US20200069431A1 - Minimally invasive surgical systems for fusion of the sacroiliac joint - Google Patents

Minimally invasive surgical systems for fusion of the sacroiliac joint Download PDF

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Publication number
US20200069431A1
US20200069431A1 US16/312,866 US201716312866A US2020069431A1 US 20200069431 A1 US20200069431 A1 US 20200069431A1 US 201716312866 A US201716312866 A US 201716312866A US 2020069431 A1 US2020069431 A1 US 2020069431A1
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Prior art keywords
lateral surface
sifs
junction
arm
projections
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Abandoned
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US16/312,866
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Frank H. Boehm, Jr.
Gregory B. SHANKMAN
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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
    • A61F2/30988—Other joints not covered by any of the groups A61F2/32 - A61F2/4425
    • 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
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • 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
    • A61F2002/30135—
    • 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
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30136—Rounded shapes, e.g. with rounded corners undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
    • 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

Definitions

  • SIJ sacroiliac joint
  • measures such as chiropractic adjustments, massage, anti-inflammatory medications, and local injections.
  • patients who do not respond well to these measures, or in whom the response to other measures was merely transient, and in this setting fusion of the lumbar spine is often considered.
  • This is somewhat controversial; detractors of the procedure point to the fact that this joint is a fixed joint to begin with, and as such there is little movement naturally occurring.
  • Proponents suggest that even a minute amount of movement can cause symptoms, and point to the fact that this procedure was first performed many years ago and has been reliably performed since then with reasonable success. Fusion seems to resolve sacroiliac joint pain syndromes with a fairly high rate of success.
  • SIJ pain syndromes A common scenario for SIJ pain syndromes is in the post lumbar fusion patient, particularly patients who have undergone fusion of the L5-S1 segment. Such individuals have had motion eliminated at L5-S1 and are now believed to be passing increased stress along to the SIJ, much the same way that the so-called “adjacent disc disease” inflicts its pathophysiology. Such patients may be candidates for SIJ fusion.
  • a sacroiliac fusion stabilizer for fusing a first bone fracture fragment to a second bone fracture fragment.
  • the SIFS comprising: a first lateral surface having a first curvature; a second lateral surface, opposite the first lateral surface, having a second curvature; the first lateral surface being spaced from the second lateral surface by a depth that defines a first side and a second side; a cannulation that extends from the first side, through the SIFS and terminates at the second side; and the first curvature and the second curvature providing a lazy-S shape such that the first lateral surface contacts the second lateral surface at a first junction and a second junction, the first junction being disposed proximate the first lateral surface and the second junction being disposed proximate the second lateral surface.
  • a sacroiliac fusion stabilizer for fusing a first bone fracture fragment to a second bone fracture fragment.
  • the SIFS comprising at least a first arm and a second arm defined by: a first lateral surface having a first curvature; a second lateral surface, opposite the first lateral surface, having a second curvature; the first lateral surface being spaced from the second lateral surface by a depth that defines a first side and a second side; a cannulation that extends from the first side, through the SIFS and terminates at the second side; the first curvature and the second curvature providing a lazy-S shape such that the first lateral surface contacts the second lateral surface at a first junction and a second junction, the first junction being disposed proximate the first lateral surface to form the first arm and the second junction being disposed proximate the second lateral surface to form the second arm; the first junction providing a first plurality of projections, and the second junction providing
  • a sacroiliac fusion stabilizer for fusing a first bone fracture fragment to a second bone fracture fragment.
  • the SIFS comprising at least a first arm and a second arm defined by: a first lateral surface having a first curvature; a second lateral surface, opposite the first lateral surface, having a second curvature; the first lateral surface being spaced from the second lateral surface by a depth that defines a first side and a second side; a cannulation that extends from the first side, through the SIFS and terminates at the second side; the first curvature and the second curvature providing a lazy-S shape such that the first lateral surface contacts the second lateral surface at a first junction and a second junction, the first junction being disposed proximate the first lateral surface to form the first arm and the second junction being disposed proximate the second lateral surface to form the second arm; the first junction providing a first plurality of projections, and the second junction providing
  • FIG. 1 is a posterior view of a right sacroiliac joint with guide needles in position
