Surgical spacer with shape control
An interspinous spacer for placement between adjacent spinous processes includes a flexible, fillable container (e.g., a bag or balloon) for containing a material that is compressible during end use, for example, silicone after curing. The container is impermeable to the material it will be filled with. A structural mesh, for example, made of PET fabric and interwoven shape-memory alloy wire, provides structure for and containment of the container, as well as shape control. The material can be injected into the container through an optional conduit, for example, a one-way valve.
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This application contains subject matter which is related to the subject matter of the following applications, each of which is assigned to the same assignee as this application and filed on the same day as this application. Each of the below listed applications is hereby incorporated herein by reference in its entirety:
“Surgical Spacer,” by Lange et al. (Attorney Docket No. P22790.00).
“Systems and Methods for Adjusting Properties of a Spinal Implant,” by Lange et al. (Attorney Docket No. P23186.00); and
TECHNICAL FIELDThe present invention generally relates to surgical spacers for spacing adjacent body parts. More particularly, the present invention relates to surgical spacers having a flexible container for containing a material that is compressible during end use, the container being substantially impermeable to the material, and a structure for controlling at least part of a shape of the container when containing the material.
BACKGROUND OF THE INVENTIONThe human spine is a biomechanical structure with thirty-three vertebral members, and is responsible for protecting the spinal cord, nerve roots and internal organs of the thorax and abdomen. The spine also provides structural support for the body while permitting flexibility of motion. A significant portion of the population will experience back pain at some point in their lives resulting from a spinal condition. The pain may range from general discomfort to disabling pain that immobilizes the individual. Back pain may result from a trauma to the spine, the natural aging process, or the result of a degenerative disease or condition.
Procedures to address back problems sometimes require correcting the distance between spinous processes by inserting a device (e.g., a spacer) therebetween. The spacer, which is carefully positioned and aligned within the area occupied by the interspinous ligament, after removal thereof, is sized to position the spinous processes in a manner to return proper spacing thereof.
Dynamic interspinous spacers are currently used to treat patients with a variety of indications. Essentially, these patients present a need for distraction of the posterior elements (e.g., the spinal processes) using a mechanical device. Current clinical indications for the device, as described at SAS (Spine Arthroplasty Society) Summit 2005 by Guizzardi et al., include stenosis, disc herniation, facet arthropathy, degenerative disc disease and adjacent segment degeneration.
Marketed interspinous devices include rigid and flexible spacers made from PEEK, titanium or silicone. Clinical success with these devices has been extremely positive so far as an early stage treatment option, avoiding or delaying the need for lumbar spinal fusion. However, all devices require an open technique to be implanted, and many require destroying important anatomical stabilizers, such as the supraspinous ligament.
Current devices for spacing adjacent interspinous processes are preformed, and are not customizable for different sizes and dimensions of the anatomy of an interspinous area of an actual patient. Instead, preformed devices of an approximately correct size are inserted into the interspinous area of the patient. Further, the stiffness or flexibility of the devices must be determined prior to the devices being inserted into the interspinous area.
Thus, a need exists for improvements to surgical spacers, such as those for spacing adjacent interspinous processes.
SUMMARY OF THE INVENTIONBriefly, the present invention satisfies the need for improvements to surgical spacers by providing shape control. A flexible container is provided that is fillable in situ to a desired amount, with a structure for at least part of the container providing shape control thereto. An optional conduit coupled to the container allows for filling of the container, for example, by injecting a material into the container.
The present invention provides in a first aspect, a surgical spacer. The surgical spacer comprises a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material. The surgical spacer further comprises a structure for at least part of the container when containing the material, wherein the structure controls at least part of a shape of the surgical spacer.
The present invention provides in a second aspect, an interspinous spacer. The interspinous spacer comprises a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material. The interspinous spacer further comprises a conduit coupled to the container for accepting the injectable material, and a structure for at least part of the container when containing the material, wherein the structure has a shape during end use to fit between adjacent spinous processes.
The present invention provides in a third aspect, a method of controlling at least part of a shape of a surgical spacer. The surgical spacer comprises a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material. The surgical spacer further comprises a structure for at least part of the container when containing the material. The method comprises creating the structure with at least one material for controlling at least part of a shape of the surgical spacer during end use.
