Materials, Systems, Devices, And Methods For Endoluminal Electropolymeric Paving And Sealing

• US 20160051735A1
• Filed: 04/04/2014
• Published: 02/25/2016
• Est. Priority Date: 04/04/2013
• Status: Active Grant

• Current Assignee: Arizona Board of Regents (University of Arizona)
• Original Assignee: Arizona Board of Regents (University of Arizona)
• Inventors: Slepian, Marvin J.
• Granted Patent: US 10,226,552 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• 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 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/488 involving Doppler signals
• 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 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0043 differing in electric properties, e.g. in electrical conductivity, in galvanic properties
• 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: A61L 2400/06 : Flowable or injectable implant compositions
• CPC Class Codes: A61L 31/04 : Macromolecular materials
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/148 : Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61N 1/326 : for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula

Abstract

Methods, materials, devices, and systems for electropolymeric paving and sealing (ePEPS) are provided. The methods include delivering paving materials to an interior surface of a blood vessel, tissue lumen or other hollow space, delivering electronic components to the surface, and forming a conformal device that contains the paving material and the integrated electronic components. Integrated electronic components can be homogenously or heterogeneously distributed in the material, such as on the top, middle, and/or bottom of the polymeric material. The devices are biocompatible, and preferably biodegradable or bioerodible. The devices integrated electrical properties useful for sensing or detecting one or more analytes, signals or conditions, transmitting or generating a signal, or releasing a therapeutic, prophylactic or diagnostic agent. Optionally, the devices are smart devices that include feedback and logic means to respond to a change in local conditions.

Claims

1. A device for electropolymeric paving, the device comprising a biocompatible implantable polymeric material having integrated electronic components useful for sensing or detecting one or more analytes, signals or conditions;

storing data from said electronic components, transmitting or generating a signal;

or effecting a therapy or releasing a therapeutic, prophylactic or diagnostic agent.

3. The device of claim 1, wherein the material is in a non-fluent state and is converted to a fluent state following delivery in vivo, by a change in temperature, electrical current, ultrasound, polymerization, or interaction with biological fluid.

4. The device of claim 1, wherein the material is in a fluent state and is converted to a less fluent state following delivery in vivo, by a change in temperature, electrical current, ultrasound, polymerization, or interaction with biological fluid.

5. The device of claim 1, wherein the material comprises monomers or partially polymerized prepolymers that are polymerizable at the time of delivery.

6. The device of claim 1, wherein the material is biodegradable.

7. The device of claim 1, further comprising non-degradable components.

8. The device of claim 1, further comprising a stent or a continuous, perforated, or helical sleeve.

9. The device of claim 1, wherein the electronic components are selected from the group consisting of sensors, actuators, power storage, and power generation means.

10. The device claim 1, wherein the material degrades by hydrolysis, oxidation, enzymatic degradation, reductive mechanisms, Norrish type I or type II ester formation, and/or corrosion.

11. The device of claim 1, wherein the integrated electronic components are homogenously or heterogeneously distributed in the polymeric material, and are located on the top, middle or bottom of the polymeric material, or a combination thereof.

12. The device of claim 1, wherein the electronic components sense flow, pressure, pH change, specific analytes such as biomarkers, proteins, drugs, change in mass, changes in cells or in tissue such as restenosis, thrombosis, malignancy, inflammation and infection.

13. The device of claim 1, further comprising nested loops to store, interrogate, and/or telemeter data.

14. The device of claim 13, further comprising feedback and logic means to respond to a change in local conditions.

15. The device of claim 1, further comprising means for adhering the device at the site of implantation, wherein the means are chemical and/or mechanical.

16. The device of claim 1, further comprising a therapeutic, prophylactic, or diagnostic agent, or cells or another biological agent.

28. The method of claim 17, wherein following delivery, the material and electronic components form the device of claim 1.

2. A system for electropolymeric paving comprising a material, and

one or more electronic components useful for sensing or detecting one or more analytes, signals or conditions;

transmitting or generating a signal;

or releasing a therapeutic, prophylactic or diagnostic agent,

wherein the material comprises monomers, polymers, or prepolymers, or a combination thereof.

17. A method for electropolymeric paving comprising delivering the system of claim 2 to a surface within a lumen.

18. The method of claim 17, wherein the material is delivered prior to, subsequent to, or simultaneously with the one or more electronic components.

19. The method of claim 17, wherein the material is delivered via a delivery system selected from the group consisting of catheters, tubular devices, trocars, needles, and endoscopes.

20. The method of claim 17, further comprising applying means to convert the material from a fluent state to a less fluent state or vice-versa.

21. The method of claim 17, wherein the material is delivered into a blood vessel, such as the coronary, carotid, femoral, iliac, renal, vertebral, mesenteric, uterine, prostate arteries or veins, or intratumoral arteries.

22. The method of claim 17, wherein the lumen is a tube selected from the group consisting of gut, lung, nose, ear, bile ducts, fallopian tubes, ureter, erethra, trachea, bronchi, or body cavity selected from the group consisting of peritoneum, the thoracic cavity, the oral cavity, the rectal cavity, or the vaginal or uterine cavity.

23. The method of claim 17, wherein the material is delivered within the lumen wall or between layers of the lumen wall, or on the tissue side of the lumen.

24. The method of claim 17, wherein the material is delivered endolumenally or ectolumenally.

25. The method of claim 20, wherein the material is administered in conjunction with a deployed device, such as a stent, graft, pacemaker, defibrillator, VADS, artificial heart, insulin pump, or nerve stimulator.

26. The method of claim 20, wherein the material is delivered by spraying, brushing or as a flowable liquid.

27. The method of claim 26, wherein the liquid is solidified by application of light, temperature change, by an electrical current, ultrasound, polymerization, or interaction with biological fluid.

29. The method of claim 25, wherein the device is suitable for killing infectious agents, tumor cells, or to sterilizing cells at the site.