METHOD OF CONTROLLED RELEASE AND SUBSEQUENT DEPLOYMENT OF A PERCUTANEOUS REPLACEMENT HEART VALVE

• US 20140257469A1
• Filed: 05/21/2014
• Published: 09/11/2014
• Est. Priority Date: 01/04/2002
• Status: Abandoned Application

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: PANIAGUA, David, FISH, R. David
• Application Number:
  US14/284,049
• Publication Number:
  US 20140257469A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• 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 2/2415 Manufacturing methods
• 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 2/2433 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 2/2475 Venous valves
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/0095 : Saddle-shaped
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2310/00371 : Collagen
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3687 : characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 : characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: Y10S 623/917 : Collagen
• CPC Class Codes: Y10S 623/918 : Heart
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making

Abstract

A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Claims

1-33. -33. (canceled)

34. A method of controlled release and subsequent deployment of a percutaneous replacement heart valve in a patient where a bioprosthetic heart valve is indicated, comprising:

providing a replacement heart valve device and a delivery and implantation system;

the replacement heart valve device including;

a stent member that is collapsible, expandable and configured for percutaneous delivery; and

a valve attached to the stent member, the valve including two to four individual leaflets;

the delivery and implantation system including;

a balloon catheter and a moveable sheath, wherein the balloon catheter includes a lumen for receiving a guide wire, wherein the moveable sheath includes a lumen configured for receiving the balloon catheter, and wherein the replacement heart valve device is collapsed onto the balloon catheter to reside in a collapsed configuration on the balloon catheter and is restrained in a collapsed configuration by the moveable sheath;

after the providing step, guiding the delivery and implantation system over the guide wire within the patient to position the replacement heart valve device for deployment within the patient, wherein the replacement heart valve device remains collapsed onto the balloon catheter and continues to be restrained in the collapsed configuration by the moveable sheath;

after the guiding step, partially deploying a distal portion of the replacement heart valve device within the patient by partially exposing the replacement heart valve device from the moveable sheath;

after the partially deploying step, restraining the replacement heart valve device so that it does not pop out and is held for controlled release, with a potential that the replacement heart valve device can be recovered if there is a problem with positioning;

after the restraining step, recovering the distal portion of the replacement heart valve device that was exposed in order to address a problem with the position of the replacement heart valve device within the patient; and

after the recovering step, slightly retracting the moveable sheath to release the replacement heart valve device from the moveable sheath to allow the replacement heart valve device to fully expand.

35. The method of claim 34, wherein partially exposing the replacement heart valve device from the moveable sheath comprises pushing out the balloon catheter from the moveable sheath to expose a portion of the replacement heart valve device from the moveable sheath.

36. The method of claim 34, wherein partially exposing the replacement heart valve device from the moveable sheath comprises pulling back the moveable sheath to expose a portion of the replacement heart valve device from the moveable sheath.

37. The method of claim 34, wherein the guiding step is done transluminally.

38. The method of claim 37, wherein the guiding step is done transluminally over the guide wire.

39. The method of claim 34, further comprising using an introducer for receiving the moveable sheath.

40. The method of claim 34, wherein the stent member is self-expanding.

41. The method of claim 40, wherein the stent member comprises nitinol.

42. The method of claim 34, wherein constant high definition imaging is conducted after the providing step.

43. The method of claim 42, wherein the constant high definition imaging includes using intravascular ultrasound.

44. The method of claim 42, wherein the constant high definition imaging includes using an angioscope.

45. The method of claim 34, wherein after the replacement heart valve device is fully expanded, monitoring of the replacement heart valve device is performed.

46. The method of claim 45, wherein the monitoring comprises echocardiography.

47. The method of claim 45, wherein the monitoring comprises angiography.