Invasive sense measurement in prosthesis installation and bone preparation

Patent metadata

Field	Value
Publication number	US-12102446-B2
Application number	US-202117238148-A
Country	US
Kind code	B2
Filing date	Apr 22, 2021
Priority date	Jan 11, 2016
Publication date	Oct 1, 2024
Grant date	Oct 1, 2024

Abstract

A system and method for allowing any surgeon, including those surgeons who perform a fewer number of a replacement procedure as compared to a more experienced surgeon who performs a greater number of procedures, to provide an improved likelihood of a favorable outcome approaching, if not exceeding, a likelihood of a favorable outcome as performed by a very experienced surgeon with the replacement procedure. Force sensing is included to aid in quantifying installation of an implant, particularly a cup into a pelvic bone.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

1. An apparatus for preparation of a cavity in a portion of bone for an insertion of a prosthesis, the prosthesis having a prosthesis profile, the cavity having a cavity profile with the cavity profile configured, responsive to the prosthesis profile, to retain the prosthesis within the cavity using a press fit fixation, comprising:
means for applying a bone preparation force to the portion of bone to form the cavity; and
means, for determining, responsive to said bone preparation force, a parametric evaluation of an estimated extractive force of an interface between the prosthesis, after an installation into the cavity, and the cavity.

2. The apparatus of claim 1 further comprising:
means for assessing a predicted quality of seatedness of the prosthesis within the cavity before the insertion of the prosthesis within the cavity.

3. The apparatus of claim 1 wherein said means for applying a bone preparation force includes a bone processing implement selected from the group consisting of a broach, an acetabular broach, a femoral broach, a humeral broach, or a broach for any long bone of a human anatomy.

4. The apparatus of claim 2 wherein said means for applying a bone preparation force includes a bone processing implement selected from the group consisting of a broach, an acetabular broach, a femoral broach, a humeral broach, or a broach for any long bone of a human anatomy.

5. The apparatus of claim 1 wherein said means for applying a bone preparation force includes a device and means for applying an applied force to said device; wherein said device includes a bone preparation implement operative at said interface; and wherein said means for determining a parametric evaluation includes means for measuring, responsive to an application of said applied force to said device, a measured force within said device wherein said measured force is responsive to operation of said bone preparation implement on the portion of bone at said interface responsive to said applied force.

6. The apparatus of claim 5 wherein said means for determining a parametric evaluation further includes means for comparing a magnitude of said applied force to a magnitude of said measured force.

7. An impact control system for preparing a cavity in a portion of bone for an insertion of a prosthesis, the prosthesis having a prosthesis profile, the cavity having a cavity profile with the cavity profile configured, responsive to the prosthesis profile, to retain the prosthesis within the cavity using a press fit fixation, comprising:
a) means for imparting a first initial known force to a bone preparation implement;
b) means for imparting a first subsequent known force to said bone preparation implement, said first subsequent known force about equal to said first initial force;
c) means for measuring, for each said imparted known force, an X th number impact force;
d) means for comparing said X th impact force to said X th-1 impact force against a predetermined threshold for a threshold test; and
e) means for repeating recitations b)-d) as long as said threshold test is negative.

8. The impact control system of claim 7 further comprising:
f) means for providing an indication when said threshold test is positive.

9. The impact control system of claim 7 further comprising:
f) means for imparting a second initial known force to said bone preparation implement, said second initial known force greater than said first initial known force;
g) means for imparting a second subsequent known force to said bone preparation implement, said second subsequent known force about equal to said second initial force;
h) means for measuring, for each said applied force, an Y th number impact force;
i) means for comparing said Y th impact force to said Y th-1 impact force against said predetermined threshold for a second threshold test; and
j) means for repeating recitations g)-i) as long as said second threshold test is negative.

10. The impact control system of claim 7 further comprising:
f) means for providing an indication when said threshold test is positive and X is less than or equal to three.

11. A system for automated bone preparation of a cavity in a portion of bone for an insertion of a prosthesis into the cavity, comprising:
a) means for initiating an application of a bone preparation force to the portion of bone, said bone preparation force including an energy removing bone from the portion of bone forming the cavity;
b) means for recording a set of measured response forces responsive to said bone preparation force;
c) means for continuing applying and recording until a difference in successive measured responses is within a predetermined threshold to estimate a magnitude of a displacement of the prosthesis at said energy when the prosthesis is subsequently installed into the cavity, said magnitude less than a predetermined threshold displacement;
d) means for increasing said energy;
e) means for repeating recitations b)-c) until a plateau of said set of said measured response forces; and
f) means for terminating recitations b)-e) when an immediate steady-state is detected.

12. The system of claim 11 wherein said bone preparation force includes a vibratory insertion force.

13. The system of claim 11 wherein said bone preparation force includes a periodic controlled impaction insertion force.

14. The system of claim 11 further including a robot and wherein said bone preparation force includes a continuous insertion force provided by said robot.

15. An impact control system for preparing a cavity in a portion of bone for inserting a prosthesis into the cavity, the prosthesis having a prosthesis profile, the cavity having a cavity profile with the cavity profile configured, responsive to the prosthesis profile, to retain the prosthesis within the cavity using a press fit fixation, comprising:
a) means for determining a series of theoretical estimated maximum impact forces applied to a bone preparation tool operating on the portion of bone;
b) means for determining, responsive to said series of theoretical estimated maximum impact forces, a series of measured impact forces in said bone preparation tool; and
c) means for estimating, responsive to said series of forces, a quality of a seatedness of the prosthesis within the cavity when the prosthesis is installed within the cavity.

16. The impact control system of claim 15 wherein said quality of seatedness includes a quality of fixation of the prosthesis within the cavity.

17. The impact control system of claim 15 wherein said quality of seatedness includes a quality of fracture risk of the prosthesis within the cavity.

18. The impact control system of claim 17 wherein said quality of seatedness includes a quality of fixation of the prosthesis within the cavity.

Assignees

• Behzadi Kambiz

Inventors

• Behzadi Kambiz

Classifications

• A61B2562/0261

  Strain gauges · CPC title

• A61B7/00

  Instruments for auscultation · CPC title

• A61F2/34

  Acetabular cups · CPC title

• A61F2/468

  Testing instruments for artificial joints (for testing non-implantable prostheses A61F2/76) · CPC title

• A61B5/11

  Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)} · CPC title