HK1241681B - Surgical tools with positional components - Google Patents

Description

Surgical tool with positioning component

Related applications

This application claims the benefit of and priority to U.S. Provisional Application Serial No. 62/091,226, filed December 12, 2014, and U.S. Provisional Application Serial No. 62/093,589, filed December 18, 2014, the contents of which are incorporated herein by reference as if fully set forth herein.

Technical Field

The present invention relates to surgical tools that may be particularly suitable for use in spinal medical procedures.

Background Art

Some surgical procedures involve inserting surgical tools into the body via tubes or portals to perform minimally invasive procedures. For some surgical procedures, it may be necessary to provide an external support or stabilizer. When such a support is placed against the skin or soft tissue, it can be difficult to accommodate the varying body shapes/positions of different patients while providing a sufficiently stable device-tissue interface contact surface.

Summary of the Invention

Embodiments of the present invention are provided/described that relate to a surgical tool having an upwardly extending tubular member having an open passage extending longitudinally. The tubular member has a wall surrounding the open passage. The tubular member may include a base that is pivotally attached to the tubular support member so that the pivot axis extends through the bottom portion of the tubular support member above the bottom surface of the base to allow the tubular support member to pivot back and forth above the bottom surface of the base. The tubular member can cooperate with downwardly extending Kirschner wires and/or bands anchored to the patient's bone. The base, band and/or Kirschner wires can be used with the surgical tool to treat back pain using a spinal facet debridement tool that can expose and cauterize soft tissue associated with the synovial sac of the spinal facet joints in a cauterizing and denuding action and minimally invasive approach.

Embodiments of the present invention provide a stabilizer that can be configured with a base that rests against the patient's skin and/or soft tissue and can support a tube guide in a manner that allows the tube guide to articulate and/or pivot relative to the stabilizer.

Embodiments of the present invention can utilize stabilizers with surgical tools that can be used to provide relatively rapid, minimally invasive, and cost-effective treatment for long-term (often permanent) pain relief of spondyloarthritis and/or spondyloarthritis pain.

Embodiments of the present invention relate to a surgical tool comprising an upwardly extending tubular member having a longitudinally extending open passageway. The tubular member has a wall surrounding the open passageway and at least one of: (a) a base pivotally attached to a tubular support member such that a pivot axis extends through a bottom portion of the tubular support member above a bottom surface of the base, thereby allowing the tubular support member to pivot back and forth above the bottom surface of the base; (b) a plurality of circumferentially spaced K-wires retained by the tubular member; and/or (c) at least one strap attached to the tubular member.

Embodiments of the present invention provide a stabilizer which may have a base of (a) and the base may have two opposing segments which are independently articulatable, one on opposite sides of a tubular support held by the base.

The surgical tool can include a K-wire of configuration (b), and the tubular member can include a longitudinally extending channel that receives a corresponding K-wire.

The surgical tool can have a strap of configuration (c), and the strap can be attached to an anchor pad under the patient or have a length sufficient to define a closed configuration extending around the patient's torso.

Embodiments of the present invention relate to a surgical tool comprising an upwardly extending tubular member having an open passage extending longitudinally. The tubular support member also has a wall surrounding the open passage.

The tool may further include a base pivotally attached to the tubular member such that the pivot axis extends through a bottom portion of the tubular support member above the bottom surface of the base, thereby allowing the tubular support member to pivot back and forth above the bottom surface of the base.

The tool can have one or more of: (a) a base pivotally attached to a tubular support member having a pivot axis extending through a bottom portion of the tubular member above a bottom surface of the base; (b) a plurality of circumferentially spaced K-wires held by the tubular support member; and/or (c) at least one strap attached to the tubular support member.

For configurations including (a), the tubular member can include an open longitudinally extending channel that retains the guide cannula with the shaft of the debridement tool extending through the guide cannula to allow the tubular member, guide cannula and rotatable shaft to pivot back and forth about the pivot axis above the bottom surface of the base while the shaft of the tool rotates during treatment.

The pivot axis is capable of extending through an axially extending centerline of first and second laterally spaced attachment members retained by one of the tubular support member or the base, the attachment members cooperating with an articulation member retained by the other of the tubular support member or the base to allow the tubular support member to pivot above the bottom surface of the base as the laterally extending arms rotate in the articulation member.

The tubular support member can include first and second laterally outwardly extending base attachment members spaced apart from each other and defining a pivot axis. The base can include a plurality of hinge members, at least one hinge member engaging the first base attachment member and at least one hinge member engaging the second base attachment member, such that the tubular support member can pivot relative to the base.

The laterally extending base attachment member can be cylindrical.

The base can include first and second base members (optionally having planar bottom surfaces), one attached to each side of the tubular support member, each base member configured to move independently of the other.

The bottom surface of the base can be curved in a direction facing away from the tube.

The bottom surface of the base can have a radius of curvature between about 4 inches and about 12 inches.

The base can have a one-piece member with an upwardly extending hinge member that engages laterally outwardly extending arms extending from the wall of the tubular support member. The bottom surface can be sized and configured to rest against the patient's skin and have a width and/or length of between approximately 2-6 inches.

The tubular support member can include at least one elongated outwardly extending fluid passageway in fluid communication with the longitudinally extending open passageway.

The base can have a planar bottom surface and the bottom surface of the base can have a width between approximately 2-6 inches.

The tubular support member can include first and second laterally extending attachment arms defining a pivot axis, extending outwardly from a wall of the tubular support member. The base can include first and second base members, each having first and second upwardly extending spaced-apart hinge members. One of the base members can be attached to the first attachment arm and the other of the base members can be attached to the second attachment arm, such that the first and second base members can move up and down independently of each other and the tubular support member can pivot relative to the base.

The tubular support member can include laterally outwardly extending finger grips.

The surgical tool can be used with a guide cannula that is sized and configured to be retained in the open passageway of the tubular support member.

The tubular support member can include at least one elongated, outwardly extending fluid channel in fluid communication with an open longitudinally extending channel thereof. The guide cannula can have a wall surrounding the open longitudinally extending channel. The wall can include at least one laterally extending, open aperture in fluid communication with the fluid channel of the tubular support member.

The first and second base members can be substantially semi-circular and can be held by a tubular support member to form a circular base member.

The pivot axis can extend through the axially extending centerlines of first and second laterally spaced-apart attachment arms held by one of the tubular support member or the base, the attachment arms cooperating with a hinge member held by the other of the tubular support member or the base to allow the tubular support member to pivot above the bottom surface of the base when the laterally extending attachment arms rotate in the hinge member. The attachment arms can be cylindrical and the hinge member can define a laterally extending cylindrical channel that slidably engages the cylindrical attachment arms.

The hinge member can have an arcuate upper section and merge into a flat bottom section below the cylindrical channel.

The surgical tool can be used in conjunction with a debridement surgical tool that extends through the open passage of the guide cannula while the guide cannula is held by the tubular support member.

Embodiments of the present invention relate to surgical tools for treating spinal facet joints. The tool can include: (a) a debrider tool having an elongated, rotatable shaft with a distal end having a denuding and cauterizing head and a motor, the motor being in communication with the shaft to drive the rotatable denuding and cauterizing head; (b) a guide cannula that holds the debrider tool's shaft during treatment; and (c) an external stabilizer sized and configured to rest against the patient's skin and control the insertion depth of the distal end of the rotatable shaft. The external stabilizer can include a base and a tubular support member pivotally attached to the base such that a pivot axis extends through a bottom portion of the tubular support member above a bottom surface of the base. The tubular support member can include an open, longitudinally extending channel that holds the guide cannula while the debrider tool's shaft extends through the guide cannula, allowing the tubular support member, the guide cannula, and the rotatable shaft to pivot back and forth about the pivot axis above the bottom surface of the base while the tool's shaft rotates during treatment.

The base includes first and second base members, one attached to each side of the tubular support member, each base member being configured to move independently of the other.

