Implant with graded radiopacity calibration feature

Patent metadata

Field	Value
Publication number	US-11357645-B2
Application number	US-202016851857-A
Country	US
Kind code	B2
Filing date	Apr 17, 2020
Priority date	Apr 17, 2020
Publication date	Jun 14, 2022
Grant date	Jun 14, 2022

Abstract

An implant device for use in achieving spinal fusion, includes an implant having an implant body. The device includes a graded radiopacity calibration tool integrated with the implant body. The tool has a plurality of graded levels of radiopacity representative of a range of bone density parameter amounts. Each of the graded levels corresponds to a different bone density parameter amount. A method is provided that uses the device to determine a degree of one of bone maturity, strength, osteoporotic state, state of healing and state of degrading bone tissue based on a comparison of a bone at the site in the image and radiopacity correlated from a calibration standardized curve defined by the standard, with a range of grey levels representative of degrees of one of the bone maturity, the strength, the osteoporotic state, the state of healing and the state of degrading bone tissue.

First claim

What is claimed is:

1. An implant device for use in achieving spinal fusion, the implant device comprising:
an implant having an implant body; and
a graded radiopacity calibration tool integrated with the implant body and having a plurality of sequentially increasing graded levels of radiopacity representative of a range of bone density parameter amounts, each level corresponding to a different bone density parameter amount.

2. The implant device according to claim 1 , wherein:
a smallest graded level of radiopacity is configured to appear slightly more visible than a background density of an image captured by ionizing radiation; and
a largest graded level of radiopacity configured to appear as exceeding the range of the bone density parameter amounts.

3. The implant device according to claim 1 , wherein:
the graded radiopacity calibration tool is integrated into the implant body; and
the plurality of sequentially increasing graded levels of radiopacity are configured to represent a grey level scale of from white to black or dark grey, in response to ionizing radiation.

4. The implant device according to claim 1 , wherein the implant body is configured as one of a screw, intervertebral implant, a rod, a cross-brace, and a corpectomy device.

5. The implant device according to claim 1 , wherein grading the radiopacity of each graded level of radiopacity occurs on one or more surfaces of the implant body.

6. The implant device according to claim 1 , wherein the plurality of graded levels of radiopacity is made of composite materials, graded by material thickness to create a step wedge.

7. The implant device according to claim 6 , wherein the composite material comprises one of boron nitrite in polyether ether ketone (PEEK), Hydroxyapatite (HA) in PEEK, and osteoconductive PEEK, and composites of silicon nitride.

8. The implant device according to claim 1 , wherein the plurality of sequentially increasing graded levels of radiopacity comprises different thicknesses of radiopaque implant material, wherein each graded level corresponds to a different thickness.

9. The implant according to claim 8 , wherein the graded radiopacity calibration tool comprises one of titanium, titanium alloys, cobalt chromium, tantalum, stainless steel, or alloys.

10. The implant device according to claim 1 , wherein each level of the plurality of sequentially increasing graded levels of radiopacity comprises a radiopaque implant material having a different porosity.

11. The implant device of claim 1 , wherein:
the plurality of graded levels of radiopacity are configured, in response to ionizing radiation, to represent degrees of bone maturity, strength, osteoporotic state, state of healing, or state of degrading of bone tissue.

12. The implant device of claim 1 , wherein the implant body further comprises an orientation guide to denote an image plane for image calibration, in response to ionizing radiation.

13. A method of measuring fusion of adjacent boney structures, the method comprising:
capturing, in response to ionizing radiation generated by an imaging machine, an image of a fusion implant device at an implant site, the fusion implant device comprising:
a graded radiopacity calibration tool having a plurality of graded levels of radiopacity representative of a range of bone density parameter amounts, each level corresponding to a different one bone density parameter amount;
detecting, by a processor, a region of interest in the image, the region of interest including the fusion implant device and the plurality of graded levels of radiopacity in the image wherein the plurality of graded levels of radiopacity in the image configured to represent a grey level scale from white to black or dark grey, and
determining an extent of a fusion process at the implant site based on the plurality of graded levels of radiopacity in the image.

14. The method according to claim 13 , further comprising interpreting in the image fusion maturity in units of bone mineral density, bone mineral content, fusion status, fusion maturity, millimeters of calibration metal or houndsfield units.

15. The method according to claim 13 , wherein the grey level scale of from white to black or dark grey represent degrees of bone maturity, strength, osteoporotic state, state of healing or state of degrading bone tissue.

16. The method according to claim 13 , further comprising:
detecting, by the processor, a smallest graded level of radiopacity configured to appear slightly more than a background density in the image captured by ionizing radiation;
detecting, by the processor, a largest graded level of radiopacity configured to appear as exceeding the range of the bone density parameter amounts; and
determine a degree of one of bone maturity, strength, osteoporotic state, state of healing and state of degrading bone tissue based on a comparison of a bone at the site in the image and radiopacity correlated from a calibration standardized curve defined by a standard, with a range of grey levels representative of degrees of one of the bone maturity, the strength, the osteoporotic state, the state of healing and the state of degrading bone tissue.

17. The method according to claim 13 , further comprising:
digitizing, by a processor, the captured image; and
using a film densitometer to quantify the grey level scale in the captured image.

18. The method according to claim 17 , further comprising:
identifying a fused status threshold in the captured image based on the grey level scale.

19. The method according to claim 13 , further comprising:
digitizing, by a processor, the captured image into pixels;
reading the pixels in the captured image at the region of interest; and
generating a baseline of the grey level scale relative to one of the fusion implant device and the implant site.

20. The method according to claim 19 , wherein the image is a baseline image; and further comprising, after generating the baseline:
capturing, in response to ionizing radiation generated by the imaging machine, a second image of the fusion implant device at the implant site comprising the graded radiopacity calibration tool having the plurality of graded levels of radiopacity;
detecting, by the processor, the region of interest including the fusion implant device and the plurality of graded levels of radiopacity in the image representative of the grey level scale; and
comparing the grey level scale of the baseline image with the grey level scale of the second image.

21. The method according to claim 13 , wherein the implant device is configured as one of a screw, intervertebral implant, a rod, a cross-brace, and a corpectomy device.

22. The method according to claim 13 , wherein the grey level scale is represented in a step wedge.

Assignees

• Warsaw Orthopedic Inc

Inventors

• Boyce Todd
• Selders Gretchen S
• Morrison Matthew M

Classifications

• A61F2002/3008

  radio-opaque, e.g. radio-opaque markers · CPC title

• A61F2/4455 Primary

  for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442) · CPC title

• A61F2/4657 Primary

  Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06) · CPC title

• A61F2002/4661

  for measuring thickness · CPC title

• A61F2002/30056

  differing in radiographic density · CPC title