WO2010065015A1 - Systèmes et procédés pour la fixation ou la fusion d’os à ou près d’une articulation sacro-iliaque - Google Patents

Systèmes et procédés pour la fixation ou la fusion d’os à ou près d’une articulation sacro-iliaque Download PDF

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Publication number
WO2010065015A1
WO2010065015A1 PCT/US2008/013351 US2008013351W WO2010065015A1 WO 2010065015 A1 WO2010065015 A1 WO 2010065015A1 US 2008013351 W US2008013351 W US 2008013351W WO 2010065015 A1 WO2010065015 A1 WO 2010065015A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
stem
sacroiliac joint
joint
fixation
Prior art date
Application number
PCT/US2008/013351
Other languages
English (en)
Inventor
Mark A. Reiley
Original Assignee
Si-Bone, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Si-Bone, Inc. filed Critical Si-Bone, Inc.
Priority to PCT/US2008/013351 priority Critical patent/WO2010065015A1/fr
Priority to JP2011539482A priority patent/JP2012510852A/ja
Priority to EP08878635A priority patent/EP2367484A4/fr
Priority to CN2008801321905A priority patent/CN102238919A/zh
Priority to DE08878635T priority patent/DE08878635T8/de
Publication of WO2010065015A1 publication Critical patent/WO2010065015A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7055—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/866—Material or manufacture
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30261—Three-dimensional shapes parallelepipedal
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30273—Three-dimensional shapes pyramidal
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/3028—Three-dimensional shapes polyhedral different from parallelepipedal and pyramidal
    • 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
    • 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
    • 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
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • A61F2002/30995—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for sacro-iliac joints
    • 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
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • A61F2002/30996—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for sterno-clavicular joints
    • 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
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • A61F2002/30998—Other joints not covered by any of the groups A61F2/32 - A61F2/4425 for acromio-clavicular joints

Definitions

  • This application relates generally to the fixation of bone.
  • the invention provides bone fixation devices and related methods for stabilizing bone segments.
  • the systems and methods include a stem- like structure adapted for passage between adjacent bone segments. At least a portion of the stem- like structure includes a surface that enhances bony in- growth. Boney in- growth into the stem- like structure helps speed up the fusion process or fracture healing time.
  • At least one bone fixation device comprising a stem having a maximum outer diameter is inserted into the sacroiliac joint through a minimally invasive incision path sized approximately at or about the maximum outer diameter of the stem in soft tissue, into the iliac bone, across the sacroiliac joint and into the sacrum.
  • the stem is inserted through the incision path to a position within the sacroiliac joint between the iliac bone and the sacrum, to fuse the sacroiliac joint, without invasive joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint.
  • at least a portion of the stem includes a surface permitting bony in-growth.
  • Figure 1 is a perspective view of a bone fixation stem having a boney in-growth surface of a mesh configuration.
  • Figure 2 is a perspective view of an alternative embodiment of a bone fixation stem having a boney in-growth surface of a beaded configuration.
  • Figure 3 is a perspective view of an alternative embodiment of a bone fixation stem having a boney in-growth surface of a trabecular configuration.
  • Figure 4 is a schematic view of a bone fixation stem of the type shown in Fig. being inserted into bone across a fracture line or bone joint.
  • Figure 5 is a schematic view of a bone fixation stem positioned within bone and illustrating a boney in-growth surface of the stem extending across a fracture line or bone joint.
  • Figure 6 is a front plan view of an alternative embodiment of a bone fixation stem having a boney in-growth surface in which the stem has a conical configuration.
  • Figure 7 is front plan view of an alternative embodiment of a bone fixation stem having a boney in- growth surface in which the stem has a beveled distal tip.
  • Figures 8A and 8B are schematics illustrating the insertion of a conical bone fixation stem of the type shown in Fig. 6 to reduce the gap between bone segments.
  • Figure 9 is a schematic illustrating a guidewire being introduced into bone across bone segments .
