Search

US-12616845-B2 - Devices and related methods for light-based modulation of foreign body responses in living tissue

US12616845B2US 12616845 B2US12616845 B2US 12616845B2US-12616845-B2

Abstract

Modulation of foreign body responses in living tissue, and more particularly, devices and related methods for light-based modulation of foreign body responses in living tissue are disclosed. Light sources are disclosed that provide light with characteristics for modulation of foreign body responses that may be elicited by percutaneous and/or subcutaneous devices, including medical devices and other consumer electronic devices. Light delivery structures are disclosed that propagate light from the light sources to irradiate associated subcutaneous tissues. Modulation of foreign body responses may include inhibiting collagen and fibrous tissue generation, modulating inflammation and healing, and/or increasing nitric oxide production and/or release. By modulating foreign body responses associated with percutaneous and/or subcutaneous devices, performance characteristics and lifetimes of such devices may be improved.

Inventors

  • Michael John Bergmann
  • Mark Tapsak
  • David T. Emerson
  • F. Neal HUNTER
  • Andrew P. Gaudet de Lestard

Assignees

  • KNOW BIO, LLC

Dates

Publication Date
20260505
Application Date
20210526

Claims (20)

  1. 1 . A method of modulating a foreign body response, the method comprising: providing a foreign body within a region of subcutaneous tissue of a host, the foreign body comprising a sensor probe having an active sensing region proximate a distal end of the sensor probe; providing a light source capable of emitting one or more peak wavelengths of light, the one or more peak wavelengths comprising a first wavelength in a range from 400 nanometers (nm) to 450 nm; inserting a light delivery structure through skin of the host such that a distal end of the light delivery structure is separated from the active sensing region by a portion of the region of subcutaneous tissue and the distal end comprises a light-scattering region integral to the light delivery structure, wherein the light-scattering region is positioned at an offset depth above the active sensing region and the light delivery structure is optically coupled with the light source; and irradiating one or more portions of the region of subcutaneous tissue with the light through the light-scattering region of the light delivery structure to modulate a foreign body response within the region of subcutaneous tissue.
  2. 2 . The method of claim 1 , wherein the light is irradiated to the one or more portions of the region of subcutaneous tissue at a tissue depth in a range from 1 millimeter (mm) to 15 mm.
  3. 3 . The method of claim 1 , wherein the light is irradiated to the one or more portions of the region of subcutaneous tissue at a tissue depth in a range from 4 millimeters (mm) to 15 mm.
  4. 4 . The method of claim 1 , wherein the one or more peak wavelengths of light comprises a second wavelength in a range from 315 nm to 400 nm.
  5. 5 . The method of claim 1 , wherein the one or more peak wavelengths of light comprises a second wavelength in a range from 400 nm to 1600 nm.
  6. 6 . The method of claim 1 , wherein the one or more peak wavelengths of light comprises a second wavelength in a range from 600 nm to 1600 nm.
  7. 7 . The method of claim 6 , wherein the second wavelength is in a range from 630 nm to 670 nm.
  8. 8 . The method of claim 6 , wherein the first wavelength is irradiated to the region of subcutaneous tissue during a first time interval and the second wavelength is irradiated to the region of subcutaneous tissue during a second time interval that is different than the first time interval.
  9. 9 . The method of claim 8 , wherein the first time interval overlaps with the second time interval.
  10. 10 . The method of claim 8 , wherein the first time interval is nonoverlapping with the second time interval.
  11. 11 . The method of claim 8 , wherein the first time interval is in a range from 3 to 30 days, and the second time interval is in a range from 0 days to 4 days.
  12. 12 . The method of claim 8 , wherein the second time interval is provided during hemostasis and inflammation stages of the foreign body response and the first time interval is provided during proliferation and remodeling stages of the foreign body response.
  13. 13 . The method of claim 1 , wherein inserting the light delivery structure through the skin of the host comprises positioning the distal end of the light delivery structure to be separated from the active sensing region by 1 millimeter (mm) or less of the region of subcutaneous tissue.
  14. 14 . The method of claim 13 , wherein the light delivery structure comprises an optical waveguide.
  15. 15 . The method of claim 13 , wherein the light delivery structure comprises a fiber optic with a diameter in a range from 8 microns (μm) to 250 μm.
  16. 16 . The method of claim 1 , further comprising irradiating skin that is above the region of subcutaneous tissue with additional light.
  17. 17 . A device comprising: a foreign body that is configured to be at least partially inserted within a region of subcutaneous tissue of a host, the foreign body comprising a sensor probe having an active sensing region proximate a distal end of the sensor probe; a light source capable of emitting one or more peak wavelengths of light for irradiating one or more portions of the region of subcutaneous tissue to modulate a foreign body response within the region of subcutaneous tissue, the one or more peak wavelengths comprising a first wavelength in a range from 400 nanometers (nm) to 450 nm; and a light delivery structure optically coupled with the light source, the light delivery structure configured to be inserted through skin of the host such that a distal end of the light delivery structure is separated from the active sensing region by a portion of the region of subcutaneous tissue and the distal end comprises a light-scattering region integral to the light delivery structure, and the light-scattering region is positioned at an offset depth above the active sensing region.
  18. 18 . The device of claim 17 , wherein the light source is provided outside the region of subcutaneous tissue for irradiating the light through a portion of the host's skin that is registered with the region of subcutaneous tissue.
  19. 19 . The device of claim 17 , wherein at least a portion of the light delivery structure is capable of residing within the region of subcutaneous tissue to irradiate one or more portions of the region of subcutaneous tissue.
  20. 20 . The device of claim 19 , further comprising an additional light source that is provided for irradiating light through a portion of the host's skin that is registered with the region of subcutaneous tissue.