  • FIG. 2 depicts a cannulated drill being disposed over the guide needle
  • FIG. 3 is a lateral view of a cannulated drill
  • FIG. 4 shows a receiving bed formed in the right sacroiliac joint
  • FIG. 5A is an elevational perspective view of one embodiment of the sacroiliac fusion stabilizer (SIFS);
  • FIG. 5B is an enlarged view of projections of the SIFS
  • FIG. 6 shows a SIFS after implantation and rotation
  • FIG. 7 depicts one embodiment of a SIFS that is oriented along the SI joint axis
  • FIG. 8 is a top view of another embodiment with four arms on the SIFS;
  • FIG. 9 demonstrates certain sites for placement of two SIFS units
  • FIG. 10 shows implantation of an alternative embodiment
  • FIG. 11 shows a SIFS placed into a pseudoarthrosis of a long bone
  • FIG. 12 depicts a view of a SIFS placed into the long bone.
  • This disclosure relates to the general field of spinal surgery and specifically to a device and method for use by which a surgeon can stabilize and fuse the sacroiliac joint using a minimally invasive technique.
  • the same technique can be applied to sites of non-healing fractures at other sites.
  • the disclosed device and method fuses the sacroiliac joint using a minimally invasive technique. Once the joint is identified, a guide needle is passed into the joint and the position of the needle is confirmed. A cannulated drill is then disposed over the needle, and advanced until the drill is at the level of the joint. The drill is then activated and a receiving bed is cored out.
  • a sacroiliac fusion stabilizer (SIFS) is then disposed over the needle and passed into the joint at the level of the receiving bed.
  • the SIFS is then rotated a partial turn and projections of the SIFS engage the bone and lock the SIFS into position.
  • the SIFS is then filled with bone fusion substrate.
  • the SIFS can also be utilized in the setting of non-healing fractures at other sites.
  • the SIFS is implanted into the sacroiliac joint to provide stabilization and promote fusion.
  • FIG. 1 a posterior view of the right sacroiliac joint is shown. Superior guide needle 11 and inferior guide needle 12 have been inserted into respective target joint spaces. This may be done under radiological guidance. For example, the procedure may be performed under X-rays, CAT scanning, MRI scanning, or any other acceptable imaging techniques. The sacroiliac joint is then identified.
  • a cannulated drill is disposed over the superior guide needle 11 and inferior guide needle 12 and cores out a receiving bed for the SIFS.
  • FIG. 2 in which a cannulated drill 8 is passing over both the superior guide needle 11 and inferior guide needle 12 .
  • a lateral view of one cannulated drill 8 is provided in FIG. 3 .
  • the cannulated drill 8 is provided with a leading end 9 which provides a cutting blade of the cannulated drill 8 .
  • a shaft 10 is connected to either a manual actuator or a power-driven actuator which is powered by a pneumatic, electric, or other power source which is known in the art.
  • a receiving bed 13 is cored out for implantation of the SIFS as shown in FIG. 4 .
  • the receiving bed 13 is seen centered over the sacroiliac joint.
  • the receiving bed 13 is coextensive with both the sacrum and the ilium thus encouraging fusion of the SIJ.
  • the SIFS is positioned initially with the long axis of the SIFS being parallel to the long axis of the SIJ.
  • the SIFS is then rotated a quarter of a turn, at which point projections engage the bone of the sacrum and the ilium, thus bridging the joint and promoting fusion.
  • Additional bone can be packed around the SIFS.
  • Other media, such as BMP, can be utilized instead of the additional bone.
  • a similar procedure is utilized when implanting the SIFS into the site of a fracture with a non-union.
  • the non-union would be radiographically identified, and after anesthesia is established, a needle would be passed into the site of the non-union. Then a small incision would be accomplished, and the drill is disposed over the non-union.
  • the SIFS is filled with bone and implanted using the technique described above.
  • the SIFS is disposed over the guide needle and rotated approximately one-quarter turn (90°) to lock projections at the lateral ends of the SIFS into the bone of the receiving bed. Additional bone can be packed around the SIFS.
  • FIG. 5A depicts an elevational perspective view a SIFS 1 .
  • Multiple fenestrations 4 are seen in the frame of the SIFS 1 and these are deigned to permit bony growth to be incorporated through the body of the SIFS 1 .
  • a leading end of the SIFS 1 has been provided with multiple projections 5 which engages the bone, stabilizes the construct and promotes bony growth.
  • the large surface area of the SIFS 1 encourages increased bone growth in the area.
  • the SIFS 501 has a first lateral surface 504 and a second lateral surface 506 separated by a depth 508 that defines a first side 510 and a second side 512 .
  • the first lateral surface 504 and the second lateral surface 506 have curvatures that produce the lazy-S shape such that the first lateral surface 504 contacts the second lateral surface 506 at a first junction 514 and a second junction 516 .
  • the first junction 514 is proximate the first lateral surface 504 and the second junction 516 is proximate the second lateral surface 506 .
  • the SIFS 1 is multi-curvilinear in configuration, substantially configured to be shaped like a “Lazy-S” in its appearance.
  • the SIFS 1 has a central portion, being tapered to a point along its superior and inferior edges.
