In vivo sensor and method of making same

• US 9,433,515 B2
• Filed: 08/28/2012
• Issued: 09/06/2016
• Est. Priority Date: 02/14/2001
• Status: Expired due to Term

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Bailey, Steven R., Boyle, Christopher T., Marton, Denes, Banas, Christopher E.
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US13/596,923
• Publication Number:
  US 20130041251A1
• Time in Patent Office: 1,470 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0276 comprising a thermosensitive compound
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02035 Determining blood viscosity
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02427 Details of sensor
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 6/12 : Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 8/0841 : for locating instruments
• CPC Class Codes: 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; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 : made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/4672 : for measuring temperature
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0023 : operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/0042 : using a fluid, e.g. circulating
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 : adjustable
• CPC Class Codes: 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
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0029 : differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0035 : differing in release or diffusion time
• CPC Class Codes: A61F 2250/0042 : differing in shape-memory transition temperatures, e.g. in martensitic transition temperature, in austenitic transition temperature
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 : the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0096 : Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61L 27/04 : Metals or alloys
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: B23K 1/19 : taking account of the properties of the materials to be soldered

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

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.

2. The method as defined in claim 1, further comprising the steps of:

remodeling the in-vivo sensor device.

3. The method as defined in claim 2, wherein the remodeling step comprises:

applying the external force to the in-vivo sensor device.

4. 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.

5. 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.

6. The method as defined in claim 1, further comprising the step of:

thermally changing the in-vivo sensor device.

7. The method as defined in claim 6, wherein the thermally changing step (e) comprises:

dampening molecular vibrations of the in-vivo sensor device.

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

9. 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.

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

11. 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.

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.

13. The method as defined in claim 12, further comprising the steps of:

remodeling the in-vivo sensor device.

14. The method as defined in claim 13, wherein the remodeling step comprises:

applying the external force to the in-vivo sensor device.

15. The method as defined in claim 14, wherein the applying step comprises:

altering stress-strain applied to the in-vivo sensor device.

16. 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.

17. The method as defined in claim 12, further comprising the step of:

thermally changing the in-vivo sensor device.

18. The method as defined in claim 17, wherein the thermally changing step comprises:

dampening molecular vibrations of the in-vivo sensor device.

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

20. 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.