WO2006068682A1 - Dispositif de support expansible et procede d'utilisation - Google Patents
Dispositif de support expansible et procede d'utilisation Download PDFInfo
- Publication number
- WO2006068682A1 WO2006068682A1 PCT/US2005/034728 US2005034728W WO2006068682A1 WO 2006068682 A1 WO2006068682 A1 WO 2006068682A1 US 2005034728 W US2005034728 W US 2005034728W WO 2006068682 A1 WO2006068682 A1 WO 2006068682A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- support device
- spinal fusion
- fusion support
- expandable
- spinal
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
- A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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- A—HUMAN NECESSITIES
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- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
- A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
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- A—HUMAN NECESSITIES
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- A61F2/02—Prostheses implantable into the body
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- A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00101—Molybdenum or Mo-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00131—Tantalum or Ta-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00137—Tungsten or W-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00155—Gold or Au-based alloys
-
- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00359—Bone or bony tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00952—Coating, pre-coating or prosthesis-covering structure made of bone cement, e.g. pre-applied PMMA cement mantle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
Definitions
- Field of the Invention relates to devices for providing support for biological tissue, for example to repair spinal compression fractures, and methods of using the same.
- Background of the Invention [0003]
- the vertebral disc provides cushion between adjacent vertebrae. The disc sometimes becomes damaged or deteriorates due to age, disease, injury, or congenital defect. As a result, the vertebrae may also become compressed or otherwise damaged. Vertebrae may also become too closely spaced anteriorly, especially due to age, but also because of other factors that produce an undesired abnormal curvature of the spine with respect to lordosis or kyphosis.
- a patient may undergo surgery to place spacers or interbody devices between the vertebrae.
- These spacers provide proper spacing of the vertebrae and also promote fusion between the vertebrae.
- Such devices are often referred to as a fusion cages or an intervertebral fusion device.
- bone or bone fusion material is often placed about the interbody devices to promote growth of the bone between the vertebrae.
- Some procedures include packing bone fusion materials between one or more interbody devices to promote growth of bone. This is intended to create a fusion between the vertebrae.
- interbody devices have typically been either generally rectangular or at least partially cylindrical and threaded. The cylindrical devices can be threadably received between and partially into the adjacent vertebrae.
- the vertebrae are typically first spaced apart, and then a drill creates a partial bore (radiused channel) in facing surfaces of opposed vertebrae which allows this type of interbody device to be received between the vertebrae.
- the interbody device usually engages the bones only along an upper surface and a lower surface of the device.
- the interbody device is of a cylindrical threaded type, the upper and lower surfaces are radiused relative to a front to rear axis and such are essentially designed to engage the portion of the vertebrae where bone is removed by boring to create an opening for the device.
- Such interbody devices function well if they engage as much surface of the bone as possible.
- This provides support to the bone and reduces the chance of subsidence of the device into the bone, where subsidence results from contact pressure of the interbody spacer against an intervertebral surface of a vertebra. Subsidence can occur since part of the bone is somewhat spongy in nature, especially near the centers of the facing upper and lower surfaces of the vertebrae.
- the remainder of the structure of the intervertebral device mainly functions to support the two vertebral surfaces, unless the device is also used as a cage within or around which to pack bone fusion material. Because it is also desirable in such structures to maintain weight and volume as low as possible in order to make the device more compatible with the body, it is also desirable to make the entire device as small and lightweight as possible, while maintaining strength.
- An expandable support device configured to fuse to surrounding tissue.
- the expandable support device can be deployed into bone.
- the expandable support device can increase stability and reduce motion of the bones and/or the expndable support device.
- the expandable support device can have struts that can be blades configured to dig into the surrounding tissue when the expandable support device is rotatably deployed.
- the expandable support device can have one or more struts that are thinner on the radial outside of the expandable support device and thicker on the radial inside of the expandable support device.
- a deployment tool that can have a balloon configured to deploy an expandable support device is disclosed.
- the expandable support device can releasably attach (i.e., mate) with the deployment tool to enable the deployment tool to deploy the expandable support device into hard tissue, such as bone.
- Figure 1 illustrates an embodiment of a deployment tool loaded with an embodiment of an expandable support device.
- Figure 2 illustrates an embodiment of the expandable support device.
- Figures 3 and 4 illustrate various embodiments of cross-section A-A of Figure 2.
- Figures 5 through 8 illustrate various embodiments of the struts of Figure 4.
- Figures 9 through 11 illustrate various embodiments of the expandable support device.
- Figure 12 illustrates a side perspective view of an embodiment of the expandable support device.