The present invention provides in a fourth aspect, a method of spacing adjacent spinous processes. The method comprises providing an interspinous spacer, the interspinous spacer comprising a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material. The interspinous spacer further comprises a conduit coupled to the container for accepting the injectable material, and a structure for at least part of the container when containing the material, wherein the structure has a shape during end use to fit between adjacent spinous processes. The method further comprises implanting the interspinous spacer between adjacent spinous processes, and injecting the injectable material into the container through the conduit such that the shape is achieved.
Further, additional features and advantages are realized through the techniques of the present invention. Other embodiments and aspects of the invention are described in detail herein and are considered a part of the claimed invention.
The subject matter which is regarded as the invention is particularly pointed out and distinctly claimed in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:
A surgical spacer of the present invention can be formed in situ during a procedure. The spacer includes the following basic aspects: a flexible container, and a structure for at least part of the container that controls at least part of the shape of the surgical spacer. The flexible container can be filled or injected though an optional conduit after placement. Further, the structure may be folded or otherwise reduced in size prior to use in some aspects. Together with an unfilled container, in some aspects, the spacer can create a smaller footprint during implantation. Once filled, the structure provides support and containment for the container, as well as providing shape control for at least part of the spacer.
The container is flexible and substantially impermeable to the material it will be filled with. However, depending on the application, the container may be permeable to other materials, for example, it may be air and/or water permeable. In the present example, the container takes the form of a bag or balloon, but can take other forms, so long as flexible and substantially impermeable to the material it will be filled with. Thus, the container must be substantially impermeable to the filling material, for example, in a liquid state during filling and prior to curing. Examples of container materials include silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymers.
Conduit 406 accepts the material being used to fill the container. Preferably, the conduit comprises a one-way valve, however, a two-way valve is also contemplated, as another example. The conduit can comprise any material suitable for implanting, for example, various plastics. Also preferably, the conduit is constructed to be used with a delivery system for filling the container, such as, for example, a pressurized syringe-type delivery system. However, the delivery system itself forms no part of the present invention. As noted above, the conduit is optional. Other examples of how to fill the container comprise the use of a self-sealing material for the container, or leaving an opening in the container that is closed (e.g., sewn shut) intraoperatively after filling. Using a curable material to fill the container may also serve to self-seal the container.
In use, the container is filled with a material that is compressible during end use. The compressibility characteristic ensures that the material exhibits viscoelastic behavior and that, along with the structure, the spacer can accept compressive loads. Of course, the degree of compressibility will depend on the particular application for the surgical spacer. For example, if a spacer according to the present invention is used between adjacent spinous processes, the spacer would need to accept compressive loads typically experienced in the posterior region of the spine, for example, up to about 80 shore A. In other words, the spacer is preferably capable of resisting compressive motion (or loads) with a stiffness of about 40 to about 240 N/mm (newtons per millimeter). The material is preferably injectable, and may be compressible immediately or after a time, for example, after curing. For purposes of the invention, the compressibility characteristic is necessary during end use, i.e., after implantation. Materials that could be used include, for example, a plurality of beads (e.g., polymer beads) that in the aggregate are compressible, or materials that change state from exhibiting fluid properties to exhibiting properties of a solid or semi-solid. Examples of such state-changing materials include two-part curing polymers and adhesive, for example, platinum-catalyzed silicone, epoxy, polyurethane, etc.
