Devices and methods for sizing valve apertures and luminal organs

• US 10,568,546 B2
• Filed: 06/17/2015
• Issued: 02/25/2020
• Est. Priority Date: 02/21/2003
• Status: Expired due to Fees

• Current Assignee: 3DT Holdings LLC, Markowitz H. Toby
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S., Markowitz, H. Toby
• Primary Examiner(s): Henson, Devin B
• Application Number:
  US14/742,025
• Publication Number:
  US 20150366485A1
• Time in Patent Office: 1,714 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/027 using catheters
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6886 Monitoring or controlling distance between sensor and tissue

Abstract

Devices and methods for sizing valve apertures and luminal organs. In at least one embodiment of a device for obtaining measurements within a luminal organ of the present disclosure, the device comprises an elongated body, and at least one sizing finger positioned at a distal end of the elongated body, the at least one sizing finger configured to move from a first position to a second position by way of adjustment of at least one movable device coupled thereto, wherein a dimensional measurement within the luminal organ can be determined based upon the first position and the second position.

Claims

1. A device for obtaining measurements within a luminal organ, comprising:

an elongated body;

a first sizing finger and a second sizing finger, each comprising a proximal end and an unattached distal tip, the proximal end positioned at a distal end of the elongated body and the first sizing finger and the second sizing finger each configured to move from a first position to a second position by way of adjustment of at least one movable device coupled thereto, wherein the at least one movable device comprises a first control wire coupled to the first sizing finger and a second control wire coupled to the second sizing finger, wherein the first control wire is configured to move the first sizing finger independently from the second sizing finger controlled by the second control wire, and wherein the proximal end of each of the first sizing finger and the second sizing finger is hingedly coupled to the elongated body;

a first electrode positioned upon the first sizing finger;

a second electrode positioned upon the second sizing finger; and

a third electrode and a fourth electrode positioned along the elongated body proximal to the first and second sizing fingers and separated a known distance from one another;

wherein a first dimensional measurement within the luminal organ can be determined based upon the first position and the second position of each of the first sizing finger and the second sizing finger, the first dimensional measurement indicative of a measurement along a first axis; and

wherein an additional dimensional measurement within the luminal organ can be obtained using the third electrode and the fourth electrode, based in part upon the known distance between the third electrode and the fourth electrode and a voltage difference between the third electrode and the fourth electrode, the additional dimensional measurement indicative of a measurement along a second axis orthogonal to the first axis.

2. The device of claim 1, further comprising at least one force measuring apparatus coupled to each of the first sizing finger and the second sizing finger, the at least one force measuring apparatus configured to quantify mechanical resistance of each of the first sizing finger and the second sizing finger relative to a wall of the luminal organ.

3. The device of claim 1, whereby a first difference in voltage obtained using the first electrode and the second electrode can be obtained using the device, whereby a second difference in voltage obtained using the third electrode and the fourth electrode can be obtained using the device, the first voltage difference and the second voltage difference being a function of at least one distance between two or more of the first electrode, the second electrode, the third electrode, and/or the fourth electrode.

4. The device of claim 1, further comprising a first coil positioned upon one of the first sizing finger or the second sizing finger, the first coil configured to generate a magnetic field detectable using at least one of the first electrode, the second electrode, or an additional electrode positioned upon a portion of the device.

5. The device of claim 1, further comprising a first piezoelectric sensor positioned upon the first sizing finger and a second piezoelectric sensor positioned upon the second sizing finger, the first piezoelectric sensor configured to generate an ultrasonic wave detectable by the second piezoelectric sensor, whereby a transmission time of the ultrasonic wave is indicative of a distance between the first piezoelectric sensor and the second piezoelectric sensor, which is indicative of the dimensional measurement.

6. The device of claim 1, wherein the third electrode and the fourth electrode are configured to detect an electric field within the luminal organ to generate impedance data, wherein the impedance data and a known distance between the third electrode and the fourth electrode are used to determine the dimensional measurement.

