Intrauterine access catheter for delivering and facilitating operation of a medical apparatus for assisting parturition

• US 10,105,070 B2
• Filed: 11/16/2015
• Issued: 10/23/2018
• Est. Priority Date: 11/17/2014
• Status: Active Grant

• Current Assignee: 3VO Medical, Inc.
• Original Assignee: 3VO Medical, Inc.
• Inventors: Chinchoy, Ed, Kelley, James, Snell, Jay
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/942,577
• Publication Number:
  US 20160135844A1
• Time in Patent Office: 1,072 Days
• CPC Class Codes: A61B 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

A catheter to access and navigate the uterine cavity through the cervical canal for delivering, deploying, and facilitating operation of a peripheral intrauterine medical apparatus during parturition includes an elongated, flexible tubular catheter body with a handle at the proximal end controlling a steering mechanism and deflecting the distal tip. The catheter includes a lumen that extends the length of catheter body to a distal end region of the catheter. The peripheral medical apparatus is located in the distal end region and is configured to deploy from the distal tip of the catheter into the uterine cavity. A soft catheter tip reduces the likelihood of injury during intrauterine navigation and placement, and sensors associated with the catheter body provide signals that allow for the monitoring of infant, umbilical cord, placenta and uterine muscle activity during labor to assist operation of the peripheral medical apparatus.

Claims

1. A birthing system for augmenting expulsive uterine forces towards a cervical canal during delivery of a fetus from a uterus, the birthing system comprising:

a medical apparatus having a balloon body configured to be placed in an intrauterine cavity at a location between an infant and uterine walls, the balloon body configured to transition between a compacted state and an expanded state, wherein when in the expanded state the balloon body applies a force to a base of the fetus in a direction of the cervical canal;

a catheter configured to receive the medical apparatus, circumnavigate the fetus and one or more structures within the uterus to place the balloon body in the intrauterine cavity at the location between the infant and the uterine walls, and obtain 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 configured to;

process the electrical signals to detect one of an onset of an intrinsic uterine contraction, an increase in uterine contraction forces, and a decrease in uterine contraction forces,

in response to either of a detection of an onset of an intrinsic uterine contraction or an increase in uterine contraction forces, deliver agent from the agent source to the balloon body to at least partially expand the balloon body toward the cervical canal and into contact with the fetus, and

in response to a detection of a decrease in uterine contraction forces, discharge agent from the balloon body to at least partially collapse the balloon body away from the fetus and the cervical canal.

2. The birthing system of claim 1, wherein the medical apparatus further comprises a conduit body having a proximal region, a distal region, and an internal lumen, wherein the balloon body is coupled to the distal region of the conduit body and has an internal chamber in fluid communication with the internal lumen of the conduit body.

3. The birthing system of claim 1, wherein the catheter comprises:

a handle having a proximal end, a distal end, and a port at the proximal end;

an elongated body having a proximal section, a distal section, a port at a distal tip of the distal section; and

an inner lumen extending from the distal tip of the elongated body to the port at the proximal end of the handle, the inner lumen configured to slidably receive the medical apparatus through the port at the proximal end of the handle.

4. The birthing system of claim 3, wherein the catheter further comprises:

a plurality of sensors at the distal section configured to provide the electrical signals indicative of intrinsic uterine contractions;

a connector associated with the handle; and

a plurality of electrical wires electrically connecting the plurality of sensors to the controller through the connector associated with the handle.

5. The birthing system of claim 1, wherein:

the medical apparatus comprises a pressure sensor configured to obtain an intrauterine pressure measurement, and

the controller is coupled to the medical apparatus to receive the intrauterine pressure measurement, and configured to compare the intrauterine pressure measurement to a threshold, and in response to the intrauterine pressure measurement exceeding the threshold, discharge an agent from the balloon body.

6. The birthing system of claim 3, wherein the distal section of the elongated body comprises a distal portion and a proximal portion, the distal portion being more flexible than the proximal portion, and the proximal portion being more flexible than the proximal section of the elongated body, and at least one of the distal portion and proximal portion being configured to bend.

7. The birthing system of claim 3, wherein the distal section of the elongated body has a length of about 2 centimeters to about 13 centimeters.

8. The birthing system of claim 3, wherein a distal portion of the distal section of the elongated body is formed of a polymer material having a hardness of about 10 D to about 60 D (Shore).

9. The birthing system of claim 3, wherein a proximal portion of the distal section of the elongated body is formed of a polymer material having a hardness of about 30 D to about 80 D (Shore).

10. The birthing system of claim 3, wherein the proximal section of the elongated body is formed of a polymer material having a hardness of about 60 D to about 85 D (Shore).

11. The birthing system of claim 3, wherein the elongated body further comprises an intermediate section between the proximal section and the distal section, the intermediate section being more flexible than the proximal section and less flexible than the distal section.

12. The birthing system of claim 11, wherein the intermediate section of the elongated body has a hardness of about 30 D to about 60 D (Shore).

13. The birthing system of claim 11, wherein the intermediate section of the elongated body has a length of about 1 centimeter to about 8 centimeters.

14. The birthing system of claim 3, wherein the distal section of the elongated body is formed with a curve so that the port in the distal tip is directed away from a longitudinal axis of the proximal section.

15. The birthing system of claim 3, wherein the port in the distal tip has a diameter equal to the diameter of the inner lumen.