METHOD AND SYSTEM FOR DIRECTING A LOCALIZED BIOLOGICAL RESPONSE TO AN IMPLANT

• US 20100303772A1
• Filed: 05/27/2010
• Published: 12/02/2010
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Profusa, Inc.
• Original Assignee: Profusa, Inc.
• Inventors: Wisniewski, Natalie, McMillan, William A.
• Granted Patent: US 9,517,023 B2
• Time in Patent Office: Days
• US Class Current: 424/93.7
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/7038 Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 2005/0626 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 2005/0645 Applicators worn by the patient
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61N 5/067 : using laser light

Abstract

The invention provides methods for directing a localized biological response of a mammalian body to an implant disposed within the body. In one embodiment, a delivery system is positioned outside the body and adjacent to the implant within the body. The delivery system comprises a first tissue response modifier effective for directing a localized biological response of the body to the implant. The tissue response modifier is nonsurgically delivered from the delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant. The invention also provides an implant system for long-term use comprising an implant and nonsurgical means for delivering a tissue response modifier through the epidermis of the body, the tissue response modifier effective for directing a localized biological response of the body to the implant.

Claims

1. A method for directing a localized biological response of a mammalian body to an implant disposed within the body, the method comprising:

positioning a first delivery system outside the body and adjacent to the implant, the first delivery system comprising a first tissue response modifier effective for directing a localized biological response of the body to the implant; and

delivering the first tissue response modifier from the first delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant, wherein the first tissue response modifier is delivered nonsurgically.

2. The method of claim 1 further comprising:

positioning a second delivery system outside the body and adjacent to the implant, the second delivery system comprising a second tissue response modifier effective for directing the localized biological response of the body to the implant; and

delivering the second tissue response modifier from the second delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant, wherein the second tissue response modifier is delivered nonsurgically.

3. The method of claim 2 further comprising:

removing the first delivery system prior to the positioning the second delivery system outside the body and adjacent to the implant.

4. The method of claim 1 wherein the implant is disposed within the body adjacent to an outside surface of the body.

5. The method of claim 1 wherein the implant is fully enclosed within the body.

6. The method of claim 1 wherein the positioning the first delivery system outside the body and adjacent to the implant comprises applying the first delivery system to an outside surface of the body adjacent to the implant.

7. The method of claim 1 wherein the delivering the first tissue response modifier from the first delivery system into the body comprises delivering the first tissue response modifier transdermally.

8. The method of claim 1 wherein the delivering the first tissue response modifier from the delivery system into the body comprises injecting the first tissue response modifier from the delivery system into the body through skin tissue adjacent to the implant.

9. The method of claim 1 wherein the first delivery system is selected from the group consisting of a cream, a gel, an ointment, a sprayer, a patch, a bandage insert, an array of microneedles, a syringe, and combinations thereof.

10. The method of claim 1 wherein the first delivery system comprises one or more of a radiation source and a pressure source.

11. The method of claim 1 wherein the first tissue response modifier is selected from the group consisting of a collagen inhibitor, an anti-fibrotic agent, an angiogenic agent, a vasculogenic agent, an immunosuppressive agent, an anti-proliferative agent, an anti-migratory agent, an anti-inflammatory agent, a vasodilator, an anti-histamine, an anti-protein-fouling agent, a synthetic molecule, a biologically produced molecule, a gene therapy agent, a stem cell, a mammalian cell, a drug, and combinations thereof.

12. The method of claim 1 wherein the first tissue response modifier is selected from the group consisting of visible light, other wavelengths of light, ultrasound, heat, an electrical field, an electrical pulse, a magnetic field, a magnetic pulse, and combinations thereof.

13. The method of claim 1 wherein the first delivery system further comprises a material effective to target delivery of the tissue response modifier to a specific location within the body.

14. The method of claim 1 wherein the first delivery system further comprises a material effective to modulate uptake of the tissue response modifier by the body.

15. The method of claim 1 wherein the delivering the first tissue response modifier from the first delivery system into the body is aided by a process selected from the group consisting of electroporation, iontophoresis, sonophoresis, laser-induced pressure, delivery of permeation enhancers, and combinations thereof.

16. The method of claim 1 wherein the implant is disposed in one or more of the hypodermis, the subcutis, the subcutaneous adipose fat, the dermis, an intradermal location, and a subdermal location.

17. The method of claim 1 wherein the implant is selected from the group consisting of a sensor, a drug-delivery device, a pump, a chip, and combinations thereof.

18. The method of claim 1 wherein the first delivery system further comprises a component selected from the group consisting of an illuminator, a detector, a signal receiver, a signal transmitter, an energy storage component, a data storage component, and combinations thereof.

19. The method of claim 1 further comprising:

after delivering the first tissue response modifier from the first delivery system into the body, removing the implant from the body.

20. A method for directing a localized biological response of a mammalian body to an implant, the method comprising:

positioning a delivery system outside the body adjacent to a location within the body identified for receiving the implant, the delivery system comprising a tissue response modifier effective for directing a localized biological response of the body to the implant; and

delivering the tissue response modifier from the delivery system into the body in a quantity effective to direct a localized biological response of the body, wherein the tissue response modifier is delivered nonsurgically.

21. The method of claim 20 further comprising:

removing the delivery system; and

positioning the implant at the location within the body identified for receiving the implant.

22. An implant system for long-term use within a mammalian body, comprising:

an implant; and

nonsurgical means for delivering a tissue response modifier through the epidermis of the mammalian body, the tissue response modifier effective for directing a localized biological response of the body to the implant.

23. The system of claim 22 wherein the nonsurgical delivery means is selected from the group consisting of a cream, a gel, an ointment, a sprayer, a patch, a bandage insert, an array of microneedles, a syringe, and combinations thereof.

24. The system of claim 22 wherein the nonsurgical delivery means comprises a component selected from a group consisting of an interrogator, an illuminator, a detector, a signal receiver, a signal transmitter, an energy storage component, a data storage component, and combinations thereof.

25. The system of claim 22 wherein the tissue response modifier is selected from a group consisting of a collagen inhibitor, an anti-fibrotic agent, an angiogenic agent, a vasculogenic agent, a pro-vascular dilation agent, an immunosuppressive agent, an anti-proliferative agent, an anti-migratory agent, an anti-inflammatory agent, a vasodilator, an anti-histamine, an anti-protein-fouling agent, a metabolic depressor, a synthetic molecule, a biologically produced molecule, a permeation enhancer, a gene therapy agent, a stem cell, a mammalian cell, a drug, and combinations thereof.