Retrievable heart valve anchor and method

• US 9,393,113 B2
• Filed: 12/09/2013
• Issued: 07/19/2016
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff A.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US14/100,482
• Publication Number:
  US 20140094904A1
• Time in Patent Office: 953 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

A method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor in an unexpanded configuration within a catheter to a vicinity of the heart valve; deploying the anchor from the catheter; expanding the anchor to contact tissue at an anchor site; and retrieving the anchor into the catheter. The invention also includes an apparatus for endovascularly replacing a heart valve, including: a catheter; a replacement valve configured to be disposed within the catheter for delivery to a vicinity of the heart valve; and an expandable anchor configured to be disposed within the catheter for delivery to a vicinity of the heart valve, to be deployed from the catheter, to be expanded to contact tissue at an anchor site and to be retrieved back into the catheter after having been expanded.

Claims

1. An apparatus for endovascularly replacing a heart valve comprising:

a catheter tube;

an expandable anchor configured to be disposed within the catheter tube for delivery to a vicinity of the heart valve, to be deployed from the catheter tube, to be expanded through application of a radially directed force directed to contact tissue at an anchor site, the expandable anchor comprises posts or arms with interlocking female elements extending from a lip region at a proximal end of the anchor and interlocking male elements extending from a skirt region at a distal end of the anchor which form actuatable locks;

a replacement valve having valve commissures is disposed within a lumen of the expandable anchor, the valve commissures are connected to the male interlocking elements, the replacement valve comprises an annular base, the annular base is connected to the distal end of the anchor, the male interlocking elements include holes that mate with tabs extending into holes in the female interlocking elements;

an inflatable member disposed within the catheter tube and upon deployment is delivered within the lumen of the anchor between a deflated configuration and expanding to an expanded configuration, said inflatable member expands said expandable anchor through application of said radially directed force; and

wherein the anchor can be retrieved back into the catheter tube upon actuation of the actuatable locks.

2. The apparatus of claim 1 further comprising a deployment tool to reposition, lock and retrieve the anchor.

3. The apparatus of claim 2 wherein said deployment tool comprises a distal region, the distal region comprising control wires, control rods or tubes and a proximal region comprising control wires.

4. The apparatus of claim 3 wherein the male interlocking elements have eyelets formed therein, the distal region of the deployment tool comprises control wires, the control wires pass from a catheter delivery system through the female interlocking elements, through the eyelets of the male interlocking elements and back through the female interlocking elements for manipulation external of a body lumen.

5. The apparatus of claim 3 wherein the anchor is releasably connected to the control wires, control rods or tubes.

6. The apparatus of claim 4 wherein the interlocking elements are connected to a braided structure by one of interweaving elements, suturing, soldering, welding or adhesively.

7. The apparatus of claim 1 further comprising control wires, the male interlocking elements and female interlocking elements further comprising eyelets, the control wires pass through the eyelets and holes of the male interlocking elements and can be pulled proximally of a proximal end of the anchor drawing the male interlocking elements through the holes such that the tabs engage the holes of the male interlocking elements.

8. The apparatus of claim 7 further comprising release wires, the release wires pass through the eyelets of the female interlocking elements such that if the release wires are pulled, the orientation of the tabs are reversed and the anchor is released allowing for repositioning of the device.

9. The apparatus of claim 1 wherein the inflatable member is inflated at pressures of about 3 to about 6 atmospheres.

10. The apparatus of claim 1 wherein the inflatable member is separated from the replacement valve until partial deployment of the apparatus at the treatment site.

11. The apparatus of claim 1 wherein the inflatable member comprises an inner shaft, the inner shaft comprises a lumen configured for passage of a guidewire, the apparatus further comprising a guide tube for passage of push tubes and pull wires, guide tube is disposed within the lumen of the catheter tube.

12. The apparatus of claim 1 wherein the catheter tube has a diameter no more than 21 french.