# Patent

## Title
Minimally-invasive portal methods for performing lumbar decompression, instrumented fusion/stabilization, and the like

## Abstract

Minimally-invasive portal systems and methods for performing lumbar decompression, instrumented fusion/stabilization, and the like. In some implementations, an access tube defining a depth may be disposed at least partially within the body of a patient. A cross-sectional area of the access tube may be adjusted in one or more dimensions. One or more retractor devices may be positioned at least substantially concentrically within the access tube and then secured to the access tube in a fixed position.

## Background
CROSS-REFERENCE TO RELATED APPLICATION(S)
This application is a continuation of U.S. patent application Ser. No. 11/323,002 filed Dec. 29, 2005 and titled “MINIMALLY-INVASIVE PORTAL SYSTEM FOR PERFORMING LUMBAR DECOMPRESSION, INSTRUMENTED FUSION/STABILIZATION, AND THE LIKE,” which claims the benefit of priority of U.S. Provisional Patent Application No. 60/639,936, filed Dec. 29, 2004 and titled “MINIMALLY-INVASIVE PORTAL SYSTEM FOR PERFORMING LUMBAR DECOMPRESSION, INSTRUMENTED FUSION/STABILIZATION, AND THE LIKE.” Each of the foregoing applications is hereby incorporated herein by specific reference.


FIELD OF THE INVENTION
The present invention relates generally to the medical and surgical fields. More specifically, the present invention relates to a minimally-invasive portal system for performing lumbar decompression, instrumented fusion/stabilization, and the like. Advantageously, the minimally-invasive portal system of the present invention provides enhanced access to and visualization of an area of interest within the body of a human patient, a veterinary patient, or the like, such that a surgical procedure may be performed, especially a surgical procedure involving the lumbar or cervical spine of the patient.
BACKGROUND OF THE INVENTION
Various portal systems exist in the prior art for providing access to and visualization of an area of interest within the body of a human patient, a veterinary patient, or the like, such that a surgical procedure may be performed, especially a surgical procedure involving the lumbar or cervical spine of the patient. However, none of these portal systems are capable of being inserted and/or adjusted such that they are sufficiently minimally invasive. Advantageously, minimally-invasive medical and surgical systems and procedures result in as little damage and trauma to adjacent anatomical structures as possible, thus minimizing discomfort and speeding recovery. For example, it is important in surgical procedures involving the lumbar or cervical spine of a patient to minimize damage and trauma to the skin, musculature, and ligaments adjacent to the spine. Of primary importance, however, is providing an adequate field of view.
Thus, what is needed is an improved minimally-invasive portal system that provides enhanced access to and visualization of an area of interest within the body of a human patient, a veterinary patient, or the like, such that a surgical procedure may be performed, especially a surgical procedure involving the lumbar or cervical spine of the patient. The minimally-invasive portal system should be relatively simple to insert, adjust, and remove, and should provide an adequate field of view.
BRIEF SUMMARY OF THE INVENTION
In various exemplary embodiments, the present invention provides a minimally-invasive portal system that provides enhanced access to and visualization of an area of interest within the body of a human patient, a veterinary patient, or the like, such that a surgical procedure may be performed, especially a surgical procedure involving the lumbar or cervical spine of the patient. Advantageously, the minimally-invasive portal system of the present invention is relatively simple to insert, adjust, and remove, and provides an adequate field of view.
