Method and system for directing a localized biological response to an implant

• US 10,583,308 B2
• Filed: 12/12/2016
• Issued: 03/10/2020
• Est. Priority Date: 06/01/2009
• Status: Active Grant

• Current Assignee: Profusa, Inc.
• Original Assignee: Profusa, Inc.
• Inventors: McMillan, William A., Wisniewski, Natalie
• Primary Examiner(s): Crow, Robert T.
• Application Number:
  US15/376,147
• Publication Number:
  US 20170087376A1
• Time in Patent Office: 1,184 Days
• Field of Search: None
• 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, comprising:

delivering a first tissue response modifier from a first patch placed on a surface of a mammalian body, the first tissue response modifier delivered such that the first tissue response modifier does not reach systemic levels in the mammalian body, the first tissue response modifier configured to, at least one of, (1) minimize a first response of the mammalian body to an implantation of an implant or (2) enhance a second response of the mammalian body to the implantation of the implant;

placing a second patch on the surface of the mammalian body over the implant after the first patch is placed on the surface of the mammalian body;

receiving, from the implant and at the second patch, a signal associated with an analyte, the implant having a first sensitivity to the analyte before a foreign body response of the mammalian body and a second sensitivity less than the first sensitivity after the foreign body response of the mammalian body; and

delivering a second tissue response modifier from the second patch and through an epidermis of the mammalian body to reduce or eliminate the foreign body response of the mammalian body, the second tissue response modifier delivered such that the second tissue response modifier does not reach systemic levels in the mammalian body.

2. The method of claim 1, further comprising:

receiving, from the implant and at a third patch placed on the mammalian body after the first patch, the signal associated with the analyte; and

delivering a third tissue response modifier from the third patch and through an epidermis of the mammalian body such that the third tissue response modifier does not reach systemic levels in the mammalian body.

3. The method of claim 1, further comprising:

placing the first patch on the surface of the mammalian body; and

implanting the implant within the mammalian body after the first patch is placed on the surface of the mammalian body.

4. The method of claim 1, further comprising:

placing the first patch on the surface of the mammalian body; and

removing the first patch prior to placing the second patch on the surface of the mammalian body.

5. The method of claim 1, wherein:

delivering the first tissue response modifier includes injecting the first tissue response modifier from the first patch into the mammalian body through skin tissue disposed between the first patch and the implant such that the first tissue response modifier does not reach systemic levels in the mammalian body.

6. The method of claim 1, the method further comprising modulating an uptake of the first tissue response modifier using the first patch.

7. The method of claim 1, wherein the first patch includes at least one of an illuminator, a detector, a signal receiver, a signal transmitter, an energy storage component, or a data storage component.

8. The method of claim 1, further comprising removing the implant from the mammalian body after delivering the second tissue response modifier.

9. The method of claim 1, further comprising implanting the implant within the mammalian body, the implant including a hydrogel surrounding a sensing material, the hydrogel configured to be bioabsorbed by the mammalian body when the implant is within the mammalian body exposing the sensing material to a tissue of the mammalian body.

10. The method of claim 1, further comprising:

placing the first patch on the surface of the mammalian body;

implanting the implant within the mammalian body after placing the first patch; and

removing the first patch from the surface of the mammalian body after delivering the first tissue response modifier from the mammalian body.

11. The method of claim 1, further comprising:

removing the second patch from the surface of the mammalian body after receiving the signal; and

placing a third patch on the surface of the mammalian body after removing the second patch; and

receiving, from the implant and at the third patch, the signal associated with the analyte.

12. A method, comprising:

implanting an implant within a mammalian body, the implant configured to measure an analyte of the mammalian body, the implant having a first sensitivity to the analyte before a foreign body response of the mammalian body and a second sensitivity less than the first sensitivity after the foreign body response of the mammalian body;

placing a first patch on a surface of the mammalian body over the implant;

receiving, from the implant and at the first patch, a signal associated with the analyte;

delivering, from the first patch, a first tissue response modifier through an epidermis of the mammalian body to reduce or eliminate the foreign body response of the mammalian body, the first tissue response modifier delivered such that the first tissue response modifier does not reach systemic levels in the mammalian body;

placing a second patch on the mammalian body after the first patch is placed on the surface of the mammalian body;

receiving, from the implant and at the second patch, the signal associated with the analyte; and

delivering, from the second patch, a second tissue response modifier through an epidermis of the mammalian body such that the second tissue response modifier does not reach systemic levels in the mammalian body.

13. The method of claim 12, wherein:

the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material; and

the first patch includes a detector that receives the signal from the sensing material of the implant.

14. The method of claim 12, wherein:

the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material;

the first patch includes a detector that receives the signal from the sensing material of the implant, the method further comprising;

illuminating the sensing material with an illuminator of the first patch such that the sensing material produces the signal in response to being illuminated.

15. The method of claim 12, wherein the first tissue response modifier includes at least one selection 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, and a drug.

16. The method of claim 12, further comprising delivering, from the first patch, at least one of radiation or pressure.

17. The method of claim 12, wherein:

the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material; and

the first patch includes a detector that receives the signal from the sensing material of the implant, the method further comprising;

transmitting, from an interrogator of the first patch, an interrogating signal through the epidermis to the sensing material of the implant.

18. The method of claim 12, wherein:

the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, an effectiveness of the sensing material degraded when the analyte is impeded from reaching the sensing material by collagen; and

the first patch includes a detector that receives the signal from the sensing material of the implant.

19. The method of claim 12, wherein:

the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, an effectiveness of the sensing material degraded when the analyte is impeded from reaching the sensing material by collagen; and

the first patch includes a detector that receives the signal from the sensing material of the implant; and

the first tissue response modifier inhibits the local accumulation of collagen.

20. The method of claim 12, wherein:

implanting the implant includes implanting the implant within at least one of a dermis or a subcutis of a mammalian body.

21. The method of claim 12, wherein the implant includes a glucose-binding material configured to produce the signal in proportion to a quantity glucose, the foreign body response reducing an availability of glucose to the glucose-binding substance by reducing a local concentration of glucose below a systemic concentration of glucose.

22. The method of claim 12, further comprising removing the first patch from the mammalian body.