Pigtail for optimal aortic valvular complex imaging and alignment

• US 10,507,301 B2
• Filed: 01/30/2015
• Issued: 12/17/2019
• Est. Priority Date: 01/31/2014
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Al-Jilaihawi, Hasanian
• Primary Examiner(s): Behringer, Luther
• Assistant Examiner(s): Mattson, Sean D
• Application Number:
  US15/103,690
• Publication Number:
  US 20160310699A1
• Time in Patent Office: 1,782 Days
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/6857 with a distal pigtail shape
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/503 for diagnosis of the heart
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• 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 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

Devices, systems and methods using two, three or more pigtails for precisely imaging an aortic valve complex with minimal contrast and/or for advancing an instrument, such as a wire, or device, such as a transcatheter valve, across an aortic valve. These devices, systems and methods may be used to diagnose and/or treat patients with aortic stenosis, other valvular heart disease or other cardiovascular or non cardiovascular disease, facilitating precise contrast or drug or device delivery, precise pressure measurement and/or precise drainage or sampling.

Claims

1. A device, comprising:

a catheter comprising an interior wall and an exterior wall,

wherein the catheter has a proximal portion, a distal portion, and a center portion between the proximal portion and the distal portion,

wherein the interior wall forms a central lumen along the longitudinal axis of the catheter,

wherein the interior wall and the exterior wall form a single peripheral lumen around the central lumen along the longitudinal axis of the catheter,

wherein the interior wall and the exterior wall form at least three distal branches at a fixed branch point of the distal portion of the catheter, wherein the central lumen terminates in a fixed opening at the fixed branch point, and the at least three distal branches fan out and retain an orientation at the fixed branch point, spaced from each other, when unrestrained;

wherein the single peripheral lumen branches into at least three peripheral lumen branches inside the at least three distal branches, wherein the at least three peripheral lumen branches are all in fluid communication with each other and the single peripheral lumen; and

wherein each of the at least three distal branches comprises one or more side openings at or near the distal end.

2. The device of claim 1, wherein each of the at least three distal branches comprises one radiographic marker at or near the distal end of the distal branch.

3. The device of claim 1, wherein the interior wall forms a first inlet of the central lumen at the proximal portion of the catheter.

4. The device of claim 1, wherein the exterior wall forms a second inlet of the peripheral lumen at the proximal portion of the catheter.

5. The device of claim 1, wherein the at least three distal branches are pigtail-shaped or J-shaped and may be advanced independently of each other.

6. The device of claim 1, wherein the at least three distal branches are curved.

7. The device of claim 1, wherein the at least three distal branches have rounded tips.

8. The device of claim 1, wherein the at least three distal branches are configured to be equally spaced from one another on a radial plane perpendicular to the longitudinal axis of the catheter when not physically restrained by a sheath.

9. The device of claim 1, further comprising an outer sheath enclosing the catheter, wherein the at least three distal branches are straightened when the outer sheath encloses the distal portion of the catheter, and wherein the at least distal branches are pigtail-shaped or J-shaped when the outer sheath does not enclose the distal portion of the catheter.

10. The device of claim 1, further comprising a contrast dye or drug, wherein the contrast dye or drug is injected into the single peripheral lumen.

11. The device of claim 1, further comprising an instrument, wherein the instrument is inserted into the central lumen.

12. The device of claim 1, further comprising a tube, wherein the tube is inserted into the central lumen and can be advanced or retracted independently.

13. The device of claim 1, wherein the central lumen is co-axially aligned with a heart valve orifice.

14. A method, comprising:

providing an outer sheath;

maneuvering the outer sheath to reach the sinotubular junction or aortic root just above the aortic valve of a subject;

providing the device of claim 1;

inserting the device into the outer sheath;

advancing the device out of the outer sheath, wherein the at least three distal branches are J-shaped outside the outer sheath;

maneuvering the catheter into a position that brings each aortic leaflet of the subject within proximity to one distal branch;

injecting a contrast dye to the aortic valve complex of the subject through the peripheral lumen of the device; and

imaging the aortic valve complex of the subject.

15. The method of claim 14, wherein the aortic valve complex is imaged with X-ray, fluoroscopy, ultrasound, computerized tomography (CT), or magnetic resonance imaging (MRI).

16. The method of claim 14, wherein proximity comprises physical contact.

17. The method of claim 14, further comprising inserting an instrument into the central lumen and advancing the instrument through the aortic valve orifice into the left ventricle.

18. The method of claim 14, further comprising performing a balloon aortic valvuloplasty (BAV) or transcatheter aortic valve replacement (TAVR) procedure.

19. A method, comprising:

providing an outer sheath;

maneuvering the outer sheath to reach the sinotubular junction or aortic root just above the aortic valve of a subject;

providing the device of claim 3;

inserting the device into the outer sheath, wherein the at least three branches are straightened inside the outer sheath;

advancing the device out of the outer sheath, wherein the at least three distal branches are J-shaped outside the outer sheath;

maneuvering the device in order to position each aortic leaflet of the subject within proximity to one distal branch; and

imaging the aortic valve complex of the subject and the radiographic markers.

20. The method of claim 19, wherein the aortic valve complex is imaged with X-ray, fluoroscopy, ultrasound, CT or MRI.

21. The method of claim 19, further comprising inserting an instrument into the central lumen and advancing the instrument through the aortic valve orifice into the left ventricle.

22. The method of claim 19, further comprising performing a BAV or TAVR procedure.