U.S. patent application number 12/388446 was filed with the patent office on 2009-08-20 for percutaneous single-phase surgical procedure for creating a pneumostoma to treat chronic obstructive pulmonary disease.
This patent application is currently assigned to Portaero, Inc.. Invention is credited to David C. Plough, Don Tanaka, Joshua P. Wiesman.
Application Number | 20090209909 12/388446 |
Document ID | / |
Family ID | 40953964 |
Filed Date | 2009-08-20 |
United States Patent
Application |
20090209909 |
Kind Code |
A1 |
Tanaka; Don ; et
al. |
August 20, 2009 |
PERCUTANEOUS SINGLE-PHASE SURGICAL PROCEDURE FOR CREATING A
PNEUMOSTOMA TO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Abstract
A percutaneous single-phase surgical procedure is disclosed for
creating a pneumostoma to treat chronic obstructive pulmonary
disease. A pneumostomy instrument is introduced percutaneously
through the thoracic wall, parietal membrane, visceral membrane and
into the parenchymal tissue of the lung. The pneumostomy instrument
crosses the pleural cavity between the parietal membrane and
visceral membrane there being no pleurodesis between the membranes
prior to passage of the pneumostomy instrument. A pneumoplasty
device at the distal end of the pneumostomy instrument displaces
and engages the parenchymal tissue of the lung and the pneumostomy
instrument is used to secure the lung and visceral membrane in
contact with the parietal membrane and chest wall. The pneumostomy
instrument is left in place while a pneumostoma tract heals and
pleurodesis occurs between the pleural membranes surrounding the
pneumostomy instrument.
Inventors: |
Tanaka; Don; (Saratoga,
CA) ; Wiesman; Joshua P.; (Boston, MA) ;
Plough; David C.; (Portola Valley, CA) |
Correspondence
Address: |
FLIESLER MEYER LLP
650 CALIFORNIA STREET, 14TH FLOOR
SAN FRANCISCO
CA
94108
US
|
Assignee: |
Portaero, Inc.
Cupertino
CA
|
Family ID: |
40953964 |
Appl. No.: |
12/388446 |
Filed: |
February 18, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61029830 |
Feb 19, 2008 |
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61032877 |
Feb 29, 2008 |
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61038371 |
Mar 20, 2008 |
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61082892 |
Jul 23, 2008 |
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61083573 |
Jul 25, 2008 |
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61084559 |
Jul 29, 2008 |
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61088118 |
Aug 12, 2008 |
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61143298 |
Jan 8, 2009 |
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61151581 |
Feb 11, 2009 |
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Current U.S.
Class: |
604/97.02 ;
227/175.1; 604/96.01; 606/139 |
Current CPC
Class: |
A61M 1/04 20130101; A61M
2205/075 20130101; A61M 2202/0208 20130101; A61M 25/10 20130101;
A61M 2202/064 20130101; A61M 2205/7536 20130101; A61M 2039/0252
20130101; A61M 2202/025 20130101; A61M 15/009 20130101; A61M 11/005
20130101; A61M 16/202 20140204; A61M 11/00 20130101; A61M 16/0833
20140204; A61M 25/02 20130101; A61M 39/02 20130101; A61M 15/0085
20130101; A61M 16/0816 20130101; A61M 2039/0276 20130101; A61M
11/042 20140204; A61K 9/007 20130101; A61M 25/04 20130101; A61M
27/00 20130101; A61M 2205/7518 20130101; A61B 2017/00809 20130101;
A61M 15/02 20130101; A61M 13/00 20130101; A61M 39/0247
20130101 |
Class at
Publication: |
604/97.02 ;
604/96.01; 606/139; 227/175.1 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61M 25/10 20060101 A61M025/10; A61B 17/068 20060101
A61B017/068 |
Claims
1. A surgical procedure used to create a pneumostoma which passes
through a chest wall, parietal membrane, pleural cavity and
visceral membrane into a lung of a patient, wherein the surgical
procedure comprises: (a) obtaining a pneumostomy instrument
comprising an elongated body with an expandable body at a distal
end thereof; (b) inserting the distal end of the pneumostomy
instrument through the chest wall, and parietal membrane into the
pleural cavity; (c) passing the distal end of the pneumostomy
instrument across the pleural cavity; (d) inserting the distal end
of the pneumostomy instrument through the visceral membrane and
into parenchymal tissue of the lung; (e) expanding the expandable
body within the parenchymal tissue of the lung thereby displacing
parenchymal tissue and securing the distal end of the pneumostomy
instrument within the lung; (f) pulling the pneumostomy instrument
in the direction of a proximal end of the pneumostomy instrument to
approximate the visceral membrane and the parietal membrane
sufficiently for pleurodesis to occur; (g) securing the pneumostomy
instrument to the chest wall while pleurodesis occurs between the
visceral membrane and parietal membrane surrounding the pneumostomy
instrument thereby sealing the pneumostoma from the pleural cavity;
(h) reducing the expandable body; (i) removing the pneumostomy
instrument from the pneumostoma.
2. The surgical procedure of claim 1, wherein; step (b) comprises
percutaneously inserting the distal end of the pneumostomy
instrument through the chest wall, and parietal membrane into the
pleural cavity;
3. The surgical procedure of claim 1, further comprising, prior to
step (a) the step of: securing the visceral membrane to the
parietal membrane by percutaneously implanting one or more
fasteners which engage the parietal membrane and the visceral
membrane.
4. The surgical procedure of claim 1, further comprising, prior to
step (a) the step of: securing the visceral membrane to the
parietal membrane by percutaneously implanting one or more
fasteners which engage the parietal membrane and the visceral
membrane; and wherein the fasteners comprise one or more fasteners
from the group consisting of: staples, clips, tacks, barbed
filaments and sutures.
5. The surgical procedure of claim 1, wherein the expandable device
is a balloon which is connected to a tube and wherein step (e)
comprises: operating a syringe to introduce a fluid through the
tube into the balloon and thereby expanding the expandable body
within the parenchymal tissue of the lung thereby displacing
parenchymal tissue and securing the distal end of the pneumostomy
instrument within the lung.
6. The surgical procedure of claim 1, wherein step a) comprises
obtaining a pneumostomy instrument comprising an elongated body
with a lumen running from a proximal end to a distal end with an
expandable body at the distal end of the elongate body and a
mandrel received within the lumen; and wherein the method further
comprises, subsequent to step (d), the step of: (h) removing the
mandrel from the lumen.
7. The surgical procedure of claim 1, further comprising, at the
same time or subsequent to step (b) and prior to step (g), the step
of: (h) introducing into the pleural cavity an agent to promote
pleurodesis between the parietal membrane and visceral
membrane.
8. The surgical procedure of claim 1, further comprising, at the
same time or subsequent to step (b) and prior to step (g), the step
of: (h) introducing into the pleural cavity an adhesive to induce
acute adhesion between the parietal membrane and the visceral
membrane and wherein the adhesive induces the acute adhesion with a
few minutes of application.
9. A surgical procedure used to create a stoma through a chest
wall, parietal membrane, pleural cavity and visceral membrane into
a lung of a patient, wherein the surgical procedure comprises: (a)
obtaining a surgical instrument comprising an elongated body with
an expandable body at a distal end thereof; (b) inserting the
distal end of the surgical instrument through the chest wall, and
parietal membrane into the pleural cavity; (c) passing the distal
end of the surgical instrument across the pleural cavity; (d)
inserting the distal end of the surgical instrument through the
visceral membrane and into parenchymal tissue of the lung; (e)
expanding the expandable body within the parenchymal tissue of the
lung thereby displacing parenchymal tissue and securing the distal
end of the pneumostomy instrument within the lung; (f) pulling the
surgical instrument in a direction of a proximal end of the
surgical instrument to approximate the visceral membrane and the
parietal membrane sufficiently for pleurodesis to occur; (g)
securing the surgical instrument to the chest wall while
pleurodesis occurs between the visceral membrane and parietal
membrane surrounding the surgical instrument thereby sealing the
pneumostoma from the pleural cavity; (h) reducing the expandable
body; (i) removing the surgical instrument from the
pneumostoma.
10. The surgical procedure of claim 9, wherein; step (b) comprises
percutaneously inserting the distal end of the pneumostomy
instrument through the chest wall, and parietal membrane into the
pleural cavity;
11. The surgical procedure of claim 9, further comprising, prior to
step (a) the step of: securing the visceral membrane to the
parietal membrane by percutaneously implanting one or more
fasteners which engage the parietal membrane and the visceral
membrane.
12. The surgical procedure of claim 9, further comprising, prior to
step (a) the step of: securing the visceral membrane to the
parietal membrane by percutaneously implanting one or more
fasteners which engage the parietal membrane and the visceral
membrane; and wherein the fasteners comprise one or more fasteners
from a group consisting of: staples, clips, tacks, barbed filaments
and sutures.
13. The surgical procedure of claim 9, wherein the expandable
device is a balloon which is connected to a tube and wherein step
(e) comprises: operating a syringe to introduce a fluid through the
tube into the balloon and thereby expanding the expandable body
within the parenchymal tissue of the lung thereby displacing
parenchymal tissue and securing the distal end of the pneumostomy
instrument within the lung.
14. The surgical procedure of claim 9, wherein step a) comprises
obtaining a pneumostomy instrument comprising an elongated body
with a lumen running from a proximal end to a distal end with an
expandable body at the distal end of the elongate body and a
mandrel received within the lumen; and wherein a method further
comprises, subsequent to step (d), the step of: (h) removing the
mandrel from the lumen.
15. The surgical procedure of claim 9, further comprising, at the
same time or subsequent to step (b) and prior to step (g), the step
of: (h) introducing into the pleural cavity an agent to promote
pleurodesis between the parietal membrane and visceral
membrane.
16. The surgical procedure of claim 9, further comprising, at the
same time or subsequent to step (b) and prior to step (g), the step
of: (h) introducing into the pleural cavity an adhesive to induce
acute adhesion between the parietal membrane and the visceral
membrane and wherein the adhesive induces the acute adhesion with a
few minutes of application.
17. A method for creating a stoma tract which passes through a
chest wall, parietal membrane, pleural cavity and visceral membrane
into a lung of a patient, wherein a surgical procedure comprises:
(a) percutaneously inserting a distal end of a surgical instrument
through the chest wall, and parietal membrane into the pleural
cavity; (b) passing the distal end of the surgical instrument
across the pleural cavity; (c) inserting the distal end of the
surgical instrument through the visceral membrane and into
parenchymal tissue of the lung; (d) expanding an expandable portion
of the surgical instrument adjacent the distal end of the surgical
instrument within the lung thereby displacing parenchymal tissue of
the lung and securing the distal end of the surgical instrument
within the lung; (e) drawing the expandable portion of the surgical
instrument toward the chest wall to approximate the visceral
membrane and the parietal membrane sufficiently for pleurodesis to
occur; (g) securing the surgical instrument to the chest wall for a
period of time sufficient for a tract to heal around the surgical
instrument; (h) causing the expandable body to contract; and (i)
removing the surgical instrument from the stoma tract.
18. The method of claim 17, further comprising: (j) promptly after
performing step (i), inserting the tube of a pneumostoma management
device into the stoma to promote escape of gases from the lung
through the stoma.
19. The method of claim 17, further comprising: (j) promptly after
performing step (i), inserting a tube into the stoma to promote the
escape of gases from the lung through the stoma.
20. The method or claim 17, further comprising, at the same time or
subsequent to step (a) and prior to step (e), the step of: (j)
introducing into the pleural cavity an agent to promote pleurodesis
between the parietal membrane and visceral membrane.
Description
CLAIM TO PRIORITY
[0001] This application claims priority to all of the following
applications including: U.S. Provisional Application No.
61/029,830, filed Feb. 19, 2008, entitled "ENHANCED PNEUMOSTOMA
MANAGEMENT DEVICE AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE
PULMONARY DISEASE" (Attorney Docket No. LUNG1-06013US0);
[0002] U.S. Provisional Application No. 61/032,877, filed Feb. 29,
2008, entitled "PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06001US0);
[0003] U.S. Provisional Application No. 61/038,371, filed Mar. 20,
2008, entitled "SURGICAL PROCEDURE AND INSTRUMENT TO CREATE A
PNEUMOSTOMA AND TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE"
(Attorney Docket No. LUNG1-06000US0);
[0004] U.S. Provisional Application No. 61/082,892, filed Jul. 23,
2008, entitled "PNEUMOSTOMA MANAGEMENT SYSTEM HAVING A COSMETIC
AND/OR PROTECTIVE COVER" (Attorney Docket No. LUNG1-06008US0);
[0005] U.S. Provisional Application No. 61/083,573, filed Jul. 25,
2008, entitled "DEVICES AND METHODS FOR DELIVERY OF A THERAPEUTIC
AGENT THROUGH A PNEUMOSTOMA" (Attorney Docket No.
LUNG1-06003US0);
[0006] U.S. Provisional Application No. 61/084,559, filed Jul. 29,
2008, entitled "ASPIRATOR FOR PNEUMOSTOMA MANAGEMENT" (Attorney
Docket No. LUNG1-06011US0);
[0007] U.S. Provisional Application No. 61/088,118, filed Aug. 12,
2008, entitled "FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS
FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06004US0);
[0008] U.S. Provisional Application No. 61/143,298, filed Jan. 8,
2009, entitled "METHODS AND APPARATUS FOR THE CRYOTHERAPY CREATION
OR RE-CREATION OF PNEUMOSTOMY" (Attorney Docket No.
LUNG1-06006US0); and
[0009] U.S. Provisional Application No. 61/151,581, filed Feb. 11,
2009, entitled "SURGICAL INSTRUMENTS AND PROCEDURES TO CREATE A
PNEUMOSTOMA AND TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE"
(Attorney Docket No. LUNG1-06002US0).
[0010] All of the afore-mentioned applications are incorporated
herein by reference in their entireties.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0011] This application is related to all of the above provisional
applications and all the patent applications that claim priority
thereto including:
[0012] This application is related to all of the following
applications including U.S. patent application Ser. No. 12/______,
filed Feb. 18, 2009, entitled "ENHANCED PNEUMOSTOMA MANAGEMENT
DEVICE AND METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY
DISEASE" (Attorney Docket No. LUNG1-06013US1);
[0013] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS FOR
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06001US1);
[0014] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "PNEUMOSTOMA MANAGEMENT METHOD FOR TREATMENT OF
CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney Docket No.
LUNG1-06001US2);
[0015] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "TWO-PHASE SURGICAL PROCEDURE FOR CREATING A
PNEUMOSTOMA TO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE"
(Attorney Docket No. LUNG1-06000US1);
[0016] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ACCELERATED TWO-PHASE SURGICAL PROCEDURE FOR
CREATING A PNEUMOSTOMA TO TREAT CHRONIC OBSTRUCTIVE PULMONARY
DISEASE" (Attorney Docket No. LUNG1-06000US2);
[0017] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "SINGLE-PHASE SURGICAL PROCEDURE FOR CREATING A
PNEUMOSTOMA TO TREAT CHRONIC OBSTRUCTIVE PULMONARY DISEASE"
(Attorney Docket No. LUNG1-06000US3);
[0018] U.S. patent application Ser. No. 12/______, filed Feb. 13,
2009, entitled "PNEUMOSTOMA MANAGEMENT SYSTEM HAVING A COSTMETIC
AND/OR PROTECTIVE COVER" (Attorney Docket No. LUNG1-06008US1)
[0019] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "DEVICES AND METHODS FOR DELIVERY OF A THERAPEUTIC
AGENT THROUGH A PNEUMOSTOMA" (Attorney Docket No.
LUNG1-06003US1);
[0020] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ASPIRATOR FOR PNEUMOSTOMA MANAGEMENT" (Attorney
Docket No. LUNG1-06011US1);
[0021] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ASPIRATOR AND METHOD FOR PNEUMOSTOMA MANAGEMENT"
(Attorney Docket No. LUNG1-06011US2);
[0022] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "FLEXIBLE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS
FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06004US1);
[0023] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "METHODS AND DEVICES FOR FOLLOW-UP CARE AND
TREATMENT OF A PNEUMOSTOMA" (Attorney Docket No.
LUNG1-06006US1);
[0024] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "SURGICAL INSTRUMENTS FOR CREATING A PNEUMOSTOMA AND
TREATING CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney Docket
No. LUNG1-06002US1);
[0025] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ONE-PIECE PNEUMOSTOMA MANAGEMENT SYSTEM AND METHODS
FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06017US1);
[0026] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "PNEUMOSTOMA MANAGEMENT SYSTEM WITH SECRETION
MANAGEMENT FEATURES FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY
DISEASE" (Attorney Docket No. LUNG1-06019US1);
[0027] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "MULTI-LAYER PNEUMOSTOMA MANAGEMENT SYSTEM AND
METHODS FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE"
(Attorney Docket No. LUNG1-06022US1);
[0028] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "VARIABLE LENGTH PNEUMOSTOMA MANAGEMENT SYSTEM FOR
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (Attorney
Docket No. LUNG1-06023US1); and
[0029] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "SELF-SEALING DEVICE AND METHOD FOR DELIVERY OF A
THERAPEUTIC AGENT THROUGH A PNEUMOSTOMA" (Attorney Docket No.
LUNG1-06025US1).
[0030] All of the afore-mentioned applications are incorporated
herein by reference in their entireties. This patent application
also incorporates by reference all patents, applications, and
articles discussed and/or cited herein.
BACKGROUND OF THE INVENTION
[0031] In the United States alone, approximately 14 million people
suffer from some form of Chronic Obstructive Pulmonary Disease
(COPD). However an additional ten million adults have evidence of
impaired lung function indicating that COPD may be significantly
underdiagnosed. The cost of COPD to the nation in 2002 was
estimated to be $32.1 billion. Medicare expenses for COPD
beneficiaries were nearly 2.5 times that of the expenditures for
all other patients. Direct medical services accounted for $18.0
billion, and indirect cost of morbidity and premature mortality was
$14.1 billion. COPD is the fourth leading cause of death in the
U.S. and is projected to be the third leading cause of death for
both males and females by the year 2020.
[0032] Chronic Obstructive Pulmonary Disease (COPD) is a
progressive disease of the airways that is characterized by a
gradual loss of lung function. In the United States, the term COPD
includes chronic bronchitis, chronic obstructive bronchitis, and
emphysema, or combinations of these conditions. In emphysema the
alveoli walls of the lung tissue are progressively weakened and
lose their elastic recoil. The breakdown of lung tissue causes
progressive loss of elastic recoil and the loss of radial support
of the airways which traps residual air in the lung. This increases
the work of exhaling and leads to hyperinflation of the lung. When
the lungs become hyperinflated, forced expiration cannot reduce the
residual volume of the lungs because the force exerted to empty the
lungs collapses the small airways and blocks air from being
exhaled. As the disease progresses, the inspiratory capacity and
air exchange surface area of the lungs is reduced until air
exchange becomes seriously impaired and the individual can only
take short shallow labored breaths (dyspnea).