As noted above, the structure provides support for and containment of the container when filled, as well as at least partial shape control of the spacer. The structure comprises, for example, a structural mesh comprising a plurality of fibers and/or wires 408. Within the structural mesh are shape-control fibers and/or wires 410. In one example, shape control is provided by wires of a shape-memory alloy (e.g., Nitinol). The shape-memory alloy wire(s) can be coupled to the structural mesh (inside or outside), or weaved into the mesh (i.e., integrated). Coupling can be achieved, for example, by stitching, twisting, or closing the wire on itself. Alternatively, shape control can be provided by other wires or fibers that do not “give” in a particular direction, for example, metal or metal alloys (e.g., tantalum, titanium or steel, and non-metals, for example, carbon fiber, PET, polyethylene, polypropalene, etc.). The shape-memory alloy can be passive (e.g., superelastic) or active (e.g., body-temperature activated). The use of metal, metal alloy or barium coated wires or fibers can also improve radiopacity for imaging. The remainder of the structure can take the form of, for example, a fabric jacket, as shown in
Although the structure is shown in a roughly H-shape in the example of
One example of the construction of a structural mesh 700 for use as one example of a structure of the present invention will now be described with reference to
In an alternate aspect, the rubber shell of
As shown in the example of
Similarly,
Although preferred embodiments have been depicted and described in detail herein, it will be apparent to those skilled in the relevant art that various modifications, additions, substitutions and the like can be made without departing from the spirit of the invention and these are therefore considered to be within the scope of the invention as defined in the following claims.
Claims
1. A surgical spacer, comprising:
- a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material; and
- a structure for at least part of the container when containing the material;
- wherein the structure controls at least part of a shape of the surgical spacer.
2. The surgical spacer of claim 1, wherein the material is flowable during filling of the container, the surgical spacer further comprising a conduit coupled to the container for accepting the material.
3. The surgical spacer of claim 2, wherein the conduit comprises a one-way valve.
4. The surgical spacer of claim 1, wherein the container is situated inside the structure.
5. The surgical spacer of claim 1, wherein the container is situated outside the structure.
6. The surgical spacer of claim 1, wherein the container is integral with the structure.
7. The surgical spacer of claim 1, wherein the structure comprises a shape memory alloy.
8. The surgical spacer of claim 7, wherein the shape memory alloy is body temperature activated.
9. The surgical spacer of claim 7, wherein the shape memory alloy is superelastic.
10. The surgical spacer of claim 7, wherein the shape memory alloy is coupled to an inside of the structure.
11. The surgical spacer of claim 7, wherein the shape memory alloy is coupled to an outside of the structure.
12. The surgical spacer of claim 11, wherein the structure comprises a plurality of interlocking links, and wherein the plurality of interlocking links comprise the shape memory alloy.
13. The surgical spacer of claim 7, wherein the structure comprises a structural mesh, and wherein the shape memory alloy comprises at least one shape memory alloy wire within the structural mesh.
14. The surgical spacer of claim 1, wherein the structure has at least a partially preformed shape.
15. The surgical spacer of claim 1, wherein the structure comprises at least one substantially inflexible shaped member.
16. The surgical spacer of claim 15, wherein the at least one substantially inflexible shaped member comprises a substantially straight member.
17. The surgical spacer of claim 15, wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member.
18. The surgical spacer of claim 1, wherein the container and the structure together comprise a layer of rubber thick enough to roughly maintain a desired shape.
19. The surgical spacer of claim 1, wherein the container comprises at least one of silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymer.
20. The surgical spacer of claim 1, wherein the material comprises at least one of a curable polymer and an adhesive.
21. The surgical spacer of claim 1, wherein the structure comprises at least one of PET fabric, polypropylene fabric, polyethylene fabric and metal wire.
22. The surgical spacer of claim 1, wherein the surgical spacer comprises an interspinous spacer, and wherein the structure is shaped to fit between adjacent spinous processes.
23. The surgical spacer of claim 1, wherein the structure is shaped for spacing adjacent spinous processes, and wherein the surgical spacer is capable of resisting a compressive load with a stiffness of about 40 N/mm to about 240 N/mm.
24. The surgical spacer of claim 1, wherein the structure is shaped to replace at least part of an intervertebral disc.
25. The surgical spacer of claim 1, wherein the structure is at least partially permeable.
26. An interspinous spacer, comprising:
- a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material;
- a conduit coupled to the container for accepting the injectable material; and
- a structure for at least part of the container when containing the material;
- wherein the structure has a shape during end use to fit between adjacent spinous processes.
27. The interspinous spacer of claim 26, wherein the structure is roughly H-shaped.
28. The interspinous spacer of claim 26, wherein the structure comprises:
- at least one substantially inflexible member; and
- a mesh for enveloping the at least one substantially inflexible member.
