# US 9,433,515 B2 · In vivo sensor and method of making same

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,433,515 B2
- Document ID: US9433515B2
- Status: Granted
- Kind: B2
- Application number: 13/596,923
- Filed: 2012-08-28
- Published: 2013-02-14
- Granted: 2016-09-06
- Earliest claimed: 2001-02-14
- Assignees: Advanced Bio Prosthetic Surfaces, Ltd.
- Applicants: Steven R. Bailey; Christopher T. Boyle; Denes Marton; Christopher E. Banas
- Inventors: Steven R. Bailey; Christopher T. Boyle; Denes Marton; Christopher E. Banas
- Web page: https://patentgrep.com/patent/US9433515B2

## CPC

- A61B 5/02035: {Determining blood viscosity}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/0215: by means inserted into the body
- A61B 5/0507: using microwaves or terahertz waves
- A61B 5/076: {Permanent implantation}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/4842: {Monitoring progression or stage of a disease}
- A61B 5/6862: {Stents}
- A61B 5/6876: {Blood vessel}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 8/0841: {for locating instruments}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61L 27/04: Metals or alloys
- A61L 31/022: {Metals or alloys}
- A61B 5/02: Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/02427: {Details of sensor}
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/6846: {specially adapted to be brought in contact with an internal body part, i.e. invasive}
- A61B 2562/0247: Pressure sensors
- A61B 2562/0276: comprising a thermosensitive compound
- A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- A61F 2002/4672: {for measuring temperature}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0023: operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
- A61F 2210/0042: using a fluid, e.g. circulating
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2250/0001: Means for transferring electromagnetic energy to implants
- A61F 2250/0004: adjustable
- A61F 2250/0014: having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F 2250/0018: differing in elasticity, stiffness or compressibility
- A61F 2250/0029: differing in bending or flexure capacity
- A61F 2250/0035: differing in release or diffusion time
- A61F 2250/0042: differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2250/0068: the pharmaceutical product being in a reservoir
- A61F 2250/0096: Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- B23K 1/19: taking account of the properties of the materials to be soldered
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM

## Abstract

Implantable in vivo sensors used to monitor physical, chemical or electrical parameters within a body. The in vivo sensors are integral with an implantable medical device and are responsive to externally or internally applied energy. Upon application of energy, the sensors undergo a phase change in at least part of the material of the device which is then detected external to the body by conventional techniques such as radiography, ultrasound imaging, magnetic resonance imaging, radio frequency imaging or the like. The in vivo sensors of the present invention may be employed to provide volumetric measurements, flow rate measurements, pressure measurements, electrical measurements, biochemical measurements, temperature, measurements, or measure the degree and type of deposits within the lumen of an endoluminal implant, such as a stent or other type of endoluminal conduit.

## Claims

### Claim 1

A method of using an in-vivo sensor device, the method comprising the steps of:
delivering an in-vivo sensor device into vasculature, the in vivo sensor device comprising a plurality of structural elements forming the in-vivo sensor device, the plurality of structural elements each include a first region being composed of a first material, the first material having a first transition temperature and a first transition coefficient to expand from a first diametric state to a second diametric state, the plurality of structural elements each include a second region being composed of a second material, the second material having a second transition temperature and a second transition coefficient higher than the first transition temperature and the first transition coefficient, wherein the second transition temperature and the second transition coefficient allows for a change in the geometry or conformation of the second region in the second diametric state upon application of at least one of an internal force and an external force to the in vivo sensor device, wherein the change in geometry or conformation changes the positioning of the second region relative to the geometry of the first region during the second transition temperature; and means for detecting the change in the geometry or conformation of the in vivo sensor device, the means for detecting further comprising at least one of: radiography, ultrasonography, magnetic resonance imaging, and radio frequency detection, and wherein the second material comprises at least one of a shape memory material and a superelastic material;
at least one of the geometry and the conformation of the in-vivo sensor device changing due to application of the at least one of the internal force and the external force to the in-vivo sensor device; and
imaging the in-vivo sensor device to provide an image of a profile of the vasculature.

### Claim 2 (depends on 1)

The method as defined in claim 1, further comprising the steps of: remodeling the in-vivo sensor device.