7. A device for obtaining measurements within a luminal organ, comprising:

an elongated body;

a first sizing finger and a second sizing finger, each comprising a proximal end and an unattached distal tip, the proximal end positioned at a distal end of the elongated body and the first sizing finger and the second sizing finger each configured to move from a first position to a second position by way of adjustment of at least one movable device coupled thereto, wherein the at least one movable device comprises a first control wire coupled to the first sizing finger and a second control wire coupled to the second sizing finger, wherein the first control wire is configured to move the first sizing finger independently from the second sizing finger controlled by the second control wire, and wherein the proximal end of each of the first sizing finger and the second sizing finger is hingedly coupled to the elongated body;

a first electrode positioned upon the first sizing finger;

a second electrode positioned upon the second sizing finger; and

a third electrode and a fourth electrode positioned along the elongated body proximal to the first and second sizing fingers and separated a known distance from one another;

wherein a first dimensional measurement within the luminal organ can be determined based upon the first position and the second position of each of the first sizing finger and the second sizing finger, the dimensional measurement selected from the group consisting of a cross-sectional area of the luminal organ, a valve aperture dimensional measurement, and a valve annulus dimensional measurement; and

wherein an additional dimensional measurement within the luminal organ can be obtained using the third electrode and the fourth electrode, based in part upon the known distance between the third electrode and the fourth electrode and a voltage difference between the third electrode and the fourth electrode, the additional dimensional measurement indicative of a measurement along a second axis orthogonal to a first axis.

8. The device of claim 7, whereby a first difference in voltage obtained using the first electrode and the second electrode can be obtained using the device.

9. A method for obtaining measurements within a luminal organ, comprising the steps of:

positioning at least part of a device within a luminal organ, the device comprising;

an elongated body,

a first sizing finger and a second sizing finger, each comprising a proximal end and an unattached distal tip, the proximal end positioned at a distal end of the elongated body and the first sizing finger and the second sizing finger each configured to move from a first position to a second position by way of adjustment of at least one movable device coupled thereto, wherein the at least one movable device comprises a first control wire coupled to the first sizing finger and a second control wire coupled to the second sizing finger, wherein the first control wire is configured to move the first sizing finger independently from the second sizing finger controlled by the second control wire, and wherein the proximal end of each of the first sizing finger and the second sizing finger is hingedly coupled to the elongated body;

a first electrode positioned upon the first sizing finger,

a second electrode positioned upon the second sizing finger, and

a third electrode and a fourth electrode positioned along the elongated body proximal to the first and second sizing fingers and separated a known distance from one another,

wherein a first dimensional measurement within the luminal organ can be determined based upon the first position and the second position of each of the first sizing finger and the second sizing finger, the first dimensional measurement indicative of a measurement along a first axis, and

wherein an additional dimensional measurement within the luminal organ can be obtained using the third electrode and the fourth electrode, based in part upon the known distance between the third electrode and the fourth electrode and a voltage difference between the third electrode and the fourth electrode, the additional dimensional measurement indicative of a measurement along a second axis orthogonal to the first axis;

moving the at least one movable device in a first direction to cause each of the first sizing finger and the second sizing finger to move from the first position to the second position; and

determining the first dimensional measurement within the luminal organ based upon the first position and the second position of each of the first sizing finger and the second sizing finger; and

obtaining the additional dimensional measurement within the luminal organ using the third electrode and the fourth electrode.

10. The method of claim 9, wherein the determining step includes the step of identifying a distance of movement of the at least one movable device based upon indicia of the at least one movable device.

11. The method of claim 9, wherein the determining step includes the step of obtaining a first voltage measurement between the first electrode and the second electrode.

12. The method of claim 9, wherein the moving step is performed to cause each of the first sizing finger and the second sizing finger to move from the first position of being relatively aligned with the elongated body to the second position of extending from the elongated body so that at least part of each of the first sizing finger and the second sizing finger contacts a wall of the luminal organ.

13. The method of claim 9, wherein the moving step is performed to cause the first sizing finger and the second sizing finger to move from the first position of being within the elongated body to the second position of extending from the elongated body so that at least part of each of the first sizing finger and the second sizing finger contact a wall of the luminal organ.