# US 12,702,805 B2 · Methods and devices to prevent premature birth > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,702,805 B2 - Document ID: US12702805B2 - Status: Granted - Kind: B2 - Application number: 19/025,834 - Filed: 2025-01-16 - Published: 2025-05-15 - Granted: 2026-08-11 - Earliest claimed: 2015-01-10 - Assignees: Nine Medical, Inc. - Applicants: Nine Medical, Inc. - Inventors: Ryan Kendall Pierce; Benjamin Kahn Cline - Web page: https://patentgrep.com/patent/US12702805B2 ## CPC - 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}) - A61M 11/007: {Syringe-type or piston-type sprayers or atomisers} - 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 - A61M 2205/3331: Pressure; Flow - A61M 2210/14: Female reproductive, genital organs - A61M 2210/1475: Vagina - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B05B: SPRAYING APPARATUS; ATOMISING APPARATUS; NOZZLES (spray-mixers with nozzles B01F25/72; processes for applying liquids or other fluent materials to surfaces by spraying B05D) ## Abstract Methods and devices to affect types, proportion, quantity, distribution, or proliferation of microorganisms within a female reproductive system. ## Claims ### Claim 1 A medical device, comprising: a device configured to assume a volume fully within a female reproductive tract, fully outside of a uterine cavity, between a first region of the female reproductive tract and a second region of the female reproductive tract, and at least partially surrounding a vaginal portion of a cervix; wherein the device is configured to occupy at least part of a path from a first site in a vagina of the female reproductive tract to a second site on the cervix, in a cervical canal of the cervix, or in the uterine cavity of the female reproductive tract; wherein the device includes a contacting region that is configured to impart a normal force that is in a direction perpendicular to and against a vaginal wall and/or a frictional force on the vaginal wall, from which results an opposing force that is opposite the normal force and/or an opposing frictional force that favors a stable position of the device; wherein the device is configured to provide at least one unobstructed path from the second site to the first site; wherein the device is configured to isolate the first region of the female reproductive tract from the second region of the female reproductive tract; and wherein the first region is a region where a type, proportion, quantity, distribution, or proliferation of a microorganism is suspected to be or to become present, and wherein the second region is a region where the type, proportion, quantity, distribution, or proliferation of the microorganism is unwanted. ### Claim 2 (depends on 1) The medical device of claim 1, further comprising one or more of: an antimicrobial agent; a drug; an antibacterial agent; a material or a combination of materials having antibacterial properties; a material that possesses antimicrobial properties; a coating comprised of an agent that affects bacterial growth. ### Claim 3 (depends on 1) The medical device of claim 1, further comprising a light-emitting component configured to deliver an antimicrobial light onto a path between the first site and the second site. ### Claim 4 (depends on 1) The medical device of claim 1, further comprising a handling feature. ### Claim 5 (depends on 1) The medical device of claim 1, wherein the device is configured to include one or more tissue-contacting augmentations configured to impart the normal force and/or the frictional force on the vaginal wall. ### Claim 6 (depends on 1) The medical device of claim 1, the device is configured to provide at least one continuous path from the second site to the first site along a surface of the device. ### Claim 7 (depends on 1) The medical device of claim 1, wherein the device is configured to increase a length of a shortest unobstructed path between the second site and the first site. ### Claim 8 (depends on 1) The medical device of claim 1, wherein the device is configured to increase an unobstructed distance between the second site and the first site. ### Claim 9 (depends on 1) The medical device of claim 1, wherein the device is configured to cover an external opening of the cervical canal of the cervix. ### Claim 10 (depends on 1) The medical device of claim 1, wherein the device is configured to prevent disruption or dislodging of a cervical mucus plug formed during pregnancy. ### Claim 11 A medical device, comprising: a device configured to assume a volume fully within a female reproductive tract, fully outside of a uterine cavity, and between a first region of the female reproductive tract and a second region of the female reproductive tract; wherein the device is configured to occupy at least part of a path from a first site in a vagina of the female reproductive tract to a second site on a cervix, in a cervical canal of the cervix, or in the uterine cavity of the female reproductive tract; wherein the device includes a contacting region that is configured to impart a normal force that is in a direction perpendicular to and against a wall of the female reproductive tract and/or a frictional force on the wall, from which