Description

RELATED APPLICATIONS This application claims the benefit of provisional patent application Ser. No. 63/031,970, filed May 29, 2020, and provisional patent application Ser. No. 63/032,022, filed May 29, 2020, the disclosures of which are hereby incorporated herein by reference in their entireties. FIELD OF THE DISCLOSURE The disclosure relates generally to modulation of foreign body responses in living tissue, and more particularly, to devices and related methods for light-based modulation of foreign body responses in living tissue. BACKGROUND Foreign body response (FBR) generally initiates upon the insertion of a foreign object into subcutaneous tissue, starting with the creation of a wound and initiation of a body's innate wound healing cascade. Proteins can adhere to surfaces of the foreign body and associated protein adsorption can provide an interface that promotes adhesion of inflammatory cells during early stages of FBR. As FBR progresses, monocytes, macrophages, mast cells, and fibroblasts are signaled to the site of the foreign body to initiate clearance of the foreign body by releasing chemokines and cytokines. The concentrations and types of mediators released elicit further cell recruitment as the body may attempt phagocytosis to digest the foreign body. When digestion of the foreign body is unsuccessful, frustrated phagocytosis from activated macrophages can lead to the fusion of macrophages into foreign body giant cells (FBGCs) that attempt to further break down the foreign body. After a period of time, the FBR may progress to fibroblast infiltration and formation of a collagen matrix for encapsulation and sequestering of the foreign body from native tissue. A wide variety of medical devices exist that are designed to be inserted percutaneously in order to extend through at least the epidermis and the dermis of a host, thereby having at least one region that resides in subcutaneous tissue. Additionally, other medical devices exist that are designed to be implanted subcutaneously so as to reside completely under the dermis of a host. Exemplary devices and applications include biometric sensors, catheters, pacemakers, prosthetics, breast implants, biomaterials, etc., and new devices and applications are constantly being developed. While a body's innate FBR may be useful in certain instances, the characteristic outcome of collagen encapsulation can be detrimental to the performance of some inserted or implanted medical devices. Continuous glucose monitors (CGMs) are an exemplary device where FBR can lead to adverse performance characteristics. Diabetes mellitus is a worldwide epidemic characterized by chronic hyperglycemia that results from either a deficiency or tolerance of insulin. Blood glucose levels in diabetic patients can fluctuate significantly throughout the day, resulting in serious complications including heart attacks, strokes, high blood pressure, kidney failure, blindness and limb amputation. Portable glucose sensors give patients the ability to monitor blood glucose levels, manage insulin levels, and reduce the morbidity and mortality of diabetes mellitus. Traditional glucose monitoring techniques are primarily based on electrochemical amperometric glucose sensors. There are a number of approved biometric sensors for use as glucose monitors, with one example employing test strips with either glucose dehydrogenase (GDH) or glucose oxidase (GOx) immobilized on a screen-printed electrode. The analysis is based on obtaining a small blood sample, such as less than 1 microliter (μL), through a finger prick that is subsequently introduced into the test strip via capillary action. While these monitors have augmented the health outcomes for people with diabetes by improving blood glucose management, such monitoring only provides instantaneous blood glucose concentrations, and so such devices are unable to warn of hyperglycemic or hypoglycemic events in advance. Additionally, the sample collection (i.e., finger prick) method can be inconvenient, painful, and may result in poor patient compliance. Analytical methods that enable continuous monitoring of blood glucose have thus been sought. CGMs have been developed that provide glucose levels at suitable time intervals, which can enable acquiring real-time information on trends (e.g., whether the glucose levels are increasing or decreasing), magnitude, duration, and frequency of glucose fluctuations during the day. CGM systems take glucose measurements at regular intervals, 24 hours a day, and translate the readings into dynamic data, generating glucose direction and rate of change. Having this context helps CGM users proactively manage glucose highs and lows, plus gives added insight into impacts that meals, exercise and illness may have on an individual's glucose levels. CGM can also contribute to better diabetes management by helping to reduce or minimize the guesswork that comes with making treatment decisions based solely on a number from