Implant device and implantation kit

Abstract

An implant device (V), such as a heart valve, for implantation in an animal body includes an annular structure and one or more elongated anchoring members deployable to a deployed condition for insertion into an animal body. The anchoring members are retractable from the deployed condition to a rolled up condition wherein the anchoring members protrude radially out from the annular structure of the device (V) to provide anchoring to a body structure (AS) of an animal. In the rolled up condition the anchoring members at least partly protrude axially of the annular structure of the device (V).

The invention claimed is: 
     
       1. An implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device, and wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent between 180° and 900°. 
     
     
       2. The implant device of  claim 1 , wherein the at least one elongated anchoring member includes a proximal portion which retains the deployed condition and a distal portion subject to winding from the deployed condition to the rolled up condition. 
     
     
       3. The implant device of  claim 1 , wherein the anchoring member is located at one end of the annular structure of the device and includes a distal portion, which, in said rolled up condition, extends in a trajectory centered around a point coplanar with said one end of the annular structure of the device. 
     
     
       4. The implant device of  claim 1 , wherein the anchoring member includes a proximal portion coextensive with the annular structure of the device and a distal portion extending away from the annular structure of the device, wherein in said rolled up condition, the region of the said distal portion adjacent to said proximal portion has an axial orientation with respect to the annular structure of the device. 
     
     
       5. The implant device of  claim 1 , wherein the at least one elongated anchoring member includes elastic material, whereby the anchoring member is deployable to the deployed condition and elastically returns to the rolled up condition from the deployed condition. 
     
     
       6. The implant device of  claim 1 , wherein the at least one elongated anchoring member includes shape memory material, whereby the anchoring member returns to the rolled up condition from the deployed condition by shape memory effect. 
     
     
       7. The implant device of  claim 1 , wherein the at least one elongated anchoring member includes material selected out of one or combinations of flexibly resilient materials, medical grade materials, metal materials, plastics materials, shape memory materials, Nitinol, and stainless steel. 
     
     
       8. The implant device of  claim 1 , wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory which is spiral-shaped or helix-shaped. 
     
     
       9. The implant device of  claim 1 , wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent in excess of 360°. 
     
     
       10. The implant device of  claim 1 , wherein the at least one elongated member is blade-like or wire-like. 
     
     
       11. The implant device of  claim 1 , wherein the at least one elongated member is of solid cross-section or tubular. 
     
     
       12. The implant device of  claim 1 , wherein the device includes a prosthetic heart valve. 
     
     
       13. An implantation kit for an implant device including:
 an implant device according to  claim 1 ,   at least one constraint member to cooperate with the at least one anchoring member to constrain the at least one anchoring member to the deployed condition during insertion into an animal body and to permit winding of the at least one anchoring member to a rolled up condition to provide anchoring of the implant device to a body structure of an animal.   
     
     
       14. The kit of  claim 13 , wherein the at least one constraint member includes a tubular sheath extending along an axis, the tubular sheath maintaining the at least one anchoring member in the deployed condition by confining the at least one anchoring member radially of said axis, the tubular sheath withdrawable along said axis to at least partly uncover the at least one anchoring member to permit winding thereof to the rolled up condition. 
     
     
       15. The kit of  claim 13 , wherein the at least one anchoring member is tubular with a longitudinal cavity and the at least one constraint member includes a wire member for insertion into the longitudinal cavity of the at least one anchoring member to maintain the at least one anchoring member in the deployed condition, the wire member extractable from the longitudinal cavity of the at least one anchoring member to permit winding thereof to the rolled up condition. 
     
     
       16. The kit of  claim 13 , wherein the at least one constraint member includes an inflatable balloon element vested onto the at least one anchoring member to form a tubular tunic therearound, the inflated balloon to maintain the at least one anchoring member to the deployed condition and de-inflatable to permit winding of the at least one anchoring member to the rolled up condition. 
     
     
       17. An implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device, and wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory having an angular extent in excess of 360°. 
     
     
       18. The implant device of  claim 17 , wherein the at least one elongated anchoring member includes a proximal portion which retains the deployed condition and a distal portion subject to winding from the deployed condition to the rolled up condition. 
     
     
       19. The implant device of  claim 17 , wherein winding of the at least one elongated anchoring member from the deployed condition to the rolled up condition is with a winding trajectory which is spiral-shaped or helix-shaped. 
     
     
       20. An implantation kit for an implant device including:
 an implant device for implantation in an animal body, the device including an annular structure extending axially between opposed ends and at least one elongated anchoring member deployable to a deployed condition for insertion into an animal body and retractable from said deployed condition to a rolled up condition wherein the anchoring member protrudes radially outwardly of the annular structure of the device to provide anchoring of the implant device to a body structure of an animal, wherein in said rolled up condition the anchoring member at least partly protrudes axially outwardly of the annular structure of the device; and   at least one constraint member to cooperate with the at least one anchoring member to constrain the at least one anchoring member to the deployed condition during insertion into an animal body and to permit winding of the at least one anchoring member to a rolled up condition to provide anchoring of the implant device to a body structure of an animal,   wherein the at least one anchoring member is tubular with a longitudinal cavity and the at least one constraint member includes a wire member for insertion into the longitudinal cavity of the at least one anchoring member to maintain the at least one anchoring member in the deployed condition, the wire member extractable from the longitudinal cavity of the at least one anchoring member to permit winding thereof to the rolled up condition.   
     
