Enteral Feeding Catheter Assembly Incorporating an Indicator

Patent metadata

Field	Value
Publication number	US-2016000658-A1
Application number	US-201514853145-A
Country	US
Kind code	A1
Filing date	Sep 14, 2015
Priority date	Dec 23, 2009
Publication date	Jan 7, 2016
Grant date	—

Abstract

A catheter assembly incorporating a pre-biased indicator, the assembly includes a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen. The assembly further includes a base located at the proximal end of the catheter, the base defining an opening to the catheter lumen, the base having a first end and a second end. An inflatable balloon having a predetermined fill volume is located at a distal end of the catheter. An inflation valve is located on the base; the inflation valve is in fluid communication with the balloon through an inflation lumen defined by the catheter walls. The pre-biased indicator located on the base in fluid communication with the balloon is configured to provide a discrete visual signal that the pressure of a fluid in the balloon is different from a predetermined level of pressure or the volume of the balloon is different from the predetermined fill volume.

First claim

We claim:

1 . 1 . An enteral feeding catheter assembly comprising:
a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen; a base located at the proximal end of the catheter, the base defining an opening to the catheter lumen, the base having a first end and a second end; an inflatable balloon having a predetermined fill volume, the balloon located at a distal end of the catheter, an inflation valve located on the base, the inflation valve in fluid communication with the balloon through an inflation lumen defined by the catheter walls; and a pre-biased indicator located on the base in fluid communication with the balloon, the pre-biased indicator configured to provide a discrete visual signal that the pressure of a fluid in the balloon is different from a predetermined level of pressure or the volume of the balloon is different from the predetermined fill volume.

2 . The enteral feeding catheter assembly of claim 1 , wherein the pre-biased indicator comprises:
a housing having a first end, a second end, one or more walls defining an interior channel, and an axial dimension, the first end of the housing being in fluid communication with the inflatable balloon, and at least a portion of the housing being transparent or translucent; a flexible sleeve positioned within the interior channel of the housing, the flexible sleeve comprising: a first surface, an opposed second surface, a first end located within the interior channel of the housing near the first end of the housing and in fluid communication with the inflatable balloon, a second end sealingly engaged with the housing, and a flexible, generally annular portion joining the first end and second end of the sleeve, the annular portion defining a rolling annular fold intermediate the first end and the second end such that at least a portion of the first surface of the flexible sleeve is generally adjacent the one or more housing walls and at least a portion of the second surface of the flexible sleeve defines a sleeve cavity; and a biasing element located at least partially within the sleeve cavity and between the first end of the housing and the second end of the housing, the biasing element being configured to deform at a predetermined pressure so the first end of the flexible sleeve moves from a first axial position to at least a second axial position to provide a discrete visual signal that the pressure of a fluid in the balloon is different from the predetermined level of pressure or the volume of the balloon is different from the predetermined fill volume. wherein the movement of the flexible sleeve in an axial direction causes a portion of the second surface of the flexible sleeve to evert at the rolling annular fold so that it becomes directly adjacent the one or more housing walls.

3 . The enteral feeding catheter assembly of claim 1 , where in the inflation valve is location on the first end of the base and the indicator is located on the second end of the base.

4 . The enteral feeding catheter assembly 1 , wherein the catheter defines an inflation lumen and the balloon is in fluid communication with the inflation valve and the indicator through the inflation lumen.

5 . The enteral feeding catheter assembly of claim 1 , wherein the catheter defines an indicator lumen and the balloon is in fluid communication with the indicator through the indicator lumen.

6 . The enteral feeding catheter assembly of claim 1 , wherein the pre-biased indicator is configured to provide a discrete visual signal that the pressure of the fluid in the balloon is less than a predetermined level of pressure or the volume of the balloon is less than the predetermined fill volume.

7 . The enteral feeding catheter assembly of claim 1 , wherein the pre-biased indicator is configured to provide a discrete visual signal that the pressure of the fluid in the balloon is greater than a predetermined level of pressure or the volume of the balloon is greater than the predetermined fill volume.

8 . A balloon catheter device, the balloon catheter comprising:
a catheter having a proximal end, a distal end, and catheter walls defining a catheter lumen; a base located at the proximal end of the catheter defining an opening to the catheter lumen; an inflatable balloon having a predetermined fill volume, the balloon located at a distal end of the catheter and configured to contain a fluid under pressure; an inflation valve located on the base, the inflation valve in fluid communication with the balloon; and a pre-biased pressure indicator in fluid communication with the balloon, the pre-biased pressure indicator configured to provide a discrete visual signal that the pressure of the fluid in the balloon is different from a predetermined level of pressure or the volume of the balloon is different from the predetermined fill volume.

9 . The device of claim 8 , wherein the pre-biased indicator comprises a housing having an axial dimension, a flexible sleeve fitted within the housing, and a biasing element in communication with the flexible sleeve, the biasing element being configured to deform at a predetermined pressure so the flexible sleeve travels along the axis of the housing from a first axial position to a second axial position.

10 . The device of claim 8 , where in the pre-biased indicator is located on the base at the proximal end of the catheter.

11 . The device of claim 9 , wherein the first position of the flexible sleeve provides a discrete visual signal that the pressure of the fluid in the balloon is less than the predetermined level of pressure or the volume of the balloon is less than the predetermined fill volume.

12 . The device of claim 9 , wherein the second position of the flexible sleeve provides a discrete visual signal that the pressure of the fluid in the balloon is greater than the predetermined level of pressure or the volume of the balloon is greater than the predetermined fill volume.

13 . The device of claim 9 , wherein the flexible sleeve is visible through at least a portion of the housing while the flexible sleeve is in its first position.

14 . The device of claim 8 , wherein the catheter defines an inflation lumen and the balloon is in fluid communication with the inflation valve and the indicator through the inflation lumen.

15 . The device of claim 8 , wherein the catheter defines an indicator lumen and the balloon is in fluid communication with the indicator through the indicator lumen.

Assignees

• Avent Inc

Inventors

• Hershey Adrienne A
• Mcmichael Donald J
• Rotella John A

Classifications

• A61J15/0015 Primary

  Gastrostomy feeding-tubes (insertion tools or methods A61B17/34) · CPC title

• A61J2200/76

  for fluid level · CPC title

• A61J15/0092

  Valves on feeding tubes (tube valves A61M39/22) · CPC title

• A61J15/0088

  for sensing parameters related to the device · CPC title

• A61J15/0049 Primary

  Inflatable Balloons (balloon catheters A61M25/10) · CPC title