STENT SEALS AND METHOD OF PRODUCTION

• US 20180263765A1
• Filed: 02/02/2016
• Published: 09/20/2018
• Est. Priority Date: 02/02/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Symetis SA (Boston Scientific Corporation)
• Inventors: Flaction, Lionel
• Granted Patent: US 11,045,312 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Various embodiments of a seal for a stent-valve, and methods of production, are described. In some embodiments, the seal or a skirt comprises a fabric wall portion and a polymeric material fused to the fabric wall portion, the polymeric material having a melting temperature that is lower than that of the fabric wall portion. The fibres of the fabric may remain unmelted at the interface with the polymeric material, the polymeric material being attached to material to the fibres of the fabric wall portion by fusion. The polymeric material may provide a welded joint to another fabric wall portion and/or may reinforce the fabric and/or may occlude pores of the fabric.

Claims

1-45. -45. (canceled)

46. A prosthetic cardiac valve comprising a fabric wall portion and a polymeric material fused to the fabric wall portion, the polymeric material having a melting temperature that is lower than that of the fabric wall portion.

47. The prosthetic valve of claim 46, wherein fibres of the fabric remain unmelted at the interface with the polymeric material, the polymeric material being attached to material to the fibres of the fabric wall portion by fusion.

48. The prosthetic valve of claim 46, further comprising a second fabric wall portion to which the polymeric material is fused.

49. The prosthetic valve of claim 48, wherein the polymeric material provides a welded joint between the fabric wall portions.

50. The prosthetic valve of claim 46, wherein the polymeric material substantially occludes pores of the fabric wall portion.

51. The prosthetic valve of claim 46, wherein the polymeric material does not extend substantially through the fabric wall portion.

52. The prosthetic valve of claim 46, wherein the polymeric material extends substantially through the fabric wall portion from one face to the opposite face.

53. The prosthetic valve of claim 46, wherein the fabric comprises one or more first regions provided with polymeric material fused to the fabric wall portion, and one of more second regions absent said polymeric material.

54. The prosthetic valve of claim 46, comprising at least one welded region in which polymeric material is fused to first and second fabric wall portions to provide a joint between the wall portion, and at least one non-welded region in which polymeric material is fused to only a single fabric wall portion.

55. The prosthetic valve of claim 46, wherein the fabric is a woven fabric.

56. The prosthetic valve of claim 46, wherein the fibres of the fabric are capable of at least partial re-orientation in a region away from the polymeric material, to permit the fabric to adapt to changes in size.

57. The prosthetic valve of claim 46, wherein at least one of the fabric wall portion and the polymeric material is selected from the group consisting of:

polyester;

polyethylene terephthalate (PET);

polyether ether keeton (PEEK);

polypropylene (PP);

polytetraflurothylene (PTFE);

polyurethane (PU);

ultra-high molecular weight polyethylene (UHMWPE);

silicone;

polyacetal;

polyphenylsulfone;

polysulfone;

polyvinylidene fluoride;

polyamide.

58. The prosthetic valve of claim 57, wherein the fabric wall portion comprises polyester (e.g. PET), and the polymeric material comprises polyurethane.

59. The prosthetic valve of claim 46, further comprising a stent component and a skirt carried by the stent component, wherein the skirt comprises the fabric wall portion.

60. The prosthetic valve of claim 46, wherein the skirt does not have a peelable cover.

61. The prosthetic valve of claim 60, wherein the skirt defines an envelope containing a material that swells when contact by blood or a blood component.

62. A prosthesis, optionally a stent-valve, comprising first and second fabric wall portions joined together at a welded joint, the welded joint comprising a polymeric material having a melting temperature that is lower than that of at least one, optionally both, of the fabric wall portions.

63. The prosthesis of claim 62, wherein fibres of the fabric remain unmelted at the weld, the weld being effected by fusion of the polymeric material to the fibres of the fabric wall portions.

64. A seal for a stent-valve, comprising a seal envelope containing a swellable material, wherein the envelope comprises at least one section of material that extends around the entire circumference of the stent, and is continuous in the circumferential direction of the stent and a fabric section that has a self-supporting bulged shape, optionally an annular bulge or annular channel.

65. The seal of claim 64, wherein the bulged shape is set in the fabric as a thermoset or thermoformed shape.