Medical device and method for manufacturing a medical device
US-2019388013-A1 · Dec 26, 2019 · US
US12369879B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12369879-B2 |
| Application number | US-202117924029-A |
| Country | US |
| Kind code | B2 |
| Filing date | May 7, 2021 |
| Priority date | May 8, 2020 |
| Publication date | Jul 29, 2025 |
| Grant date | Jul 29, 2025 |
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Embodiments of the present disclosure relate to transcutaneous sound sensors. In at least one embodiment, a transcutaneous sound sensor system comprises a mounting unit and a sound sensor. The mounting unit detachably connects to an electronics unit and mounts to skin on a body. The sound sensor senses sounds originating from inside the body. The sound sensor comprises an in-vivo portion and an ex-vivo portion. The in-vivo portion is configured to be inserted through and placed beneath the skin of the body. In addition, the in-vivo portion has a sound-sensing element configured to produce an electrical signal in response to a mechanical stress or strain on the sound-sensing element. The ex-vivo portion is configured to operably connect to the electronics unit when the electronics unit is connected to the mounting unit.
Opening claim text (preview).
What is claimed is: 1. A transcutaneous sound sensor system comprising: a mounting unit detachably connectable to an electronics unit and mountable on a skin of a body; and a sound sensor configured to sense sounds originated from inside the body, the sound sensor comprising an in-vivo portion and an ex-vivo portion, the in-vivo portion being insertable through and placed beneath the skin of the body, wherein the in-vivo portion has a sound-sensing element that produces an electrical signal in response to a mechanical stress or strain on the sound-sensing element, wherein the ex-vivo portion is arrangeable exterior to the skin and is operably connected to the electronics unit when the electronics unit is connected to the mounting unit, wherein the sound sensor has a coaxial structure comprising multiple layers, an innermost layer of the sound sensor is a core conductor, a second layer of the coaxial structure arranged around the innermost layer at the in-vivo portion of the sound sensor includes a polarized piezo-polymer layer, and the second layer of the coaxial structure arranged around the innermost layer at the ex-vivo portion of the sound sensor includes an electrically insulating material. 2. The transcutaneous sound sensor system of claim 1 , further comprising a device configured to receive and process sound measurements from the electronics unit through a wired or non-wired communication link between the device and the electronics unit. 3. The transcutaneous sound sensor system of claim 1 , wherein the mounting unit further comprises electrocardiograph (ECG) electrodes configured to measure one or more ECG signals of the body. 4. The transcutaneous sound sensor system of claim 1 , wherein at least a portion of an outer surface of the in-vivo portion comprises a hydrophilic coating. 5. The transcutaneous sound sensor system of claim 1 , wherein the second layer is a spiral layer wrapped around the innermost layer. 6. The transcutaneous sound sensor system of claim 1 , wherein the second layer is a continuous, solid layer arranged around the innermost layer. 7. The transcutaneous sound sensor system of claim 1 , wherein a third layer arranged around the second layer is a conductor. 8. The transcutaneous sound sensor system of claim 7 , wherein the third layer is a spiral layer wrapped around the second layer. 9. The transcutaneous sound sensor system of claim 7 , wherein a fourth layer arranged around the third layer is a protective layer. 10. The transcutaneous sound sensor system of claim 1 , further comprising the electronics unit. 11. A transcutaneous sound sensor comprising: a sound-sensing element implanted under skin of a subject and producing an electrical signal in response to a mechanical stress or strain on the sound-sensing element; a proximal end disposed external to the skin of the subject to be releasably and communicatively coupled to an electronics unit, the proximal end comprising an electrical insulation layer disposed at an end of the sound-sensing element; and a protective layer arranged around the sound-sensing element. 12. The transcutaneous sound sensor of claim 11 , wherein the sound-sensing element and the electrical insulation layer surround core conductor. 13. The transcutaneous sound sensor of claim 12 , wherein the sound-sensing element is spirally wrapped around the core conductor. 14. The transcutaneous sound sensor of claim 11 , wherein a conductor layer is arranged around the sound-sensing element and the electrical insulation layer. 15. The transcutaneous sound sensor of claim 14 , wherein conductor layer is spirally wrapped around the sound-sensing element. 16. The transcutaneous sound sensor of claim 14 , wherein the protective layer surrounds the conductor layer. 17. The transcutaneous sound sensor of claim 11 , wherein at least a portion of an outer surface of the transcutaneous sound sensor comprises a hydrophilic coating. 18. The transcutaneous sound sensor of claim 11 , wherein the sound-sensing element is formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer film, or a piezoceramic material. 19. The transcutaneous sound sensor of claim 18 , wherein the PVDF copolymer film includes PVDF-TrFE. 20. The transcutaneous sound sensor of claim 11 , wherein the protective layer is formed from a biocompatible insulation material. 21. The transcutaneous sound sensor of claim 20 , wherein the biocompatible insulation material is at least one of: a parylene, a silicon rubber, or ePTFE. 22. A method of treatment using a transcutaneous sound sensor system, the method comprising: coupling an electronics unit to a sound sensor, the sound sensor configured to sense sounds originating from inside a subject, the sound sensor comprising an in-vivo portion arranged beneath a skin surface of the subject and an ex-vivo portion arranged exterior to the skin surface, wherein the sound sensor has a coaxial structure comprising multiple layers, an innermost layer of the sound sensor is a core conductor, a second layer of the coaxial structure arranged around the innermost layer at the in-vivo portion of the sound sensor includes a polarized piezo-polymer layer, and the second layer of the coaxial structure arranged around the innermost layer at the ex-vivo portion of the sound sensor includes an electrically insulating material; receiving signals at the electronics unit corresponding to sound measurements sensed by the sound sensor; and processing the received signals to determine characteristics of the sound measurements. 23. The method of claim 22 , further comprising implanting the in-vivo portion beneath the skin surface and the ex-vivo portion exterior to the skin surface. 24. The method of claim 22 , further comprising correlating the characteristics of the sound measurements to specific parts of the subject. 25. A transcutaneous sound sensor system comprising: a mounting unit detachably connectable to an electronics unit and mountable on a skin of a body; and a sound sensor configured to sense sounds originated from inside the body, the sound sensor comprising an in-vivo portion and an ex-vivo portion, the in-vivo portion being insertable through and placed beneath the skin of the body, wherein the in-vivo portion has a sound-sensing element that produces an electrical signal in response to a mechanical stress or strain on the sound-sensing element, wherein the ex-vivo portion is arrangeable exterior to the skin and is operably connected to the electronics unit when the electronics unit is connected to the mounting unit, wherein the sound sensor has a coaxial structure comprising multiple layers, an innermost layer of the sound sensor is a core conductor, a second layer of the coaxial structure arranged around the innermost layer at the in-vivo portion of the sound sensor includes a piezo-ceramic layer, and the second layer of the coaxial structure arranged around the innermost layer at the ex-vivo portion of the sound sensor includes an electrically insulating material.
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