  • Figure 10 is a schematic similar to Figure 9 and illustrating a drill bit being introduced over the guidewire .
  • Figure 11 is a schematic similar to Figure 10 and illustrating a bore formed in the bone remaining after withdrawal of the drill bit.
  • Figure 12 is a schematic similar to Figure 11 and illustrating insertion of a bone fixation stem into the pre- formed bore.
  • Figure 13 is an exploded front plan view illustrating the coupling of a pair of bone fixation stems by threaded engagement.
  • Figure 14 is a schematic illustrating a pair of bone fixation stems coupled together and inserted into bone across multiple bone segments.
  • Figure 15 is a front plan view illustrating passage of a bone fixation stem through a fenestration in another bone fixation stem.
  • Figure 16 is a schematic illustrating the placement of a series of bone fixation stems in bone.
  • Figure 17 is a lateral anterior anatomic view of bones in the hip region of the body, showing the iliac bones, the sacrum, and the sacroiliac joint therebetween.
  • Figure 18 is a posterior anatomic view of the hip region shown in Figure 17, showing the incision paths for inserting one or more bone fixation devices into the sacroiliac joint through soft tissue, into the iliac bone, across the sacroiliac joint and into the sacrum.
  • Figure 19 is a posterior anatomic view as shown in Fig. 18, after insertion of the one or more bone fixation devices into the sacroiliac joint, to fuse the sacroiliac joint.
  • Fig. 1 shows a device 10 sized and configured for the fixation of bone fractures or for the fixation of bones which are to be fused (arthrodesed) .
  • the device 10 comprises an elongated, stem-like structure.
  • the device 10 can be formed - e.g., by machining, molding, or extrusion - from a material usable in the prosthetic arts, including, but not limited to, titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, or any- other total joint replacement metal and/or ceramic, sintered glass, artificial bone, any uncemented metal or ceramic surface, or a combination thereof.
  • the device 10 may be formed from a suitable durable biologic material or a combination of metal and biologic material, such as a biocompatible bone-filling material.
  • the device 10 may be molded from a flowable biologic material, e.g., acrylic bone cement, that is cured, e.g., by UV light, to a non- flowable or solid material.
  • the device 10 can take various shapes and have various cross-sectional geometries.
  • the device 10 can have, e.g., a generally curvilinear (i.e., round or oval) cross-section, or a generally rectilinear cross section (i.e., square or rectangular) , or combinations thereof.
  • the device 10 can be conical or wedge shaped.
  • the structure 10 includes surface texturing 12 along at least a portion of its length to promote bony in-growth on its surface.
  • the surface texturing 12 can comprise, e.g., through holes, and/or various surface patterns, and/or various surface textures, and/or pores, or combinations thereof.
  • the device 10 can be coated or wrapped or surfaced treated to provide the surface texturing 12, or it can be formed from a material that itself inherently possesses a surface conducing to bony in-growth, such as a porous mesh, hydroxyapetite, or other porous surface.
  • the device 10 may further be covered with various other coatings such as antimicrobial, antithrombotic, and osteoinductive agents, or a combination thereof.
  • the surface texturing 12 may be impregnated with such agents, if desired.
  • Fig. 1 shows the surface 12 as an open mesh configuration
  • Fig. 2 shows the surface 12 as beaded configuration
  • Fig. 3 shows the surface 12 as a trabecular configuration. Any configuration conducive to bony in-growth will suffice.
  • the device 10 is inserted into a space between two adjacent bone surfaces, e.g., into a fracture site or between two bones (e.g., adjacent vertebral bodies) which are to be fused together.
  • Fig. 4 the device 10 is shown being tapped into bone through bone segments 14 (i.e., across a fracture line or between adjacent bones to be fused) with a tap 16.
  • the bone may be drilled first to facilitate insertion of the device 10.
  • the bony in-growth surface 12 along the surface of the device 10 accelerates bony in- growth into the device 10.
