IP Library Granted Patent US 11,039,898
Granted Patent B2
US 11,039,898 · App. 16/173,079 · Granted Jun 22, 2021

MRI safe tissue expander port

Inventor: William T. McClellan (Morgantown, WV)
A61B90/02A61B90/39A61F2/12A61M39/0208A61B2090/3954A61F2250/0003A61M2039/0238
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Quick Facts
Patent No.
US 11,039,898
App. No.
16/173,079
Granted
Jun 22, 2021
Kind
B2
Abstract

Improvements for use with tissue expanders are provided. A tissue expander includes: a selectively inflatable and deflatable shell that is configured to be implanted; and an access port for selectively inflating and deflating the shell, the access port comprising a sidewall, a base at a first end, and a membrane at a second end opposite the first end, wherein the sidewall and the base of the access port are constructed of a material that is non-reactive with a magnetic resonance imaging (MRI) machine. In embodiments, the tissue expander includes a magnet at the access port. In embodiments, the magnet is configured with a physical size and magnetic force such that, when the tissue expander is implanted, the magnet is detectable by an external magnetometer sensor but is not detectable by an external dangle-magnet.

Claims (45)

1. A tissue expander, comprising:

a selectively inflatable and deflatable shell that is configured to be implanted;

an access port for selectively inflating and deflating the shell, the access port comprising a sidewall, a base at a first end, and a membrane at a second end opposite the first end; and

a magnet at the access port,

wherein the sidewall and the base of the access port are constructed of a material that is non-reactive with a magnetic resonance imaging (MRI) machine.

2. The tissue expander of claim 1 , wherein the material is a non-metallic and non-ferromagnetic material.

3. The tissue expander of claim 1 , wherein the material is a non-metallic and non-ferromagnetic polymer.

4. The tissue expander of claim 1 , wherein the material is polyoxymethylene.

5. The tissue expander of claim 1 , wherein:

the membrane is pierceable by a needle; and

the sidewall and the base function as a hard-stop that limit travel of the needle within access port after the needle has pierced the membrane.

6. The tissue expander of claim 1 , wherein the magnet has a diameter less than half a diameter of the base.

7. The tissue expander of claim 6 , wherein the magnet is embedded in the material.

8. The tissue expander of claim 7 , wherein the magnet is under the base.

9. The tissue expander of claim 7 , wherein the magnet is centered in the access port.

10. The tissue expander of claim 1 , wherein the magnet is sized and shaped such that there is no significant heating, dislodgment, or artifact produced when the magnet is influenced by the MRI.

11. The tissue expander of claim 1 , wherein the magnet is configured with a physical size and magnetic force such that, when the tissue expander is implanted, the magnet is detectable by an external magnetometer sensor but is not detectable by an external dangle-magnet.

12. A device configured to detect an implanted tissue expander, the device comprising:

a housing comprising a display; and

a magnetic sensor configured to detect a direction and a strength of a magnetic field of a magnet in the implanted tissue expander,

wherein the device controls an output of the display based on signals received from the magnetic sensor, and

the magnet is located at an access port of the of the tissue expander for selectively inflating and deflating a shell of the tissue expander.

13. The device of claim 12 , wherein the output of the display comprises a graphic that depicts an indication of a location of the magnet relative to a frame of reference.

14. The device of claim 12 , further comprising a computer memory, a computer processor, and a power supply in the housing, wherein the computer memory stores program code that is executed by the computer processor to perform the controlling the output of the display based on signals received from the magnetic sensor.

15. A method comprising using the device of claim 12 to detect a tissue expander that is implanted under the skin of a patient.

16. A system, comprising:

(i) a tissue expander comprising: a selectively inflatable and deflatable shell that is configured to be implanted; and an access port for selectively inflating and deflating the shell, the access port comprising a sidewall, a base at a first end, and a membrane at a second end opposite the first end, wherein the sidewall and the base of the access port are constructed of a material that is non-reactive with a magnetic resonance imaging (MRI) machine; and

(ii) a device configured to detect the tissue expander when the tissue expander is implanted, the device comprising: a housing comprising a display; and a magnetic sensor configured to detect a direction and a strength of a magnetic field of a magnet in the implanted tissue expander, wherein the device controls an output of the display based on signals received from the magnetic sensor,

wherein the magnet is located at the access port, and

the magnet is centered in the access port.

17. The system of claim 16 , wherein the material is a non-metallic and non-ferromagnetic material.

18. The system of claim 17 , wherein the material is polyoxymethylene.

19. The system of claim 16 , wherein:

the membrane is pierceable by a needle; and

the sidewall and the base function as a hard-stop that limit travel of the needle within access port after the needle has pierced the membrane.

20. A system, comprising:

(i) a tissue expander comprising: a selectively inflatable and deflatable shell that is configured to be implanted; and an access port for selectively inflating and deflating the shell, the access port comprising a sidewall, a base at a first end, and a membrane at a second end opposite the first end, wherein the sidewall and the base of the access port are constructed of a material that is non-reactive with a magnetic resonance imaging (MRI) machine; and

(ii) a device configured to detect the tissue expander when the tissue expander is implanted, the device comprising: a housing comprising a display; and a magnetic sensor configured to detect a direction and a strength of a magnetic field of a magnet in the implanted tissue expander, wherein the device controls an output of the display based on signals received from the magnetic sensor,

wherein the magnet is located at the access port, and

wherein the magnet has a diameter less than half a diameter of the base.

21. The system of claim 16 , wherein the magnet is embedded in the material.

22. The system of claim 16 , wherein the magnet is under the base.

23. The system of claim 16 , wherein the magnet is configured with a physical size and magnetic force such that, when the tissue expander is implanted, the magnet is detectable by the magnetic sensor of the device, but is not detectable by an external dangle-magnet.

24. The system of claim 16 , wherein the output of the display comprises a graphic that depicts an indication of a location of the magnet relative to a frame of reference.

25. The system of claim 16 , further comprising a computer memory, a computer processor, and a power supply in the housing, wherein the computer memory stores program code that is executed by the computer processor to perform the controlling the output of the display based on signals received from the magnetic sensor.

Assignments (2)
RELEASE OF SECURITY INTEREST Recorded May 14, 2024
From: DEERFIELD PARTNERS, L.P.
To: SIENTRA, INC.
Reel/Frame 067400/0048 →
SECURITY INTEREST Recorded Oct 12, 2022
From: SIENTRA, INC.
To: DEERFIELD PARTNERS, L.P., AS AGENT
Reel/Frame 061388/0629 →
Continuity (2)
Provisional Application 62627940 · Feb 8, 2018
Related Publication 20190239976A1 · Aug 8, 2019
Cited By (2)
US 12,406,161 US 12,508,096