[0033] The symptoms of COPD can range from the chronic cough and
sputum production of chronic bronchitis to the severe disabling
shortness of breath of emphysema. In some individuals, chronic
cough and sputum production are the first signs that they are at
risk for developing the airflow obstruction and shortness of breath
characteristic of COPD. With continued exposure to cigarettes or
noxious particles, the disease progresses and individuals with COPD
increasingly lose their ability to breathe. Acute infections or
certain weather conditions may temporarily worsen symptoms
(exacerbations), occasionally where hospitalization may be
required. In others, shortness of breath may be the first
indication of the disease. The diagnosis of COPD is confirmed by
the presence of airway obstruction on testing with spirometry.
Ultimately, severe emphysema may lead to severe dyspnea, severe
limitation of daily activities, illness and death.
[0034] There is no cure for COPD or pulmonary emphysema, only
various treatments, for ameliorating the symptoms. The goal of
current treatments is to help people live with the disease more
comfortably and to prevent the progression of the disease. The
current options include: self-care (e.g., quitting smoking),
medications (such as bronchodilators which do not address emphysema
physiology), long-term oxygen therapy, and surgery (lung
transplantation and lung volume reduction surgery). Lung Volume
Reduction Surgery (LVRS) is an invasive procedure primarily for
patients who have a localized (heterogeneous) version of emphysema;
in which, the most diseased area of the lung is surgically removed
to allow the remaining tissue to work more efficiently. Patients
with diffuse emphysema cannot be treated with LVRS, and typically
only have lung transplantation as an end-stage option. However,
many patients are not candidates for such a taxing procedure.
[0035] A number of less-invasive surgical methods have been
proposed for ameliorating the symptoms of COPD. In one approach new
windows are opened inside the lung to allow air to more easily
escape from the diseased tissue into the natural airways. These
windows are kept open with permanently implanted stents. Other
approaches attempt to seal off and shrink portions of the
hyperinflated lung using chemical treatments and/or implantable
plugs. However, these proposals remain significantly invasive and
are still in clinical trails in 2008. None of the surgical
approaches to treatment of COPD is widely accepted. Therefore, a
large unmet need remains for a medical procedure that can
sufficiently alleviate the debilitating effects of COPD and
emphysema.
SUMMARY OF THE INVENTION
[0036] In view of the disadvantages of the state of the art,
Applicants have developed a method for treating COPD in which an
artificial passageway is made through the chest wall into the lung.
An anastomosis is formed between the artificial passageway and the
lung by creating a seal, adhesion and/or pleurodesis between the
visceral and parietal membranes surrounding the passageway as it
enters the lung. The seal, adhesion and/or pleurodesis prevent air
from entering the pleural cavity and causing a pneumothorax
(deflation of the lung due to air pressure in the pleural cavity).
The pleurodesis is stabilized by a fibrotic healing response
between the membranes. The artificial passageway through the chest
wall also becomes epithelialized. The result is a stable artificial
aperture through the chest wall which communicates with the
parenchymal tissue of the lung.
[0037] The artificial aperture into the lung through the chest wall
is referred to herein as a pneumostoma. A pneumostoma provides an
extra pathway that allows air to exit the lung while bypassing the
natural airways which have been impaired by COPD and emphysema. By
providing this ventilation bypass, the pneumostoma allows the stale
air trapped in the lung to escape from the lung thereby shrinking
the lung (reducing hyperinflation). By shrinking the lung, the
ventilation bypass reduces breathing effort (reducing dyspnea),
allows more fresh air to be drawn in through the natural airways
and increases the effectiveness of all of the tissues of the lung
for gas exchange. Increasing the effectiveness of gas exchange
allows for increased absorption of oxygen into the bloodstream and
also increased removal of carbon dioxide from the bloodstream.
Reducing the amount of carbon dioxide retained in the lung reduces
hypercapnia which also reduces dyspnea. The pneumostoma thereby
achieves the advantages of lung volume reduction surgery without
surgically removing a portion of the lung or sealing off a portion
of the lung.
[0038] Pneumonostomy is a general term for the surgical creation of
an artificial opening into the pleural cavity or lung such as for
drainage of an abscess. The procedure for creating a pneumostoma is
a type of pneumonostomy. However, to differentiate it from other
types of pneumonostomy procedures, the term pneumostomy will be
used herein to refer to procedures for creating a pneumostoma.
[0039] In accordance with embodiments, the present invention
provides surgical techniques, procedures and instruments for
pneumostomy.
[0040] In accordance with one embodiment, the present invention
provides a two-phase pneumostomy technique in which a pleurodesis
is created in a first procedure and a pneumostoma is created as a
second procedure after a delay for creation of the pleurodesis.
[0041] In accordance with one embodiment, the present invention
provides an accelerated two-phase pneumostomy technique in which a
pleurodesis is created acutely at the first phase of a procedure
and a pneumostoma is created as a second phase of the same
procedure after creation of the pleurodesis.
[0042] In accordance with one embodiment, the present invention
provides a single-phase pneumostomy technique for creating a
pneumostoma in which a pleurodesis and a pneumostoma are created
concurrently.
[0043] In accordance with specific embodiments, the present
invention provides minimally-invasive approaches for performing a
pneumostomy.
[0044] In accordance with specific embodiments, the present
invention provides a percutaneous approach for performing a
pneumostomy.
[0045] In accordance with specific embodiments, the present
invention provides a mini-thoracotomy approach for performing a
pneumostomy.
[0046] In accordance with specific embodiments, the present
invention provides an intercostal approach for performing a
pneumostomy.
[0047] In accordance with specific embodiments, the present
invention provides perioperative procedures associated with
performing pneumostomy.
[0048] Thus, various pneumostomy techniques, procedures and
instruments are provided for creating a pneumostoma and thereby
treating COPD. Other objects, features and advantages of the
invention will be apparent from drawings and detailed description
to follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] The above and further features, advantages and benefits of
the present invention will be apparent upon consideration of the
present description taken in conjunction with the accompanying
drawings.
[0050] FIG. 1A shows the chest of a patient indicating alternative
locations for pneumostoma that may be created using pneumostomy
procedures and surgical tools of the present invention.
[0051] FIG. 1B shows a sectional view of the chest illustrating the
relationship between the pneumostoma, lung and natural airways.
[0052] FIG. 1C shows a detailed sectional view of the
pneumostoma.
[0053] FIG. 2 shows the general steps for pneumostomy in accordance
with an embodiment of the present invention.
[0054] FIGS. 3A-3C show views of a pneumostomy catheter for use in
pneumostomy procedures in accordance with embodiments of the
present invention.
[0055] FIGS. 3D-3E show views of an alternative pneumostomy
catheter assembled with a percutaneous insertion tool for use in
pneumostomy procedures in accordance with embodiments of the
present invention.
[0056] FIG. 3F shows a sectional view of an alternative component
of the pneumostomy catheters of FIGS. 3A-3E.
[0057] FIG. 3G shows a section view of the tip of an alternative
pneumostomy catheter in accordance with an embodiment of the
present invention.
[0058] FIG. 4A shows the steps of a two-phase pneumostomy technique
in accordance with an embodiment of the present invention.
[0059] FIGS. 4B-4C illustrate the first phase of the two-phase
pneumostomy technique of FIG. 4A.
[0060] FIGS. 4D-4E illustrate the second phase of the two-phase
pneumostomy technique of FIG. 4A.
[0061] FIG. 4F illustrates an optional step of the second phase of
the two-phase pneumostomy technique of FIG. 4A.
[0062] FIG. 5A shows the steps of an accelerated two-phase
pneumostomy technique in accordance with an embodiment of the
present invention.
[0063] FIG. 5B illustrates the first part of the procedure of the
accelerated two-phase pneumostomy technique of FIG. 5A.
[0064] FIG. 5C illustrates the second part of the procedure of the
accelerated two-phase pneumostomy technique of FIG. 5A.
[0065] FIG. 6A shows the steps of a single-phase pneumostomy
technique in accordance with an embodiment of the present
invention.
[0066] FIGS. 6B-6C illustrate steps of the single-phase pneumostomy
technique of FIG. 6A.
[0067] FIG. 7A shows the steps of a percutaneous single-phase
pneumostomy technique in accordance with an embodiment of the
present invention.
[0068] FIGS. 7B-7C illustrate steps of the percutaneous
single-phase pneumostomy technique of FIG. 7A.
[0069] FIG. 7D illustrates a lung retraction instrument for use in
a pneumostomy procedure in accordance with an embodiment of the
present invention.
[0070] FIG. 7E illustrates a lung anchor for use in a pneumostomy
procedure in accordance with an embodiment of the present
invention.
[0071] FIGS. 7F-7H illustrate a lung anchor and applicator for use
in pneumostomy procedures in accordance with embodiments of the
present invention.
[0072] FIGS. 8A and 8B show use of a pneumostoma management device
after removal of a pneumostomy catheter in accordance with any one
of the above procedures.
[0073] FIGS. 9A-9G show alternative pneumostomy instruments and
accessories for use in pneumostomy procedures in accordance with
embodiments of the present invention.
[0074] FIGS. 10A-10F show views of an alternate pneumostomy
instrument for use in pneumostomy procedures in accordance with
embodiments of the present invention.
[0075] FIGS. 11A-11C show views of a percutaneous insertion
instrument for use in pneumostomy procedures in accordance with
embodiments of the present invention.
[0076] FIGS. 12A-12E show views of an external support for a
pneumostomy instrument in accordance with embodiments of the
present invention
[0077] FIGS. 13A-13C show steps for pneumostomy procedures in
accordance with embodiments of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0078] The following description is of the best modes presently
contemplated for practicing various embodiments of the present
invention. The description is not to be taken in a limiting sense
but is made merely for the purpose of describing the general
principles of the invention. The scope of the invention should be
ascertained with reference to the claims. In the description of the
invention that follows, like numerals or reference designators will
be used to refer to like parts or elements throughout. In addition,
the first digit of a reference number identifies the drawing in
which the reference number first appears.
Pneumostoma Anatomy
[0079] FIG. 1A shows the chest of patient indicating alternative
locations for creating a pneumostoma that may be managed using the
system and methods of the present invention. A first pneumostoma
110 is shown on the front of the chest 100 over the right lung 101
(shown in dashed lines). The pneumostoma is preferably positioned
over the second or third intercostal space on the mid-clavicular
line. Thus the pneumostoma 110 is located on the front of the chest
between the second and third or third and fourth ribs. Although the
pneumostoma 110 is preferably located between two ribs, in
alternative procedures a pneumostoma can also be prepared using a
minithoracotomy with a rib resection.
[0080] In FIG. 1A a second pneumostoma 112 is illustrated in a
lateral position entering the left lung 103 (shown in dashed
lines). The pneumostoma 112 is preferably positioned over the
second, third, fourth or fifth intercostal space on the
mid-axillary line under the arm 104. In FIG. 1A a third pneumostoma
114 is illustrated on the front of the chest over the left lung 103
(shown in dashed lines). The pneumostoma 114 is oval rather than
round which allows a larger cross-section for the pneumostoma while
still fitting within the intercostal space. In general, one
pneumostoma per lung is created; however, more or less than one
pneumostoma per lung may be created depending upon the needs of the
patient. In most humans, the lobes of the lung are not completely
separate and air may pass between the lobes. Although the
pneumostoma 112 and 114 are preferably located between two ribs, in
alternative procedures a pneumostoma can also be prepared using a
minithoracotomy with a rib resection.
[0081] A pneumostoma is surgically created by forming an artificial
channel through the chest wall and joining that channel with an
opening through the visceral membrane of the lung into parenchymal
tissue of the lung. The joining of two separate hollow cavities,
vessels or organs to form a continuous channel is termed
anastomosis. In this case the anastomosis is the joining of the
artificial channel and the opening in the visceral membrane.
Anastomosis seals the channel from the pleural cavity and can be
achieved using adhesives, mechanical sealing and/or pleurodesis.
General methods for forming the channel, forming the opening,
anastomosis and pleurodesis are disclosed in applicant's pending
and issued patents and applications including U.S. patent
application Ser. No. 10/881,408 entitled "Methods and Devices to
Accelerate Wound Healing in Thoracic Anastomosis Applications" and
U.S. patent application Ser. No. 12/030,006 entitled "Variable
Parietal/Visceral Pleural Coupling" which are incorporated herein
by reference in their entirety.
[0082] FIG. 1B shows a sectional view of chest 100 illustrating the
position of the pneumostoma 110 relative to the lung and natural
airways. The parenchymal tissue 132 of the lung 130 is comprised
principally of alveoli 134. The alveoli 134 are the thin walled
air-filled sacs in which gas exchange takes place. Air flows into
the lungs through the natural airways including the trachea 136,
carina 137, and bronchi 138. Inside the lungs, the bronchi branch
into a multiplicity of smaller vessels referred to as bronchioles
(not shown). Typically, there are more than one million bronchioles
in each lung. Each bronchiole connects a cluster of alveoli to the
natural airways. As illustrated in FIG. 1B, pneumostoma 110
comprises a channel through the thoracic wall 106 of the chest 100
between two ribs 107. Pneumostoma 110 opens at an aperture 126
through the skin 114 of chest 100. Aperture 126 may be round, oval
or another suitable shape that allows air flow while fitting within
a desirable anatomical position.
[0083] FIG. 1C shows a detailed sectional view of the pneumostoma
110 and the tissue of the lung 130. As illustrated in FIG. 1C, the
thoracic wall 106 is lined with the parietal membrane 108. The
surface of the lung 130 is covered with a continuous sac called the
visceral membrane 138. The parietal membrane 108 and visceral
membrane 138 are often referred to collectively as the pleural
membranes. Between the parietal membrane 108 and visceral membrane
138 is the pleural cavity (pleural space) 140. The pleural cavity
usually only contains a thin film of fluid that serves as a
lubricant between the lungs and the chest wall. As illustrated in
FIG. 1C, pneumostoma 110 comprises a channel 120 through the
thoracic wall 106 of the chest 100 between the ribs 107. The
channel 120 is joined to cavity 122 in the parenchymal tissue 132
of lung 130. Although shown in FIG. 1C, having a particular shape,
the channel 120 and cavity 122 will typically conform to the shape
of a device inserted into the pneumostoma 1 10. The channel 120 may
be round, oval or another suitable shape that allows air flow while
fitting within a desirable anatomical position. An adhesion or
pleurodesis 124 surrounds the channel 120 where it enters the lung
130. In pleurodesis 124 the pleural membranes are fused and/or
adhered to one another eliminating the space between the pleural
membranes in that region.
[0084] An important feature of pneumostoma 110 is the seal or
adhesion surrounding the channel 120 where it enters the lung 130
which may comprise a pleurodesis 124. Pleurodesis 124 is the fusion
or adhesion of the parietal membrane 108 and visceral membrane 138.
A pleurodesis may be a complete pleurodesis in which the entire
pleural cavity 140 is removed by fusion of the visceral membrane
138 with the parietal membrane 108 over the entire surface of the
lung 130. However, as shown in FIG. 1C, the pleurodesis is
preferably localized to the region surrounding the channel 120. The
pleurodesis 124 surrounding the channel 120 prevents air from
entering the pleural cavity 140. If air is permitted to enter
pleural cavity 140, a pneumothorax will result and the lung 130 may
collapse.
[0085] When formed, pneumostoma 110 provides an extra pathway for
exhaled air to exit the lung 130 reducing residual volume and
intra-thoracic pressure without the air passing through the major
natural airways such as the bronchi 138 and trachea 136. Collateral
ventilation is particularly prevalent in an emphysemous lung
because of the deterioration of lung tissue caused by emphysema.
Collateral ventilation is the term given to leakage of air through
the connective tissue between the alveoli 134. Collateral
ventilation may include leakage of air through pathways that
include the interalveolar pores of Kohn, bronchiole-alveolar
communications of Lambert, and interbronchiolar pathways of Martin.
This air typically becomes trapped in the lung and contributes to
hyperinflation. In lungs that have been damaged by COPD and
emphysema, the resistance to flow in collateral channels (not
shown) of the parenchymal tissue 132 is reduced allowing collateral
ventilation to increase. Air from alveoli 134 of parenchymal tissue
132 that passes into collateral pathways of lung 130 is collected
in cavity 122 of pneumostoma 110. Pneumostoma 110 thus makes use of
collateral ventilation to collect air in cavity 122 and vent the
air outside the body via channel 120 reducing residual volume and
intra-thoracic pressure and bypassing the natural airways which
have been impaired by COPD and emphysema.
[0086] By providing this ventilation bypass, the pneumostoma allows
stale air trapped in the parenchymal tissue 132 to escape from the
lung 130. This reduces the residual volume and intra-thoracic
pressure. The lower intra-thoracic pressure reduces the dynamic
collapse of airways during exhalation. By allowing the airways to
remain patent during exhalation, labored breathing (dyspnea) and
residual volume (hyperinflation) are both reduced. Pneumostoma 110
not only provides an extra pathway that allows air to exit the lung
130 but also allows more fresh air to be drawn in through the
natural airways. This increases the effectiveness of all of the
tissues of the lung 130 and improves gas exchange. Increasing the
effectiveness of gas exchange allows for increased absorption of
oxygen into the bloodstream and also increased removal of carbon
dioxide from the bloodstream. Reducing the amount of carbon dioxide
retained in the lung reduces hypercapnia which also reduces
dyspnea. Pneumostoma 110 thus achieves many of the advantages
sought by lung volume reduction surgery without surgically
removing, disabling and/or sealing off a portion of the lung.
[0087] Applicants have found that pneumostomy procedures carried
out with the techniques, procedures, and instruments of the present
invention are desirable to create the pneumostoma. The pneumostomy
procedures may also advantageously utilize one or more of the
associated kits and perioperative methods described herein.
Perioperative Procedure & General Procedure
[0088] FIG. 2 provides a flowchart illustrating the general steps
of a pneumostomy procedure 200 including diagnosis, scanning,
pneumostomy and perioperative procedures.
[0089] The first step 202 of the procedure is functional testing
and diagnosis. Preliminary diagnosis of COPD is considered where a
patient has symptoms of a chronic cough, sputum production, dyspnea
(difficult or labored breathing) and a history of exposure to risk
factors for the disease--the most significant risk factor being a
history of smoking. Clinical diagnosis of COPD requires
confirmation by pulmonary function testing.