- Figure 13 illustrates an end view of the embodiment of the expandable support device of Figure 12.
- Figure 14 illustrates a side perspective view of an embodiment of the expandable support device.
- Figure 15 illustrates an end view of the embodiment of two expandable support devices of Figure 14.
- Provisional Patent Application No. 60,612,001, titled “EXPANDABLE SUPPORT DEVICE AND METHOD OF USE”, filed on 21 September 2004 is herein incorporated by reference in its entirety, and herein referred to as the POOl Patent Application.
- U.S. Provisional Patent Application No. 60/611,972, titled “BALLOON AND METHODS OF MAKING AND USING”, filed on 21 September 2004 is herein incorporated by reference in its entirety, and herein referred to as the P005 Patent Application.
- FIG. 1 illustrates an expandable support device 2 loaded onto a deployment tool 4.
- the expandable support device 2 can have threads 6 in and/or on the surface of the expandable support device 2.
- the threads 6 can be in the direction necessary to deploy the expandable support device 2 into a bone, such as within and/or between vertebrae.
- the expandable support device 2 can be balloon expandable and/or self- expandable.
- the expandable support device 2 can be resilient and/or deformable.
- the expandable support device 2 can have a notch 8.
- the notch 8 can tightly interference fit a deployment driver head 10.
- the deployment tool 4 can be rotated, as shown by arrow 12, during use. Rotation of the deployment tool 4 can cause the threads 6 to screw into a deployment site, such as a bone (e.g., a vertebra).
- the deployment tool 4 can also be otherwise used (e.g., by inflation of a deployment balloon 14 that is part of the deployment tool 4) to deploy the expandable support device 2, for example, after the expandable support device 2 is properly screwed into position.
- the threads 6 can be fixed in the deployment site, for example, during and/or after screwing the expandable support device 2 during use.
- the balloon 14 on the deployment tool 4 can translate radial force loads directly to the expandable support device 2.
- the expandable support device 2 can have a maximum outer diameter equal or smaller the maximum outer diameter of the balloon 14.
- the expandable support device 2 can be a stent. Figures 3 and 4 illustrates that th expandable support device 2 can have struts 16.
- the struts can have a circular or oval cross-section.
- the struts 16 can be porous, for example, to allow tissue ingrowth into the strut 16 and fusion of the strut 16 to the surrounding tissue after implantation.
- the expandable support device 2 can have a first strut 16a and a second strut 16b.
- the first strut 16a can have a first porosity.
- the second strut 16b can have a second porosity.
- the first and second porosities can be equal.
- the first porosity can be greater than the second porosity.
- the porosity of the struts 16 can vary discretely and/or continuously around the perimeter or the expandable support device 2.
- the porosity of the struts 16 can vary discretely and/or continuously around the perimeter of the individual strut 16.
- Figure 4 illustrates that some or all of the struts 16 can be narrower (i.e., thinner) on the side of the strut 16 that is radially outside of the expandable support device 2 compared to the side of the strut 16 that is radially inside the expandable support device 2. The strut 16 can become narrower relative to the radius with respect to the expandable support device 2.
- the thinner radial exterior of the struts 16 can imbed or poke into the surround tissue (e.g., bone) during deployment, for example, to increase the stability (i.e., minimize movement/motion, such as slipping out of the space and rolling) of the struts 16 in the bone, also for example to increase the depth of implantation (e.g., jamming) of the struts 16 into the surrounding tissue of the stent in the bone, for example, creating deflecting struts 16 (e.g., threads) that can imbed into the surrounding tissue (i.e., bone) after expansion of the expandable support device 2.
- Figure 5 illustrates that the strut 16 can be configured to have a triangular cross- section.
- Figure 6 illustrates that the strut 16 can be configured to have a quadrilateral (e.g., trapezoidal) cross-section.
- Figure 7 illustrates that the strut 16 can have a sharp tip or barb on the radial exterior (i.e., with respect to the expandable support device 2) of the strut 16.
- Figure 18 illustrates that the strut 16 can have an exterior zone 18a and an interior zone 18b.
- the exterior zone 18a can have a first porosity.
- the interior zone 18b can have a second porosity.
- the first porosity can be greater, equal to, or less than the second porosity.
- the expandable support device 2 can be tapered radially inward and/or radially outward at one or both ends 22a and 22b and/or along the middle 22c, for example as shown in Figures 2, 9 through 11, and the P008 Patent Application.
- the expandable support device 2 can be tapered, for example, by crimping on to the deployment tool 4, and/or by forming a bullet shape tip on the expandable support device 2.
- the expandable support device 2 can self tap into the deployment site (e.g., bone).
