# Patent

## Title
Expandable device for insertion between anatomical structures and a procedure utilizing same

## Abstract

A surgical implantation procedure and device according to which an expandable member is inserted between anatomical structures, and is expanded into engagement with the structures. The expansion is terminated when the member is in engagement with the structures.

## Background
BACKGROUND
The present invention relates to an expandable device for insertion between anatomical structures and a procedure utilizing same.
It is often desirable to insert a device between anatomical structures for several reasons. For example, it can be inserted between two structures in a manner so that it engages the structures and serves as an implant for stabilizing the structures and absorbing shock. Alternately, a device can be temporarily inserted between the structures and function to distract the structures to permit another device, such as a prosthesis, to be implanted between the structures. According to another example, a device can be inserted between the structures and distract the structures to permit another surgical procedure to be performed in the space formed by the distraction, after which the device is released and removed.
Although devices have been designed for one or more of the above uses, they are not without problems. For example, it is often difficult to insert the device without requiring excessive invasion of the anatomy, damage to the adjacent anatomical structures, or over-distraction. Embodiments of the present invention improve upon these techniques and various embodiments of the invention may possess one or more of the above features and advantages, or provide one or more solutions to the above problems existing in the prior art.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of an adult human vertebral column.
FIG. 2 is a posterior elevational view of the column of FIG. 1.
FIG. 3 is an elevational view of one of the vertebrae of the column of FIGS. 1 and 2.
FIG. 4A is an isometric view of a device for implantation in the column of FIGS. 1-3.
FIG. 4B is a view similar to that of FIG. 4A but depicting the device of FIG. 4A in an expanded condition.
FIG. 5A is an enlarged, partial, isometric view of a portion of the column of FIGS. 1 and 2, including the lower three vertebrae of the column, with the device of FIG. 4A implanted between two adjacent vertebrae.
FIG. 5B is a view similar to that of FIG. 5A, but depicting the implanted device of FIG. 5A in its expanded condition of FIG. 4B.
FIGS. 6A and 6B are views similar to those of FIGS. 4A and 4B, respectively, but depicting an alternate embodiment of a device for implantation in the column of FIGS. 1-3.
FIGS. 7A and 7B are views similar to those of FIGS. 4A and 4B, respectively, but depicting an alternate embodiment of a device for implantation in the column of FIGS. 1-3.
FIG. 8A-8C are enlarged, partial, isometric views of a portion of the column of FIGS. 1 and 2, including the lower three vertebrae of the column, depicting the procedure of inserting the device of FIGS. 7A and 7B between two adjacent vertebrae.
FIG. 9A is a view similar to those of FIGS. 4A, 6A, and 7A, but depicting an alternate embodiment of a device for implantation in the column of FIGS. 1-3.
FIGS. 9B and 9C are views similar to those of FIGS. 5A and 5C, respectively, but depicting the insertion procedure for the device of FIG. 9A.