  • Boney in-growth into the device 10 helps speed up the fusion process or fracture healing time.
  • the bony in-growth surface 12 may cover the entire outer surface of the device 10, as shown in Fig. 4 , or the bony in-growth surface 12 may cover just a specified distance on either side of the joint surface or fracture line, as shown in Fig. 5.
  • the size and configuration of the device 10 can be varied to accommodate the type and location of the bone to be treated as well as individual anatomy.
  • the device 10 can be angled or tapered in a conical configuration.
  • the degree of angle can be varied to accommodate specific needs or individual anatomy.
  • a lesser degree of angle i.e., a more acute angle
  • the device 10 may also include a beveled distal tip 18 to further add in insertion of the device 10 into bone, as shown in Fig. 7.
  • the conical shape also helps drive the joint surfaces or fracture fragments together, reducing the gap (G) between the bone segments 14.
  • the device 10 is cannulated, having a central lumen or throughbore 20 extending through it, to assist in the placement of the device 10 within bone.
  • the physician can insert a conventional guide pin 22 through the bone segments 14 by conventional methods, as Fig. 9 shows.
  • a cannulated drill bit 24 can then be introduced over the guide pin 22, as seen in Fig. 10.
  • a single or multiple drill bits 24 can be employed to drill through bone fragments or bone surfaces to create a bore 26 of the desired size and configuration.
  • the drill bit 24 is sized and configured to create a conical bore 26 similar in size and configuration to the device 10.
  • the bore 26 is desirably sized and configured to permit tight engagement of the device 10 within the bore 26 and thereby restrict movement of the device 10 within the bore 26.
  • the pre-formed bore 26 may be slightly smaller than the device 10, while still allowing the device 10 to be secured into position within the bore 26 by tapping.
  • the drill bit 24 is then withdrawn.
  • the device 10 is then inserted into the bore 26 over the guide pin 22, as Fig. 12 shows.
  • the guide pin 22 is then withdrawn.
  • the device 10 itself can include screw- like threads along the body for screwing the device into place.
  • the device 10 be self -tapping.
  • the device 10 can be cannulated for use with a guide pin 22, or it need not be cannulated.
  • Multiple devices 10 may be employed to provide additional stabilization. While the use of multiple devices 10 will now be described illustrating the use of multiple devices 10 of the same size and configuration, it is contemplated that the devices 10 may also be of different size and/or configuration, e.g., one device 10 is of a cylindrical configuration and a second device 10 is of a conical configuration.
  • a series of devices 10 may be coupled together be any suitable means, e.g., by a snap fit engagement or a groove and tab key arrangement.
  • a series of devices 10 are coupled by threaded engagement.
  • a first device 1OA includes a recess 28 at one end providing a series of internal threads 30.
  • the first device 10 is of a cylindrical configuration, but may be of any desired configuration.
  • the internal threads 30 couple with a series of complementary external threads 32 on a second device 1OB of a similar or of a different configuration to couple the first and second devices 1OA and 1OB together.
  • the devices 1OA and 1OB are desirably coupled together prior to being inserted into the pre- formed bore 26.
  • the series of internal and external threads 30 and 32 provide an interlocking mechanism that permits a series of devices 10 to be stacked and connected to cover a larger area or multiple bone segments 14 (e.g., a bone having multiple fractures) and thereby provides additional stabilization, as seen in Fig. 14.
  • Fig. 15 illustrates another embodiment in which a device 10' includes an opening or fenestration 34 to allow another device 10 to pass through, thereby providing additional stabilization.
  • the fenestration 34 can be sized and configured to permit another device 10 to be passed through the device 10' at virtually any angle.
  • the fenestration 34 can also be sized and configured to limit movement of the second device 10 relative to the second device 10' .
  • the physician taps a first device 10' having a fenestration 34 through the bone segments.
  • a second device 10 is then inserted (e.g., by tapping) through the fenestration 34 of the first device 10' into place.
