U.S. patent application number 12/388459 was filed with the patent office on 2009-08-20 for methods and devices for follow-up care and treatment of a pneumostoma.
This patent application is currently assigned to Portaero, Inc.. Invention is credited to David C. Plough, Don Tanaka, Joshua P. Wiesman.
Application Number | 20090205665 12/388459 |
Document ID | / |
Family ID | 40953964 |
Filed Date | 2009-08-20 |
United States Patent
Application |
20090205665 |
Kind Code |
A1 |
Tanaka; Don ; et
al. |
August 20, 2009 |
METHODS AND DEVICES FOR FOLLOW-UP CARE AND TREATMENT OF A
PNEUMOSTOMA
Abstract
A pneumostoma assessment and treatment system includes methods
and devices for aftercare of a pneumostoma and for additional
patient care utilizing a pneumostoma. The system utilizes a number
of modalities to assess the health and functionality of the
pneumostoma, the lungs and/or the patient as a whole. In response
to an assessment of the health and functionality of the
pneumostoma, lungs and patient, the tissues of pneumostoma may be
treated with a treatment device and utilizing one or more different
modalities to preserve or enhance the health and function of the
pneumostoma and/or treat other conditions of the patient.
Inventors: |
Tanaka; Don; (Saratoga,
CA) ; Wiesman; Joshua P.; (Boston, MA) ;
Plough; David C.; (Portolla 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.: |
12/388459 |
Filed: |
February 18, 2009 |
Related U.S. Patent Documents
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Application
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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 |
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61088118 |
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61143298 |
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61151581 |
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Current U.S.
Class: |
128/205.27 ;
128/200.24 |
Current CPC
Class: |
A61B 2017/00809
20130101; A61M 2202/064 20130101; A61M 39/0247 20130101; A61M 25/02
20130101; A61M 25/04 20130101; A61M 2205/075 20130101; A61M 11/042
20140204; A61M 15/0085 20130101; A61M 15/02 20130101; A61M 11/00
20130101; A61M 2039/0252 20130101; A61M 1/04 20130101; A61M 11/005
20130101; A61M 15/009 20130101; A61M 2039/0276 20130101; A61M
16/0833 20140204; A61M 16/0816 20130101; A61M 2202/025 20130101;
A61M 39/02 20130101; A61M 2205/7536 20130101; A61M 27/00 20130101;
A61M 2205/7518 20130101; A61M 16/202 20140204; A61M 2202/0208
20130101; A61M 25/10 20130101; A61M 13/00 20130101; A61K 9/007
20130101 |
Class at
Publication: |
128/205.27 ;
128/200.24 |
International
Class: |
A61M 16/00 20060101
A61M016/00 |
Claims
1. A method for treating a pneumostoma into a lung of a patient
comprising; (a) removing a pneumostoma management device from the
pneumostoma; (b) inserting the treatment part of a pneumostoma
treatment instrument into the pneumostoma; (c) treating the
pneumostoma with the treatment part so as to maintain and/or
enhance escape of gases from the lung through the pneumostoma; (d)
removing the treatment part of the pneumostoma treatment instrument
from the pneumostoma; and (e) inserting a pneumostoma management
device into the pneumostoma.
2. The method of claim 1, wherein the method steps are performed in
the order of (a), (b), (c), (d) then (e).
3. The method of claim 1, further comprising: (f) selecting a
pneumostoma treatment instrument for treating the pneumostoma prior
to step (b).
4. The method of claim 1, further comprising: (f) determining a
dimension of the pneumostoma; and (g) configuring the pneumostoma
treatment instrument based on the dimension of the pneumostoma
prior to step (b).
5. The method of claim 1, further comprising: (f) selecting a
portion of a tissue of the pneumostoma being less than all of the
tissue of the pneumostoma to treat with the treatment part; wherein
step (b) comprises inserting the treatment part of the pneumostoma
treatment instrument into the pneumostoma so as to treat a portion
of tissue of the pneumostoma selected in step (f); and, wherein
step (c) comprises treating the portion of tissue of the
pneumostoma selected in step (f) with the pneumostoma treatment
part so as to maintain and/or enhance the escape of gases from the
lung through the pneumostoma without treating other tissue of the
pneumostoma with the treatment part.
6. The method of claim 1, further comprising the step of: (f)
applying one or more of suction and irrigation to the
pneumostoma.
7. The method of claim 1, further comprising the step of (f)
applying one or more of suction and irrigation to the pneumostoma
after step (c) and before step (e).
8. The method of claim 1, wherein the pneumostoma treatment device
comprises an energy source and wherein the method comprises: (c)
applying energy to the pneumostoma with the treatment part so as to
maintain and/or enhance the escape of gases from the lung through
the pneumostoma.
9. The method of claim 1, wherein the pneumostoma treatment device
comprises an electromagnetic energy source and wherein the method
comprises: (c) applying electromagnetic energy to the pneumostoma
with the treatment part so as to maintain and/or enhance the escape
of gases from the lung through the pneumostoma.
10. The method of claim 1, wherein the pneumostoma treatment device
comprises a sound source, wherein the sound source supplies one or
more of infrasound, acoustic sound and infrasound and wherein the
method comprises: (c) applying sound to the pneumostoma with the
treatment part so as to maintain and/or enhance the escape of gases
from the lung through the pneumostoma.
11. The method of claim 1, wherein the pneumostoma treatment part
comprises a temperature-controlled surface and wherein the method
comprises: (b) inserting the treatment part of the pneumostoma
treatment instrument into the pneumostoma so as to bring the
temperature-controlled surface into contact with a tissue of the
pneumostoma; and (c) treating the tissue of the pneumostoma with
the treatment part by changing the temperature of the tissue away
from body temperature for a selected period of time so as to
maintain and/or enhance the escape of gases from the lung through
the pneumostoma.
12. The method of claim 1, wherein the pneumostoma treatment part
comprises a temperature-controlled surface and wherein the method
comprises: (b) inserting the treatment part of the pneumostoma
treatment instrument into the pneumostoma so as to bring the
temperature-controlled surface into contact with a tissue of the
pneumostoma; and (c) treating the tissue of the pneumostoma with
the temperature-controlled surface of the treatment part by cooling
the tissue to a temperature lower than body temperature for a
selected period of time so as to maintain and/or enhance the escape
of gases from the lung through the pneumostoma.
13. A method for treating a tissue of a surgically-created passage
which passes through a thoracic wall, parietal membrane and
visceral membrane into a lung of a patient and through which gasses
may escape from the lung, the parietal membrane being sealed to the
visceral membrane surrounding the passage, wherein the method
comprises; (a) selecting a treatment device having a treatment
probe; (b) inserting the treatment probe of the treatment device
into the passage; (c) treating a tissue of the passage with the
treatment probe; (d) removing the treatment probe from the passage;
and (e) inserting a tube into the passage through which gases may
escape the lung via the chest wall.
14. The method of claim 13, wherein step (c) comprises treating a
tissue of the passage with the treatment probe to enhance escape of
gases from the lung through the passage.
15. The method of claim 13, wherein the method steps are performed
in the order (a) (b) (c) (d) (e).
16. The method of claim 13, further comprising: (f) determining a
dimension of the passage; and (g) configuring the treatment device
based on the dimension of the passage prior to step (b).
17. The method of claim 13, further comprising: (f) selecting a
tissue of the passage being less than all of the tissue of the
passage to treat with the treatment device; and wherein step (c)
comprises selectively treating the portion of a tissue of the
passage selected in step (f) with the treatment probe without
treating other tissues of the passage with the treatment part.
18. The method of claim 13, further comprising the step of (f)
applying one or more of suction and irrigation to the passage after
step (b) and before step (e).
19. The method of claim 13, wherein the treatment device comprises
a means for transmitting energy and wherein the method comprises:
(c) applying energy to a tissue of the passage with the treatment
probe.
20. The method of claim 13, wherein the treatment probe comprises a
coolable surface and wherein the method comprises: (b) inserting
the treatment probe into the passage so as to bring the coolable
surface into contact with a tissue of the passage; and (c) treating
the tissue of the passage with the coolable surface of the
treatment part by cooling the tissue to a temperature lower than
body temperature for a selected period of time.
21. A method for treating a tissue of a stoma which passes through
a thoracic wall, parietal membrane and visceral membrane into a
lung of a patient and through which gasses may escape from the
lung, the parietal membrane being sealed to the visceral membrane
surrounding a passage, wherein the method comprises; (a) selecting
a treatment device having a treatment probe; (b) measuring a
dimension of the stoma; (c) configuring the treatment probe in
response to the dimension of the stoma; (d) inserting the treatment
probe into the stoma; (e) treating a tissue of the stoma with the
treatment probe so as to promote the escape of gases from the lung
through the stoma; and (f) removing the treatment probe from the
stoma.
22. The method of claim 21 further comprising: (g) selecting some
but not all of the tissue of the stoma to treat with the treatment
probe so as to promote the escape of gases from the lung through
the stoma; and wherein step (c) comprises selectively treating the
some but not all of the tissue of the stoma selected in step (g)
with the treatment probe so as to promote the escape of gases from
the lung through the stoma.