In one exemplary embodiment of the present invention, a minimally-invasive portal system for performing a medical or surgical procedure includes an access tube having a selectively adjustable cross-sectional area; and one or more retractor devices each having a first portion and a second portion aligned at a predetermined angle relative to the first portion, wherein the first portion of each of the one or more retractor devices is disposed substantially concentrically with the access tube, and wherein the second portion of each of the one or more retractor devices protrudes substantially beyond a bottom portion of the access tube.
In another exemplary embodiment of the present invention, a minimally-invasive portal system for performing a medical or surgical procedure includes an access tube having a selectively adjustable cross-sectional area; a plurality of adjustment mechanisms coupled to the access tube for selectively adjusting the cross-sectional area of the access tube; and one or more retractor devices each having a first portion and a second portion aligned at a predetermined angle relative to the first portion, wherein the first portion of each of the one or more retractor devices is disposed substantially concentrically with the access tube, and wherein the second portion of each of the one or more retractor devices protrudes substantially beyond a bottom portion of the access tube.
In a further exemplary embodiment of the present invention, a minimally-invasive method for performing a medical or surgical procedure includes disposing an access tube having a selectively adjustable cross-sectional area at least partially within the body of a patient; and disposing one or more retractor devices each having a first portion and a second portion aligned at a predetermined angle relative to the first portion at least partially within an interior volume defined by the access tube, wherein the first portion of each of the one or more retractor devices is disposed substantially concentrically with the access tube, and wherein the second portion of each of the one or more retractor devices protrudes substantially beyond a bottom portion of the access tube.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention is illustrated and described herein with reference to the various drawings, in which like reference numbers denote like system components or method steps, and in which:
FIG. 1 is a cross-sectional side view illustrating one exemplary embodiment of the minimally-invasive portal system of the present invention, the minimally-invasive portal system including an access tube, one or more retractor devices, one or more retaining clips, and a plurality of adjustment mechanisms that assist a user (doctor/surgeon) in visualizing and gaining access to an area within the body of a patient;
FIG. 2 is a series of cross-sectional side views illustrating several exemplary steps in the insertion of the minimally-invasive portal system of FIG. 1;
FIG. 3 is a planar top view illustrating the minimally-invasive portal system of FIG. 1, specifically a single-level configuration of the minimally-invasive portal system;
FIG. 4 is another planar top view illustrating the minimally-invasive portal system of FIGS. 1 and 3, the figure including the placement of a retractor device;
FIG. 5 is a further planar top view illustrating the minimally-invasive portal system of FIG. 1, specifically a multi-level configuration of the minimally-invasive portal system;
FIG. 6 is a still further planar top view illustrating the minimally-invasive portal system of FIGS. 1, 3, and 4, the minimally-invasive portal system incorporating an optional handle attachment;
FIG. 7 is a still further planar top view illustrating the minimally-invasive portal system of FIGS. 1, 3, and 4, the minimally-invasive portal system incorporating an optional adjustable table attachment;
FIG. 8 is a perspective view illustrating one exemplary embodiment of the one or more retaining clips of FIG. 1;
FIG. 9 is a cross-sectional side view illustrating one exemplary embodiment of the plurality of adjustment mechanisms of FIGS. 1 and 3-7; and
FIG. 10 is another cross-sectional side view illustrating another exemplary embodiment of the plurality of adjustment mechanisms of FIGS. 1 and 3-7.



DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
In various exemplary embodiments, the present invention provides a minimally-invasive portal system that provides enhanced access to and visualization of an area of interest within the body of a human patient, a veterinary patient, or the like, such that a surgical procedure may be performed, especially a surgical procedure involving the lumbar or cervical spine of the patient. Advantageously, the minimally-invasive portal system of the present invention is relatively simple to insert, adjust, and remove, and provides an adequate field of view.
Referring to FIG. 1, in one exemplary embodiment of the present invention, the minimally-invasive portal system 10 includes an access tube 12 that is selectively positioned through the skin 14 of a patient adjacent to an area of interest (i.e. an area to be operated on or otherwise visualized). Optionally, the access tube 12 may be positioned using one or more conventional dilation tubes, well known to those of ordinary skill in the art, for successively dilating the skin 14 and musculature of the patient to greater diameters or dimensions. Preferably, the access tube 12 has a substantially circular, oval-shaped, square-shaped, or rectangular cross-sectional shape, although other suitable cross-sectional shapes may be utilized. Likewise, the access tube 12 may have any suitable diameter, dimension, and/or depth suitable for the procedure to be performed.
One or more retractor devices 16 are selectively disposed concentrically within/through the access tube 12. Each of the one or more retractor devices 16 includes a top portion 18 which remains external to the body of the patient, a central portion 20 which is disposed concentrically within the access tube 12, and a bottom portion 22 which is disposed through and protrudes beneath the access tube 12 into the body of the patient. The bottom portion 22 of each of the one or more retractor devices 16 is disposed at a predetermined angle (θ) 24 relative to the central portion 20 of each of the one or more retractor devices 16, the predetermined angle (θ) 24 varying from about 0 degrees to about 45 degrees, in an exemplary embodiment of the present invention. Optionally, the predetermined angle (θ) 24 is adjustable during the procedure to be performed. It should be noted that the central portion 20 and the bottom portion 22 of each of the one or more retractor devices 16 may be sized and/or shaped such that they fit comfortably within/through the access tube 12 and provide visualization of/access to an exposed area 26 via a portal 28. Preferably, the top portion 18 of each of the one or more retractor devices 16 includes a post 30 and handle 32, which may be selectively removable.
In use, one or more retaining clips 34 (described in greater detail herein below) may be used to selectively couple the one or more retractor devices 16 to the access tube 12. Preferably, the access tube 12 incorporates one or more adjustment mechanisms 36 (also described in greater detail herein below). The one or more adjustment mechanisms 36 are each operable for selectively adjusting the diameter or dimensions of the access tube 12, and, correspondingly, the separation of the one or more retractor devices 16, the diameter or dimensions of the portal 28, and the diameter or dimensions of the exposed area 26, providing visualization and/or access flexibility.
Referring to FIG. 2, as described above, the access tube 12 may be positioned using one or more conventional dilation tubes 40, well known to those of ordinary skill in the art, for successively dilating the skin 14 and musculature of the patient to greater diameters or dimensions. The dilation tube(s) 40 is/are first inserted through the skin 14 and musculature of the patient, either singly or successively. The access tube 12 is then disposed concentrically about the dilation tube(s) 40. Finally, the dilation tube(s) 40 is/are removed, leaving the access tube 12 in place. The one or more retractor devices 16 (FIG. 1) are then inserted (not shown in FIG. 2) and the appropriate adjustments are made using the one or more adjustment mechanisms 36 (FIG. 1).
Referring to FIG. 3, in another exemplary embodiment of the present invention, the access tube 12 consists of a plurality of segments 50 which are selectively adjustable relative to one another via a plurality of adjustment areas 52. When adjusted, the plurality of segments 50 of the access tube 12 may separate from one another (as shown in FIG. 3), or they may overlap in the plurality of adjustment areas 52 (not shown in FIG. 3). Alternatively, a portion of one of the plurality of segments 50 may be substantially disposed within and move relative to another one of the plurality of segments 50. The plurality of segments 50 of the access tube 12 are selectively adjustable relative to one another using the one or more adjustment mechanisms 36 (described in greater detail herein below). Again, the one or more adjustment mechanisms 36 are each operable for selectively adjusting the diameter or dimensions of the access tube 12, and, correspondingly, the separation of the one or more retractor devices 16 (FIG. 1), the diameter or dimensions of the portal 28, and the diameter or dimensions of the exposed area 26 (FIG. 1), providing visualization and/or access flexibility. It should be noted that a single-level configuration of the minimally-invasive portal system 10 of the present invention is shown in FIG. 3, meaning that there is one adjustment area 52 for any given portion or “side” of the access tube 12.
