Method for cervical dilation and/or measurement

• US 7,713,216 B2
• Filed: 04/10/2006
• Issued: 05/11/2010
• Est. Priority Date: 04/10/2006
• Status: Expired due to Fees

• Current Assignee: Intrapartum LLC
• Original Assignee: Intrapartum LLC
• Inventors: Báird, Tim, Dubey, Dharmesh
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/401,623
• Publication Number:
  US 20070239197A1
• Time in Patent Office: 1,492 Days
• Field of Search: 600/586, 600/587, 600/591, 600/588
• US Class Current: 600/588
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/435 Assessing cervix alteration or dilation
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2210/14 Female reproductive, genital organs
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present invention provides a medical device for measuring and/or providing cervical dilation including an elongate body defining a proximal end and a distal end, as well as an expandable element coupled to the distal end of the elongate body. An array of movable elements may be disposed circumferentially about the elongate body, where the array of movable elements is movably coupled to the distal end of the elongate body by a plurality of wires. The medical device may further include a measurement mechanism able to determine a radial spacing of the array of movable elements, as well as a dilation indicator in communication with the measurement mechanism. One or more pressure sensors may be coupled to the array of movable elements, whereby a control element is in communication with the pressure sensors. In addition, an inflation source may be included in fluid communication with the expandable element.

Claims

1. A method for performing cervical dilation, comprising the steps of:

providing a medical device having an array of movable elements disposed circumferentially about an axis and a plurality of wires coupled to the array of movable elements;

positioning the medical device proximate a region of cervical tissue to be dilated; and

applying a force to the plurality of wires thereby extending the array of movable elements, such that the entirety of each movable element radially extends from the axis to cause dilation of the cervical tissue,

wherein each movable element is spaced a distance outwardly from the axis, is disposed a distance from an adjacent movable element, and is positioned such that the entirety of each movable element is substantially parallel to the axis about which the array of movable elements is disposed.

2. The method according to claim 1, further comprising the step of measuring a radial spacing of the array of movable elements.

3. The method according to claim 2, wherein the array of movable elements is extended to achieve a radial spacing of a predetermined value.

4. The method according to claim 1, wherein the medical device further includes an expandable element coupled to the away of movable elements, and wherein the step of extending the array of movable elements includes inflating the expandable element.

5. The method according to claim 4, wherein the expandable element has an internal pressure, and wherein the step of extending the away of movable elements includes inflating the expandable element to an internal pressure of a predetermined value.

6. The method according to claim 1, further comprising the step of measuring a pressure level between at least a portion of the medical device and a portion of the cervical tissue.

7. The method according to claim 6, wherein the step of extending the array of movable elements includes extending the array of movable elements until the pressure level reaches a predetermined value.

8. The method according to claim 1, wherein the medical device further includes a distal end, further comprising the step of measuring a pressure level between the distal end and a tissue portion.

9. The method according to claim 8, wherein the step of positioning the medical device proximate a region of cervical tissue to be dilated includes axially positioning the medical device until the pressure level reaches a predetermined value.

10. The method according to claim 1, wherein the medical device further includes a camera, further comprising the step of monitoring the positioning of the medical device with the camera.

11. A method for performing cervical dilation, comprising the steps of:

providing a medical device having an array of movable elements disposed circumferentially about an axis, a plurality of wires coupled to the array of movable elements, an expandable element coupled to the array of movable elements, and a pressure sensor coupled to the array of movable elements;

positioning the medical device proximate a region of cervical tissue to be dilated; and

inflating the expandable element, thereby applying a force to the plurality of wires and extending the array of movable elements, such that the entirety of each movable element radially extends from the axis to cause dilation of the cervical tissue,

wherein each movable element is spaced a distance outwardly from the axis, is disposed a distance from an adjacent movable element, and is positioned such that the entirety of each movable element is substantially parallel to the axis about which the array of movable elements is disposed.

12. The method according to claim 11, further comprising the step of measuring a pressure level between at least a portion of the medical device and a portion of the cervical tissue.

13. The method according to claim 12, wherein the expandable element is inflated until the pressure level reaches a predetermined value.

14. The method according to claim 11, further comprising the step of measuring a radial spacing of the array of movable elements.

15. The method according to claim 14, wherein the array of movable elements is extended to achieve a radial spacing of a predetermined value.

16. A method for performing cervical dilation, comprising the steps of:

providing a medical device having an array of movable elements disposed circumferentially about an axis, a plurality of wires coupled to the array of movable elements, an expandable element coupled to the array of movable elements, and a pressure sensor coupled to the array of movable elements;

positioning the medical device proximate a region of cervical tissue to be dilated;

inflating the expandable element, thereby applying a force to the plurality of wires and extending the array of movable elements, such that the entirety of each movable element radially extends from the axis to cause dilation of the cervical tissue,

wherein each movable element is spaced a distance outwardly from the axis, is disposed a distance from an adjacent movable element, and is positioned such that the entirety of each movable element is substantially parallel to the axis about which the array of movable elements is disposed;

measuring a pressure level between at least a portion of the medical device and a portion of the cervical tissue; and

measuring a radial spacing of the array of movable elements.