Methods for using cervical control systems and cervical control devices
Systems, devices, and methods are provided that control, support, and/or elongate a cervix to treat pregnancy complications and/or delay an onset of labor so that a gestational period for a fetus may be extended, thereby preventing preterm labor and delivery of the fetus. The cervical control systems may include a main body configured for placement in a vagina. The main body has in internal passageway configured for acceptance of a cervix therein and an inflatable and/or expandable inner cuff extends from portion of the internal passageway. The inner cuff may be expandable inward toward the cervix, or downward away from the uterus, or both inward and downward so that the inner cuff may engage, or grip, the cervix thereby holding the cervical control system in place while compressing the cervix closed, elongating the cervix, and/or adjusting an angle of orientation of the cervix.
1 . A method to compress a cervix, comprising:
positioning a cervix of a patient within an internal passageway of a cervical control system, the cervical control system comprising:
an expandable cuff configured to surround at least a portion of the cervix of the patient;
a positioning balloon disposed at an exterior surface of the cervical control system, wherein the positioning balloon surrounds a portion of a circumference of the exterior surface;
a first inflation media conduit comprising a first end in fluid communication with the expandable cuff and a second end opposite the first end configured to receive inflation media;
a second inflation media conduit comprising a first end in fluid communication with the positioning balloon and a second end opposite the first end configured to receive inflation media; and
a bi-lumen tube configured to extend the patient's vaginal canal and exit the introitus when the cervical control system is in position within the patient, wherein a first end of a first lumen of the bi-lumen tube is in fluid communication with the second end of the first inflation media conduit and a second opposing end of the first lumen is configured to receive inflation media, and wherein a first end of a second lumen of the bi-lumen tube is in fluid communication with the second end of the second inflation media conduit and a second opposing end of the second lumen is configured to receive inflation media;
accessing the second end of each of the first and second lumens of the bi-lumen tube outside the patient's body; and
adding inflation media to each of the second ends of the first and second lumens of the bi-lumen tube for communication to the respective first and second inflation media conduits; and
adding inflation media to the second end of each of the first and second inflation media conduits thereby expanding the expandable cuff and the positioning balloon respectively.
2 . The method of claim 1 , wherein the second end of the first inflation media conduit or the second inflation media conduit is in fluid communication with a valve, the method further comprising:
opening the valve to add inflation media to the respective first or second inflation media conduit and closing the valve to hold inflation media within the respective first or second inflation media conduit.
3 . The method of claim 1 , wherein the second end of the first inflation media conduit is in fluid communication with a first valve and the second end of the second inflation media conduit is in fluid communication with a second valve, the method further comprising:
opening the first valve to add inflation media to the first inflation media conduit;
closing the valve to hold inflation media within the first inflation media conduit;
opening the second valve to add inflation media to the second inflation media conduit;
closing the second valve to hold inflation media within the second inflation media conduit.
4 . The method of claim 1 , wherein the expansion of the expandable cuff compresses the cervix.
5 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the expandable cuff to adjust a degree of traction applied to the cervix.
6 . The method of claim 1 , wherein the expansion of the expandable cuff compresses the cervix and slows or stops a flow of amniotic fluid from the cervix.
7 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the expandable cuff to treat premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
8 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the expandable cuff to treat short cervix.
9 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the positioning balloon to adjust the angle of orientation of the cervix.
10 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the expandable cuff and/or the positioning balloon to prevent onset of labor and delivery of a fetus.
11 . The method of claim 1 , further comprising:
adjusting a volume of inflation media in the positioning balloon to anchor the cervical control system within the patient's vagina.
12 . The method of claim 1 , wherein the cervical control system is placed responsively to the patient being associated with a risk factor for pre-term labor.
13 . The method of claim 1 , wherein the cervical control system is placed responsively to the patient being diagnosed with a short cervix.
