# US 10,441,210 B2 · Method of normalizing implant strain readings to assess bone healing

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- Number: US 10,441,210 B2
- Document ID: US10441210B2
- Status: Granted
- Kind: B2
- Application number: 12/909,220
- Filed: 2010-10-21
- Published: 2011-04-28
- Granted: 2019-10-15
- Earliest claimed: 2009-10-21
- Assignees: DePuy Synthes Products, Inc.
- Applicants: Carl Deirmengian; George Mikhail; Glen Pierson
- Inventors: Carl Deirmengian; George Mikhail; Glen Pierson
- Web page: https://patentgrep.com/patent/US10441210B2

## CPC

- A61B 5/4504: {Bones (A61B5/4547 takes precedence)}
- A61B 5/076: {Permanent implantation}
- A61B 5/103: Measuring devices for testing the shape, pattern, {colour,} size or movement of the body or parts thereof, for diagnostic purposes (measuring instruments specially adapted for dentistry A61C19/04)
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61F 2/4657: {Measuring instruments used for implanting artificial joints (for surgical instruments A61B90/06)}
- A61B 17/8625: {Shanks, i.e. parts contacting bone tissue}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2562/0261: Strain gauges
- A61B 2562/028: Microscale sensors, e.g. electromechanical sensors [MEMS]
- A61B 2562/166: the sensor is mounted on a specially adapted printed circuit board
- A61F 2002/4666: {for measuring force, pressure or mechanical tension}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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 device for treating bone in a living body includes (a) comprises an implant configured for attachment to a bone; (b) a first sensor measuring a strain on a first portion of the implant, the first portion of the implant being configured to be mechanically coupled to a weakened portion of a bone when the implant is coupled to the bone in a target position in combination; and (c) a second sensor measuring strain in a non-weakened portion of the bone.

## Claims

### Claim 1

A device for treating bone in a living body, comprising:
an implant configured for attachment to an exterior of a bone;
a first sensor measuring a strain on a first portion of the implant, the first portion of the implant being configured to be mechanically coupled to a weakened portion of a bone when the implant is coupled to the bone in a target position; and
a second sensor isolated between two bone fixation element receiving holes of the implant measuring strain in a non-weakened portion of the bone.

### Claim 2 (depends on 1)

The device of claim 1, wherein the implant is a plate configured to be coupled to a bone overlying a fracture site.

### Claim 3 (depends on 2)

The device of claim 2, wherein the second sensor is configured for placement in a shoe to measure the load on a leg including the bone simultaneously with a measurement of strain across the fracture site from the first sensor.

### Claim 4 (depends on 1)

The device of claim 1, wherein the second sensor is configured to be coupled directly to the non-weakened portion of the bone.

### Claim 5 (depends on 1)

The device of claim 1, further comprising:
a third sensor mounted to a portion of a bone fixation element which, when in an operative position, is inserted into the non-weakened portion of the bone so that the third sensor contacts a cortical wall of the non-weakened portion of the bone.

### Claim 6 (depends on 5)

The device of claim 5, wherein the third sensor extends about a circumference of a proximal portion of the bone fixation element.

### Claim 7 (depends on 1)

The device of claim 1, wherein the implant includes a rigid portion and a flexible portion having a first bending stiffness less than a second bending stiffness of the rigid portion, the second sensor being mounted on the flexible portion.

### Claim 8 (depends on 1)

The device of claim 1, wherein the second sensor is a load sensor measuring a load on the bone.

### Claim 9 (depends on 1)

The device of claim 1, wherein the first and second sensors provide data to an external data gathering unit wirelessly.

### Claim 10 (depends on 9)

The device of claim 9, wherein the first and second sensors are one of MEMs sensors and powered chips connected to printed circuit boards.

### Claim 11

A system for tracking a bone healing progress, comprising:
an implant fixing a fracture of a bone including a first sensor measuring strain mounted thereon at a position which, when the implant is mounted on an exterior of the bone in a target position, is mechanically coupled to a fracture of the bone; and
a second sensor isolated between two bone fixation element receiving holes of the implant measuring strain on a portion of the bone separated from the fracture such that a ratio of the first strain to the second strain normalizes an effect of loads on the bone and indicates an increased stiffness as the fracture heals.

### Claim 12 (depends on 11)

The system of claim 11, further comprising:
a bone fixation element, a third sensor being mounted at a proximal end thereof so that, when the bone fixation element is inserted into the bone to a desired position, the third sensor contacts a cortical wall of the bone.

### Claim 13 (depends on 11)

The system of claim 11, wherein the implant includes a flexible portion and a rigid portion, a first bending stiffness of the rigid portion being greater than a second bending stiffness of the flexible portion, the second sensor being mounted on the flexible portion while the first sensor is mounted on the rigid portion.

### Claim 14 (depends on 13)

The system of claim 13, further comprising:
first and second locking screws which, when the implant is coupled to the bone in a target configuration, are inserted through the two bone fixation element receiving holes on opposing sides of the flexible portion.

### Claim 15

A method, comprising:
measuring strain on a first portion of an implant via a first sensor which, when the implant is coupled to a bone in a desired configuration, is mechanically coupled to a fracture of the bone, the implant being attached to an exterior of a bone;
measuring a second strain spaced from the fracture in a non-weakened portion of the bone via a second sensor isolated between two bone fixation element receiving holes of the implant; and
determining a ratio of the strain measured by the first sensor to the strain measured by the second sensor to normalize an effect of loads on the bone.

### Claim 16 (depends on 15)

The method of claim 15, wherein the second sensor is mounted on a second portion of the implant which, when the implant is coupled to the bone in the desired configuration, is spaced from the fracture on a solid portion of the bone.

### Claim 17 (depends on 15)

The method of claim 15, further comprising:
mounting a further sensor on a solid portion of the bone, outside a perimeter of the implant.

### Claim 18 (depends on 15)

The method of claim 15, further comprising:
inserting a bone fixation element into a solid portion of the bone, a third sensor extending about a circumference of a proximal portion of the bone fixation element such that, when the bone fixation element is inserted into the bone, the third sensor contacts a cortical wall of the bone to measure deformation thereof.

### Claim 19 (depends on 15)

The method of claim 15, wherein the strain measurements from the first and second sensors are obtained wirelessly by a device which remains external to the body.

### Claim 20 (depends on 19)

The method of claim 19, wherein the first and second sensors are one of MEMs sensors and powered chips connected to printed circuit boards.
