# US 12,397,139 B1 · Geometric voids for implantable therapeutic delivery device

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- Number: US 12,397,139 B1
- Document ID: US12397139B1
- Status: Granted
- Kind: B1
- Application number: 16/881,169
- Filed: 2020-05-22
- Granted: 2025-08-26
- Earliest claimed: 2019-05-22
- Assignees: Cochlear Limited
- Applicants: Peter Raymond Sibary; Andrian Sue; Alexander Stephen Baume
- Inventors: Peter Raymond Sibary; Andrian Sue; Alexander Stephen Baume
- Web page: https://patentgrep.com/patent/US12397139B1

## CPC

- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61N 1/0541: {Cochlear electrodes}
- A61N 1/36038: {Cochlear stimulation}
- A61M 2210/0668: Middle ear
- 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)

## Abstract

A device, including an electrode array carrier, that carries one or more electrode arrays, and a therapeutic substance such as for example an anti-inflammatory, wherein the therapeutic substance is located in at least one cavity of the carrier, the cavity having at least one of a non-uniform depth or a non-uniform width with respect to location in a direction of the depth that has an effective impact on a delivery of the therapeutic substance to a human.

## Claims

### Claim 1

A device, comprising:
an electrode array carrier; and
therapeutic substance, wherein
the therapeutic substance is located in a well of the electrode array carrier.

### Claim 2 (depends on 1)

The device of claim 1, wherein:
the well is deeper than a maximum width.

### Claim 3 (depends on 1)

The device of claim 1, wherein:
the carrier is made of silicone; and
the well is at least partially filled with a silicone-medicament mixture distinct from the silicone of the carrier, the medicament of the medicament mixture being the therapeutic substance.

### Claim 4 (depends on 1)

The device of claim 1, wherein:
there are a plurality of wells spaced apart from one another; and
at least most of the wells of the device are located away from a plane extending through a longitudinal axis of the carrier and electrodes of the carrier.

### Claim 5 (depends on 1)

The device of claim 1, wherein:
there are a plurality of wells spaced apart from one another;
a first group of wells numbering between 2 and 10 have a first general depth and width profile;
a second group of wells numbering between 2 and 10 have a second general depth and width profile different from the first general depth and width profile;
a third group of wells numbering between 2 and 10 have a third general depth and width profile different from the second general depth and width profile; and
at least one of:
one or two of the first, second and third group is at least mostly devoid of therapeutic substance;
one or two of the first, second and third group is at least mostly full of therapeutic substance;
one or two of the first, second and third group contains a different therapeutic substance than that contained in one or two of the first, second or third group.

### Claim 6 (depends on 1)

The device of claim 1, wherein:
the well is located such that any stress that exists in the array as a result of implantation of the array into a cochlea has no effective impact on the well, all other things being equal.

### Claim 7 (depends on 1)

The device of claim 1, wherein:
the well is located such that any stress that exists in the array as a result of implantation of the array into a cochlea has an effective impact on the well, all other things being equal.

### Claim 8 (depends on 2)

The device of claim 2, wherein:
the well has a diameter at an outlet of the well of greater than 0.1 mm.

### Claim 9 (depends on 1)

The device of claim 1, wherein:
a width of the well is constant with depth of the well over all of the depth.

### Claim 10 (depends on 1)

The device of claim 1, wherein:
the device is a membraneless therapeutic substance delivery device.

### Claim 11 (depends on 1)

The device of claim 1, wherein:
the well has a uniform depth with respect to location in the direction of the depth at all locations of the well along a longitudinal axis of the array carrier.

### Claim 12 (depends on 1)

The device of claim 1, wherein:
a length of the well is constant with depth of the well over all of the depth.

### Claim 13 (depends on 1)

The device of claim 1, wherein:
only the therapeutic substance or a mixture containing the therapeutic substance is located in the well.

### Claim 14 (depends on 13)

The device of claim 13, wherein:
the electrode array carrier is arranged so that the therapeutic substance is delivered by dissolution, and wherein the device is cochlear implant electrode array.

### Claim 15 (depends on 1)

The device of claim 1, wherein:
the device includes a plurality of wells that are spaced apart from one another, at least some of the wells of the plurality of wells being located singularly relative to other wells of the plurality of wells at a same distance along a longitudinal axis of the carrier.

### Claim 16

The device of 1, wherein:
there are at least four wells that are spaced apart from one another.

### Claim 17 (depends on 1)

The device of claim 1, wherein:
the device is devoid of a backstrap and tip containing a therapeutic substance.

### Claim 18

A device, comprising:
an electrode array carrier; and
a therapeutic substance, wherein
the therapeutic substance is located in at least one cavity of the carrier, the cavity having at least one of a non-uniform depth or a non-uniform width with respect to location in a direction of the depth.

