Device for surgical interventions

• US 9,168,105 B2
• Filed: 05/13/2009
• Issued: 10/27/2015
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Giannetti, Arnaldo, Ghione, Laura, Gaschino, Paolo, Righini, Giovanni
• Primary Examiner(s): TANNER, JOCELIN C
• Application Number:
  US12/465,269
• Publication Number:
  US 20100292783A1
• Time in Patent Office: 2,358 Days
• Field of Search: 623/2.11, 623/2.38, 623/1.11, 623/902, 623/904, 623/2.1, 623/2.12, 623/2.17, 623/2.36, 623/23.68, 623/1.12, 606/108, 606/194, 606/192, 606 13- 16, 600/107, 600178-182, 600/200
• US Class Current: 1/1
• CPC Class Codes: A61B 1/0676 at distal tip of an endoscope
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath

Abstract

A device for locating an operational unit within a patient'"'"'s body within the framework of a minimally-invasive surgery intervention includes a shaft having a distal end carrying an operational unit. The device includes an illuminator located at the distal end of the shaft. The illuminator is selectively adjustable to provide a selectively variable lighting field in correspondence with the operational unit. The device may be, for example, a delivery system for a heart valve or a balloon device for post-dilation of such a heart valve once implanted.

Claims

1. A device for implanting a minimally-invasive prosthetic heart valve at an implantation site, the prosthetic heart valve including an anchoring structure and a plurality of leaflets, the prosthetic heart valve having a collapsed configuration for delivery and an expanded configuration for anchoring at the implantation site, the device including:

a shaft extending from a handle at a proximal end to a valve holder at a distal end, the valve holder adapted to couple to the prosthetic heart valve and maintain the prosthetic heart valve in the collapsed configuration, the shaft having a diameter at the proximal end where the shaft extends from the handle that is smaller than a diameter of the handle;

an illuminator selectively adjustable to provide a variable lighting field, the illuminator coupled at or near the distal end of the shaft;

an optical fiber extending through at least a portion of the shaft, the optical fiber having a proximal end extending from the proximal end of the shaft and a distal end coupled to the illuminator, the optical fiber is adapted to transmit the lighting field from the illuminator to the distal end of the shaft, and adapted to be axially slidable with respect to the shaft to selectively displace the illuminator to provide a selectively variable lighting field;

an actuator coupled to the illuminator and adapted to effect a change to the variable lighting field; and

a lock means actuatable to permit the optical fiber to be axially slidable with respect to the shaft to allow the illuminator to be positioned at multiple selective locations in order to provide the selectively variable lighting field, and the lock means being actuatable to prevent the optical fiber from being axially slidable with respect to the shaft in order to lock the illuminator at a particular selective location, wherein the lock means is located proximal to the handle and proximal to the valve holder.

2. The device of claim 1, including adjustment means at a proximal end of the device whereby at least one of the geometry and the position of the illuminator to provide the selectively variable lighting field is made variable.

3. The device of claim 1, wherein the optical fiber conveys light radiation along the shaft, and the illuminator includes the distal end of the optical fiber.

4. The device of claim 1, wherein the shaft includes a distal transparent portion for light radiation from the illuminator to propagate therethrough.

5. The device of claim 1, wherein the actuator is a microactuator.

6. The device of claim 5, wherein the microactuator is operable from a proximal end of the device and wherein at least one of the geometry and the position of the illuminator are variable in order to provide the selectively variable lighting field.

7. A device for minimally-invasive implantation of a prosthetic heart valve within a patient'"'"'s body, the prosthetic heart valve including an anchoring structure and a plurality of leaflets, the prosthetic heart valve having a collapsed configuration for delivery and an expanded configuration for anchoring at an implantation site, the device including a shaft extending from a handle at a proximal end to a valve holder at a distal end for maintaining the prosthetic heart valve in the collapsed configuration, the shaft having a diameter at the proximal end where the shaft extends from the handle that is smaller than a diameter of the handle, wherein the device includes an illuminator located at the distal end of the shaft, the illuminator selectively adjustable to provide a selectively variable lighting field at an operational unit, wherein the illuminator includes an autonomous light source located at the distal end of the shaft, the device further including an electrical line to convey along the shaft electrical power for energizing the autonomous light source, wherein the electrical line is adapted to be axially slidable with respect to the shaft to selectively displace the illuminator to provide the selectively variable lighting field at the operational unit;

and a lock means actuatable to permit the electrical line to be axially slidable with respect to the shaft to allow the autonomous light source to be positioned at multiple selective locations in order to provide the selectively variable lighting field, and the lock means being actuatable to prevent the electrical line from being axially slidable with respect to the shaft in order to lock the illuminator at a particular selective location, wherein the lock means is located proximal to the handle and proximal to the valve holder.

8. The device of claim 7, wherein the operational unit is selected out of a heart valve delivery unit, a post-dilation balloon member for a heart valve, a unit for the ablation of natural valve leaflets, and a sizer unit for sizing a valve implantation site.

9. The device of claim 7, wherein the illuminator includes at least one of a reflector and a diffuser.

10. The device of claim 7, wherein the autonomous light source is a LED source.

11. The device of claim 7, wherein the shaft includes a distal transparent portion for light radiation from the illuminator to propagate therethrough.

12. A device for minimally-invasive implantation of a prosthetic heart valve within a patient'"'"'s body, the prosthetic heart valve including an anchoring structure and a plurality of leaflets, the prosthetic heart valve having a collapsed configuration for delivery and an expanded configuration for anchoring at an implantation site, the device including a shaft extending from a handle at a proximal end to a valve holder at a distal end for maintaining the prosthetic heart valve in the collapsed configuration, the shaft having a diameter at the proximal end where the shaft extends from the handle that is smaller than a diameter of the handle, wherein the device includes an illuminator located at the distal end of the shaft, the illuminator selectively adjustable to provide a selectively variable lighting field at an operational unit, and an actuator coupled to the illuminator that is adapted to effect a change to the variable lighting field, wherein the illuminator includes an autonomous light source located at the distal end of the shaft, the device further including an electrical line to convey along the shaft electrical power for energizing the autonomous light source, wherein the electrical line is adapted to be axially slidable with respect to the shaft to selectively displace the illuminator to provide the selectively variable lighting field at the operational unit;

and a lock means actuatable to permit the electrical line to be axially slidable with respect to the shaft to allow the autonomous light source to be positioned at multiple selective locations in order or provide the selectively variable lighting field, and the lock means being actuatable to prevent the electrical line from being axially slidable with respect to the shaft in order to lock the illuminator at a particular selective location, wherein the lock means is located proximal to the handle and proximal to the valve holder.

13. The device of claim 12, wherein the actuator is a microactuator.

14. The device of claim 13, wherein the microactuator is operable from a proximal end of the device and wherein at least one of the geometry and the position of the illuminator are variable in order to provide the selectively variable lighting field.

15. The device of claim 12, wherein the shaft includes a distal transparent portion for light radiation from the illuminator to propagate therethrough.

16. The device of claim 12, wherein the operational unit is selected out of a heart valve delivery unit, a post-dilation balloon member for a heart valve, a unit for the ablation of natural valve leaflets, and a sizer unit for sizing a valve implantation site.

17. The device of claim 12, wherein the illuminator includes at least one of a reflector and a diffuser.

18. The device of claim 12, wherein the autonomous light source is a LED source.