23. The method of claim 21, further comprising the step of (g)
removing a material from the stoma.
24. The method of claim 21, further comprising: (g) inserting a
tube into the stoma through which gases may escape the lung via the
chest wall.
25. The method of claim 21, wherein the treatment device comprises
a means for transmitting energy and wherein the method comprises:
(c) applying energy to a tissue of the stoma with the treatment
probe.
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. 18,
2009, entitled "PERCUTANEOUS SINGLE-PHASE SURGICAL PROCEDURE FOR
CREATING A PNEUMSOTOMA TO TREAT CHRONIC OBSTRUCTIVE PULMONARY
DISEASE" (Attorney Docket No. LUNG1-06000US4);
[0019] 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)
[0020] 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);
[0021] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ASPIRATOR FOR PNEUMOSTOMA MANAGEMENT" (Attorney
Docket No. LUNG1-06011US1);
[0022] U.S. patent application Ser. No. 12/______, filed Feb. 18,
2009, entitled "ASPIRATOR AND METHOD FOR PNEUMOSTOMA MANAGEMENT"
(Attorney Docket No. LUNG1-06011US2);
[0023] 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);
[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 PULJMONARY 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),
therapeutic agents (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. None of the surgical approaches to
treatment of COPD has been widely adopted. Therefore, a large unmet
need remains for a medical procedure that can sufficiently
alleviate the debilitating effects of COPD and emphysema and is
accepted by physicians and patients.
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 pleurodesis between the visceral and parietal membranes
surrounding the passageway as it enters the lung. The pleurodesis
creates an adhesion between the pleural membrane surrounding the
passageway which prevents air from entering the pleural cavity and
causing a pneumothorax (deflation of the lung due to air pressure
in the pleural cavity). Pleurodesis results from a fibrotic healing
response between the pleural membranes and may be localized to the
vicinity of the passageway. 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 is
referred to herein as a pneumostoma. The 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, reduces expiratory
pressures, reduces dyspnea, and 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. 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 or sealing off a portion of the lung or
transplanting a lung.
[0038] The present invention provides methods and devices for
assessing, and treating the health and functionality of a
pneumostoma. Utilizing the methods and devices of the present
invention a physician can enhance the health, patency and/or
effectiveness of a pneumostoma thereby enhancing the remediation of
COPD. Other objects, features and advantages of the invention are
apparent from drawings and detailed description to follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] The above and further features, advantages and benefits of
the present invention are apparent upon consideration of the
present description taken in conjunction with the accompanying
drawings.
[0040] FIG. 1A shows the chest of a patient indicating alternative
locations for a pneumostoma that may be managed using the devices
and methods of the present invention.
[0041] FIG. 1B shows a sectional view of the chest illustrating the
relationship between the pneumostoma, lung and natural airways.
[0042] FIG. 1C shows a detailed sectional view of a
pneumostoma.
[0043] FIG. 1D shows a perspective view of a pneumostoma management
device.
[0044] FIG. 1E shows the chest of a patient showing the pneumostoma
management device positioned at alternative pneumostoma
locations.
[0045] FIG. 1F shows a detailed sectional view of a pneumostoma
management device positioned inside a pneumostoma.
[0046] FIG. 2A is a flow chart illustrating general steps for
follow-up care and assessment of a patient having a pneumostoma
according to an embodiment of the invention.
[0047] FIG. 2B is a flow chart illustrating general steps for
follow-up care and treatment of a patient having a pneumostoma
according to an embodiment of the invention.
[0048] FIG. 3A shows an exterior view of an instrument for internal
inspection of a pneumostoma according to an embodiment of the
invention.
[0049] FIG. 3B shows a sectional view of the instrument for
internal inspection of a pneumostoma of FIG. 3A positioned within a
pneumostoma.
[0050] FIG. 3C shows an exterior view of an alternative instrument
for internal inspection of a pneumostoma according to an embodiment
of the invention.
[0051] FIG. 3D is a flow chart illustrating steps for examination
of a pneumostoma with a pneumoscope according to an embodiment of
the invention.
[0052] FIG. 4A shows a view of a spirometry system for assessing
the functionality of a pneumostoma according to an embodiment of
the present invention.
[0053] FIG. 4B shows a view of a gas analysis system for assessing
the functionality of a pneumostoma according to an embodiment of
the present invention.
[0054] FIG. 4C shows a view of lung imaging system for imaging gas
diffusion from a pneumostoma according to an embodiment of the
present invention.
[0055] FIG. 4D and 4E show views of a diagnostic device for
delivering diagnostic gas to a pneumostoma or sampling gas from a
pneumostoma according to embodiments of the present invention.
[0056] FIGS. 5A-5C show views of a device for cleaning and treating
the pneumostoma according to an embodiment of the invention.
[0057] FIG. 5D is a flow chart illustrating steps for treatment of
a pneumostoma with suction, irrigation and/or lavage according to
an embodiment of the invention.
[0058] FIG. 6A shows a view of an ultrasound device for cleaning or
treating the pneumostoma according to an embodiment of the
invention.
[0059] FIG. 6B shows a view of a sound-wave therapy device for
cleaning or treating the pneumostoma according to an embodiment of
the invention.
[0060] FIG. 6C is a flow chart illustrating steps for treatment of
a pneumostoma with sound and/or ultrasound according to an
embodiment of the invention.
[0061] FIGS. 7A-7D show views of a mechanical instrument for
dilating the pneumostoma or a portion of the pneumostoma according
to an embodiment of the present invention.
[0062] FIG. 7E is a flow chart illustrating steps for treatment of
a pneumostoma with a mechanical instrument for dilating the
pneumostoma according to an embodiment of the invention.
[0063] FIG. 7F shows an alternative mechanical instrument for
dilating the pneumostoma or a portion of the pneumostoma according
to an embodiment of the present invention.
[0064] FIG. 7G shows an alternative mechanical instrument for
dilating the pneumostoma or a portion of the pneumostoma according
to an embodiment of the present invention.
[0065] FIGS. 8A-8C show views of a thermotherapy device for
treating tissues of a pneumostoma according to an embodiment of the
present invention.
[0066] FIGS. 8D-8E show views of an alternate thermotherapy device
for treating tissues of a pneumostoma according to an embodiment of
the present invention.
[0067] FIGS. 9A-9B show views of an electromagnetic treatment
device for treating tissues of the pneumostoma according to an
embodiment of the present invention.
[0068] FIG. 9C shows a view of an alternate electromagnetic
treatment device for treating tissues of the pneumostoma according
to an embodiment of the present invention.
[0069] FIG. 9D shows a view of an alternate electromagnetic
treatment device for treating tissues of the pneumostoma according
to an embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0070] 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 are
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 Formation and Anatomy
[0071] FIG. 1A shows the chest of a patient identifying alternative
locations for creating a pneumostoma that may be managed using the
system 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
third intercostal space on the mid-clavicular line. Thus the
pneumostoma 110 is located on the front of the chest between the
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.
[0072] 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
fourth or fifth intercostal space under the left arm 104. 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. The upper
lobe is the preferred location for a pneumostoma as the upper lobe
tends to move less during breathing. However depending upon the
patient, it may be desirable to position a pneumostoma in any one
of the lobes of the lung including the lower lobes.
[0073] 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 to form an anastomosis. The anastomosis is
joined and sealed by sealing the channel from the pleural cavity
using adhesives, mechanical sealing and/or pleurodesis.
[0074] FIG. 1B shows a sectional view of chest 100 illustrating the
position of the pneumostoma 110. 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.
[0075] FIG. 1C shows a detailed sectional view of the pneumostoma
110. 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. The cavity 122 will typically conform to
the shape of the device inserted into the pneumostoma 110. An
adhesion or pleurodesis 124 surrounds the channel 120 where it
enters the lung 130. 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. In pleurodesis 124 the pleural membranes are fused
and/or adhered to one another eliminating the space between the
pleural membranes in that region.
[0076] An important feature of the pneumostoma is the seal or
adhesion 124 surrounding the channel 120 where it enters the lung
130 which may be formed by pleurodesis. Pleurodesis creates a
fusion or adhesion 124 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 adhesion 124 is
preferably localized to the region surrounding the channel 120. The
adhesion 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 may collapse.
[0077] Adhesion 124 can be created between the visceral pleura of
the lung and the inner wall of the thoracic cavity 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 therapeutic agents
(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). Pleurodesis can also be
performed 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 formed 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. Alternatively, a seal can be
created in an acute manner between the pleural membranes using
biocompatible glues, meshes or mechanical means such as clamps,
staples, clips and/or sutures. The adhesive or mechanical seal may
develop cause pleurodesis over time. 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.
[0078] 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 COPD.
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. Cavity 122 will typically
conform/adapt to the size and shape of the device inserted into the
pneumostoma.
[0079] 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. Pneumostoma 110
thus achieves many of the advantages sought by lung volume
reduction surgery without surgically removing a portion of the lung
or sealing off a portion of the lung.
