Partial encapsulation of stents

• US 6,398,803 B1
• Filed: 09/02/1999
• Issued: 06/04/2002
• Est. Priority Date: 02/02/1999
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Cundy, Sandra, Bebb, Debra, Layne, Richard
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): Pellegrino, Brian E
• Application Number:
  US09/388,496
• Time in Patent Office: 1,006 Days
• Field of Search: 623/1.13, 623/1.15, 623/1.16, 623/1.27, 623/1.44, 623/1.49, 623/1.28, 623/1.29
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10T 156/1026 with slitting or removal of material at reshaping area prior to reshaping
• CPC Class Codes: Y10T 156/1056 Perforating lamina
• CPC Class Codes: Y10T 156/1062 Prior to assembly
• CPC Class Codes: Y10T 156/109 Embedding of laminae within face of additional laminae

Abstract

Partially encapsulated stents are made using gaps cut into ePTFE covering material. Ring stents are placed over an inner ePTFE tube (e.g., supported on a mandrel) and are covered by a “lacey” graft sleeve, which is constructed by cutting apertures into an ePTFE tube so that a series of circumferential and longitudinal strips is created. This “lacey” sleeve is then laminated to the inner ePTFE tube to capture the stents. By selecting the size and position of the apertures in the ePTFE covering, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. Alternatively, the gaps can consist of slits cut into the ePTFE covering material. These slits can be cut in any direction including longitudinally, radially, or diagonally. In addition, the slits can be spaced at varying intervals around the covering material to maximize flexibility and expandability. Although a single stent can be used, these approaches lend themselves to use of a plurality of individual ring stents spaced apart along the inner ePTFE tube.

Claims

1. A radially expandable reinforced vascular graft exhibiting improved flexibility, comprising:

an expanded polytetrafluoroethylene layer;

a radially expandable support layer comprising at least one stent, wherein said support layer is in contact with a surface of the expanded polytetrafluoroethylene layer; and

an expanded polytetrafluoroethylene tube, comprising a tube wall and a plurality of openings, each of the openings extending through the tube wall comprising a longitudinal component and a circumferential component, wherein the length of the longitudinal component is less than the total length of the tube, and wherein the length of the circumferential component is less than 360°

;

wherein the radial expandable support layer is secured between the expanded polytetrafluoroethylene layer and the expanded polytetrafluoroethylene tube, and wherein at least a portion of the support layer is positioned within the openings.

2. The radially expandable reinforced vascular graft of claim 1, wherein said radially expandable support layer comprises a plurality of ring stents.

3. The radially expandable reinforced vascular graft of claim 2, wherein each of said ring stents is formed in a zigzag pattern of alternating peaks and valleys.

4. The radially expandable reinforced vascular graft of claim 3, wherein said zigzag ring stents are disposed with the alternating peaks and valleys in phase.

5. The radially expandable reinforced vascular graft of claim 1, wherein said stent is made of metal.

6. The radially expandable reinforced vascular graft of claim 1, wherein an end of said radially expandable reinforced vascular graft is fully encapsulated.

7. The radially expandable reinforced vascular graft of claim 1, wherein the openings comprise similarly shaped apertures, further comprising a ring of said apertures at a distinct point along the length of the expanded polytetrafluoroethylene tube.

8. The radially expandable reinforced vascular graft of claim 7, further comprising a plurality of rings of apertures along the length of the expanded polytetrafluoroethylene tube.

9. The radially expandable reinforced vascular graft of claim 8, wherein the apertures are rectangular in shape and wherein each ring is comprised of at least three apertures.