Referring to FIG. 4, the single-level configuration of the minimally-invasive portal system 10 of the present invention is shown with one retractor device 16 in place. Again, each of the one or more retractor devices 16 includes a top portion 18 which remains external to the body of the patient and a central portion 20 which is disposed concentrically within the access tube 12. Preferably, the top portion 18 of each of the one or more retractor devices 16 includes a handle 32, which may be selectively removable. The handle 32 allows a user to effectively grasp and manipulate the retractor device 16. It should be noted that, although one retractor device 16 is shown in FIG. 4, more than one retractor device 16 may be used. It should also be noted that the one or more retaining clips 34 (FIG. 1) (described in greater detail herein below) that are used to selectively couple the one or more retractor devices 16 to the access tube 12 are not shown in FIG. 4.
Referring to FIG. 5, in a further exemplary embodiment of the present invention, a multi-level configuration of the minimally-invasive portal system 10 includes a plurality of adjustment areas 52 for one or more portions or “sides” of the access tube 12, providing enhanced adjustment flexibility.
Referring to FIGS. 6 and 7, in two still further exemplary embodiments of the present invention, the minimally-invasive portal system 10 includes either a handle attachment 60 (FIG. 6) or a table attachment 70 (FIG. 7) attached to the one or more adjustment mechanisms 36 and/or the access tube 12. Both the handle attachment 60 and the table attachment 70 protrude substantially upwardly and outwardly from the one or more attachment mechanisms 36 and/or the access tube 12. The handle attachment 60 allows a user to effectively grasp and manipulate the one or more attachment mechanisms 36 and/or the access tube 12. Likewise, the table attachment 70 allows the one or more attachment mechanisms 36 and/or the access tube 12 to be securely fastened to an operating table or the like, thereby effectively stabilizing the minimally-invasive portal system 10 of the present invention.
Referring to FIG. 8, each of the one or more retaining clips 34 includes a body portion 80 and a tongue portion 82. The body portion 80 of each of the one or more retaining clips 34 is substantially U-shaped, or has another suitable shape for selectively coupling the one or more retractor devices 16 (FIGS. 1 and 4) to the access tube 12 (FIGS. 1-7). The tongue portion 82 of each of the one or more retaining clips 34 defines an opening 84 through which the post 30 (FIGS. 1 and 4) and handle 32 (FIGS. 1 and 4) of each of the one or more retractor devices 16 may pass. In use, the tongue portion 82 of the retaining clip 34 is grasped with the thumb and index finger of the user, advanced downward over the post 30 and handle 32 of the retractor device 16, and engages/retains the retractor device 16.
FIGS. 9 and 10 show two exemplary embodiments of the adjustment mechanism 36 of the present invention. In general, the adjustment mechanism 36 may consist of an extendable/retractable device that is suitable for selectively adjusting the diameter/dimensions of the access tube 12 (FIGS. 1-8). For example, FIG. 9 shows an adjustment mechanism 36 that incorporates a screw 90 and a retaining band 92. FIG. 10 shows an adjustment mechanism 36 that incorporates a screw 90, a retaining band 92, and one or more stabilizing bands 94.
It should be noted that any medically/surgically suitable materials may be used to manufacture the components of the minimally-invasive portal system of the present invention. Such materials are well known to those of ordinary skill in the art and may include, but are not limited to, suitable metals, plastics, and composite materials.
Although the present invention has been illustrated and described with reference to preferred embodiments and examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments and/or examples may perform similar functions and/or achieve similar results. All such equivalent embodiments and examples are within the spirit and scope of the present invention and are intended to be covered by the following claims.