29. The interspinous spacer of claim 28, wherein the at least one substantially inflexible shaped member comprises a substantially straight member.
30. The interspinous spacer of claim 28, wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member.
31. The interspinous spacer of claim 26, wherein the conduit comprises a one-way valve.
32. The interspinous spacer of claim 26, wherein the container is situated inside the structure.
33. The interspinous spacer of claim 26, wherein the container is situated outside the structure.
34. The interspinous spacer of claim 26, wherein the container is integral with the structure.
35. The interspinous spacer of claim 26, wherein the structure comprises a shape memory alloy.
36. The interspinous spacer of claim 35, wherein the shape memory alloy is body temperature activated.
37. The interspinous spacer of claim 35, wherein the shape memory alloy is superelastic.
38. The interspinous spacer of claim 35, wherein the shape memory alloy is coupled to an inside of the structure.
39. The interspinous spacer of claim 35, wherein the shape memory alloy is coupled to an outside of the structure.
40. The interspinous spacer of claim 39, wherein the structure comprises a plurality of interlocking links, and wherein the plurality of interlocking links comprise the shape memory alloy.
41. The interspinous spacer of claim 35, wherein the structure comprises a structural mesh, and wherein the shape memory alloy comprises at least one shape memory alloy wire within the structural mesh.
42. The interspinous spacer of claim 26, wherein the structure has at least a partially preformed shape.
43. The interspinous spacer of claim 26, wherein the structure comprises at least one substantially inflexible shaped member.
44. The interspinous spacer of claim 43, wherein the at least one substantially inflexible shaped member comprises a substantially straight member.
45. The interspinous spacer of claim 43, wherein the at least one substantially inflexible shaped member comprises a roughly U-shaped member.
46. The interspinous spacer of claim 26, wherein the container and the structure together comprise a layer of rubber thick enough to roughly maintain a desired shape.
47. The interspinous spacer of claim 26, wherein the container comprises at least one of silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymer.
48. The interspinous spacer of claim 26, wherein the material comprises at least one of a curable polymer and an adhesive.
49. The interspinous spacer of claim 26, wherein the structure comprises at least one of PET fabric, polypropylene fabric, polyethylene fabric and metal wire.
50. A method of controlling at least part of a shape of a surgical spacer, the surgical spacer comprising a flexible container for containing a material that is compressible during end use, wherein the container is substantially impermeable to the material, and a structure for at least part of the container when containing the material, the method comprising creating the structure with at least one material for controlling at least part of a shape of the surgical spacer.
51. The method of claim 50, wherein the creating comprises adding a shape memory alloy to the structure.
52. The method of claim 51, wherein the structure comprises a structural mesh, and wherein the creating comprises adding at least one shape-memory alloy wire to the structural mesh.
53. The method of claim 51, wherein the creating comprises coupling the at least one shape memory alloy to the structure.
54. The method of claim 50, wherein the creating comprises adding at least one substantially inflexible shaped member to the structure.
55. The method of claim 50, wherein the creating comprises adding a layer of rubber thick enough to roughly maintain a desired shape.
56. A method of spacing adjacent spinous processes, the method comprising:
- providing an interspinous spacer, the interspinous spacer comprising: a flexible container for containing an injectable material that is compressible during end use, wherein the container is substantially impermeable to the injectable material; a conduit coupled to the container for accepting the injectable material; and a structure for at least part of the container when containing the material; wherein the structure has a shape during end use to fit between adjacent spinous processes;
- implanting the interspinous spacer between adjacent spinous processes; and
- injecting the injectable material into the container through the conduit such that the shape is achieved.
Type: Application
Filed: May 23, 2006
Publication Date: Nov 29, 2007
Applicant: SDGI Holdings, Inc. (Wilmington, DE)
Inventors: Eric C. Lange (Collierville, TN), Hai H. Trieu (Cordova, TN), Kent M. Anderson (Memphis, TN), Randall L. Allard (Germantown, TN), Aurelien Bruneau (Memphis, TN)
Application Number: 11/438,891
International Classification: A61F 2/44 (20060101);