# US 8,751,198 B2 · Variable stiffness stem for prosthetic implants

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- Number: US 8,751,198 B2
- Document ID: US8751198B2
- Status: Granted
- Kind: B2
- Application number: 12/442,326
- Filed: 2007-09-20
- Published: 2010-05-27
- Granted: 2014-06-10
- Earliest claimed: 2006-09-20
- Assignees: Smith & Nephew, Inc.
- Applicants: David C. Kelman; Michael A. Croxton; Charles Wayne Allen; William L. Waltersdorff
- Inventors: David C. Kelman; Michael A. Croxton; Charles Wayne Allen; William L. Waltersdorff
- Web page: https://patentgrep.com/patent/US8751198B2

## CPC

- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/36: Femoral heads {; Femoral endoprostheses}
- A61F 2/367: {Proximal or metaphyseal parts of shafts (trochanteric devices connected to said proximal parts A61F2/30739)}
- A61F 2/3676: {Distal or diaphyseal parts of shafts}
- A61F 2/38: for elbows or knees
- A61F 2/40: for shoulders
- A61F 2002/30014: {differing in elasticity, stiffness or compressibility}
- A61F 2002/30171: {rosette- or star-shaped}
- A61F 2002/30322: {differing in surface structures}
- A61F 2002/30327: {differing in diameter}
- A61F 2002/30827: {Plurality of grooves}
- A61F 2002/30879: {Ribs}
- A61F 2002/30891: {Plurality of protrusions}
- A61F 2002/30943: {using mathematical models}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2002/3625: {Necks}
- A61F 2002/365: {Connections of heads to necks}
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/002: differing in moment of inertia
- A61F 2250/0026: differing in surface structures
- A61F 2250/0029: differing in bending or flexure capacity
- A61F 2250/0039: differing in diameter
- 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: 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)

## Abstract

A method for forming an implant for a bone including the steps of generating a first general shape for the implant having a length extending along a long axis of the bone, determining an area moment of inertia of a cross section of the implant, determining an area moment of inertia for a cross section of bone coplanar to the cross section of the implant, calculating a percent stress shielding from the area moments of inertia of the implant and the bone, comparing the calculated percent stress shielding to a preset threshold, and iteratively generating additional general shapes for the implant by locally adjusting the cross section of the implant until the calculated percent stress shielding meets the preset threshold.

## Claims

### Claim 1

A method for forming an implant for a bone, comprising the steps of:
generating a first general shape for the implant having a length extending along a long axis of the bone;
determining an area moment of inertia of a cross section of the implant, wherein the area moment of inertia of the cross section of the implant is calculated using a computer-aided design module;
determining an area moment of inertia of a cross section of bone coplanar to the cross section of the implant, wherein the area moment of inertia of the cross section of bone coplanar to the cross section of the implant is calculated using the computer-aided design module;
calculating a percent stress shielding from the area moments of inertia of the implant and the bone;
comparing the calculated percent stress shielding to a preset threshold; and
iteratively generating additional general shapes for the implant by locally adjusting the cross section of the implant until the calculated percent stress shielding meets the preset threshold, wherein the locally adjusting of the cross section of the implant comprises adjusting local stiffness of the implant based on combined stiffness of an implant and bone composite at the cross section of the implant to minimize stress shielding of the bone such that bone loss from the stress shielding may be lessened.

### Claim 2 (depends on 1)

The method of claim 1, wherein the determining an area moment of inertia for a cross section of bone is determined from radiographic information of the bone.

### Claim 3 (depends on 1)

The method of claim 1, further comprising the step of setting a modulus of elasticity of the implant and a modulus of elasticity of the bone.

### Claim 4 (depends on 3)

The method of claim 3, wherein the modulus of elasticity of the bone is calculated from the quality of the bone.

### Claim 5 (depends on 4)

The method of claim 4, wherein the quality of bone is calculated from radiographic information.

### Claim 6 (depends on 1)

The method of claim 1, further comprising the step of iteratively performing the determining steps, the calculating step, the comparing step and the iteratively generating additional general shapes step along the length of the implant.

### Claim 7 (depends on 6)

The method of claim 6, wherein the iteratively performing step is performed at positions equally spaced from one another.

### Claim 8 (depends on 6)

The method of claim 6, wherein the iteratively performing step is performed incrementally closer to adjacent cross sections when the cross section of the implant along the length of the implant changes.

### Claim 9 (depends on 6)

The method of claim 6, wherein the iteratively performing step is performed incrementally closer to adjacent cross sections when the cross section of the bone along the length of the implant changes.

### Claim 10 (depends on 6)

The method of claim 6, wherein the iteratively performing step is performed incrementally closer to adjacent cross sections when the quality of the bone along the length of the implant changes.

### Claim 11 (depends on 1)

The method of claim 1, further comprising the step of forming a prosthetic implant having a locally adjusted cross section wherein the calculated percent stress shielding meets the preset threshold; and
implanting the prosthetic implant in the bone.