## Claims

1. A method for performing a medical or surgical procedure, the method comprising the steps of:
positioning an access tube at least partially within the body of a patient, wherein the access tube defines a depth;
adjusting a cross-sectional area of the access tube;
positioning a retractor device at least partially within an interior volume defined by the access tube, wherein the retractor device comprises a first portion and a second portion extending at an angle with respect to the first portion, and wherein the retractor device is positioned within the access tube such that the first portion of the retractor device is positioned at least substantially concentrically within the access tube, such that the access tube depth extends along at least substantially an entire length of the first portion of the retractor device, and such that the second portion is positioned at a predetermined angle with respect to the first portion of the retractor device; and
securing the retractor device to the access tube in a fixed position.

2. The method of claim 1, wherein the step of adjusting a cross-sectional area of the access tube comprises selectively adjusting a cross-sectional area of the access tube in a first direction via at least one first adjustment mechanism.

3. The method of claim 2, wherein the step of adjusting a cross-sectional area of the access tube further comprises selectively adjusting a cross-sectional area in a second direction.

4. The method of claim 3, wherein the step of selectively adjusting the cross-sectional area in the second direction comprises selectively adjusting the cross-sectional area in the second direction via at least one second adjustment mechanism.

5. The method of claim 3, wherein the second direction is at least substantially perpendicular to the first direction.

6. The method of claim 1, wherein the second portion of the retractor device is positioned so as to protrude beyond a bottom edge of the access tube.

7. The method of claim 1, wherein the retractor device further comprises a third portion, and wherein the third portion is coupled with a top region of the first portion of the retractor device.

8. The method of claim 7, wherein the third portion of the retractor device is positioned so as to protrude beyond a top edge of the access tube.

9. The method of claim 8, wherein the retractor device further comprises a handle portion coupled with the third portion of the retractor device.

10. The method of claim 1, further comprising selectively adjusting the predetermined angle of the second portion with respect to the first portion of the retractor device.

11. The method of claim 1, wherein the access tube further comprises a plurality of segments, and wherein the method further comprises selectively adjusting a relative position of at least a first subset of the plurality of segments relative to at least a second subset of a remainder of the plurality of segments.

12. The method of claim 1, wherein the step of securing the retractor device to the access tube comprises using at least one retaining clip to secure the retractor device to the access tube.

13. The method of claim 12, wherein the step of securing the retractor device to the access tube further comprises positioning a body portion of the at least one retaining clip to simultaneously engage a top edge of the access tube and a top region of the first portion of the retractor device.

14. The method of claim 12, wherein the retaining clip comprises a tongue portion that at least partially defines an opening, wherein the retractor device further comprises a handle portion, and wherein the step of securing the retractor device to the access tube further comprises extending the handle portion of the retractor device through the opening as the body portion simultaneously engages the top edge of the access tube and the top region of the first portion of the retractor device in direct physical contact.

15. A method for performing a medical or surgical procedure, the method comprising the steps of:
positioning an access tube at least partially within the body of a patient, wherein the access tube defines a depth;
adjusting a cross-sectional area of the access tube;
positioning a retractor device at least partially within an interior volume defined by the access tube, wherein the retractor device comprises a first portion, and wherein the retractor device is positioned within the access tube such that the first portion of the retractor device is positioned at least substantially concentrically within the access tube, and such that the access tube depth extends along at least substantially the entire length of the first portion of the retractor device; and
securing the retractor device to the access tube in a fixed position using at least one retaining clip to simultaneously engage a top edge of the access tube and a top region of the first portion of the retractor device, wherein the at least one retaining clip comprises a body portion and a tongue portion that at least partially defines an opening, and wherein the retractor device is secured to the access tube such that a portion of the retractor device protrudes through the opening as the body portion simultaneously engages the top edge of the access tube and the top region of the first portion of the retractor device in direct physical contact.

16. The method of claim 15, wherein the retractor device further comprises a second portion extending at an angle with respect to the first portion of the retractor device.

17. The method of claim 15, wherein the portion of the retractor device protruding through the opening of the tongue portion comprises a handle.

18. The method of claim 15, wherein the step of adjusting a cross-sectional area of the access tube comprises adjusting the cross-sectional area in a first direction via a pair of adjustment mechanisms.

19. A method for performing a medical or surgical procedure, the method comprising the steps of:
positioning an access tube at least partially within the body of a patient, wherein the access tube comprises a plurality of segments, wherein each of the plurality of segments is selectively adjustable relative to a remainder of the plurality of segments, and wherein the access tube defines a depth;
adjusting a cross-sectional area of the access tube by adjusting one or more of the plurality of segments relative to the remainder of the plurality of segments;
positioning a retractor device at least partially within an interior volume defined by the access tube, wherein the retractor device comprises a first portion, and wherein the retractor device is positioned within the access tube such that the first portion of the retractor device is positioned at least substantially concentrically within the access tube, and such that the access tube depth extends along at least substantially an entire length of the first portion of the retractor device; and
securing the retractor device to the access tube.

20. The method of claim 19, wherein the step of adjusting a cross-sectional area of the access tube further comprises overlapping at least a subset of the plurality of segments in a plurality of adjustment areas.