PERCUTANEOUS, ULTRASOUND-GUIDED INTRODUCTION OF MEDICAL DEVICES

• US 20130267848A1
• Filed: 12/31/2012
• Published: 10/10/2013
• Est. Priority Date: 06/30/2010
• Status: Active Grant

• Current Assignee: Muffin Incorporated
• Original Assignee: Muffin Incorporated
• Inventors: Fearnot, Neal E., McKinnis, Peter S.
• Granted Patent: US 10,111,645 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 2090/3788 transmitter only
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/5238 for combining image data of patient, e.g. merging several images from different acquisition modes into one image for image registration algorithms G06T7/30
• CPC Class Codes: A61B 8/5246 combining images from the same or different imaging techniques, e.g. color Doppler and B-mode
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

Described are methods and systems and system components useful for percutaneously delivering or retrieving vascular implant devices, such as filters, utilizing intravenous ultrasound (IVUS) imaging alone or in combination with external (e.g. transabdominal) ultrasound or other imaging technology. Implants deliverable by such systems, such as vena cava or other vascular filters, can have two or more echogenic markers spaced at such a distance that they are separately discernible by IVUS and/or external ultrasound imaging.

Claims

1. A retrievable vascular filter, comprising:

a filter structure configured to trap embolic matter in a vascular vessel;

a retrieval structure connected to the filter structure, for retrieval of the vascular filter from the vessel;

a first echogenic marker on the filter; and

a second echogenic marker on the filter;

wherein the first and second echogenic markers are operable to generate discrete, spaced ultrasound images of the first and second echogenic markers demarking a retrieval structure capture zone between the first and second echogenic markers.

2. The filter of claim 1, which is a vena cava filter.

3. The filter of claim 1, wherein said distance is greater than 3 mm.

4. The filter of claim 1, wherein said distance is in the range of 4 mm to 10 mm.

5. The filter of claim 1, comprising a filter hub, and wherein the first echogenic marker is on the hub, and the second echogenic marker is on the retrieval structure.

6. The filter of claim 1, also comprising at least a third echogenic marker, the third echogenic marker positioned on the filter structure.

7. The filter of claim 1, wherein the filter structure comprises a plurality of struts.

8. The filter of claim 1, wherein the retrieval structure comprises a hook.

9. A method for the capture of a vascular filter positioned within avascular vessel of a patient, comprising:

introducing a snare device through a percutaneous access site spaced from the vascular filter;

advancing the snare device through the vascular system toward the vascular filter;

visually observing an ultrasound-generated image of a first echogenic marker on the vascular filter;

visually observing an ultrasound-generated image of a second echogenic marker on the vascular filter, the second echogenic marker longitudinally spaced a distance from the first echogenic marker;

visually observing an ultrasound-generated image of a third echogenic marker within a capture zone between the first and second echogenic markers, the third echogenic marker on the snare device; and

closing a snare loop of the snare device within the capture zone so as to capture the vascular filter.

10. The method of claim 9, wherein the vascular filter is a vena cava filter.

11. The method of claim 9, wherein said distance is greater than 3 mm.

12. The method of claim 9, wherein said distance is in the range of 4 mm to 10 mm.

13. The method of claim 9, wherein said visually observing an ultrasound image of the third echogenic marker comprises visually observing a transabdominal-generated ultrasound image.

14. The method of claim 9, wherein said visually observing an ultrasound-generated image of the first echogenic marker comprises visually observing an intravenous ultrasound-generated image of the first echogenic marker.

15. The method of claim 9, wherein said visually observing an ultrasound-generated image of the second echogenic marker comprises visually observing an intravenous ultrasound-generated image of the second echogenic marker.

16. The method of claim 9, wherein said visually observing an ultrasound-generated image of the first echogenic marker comprises visually observing both an intravenous ultrasound-generated image of the first echogenic marker and an external ultrasound-generated image of the first echogenic marker.

17. The method of claim 16, wherein said visually observing an ultrasound-generated image of the second echogenic marker comprises visually observing both an intravenous ultrasound-generated image of the second echogenic marker and an external ultrasound-generated image of the second echogenic marker.

18. A system for delivering a vascular filter to a target site in a patient, the system comprising:

a sheath introducible through a percutaneous access site of the patient, the sheath having an inner lumen and a distal tip, the sheath having an echogenic marker located proximate the distal tip and a first series of visible indicia occurring along a first longitudinal region of the sheath, the first longitudinal region positioned to include a location aligned with a reference point external of the percutaneous access site when the distal tip of the sheath is at the target site;

an intravascular ultrasound device configured for slidable receipt through the inner lumen of the sheath and having an intravascular ultrasound probe in a distal region thereof for generating an ultrasound image signal for identifying the target site; and

a filter introducer configured for slidable receipt through the inner lumen of the sheath, the filter introducer including a filter delivery instrument and a vascular filter carried by the filter delivery instrument.

19. The system of claim 18, wherein the vascular filter includes a first echogenic marker, and a second echogenic marker longitudinally spaced a distance from the first echogenic marker.

