Diagnostic catheters, guide catheters, visualization devices and chord manipulation devices, and related kits and methods

• US 10,625,046 B2
• Filed: 09/28/2015
• Issued: 04/21/2020
• Est. Priority Date: 01/20/2009
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Ancora Heart, Inc.
• Inventors: Fabro, Mariel
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US14/868,290
• Publication Number:
  US 20160220785A1
• Time in Patent Office: 1,667 Days
• Field of Search: 604532
• CPC Class Codes: A61B 1/00078 with stiffening means
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/7208 Flexible pins, e.g. ENDER pins
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• 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: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Described herein are devices, methods and kits for assessing and/or enhancing the accessibility of a subvalvular space of a heart, accessing the subvalvular space of the heart (e.g., to provide access for one or more other devices), and/or positioning one or more devices in the subvalvular space of the heart. The devices described herein may, for example, comprise catheters that may be used to manipulate one or more chordae tendineae, diagnostic catheters having different sizes and/or shapes (e.g., different curvatures), guide catheters having different sizes and/or shapes (e.g., different curvatures), and visualization catheters. In some variations, the devices, methods, and/or kits may be used to visualize a target site, such as a subannular groove of a heart valve. In certain variations, the devices, methods, and/or kits may be used to manipulate chordae tendineae to provide additional space in a ventricle of a heart (e.g., enhancing the accessibility of the ventricle).

Claims

1. A shaped catheter configured for advancement into a subvalvular space of a heart comprising:

an elongated member comprising a proximal end, a distal end, and a lumen therethrough, and further comprising an aortic arch curve region defining a first plane, a transition curve region distal to the aortic arch curve region and defining a second plane at a first angle with respect to the first plane, and a valve curve region distal to the transition curve region and defining a third plane at a second angle with respect to the second plane,

wherein the aortic arch curve region comprises a first preformed curve that corresponds to a curve of an aortic arch and has a first arc defining a central angle of about 60°

to about 270°

, the transition curve region comprises a second preformed curve that corresponds to a curve between an aortic root and a subannular groove of a mitral valve and has a second arc defining a central angle of about 90°

to about 270°

, and the valve curve region comprises a third preformed curve that corresponds to a curve of the subannular groove of the mitral valve and has a third arc defining a central angle of about 60°

to about 120°

.

2. The catheter of claim 1, wherein the first angle is from about 30°

to about 90°

, and the second angle is from about 1°

to about 50°

.

3. The catheter of claim 1, wherein the first angle is from about 30°

to about 65° and

the second angle is from about 5°

to about 45°

.

4. The catheter of claim 3, wherein the second angle is from about 15°

to about 35°

.

5. The catheter of claim 3, wherein the second angle is from about 20°

to about 45°

.

6. The catheter of claim 1, wherein the first angle is from about 50°

to about 80°

.

7. The catheter of claim 6, wherein the second angle is from about 5°

to about 45°

.

8. The catheter of claim 7, wherein the second angle is from about 15°

to about 35°

.

9. The catheter of claim 7, wherein the second angle is from about 20°

to about 45°

.

10. The catheter of claim 1, wherein the catheter has a size of 4 Fr to 9 Fr.

11. The catheter of claim 1, wherein the catheter has a size of 5 Fr to 10 Fr.

12. The catheter of claim 1, wherein the elongated member comprises a deflectable portion.

13. The catheter of claim 12, wherein the deflectable portion comprises a first polymer and a second polymer having a different durometer from the first polymer.

14. The catheter of claim 1, wherein the first preformed curve directs the catheter away from a center of a ventricular cavity when the catheter is located within vasculature near the heart.

15. The catheter of claim 14, wherein the first preformed curve directs the catheter toward an endocardial surface when the catheter is located within vasculature near the heart.

16. The catheter of claim 1, wherein the first preformed curve comprises an arc having a diameter of about 3.5 inches to about 5 inches.

17. The catheter of claim 1, wherein the second preformed curve directs the catheter toward an anterior side of the left ventricle when the catheter is located within vasculature near the heart.

18. The catheter of claim 1, wherein the second preformed curve comprises an arc having a diameter of about 1 inch to about 3 inches.

19. The catheter of claim 1, wherein the second preformed curve presses against a septal wall of the heart when the distal end is positioned in the subannular groove.

20. The catheter of claim 1, wherein the third preformed curve comprises an arc having a diameter of about 0.75 inch to about 1.5 inches.

21. The catheter of claim 1, wherein one or more of the aortic arch curve region, transition curve region, and the valve curve region comprises a bracing point that contacts an interior portion of vasculature near the heart to stabilize the position of the catheter within the vasculature.

22. The catheter of claim 17, wherein the aortic arch curve region comprises a first bracing point that contacts a length of the aortic arch and a second bracing point that contacts a length of the aortic root.

23. The catheter of claim 1, wherein the curves of the aortic arch curve region, transition curve region, and the valve curve region automatically register the distal end of the catheter within the subannular groove.

24. The catheter of claim 1, wherein the central angle of the first preformed curve is about 90°

.

25. The catheter of claim 1, wherein the central angle of the second preformed curve is about 90°

.

26. The catheter of claim 1, wherein the central angle of the third preformed curve is about 90°

.