Cardiac valve prosthesis deployment system

• US 10,092,401 B2
• Filed: 11/26/2013
• Issued: 10/09/2018
• Est. Priority Date: 06/01/2011
• Status: Active Grant

• Current Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Original Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Inventors: Centola, Marcos, Kawa, Emilia
• Primary Examiner(s): Miles, Jonathan
• Assistant Examiner(s): GABR, MOHAMED GAMIL
• Application Number:
  US14/090,886
• Publication Number:
  US 20140088686A1
• Time in Patent Office: 1,778 Days
• Field of Search: 623 111, 623 211
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

The present invention relates to a deployment system (10) for deploying an expandable cardiac valve prosthesis. The deployment system comprises a first tube (11) being designed to carry an expandable cardiac valve prosthesis; further, a tip (13), being firmly connected to the first tube at a distal end of the first tube, wherein the tip is designed such, that it detachably accommodates and holds a proximal end (21) of a cardiac valve prosthesis (20); a sheath (15) designed to be disposed over and holding the prosthesis (20) in a compressed state, and a first actuating mechanism (16) being linked to the sheath (15) and being slidable in a proximal direction for stepwise retracting the sheath (15). The deployment system (10) further comprises a biasing element being linked to the tip (13), and a blocking mechanism (24), wherein the blocking mechanism is being designed such, that a movement of the first actuating mechanism (16) in the proximal direction relative to the tip (13) is limitable to a maximum path of travel by the blocking mechanism (24).

Claims

1. A deployment system (10) for deploying a cardiac valve prosthesis, the deployment system comprising:

a first tube (11) having a distal end and a proximal end, wherein the first tube comprises a lumen (12) configured to carry a cardiac valve prosthesis, wherein the cardiac valve prosthesis is capable of disposal over a distal portion (11a) of the first tube (11), wherein the cardiac valve prosthesis is capable of compression or expansion;

a tip (13) fixedly connected to the distal end of the first tube, wherein the tip is configured to detachably accommodate and hold a proximal end (21) of the cardiac valve prosthesis (20), wherein the tip (13) is configured to slide distally relative to the cardiac valve prosthesis (20) resulting in a release of the proximal end (21) of the cardiac valve prosthesis (20),

a sheath (15) disposed over and holding a cardiac valve prosthesis (20) in a compressed state, wherein the sheath (15) is configured to slide proximally relative to the cardiac valve prosthesis (20) resulting in a release and expansion of the cardiac valve prosthesis (20),

a first actuating mechanism (16) comprising a lever (17) and a tubular grip (18), wherein the tubular grip is disposed about the sheath (15) such that the sheath is attached within the tubular grip, wherein actuation of the first actuating mechanism permits the first actuation mechanism to slide over the first tube in a proximal direction thereby resulting in a stepwise retraction of the sheath, wherein such retraction of the sheath permits expansion of the cardiac valve prosthesis,

a biasing element (19) positioned in the proximal portion (11b) of the first tube (11) and being directly linked to the tip (13), and

a blocking mechanism (25) comprising a punch element (26), two spring-loaded wing elements (28), and an abutment element (30), wherein the blocking mechanism is positioned over the first tube between the distally positioned first actuating mechanism and the proximally positioned biasing element, wherein the blocking mechanism is capable of preventing movement of the first actuating mechanism (16) in a proximal direction relative to the tip (13) beyond the blocking mechanism (25).

2. The deployment system (10) according to claim 1 further comprising a second actuating mechanism (27) comprising a knob directly linked with the tip (13), wherein actuation of the second mechanism permits movement of the tip (13) in a distal direction thereby resulting in a release of the proximal end (21) of the cardiac valve prosthesis (20).

3. The deployment system (10) according to claim 1, wherein the punch element (26) is capable of movement between the two spring-loaded wing elements (28) resulting in a forcing of the two spring-loaded wing elements apart and into a stressed position abutting against the abutment element (30) thereby blocking the first actuating mechanism'"'"'s (16) path of travel in the proximal direction.

4. The deployment system (10) according to claim 1, wherein the first actuating mechanism (16) and the abutment element (30) are, prior to the deployment of the cardiac valve prosthesis (20), spaced apart from one another in a distance corresponding to a first retraction length of the sheath (15), the first retraction length of the sheath (15) being such that a medial portion of the prosthesis (20) is released and the proximal (21) end of the prosthesis (20) is covered by the tip and the distal end (22) of the prosthesis (20) is still covered by the sheath (15).

5. The deployment system (10) according to claim 1, wherein the biasing element (19) is designed, via the punch element (26), to engage with the blocking mechanism (25).

6. The deployment system (10) according to claim 1, wherein the first tube (11) comprises a guidewire lumen (12).

7. The deployment system (10) according to claim 1, wherein it further comprises:

a shaft (32) disposed about and concentrically aligned with the first tube (11), wherein the shaft (32) is non-slidably positioned between the sheath (15) and the first tube (11), and is capable of engaging with the distal end (22) of the prosthesis (20).

8. The deployment system (10) according to claim 1, wherein it further comprises a tubular knurled rod (36) disposed about and concentrically aligned with a proximal portion of the sheath (15).

9. The deployment system (10) according to claim 8, wherein the tubular knurled rod (36) comprises at least one fixation element (37, 38), permitting releasable attachment of the tubular rod (36) with an abutment element (30).

10. The deployment system (10) according to claim 1, further comprising a cardiac valve prosthesis (20).