20. The system of claim 19, wherein the ultrasound probe is operable to generate an ultrasound image signal having a longitudinal resolution, and wherein said distance is greater than said longitudinal resolution.

21. The system of claim 19, wherein said distance is greater than 3 mm.

22. The system of claim 19, wherein said distance is 4 to 10 mm.

23. The system of claim 19, wherein the filter includes a hub and plurality of struts emanating from the hub, and wherein the first echogenic marker is provided on the hub.

24. The system of claim 23, wherein the filter further includes a retrieval element emanating from the hub, and wherein the second echogenic marker is provided on the retrieval element.

25. The system of claim 18, wherein the filter includes at least one echogenic marker provided on at least one strut of the filter.

26. The system of claim 18, wherein the series of indicia includes scale markings.

27. The system of claim 26, wherein said scale markings register distances from the distal tip of the sheath.

28. A method for delivering a vascular filter into the inferior vena cava of a patient, comprising:

establishing a percutaneous access to the venous system of the patient;

positioning a guidewire through the percutaneous access and into the inferior vena cava of the patient;

advancing an intravascular ultrasound device over the guidewire through the percutaneous access and into the inferior vena cava of the patient;

identifying first and second renal veins of the patient in one or more images generated with the intravascular ultrasound device;

positioning a distal end of the intravascular ultrasound device caudal to the first and second renal veins;

advancing a sheath over the intravascular ultrasound device;

positioning a distal end of the sheath proximate to the distal end of the intravascular ultrasound device with the distal end of the intravascular ultrasound device caudal to the first and second renal veins;

visually determining that a visible marking along the sheath is at a reference point external of the patient with the distal end of the sheath positioned proximate to the distal end of the intravascular ultrasound device;

withdrawing the guidewire and intravascular ultrasound device from the sheath while maintaining the position of the distal end of the sheath caudal to the first and second renal veins with said visible marking at said reference point;

advancing a filter delivery catheter through the sheath while maintaining the position of the distal end of the sheath caudal to the first and second renal veins with said visible marking at said reference point; and

deploying a vascular filter from the filter delivery catheter to a site of the inferior vena cava caudal of the first and second renal veins.

29. A retrievable vascular filter, comprising:

a filter structure configured to trap emboli in a vascular vessel; and

at least one echogenic marker positioned on the filter structure and positioned to appose a wall of the vascular vessel when the filter is deployed in the vessel.

30. The filter of claim 29, wherein the filter structure comprises a plurality of struts, and said at least one echogenic marker positioned on a strut of said plurality of struts.

31. A vascular snare device, comprising:

a snare catheter having a lumen; and

a snare loop deployable into and from said lumen; and

an echogenic marker on said snare loop.

32. The vascular snare device of claim 31, also comprising an intravascular ultrasound probe located on a distal region of said snare catheter.

33. The vascular snare device of claim 31, wherein:

said snare loop is deployable from said lumen to an open condition; and

said echogenic marker is viewable with said probe with said snare loop in said open condition.

34. A method for the capture of a vascular filter positioned within a vascular vessel of a patient, comprising:

introducing a retrieval device through a percutaneous access site spaced from the vascular filter;

advancing the retrieval device through the vascular system toward the vascular filter;

visually observing an ultrasound-generated image of a first echogenic marker on the vascular filter;

visually observing an ultrasound-generated image of a second echogenic marker on the vascular filter, the second echogenic marker longitudinally spaced a distance from the first echogenic marker;

visually observing an ultrasound-generated image of a third echogenic marker within a capture zone between the first and second echogenic markers, the third echogenic marker on the retrieval device; and

actuating the retrieval device within the capture zone so as to capture the vascular filter.

35. A method for confirming placement of a vascular device implanted in a vascular vessel, comprising:

advancing a catheter having an IVUS probe beyond the implanted device;

pulling the catheter back to capture IVUS data; and

generating an IVUS image from the IVUS data, the IVUS image showing the implanted device and one or more adjacent anatomical landmarks.

36. The method of claim 35, wherein the vascular device is a vena cava filter and the vascular vessel is a vena cava.

37. The method of claim 36, wherein the one or more adjacent anatomical landmarks include at least one renal vein and an ileo-caval junction.

38. The method of, claim 35 wherein the image depicts first and second ends of the implanted device.

39. A method for maintaining a patient medical record, comprising electronically storing an image generated by a method of claim 35 in a database containing the patient medical record.

40. A method for delivering a vascular filter into the inferior vena cava of a patient, comprising:

percutaneously advancing a sheath through a percutaneous access site so as to position a distal end of the sheath to a target position within the inferior vena cava of a patient, said advancing conducted at least partially under ultrasound imaging guidance;

engaging a reference marker device on the sheath proximate to skin level on the patient;

deploying a vascular filter out of the sheath and into the inferior vena cava of the patient.