[0080] Methods and instruments for forming the channel, opening,
anastomosis and pleurodesis are disclosed in applicant's pending
and issued patents and applications including those related cases
incorporated by reference above.
Pneumostoma Management Device
[0081] 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. FIGS. 1D, 1E and 1F show an example of pneumostoma
management device ("PMD") 150. FIG. 1D shows a perspective view of
PMD 150. FIG. 1E shows a view of the chest of a patient showing PMD
150 positioned in pneumostomas. FIG. 1F shows a sectional view of
PMD 150 positioned within pneumostoma 110.
[0082] Referring to FIG. 1D, PMD 150 includes a vent tube 152, a
flange 154 and a filter 156. Filter 156 prevents liquid and solid
discharge from leaking out of the PMD and such discharge is trapped
inside the pneumostoma or vent tube until the PMD is removed and
replaced. Filter 156 also prevents the entry of contaminants into
the pneumostoma. Filter 156 is preferably a hydrophobic filter to
prevent leakage of fluids into or out of the pneumostoma. Flange
154 has an adhesive coating 162 (not shown) on the distal side. The
adhesive coating 162 temporarily secures flange 154 to the skin 114
of the patient. Flange 154 also prevents over insertion of vent
tube 152 by providing a mechanical stop to further insertion.
[0083] As shown in FIGS. 1E and IF, during use, the vent tube 152
of PMD 150 is pushed into the pneumostoma 1 10. The vent tube is
configured to fit into a pneumostoma to keep the pneumostoma open.
Gases from the lung enter an opening 158 in the distal end of vent
tube 152. Vent tube 152 is sized so as to pass through the thoracic
wall into a portion of the pneumostoma 110 within the lung 130 as
shown in FIG. 1F. However, vent tube 152 but is not so long that it
causes damage to the parenchymal tissue 132 of the lung 130. Vent
tube 152 is preferably rounded over to provide an atraumatic tip
166 at the distal end. A patient is provided with a PMD having a
vent tube 152 of the appropriate length for their pneumostoma. When
the patient exhales, the pressure inside the chest is above
atmospheric pressure and gases are consequently pushed through the
central lumen of vent tube 152 and out through filter 156.
Additional details and variations of pneumostoma management devices
are described in applicant's pending and issued patents and
applications including those related cases incorporated by
reference above.
Pneumostoma Follow-Up Care
[0084] The patient is typically responsible for day-to-day
management of the pneumostoma including replacement of the PMD and
whatever daily cleaning and skin care may be required. In preferred
embodiments, the PMD is a disposable unit which is changed on a
daily basis or as needed. While changing the PMD, the patient
and/or caregiver can clean the skin surrounding the pneumostoma and
observe the condition of the pneumostoma.
[0085] A patient with a pneumostoma is also under the care of a
physician and undergoes periodic checkups to monitor the condition
of their lungs and of the pneumostoma. Moreover, the patient is
advised to visit the physician if certain conditions are observed.
The patient therefore visits the physician for regular follow-up
visits and as indicated by observed conditions. The patient will
also preferably be enrolled in a pulmonary rehabilitation program
which will include: medical evaluation and management including
monitoring patient compliance with pneumostoma care procedures;
setting short term and long-term exercise goals; therapy programs
(including smoking cessation if necessary); evaluation; and
exercise. The rehabilitation program can also monitor the
pneumostoma and refer the patient for assessment and treatment of
the pneumostoma where indicated.
[0086] The present invention provides a number of methods and
devices for pneumostoma assessment and treatment. Such assessment
and treatment is typically carried by a medical professional, for
example a physician, nurse, respiratory therapist and/or medical
assistant (this patent will use the term physician to include other
medical care providers). FIG. 2A shows general assessment steps
that may be performed when a patient visits a physician. The
physician will typically assess the lung function of the patient
(step 200). The physician will also assess each pneumostoma of the
patient. The assessment of the pneumostoma may include one or more
of an external visual inspection of the pneumostoma (step 202), an
internal visual inspection of the pneumostoma (step 204); physical
measurement of the pneumostoma (step 206), and a functional
assessment of the pneumostoma (step 208). The results of the
assessments may be compared with standard results and with prior
assessments of the patient (step 210) to determine trends and
variations in the lung/pneumostoma function. Based on the
assessment of the lung function and pneumostoma, the physician
determines whether any follow-up assessments and/or treatments are
required (step 212).
[0087] The assessment of lung function (step 200) is performed as
is typically done for COPD and emphysema patients. Such assessment
may utilize one or more of: patient questionnaire/self reporting,
spirometry (pre-/post-bronchodilator), pulmonary function test
(lung volumes), diffusion capacity (DLLO), and arterial blood gas
measurement.
[0088] In the external visual inspection (step 202) the physician
examines the opening to the pneumostoma and the skin of the chest
surrounding the pneumostoma. The physician observes any irritation,
inflammation or infection and remediates where necessary. In the
internal visual inspection (step 204) the physician examines the
inside of the pneumostoma. The physician may use a pneumostoma
inspection instrument. The pneumostoma inspection instrument
includes a short inspection tube that may be pushed into the
pneumostoma and that provides illumination and magnification for
observation of the interior of the pneumostoma. The observation may
be achieved using a direct optical train or a video device which
displays images on a video display. The pneumostoma inspection
instrument is typically provided with a range of inspection tubes
of different diameters and lengths. The physician chooses the
inspection tube appropriate to the dimensions of the pneumostoma of
the patient and is careful not to damage tissue of the pneumostoma
during insertion. During the internal visual inspection the
physician observes any irritation, inflammation or infection and
remediates where necessary. The physician also makes a qualitative
assessment of tissues surrounding the pneumostoma to determine
encroachment to the pneumostoma. The physician may also use the
pneumostoma inspection instrument to measure the diameter and
length of the pneumostoma and the shape and/or profile of the
pneumostoma. (step 206). These may be used to determine the size of
any pneumostoma management device prescribed to the patient and the
size of any instruments to be used during treatment of the
pneumostoma. This step also allows the physician to monitor any
tissue encroachment into the pneumostoma as indicated by change in
dimensions of the pneumostoma over time.
[0089] In the functional assessment of the pneumostoma (step 208)
the physician examines the ability of gas to pass through the
pneumostoma. The ability of gas to pass through the pneumostoma may
be measured in a number of ways. First, gas flow through the
pneumostoma can be measured passively by placing a device over the
pneumostoma which measures airflow out of and/or into the
pneumostoma during regular breathing of the patient. Alternatively,
gas may be provided to the pneumostoma at a slight positive
pressure from outside the chest of the patient and the rate of flow
of gas into the lung through the pneumostoma may be measured.
Alternatively, as discussed below, diagnostic gases may be
introduced through the pneumostoma to assess the patency and
functionality of the pneumostoma. The diagnostic gases may be used
for imaging the lungs and/or measuring collateral ventilation and
gas exchange. The physician may compare the results of the visual,
functional and/or structural assessment with prior assessment
results and standard assessment results to determine changes and or
trends in the results (step 210).
[0090] Based upon the results of the visual, functional and/or
structural assessment of the pneumostoma and any trends in such
results, the physician may decide to treat the pneumostoma and/or
surrounding tissues to maintain or enhance the pneumostoma (step
212). The physician will select from the available treatment
modalities a treatment suitable to maintain and/or enhance the
function of the pneumostoma in light of the assessment results.
(see step 220 of FIG. 2B). One or more treatment modalities may be
used.
[0091] FIG. 2B illustrates a general method for treatment of a
pneumostoma. First, based on the assessment results, the physician
selects a treatment modality to maintain or enhance the health
and/or functionality of the pneumostoma (step 220). For example,
suction may be used to aspirate discharge or other materials from
the pneumostoma. Irrigation/lavage may be used to introduce a
liquid into the pneumostoma in order to treat the tissue or aid in
the removal of material from the pneumostoma. Irrigation/lavage may
be used in conjunction with suction/aspiration to remove the
liquid. Suction and/or irrigation may also be used in conjunction
with a mechanical cleaning mechanism such as soft bristles,
mechanical agitation, sonic/ultrasonic agitation or the like. The
pneumostoma may be mechanically expanded using a balloon dilator,
mechanical dilator or other tools. The pneumostoma may additionally
be treated with heat, cold, light, electromagnetic radiation,
electrocautery, sound/ultrasound, and the like.
[0092] The physician next selects a pneumostoma treatment
instrument suitable to apply the treatment modality to the
pneumostoma (step 222). The selected instrument is preferably sized
such that it can be introduced into the pneumostoma and placed at a
desired depth in the pneumostoma. As pneumostomas may vary in size,
the instrument may have a configurable size, or may have a range of
different adapters. Thus selection of the instrument will include
selecting an instrument appropriate for the treatment modality and
selecting/configuring the instrument for the pneumostoma of a
particular patient.
