EP-4735088-A1 - SUBSTANCE DELIVERY CONTROLLED INSIDE MAMMALS

Abstract

An apparatus including a reservoir and a therapeutic substance located in the reservoir, wherein the apparatus is an implantable therapeutic substance delivery apparatus, and the apparatus is configured to deliver the therapeutic substance to a recipient thereof by diffusion controlled release. In an exemplary embodiment, the apparatus is also a cochlear implant.

Inventors

• SMYTH, DANIEL
• DUECK, Wolfram Frederik

Assignees

• Cochlear Limited

Dates

Publication Date

20260506

Application Date

20240627

Claims (20)

1. 1. An apparatus, comprising: a reservoir; and a therapeutic substance located in the reservoir, wherein the apparatus is an implantable therapeutic substance delivery apparatus, and the apparatus is configured to deliver the therapeutic substance to a recipient thereof by diffusion controlled release.
2. 2. The apparatus of claim 1, wherein: the reservoir includes a first sub-reservoir and a second sub-reservoir, the second subreservoir being constricting relative to the first sub-reservoir; and molecules of the therapeutic substance move from the first sub-reservoir to the second sub-reservoir during delivery of the therapeutic substance to the recipient.
3. 3. The apparatus of claim 1, wherein: the reservoir includes a first sub-reservoir, a second sub-reservoir, and a third subreservoir the second sub-reservoir being constricting relative to the first sub-reservoir and the third sub-reservoir being constricting relative to the second sub-reservoir; molecules of the therapeutic substance move from the first sub-reservoir to the second sub-reservoir to the third sub-reservoir during delivery of the therapeutic substance to the recipient.
4. 4. The apparatus of claims 1, 2 or 3, wherein: the reservoir is established by at least a cistern and a conduit device; the conduit device includes a first conduit section having a first cross-sectional area normal to a direction of extension of the first conduit section that is larger than a second cross-sectional area of a second conduit section normal to a direction of extension of the second conduit section; and the cross-sectional area of the second conduit section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into the recipient is less than l/3 rd of that which would exist if the first cross-sectional area was the same as the second cross-sectional area, all other things being equal.
5. 5. The apparatus of claims 1, 2 or 3, wherein: the reservoir is established by at least a cistern and a conduit device; the conduit device includes a first conduit section having a first cross-sectional area normal to a direction of extension of the first conduit section that is larger than a second cross-sectional area of a second conduit section normal to a direction of extension of the second conduit section; and the cross-sectional area of the second conduit section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is less than 10% of that which would be the case if the first cross-sectional area was the same as the second cross-sectional area, all other things being equal.
6. 6. The apparatus of claims 1, 2 or 3, wherein: the reservoir is established by at least a cistern and a conduit device; the conduit device includes a first conduit section having a first cross-sectional area normal to a direction of extension of the first conduit section that is at least five times larger than a second cross-sectional area of a second conduit section normal to a direction of extension of the second conduit section; the first conduit section has a first length that is larger than a second length of the second conduit section; and the length of the second conduit section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is less than 50% of that which would be the case if the first length was 25 times the second length, all other things being equal.
7. 7. The apparatus of claims 1, 2 or 3, wherein: the reservoir is established by at least a cistern and a conduit device; the conduit device includes a first conduit section having a first cross-sectional area normal to a direction of extension of the first conduit section that is at least five times larger than a second cross-sectional area of a second conduit section normal to a direction of extension of the second conduit section; the first conduit section has a first length that is larger than a second length of the second conduit section; and the length of the second conduit section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is less than 70% of that which would be the case if the length of the second section was 25 times the second length, all other things being equal.
8. 8. An apparatus, comprising: a cistern; and a delivery tube device, wherein the apparatus is an implantable therapeutic substance delivery apparatus, the delivery tube device is a diffusion delivery tube device, and the apparatus is configured so that therapeutic substance located in the cistern travels to the delivery tube device for delivery to a human implanted with the device.
9. 9. The apparatus of claim 8, wherein: the cistern has an internal volume of at least an order of magnitude larger than that of the delivery tube.
10. 10. The apparatus of claims 8 or 9, wherein: the delivery tube device has a first section having a first cross-sectional area normal to a direction of extension of the first section that is larger than a second cross-sectional area of a second section of the delivery tube device, the second cross-sectional area being normal to a direction of extension of the second section; and the first cross-sectional area is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is at least twice that which would be the case if the first cross-sectional area was the same as the second cross- sectional area, all other things being equal.
11. 11. The apparatus of claims 8 or 9, wherein: the delivery tube device has a first section having a first cross-sectional area normal to a direction of extension of the first section that is larger than a second cross-sectional area of a second section of the delivery tube device, the second cross-sectional area being normal to a direction of extension of the second section; and the first cross-sectional area is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is within 20% of that which would be the case if the first cross-sectional area was the same as the second cross- sectional area, all other things being equal.
12. 12. The apparatus of claims 8 or 9, wherein: the delivery tube device has a first section having a first length that is larger than a second length of a second section of the delivery tube device; the first section has a first cross-sectional area normal to a direction of extension of the first section that is at least five times larger than a second cross-sectional area of the second section of the delivery tube device normal to a direction of extension of the second section; and the length of the first section is at least four times larger than the length of the second section, and the length of the first section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is within 10% of that which would exist if the length of the first section was at least 6 times larger than the length of the second section, all other things being equal.
13. 13. The apparatus of claims 8 or 9, wherein: the delivery tube has a first section having a first length that is larger than a second length of a section of the delivery tube; the first section has a first cross-sectional area normal to a direction of extension of the first section that is at least five times larger than a second cross-sectional area of the second section of the delivery tube device normal to a direction of extension of the second section; and the length of the first section is at least four times larger than the length of the second section, and the length of the first section is such that a release rate of the therapeutic substance from the apparatus at and/or after seven days of release into a human is within 10% of that which would exist if the length of the first section was at least 8 times larger than the length of the second section, all other things being equal.
14. 14. The apparatus of claims 8 or 9, wherein: the delivery tube device has a first section having a first length that is larger than a second length of a second section of the delivery tube device; the first section has a first cross-sectional area normal to a direction of extension of the first section that is larger than a second cross-sectional area of the second section of the delivery tube device normal to a direction of extension of the second section; and the second cross-sectional area is such that a release rate of the therapeutic substance at and/or after 12 hours of release into a human of the therapeutic substance from the apparatus is less than 60% of that which would exist if the second cross-sectional area was the same as the second cross-sectional area; and the second cross-sectional area is such that a release rate of the therapeutic substance at and/or after 12 hours of release into the human of the therapeutic substance from the apparatus is within 10% of that which would exist if the second cross-sectional area was at least one of 10 times smaller or 10 times larger.
15. 15. A method, comprising: accessing an interior of a human; and treating an ailment of the human by controllably delivering a therapeutic substance delivered from an implantable therapeutic substance delivery device, wherein the action of controllably delivering the therapeutic substance is executed passively.
16. 16. The method of claim 15, wherein: a fluidic bridge between the therapeutic substance and a body fluid in the human is present.
17. 17. The method of claim 16, wherein: the bridge allows molecules of the therapeutic substance to diffuse from the device into the interior of the human.
18. 18. The method of claims 15, 16 or 17, wherein: the body fluid is perilymph.
19. 19. The method of claims 15, 16, 17 or 18, wherein: after an initial temporal period where therapeutic substance release rate steadily reduces from a relatively higher rate, the therapeutic substance release rate quasi-stabilizes at a lower rate.
20. 20. The method of claim 19, wherein: the quasi-stabilized release rate is due to a slowly changing concentration gradient of the substance within the device.