The pivot axis of the stabilizer is capable of extending through the axially extending centerline of first and second laterally spaced attachment members retained by one of the tubular support member or the base, the attachment members cooperating with an articulation member retained by the other of the tubular support member or the base to allow the tubular support member to pivot above the bottom surface of the base as the laterally extending arms rotate in the articulation member.

The external stabilizer can include at least one fluid channel extending laterally outward from a wall of the tubular support member, wherein the at least one fluid channel is in fluid communication with the longitudinally extending channel of the opening of the guide cannula.

It should be noted that aspects of the present invention described with respect to one embodiment may be incorporated into a different embodiment, even though not specifically described therewith. That is, all embodiments and/or features of any embodiment may be combined in any manner and/or combination. Applicants reserve the right to amend any initially filed claim or to file any new claim accordingly, including the right to amend any feature of any initially filed claim to be dependent upon and/or combined with any other claim (even though not originally claimed in that manner). These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.

Other systems and/or methods according to embodiments of the present invention will be or will become apparent to one skilled in the art upon review of the following figures and detailed description. It is intended that all such additional systems, methods, and/or apparatuses be included within this description, be within the scope of the present invention, and be protected by the following claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features of the present invention will be more readily understood from the following detailed description of exemplary embodiments of the present invention when read in conjunction with the accompanying drawings.

1A is a side perspective view of a guide cannula held by a cooperating stabilizer, in accordance with an embodiment of the present invention.

1B is a side perspective view of another embodiment of a guide cannula and stabilizer, according to an embodiment of the present invention.

1C is a top view of the guide cannula and stabilizer shown in FIG. 1B .

2 is a top perspective view of a guide cannula and stabilizer according to an embodiment of the present invention.

3A is a side view of the stabilizer shown in FIG. 1A and FIG. 1B , according to an embodiment of the present invention.

3B is a side bottom perspective view of a stabilizer similar to that shown in FIG. 3A , but showing a curved base in accordance with an embodiment of the present invention.

3C is a side view of the stabilizer shown in FIG. 3B , according to an embodiment of the present invention.

FIG. 4 is an exploded view of a stabilizer according to an embodiment of the present invention.

5A is an enlarged side perspective view of the stabilizer shown in FIG. 1A and FIG. 1B , according to an embodiment of the present invention.

5B is a bottom view of the stabilizer shown in FIG. 5A .

5C is a top view of the stabilizer shown in FIG. 5A .

6A is a side perspective view of the stabilizer shown in FIG. 5A .

6B is a schematic diagram of an alternative embodiment of a stabilizer according to an embodiment of the present invention.

FIG. 7 is an exploded view of another embodiment of a stabilizer according to an embodiment of the present invention.

8A is a side perspective view illustrating an exemplary assembly sequence for attaching the base of the stabilizer shown in FIG. 7 to a tubular support member according to an embodiment of the present invention.

8B is an assembled side perspective view of the device shown in FIG. 8A .

8C is an enlarged side perspective assembled view of the device shown in FIG. 8B .

8D is an enlarged side perspective assembled view rotated approximately 90 degrees from the orientation shown in FIG. 8C .

8E is a side perspective view of the device shown in FIG. 7 illustrating the pivotal attachment between the tubular support member and the base, according to an embodiment of the present invention.

9 is a schematic diagram of an exemplary shape of a shoulder of the stabilizer base shown in FIG. 7 , according to an embodiment of the present invention.

10 illustrates a surgical tool inserted into a tubular support member to allow the surgical tool to pivot with the tubular support member relative to the stabilizer base (eg, the distal end of the surgical tool is shown in line with the target spinal facet joint), according to an embodiment of the present invention.

11 is a greatly enlarged end perspective view of a rotatable shaft of a surgical tool having a cauterizing element forming a combination tissue removal (skin denudation) and cauterization tool for use with a stabilizer in accordance with an embodiment of the present invention.

12 is a side perspective view of another embodiment of a surgical tool according to an embodiment of the present invention including a guide cannula held by a cooperating stabilizer with optional supplemental components such as K-wires and/or stabilizer bands.

13A is a top perspective view of the tool shown in FIG. 12 .

13B is a top side perspective view of the tool shown in FIG. 12 having an alternative alignment key feature in accordance with an embodiment of the present invention.

13C is a bottom view of a stabilizer and column support member, according to an embodiment of the present invention.

13D is a top view of the stabilizer and column support member shown in FIG. 13A .

13E is a top perspective view of the device shown in FIG. 13B , but showing that the K-wire channel can be positioned in the guide cannula, in accordance with an embodiment of the present invention.

14A is a side view of another embodiment of a surgical tool with a guide cannula and a post support member in accordance with an embodiment of the present invention.

14B is a side perspective view of the tool shown in FIG. 14A .

15 is a side perspective view of a post support member with external K-wire or guide pin channels, in accordance with an embodiment of the present invention.

16A is a side perspective view of another embodiment of a surgical tool with a post support member in accordance with an embodiment of the present invention.

16B is a side perspective view of yet another embodiment of the present invention.

17 is a schematic diagram of a kit and/or set of surgical tools for spinal facet surgery according to an embodiment of the present invention.

18A-18C are schematic diagrams of different configurations of surgical tools for spinal facet joint treatment according to embodiments of the present invention.

DETAILED DESCRIPTION

The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art.

Throughout the text, the same numbers refer to the same elements. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Dashed lines illustrate optional features or operations, unless otherwise specified. One or more features shown and discussed with respect to one embodiment may be included in another embodiment, even if it is not explicitly described or shown with the other embodiment. The term "Fig." (whether or not all capital letters are represented) is used interchangeably with the word "Figure" in the specification and figures as an abbreviation. In addition, the order of operations (or steps) is not limited to the order presented in the claims unless otherwise specified.

The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. Unless the context clearly indicates otherwise, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well. It will be further understood that the terms "include" and/or "comprising," when used in this specification, list the presence of stated features, steps, operations, elements, and/or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between approximately X and Y" should be interpreted as including X and Y. As used herein, phrases such as "between approximately X and Y" mean "between approximately X and approximately Y." As used herein, phrases such as "from approximately X to Y" mean "from approximately X to approximately Y."

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. It will also be further understood that terms (such as those defined in commonly used dictionaries) should be interpreted as having the same meaning as in the context of this specification and the relevant art and should not be interpreted in an idealized or overly formal sense unless explicitly defined as such herein. For the sake of brevity and/or clarity, well-known functions or structures may not be described in detail.

It will be understood that when an element is referred to as being "on," "attached" to, "connected" to, "coupled to," "in contact with," or the like, another element, the element can be directly on, attached to, connected to, coupled to, in contact with, or there may be intervening elements. In contrast, when an element is referred to as being, for example, "directly on," "directly attached" to, "directly connected" to, "directly coupled to," or "in direct contact with" another element, there may be no intervening elements. Those skilled in the art will also appreciate that reference to a structure or feature being disposed "adjacent" another feature may have a portion that overlaps or is located below the adjacent feature.

For ease of description, spatially relative terms such as "under," "below," "lower," "above," "upper," and similar terms may be used herein to describe the relationship of one element or feature to another element or feature as shown in the figures. It will be understood that these spatially relative terms are intended to encompass different orientations of the device when in use or operation, in addition to the orientation depicted in the figures. For example, if the device in the drawings is turned upside down, an element described as "under" or "below" other elements or features can then be oriented "above" the other elements or features. Thus, the exemplary term "under" can encompass both the above and below orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations) and the spatially relative descriptions used herein are interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," etc. are used herein for illustrative purposes only, unless otherwise specified.

It will be understood that although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are merely used to distinguish one element, component, region, layer or section from another region, layer or section. Therefore, without departing from the teachings of this application, the first element, component, region, layer or section discussed below may be referred to as the second element, component, region, layer or section. The order of operations (or steps) is not limited to the order given in the claims or figures unless otherwise specifically indicated. In the claims, the word "a" with respect to an element is intended to include one or more such elements and is not limited to a single such element unless otherwise specified.

The term "about" means that the stated number or value can vary by +/- 20%.

