PNEUMOSTOMA MANAGEMENT DEVICE WITH INTEGRATED PATENCY SENSOR AND METHOD

• US 20100170507A1
• Filed: 01/08/2010
• Published: 07/08/2010
• Est. Priority Date: 01/08/2009
• Status: Active Grant

• Current Assignee: Portaero, Inc
• Original Assignee: Portaero, Inc
• Inventors: Tanaka, Don, Wiesman, Joshua P., Plough, David C.
• Granted Patent: US 8,347,881 B2
• Time in Patent Office: Days
• US Class Current: 128/202.220
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61M 16/0406 implanted flow modifiers
• CPC Class Codes: A61M 16/0429 with non-integrated distal obturators
• 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 2025/0246 fixed on the skin having a cover for covering the holding means
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2039/0252 for access to the lungs
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2205/7536 allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 2210/1039 Lungs
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2005/0651 : Diodes
• CPC Class Codes: A61N 2005/0654 : Lamps
• CPC Class Codes: A61N 2005/0659 : infrared
• CPC Class Codes: A61N 2005/0661 : ultraviolet
• CPC Class Codes: A61N 2005/0662 : Visible light
• CPC Class Codes: A61N 5/10 : X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy A61N5/01 takes precedence
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A flexible pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. The pneumostoma management device includes a pneumostoma vent having a tube which enters the pneumostoma to allow gases to escape the lung, a flange and a filter/valve to control flow of materials through the tube. The flange is a thin flexible patch comprises of multiple thin layers of materials and which conforms and attaches to the chest of the patient. The flange includes a filter, a protective outer layer and an inner hydrocolloid layer. The flange secures the tube in position in the pneumostoma. An indicator responsive to gases exiting the pneumostoma is integrated into the device and provides and external indicia of the patency and efficacy of the pneumostoma.

Claims

1. A pneumostoma vent to allow gases to exit a lung through a pneumostoma in a chest of a patient, wherein the pneumostoma vent comprises;

a tube adapted to be inserted into the chest through the pneumostoma,

the tube having a lumen, a proximal end and a distal end

the distal end of the tube having at least one opening adapted to admit gases from the lung;

the proximal end of the tube having a feature projecting a sufficient distance from the tube to preclude passage of proximal end of the tube into the pneumostoma,

an adhesive patch surrounding the tube;

the adhesive patch having an aperture through which the tube passes, the aperture being too small to allow passage of the arms projecting from the tube;

a filter disposed over the proximal end of the tube such that gases passing into and out of the lumen of the tube pass through the filter;

an adhesive cover having an aperture smaller than the filter and positioned such that the adhesive cover contacts the perimeter of the filter, the feature of the tube and at least a portion of the adhesive patch, such that the arms are disposed between the adhesive patch and the adhesive cover, and the filter is disposed between the adhesive cover and the proximal end of the tube; and

an indicator adapted to provide a visible indicia of patency of the pneumostoma.

2. The pneumostoma vent of claim 1, wherein the indicator is adapted to change color in response to a gas exiting the lung through the pneumostoma vent to provide a visible indicia of efficacy of the pneumostoma.

3. The pneumostoma vent of claim 1, wherein the indicator is a colorimetric reagent integrated with the filter.

4. The pneumostoma vent of claim 1, wherein:

the indicator is a colorimetric reagent integrated with the filter; and

wherein the colorimetric reagent is adapted to change color in response to a gas exiting the lung through the pneumostoma vent.

5. The pneumostoma vent of claim 1, wherein:

the filter is a hydrophobic filter adapted to allow gases to escape from the tube but retain liquids or solids; and

the indicator is a colorant bound to the filter and adapted to change color in response to a gas exiting the lung through the pneumostoma vent.

6. The pneumostoma vent of claim 1, wherein the indicator is integrated into the filter and the filter is adapted to change color in response to a gas exiting the lung through the pneumostoma vent.

7. The pneumostoma vent of claim 1, wherein the indicator is integrated into the filter and a geometrically-shaped portion of the filter is adapted to change color compared to other portions of the filter in response to gases exiting the lung through the pneumostoma.

8. The pneumostoma vent of claim 1, wherein the indicator is adapted to reversibly change color in response to gases exiting the lung through the pneumostoma.

9. The pneumostoma vent of claim 1, wherein the indicator is adapted to irreversibly change color in response to gases exiting the lung through the pneumostoma.

10. The pneumostoma vent of claim 1, wherein the feature, filter, adhesive coating and adhesive patch is less than 5 mm in thickness in combination.

11. A medical device adapted to allow gases to exit a lung through a pneumostoma in a chest of a patient, wherein the medical device comprises;

a tube adapted to be inserted into the chest through the pneumostoma,

the tube having a lumen, a proximal end and a distal end;

the distal end of the tube having at least one opening adapted to admit gases from the lung;

the proximal end of the tube having a flange projecting a sufficient distance from the tube to preclude passage of proximal end of the tube into the pneumostoma,

a hydrocolloid patch surrounding the tube;

a hydrophobic filter disposed over the proximal end of the tube adapted to allow gases to escape the tube;

an adhesive cover having an aperture smaller than the filter; and

an indicator adapted to provide a visible indicia of patency of the pneumostoma;

wherein the adhesive cover secures the filter over the proximal end of the tube, and the adhesive cover is secured to a portion of the hydrocolloid patch;

with the flange positioned between the adhesive cover and the hydrocolloid patch.

12. The medical device of claim 11, wherein the indicator is a colorimetric indicator.

13. The medical device of claim 12, wherein the colorimetric indicator is adapted to change color in response to a gas exiting the lung through the pneumostoma.

14. The medical device of claim 13, wherein the colorimetric indicator is adapted to irreversibly change color in response to a gas exiting the lung through the pneumostoma.

15. The medical device of claim 14, wherein the colorimetric indicator is a colorant bound to the filter.

16. The medical device of claim 15, wherein the colorant is adapted to change color in response to carbon dioxide exiting the lung through the pneumostoma.

17. The medical device of claim 16, wherein the adhesive cover is a breathable polymer film having one adhesive surface adapted to be releasably secure the medical device to the chest of the patient.

18. A medical device adapted to allow gases to exit a lung through a pneumostoma in a chest of a patient, wherein the medical device comprises;

a tube adapted to be inserted into the chest through the pneumostoma,

the tube having a lumen, a proximal end and a distal end;

the distal end of the tube having at least one opening adapted to admit gases from the lung;

the proximal end of the tube having a flange projecting a sufficient distance from the tube to preclude passage of proximal end of the tube into the pneumostoma,

a hydrocolloid patch surrounding the tube;

a hydrophobic filter disposed over the proximal end of the tube adapted to allow gases to escape the tube;

an adhesive cover having an aperture smaller than the filter and positioned such that the adhesive cover secures the filter over the proximal end of the tube, and the adhesive cover is secured at least a portion of the hydrocolloid ring; and

a colorant bound to the filter and adapted to change color in response to a gas exiting the lung through the pneumostoma and thereby provide a visible indicia of patency of the pneumostoma.

19. The medical device of claim 18, wherein the colorant is adapted to undergo an irreversible color change in response to a gas dioxide exiting the lung through the pneumostoma.

20. The medical device of claim 18, wherein the colorant is adapted to undergo an irreversible color change in response to carbon dioxide exiting the lung through the pneumostoma.