DETAILED DESCRIPTION
With reference to FIGS. 1 and 2, the reference numeral 10 refers, in general, to the lower portion of a human vertebral column. The column 10 includes a lumbar region 12, a sacrum 14, and a coccyx 16. The flexible, soft portion of the column 10, which includes the thoracic region and the cervical region, is not shown.
The lumbar region 12 of the vertebral column 10 includes five vertebrae V1, V2, V3, V4 and V5 separated by intervertebral discs D1, D2, D3, and D4, with the disc D1 extending between the vertebrae V1 and V2, the disc D2 extending between the vertebrae V2 and V3, the disc D3 extending between the vertebrae V3 and V4, and the disc D4 extending between the vertebrae V4 and V5.
The sacrum 14 includes five fused vertebrae, one of which is a superior vertebra V6 separated from the vertebra V5 by a disc D5. The other four fused vertebrae of the sacrum 14 are referred to collectively as V7. A disc D6 separates the sacrum 14 from the coccyx 16, which includes four fused vertebrae (not referenced).
With reference to FIG. 3, the vertebra V5 includes two laminae 20a and 20b extending to either side (as viewed in FIG. 2) of a spinous process 22 that extends posteriorly from the juncture of the two laminae. Two transverse processes 24a and 24b extend laterally from the laminae 20a and 20b, respectively. Two articular processes 26a and 26b extend superiorly from the laminae 20a and 20b, respectively, and two articular processes 28a and 28b extend inferiorly from the laminae 20a and 20b, respectively. The inferior articular processes 28a and 28b rest in the superior articular process of the vertebra V2 to form a facet joint. Since the vertebrae V1-V4 are similar to the vertebra V5, and since the vertebrae V6 and V7 are not involved in the present invention, they will not be described in detail.
It will be assumed that, for one or more of the reasons set forth above, the vertebrae V4 and V5 are not being adequately supported by the disc D4 and that it is therefore necessary to provide supplemental support and stabilization of these vertebrae. To this end, and referring to FIGS. 4A and 4B, device 30 according to an embodiment of the invention is provided and consists of a hollow expandable member 32 having a generally rectangular shape. The member 32 is fabricated from a relatively soft, inflatable material so that the member can be expanded and can function in the manner to be described.
One end of a tube 34 registers with an opening in the member 32 and the other end is connectable to a source (not shown) of fluid for inflating the member. The fluid could be air, water, a curable polymer, or any other suitable fluid. The member 32 is shown in a rolled-up, unexpanded state in FIG. 4A, with a pair of strings 36 extending around the member 32 to retain it in its rolled-up condition. To transform the member from its unexpanded, rolled-up, condition of FIG. 4A to its expanded condition of FIG. 4B, the strings 36 are removed and fluid is introduced into the member, via the tube 34.
Referring to FIG. 5A, the device 30 is initially inserted between the processes 22 in its rolled-up, collapsed, or compressed, condition of FIG. 4A. In this position, the device 30 easily fits between the processes 22 in a relatively loose arrangement, i.e., the member is not pressed against the processes with any appreciable force.
The surgeon then removes the strings 36 from the rolled up member 32 and introduces fluid into the member, via the tube 34. This causes the member 32 to expand to its expanded condition of FIGS. 4B and 5B in which the corresponding outer surfaces of the member 32 press against the processes 22. When the resulting forces are sufficient to lock, or retain, the device 30 in the implanted position of FIG. 5B, the introduction of the fluid is terminated, and the device 30 is firmly implanted between the processes 22. Alternately, the strings 36 are not manually removed prior to the expansion of the member 32, but rather are made of a relatively weak, or fragile, material so that they will break in response to the forces thereon caused by the expansion of the member 32.
The presence of the device 30 prevents the collapse of the intervertebral space between the adjacent vertebrae and thus stabilizes the vertebral column 10. The flexible nature of the device 30 does not cause any damage to the processes 22 and absorbs shock that contributes to the dynamic stabilization of the vertebral column 10.
Referring to FIGS. 6A and 6B, a device 40 according to an embodiment of the invention is provided and consists of a hollow expandable member 42 having a generally rectangular shape with two large notches, or saddles, 42a and 42b formed at each end. The member 42 is fabricated from a relatively soft, inflatable material so that it can function in the manner to be described.
One end of a tube 44 registers with an opening in the member 42, and the other end of the tube is connectable to a source of fluid for inflating the member. The fluid could be air, water, a curable polymer, or any other suitable fluid.
The member 42 is shown in a collapsed, or compressed, condition in FIG. 6A, and it is maintained in this condition by a pair of spaced U-shaped retaining members, or clamps, 46 that extend over the upper surface of the body member, as viewed in FIG. 6A, and along two side walls thereof.
The device 40 is initially inserted between the processes 22 (FIG. 5A) with the body member 42 in the unexpanded, collapsed state of FIG. 6A. In this position, the device 40 easily fits between the processes 22 in a relatively loose arrangement, i.e., the device is not pressed against the processes with any appreciable force. The surgeon then removes the retaining members 46 from the member 42 and introduces fluid into the member, via the tube 44. This causes the member 42 to expand to its expanded condition of FIG. 6B in which the corresponding outer surfaces of the member 42 press against the processes 22.
When the resulting forces are sufficient to lock, or retain, the device 40 in the implanted position, the introduction of the fluid is terminated, and the device 40 is firmly implanted between the processes 22. Alternately, the retaining members 46 are not manually removed prior to the expansion of the member 42, but rather are made of a relatively weak, or fragile, material so that they will break in response to the forces thereon caused by the expansion of the member 42.