[0090] There are four components to pulmonary function testing:
spirometry, post-bronchodilator spirometry, lung volumes, and
diffusion capacity. Spirometry is the most reliable way to
determine reversible airway obstruction. Spirometry is therefore
often performed to assess progression of disease and to determine
the effectiveness of medication. Spirometry measures the amount of
air entering and leaving the lungs using a spirometry machine. The
patient inhales as deeply as possible and then exhales, as
forcefully and rapidly as they can into a port in the machine. The
machine measures airflow that passes through the port. Usually,
several exhalations are measured. The machine provides several
metrics. They are expressed as percentages of what is predicted for
normal lung function. Those most commonly used diagnostics of COPD
are (1) forced expiratory volume after 1 second [FEV1], (2) forced
vital capacity [FVC], and (3) forced expiratory flow at 25%-75% of
maximal lung volume [FEF25-75]. Peak expiratory flow rate (PEFR)
also can be obtained. PEFR can be compared with readings the
patient obtains at home with a peak flow meter.
[0091] In a patient with COPD, the amount of air exhaled (forced
vital capacity, or FVC) is reduced, compared to a person with
normal lung function. Furthermore, the amount of air exhaled during
the initial 1 second (FEV1) is reduced and is reduced to a greater
degree than the entire FVC. Therefore, the ratio of air exhaled
after 1 second is low compared to the total amount of air exhaled.
In healthy lungs, 70%-75% of all the air exhaled after maximum
inhalation (FVC) is exhaled within the first second (FEV1), known
as the FEV1/FVC ratio. In lungs with COPD, the FEV1/FVC ratio falls
below 70%-75%. The absolute value of the FEV1 is also reduced and
the extent of the reduction in FEV1 is used to quantify the
severity of obstruction. FEV1<70% of what is predicted for age,
height, weight and race is considered mild COPD; <50% to 69%,
moderate COPD; <35%-49%, severe COPD; and <35%, very severe
COPD.
[0092] Post-bronchodilator Spirometry uses the same spirometry
testing after giving the patient a bronchodilator, such as an
inhaled beta-agonist. This procedure provides information regarding
whether the airway obstruction is reversible and the potential
responsiveness of the airways to medication. It is also useful for
determining whether steroid treatment has been beneficial, a few
weeks after initiating therapy.
[0093] Lung volumes are measured in two ways, gas dilution or body
plethysmography. The gas dilution method is performed after the
patient inhales a gas, such as nitrogen or helium. The amount of
volume in which the gas is distributed is used to calculate the
volume of air the lungs can hold. Body plethysmography requires the
patient to sit in an airtight chamber (usually transparent to
prevent claustrophobia) and inhale and exhale into a tube. The
pressure changes in the plethysmograph are used to calculate the
volumes of air in the lungs. The most important lung volume
measurements obtained are residual volume and total lung capacity
(TLC). These measurements vary with age, height, weight, and race
and are usually expressed as an absolute number and a percentage of
what is predicted for a person with normal lung function. A high
TLC demonstrates hyperinflation of the lungs, which is consistent
with emphysema. Increased residual volume signifies air trapping.
This demonstrates an obstruction to exhalation.
[0094] Blood gas analysis determines the effectiveness of gas
exchange in the lungs by observing concentrations in the blood.
Various non-invasive oxymetric methods may be used for measuring
blood gas concentrations. Alternatively, arterial blood can be
drawn and analyzed. Arterial blood gases are measured to determine
the amount of oxygen dissolved in the blood (pO2), the percentage
of hemoglobin saturated with oxygen (O2 sat), the amount of carbon
dioxide dissolved in the blood (pCO2), and the amount of acid in
the blood pH. The carbon dioxide and oxygen measures may be used to
determine whether a patient needs oxygen therapy. Gas exchange can
also be measured using diffusion capacity which is a measurement of
gases transferred from the alveoli to the capillary. Diffusion
capacity is measured by examining the uptake of a very small amount
of inhaled carbon monoxide. A reduced diffusion capacity is
consistent with emphysema.
[0095] Referring again to FIG. 2, lung scanning at step 204 may be
used to confirm the diagnosis of COPD developed during the
functional testing step 202. The CT scan may be useful to more
accurately diagnose emphysema. This is usually not necessary,
however, and abnormal lung anatomy is not always detected. The
development of multi-channel CT scanning allows for the
quantitative assessment of both the airway and parenchymal
processes. CT scanning is also useful to provided images of the
lung as an aid to the planning of surgical interventions such as
pneumostomy. Lung scanning such as CT scanning may also be used to
assess collateral ventilation in the lung including the extent of
collateral ventilation both within and between lobes of the lung.
The results of the pneumostomy procedure are improved by placing
the pneumostoma in a region of high collateral ventilation. Thus,
the extent of collateral ventilation observed by lung scanning may
be used to determine the patients that will benefit most of
pneumostomy and the best placement of a pneumostoma in a particular
patient. Lung scanning is therefore typically performed to confirm
the COPD diagnosis and determine a suitable placement for the
pneumostoma.
[0096] Based upon the functional testing and lung imaging, it may
be determined at step 206 whether a particular patient meets the
criteria for pneumostoma creation. As a general rule, pneumostoma
creation is suitable for patients with COPD that is not reversible
using pharmaceuticals and pulmonary rehabilitation therapy.
Pneumostomy will be most advantageous for patients with severe and
very severe COPD as indicated by functional testing though patients
with moderate COPD may also benefit. The general health of the
patient and their ability to tolerate the procedure should also be
taken into account.
[0097] For patients who will benefit from pneumostomy, several
weeks of pulmonary rehabilitation therapy 208 should be performed
before the procedure. Pulmonary rehabilitation therapy 208 combines
exercise training and behavioral and educational programs designed
to help patients with COPD control symptoms and improve day-to-day
activities. The main goals of pulmonary rehabilitation therapy are
to help patients improve their lung health and function. Pulmonary
rehabilitation may reduce and control breathing difficulties and
other symptoms; provide coping strategies and maintain healthy
behaviors such as smoking cessation, good nutrition, and exercise.
Pulmonary rehabilitation can reduce the number and length of
hospital stays and increase the patient's chances of living longer.
Pulmonary rehabilitation improves the likelihood of a successful
outcome in a procedure to create a pneumostoma and maintain a
pneumostoma after the procedure.
[0098] In procedure planning step 210, the physician determines a
suitable placement for the pneumostoma based upon the results of
the lung scanning, patient anatomy and physical abilities of the
patient. It is desirable that the patient be able to undertake the
long-term management of the pneumostoma. Thus, it is important that
the patient be able to comfortably view (with a mirror) and reach
the location of the pneumostoma in order to clean the pneumostoma
and insert or remove pneumostoma management devices. Other factors
to consider in determining placement include the thickness of
muscle and/or fat at the possible location sites, the disease state
of the lung, any abnormal lung anatomy, and cosmetic
considerations. Also, in planning the procedure the physician may
choose one of several different approaches to the procedure. In
particular there are open, minimally invasive and percutaneous
approaches. Which approach is selected will depend upon the
selected placement, the results of the CT scan, patient anatomy and
patient procedure tolerance. One important aspect of procedure
tolerance is the need for general anesthetic and ventilation. COPD
patients are often highly sensitive to anesthesia and ventilation
and thus it is desirable to avoid them if possible. In general the
physician will select the least invasive procedure with good
probability of success.
[0099] After planning the placement, procedure and approach, the
pneumostomy procedure 212 may be performed. The pneumostomy
procedure creates a pneumostoma as described with respect to FIGS.
1A-1C above. The goal of the procedure is to form a stable
epithelialized channel through the chest wall connected with a
cavity in the parenchymal tissue of the lung inside the visceral
membrane with a seal between the visceral and parietal membranes
surrounding the channel such as a pleurodesis. There are four
different techniques for the pneumostomy procedure which differ
primarily in the time and/or manner in which a pleurodesis is
created. In a two-phase technique, a pleurodesis is formed in a
preliminary procedure and after one or more days, when the
pleurodesis has developed, the pneumostoma is created utilizing a
pneumostomy catheter in a second procedure. (See FIGS. 4A-4E). In
an accelerated two-phase technique, a pleurodesis is formed in an
acute manner at the beginning of a procedure. After a short period,
when the pleurodesis is secure, the pneumostoma is created using a
pneumostomy catheter as a second step in the same procedure. (See
FIGS. 5A-5C). In a single-phase technique the pleurodesis is formed
at the same time as the pneumostoma and does not require a separate
step. The thoracic cavity is accessed to visualize the lung, the
pneumostomy catheter is inserted into the lung and then the lung is
secured to the channel through the chest wall creating a sealed
anastomosis which matures into a pleurodesis after the procedure.
(See FIGS. 6A-6C). In a percutaneous single-phase technique, an
instrument including the pneumostomy catheter is inserted
percutaneously through the thoracic wall and into the lung. The
pneumostomy catheter is then used to secure the lung to the channel
through the chest wall creating a sealed anastomosis which matures
into a pleurodesis after the procedure. (See FIGS. 7A-7C). Each of
these procedures is described in detail below.
[0100] In each procedure, the patency of the channel is maintained
in the immediate post-operative period utilizing a pneumostomy
catheter. (See FIGS. 3A-3C). When the channel has healed
sufficiently--usually between one and two weeks
post-operatively--the pneumostomy catheter is removed and replaced
with a pneumostoma management device (PMD) (See FIGS. 8A-8B). The
procedure then progresses to long-term pneumostoma management
214.
[0101] After the procedure it is important that the patient
continues with pulmonary rehabilitation therapy 216 to maximize the
benefit of the procedure and ensure compliance with the pneumostoma
management protocols. At follow-up visits the pneumostoma is
inspected for injury and/or infection. Additionally, the
pneumostoma is checked for continued patency. In some cases it may
be necessary to intermittently reestablish the patency of the
channel. Follow-up on spirometry testing may be used to monitor the
benefits of the pneumostoma.
Pneumostomy Catheter
[0102] A specialized pneumostomy catheter is utilized to create a
cavity in the parenchymal tissue of the lung and maintain the
patency of the channel through the chest wall into the lung in each
technique. The pneumostomy catheter keeps the lung apposed to the
interior of the thoracic wall to safely and properly allow the
pneumonostomy to heal and form. In general the aperture and channel
of the pneumostoma will conform to the exterior dimensions of the
pneumostomy catheter. The pneumostomy catheter may be round, oval
or another suitable shape that allows air flow while fitting within
a desirable anatomical position. The pneumostomy catheter is used
by the physician during the procedure to safely create the
pneumonostomy channel through the chest wall and cavity in the
parenchymal tissue of the lung. The pneumostomy catheter secures
the lung by means of an inflatable pneumoplasty balloon on the
distal end of the catheter. The pneumoplasty balloon is inflated
within the parenchymal tissue to create a chamber and engage the
tissue. With the pneumoplasty balloon inflated, the pneumostomy
catheter can be used to position the lung against the inner
thoracic wall. The catheter will be placed under a slight tension
by the physician in order to hold the lung up against the inner
thoracic wall. A flange sliding on the catheter acts as the
counterforce member to keep the lung and the device/pneumoplasty
balloon apposed to the thoracic wall. The position of the catheter
and pneumoplasty balloon and the apposition of the tissues guide
the formation of the transthoracic pneumostoma.
[0103] As is commonly with respect to medical devices, the proximal
end of the device is that end that is closest to the user,
typically an EMT, paramedic, surgeon, or emergency physician. The
distal end of the device is that end closest to the patient or that
is first inserted into the patient. The diameter of a catheter is
often measured in "French Size" which is 3 times the diameter of a
round catheter in millimeters (mm). For example, a 15 French
catheter is 5 mm in diameter. The French size is designed to
approximate the circumference of the catheter in mm and is often
useful for catheters that have non-circular cross-sectional
configurations.
[0104] A pneumostomy catheter in accordance with one embodiment of
the present invention is illustrated in FIGS. 3A-3C. As shown in
FIG. 3A, pneumostomy catheter 300 comprises a tube 302 having an
atraumatic distal tip 304. The tube may be from 5 to ten inches
from length and is preferably between 6 and seven inches in length.
The tube may be from one quarter to three quarters of an inch in
diameter and is preferably between one quarter and one half an inch
in diameter. A pneumoplasty balloon 306 is located adjacent distal
tip 304. An access flange 308 is connected by a collar 309 fitted
around tube 302 and can slide up and down tube 302. Markings 310 on
tube 302 indicate the distance from tip 304. A radio-marker or
radiopaque material may be incorporated in the distal tip so that
the tip may be visualized during insertion of the pneumostomy
catheter. Tube 302 is also connected to an inflation tube 320. At
the proximal end of the inflation tube 320 is a pilot balloon 322,
a check valve 324 a coupling 326 and cap 328. Coupling 326 is
designed to receive a syringe so that air, water or saline may be
injected through inflation tube 320 into pneumoplasty balloon 306.
Pilot balloon 322 is also connected to inflation tube 320 such that
a physician may palpate pilot balloon 322 in order to gauge the
level to which pneumoplasty balloon 306 is inflated. Additionally,
a contrast medium may be injected into the balloon during inflation
so that the inflation of the balloon may be visualized
fluoroscopically or using ultrasound.
[0105] Pneumoplasty balloon 306 is preferably an elastic balloon
made of silicone or its equivalent that has a low profile when not
inflated. Pneumoplasty balloon 306 can alternatively be formed of a
relatively inelastic material, such as polyurethane or its
equivalent so that, upon injection of air water or saline, it takes
on a fixed shape. In some case pneumoplasty balloon 306 may be made
of, impregnated with or coated with a material that promotes
pleurodesis. For example use of a latex balloon, without another
pleurodesis agent, can cause inflammation leading to pleurodesis.
Pneumoplasty balloon 306 is designed to push aside the parenchymal
tissues of the lung when inflated thereby creating a cavity within
the parenchymal tissue. Pneumoplasty balloon 306 is also designed
to anchor pneumostomy catheter 300 within the parenchymal tissue of
the lung. Alternative expanding devices may be used so long as they
achieve these same functions.
[0106] Pneumoplasty balloon 306 is formed as a tube, then assembled
over tube 302 and sealed to tube 302 at a proximal seal 305 and
distal seal 307. Pneumoplasty balloon 306 is designed to be
inflated within the parenchymal tissue of the lung. Pneumoplasty
balloon 306 is designed to create a cavity with the parenchymal
tissue. After the cavity is created, pneumoplasty balloon 306 is
designed to anchor tube 302 within the lung. Upon inflation the
diameter of pneumoplasty balloon 306 is sized as needed to create a
chamber within the parenchymal tissue of the lung and anchor the
pneumostomy catheter within the lung. The diameter of pneumoplasty
balloon 306 may be between three quarters of an inch and two inches
in diameter and is preferably between one inch and one and a
quarter inches in diameter
[0107] FIG. 3B shows a sectional view of tube 302 along line B-B of
FIG. 3A. Tube 302 has two lumens. Main lumen 330 which passes along
the entire length of tube 302 and is open at the proximal end and
distal end of tube 302. Inflation lumen 332 is located on the side
of tube 302. Lumen 332 is open at a slit along most of the length
of tube 302. Inflation lumen 332 is connected to inflation tube 320
adjacent pneumoplasty balloon 306. The distal tip of inflation tube
320 is secured into inflation lumen 332 and inflation tube 320 is
removably received in the open portion of inflation lumen 332. As
shown in FIG. 3C, the distal end of inflation lumen 332 is sealed.
However, tube 302 is skived at location 336 between proximal seal
305 and distal seal 307 creating an aperture 338 penetrating into
inflation lumen 332. The aperture 338 allows air, water or saline
to be forced into pneumoplasty balloon 306 from inflation lumen
332. The components may be secured to each other using adhesive,
welding, melting or other techniques appropriate to the materials
to be secured.
[0108] The pneumostomy catheter may be round, oval or another
suitable shape that allows air flow while fitting within a
desirable anatomical position. FIG. 3F shows a sectional view of an
alternative tube 303 having an oval cross-section. The
cross-sectional area of tube 303 and inflation lumen 330 is
increased relative to tube 302. There is no need to increase the
size of inflation lumen 332 as the inflation tube 320 remains the
same size. The minor dimension of tube 303 is selected such that it
will fit in the intercostal space. This oval tube 303 creates an
oval pneumostoma allowing for the creation of a larger
cross-section pneumostoma in the intercostal space than may be
achieved using a round pneumostomy catheter. Where oval tube 303 is
used instead of tube 302, the other components of the pneumostomy
catheter (such as flange 308) are shaped as necessary to
accommodate oval tube 303.
[0109] FIG. 3G shows a sectional view of an alternative distal tip
of a pneumostomy catheter 360. In the design shown in FIG. 3G, tube
302 is necked down in the vicinity 362 of pneumoplasty balloon 306.
The necking down of tube 302 allows additional space for
pneumoplasty balloon 306 in its deflated state. This is
particularly useful for non-porous inelastic balloons which may be
bulky when deflated. By necking down tube 302, towards the distal
tip in region 362 the exterior profile of pneumoplasty balloon 306
when deflated approaches the diameter of the main length of tube
302. This allows for easier insertion and removal of pneumostomy
catheter 360.
[0110] Referring again to FIG. 3A, access flange 308 is designed
such that it may be secured against the skin of the chest of the
patient and collar 309 may be secured to tube 302 thereby fixing
tube 302 in position relative to the chest of the patient. Access
flange 308, is slidable along the length of the tube 302. The
flange is designed to be positioned against the skin. The flange
308 can be sutured to the main shaft to secure the flange in
position along the catheter or fixed in place by other means such
as tape, adhesive, clips and staples and the like or by having a
built-in securing mechanism, such as a cam, ratchet, lock or the
like. The pneumostomy catheter 300 is designed to maintain a
tension between the pneumoplasty balloon embedded in the lung and
the thoracic wall. Once access flange 308 is secured to the main
shaft, access flange 308 provides the necessary counterforce for
the pneumoplasty balloon 306. Access flange 308 may also be
provided with an adhesive coating to temporarily secure the flange
to the skin of the patient and thereby preclude accidental
dislodgment of the catheter.
[0111] After access flange 308 has been secured to the catheter,
the excess length of tube 302 can be trimmed. However, prior to
cutting the excess length of the tube 302, the inflation tube 320
must be separated from the tube 302 in order to maintain the
inflation of the pneumoplasty balloon 306. The inflation tube 320
fits in lumen 332 of tube 302. Lumen 332 has a tear-away feature
that allows inflation tube 320 to be separated from tube 302 by
pulling it through the slit in the inflation lumen along the excess
length. When inflation tube 320 has been separated along the excess
length of tube 302, the tube 302 can be trimmed safely. Inflation
tube 320 with the check valve/pilot balloon assembly is wrapped
around collar 309 of access flange 308 and taped down so as not to
inconvenience the patient.
[0112] For certain applications it is desirable to assemble a
pneumostomy catheter with a percutaneous insertion tool so that the
pneumostoma catheter can penetrate through the pleural membranes
and the parenchymal tissue without previous incision or dissection.