     
       21. An implantable prosthetic heart valve device for implantation at an implantation site in a human heart having a valve annulus, the device comprising:
 an annular structure extending axially between opposed ends; and   a plurality of elongated anchoring members, each of the plurality of elongated anchoring members having a first condition for insertion to the implantation site and a second condition wherein the elongated anchoring members protrude radially outwardly of the annular structure of the device, the plurality of elongated anchoring members sized and shaped to entrap one or more native valve leaflets in the second condition to provide anchoring of the device at the valve annulus,   wherein in the second condition the elongated anchoring members at least partly protrude axially outwardly of the annular structure of the device,   wherein each of the elongated anchoring members is elastically biased towards the second condition, and   wherein winding of the elongated anchoring members from the first condition to the second condition is with a winding trajectory having an angular extent in excess of 360°.   
     
     
       22. The implantable prosthetic heart valve device of claim 21, wherein the device is adapted for implantation at a mitral valve annulus. 
     
     
       23. The implantable prosthetic heart valve device of claim 21, wherein the annular structure has a collapsed configuration for delivery of the device to the implantation site and an expanded configuration for contacting the valve annulus. 
     
     
       24. The implantable prosthetic heart valve device of claim 21, wherein each of the elongated anchoring members includes a proximal portion coupled to the annular structure's proximal region, an axial orientation with respect to the annular structure, and a distal portion that protrudes radially outwardly of the annular structure in the second condition with the winding trajectory to be a rolled-up portion. 
     
     
       25. The implantable prosthetic heart valve device of claim 24, wherein the rolled-up portion is adapted to grasp one or more of native valve leaflets and chordae tendinae. 
     
     
       26. The implantable prosthetic heart valve device of claim 24, wherein the proximal portion is coextensive with the annular structure. 
     
     
       27. The implantable prosthetic heart valve device of claim 21, wherein each of the elongated anchoring members is structurally distinct from and coupled to the annular structure. 
     
     
       28. The implantable prosthetic heart valve device of claim 24, wherein the rolled-up portion extends in a winding trajectory having an angular extent in excess of 450°. 
     
     
       29. The implantable prosthetic heart valve device of claim 24, wherein the rolled-up portion extends in a winding trajectory having an angular extent of no more than 900°. 
     
     
       30. The implantable prosthetic heart valve device of claim 24, wherein the rolled-up portion of each of the elongated anchoring members is spiral-shaped or helix-shaped. 
     
     
       31. The implantable prosthetic heart valve device of claim 21, wherein each of the elongated anchoring members is formed from an elastic material, such that each elongated anchoring member is deployable to the first condition and elastically returns to the second condition. 
     
     
       32. The implantable prosthetic heart valve device of claim 21, wherein each of the elongated anchoring members includes shape memory material, whereby each anchoring member returns to the second condition by shape memory effect. 
     
     
       33. An implantation kit for a prosthetic heart valve including the implantable prosthetic heart valve device according to claim 21, comprising a constraint member to cooperate with the elongated anchoring members to constrain the elongated anchoring members in the first condition during insertion to the implantation site and to permit return of the elongated anchoring member to the second condition to provide anchoring of the device at the valve annulus. 
     
     
       34. An implantable prosthetic heart valve device for replacing a native valve in a human heart having a valve annulus, the device comprising:
 an annular structure extending axially between opposed ends; and   a plurality of elongated anchoring members having a first condition for insertion to the implantation site and a second condition wherein the elongated anchoring members protrude radially outwardly of the annular structure of the device, each of the plurality of elongated anchoring members sized and shaped to entrap one or more native valve leaflets in the second condition to provide anchoring of the device at the valve annulus,   wherein in the second condition the elongated anchoring members at least partly protrude axially outwardly of the annular structure of the device, and   wherein winding of the elongated anchoring members from the first condition to the second condition is with a winding trajectory having an angular extent in excess of 360°.   
     
     
       35. The implantable prosthetic heart valve device of claim 34, wherein, in the second condition, each of the elongated anchoring members include a proximal portion which retains an axial orientation with respect to the annular structure and a rolled-up portion. 
     
     
       36. The implantable prosthetic heart valve device of claim 35, wherein the rolled-up portion extends in a winding trajectory having an angular extent of no more than 900°. 
     
     
       37. The implantable prosthetic heart valve device of claim 35, wherein the rolled-up portion of each of the elongated anchoring members is spiral-shaped or helix-shaped. 
     
     
       38. The implantable prosthetic heart valve device of claim 35, wherein the rolled-up portion is adapted to grasp one or more of native valve leaflets and chordae tendinae. 
     
     
       39. The implantable prosthetic heart valve device of claim 34, wherein each of the elongated anchoring members is formed from an elastic material, such that each elongated anchoring member is deployable to the first condition and elastically returns to the second condition. 
     
     
       40. The implantable prosthetic heart valve device of claim 34, wherein the plurality of elongated anchoring members are individually coupled to the annular structure. 
     
     
       41. The implantable prosthetic heart valve device of claim 34, wherein the plurality of elongated anchoring members are uncovered.