Two-phase surgical procedure for creating a pneumostoma to treat chronic obstructive pulmonary disease

• US 8,506,577 B2
• Filed: 07/06/2012
• Issued: 08/13/2013
• Est. Priority Date: 02/19/2008
• Status: Expired due to Fees

• Current Assignee: Portaero, Inc
• Original Assignee: Portaero, Inc
• Inventors: Tanaka, Don, Wiesman, Joshua P., Plough, David C.
• Primary Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US13/543,588
• Publication Number:
  US 20120277584A1
• Time in Patent Office: 403 Days
• Field of Search: 128/898, 128/200.24, 128/200.26, 128/204.18, 12820714-20717, 604 44- 45, 604/93.01, 604/96.01, 604/99.03, 60410201-10203, 604/174, 604/180, 604/288.01, 604540-541, 604 23- 26, 604 27- 28, 604/264, 604/164.04, 606/108
• US Class Current: 606/108
• 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 two-phase surgical procedure is disclosed for creating a pneumostoma to treat chronic obstructive pulmonary disease The first phase is a procedure to induce creation of a localized pleurodesis and is preferably performed as an outpatient procedure. The second phase is a procedure to introduce a surgical instrument into the lung via the pleurodesis to create the pneumostoma. An interval of about one of more days between the first and second phases allows the formation of a stable pleurodesis to prevent pneumothorax during the procedure.

Claims

1. A pneumostomy technique used to create a pneumostoma through a chest wall, parietal membrane and visceral membrane into a lung of a patient, wherein:

the pneumostomy technique comprises a first procedure, an interval and a second procedure;

the first procedure comprises,

(1a) accessing the parietal membrane by making an incision in the chest wall and exposing a localized region of the parietal membrane without puncturing the parietal membrane; and

(1b) treating the localized region of said parietal membrane to induce a pleurodesis without puncturing the parietal membrane;

the interval comprises a waiting period between the first procedure and the second procedure in order to allow the pleurodesis to form; and

the second procedure comprises,

(2a) identifying the position of the localized region,

(2b) verifying that a pleurodesis has been formed between the parietal and visceral membranes within the localized region,

(2c) making an incision through parietal and visceral membranes within the localized region and pleurodesis,

(2d) inserting a distal end of a pneumostomy catheter through the incision into the lung such the distal end of the pneumostomy catheter is embedded within parenchymal tissue of the lung,

(2e) expanding an expandable device at the distal end of the pneumostomy catheter to displace parenchymal tissue surrounding the distal end of the pneumostomy catheter for creating a cavity in the parenchymal tissue and securing the pneumostomy catheter within the lung,

(2f) applying tension to the pneumostomy catheter to draw the lung towards the incision;

(2g) after the lung is drawn toward the incision, securing the pneumostomy catheter to the chest wall of the patient thereby stabilizing the incision during healing of the pneumostoma;

(2h) leaving the distal end of the pneumostomy catheter embedded in the parenchymal tissue to create the pneumostoma;

(2i) collapsing the expandable device at the distal end of the pneumostomy catheter;

(2j) removing the pneumostomy catheter from the patient after formation of the pneumostoma, wherein the pneumostoma includes an artificial channel connecting the cavity in the parenchymal tissue created by the pneumostomy catheter to the air external to the patient'"'"'s body; and

(2k) inserting a pneumostoma management device into the pneumostoma to protect the pneumostoma and maintain patency of the pneumostoma, wherein the pneumostoma management device has a different structure than the pneumostomy catheter.

2. The pneumostomy technique of claim 1, wherein the first procedure is performed as an outpatient procedure and without the use of general anesthetic.

3. The pneumostomy technique of claim 1, wherein the expandable device at the distal end of the pneumostomy catheter is a balloon which is connected by a tube to a coupling at a proximal end of the pneumostomy catheter and wherein step (2e) comprises:

(2e) operating a syringe connected at the proximal end of the pneumostomy catheter to introduce a fluid through the tube into the balloon thereby expanding the balloon at the distal end of the pneumostomy catheter to displace parenchymal tissue of the lung and secure the pneumostomy catheter within the lung.

4. The technique of claim 1 wherein the interval is one or more days.

5. The technique of claim 1, wherein step (2h) of the second procedure comprises leaving the distal end of the pneumostomy catheter embedded in the parenchymal tissue for one to two weeks to create the pneumostoma.

