# US 11,992,409 B2 · Implant for bone segment fusion

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- Number: US 11,992,409 B2
- Document ID: US11992409B2
- Status: Granted
- Kind: B2
- Application number: 17/171,103
- Filed: 2021-02-09
- Published: 2021-07-01
- Granted: 2024-05-28
- Earliest claimed: 2019-02-21
- Assignees: Statford Sacroiliac Implant, LLC
- Applicants: Anjali Investments LLC
- Inventors: Amit R. Patel
- Web page: https://patentgrep.com/patent/US11992409B2

## CPC

- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- A61B 17/7032: {Screws or hooks with U-shaped head or back through which longitudinal rods pass}
- A61B 17/7055: {connected to sacrum, pelvis or skull}
- A61B 17/7098: {wherein the implant is permeable or has openings, e.g. fenestrated screw (hollow surgical screws A61B17/864)}
- A61B 17/863: {with thread interrupted or changing its form along shank, other than constant taper}
- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 17/8645: {Headless screws, e.g. ligament interference screws}
- A61B 17/866: {Material or manufacture}
- A61F 2/30988: {Other joints not covered by any of the groups A61F2/32 - A61F2/4425}
- A61L 27/06: Titanium or titanium alloys
- A61L 27/32: Phosphorus-containing materials, e.g. apatite
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- C22C 14/00: Alloys based on titanium
- C22C 27/02: Alloys based on vanadium, niobium, or tantalum
- A61B 17/8615: {at the central region of the screw head}
- A61B 17/8635: {Tips of screws}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30622: {Implant for fusing a joint or bone material}
- A61F 2002/30777: {Oblong apertures}
- A61F 2002/3085: {with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface}
- A61F 2002/30863: {the entry end surface having flutes, relief grooves, starter notches or bevelled indentations}
- A61F 2002/30886: {externally-threaded}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/30995: {for sacro-iliac joints}
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00131: Tantalum or Ta-based alloys
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C22C: ALLOYS (treatment of alloys C21D, C22F)

## Abstract

A bone screw implant is provided for immobilizing the articular surfaces of two bone segments by securing, fusing, or compression the two segments. The implant may be fabricated from a porous biocompatible metal and have a cylindrical shape and fully or partially threaded and may have variable pitch threads and a variable diameter of the shaft. The implant may include a blunt tip or a fluted self-drilling tip and a headless screwdriver socket. Large pitch cancellous threads may be in the leading-end portion of the cylinder shaft, and smaller pitch cortical threads may be at the trailing edge portion of the shaft. The implant may be fenestrated, it may have a roughened surface, and it may be coated with an osteoconductive material. The implant may be cannulated. In a specific embodiment, the implant is used for immobilizing the articular surfaces of a sacroiliac joint. The implant may be coated with hydroxyapatite or tricalcium phosphate at thickness of 100 nm to 100 μm thick.

## Claims

### Claim 1

An implant for bone fusion or fixation, comprising:
a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to the bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 μm and a porosity of 60-65%;
b. wherein the cylinder comprises a shaft, wherein the shaft (120) of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm;
c. wherein the implant has a distal section (122) with a distal end (125);
d. wherein the implant has a headless proximal section (123) and a proximal end (150) having a socket (152) for attachment to a tool that can rotate to screw the implant into place;
e. wherein the implant is threaded with large pitch cancellous helical threads (142) on a portion of the shaft (120), or smaller pitch cortical helical threads (144) on a portion of shaft (123), or wherein the implant has uniform threads (FIG. 12, 142);
f. wherein the implant has at least one fenestration (160) penetrating through the body of the implant latitudinally;
g. wherein the implant is surface treated to have a roughened surface; and
h. wherein the implant is coated with hydroxyapatite (HA) or tricalcium phosphate (TCP) or both wherein the coating is 100 nm to 100 μm thick.

### Claim 2 (depends on 1)

The implant according to claim 1, further comprising threads along the entire length of the implant.

### Claim 3 (depends on 1)

The implant according to claim 1, further comprising a central section having no threads on the shaft.

### Claim 4 (depends on 1)

The implant according to claim 1, wherein the implant has large pitch cancellous helical threads (142) on the shaft on a portion of the distal section, and smaller pitch cortical helical threads (144) on the shaft on a portion of the proximal section.

### Claim 5 (depends on 1)

The implant according to claim 1, wherein the distal section has large pitch cancellous threads, the proximal section has smaller pitch cortical threads, and the proximal section has a flare.

### Claim 6 (depends on 1)

The implant according to claim 1, wherein the shaft in the section with cancellous threads (122) has a smaller diameter than the diameter of the shaft in the section with the cortical threads (123), and wherein the maximum diameter of the cancellous threads are slightly smaller than the maximum diameter of the cortical threads.

