# US 12,005,219 B2 · Systems and methods for conforming treatment applicators to non-uniform surfaces

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- Number: US 12,005,219 B2
- Document ID: US12005219B2
- Status: Granted
- Kind: B2
- Application number: 17/099,443
- Filed: 2020-11-16
- Published: 2021-05-20
- Granted: 2024-06-11
- Earliest claimed: 2019-11-18
- Applicants: Anna O. Likhacheva
- Inventors: Anna O. Likhacheva
- Web page: https://patentgrep.com/patent/US12005219B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61N 5/1001: {using radiation sources introduced into or applied onto the body; brachytherapy}
- A61B 18/1477: {Needle-like probes}
- A61N 5/1027: {Interstitial radiation therapy}
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 18/20: using laser
- A61B 2018/0047: {Upper parts of the skin, e.g. skin peeling or treatment of wrinkles}
- A61B 2018/00577: {Ablation}
- A61B 2018/2005: {with beam delivery through an interstitially insertable device, e.g. needle}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/003: {having a lumen}
- A61M 2037/0061: {Methods for using microneedles}
- A61M 2205/36: related to heating or cooling
- A61N 2005/1018: {with multiple channels for guiding radioactive sources}
- A61N 2007/003: {Destruction of nerve tissue}
- 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)}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems and methods are provided for delivering therapy using an applicator guide and a plurality of catheters for delivering, e.g., radiation, drug, RF, laser or ultrasound therapy. The applicator guide includes a through hole channels through which the catheters may be introduced. The through hole channels may be sized such that the plurality of catheters may freely and independently traverse the through hole channels. By positioning the applicator guide over a target area of a patient's skin, the catheters are free to make contact with the patient's skin and conform to any contours of the patient's skin. The catheters may be microneedles that may be locked in the conformed orientation, such that the microneedles may non-invasively penetrate the patient's skin to deliver the therapy transdermally. The applicator guide may be coupled to an afterloader, drug reservoir, pulse generator, and/or power generator controlled by a healthcare provider via a computing device.

## Claims

### Claim 1

A therapy delivery system, the system comprising:
an applicator guide having a plurality of through hole channels extending from a first side of the applicator guide to a second side of the applicator guide, the plurality of through hole channels arranged in an array; and
a plurality of catheters configured to deliver a therapy, each catheter of the plurality of catheters disposed in respective through hole channels of the plurality of through hole channels in the applicator guide, the plurality of catheters independently and freely movable in at least one degree of freedom within the respective through hole channels such that the plurality of catheters are configured to conform to contours of an area of the patient's skin and to contact the area in a conformed orientation,
wherein the plurality of catheters are configured to deliver therapy to at least a portion of the area of the patent's skin while the plurality of catheters are positioned in the conformed orientation.

### Claim 2 (depends on 1)

The system of claim 1, wherein the plurality of catheters comprise a plurality of microneedles configured to non-invasively penetrate a stratum corneum (SC) of the patient's skin, such that the plurality of microneedles are configured to selectively deliver therapy to the at least a portion of the area transdermally.

### Claim 3 (depends on 2)

The system of claim 2, wherein the applicator guide comprises a plurality of locks, each one of the plurality of locks operatively coupled to a respective one of the plurality of microneedles to lock the respective one of the plurality of microneedles in the conformed orientation, such that the plurality of microneedles are configured to non-invasively penetrate the stratum corneum (SC) of the patient's skin in the conformed orientation.

### Claim 4 (depends on 3)

The system of claim 3, wherein the plurality of locks are configured to be activated individually or together.

### Claim 5 (depends on 2)

The system of claim 2, wherein the plurality of microneedles are configured to selectively deliver a drug to the at least a portion of the area transdermally.

### Claim 6 (depends on 5)

The system of claim 5, wherein the plurality of microneedles are coated with the drug.

### Claim 7 (depends on 5)

The system of claim 5, wherein the plurality of microneedles comprise an internal lumen, such that the drug is configured to be delivered to the at least a portion of the area transdermally through the internal lumen of the plurality of microneedles.

### Claim 8 (depends on 5)

The system of claim 5, wherein the drug is embedded within the plurality of microneedles, and wherein at least a portion of the plurality of microneedles is configured to dissolve to deliver the drug to the at least a portion of the area transdermally.

### Claim 9 (depends on 1)

The system of claim 1, wherein the plurality of catheters are operatively coupled to a pulse generator, and configured to selectively deliver RF energy to the at least a portion of the area.

### Claim 10 (depends on 1)

The system of claim 1, wherein the plurality of catheters are operatively coupled to an ultrasound transducer, and configured to selectively deliver ultrasound energy to the at least a portion of the area.

### Claim 11 (depends on 1)

The system of claim 1, wherein the plurality of catheters are operatively coupled to an afterloader, and configured to selectively deliver radiotherapy to the at least a portion of the area.

### Claim 12 (depends on 11)

The system of claim 11, wherein each of the plurality of catheters is configured to be individually activated to deliver radiation.

### Claim 13 (depends on 11)

The system of claim 11, wherein the afterloader is connected to each one of the plurality of catheters via a plurality of transfer tubes, the system further comprising a computing device in communication with the afterloader and configured to instruct the afterloader to deliver radioactive material to the plurality of catheters.

### Claim 14 (depends on 1)

The system of claim 1, wherein one or more of the plurality of catheters is configured to apply heat while simultaneously delivering therapy to the at least a portion of the area.

### Claim 15

A method for delivering therapy to a patient, the method comprising:
positioning an applicator guide over a target area of the patient, the applicator guide comprising a plurality of through hole channels;
loading a plurality of catheters into through hole channels of the plurality of through hole channels such that each of the plurality of through hole channels is loaded with a catheter of the plurality of catheters;
conforming the plurality of catheters to the target area of the patient, the plurality of catheters independently and freely movable within the through hole channels in at least one degree of freedom such that the plurality of catheters are configured to conform to contours of the target area of the patient in a conformed orientation; and
delivering therapy to the target area of the patient via at least one of the plurality of catheters in the conformed orientation.

### Claim 16 (depends on 15)

The method of claim 15, wherein the plurality of catheters comprises a plurality of microneedles, and wherein the method further comprises locking the microneedles in the conformed orientation.

### Claim 17 (depends on 16)

The method of claim 16, further comprising penetrating a stratum corneum (SC) of the patient's skin with the plurality of microneedles in the conformed orientation, and wherein delivering therapy to the target area of the patient comprises delivering therapy to the target area of the patient transdermally.

### Claim 18 (depends on 17)

The method of claim 17, wherein delivering therapy to the target area of the patient transdermally comprises delivering a drug to the target area of the patient.

### Claim 19 (depends on 17)

The method of claim 17, wherein delivering therapy to the target area of the patient transdermally comprises delivering energy to the target area of the patient.

### Claim 20 (depends on 15)

The method of claim 15, wherein delivering therapy to the target area of the patient comprises delivering radioactive material to at least one of the plurality of catheters.
