# US 12,004,784 B2 · Adjustable implant, system and methods

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- Number: US 12,004,784 B2
- Document ID: US12004784B2
- Status: Granted
- Kind: B2
- Application number: 17/651,594
- Filed: 2022-02-18
- Published: 2022-08-25
- Granted: 2024-06-11
- Earliest claimed: 2021-02-23
- Assignees: NuVasive Specialized Orthopedics, Inc.
- Applicants: Nuvasive Specialized Orthopedics, Inc.
- Inventors: Niels Smidth; Youngsam Bae; Khoa Pham
- Web page: https://patentgrep.com/patent/US12004784B2

## CPC

- A61B 17/7216: {for bone lengthening or compression (A61B17/7258 takes precedence)}
- A61B 17/8858: {laterally or radially expansible (inflatable A61B17/8855)}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61B 17/66: {Alignment}, compression or distraction mechanisms
- A61B 17/7241: {the nail having separate elements through which screws pass}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00022: {Sensing or detecting at the treatment site}
- A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect}
- A61B 2017/00075: {Motion}
- A61B 2017/00106: {ultrasonic}
- A61B 2017/0011: {piezoelectric}
- A61B 2017/00137: {Details of operation mode}
- A61B 2017/00221: {with wireless transmission of data, e.g. by infrared radiation or radiowaves}
- A61B 2017/00362: {Packages or dispensers for MIS instruments (A61B2017/0479 takes precedence)}
- A61B 2017/00402: {Piezo electric actuators}
- A61B 2017/00411: {actuated by application of energy from an energy source outside the body}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00734: {battery operated}
- A61B 2017/00876: {magnetic}
- A61B 2017/00991: {Telescopic means}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/681: {Alignment, compression, or distraction mechanisms}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/066: {for measuring torque}
- A61B 2560/0219: of externally powered implanted units
- A61B 2562/0252: Load cells
- A61B 2562/0261: Strain gauges
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Aspects of the disclosure relate to an adjustable implant configured to be implanted into a patient that includes an adjustable portion moveable relative to a housing. The adjustable implant may include various smart components for enhancing operation of the implant. Smart components may include a controller for managing operations and a transducer for communicating ultrasound data with an external interface device. Additional smart components may include a load cell within the housing for measuring an imparted load; a sensor for measuring angular position of the adjustable portion; a dual sensor arrangement for measuring imparted forces; a reed switch; a half piezo transducer; and an energy harvester.

## Claims

### Claim 1

An adjustable implant comprising:
a housing having a first set of apertures, each configured to receive one of a plurality of bone screws;
an adjustable portion movable relative to the housing;
an actuator positioned within the housing and configured to cause movement of the adjustable portion relative to the housing;
a sensor positioned adjacent to the actuator and configured to monitor an angular position of the actuator; and
a load cell, disposed within the housing, having a second set of apertures that line up with the first set of apertures, each of the second set of apertures configured to receive one of the plurality of bone screws, wherein a diameter of the second set of apertures is smaller than a diameter of the first set of apertures so that the plurality of bone screws anchor primarily to the load cell.

### Claim 2 (depends on 1)

The adjustable implant of claim 1, further comprising:
a controller communicatively coupled to the sensor and configured to receive angular position data from the sensor.

### Claim 3 (depends on 2)

The adjustable implant of claim 2, wherein the controller is configured to determine a number of rotations of the actuator in response to processing the angular position data.

### Claim 4 (depends on 3)

The adjustable implant of claim 3, wherein the controller is configured to calculate a distraction length or a compression length of the adjustable implant based on the number of rotations of the actuator.

### Claim 5 (depends on 4)

The adjustable implant of claim 4, further comprising:
a transducer configured to send data including at least one of the number of rotations, distraction length and compression length to an external interface device.

### Claim 6 (depends on 1)

The adjustable implant of claim 1, wherein the sensor includes a hall effect sensor that detects a magnetic field of an actuator magnet.

### Claim 7 (depends on 2)

The adjustable implant of claim 2, wherein the hall effect sensor includes one of a unidirectional hall effect sensor, a rotary hall effect sensor and a rotary hall effect sensor having a 4-hall element arrangement.

### Claim 8 (depends on 2)

The adjustable implant of claim 2, further comprising a reed switch configured to power on the controller in response to an external device being within a threshold distance of the adjustable implant and power off the controller in response to the external device being outside the threshold distance of the adjustable implant.

### Claim 9 (depends on 1)

The adjustable implant of claim 1, wherein the load cell has a strain gauge for measuring a linear force imparted on the housing.

### Claim 10

A method comprising:
adjusting an adjustable implant, the adjustable implant including:
a housing having a first set of apertures, each configured to receive one of a plurality of bone screws;
an adjustable portion moveable relative to the housing;
an actuator positioned within the housing and configured to cause movement of the adjustable portion relative to the housing;
a sensor positioned adjacent to the actuator and configured to monitor an angular position of the actuator; and
a load cell, disposed within the housing, having a second set of apertures that line up with the first set of apertures, each of the second set of apertures configured to receive one of the plurality of bone screws, wherein a diameter of the second set of apertures is smaller than a diameter of the first set of apertures so that the plurality of bone screws anchor primarily to the load cell,
determining a number of rotations of the actuator based on monitoring of the angular position; and
calculating a distraction length or a compression length of the adjustable implant based upon the number of rotations of the actuator.

### Claim 11 (depends on 10)

The method of claim 10, wherein the adjustable implant further includes a controller positioned within the housing and communicatively coupled to the sensor.

### Claim 12 (depends on 10)

The method of claim 10, wherein the sensor includes a hall effect sensor.

### Claim 13 (depends on 10)

The method of claim 10, further comprising:
sending data that includes at least one of the number of rotations, the distraction length or the compression length to an external interface device.

### Claim 14 (depends on 13)

The method of claim 13, wherein the adjustable implant further includes a transducer positioned within the housing for sending data.

### Claim 15 (depends on 13)

The method of claim 13, further comprising receiving treatment instructions from the external interface device to adjust the adjustable portion.

### Claim 16 (depends on 15)

The method of claim 15, wherein the treatment instructions are based on the calculated distraction length or compression length.

### Claim 17 (depends on 10)

The method of claim 10, wherein the controller and sensor are activated and deactivated by a reed switch in response to a proximity of an external device.