[0093] The selected/configured instrument is introduced into the
pneumostoma (step 224). In most cases, the pneumostoma management
device will need to be removed (step 223) prior to inserting the
treatment device. In some cases, the treatment modality requires
contact of a target tissue with a treatment surface of the device
(step 226). In other cases, the instrument treats the entire
pneumostoma. The treatment is applied for a selected time (step
228). The effect of the treatment may then be assessed (step 230).
In some cases the effect of the treatment is assessed with the
pneumostoma treatment instrument. In other cases the pneumostoma
treatment instrument may be removed and replaced with a pneumostoma
inspection instrument to permit the assessment. The treatment may
then be repeated if and as necessary for the pneumostoma or
additional targets within the pneumostoma (step 232) until the
desired effects have been achieved. After the treatment is over a
new pneumostoma management device should be promptly and correctly
positioned in the pneumostoma either by the physician, or by the
patient under the observation of the physician (step 234).
Particular instruments suitable for assessing and treating
pneumostomas in accordance with the general method steps of FIG. 2A
and 2B are described below.
Pneumostoma Assessment Instruments And Methods
[0094] To observe the interior of the pneumostoma the physician
uses a pneumostoma inspection instrument placed within the
pneumostoma. One type of pneumostoma inspection instrument includes
a light source for illuminating the interior of the pneumostoma and
a visualization system for visualizing (and typically magnifying)
the interior of the pneumostoma. The visualization system may be a
direct optical system comprising one or more optical components for
providing a magnified image at an object lens mounted to the
instrument. Alternatively, the visualization system may include
means for obtaining a video image of the pneumostoma tissues and
means for displaying the image, for example a video sensor and a
video display. Such a pneumostoma inspection instrument, using a
light source and visualization system, is referred to generally
herein as a pneumoscope.
[0095] A pneumoscope may include a short inspection tube or
speculum that may be pushed into the pneumostoma. The speculum
holds open the pneumostoma during the inspection. The speculum may
in some cases be a detachable metal speculum which may be
sterilized between uses. Preferably, however, the speculum is
disposable or covered with a disposable sleeve during use. The
speculum may be provided in a range of different diameters and
lengths as appropriate for a particular pneumostoma or patient. The
physician chooses the speculum appropriate to the dimensions of the
pneumostoma of the patient. The speculum may be provided with
visible exterior markings so that the physician may gauge the depth
of insertion of the speculum. The speculum may be provided with a
flange which prevents over-insertion of the speculum--however the
depth of insertion is typically under the control of the physician
who should use care not to damage tissue of the pneumostoma during
insertion. The physician may use the speculum to gauge the
diameter, length and profile of the pneumostoma.
[0096] FIGS. 3A and 3B show an example of a pneumoscope according
to one embodiment of the present invention. FIG. 3A shows an
external view of a pneumoscope 300. FIG. 3B shows a sectional view
of the pneumoscope positioned within a pneumostoma. As shown in
FIG. 3A, pneumoscope 300 comprises a handle 310 and a head 320. A
button 312 may be provided on handle 310 by which a physician may
activate the light source and/or any image capturing system. A
disposable speculum 330 is attached to head 320. Speculum 330
comprises a catch 332 at the proximal end for temporarily mounting
speculum 330 to head 320 of pneumoscope 300. Speculum 330 is long
enough to reach the end of a pneumostoma. As shown in FIG. 3A,
speculum 330 bears external markings 334 indicating how far the
distal tip 336 has travelled into the pneumostoma. External
markings 334 may also be used to measure the depth of a
pneumostoma. Pneumoscope 300 is preferably wireless and portable
for ease of use.
[0097] As shown in FIG. 3B, handle 310 includes a light source 314
and power supply 316. In use, the distal tip 336 of speculum 330 is
inserted into the pneumostoma 1 10. The physician actuates light
source 314 to illuminate the interior of the pneumostoma 1 10.
Light is directed from light source 314 to the pneumostoma 110
using an optical train 324 including e.g. fiber optics and/or
lenses. The optical train 324 preferably provides uniform
illumination of the field of view. In the embodiment of FIG. 3A,
the head 320 comprises optics for viewing and magnifying the
interior of the pneumostoma 1 10. The interior of the pneumostoma
110 may be observed by the physician through objective lens 322
within head 320. As shown in FIG. 3B, speculum 330 may be open at
the distal tip 336. In alternative embodiments, distal tip 336 may
be closed so long as a transparent window is provided through which
the physician may observe the interior of the pneumostoma.
[0098] FIG. 3C shows an alternative embodiment of a pneumoscope 302
comprising a handle 340 and a head 350. One or more buttons 342 may
be provided on handle 340 by which a physician may activate the
light source 370 and/or any image capturing system. A disposable
cover 360 is attached to head 350. Cover 360 comprises a catch 362
at the proximal end for temporarily mounting cover 360 to head 350
of pneumoscope 302. Cover 360 protects an extension 352 of head
350. Extension 352 and cover 360 are long enough to reach the end
of a pneumostoma. Cover 360 may be provided with external markings
(not shown) indicating how far the distal tip 354 has travelled
into a pneumostoma. Pneumoscope 302 is attached to a remote light
source 370 and remote display system 378. Remote display system 378
may include an image capturing system to record video images of the
pneumostoma.
[0099] Light source 370 provides light which is transmitted by a
fiber optic cable 372 to the distal tip 354 of extension 352. A
window 356 emits light to illuminate the field of view. A window
358 at the distal tip 354 admits light which is focused on an image
sensor (not shown) which may be e.g. a CCD or CMOS sensor. The
image sensor captures video image data which is transmitted to the
display 378. The surgeon may observe video images of the interior
of the pneumostoma on display 378 and/or may record images of the
pneumostoma for later analysis. In alternative embodiments, one or
both of the light source and display may be built into the head 350
and/or handle 340. Pneumoscope 302 may be inserted into a
pneumostoma in the same manner as described with respect to
pneumoscope 300 and illustrated in FIG. 3B.
[0100] FIG. 3D illustrates a general method for examining a
pneumostoma with a pneumoscope. First, based on, for example,
information from the patient or observation of the pneumostoma, the
physician makes a determination to observe the pneumostoma using a
pneumoscope (step 380). The physician next selects and/or
configures a pneumoscope suitable to observe the pneumostoma of a
particular patient (step 382). The selected instrument is
preferably sized such that it can be introduced into the
pneumostoma and placed at a desired depth in the pneumostoma. As
pneumostomas may vary in size, the pneumoscope may have a
configurable size, or may have a range of different sized speculums
330 and/or covers 360. Thus selection of the pneumoscope includes
selecting/configuring the pneumoscope for the pneumostoma of a
particular patient.
[0101] After the pneumoscope is ready, the pneumostoma management
device will be removed from the pneumostoma (step 383). The
pneumostoma should then be externally inspected (step 384) to
determine whether there are any contraindications to use of a
pneumoscope, for example any obstruction of the pneumostoma which
must first be removed. If the external inspection reveals no
contraindications, the pneumoscope is introduced into the
pneumostoma (step 386). The physician should observe tissue of the
pneumostoma through the visualization system of the pneumoscope
(388) and note and/or record the appearance of the tissue. The
physician then advances the pneumoscope into the pneumostoma (step
390) and repeats the observation (step 388) until reaching the end
of the pneumostoma. When the inspection is completed the
pneumoscope is removed (step 392). A PMD should be inserted into
the pneumostoma promptly after removal of the pneumoscope either by
the physician, or by the patient under the observation of the
physician (step 394). In some cases, inspection with the
pneumoscope is made in conjunction with treatment of the
pneumostoma. In such a case, the pneumoscope may be used before,
after and or during the treatment to observe effects of the
treatment upon the tissue of the pneumostoma.
[0102] The pneumoscope allows the physician to visually inspect and
examine the tissues of the pneumostoma. The physician may observe
the pneumostoma and examine the tissue in the region of the chest
wall, pleurodesis, and/or within the parenchymal tissue of the
lung. In the event that inflamed, injured or unusual tissues are
observed, it may be desirable to further assess the tissue. Further
assessment of the tissue may be made, for example, by swabbing the
tissue and culturing any microorganisms on the swab. Alternatively,
a biopsy of tissue of the pneumostoma may be made by scraping
tissue from the walls of the pneumostoma and examining cells under
the microscope. In some embodiments, the pneumoscope may be
provided with an auxiliary lumen through which a tool may be
introduced into the pneumostoma in order to scrape or swab tissue
under visualization.
Pneumostoma Assessment Using Gas
[0103] Measurement of gases entering or leaving the pneumostoma may
be useful for assessing the functionality of the pneumostoma. The
ability of gas to pass through the pneumostoma may be measured in a
number of ways. First, gas flow through the pneumostoma can be
measured passively by placing a device over the pneumostoma which
measures airflow out of and/or into the pneumostoma during regular
breathing of the patient. Essentially, gases exiting the
pneumostoma are collected by a system which records the volume of
gas.
