuroforamen 30, and best placed halfway along the outer aspect of the superior articulating process 18 on AP view. On lateral fluoroscopy, the needle tip should be approximately halfway along the inferior aspect of the neuroforamen 30. A guide wire is then advanced through the needle in such a way that the wire 250 lies in the suprapedicular canal 36 in close proximity to the pedicle 14. Placing the guide wire 250 at the anterior aspect of the suprapedicular canal 36 is preferred. The guide wire 250 is then advanced into the epidural space within the vertebral foramen 32. Usually, placement will be anterior to the dura mater 55, though this placement is not necessary, and may be posterior to the dura 55 or may run perpendicular to the dura 55 as well. The needle is then removed when the guide wire 250 is placed appropriately (particularly not penetrating the dura 55). Placement of the wire 250 may be confirmed through a variety of methods, including fluoroscopy, endoscopy and epiduroscopy, or direct vision, depending on the manner of access to the suprapedicular space 34. It will be understood that the soft tip of the guide wire 250 will prevent damage to the dura 55, nerve root(s) 42, spinal cord/nerve root bundle 40, blood vessels, and other structures in the spinal canal.

[0095] A small incision is then made through the skin to allow advancement of a cone or wedge shaped tipped dilator over the wire 250 through the suprapedicular canal 36 and into the spinal canal 32. With the dilator, a reinforced flexible sheath may be advanced to or in close proximity to the outer inferior neuroforamen 30 and lined up in the direction of the suprapedicular canal 36. It is strongly preferred for the dilator and sheath to be made of a flexible material insofar as in most patients, the lateral-to-medial direction of the suprapedicular canal 36 is slightly dorsal to ventral and slightly caudad to cephalad; curvature of the instrument is therefore required to avoid injury to organs in the intraperitoneal cavity and retroperitoneal space.

[0096] Once this dilator and sheath are in place, an instrument in the form of the tool 200 provided herein, is introduced through the sheath into the suprapedicular canal 36 and lateral recess. The tool 200 is guided into the suprapedicular space 34 by the sheath, which protects nontargeted tissues from possible damage caused by the tool 200. The tool 200 has other properties as described herein, but with respect to its use in the instant procedure, is used to enlarge the suprapedicular canal 36; remove irregularities in the suprapedicular space 34 without inflicting damage upon the dura 55; create a pathway through the suprapedicular canal into the spinal canal; and to remove bony irregularities, perform curettage of the pedicular periosteum, and to destruct inflammatory soft tissues including nerves, nerve branches, and membranes in the suprapedicular canal 36; or to electrocauterize select tissues, including ablation of nerve tissue, the periosteum, and the peridural membrane 50, as well as to perform haemostasis and the resection of ligaments, membranes, or fascia. It will be readily understood that the operator of the tool 200 may manipulate the tool 200 via rotational or translational force to effect destruction of tissues, and even with a variety in which the tip has a blunt end with a non-active surface, may be used to open the suprapedicular canal via application of sufficient translational force and/or torque. Medications such as corticosteroids, local anesthetics, hyaluronidase, hypertonic saline, coagulants, or resins for bleeding control may be injected via the tool 200, as well as radiologically opaque material for diagnostic purposes (including confirmation of the patency of the suprapedicular canal 36 and adjacent spaces).

