# US 11,571,586 B2 · Devices and methods for light delivery

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- Number: US 11,571,586 B2
- Document ID: US11571586B2
- Status: Granted
- Kind: B2
- Application number: 17/056,094
- Filed: 2019-05-17
- Published: 2021-07-08
- Granted: 2023-02-07
- Earliest claimed: 2018-05-18
- Assignees: Northwestern University
- Applicants: Northwestern University
- Inventors: Shuai Xu; Chenkai Xu; Hao Zhang; Hangbo Zhao; John A. Rogers
- Web page: https://patentgrep.com/patent/US11571586B2

## CPC

- A61N 5/0601: {Apparatus for use inside the body}
- A61N 5/0616: {Skin treatment other than tanning}
- A61M 37/0015: {by using microneedles}
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61B 18/203: {applying laser energy to the outside of the body}
- A61B 2018/00351: {Heart}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00458: {Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains}
- A61B 2018/0047: {Upper parts of the skin, e.g. skin peeling or treatment of wrinkles}
- A61B 2018/2005: {with beam delivery through an interstitially insertable device, e.g. needle}
- A61M 2025/0093: {wherein at least one needle is a microneedle}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- A61M 2037/003: {having a lumen}
- A61M 2037/0046: {Solid microneedles}
- A61M 2037/0061: {Methods for using microneedles}
- A61N 5/0619: {Acupuncture}
- A61N 5/0624: {for eliminating microbes, germs, bacteria on or in the body}
- A61N 5/0625: {Warming the body, e.g. hyperthermia treatment}
- A61N 2005/0602: {for treatment of blood vessels}
- A61N 2005/063: {comprising light transmitting means, e.g. optical fibres}
- A61N 2005/0645: {Applicators worn by the patient}
- A61N 2005/0652: {Arrays of diodes}
- A61N 2005/0659: {infrared}
- A61N 2005/0661: {ultraviolet}
- A61N 2005/0663: {Coloured light}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Provided are conformable light delivery devices for increasing light penetration depth and related methods. The device may comprise a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member and a substrate that supports the tissue penetrating members, wherein the substrate is optionally a flexible substrate.

## Claims

### Claim 1

A conformable light delivery device for increasing light penetration depth into a tissue, comprising:
a microarray of tissue penetrating members, each tissue penetrating member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member;
a substrate that supports the tissue penetrating members; and
an optical source in optical communication with the microarray of tissue penetrating members,
wherein the microarray and the optical source are integrated or removably connected to each other; and
wherein the microarray of tissue penetrating members are configured to penetrate the tissue during use and to increase the penetration depth of light into the tissue.

### Claim 2 (depends on 1)

The light delivery device of claim 1, wherein the optical source delivers at least 0.1 mW/cm2 and/or at least 10 mJ/cm2 to the tissue during use.

### Claim 3 (depends on 1)

The light delivery device of claim 1, wherein the optical source is at least partially encapsulated in a transparent encapsulation layer.

### Claim 4 (depends on 1)

The light delivery device of claim 1, wherein the penetration depth of said light into the tissue is increased by at least a factor of 1.1 compared to said light exposed to skin without the microarray of tissue penetrating members.

### Claim 5 (depends on 1)

The light delivery device of claim 1, wherein each tissue penetrating member transmits at least 90% of ultraviolet light or a desired subrange thereof.

### Claim 6 (depends on 1)

The light delivery device of claim 1, wherein the tissue penetrating members have an optical property that is optically matched to the optical source, wherein the optical property is selected from the group consisting of: optical transmission/output light spectrum; index of refraction; scattering, absorption, emissivity, fluorescence, heat generation; and thermal relaxation time of tissue.

### Claim 7 (depends on 1)

The light delivery device of claim 1, wherein said light is transmitted from the tissue penetrating members through all side surfaces.

### Claim 8 (depends on 1)

The light delivery device of claim 1, wherein the light delivery device is flexible with a bulk bending stiffness selected so that the device is capable of conforming to a tissue surface during a light therapy application to reduce surface reflection and increase light delivery to a target.

### Claim 9 (depends on 8)

The light delivery device of claim 8, wherein the reduced surface reflection is by the substrate having a composition that provides an index of refraction that is within 10% of an index of refraction of a material from which the tissue penetrating members are formed.