The term "sterile" means that the referenced device or material meets or exceeds defined medical cleanliness guidelines as are well known to those skilled in the art to be substantially, if not completely, free of contaminants so as to be suitable for medical use and/or in compliance with defined medical guidelines, rules and/or regulations.

Embodiments of the present invention are suitable for human or animal use, and are particularly suitable for human use.

The term "grooved" and its derivatives refer to a recess, typically a flat or concave groove, on one or more of the inner wall, outer wall, or shaft of a surgical tool barrel, drive shaft, rotatable head, or post.

The term "denudement" and its derivatives refer to the procedure of polishing, (gently) grinding, scraping, filing, rubbing, cleaning, and/or rasp-ing away the soft tissue of a facet joint to denudate the tissue and uncover or expose the underlying bone without cutting into or removing the bone (e.g., as opposed to a sharp cutting edge such as a knife). The denuding tool can have a surface with an abrasive texture and/or can include small teeth.

The term "debridement" and its derivatives refer to the removal of soft tissue associated with the endplate receptor region of the targeted spinal facet joint, including the synovial bursa and tissue scraping from the external bony surface of the joint.

Referring now to the drawings, Figures 1A-6A illustrate an example of a surgical tool having a tubular support member 20 with a cooperating external base 30. The tool can be described as a stabilizer 10. That is, in some embodiments, the stabilizer tool can include a base 30 that can be positioned against the patient's skin S, generally on the exterior of the patient's body (Figure 10). The bottom surface 31 of the base 30 can be configured to directly abut the patient's skin S. In other embodiments, a sterile membrane can be positioned between the base and the skin (not shown). The bottom surface 31 can be textured or smooth. The bottom 31 can include an adhesive or double-sided adhesive strip, or be adhesive-free or strip-free.

The base 30 can have a larger circumference and cross-section and/or surface area than the tubular support member 20. The lower surface 31 of the base 30 can be configured to contact the skin S on each side of the tubular support member 20. The base 30 can be configured to flex against the patient's skin S and/or can engage the skin S at the target entry site entirely around the circumference of the tubular support member 20, typically so that the base lower surface 31 engages tissue for at least 75% of the surface area of the base lower surface 31.

As shown in FIG. 1A , the base 30 and the tubular support member 20 can be attached to each other in a manner that allows one or both of the tubular support member 20 and the base 30 to move relative to each other.

1A-6A , for example, the tubular support member 20 can include first and second laterally extending base attachment arms 25, one attachment arm 25 on each side of the longitudinally extending passage 20 c. As shown, the base attachment arms 25 are cylindrical and are configured to be oriented orthogonal to the longitudinally extending through-passage 20 c of the tubular support member 20. The arms 25 can have other shapes, for example, can be semicircular or have a body with an upper arched portion or be otherwise configured to attach to the base.

The laterally extending arms 25 can be collinear with one another on either side of the open through-passage 20 c (divided therethrough). The base 30 can include a hinge member 32 attached to the arms 25. The base attachment arms 25 can have an axially extending centerline 25 a ( FIG. 2 ) extending through the cylindrical arms 25 and the central passage 20 c of the tubular support member 20 and can define a hinge axis located above the bottom 31 of the base.

As shown in FIG. 6B , for example, it is contemplated that the base 30 could be configured with laterally extending arms 25 and the tubular support member 20 could have hinge members 32 that would allow the base 30 and tubular support member 20 to move relative to each other.

As the laterally extending arms 25 rotate in the hinge members 32, the tubular support member 20 is able to pivot back and forth relative to the base 30. This allows the guide cannula 40 (FIGS. 1A, 1B, 2) along with any surgical tools extending through the support member 20 and/or guide cannula 40 to rotate and/or pivot left and right about the hinge axis 25a while the base 30 is held against the patient's skin S.

As shown in Figures 1A and 1B, for example, the tubular support member 20 can have a keyed alignment configuration, wherein one member has a recessed keying area and the other member has a corresponding protruding keying area 20k, 40k, which, when aligned, allows the two members 20, 40 to slidably engage and/or attach to prevent rotation about the longitudinal axis 20a while allowing the guide cannula 40 to move longitudinally relative to the tubular support member 20. Figure 1A shows the guide cannula 40 having a longitudinally extending protruding section as the keying section 40k, and the tubular support member 20 having a recessed section as the keying section 20k. Figures 1B and 1C show an opposite configuration, wherein the guide cannula 40 has a longitudinally extending recessed section as the keying section 40k, and the tubular support member 20 has a protruding longitudinally extending section as the corresponding keying section 20k. The guide cannula keying section 40k (protruding in Figure 1A or recessed in Figure 1B) can retain the longitudinally spaced ports 40p.

4 , the articulating member 32 can include an arcuate upper wall segment 32a positioned above an arcuate channel 32c. Channel 25c can be configured to slidably retain the laterally extending arm 25 (which can also be described as an "articulating arm"). The articulating member 32 can have a flat bottom surface 32f that rests against the patient's skin. However, in other embodiments, the articulating member 32 can have other configurations, and the bottom surface need not be flat or contact the patient's skin.

In the embodiment shown in Figures 1A, 1B, and 2-6A, the base 30 includes first and second base members 30a, 30b. A hinge member 32 allows the first and second base members 30a, 30b to move relative to the pivot axis/hinge axis 25a of the laterally extending arm 25 so as to pivot up and down relative thereto. That is, the first and second base members 30a, 30b allow for independent angular adjustment on each side of the support member 20. It is contemplated that the first and second members 30a, 30b could allow the base to self-adjust and/or independently articulate to conform to most patient sizes simply by pressing the base downward or inward against the patient's skin S.

The base 30 can have a circular perimeter as shown, but can alternatively have other shapes. The first and second base members 30a, 30b can have a semicircular shape as shown in Figures 1A-6A, or can have other perimeter shapes. The base body can be solid as shown, or can include holes or channels.

As shown in Figures 3B and 3C, the base 30 can be curved in a direction facing the patient's skin, rather than being flat, as shown in Figure 3A. The base 30 can have a bottom 31 having a radius of curvature R. The radius of curvature R can be measured from a center point collinear with the axially extending centerline of the tube 20, which extends a distance downward below the tube itself. The radius of curvature R can be between about 4 inches and about 12 inches, including any integer and/or fractional values therebetween. For example, the curvature R can be about 4 inches, about 4.5 inches, about 5 inches, about 5.5 inches, about 6 inches, about 6.5 inches, about 7 inches, about 7.5 inches, about 8 inches, about 8.5 inches, about 9 inches, about 9.5 inches, about 10 inches, about 10.5 inches, about 11 inches, about 11.5 inches, and about 12 inches. Although only the base and cooperating first and second members 30a, 30b are shown, the same curved shape(s) can be applied to the one-piece base shown in Figures 7 and 8A-8E.

The first and second base members 30a, 30b can each have a hinge member 32 (right and left or top and bottom sides), and can each have an asymmetrical shape such that one outermost forward-facing ("forward" means facing in the direction of the tubular support member 20) side has a different configuration than the other side, wherein one side has a forward-facing segment 33 extending a distance forward of the hinge axis 25a, and the opposite side has a forward-facing segment 34 disposed behind the hinge axis 25a.

The first and second base members 30a, 30b can each include an articulation member 32 attached to the arm 25 of the support member 20. As shown, each of the first and second base members 30a, 30b includes a first articulation member 32 positioned adjacent to one another on a common first arm 25 and a laterally spaced second articulation member 32 positioned adjacent to one another on the other (second) arm 25. However, as described above, the first and second base members 30a, 30b can include laterally extending attachment arms 25 and the tubular body 20 can have the articulation members 32.

In some embodiments, the first and second members 30a, 30b are mirror images of each other so that the same parts can be molded and used in cooperating pairs to reduce tooling costs. The base members 30a, 30b can include a forward-facing side segment 33 that extends laterally spaced from one hinge member 32 such that an open channel 35 is between the hinge member 32 and the forward-facing side segment 33. The open channel 35 of each base member 30a, 30b can be configured to receive the hinge member 32 of the other base member 30b, 30a, as shown, for example, in Figures 5A and 5B.