6. A surgical technique used to create a pneumostoma through a chest wall, parietal membrane and visceral membrane into a lung of a patient, wherein:

the surgical technique comprises a first procedure, an interval and a second procedure;

the first procedure comprises,

(1a) accessing the parietal membrane by making an incision in the chest wall and exposing a localized region of the parietal membrane without puncturing the parietal membrane; and

(1b) treating the localized region of said parietal membrane to induce a pleurodesis without puncturing the parietal membrane;

the interval comprises a waiting period between the first procedure and the second procedure in order to allow the pleurodesis to form; and

the second procedure comprises,

(a) identifying the position of the localized region,

(b) verifying that a pleurodesis has been formed between the parietal and visceral membranes within the localized region,

(c) inserting a distal end of a pneumostomy catheter into the lung through the chest wall, parietal membrane and visceral membrane within the localized region such the distal end of the pneumostomy catheter is embedded within parenchymal tissue of the lung,

(d) expanding an expandable component attached to the distal end of the pneumostomy catheter to displace parenchymal tissue surrounding the distal end of the pneumostomy catheter for creating a cavity in the parenchymal tissue and securing the distal end of the pneumostomy catheter within the lung;

(d1) applying tension to the pneumostomy catheter to draw the expandable component towards the incision;

(d2) after the expanded component is drawn toward the incision, securing the pneumostomy catheter to the chest wall of the patient thereby stabilizing the pneumostoma during healing;

(e) leaving the distal end of the pneumostomy catheter embedded in the parenchymal tissue to create the pneumostoma;

(f) collapsing the expandable component at the distal end of the pneumostomy catheter;

(g) removing the pneumostomy catheter from the patient after formation of the pneumostoma, wherein the pneumostoma includes an artificial channel connecting the cavity in the parenchymal tissue created by the pneumostomy catheter to the air external to the patient'"'"'s body; and

(h) inserting a pneumostoma management device into the pneumostoma to protect the pneumostoma and maintain patency of the pneumostoma, wherein the pneumostoma management device has a different structure than the pneumostomy catheter.

7. The surgical technique of claim 6, wherein the first procedure is performed as an outpatient procedure and without the use of general anesthetic.

8. The surgical technique of claim 6, wherein the expandable component at the distal end of the pneumostomy catheter is a balloon and wherein step (d) comprises inflating the balloon with a fluid to displace parenchymal tissue of the lung and secure the pneumostomy catheter within the lung.

9. The surgical technique of claim 6 wherein:

the first procedure includes the additional step of depositing adjacent the localized region a marker which may be visualized external to the patient; and

step (a) of the second procedure comprises locating the localized region by locating the marker from external to the patient.

10. The surgical technique of claim 6 wherein:

the first procedure includes the additional step of depositing adjacent the localized region a radiopaque marker; and

step (a) of the second procedure comprises locating the localized region by locating the radiopaque marker using x-rays.

11. The technique of claim 6 wherein the interval is one or more days and the leaving step (e) is one or more days.

12. The technique of claim 6, wherein step (e) of the second procedure comprises leaving the distal end of the pneumostomy catheter embedded in the parenchymal tissue for more than one week to create the pneumostoma.

13. A surgical technique used to create a pneumostoma through a chest wall, parietal membrane and visceral membrane into a lung of a patient comprising:

an outpatient procedure to create a localized pleurodesis;

an interval of one or more days between the outpatient procedure and before an inpatient procedure, wherein the inpatient procedure creates a pneumostoma,

the inpatient procedure comprising

introducing a distal end of a pneumostomy catheter into parenchymal tissue of the lung through the chest wall, parietal membrane and visceral membrane, and within the localized pleurodesis,

expanding the distal end of the pneumostomy catheter within the parenchymal tissue of the lung thereby displacing the parenchymal tissue of the lung in order to urge the parenchymal tissue of the lung towards the localized pleurodesis and after the parenchymal tissue of the lung is adjacent to the localized pleurodesis securing the pneumostomy catheter to the chest wall,

leaving the distal end of the pneumostomy catheter embedded in the parenchymal tissue to create the pneumostoma,

removing the pneumostomy catheter after a period of three or more days to expose the pneumostoma, and

inserting a pneumostoma management device into the pneumostoma to protect the pneumostoma and maintain patency of the pneumostoma, wherein the pneumostoma management device has a different structure than the pneumostomy catheter.

14. The surgical technique of claim 13, wherein the distal end of the pneumostomy catheter comprises a balloon and the step of expanding the distal end of the pneumostomy catheter includes inflating the balloon.

15. The surgical technique of claim 13, wherein the outpatient procedure to create the localized pleurodesis further comprises introducing a radiopaque marker to identify the location of the pleurodesis.