### Claim 10 (depends on 1)

The light delivery device of claim 1, further comprising an optical dispersion element in optical communication with the tissue penetrating members to increase light dispersion and increase light intensity uniformity to the tissue that surrounds the tissue penetrating members during use, wherein the optical dispersion element comprises one or more of: a roughened tissue penetrating member surface; an optical coating; a diffraction grating; a waveguide; a chemically-modified tissue penetrating member surface; a patterned optically opaque layer; lenses; or upconverting or downconverting phosphors.

### Claim 11 (depends on 1)

The light delivery device of claim 1, having a light transmission footprint that is greater than or equal to 0.2 cm2.

### Claim 12 (depends on 1)

The light delivery device of claim 1, wherein the substrate has a bottom surface that supports the microarray of tissue penetrating members and a top surface that supports a plurality of optical sources.

### Claim 13 (depends on 12)

The light delivery device of claim 12, wherein the microarray of tissue penetrating members are optically aligned with the plurality of optical sources to provide substantially uniform light intensity to the tissue that surrounds the microarray of tissue penetrating members.

### Claim 14 (depends on 1)

The light delivery device of claim 1, wherein the substrate is a flexible substrate.

### Claim 15 (depends on 1)

The light delivery device of claim 1, wherein said light is transmitted from the tissue penetrating members through the distal end to tissue surrounding the tissue penetrating members.

### Claim 16

A conformable light delivery device for increasing light penetration depth into a tissue, comprising:
a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member; and
a substrate that supports the tissue penetrating members,
wherein the microarray of tissue penetrating members is formed from a microarray material having an index of refraction that is matched to an index of refraction of the substrate; and
wherein the tissue penetrating members have an effective Young's modulus selected to withstand stresses during insertion through a tissue surface without substantial deformation in a direction that decreases the penetration depth into the tissue.

### Claim 17 (depends on 16)

The light delivery device of claim 16, having a tissue penetrating member occupancy fraction (area of member base to area of substrate) equating to n*(proximal member surface area)/(surface area of substrate bottom surface), wherein n is the number of penetrating members in the microarray of microneedles.

### Claim 18 (depends on 16)

The light delivery device of claim 16, wherein the light delivery device is integrated in a stent, a guidewire, a catheter, a balloon catheter for use in a blood vessel; a subdermal implant; an orthopedic implant, a prosthesis, or a neurological implant.

### Claim 19 (depends on 18)

The light delivery device of claim 18, wherein the light delivery device is a conformable intra-arterial or intra-venous device and comprises a plurality of LEDs in optical communication with the microarray of tissue penetrating members.

### Claim 20 (depends on 19)

The light delivery device of claim 19, wherein the LEDs are UV-emitting LEDs.

### Claim 21 (depends on 20)

The light delivery device of claim 20, wherein UV light emitted by the UV-emitting LEDs is configured to vasodilate a blood vessel.

### Claim 22 (depends on 16)

The light delivery device of claim 16, further comprising a light intensity modulator for controlling light intensity as a function of depth from the tissue surface.

### Claim 23 (depends on 22)

The light delivery device of claim 22, wherein the light intensity output is focused toward or at the distal end of the tissue penetrating members.

### Claim 24 (depends on 16)

A method of providing light to the tissue, the method comprising the steps of:
providing a device of claim 16;
conformally contacting the microarray with a tissue surface;
inserting at least a portion of the microarray of tissue penetrating members into skin;
transmitting light through the substrate and the microarray of tissue penetrating members to the tissue that surrounds the microarray of tissue penetrating members,
wherein the transmitting step comprises:
energizing a plurality of LEDs connected to the substrate surface, wherein the LEDs have an emission maximum in an UV range, an IR range or a visible portion of the electromagnetic spectrum.

### Claim 25

A conformable light delivery device for increasing light penetration depth in a tissue, comprising:
a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member;
a substrate that supports the tissue penetrating members, wherein the microarray of tissue penetrating members is formed from a microarray material having an index of refraction that is matched to an index of refraction of the substrate; and
a bioactive agent releasably connected to the microarray of tissue penetrating members, wherein the bioactive agent is activated by light transmitted by the microarray of tissue penetrating members.

### Claim 26 (depends on 25)

The light delivery device of claim 25, wherein the bioactive agent comprises a coating on at least a portion of a surface of the penetrating members.

