Lumen-measuring devices and method

• US 20050010138A1
• Filed: 07/11/2003
• Published: 01/13/2005
• Est. Priority Date: 07/11/2003
• Status: Abandoned Application

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Borg, Ulf R., Reynolds, Jason M., Mangiardi, Eric K., Alexander, Tony D.
• Application Number:
  US10/618,223
• Publication Number:
  US 20050010138A1
• Time in Patent Office: Days
• US Class Current: 600/587
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket

Abstract

The present invention provides a lumen measuring device and method that allows the user to calculate the exact length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure.

Claims

1. A device that allows a user to calculate the length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure, the device comprising:

an exterior conduit longitudinally extending between proximal and distal ends, the exterior conduit having measurement markers formed on a portion thereof;

an interior conduit longitudinally extending between proximal and distal ends, disposed within the exterior conduit, and displaceable with respect to the exterior conduit, the interior conduit having a depth marking mechanism visible through a portion of the exterior conduit;

a measurement assembly comprising at least two legs having distal and proximal ends and inward facing and lumen facing surfaces, the legs coupled with each other proximal the distal ends thereof, the measurement assembly also coupled about the distal end of the interior conduit;

a handle operatively connected with the measurement assembly, the handle comprising a means for opening and closing the measurement assembly by actuating the handle along a continuum between a first closed configuration and a second open configuration.

2. The device of claim 1, wherein the inward facing surfaces of the legs are substantially flush with one another when the measurement assembly is closed.

3. The device of claim 2, wherein when the measurement assembly is moved distally in relation to the first conduit, the legs form an acute angle with respect to one another.

4. The device of claim 3, wherein the measurement assembly further comprises a third leg.

5. The device of claim 1, wherein the distal ends of the legs are coupled together, wherein measurement of the target site takes place between the distal and proximal ends thereof.

6. The device of claim 1, wherein the handle further comprises a measurement indicator, wherein target lumen dimensions are calculated based on the relative distance the handle travels along the continuum between the first and second handle locations.

7. A method of measuring a target segment of a lumen of a patient so as to select a suitable interventional prosthesis, the method comprising:

providing a measuring device having an exterior conduit longitudinally extending between proximal and distal ends, the exterior conduit having measurement markers formed on a portion thereof;

an interior conduit longitudinally extending between proximal and distal ends, disposed within the exterior conduit, and displaceable with respect to the exterior conduit, the interior conduit having a depth marking mechanism visible through a portion of the exterior conduit;

a measurement assembly comprising at least two legs having distal and proximal ends and inward facing and lumen facing surfaces, the legs coupled with each other proximal the distal ends thereof, the measurement assembly also coupled about the distal end of the interior conduit;

a handle operatively connected with the measurement assembly, the handle comprising a means for opening and closing the measurement assembly by actuating the handle along a continuum between a first closed configuration and a second open configuration;

introducing the device into an appropriate anatomical orifice of a patient;

delivering the device adjacent a target segment of a lumen within the patient; and

measuring the length of the target segment of the lumen within the patient.

8. The method of claim 7, wherein the device further comprises an optical scope operatively coupled therewith, such that the measuring step is accomplished using the optical scope.

9. The method of claim 7, wherein the inward facing surfaces of the legs are substantially flush with one another when the measurement assembly is closed.

10. The method of claim 9, wherein when the measurement assembly is moved distally in relation to the first conduit, the legs form an acute angle with respect to one another.

11. The method of claim 10, wherein the measurement assembly further comprises a third leg.

12. The method of claim 7, wherein the distal ends of the legs are coupled together, wherein measurement of the target site takes place between the distal and proximal ends thereof.

13. The method of claim 7, wherein the handle further comprises a measurement indicator, wherein target lumen dimensions are calculated based on the relative distance the handle travels along the continuum between the first and second handle locations.

14. The method of claim 7, further comprising the step of measuring the diameter of the target segment of the lumen within the patient.

15. The method of claim 14, wherein the diameter measuring step comprises the step of actuating the handle along the continuum from the first closed configuration toward the second open configuration until the legs of the measurement mechanism come in contact with the target segment of the lumen and calculating the length as a function of the number of leg measurement markings distal the exterior conduit.