The percutaneous insertion tool is a device that permits the rapid
deployment of the pneumostomy catheter through the parietal and
visceral membranes into the lung. The insertion tool preferably
prevents deflation of the lung by rapid deployment of the
pneumostomy catheter and subsequent inflation of the pneumoplasty
balloon. The percutaneous insertion tool may comprise a trocar,
mandrel or the like designed to fit through the main lumen of the
pneumostomy catheter and dissect tissue in a minimally traumatic
way thereby allowing the pneumostomy catheter to penetrate the
pleural membranes and enter the parenchymal tissue of the lung.
[0113] FIG. 3D shows a pneumostomy catheter 350 assembled with a
percutaneous insertion tool 370. Percutaneous insertion tool 370 is
sized to fit through the main lumen of pneumostomy catheter 350. A
dissecting tip 372 of percutaneous insertion tool 370 protrudes
beyond the distal tip of pneumostomy catheter 350. Dissecting tip
372 is preferably a blunt dissecting tip that pushes tissue aside
rather than cutting through tissue. A shoulder 374 engages the
proximal end of pneumostomy catheter 350 such that dissecting tip
372 is correctly positioned relative to the distal tip of
pneumostomy catheter 350. The percutaneous insertion tool 370 has a
handle 376 at the proximal end. The handle 376 is used by a
physician to position the percutaneous insertion tool 370.
Pneumostomy catheter 350 is similar in design to pneumostomy
catheter 300 of FIG. 3A.
[0114] As shown in FIGS. 3D and 3E, the pneumoplasty balloon 356 of
pneumostomy catheter 350 is preferably low profile. Likewise, tube
352 of pneumostomy catheter 350 is also preferably low profile such
that the diameter of tube 352 is preferably only slightly greater
than the diameter of dissecting tip 372 of percutaneous insertion
tool 370. The low profile of pneumoplasty balloon 356 and tube 352
facilitate the passage of pneumostomy catheter 350 into the
parenchymal tissue of the lung following the dissecting tip 372 of
percutaneous insertion tool 370. In addition, as shown in FIGS. 3D
and 3E balloon 356 is attached at its distal end inside main lumen
353 of tube 352. This allows pneumostomy catheter 350 to have a
lower profile at its distal end. This also allows the inflation
profile of balloon 356 shown by dashed line 358 to overlap somewhat
the position of dissecting tip 372.
Two-phase Pneumostomy Technique
[0115] FIG. 4A is a flowchart showing the steps of the two-phase
pneumostomy technique. The two-phase technique is divided into two
separate procedures. In the first procedure 420 a pleurodesis is
created at the site of each planned pneumostoma. The pleurodesis
can be created using chemical methods including introducing into
the pleural space irritants such as antibiotics (e.g. Doxycycline
or Quinacrine), antibiotics (e.g. iodopovidone or silver nitrate),
anticancer drugs (e.g. Bleomycin, Mitoxantrone or Cisplatin),
cytokines (e.g. interferon alpha-2.beta. and Transforming growth
factor-.beta.); pyrogens (e.g. Corynebacterium parvum,
Staphylococcus aureus superantigen or OK432); connective tissue
proteins (e.g. fibrin or collagen) and minerals (e.g. talc slurry).
A pleurodesis can also be created using surgical methods including
pleurectomy. For example, the pleural space may be mechanically
abraded during thoracoscopy or thoracotomy. This procedure is
called dry abrasion pleurodesis. A pleurodesis may also be created
using radiotherapy methods, including radioactive gold or external
radiation. These methods cause an inflammatory response and or
fibrosis, healing, and fusion of the pleural membranes.
[0116] In preferred embodiments the pleurodesis procedure is
performed under local anesthetic as an out-patient procedure. The
pleurodesis is created between the visceral membrane of the lung
and the parietal membrane on the inner wall of the thoracic cavity.
At step 422, a small incision is made at the target location under
local anesthesia. At step 424, a catheter is introduced into the
pleural cavity to deliver a pleurodesis agent to the localized area
surrounding the target location. A guide-wire may optionally be
used to guide the catheter or other delivery mechanism into the
pleural cavity while avoiding perforation of the lung. The
pleurodesis agent is preferably a solid, mesh or gel which can be
localized to the target location. Alternatively or in combination,
a device may be introduced through the incision to perform a
pleurectomy of the target location by e.g. mechanical abrasion of
the parietal membrane. Localized pleurodesis may be enhanced by
insertion of an absorbable polyglactin mesh in combination with
localized pleurodesis. The mesh may be anchored in place with a
suture to the chest wall. The absorbable mesh also serves to
reinforce the pleural membranes at the site of the pleurodesis
which may be advantageous in the second phase of the technique.
[0117] A pleurodesis may also be created at step 422 without
entering the thoracic cavity or penetrating the parietal pleura.
The physician makes a small incision to visualize the parietal
membrane without penetrating the parietal membrane. Once the
parietal membrane is exposed, an irritant is packed against the
parietal membrane external to the pleural cavity. Over time the
irritant causes inflammation of the parietal membrane and
pleurodesis between pleural membranes. Pleurodesis agents may be
utilized as described above.
[0118] The location of the pleurodesis should either be recorded
with respect to a stable anatomic feature, or marked on the skin of
the patient (if the time between the first and second procedures is
to be short). Alternatively, an implantable marker may be used that
can be located fluoroscopically or under ultrasound. Where an
implantable mesh is used as part of the pleurodesis procedure, the
mesh may be provided with markers including, for example,
radiopaque fibers for radiographic imaging, or echogenic cavities
for ultrasound imaging. Echogenic cavities may be readily formed
when extruding polyglactin and can be incorporated in the
polyglactin mesh used to help generate pleurodesis. Alternatively,
markers such as RFID tags or metal components may be used which may
be located from out side of the device with simple handheld
devices, for example, RFID antenna and/or metal detector. The
marker is preferably readily localized in order to guide placement
of the channel for the pneumostoma in the second phase of the
procedure.
[0119] FIG. 4B, illustrates the delivery of a mesh 450 through a
delivery catheter 452 into the pleural cavity 140 between the
visceral membrane 138 and parietal membrane 108. After initiating
the pleurodesis, catheter 452 is removed and the opening closed
with a suture. Alternatively, a catheter or other device may be
left in place to continue delivery of a pleurodesis-inducing agent
until the pleurodesis is formed. Mesh 450 may be anchored in place
with a suture and/or adhesive. Applicant's copending U.S. patent
application Ser. No. 12/030006 entitled "VARIABLE PARIETAL/VISCERAL
PLEURAL COUPLING" discloses methods such as pleurodesis for
coupling a channel through the chest wall to the inner volume of
the lung without causing a pneumothorax and is incorporated herein
by reference for all purposes.
[0120] Referring again to FIG. 4A, the formation of a stable
pleurodesis may take two or more days depending upon the method
used. The second procedure of the first technique should not be
performed until sufficient time has passed for the pleurodesis to
be secure. Thus, at step 425 of the first technique, there is a
waiting period having a duration of 48 hours or more. This wait
step is acceptable because the initial pleurodesis procedure can be
performed on an outpatient basis and the patient may therefore
resume their regular activities between the first procedure and
second procedure. FIG. 4C illustrates the formation of a stable
pleurodesis. Note that in the localized region of pleurodesis 124,
the visceral membrane 138 is fused with the parietal membrane 108
and there is no longer pleural space 140 between the pleural
membranes in the localized target area.
[0121] Referring again to FIG. 4A, the second procedure begins at
step 426. The patient is prepared using local anesthesia at the
target site in addition to a sedative or general anesthesia. A
chest tube may optionally be inserted into the pleural cavity in a
standard manner. An incision is then opened over the pleurodesis at
step 428 and the physician performs dissection to reach the
parietal membrane. At step 430, the physician may palpate
and/observe the parietal membrane to verify the existence of a
stable pleurodesis at the incision. At step 432 the physician
creates an incision through the fused parietal and visceral
membranes within the pleurodesis. If the pleurodesis has been
formed correctly, the incision should not leak air into the pleural
cavity and the lung will remain inflated and pushed against the
chest wall. At step 434, the physician inserts the pneumostomy
catheter 300 into the lung through the incision. The insertion may
alternatively be accomplished using the percutaneous insertion tool
370 of FIGS. 3D-3E instead of making an incision. Pneumostomy
catheter 300 should be inserted until the distal tip of the
pneumostomy catheter and the entirety of pneumoplasty balloon 306
is located within the parenchymal tissue. FIG. 4D shows the
pneumostomy catheter 300 correctly positioned through the chest
wall 106 and passing through pleurodesis 124 so that the distal tip
304 of the pneumostomy catheter 300 and the entirety of deflated
pneumoplasty balloon 306 is located within the parenchymal tissue
132 of lung 130.
[0122] Because the pneumostomy catheter 300 will likely fill the
incision through chest wall 106, the pneumostomy catheter is
provided with markings 310 so that the physician may gauge the
placement of the catheter 300. The physician should measure the
distance from the skin to the parietal membrane and then insert the
catheter to the appropriate depth. The physician may conduct a
dissection of the parenchymal tissue prior to insertion of the
pneumostomy catheter--however, the parenchymal tissue is generally
rather friable especially in patients with advanced COPD and so
dissection may not be necessary. If a large incision in the pleural
membranes was made then a purse-string suture should be made around
the opening prior to incision of the catheter. The purse-string
suture may be tightened after insertion of pneumostomy catheter
300.
[0123] Referring again to FIG. 4A, at step 436, after pneumoplasty
balloon 306 has been correctly positioned within the parenchymal
tissue, a water-filled, saline-filled or air-filled syringe is
connected to the coupling of the pneumostomy catheter and material
is injected into the pneumoplasty balloon. Although the filling of
the pneumoplasty balloon may not be directly observed, the
physician may palpate the pilot balloon 322 as a marker for
pneumoplasty balloon inflation. Additionally, the amount of air,
water or saline required to inflate the pneumoplasty balloon to the
desired shape is relatively predictable. A contrast medium may be
used to inflate the pneumostomy balloon thereby allowing the
position and size of the balloon to be observed and verified, for
example, with X-ray or ultrasound visualization. Inflation of
pneumoplasty balloon 306 pushes aside parenchymal tissue 132 within
lung 130 creating a cavity with the parenchymal tissue. The cavity
should be approximately the same size and shape as pneumoplasty
balloon 306. The inflated pneumostomy balloon 306 secures the
distal end of the pneumostomy catheter 300 within the parenchymal
tissue of the lung 130.
[0124] When the pilot balloon 322 indicates that the pneumoplasty
balloon is inflated, the syringe is removed and the cap 328
inserted in coupling 326. At step 438, after the pneumoplasty
balloon 306 is inflated, the incision through the chest wall is
closed around the pneumostomy catheter using one or more sutures as
necessary. A suture technique suitable for a straight incision is
preferred over a, purse-string suture. Access flange 308 is then
pushed against the skin of the chest wall. A slight tension is
applied to the pneumostomy catheter 300. In the event of air
leakage around the incision, this tension will serve to occlude the
leak and prevent a pneumothorax from developing. When the desired
degree of tension has been achieved, the collar 309 is fixed to
tube 302 with, for example, a suture, a clamp, a hose clamp,
locking collar, pin, and/or surgical tape. Access flange 308 is
also secured to the skin of the patient. With access flange 308
pushed against the skin and secured, inflation tube 320 can be
pulled out of the open portion of inflation lumen 332 of tube 320
up to the back of collar 309. Tube 302 can then be shortened
leaving enough length to connect main lumen 330 to a water seal.
Inflation tube 320 is then wrapped around collar 309 and secured.
The pneumostoma site is dressed and the patient provided with
standard postoperative care. FIG. 4E, illustrates pneumostomy
catheter 300, with the inflated pneumoplasty balloon 306 properly
located within the parenchymal tissue 132, the access flange 308
against the skin 114 of the chest 100 and the inflation tube 320
secured.
[0125] In some cases it may be desirable to connect tube 302 to a
water seal, Heimlich valve or similar sealing device during the
immediate postoperative period to trap air or discharge from tube
302 and prevent entry of material into the lung 130 through tube
302. FIG. 4F, illustrates pneumostomy catheter 300, with the
inflated pneumoplasty balloon 306 properly located within the
parenchymal tissue 132, the access flange 308 against the skin 114
of the chest 100 and the tube 302 connected to a sealing device
460. Access flange 308 may be temporarily secured to the skin of
the patient using adhesive 470. As shown in FIG. 4F, a right-angle
adapter 462 is connected to the proximal end of tube 302 of
pneumostomy catheter 300. A flexible tube 464 connects right-angle
adapter 464 to sealing device 460. Right-angle adapter 462 reduces
the profile/trajectory of tube 464 away from the chest 100 of the
patient. Tube 464 may be taped or secured to the chest of the
patient. Sealing device 460 may be secured to the patient but will
more likely be secured bedside during the immediate postoperative
period.
[0126] As shown in FIG. 4F, sealing device 460 may comprise a water
seal which maintains the outlet of a tube 466 under water 468. The
use of a water seal for sealing device 460 allows for direct
observation of any air that may exit through tube 302. Air exiting
the lung via tube 302 is visible as bubbles leaving tube 466 and
passing through water 468. Although a water seal in shown, sealing
device 460 may alternatively comprise any suitable sealing device
including a Heimlich valve, flapper valve vacuum bottle and the
like. After the immediate post-operative period, the sealing device
460 may be removed and pneumoplasty catheter 300 protected with a
dressing or protective cover as shown, for example, in FIGS.
9D-9G.
[0127] The patient may be discharged after a short period of
observation so long as there is no evidence of air leakage into the
pleural cavity and consequent pneumothorax. If a chest tube has
been inserted, the chest tube may be removed when no gases are
being expelled from the pleural cavity. The chest tube opening is
closed and dressed after removing the chest tube. The pneumostoma
catheter is left in place from seven days to two weeks as the
pneumostoma heals. Air flow out through the main lumen 330 of
pneumostomy catheter 300 is expected and is not an indicator of
pneumothorax. It is, however, preferable to prevent air flow into
the lung through the main lumen during the immediate postoperative.
Thus during this time the proximal end of main lumen 330 may be
sealed with a check valve, water seal or provided with slight
vacuum. The patient may be observed on an outpatient basis during
this period until the pneumostoma has healed. The dressing may be
changed periodically and the pneumostoma observed to ensure that
the pneumostomy catheter 300 is not disturbed and pneumoplasty
balloon 306 remains inflated.
[0128] When the physician considers that the pneumostoma has healed
adequately, the pneumostomy catheter 300 is removed and the
pneumostoma is inspected. The physician will then confirm the size
of the pneumostoma as preliminarily indicated by the markings 310
on the pneumostomy catheter 300. The physician will then provide a
pneumostoma management device (PMD) of the appropriate size. PMD's
are described in applicant's provisional patent applications, Ser.
No. 61/029826 titled "Pneumostoma Management Device And Methods For
Treatment Of Chronic Obstructive Pulmonary Disease" filed Feb. 19,
2008; Ser. No. 61/29830 titled "Enhanced Pneumostoma Management
Device And Methods For Treatment Of Chronic Obstructive Pulmonary
Disease" filed Feb. 19, 2008; and Ser. No. 61/032877 titled
"Pneumostoma Management System And Methods For Treatment Of Chronic
Obstructive Pulmonary Disease" filed Feb. 29, 2008. The application
of the PMD to the pneumostoma upon removal of pneumostomy catheter
is described in more detail with respect to FIGS. 8A and 8B,
below.
Accelerated Two-Phase Pneumostomy Technique
[0129] FIG. 5A is a flowchart showing the steps of an accelerated
two-phase pneumostomy technique. This pneumostomy technique is
similar to the two-phase technique with the primary difference that
the accelerated two-phase technique is performed as a single
procedure. Because there is a limited time for the pleurodesis to
form in this technique, different pleurodesis technology is
utilized. The patient is prepared using local anesthesia at the
target site in addition to a sedative or general anesthesia. A
chest tube may optionally be inserted into the pleural cavity in a
standard manner. At step 522, an incision is opened at the target
location and the physician performs dissection to expose the
parietal membrane. A larger incision may be required than in the
first technique to permit use of the acute pleurodesis
technology.
[0130] At step 524, a material or device is delivered to the
localized area surrounding the target location to create a seal
between the visceral and parietal membranes in an acute manner. The
seal is created in an acute manner between the pleural membranes
using biocompatible glues, adhesive meshes or mechanical means such
as clamps, staples, clips and/or sutures. A range of biocompatible
glues are available that may be used on the lung, including
light-activatable glues, fibrin glues, cyanoacrylates and two part
polymerizing glues. The application of energy such as RF energy may
also be used to weld the visceral and parietal membranes to each
other in an acute manner. The membranes are heated to an adequate
temperature using the directed energy to sufficiently denature the
collagen and/or other connective tissue fibers. The membranes are
then pushed into contact allowing the partially denatured fibers of
the parietal and visceral membrane to contact one another mingle
and bind to each other. In a preferred embodiment, RF energy is
used to denature the collagen fibers which are then pressed
together using a vacuum device. The adhesive, mechanical seal or
tissue weld preferably develops into a pleurodesis over time. One
or more of the pleurodesis agents discussed above may be used in
conjunction with the sealing agent in order to promote pleurodesis
formation following the procedure.
[0131] As shown in FIG. 5B, an incision 552 is created over an
intercostal space 554 between ribs 107. Dissection is used to
expose the parietal membrane 108. The visceral membrane 138 should
be visible through the parietal membrane 108. One or more
retractors 550 may be used to aid visualization of the intercostal
space 554. A polyglactin mesh torus 556 may be coated with an
adhesive and introduced between the visceral membrane 138 and the
parietal membrane 108 as shown.
[0132] After insertion of the polyglactin mesh torus 556, further
steps may optionally be taken to secure the visceral membrane 138
to the parietal membrane 108 surrounding the target site. For
example, an automated device 558 such as automated purse-string
suturing device may be used to place a ring of suture 560 around
the target site and mesh (see FIG. 5C). A suitable automated
purse-string suturing device may be found in U.S. Pa. No. 5,891,159
which is incorporated herein by reference. Alternatively, suture
560 may be placed by hand. Although a purse-string suture is
preferred, other tissue approximation devices such as tissue
anchors, staples and clips may be used instead of or in addition to
the adhesive and mesh in order to create an interpleural seal in an
acute manner at the target location. Depending on the
technology/adhesive used the interpleural seal may be stable
immediately or after a period of a few minutes.
[0133] Referring again to FIG. 5A, at step 530, the physician
palpates and/or observes the parietal membrane to verify the
existence of a stable interpleural seal at the incision. At step
532 the physician creates an incision through the parietal and
visceral membranes within the sealed region. If the interpleural
seal has been formed correctly, the incision should not leak
significant amounts of air into the pleural cavity and the lung
will remain inflated and pushed against the chest wall 106. A
purse-string suture may be placed by hand in the visceral membrane
around the incision. At step 534, the physician inserts the
pneumostomy catheter 300 into the lung through the incision. The
insertion may alternatively be accomplished using the percutaneous
insertion tool 370 of FIGS. 3D-3E instead of making an
incision.