- Figure 2 illustrates that the expandable support device 2 can have a first taper 20a at a first end 22a and a second taper 20b at a second end 22b.
- the first taper 20a can be radially inward.
- the second taper 20b can be radially inward.
- the middle 22c can have no taper.
- Figure 9 illustrates that the first taper 20a can be radially inward and that the expandable support device 2 can have no second taper 20b.
- Figure 10 illustrates that the first taper 20a can be radially inward and that the second taper 20b can be radially outward.
- the second taper 20b can be a flare.
- Figure 11 illustrates that the second taper 20b can extend from the second end 22b to the first end 22a.
- the expandable support device 2 can be tapered radially inward and/or radially outward at any combination of the expandable support device ends and/or middle 22a, 22b, and/or 22c.
- the expandable support device 2 can have a sharp end 22a or 22b.
- the sharp end can be used, for example, to push or hammer the expandable support device in place.
- the first end 22a can have a reinforced first end 22a and/or second end 22b, for example a reinforced first rim 24.
- the first end 22a and/or second end 22b (e.g., the first rim 24 and/or second rim) can be made from a different material than the middle 22c.
- the material of the first end 22a and/or second end 22b can be any of the materials described herein, for example, non-radiopaque, plastic (e.g., polyethylene (PE), polyethylene terephthalate (PET), Nylon, polyglycolic acid (PGA), ploy-L-lactic acid (PLLA)) ceramics, metals or combinations thereof.
- the struts 16 can be laser cut to create a mesh- like structure (e.g., many thin struts).
- the struts 16 can contain any of the agents or other materials described herein.
- the expandable support device 2 can be porous and/or hollow.
- the expandable support device 2 can have a first hole 26 and/or a second hole.
- the first hole 26 can be at the first end 22a.
- the second hole can be at the second end 22b.
- the tissue (e.g., bone) carved out during deployment (e.g., during rotation, such as screwing, and/or translation) of the expandable support device 2 can fill the porous and/or hollow space within the expandable support device 2.
- Figures 12 and 13 illustrate that the expandable support device 2 can have a square or rectangular cross-section with sharp or rounded edges.
- the expandable support device 2 can be round when contracted and square or rectangular when expanded.
- Figure 14 illustrates that the expandable support device 2 can have an oval or circular cross- section.
- Figure 15 illustrates that a first expandable support device 2a can be fixedly or removable attached to a second expandable support device 2b, for example at an attachment point or area 28.
- the attachment point or area 28 can be a weld, glue, snap, or combinations thereof.
- the first and second expandable support devices 2a and 2b can be held together by exterior forces alone.
- Figure 16 illustrates the expandable support device 2 that can have an inverse thread, such as an engagement groove 30.
- the engagement groove 30 can be on the inner diameter of the expandable support device 2.
- the engagement groove 30 can be configured to engage an external engagement thread on the deployment tool 4.
- the expandable support device 2 can be or have any characteristics or features disclosed in the POO 1 Patent Application.
- Figure 17 illustrates that the expandable support device can have a thread 6.
- the expandable support device 2 can be rotated during implantation to screw into an implant site, such as a vertebra.
- the expandable support device 2 can have a thread 6 on the inside and/or outside diameter of the expandable support device 2.
- Figures 18 and 19 illustrate that the thread 6 can be configured to allow rotation in a first direction and inhibit rotation in a second direction.
- Figure 18 shows that the thread 6 can have a ridge 32.
- the thread 6 can have uni-directional thread vertebrae 34.
- Figure 19 illustrates that uni-directional fins 36 can extend from the ridge 32.
- Figure 20 illustrates that the expandable support device 2 can have a first thread 6a and a second thread 6b.
- the first thread 6a can be overlapping or non-overlapping (as shown) with the second thread 6b.
- the first thread 6a can have a first pitch, first thread shape, and first coefficient of friction.
- the second thread 6b can have a second pitch, second thread shape, and second coefficient of friction.
- the first pitch, first thread shape, and first coefficient of friction can be the same or different than the second pitch, second thread shape, and second coefficient of friction, respectively.
- Figure 21 illustrates that the expandable support device 2 can have a substantially circular cross-section.
- the expandable support device 2 can have a longitudinal axis 38.
- Figure 22 illustrates that the struts 16 can be blades, tapping threads, cutting threads, or combinations thereof.
- the expandable support device 2 can have struts 16 that are blades, tapping threads, cutting threads, or combinations thereof and struts 16 that are not blades, tapping threads, cutting threads, or combinations thereof.
- the blade struts 16 can be straight blades.