As shown in Figures 1A, 1B, and 2, the tubular support member 20 can slidably engage a guide cannula 40 and/or other tubular device. In some embodiments, the guide cannula 40 can include a longitudinally extending open channel 40c and a wall 40w. The guide cannula 40 can include at least one open port 40p, which is shown as a plurality of longitudinally spaced, generally aligned ports.

As schematically shown in Figure 2, the stabilizer 10 may be provided in a kit 200, which may also optionally include a guide cannula 40 and/or a tool 100 (Figure 10).The stabilizer 10 may be provided in an assembled or unassembled state.

The guide cannula 40 (which may be described as a "portal" device) can be configured to allow a surgical tool or tools (e.g., the elongated barrel and/or shaft 101 (Figs. 10, 11) of a (e.g., electrocautery) tool 100 (Fig. 10)) to be inserted therethrough into the patient's body to position the distal end 101d at the target surgical site. See, e.g., co-pending U.S. patent application Ser. Nos. 14/257,490 and 14/810,683, the contents of which are incorporated herein by reference as if fully set forth herein, for examples of suitable tools for spinal facet treatment.

The tubular support member 20 can include at least one laterally outwardly extending arm 22 having a fluid channel 22c and a port 22p. The fluid channel 22c can be located on a laterally extending base attachment/articulating arm 25. The fluid channel 22c can have an axially extending centerline above and parallel to the articulation axis 25a. The arm 22 having the fluid channel 22c can have a length greater than the articulating arm 25. As shown in FIG. 10 , a catheter 122 can be attached to the arm 22 and a vacuum source 170 so that fluid and/or tissue (typically heated air) can be removed from the surgical site via a guide cannula port 40p that is aligned with and/or in fluid communication with the support member fluid channel 22c.

1A-6 , the tubular support member 20 can also include laterally outwardly extending finger grips 24. The finger grips 24 can be circumferentially spaced from the arms 22 carrying the fluid passages 22 c, typically between about 30-270 degrees from the arms 22, such as about 45 degrees, about 90 degrees, about 180 degrees, or about 270 degrees (shown offset about 180 degrees from the arms 22).

1A , 1B , and 2 , the tubular support member 20 of the stabilizer 10 can be sized and configured to snugly hold a guide cannula 40 while allowing a user to adjust the height of the tube 40 to allow it to extend to a desired length beneath the stabilizer base 30. The term "snugly" means that there is a frictional engagement between the two components so that the two components cannot freely slide relative to each other and/or the two components remain stationary relative to each other so as to be maintained in a fixed position without applying sufficient force to push or pull the guide cannula 40 relative to the support member 20. The guide cannula 40 can be slidably adjusted relative to the support member 20 to a desired longitudinal height position so that its distal end is placed at a desired in vivo location by applying an appropriate (typically manual) force to push or pull the guide cannula 40 relative to the support member 20 for height adjustment and/or removal.

The tubular support member 20 of the stabilizer 10 is capable of tightly holding the guide cannula 40 at a desired height. The tool shaft 101 (Figures 10 and 11) can be tightly or freely held within the channel 40c of the guide cannula 40. This height is user-selectable/adjustable, allowing the user to adjust where the stabilizer support 20 holds the cannula 40, thereby adjusting the height of the device 40 within the patient's body and/or beneath the bottom of the stabilizer base 30. The shaft or barrel of the surgical tool 100 (Figure 10) can extend through the open channel 40c lumen of the guide cannula 40 while the guide cannula 40 is held at a desired height by the stabilizer tubular support member 20.

Figures 7 and 8A-8E illustrate another embodiment of a stabilizer 10'. In this embodiment, the base 30' has a one-piece design, for example, it has a unitary or monolithic configuration. The base 30' has first and second hinge members 32 spaced apart on either side of an open space 30s.

7 , tubular support member 20 can be positioned so that attachment arm 25 is below hinge member 32 , then tubular support member 20 and/or base 30 ′ can be rotated so that attachment arm 25 engages hinge member 32 , as shown in FIG. 8A .

As shown in Figures 8A-8E, the base 30' can include a bottom surface 31 having a groove 30g that extends through the center of the main base body. The groove 30g can define a thinner section of the base body. The groove 30g can be configured to allow opposing sides of the base body, typically partially or completely independent of each other, to flex inwardly and/or articulate to contact the patient, for example, one side can extend at a different angle relative to the other side under the support member 22 against the patient's skin. The groove 30g can be below and aligned with the articulation axis 25a or can be offset a distance, for example, such as a distance between about 1-10 mm.

FIG9 shows that the hinge member 32 can have an upper arched section 32a and a lower flat section 32f, as discussed above. The channel 32c can have a radius of curvature R corresponding to the radius of the attachment arm 25. The hinge member 32 can have an open perimeter section 32s that allows the base 30' to be attached to the tubular support member 20. The hinge member 32 can be configured to have appropriate structural integrity to facilitate proper frictional pivotal engagement with the arm 25. The hinge member 32 can have a channel 32c, with the end section located a distance below the contact point of the radius of curvature to allow for an appropriate capture configuration while allowing assembly. Corresponding to the radius of curvature R of the channel 32, the capture point 32p can be located at a distance _H1 below the top perimeter and at a distance _H2 above the bottom perimeter contact locations _P1 and _P2 . _H2 is typically greater than _H1 . In some embodiments, _H2 can be approximately 0.010 inches and _H1 can be approximately 0.008 inches. In some embodiments, _H2 can be 0.010 inches and _H1 can be 0.008 inches.

Referring to FIG10 , embodiments of the present invention provide stabilizers 10, 10' that cooperate with a guide cannula 40 and a surgical tool 100 to allow relative movement between the stabilizer base 30, the guide cannula 40, and the tool shaft 101. In some embodiments, the tool shaft 101 can pivot left and right to allow for debridement of spinal facet joints, removing the endplate receptor area, including the synovial bursa and outer surface of the joint. Once the synovial bursa and outer surface of the joint are exposed, the nerves no longer have a place to attach to the joint, and the joint nerves are permanently denervated (communication between the facet joint and the brain is lost). Studies conducted by one of the present inventors have shown that 75-80% of patients experience permanent pain relief. While the joint continues to experience arthritis, the patient's perception of pain is absent because the pain is perceived by the brain, and the patient simply cannot feel spinal pain. The joint does not degenerate more severely than would be experienced with currently used RFL procedures, as both procedures utilize denervation techniques, which cut off pain signals between the brain and the joint.

10 and 11 , a spinal facet therapy delivery tool (e.g., a "debrider" tool) 100 has a shaft 101 with a distal head 101 d that contacts the target tissue and is rotatable for denuding the target tissue. As shown in FIG. 10 , the tool 100 is connectable to a cautery generator 80 to provide cautery power to a cautery element 101 e ( FIG. 11 ).

The cautery generator 80 can be any suitable electric, electrosurgical generator, including third-party generators and/or custom generators specifically for spinal facet surgery (e.g., configured for use only with the tool 100). If a third-party generator is used, the tool 100 can include control circuitry that can communicate with a selected generator input so as to be able to operate a plurality of different generators. For example, a computer lookup table can provide a selection of different defined generators 80, and the control circuitry can be used to provide appropriate settings, automatically or for manual adjustment. The generator 80 can optionally be provided as a custom generator with the tool 100, or can be obtained from an authorized supplier according to defined operating specifications to meet regulatory guidelines for medical use and comply with, for example, good manufacturing practices.

In some embodiments, the cautery generator 80 can be housed in a unit or housing 80h that also holds a motor power supply 80m for the motor M that rotates the shaft 101, so that the tool 100 can be electrically connected to the combined unit for powering both functions during a medical procedure ( FIG. 10 ). The unit 80h can thus provide cautery power to the surgical tool 100 and also provide electrical power to the tool 100 for the motor M that rotates the shaft or barrel 101. Having the generator unit 80h both provide cautery and generate electricity can eliminate the need for batteries for powering the rotational motor to be retained on the body of the tool.