  • the central portion is provided with a central chamber which is hollow. This central chamber may be filled with fusion substrate to promote in-growth of fusion mass through the SIFS 1 and from the ilium to the sacrum.
  • the leading end is that portion of the device which is initially placed into the receiving bed.
  • the leading end is slightly tapered in contrast to the trailing end, but any geometric configuration is within the spirit and scope of the invention.
  • a tapered leading end is more easily implanted within a receiving bed which has been drilled out.
  • a prominent feature along the broad lateral surface of the SIFS 1 is the presence of multiple fenestrations 4 , which communicate with the central chamber. Furthermore, the fenestrations 4 are present on both sides of the SIFS 1 and communicate with each other through the central channel. This presents a large surface area to the SIFS 1 and promotes bony fusion to extend through the central portion. This also promotes bony fusion in the setting of non-healing fractures.
  • the projections 5 are extending from the lateral edges of the SIFS 1 .
  • the projections 5 are slightly curved as viewed from the top view, conforming to and aligning with the curvature created by the tapered ends of the “Lazy S” configuration of the SIFS 1 .
  • These curved projections 5 designed to be implanted into a receiving bed.
  • the projections 5 contribute significantly to the overall function and purpose of the SIFS 1 .
  • the projections 5 are somewhat eccentric in their orientation. Referring to FIG. 5A , the projections 5 include a proximate projection 5 A and a distal projection 5 B, with the proximate projection 5 A being that end of the projections which engages the bone initially during insertional rotation.
  • the eccentric orientation of the projection 5 is such that the distal projection 5 B is slightly closer to the cannulation 3 of the SIFS 1 while the proximate projection 5 A is closer to the cannulation 3 of the SIFS 1 (distance 500 is greater than distance 502 ).
  • these projections 5 function very much the same as the threading of a screw.
  • the function of the projections 5 is to secure the SIFS into the target area of the bone, so any embodiment of these projections which achieves that end is acceptable.
  • the curved projections 5 are configured such that a concave end of the curved projections 5 is the leading end during insertional rotation. This is generally accomplished with rotation of the SIFS during insertion; hence, as viewed from the top view, this would be accomplished with rotation to the viewer's right. Therefore, again as viewed from the top view, the concave surface of the superior projection would be located on the right side of the projection and the convex surface would be on the left. This arrangement would be reversed on the inferior projection. However, other configurations of such a projection would be within the spirit and scope of this application.
  • the SIFS is positioned into the receiving bed and rotated at least one-quarter turn in order to be locked into place.
  • the SIFS may be gently rotated in a clockwise or counter-clockwise direction.
  • these projections 5 are of equal size.
  • the projects 5 may be more robust at the trailing end of the device.
  • the SIFS is slightly larger than the receiving bed which has been drilled out. In this way, the SIFS can be secured into the bed with the projections 5 securely engaging the bone, and the SIFS being somewhat compressed in its final position. This will promote bony fusion.
  • FIG. 6 is a close-up of the implanted SIFS 1 within the right sided sacroiliac joint.
  • the projections 5 can be seen engaging the bone of the ilium.
  • Fenestrations 4 in the SIFS 1 promote bone fusion.
  • the SIFS 1 can also be oriented along the course of the sacroiliac joint as seen in FIG. 7 .
  • FIG. 8 demonstrates the top view of an alternative embodiment of a SIFS 6 in which there are four arms 7 rather than two such that the overall embodiment resembles an “X shape” rather than a “Lazy S” as viewed from the top perspective.
  • the SIFS 6 comprises a first arm 801 and a second arm 802 . These arms provide a lazy-S shape as described with regard to SIFS 1 .
  • the SIFTS 6 comprises a third arm 803 and a fourth arm 804 that provides a second lazy-S shape.
  • the SIFS 6 consists of four arms with two overlapping lazy-S shapes.
  • the SIFS 1 consists of two arms with a single lazy-S shape.
  • At least two SIFS devices are used to stabilize and fuse the SIJ and, in some instances, three SIFS may be used. This is a decision left to the judgment of the surgeon.
  • a pair of SIFS 1 has been disposed over the respective guide needles and into the receiving bed.
  • FIG. 10 demonstrates an alternative embodiment of the SIFS 6 which has been provided with four arms, and is secured into the sacroiliac joint with two arms 14 engaging the sacrum and two arms 15 engaging the ilium.
  • the SIFS could also be utilized to treat fracture sites which suffer from non-union.
  • a non-union site is pictured with an SIFS having been placed in between the bone fracture fragments 16 , 17 . Because the projections 5 engage the bone, the site is stabilized and bone fusion is promoted.
  • all implanted components of the sacroiliac stabilizer may be fabricated from surgical titanium.
  • stainless steel, molybdenum, other metal alloys such as chromium containing alloys, Nitinol, ceramic, porcelain, composite, polyesters, or any other substance known or acceptable to the art.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
US16/312,866 2016-06-23 2017-06-23 Minimally invasive surgical systems for fusion of the sacroiliac joint Abandoned US20200069431A1 (en)

