Methods and devices to prevent premature birth

• US 9,764,120 B2
• Filed: 10/24/2016
• Issued: 09/19/2017
• Est. Priority Date: 01/10/2015
• Status: Active Grant

• Current Assignee: Nine Medical, Inc.
• Original Assignee: Nine Medical, Inc.
• Inventors: Cline, Benjamin Kahn, Pierce, Ryan Kendall
• Primary Examiner(s): HAWTHORNE, OPHELIA ALTHEA
• Application Number:
  US15/332,906
• Publication Number:
  US 20170036000A1
• Time in Patent Office: 330 Days
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2210/14 Female reproductive, genital organs
• CPC Class Codes: A61M 2210/1475 Vagina
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: B05B 11/00 Single-unit hand-held apparatus in which flow of contents is produced by the muscular force of the operator at the moment of use

Abstract

Methods and devices to affect types, proportion, quantity, distribution, or proliferation of microorganisms within a female reproductive system.

Claims

1. A method of applying a microbial barrier to a vaginal portion of a cervix, the method comprising:

preparing a surface of the vaginal portion of the cervix for application of the microbial barrier;

inserting an applicator device through a vagina so that an applicator is adjacent the vaginal portion of the cervix; and

forming the microbial barrier by applying a coating material to the surface, wherein the coating material comprises a tissue-adhesive polymer or mucus-adhesive polymer, further wherein applying the coating material comprises applying the coating material to a region of the surface that includes a closed path that circumnavigates an inferior portion of the cervical canal.

2. The method of claim 1, wherein preparing the surface of the vaginal portion of the cervix comprises one or more of:

drying the surface, removing bacteria from the surface, wiping mucus or fluids from the surface, disinfecting the surface, or applying an agent to the surface that promotes adhesion of the coating material to the surface.

3. The method of claim 1, wherein the coating material is prevented from completely occluding the cervical canal.

4. The method of claim 1, further wherein the coating includes a chemical agent that elutes from the coating after application of the coating to the surface of the vaginal portion of the cervix, wherein the chemical agent is one or more of:

progesterone, a progesterone-derived hormone, an antibiotic, a probiotic.

5. The method of claim 1, further wherein applying comprises applying the coating material to a region of the surface that includes a closed path contained within the opening of the cervical canal.

6. The method of claim 1, further wherein applying comprises applying the coating material to a region of the surface that includes a rim of an inferior opening into the cervical canal.

7. The method of claim 1, further comprising removing a portion of the coating material after initial application.

8. The method of claim 1, further comprising preventing the coating material from completely occluding the cervical canal by directing one or more coating material delivery apertures on the applicator device away from a central axis of the cervical canal.

16. The method of claim 1, further wherein applying comprises applying the coating material to a region of the surface that includes a closed path contained outside of the opening of the cervical canal.

9. A method of applying a microbial barrier to a vaginal portion of a cervix, the method comprising:

preparing a surface of the cervical epithelial tissue for application of a microbial barrier;

inserting an applicator device through the vagina so that an applicator is adjacent the cervical epithelial tissue; and

applying a barrier material over the cervical epithelial tissue while preventing the barrier material from completely occluding the cervical canal, thereby isolating cervical epithelial tissue from microbes and microbial byproducts in the vagina,

wherein applying the barrier material comprises applying an adhesive coating through one or more apertures on the applicator device while visualizing the external os of the cervix.

10. The method of claim 9, wherein preparing the surface of the cervical epithelial tissue comprises one or more of:

drying the surface, removing bacteria from the surface, wiping mucus or fluids from the surface, disinfecting the surface, or applying an agent to the surface that promotes adhesion of barrier material to the surface.

11. The method of claim 9, wherein the barrier material comprises an adhesive coating.

12. The method of claim 9, further comprising repeating inserting the applicator device and applying a barrier material after between 1 and 6 weeks.

13. The method of claim 9, further comprising that the barrier material is desirably applied by visualizing a colorant in the material.

14. The method of claim 9, further comprising confirming that the patient does not have a cervicovaginal infection prior to applying the barrier material.

15. The method of claim 9, further comprising confirming that a chorioamniotic membrane is not disrupted prior to applying the barrier material.

17. A device for delivering a microbial barrier to an ectocervix of a cervix without disrupting a cervical mucus plug within a cervical canal, the device comprising:

an elongate body comprising a first delivery lumen;

a proximal end region having a handle and a chamber for a coating material wherein the chamber is continuous with the first delivery lumen;

an applicator at a distal end of the elongate body that is configured to apply the coating material on the ectocervix but not onto a section of the wall of the cervical canal, the applicator comprising a distal face having a central region configured to be positioned opposite an opening into the cervical canal when the applicator is adjacent the ectocervix; and

one or more delivery apertures through the distal face, wherein the delivery apertures are outside of the central region or are prevented by their orientation or by a shield on the device from applying coating material perpendicular to the central region and onto the section of the wall of the cervical canal when the applicator is adjacent the ectocervix.

18. The device of claim 17, further comprising a baffle configured to reduce a fluid pressure of the coating material ejected from the one or more delivery apertures.

19. A method of applying a microbial barrier to a vaginal portion of a cervix, the method comprising:

preparing a surface of the vaginal portion of the cervix for application of the microbial barrier;

inserting an applicator device through a vagina so that an applicator is adjacent the vaginal portion of the cervix; and

forming the microbial barrier by applying a coating material to the surface, wherein the coating material comprises a tissue-adhesive polymer or mucus-adhesive polymer, and preventing the coating material from completely occluding the cervical canal by shielding the cervical canal from one or more coating material delivery apertures on the applicator device.