16. The method of claim 14, wherein the target segment of the lumen is stenotic.

17. The method of claim 7, wherein the device further comprises an optical scope operatively coupled therewith, such that the measuring step is accomplished using the optical scope.

18. The method of claim 16, further comprising the step of measuring the length of the stenosis.

19. The method of claim 18, wherein the delivering step further comprises the step of positioning the distal end of the first conduit distal the stenosis.

20. The method of claim 19, wherein the measurement mechanism is opened and placed distal the stenosis such that the exterior conduit is retracted and the stenosis length measurement is a function of the distance the exterior conduit is retracted proximally.

21. The method of claim 18, wherein the stenosis length measuring step comprises the step of actuating the handle along the continuum from the first closed configuration toward the second open configuration until the legs of the measurement mechanism come in contact with the target segment of the lumen and calculating the length as a function of the distance between the first handle position and the current point of the handle along the continuum.

22. The method of claim 16, further comprising the step of measuring the height of the stenosis.

23. The method of claim 22, further comprising the step of measuring the length of the stenosis.

24. A method of measuring a target segment of a lumen of a patient so as to select a suitable interventional prosthesis, the method comprising:

providing a measuring device having an exterior conduit longitudinally extending between proximal and distal ends, the exterior conduit having measurement markers formed on a portion thereof;

an interior conduit longitudinally extending between proximal and distal ends, disposed within the exterior conduit, and displaceable with respect to the exterior conduit, the interior conduit having a depth marking mechanism visible through a portion of the exterior conduit;

a measurement assembly comprising four legs having distal and proximal ends and inward facing and lumen facing surfaces, the legs coupled with each other proximal the distal ends thereof, the measurement assembly also coupled about the distal end of the interior conduit;

a handle operatively connected with the measurement assembly, the handle comprising a means for opening and closing the measurement assembly by actuating the handle along a continuum between a first closed configuration and a second open configuration;

introducing the device into an appropriate anatomical orifice of a patient;

delivering the device adjacent a target segment of a lumen within the patient; and

measuring the diameter of the target segment of the lumen within the patient.

25. A device that allows a user to calculate the length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure, the device comprising:

a diameter measurement balloon comprising substantially flat distal and proximal surfaces, with a substantially circular edge there between, the diameter measuring balloon having diameter measurement markers on the proximal and/or distal surface thereof;

a dilation balloon that has a substantially cylindrical shape with proximal and distal ends;

a plurality of conduits, a diameter measurement conduit for inflating the diameter measurement balloon, a dilation conduit for inflating the dilation balloon and an outermost conduit, the outermost conduit having proximal and distal ends and measurement markings there between, the diameter measurement conduit and the dilation conduit disposed within the outermost conduit such that the dilation balloon and the diameter measurement balloon are coupled along the outermost conduit yet operatively coupled with the dilation and measurement conduits, respectively through the outermost conduit.

26. The device of claim 25, wherein the plurality of conduits are co-extruded.

27. A method of measuring a target segment of a lumen of a patient so as to select a suitable interventional prosthesis, the method comprising:

providing a measuring device having a diameter measurement balloon comprising a substantially flat distal and proximal surfaces, with a substantially circular edge there between, the diameter measuring balloon having diameter measurement markers on the proximal and/or distal surface thereof;

a dilation balloon that has a substantially cylindrical shape with proximal and distal ends;

a plurality of conduits, a diameter measurement conduit for inflating the diameter measurement balloon, a dilation conduit for inflating the dilation balloon and an outermost conduit, the outermost conduit having proximal and distal ends and measurement markings there between, the diameter measurement conduit and the dilation conduit disposed within the outermost conduit such that the dilation balloon and the diameter measurement balloon are coupled along the outermost conduit yet operatively coupled with the dilation and measurement conduits, respectively through the outermost conduit;

introducing the device into an appropriate anatomical orifice of a patient;

delivering the device adjacent a target segment of a lumen within the patient; and

measuring the specific dimensions of the target segment of the lumen within the patient.

28. The method of claim 27, wherein the device further comprises an optical scope operatively coupled therewith, such that the measuring step is accomplished using the optical scope.