### Claim 19 (depends on 18)

The device of claim 18, wherein:
the cavity has the non-uniform width with respect to the location in the direction of the depth; and
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 20 (depends on 18)

The device of claim 18, wherein:
the cavity is a well extending from the outer surface of the carrier; and
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 21 (depends on 18)

The device of claim 18, wherein:
the cavity has an elongate portion that extends in a longitudinal direction of the carrier; and
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 22 (depends on 18)

The device of claim 18, wherein:
there are at least four cavities having the at least one of a non-uniform depth or a non-uniform width with respect to location in a direction of the depth; and
with respect to the respective cavities of the at least four cavities, the respective at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 23 (depends on 18)

The device of claim 18, wherein:
the device is devoid of a backstrap and tip containing a therapeutic substance; and
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 24 (depends on 18)

The device of claim 18, wherein:
the cavity has a uniform depth with respect to location in the direction of the depth at all locations of the cavity along a longitudinal axis of the array carrier; and
the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 25 (depends on 18)

The device of claim 18, wherein:
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 26 (depends on 25)

The device of claim 25, wherein:
the cavity of the carrier has a diameter at an opening of the cavity of greater than 2 mm.

### Claim 27 (depends on 18)

The device of claim 18, wherein:
the cavity is more shallow than a maximum width and more shallow than a maximum length; and
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 28 (depends on 18)

The device of claim 18, wherein:
the cavity of the carrier has a minimum diameter at an opening of the cavity of greater than 0.3 mm.

### Claim 29 (depends on 28)

The device of claim 28, wherein:
the cavity of the carrier has a diameter at an opening of the cavity of greater than 2 mm.

### Claim 30 (depends on 29)

The device of claim 29, wherein:
the diameter at the opening greater than 2 mm is normal to the minimum diameter.

### Claim 31 (depends on 29)

The device of claim 29, wherein:
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human.

### Claim 32 (depends on 28)

The device of claim 28, wherein:
the cavity of the carrier has a diameter at an opening of the cavity of greater than 5 mm.

### Claim 33 (depends on 18)

The device of claim 18, wherein
the at least one of the non-uniform depth or the non-uniform width with respect to location in the direction of the depth has an effective impact on a delivery of the therapeutic substance to a human and a distal tip of the device is devoid of a cavity configured to receive a therapeutic substance.

### Claim 34 (depends on 18)

The device of claim 18, wherein:
there are at least three cavities in the carrier, and respective cavities of the at least three cavities have a minimum diameter at an opening of the respective cavity of greater than 0.2 mm, and respective cavities of the at least three cavities have a diameter at an opening of the respective cavity of greater than 3 mm.

### Claim 35 (depends on 34)

The device of claim 34, wherein:
respective cavities of the at least three cavities are located such that any stress that exists in the array carrier as a result of implantation of the array carrier into a cochlea has no effective impact on respective cavities of the at least three cavities all other things being equal.

### Claim 36 (depends on 19)

The device of claim 19, wherein:
the cavity also has the non-uniform depth.

### Claim 37 (depends on 19)

The device of claim 19, wherein:
the cavity has the non-uniform width with respect to location in a direction of a longitudinal axis of the electrode array carrier.

### Claim 38

A device, comprising:
an electrode array carrier; and
a therapeutic substance, wherein
at least one of:
the electrode array carrier and the therapeutic substance are collectively arranged to provide for a therapeutic substance release rate that is variable over time; or
the therapeutic substance is located in a plurality of wells that are spaced apart from one another, at least some of the wells being located in pairs at a same distance along a longitudinal axis of the carrier.

### Claim 39 (depends on 38)

The device of claim 38, wherein:
a layer of silicone is located over the therapeutic substance at some locations and not at other locations.

### Claim 40 (depends on 38)

The device of claim 38, wherein:
the electrode array carrier includes a well in which the therapeutic substance is located; and
the well has a geometry such that the therapeutic substance therein has a two state release profile owing to the geometry.

### Claim 41 (depends on 38)

The device of claim 38, wherein:
the electrode array carrier includes a well in which the therapeutic substance is located; and
the well has a cross-section, lying on a plane that is normal to a longitudinal axis of the carrier, such that the well at least one of widens or narrows with location closer to the longitudinal axis.

### Claim 42 (depends on 38)

The device of claim 38, wherein:
the device is devoid of glue holding the therapeutic substance; and
the therapeutic substance is a drug that is mixed in a silicone separate from the electrode array carrier.

### Claim 43 (depends on 38)

The device of claim 38, wherein:
the therapeutic substance is located in a plurality of wells that are spaced apart from one another, at least some of the wells being located in pairs at a same distance along a longitudinal axis of the carrier.

### Claim 44 (depends on 38)

The device of claim 38, wherein:
the therapeutic substance is located in a plurality of wells that are spaced apart from one another, at least some of the wells being located singularly relative to other wells at a same distance along a longitudinal axis of the carrier.

### Claim 45 (depends on 38)

The device of claim 38, wherein:
the electrode array carrier and the therapeutic substance are collectively arranged to provide for the therapeutic substance release rate that is variable over time; and
the therapeutic substance is located in a plurality of wells that are spaced apart from one another.

### Claim 46 (depends on 38)

The device of claim 38, wherein:
the electrode array carrier is arranged so that the therapeutic substance is delivered by diffusion.

### Claim 47 (depends on 38)

The device of claim 38, wherein:
the electrode array carrier is arranged so that the therapeutic substance is delivered by dissolution, and wherein the device is cochlear implant electrode array.

### Claim 48 (depends on 38)

The device of claim 38, wherein:
the electrode array includes a cavity having a circular cross-section lying on a plane normal to a longitudinal axis of the electrode array, in which cavity is located the therapeutic substance; and
the electrode array includes a passageway extending from the cavity to an outside of the electrode array through which the therapeutic substance travels from the cavity to the outside of the electrode array.