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US 12,672,853 B2Granted
Method and probe for predicting spontaneous preterm delivery
AssigneeAdvanced Tactile Imaging Inc.
InventorVladimir Egorov
Life of this patent
Estimating the term…
Abstract
A cervix probe is equipped with a tactile sensor array and an ultrasound transducer and configured for simultaneous acquisition of stress data and ultrasound strain data for the same sector of the cervix. Acquired and recorded stress and strain data are transmitted to a data processor for calculating cervix elasticity and cervix length, followed by calculating a probability of spontaneous preterm delivery using a clinically validated predictive model.
Claims14
A method for predicting spontaneous preterm delivery, the method comprising the steps of:
- a) providing a cervix probe with a head equipped with a plurality of tactile sensors forming together a flat tactile sensor array, and an ultrasound transducer, said head positioned at an angle to a probe shaft, thereby said probe is configured for an orthogonal contact of the entire flat tactile sensor array with an external cervix surface of a pregnant woman,
- b) inserting said cervix probe into a vagina to contact said external cervix surface,
- c) applying cervix deformation at an external cervical wall facing the vagina and adjacent to an external cervical os with said cervix probe, while simultaneously acquiring cervix stress data using all of said plurality of tactile sensors and cervix strain data using said ultrasound transducer,
- d) calculating cervix elasticity and cervix length using said cervix stress data and said cervix strain data, wherein said cervix elasticity is calculated as a ratio of (i) cervix stress derived from said cervix stress data to (ii) cervix strain derived from changes in ultrasound echo time-of-flight during said cervix deformation, wherein said steps (c) and (d) are performed on four radial sectors of cervix, and e) calculating a probability of spontaneous preterm delivery using a predictive model having as inputs respective cervix elasticity and respective cervix length of four radial sectors of cervix.
1 more element
A probe for predicting spontaneous preterm delivery, said probe comprising:
- a head equipped with a plurality of solely cervix-facing tactile sensors forming together angle to a probe shaft, thereby said probe is configured for detecting cervical wall pressure distribution during an orthogonal contact with and deformation of an external cervical wall adjacent an external cervical os and facing a vagina, while avoiding contact with adjacent vaginal walls, said ultrasound transducer is positioned adjacent to said plurality of tactile sensors on said head, said tactile sensor array is configured to acquire stress data from four radial sectors of cervix, and said ultrasound transducer is configured to emit an ultrasound pulse and to acquire a scattered ultrasound waveform from four radial sectors of cervix during deformation by said head at the external cervical os facing the vagina and without deforming adjacent vaginal walls, a control unit operably connected to said tactile sensor array and said ultrasound transducer and configured for acquiring said stress data from four radial sectors of said cervix using said tactile sensors and said scattered ultrasound waveform from four radial sectors of said cervix using said ultrasound transducer, and a data processor operably connected to said control unit and configured for calculating cervix elasticity and cervix length of four radial sectors of said cervix using said stress data from four radial sectors of said cervix and said ultrasound waveform from four radial sectors of said cervix, wherein (i) cervix length is calculated from receive-side echo time-of-flight to an internal os reflection, and (ii) cervix elasticity is calculated as ratio of (i) cervix stress derived from stress data to (ii) cervix strain derived from changes in ultrasound eco time-of-flight during said cervix deformation, said processor is further configured to calculate a probability of spontaneous preterm delivery using a predictive model having as inputs of respective cervix elasticity and respective cervix length of four radial sectors of said cervix.
Dependencies are inferred from the claim text.