IP Library Granted Patent US 12,059,310
Granted Patent B2
US 12,059,310 · App. 17/352,977 · Granted Aug 13, 2024

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 12,059,310
App. No.
17/352,977
Granted
Aug 13, 2024
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 (40)

1. 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;

the membrane is pierceable by a needle;

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

the access port being in fluidic communication with a drainage system around the shell.

2. The tissue expander of claim 1 , wherein the access port is configured to deliver fluid and extract fluid from the drainage system.

3. The tissue expander of claim 2 , wherein the drainage system comprises one or more channels in fluidic communication with a pocket defined around the tissue expander.

4. The tissue expander of claim 1 , wherein the access port is formed integrally with the shell.

5. The tissue expander of claim 1 , further comprising a magnet at the access port.

6. 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, 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

the access port being in fluidic communication with a drainage system around the shell; and

a magnet at the access port.

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

8. The tissue expander of claim 6 , wherein the magnet is embedded in the material that is non-reactive with the MRI machine.

9. The tissue expander of claim 8 , 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 machine.

10. The tissue expander of claim 6 , wherein the magnet is under the base.

11. The tissue expander of claim 6 , wherein the magnet is centered in the access port.

12. The tissue expander of claim 6 , 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.

13. 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

the access port being in fluidic communication with a drainage system around the shell;

(ii) a device configured to detect the tissue expander when the tissue expander is implanted, the device comprising:

a housing comprising a display;

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

14. The system of claim 13 , wherein the magnet is located at the access port.

15. The system of claim 13 , 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.

16. The system of claim 13 , 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.

17. The system of claim 13 , wherein the access port is formed integrally with the shell.

18. The system of claim 13 , wherein the material that is non-reactive with the MRI machine is a non-metallic and non-ferromagnetic material comprising polyoxymethylene.

19. The system of claim 13 , wherein the access port provides percutaneous access for delivering antibiotics to a pocket surrounding the tissue expander via one or more channels comprised in the drainage system.

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 (3)
Continuation 16173079 · Oct 29, 2018
Provisional Application 62627940 · Feb 8, 2018
Related Publication 20210307858A1 · Oct 7, 2021