### Claim 12 (depends on 1)

The method of claim 1, wherein the locally adjusting of the cross section of the implant results in minimizing stress shielding of the bone surrounding the implant when the implant is implanted in the bone.

### Claim 13 (depends on 1)

The method of claim 1, wherein the locally adjusting of the cross section of the implant comprises altering geometry of the implant to reduce load transferring between the bone and the implant.

### Claim 14 (depends on 1)

The method of claim 1, wherein the locally adjusting of the cross section of the implant comprises altering geometry of the implant to a stiffness that does not ignore added stiffness of the bone surrounding the implant to reduce load transferring between the bone and the implant.

### Claim 15 (depends on 1)

The method of claim 1, wherein the percentage stress shielding is calculated using the equation:
Percentage Stress Shielding=[1−(1/(1+N(IIZIB)))]*100;
where N=ratio of modulus of elasticity=Eimplant/Ebone,
II=area moment of inertia of implant, and
IB=area moment of inertia of bone.

### Claim 16

A method for forming an implant for a bone, comprising the steps of:
generating a first general shape for the implant having a length extending along a long axis of the bone;
determining an area moment of inertia of a cross section of the implant, wherein the area moment of inertia of the cross section of the implant is calculated using a computer-aided design module;
determining an area moment of inertia of a cross section of bone coplanar to the cross section of the implant, wherein the area moment of inertia of the cross section of bone coplanar to the cross section of the implant is calculated using the computer-aided design module;
calculating a percent stress shielding from the area moments of inertia of the implant and the bone;
comparing the calculated percent stress shielding to a preset threshold; and
iteratively generating additional general shapes for the implant by locally adjusting the cross section of the implant until the calculated percent stress shielding meets the preset threshold; and
wherein the percentage stress shielding is calculated using the equation:
Percentage Stress Shielding=[1−(1/(1+N(IIZIB)))]*100;
where N=ratio of modulus of elasticity=Eimplant/Ebone,
II=area moment of inertia of implant, and
IB=area moment of inertia of bone.

### Claim 17

A system for creating an implant for implantation in a bone, comprising:
a computer-aided design module;
an initial representation of an implant member having an implant length configured to extend along the length of the bone, the implant member having cross sections along the implant length, the cross sections each having an area moment of inertia, wherein the area moment of inertia of the cross sections of the implant member are calculated by the computer-aided design module;
bone information relating to the quality and dimensions of the bone, the bone information providing an area moment of inertia for a cross section of bone coplanar to a corresponding one of the cross sections of the implant member, wherein the area moment of inertia of the cross section of bone coplanar to the corresponding one of the cross sections of the implant member is calculated by the computer-aided design module, wherein a percent stress shielding using the area moment of inertia of the cross sections of the implant member and the area moment of inertia of the cross section of the bone coplanar to the corresponding one of the cross sections of the implant member is calculated and compared to a preset threshold, wherein the percentage stress shielding is calculated using the equation:
Percentage Stress Shielding=[1−(1/(1+N(IIZIB)))]*100;
where N=ratio of modulus of elasticity=Eimplant/Ebone,
II=area moment of inertia of implant, and
IB=area moment of inertia of bone; and
an iterative representation of an implant member generated by locally adjusting the corresponding one of the cross sections of the implant member until the calculated percent stress shielding meets the preset threshold whereby the initial representation is changed to the iterative representation.

### Claim 18 (depends on 17)

The system of claim 17, wherein the bone information is determined from radiographic information of the bone.

### Claim 19 (depends on 17)

The system of claim 17, wherein the initial representation further comprises the modulus of elasticity of the implant member and the bone information comprises the modulus of elasticity of the bone.

### Claim 20 (depends on 19)

The system of claim 19, wherein the modulus of elasticity of the bone is calculated from the quality of the bone.

### Claim 21 (depends on 20)

The system of claim 20, wherein the quality of bone is calculated from radiographic information.

### Claim 22 (depends on 17)

The system of claim 17, further comprising additional cross sections of the implant member along the length of the bone.

### Claim 23 (depends on 17)

The system of claim 17, wherein the additional cross sections are positioned equally spaced from one another.

### Claim 24 (depends on 22)

The system of claim 22, wherein the additional cross sections are positioned incrementally closer to adjacent cross sections when the cross section of the implant member along the length of the implant member changes.

### Claim 25 (depends on 22)

The system of claim 22, wherein the additional cross sections are positioned incrementally closer to adjacent cross sections when the cross section of the bone along the length of the implant member changes.

### Claim 26 (depends on 22)

The system of claim 22, wherein the additional cross sections are positioned incrementally closer to adjacent cross sections when the quality of the bone along the length of the implant member changes.

### Claim 27 (depends on 17)

The system of claim 17, further comprising a prosthetic implant having a locally adjusted cross section wherein the calculated percent stress shielding meets the preset threshold, the prosthetic implant sized and shaped for implantation in the bone.