After a defined active cautery time (e.g., an active cautery time of between about 10-30 seconds, wherein the temperature of an exemplary cautery site is about 302 degrees Fahrenheit), the vacuum port 22p cooperating with the guide cannula 40 can be configured to discharge heat from the interior of the guide cannula 40 to the outside of the patient's body and maintain the maximum temperature inside the guide cannula 40 at about 122 degrees Fahrenheit (e.g., no more than +2 degrees) or lower, such as typically below 122 degrees Fahrenheit and at or above about 80 degrees Fahrenheit. The maximum temperature can be tested using animal laboratory tests or cadaver tests using the vacuum port 22p on the stabilizer 20 and cooperating with the guide cannula 40 and the cautery surgical tool 100. The target safe temperature for humans (away from the cautery site) is about 122 degrees Fahrenheit.

10 shows a tool 100 having a barrel or shaft 101 that is rotated by an onboard motor M. The tool 10 can include one or more electrical wires 83 connected to a cautery generator housing 80h.

1A, 1B, 1C and 2, the ports 40p can be spaced longitudinally along the length of the guide cannula 40. Although shown as vertically aligned, they can be laterally offset and can be clustered together rather than regularly spaced. Moreover, although shown as multiple ports 40p, the cannula 40 can also include a single port 40p. Although shown as a single fluid channel 22c, multiple channels can be provided in the same arm 22 or in different arms or other shaped components.

Still referring to Figures 1A, 1B and 2, in some embodiments, the port 40p can be provided in a closed state before the user selects the desired port or ports for a particular surgical procedure or patient. The port 40p can include a sealant or cover suitable in terms of thermal properties that is attached to the inner and/or outer wall of the guide cannula 40 and extends over one or more of the ports 40p. The port 40p can preferably be scored but intact so as to be fully sealed when intact to prohibit exhaust. The port 40p can be substantially or completely sealed with a thinner wall perimeter segment that can be removed to expose the port, thereby allowing the user to push open the desired port 40p during or before the surgical procedure.

It is preferred, but not required, that the port 40p used for the surgical procedure be longitudinally and laterally aligned with the fluid passage 22c. However, the ports 22c, 40p may be misaligned as long as sufficient fluid communication is provided for the heated exhaust gas to be removed to maintain the temperature in the guide cannula 40 (at least the portion within the patient's body and adjacent to the skin S) at or below 122 degrees Fahrenheit.

In a preferred embodiment, the wattage of the cautery generator is between about 40 watts and about 50 watts, which is significantly less than the maximum wattage that many surgical cautery generators can provide.

In some embodiments, the head 101d (FIGS. 10 and 11) can have a conductive member and/or outer surface 101e to which electrical energy (in bipolar or monopolar mode, typically monopolar mode) is supplied, thereby permitting the head 101d to cauterize tissue. The electrical cautery can be any suitable cautery source 80, typically RF power, although other power sources may also be used. For additional discussion of components of a suitable combined spinal facet debridement tool 10, see, for example, U.S. Patent No. 8,167,879; and co-pending U.S. Patent Application Serial No. 14/257,490, the contents of which are incorporated herein by reference as if fully set forth herein.

The distal end portion of the treatment delivery tool 101d can have a maximum outer diameter between about 5-15 mm, such as about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm and about 15 mm, typically between 10-12 mm.

Depending on the surgeon and patient's preference, embodiments of the present invention and the surgical procedure in which they are used can be performed under conscious sedation and local or general anesthesia. For example, conscious sedation can be used with a mixture of remifentanil. The spinal region is typically prepared and draped with a surgical drape. Fluoroscopy or other suitable imaging guidance can be used to identify the facet joints that can be treated.

The width of the bottom of the base 30, 30' is between about 2-6 inches, typically between about 3-5 inches, such as about 3 inches, about 3.5 inches, about 4 inches, about 4.5 inches, and about 5 inches. The height of the stabilizer tubular support member 20 is typically less than the height of the shaft 101 (Figures 10, 11) of the treatment delivery tool 100 and/or the height of the guide cannula 40. In some specific embodiments, the height of the stabilizer tubular support member 20 can be between about 2-10 inches, typically between about 3-6 inches, such as about 3 inches, about 3.5 inches, about 4 inches, about 4.5 inches, about 5 inches, about 5.5 inches, and about 6 inches, although the stabilizer tubular support member 20 can have other height dimensions.

As shown in Figures 1A, 1B, and 2, the stabilizer 40 can be releasably and slidably engaged with the guide cannula 40. The stabilizer tubular support member 20 can be configured to releasably lock against the outer surface of the guide cannula 40. The locking engagement can be provided using a physical locking member (e.g., a clamp or other suitable lock) or a locking configuration (e.g., a frictional engagement or other locking configuration). The engagement of the stabilizer support member 20 with the cannula 40 can be by any suitable physical engagement that allows the stabilizer support member 20 to be locked directly or indirectly against the cannula 40, and preferably also allows for height adjustment of the cannula 40 within the stabilizer support member 20.

The treatment device 100 can be configured such that when the elongated barrel 101 and/or shaft is fully inserted through the guide cannula 40 in the operational configuration, the head and/or distal end 101 d of the treatment device extends only between about 2 mm and about 7 mm, such as about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, or about 7 mm, beyond the leading or distal end of the cannula 30. Thus, the stabilizer tubular support member 20 can lock the cannula 40 in a longitudinal position and retain the distal end 101 d of the barrel or shaft at the target site based on the stabilized/locked position of the stabilizer 10, 10' cannula 40 relative to the patient's skin S, and can act as a stop to prevent the head 110 d from moving deeper into the body.

The stabilizer 10, 10' can optionally provide some structural support for the guide cannula 30 and/or tool 10 at the entry site. The stabilizer base 30, 30' can have a thin base, typically between about 1-10 mm, more typically between about 2 and about 4 mm. The base can be semi-rigid or rigid. The base 31 can be configured to conformably rest against the patient's skin.

Optionally, the cannula 40 can be slidably extended over the dilator and seated thereon. The cannula 40 can be sized and configured to fit tightly against the dilator so that it does not slide freely along the dilator when not pushed by the user. Before the dilator is inserted into the body, the guide cannula 40 retained in the tubular support member 20 can be positioned upstream of the tapered end on the dilator 50. In other embodiments, the cannula 40 can be separately inserted onto the dilator after the dilator 50 is inserted into the body. In any case, once the tapered end reaches the facet joint, the guide cannula 40 (e.g., a working tube) can be pushed downward to the facet joint J so that the distal end of the cannula is seated at the facet joint. The dilator can then be removed, leaving the cannula 40 in the proper position.

The guide cannula 40 and the tubular support member 10 are generally rigid. The cannula 40 and the stabilizers 10, 10' can be formed from, or can include, materials suitable for autoclaving. The cannula 40 and the tubular support member 20 can be metallic or other non-toxic and/or biocompatible materials that are sufficiently rigid and can be heat-resistant (high-temperature) or suitable for exposure to heat during cauterization. Other sterilization schemes that do not require heating can be used. The guide cannula 40 and the tubular support member 20 can be metallic (and, if metallic, can have an electrically insulating material on their end portions or surfaces) or can be a polymer or other plastic material that is sufficiently rigid to provide a guide path for the tool 100. By way of example only, one exemplary material is polyetheretherketone (PEEK).

In some specific embodiments, the guide cannula 40 may be comprised of stainless steel with an inner surface having an electrically insulating material. When the tool is configured to apply RF energy for cauterization, the electrically insulating material can be configured to inhibit arcing from the electrocautery output (e.g., RF energy at the head 101d). The electrically insulating material can be provided by an internal sleeve or coating or in other ways. The insulating material can be provided only on the distal end portion of the guide cannula 40 or on the entire inner surface of the cannula 40. The electrically insulating material can optionally be provided on an outer surface of the guide cannula 40, such as on its distal end.

The stabilizer 10 , 10 ′ can be positioned before, during, or after insertion of a guidewire/pin (if used), dilation tube, and/or cannula 40 .

