In VIVO sensor and method of making same

• US 20060074479A1
• Filed: 02/14/2001
• Published: 04/06/2006
• Est. Priority Date: 02/14/2001
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Banas, Christopher E., Bailey, Steven R., Marton, Denes, Boyle, Christopher T.
• Granted Patent: US 8,372,139 B2
• Time in Patent Office: Days
• US Class Current: 623/1.130
• 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. The in vivo sensors may also be used therapeutically to modulate mechanical and/or physical properties of the endoluminal implant in response to the sensed or monitored parameter.

Claims

1-47. -47. (canceled)

48. An implantable sensor device having a plurality of structural elements capable of expanding within an anatomical passageway at least some of the plurality of structural elements further comprising at least one sensor element that selectively detects an energy stimulus and responds to the detection of the energy stimulus by altering the geometry or conformational profile of the device body member.

49. The implantable sensor device according to claim 48, wherein the structural elements are fabricated of a forming material selected from the group consisting of shape memory materials, superelastic materials, plastically deformable materials, and elastically deformable materials.

51. The implantable sensor device according to claim 49, wherein the energy stimulus comprises an exogenous energy stimulus selected from the group consisting of microwave, ultrasound, radio frequency, ultraviolet, infrared, magnetic resonance, x-rays, laser, and beta and gamma irradiation.

52. The implantable sensor device according to claim 51, wherein the exogenous energy stimulus results in localized heating in vivo.

53. The implantable sensor device according to claim 52, wherein the exogenous energy stimulus is a laser delivered by a laser catheter.

54. The implantable sensor device according to claim 49, wherein the energy stimulus is a physiological stimulus.

55. The implantable sensor device according to claim 54, wherein the physiological stimulus comprises an endogenous energy stimulus selected from the group consisting of fluid pressure, fluid shear forces, body temperature, cellular binding and molecular binding.

56. The implantable sensor device according to claim 49, further comprising a sensor element that facilitates the interaction with the energy stimulus and mediates the altering of the geometry or conformational profile of the device body member.

57. The implantable sensor device according to claim 56, wherein the sensor element comprises a plurality of sensor regions integrally defined on at least one of a luminal or abluminal surface of the device body member.

58. The implantable sensor device according to claim 57, wherein the sensor regions are fabricated of a shape memory or superelastic material so that the properties of the sensor regions differ from that of the remaining structural elements.

59. The implantable sensor device according to claim 58, wherein the sensor regions exhibit a martensitic transition temperature higher than that of the remaining structural elements.

60. The implantable sensor device according to claim 59, wherein upon the sensor regions undergoing martensitic transformation, the sensor region stimulates the remaining structural elements to undergo martensitic transformation and effect a change in the geometry of the implantable sensor device.

61. The implantable sensor device according to claim 60, wherein the implantable sensor device displays an altered geometry that produces an image detectable using non-invasive imaging techniques.

62. The implantable sensor device according to claim 48, wherein the altered geometry or altered conformation is capable of detection by non-invasive imaging techniques.

63. The implantable sensor device according to claim 62, wherein the implantable sensor device further comprises structural elements having areas of inclusion of superelastic material, wherein the superelastic material is responsive to externally applied forces resulting in a martensitic transformation in the structural elements having areas of inclusion of superelastic material.

64. The implantable sensor device according to claim 63, wherein the externally applied forces is a force selected from the group consisting of ultrasound, irradiation, microwave, radio frequency, ultraviolet, infrared, magnetic resonance, x-rays and gamma irradiation.

65. The implantable sensor device according to claim 48, wherein the structural elements form the walls of the sensor device, the structural elements being fabricated of laminate layers of shape memory or superelastic material.

66. The implantable sensor device according to claim 65, wherein the structural elements are formed of at least two laminate layers, wherein a first laminate layer has a first martensitic transition point at normal physiological temperature and a second laminate layer has a second martensitic transition point that is greater than the first martensitic transition point.

50. (canceled)

67. (canceled)