Description

SUBSTANCE DELIVERY CONTROLLED INSIDE MAMMALS CROSS-REFERENCE TO RELATED APPLICATIONS [oooi] This application claims priority to U.S. Provisional Application No. 63/524,327, entitled SUBSTANCE DELIVERY CONTROLLED INSIDE MAMMALS, filed on June 30, 2023, naming Daniel SMYTH as an inventor, the entire contents of that application being incorporated herein by reference in its entirety. BACKGROUND [0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years. [0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components. SUMMARY [0004] In an exemplary embodiment, there is an apparatus, comprising: a reservoir; and a therapeutic substance located in the reservoir, wherein the apparatus is an implantable therapeutic substance delivery apparatus, and the apparatus is configured to deliver the therapeutic substance to a recipient thereof by diffusion controlled release. [0005] In an exemplary embodiment, there is an apparatus, comprising: a cistern; and a delivery tube device, wherein the apparatus is an implantable therapeutic substance delivery apparatus, the delivery tube device is a diffusion delivery tube device, and the apparatus is configured so that therapeutic substance located in the cistern travels to the delivery tube for delivery to a human implanted with the device. [0006] In an exemplary embodiment, there is a method, comprising: accessing an interior of a human; and treating an ailment of the human by controllably delivering a therapeutic substance delivered from an implantable therapeutic substance delivery device, wherein the action of controllably delivering the therapeutic substance is executed passively. [0007] In an exemplary embodiment, there is an apparatus, comprising: a first at least partially bounded volume; a second at least partially bounded volume; and at least one apparatus outlet at the second bounded volume, wherein the apparatus is an implantable therapeutic substance delivery apparatus, and the apparatus delivers the therapeutic substance to a recipient thereof effectively entirely due to a concentration gradient. [0008] In an exemplary embodiment, there is a method, comprising: accessing an interior of a human; and treating an ailment of a human by controllably delivering a therapeutic substance delivered from an implantable therapeutic substance delivery device, wherein the action of controllably delivering the therapeutic substance is executed effectively without a net movement of solvent in which the therapeutic substance is present from a therapeutic substance containing volume of the device to the ambient environment outside the device. [0009] In an exemplary embodiment, there is an implantable therapeutic substance delivery apparatus, comprising a cistern and a delivery tube device, wherein the delivery tube device includes a tubular apparatus that includes a first lumen and a second lumen distinctly different from the first lumen, the delivery tube device is a diffusion delivery tube device, the first lumen is in fluid communication with the cistern and the second lumen is in fluid communication with the first lumen, and the apparatus is configured so that the therapeutic substance located in the cistern travels to the delivery tube device for delivery to a human implanted with the device. BRIEF DESCRIPTION OF THE DRAWINGS [ooio] Embodiments are described below with reference to the attached drawings, in which: [0011] FIG. 1A is a perspective view of an exemplary hearing prosthesis in which at least some of the teachings detailed herein are applicable; [0012] FIGs. 1B-1D are quasi functiona