[0104] Additionally, the gas may be analyzed to determine
composition of the gases exiting the pneumostoma. In particular it
may be useful to analyze the proportion of oxygen, carbon dioxide
and carbon monoxide in the gases exiting the pneumostoma as
compared to in air exhaled through the natural airways or in the
ambient atmosphere. Levels of carbon dioxide in gases exiting the
pneumostoma are a useful indicator that the pneumostoma is still
functioning to allow gases to exit the lung. It may also be useful
to measure the presence of nitric oxide in the gases exiting the
pneumostoma because nitric oxide may be indicative of inflammation
of the tissues of the lung.
[0105] Gases exiting the pneumostoma may be measured and/or
analyzed with a pneumostoma management device in place. However it
is preferable to avoid any confounding effects due to the PMD, for
example obstruction of the pneumostoma by the PMD, the filter of
the PMD or accumulated discharge in the PMD. Therefore gas
measurement/analysis is preferably performed using a gas analysis
device inserted into the pneumostoma which is designed to collect
gases and interface with the gas measurement/analysis equipment.
See, e.g. FIGS. 4D and 4E. Gas analysis and measurement may be
performed in a number of modes depending upon the results desired.
Different systems may be used for analysis of pneumostoma function,
lung function or lung imaging as required.
[0106] Systems for supplying gases, to a patient and analyzing
gases received from a patient are already in use for supplying
gases to be inhaled through the natural airways and analyzing gases
exhaled through the natural airways. For example a system for
analyzing expiratory gases is described in U.S. Pat. No. 6,506,608
titled "Method And Apparatus For Respiratory Gas Analysis Employing
Enhanced Measurement Of Expired Gas Mass" to Mault. A system for
supplying and analyzing diagnostic gases is described in U.S. Pat.
No. 5,022,406 title "Module For Determining Diffusing Capacity Of
The Lungs For Carbon Monoxide And Method" to Tomlinson et al. A
review of DLCO spirometry can be found in Macintyre et al.,
"Standardisation Of The Single-Breath Determination Of Carbon
Monoxide Uptake In The Lung," Eur. Respir. J. 26 (4): 720-35 (2005)
and reference cited therein. A system for supplying and imaging
hyperpolarized noble gases in the lungs is described in U.S. Patent
Publication 2005/0174114 title "Method And System For Rapid
Magnetic Resonance Imaging Of Gases With Reduced Diffusion-Induced
Signal Loss" to Mugler III et al. A review of diffusion imaging of
the lung can be found in Mayo et al., "Hyperpolarized Helium 3
Diffusion Imaging Of The Lung," Radiology 222:8-11 (2202) and
reference cited therein. The above articles, patents and
applications are incorporated herein by reference. These and other
such systems may be adapted as described herein to supply and
analyze gases utilizing the pneumostoma and thereby provide
information regarding lung function, pneumostoma function and
collateral ventilation not previously available.
[0107] FIG. 4A shows a system for measuring/analyzing gases leaving
the pneumostoma. Gas analysis equipment may be connected to a PMD
and/or pneumostoma using one of the several techniques and
mechanisms described herein. As shown in FIG. 4A, a gas analysis
device 400 is inserted into the pneumostoma 110 of a patient. Gas
analysis device 400 is connected by tube 402 to gas analyzer 412.
The gases exhaled from the pneumostoma 110 may then be measured
and/or analyzed during normal breathing or during an exercise test.
The volume of gas exhaled may be measured by gas analyzer 412 to
provide information regarding the patency/functionality of the
pneumostoma. The exhaled gas may be also be analyzed by gas
analyzer 412 to determine oxygen and carbon dioxide concentrations.
In some cases, the concentrations are compared to oxygen and carbon
dioxide concentrations in the gases exhaled through the natural
airways or in the ambient atmosphere. Such evaluation may be useful
in determining the effectiveness of a pneumostoma and the location
and/or desirability of additional pneumostomas. The output of gas
analyzer 412 may be provided to a computer system 414 to display
the results of the gas analysis. Computer system 414 preferably
records the results of the gas measurement and analysis and allows
the physician to compare the results of the gas
measurement/analysis with prior results for the same patient.
[0108] Optionally, a mask 416 may be provided. Mask 416 may be used
to measure the volume of gas inhaled and exhaled by the patient
through the natural airways. The volume of gas inhaled and exhaled
through the natural airways may be compared to the volume of gas
exiting the pneumostoma. Optionally, a diagnostic gas 418 is
introduced through the natural airways and the expiration of gases
from the pneumostoma is measured. Computer system 414 controls
valve 406 to supply the diagnostic gas 418 to the mask 416. The
diagnostic gas may, for example, be a gas mixture such as DLCO gas
used in diffusion spirometry (which nominally consists of 10%
helium, 3000 ppm carbon monoxide and the balance air). As shown in
FIG. 4A, optional mask 416 may be used to provide a diagnostic gas
mixture 418 via the natural airways. The concentration of gases
exiting the pneumostoma 110 may be compared to the concentration of
gases in the diagnostic gas supply 418. The time-course of
exhalation of diagnostic gases through the pneumostoma may be
analyzed by gas analyzer 412 to evaluate the function of the
pneumostoma and the prevalence of collateral ventilation pathways
connecting the pneumostoma to the remainder of the lung. Such
evaluation may be useful in determining the effectiveness of a
pneumostoma and the location and/or desirability of additional
pneumostomas.
[0109] Alternatively, gases may be provided through the pneumostoma
from outside the chest of the patient. Gas supply equipment may be
connected to a PMD and/or pneumostoma using one of the several
techniques and mechanisms described herein. The gas is preferably
supplied at a controlled pressure slightly above the ambient air
pressure so as not to cause injury to the pneumostoma. In a simple
case, the rate of flow of gas into the lung through the pneumostoma
may be measured. The rate of gas flow at a particular pressure may
be used to assess the patency of the pneumostoma. Alternatively,
diagnostic gases may be introduced through the pneumostoma for
assessing collateral ventilation and gas exchange. Diagnostic gases
may be helpful in measuring functional attributes of the
pneumostoma and the lung. In particular, introduction of diagnostic
gases through the pneumostoma may be useful for assessing gas
diffusion between the pneumostoma and the lung.
[0110] In one example, a diagnostic gas is introduced through the
pneumostoma and the gas is measured as it is exhaled through the
natural airways. The diagnostic gas may, for example, be a gas
mixture such as DLCO gas used in diffusion spirometry (which
nominally consists of 10% helium, 3000 ppm carbon monoxide and the
balance air). Gases exhaled through the natural airways are
analyzed to determine gas concentrations. The time course of
exhalation of the diagnostic gas is indicative of factors such as
pneumostoma functionality and collateral ventilation. The time
course of exhalation of gas through the natural airways compared to
introduction into the pneumostoma may be analyzed to evaluate the
function of the pneumostoma and the prevalence of collateral
ventilation pathways connecting the pneumostoma to the remainder of
the lung. Such evaluation may be useful in determining the
effectiveness of a pneumostoma and the location and/or desirability
of additional pneumostomas. A supply of the diagnostic gas may be
connected to a PMD and/or pneumostoma using one of the several
techniques and mechanisms described herein.
[0111] FIG. 4B shows a schematic view of a lung assessment system
using introduction of diagnostic gas 418 through a pneumostoma 110.
As shown in FIG. 4B a gas analysis device 400 is inserted into the
pneumostoma 110 of a patient. Gas analysis device 400 is connected
by tube 402 to a pressure-regulated source of diagnostic gas 418. A
solenoid-controlled valve 406 in tube 402 controls the flow of
diagnostic gas into pneumostoma 110. The patient is provided with a
mask 416 which allows the patient to inhale ambient air but that
collects the exhaled air and passes it to gas analyzer 412. During
exhalation, a portion of the exhaled gases is collected in a sample
collection system and then analyzed using discrete gas sensors
and/or a gas chromatograph. The gas analyzer 412 and the
solenoid-controlled valve 406 are connected to a computer system
420 which may be a general purpose computer. Computer system 420
controls solenoid-controlled valve 406 and receives data from gas
analyzer 412. Computer system 420 analyzes the gas concentrations
in the gas exhaled by the patient and factors the relative values
with inspired gas volume and other parameters to calculate factors
related to collateral ventilation and pneumostoma function. The
output of gas analyzer 412 may be provided to computer system 420
to display the results of the gas analysis. Computer system 420
preferably records the results of the gas measurement and analysis
and allows the physician to compare the results of the gas
measurement/analysis with prior results for the same patient.
[0112] Introduction of diagnostic gases through a pneumostoma may
also be used to enhance imaging the lung with a CT scan or NMR
scan. For example polarized Helium-3 may be utilized to enhance
nuclear magnetic resonance/magnetic resonance imaging of the lung
(analogous to the way contrast agents enhance X-ray imaging). For
example, polarized helium-3 may be produced with lasers and the
magnetized pressurized gas may be stored for several days. When
introduced into the lung, the polarized helium-3 can be imaged with
an MRI-like scanner which produces breath-by-breath images of lung
ventilation, in real-time. Polarized helium-3 may thus, be used to
visualize airways in static or dynamic fashion. Alternative gases
which may be used as visualization agents include gaseous
radionuclide xenon or technetium DTPA in an aerosol form.