results an opposing force that is opposite the normal force and/or an opposing frictional force that favors a stable position of the device; wherein the device is configured to provide at least one unobstructed path from the second site to the first site; and wherein the first region is a region where a first type, proportion, quantity, distribution, or proliferation of a microorganism is suspected to be or to become present, and wherein the second region is a region where the first type, proportion, quantity, distribution, or proliferation of the microorganism is unwanted. ### Claim 12 (depends on 11) The medical device of claim 11, configured to assume a volume at least partially surrounding a vaginal portion of the cervix, and wherein the wall is a vaginal wall of the female reproductive tract. ### Claim 13 (depends on 11) The medical device of claim 11, configured to assume a volume at least partially within the cervical canal of the female reproductive tract, and wherein the wall is a wall of the cervical canal of the female reproductive tract. ### Claim 14 (depends on 11) The medical device of claim 11, further comprising one or more of: an antimicrobial agent; a drug; an antibacterial agent; a material or a combination of materials having antibacterial properties; a material that possesses antimicrobial properties; a coating comprised of an agent that affects bacterial growth. ### Claim 15 (depends on 11) The medical device of claim 11, further comprising a light-emitting component configured to deliver an antimicrobial light onto a path between the first site and the second site. ### Claim 16 (depends on 11) The medical device of claim 11, wherein the device is configured to prevent disruption or dislodging of a cervical mucus plug formed during pregnancy. ### Claim 17 A method of reducing risk of premature birth in a patient, comprising: (a) receiving a device configured to: (i) assume a volume fully within a female reproductive tract, fully outside of a uterine cavity, between a first region of the female reproductive tract and a second region of the female reproductive tract, and at least partially surrounding a vaginal portion of a cervix; (ii) occupy at least part of a path from a first site in a vagina of the female reproductive tract to a second site on the cervix, in a cervical canal of the cervix, or in the uterine cavity of the female reproductive tract; (iii) include a contacting region configured to impart a normal force perpendicular to and against a vaginal wall and/or a frictional force on the vaginal wall, from which results an opposing force opposite the normal force and/or an opposing frictional force that favors a stable position of the device; (iv) provide at least one unobstructed path from the second site to the first site; and (v) isolate the first region of the female reproductive tract from the second region of the female reproductive tract, wherein the first region is a region where a type, proportion, quantity, distribution, or proliferation of a microorganism is suspected to be or to become present, and wherein the second region is a region where the type, proportion, quantity, distribution, or proliferation of the microorganism is unwanted; (b) positioning the device in the female reproductive tract of the patient, thereby reducing risk of premature birth in the patient. ### Claim 18 (depends on 17) The method of claim 17, further comprising screening the patient for candidacy for the method, the screening comprising: (a) assessing at least one criterion selected from a group consisting of: (i) having previously given birth prematurely; (ii) previous miscarriage; (iii) positive or negative test for a particular type, proportion, quantity, distribution, and/or proliferation of microorganisms in a female reproductive system of the patient; (iv) elevated risk of premature birth, according to known and/or suspected risk factors; (v) cervical insufficiency; (vi) prior cervical surgery; (vii) removal of at least a portion of a cervical gland; (viii) having a reproductive tract infection; (ix) having bacterial vaginosis; (x) having intermediate bacterial flora as assessed based on a Nugent score; (xi) elevated vaginal pH; (xii) having an elevated level of sialidase in at least a part of the female reproductive system of the patient; (xiii) elevated cervical mucus permeability; (xiv) elevated cervical mucus spinnbarkeit; (xv) low cervical mucus viscosity; and (b) selecting the patient for the method when the at least one criterion is met. ### Claim 19 (depends on 17) The method of claim 17, further comprising screening the patient for candidacy for the method, the screening comprising: (a) evaluating at least one characteristic of a cervical mucus plug selected from a group consisting of: (i) length; (ii) permeability; (iii) impedence; (iv) modulus of elasticity; (v) spinnbarkeit; (vi) storage modulus; (vii) loss modulus; (viii) transparency; (ix) color; and (b) selecting the patient for the method based on the evaluation. ### Claim 20 (depends on 17) The method of claim 17, wherein the device is configured to isolate a lower vaginal region of the female reproductive tract from a region of the cervical canal of the cervix.