- the struts 16 can scoop out tissue (e.g., bone). The scooped out tissue can be held in the hollow interior of the expandable support device 2.
- the struts 16 can be oriented unidirectionally.
- the struts 16 can be configured such that during rotation in a first direction, shown by arrow 40, the expandable support device 2 is minimally inhibited from rotating (i.e., easy to turn), and that during rotation in a second direction, shown by arrow 42, the rotation is resisted by the surrounding tissue and/or the expandable support device 2 can lock against the surrounding tissue.
- the struts 16 can be configured such that during rotation in a first direction, shown by arrow 40, the expandable support device 2 can be radially contracted, and that during rotation in a second direction, shown by arrow 42, the expandable support device 2 can be radially expanded.
- Figure 23 illustrates that the struts 16 can be convex with respect to the longitudinal axis 38 at the center of the expandable support device 2.
- the struts 16 can be angled outward with respect to the circumference of the expandable support device 2.
- the struts 16 can anchor into the surrounding tissue.
- Figure 24 illustrates that the struts 16 can be concave with respect to the longitudinal axis 38 at the center of the expandable support device 2.
- the struts 16 can be angled outward with respect to the circumference of the expandable support device 2.
- the struts 16 can scoop surrounding tissue into the expandable support device 2 and anchor into the remaining surrounding tissue.
- the cross-sections of the expandable support device 2 can be substantially identical at cross-section C-C and D-D.
- Figures 24 and 25 illustrate that the cross- sections can vary between cross-section C-C and D-D.
- Figure 25 illustrates that the struts 16 can form a helix around the expandable support device 2.
- the expandable support device 2 can have a first strut 16a at top dead center.
- the first strut 16a can be at a twist angle 44 from top dead center.
- the porous elements can be made from any materials described herein including, fabric surfaces, metals, sintered fabrics, sintered beads, acid etched surfaces, foamed metals, and combinations thereof.
- the surface of any or all elements of the expandable support device and/or other devices or apparatuses described herein can be textured, for example with a rough surface to match trabecular bone.
- Parts of the expandable support device 2 can be self expanding and some parts of the expandable support device 2 can be balloon expandable. Some or all of the self- expanding struts 16 can "poke" out with additional force when the stent is deployed.
- FIG. 26 illustrates that a deployment extension 46 can enter through the subject's back.
- the first deployment extension 46a can enter through a first incision 48a in skin 50 on the posterior side of the subject near a vertebral column 52.
- the first deployment extension 46a can be translated, as shown by arrow 54, to position the first deployment tool 4a (e.g., loaded with the expandable support device 2) adjacent or into an intervertebral disc 56 (as shown) or vertebra 58.
- a second deployment extension 46b e.g., loaded with the expandable support device 2 can enter through a second incision 48b (as shown) in the skin 50 on the posterior or through the first incision 48a.
- the second deployment extension 46b can be translated through muscle (not shown), around nerves 60, and anterior of the vertebral column 52.
- the second deployment extension 46b can be steerable.
- the second deployment extension 46b can be steered, as shown by arrow 62, to align the distal tip of a second deployment tool 4b with the anterior side of the disc 56 or vertebra 58.
- the second deployment extension 46b can translate, as shown by arrow 54b, to position the second deployment tool 4b in the disc 56 or vertebra 58.
- the disc 56 or vertebra 58 can have multiple expandable support devices 2 deployed therein.
- the expandable support devices 2 can be deployed from the anterior, posterior, both lateral, superior, inferior, any angle, or combinations of the directions thereof. Multiple expandable support devices 2 can be deployed sequentially and/or simultaneously.
- Figures 27 through 29 illustrate various methods for using the expandable support device 2.
- Figure 27 illustrates that multiple, for example two, expandable support devices 2 can be implanted into a spine, for example a vertebra 58 (as shown) and/or intervertebral disc, in a substantially parallel and/or side-by-side configuration.
- Figure 28 illustrates that the expandable support device can be implanted from and/or into a lateral portion of the vertebra (as shown) and/or intervertebral disc.
- Figure 28 illustrates that multiple expandable support devices can be implanted from and/or into anterior and/or lateral portions of the vertebra (as shown) and/or intervertebral disc.
- Curved expandable support devices can also be implanted into the spine, such that the curve can prevent rolling the expandable support device during primary force application.
- a pilot hole can be created and a tapping screw can be used to create a channel at the target site for the expandable support device 2.
- the tapping screw can be used to make a pilot hole at the target site for the expandable support device 2.
- the thread on the tapping screw can be used to scoop out bone and create arches for the expanded expandable support device 2 to sit in (e.g., for increased stability) once deployed.
