Methods and systems of matching voice deficits with a tunable mucosal implant to restore and enhance individualized human sound and voice production

• US 9,198,568 B2
• Filed: 03/04/2011
• Issued: 12/01/2015
• Est. Priority Date: 03/04/2010
• Status: Active Grant

• Current Assignee: Massachusetts Institute of Technology, The General Hospital Corporation (Mass General Brigham, Inc.)
• Original Assignee: Massachusetts Institute of Technology, The General Hospital Corporation (Mass General Brigham, Inc.)
• Inventors: Zeitels, Steven M., Hillman, Robert E., Karajanagi, Sandeep Sidram, Langer, Robert S.
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US13/579,347
• Publication Number:
  US 20130041467A1
• Time in Patent Office: 1,733 Days
• Field of Search: 623/14.11, 623/9, 424 931- 937, 424/445, 424/484, 568/679, 568/852, 530353-354, 530/356, 530/403, 536/30, 536/51, 536/55.1, 536/123.1, 514/2, 514/12, 514/44.R, 514 55- 57
• US Class Current: 1/1
• CPC Class Codes: A61B 1/2673 for monitoring movements of vocal chords
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

The disclosure relates to methods and systems for making customized treatments to a subject'"'"'s vocal tissues to provide a desired level of vocal function.

Claims

1. A method of providing a customized vocal treatment to a subject having a vocal dysfunction caused by a diminished pliability or absence of phonatory mucosa, the method comprising

assessing both a cause of the subject'"'"'s vocal dysfunction and the subject'"'"'s vocal needs;

selecting a specific vocal implant to provide a mucosal tissue with sufficient pliability to produce an approximate desired level of dynamic variation of vocal parameters of pitch or phonation threshold pressure, or both and vocal control in the subject based on both the cause of the subject'"'"'s vocal dysfunction and the subject'"'"'s vocal needs, wherein the vocal implant is a liquid, a gel, or a solution of one or more polymers; and

implanting the selected vocal implant in a location within glottal, supraglottal, subglottal, or pharyngeal mucosal tissue in the subject that achieves the desired level of dynamic variation of vocal parameters and vocal control to provide a customized vocal treatment specific to the subject'"'"'s vocal dysfunction and needs.

2. The method of claim 1, wherein the assessing comprises determining any one or more of a deficit in a primary mode of sound production, a deficit in structural anatomy, or a deficit in vocal function.

3. The method of claim 2, wherein the assessing comprises using any one or more of:

high-speed endoscopic laryngeal imaging, laryngeal stroboscopy, acoustic and aerodynamic measures of vocal function, standard interview, and self-reporting of the impact of the vocal deficit on daily function using a standardized self-assessment scale.

4. The method of claim 2, wherein the deficits in structural anatomy or vocal function are due to one or more of an anatomical structure that is missing, and an anatomical structure that is functionally impaired.

5. The method of claim 2, wherein the deficits in structural anatomy or vocal function are due to at least one of a loss of muscle, loss of ligament, and loss of the superficial lamina propria of normal phonatory mucosa.

6. The method of claim 1, wherein the vocal implant is placed into mucosal tissue under epithelium of a region of the subject'"'"'s supraglottis, subglottis, or pharynx in a location and in an amount that provides aerodynamically-driven mucosal vibration, wherein the supraglottal, subglottal, or pharyngeal mucosa is converted into a phonatory sound source.

7. The method of claim 1, wherein the vocal implant is placed into mucosal tissue under epithelium of one or both vocal folds of the glottis.

8. The method of claim 1, wherein the vocal implant has an elastic shear modulus (G′

) within a range of 0 to 150 pascals.

9. The method of claim 1, wherein the vocal implant has an in vivo residence time that is inversely related to the elastic shear modulus (G′

) of the vocal implant.

10. The method of claim 1, wherein the vocal implant is tuned based on the assessing.

11. The method of claim 1, wherein the vocal implant comprises a network of one or more polymers.

12. The method of claim 1, wherein the vocal implant comprises at least one crosslinked polymer.

13. The method of claim 1, wherein the vocal implant comprises a crosslinked polymer and a non-crosslinked polymer.

14. The method of claim 1, wherein the vocal implant comprises a crosslinked poly(ethylene glycol) derivative and a non-crosslinked polymer.

15. The method of claim 13, wherein the non-crosslinked polymer comprises poly(ethylene glycol), hyaluronic acid, alginate, poly(lysine), dextran, or combinations thereof.

16. The method of claim 12, wherein prior to crosslinking, the crosslinked poly(ethylene glycol) derivative is poly(ethylene glycol)diacrylate.

17. The method of claim 1, wherein the vocal implant comprises polysaccharides, water-soluble synthetic polymers, proteins and their derivatives, or combinations thereof.

18. The method of claim 1, wherein the vocal implant further comprises a biologically active agent.

19. The method of claim 1, wherein the vocal implant comprises a crosslinked poly(ethylene glycol) derivative and a non-crosslinkable polymer selected from the group consisting of polysaccharides, water-soluble synthetic polymers, and proteins and their derivatives.

20. The method of claim 13, wherein the crosslinked polymer comprises an acrylate derivative and the non-crosslinked polymer comprises a water-soluble polymer.

21. The method of claim 13, wherein the crosslinked polymer comprises at least one of hyaluronic acid methacrylate, crosslinkable derivatives of dextrans, crosslinkable derivatives of hyaluronic acid, crosslinkable derivatives of alginates, crosslinkable derivatives of gelatins, crosslinkable derivatives of elastins, crosslinkable derivatives of collagens, crosslinkable derivatives of celluloses, crosslinkable derivatives of methylcelluloses, crosslinkable derivative of polyalkylene glycol, crosslinkable derivative of polyethylene glycol, and polyethylene glycol diacrylate;

and the non-crosslinked polymer is selected from the group consisting of any one or more of polyethylene glycol (PEG), poly(lysine), hyaluronic acid (HA), dextrans, alginates, gelatins, elastins, collagens, celluloses, methylcelluloses, and derivatives thereof.

22. The method of claim 13, wherein the crosslinked polymer comprises an acrylated derivative of dextrans, acrylated derivatives of hyaluronic acid, acrylated derivatives of alginates, acrylated derivatives of gelatins, acrylated derivatives of elastins, acrylated derivatives of collagens, acrylated derivatives of celluloses, acrylated derivatives of methylcelluloses, acrylated derivative of polyalkylene glycol, acrylated derivatives of polyethylene glycol, and polyethylene glycol diacrylate;

and the non-crosslinked polymer is selected from the group consisting of any one or more of polyethylene glycol (PEG), poly(lysine), hyaluronic acid (HA), dextrans, alginates, gelatins, elastins, collagens, celluloses, methylcelluloses, and derivatives thereof.

23. The method of claim 1, wherein the vocal parameter is pitch.

24. The method of claim 8, wherein the vocal implant comprises a hydrogel having a G′

of 0 to 50 Pa and a residence time in vivo of from about 1 day to about 2 months, a hydrogel having G′

of 50 to 100 Pa and a residence time in vivo of about 2 to about 4 months, or a hydrogel having a G′

of 100 to 150 and a residence time in vivo of over 4 months.

25. The method of claim 8, wherein the vocal implant comprises a hydrogel having a G′

of 15 to 35 Pa and a residence time in vivo of from about 1 day to about 2 months, a hydrogel having G′

of 75 to 88 Pa and a residence time in vivo of about 2 to about 4 months, or a hydrogel having a G′

of 125 to 149 Pa and a residence time in vivo of over 4 months.