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US16/312,866 US20200069431A1 (en) 2016-06-23 2017-06-23 Minimally invasive surgical systems for fusion of the sacroiliac joint

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US201662353828P 2016-06-23 2016-06-23
US16/312,866 US20200069431A1 (en) 2016-06-23 2017-06-23 Minimally invasive surgical systems for fusion of the sacroiliac joint
PCT/US2017/039007 WO2017223454A1 (fr) 2016-06-23 2017-06-23 Système minimalement invasifs de fusion de l'articulation sacro-iliaque.

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US11672664B2 (en) 2012-03-09 2023-06-13 Si-Bone Inc. Systems, devices, and methods for joint fusion
US11678997B2 (en) 2019-02-14 2023-06-20 Si-Bone Inc. Implants for spinal fixation and or fusion
US11752011B2 (en) 2020-12-09 2023-09-12 Si-Bone Inc. Sacro-iliac joint stabilizing implants and methods of implantation
US11877756B2 (en) 2017-09-26 2024-01-23 Si-Bone Inc. Systems and methods for decorticating the sacroiliac joint

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US11273043B1 (en) 2018-06-15 2022-03-15 Advance Research System, Llc System and method for fusion of sacroiliac joint

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US11672664B2 (en) 2012-03-09 2023-06-13 Si-Bone Inc. Systems, devices, and methods for joint fusion
US11877756B2 (en) 2017-09-26 2024-01-23 Si-Bone Inc. Systems and methods for decorticating the sacroiliac joint
US11678997B2 (en) 2019-02-14 2023-06-20 Si-Bone Inc. Implants for spinal fixation and or fusion
US11752011B2 (en) 2020-12-09 2023-09-12 Si-Bone Inc. Sacro-iliac joint stabilizing implants and methods of implantation

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EP3500218A4 (fr) 2020-06-03
CN110114041A (zh) 2019-08-09
EP3500218B1 (fr) 2021-10-13
CN110114041B (zh) 2022-02-25
US11944548B2 (en) 2024-04-02
US20220110754A1 (en) 2022-04-14
EP3500218A1 (fr) 2019-06-26
WO2017223454A1 (fr) 2017-12-28

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