# US 11,432,896 B2 · Flexible skin based patient tracker for optical navigation

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- Number: US 11,432,896 B2
- Document ID: US11432896B2
- Status: Granted
- Kind: B2
- Application number: 16/572,035
- Filed: 2019-09-16
- Published: 2020-01-09
- Granted: 2022-09-06
- Earliest claimed: 2015-03-19
- Assignees: Medtronic Navigation, Inc.
- Applicants: Medtronic Navigation, Inc.
- Inventors: Marco Capote; Matthew F. Dicorleto
- Web page: https://patentgrep.com/patent/US11432896B2

## CPC

- A61B 46/00: Surgical drapes
- A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2017/00951: {adhesive}
- A61B 2034/2051: {Electromagnetic tracking systems}
- A61B 2034/2055: {Optical tracking systems}
- A61B 2046/205: {Adhesive drapes}
- A61B 2090/363: {Use of fiducial points}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3937: {Visible markers}
- A61B 2090/3945: {Active visible markers, e.g. light emitting diodes}
- A61B 2090/3983: {Reference marker arrangements for use with image guided surgery}
- A61B 2090/3991: {having specific anchoring means to fixate the marker to the tissue, e.g. hooks}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A skin-based patient tracking apparatus for surgical navigation. The apparatus includes an adhesive layer, a plurality of surgical tracking elements, a base layer between the adhesive layer and the plurality of surgical tracking elements, and an outer layer covering the plurality of surgical tracking elements.

## Claims

### Claim 1

A system for tracking movement of a patient during surgery comprising:
a skin-based flexible patient tracking apparatus for surgical navigation including:
a base layer having a first side and a second side;
an adhesive layer on the first side of the base layer including an adhesive material configured to stick the skin-based flexible patient tracking apparatus to the patient's skin over a surgical site;
a plurality of optical surgical tracking elements on the second side of the base layer;
the base layer between the adhesive layer and the plurality of optical surgical tracking elements; and
an outer transparent layer covering the plurality of optical surgical tracking elements;
wherein the skin-based flexible patient tracking apparatus is formed of a material configured to be cut through with an incision during surgery to access the surgical site beneath the patient's skin; and
wherein the skin-based flexible patient tracking apparatus is formed of the material configured to be stretched, wherein a separation distance between at least two optical tracking elements will increase in a stretched position;
wherein the plurality of optical surgical tracking elements are configured such that an average position of the plurality of surgical tracking elements both before and after the incision is made through the skin-based flexible patient tracking apparatus and into the patient's skin as detected by a surgical tracking system corresponds to movement of the patient's skin when the patient tracking apparatus is secured over the surgical site.

### Claim 2 (depends on 1)

The system of claim 1, wherein the surgical tracking elements are bonded to the base layer.

### Claim 3 (depends on 1)

The system of claim 1, wherein the surgical tracking elements are secured to the base layer with an adhesive.

### Claim 4 (depends on 1)

The system of claim 1, wherein the surgical tracking elements are molded to the base layer.

### Claim 5 (depends on 1)

The system of claim 1, wherein the surgical tracking elements are arranged in a plurality of rows and columns.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a surgical drape integral with the patient tracking apparatus and sized to extend from and surrounded an area beyond the patient tracking apparatus and the surgical site.

### Claim 7 (depends on 1)

The system of claim 1, wherein the base layer includes a surgical drape extending beyond a portion of the patient tracking apparatus including the plurality of surgical tracking elements.

### Claim 8 (depends on 1)

The system of claim 1, wherein the average position of the plurality of surgical tracking elements is determined by a processor of the surgical tracking system.

### Claim 9

A system for tracking movement of a patient during surgery comprising:
a skin-based flexible patient tracking apparatus for surgical navigation including a plurality of surgical tracking elements and an adhesive material configured to stick the skin-based flexible patient tracking apparatus to the patient's skin over a surgical site, the skin-based flexible patient tracking apparatus formed of a material configured to be stretched and cut through with an incision during surgery to access the surgical site beneath the patient's skin;
a drape extending from and surrounding the skin-based flexible tracking apparatus and sized to drape over an area of the patient surrounding the surgical site; and
a surgical tracking system including a processor configured to determine an average position of the plurality of surgical tracking elements both before and after the incision is made through the skin-based flexible patient tracking apparatus and into the patient's skin corresponding to movement of the patient's skin when the patient tracking apparatus is secured over the surgical site.

### Claim 10 (depends on 9)

The system of claim 9, wherein the adhesive material is included with an adhesive layer, a base layer is between the adhesive layer and the plurality of surgical tracking elements, and an outer transparent layer covers the plurality of surgical tracking elements.

### Claim 11 (depends on 9)

The system of claim 9, wherein the plurality of surgical tracking elements are arranged in a plurality of rows and columns.

### Claim 12 (depends on 9)

The system of claim 9, wherein the plurality of surgical tracking elements are secured to the skin-based flexible patient tracking apparatus with an adhesive.

### Claim 13 (depends on 12)

The system of claim 12, wherein the plurality of surgical tracking elements are molded to the skin-based flexible patient tracking apparatus.

### Claim 14 (depends on 9)

The system of claim 9, wherein the surgical tracking system is an optical surgical tracking system, and the plurality of surgical tracking elements are optical surgical tracking elements viewable through the skin-based flexible patient tracking apparatus.