The presence of the implanted expanded device 40 prevents the collapse of the intervertebral space between the adjacent vertebrae and thus stabilizes the vertebral column 10. The soft nature of the material making up the body member 42 does not cause any damage to the processes 22 and absorbs shock, which contributes to the dynamic stabilization of the vertebral column.
Referring to FIG. 7A, a device 50 according to an embodiment of the invention is provided and consists of a member 52 that is identical to the member 42 of the previous embodiment. One end of a tube 54 registers with an opening in the wall of the member 52, and the other end of the tube is connectable to a source of fluid for inflating the wall of the member 52 when it is removed from the sleeve 54. The fluid could be air, water, a curable polymer, or any other suitable fluid.
The member is shown in a folded, or collapsed, state in FIG. 7A and is contained in a hollow cylindrical retaining sleeve 54. The member 52 is fabricated from a relatively soft, inflatable material so that its wall can be expanded and so that the member can function in the manner to be described. The sleeve 56 maintains the member in its collapsed state. A push rod 58 is provided for pushing the member 52 out of the sleeve 56 under conditions to be described.
The device 50, with the folded member contained in the sleeve, is initially positioned adjacent the processes 22 as shown in FIG. 8A, and an axially-directed force is applied to the push rod 58 in the direction indicated by the arrow in FIG. 8A, to push the member 52 out of the sleeve 56 and towards the processes, as shown in FIGS. 7B and 8B. This pushing continues until the member 52 is pushed completely out of the sleeve 56, and into a position between the processes 22 in a relatively loose arrangement, i.e., the member is not pressed against the processes with any appreciable force. The surgeon then introduces fluid into the member 52, via the tube 54. This causes the member 52 to expand to its expanded condition shown in FIG. 8B in which the corresponding outer surfaces of the member press against the processes 22. When the resulting forces are sufficient to lock, or retain, the device 50 in the implanted position, the introduction of the fluid is terminated, and the device 50 is firmly implanted between the processes 22.
The presence of the implanted, expanded device 50 prevents the collapse of the intervertebral space between the adjacent vertebrae and thus stabilizes the vertebral column 10. The soft nature of the material making up the body member 52 does not cause any damage to the processes 22 and absorbs shock, which contributes to the dynamic stabilization of the vertebral column.
The embodiment of FIGS. 9A-9C is similar to that of the previous embodiment and identical components are given the same reference numerals. According to the embodiment of FIGS. 9A-9C, a device 50′ is provided that is similar to the device 50 of the previous embodiment with the exceptions that the sleeve 56 of the previous embodiment is replaced by a sleeve 56′, and the push rod 58 of the previous embodiment is eliminated. The sleeve 56′ is similar to the sleeve 56 of the previous embodiment and, as such, contains the member 52, but has series of axially-extending perforations 60 provided in two diametrically-opposed portions of its wall. The perforations 60 are designed to allow the wall portions to break apart when the member 52 is expanded against the sleeve 56′ under conditions to be described.
The device 50′, with the folded member 52 contained in the sleeve 56′ as shown in FIG. 9A, is inserted between the processes 22 in a relatively loose arrangement as shown in FIG. 9B. The surgeon then introduces fluid into the member 52, via the tube 54, which causes the member 52 to expand. During this expansion, the resultant forces acting on the sleeve 56′ causes the sleeve to break-away, or tear, along the perforations 60 permitting the expanded member 52 to press against the processes 22, as shown in FIG. 9C. When the resulting forces are sufficient to lock, or retain, the device 50′ in the implanted position, the introduction of the fluid is terminated, and the device 50′ is firmly implanted between the processes 22.
The presence of the implanted, expanded device 50′ prevents the collapse of the intervertebral space between the adjacent vertebrae and thus stabilizes the vertebral column 10. The soft nature of the material making up the body member 52 does not cause any damage to the processes 22 and absorbs shock, which contributes to the dynamic stabilization of the vertebral column.
It is understood that, in each of the above embodiments, after the strings 36, the retaining members 46, and the sleeves 56 and 56′ have been removed from their respective body members 32, 42 and 52, they can be disposed of by the surgeon. Alternately, they can be fabricated from a resorbable, bio-absorbable, or dissolvable material that will not require disposal.
It is also understood that the term “expandable,” as used herein, is meant to cover the situation in which the body members 32, 42 and 52 are initially folded, or wadded up, and then allowed to return to their normal state; or the situation in which the body members are actually inflated in response to the introduction of the fluid; or both.
It is further understood that, in each of the above embodiments, the devices 30, 40, 50 and 50 do not necessarily have to function as an implant as described in the example above, but rather can be used in other different procedures. For example, each device 30, 40, and 50 can be inserted between the structures, such as the processes used in the above examples, and expanded to an extent that it engages and distracts, or moves, the structures in a direction away from each other, to permit another device, such as a prosthesis, to be implanted between the structures or in an area near the structures. According to another example, each device 30, 40 and 50 can be inserted between the structures and expanded to an extent that it engages and distracts the structures to permit another surgical procedure to be performed in the space formed by the distraction. In each of these examples the device 30, 40 and 50 would be released and removed after the procedure is completed.
Variations