  • device 10' may also be adapted for coupling with another device 1OA (e.g., by a series of external and internal threads) , permitting the devices 10' and 1OA to be additionally stacked and connected, as also shown in Fig. 16.
  • Arthrodesis of the Sacroiliac Joint As shown in Fig. 17, the human hip girdle is made up of three large bones joined by three relatively- immobile joints. One of the bones is called the sacrum and it lies at the bottom of the lumbar spine, where it connects with the L5 vertebra. The other two bones are commonly called “hip bones” and are technically referred to as the right ilium and the left ilium. The sacrum connects with both hip bones at the sacroiliac (SI) joint .
  • SI sacroiliac
  • Sacroiliac joint fusion is typically indicated as a surgical treatment for degenerative sacroiliitis, inflammatory sacroiliitis, iatrogenic instability of the sacroiliac joint, osteitis condensans ilii, or traumatic fracture dislocation of the pelvis .
  • Figs. 18 and 19 show one or more devices 100, as previously described and shown, e.g., in Fig. 1, each of which is sized and configured for the fusion (arthrodesis) of the sacro-iliac joint.
  • each device 100 comprises an elongated, stem- like structure.
  • Each device 100 can be formed - e.g., by machining, molding, or extrusion - from a material usable in the prosthetic arts, including, but not limited to, titanium, titanium alloys, tantalum, chrome cobalt, surgical steel, or any other total joint replacement metal and/or ceramic, sintered glass, artificial bone, any uncemented metal or ceramic surface, or a combination thereof.
  • each device 100 may be formed from a suitable durable biologic material or a combination of metal and biologic material, such as a biocompatible bone-filling material.
  • the device 100 may be molded from a flowable biologic material, e.g., acrylic bone cement, that is cured, e.g., by UV light, to a non-flowable or solid material.
  • a given device 100 can take various shapes and have various cross-sectional geometries.
  • a given device 100 can have, e.g., a generally curvilinear (i.e., round or oval) cross-section, or a generally rectilinear cross section (i.e., square or rectangular) , or combinations thereof.
  • a given device 100 can be conical or wedge shaped.
  • the devices 100 used for a given arthrodesis can be of different sizes and shapes, depending upon the anatomic conditions encountered.
  • One or more of the devices 100 desirably includes surface texturing 120 along at least a portion of its length to promote bony in-growth on its surface, as previously described.
  • the surface texturing 120 can comprise, e.g., through holes, and/or various surface patterns, and/or various surface textures, and/or pores, or combinations thereof.
  • the device 100 can be coated or wrapped or surfaced treated to provide the surface texturing 120, or it can be formed from a material that itself inherently possesses a surface conducing to bony in-growth, such as a porous mesh, hydroxyapetite, or other porous surface.
  • the device 100 may further be covered with various other coatings such as antimicrobial, antithrombotic, and osteoinductive agents, or a combination thereof.
  • the surface texturing 120 may be impregnated with such agents, if desired.
  • One or more of the devices 100 are individually inserted in a minimally invasive fashion through an insertion path 140 in the soft tissue, into the respective iliac bone, across the respective sacroiliac joint and into the sacrum, as Figs. 18 and 19 show.
  • Conventional tissue access tools, obturators, cannulas, and/or drills can be used for this purpose.
  • No joint preparation, removal of cartilage, or scraping are required before formation of the insertion path or insertion of the device 100, so an minimally invasive insertion path sized approximately at or about the maximum outer diameter of the device 100 need be formed.
  • one to six, or perhaps eight, devices 100 might be needed, depending on the size of the patient and the size of the devices 100.
  • the described method comprises providing at least one device 100 comprising a stem having a maximum outer diameter.
  • the method creates a minimally invasive incision path sized approximately at or about the maximum outside diameter through soft tissue, into the iliac bone, across the sacroiliac joint and into the sacrum.