Tool head 101d can be rotated to denature tissue until bone at the target spinal facet joint is reached. In a preferred embodiment, head 101d is automatically rotated using motor M ( FIG. 10 ) with drive shaft 101. However, in some embodiments, denuding head 101d can be rotated manually. Treatment tool head 101d can also be configured to cauterize soft tissue during and/or after denudation.

10, in some embodiments, the tool 100 can have an elongated barrel and/or shaft 101 that is long enough to reach the target spinal facet region in the body. The barrel and/or shaft 101 can be between about 100 mm and about 150 mm long.

The diameter of the guide cannula 40 can be slightly larger than the outer diameter of the tool barrel or shaft 101, for example, between approximately 0.1 mm and approximately 1 mm, to allow the tool 100 to slide in snugly. The tool 10 can have various form factors. The barrel 10b can rotate or be stationary. The drive shaft 101 rotates with the head 101d, either as an integral component or as a separate component, and the shaft 101 can be enclosed in a barrel housing, allowing the head 110d to extend therefrom. Denaturing the target soft tissue using the tool 100 can have an average duration of between approximately 30 seconds and approximately 3 minutes, typically between approximately 30 seconds and approximately 2 minutes (during which the debridement tool head actively rotates). The tool 100 can be configured to continuously rotate the head 101d during contact with bone at the facet joint, during cauterization and subsequent (gentle) tissue scraping/cleaning. In some embodiments, the tool 100 can be configured to intermittently rotate the head 101d and/or interleave cauterization and rotation.

Once the soft tissue is denuded, the tool head 101d can be rotated with sufficient force and time to contact the outer surface of the bone beneath the denuded tissue for a desirably short time, e.g., between about 10 seconds and about 2 minutes, more typically between about 10 seconds and about 60 seconds, to clean the exposed outer surface of the bone therein without substantially removing the bone. The short tissue cleaning/scraping time after cauterization (e.g., after denudation) can be controlled by an automatic shutoff for tool rotation and can be timed based on user or electronic (automatic) shutoff of cauterization/burning or based on sensor feedback of contact with the bone.

The tool 100 can be rotated at the same speed as the denuding action to clean the bone surface, or at a different speed and/or force than the denuding action to clean the bone surface. In some embodiments, the tool 100 has a first defined speed range for denuding and a different defined speed range for cleaning. The transition from denuding (with or without cauterization) to cleaning can be automatic or manual. If automatic, a sensor can trigger a transition to a different speed and/or terminate the power to stop the cauterization action. If manual, a user interface (UI) can direct the change in operation, for example, slowing the rotation and stopping cauterization/burning, via a control such as a switch or voice prompts to the control circuit.

In some embodiments, tool 100 can be configured to apply cautery without rotating head 110d and then perform cleaning/tissue scraping with rotation of head 101d. This may be particularly useful in laser, ultrasound, or cryoablation configurations.

The rotational speed of the treatment delivery tool head 101d (e.g., a tissue scraping and cauterizing head) can be relatively low to avoid cutting into bone. Most orthopedic bone drills will operate at up to 60,000 rpm, which can be difficult to control and may dig into bone. Therefore, lower rotational speeds are required for both the stripping and cleaning modes or actions. The goal is to sweep tissue away from the bone during the cleaning mode rather than drilling into the bone. Therefore, in some embodiments, for both stripping and cleaning bone, speeds below about 5000 rpm may be appropriate, typically between about 10 rpm and about 5000 rpm, and more typically between about 10-1000 rpm. The speed may be different for cauterizing and tissue cleaning/scraping. In some embodiments, the speed can be between about 10 and about 5000, including about 125 rpm, about 150 rpm, about 200 rpm, about 250 rpm, about 300 rpm, about 350 rpm, about 400 rpm, about 450 rpm, about 500 rpm, about 550 rpm, about 600 rpm, about 650 rpm, about 700 rpm, about 750 rpm, about 800 rpm, about 850 rpm, about 900 rpm, about 950 rpm, about 1000 rpm, about 1500 rpm, about 2000 rpm, about 2500 rpm, about 3000 rpm, about 3500 rpm, about 4000 rpm, about 4500 rpm and about 5000 rpm.

In some embodiments, the speed is low for one or both of exfoliation (with or without cauterization) and cleaning. The term "low speed" means between about 10 rpm and about 100 rpm, including about 10 rpm, about 15 rpm, about 20 rpm, about 30 rpm, about 40 rpm, about 50 rpm, about 60 rpm, about 70 rpm, about 80 rpm, about 90 rpm, and about 100 rpm.

In some embodiments, the order in which the components are used when a stabilizer 10, 10' is used can be: insert the guide pin, then insert the dilator. Next, the stabilizer 10, 10' can be placed on the skin S over the guide pin and/or dilator. Then, if a dilator is used, the dilator can be removed. The guide cannula 40 and/or treatment tool 100 can be inserted through the stabilizer 10, 10' with or without the guide pin in place (i.e., when a guide pin is used, the guide pin can be removed in advance, or after the cannula 40 and/or tool 100 are inserted through the stabilizer 10, 10'). The tool 100 can treat the facet joint with the pin in place and extending through the pin hole, or can treat the facet joint after the pin is retracted.

The stop depth provided by the stabilizer 10, 10' and/or the stabilizer and guide cannula 40 combination may be adjustable. A clinician can determine the appropriate stop depth for a patient prior to placing one or more of these components in the patient.

It is also possible to place the stabilizer 10 , 10 ′ on the skin S before or after the guide pin is inserted at the treatment joint. The entire tool 10 with the cable 13 can be sterile and disposable.

FIG11 also shows a shaft 101, which can be configured with a grooved configuration to prevent tissue clogging during denudation or tissue scraping. The grooved configuration can include first and second curvilinear, longitudinally extending recesses 101r, which can extend over a substantial portion of the length of the shaft 101, typically extending the entire length. The distal end or head 101d of the shaft 101 can include first and second tissue scraping elements 101s positioned opposite each other, with a linear cauterizing element 101e therebetween. The tissue scraping elements or members 101s can comprise a molded, rigid polymeric material used in engineering applications, such as polyetheretherketone (PEEK), a colorless, organic thermoplastic polymer in the polyaryletherketone (PAEK) family. The tissue scraping elements or members 101s can be rectangular, as shown, or can have other geometric shapes. The first and second tissue scraping members 101s can have the same or different shapes, but typically have the same projected distance relative to the cauterizing element 101e. The tissue scraping member 101s can be provided as only two or as one or more than two parts that are spaced apart from each other.

The groove 101r can be straight or curved. The groove 101r can be thin, for example, between about 1 mm and about 5 mm. The groove 101r can extend longitudinally over a fraction of the length of the shaft and/or barrel, such as between about 3 mm and 1 inch, or substantially over a length of the shaft and/or barrel 101 sufficient to extend through the working cannula 40, for example, between about 50 mm and about 200 mm, including about 50 mm, about 75 mm, about 100 mm, about 150 mm, and about 200 mm.

The lateral dimension of the distal end of the shaft or head 101d can be between about 3-15 mm (if a non-expandable configuration is used) and between about 3-25 mm (if an expandable version is used). In some embodiments, the maximum lateral dimension of the distal head with the groove 101r can be between about 5-15 mm, such as about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, and about 15 mm.

The discrete electrocautery member 101e can be configured to slidably extend and retract longitudinally relative to the adjacent non-conductive shaft or barrel 101 , or can be stationarily attached to the adjacent non-conductive shaft or barrel 101 .

It is expected that the spinal facet debridement procedure using the combination cleaner tool 100 will allow general surgeons, radiologists, pain physicians, physical therapists, orthopedic surgeons, and neurosurgeons to perform the spinal debridement procedure, and/or allow more surgeons to be competent in performing the procedure, thereby making it more common for patients to receive this treatment for long-term pain relief and eliminating the need for follow-up treatment while reinnervation occurs at the treated facet joint(s).

Embodiments of the present invention provide treatment methods that can be performed at an outpatient clinic and/or as an outpatient surgical procedure at a hospital or surgical center.