    
    
        (1) It is understood that variations may be made in the foregoing without departing from the invention and examples of some variations are as follows:
        (2) The body members 32, 42, and 52 can take shapes that are different from the examples disclosed above.
        (3) The devices 30, 40, 50 and 50′ can be inserted in other areas of the anatomy such as, for example, in an intervertebral disc space represented by the references D1-D5 in FIG. 1.
        (4) The devices 30, 40, 50 and 50′ can be inserted between two vertebrae following a corpectomy in which at least one vertebrae is removed.
        (5) The members used to retain the body members 32, 42, and 52 in their collapsed condition can vary.
        (6) Any spatial references made above, such as “under”, “over”, “between”, “upper”, “lower”, “top”, “bottom”, etc. are for the purpose of illustration only and do not limit the specific orientation or location of the structure described above.
    
    


The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, therefore, that other expedients known to those skilled in the art, or disclosed herein, may be employed without departing from the invention or the scope of the appended claims, as detailed above. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts, a nail and a screw are equivalent structures.

## Claims

1. A surgical implantation procedure comprising:
applying a sleeve to an expandable member such that the sleeve overlaps a longitudinally-center portion of the expandable member to releasably retain the expandable member in a non-expanded condition with the expandable member having an arcuate collapsed shape inside the sleeve;
thereafter, inserting the expandable member, in the non-expanded condition, between first and second adjacent spinous processes;
expanding the expandable member subsequent to performing the inserting step by introducing fluid into the member via a fill tube associated with the expandable member while the expandable member is disposed within the sleeve;
releasing the sleeve from the inserted expandable member so that the expandable member expands between the first and second adjacent spinous processes;
terminating the step of expanding when the expandable member is in engagement with at least one of the first and second adjacent spinous processes.

2. The procedure of claim 1 wherein the step of expanding comprises inflating the expandable member.

3. The procedure of claim 1 wherein the expandable member is of a generally rectangular shape having two saddles disposed at each end to receive the first and second adjacent spinous processes.

4. The procedure of claim 1 wherein the step of releasing comprises manually removing the sleeve from the expandable member.

5. The procedure of claim 1 wherein the step of releasing comprises allowing the expandable member to break the sleeve during the expansion of the expandable member.

6. The procedure of claim 1 wherein the step of terminating occurs when the spinous processes are stabilized.

7. The procedure of claim 1 wherein the step of expanding causes movement of at least one of the spinous processes, and the step of terminating occurs when the spinous processes are stabilized in a predetermined spatial relationship.

8. The procedure of claim 1 wherein the fluid is taken from a group consisting of air, water, and a curable polymer.

9. The procedure of claim 1 wherein the step of inserting includes inserting the expandable member in the non-expanded condition between first and second spinous processes such that the expandable member in the non-expanded condition is approximately bilaterally centered across the first spinous process.

10. The procedure of claim 5 wherein the step of releasing the sleeve includes breaking the sleeve along at least one perforation extending along the sleeve.

11. A surgical implantation procedure comprising:
inserting a sleeve and an expandable member between first and second adjacent spinous processes, wherein, during the inserting step, the sleeve overlaps a longitudinally-center portion of the expandable member and releasably retains the expandable member in a non-expanded condition with the expandable member having an arcuate collapsed shape inside the sleeve;
expanding the expandable member to an expanded condition subsequent to performing the inserting step by introducing fluid into the member via a fill tube associated with the expandable member while the expandable member is disposed within the sleeve;
releasing the sleeve from the inserted expandable member so that the expandable member expands between the first and second adjacent spinous processes;
terminating the step of expanding when the expandable member is in engagement with at least one of the first and second adjacent spinous processes.