  • the method includes, without further joint preparation, removal of cartilage, or scraping at or near the sacroiliac joint, inserting the stem through the incision path to a position within the sacroiliac joint between the iliac bone and the sacrum, to fuse the sacroiliac joint.
  • at least a portion of the stem includes a surface permitting bony in-growth. After installation, the patient would be advised to prevent loading of the sacroiliac joint while fusion occurs.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne au moins un dispositif de fixation osseuse comprenant une tige ayant un diamètre externe maximal qui est insérée dans l’articulation sacro-iliaque par une voie d’incision mini-invasive dimensionnée approximativement ou environ au diamètre externe maximal de la tige dans un tissu mou, dans l’os iliaque, à travers l’articulation sacro-iliaque et dans le sacrum. La tige est insérée à travers la voie d’incision à une position dans l’articulation sacro-iliaque entre l’os iliaque et le sacrum, pour fusionner l’articulation sacro-iliaque, sans préparation d’articulation invasive, retrait de cartilage, ou raclage à ou à proximité de l’articulation sacro-iliaque. De manière souhaitable, au moins une partie de la tige comprend une surface permettant la croissance osseuse.
PCT/US2008/013351 2008-12-04 2008-12-04 Systèmes et procédés pour la fixation ou la fusion d’os à ou près d’une articulation sacro-iliaque WO2010065015A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/US2008/013351 WO2010065015A1 (fr) 2008-12-04 2008-12-04 Systèmes et procédés pour la fixation ou la fusion d’os à ou près d’une articulation sacro-iliaque
JP2011539482A JP2012510852A (ja) 2008-12-04 2008-12-04 仙腸関節または仙腸関節付近における骨の固定または癒着のためのシステムおよび方法
EP08878635A EP2367484A4 (fr) 2008-12-04 2008-12-04 Systèmes et procédés pour la fixation ou la fusion d os à ou près d une articulation sacro-iliaque
CN2008801321905A CN102238919A (zh) 2008-12-04 2008-12-04 用于在骶髂关节处或骶髂关节附近固定或融合骨的系统和方法
DE08878635T DE08878635T8 (de) 2008-12-04 2008-12-04 Systeme und verfahren zur fixierung oder fusion von knochen an dem oder in der nähe des sakroiliakalgelenks

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PCT/US2008/013351 WO2010065015A1 (fr) 2008-12-04 2008-12-04 Systèmes et procédés pour la fixation ou la fusion d’os à ou près d’une articulation sacro-iliaque

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US9149283B2 (en) 2010-11-03 2015-10-06 Zyga Technology, Inc. Sacroiliac fusion system
US9101371B2 (en) 2010-11-03 2015-08-11 Zyga Technology, Inc. Method of repairing sacroiliac fusion
US8900279B2 (en) 2011-06-09 2014-12-02 Zyga Technology, Inc. Bone screw
US9113972B2 (en) 2011-08-24 2015-08-25 Pioneer Surgical Technology, Inc. Apparatus and methods for immobilization and fusion of a synovial joint
US10314630B2 (en) 2011-08-24 2019-06-11 Pioneer Surgical Technology, Inc. Apparatus and methods for immobilization and fusion of a synovial joint
US11653962B2 (en) 2011-08-24 2023-05-23 Pioneer Surgical Technology, Inc. Apparatus for immobilization and fusion of a synovial joint
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JP2021045556A (ja) * 2012-05-04 2021-03-25 エスアイ−ボーン・インコーポレイテッドＳｉ−Ｂｏｎｅ， Ｉｎｃ． 有窓のインプラント
US11253302B2 (en) 2012-06-01 2022-02-22 Nuvasive, Inc. Systems and methods for promoting sacroiliac joint fusion
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JP2012510852A (ja) 2012-05-17
DE08878635T8 (de) 2013-04-25
CN102238919A (zh) 2011-11-09
EP2367484A1 (fr) 2011-09-28
DE08878635T1 (de) 2012-10-11
EP2367484A4 (fr) 2012-09-12

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