DEFLATION INDICATOR FOR A MEDICAL DEVICE BOLSTER

• US 20110196341A1
• Filed: 02/09/2011
• Published: 08/11/2011
• Est. Priority Date: 02/09/2010
• Status: Abandoned Application

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Howell, Glade H.
• Application Number:
  US13/024,046
• Publication Number:
  US 20110196341A1
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61F 2005/4455 Implantable
• CPC Class Codes: A61F 5/4408 Means for securing receptacles or bags to the body otherwise than by adhesives, e.g. belts, straps or harnesses A61F5/449 takes precedence
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61J 15/0088 for sensing parameters related to the device
• CPC Class Codes: A61J 15/0092 Valves on feeding tubes tube valves A61M39/22
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

A deflation indicator system for visually indicating an inflation status of a balloon-type or other inflatable internal bolster of a medical device is disclosed. The indicator system enables an observer to ascertain from an external vantage point whether the internal bolster of the indwelling device is inflated. In one embodiment, the medical device comprises an elongate body defining a lumen, and an inflatable internal bolster for securing a portion of the medical device within the patient. A deflation indicator is also disclosed, including a flexible membrane in fluid communication with the internal bolster. The membrane is included in an external portion of the medical device. The membrane assumes a first concavely-shaped position when the internal bolster is deflated. Correspondingly, the membrane assumes a second convexly-shaped position when the internal bolster is inflated. The positions of the membrane are externally observable to indicate the inflation status of the internal bolster.

Claims

1. A medical device, comprising:

an elongate body defining a lumen extending from a proximal end to a distal end;

an inflatable internal bolster for securing a portion of the medical device within the patient; and

a deflation indicator including;

a flexible membrane in fluid communication with the internal bolster and disposed on an external portion of the medical device, wherein the membrane assumes a first concavely-shaped position when the internal bolster is deflated, and wherein the membrane assumes a second convexly-shaped position when the internal bolster is inflated, the position of the membrane being externally observable to indicate an inflation status of the internal bolster.

2. The medical device as defined in claim 1, wherein the deflation indicator is included in an external head portion of the medical device, at least a portion of the head portion being translucent so as to enable observation of the membrane.

3. The medical device as defined in claim 1, wherein the indicator is housed in a cavity of the external head portion, the cavity defining a perimeter, the indicator sealed about the perimeter.

4. The medical device as defined in claim 1, wherein at least a portion of the membrane defines a substantially domed shape when in at least one of the first and the second positions.

5. The medical device as defined in claim 1, wherein a first surface of the membrane is visible when the membrane is in the first position, the first surface including a first indicium thereon.

6. The medical device as defined in claim 5, wherein a second surface of the membrane is visible when the membrane is in the second position.

7. The medical device as defined in claim 6, wherein the second surface of the membrane includes a second indicium visible when the second surface is visible, and wherein at least one of the first and second indicia includes a colored surface.

8. The medical device as defined in claim 1, wherein the medical device includes a gastrostomy device, and wherein the membrane is in fluid communication with the internal bolster via a connecting lumen.

9. A method for inserting a medical device into a patient, the method comprising:

providing the medical device disclosed in claim 1;

inserting a distal portion of the medical device into the patient such that the internal bolster is disposed within the patient; and

inflating the internal bolster to secure the medical device within the patient and such that the membrane of the deflation indicator is disposed in the second position,

wherein the membrane is externally observable such that deflation of the internal bolster is indicated when the membrane is disposed in the first position.

10. The method for inserting as defined in claim 9, further comprising:

attending to the medical device to re-inflate the internal bolster to dispose the membrane in the second position.

11. The method for inserting as defined in claim 9, wherein a first indicium of the membrane is visible when the membrane is disposed in the first position.

12. The method for inserting as defined in claim 11, wherein inflating the internal bolster further comprises:

inflating the internal bolster to secure the medical device within the patient and such that a second indicium of the membrane is visible when the membrane is disposed in the second position.

13. A deflation indicator for a medical device, the medical device including an inflatable internal bolster for securing a portion of the medical device within the patient, the deflation indicator comprising:

a bi-positional membrane in fluid communication with the internal bolster and included with an external portion of the medical device, wherein the membrane assumes a substantially dome-shaped first position when the internal bolster is deflated, and wherein the membrane assumes an opposing substantially dome-shaped second position when the internal bolster is inflated.

14. The deflation indicator as defined in claim 13, wherein a perimeter of the membrane is attached within a cavity of a head portion of the medical device, and wherein the membrane is visually observable within the cavity.

15. The deflation indicator as defined in claim 14, wherein the head portion is translucent to enable external observation of the membrane, and wherein the membrane assumes a cross sectionally concave shaped when in the first position and a cross sectionally convex shape when in the second position.

16. The deflation indicator as defined in claim 13, wherein the membrane includes a first indicium visible only when the membrane assumes the first position, the first indicium including a red color portion of the membrane.

17. The deflation indicator as defined in claim 16, wherein the membrane includes a second indicium visible when the membrane assumes the second position.

18. A feeding device, comprising:

an elongate body defining a feeding lumen that extends from a proximal end to a distal end of the body, the body extendable through a stoma defined in a body of a patient;

an inflatable balloon for providing an internal bolster for the feeding device; and

a deflation indicator system including;

a connecting lumen in fluid communication with the balloon; and

a bi-positional dome-shaped indicator in fluid communication with the connecting lumen and including a first indicium that is only visible when the indicator is in a first position, the first position corresponding to a deflated state of the balloon and a second indicium that is visible when the indicator is in a second position, the second position corresponding to an inflated state of the balloon.

19. The feeding device as defined in claim 18, wherein the indicator is included in a cavity disposed in a proximal head portion of the feeding device body, and wherein the membrane is in fluid communication with the internal bolster via a connecting lumen.

20. The feeding device as defined in claim 19, further comprising an inflation port including a valve.

21. The feeding device as defined in claim 20, wherein the inflation port and the indicator are in fluid communication with the internal bolster via the connecting lumen.

22. A deflation indicator for a medical device, the medical device including an inflatable internal bolster for securing a portion of the medical device within the patient, the deflation indicator comprising:

a rippled membrane in fluid communication with the internal bolster and included with an external portion of the medical device, wherein the membrane assumes a substantially collapsed first position when the internal bolster is deflated, and wherein the membrane assumes an extended second position when the internal bolster is inflated.

23. The deflation indicator as defined in claim 22, wherein the membrane is substantially fluid-impermeable and wherein an indicium is included with the membrane that is visible when the membrane assumes the second position.

24. A deflation indicator for a medical device, the medical device including an inflatable internal bolster for securing a portion of the medical device within the patient, the deflation indicator comprising:

a substantially fluid-impermeable membrane in fluid communication with the internal bolster and disposed in an external portion of the medical device, wherein the membrane is capable of moving from a first position when the internal bolster is deflated to at least a second position when the internal bolster is inflated, the membrane being biased to return to the first position when the internal bolster is deflated; and

a rod movable with the membrane such that the rod assumes a first rod position when the membrane is in the first position and such that the rod assumes a second rod position when the membrane is in the second position.

25. The deflation indicator as defined in claim 24, wherein the rod includes at least a first colored band that is visible when the rod is in the second rod position to indicate an inflation status of the internal bolster.

26. The deflation indicator as defined in claim 24, wherein the membrane is capable of moving to a third position when the internal bolster is over-inflated, and wherein the rod assumes a third rod position when the membrane is in the third position.

27. The deflation indicator as defined in claim 24, wherein the rod includes a groove that receives a rail to enable the rod to slide along the rail when the rod moves from the first rod position to at least the second rod position.