14 . The method of claim 1 , wherein the cervical control system is placed responsively to the patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
15 . The method of claim 1 , wherein a degree of expansion or contraction of the expandable cuff and/or the positioning balloon is responsive to at least one of a clinical need, an orientation of the cervix, an orientation of the patient's uterus, a degree of dilation of the cervix, a length of the cervix, a degree of softness of the cervix, a level of amniotic fluid present in the patient's uterus, or an indication of a status of the patient's amniotic sac membrane.
16 . The method of claim 1 , wherein the expansion of the positioning balloon adjusts an angle of orientation of the cervix.
17 . A method to compress a cervix, comprising:
positioning a cervix of a patient within an internal passageway of a cervical control system, the cervical control system comprising:
a cuff comprising:
an exterior surface defining an internal passageway configured to accept insertion of the cervix of the patient therein;
an interior surface; and
a first inner chamber disposed between the inner surface and the exterior surface;
an expandable positioning balloon disposed on an exterior surface of the cervical control system and including a second inner chamber;
a first inflation media conduit, the first inflation media conduit comprising:
a first end in fluid communication with the first inner chamber; and
a second end configured to receive inflation media;
a second inflation media conduit, the second inflation media conduit comprising:
a first end in fluid communication with the second inner chamber; and
a second end configured to receive inflation media; and
a bi-lumen tube configured to extend through the patient's vaginal canal and exit the introitus when the cervical control system is in position within the patient, wherein a first end of a first lumen of the bi-lumen tube is in fluid communication with the second end of the first inflation media conduit and a second opposing end of the first lumen is configured to receive inflation media, and wherein a first end of a second lumen of the bi-lumen tube is in fluid communication with the second end of the second inflation media conduit and a second opposing end of the second lumen is configured to receive inflation media;
accessing the second end of each of the first and second lumens of the bi-lumen tube outside the patient's body;
adding inflation media to the second end of each of the first and second lumens of the bi-lumen tube for communication to the respective first and second inflation media conduits;
adding inflation media to the second end of the first inflation media conduit, thereby expanding the cuff; and
adding inflation media to the second end of the second inflation media conduit, thereby expanding the expandable positioning balloon.
18 . The method of claim 17 , wherein the second end of the first inflation media conduit is in fluid communication with a first valve and the second end of the second inflation media conduit is in fluid communication with a second valve, the method further comprising:
opening the first valve to add inflation media to the first inflation media conduit;
closing the valve to hold inflation media within the first inflation media conduit;
opening the second valve to add inflation media to the second inflation media conduit;
closing the second valve to hold inflation media within the second inflation media conduit.
19 . The method of claim 17 , wherein the expansion of the cuff compresses the cervix.
20 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the cuff to adjust a degree of traction applied to the cervix.
21 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the cuff to slow or stop a flow of amniotic fluid from the cervix.
22 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the cuff to treat premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
23 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the cuff to treat short cervix.
24 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the expandable positioning balloon to adjust the angle of orientation of the cervix.
25 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the cuff and/or the expandable positioning balloon to prevent onset of labor and delivery of a fetus.
26 . The method of claim 17 , further comprising:
adjusting a volume of inflation media in the expandable positioning balloon to anchor the cervical control system within the patient's vagina.
27 . The method of claim 17 , wherein the cervical control system is placed responsively to the patient being associated with a risk factor for pre-term labor.
28 . The method of claim 17 , wherein the cervical control system is placed responsively to the patient being diagnosed with a short cervix.
29 . The method of claim 17 , wherein the cervical control system is placed responsively to the patient being diagnosed with premature rupture of membranes (PROM) or preterm premature rupture of membranes (PPROM).
30 . The method of claim 17 , wherein a degree of expansion or contraction of the cuff and/or the expandable positioning balloon is responsive to at least one of a clinical need, an orientation of the cervix, an orientation of the patient's uterus, a degree of dilation of the cervix, a length of the cervix, a degree of softness of the cervix, a level of amniotic fluid present in the patient's uterus, and/or an indication of a status of the patient's amniotic sac membrane.