[0134] As before, the pneumostomy catheter 300 should be inserted
until the distal tip of the pneumostomy catheter 300 and the
entirety of pneumoplasty balloon 306 are located within the
parenchymal tissue. FIG. 5C illustrates the insertion of
pneumostomy catheter 300 through the hole 557 in the center of
polyglactin mesh torus 556 and through the parietal membrane 108
and visceral membrane 138. As described above, a purse string
suture may be placed in the visceral membrane in addition to any
suture of anchoring device that may be introduced to hold the
visceral membrane to the parietal membrane. Where a mesh is used,
the mesh is provided with a central opening which constrains the
aperture through the visceral membrane without the use of a
purse-string suture. Where the technology used to form the
adhesion/pleurodesis does not constrain the opening through the
visceral membrane with a two-dimensional structure, a purse-string
suture may be useful around the opening in the visceral membrane.
The purse-string suture 560 may be tightened prior to inflation of
pneumoplasty balloon 306.
[0135] Referring again to FIG. 5A, at step 536, after pneumoplasty
balloon 306 is located within the parenchymal tissue, a saline, air
or water-filled syringe is connected to the coupling of the
pneumostomy catheter and the pneumoplasty balloon is inflated as in
the first technique. At step 538, after the pneumoplasty balloon
306 is inflated, the incision 552 through the chest wall is closed
around the pneumostomy catheter 300 using one or more sutures as
necessary. A suture technique suitable for a straight incision is
preferred over a, purse-string suture. Flange 308 is then pushed
against the skin of the chest and secured and dressed as in the
two-phase technique. (See FIG. 4E and accompanying text).
[0136] The patient is provided with the same postoperative
treatment as with the two-phase technique. When the physician
considers that the pneumostoma has healed adequately, the
pneumostomy catheter 300 is removed and the pneumostoma is
inspected. The physician will then verify the size of the
pneumostoma and provide a pneumostoma management device (PMD) of
the appropriate size. The application of the PMD to the pneumostoma
upon removal of pneumostomy catheter 300 is described in more
detail with respect to FIGS. 8A and 8B, below.
Percutaneous Approach for Two-Phase Pneumostomy Techniques
[0137] The two-phase pneumostomy techniques described in FIGS.
4A-4F and 5A-5C and accompanying text may be performed, in whole or
in part using a percutaneous approach. In an exemplary procedure, a
catheter is introduced to the pleural cavity using a technique such
as the Seldinger technique. A needle is passed percutaneously into
the pleural cavity. A guidewire is placed into the pleural cavity
through the needle. The needle is then removed. A catheter is then
percutaneously introduced into the pleural cavity over the
guidewire. The catheter is guided fluoroscopically to the desired
position for creating a pleurodesis between the visceral and
parietal membranes. The catheter delivers an agent or device for
forming an adhesion/pleurodesis between the visceral and parietal
membranes at the desired location. The device may be, for example,
an adhesive, adhesive mesh, tissue welding device, pleurodesis
agent or other agent or device for bonding the visceral and
parietal membranes to each other in an acute manner. In the second
step of the technique the pneumostomy catheter is introduced
through the adhesion/pleurodesis into the lung. The introduction of
the pneumostomy catheter may also be carried out percutaneously.
The introduction of the pneumostomy catheter may be performed in as
separate procedure (two-phase technique) or in the same procedure
(accelerated two-phase technique) depending upon the technology
used to form the adhesion/pleurodesis.
[0138] As part of the percutaneous approach a percutaneous catheter
may be used to apply energy such as RF energy may to weld the
visceral and parietal membranes to each other in an acute manner.
The catheter is introduced to the pleural cavity using a technique
such as the Seldinger technique and guided to the desired site of
the pleurodesis using e.g. fluoroscopic visualization. The catheter
then heats the membranes to an adequate temperature using directed
energy to sufficiently denature the collagen and/or other
connective tissue fibers. In a preferred embodiment, RF energy is
used as the heat source. The catheter then applies vacuum to the
parietal and visceral membranes, pushing them into contact, and
allowing the partially denatured fibers of the parietal and
visceral membrane to contact one another, mingle and bind to each
other.
Single-Phase Pneumostomy Technique
[0139] FIG. 6A is a flowchart showing the steps of the single-phase
pneumostomy technique. This technique is similar to the accelerated
two-phase technique with the exception that no interpleural seal is
created prior to entering the pleural space and lung. Because no
preliminary interpleural seal is created the lung may deflate
during the procedure resulting in a temporary pneumothorax. The
technique 612 begins with the patient given a general anesthetic,
intubated and ventilated via the other lung. A chest tube is
inserted into the pleural cavity in a standard manner at a location
away from the target area to assist with re-inflation of the lung
after the procedure. At step 622, an incision is opened at the
target location and the physician performs dissection to expose the
parietal membrane 108. A larger incision may be required than in
the first two techniques to permit access to the pleural cavity. In
some cases a minithoracotomy may be performed, in other cases, a
smaller rib resection may be used instead of a minithoracotomy. In
other cases sufficient access may be obtained by retracting the
ribs without resection. At step 624, a small incision is made in
the parietal membrane at the target location. The incision in the
parietal membrane allows air to enter the pleural space causing the
lung to shrink away from the parietal membrane 108. At step 624, a
lung manipulation device is inserted through the incision to grasp
the visceral membrane of the lung and approximate it to the opening
in the parietal membrane. A pleurodesis agent may be applied
between the visceral membrane and parietal membrane surrounding the
opening at this time to promote pleurodesis after the
procedure.
[0140] FIG. 6B shows a minithoracotomy in which a section of a rib
107 has been resected to provide access to the pleural cavity 140
through an incision 650. Dissection is used to expose the parietal
membrane 108. The parietal membrane 108 has been retracted around
opening 650 to provide access to the lung 130. One or more
retractors 654 may be used to aid with visualization of the pleural
cavity 140. Note that the lung 130 has pulled back from the
parietal membrane because air has entered the pleural cavity 140. A
lung manipulation device 652 is therefore inserted through the
opening 650 to manipulate the visceral membrane 138 of the surface
of lung 130. The lung manipulation device may be a blunt forceps or
a suction device or similar tool designed to grip the visceral
membrane without tearing the visceral membrane. One or more of the
pleurodesis agents discussed above may be applied to the parietal
membrane 108 or visceral membrane at this time to promote
pleurodesis formation following the procedure.
[0141] Referring again to FIG. 6A, at step 630, the physician may
choose to secure the visceral membrane 108 to the parietal membrane
138 around the opening into the pleural cavity 140. The lung
manipulation device is used to approximate the visceral and
parietal membranes. When the membranes are approximated, the
visceral membrane is fixed to the parietal membrane using several
sutures distributed around the perimeter of the opening in the
parietal membrane. Although sutures are preferred, other materials
and methods may be used, such as, e.g. adhesives, staples, clips,
tissue anchors and the like.
[0142] At step 632 the physician creates a small incision through
the visceral membrane. The surgeon may additionally put a
purse-string suture around the site of the incision. At step 634
the physician inserts the distal tip of the pneumostomy catheter
300 through the incision into the lung. If the visceral membrane
was not secured to the parietal membrane at step 630, it will be
necessary to provide counter-pressure with the lung manipulation
tool during introduction of the pneumostomy catheter 300 into the
lung. As before, the pneumostomy catheter 300 should be inserted
until the distal tip of the pneumostomy catheter 300 and the
entirety of pneumoplasty balloon 306 is located within the
parenchymal tissue of the lung. The purse-string suture may be
tightened prior to inflation of pneumoplasty balloon 306. At step
636, after the pneumoplasty balloon 306 is located within the
parenchymal tissue, a saline, water or air-filled syringe is
connected to the coupling of the pneumostomy catheter 300 and the
pneumoplasty balloon 306 is inflated as in the first technique.
[0143] FIG. 6C illustrates a pneumostomy catheter 300 inserted
through the visceral membrane 138 into the parenchymal tissue of
lung 130. A purse-string suture 656 is shown around the pneumostomy
catheter 300. The lung 130 shown in FIG. 6C was not fixed to the
parietal membrane prior to insertion of pneumostomy catheter 300.
However, now that the pneumostomy catheter is secured within the
lung by the pneumoplasty balloon and the purse-string suture, the
visceral membrane may be approximated to the parietal membrane
during the closing of the opening.
[0144] Referring again to FIG. 6A, at step 638, after the
pneumoplasty balloon 306 is inflated, the incision through the
chest wall is closed around the pneumostomy catheter using one or
more sutures as necessary. If the pleural membranes were not
previously secured to one another, the visceral membrane is drawn
into contact with the parietal membrane using the pneumostomy
catheter 300. After the opening through the chest wall has been
closed, flange 308 is pushed against the skin of the chest wall and
secured as in the two-phase technique. (See FIG. 4E and
accompanying text). Slight tension is applied to the pneumostomy
catheter 300 prior to securing flange 308 to ensure that the
pleural membranes are in good contact with each other. The
pneumostoma site is dressed. At this point, the chest should be
sealed and there should be little air leaking into the pleural
cavity at the site of the pneumostomy catheter. However, some air
may continue to leak until a pleurodesis forms between the visceral
and parietal membranes surrounding the pneumostomy catheter. The
chest drain should therefore be left in to apply negative pressure
to the pleural cavity to re-inflate and then maintain the inflation
of the lung until there is no longer any leakage into the pleural
cavity. This may take from one to three days. After any air leakage
into the pleural cavity is resolved, the chest tube is removed. The
pneumostomy catheter is left in place from one to two weeks while
the pneumostoma heals as in the two-phase pneumostomy
techniques.
[0145] Although this procedure has been illustrated using a
minithoracotomy for access to the lung, other approaches may be
used. For example, the procedure may also be performed in a less
invasive fashion by entering the pleural cavity through the
intercostal space and retracting the ribs rather than removing a
section of rib. The procedure may also be performed using a
minimally invasive approach under thorascopic guidance.
[0146] The patient is provided with the same postoperative
treatment as with the two-phase pneumostomy techniques. When the
physician considers that the pneumostoma has healed adequately, the
pneumostomy catheter is removed and the pneumostoma is inspected.
The physician will then verify the size of the pneumostoma and
provide a pneumostoma management device (PMD) of the appropriate
size. The application of the PMD to the pneumostoma upon removal of
pneumostomy catheter is described in more detail with respect to
FIGS. 8A AND 8B, below.
Percutaneous Single-Phase Pneumostomy Technique
[0147] FIG. 7A is a flowchart showing the steps of a percutaneous
single-phase pneumostomy technique. This pneumostomy technique is
similar to the accelerated two-phase technique with the primary
difference that no prior pleurodesis is formed. Because no
pleurodesis is formed in this technique, different technology is
utilized to deliver the pneumostomy catheter into the lung. The
pneumostomy catheter is assembled with a percutaneous insertion
tool and delivered into the parenchymal tissue of the lung through
the pleural cavity. Tension on the pneumostomy catheter after the
balloon is inflated serves to hold the visceral and parietal
pleural membranes in opposition and seal any leakage during
pneumostoma formation. A chest tube may be inserted prior to the
procedure in order to extract any air that may leak into the
pleural cavity during the procedure.
[0148] Referring again to FIG. 7A, prior to the procedure, the
patient is prepared using local anesthesia at the target site in
addition to a sedative or general anesthesia. A chest tube is
preferably inserted into the pleural cavity as a prophylactic
measure. At step 722, an incision is opened at the target location
and the physician performs dissection to expose the parietal
membrane. At step 724, a material or device may be optionally
delivered to the localized area surrounding the target location to
promote pleurodesis between the visceral and parietal membranes
after the procedure. One or more of the pleurodesis agents
discussed above may be used in order to promote pleurodesis
formation following the procedure however it is not expected that
the pleurodesis will form during the procedure itself. At step 726,
the physician assembles the pneumostomy catheter 350 with the
percutaneous insertion tool 370 as described in FIGS. 3D and 3E and
accompanying text. At step 734, the physician inserts the
pneumostomy catheter 350 into the lung through the parietal and
visceral membranes using the percutaneous insertion tool 370. As
before, the pneumostomy catheter 350 should be inserted until the
distal tip of the pneumostomy catheter 350 and the entirety of
pneumoplasty balloon 356 are located within the parenchymal tissue.
FIG. 7B illustrates the insertion of pneumostomy catheter 350
through the parietal membrane 108 and visceral membrane 138 through
the pleural cavity 140. Because there is no pleurodesis between the
parietal membrane 108 and visceral membrane 138, a small amount of
air may leak into the pleural cavity around tube 352. However, the
chest tube should be able to extract the small amount of air and
the lung 130 will remain inflated and pushed against the chest wall
106.
[0149] Referring again to FIG. 7A, at step 736, after pneumoplasty
balloon 356 is located within the parenchymal tissue 132 the
pneumoplasty balloon 356 is inflated as in the first technique. At
step 737, the percutaneous insertion tool 370 is removed from the
main lumen of pneumostomy catheter 350 (this step may alternatively
be performed before balloon inflation). At step 738, after the
pneumoplasty balloon 356 is inflated, flange 308 is pushed against
the skin of the chest as shown in FIG. 7C. Tension is applied to
tube 352 of pneumostomy catheter 350 drawing the lung 130 towards
thoracic wall 106 and bringing the parietal membrane 108 and
visceral membrane 138 into contact. The contact between the
parietal membrane 108 and visceral membrane 138 should reduce or
eliminate any air leak around tube 352. Moreover, the contact
between the parietal membrane 108 and visceral membrane 138 should
mature into a pleurodesis during the postoperative period. The
balloon 356 and tube 352 may be coated and/or impregnated with a
pleurodesis agent to promote the formation of the pleurodesis.
After the tension is applied to tube 352, pneumostomy catheter 350
is secured and dressed as in the two-phase technique. (See FIG. 4E
and accompanying text).
[0150] The patient is provided with the same postoperative
treatment as with the two-phase technique. When the physician
considers that the pneumostoma has healed adequately, the
pneumostomy catheter 350 is removed and the pneumostoma is
inspected. The physician will then verify the size of the
pneumostoma and provide a pneumostoma management device (PMD) of
the appropriate size. The application of the PMD to the pneumostoma
upon removal of pneumostomy catheter 350 is described in more
detail with respect to FIGS. 8A and 8B, below.
[0151] Referring again to FIG. 7A, additional tools or devices may
be used at step 724 to stabilize the parietal and visceral
membranes in the region surrounding the target location for the
pneumostoma. Such tools and/or device may be used to stabilize the
visceral and parietal membranes before insertion of the pneumostomy
catheter 350. They may optionally remain in place after insertion
of the pneumostomy catheter 350. In some cases the devices may be
implantable and/or absorbable such that they may be left in place
and be absorbed by the body over time.
[0152] FIG. 7D shows an example of a lung retraction tool 740
inserted percutaneously through thoracic wall 106 into the lung 130
prior to insertion of the pneumostomy catheter 350. Retraction tool
740 comprises a thin tubular shaft 742 in which is received a rod
744. At the proximal end of shaft 742 is mounted an actuator 746.
Operation of actuator 746 generates reciprocal movement of rod 744
and shaft 742.
[0153] At the distal end of shaft 742 is mounted an anchor 748.
Anchor 748 has a first low-profile configuration (not shown) in
which it has approximately the same diameter as shaft 742. Anchor
748 may be readily introduced percutaneously into the lung in this
first low-profile configuration. After anchor 748 is positioned
within the lung, actuator 746 is operated to move rod 744 within
shaft 742. The movement of rod 744 relative to shaft 742 cause
anchor 748 to reconfigure into a second configuration (as shown) in
which it extends laterally from the diameter of shaft 742. In this
second configuration (as shown), anchor 748 is designed to engage
the visceral membrane 138 of the lung 130.
[0154] After anchor 748 has been deployed to the second
configuration, a slight tension may be applied to lung retraction
tool 740 to draw visceral membrane 138 into contact with parietal
membrane 108. Lung retraction tool 740 may then be secured into
position using a locking flange 747 mounted on shaft 742. Lung
retraction tool 740 is preferably positioned laterally displaced
and adjacent the target site for the pneumostoma in the same
intercostal space. A second lung retraction tool 740 may be
positioned on the other side of the target site with sufficiency
space between the lung retraction tools for introduction of
pneumostomy catheter 350. After introduction and deployment of the
pneumostomy catheter (as described above), the anchor 748 is
returned to the first low-profile configuration and the lung
retraction tool(s) is(are) removed.
[0155] A number of different devices may be delivered
percutaneously to stabilize the visceral and parietal membranes,
including for example, suture, clips, staples, adhesive and/or
adhesive patches. FIG. 7E shows an example of a lung anchor 750
inserted percutaneously through thoracic wall 106 into the lung 130
prior to insertion of the pneumostomy catheter 350. Lung anchor 750
comprises an elongate body 752. At the distal end of body 752 is
anchor head 758. Along the elongated body 752 are arrayed a
plurality of barbs 754 oriented so as to prevent distal movement of
elongate body 752 through tissue in the direction of anchor head
758.
[0156] Lung anchor 750 is inserted into a thin walled
needle/cannula 760 for insertion through the chest wall.
Needle/cannula 760 holds anchor head 758 in a low profile
configuration during introduction into lung 130. When anchor head
758 is correctly positioned within the lung 130, needle/cannula 760
is withdrawn. Anchor head 758 springs into a wide profile
configuration designed to engage the visceral membrane of the
lung--see anchor head 758a. After needle/cannula has been
withdrawn, barbs 754 are also able to engage the tissue of chest
wall 130. As light tension may be applied to elongate body 752 to
draw visceral membrane 138 into contact with parietal membrane 108.
Barbs 754 engage the tissue of chest wall 130 to maintain the
tension in elongate body 752. One or more lung anchors 750 may be
introduced adjacent the target site for the pneumostoma in the same
intercostal space to stabilize the visceral and parietal membranes
during insertion of pneumostomy catheter 350.
[0157] Lung anchor 750 may be made from biocompatible metals and/or
polymers. In particular lung anchor 750 may be made from a
superelastic metal, for example NITINOL. Alternatively, lung anchor
750 maybe made of an absorbable material, for example polyglactin.
Where the anchoring device is made of an absorbable material it may
be left in place and absorbed following the introduction and
securing or pneumostomy catheter 350.
