RETRIEVAL AND REPOSITIONING SYSTEM FOR PROSTHETIC HEART VALVE

• US 20140324161A1
• Filed: 07/11/2014
• Published: 10/30/2014
• Est. Priority Date: 04/04/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: VIDLUND, Robert, TEGELS, Zachary, CHRISTIANSON, Mark
• Granted Patent: US 10,478,293 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

This invention relates to the design and function of a retrieval device for a prosthetic heart valve for re-positioning or removal of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system.

Claims

1. A prosthetic heart valve retrieval and repositioning device, comprising:

a dilator sheath, said dilator sheath having a lumen therethrough and a dilator base mounted on a proximal side of said dilator sheath, said dilator base having a sheath lock for operatively engaging the dilator sheath for opening and closing the lumen of said dilator sheath, said dilator base having a slidably removable inner catheter disposed within the lumen, said inner catheter having a tapered tip at a distal end and an inner catheter base at a proximal end wherein said inner catheter base is adjacent and proximal to the dilator base, said dilator base having a guide rod aperture for engaging a guide rod that is connected to a guide rod handle mount that is attached to a handle apparatus, said inner catheter base having a traveller strap affixed on a proximal side and said traveller strap extending proximally to engage a tensioning unit on the handle apparatus, said handle apparatus having an actuator and a spring operatively connected to the traveller strap, wherein when the actuator is engaged the traveller strap is pulled proximally through the tensioning unit and the inner catheter base slides along guide rod towards the handle apparatus.

2. The prosthetic heart valve retrieval device of claim 1, further comprising wherein the tapered tip is bullet-shaped, cone-shaped, hooded, or otherwise shaped to guide the valve tether into the lumen of the dilator sheath.

3. The prosthetic heart valve retrieval device of claim 1, further comprising wherein the dilator has a radio band affixed thereto.

4. A method of using the retrieval device of claim 1 for capturing a tethered expandable prosthetic heart valve to retrieve and re-position said valve, comprising the steps of:

(i) inserting said retrieval and repositioning device into a body cavity of a patient containing a tethered and expandable prosthetic heart valve into a patient, (ii) capturing and retracting the tether into the retrieval device, and (iii) repositioning the tethered expandable prosthetic heart valve.

5. The method of claim 3, wherein the step of inserting the retrieval device by directly accessing the heart through the intercostal space, or using an apical approach to enter a heart ventricle.

6. The method of claim 3, wherein the step of inserting the retrieval device by directly accessing the heart through a thoracotomy, sternotomy, or minimally-invasive thoracic, thorascopic, or trans-diaphragmatic approach to enter the left ventricle.

7. The method of claim 3, further comprising the step of (iv) removing the tethered and expandable heart valve from the patient by collapsing the expandable prosthetic heart valve apparatus into the dilator sheath catheter and retracting the dilator sheath.

8. A prosthetic heart valve retrieval and removal device, comprising:

a dilator sheath having a lumen therethrough and a dilator base mounted on a proximal side of said dilator sheath, said dilator base having a sheath lock for operatively engaging the dilator sheath for opening and closing the lumen of said dilator sheath, said dilator base having a slidably removable intermediate beveled catheter disposed within the lumen, said intermediate beveled catheter having an intermediate base mounted on a proximal side of said intermediate beveled catheter, said intermediate beveled catheter having a lumen therethrough and having inner catheter having a tapered tip at a distal end disposed within the intermediate beveled catheter, said inner catheter having an inner catheter base mounted on a proximal side of said inner catheter, wherein said inner catheter base is adjacent and proximal to the intermediate base and said intermediate base is adjacent and proximal to the dilator base, said dilator base having a guide rod aperture for engaging a guide rod that is connected to a guide rod handle mount that is attached to a handle apparatus, said inner catheter base having a traveller strap affixed on a proximal side and said traveller strap extending proximally to engage a tensioning unit on the handle apparatus, said handle apparatus having an actuator and a spring, wherein when the actuator is engaged the traveller strap is pulled proximally through the tensioning unit and the inner catheter base slides along guide rod towards the handle apparatus.

9. The prosthetic heart valve retrieval device of claim 8, further comprising wherein the tapered tip is bullet-shaped, cone-shaped, hooded, or otherwise shaped to guide the valve tether into the lumen of the dilator sheath.

10. The prosthetic heart valve retrieval device of claim 8, further comprising wherein the dilator has a radio band affixed thereto.

11. A method of using the retrieval device of claim 8 for capturing a tethered expandable prosthetic heart valve to retrieve and remove said valve, comprising the steps of:

(i) inserting said retrieval and removal device into a body cavity of a patient containing a tethered and expandable prosthetic heart valve into a patient, and (ii) capturing and retracting the tethered expandable prosthetic heart valve into the retrieval and removal device.

12. The method of claim 11, wherein the step of inserting the retrieval device by directly accessing the heart through the intercostal space, or using an apical approach to enter a heart ventricle.

13. The method of claim 11, wherein the step of inserting the retrieval device by directly accessing the heart through a thoracotomy, sternotomy, or minimally-invasive thoracic, thorascopic, or trans-diaphragmatic approach to enter the left ventricle.