Methods and devices to prevent premature birth

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.

2 . 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.

3 . 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.

4 . The medical device of claim 1 , further comprising a handling feature.

5 . 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.

6 . 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.

7 . 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.

8 . The medical device of claim 1 , wherein the device is configured to increase an unobstructed distance between the second site and the first site.

9 . The medical device of claim 1 , wherein the device is configured to cover an external opening of the cervical canal of the cervix.

10 . The medical device of claim 1 , wherein the device is configured to prevent disruption or dislodging of a cervical mucus plug formed during pregnancy.

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.

12 . 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.

13 . 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.

14 . 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.

15 . 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.

16 . The medical device of claim 11 , wherein the device is configured to prevent disruption or dislodging of a cervical mucus plug formed during pregnancy.

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.

18 . 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.

19 . 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.

20 . 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.