[0158] FIGS. 7F-7H illustrate an alternative lung anchor 778 which
may be used to stabilize the visceral membrane 138 and parietal
membrane 108 prior to and during the pneumostomy procedure. As
shown in FIG. 7F, lung anchor 778 is implanted with an applicator
770. Applicator 770 has a thin tubular shaft 772 in which is
received lung anchor 778. Shaft 772 is inserted percutaneously
until lung anchor 778 is correctly positioned. At the proximal end
of shaft 772 is mounted an actuator 776. Operation of actuator 776
operates to eject lung anchor 778 from shaft 772 into tissue
adjacent the distal end of shaft 772 in the manner of a surgical
staple or clip applier. Actuator 776 is then removed leaving the
lung anchor in position to stabilize the parietal membrane 108 and
visceral membrane 138--see deployed anchor 778a of FIG. 7F. On or
more lung anchors 778 are preferably positioned laterally displaced
and adjacent the target site for the pneumostoma in the same
intercostal space prior to the pneumostomy procedure.
[0159] FIG. 7G shows an enlarged view of lung anchor 778. Lung
anchor 778 includes a longitudinal body 780, a first set of
retainers 782 and a second set of retainers 784. As shown in FIG.
7G, the retainers 782, 784 lie flat against the body 780 in the
undeployed configuration. The lung anchor is place in applicator
770 in this undeployed configuration. After insertion into the
tissue retainers 782, 784 move away from body 780 to engage tissue
as shown in FIG. 7G. FIG. 7H shows a lung anchor 778a with
retainers 782, 784 in the deployed configuration. Retainers 782,
784 are oriented in opposite directions so that one set of
retainers may engage the parietal membrane 108 and the other set
may engage the visceral membrane 138 and thereby secure the two
pleural membranes to one another.
[0160] The transition from undeployed configuration to deployed
configuration may be achieved in a number of ways. For example lung
anchor 778 may be mechanically constrained in the undeployed
configuration by tubular shaft 772 such that, when released,
retainers 782, 784 spring out into the deployed configuration.
Alternatively, lung anchor 778 may be formed of a shape memory
polymer or metal such that upon insertion into the tissue, the
material of the anchor transitions from the undeployed
configuration 778 (FIG. 7G) to the stored deployed configuration
778a (FIG. 7H). Lung anchor 778 may be made from biocompatible
metals and/or polymers. In particular lung anchor 778 may be made
from a superelastic metal, for example NITINOL. Alternatively, lung
anchor 778 maybe made of an absorbable material, for example
polyglactin. Where the anchoring device is made of an absorbable
material it may be left in place and absorbed following the
pneumostomy procedure.
Pneumostoma Management Device
[0161] As described above, a pneumostoma may be created to treat
the symptoms of chronic obstructive pulmonary disease. A patient is
typically provided with a pneumostoma management system to protect
the pneumostoma and keeps the pneumostoma open on a day-to-day
basis. In general terms a pneumostoma management device ("PMD")
comprises a tube which is inserted into the pneumostoma and an
external component which is secured to the skin of the patient to
keep the tube in place. Gases escape from the lung through the tube
and are vented external to the patient. The pneumostoma management
device may, in some, but not all cases, include a filter which only
permits gases to enter or exit the tube. The pneumostoma management
device may, in some, but not all cases, include a one-way valve
which allows gases to exit the lung but not enter the lung through
the tube.
[0162] FIGS. 8A and 8B illustrate application of a pneumostoma
management device ("PMD") 800 to a pneumostoma 110 formed in
accordance with a pneumostomy procedure of the present invention.
PMD 800 includes a chest mount 802 which may be mounted to the
chest 100 of the patient and a pneumostoma vent 804 which is fitted
to the chest mount 802. Pneumostoma vent 804 is mounted through an
aperture 824 in chest mount 802. Chest mount 802 has a first
coupling that engages a second coupling of the pneumostoma vent to
releasably secure the pneumostoma vent 804 to the chest mount 802.
A patient will typically wear a PMD at all times after formation of
the pneumostoma and thus the materials should meet high standards
for biocompatibility. A pneumostoma management device and system
for use with such a pneumostoma management device is described in
provisional patent application 61/032877 entitled "Pneumostoma
Management System And Methods For Treatment Of Chronic Obstructive
Pulmonary Disease" filed Feb. 29, 2008, which is incorporated
herein by reference.
[0163] Pneumostoma vent 804 includes a tube 840 sized and
configured to fit within the channel of pneumostoma 110. Tube 840
is stiff enough that it may be inserted into pneumostoma 110
without collapsing. Tube 840 may be round, oval or some other shape
depending on the shape of the pneumostoma. Over time a pneumostoma
may constrict and the PMD 800 is designed to preserve the patency
of the channel 120 of pneumostoma 110 by resisting the natural
tendency of the pneumostoma to constrict. Pneumostoma vent 804
includes a cap 842 and a hydrophobic filter 848 over the proximal
end of tube 840. Hydrophobic filter 848 is positioned and mounted
such that material passing in and out of pneumostoma 110 through
tube 840 of pneumostoma vent 804 must pass through hydrophobic
filter 848.
[0164] Tube 840 of pneumostoma vent 804 is sufficiently long that
it can pass through the thoracic wall 106 and into the cavity 122
of a pneumostoma inside the lung 130. Pneumostoma vent 804 is not
however so long that it penetrates so far into the lung 130 that it
causes injury. The length of tube 840 required for a pneumostoma
vent 804 varies significantly between different pneumostomas. A
longer tube 840 is usually required in patients with larger amounts
of body fat on the chest. A longer tube 840 is usually required
where the pneumostoma is placed in the lateral position 112 rather
than the frontal position 110. Because of the variation in
pneumostomas, pneumostoma vents 804 are manufactured having tubes
840 in a range of sizes. Tube 840 may be from 30 to 180 mm in
length and from 5 mm to 20 mm in diameter depending on the size of
a pneumostoma. A typical tube 840 may be between 40 mm and 100 mm
in length and between 8 mm and 12 mm in diameter. When the
pneumostomy catheter is removed, the physician should gauge the
size of the pneumostoma that has been created for the particular
patient and provide a pneumostoma vent 804 having a tube 840 of
appropriate length for the pneumostoma. The markings on the side of
the pneumostomy catheter 300 may also assist the physician in
determining the approximate length of pneumostoma vent 804.
[0165] To use PMD 800, chest mount 802 is first positioned over a
pneumostoma and secured with adhesive to the skin 114 of the
patient. Chest mount 802 may be positioned by manual alignment of
the aperture 824 of chest mount 802 with the aperture of the
pneumostoma 110. Alternatively a pneumostoma vent 804 or an
alignment tool may be used to help align the chest mount 802. As
shown in FIG. 8B the low profile of chest mount 802 allows it to be
inconspicuously positioned on the chest 100 of a patient in either
of the frontal 110 or lateral 112 locations illustrated in FIG. 1A.
Cap 842 of pneumostoma vent 804 is received in a recess in chest
mount 802 such that tube 840 is secured inside the channel 120 of
the pneumostoma 110.
[0166] The removal of the pneumostomy catheter 300 and application
of the first PMD 800 will be performed by the physician. However,
the patient will subsequently be responsible for applying and
removing the chest mount 802 and the insertion, removal and
disposal of pneumostoma vent 804. The pneumostoma management device
800 is preferably provided as part of a system which assists the
patient in utilizing the chest mount and pneumostoma vent and
keeping the pneumostoma clean and free of irritation/infection
while trapping sputum, mucous and other discharge. The patient will
exchange one pneumostoma vent 804 for another and dispose of the
used pneumostoma vent 804. Pneumostoma vent 804 will be replaced
periodically, such as daily, or when necessary. The patient will be
provided with a supply of pneumostoma vents 804 of the appropriate
size by a medical practitioner or by prescription. Chest mount 802
will also be replaced periodically, such as weekly, or when
necessary. The patient will also be provided with a supply of chest
mount 802 by a medical practitioner or by prescription. A one week
supply of pneumostoma vent 804 (such as seven pneumostoma vents
804) may be conveniently packaged together with one chest mount
802. Pneumostoma management devices of different design as
discussed in the previously referenced patent applications may also
be used.
Alternative Pneumostomy Instruments
[0167] FIGS. 9A-E show alternative pneumostomy instruments for use
in pneumostomy procedures in accordance with embodiments of the
present invention. The instruments have an expanding mechanism
(such as a balloon) for creating a cavity in the parenchymal tissue
of the lung thereby engaging the parenchymal tissue and allowing
the lung to be drawn towards the thoracic wall. The instruments
have a tube connected to the expanding mechanism for drawing the
expanding mechanism towards the chest wall and having a lumen to
connect to the cavity in the parenchymal tissue. The instruments
have a securing mechanism (such as a sliding flange) for securing
the position of the expanding mechanism after applying tension to
the tube. The function of the various components can be achieved in
a variety of ways.
[0168] FIGS. 9A and 9B show different sectional views an
alternative pneumostomy instrument 900 having an outer tube 902 and
an inner tube 904 in a coaxial relationship. The inner tube is 904
connected to the outer tube 902 at the proximal end of the
instrument by a fitting 906. An inflation lumen 908 is defined by
the space between the inner tube 904 and outer tube 906. The
inflation lumen 908 is sealed at the proximal end of the instrument
900 by the fitting 906. At the distal end, the inner tube 904
protrudes beyond the end of the outer tube 906. An inflatable
pneumoplasty balloon 910 is connected between the end of the inner
tube 904 and the end of the outer tube 906 as shown in FIG. 9A
thereby sealing the distal end of the inflation lumen 908. Thus
air, water or saline inserted through fitting 906 passes through
inflation lumen 908 into pneumoplasty balloon 910 thereby inflating
balloon 910 to the position shown by dotted line 911. An access
flange 912 is provided in sliding engagement with the exterior of
the outer tube 902. FIG. 9B shows a sectional view of pneumostomy
instrument 900 along the line B-B of FIG. 9A. FIG. 9B shows outer
tube 902, inner tube 904, inflation lumen 908 and main lumen 914.
Pneumostomy instrument 900 is used in the same way as pneumostomy
catheter 300 of FIGS. 3A through 3C with the exception that
pneumostomy instrument 900 has no facility to be shortened after
the pneumostomy procedure. Pneumostomy instrument 900 may also be
used with a percutaneous insertion instrument 370 as shown in FIGS.
3D-3E.
[0169] FIG. 9C shows a perspective view of an alternative
pneumostomy instrument 920 that uses an expanding pneumoplasty
mechanism instead of a pneumoplasty balloon. As shown in FIG. 9C,
the expanding pneumoplasty mechanism 922, comprises a polymer skin
924 covering a flexible expanding cage formed of six bars 926. The
distal end of each bar 926 is fixed to the distal end of inner tube
928 adjacent atraumatic distal tip 931. The proximal end of each
bar 926 is fixed to the distal end of outer tube 930. Outer tube
930 is received over inner tube 928 and can slide relative to inner
tube 928. At the proximal end of outer tube 930 is a threaded nut
932 which rides on threads 933 on the exterior of inner tube 928.
Inner tube 928 comprises a main lumen 929 which runs from the
proximal end to the distal end of pneumostomy instrument 920.
[0170] Expanding pneumoplasty mechanism 922 is expanded by turning
nut 932 clockwise which drives nut 932 and outer tube 930 distally
relative to inner tube 928. When outer tube 930 moves distally
relative to inner tube 928, bars 926, which are initially
approximately parallel to inner tube 928, bend outwards from inner
tube 928 as shown. The bars 926 push polymer skin 924 outwards in
the ball shape shown. Nut 932 may be provided with a stop to
indicate when the expanding pneumoplasty mechanism 922 is fully
expanded. Nut 932 may also be provided with a safety lock, such as
a ratchet which locks the nut in position until removal of the
pneumoplasty instrument is desired.
[0171] Pneumostomy instrument 920 includes an access flange 934
which slides on the exterior of outer tube 930 for engaging the
chest of the patient. However, as shown in FIG. 9C, access flange
934 is also driven by a nut 936 which rides on threads 938 on the
exterior of outer tube 930. Turning nut 936 clockwise drives access
flange 934 distally thereby drawing the expanding pneumoplasty
mechanism 922 closer towards the chest wall. Nut 936 may also be
provided with a safety lock, such as a ratchet which locks the nut
in position until removal of the pneumoplasty instrument is
desired. Access flange 934 and its driving and locking mechanism
may be substituted for access flange 912 or access flange 308.
[0172] Pneumostomy instrument 920 is used in the same way as
pneumostomy catheter 300 of FIGS. 3A through 3C with the exceptions
that expansion of expanding pneumoplasty mechanism 922 is by
turning nut 932 rather than inflating a balloon and positioning of
access flange 934 is by turning nut 936 rather then sliding and
suturing. Pneumostomy instrument 920 may also be used with a
percutaneous insertion instrument 370 as shown in FIGS. 3D-3E.
[0173] FIGS. 9D and 9E show sectional and perspective views
respectively of a post-operative protective cover 940. Protective
cover 940 includes dome 942 which is specially-shaped to protect
the exterior components of the pneumostomy catheter 300 during the
post-operative period in which a pneumostoma is healing. As shown
in FIGS. 9D and 9E, dome 942 is pear-shaped to accommodate the
pilot balloon 322, check valve 324 and cap 328. Flange 308 is
shaped to fit snugly within cover 940 and thus is also pear-shaped.
The contact between the inside edge of dome 942 and the raised lip
950 of flange 308 effectively seals the space between dome 942 and
flange 308. Dome 942 should be relatively low-profile and smooth so
as not to restrict movement of the patient or interfere with the
patient's clothing.
[0174] Protective cover 940 has two clips 944 for engaging access
flange 308. Each of clips 944 comprises a catch 946 for engaging a
detent in raised lip 950 of flange 308. Each of clips 944 also has
a release lever 948 for disengaging catch 946 from flange 308. In
use, protective cover 940 can be clipped to flange 308 by pushing
clips 944 into position over raised lip 950. Protective cover 940
is released by squeezing lever arms 948 towards dome 942. In other
embodiments, protective cover 940 may be releasably secured to
flange 308 using other suitable mechanisms or by a releasable
adhesive. Alternatively, protective cover 940 may be secured to the
chest 100 of the patient directly as shown in FIGS. 9F-9G.
[0175] Dome 942 is preferably made of a stiff hydrophobic material
such that when protective cover 940 is in position over pneumostomy
catheter 300, protective cover 940 prevents entry of water or other
foreign matter into tube 302. Dome 942 is also designed to capture
any discharge from tube 302. Dome 942 is also preferably porous
either in whole or in part to allow air to circulate and pass in
and out of tube 302. Protective cover 940 is a disposable
component--like a dressing--and will typically be removed and
exchanged for a replacement every day or few days as required.
[0176] FIGS. 9F and 9G shows sectional and perspective views
respectively of an alternative post-operative protective cover 960.
Protective cover 960 is similar in shape and function to protective
cover 940, however, protective dome 960 attaches directly to the
skin of the patient rather than to the flange of the pneumostomy
catheter 300. Protective cover 960 includes dome 962 which is
specially-shaped to protect the exterior components of the
pneumostomy catheter 300 during the post-operative period in which
a pneumostoma is healing. As shown in FIGS. 9F and 9G, dome 962 is
pear-shaped and defines a cavity 964 sized to accommodate the tube
302, pilot balloon 322, check valve 324, flange 308 and cap 328 of
pneumostomy catheter 300. The flat edge of dome 962 is coated with
an adhesive 966, such as a hydrocolloid adhesive, to attach cover
960 to the chest 100 of the patient. The contact between the
adhesive 966 and the skin 114 on the chest 100 of the patient
effectively seals the space surrounding pneumostomy catheter 300.
Dome 962 should be relatively low-profile and smooth so as not to
restrict movement of the patient or interfere with the patient's
clothing during the postoperative period.
[0177] Dome 962 is preferably made of a stiff hydrophobic material
such that when protective cover 960 is in position over pneumostomy
catheter 300, protective cover 960 prevents entry of water or other
foreign matter into tube 302. Dome 962 is also designed to capture
any discharge form tube 302. Dome 962 is also preferably porous
either in whole or in part to allow air to circulate and pass in
and out of tube 302. Protective cover 960 is a disposable
component--like a dressing--and will typically be removed and
exchanged for a replacement every day or every few days as
required.
[0178] FIGS. 10A-10F show views of an alternate pneumostomy
instrument 1000. FIGS. 10A-10C show pneumostomy instrument 1000 in
its expanded position in which the pneumostomy instrument is
configured to secure the lung of a patient. FIGS. 10D-10F show
pneumostomy instrument 1000 in its expanded position in which the
pneumostomy instrument is configured during insertion to and
removal from the lung.
[0179] FIG. 10A shows a perspective view of pneumostomy instrument
1000. FIG. 10B shows a sectional view of pneumostomy instrument
1000 and FIG. 10C shows an enlarged sectional view of the distal
end of pneumostomy instrument 1000. As shown in FIG. 10A,
pneumostomy instrument 1000 comprises a tube 1002 having at the
distal end an expanding basket 1010 and having a proximal structure
1020.
[0180] The tube 1002 is between five and ten inches in length and
is preferably between six and seven inches in length. The tube may
be from one quarter to three quarters of an inch in diameter and is
preferably 3/8 of an inch in diameter. The tube has a lumen 1003.
In a preferred embodiment, the tube is made from e.g. c-flex 50A).
However other biocompatible thermoplastic elastomers may be used.
The relatively soft material of the tube 1002 allows the tube 1002
to fold over outside the body in order that it may be secured
during the immediate postoperative period. Reinforcing features may
be added to tube 1002 to increase its column strength and tensile
strength. However, it is preferred that the reinforcement does not
prevent the tube 1002 from bending. For example longitudinal
inelastic reinforcing fibers may be embedded in tube 1002 or
otherwise affixed the tube 1002 in order to increase the tensile
strength while still permitting bending. In another example, tube
1002 may be spiral wound with wire (or be embedded with said wire)
to increase its column strength while still permitting bending.
[0181] The material of the expanding basket 1010 is selected such
that it can maintained the desired expanded profile when positioned
within the lung but can be safely returned to a low profile for
extraction. The harder durometer material of the basket allows it
to maintain its expanded shape in the lung. In a preferred
embodiment, the expanding basket 1010 is made from a harder
durometer material, for example c-flex (e.g. c-flex 90A) than the
tube (e.g. c-flex 50A). However other thermoplastic elastomers may
be used.
[0182] The expanding basket 1010 may also be covered with a thin
elastic covering that allows for expansion and collapse of the
basket for example an elastic balloon material. See, for example,
polymer skin 924 covering the flexible expanding cage in FIG. 9C.
