# US 12,004,961 B2 · Apparatus, systems, and methods for the fixation or fusion of bone

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- Number: US 12,004,961 B2
- Document ID: US12004961B2
- Status: Granted
- Kind: B2
- Application number: 16/930,174
- Filed: 2020-07-15
- Published: 2020-11-05
- Granted: 2024-06-11
- Earliest claimed: 2005-05-24
- Assignees: SI-Bone Inc.
- Applicants: SI-Bone Inc.
- Inventors: Mark A. Reiley
- Web page: https://patentgrep.com/patent/US12004961B2

## CPC

- A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section}
- A61B 17/1604: {Chisels; Rongeurs; Punches; Stamps}
- A61B 17/1615: {Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material}
- A61B 17/1659: {Surgical rasps, files, planes, or scrapers}
- A61B 17/1664: {for the hip}
- A61B 17/1671: {for the spine}
- A61B 17/68: Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)}
- A61B 17/7055: {connected to sacrum, pelvis or skull}
- A61B 17/7058: {Plates mounted on top of bone anchor heads or shoulders}
- A61B 17/844: {with expandable anchors or anchors having movable parts}
- A61B 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 17/866: {Material or manufacture}
- A61B 17/8685: {comprising multiple separate parts}
- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61F 2/446: {having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones}
- A61B 17/1637: {Hollow drills or saws producing a curved cut, e.g. cylindrical (A61B10/025, A61B17/1695 take precedence)}
- A61B 17/1757: {for the spine}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 2017/00889: {antimicrobial, disinfectant}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/28: Bones
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30156: {triangular}
- A61F 2002/30179: {X-shaped}
- A61F 2002/3023: {wedge-shaped cylinders}
- A61F 2002/30235: {tubular, e.g. sleeves}
- A61F 2002/30405: {made by screwing complementary threads machined on the parts themselves}
- A61F 2002/305: {Snap connection}
- A61F 2002/30576: {with extending fixation tabs}
- A61F 2002/30604: {modular}
- A61F 2002/30622: {Implant for fusing a joint or bone material}
- A61F 2002/30777: {Oblong apertures}
- A61F 2002/30785: {parallel}
- A61F 2002/30787: {inclined obliquely with respect to each other}
- A61F 2002/3082: {Grooves}
- A61F 2002/30841: {Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes}
- A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface}
- A61F 2002/30995: {for sacro-iliac joints}
- A61F 2002/4238: {for tarso-metatarsal joints, i.e. TMT joints}
- A61F 2002/448: {comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants}
- A61F 2210/0004: bioabsorbable
- A61F 2220/0025: Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F 2230/0023: triangular
- A61F 2230/0058: X-shaped
- A61F 2230/0069: cylindrical
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00131: Tantalum or Ta-based alloys
- A61F 2310/00179: Ceramics or ceramic-like structures
- A61F 2310/00329: Glasses, e.g. bioglass
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- A61F 2310/0097: Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
- 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 (dental prosthetics A61C)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Assemblies of one or more implant structures make possible the achievement of diverse interventions involving the fusion and/or stabilization of the SI-joint and/or lumbar and sacral vertebra in a non-invasive manner, with minimal incision, and without the necessitating the removing the intervertebral disc. The representative lumbar spine interventions, which can be performed on adults or children, include, but are not limited to, SI-joint fusion or fixation; lumbar interbody fusion; translaminar lumbar fusion; lumbar facet fusion; trans-iliac lumbar fusion; and the stabilization of a spondylolisthesis.

## Claims

### Claim 1

A method of fusing a bone joint, the method comprising:
identifying the bone joint to be fused, the bone joint comprising a first bone segment, a second bone segment, and a joint region located between the first and second bone segments;
providing an elongated bone fixation/fusion implant having a longitudinal axis along a direction of elongation, and having a plurality of cross-sectional profiles transverse to the longitudinal axis, each of the plurality of cross-sectional profiles encompassing an entire cross-section of the implant and being at least partially defined by a plurality of longitudinal apices;
inserting a distal end of the elongated implant in a direction along the longitudinal axis through the first bone segment, transversely across the joint region and at least partially into the second bone segment, wherein at least one of the plurality of cross-sectional profiles is completely surrounded by the first bone segment, and wherein at least one of the plurality of cross-sectional profiles is completely surrounded by the second bone segment; and
implanting the elongated implant across the bone joint by leaving the elongated implant in place across the bone joint postoperatively.

### Claim 2 (depends on 1)

The method of claim 1, further comprising creating a bore through the first bone segment, transversely across the joint region and at least partially into the second bone segment, wherein creating the bore occurs at a time before the inserting step.

### Claim 3 (depends on 2)

The method of claim 2, wherein the bore has the same shape as the elongated implant.

### Claim 4 (depends on 2)

The method of claim 2, further comprising, at a time after creating the bore and at a time before the inserting step, reshaping a profile of the bore.

### Claim 5 (depends on 1)

The method of claim 1, wherein the providing step comprises providing the elongated implant with a cross-sectional profile defined by three longitudinal apices.

### Claim 6 (depends on 1)

The method of claim 1, wherein the elongated implant is cannulated, having a central lumen extending therethrough to assist in the placement of the elongated implant within the bone segments.

### Claim 7 (depends on 6)

The method of claim 6, further comprising placing a guide pin into the first and second bone segments.

### Claim 8 (depends on 7)

The method of claim 7, further comprising introducing a cannulated drill bit over the guide pin to form an implant bore in the bone segments.

### Claim 9 (depends on 7)

The method of claim 7, wherein the inserting step comprises sliding the elongated implant over the guide pin.

### Claim 10 (depends on 9)

The method of claim 9, further comprising removing the guide pin from the bone segments after the elongated implant has been inserted into the bone segments.

### Claim 11 (depends on 1)

The method of claim 1, wherein the providing step comprises providing the elongated implant with the cross-sectional profile defined by exactly three longitudinal apices.

### Claim 12 (depends on 1)

The method of claim 1, wherein the elongated implant is cannulated, having a central lumen extending therethrough with an inside diameter matching a nominal outside diameter of a guide pin to assist in the placement of the elongated implant within the bone segments.

### Claim 13

A method of fusing a bone joint, the method comprising:
identifying the bone joint to be fused, the bone joint comprising a first bone segment, a second bone segment, and a joint region located between the first and second bone segments;
providing an elongated bone fixation/fusion implant having a cross-sectional profile defined by a plurality of longitudinal apices;
inserting a distal end of the elongated implant first through the first bone segment, then transversely across the joint region and then at least partially into the second bone segment; and
implanting the elongated implant across the bone joint by leaving the elongated implant in place across the bone joint postoperatively.