Methods and devices for controlling biologic microenvironments

• US 9,474,847 B2
• Filed: 01/22/2014
• Issued: 10/25/2016
• Est. Priority Date: 10/04/2006
• Status: Expired due to Fees

• Current Assignee: MarcTec LLC, P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter M., Beyers, Justin E.
• Primary Examiner(s): HAYMAN, IMANI N
• Application Number:
  US14/161,210
• Publication Number:
  US 20140309585A1
• Time in Patent Office: 1,007 Days
• US Class Current: 1/1
• 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 portion of a body to be treated, comprising:

at least one sensor for sensing environmental parameters proximate the portion to be treated;

at least one effector that changes at least one environmental parameter proximate the portion to be treated;

at least one reservoir, each reservoir storing a quantity of a therapeutic substance effective to treat the portion of the body;

a release operatively connected with said at least one reservoir to control release of at least a portion of the contents of said at least one reservoir proximate the portion to be treated; and

,

at least one electronic processor, responsive to said at least one sensor, operative to control said at least one effector, and operative to control said release;

whereby when said at least one effector changes at least one environmental parameter, the efficacy of the therapeutic substance released proximate the portion to be treated is improved;

wherein the elements of the system are connected to an object placed inside the body, the object being at least one of an endoscope, intramedullary rod, fastener, plate, joint replacement, spinal implant, acetabular replacement, and sheet wrapped around a tubular body structure.

2. The system of claim 1, wherein said environmental parameters are at least one of a temperature, pH, 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 1, where said at least one effector is at least one of a resistive heater, ultrasonic heater, IR heater, RF heater, microwave heater, convection cooling device, conduction cooling device, electronic cooling device, Peltier cooling device, and suction device.

4. The system of claim 1, wherein said therapeutic substance is at least one of a 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, and anti-leukemic agents.

5. The system of claim 1, wherein said object comprises the sheet, the sheet being wrapped around a tubular structure comprising a blood vessel, wherein the wrapped sheet constricts the tubular structure decreasing the diameter of same, thereby increasing the rate of blood flow through the constricted space, whereby an increased amount of therapeutic agent is delivered to the body.

6. The system of claim 1, wherein said object comprises the endoscope, the endoscope having a plurality of lumens, said system further comprising:

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.

7. The system of claim 1, wherein said object comprises the endoscope, the endoscope having a plurality of lumens, said system further comprising:

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.

8. The system of claim 1, further comprising:

at least one port proximate the portion to be treated, connected to said release operative to conduct released therapeutic substance proximate the portion of a body.

9. The system of claim 1, wherein at least one of said at least one effector is operative to change temperature;

and

whereby said at least one effector is operative, by changing the temperature proximate the portion to be treated, to change the pH proximate the portion to be treated, wherein the efficacy of the therapeutic substance released proximate the portion to be treated is improved.

10. The system of claim 1, wherein said electronic processor controls at least one of the at least one effector and the release by at least one of manual controls, wired remote, radio frequency telemetry, acoustic telemetry, microwave telemetry, and internal programming.

11. The system of claim 1, wherein said at least one effector includes a suction device operative to create a negative pressure proximate the portion of a body to be treated, whereby the efficacy of the therapy is improved.

12. The system of claim 11, 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.

13. The system of claim 11, wherein said suction device further includes:

a chamber connected with a first side of the knee joint;

a valve connected with said chamber;

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

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

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

14. A system for administering therapy to a portion of a body to be treated, comprising:

at least one sensor for sensing environmental parameters proximate the portion to be treated;

at least one pH reservoir containing a substance operative to change pH proximate the portion of the body upon release proximate the portion of the body;

at least one therapeutic substance reservoir that stores a quantity of a therapeutic substance effective to treat the portion of the body;

a release operatively connected with said at least one pH reservoir and said at least one therapeutic reservoir to control release of at least a portion of the contents of each of said reservoirs, proximate the portion to be treated; and

,

at least one electronic processor, responsive to said at least one sensor, operative to control said release;

whereby when the pH proximate the portion to be treated is changed, the efficacy of the therapeutic substance released proximate the portion to be treated is improved;

wherein the elements of the system are connected to an object placed inside the body, the object being at least one of an endoscope, intramedullary rod, fastener, plate, joint replacement, spinal implant, acetabular replacement, and sheet wrapped around a tubular body structure.

15. A system for delivery of a therapeutic substance through a body surface, comprising:

at least one sensor for sensing environmental parameters proximate the body surface;

at least one effector that changes environmental parameters proximate the body surface;

at least one reservoir, each reservoir storing a quantity of a therapeutic substance, at least one of said at least one therapeutic substances being passable through the body surface;

a release operatively connected with said at least one reservoir to control release of at least a portion of the contents of said at least one reservoir to the body surface; and

,

at least one electronic processor, responsive to said at least one sensor, operative to control said at least one effector, and operative to control said release;

whereby when said at least one effector changes at least one environmental parameter, at least one of said therapeutic substances passable through the body surface passes through the body surface at a changed rate;

wherein the elements of the system are connected to an object placed inside the body, the object being at least one of an endoscope, intramedullary rod, fastener, plate, joint replacement, spinal implant, acetabular replacement, and sheet wrapped around a tubular body structure.

16. The system of claim 15, where at least one of said at least one effector changes the temperature proximate the body surface, thereby changing the pH proximate the body surface, and thus changing the rate at which said therapeutic substance is delivered through the body surface.

17. The system of claim 15, wherein the body surface comprises skin.

18. The system of claim 15, wherein said reservoir further includes at least one of a gel, gelatin, biologic foam, biodegradable foam, pluronic gel, poloxamer lecithin organogel, lecithin isopropyl palmitate, polypropylene glycol, ethyl propylene glycol, ethoxydiglycol, and liposomal components.