The covering would assist the expanding basket 1010 in pushing
aside parenchymal tissue of the lung during expansion of the
basket. The covering would thus assist anchoring of the expanding
basket 1010 within the lung while facilitating later removal of
expanding basket after the pneumostoma has formed. The thin
covering may also extend along the length of tube 1002 to maintain
a uniform outside diameter and to help with stabilization of the
tube 1002. As shown in FIG. 10A, pneumostomy instrument 1000 is
provided with a mandrel 1040. Mandrel 1040 includes an elongated
member 1042 adapted to fit through tube 1002 into expanding basket
1010. The distal tip 1046 of mandrel 1042 is adapted to engage
expanding basket 1010 and stretch it into a linear configuration
suitable for insertion and removal of the instrument. The mandrel
also imparts extra stiffness to pneumostomy instrument 1000 during
insertion and removal. Mandrel 1040 has a luer fitting 1048
attached to the proximal end. Luer fitting 1048 engages the female
luer fitting 1026 to secure mandrel 1040 within pneumostomy
instrument 1000 during insertion and removal. Mandrel 1040 may be
provided with a radio marker, radiopaque or echogenic material
incorporated in the distal tip 1046 so that the tip may be
visualized during insertion of the pneumostomy instrument.
[0183] As shown in FIG. 10A, pneumostomy instrument 1000 may also
be provided with an access flange 1050. Access flange 1050 is
designed such that it may be secured against the skin of the chest
of the patient and collar 1052 may be secured to tube 1002 thereby
fixing tube 1002 in position relative to the chest of the patient.
Access flange 1052, is slidable along the length of the tube 1002.
The flange 1052 is designed to be positioned against the skin. The
flange 1050 can be sutured to tube 1002 to secure the flange in
position along the catheter or fixed in place by other means such
as tape, adhesive, clips and staples and the like or by having a
built-in securing mechanism, such as a cam, ratchet, lock or the
like. The flange 1052 is designed to maintain a tension between the
expanding basket 1010 embedded in the lung and the thoracic wall.
Once access flange 1050 is secured to tube 1002, access flange 1050
provides the necessary counterforce for the expanding basket 1010.
Access flange 1050 may also be provided with an adhesive coating
1054 to temporarily secure the flange 1050 to the skin of the
patient and thereby preclude accidental dislodgment of the
catheter.
[0184] FIG. 10C shows a sectional view of expanding basket 1010.
Expanding basket 1010 comprises an outer section 1012 and an inner
section 1014. Outer section 1012 has a proximal tube 1011 and a
distal tube 1013 connected by a plurality of expanding elements
1016. Proximal tube 1011 is bonded to tube 1002. Distal tube 1013
end in distal aperture 1018. Optional, side apertures may also be
provided in distal tube 1013 and or proximal tube 1011. Expanding
elements 1016 are shaped such that they extend radially from the
long axis of expanding basket 1010. Expanding elements are formed
in the expanded configuration. Outer section 1012 is butt joined to
the distal end of tube 1002. Expanding basket 1010 may be provided
with a radio marker, radiopaque or echogenic material incorporated
in the distal tip 1046 so that the tip may be visualized during
insertion of the pneumostomy instrument. Expanding basket 1010 is
designed to push aside the parenchymal tissues of the lung when
expanded thereby creating a cavity within the parenchymal tissue.
Expanding basket 1010 is also designed to anchor pneumostomy
catheter 1000 within the parenchymal tissue of the lung.
Alternative expanding devices may be used so long as they achieve
these same functions.
[0185] Inner section 1014 is generally tubular and fits within
proximal tube 1011 and distal tube 1013 of outer section 1012. In a
preferred embodiment inner section 1014 is a hollow metal tube
having a reduced diameter tip 1017. Inner section 1014 is bonded to
distal tube 1013. Inner section 1014 also has a plurality of barbs
1015 for securing inner section 1014 to distal tube 1013. Inner
section 1014 is slidingly received within proximal tube 1011.
[0186] A length of suture 1004 is fixed to the proximal end of
inner section 1014. Suture 1004 may be used to secure inner section
1014 in the position shown in FIG. 10C. Suture 1004 runs through
the lumen 1003 of tube 1004 and out through proximal structure
1020. As shown in FIG. 10B, two stops 1006 and 1007 are crimped
and/or UV-bonded to suture 1004. The distal stop 1007 is
responsible for limiting the pull or throw of the suture,
preventing the physician from over expanding the basket. The
proximal stop 1006 is used to assure the basket stays expanded
while in place in the body. The proximal end of suture 1004 is
securely fixed to a pull-ring 1028 which helps the physician or
user grasp and pull the suture.
[0187] FIG. 10B shows a sectional view of proximal structure 1020.
The distal end of inner section 1014 and section 1012 (as shown in
FIG. 10C) suture 1004 runs through the lumen 1003. Proximal
structure 1020 includes a plastically Y-connector 1022. The distal
end of Y-connector 1022 is bonded to the proximal end of tube 1002
with a UV-cured adhesive. The straight arm 1021 of the Y-connector
1022 is attached to a high flow female luer fitting 1026 with a
UV-cured adhesive. The side arm 1023 of the Y-connector is attached
to a Tuohy Borst connector (Tuohy) 1024. The components may be
secured to each other using adhesive, welding, melting or other
techniques appropriate to the materials to be secured. Suture 1004
passes through the Tuohy 1024. Stop 1006 is sized such that when
Tuohy 1024 is open it may pass through grommet 1023. However, when
Tuohy 1024 is closed (as shown in FIG. 10B) stop 1006 may not pass
through grommet 1023. Stop 1007 is too large to pass into Tuohy
1024.
[0188] FIGS. 10D-10F show views of pneumostomy instrument 1000
configured for introduction or removal from the lung of a patient.
In this configuration mandrel 1040 has been inserted into
pneumostomy instrument 1000. As shown in FIG. 10D the luer fitting
1048 of mandrel 1040 has been secured to female luer 1026 of
pneumostomy instrument 1000. The insertion of mandrel 1040 has
caused expanding head 1010 to assume a reduced diameter
configuration in which expanding elements 1016 are substantially
flush with the surface of proximal tube 1011 and distal tube
1013.
[0189] As shown in FIGS. 10E and 10F, mandrel 1040 passes through
female luer 1026, through lumen 1003 of tube 1002 and into inner
section 1014 of expanding basket 1010. Tip 1046 of mandrel 1040
engages tip 1017 of inner section 1014. Mandrel 1040 is of
sufficient length that insertion of mandrel 1040 into pneumostomy
instrument 1000 pushes distal tube 1013 of expanding basket 1010
away from proximal tube 1012 thereby causing expanding elements
1016 to be stretched out and assume the configuration shown in
FIGS. 10D-10F.
[0190] The pneumostomy instrument 1000 may be utilized in any of
the pneumostomy procedures described herein including those
procedures described in FIGS. 4A-4F, 5A-5C, 6A-6C, 7A-7C and
accompanying text. For certain applications, it is desirable to
assemble pneumostomy instrument 1000 with a percutaneous insertion
tool so that the pneumostoma catheter can penetrate through the
chest wall and pleural membranes and the parenchymal tissue without
need for previous incision or dissection. The percutaneous
insertion tool is a device that permits the rapid deployment of the
pneumostomy catheter through chest wall and the parietal and
visceral membranes into the lung. The insertion tool preferably
prevents deflation of the lung by rapid deployment of the
pneumostomy catheter and subsequent expansion of expanding basket
1010. The percutaneous insertion tool may comprise a trocar
designed to fit through lumen of the pneumostomy instrument in
place of mandrel 1040 and dissect tissue in a minimally traumatic
way thereby allowing the pneumostomy catheter to penetrate the
pleural membranes and enter the parenchymal tissue of the lung.
[0191] FIGS. 11A-11C show a pneumostomy instrument 1000 assembled
with a percutaneous insertion tool 1100. FIG. 11A shows a
perspective view of the pneumostomy instrument 1000 assembled with
the percutaneous insertion tool 1100. FIGS. 11B and 11C show
detailed sectional views of the distal end of the pneumostomy
instrument 1000 and insertion tool 1100. Referring first to FIG.
11A, percutaneous insertion tool 1100 is sized to fit through the
main lumen of pneumostomy instrument 1000. A dissecting tip 1102 of
percutaneous insertion tool 1100 protrudes beyond the distal tip of
pneumostomy instrument 1000. Dissecting tip 1102 is preferably a
dissecting tip that pushes tissue aside rather than cutting through
tissue. A handle 1104 extends from the proximal end of pneumostomy
instrument 1000 allowing the physician to control the instrument. A
coupling 1106 temporarily secures the percutaneous insertion tool
1100 to the female luer 1026 (shown in FIG. 11A) at the proximal
end of pneumostomy instrument 1000.
[0192] FIG. 11B shows a sectional view of the distal tip of
pneumostomy instrument 1000 and insertion tool 1100. As seen in
FIG. 11B, percutaneous insertion tool 1100 includes a sleeve 1101
in which distal tip 1102 is received. The distal end of sleeve 1101
engages the distal end 1017 of inner section 1014 of expanding
basket 1010. The dissecting tip extends through the aperture 1018
in the end of pneumostomy instrument 1000. An actuator 1106
comprises a spring-loaded mechanism for withdrawing dissecting tip
1101 back towards the proximal end of pneumostomy instrument. The
actuator latches the dissecting tip in the forward position until
triggered. The actuator is triggered by the insertion of dissecting
tip 1102 through the chest wall and then into the softer tissue of
the lung. The retraction of the dissecting tip after passage of the
instrument into the parenchymal tissue of the lung helps prevent
injury to the lung caused by over insertion. The retraction of the
dissecting tip may also be used, in some embodiments, to trigger
deployment of expanding basket 1010, by, for example, releasing
coupling 1106 and allowing the pneumostomy instrument 1000 to relax
and allowing the expanding basket 1010 to take on its expanded
configuration.
[0193] FIG. 11C illustrates the configuration of the percutaneous
insertion tool 1100 and pneumostomy instrument 1000 after
deployment into lung tissue. As shown in FIG. 11C, tip 1102 has
been retracted into opening 1018 in the distal end of pneumostomy
instrument 1000. Expanding elements 1016 have moved out radially
from the axis of pneumostomy instrument 1000. The expanding
elements push aside the parenchymal tissue to make a cavity and
secure the end of pneumostomy instrument 1000 into the lung.
Percutaneous insertion tool 1100 may now be removed, leaving
pneumostomy instrument 1000 in place. After stabilization of the
pneumostoma in 7 to 14 days a mandrel (such as mandrel 1040 of FIG.
10A) is inserted into the lumen of the pneumostomy instrument 1000
again causing expanding elements 1016 to return to their low
profile configuration. When mandrel 1040 is secured to pneumostomy
instrument 100 (see e.g. FIG. 10E) the instrument may be removed
from the chest of the patient. A pneumostoma management device
should then be placed in the pneumostoma (see FIGS. 8A-8B and
accompanying text).
Postoperative Pneumostomy Instrument Support
[0194] As described above, the instrument used to create the
pneumostoma remains in place in the patient for a period of time in
order for the tissues displaced by the instrument to heal and to
allow pleurodesis between the visceral and pleural membranes
surrounding the instrument. During this immediate postoperative
period it is desirable to maintain the comfort and/or mobility of
the patient. Thus, it is desirable that the instrument used to
perform the pneumostomy procedure be secured in a low-profile
configuration that reduces inconvenience to the patient. It is also
desirable that the instrument be aligned approximately
perpendicular to the chest wall where it passes through the chest
wall, so that pneumostoma forms in approximately this
configuration. It is also desirable that the instrument be
maintained under a slight tension to aid pleurodesis. In order to
achieve and maintain the appropriate configuration of the
pneumostomy instrument during the post-operative period while
reducing inconvenience and discomfort to the patient, a
postoperative pneumostomy instrument support is provided. The
post-operative pneumostomy instrument support keeps the pneumostomy
instrument aligned with the stoma, applies a slight tension to the
pneumostomy instrument, prevents kinking of the instrument; and
secures the instrument in a low-profile configuration for the
post-operative period.
[0195] FIGS. 12A and 12B show a postoperative pneumostomy
instrument support 1200. FIG. 12A shows an exploded view of the
components of support 1200. Support 1200 has three main components:
adhesive backing 1202, strap 1204 and block 1206.
[0196] Adhesive backing 1202 is a compliant foam pad coated on each
side with a thin layer of biocompatible adhesive. The compliant
foam allows the pad to conform somewhat to the chest of the
patient. The adhesive backing has a U-shaped opening 1203 in one
edge to allow it to fit around the pneumostomy instrument at the
insertion site. The opening 1203 is large enough that the adhesive
backing 1202 does not interfere with the incision.
[0197] Block 1206 is formed from light weight rigid and/or
semi-rigid foam. The block has a flat surface 1205 for attachment
to the adhesive backing 1202. The block has a curved front surface
1207 for supporting the pneumostomy instrument. The front surface
1207 has a semicircular channel 1212 designed to receive the tube
of the pneumostomy instrument. The channel 1212 is aligned
perpendicular to the patient-side 1208 where the front surface 1207
meets the flat surface 1205. The front surface 1207 of block 1206
and channel 1212 subsequently curve away from perpendicular until
approximately parallel with the flat surface 1205. The radius of
curvature and shape of the channel is selected so as not to cause
the tube of the pneumostomy instrument to kink. An aperture 1214
passes through block 1206 from one side of channel 1212 to the
other.
[0198] Strap 1204 is designed to hold instrument to block 1206 and
maintain a slight tension in the instrument. Strap 1204 is sized to
fit through aperture 1214 of block 1206. Strap 1204 may be provided
with a releasable adhesive for securing the strap to itself and the
pneumostomy instrument. Strap 1204 may additionally or
alternatively be provided with a fastener for securing the
pneumostomy instrument. Strap 1204 is preferably made of a somewhat
elastic material to aid in fixing the instrument to block 1206 and
applying tension to the pneumostomy instrument without crushing the
pneumostomy instrument.
[0199] FIG. 12B shows the assembled support 1200. Strap 1204 is
positioned through aperture 1214 such that the free ends of strap
1204 are available to secure a pneumostomy instrument into channel
1212. Adhesive backing 1202 is secured to the flat surface 1205 of
block 1206 by a layer of adhesive. Typically the remaining adhesive
layer is protected with a removable layer of paper until ready for
use. The U-shaped opening 1203 is aligned with channel 1212. Note
that adhesive backing 1202 is preferably larger is area than the
flat surface 1205 of block 1206 to facilitate removal of support
1200 by peeling up of adhesive backing 1202.
[0200] FIG. 12C shows a sectional view through support 1200 to
illustrate the use of support 1200 in conjunction with a
pneumostomy instrument 1000 positioned within a pneumostoma 110.
Block 1206 is secured to the skin 114 of chest 100 adjacent
pneumostoma 110 by adhesive backing 1202. As shown in FIG. 12C,
tube 1002 is aligned perpendicular to the wall of chest 100 where
tube 1002 exits chest 100. Tube 1002 follows the curvature of block
1206 until approximately parallel with chest 100. The shape of
channel 1212 and the radius of curvature of block 1206 prevent tube
1002 from kinking. Tube 1002 is releasably secured to block 1206
and under tension by strap 1204. Using support 1200 in this manner
allows the pneumostomy instrument 1000 to be secured to the chest
of the patient in a low profile configuration during the post
operative period while maintaining the alignment of the pneumostoma
110.
[0201] FIG. 12C also illustrates the use of a discharge trap 1220
with pneumostomy instrument 1000. During the immediate
postoperative period, there may be drainage of blood and other
fluids through pneumostomy instrument 1000 in addition to gases
from the lung. It is desirable to contain such discharge using a
passive of vacuum discharge trap. Discharge trap 1220 has a fitting
1224 to mate with the female luer fitting of pneumostomy instrument
1000. Gases and/or discharge flow though the fitting 1224 into a
vessel 1222 via a valve 1226. Valve 1226 is a one-way valve which
prevents discharge from reentering the pneumostomy instrument from
vessel 1222. Discharge 1230 may collect in vessel 1222 which may be
emptied or changed when necessary. Gases may escape from vessel
1222 through outlet 1228. Outlet 1228 preferably includes a
hydrophobic filter element to prevent the exit of discharge from
vessel 1222. Outlet 1228 may vent to atmosphere or may
alternatively be connected to a regulated vacuum source (such as a
medical vacuum line).
[0202] Support 1200 may be used instead of or in addition to flange
1050 of pneumostomy instrument 1000 (not shown but see FIG. 10A).
FIG. 12D shows a sectional view through a support 1200a to
illustrate the use of a support 1200a in conjunction with a
pneumostomy instrument 1000 having a flange 1050 (See FIG. 10A).
Support 1200a is similar to support 1200 but has adaptations to
make it compatible with flange 1050. Block 1206a is secured to the
skin 114 of chest 100 adjacent flange 1050 by adhesive backing
1202a. Block 1206a and adhesive backing 1202a are adapted to
provide sufficient space for flange 1050. Block 1206a may also be
provided with a clip, strap or other fastener to secure support
1200a to flange 1050. As shown in FIG. 12D tube 1002 is aligned
perpendicular to the wall of chest 100 where tube 1002 exits chest
100. Flange 1050 works in conjunction with block 1206a to align
tube 1002 and apply tension to tube 1002. Using support 1200a in
this manner again allows the pneumostomy instrument 1000 to be
secured to the chest of the patient in a low profile configuration
during the post operative period while maintaining the alignment of
the pneumostoma 110.
[0203] FIG. 12D also illustrates the use of a cap 1240 with
pneumostomy instrument 1000. During the immediate postoperative
period there may be drainage of blood and other fluids through
pneumostomy instrument 1000 in addition to gases from the lung.
After a few days however, there may be little further drainage.
Thus, it may be possible to remove the discharge trap or vacuum
source attached to instrument 1050. In order to prevent
contaminants entering the lung through pneumostomy instrument 1000,
a cap 1240 may be used to close the lumen of the instrument. Cap
1240 has a fitting 1244 to mate with the female luer fitting of
pneumostomy instrument 1000. Cap 1240 may optionally be provided
with a vent 1242 to allow gases to escape. Cap 1240 may be used to
enhance patient mobility with occasional use of a discharge trap or
vacuum aspiration to clear any discharge from instrument 1000.
[0204] Supports 1200, 1200a may be used in conjunction with a
second support 1250. FIG. 12E shows a sectional view through a
support 1200a to illustrate the use of a support 1200a in
conjunction with a pneumostomy instrument 1000 having a flange 1050
(See FIG. 10A) and with a second support 1250. Second support 1250
comprises a block 1256 secured to the skin 114 of chest 100
adjacent flange 1050 by adhesive backing 1252. Block 1256 and
adhesive backing 1252 are adapted to provide sufficient space for
flange 1050. Block 1256 may also be provided with a clip, strap or
other fastener (not shown) to secure second support 1250 to flange
1050. As shown in FIG. 12D tube 1002 is aligned perpendicular to
the wall of chest 100 where tube 1002 exits chest 100. Second
support 1250 works in conjunction with support 1200a and flange
1050 to align tube 1002 and apply tension to tube 1002. Second
support 1250 helps constrain tube 1002 perpendicular to the wall of
chest 100 while relieving strain in tube 1002 that might otherwise
misalign the pneumostoma 110. Second support 1250 may in some cases
be attached to support 1200a or even formed in one piece with
support 1200a. In some embodiments, the distance between support
1250 and support 1200a may be adjusted in order to adjust the
radius of curvature of the tube 1002.
