Cardiac valve leaflet augmentation

• US 8,758,431 B2
• Filed: 06/04/2008
• Issued: 06/24/2014
• Est. Priority Date: 06/04/2007
• Status: Active Grant

• Current Assignee: Boris Orlov
• Original Assignee: Mor Research Applications Ltd. (Clalit Health Services)
• Inventors: Orlov, Boris, Zef, Nisan
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US12/602,807
• Publication Number:
  US 20100204662A1
• Time in Patent Office: 2,211 Days
• Field of Search: 623/2.11, 623/2.12, 623/2.17, 623/900, 623/904, 623/1.26, 623/2.38, 623/2.14, 606/167, 606/170, 606/185, 606/139, 606/142, 606/143, 606/151, 606153-158, 606/213, 606/215, 606/184
• US Class Current: 623/2.11
• 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 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Methods and devices for augmenting an atrioventricular valve leaflet is disclosed. A method according to an exemplary embodiment includes piercing a leaflet of the valve to at least a portion of the leaflet'"'"'s thickness to form a pierced section; and extending the leaflet using said pierced section. A device according to an exemplary embodiment of the invention includes a catheter comprising: a longitudinal tube having a lumen; and a cutting element extendable from the lumen. The cutting element is adapted for forming a limited cut in an atrioventricular valve. A device according to another exemplary embodiment of the invention includes a catheter comprising a longitudinal tube having a lumen; a cutting element extendable from the lumen and adapted for forming a cut in a leaflet of an atrioventricular valve; and a frame, configured to attach to the leaflet and stay attached to the leaflet when the heart beats.

Claims

1. A method of augmenting an atrioventricular valve leaflet, the method comprising:

transcutaneously penetrating a leaflet of the valve to at least a portion of the leaflet'"'"'s thickness to form a penetrated section; and

extending said leaflet using said penetrated section, leaving the penetrated leaflet permanently obstructed so as to prevent blood flow through the penetrated section.

2. A method according to claim 1, wherein said atrioventricular valve is a mitral valve.

3. A method of according to claim 1, comprising:

delivering, with a catheter, a penetrating element to the vicinity of the valve leaflet; and

cutting, with said penetrating element, a valve leaflet to at least a portion of the leaflet'"'"'s thickness so as to allow the leaflet to stretch.

4. A method according to claim 1, wherein penetrating a leaflet to at least a portion of the leaflet'"'"'s thickness substantially consists of cutting to a portion of the leaflet'"'"'s thickness so as to leave one of the leaflet'"'"'s surfaces intact.

5. A method according to claim 1, wherein penetrating a leaflet to at least a portion of the leaflet'"'"'s thickness comprises piercing the leaflet through the entire leaflet'"'"'s thickness so as to form an opening going through the leaflet from one surface to the other.

6. A method according to claim 5, comprising dilating the opening.

7. A method according to claim 6, comprising:

deploying a dilation brace in the dilated opening so as to maintain the dilated opening in a dilated state.

8. The method of claim 7, wherein said dilation brace includes an inflatable balloon.

9. The method of claim 8, wherein said dilation brace includes an expandable ring mounted on said inflatable balloon during said dilating.

10. The method of claim 7, wherein said dilation brace includes an expandable ring.

11. The method of claim 7, further comprising deploying a mitral valve annulus supporting device.

12. A method according to claim 1, wherein penetrating comprises performing a plurality of discontinuous penetrated segments.

13. A method according to claim 12, comprising:

obstructing a plurality of said discontinuous penetrated segments with a single obstructor.

14. A method according to claim 1, comprising attaching to a surface of an atrioventricular valve leaflet a frame that holds a portion of the leaflet when the heart beats.

15. A method according to claim 14, wherein attaching comprises attaching by suction.

16. A method according to claim 14, wherein said frame comprises double walls from between which suction is applied, and the frame is configured to prevent collapsing of the walls towards each other when said suction is applied.

17. A method according to claim 14, wherein said penetration is guided by a guiding element.

18. The method according to claim 17, further comprising overlaying said guiding element on a portion of the leaflet, said penetrating comprising penetrating with the guidance of said guiding element, wherein said guiding element is integral with said frame.

19. A method according to claim 1, comprising overlaying a cutting guide on a portion of the leaflet, said penetrating comprising penetrating with the guidance of said cutting guide.

20. A method according to claim 19, wherein the cutting guide comprises a plurality of openings, and said penetrating comprises penetrating through a plurality of said openings.

21. A method of augmenting an atrioventricular valve leaflet, the method comprising:

transcutaneously penetrating a leaflet of the valve to at least a portion of the leaflet'"'"'s thickness to form a penetrated section,

wherein said penetrating comprises;

delivering a penetrating device to a first position in the vicinity of the leaflet during a first systole, such that at a first diastole the leaflet hits against the penetrating device and is penetrated at a first place.

22. A method according to claim 21, further comprising moving the penetrating device to a second position, such that at a second diastole the leaflet hits against the penetrating device and is penetrated at a second place.