- the carved-out tissue e.g., bone
- the deployment tool 4 can deploy the expandable support device 2 by tapping or hammering the expandable support device 2 into the target site.
- the deployment tool 4 can deploy the expandable support device 2 by screwing the expandable support device 2 into the target site.
- the thread 6 and/or struts 16 can pull and/or lock the expndable support device 2 into the target site.
- Figures 30a through 30c illustrate the expandable support device in a relaxed configuration.
- Figures 31a through 31c illustrate the expandable support device 2 in a contracted configuration, for example, due to rotation 42.
- Figures 32a through 32c illustrate the expandable support device in an expanded configuration, for example, due to rotation 40.
- Diameter 64 is a baseline diameter in a relaxed configuration, from which the contracted diameter and the expanded diameter can be viewed in reference.
- Figures 33 and 34 illustrate that the expandable support device 2 and/or the first and second expandable support devices 2a and 2b can be deployed in a stable configuration in a single, or between vertebrae 58.
- Figure 35 illustrates that the expandable support device 2 can be filled with agents, fillers 64, or other materials described herein including morselized bone, cement, hydroxy apatite, ceramic chips, and combinations thereof.
- the fillers can be used to create the fusion environment.
- the fillers 64 can add to the compressive strength of the expandable support device 2.
- the ends of the expandable support device 2 can be closed after adding the filler 64.
- a small pilot hole can be created by a pilot tool to guide the expandable support device.
- the deployment tool can forcefully impact the deployment site, for example, to seat the stent before the screw is turned.
- any or all elements of the expandable support device and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys (e.g., Spring steel) , nickel titanium alloys (e.g., Nitinol), cobalt- chrome alloys (e.g., ELGILO Y® from Elgin Specialty Metals, Elgin, IL; CONICHROME® from Carpenter Metals Corp., Wyomissing, PA), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, CT), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No.
- a single or multiple stainless steel alloys e.g., Spring steel
- nickel titanium alloys e.g., Nitinol
- cobalt- chrome alloys e.g., ELGILO Y® from Elgin Specialty Metal
- WO 03/082363 A2 published 9 October 2003, which is herein incorporated by reference in its entirety
- tungsten-rhenium alloys for example, as disclosed in International Pub. No. WO 03/082363
- polymers such as polyethylene teraphathalate (PET)/polyester (e.g., DACRON® from E. I.
- radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel -titanium alloys, tantalum and gold.
- Any or all elements of the expandable support device 2 and/or other devices or apparatuses described herein can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth, a ceramic, a polymer, a biodegrading material, drugs or agents described herein, or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth.
- the matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I.
- the expandable support device 2 and/or elements of the expandable support device and/or other devices or apparatuses described herein and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements, fillers, glues, and/or an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors.
- cements and/or fillers examples include bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof.
- DBM demineralized bone matrix
- PMMA polymethyl methacrylate
- BMPs bone morphogenic proteins
- rhBMPs recombinant human bone morphogenetic proteins
- the agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal antiinflammatories (NSAIDs) such as cyclooxygenase-1 (COX-I) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, PA; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, NJ; CELEBREX® from
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Neurology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Physical Education & Sports Medicine (AREA)
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Abstract
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US61272804P | 2004-09-24 | 2004-09-24 | |
US60/612,728 | 2004-09-24 |
Publications (1)
Publication Number | Publication Date |
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WO2006068682A1 true WO2006068682A1 (fr) | 2006-06-29 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2005/034728 WO2006068682A1 (fr) | 2004-09-24 | 2005-09-26 | Dispositif de support expansible et procede d'utilisation |
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Cited By (28)
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EP2131767A1 (fr) * | 2007-03-12 | 2009-12-16 | Stout Medical Group LP | Dispositif de fixation gonflable et procédé associé |
USD626233S1 (en) | 2008-02-28 | 2010-10-26 | Stryker Spine | Expandable intervertebral implant |
US7846206B2 (en) | 2004-06-09 | 2010-12-07 | Vexim Sas | Methods and apparatuses for bone restoration |
WO2011019367A1 (fr) | 2009-08-10 | 2011-02-17 | Virak Tan | Fixateur orthopédique externe et procédé d'utilisation |
US8287538B2 (en) | 2008-01-14 | 2012-10-16 | Conventus Orthopaedics, Inc. | Apparatus and methods for fracture repair |
US8382842B2 (en) | 2009-05-14 | 2013-02-26 | Stout Medical Group, L.P. | Expandable support device and method of use |
US8636784B2 (en) | 2007-11-02 | 2014-01-28 | Stout Medical Group, LP | Expandable attachment device and method |
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