29. The method of claim 27, wherein the target segment of the lumen is stenotic.

30. The method of claim 29, wherein the specific dimensions of the target segment is selected from the group consisting of length, height, circumference, radius, diameter and combinations thereof.

31. A device that allows a user to calculate the length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure, the device comprising:

a diameter measurement balloon comprising substantially flat distal and proximal surfaces, with a substantially circular edge there between, the diameter measuring balloon having diameter measurement markers on the proximal and/or distal surface thereof;

a dilation balloon that has a substantially cylindrical shape with proximal and distal ends;

a tube having and interior and an exterior, the interior defining three apertures passing at least partially there through, the first aperture comprising a diameter measurement conduit for inflating the diameter measurement balloon, the second aperture comprising a dilation conduit for inflating the dilation balloon and an third aperture that extends the length thereof, the third aperture comprising a working channel, the diameter measurement conduit and the dilation conduit disposed within the tube conduit such that the dilation balloon and the diameter measurement balloon are coupled along the exterior of the tube yet operatively coupled with the dilation and measurement conduits, respectively through the outermost conduit.

32. A method of measuring a target segment of a lumen of a patient so as to select a suitable interventional prosthesis, the method comprising:

providing a measuring device having a diameter measurement balloon comprising a substantially flat distal and proximal surfaces, with a substantially circular edge there between, the diameter measuring balloon having diameter measurement markers on the proximal and/or distal surface thereof;

a dilation balloon that has a substantially cylindrical shape with proximal and distal ends;

a tube having and interior and an exterior, the interior defining three apertures passing at least partially there through, the first aperture comprising a diameter measurement conduit for inflating the diameter measurement balloon, the second aperture comprising a dilation conduit for inflating the dilation balloon and an third aperture that extends the length thereof, the third aperture comprising a working channel, the diameter measurement conduit and the dilation conduit disposed within the tube conduit such that the dilation balloon and the diameter measurement balloon are coupled along the exterior of the tube yet operatively coupled with the dilation and measurement conduits, respectively through the outermost conduit;

introducing the device into an appropriate anatomical orifice of a patient;

delivering the device adjacent a target segment of a lumen within the patient; and

measuring the specific dimensions of the target segment of the lumen within the patient.

33. The method of claim 32, wherein the device further comprises an optical scope operatively coupled therewith, such that the measuring step is accomplished using the optical scope.

34. The method of claim 32, wherein the target segment of the lumen is stenotic.

35. The method of claim 34, wherein the specific dimensions of the target segment is selected from the group consisting of length, height, circumference, radius, diameter and combinations thereof.

36. The device of claim 35, wherein the tube further comprises proximal and distal ends and measurement markings there between.

37. A device that allows a user to calculate the length and diameter of a suitable interventional prosthesis as well as the height and length of stenosis during the same exploratory procedure, the device comprising:

an exterior conduit longitudinally extending between proximal and distal ends, the exterior conduit having measurement markers formed on a portion thereof;

an interior conduit longitudinally extending between proximal and distal ends, disposed within the exterior conduit, and displaceable with respect to the exterior conduit;

a measurement assembly comprising a plurality of legs having distal and proximal ends and inward facing and lumen facing surfaces, the legs coupled with each other proximal the distal ends thereof, the measurement assembly also coupled about the distal end of the interior conduit;

a handle operatively connected with the measurement assembly, the handle comprising a means for opening and closing the measurement assembly by actuating the handle along a continuum between a first closed configuration and a second open configuration.

38. The device of claim 37, wherein the inward facing surfaces of the legs are substantially flush with one another when the measurement assembly is closed.

39. The device of claim 38, wherein when the measurement assembly is moved distally in relation to the first conduit, the legs form an acute angle with respect to one another.

40. The device of claim 39, wherein the measurement assembly comprises four legs.

41. The device of claim 37, wherein the distal ends of the legs are coupled together, wherein measurement of the target site takes place between the distal and proximal ends thereof.

42. The device of claim 37, wherein the handle further comprises a measurement indicator, wherein target lumen dimensions are calculated based on the relative distance the handle travels along the continuum between the first and second handle locations.