[0113] Introducing a controlled amount of a visualizable gas, e.g.
polarized Helium-3, through the pneumostoma and imaging the
diffusion of the gas into the lung over time may be utilized for
quantitative evaluation of the function of the pneumostoma and the
prevalence of collateral ventilation pathways connecting the
pneumostoma to the parenchymal tissue of the lung. Measuring the
time-course variations in diffusion of Helium-3 into the lung
allows analysis of diffusion coefficients for areas of the lung.
Such evaluation may be useful in determining the effectiveness of a
pneumostoma and the location and/or desirability of additional
pneumostomas. A source of polarized Helium-3 may be connected to a
PMD and/or pneumostoma using one of the several techniques and
mechanisms described herein.
[0114] FIG. 4C shows a schematic view of a lung assessment system
using a diagnostic gas in conjunction with an imaging scanner 450.
Scanner 450 may be an MRI, NMR, CT or X-Ray so long as the
particular diagnostic gas used may be successfully imaged with the
system. As shown in FIG. 4B, gas analysis device 400 is inserted
into the pneumostoma 110 of a patient. Gas analysis device 400 is
connected by tube 430 to a pressure-regulated source of a
visualizable gas (e.g. polarized Helium-3). A solenoid-controlled
valve 432 in tube 430 controls the flow of diagnostic gas into
pneumostoma 110. The scanner 450 and the solenoid-controlled valve
432 are connected to a computer system 420 (not shown) which may be
a general purpose computer. The computer system 420 (not shown)
controls solenoid-controlled valve 432 and receives data from
scanner 450. The computer system 420 coordinates the introduction
of diagnostic gas into the patient with the patient's breathing and
also with the operations of scanner 450 in order to accurately
image dispersion of the diagnostic gas from the pneumostoma 110 to
other parts of the lung. Computer system 420 analyzes the time
course distribution of the diagnostic gas from the pneumostoma into
the lung tissues to calculate factors related to collateral
ventilation and pneumostoma function, e.g. diffusion
coefficients.
[0115] FIGS. 4D and 4E show views of the gas analysis device 400 of
FIGS. 4A-4C. FIG. 4D shows a perspective view of the gas analysis
device 400 while FIG. 4E shows a sectional view of gas analysis
device 400 positioned within a pneumostoma. In general terms, gas
analysis device 400 is a device which can be secured into a
pneumostoma for sampling gases exiting the pneumostoma and/or
providing gases into the pneumostoma. Gas analysis device 400 can
form part of a system which utilizes such gas sampling or gas
provision for assessment of pneumostoma function and/or lung
function. As used in FIGS. 4A and 4C, gas analysis device 400 is
used to introduce diagnostic gas into the pneumostoma. As used in
FIG. 4B, gas analysis device 400 is used to collect gases exhaled
from the lung for analysis by gas analyzer 412.
[0116] Referring to FIG. 4D, gas analysis device 400 includes a
hollow tube 460 for insertion into the pneumostoma. Hollow tube 460
is surrounded by a flange 462 which secures tube 460 in position in
the pneumostoma. Hollow tube 460 connects to a coupling 464 on the
proximal side of flange 462. Coupling 464 is configured so that
tube 402 (shown in FIG. 4E) may be readily connected and
disconnected. Hollow tube 460 has one or more holes 466 at the
distal end through which gas may pass into or out of a pneumostoma.
Hollow tube 460 and flange 462 also provide a temporary seal which
inhibits leakage of gas from around hollow tube 460.
[0117] FIG. 4E shows a sectional view of gas analysis device 400 of
FIGS. 4A-4D in position in a pneumostoma 110. It is preferable to
minimize leakage of gases into or out of the pneumostoma. Flange
462 is thus provided with an adhesive coating 468 on the distal
surface to provide a temporary seal between the gas analysis device
400 and the skin of the chest of the patient. Surface features may
also be provided on the distal surface of flange 462 or on tube 460
to promote sealing between gas analysis device 400 and the
pneumostoma. For example, a circular ridge 470 is shown in section
on FIG. 4E. Gas analysis device 400 is preferably a disposable
component that will be used only with one patient. One or more
filters may be interposed between gas analysis device 400 and the
gas supply and/or gas analyzer to prevent possible
cross-contamination between patients.
Pneumostoma Treatment
[0118] Based upon the assessment of the pneumostoma, it may be
necessary or desirable to treat the pneumostoma in order to
preserve and/or enhance the health and/or functionality of the
pneumostoma. A principal purpose of the pneumostoma is to permit
the escape of gases trapped in the lung thereby reducing the lung
volume and ameliorating symptoms of COPD such as dyspnea and
anoxia. To serve this purpose gases should be able to enter the
pneumostoma from the parenchymal tissue of the lung. High rates of
air flow are not required. However, if the pneumostoma becomes
completely obstructed then it will no longer permit the escape of
gases trapped in the lung. The function of the pneumostoma may be
impaired by, among other causes, the encroachment of tissues into
the pneumostoma, obstruction with secretions, discharge and/or
foreign objects, inflammation and/or infection. For example,
encroaching tissues may impair the patency and functionality of the
pneumostoma.
[0119] The pneumostoma and surrounding tissues may be treated using
a number of different treatment modalities to maintain and/or
enhance patency, remove obstructions, decrease inflammation and
prevent infection. The treatment modalities include: suction,
irrigation, lavage, mechanical agitation, ultrasound, infrasound,
mechanical dilation, balloon dilatation, cryotherapy, and energy
treatment (including e.g. UV, light, LASER, LED, IR, heat, RF and
electrocautery). The physician may select from among the several
treatment modalities a treatment modality most appropriate for the
conditions observed during the pneumostoma assessment.
Pneumostoma Treatment Using Suction, Irrigation and Lavage
[0120] The treatment modalities available for treating a
pneumostoma include suction, irrigation, mechanical agitation and
lavage. These treatment modalities are suitable for removing
obstructions and discharge from the pneumostoma, cleaning the
pneumostoma and treating the tissues of the pneumostoma. Additional
methods and devices for applying suction to a pneumostoma are
disclosed in applicant's U.S. Provisional Patent Application
61/084,559 titled "Aspirator For Pneumostoma Management" which is
incorporated herein by reference. An aspirator may be used without
irrigation for the removal of liquid/soft discharge and materials
from the pneumostoma.
[0121] FIGS. 5A-5C illustrate a device for treating a pneumostoma
with suction, irrigation, mechanical irritation and/or lavage. As
shown in FIG. 5A, a suction-irrigation device 500 includes a body
510 attached to a suction-irrigation probe 520. Suction-irrigation
probe 520 includes a multi-lumen tube 522 and a flange 524. As
shown in the sectional view FIG. 5B of suction-irrigation probe
520, multi-lumen tube 522 has an outer lumen 521 and an inner lumen
523. Referring again to FIG. 5A, multi-lumen tube 522 has a number
of side apertures 526 for releasing fluid from the outer lumen 521.
Multi-lumen tube 522 has a distal aperture 528 in the distal tip
for applying suction and removing fluid via the inner lumen 523.
Distal aperture 528 may be provided with a cage or mesh covering to
prevent damage to tissues and/or obstruction of distal aperture
528. Multi-lumen tube 522 also supports a plurality of soft
bristles 530 for mechanically agitating the surface of a
pneumostoma. Although bristles are shown, other mechanical features
may be used to assist the removal of material which may be adhered
to the tissue of the pneumostoma, for example ribs, fingers or
surface roughness.
[0122] Referring now to FIG. 5C, suction irrigation probe 520 is
connected to a body 510 by a coupling 532 which mounts releasably
to a mating coupling 512 on body 510. Body 510 is also connected to
a pressure-regulated supply of irrigation fluid and a
pressure-regulated vacuum supply (not shown). The irrigation supply
and vacuum supply are attached or connected to an irrigation
conduit 514 and suction conduit 516 within body 510. The couplings
532 and 512 releasably mount the suction-irrigation probe 520 to
body 510. The couplings 532 and 512 also put the lumens of
multi-lumen tube 522 in fluid communication with the irrigation
conduit 514 and suction conduit 516 within body 510. The releasable
couplings 532 and 512 also enable the suction-irrigation probe 520
to be removed, and either cleaned and replaced, or disposed of and
replaced. Couplings 532, 512 may be, for example, threaded
couplings, bayonet couplings, luer locks or other connector
suitable for releasable connecting lumens.
[0123] FIG. 5C shows a sectional view of suction-irrigation device
500 with suction-irrigation probe 520 inserted into a pneumostoma
110. As shown in FIG. 5C, irrigation fluid exits through side
apertures 526 and is collected through distal aperture 528.
Bristles 530 contact the tissue of the pneumostoma 110.