### Claim 3 (depends on 2)

The method as defined in claim 2, wherein the remodeling step comprises: applying the external force to the in-vivo sensor device.

### Claim 4 (depends on 3)

The method as defined in claim 3, wherein the applying step comprises: altering at least one of a stress or strain applied to the in-vivo sensor device.

### Claim 5 (depends on 3)

The method as defined in claim 3, wherein the applying step (i) comprises: applying at least one of ultrasound, irradiation, microwave, ultrasound, RF, ultraviolet, infrared, magnetic resonance, x-ray irradiation and gamma irradiation to the in-vivo sensor device.

### Claim 6 (depends on 1)

The method as defined in claim 1, further comprising the step of: thermally changing the in-vivo sensor device.

### Claim 7 (depends on 6)

The method as defined in claim 6, wherein the thermally changing step (e) comprises: dampening molecular vibrations of the in-vivo sensor device.

### Claim 8 (depends on 7)

The method as defined in claim 7, wherein the dampening step (l) comprises shifting a frequency of the external force by 180 degrees.

### Claim 9 (depends on 1)

The method as defined in claim 1, wherein the first material comprises at least one of a shape memory material, a superelastic material, a plastically deformable material, an elastically deformable material, a stainless steel and a nickel-titanium alloy.

### Claim 10 (depends on 1)

The method as defined in claim 1, wherein the second material comprises at least one of a shape memory material and a superelastic material.

### Claim 11 (depends on 1)

The method as defined in claim 1, wherein the second material has a martensite transition temperature that is higher than a martensite transition temperature of the first material.

### Claim 12

A method of using an in-vivo sensor device, the method comprising the steps of:
(a) delivering an in-vivo sensor device into vasculature, the in vivo sensor device comprising a plurality of structural elements defining the in-vivo sensor device, the plurality of structural elements including a first region being composed of a first material, the first material having a first transition temperature and a first transition coefficient to expand from a first diametric state to a second diametric state, the plurality of structural elements including a second region being composed of a second material, the second material having a second transition temperature and a second transition coefficient higher than the first transition temperature and the first transition coefficient, the second region changing from a first position to a second position in the second diametric state upon application of at least one of an internal force and an external force to the in vivo sensor device, wherein the first position is coplanar with the surface of the first region and the second position projects outwardly from the surface of the first region during the second transition temperature; and a detection mechanism configured to detect the second position of the in vivo sensor device, the detection mechanism being selected from the group consisting of: radiography, ultrasonography, magnetic resonance imaging, and radio frequency detection, wherein the second material comprises at least one of a shape memory material and a superelastic material;
at least one of the geometry and the conformation of the in-vivo sensor device changing due to application of the at least one of the internal force and the external force to the in-vivo sensor device; and
imaging the in-vivo sensor device to provide an image of a profile of the vasculature.

### Claim 13 (depends on 12)

The method as defined in claim 12, further comprising the steps of: remodeling the in-vivo sensor device.

### Claim 14 (depends on 13)

The method as defined in claim 13, wherein the remodeling step comprises: applying the external force to the in-vivo sensor device.

### Claim 15 (depends on 14)

The method as defined in claim 14, wherein the applying step comprises: altering stress-strain applied to the in-vivo sensor device.

### Claim 16 (depends on 14)

The method as defined in claim 14, wherein the applying step comprises: applying at least one of ultrasound, irradiation, microwave, ultrasound, RF, ultraviolet, infrared, magnetic resonance, x-ray irradiation and gamma irradiation to the in-vivo sensor device.

### Claim 17 (depends on 12)

The method as defined in claim 12, further comprising the step of: thermally changing the in-vivo sensor device.

### Claim 18 (depends on 17)

The method as defined in claim 17, wherein the thermally changing step comprises: dampening molecular vibrations of the in-vivo sensor device.

### Claim 19 (depends on 18)

The method as defined in claim 18, wherein the dampening step comprises shifting a frequency of the external force by 180 degrees.

### Claim 20 (depends on 12)

The method as defined in claim 12, wherein the first material comprises at least one of a shape memory material, a superelastic material, a plastically deformable material, an elastically deformable material, a stainless steel and a nickel-titanium alloy.