Noded cuffs for transcutaneous or intrabody prosthetic devices

• US 5,833,664 A
• Filed: 10/08/1996
• Issued: 11/10/1998
• Est. Priority Date: 10/08/1996
• Status: Expired due to Fees

• Current Assignee: SM Technologies LLC
• Original Assignee: William J. Seare Jr
• Inventors: Seare, William J. Jr.
• Primary Examiner(s): DeMille, Danton D.
• Application Number:
  US08/729,813
• Time in Patent Office: 763 Days
• Field of Search: 604/174, 604/175, 604/176, 604/178, 604/180, 128/DIG. 26
• US Class Current: 604/174
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

This invention relates to methods and apparatus for making and using noded cuffs on transcutaneous or intrabody prosthetic devices, such as catheters, to effect improved stability of the prosthesis/tissue opening site interface. In particular, the noded cuff apparatus of the present invention provides for positioning of the tissue opening site in a manner which facilitates more rapid establishment of a stably biointegrated and well-healed prosthesis/tissue opening site interface. In addition, in accord with the methods of the present invention, non-biointegrated portions of the noded cuff can be simply and easily removed from the underlying prosthetic device to facilitate maintenance of the stably biointegrated interface. Preferably, this removal takes place after a period of time during which the interface has become stably established. In accord with the methods and apparatus of the present invention, thus, infections or healing difficulties at the prosthesis/tissue opening site interface are greatly reduced and a more comfortable and stable interface is more rapidly established and more easily maintained.

Claims

1. A method of stabilizing a prosthetic device at an interface with a tissue opening site, said method comprising the steps of:

a) obtaining a prosthetic device having a noded cuff positioned upon a surface on said prosthetic device to interface with said tissue opening site, said noded cuff comprising;

at least a first cuff segment and an adjacent second cuff segment;

each said cuff segment extending outwardly from the surface of an underlying prosthetic device and wherein at least one of said first and second cuff segment is adapted to be selectively removable from said cuff;

a node defined by a space between said first and second cuff segments;

said node having a having a first side wall and a second side wall and a node termination at an innermost depth of said node;

wherein said first side wall is defined by a side of said first cuff segment and said second side wall is defined by a side of said second cuff segment

b) positioning a tissue opening site within a node of said cuff;

c) establishing stable biointegration of said tissue opening site with at least a portion of said node; and

d) removing at least one cuff segment external to and not contacting said tissue opening site from said prosthetic device.

2. A method of stabilizing a prosthetic device at an interface with a tissue opening site, said method comprising the steps of:

a) obtaining a prosthetic device having;

I) at least a first cuff segment and an adjacent second cuff segment, each said cuff segment extending outwardly from a surface of an underlying prosthetic device and wherein at least one of said first and second cuff segment is adapted to be selectively removable from said cuff when said cuff is positioned to traverse said tissue opening site;

ii) a node defined by a space between said first and second cuff segments, said node having a first side wall and a second side wall and a node termination between said first and second side walls at an innermost depth of said node, wherein said first side wall is defined by a side of said first cuff segment and said second side wall is defined by a side of said second cuff segment;

b) positioning a tissue opening site within a node of said cuff;

c) establishing stable biointegration of said tissue opening site with at least a portion of said node; and

d) removing cuff segments not contacting said tissue opening site from said prosthetic device.

3. A prosthetic device having a cuff for stabilizing said prosthetic device at an interface with a tissue opening site comprising:

a prosthetic device for positioning within a tissue opening site;

a noded cuff positioned upon a surface on said prosthetic device to interface with said tissue opening site, said noded cuff comprising;

at least a first cuff segment and an adjacent second cuff segment;

each said cuff segment extending outwardly from the surface of said underlying prosthetic device and wherein at least one of said first and second cuff segment is adapted to he selectively removable from said cuff;

a node defined by a space between said first and second cuff segments;

said node having a having a first side wall and a second side wall and a node termination at an innermost depth of said node;

wherein said first side wall is defined by a side of said first cuff segment and said second side wall is defined by a side of said second cuff segment.