Suction-irrigation probe 520 may be moved in and out of pneumostoma
110 so that bristles 530 dislodge any material stuck on the side of
pneumostoma 110. The irrigation fluid serves to move any dislodged
materials into aperture 528. Flange 524 serves to prevent
over-insertion of suction-irrigation probe 520 and also to prevent
excessive leakage of irrigation fluid from the pneumostoma. In some
embodiments, flange 524 may be configured to slide up and down
multi-lumen tube 522 such that the depth of the distal end of probe
520 may be adjusted while the flange remains in contact with the
chest of the patient. In other embodiments, flange 524 may be fixed
or adjustably fixed to multi-lumen tube 522.
[0124] Suction-irrigation device 500 may include additional
features to facilitate removal of material from the pneumostoma.
For example, suction-irrigation device 500 may include a
visualization system to permit the physician to guide
suction-irrigation probe 520 and visualize the tissues inside
pneumostoma 110. See, e.g. FIGS. 3A-3C and accompanying text.
Suction-irrigation device 500 may also include an ultrasound
generator or another device to agitate bristles 530 and the
irrigation fluid to aid in the mechanical removal of materials from
the pneumostoma 110. Suction irrigation device 500 may also include
a trap for trapping any solid materials dislodged from the
pneumostoma. For irrigation, a sterile but inert solution may be
used. For example, sterile saline or sterile water may be used. The
irrigation fluid will typically be sterile water or saline
solution. In some cases, it may be desirable to use a medicated
irrigation fluid. For example, an antibacterial or mucolytic
solution may be used. In such cases a small concentration of the
therapeutic agent is added to the sterile water or saline. Suitable
therapeutic agents include anti-inflammatories, antibiotics and
anti-stenosis compounds. The irrigation fluid may also include a
small concentration of an agent for maintaining the patency of the
pneumostoma, for example, Paclitaxel. The cleaning solution should
be formulated carefully to avoid injury or irritation to the
lung.
[0125] FIG. 5D illustrates a method for treatment of a pneumostoma.
First, based on, for example, information from the patient or
observation of the pneumostoma, the physician makes a determination
to treat the pneumostoma with one or more of suction, irrigation
and/or lavage. (step 580). The physician next selects and/or
configures an aspirator/irrigator suitable to treat the pneumostoma
of a particular patient. (step 582). The selected instrument is
preferably sized such that it can be introduced into the
pneumostoma and placed at a desired depth in the pneumostoma. As
pneumostomas may vary in size, the aspirator/irrigator may have a
configurable size, or may have a range of different sized probes
520. Thus selection of the aspirator/irrigator includes
selecting/configuring the aspirator/irrigator for the pneumostoma
of a particular patient. If irrigation/lavage is to be performed,
the physician should also select and/or prepare the irrigation
fluid (step 584).
[0126] After the aspirator/irrigator and optional irrigation fluid
is ready, the pneumostoma management device will be removed from
the pneumostoma (step 586). The pneumostoma should then be
externally inspected (step 588) to determine whether there are any
contraindications to use of the aspirator/irrigator, for example
any obstruction of the pneumostoma which must first be removed. If
the visual inspection reveals no contraindications, the
aspirator/irrigator is introduced into the pneumostoma (step 590).
The physician may then position the flange so as to prevent excess
leakage from the pneumostoma (step 592). The physician will the
apply suction to remove materials from the pneumostoma (step 594).
While suction is applied the physician may also provide
irrigation/lavage and or agitation to dislodge materials for
removal (step 594.) The physician may advance the
aspirator/irrigator incrementally further into the pneumostoma and
repeats the treatment (step 594) until reaching the end of the
pneumostoma. When the treatment is completed the
aspirator/irrigator is removed (step 596). A PMD should be inserted
into the pneumostoma promptly after removal of the
aspirator/irrigator either by the physician, or by the patient
under the observation of the physician (step 598). In some cases,
treatment with the aspirator/irrigator is made in conjunction with
inspection of the pneumostoma with a pneumoscope. In such case, the
pneumoscope may be used before and after treatment to observe
effects of the treatment upon the tissue of the pneumostoma and to
ensure all deleterious materials have been removed from the
pneumostoma.
Pneumostoma Treatment Using Sound
[0127] The treatment modalities available for treating a
pneumostoma include the use of sound waves. Sound waves can be used
to agitate the walls of the pneumostoma to dislodge materials.
Sound waves of different frequencies may be of use, including
infrasound below 20 Hz, acoustic sound waves between 20 Hz and 20
KHz and ultrasound above 20 KHz. These treatment modalities are
suitable for removing obstructions and discharge from the
pneumostoma, cleaning the pneumostoma and treating the tissues of
the pneumostoma to enhance and/or maintain patency of the
pneumostoma. The amplitude, frequency and duration of sound waves
supplied may be selected to achieve the desired effects. In some
cases the amplitude, frequency and duration of the sound waves may
be sufficient to kill cells, inhibit proliferation of cells or
disrupt cells and connective tissue in order to enhance or maintain
the patency of the pneumostoma. In other cases, the sound waves may
be selected to dislodge materials e.g. discharge, which may be
adhered to the tissues of the pneumostoma. In some embodiments,
ultrasound may be used in conjunction with suction/irrigation to
remove materials from the pneumostoma.
[0128] FIG. 6A shows a sectional view of an ultrasound device 600
for use in a pneumostoma 110. Ultrasound device 600 includes a body
610 containing an ultrasonic transducer 612 coupled by a coupling
614 to an ultrasound probe 620. Ultrasonic transducer 612 is
coupled to ultrasound probe 620 so that, when energized, ultrasonic
transducer 612 transmits ultrasound into ultrasound probe 620.
Ultrasound device 600 includes within body 610, a switch 617, a
controller 616 and power supply 618. The physician operates switch
617 to cause controller 616 to energize ultrasonic transducer 612.
In preferred embodiments, controller 616 energizes ultrasonic
transducer 612 for a predefined and limited period of time.
[0129] Ultrasound probe 620 is sized and configured to enter
pneumostoma 110 and conduct ultrasound energy from ultrasonic
transducer 612 to the walls of the pneumostoma and any materials
adhered thereto. Ultrasound probe 620 may also include a flange 622
which serves as protection against over insertion of probe 620. A
biocompatible gel or liquid (not shown) may be used with ultrasound
probe 620 to enhance the conduction of ultrasonic waves from
ultrasound probe 620 to tissues of the pneumostoma. In such case,
flange 622 may also be useful to create a temporary seal to retain
the gel or liquid with pneumostoma 110 during the ultrasound
treatment. In some embodiments, ultrasound probe 620 may be
provided with a channel to provide suction to remove any materials
dislodged by the ultrasound. Alternatively, a separate
suction/irrigation device may be utilized to remove materials from
the pneumostoma after treatment with the ultrasound probe 620.
[0130] FIG. 6B shows a schematic view of alternate sound delivery
device 650 for use in a pneumostoma 110. Sound delivery device 650
includes a body 660 containing a speaker 662 which typically
comprises a magnetically-driven armature or diaphragm. Speaker 662
generates acoustic and/or infrasound waves in chamber 664. Chamber
664 is in communication via coupling 668 with sound probe 670. As
shown in FIG. 6B, sound probe 670 is a hollow tube for holding open
the pneumostoma and delivering the sound waves into the
pneumostoma. Sound probe 670 may have one or more apertures. A
baffle may be provided around sound probe 670 to concentrate
pressure waves induced by the speaker with the pneumostoma.
Alternatively, sound probe 670 may be a solid probe coupled to the
armature of speaker 662 or a suitable transducer. In alternative
embodiments, the sound may be generated by a speaker located within
the probe which is thus located within the pneumostoma during use.
The energy delivered by sound delivery device 650 serves to
dislodge materials from the pneumostoma and/or disrupt the
connective tissue of the pneumostoma. In some embodiments, sound
probe 670 may be provided with a channel to provide suction to
remove any materials dislodged by the sound waves. Alternatively, a
separate suction/irrigation device may be utilized to remove
materials from the pneumostoma after treatment with the sound
delivery device 650.
[0131] FIG. 6C illustrates a method for treatment of a pneumostoma.
First, based on, for example, information from the patient or
observation of the pneumostoma, the physician makes a determination
to treat the pneumostoma with one or more of acoustic sound,
infrasound, and/or ultrasound. (step 680). The physician next
selects and/or configures a sound/ultrasound device suitable to
treat the pneumostoma of a particular patient. (step 682). The
selected instrument is preferably sized such that it can be
introduced into the pneumostoma and placed at a desired depth in
the pneumostoma. As pneumostomas may vary in size, the
sound/ultrasound device may have a configurable size, or may have a
range of different sized probes 620 or 670. Thus selection of the
sound/ultrasound device includes selecting/configuring the
sound/ultrasound device for the pneumostoma of a particular
patient. If a sound conducting liquid or gel is to be used, the
physician should also select and/or prepare the fluid (step
684).