Pneumostomy Techniques Using the Alternate Pneumostomy
Instrument
[0205] The pneumostomy instrument 1000 may be utilized in any of
the pneumostomy procedures described herein including those
procedures described in FIGS. 4A-4F, 5A-5C, 6A-6C, 7A-7C and
accompanying text. FIGS. 13A and 13B are flowcharts showing the
steps of a single-phase pneumostomy technique utilizing pneumostomy
instrument 1000. In these single-phase techniques no prior
pleurodesis is required ahead of the procedure. In the percutaneous
single-phase procedure (FIG. 13A), the pneumostomy instrument 1000
is introduced without collapsing the lung. In the open single-phase
procedure (FIG. 13B). The lung may be allowed to inflate prior to
insertion of pneumostomy instrument 1000 and then reinflated after
pneumostomy instrument 1000 is secured within the lung.
Percutaneous Technique
[0206] Referring first FIG. 13A which shows the steps of the
percutaneous single-phase technique 1300 utilizing pneumostomy
instrument 1000. Pneumostomy instrument 1000 is first assembled
with percutaneous insertion tool 1100 as shown in FIG. 11A (step
1302). In this configuration the expanding head is secured in a
low-profile configuration ready for insertion into the lung. The
patient is prepared (step 1304) using local anesthesia at the
target site in addition to a sedative or general anesthesia. A
chest tube is preferably inserted into the pleural cavity as a
prophylactic measure. The physician optionally makes an incision at
the target location and dissects to the parietal membrane (step
1306). The physician optionally introduces a pleurodesis agent to
the outer surface of the parietal membrane or, by injection,
through the parietal membrane into the pleural space at the target
location (step 1308) to promote pleurodesis between the visceral
and parietal membranes after the procedure. One or more of the
pleurodesis agents discussed above may be used in order to promote
pleurodesis formation following the procedure however it is not
expected that the pleurodesis will form during the procedure
itself. At step 1310, the physician inserts the pneumostomy
instrument and percutaneous insertion tool through the parietal and
visceral membranes using the percutaneous insertion tool. Insertion
is made by way of the incision if made, or otherwise directly
through the chest wall if no prior incision was made. The
pneumostomy instrument is inserted until the expanding head is
through the visceral membrane and embedded within the parenchymal
tissue of the lung. Because there has been no pleurodesis between
the parietal membrane and visceral membrane, a small amount of air
may leak into the pleural cavity around tube pneumostomy
instrument. However, the chest tube should be able to extract the
small amount of air and the lung will remain inflated and pushed
against the chest wall.
[0207] Referring again to FIG. 13A, at step 1312 the physician
releases the expanding head and allows it to expand within the
parenchymal tissue of the lung. Note that in some embodiments an
actuator automatically deploys the expanding head after it is
positioned with the lung. At step 1314, the suture and stop may be
pulled through the open Tuohy and the Tuohy closed to secure the
expanding head in the expanded configuration. The percutaneous
insertion tool is removed from the main lumen of pneumostomy
instrument (this step may alternatively be performed before balloon
inflation). At step 1316, the flange or instrument support is
secured to the skin of the chest of the patient adjacent the
instrument. At step 1318 a slight tension is applied to the tube of
the pneumostomy instrument, drawing the expanding head and lung
towards thoracic wall. The tension brings the parietal membrane and
visceral membrane into contact. The contact between the parietal
membrane and visceral membrane reduces or eliminates any remaining
air leak around the instrument. Moreover, the contact between the
parietal membrane and visceral membrane allows pleurodesis to occur
resulting in adhesion between the pleural membranes and sealing of
the pneumostoma from the pleural cavity. Some or the entirety of
the pneumostomy instrument may be coated and/or impregnated with a
pleurodesis agent to promote the formation of the pleurodesis.
After the tension is applied, the pneumostomy instrument is secured
to the flange or instrument support (step 1320).
[0208] The remainder of the instrument is then secured to the
chest/abdomen of the patient (step 1322). In some procedures it may
be desirable to apply a water seal or slight vacuum to the
instrument during the immediate postoperative period to collect
blood and discharge and reduce the opportunity for any infectious
agents to enter the lung. If an incision was made, it is now closed
using sutures, staples and/or tissue glue. The patient is then
monitored to ensure that pneumothorax has not occurred. A chest
tube is inserted or maintained as necessary until it is clear that
there is no leakage of air into the pleural cavity. Air flow
through the pneumostomy instrument is also monitored. Healing of
the pneumostoma is monitored and the pneumostomy instrument is
removed when the physician believes the pneumostoma is sufficiently
stable to tolerate the removal of the instrument (see FIG.
13C).
Open Technique
[0209] Referring next to FIG. 13B which shows the steps of the open
single-phase technique 1330 utilizing pneumostomy instrument 1000.
Pneumostomy instrument 1000 is first assembled with mandrel 1040 as
shown in FIG. 10A (step 1332). In this configuration the expanding
head is secured in a low-profile configuration ready for insertion
into the lung. The patient is prepared (step 1334) using local
anesthesia at the target site in addition to a sedative or general
anesthesia. If a general anesthesia is applied the patient will
also be intubated and ventilated. A chest tube is inserted into the
pleural cavity. The physician makes an incision at the target
location and dissects to the parietal membrane (step 1336). At step
1338 the surgeon makes an incision through the parietal membrane
and enters the pleural cavity. At step 1340 the physician
visualizes the lung, and engages it with a surgical tool, and
secures the lung to the chest wall adjacent the incision. The
surgeon may use sutures, staples, clips, surgical adhesive and/or a
surgical adhesive patch to secure the visceral membrane of the lung
to the chest wall in step 1340. The physician optionally introduces
a pleurodesis agent to the outer surface of the parietal membrane
or, by injection, through the parietal membrane into the pleural
space at the target location (step 1338) to promote pleurodesis
between the visceral and parietal membranes after the procedure.
One or more of the pleurodesis agents discussed above may be used
in order to promote pleurodesis formation following the procedure
however it is not expected that the pleurodesis will form during
the procedure itself.
[0210] At step 1344, the physician makes an incision through the
visceral membrane and inserts the pneumostomy instrument and
mandrel through the incision into the parenchymal tissue of the
lung. The pneumostomy instrument is inserted until the expanding
head is through the visceral membrane and embedded within the
parenchymal tissue of the lung. Counter pressure may need to be
applied to secure the lung as the pneumostomy instrument is
inserted.
[0211] Referring again to FIG. 13B, at step 1346 the physician
releases the expanding head and allows it to expand within the
parenchymal tissue of the lung. At step 1348, the suture and stop
may be pulled through the open Tuohy and the Tuohy closed to secure
the expanding head in the expanded configuration. The mandrel may
also be removed from the main lumen of pneumostomy instrument. At
step 1350, the incision in the chest wall is closed around the tube
of the pneumostomy instrument. At step 1352 the pneumostomy
instrument is then tensioned and secured as described in steps
1316-1322 of FIG. 13A.
[0212] With the incision closed and slight tension applied to the
pneumostomy instrument, the removal of air through the chest tube
will be sufficient to reinflate the lung. The patient is then
monitored to ensure that the lung inflates. A chest tube is
inserted or maintained as necessary until it is clear that there is
no leakage of air into the pleural cavity. Air flow though the
pneumostomy instrument is also monitored. Healing of the
pneumostoma is monitored (step 1354) and the pneumostomy instrument
is removed when the physician believes the pneumostoma is
sufficiently stable to tolerate the removal of the instrument (see
FIG. 13C).
Removal of Pneumostomy Instrument
[0213] When the physician considers that the pneumostoma has healed
adequately, the pneumostomy instrument is removed and the
pneumostoma is inspected. The physician will then verify the size
of the pneumostoma and provide a pneumostoma management device
(PMD) of the appropriate size. Removal of the pneumostomy
instrument requires that the expanding basket be collapsed to the
low profile configuration.
[0214] Referring next to FIG. 13C which shows the steps (1360) for
removal of the pneumostomy instrument 1000. The surgeon should
first assess the healing and stability of the pneumostoma (step
1362). The pneumostomy instrument should not be removed until the
pneumostoma is sufficiently healed to tolerate the removal
procedure. The patient is prepared (step 1364). A local anesthesia
may be applied and a sedative provided. A chest tube should be
available in case removal of the pneumostomy instrument causes
leakage of air into the pleural cavity. The pneumostomy instrument
is first released from the flange and/or instrument support (step
1366). The flange and/or support are then released from the chest
of the patient (step 1368) providing access to inspect and clean
the stoma. The Tuohy is opened to release the stop which secured
the expanding basket in the expanded position (step 1370). A
mandrel is then inserted into the pneumostomy instrument causing
the expanding basket (within the lung) to collapse to a low profile
configuration (step 1372). The pneumostomy instrument is then
withdrawn from the pneumostoma (step 1374). The pneumostoma should
be quickly assessed (step 1376). A pneumostoma management device
should then be inserted into the pneumostoma to preserve patency
during the continued healing period (step 1378). The patient should
be observed to ensure that the procedure has not caused leakage of
air into the pleural cavity. If leakage occurs a chest tube should
be inserted into the pleural cavity (at another site) until the air
leakage is resolved. The patient will be provided with standard
postoperative care transitioning to outpatient care and continued
pulmonary rehabilitation step 1380). The first pneumostoma
management device will typically be left in place till the first
outpatient visit to a physician. At the first outpatient visit, the
first pneumostoma management device will be removed, the
pneumostoma inspected again. The physician or more typically the
patient under the physician's direction will then insert the next
PMD. The PMD's will thereafter be exchanged by the patient or a
caregiver on a regular basis and/or as needed.
Materials
[0215] In preferred embodiments, the pneumostomy instruments and
PMD are formed from biocompatible polymers or biocompatible metals.
In a particular embodiment pneumostomy catheter 300 and PMD 800 are
made from PEBAX, polypropylene and ABS. The balloon of the
pneumostomy catheter 300 is preferably made of polyurethane or the
equivalent In a preferred embodiment, pneumostomy instrument 1000
is made from C-FLEX.RTM. thermoplastic elastomer manufactured by
Saint-Gobain Performance Plastics in Clearwater, Fla. A patient
will typically have pneumostomy catheter implanted for from one to
two weeks depending upon the time required for the pneumostoma to
heal and form and thus the materials, particularly of pneumostomy
catheter 300, should meet high standards for biocompatibility. In
general, preferred materials for manufacturing a pneumostomy
instrument or PMD are biocompatible thermoplastic elastomers that
are readily utilized in injection molding and extrusion processing.
As will be appreciated, other suitable similarly biocompatible
thermoplastic or thermoplastic polymer materials can be used
without departing from the scope of the invention. Biocompatible
polymers for manufacturing PMD may be selected from the group
consisting of polyethylenes (HDPE), polyvinyl chloride,
polyacrylates (polyethyl acrylate and polymethyl acrylate,
polymethyl methacrylate, polymethyl-coethyl acrylate,
ethylene/ethyl acrylate), polycarbonate urethane (BIONATEG),
polysiloxanes (silicones), polytetrafluoroethylene (PTFE,
GORE-TEX.RTM., ethylene/chlorotrifluoroethylene copolymer,
aliphatic polyesters, ethylene/tetrafluoroethylene copolymer),
polyketones (polyaryletheretherketone, polyetheretherketone,
polyetherether-ketoneketone, polyether-ketoneetherketoneketone
polyetherketone), polyether block amides (PEBAX, PEBA), polyamides
(polyamideimide, PA-11, PA-12, PA-46, PA-66), polyetherimide,
polyether sulfone, poly(iso)butylene, polyvinyl chloride, polyvinyl
fluoride, polyvinyl alcohol, polyurethane, polybutylene
terephthalate, polyphosphazenes, nylon, polypropylene,
polybutester, nylon and polyester, polymer foams (from carbonates,
styrene, for example) as well as the copolymers and blends of the
classes listed and/or the class of thermoplastics and elastomers in
general. Reference to appropriate polymers that can be used for
manufacturing a pneumostomy instrument or PMD can be found in the
following documents: PCT Publication WO 02/02158, entitled
"Bio-Compatible Polymeric Materials;" PCT Publication WO 02/00275,
entitled "Bio-Compatible Polymeric Materials;" and, PCT Publication
WO 02/00270, entitled "Bio-Compatible Polymeric Materials" all of
which are incorporated herein by reference. Other suitable
materials for the manufacture of the pneumostomy instrument or PMD
include medical grade inorganic materials such stainless steel,
titanium, ceramics and coated materials.
[0216] Additionally, components of the PMD and/or pneumostomy
instrument that are in contact with the pneumostoma before or after
healing may be designed to deliver a pharmaceutically-active
substance. For purposes of the present disclosure, an "active
pharmaceutical substance" is an active ingredient of vegetable,
animal or synthetic origin which is used in a suitable dosage as a
therapeutic agent for influencing conditions or functions of the
body, as a replacement for active ingredients naturally produced by
the human or animal body and to eliminate or neutralize disease
pathogens or exogenous substances. The release of the substance in
the pneumostoma has an effect on the course of healing and/or
counteracts pathological changes in the tissue due to the presence
of the temporarily implanted medical devices. In particular, it is
desirable in some embodiments to coat or impregnate the PMD with
pharmaceutically-active substances that preserve the patency of
pneumostoma and/or are antimicrobial in nature but that do not
unduly irritate the tissues of the pneumostoma. In particular, it
is also desirable in some embodiments to coat or impregnate the
pneumostoma instrument with pharmaceutically-active substances that
aid pleurodesis, healing and/or epithelialization of the
pneumostoma and/or are antimicrobial in nature but that do not
unduly irritate the tissues of the pneumostoma.
[0217] In particular cases, suitable pharmaceutically-active
substances may have an anti-inflammatory and/or antiproliferative
and/or spasmolytic and/or endothelium-forming effect, so that the
functionality of the pneumostoma is maintained. Suitable
pharmaceutically-active substances include:
anti-proliferative/antimitotic agents including natural products
such as vinca alkaloids (i.e. vinblastine, vincristine, and
vinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide,
teniposide), antibiotics (dactinomycin (actinomycin D)
daunorubicin, doxorubicin and idarubicin), anthracyclines,
mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin,
enzymes (L-asparaginase which systemically metabolizes L-asparagine
and deprives cells which do not have the capacity to synthesize
their own asparagine); antiplatelet agents such as G(GP) llb/llla
inhibitors and vitronectin receptor antagonists;
anti-proliferative/antimitotic alkylating agents such as nitrogen
mustards (mechlorethamine, cyclophosphamide and analogs, melphalan,
chlorambucil), ethylenimines and methylmelamines
(hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan,
nirtosoureas (carmustine (BCNU) and analogs, streptozocin),
trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic
antimetabolites such as folic acid analogs (methotrexate),
pyrimidine analogs (fluorouracil, floxuridine, and cytarabine),
purine analogs and related inhibitors (mercaptopurine, thioguanine,
pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum
coordination complexes (cisplatin, carboplatin), procarbazine,
hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen);
anti-coagulants (heparin, synthetic heparin salts and other
inhibitors of thrombin); fibrinolytic agents (such as tissue
plasminogen activator, streptokinase and urokinase), aspirin,
dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory;
antisecretory (breveldin); anti-inflammatory: such as
adrenocortical steroids (cortisol, cortisone, fludrocortisone,
prednisone, prednisolone, 6a-methylprednisolone, triamcinolone,
betamethasone, and dexamethasone), non-steroidal agents (salicylic
acid derivatives i.e. aspirin; para-aminophenol derivatives i.e.
acetaminophen; indole and indene acetic acids (inaperturethacin,
sulindac, and etodalac), heteroaryl acetic acids (tolmetin,
diclofenac, and ketorolac), arylpropionic acids (ibuprofen and
derivatives), anthranilic acids (mefenamic acid, and meclofenamic
acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and
oxyphenthatrazone), nabumetone, gold compounds (auranofin,
aurothioglucose, gold sodium thiomalate); immunosuppressives:
(cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin),
azathioprine, mycophenolate mofetil); angiogenic agents: vascular
endothelial growth factor (VEGF), fibroblast growth factor (FGF);
angiotensin receptor blockers; nitric oxide donors; antisense
oligionucleotides and combinations thereof; cell cycle inhibitors,
mTOR inhibitors, and growth factor receptor signal transduction
kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMG co-enzyme
reductase inhibitors (statins); silver compound and protease
inhibitors.
[0218] In some embodiments, the active pharmaceutical substance is
selected from the group consisting of amino acids, anabolics,
analgesics and antagonists, anaesthetics, anti-adrenergic agents,
anti-asthmatics, anti-atherosclerotics, antibacterials,
anticholesterolics, anti-coagulants, antidepressants, antidotes,
anti-emetics, anti-epileptic drugs, anti-fibrinolytics,
anti-inflammatory agents, antihypertensives, antimetabolites,
antimigraine agents, antimycotics, antinauseants, antineoplastics,
anti-obesity agents, antiprotozoals, antipsychotics,
antirheumatics, antiseptics, antivertigo agents, antivirals,
appetite stimulants, bacterial vaccines, bioflavonoids, calcium
channel blockers, capillary stabilizing agents, coagulants,
corticosteroids, detoxifying agents for cytostatic treatment,
diagnostic agents (like contrast media, radiopaque agents and
radioisotopes), electrolytes, enzymes, enzyme inhibitors, ferments,
ferment inhibitors, gangliosides and ganglioside derivatives,
hemostatics, hormones, hormone antagonists, hypnotics,
immunomodulators, immunostimulants, immunosuppressants, minerals,
muscle relaxants, neuromodulators, neurotransmitters and
neurotrophins, osmotic diuretics, parasympatholytics,
para-sympathomimetics, peptides, proteins, psychostimulants,
respiratory stimulants, sedatives, serum lipid reducing agents,
smooth muscle relaxants, sympatholytics, sympathomimetics,
vasodilators, vasoprotectives, vectors for gene therapy, viral
vaccines, viruses, vitamins, oligonucleotides and derivatives,
saccharides, polysaccharides, glycoproteins, hyaluronic acid, and
any excipient that can be used to stabilize a proteinaceous
therapeutic.
[0219] The foregoing description of preferred embodiments of the
present invention has been provided for the purposes of
illustration and description. It is not intended to be exhaustive
or to limit the invention to the precise forms disclosed. Many
embodiments were chosen and described in order to best explain the
principles of the invention and its practical application, thereby
enabling others skilled in the art to understand the invention for
various embodiments and with various modifications that are suited
to the particular use contemplated. It is intended that the scope
of the invention be defined by the claims and their
equivalents.
* * * * *