41. A method according to claim 40, further comprising:

positioning a guidewire through the percutaneous access site and into the inferior vena cava of the patient;

advancing an intravascular ultrasound device over the guidewire through the percutaneous access site and into the inferior vena cava of the patient;

identifying first and second renal veins of the patient in one or more images generated with the intravascular ultrasound device;

positioning a distal end of the intravascular ultrasound device caudal to the first and second renal veins;

advancing the sheath over the intravascular ultrasound device;

positioning a distal end of the sheath proximate to the distal end of the intravascular ultrasound device with the distal end of the intravascular ultrasound device caudal to the first and second renal veins;

visually determining that the reference marker device is at a reference point external of the patient with the distal end of the sheath positioned proximate to the distal end of the intravascular ultrasound device;

withdrawing the guidewire and intravascular ultrasound device from the sheath while maintaining the position of the distal end of the sheath caudal to the first and second renal veins with said visible marking at said reference point;

advancing a filter delivery catheter through the sheath while maintaining the position of the distal end of the sheath caudal to the first and second renal veins with said visible marking at said reference point; and

deploying a vascular filter from the filter delivery catheter to a site of the inferior vena cava caudal of the first and second renal veins.

42. A method for delivering a vascular implant to a vascular site of a patient, comprising:

percutaneously advancing a delivery device to position the delivery device to a target position within the vasculature of a patient, said advancing conducted at least partially under ultrasound imaging guidance;

engaging a reference marker device on the delivery device proximate to skin level on the patient; and

deploying a vascular implant from the delivery device and into the vascular system of the patient.

43. The method of claim 42, also comprising:

positioning an ultrasound probe of an intravascular ultrasound imaging device proximate to the target position;

advancing the delivery device over the ultrasound imaging device to position a distal end of the delivery device proximate to a distal end of the intravascular ultrasound imaging device at the target position;

with the distal end of the delivery device positioned proximate to the distal end of the intravascular ultrasound imaging device, performing said engaging step;

withdrawing the intravascular ultrasound imaging device from the delivery device while maintaining the position of the distal end of the delivery device at the target position;

advancing a vascular implant through the delivery device while maintaining the position of the distal end of the delivery device at the target position; and

deploying the vascular implant from the delivery device.

44. The method of claim 43, wherein the delivery device is a sheath or catheter having a lumen.

45. The method of claim 43, also comprising:

visually detecting the positioning of the distal end of the delivery device proximate to the distal end of the intravascular ultrasound imaging device, said visually detecting including detecting a change in an image generated by the ultrasound probe.

46. The method of claim 45, wherein said change is generated by an element of the delivery device reaching a position of at least partial alignment with said ultrasound probe.

47. The method of claim 46, wherein said element is a metallic marker.

48. A system useful for implanting a vascular device, comprising:

a dilator for percutaneous introduction into a patient, the dilator having a lumen and an intravascular ultrasound probe in a distal region thereof for generating ultrasound image data;

a wire guide device receivable through the dilator lumen; and

a delivery device receivable over the dilator.

49. The system of claim 48, wherein the delivery device is a catheter or sheath.

50. The system of claim 48, wherein the delivery device has an echogenic marker in a distal region thereof.

51. The system of claim 50, wherein the echogenic marker is also a fluoroscopic marker.

52. A medical device, comprising:

a vascular snare including an elongate shaft having an internal lumen and a snare loop; and

wherein the snare loop includes an echogenic marker and/or the elongate shaft has an ultrasound probe positioned in a distal region thereof.

53. The medical device of claim 52, wherein the snare loop includes an echogenic marker and wherein the elongate shaft has an ultrasound probe positioned in a distal region thereof.

54. The medical device of claim 53, wherein the echogenic marker is positioned on the snare loop and the snare loop deploys to a configuration such that at least a portion of the echogenic marker can be imaged using an ultrasonic signal generated with the ultrasound probe.

55. A system for delivering a vascular implant to a vascular site of a patient, comprising:

a percutaneous delivery device for delivering a vascular device;

a reference marker device engageable on a portion of the delivery device that remains external of the patient.

56. The system of claim 55, also comprising an intravascular ultrasound imaging device.

57. The system of claim 55, wherein the delivery device is a catheter or sheath.

58. The system of claim 55, wherein the delivery device has a visible marking feature that extends at least partially upon said portion of the delivery device that remains external of the patient, said marking feature located to include at least a portion that occurs at skin level of the patient when said delivery device is positioned to a target position for delivery of said vascular device.

59. The system of claim 58, wherein said marking feature demarks the distance from locations within the marking feature to a distal tip of the delivery device.

60. The system of claim 55, wherein the reference marker device is selectively engageable and disengageable on the delivery device.

61. The system of claim 55, wherein the reference marker comprises a spring collar.

62. The system of claim 55, wherein the reference marker is frictionally engageable on the delivery device.

63. A system for ultrasound guidance, comprising:

a computer processor for receiving signal data from an intravascular ultrasound probe and generating ultrasound images using the signal data;

a visual display device; and

said computer processor and display device operable to display two-dimensional, real time images generated using the signal data simultaneously with a three-dimensional image generated from prior-acquired intravascular ultrasound image signal data.

64. The system of claim 63, wherein the three-dimensional image is generated by reconstructing a plurality of previously-acquired two-dimensional, cross-sectional image data sets from the probe

65. The system of claim 63, wherein the display also includes a reference scale and/or graphical image.