[0097] FIG. 7 shows fluoroscopic images of the progression of a typical PACIF procedure. Initially, an endoscope is advanced caudally to allow for observation of the suprapedicular space 34, followed by the curved needle, guide wire 250, and tool 200 to be inserted through and to open the suprapedicular canal 36. Referring to FIG. 22, three different variations of the procedure are shown. It will be understood that the representation is a posterior coronal view without musculature or other soft tissue. In the most cephalad vertebral level depicted, the distal end of a tool 200 (having a blunt tip for protection of the dura 55) has been advanced through the suprapedicular space 34 and abuts the dura 55. In the middle depiction, the distal end of a tool 200 (having a longer, conical tip with blunted end) has been advanced through the suprapedicular space 34 and into the spinal canal 32, posterior to the spinal cord or nerve root bundle 40. Finally, the lower depiction shows a tool 200 (with blunted conical tip) advanced through a sheath and over a guide wire 250, with the guide wire 250 advanced through the right suprapedicular space 34 and through the spinal canal 32 anterior to the spinal cord/nerve root bundle 40. All of these depictions show the procedure as performed from a preferred transforaminal (“outside-in”) approach, though other approaches are possible, including caudal and inter- or trans-laminar (“inside-out”) approaches, as well as a variety of endoscopic or open approaches. FIGS. 27A/B-28A/B highlight the differences between the “outside-in” versus “inside-out” approaches. The transforaminal approach is preferred because it generally provides a more direct approach to the suprapedicular canal 36 and a greater likelihood of being able to open the suprapedicular canal 36. FIGS. 29-31 further illustrate different transforaminal approaches, providing a superior view of the procedure as conducted via insertion of a guide wire 250 through the suprapedicular space 34 and through the vertebral foramen (spinal canal) 32, either anterior (FIGS. 29 & 30) or posterior (FIG. 30) to the spinal cord/nerve root bundle 40. FIGS. 32-34 show additional transforaminal approaches, showing particularly the detail of how the various tips of the tool 200—and their active surfaces—are positioned transforaminally to place the active surface within the suprapedicular canal 36.

[0098] With respect to the tool 200, FIGS. 3-6 provide additional detail regarding its construction and orientation. The tool 200 comprises a tip 220, a tubular body 230 having tip end and handle end recesses 234 and 236, and a handle 238 having an injection port 244, wherein the fluid injection may be divided by an injection port divider 246. The handle 238 is connected to the tubular body 230 with a handle connector 240, which includes means for rotatably locking the handle 238 to the tubular body 230 to prevent rotation of the handle 238 with respect to the tubular body 230, and which will allow transmission of torque to the tip 220 via rotation of the handle 238 by a surgeon. It will be understood that the tool 200 may be made of any material with flexibility and strength, and will preferentially be made of plastic or metal. It will be further readily understood that the construction material should be opaque to radiography to allow progress of the tool to be tracked by a variety of radiographic methods during surgery; those of ordinary skill in the art will readily grasp the suitable materials. Referring to FIG. 5, the tip 220 may take the form of a variety of shapes, may be variable in size, and may be interchanged during application of the method described herein. From FIGS. 5 and 35, it will be understood that the tip 220 may be blunt with a hemispheric shape, may be conical, or may take on any shape in between or in combination. It may additionally have a smooth surface, or may have a roughened, beaded, or knurled surface or may have a plurality of sharpened cutting edges (either perpendicular to the cross-sectional plane, or oriented at some angle thereto around the circumference of the tip, as illustrated in FIGS. 5 and 35. While any of the foregoing shapes may be acceptable, it will be understood that in the preferred embodiment the tip 220, regardless of overall shape, will have a slightly blunted end to prevent damage to the dura 55 on insertion through the suprapedicular space 34. The tool 200, and the tip 220 and body 240 are preferentially circular in cross-section to allow for rotation of the tool 200 by the surgeon. It will be readily understood that in the preferred embodiment, to allow for advancement of the tool 200 over a guide wire 250, and to provide for fluid communication between the injection ports 244 of the handle 246 and the tip 220, that a channel 222, 232 through the center of and coaxial to the long axis of the tool 200 may be provided. The tip tubular body socket 224, the handle tubular body socket 242, and the tubular body recesses 234, 236 may include a variety of means for securely attaching the parts together, including friction joints or threads, amongst others.

[0099] While the foregoing description is directed to the preferred embodiment(s), it will be understood that the specific structures described herein may be varied in ways that do not substantially affect the underlying method disclosed herein. For instance, the tubular body 230 may be composed of multiple sections, including one or more sections having a preset curvature with respect to the long axis, as shown in FIG. 39; alternatively, the tip 220 and tubular body 230 may be fabricated as a single-piece unit. Where provided as a distinct unit, the tip 220 itself may further comprise more than one element, including an interchangeable active surface portion combined with a smooth-surfaced, blunted conical tip extension as shown in FIG. 35.

[0100] It will be understood that while specific embodiments of the instant invention have been described in this application and its references, other variants are possible and are encompassed within this description, which will be readily apparent to those of ordinary skill in the art and will be readily understood to be encompassed by the instant invention. Those of ordinary skill in the art will understand the method and tool as herein described and will readily comprehend their manner of use and intended use.