Methods and devices for controlling biologic microenvironments

• US 8,641,660 B2
• Filed: 10/04/2007
• Issued: 02/04/2014
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: MarcTec LLC, P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Beyers, Justin E.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US11/867,679
• Publication Number:
  US 20080086072A1
• Time in Patent Office: 2,315 Days
• Field of Search: 604 65- 67, 604/20, 604/21
• US Class Current: 604/66
• CPC Class Codes: A61B 2050/0016 Heating means
• CPC Class Codes: A61B 2050/0018 Electric heating
• CPC Class Codes: A61B 2090/0813 Accessories designed for easy sterilising, i.e. re-usable
• CPC Class Codes: A61B 2090/401 using air flow
• CPC Class Codes: A61B 50/00 Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers drapes specially adapted for instruments A61B46/10
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2007/0052 for treatment of skin or hair
• CPC Class Codes: A61F 7/00 Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

A microenvironment of a biological body is controlled, and more particularly, is measured, changed, and monitored with respect to temperature, pH level, moisture and other tissue parameters of a region of the body while, optionally, administering a therapeutic agent to that region.

Claims

1. A system for administering therapy to a human body by controlling an environmental parameter of a localized area inside the body, comprising:

at least one sensor for sensing environmental parameters proximate the localized area;

at least one effector for changing the at least one environmental parameter, implantable proximate the localized area, said at least one environmental parameter including pH;

at least one controller, operatively associated with said at least one sensor, operative to control said at least one effector;

whereby when said at least one effector changes said at least one environmental parameter, the efficacy of the therapy is improved, and wherein the elements of the system are connected to an object placed inside the body, selected from the group consisting of;

endoscope, intramedullary rod, fastener, plate, joint replacement, spinal implant, acetabular replacement, or sheet wrapped around a tubular body structure.

2. The system of claim 1, wherein a second environmental parameter is changed, and said second environmental parameter is selected from the group consisting of:

temperature, moisture, humidity, oxygen level, oxygenase, carbon dioxide level, rate of blood flow, nutrient level, osmolarity, pressure, vascular permeability, electrical charge, and therapeutic agent level.

3. The system of claim 2, wherein said second environmental parameter is selected to be temperature, and said at least one effector for changing the temperature is operative, by changing the temperature proximate the localized area, to change the pH proximate the localized area, in a controlled manner using said sensor and controller, wherein the efficacy of the therapeutic substance released proximate the localized area is improved.

4. The system of claim 1, where said at least one effector for changing environmental parameter is selected from the group consisting of:

resistive heater, ultrasonic heater, IR heater, RF heater, microwave heater, convection cooling device, conduction cooling device, electronic cooling device, Peltier cooling device, suction device, charged particles, metallic ions, and charged ions.

5. The system of claim 1, further including release means operative to release a therapeutic substance proximate the localized area of the body, wherein said therapeutic substance is selected from the group consisting of:

cellular nutrient, vasodilator, vasoconstrictor, antibiotics, hydroxypatite, anti-inflammatory agents, steroids, antibiotics, analgesic agents, chemotherapeutic agents, bone morphogenetic protein, demineralized bone matrix, collagen, growth factors, autogenetic bone marrow, progenitor cells, calcium sulfate, immu-suppressants, fibrin, osteoinductive materials, apatite compositions, fetal cells, embryonic cells, stem cells, enzymes, proteins, hormones, germicides, non-proliferative agents, anti-coagulants, anti-platelet agents, tyrosine kinase inhibitors, anti-infective agents, anti-tumor agents, anti-leukemic agents.

6. The system of claim 5, further comprising:

at least one port proximate the localized area, connected to said release means, operative to conduct released therapeutic substance proximate the localized area of a body.

7. The system of claim 5, wherein when the temperature proximate the localized area of the body is changed, the efficacy of said therapeutic substance is changed.

8. The system of claim 5, wherein said at least one controller is further operative to control the rate, frequency and duration of release of said means operative to release a therapeutic substance;

whereby when the temperature proximate the localized area is changed, the rate at which said therapeutic substance is released is changed.

9. The system of claim 1, further comprising:

an endoscope having a plurality of lumens;

a guide wire extending through one of said lumens, operative to support at least one of said at least one end effector;

whereby said guide wire may be manipulated to position at least one of said at least one end effector in a desired position beyond the end of said endoscope inside the body.

10. The system of claim 1, further comprising:

an endoscope having a plurality of lumens;

a guide wire extending through one of said lumens, operative to support at least one of said at least one sensor;

whereby said guide wire may be manipulated to position at least one of said at least one sensor in a desired position beyond the end of said endoscope inside the body.

11. The system of claim 1, wherein said controller is controlled by a method selected from the group consisting of:

manual controls, wired remote, radio frequency telemetry, acoustic telemetry, microwave telemetry, internal programming.

12. The system of claim 1, wherein the effector is an electrical transmitter.

13. The system of claim 1, wherein the effector is battery operated.

14. The system of claim 1, wherein the effector is positioned internal or external to the body.

15. The system of claim 1, wherein the localized area of the body is the stomach.

16. The system of claim 15, wherein the therapeutic benefit is a reduction in the patient'"'"'s appetite.

17. A system for administering therapy to a human body by controlling an environmental parameter of a localized area inside the body, comprising:

at least one sensor for sensing environmental parameters proximate the localized area;

at least one effector for changing the at least one environmental parameter, implantable proximate the localized area, said at least one environmental parameter including pH;

at least one controller, operatively associated with said at least one sensor, operative to control said at least one effector;

whereby when said at least one effector changes said at least one environmental parameter, the efficacy of the therapy is improved, and further including a sheet wrapped around a blood vessel, wherein the wrapped sheet constricts a tubular structure decreasing a diameter of same, thereby increasing a rate of blood flow through a constricted space.

18. A system for administering therapy to a human body by controlling an environmental parameter of a localized area inside the body, comprising:

at least one sensor for sensing environmental parameters proximate the localized area;

at least one effector for changing the at least one environmental parameter, implantable proximate the localized area, said at least one environmental parameter including pH;

at least one controller, operatively associated with said at least one sensor, operative to control said at least one effector;

whereby when said at least one effector changes said at least one environmental parameter, the efficacy of the therapy is improved, wherein said at least one effector includes a suction device operative to create a negative pressure proximate the localized area of the body, whereby the efficacy of the therapy is improved, wherein said suction device is operative to create vasodilation proximate a location where said suction is proximate body tissue, and thereby creates vasoconstriction distal to the location of vasodilation, and wherein said suction device further includes;

means for cooperating with a knee joint including a chamber connected with a first side of the knee joint;

a valve connected with said chamber;

a connector connected to said chamber and a second side of the knee joint;

a tube connected to said chamber, having a distal end extending to the localized area of the body;

whereby movement of the joint produces suction at the distal end of said tube.