12 is a side perspective view of another embodiment of a surgical stabilizer tool 10 ″ including a guide cannula 40 held by a cooperating tubular member 20 having one or more optional supplemental positioning components, such as a plurality of circumferentially spaced K-wires 120 and/or a band 330, in accordance with an embodiment of the present invention. When in use, the base 30 can optionally include an adhesive 31 a on the bottom 31 for releasable attachment to the patient's skin, as discussed above.

The strap 330 can include a ring segment 330r that, in some embodiments, surrounds the tubular support member 20. The strap 330 can be moldably or adhesively attached to the tubular support member 20, or it can be a separate, discrete component secured to the tubular patient during the treatment session. The strap 330 can be overmolded onto the tubular member 20. The strap 330 can be elastic, flexible, or inelastic (not stretchable or only stretchable by approximately 10% when exposed to manually applied tension from 10 _lbf ), or a combination thereof. The strap 330 can have a continuous length or be provided in attachable segments. The strap 330 can have a length sufficient to extend beneath the patient's stomach when the patient is lying flat on the operating table, providing a holding force against the strap 330 when attached to prevent side-to-side movement of the post support/inlet tube 20. The band 330 can extend to attach directly or indirectly to an underlying gastric member 360 having a greater width/length (or area) than the band 330, such as a pad 360p (FIGS. 16B, 18C) that can be positioned under the patient. The term "pad" is used broadly and refers to any single layer or multiple layers of material with or without cushioning properties.

K-wires 120 (which can also be interchangeably referred to as "pins") can extend through corresponding longitudinally extending channels 220 in the post support/tube 20. The K-wires 120 can be threaded K-wires. The channels 220 can be in the upwardly extending wall 21 of the post support, or can be formed on the outer or inner perimeter to snugly receive the corresponding K-wires 120 ( FIG. 15 ). The channels 220 can have a diameter between approximately 0.75 and 2 mm, more typically between approximately 1.0 and 1.75 mm. In some embodiments, when using K-wire or pin channels 220, the external base 30 is optional. The band 330 ( FIG. 12 ) is also optional.

When in use, the K-wire 120 can have a sharp end 120t and a blunt end 120b that are configured to allow a user to push downward against the blunt end 120b to "tap" the sharp end 120t against it to position the sharp end in a target spinal facet joint, typically in bone or hard tissue for anchoring. The K-wire 120 can have a length that is the same as, or slightly shorter or longer than, the inlet tube 40, typically about 10%-30% shorter, so that when in place within the patient, they are positioned below the upper end of the inlet tube 40, as shown in FIG12 , for example. The K-wires 120 can be spaced apart around the circumference of the upwardly extending wall 21 of the tubular member 20, typically diametrically opposed to each other, at least when only two such K-wires are used.

The K-wire 120 can include an insulating material 120m ( FIG. 14A ) as a coating, sheath, or base material that can be an electrical and/or thermal insulator, such as a polymer, ceramic, or other electrically non-conductive and/or poorly or non-conductive material. The entire length of the K-wire 120 can include the insulating material, or one or more defined subsections can include such material. For example, the tip or distal-most section, approximately 1-3 mm long, can be free of the insulating material 120m and can be a surgical-grade metal material. The insulating material 120m can, for example, be present only on the outer portion (at or above the skin) or along a subsection of both the inner and outer portions.

13A-13D illustrate a stabilizer tool 10" having a post support/tubular member 20 with an outwardly extending vacuum arm 22 and a longitudinally extending channel 220. Figs. 13A-13D illustrate the channel 220 in or on the wall of the tubular member 21. Fig. 13E illustrates the channel 220 in the wall of a guide cannula 40 with a port 40p. In some embodiments, the channel 220 can extend in both the tubular support member 20 and the guide cannula 40.

14A and 14B illustrate another embodiment of a surgical stabilizer tool with a guide cannula 40 and a post support member 20 having a longitudinally extending channel 220 for a K-wire 120, in accordance with an embodiment of the present invention. In this embodiment, the outer base 30 is not hinged and can be a one-piece, unitary member.

Figure 15 is a side perspective view of a column support member 20 having a Kirschner wire or guide pin channel 220' formed on an exterior or interior surface of the upwardly extending wall 21 (shown on the exterior surface) and having a partially open longitudinally extending exterior segment 220s that is configured to allow a corresponding Kirschner wire to be "press-fitted" into the channel 220 rather than being threaded through a closed channel in the wall 21 in accordance with an embodiment of the present invention.

FIG16A shows another embodiment of a surgical stabilizer tool 10″ with a post support member 20 cooperating with a strap 330, according to an embodiment of the present invention. Instead of the ring 330r shown in FIG12 , for example, the strap 330 can be attached to diametrically opposed anchoring segments 335 on the tubular member 20. FIG16B shows the strap 330 attached to an exemplary pad 360p and also shows that the base 30 is optional. FIG16B also shows a handle 200 that can allow a user to manually rotate and push against a guide cannula 40. The guide cannula 40 can optionally have a concave or convex key segment 40k.

FIG17 shows an example of a spinal facet debridement surgical tool kit 75. As shown, the kit 75 can include packaging 75p with sterile components that facilitate the procedure. The kit 75 can include a debridement tool 100 (which can be an entire treatment delivery tool 101 or a consumable, single-use or multi-use cartridge), and optionally, a plurality of guide pins or K-wires 120. The K-wires or guide pins 120 can be provided in a common size or in different sizes, typically having a diameter between about 0.75-1.5 mm, more typically between about 1.0-1.4 mm.

As shown, the kit 75 can include a K-wire 120 having a thermally and/or electrically insulating material 120m.

The kit 120 can include one or more long K-wires 120 ₁ , 120 ₂ and one or more (typically multiple) shorter K-wires 120 ₃ , 120 ₄ , but one or more of each length can be provided, or the pins/K-wires 120 can also be provided separately outside the kit. The shorter K-wires/pins 120 can be 20-50% shorter than the longer K-wires/pins 120 and can include insulating material 120m.

Kit 75 may also include a strap 330, which may have at least one sterile cover 332, which may optionally be a peel-off sterile cover. Sterile cover 332 can ensure that the section of strap 330 that will be placed on the patient's sterile surgical space is maintained under sterile conditions prior to use/placement. Strap 330 can have different lengths/shapes. For example, as shown with respect to the two exemplary strap alternatives in kit 75, strap 330 can have ends that are attached to tubular member 20 or can have loops 330r. Kit 75 may also include a pad 360 having attachment features/members 361 (VELCRO® hook-and-loop fasteners, hooks, buckles, etc.) for securing to the ends of strap 330 to form a closed perimeter configuration around tubular member 21.

The kit 75 can also include a dilator tube 50 having a tapered end 50b and at least one guide cannula 40 (or working tube) with a vacuum port 40p, and a column support 21 having a vacuum port 22. The kit 75 can also include a handle member 200. While the kit is shown with all of the aforementioned components to help simplify surgical preparation, these components can be provided as separate units or as subassemblies. K-wires ₁₂₀₃ , ₁₂₀₄ can be sized and configured to attach to and/or extend through channels 220, 220' in or on the support column 20, while one or more other K-wires can be configured to extend through the dilator tube 50 for proper positioning of the guide cannula 40 and then removed prior to commencing treatment, typically upon, after, or before the dilator tube 50 is removed and after the K-wire 120 with the insulating material 120m is attached to the tubular support member 20 and/or the band 330 is attached to the patient/tubular support member 20 and/or the guide cannula 40.

The guide cannula 40 can be provided pre-attached to the dilator tube 50 or handle 200, or can be provided as a separate unassembled component. For bilateral and/or multi-stage surgical procedures, more than one guide cannula 40 can be included, and if a stabilizer is used, more than one stabilizer 10, 10', 10" can be included, and if so, the right and left sides can be marked and/or used to indicate the spinal treatment stage. See, for example, co-pending U.S. patent application serial numbers 14/257,490 and 14/810,683, the contents of which are incorporated herein by reference as if fully set forth herein, as examples of suitable tools for spinal facet treatment.

