Prosthesis Seals and Methods for Sealing an Expandable Prosthesis

• US 20140350668A1
• Filed: 03/07/2014
• Published: 11/27/2014
• Est. Priority Date: 03/13/2013
• Status: Abandoned Application

• Current Assignee: Symetis SA (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Delaloye, Stephane, Essinger, Jacques, Hefti, Jean-Luc, Biadillah, Youssef, Mantanus, Luc, Lombardi, Fabien
• Application Number:
  US14/200,411
• Publication Number:
  US 20140350668A1
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0056 differing in wettability, e.g. in hydrophilic or hydrophobic behaviours
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient'"'"'s body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

Claims

1. -84. (canceled)

85. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent-valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the seal comprises:

a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff comprising an integral tubular structure.

86. The stent-valve of claim 85, wherein the hollow sleeve/cuff comprises a tubular extrusion or blow molded tubing.

87. The stent-valve of claim 85, wherein the hollow sleeve/cuff defines a hollow toroid shape around the stent, the toroid shape being closed-loop or split or helical.

88. The stent-valve of claim 87, wherein the hollow sleeve/cuff comprises an elongate tubular member bent to define the toroid shape.

89. The stent-valve of claim 88, wherein the ends of the elongate tubular member are joined together to define a closed-loop toroid shape.

90. The stent-valve of claim 85, wherein the hollow sleeve/cuff comprises a tubular segment from a valvuloplasty balloon.

91. The stent-valve of claim 85, wherein the hollow sleeve/cuff comprises a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow sleeve/cuff to the hollow interior, the diffusion barrier layer comprising metal or a metal compound.

92. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:

a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, comprising a laminate of (i) plastics film and (ii) a diffusion barrier layer to obstruct diffusion of liquids from outside the hollow sleeve/cuff to the hollow interior, the diffusion barrier layer comprising a layer comprising metal or a metal compound.

93. The stent-valve of claim 92, wherein the diffusion barrier layer is a plasma vapor deposited layer.

94. The stent-valve of claim 92, wherein the diffusion barrier player is formed (i) on an interior face of the cuff, or (ii) as a non-surface layer of the laminate.

95. The stent-valve of claim 92, wherein the diffusion barrier layer has a thickness of less than 100 nm, optionally less than 50 nm, optionally less than 10 nm.

96. The stent-valve of claim 92, wherein the diffusion barrier layer remains in position on the stent-valve when the valve is implanted.

97. The stent-valve of claim 92, wherein the hollow sleeve/cuff is configured to withstand post-implantation balloon expansion of the stent-valve against a calcified anatomy without substantial loss of structural integrity of the hollow cuff.

98. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:

a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff being configured to withstand post-implantation balloon expansion of the stent-valve against a calcified anatomy without substantial loss of structural integrity of the hollow cuff.

99. The stent-valve of claim 98, wherein the sleeve/cuff is configured to be manually pierceable at one or more points to define liquid admitting punctures permitting liquid entry into the cuff.

100. The stent-valve of claim 98, wherein the sleeve/cuff has one or more liquid admitting punctures made therein, prior to introduction of the stent-valve into the body of a patient, for admitting liquid into the seal.

101. A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed configuration for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets defining a prosthetic valve, and a seal for sealing against surrounding tissue, wherein the external seal comprises:

a hollow sleeve/cuff arranged to extend in a circumferential direction substantially around the stent and containing swellable material that swells when contacted by blood to distend the hollow cuff, the hollow sleeve/cuff comprising a film made of liquid-impermeable material, the sleeve/cuff having one or more liquid admitting punctures made therein, prior to introduction of the stent-valve into the body of a patient, for admitting liquid into the seal.

102. The stent-valve of claim 101, wherein the number of punctures is less than fifty, optionally less than forty, optionally less than thirty, optionally less than twenty, optionally less than ten.

103. The stent-valve of claim 101, wherein the seal further comprises a skirt secured to the hollow cuff.

104. The stent-valve of claim 103, wherein the skirt is secured to the sleeve/cuff by an attachment that does not puncture the cuff, for example, an attachment selected from:

fusion;

welding;

adhesive.

105. The stent-valve of claim 103, wherein the skirt is secured to the stent, thereby mounting the sleeve/cuff to the stent.