A method and system of and for securing a lumen or catheter, after placement in a patient, to prevent unwanted removal or dislodgement of the lumen or catheter caused by patient movement and/or further medical interventions such as cardiopulmonary chest compressions, electrical defibrillation, surgical procedures, and the like. The method and system comprising simple and sterile materials that preclude the use of excessive suturing and ineffective ad-hoc methods with tape and gauze. The catheter is secured by a rubber on plastic frictional force and will resist external forces while preventing the tube structure from bending and subsequent occlusion. The device can be comfortably attached to the patient in all of the anatomical locations typically targeted for large catheter installment. The method of securement is rapid and requires only a single personnel to handle the device and the catheter tube simultaneously.

A catheter includes a distal distension balloon and circumferentially arranged motility measurement balloons proximal of the distension balloon. A manifold includes balloon ports each configured to fluidly couple to a motility measurement balloon, pressure transducer ports, and a priming port. A port selector is coupled to the manifold and movable between different positions. Each port selector position causes the manifold to establish different fluidic couplings between the respective motility balloon, pressure transducer, and priming ports. A pressure sensing device includes pressure transducers each fluidly coupled to one of the pressure transducer ports. The pressure sensing device is configured to coordinate calibration of the pressure transducers at atmospheric pressure with the port selector in a first position and motility balloon pressure measurements with the port selector in a third position. Priming of the motility measurement balloons is implemented by moving the port selector to a second position.

In various embodiments of the invention, a manipulator attaches to and allows a sheath to be positioned inside the cervix and a catheter to thereby be inserted through the sheath and be positioned in a desired location in the uterus. In various embodiments of the invention, the manipulator may be attached or permanently connected to the sheath. In various embodiments of the invention, the sheath is fenestrated to allow the catheter to be detached from the sheath. In various embodiments of the invention, the manipulator allows the sheath to be positioned through the cervix canal to allow for catheter transmitted intrauterine pressure monitoring or balloon catheter assisted ripening of the cervix.

The invention is generally a system, apparatus, and method for monitoring and measuring a change in intrauterine pressure without rupturing the amniotic sac. A catheter is coupled to a pressure sensing module. The pressure sensing module is configured with a chamber that is in fluid communication with a balloon of the catheter. The chamber includes a pressure-sensing membrane coupled to sensing circuitry. The sensing circuitry is configured to detect a pressure applied to the pressure-sensing membrane and communicate the condition to a monitor of the system. Methods include inserting the catheter through the cervix so that the balloon may be inflated and situated in the lower segment of the uterus, resting against the amniotic sac. Because the balloon of the catheter is in fluid communication with the pressure-sensing membrane, pulsations of the amniotic sac will be sensed by the sensing circuitry of the pressure sensing module.

An intrauterine balloon apparatus to augment uterine birthing forces and assist fetal descent during parturition is provided. The body of the balloon apparatus begins packaged in a compressed state minimizing volume, enabling delivery through the birth canal. The apparatus is advanced to a proximal uterine location and deployed for operation by introducing a pressurized agent through its conduit, causing the body to expand and apply directional forces towards the infant and birth canal. The balloon body is shaped to apply pressures dispersed towards the infant and the bidirectional conduit enables fluid conduction as the infant descends. After the infant has successfully descended and been delivered through the birth canal, pressure within the balloon body is relieved through the conduit thereby collapsing the volume of the balloon body and enabling retraction through the birth canal.

A system for augmenting uterine forces includes a medical apparatus having a balloon body that transitions between a compacted state and an expanded state, a catheter that receives the medical apparatus and obtains electrical signals indicative of intrinsic uterine contractions, and a controller coupled to the catheter to receive the electrical signals, and to a source of an agent. The controller processes the electrical signals to detect an onset of an intrinsic uterine contraction, an increase in uterine contraction forces, or a decrease in uterine contraction forces. In response to a detection of an onset of an intrinsic uterine contraction or an increase in uterine contraction forces, the controller causes an agent to be delivered from the agent source to the balloon body to expand the balloon body. In response to a detection of a decrease in uterine contraction forces, the controller causes agent to discharge from the balloon body to collapse the balloon body.

A multi-lumen catheter for monitoring uterine contraction pressure having an elongated body configured and dimensioned for insertion into a bladder of a patient, the catheter having a first lumen, a second lumen, and a first balloon at a distal portion, the first lumen communicating with the first balloon. The second lumen communicates with the bladder to remove fluid from the bladder. The first balloon is filled with a gas to form along with the first lumen a gas filled chamber to monitor pressure within the bladder to thereby monitor uterine contraction pressure of the patient.

A method and system of providing therapy to a patient's uterus is provided, which can include any number of features. The method can include the steps of inserting a uterine device into the uterus and performing a uterine integrity test to determine that the uterus is intact and not perforated. If it is determined that the uterus is not perforated, a patency test can be performed to determine that the uterine device is not clogged or embedded in tissue. If the uterus is intact and the device is not clogged or embedded in tissue, the uterus can be treated with the uterine device, e.g., uterine ablation. Systems for performing these methods are also disclosed.

A multi-lumen catheter for monitoring intrauterine pressure comprising an elongated body configured and dimensioned for insertion into a uterus of a patient, the catheter having a first lumen, a second lumen, and a first balloon at a distal portion. The first lumen communicates with the first balloon and the second lumen has an opening within the uterus for injection of x-ray dye or other fluid into the uterus for imaging the uterine cavity and the fallopian tubes of a patient. The first balloon contains a gas to form along with the first lumen a chamber to monitor pressure within the uterus to thereby determine if excessive pressure is being applied to the fallopian tubes of the patient. A sensor is in communication with the first lumen to measure pressure about a circumferential area of the balloon to measure pressure in the uterus to provide readings of intrauterine pressure.

A catheter includes a distal distension balloon and circumferentially arranged motility measurement balloons proximal of the distension balloon. A manifold includes balloon ports each configured to fluidly couple to a motility measurement balloon, pressure transducer ports, and a priming port. A port selector is coupled to the manifold and movable between different positions. Each port selector position causes the manifold to establish different fluidic couplings between the respective motility balloon, pressure transducer, and priming ports. A pressure sensing device includes pressure transducers each fluidly coupled to one of the pressure transducer ports. The pressure sensing device is configured to coordinate calibration of the pressure transducers at atmospheric pressure with the port selector in a first position and motility balloon pressure measurements with the port selector in a third position. Priming of the motility measurement balloons is implemented by moving the port selector to a second position.