18A-18C are schematic diagrams of different configurations of a surgical tool for spinal facet joint therapy according to an embodiment of the present invention. FIG18A shows a stabilizer 10 ″ having a support member 20 with a channel 220 for holding a Kirschner wire 120 extending to a facet joint J. FIG18B shows the tool 10 ″ without the use of an external base 30. FIG18C shows the tool 10 ″ having a strap 330 extending under the patient's stomach, optionally attached to a pad 360p. The strap(s) 330 are connected to the inlet tube 40 and/or the column support 20 and are anchored by the patient's weight.

While the device has been described with respect to spinal facet surgery, it is contemplated that the stabilizer 10 , 10 ′, 10 ″ may be adapted for use with other surgical tools and procedures.

While the foregoing written description of the invention enables one of ordinary skill in the art to make and use what are presently considered to be the best mode of the invention, those of ordinary skill in the art will understand and appreciate that variations, combinations, and equivalents exist to the specific embodiments, methods, and examples herein. Accordingly, the present invention should not be limited to the embodiments, methods, and examples described above, but rather to all embodiments and methods within the scope and spirit of the claimed invention.

Claims (25)

1. A surgical instrument comprising: An upwardly extending tubular support member having a longitudinally extending open channel, the tubular support member including a wall surrounding the open channel; and A base, which is pivotally attached to the tubular support member, such that a pivot axis extends through the bottom portion of the tubular support member above the bottom surface of the base, allowing the tubular support member to pivot back and forth above the bottom surface of the base. The pivot axis extends through the axial centerline of the spaced-apart, laterally extending first and second arms, which are held by one of the tubular support members or the base and cooperate with a hinge member held by the other of the tubular support members or the base to allow the tubular support member to pivot above the bottom surface of the base as the first and second arms rotate in the hinge member. 2. The surgical instrument of claim 1, wherein the tubular support member includes the spaced-apart, laterally extending first and second arms defining the pivot axis, and wherein the base includes the hinge member, at least one hinge member engaging the first arm, and at least another hinge member engaging the second arm, thereby enabling the tubular support member to pivot relative to the base. 3. The surgical instrument according to claim 2, wherein the first and second arms are cylindrical. 4. The surgical tool of claim 1, wherein the base comprises first and second base members, with one base member attached to each side of the tubular support member, each base member being configured to move independently of the others. 5. The surgical tool of claim 1, wherein the base is a single piece of material having an upwardly extending hinge member as a hinge member engaging the first and second arms, wherein the first and second arms extend outwardly from the wall of the tubular support member, and wherein the bottom surface is sized and configured to rest against the patient's skin and has a width and/or length between 2 and 6 inches. 6. The surgical tool of claim 1, wherein the tubular support member includes at least one elongated radially outwardly extending fluid channel in fluid communication with the longitudinally extending opening channel. 7. The surgical instrument of claim 1, further comprising a plurality of circumferentially spaced Kirschner wires held by the tubular support member, wherein the tubular support member includes a longitudinally extending channel for receiving the respective Kirschner wires. 8. The surgical instrument of claim 1, wherein the tubular support member includes the first and second arms, wherein the first and second arms define the pivot axis and extend outwardly from the wall of the tubular support member, and wherein the base includes first and second base members, each of the first and second base members having upwardly extending, spaced-apart first and second hinge members as hinge members, one of the first and second hinge members being attached to the first arm and the other being attached to the second arm, such that the first and second base members are capable of moving up and down independently of each other and the tubular support member is capable of pivoting relative to the base. 9. The surgical tool of claim 1, wherein the tubular support member includes a laterally outwardly extending finger gripper. 10. The surgical instrument of claim 1, used in conjunction with a guide cannula, the guide cannula being sized and configured to be held in the opening channel of the tubular support member, wherein the tubular support member includes at least one elongated, outwardly extending fluid channel in fluid communication with its longitudinally extending opening channel, and wherein the guide cannula has a wall surrounding the longitudinally extending channel of the opening, and wherein the wall of the guide cannula includes at least one laterally extending opening orifice in fluid communication with the fluid channel of the tubular support member. 11. The surgical tool of claim 1, wherein the surgical tool further comprises at least one band attached to the tubular support member, wherein the band has a length sufficient to define a closed configuration extending around the patient's torso and/or is attached to the opposite side of an anchoring pad below the patient to define a closed circumference configuration. 12. The surgical tool of claim 4, wherein the first and second base members are substantially semi-circular and are held by the tubular support member to form a circular base member. 13. The surgical instrument of claim 1, wherein the first and second arms are cylindrical, and wherein the hinge member defines a laterally extending cylindrical channel that slidably engages the respective arms of the first and second arms. 14. The surgical tool of claim 13, wherein the hinge member has an arched upper section that merges into a flat bottom section below the cylindrical channel, wherein a first pair of hinge members has an open outer perimeter section facing opposite directions to thereby slidably receive the first arm, and wherein a second pair of hinge members defines an open outer perimeter section facing opposite directions to thereby slidably receive the second arm. 15. The surgical instrument of claim 10, further used in conjunction with a debridement surgical instrument, the debridement surgical instrument extending through a longitudinally extending channel of the opening of the guide cannula, while the guide cannula is held by the tubular support member. 16. The surgical tool of claim 1, wherein the bottom surface of the base is bent in a direction toward the tubular support member. 17. The surgical tool of claim 1, wherein the bottom surface of the base has a radius of curvature between 4 inches and 12 inches. 18. A surgical instrument for treating facet joints of the spine, comprising: A wound cleaning tool having an elongated rotatable shaft and a motor, the elongated rotatable shaft having a distal end with an exfoliating and cauterizing head, the motor being communicated with the shaft to drive the exfoliating and cauterizing head; The guide cannula of the shaft of the debridement tool is maintained during treatment; A tubular support member including a longitudinally extending channel sized to allow the guide cannula to extend through it, the tubular support member including a radially outwardly extending arm having a vacuum port; and A base, which is pivotally directly attached to the tubular support member having a pivot axis extending above the bottom surface of the base through the bottom portion of the tubular support member, wherein the tubular support member includes an open, longitudinally extending channel that holds the guide cannula while the axis of the debridement tool extends through the guide cannula, allowing the tubular support member, the guide cannula, and the rotatable axis to pivot back and forth about the pivot axis above the bottom surface of the base during treatment, while the axis of the debridement tool rotates. 19. The surgical instrument of claim 18, wherein the base comprises first and second base members, with one base member attached to each side of the tubular support member, each base member being configured to move independently of the others. 20. The surgical instrument of claim 19, wherein the pivot axis extends through a centerline of axially extending laterally spaced and laterally extending first and second arms held by one of the tubular support members or the base, the first and second arms cooperating with a hinge member held by the other of the tubular support member or the base to allow the tubular support member to pivot above the bottom surface of the base as the first and second arms rotate in the hinge member. 21. The surgical instrument of claim 20, wherein the arm with the vacuum port extends laterally outward from the wall of the tubular support member over the laterally spaced and laterally extending first and second arms and includes at least one fluid channel in fluid communication with a longitudinally extending channel of the opening of the guide cannula, and wherein the first pair of hinge members has an outer perimeter of the opening facing opposite directions to thereby slidably receive the first arm, and wherein the second pair of hinge members defines an outer perimeter of the opening facing opposite directions to thereby slidably receive the second arm. 22. The surgical tool of claim 18, wherein the bottom surface of the base is bent in a direction toward the tubular support member. 23. The surgical tool of claim 18, wherein the bottom surface of the base has a radius of curvature between 4 inches and 12 inches. 24. The surgical instrument of claim 18, further comprising a plurality of circumferentially spaced Kirschner wires held by the tubular support member, wherein the tubular support member includes a longitudinally extending channel for receiving the respective Kirschner wires. 25. The surgical instrument of claim 18 further includes a strap having a length sufficient to define a closed configuration extending around the patient's torso, or attached to the opposite side of an anchoring pad beneath the patient to define a closed circumference configuration.