MITRAL VALVE SPACER AND SYSTEM AND METHOD FOR IMPLANTING THE SAME

• US 20140277405A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cardiosolutions, Inc.
• Original Assignee: Cardiosolutions, Inc.
• Inventors: Wilson, Jonathan E., Conley, Eric, Cruz, Amos, Kanner, Glenn
• Granted Patent: US 9,289,297 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

A trans-femoral implant includes an anchor assembly and a balloon assembly configured to be separately delivered to an implant site within a heart. Once delivered, the anchor assembly and balloon assembly may be coupled to form an implant within the heart. The balloon anchor may include a fluid inflatable balloon that may be selectively filled via a balloon filling valve. The balloon assembly may further include a latching mechanism that may couple with a distal end of the anchor assembly, such that the length of the implant may be adjusted within the heart.

Claims

1. An implant, comprising:

a balloon spacer assembly, the balloon spacer assembly comprising;

a balloon spacer defining a spacer cavity configured to be expanded from a deflated condition to an expanded condition with a filling fluid;

a balloon filling valve disposed within and fluidly coupled to said spacer cavity, wherein said balloon filling valve comprises a lumen, is configured to be fluidly coupled to a source of said filling fluid and to selectively allow the introduction and withdrawal of said fluid into and out of said spacer cavity.

2. The implant of claim 1, wherein said balloon filling valve comprises:

a central tube comprising a lumen, an outer wall including a proximal opening and a distal opening there through, the central tube coupled to a proximal and distal portion of said balloon such that said spacer cavity is defined around said central tube;

a valve sheath disposed around said central tube, the valve sheath configured to resiliently engage an outer surface of said central tube; and

a valve wire extending through said proximal opening and comprising a tip, the valve wire configured to selectively seal and unseal said balloon filling valve depending on the location of the tip relative to a distal edge of said valve sheath4.

3. The implant of claim 2, wherein said valve wire extends from an interior of said lumen of said central tube through said proximal opening, and between said valve sheath and said outer surface of said central tube.

4. The implant of claim 3, wherein said valve wire is configured to open said valve by causing the formation of an opening between said valve sheath and said outer surface of said central tube as a tip of said valve wire is distally moved relative to said proximal opening.

5. The implant of claim 4, wherein said valve is configured to close when said valve wire is sufficiently retracted under a distal edge of said valve sheath such that said valve sheath resiliently deforms to seal said opening.

6. The implant of claim 2, wherein at least a portion of said proximal opening is tapered to an angle ranging from about 15 to about 45 degrees.

7. The implant of claim 1, wherein said balloon assembly further comprises a proximal end cap coupled to said balloon and said central tube, said proximal end cap including a lumen that is at least partially threaded with threads configured to threadably engage a distal end of a pusher catheter.

8. The implant of claim 1, wherein said balloon assembly further comprises a latching mechanism coupled to a distal end of said balloon filling valve, said latching mechanism configured to mechanically engage a proximal portion of an anchor assembly.

9. The implant of claim 8, wherein said latching mechanism comprises at least one latch, said at least one latch comprising a resiliently deformable locking element that is configured to resiliently deform outwards in response to an application of force from said proximal portion of said anchor assembly.

10. The implant of claim 9, further comprising said anchor assembly, wherein said proximal portion of said anchor assembly comprises a latch plug, said latch plug comprising a contoured region for resiliently deforming said locking element and a ridge distal to said contoured region.

11. The implant of claim 9, wherein said resilient deformable locking element is configured to:

resiliently deform outwards in response to an application of force from said contoured region of said latch plug, thereby permitting said latch plug to move proximally; and

mechanically engage and lock behind said ridge of said latch plug once said contoured region has proximally moved past said locking element.

12. The implant of claim 9, wherein:

said latch plug comprises a plurality of contoured regions and a corresponding plurality of ridges;

each of said countered regions is configured to resiliently deform said locking element outward to permit proximal movement of said latch plug through said latch; and

said locking element is configured to mechanically engage and lock behind each of said ridges of said latch plug once a corresponding contoured region has proximally moved past said locking element.

13. A method of trans-femorally delivering an implant within a heart, said implant comprising an anchor assembly and a balloon assembly configured to be separately delivered and coupled within said heart to form said implant, the method comprising:

advancing an anchor assembly comprising an anchor through a lumen of a steerable catheter extending through a septum of said heart, into a left atrium, through a mitral valve, and into a left ventrical;

deploying said anchor assembly such said anchor engages coronary tissue of said heart;

advancing said balloon assembly through said lumen of said steerable catheter, said balloon assembly comprising a balloon spacer defining a spacer cavity and a balloon filling valve, wherein the spacer cavity is configured to be expanded from a deflated condition to an expanded condition with a fluid;

coupling a distal portion of said balloon assembly to a proximal portion of said anchor assembly within said heart;

adjusting a relative position of said balloon assembly to said anchor; and

introducing a fluid from a fluid source through said balloon filling valve to expand said spacer cavity from said deflated condition to said expanded condition.

14. The method of claim 13, wherein:

said balloon filling valve is disposed within and fluidly coupled to said spacer cavity;

said balloon filling valve comprises a lumen that is configured to be fluidly coupled to a source of said fluid; and

said balloon filling valve is configured to selectively allow the introduction and withdrawal of said fluid into and out of said spacer cavity

15. The method of claim 13, wherein

said balloon filling valve comprises a central tube comprising a lumen, an outer wall including a proximal opening and a distal opening there through, the central tube coupled to a proximal and distal portion of said balloon such that said spacer cavity is defined around said central tube;

the method further comprises expanding said spacer cavity by introducing said fluid through said lumen of said central tube.

16. The method of claim 15, further comprising opening said balloon filling valve by selectively positing a valve wire within said balloon filling valve.

17. The method of claim 15, wherein said balloon filling valve further comprises a a valve sheath disposed around said central tube, the valve sheath configured to resiliently engage an outer surface of said central tube;

and the method further comprises selectively opening a closing said balloon filling valve by selectively positioning a distal tip of said valve wire relative to a distal edge of said valve sheath.

18. The method of claim 13, wherein said distal portion of said balloon assembly comprises a latching mechanism and said proximal portion of said anchoring assembly comprises a latch plug, the method further comprising urging said latching mechanism against a proximal end of said latch plug so as to mechanically engage at least one latch of said latching mechanism with said latch plug.

19. The method of claim 18, wherein said latching mechanism comprise a latch, the latch comprising a resiliently deformable locking element, the method further comprising:

urging said latching mechanism against said proximal end of said latch plug so as to resiliently deform said locking element outwards; and

advancing said latch plug at least partially through said latch.

20. The method of claim 18, wherein said latch plug comprises a contoured region for resiliently deforming said locking element and a ridge distal to said contoured region, the method further comprising:

Proximally advancing said contoured region of said latch plug past said latch; and

mechanically engaging and locking said locking element behind said ridge of said latch plug once said contoured region has proximally moved past said locking element of said latch.

21. The method of claim 20, wherein said latch plug comprises a plurality of contoured regions and a corresponding plurality of ridges, the method further comprising:

adjusting the length of said implant by selectively advancing said latch plug through said locking element.