Enhanced pneumostoma management device and methods for treatment of chronic obstructive pulmonary disease

• US 8,231,581 B2
• Filed: 01/25/2011
• Issued: 07/31/2012
• Est. Priority Date: 02/19/2008
• Status: Expired due to Fees

• Current Assignee: Portaero, Inc
• Original Assignee: Portaero, Inc
• Inventors: Tanaka, Don
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US13/012,962
• Publication Number:
  US 20110118669A1
• Time in Patent Office: 553 Days
• Field of Search: 604/275, 604/174, 604/540, 604/276, 604/307, 604/45, 604/180, 604/332, 604/368, 604/389
• US Class Current: 604/174
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61M 1/04 Artificial pneumothorax apparatus
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 13/00 Insufflators for therapeutic or disinfectant purposes , i.e. devices for blowing a gas, powder or vapour into the body hand-held units in which gas flow is produced by muscular energy at the moment of use B05B11/062
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/02 with activated or ionised fluids, e.g. electrohydrodynamic [EHD] or electrostatic devices; Ozone-inhalators with radioactive tagged particles
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/0833 T- or Y-type connectors, e.g. Y-piece
• CPC Class Codes: A61M 16/202 electrically actuated
• 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 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/025 Helium
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/075 Bulb type
• CPC Class Codes: A61M 2205/7518 bacterial
• CPC Class Codes: A61M 2205/7536 : allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• 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 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 27/00 : Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 39/02 : Access sites
• 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

Abstract

A partially-implantable pneumostoma management device maintains the patency of a pneumostoma while controlling the flow of material through the pneumostoma. A tube of the pneumostoma management device is placed through the chest wall into the lung. The tube comprises a plurality of holes in the distal end to allow the entry of gases and non-gaseous discharge from the lung. A contact surface prevents over-insertion of the tube while releasably securing the device to the chest of the patient. The contact surface has features to reduce irritation of the skin of the chest. The pneumostoma management device may provide a pharmaceutically active substance selected to maintain the patency of the pneumostoma.

Claims

1. A pneumostoma management device adapted to be mounted on a chest of a patient to treat a lung of a patient and control flow of liquids and gases through a pneumostoma wherein the pneumostoma management device comprises:

a tube with a side wall, the tube adapted to pass into the pneumostoma;

the tube configured such that a distal end of the tube is adapted to be inserted into parenchymal tissue of the lung;

the tube having at least one end opening at the distal end of the tube;

the end opening configured and positioned such that, with the distal end of the tube inserted in the parenchymal tissue of the lung, liquids and gases enter the tube directly from the parenchymal tissue of the lung without entering a pleural cavity;

at least one side opening through said side wall of said tube and adjacent to the distal end of the tube, the side opening configured and positioned such that, with the distal end of the tube inserted into the parenchymal tissue of the lung, liquid and gases enter the tube directly from the parenchymal tissue of the lung without entering the pleural cavity;

a flange substantially perpendicular to the tube and adapted to prevent over-insertion of the tube;

the flange configured to releasably secure the pneumostoma management device to the chest; and

a filter held in fluid communication with the tube such that gases from the lung exit the pneumostoma management device external to the chest of the patient through the filter.

2. The pneumostoma management device of claim 1, including a plurality of side openings through said side wall of said tube adjacent the distal end of the tube and adapted to be positioned in the parenchymal tissue of the lung.

3. The pneumostoma management device of claim 1, wherein the flange is substantially circular and arranged substantially concentric with the tube.

4. The pneumostoma management device of claim 1, wherein the flange includes at least two discrete adhesive patches positioned and adapted to secure the flange to the chest of the patient.

5. The pneumostoma management device of claim 1, wherein the flange has a plurality of raised regions adapted to contact the chest of the patient while spacing one or more non-raised regions of the flange away from the chest and being thereby adapted to inhibit accumulation of moisture between the flange and the chest of the patient.

6. The pneumostoma management device of claim 1, wherein the tube includes an active pharmaceutical substance and wherein the tube is configured to deliver the active pharmaceutical substance to tissue of the pneumostoma and wherein the active pharmaceutical substance is selected to maintain patency of the pneumostoma.

7. The pneumostoma management device of claim 1, wherein the tube includes an active pharmaceutical substance selected from the group consisting of:

steroids;

adrenocortical steroids;

cortisol;

cortisone;

fludrocortisone;

prednisone;

prednisolone;

6a-methylprednisolone, triamcinolone;

betamethasone; and

dexamethasone.

8. The pneumostoma management device of claim 1, further including an absorbent material positioned adjacent at least one of the flange and the tube and adapted to trap liquids from the pneumostoma.

9. A pneumostoma management device adapted to be mounted on a chest of a patient to treat a lung of a patient and control flow of liquids and gases through a pneumostoma wherein the pneumostoma management device comprises:

a tube with a side wall, the tube adapted to pass into the pneumostoma;

the tube configured such that a distal end of the tube is adapted to be inserted into parenchymal tissue of the lung;

the tube having at least one end opening at the distal end of the tube;

the end opening configured and positioned such that, with the distal end of the tube inserted in the parenchymal tissue of the lung, liquids and gases enter the tube directly from the parenchymal tissue of the lung without entering a pleural cavity;

a flange substantially perpendicular to the tube and adapted to prevent over-insertion of the tube;

the flange configured to releasably secure the pneumostoma management device to the chest;

the flange including at least two discrete adhesive patches positioned and adapted to secure the flange to the chest of the patient; and

a filter held in fluid communication with the tube such that gases from the lung exit the pneumostoma management device external to the chest of the patient through the filter.

