Pre-formed member for percutaneous catheter

• US 5,439,444 A
• Filed: 04/26/1994
• Issued: 08/08/1995
• Est. Priority Date: 01/28/1991
• Status: Expired due to Term

• Current Assignee: CORPAK MedSystems, Inc. (Avanos Medical, Inc.)
• Original Assignee: Corpak LLC
• Inventors: Quinn, David G., Andersen, Erik
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/233,447
• Time in Patent Office: 469 Days
• Field of Search: 604/93, 604/96-104, 604/30, 604/34, 604/167, 604/174, 604/256, 604/277, 604/278, 604/246, 604/247, 604/264, 156/580.1, 156/60, 156/73.1, 156/73.2, 600/29, 600/31, 128/768, 128/766, 606/192-194
• US Class Current: 604/102.02
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

The present invention is directed to a pre-formed retention member having an improved construction and used for anchoring or retaining a catheter within a body cavity, organ or vessel. The pre-formed retention retains a distal open end of a single body access tube against an inner body cavity wall of a patient. The pre-formed member is secured to only the inner and outer peripheral edges of the distal open end of the tube by a sleeve. The sleeve has both an outer sleeve surface and an inner sleeve surface which receives, respectively, the outer and inner surfaces of the tube. The pre-formed member includes an outer surface and an inner surface which defines a retention chamber. The retention chamber extends beyond the distal open end of the tube so that no portion of the tube passes through the chamber. When outside forces act upon the pre-formed member, the pre-formed member collapses upon itself, and in a collapsed configuration, the outer diameter of the pre-formed member is no greater than the outer diameter of the tube.

Claims

1. In a single body access tube having an inner tube surface and an outer tube surface defining a fluid lumen and an inflation lumen, the tube including a pre-formed retention member carried near a distal open end of the tube, the pre-formed member having a retention chamber surrounding the outer surface of the tube, the pre-formed member circumferentially secured to the outer surface of the tube, the improvement comprising:

the pre-formed member being circumferentially secured to the distal open end of the tube and to both the inner tube surface and the outer tube surface, the pre-formed member having an axial opening communicating with the fluid lumen of the tube, wherein the retention chamber of the pre-formed member is substantially filled with a compressible foam, and further wherein the retention chamber extends beyond the distal open end of the tube so that no portion of the tube passes through the chamber;

the pre-formed member being collapsible from its pre-formed configuration, and expandable to its non-collapsed, pre-formed configuration by passage of fluid flow through the inflation lumen,

such that when the pre-formed member is in a non-collapsed, pre-formed configuration, the pre-formed member projects beyond the distal end of the tube and has an outer configuration with an outer diameter greater than the outer diameter of the tube, and such that when the pre-formed member is in a collapsed configuration, the pre-formed member collapses upon itself and has an outer collapsed configuration with an outer diameter no greater than the outer diameter of the tube.

2. The body access tube of claim 1 wherein a proximal end of the pre-formed member includes a sleeve, the sleeve having an outer sleeve surface and an inner sleeve surface for respective securement to the outer tube surface and the inner tube surface of the tube.

3. A percutaneous access device comprising:

a tube having an outer surface and an inner surface defining a fluid lumen and an inflation lumen;

the tube having a proximal end and a distal end;

a pre-formed retention member circumferentially secured to the distal end of the tube;

a passageway through the pre-formed retention member in fluid communication with the fluid lumen of the tube;

the pre-formed retention member having a retention chamber in fluid communication with the inflation lumen;

the retention chamber having a pre-formed configuration and being collapsible from its pre-formed configuration by passage of fluid flow through the inflation lumen;

the retention chamber, when in a non-collapsed configuration, projects beyond the distal end of the tube and has a configuration with an outer diameter greater than the outer diameter of the tube, and having at least one generally flattened surface perpendicular to the tube facing the proximal end of the tube;

the retention chamber, when in a collapsed configuration, projects beyond the distal end of the tube and has a configuration with an outer diameter approximately equal to or less than the outer diameter of the tube.

4. The device of claim 3 wherein the retention chamber is substantially filled with compressible foam.

5. The device of claim 4 wherein the foam is a polyurethane foam.

6. The device of claim 3 wherein the passageway through the pre-formed retention member is axially aligned with the fluid lumen of the tube.

7. A method of forming a pre-formed retention member carried on a distal open end of a catheter tube, the catheter having a fluid lumen and an inflation lumen, the method comprising the steps of:

forming a proximal portion of the pre-formed retention member, the proximal portion having a sleeve with a small diameter mating end to receive and contact an outer surface of the distal end of the catheter tube and the proximal portion having at least one generally flattened surface integral with said small diameter mating end and perpendicular to said catheter tube, and said proximal portion having a large diameter mating end;

forming a distal portion of the pre-formed member, the distal portion having a large diameter mating end for circumferentially mating with the large diameter mating end of the proximal portion, the distal portion having a core coaxial with the sleeve, the core being insertable within only the fluid lumen to contact an inner surface of the catheter;

inserting a fluid lumen mandrel into the core and fluid lumen;

inserting an inflation lumen mandrel into the inflation lumen;

bonding the sleeve to the outer surface of the catheter and the core to the inner surface of the catheter; and

,

circumferentially bonding together the large diameter mating ends of the proximal portion and the distal portion.

8. The method of claim 7 further including the step of substantially filling the pre-formed retention member with compressible foam material.