### Claim 7 (depends on 1)

The implant according to claim 1, wherein the implant has a channel (134) through the longitudinal axis with openings at the distal end (130) and proximal end (132) for accepting a guidewire.

### Claim 8 (depends on 1)

The implant according to claim 1, wherein the porous titanium or tantalum metal or alloy has pore sizes of 300 to 400 μm.

### Claim 9 (depends on 1)

The implant according to claim 1, wherein the porous titanium or tantalum metal or alloy has a pore size of 600 μm.

### Claim 10 (depends on 1)

The implant according to claim 1, wherein the implant has internal threads (170) for the attachment of an additional device.

### Claim 11 (depends on 1)

The implant according to claim 1, wherein the distal end comprises a self-drilling tip (126) with one or more teeth (127).

### Claim 12 (depends on 1)

The implant according to claim 1, wherein the distal end comprises a blunt tip (129).

### Claim 13 (depends on 1)

The implant according to claim 1, wherein the implant is used to immobilize the articular surfaces of a sacroiliac joint.

### Claim 14

A fusion or fixation implant for immobilizing the articular surfaces of a joint or segment of bone or fracture comprising:
a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to the bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 μm and a porosity of 60-65%;
b. wherein the cylinder comprises a shaft, wherein the shaft of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm;
c. wherein the implant has a distal section with a fluted distal end (125);
d. wherein the implant has a flared headless proximal section (123) and a proximal end (152) having a socket (152) for attachment to a tool that can rotate to screw the implant into place;
e. wherein the implant is fully threaded with large pitch cancellous helical threads (142) on the shaft on a portion of the distal section, and smaller pitch cortical helical threads (144) on the shaft on a portion of the proximal section;
f. wherein the implant has a central channel (134) longitudinally spanning the entire length;
g. wherein a set of secondary female threads (170) is in the central channel adjacent to the socket in the proximal end;
h. wherein the implant has one or more fenestrations (160);
i. wherein the implant is surface treated to have a roughened surface; and
j. wherein the implant is coated with hydroxyapatite (HA) or tricalcium phosphate (TCP) or both wherein the coating is 100 nm to 100 μm thick.

### Claim 15

A fusion or fixation implant for immobilizing the articular surfaces of a joint or segment of bone or fracture comprising:
a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 μm and a porosity of 60-65%;
b. wherein the cylinder comprises a shaft, wherein the shaft of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm;
c. wherein the implant has a distal section with a distal end with a rounded tip;
d. wherein the implant has a headless proximal section and a proximal end having a socket for attachment to a tool that can rotate to screw the implant into place;
e. wherein the implant has uniform cortical helical threads on the entire length of the shaft;
f. wherein the implant has a channel through the center with openings at the distal end and proximal end for accepting a guidewire;
g. wherein the implant has one or more fenestrations;
h. wherein the implant is surface treated to have a roughened surface; and
i. wherein the implant is coated with hydroxyapatite (HA) or tricalcium phosphate (TCP) or both wherein the coating is 100 nm to 100 μm thick.

### Claim 16 (depends on 10)

The implant of claim 10, wherein a feature with male threads is screwed into the internal female threads (170), wherein the feature is selected from a pedicle screw, an extractor, an inserter, or a cap for the proximal end.

### Claim 17 (depends on 14)

The implant of claim 14, wherein a feature with male threads is screwed into the internal female threads (170), wherein the feature is selected from a pedicle screw, an extractor, an inserter, or a cap for the proximal end.

### Claim 18 (depends on 1)

The implant of claim 1, wherein the coating is HA and is applied with a sol-gel dipping method, comprising forming a precursor gel by hydrolysis and condensation of calcium and phosphate precursors in a solution water or ethanol or a combination thereof; dipping an implant into the solution to uniformly coat all surfaces of the implant with the solution, drying the implant, and sintering the implant at 460° C. to 750° C., such that the pores of the implant are not clogged by the completed HA coating.

### Claim 19 (depends on 14)

The implant of claim 14, wherein the coating is HA and is applied with a sol-gel dipping method, comprising forming a precursor gel by hydrolysis and condensation of calcium and phosphate precursors in a solution water or ethanol or a combination thereof; dipping an implant into the solution to uniformly coat all surfaces of the implant with the solution, drying the implant, and sintering the implant at 460° C. to 750° C., such that the pores of the implant are not clogged by the completed HA coating.

### Claim 20 (depends on 15)

The implant of claim 15, wherein the coating is HA and is applied with a sol-gel dipping method, comprising forming a precursor gel by hydrolysis and condensation of calcium and phosphate precursors in a solution water or ethanol or a combination thereof; dipping an implant into the solution to uniformly coat all surfaces of the implant with the solution, drying the implant, and sintering the implant at 460° C. to 750° C., such that the pores of the implant are not clogged by the completed HA coating.