### Claim 27 (depends on 25)

The light delivery device of claim 25, wherein the tissue penetrating members have an effective Young's modulus selected to withstand stresses during insertion through the tissue surface without substantial deformation in the direction that decreases the penetration depth in the tissue.

### Claim 28

A conformable light delivery device for increasing light penetration depth in a tissue, comprising:
a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member;
a substrate that supports the tissue penetrating members, wherein the microarray of tissue penetrating members is formed from a microarray material having an index of refraction that is matched to an index of refraction of the substrate; and
a light intensity modulator for controlling light intensity as a function of depth from a tissue surface, wherein the light intensity modulator comprises a non-transparent coating extending from the tissue penetrating members' proximal end to reduce optical light intensity to a tissue surface region.

### Claim 29 (depends on 28)

The light delivery device of claim 28, wherein the non-transparent coating reduces UV light transmission and the tissue surface region corresponds to an epidermal layer.

### Claim 30

A conformable light delivery device for increasing light penetration depth in a tissue, comprising:
a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member; and
a substrate that supports the tissue penetrating members,
wherein the microarray of tissue penetrating members is formed from a microarray material having an index of refraction that is matched to an index of refraction of the substrate; and
wherein the substrate further comprises a substrate component that improves light delivery, wherein the substrate component comprises one or more of glycerol or perfluorodecalin.

### Claim 31

An injectable therapeutic light delivery device comprising:
a substrate;
a tissue penetrating member having a proximal end and a distal end, wherein the proximal end is supported by the substrate;
a plurality of light sources optically dispersed along a member wall that extends between the member proximal and distal ends; and
a light intensity modulator for controlling light intensity of the plurality of light sources as a function of depth from a tissue surface, wherein the light intensity modulator comprises a non-transparent coating extending from the tissue penetrating members' proximal end to reduce optical light intensity to a tissue surface region;
wherein the tissue penetrating member and the plurality of light sources are configured to penetrate a tissue to provide controlled subsurface light intensity to the tissue that surrounds the tissue penetrating member during use.

### Claim 32 (depends on 31)

The device of claim 31, wherein the tissue penetrating member comprises a needle.

### Claim 33 (depends on 32)

The device of claim 32, wherein the needle comprises an optically non-transparent material, including a metal, and the light sources are LEDs that are distributed on a tissue-facing surface of the needle.

### Claim 34 (depends on 33)

The device of claim 33, wherein the LEDs are UV-emitting LEDs.

### Claim 35 (depends on 31)

The device of claim 31, configured to treat cancer, including cutaneous T-cell lymphoma.

### Claim 36 (depends on 31)

The device of claim 31, wherein the light delivered by the light sources is of UVA or UVB light at a tissue depth that is greater than or equal to 1 cm.

### Claim 37 (depends on 31)

The device of claim 31, comprising a plurality of tissue penetrating members, wherein each tissue penetrating member has a plurality of light sources optically dispersed along the member wall that extends between the member proximal and distal ends.

### Claim 38

A light delivery device for increasing light penetration depth in a tissue, comprising:
a microarray of tissue penetrating members, each member having a distal end and a proximal end, wherein the tissue penetrating members are at least partially optically transparent to provide optical transmission through a surface that extends between the distal and proximal ends of each tissue penetrating member, wherein the tissue penetrating members have an effective Young's modulus selected to withstand stresses during insertion through a tissue surface without substantial deformation in a direction that decreases the penetration depth in the tissue.

### Claim 39 (depends on 38)

The device of claim 38, further comprising an optical dispersion elements configured for optical communication with the tissue penetrating members and a light source.

### Claim 40 (depends on 39)

The device of claim 39, wherein the optical dispersion elements comprise lenses positioned in optical alignment with the tissue penetrating members to maximize light delivery to the tissue penetrating members and minimize light that is directed to areas of substrate not having a corresponding tissue penetrating member.

### Claim 41 (depends on 39)

The device of claim 39, wherein the optical dispersion elements comprises roughening (recess and/or relief features) of members and/or substrate, coatings, diffraction grating, waveguides, patterned optically opaque layer, and/or phosphors.

### Claim 42 (depends on 39)

The device of claim 39, wherein the optical dispersion elements are positioned in the device between the tissue and the light source, between the tissue and the tissue penetrating members, and/or between the light source and the tissue penetrating members.
