Percutaneous, ultrasound-guided introduction of medical devices

• US 10,111,645 B2
• Filed: 12/31/2012
• Issued: 10/30/2018
• Est. Priority Date: 06/30/2010
• Status: Active Grant

• Current Assignee: Muffin Incorporated
• Original Assignee: Muffin Incorporated
• Inventors: Fearnot, Neal E., McKinnis, Peter S., Klausen, Kasper
• Primary Examiner(s): LAURITZEN, AMANDA L
• Application Number:
  US13/731,313
• Publication Number:
  US 20130267848A1
• Time in Patent Office: 2,129 Days
• 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 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;

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;

wherein the vascular filter includes a first echogenic marker, and a second echogenic marker longitudinally spaced a distance from the first echogenic marker; and

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.

2. The system of claim 1, 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.

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

4. The system of claim 1, wherein the filter includes at least one echogenic marker provided on at least one strut of the filter.

5. The system of claim 1, wherein the filter further includes a retrieval element emanating from the hub, and wherein the second echogenic marker is provided on the retrieval element.

6. The system of claim 5, wherein the retrieval element includes a closed hoop.

7. The system of claim 5, wherein the retrieval element includes a reversely-turned hook.

8. The system of claim 1, wherein the series of indicia includes scale markings.

9. The system of claim 8, wherein said scale markings register distances from the distal tip of the sheath.

10. The system of claim 1, also including a reference marker device selectively engageable and disengageable on the first longitudinal region of the sheath.

11. The system of claim 10, wherein the reference marker is frictionally engageable on the first longitudinal region of the sheath, and wherein frictional engagement of the reference marker device on the first longitudinal region of the sheath requires a force of greater than 2 Newtons applied to the reference marker device in the direction of a longitudinal axis of the sheath to cause sliding movement of the reference marker device.

12. The system of claim 11, wherein said force is 3 Newtons to 10 Newtons.

13. The system of claim 1, wherein the filter has strut-positioned echogenic markers on a plurality of said struts.

14. The system of claim 13, wherein the strut-positioned echogenic markers are mounted around the struts.

15. The system of claim 14, wherein the strut-positioned echogenic markers comprise sonically-reflective coils.

16. The system of claim 14, wherein the strut-positioned echogenic markers comprise cannular segments with dimpled, grooved or textured surfaces.