10. The pneumostoma management device of claim 9, including a plurality of side openings through said side wall of said tube and adjacent the distal end of the tube, said plurality of side openings adapted to be positioned in the parenchymal tissue of the lung.

11. The pneumostoma management device of claim 9, wherein the flange is substantially circular and arranged substantially concentric with the tube.

12. The pneumostoma management device of claim 9, wherein the flange has a plurality of raised regions adapted to contact the chest of the patient while spacing one or more non-raised regions of the flange away from the chest and being thereby adapted to inhibit accumulation of moisture between the flange and the chest of the patient.

13. The pneumostoma management device of claim 9, wherein the tube includes an active pharmaceutical substance and wherein the tube is configured to deliver the active pharmaceutical substance to tissue of the pneumostoma and wherein the active pharmaceutical substance is selected to maintain patency of the pneumostoma.

14. The pneumostoma management device of claim 9, wherein the tube includes an active pharmaceutical substance selected from the group consisting of:

steroids;

adrenocortical steroids;

cortisol;

cortisone;

fludrocortisone;

prednisone;

prednisolone;

6a-methylprednisolone, triamcinolone;

betamethasone; and

dexamethasone.

15. The pneumostoma management device of claim 9, further including an absorbent material positioned adjacent at least one of the flange and the tube and adapted to trap liquids from the pneumostoma.

16. A pneumostoma management device adapted to be mounted on a chest of a patient to treat a lung of a patient and control flow of liquids and gases through a pneumostoma wherein the pneumostoma management device comprises:

a tube with a side wall adapted to pass into the pneumostoma;

the tube configured such that a distal end of the tube is adapted to be inserted into parenchymal tissue of the lung;

the tube having at least one end opening at the distal end of the tube;

the end opening configured and positioned such that, with the distal end of the tube inserted in the parenchymal tissue of the lung, liquids and gases enter the tube directly from the parenchymal tissue of the lung without entering a pleural cavity;

a flange substantially perpendicular to the tube and adapted to prevent over-insertion of the tube;

the flange configured to releasably secure the pneumostoma management device to the chest;

a filter held in fluid communication with the tube such that gases from the lung exit the pneumostoma management device external to the chest of the patient through the filter; and

wherein the tube includes an active pharmaceutical substance and wherein the tube is configured to deliver the active pharmaceutical substance to tissue of the pneumostoma and wherein the active pharmaceutical substance is selected to maintain patency of the pneumostoma.

17. The device of claim 16, including a plurality of side openings through said side wall of said tube and adjacent the distal end of the tube, said plurality of side openings adapted to be positioned in the parenchymal tissue of the lung.

18. The pneumostoma management device of claim 16, wherein the flange is substantially circular and arranged substantially concentric with the tube.

19. The pneumostoma management device of claim 16, wherein the flange includes at least two discrete adhesive patches positioned and adapted to secure the flange to the chest of the patient.

20. The pneumostoma management device of claim 16, wherein the flange has a plurality of raised regions adapted to contact the chest of the patient while spacing one or more non-raised regions of the flange away from the chest and being thereby adapted to inhibit accumulation of moisture between the flange and the chest of the patient.

21. The pneumostoma management device of claim 16, wherein the active pharmaceutical substance is selected from the group consisting of:

steroids;

adrenocortical steroids;

cortisol;

cortisone;

fludrocortisone;

prednisone;

prednisolone;

6a-methylprednisolone, triamcinolone;

betamethasone; and

dexamethasone.

22. The pneumostoma management device of claim 16, further comprising an absorbent material positioned adjacent at least one of the flange and the tube and adapted to trap liquids from the pneumostoma.

23. A pneumostoma management device adapted to be mounted on a chest of a patient to treat a lung of a patient and control flow of liquids and gases through a pneumostoma wherein the pneumostoma management device comprises:

a tube with a side wall adapted to pass into the pneumostoma;

the tube configured such that a distal end of the tube is adapted to be inserted into parenchymal tissue of the lung;

the tube having at least one end opening at the distal end of the tube;

the end opening configured and positioned such that, with the distal end of the tube inserted in the parenchymal tissue of the lung, liquids and gases enter the tube directly from the parenchymal tissue of the lung without entering a pleural cavity;

a flange substantially perpendicular to the tube and adapted to prevent over-insertion of the tube;

the flange configured to releasably secure the pneumostoma management device to the chest;

a filter held in fluid communication with the tube such that gases from the lung exit the pneumostoma management device external to the chest of the patient through the filter; and

further including an absorbent material positioned adjacent at least one of the flange and the tube so that the absorbent material is adapted to contact the chest and adapted to trap liquids from the pneumostoma.

24. The pneumostoma management device of claim 23, including a plurality of side openings through said side wall and adjacent the distal end of the tube, said plurality of side openings adapted to be positioned in the parenchymal tissue of the lung.

25. The pneumostoma management device of claim 23, wherein the flange includes a plurality of discrete adhesive patches positioned and adapted to secure the flange to the chest of the patient.