[0132] After the sound/ultrasound device and optional
sound-conducting fluid is ready, the pneumostoma management device
will be removed from the pneumostoma (step 686). The pneumostoma
should then be externally inspected (step 688) to determine whether
there are any contraindications to use of the sound/ultrasound
device, for example any obstruction of the pneumostoma which must
first be removed. If the visual inspection reveals no
contraindications, the sound/ultrasound device is introduced into
the pneumostoma (step 690). The physician may then position the
flange so as to prevent excess leakage from the pneumostoma (step
692). The physician will then energize the sound/ultrasound probe
for a selected period of time (step 694). The physician may advance
the sound/ultrasound device incrementally further into the
pneumostoma and repeat the treatment (step 694) until reaching the
end of the pneumostoma. When the treatment is completed the
sound/ultrasound device is removed (step 696). A PMD should be
inserted into the pneumostoma promptly after removal of the
aspirator/irrigator either by the physician, or by the patient
under the observation of the physician (step 698).
[0133] In some cases, treatment with the sound/ultrasound device is
made in conjunction with inspection of the pneumostoma with a
pneumoscope. In such case, the pneumoscope may be used before and
after treatment to observe effects of the treatment upon the tissue
of the pneumostoma and to ensure all deleterious materials have
been removed from the pneumostoma. It may also be desirable to
clean the pneumostoma with suction/irrigation prior to reinsertion
of the PMD in order to remove any materials that may have been
dislodged during the treatment.
Pneumostoma Treatment Using Mechanical Dilatation
[0134] The treatment modalities available for treating a
pneumostoma include the use of mechanical dilatation. Overtime, the
natural healing response of the body may cause tissues to encroach
into the lumen of the pneumostoma. Additionally, the tissues
bordering the pneumostoma may thicken over time reducing the
permeability of the pneumostoma walls to gases. A dilator may be
used to stretch the tissues of the pneumostoma to maintain the
patency of the pneumostoma. Dilatation not only increases the size
of the lumen of the pneumostoma but also thins the tissues
surrounding the pneumostoma. This thinning of the tissues bordering
the pneumostoma in the lung may enhance the ability of air to enter
the pneumostoma from the parenchymal tissue of the lung thereby
enhancing the functionality of the pneumostoma. In embodiments, a
dilator comprises an expander which can be inserted into the
pneumostoma at a first contracted size and then expanded to a
desired expanded size thereby stretching the pneumostoma. In
preferred embodiments the dilator comprises an indicator outside
the body which indicates the extent to which the expander has been
expanded and/or an adjustable limiter which limits expansion of the
expander to a safe amount.
[0135] FIGS. 7A-7D show views of one embodiment of mechanical
dilator 700. As shown in FIG. 7A, mechanical dilator 700 comprises
a handle 710, a shaft 720 and an expander 730. Handle 710 includes
two arms 712a, 712b connected by a pivot 714. A spring mechanism
716 biases arms 712a, 712b apart. A screw mechanism 717 may be used
to lock arms 712a, 712b closer together at any desired position. A
limit mechanism 715 may be used to limit the approach of arm 712a
towards arm 712b in order to prevent over expansion of the expander
730. Handle 710 is connected to shaft 720. Arm 712a, is fixedly
connected to the exterior of shaft 720, arm 712b is pivotally
connected to inner shaft 722. Moving arm 712b towards arm 712a
moves inner shaft 722 more distally relative to shaft 720. Handle
710 also includes a gauge 718 marked to indicate the amount of
expansion of expander 730. Gauge 718 is fixed to arm 712a. An
indicator 719 fixed to arm 712b moves along gauge 718 as the arms
are moved towards each other thereby expanding expander 730. The
markings on gauge 718 correspond to the expansion of expander
730.
[0136] Shaft 720 is sized so as to fit into the pneumostoma. Shaft
720 may be provided with markings 724 on the exterior surface so
the physician may determine the depth to which the distal tip of
expander 730 has been inserted in the pneumostoma. Expander 730
includes two blades 732a, 732b. Blades 732a, 732b are semicircular
in section so that, in the collapsed configuration, blades 732a,
732b form a cylinder of the same external diameter as shaft 720.
Blades 732a, 732b also form a rounded distal tip 734 in their
collapsed configuration to facilitate insertion of expander 730
into the pneumostoma.
[0137] FIG. 7B shows mechanical dilator inserted into a pneumostoma
110 (shown in section). As shown in FIG. 7B, the mechanical dilator
700 is inserted into the pneumostoma 110 in the collapsed
configuration of FIG. 7A until it is located at the desired depth
in the pneumostoma as indicated by the markings 724. In some
situations, mechanical dilator 700 may be used to measure the
diameter of a pneumostoma. The expander may be inserted into the
pneumostoma and the handles compressed until resistance is felt.
The indicator 719 will indicate on gauge 718 the degree of
expansion of expander 730 at this point of first resistance and
thus indicate the internal diameter of the pneumostoma. Limit
mechanism 715 may then be positioned to allow only a desired amount
of incremental expansion of the pneumostoma compared to the
measured initial diameter of the pneumostoma. In alternative
embodiments, a fixed or adjustable flange (not shown) may be
provided mounted on shaft 720. The flange serves as mechanical stop
to limit insertion of the mechanical dilator 700 at a fixed or
adjustable depth.
[0138] FIG. 7C shows a close-up view of the expander 730 in an
expanded configuration. As shown in FIG. 7C, each of blades 732a
and 732b are pivotably connected by linkages 736a, 736b to the
distal end of shaft 720. Each of blades 732a, 732b is also
pivotably connected to the distal end of inner shaft 722 by
linkages 738a, 738b, 738c, 738d. Linkages 738a, 738b, 738c, 738d
are designed to fit within a slot in the interior surface of blades
732a, 732b when the blades are in the collapsed configuration of
FIG. 7A. In alternative embodiments, expander 730 may have 3 or
more blades, each blade taking up a fractional portion of the
circumference of the device and each blade having three linkages
connecting the blade to the distal end of inner shaft 722. As inner
shaft 722 moves in the direction of arrow 704, blades 732a, 732b
move outwards as shown by arrows 702a, 702b.
[0139] FIG. 7D shows mechanical dilator 700 positioned in a
pneumostoma 110. As shown in FIG. 7D, expander 730 is positioned
within the pneumostoma at the desired depth. Handle 712b has been
pushed towards handle 712a until it makes contact with limit
mechanism 715. Handle 712b may optionally be locked into position
with screw mechanism 717. Inner shaft 722 has been pushed distally
relative to shaft 720. Linkages 738a, 738, b, 738c, 738d have thus
forced blades 732a, 732b away from each other causing the expander
730 to adopt the expanded position shown in FIG. 7C (see FIGS. 7B
and 7C for identification of the components of expander 730). Note
that indicator 719 has moved along gauge 718 to indicate the amount
of expansion of expander 730.
[0140] In practice, mechanical dilator 700 is preferably expanded a
small amount and then locked in place as the tissues of the
pneumostoma relax. Mechanical dilator 700 is then expanded another
small amount and then locked in place again as the tissues of the
pneumostoma relax. A number of incremental expansion steps may be
performed until the desired diameter of the pneumostoma is
achieved. The incremental steps can be controlled by incremental
movement of limit mechanism 715 and screw mechanism 717. In some
cases, it may be desirable to expand the dilator at two or more
different depths in the pneumostoma so as to expand two or more
different potions of the pneumostoma. Dilator 700 may then be
collapsed and withdrawn from the pneumostoma. The pneumostoma will
tend to contract after dilatation so it is important to insert a
pneumostoma management device into the lumen of the pneumostoma
upon removal of the mechanical dilator 700.
[0141] FIG. 7E illustrates a method for treatment of a pneumostoma
with a dilator. First, based on, for example, information from the
patient or observation of the pneumostoma, the physician makes a
determination to treat the pneumostoma with a dilator. (step 740).
The physician next selects and/or configures a dilator suitable to
treat the pneumostoma of a particular patient. (step 742). The
selected instrument is preferably sized such that it can be
introduced into the pneumostoma and placed at a desired depth in
the pneumostoma. As pneumostomas may vary in size, the dilator may
have a configurable size, or a range of initial sizes. Thus
selection of the dilator includes selecting/configuring the dilator
for the pneumostoma of a particular patient such that it may be
inserted into the pneumostoma to the desired depth prior to
dilation. After dilation of the pneumostoma it is preferable to
insert a PMD to support the pneumostoma as soon as the dilator is
removed. Therefore, it is preferable to select and prepare a larger
PMD for the patient to fit the anticipated dilated pneumostoma
(step 744).
[0142] After the dilator and replacement PMD are, the original
(smaller) pneumostoma management device will be removed from the
pneumostoma (step 746). The pneumostoma should then be externally
inspected (step 748) to determine whether there are any
contraindications to use of the dilator, for example any
obstruction of the pneumostoma which must first be removed. If the
visual inspection reveals no contraindications, the dilator is
introduced into the pneumostoma (step 750). The physician may then
expand the dilator incrementally (step 752). The physician will
then allow the tissue of the pneumostoma to relax (step 754) and
repeat the incremental expansion (step 752) until the desired
dilation has been achieved. The physician may also repeat the
dilation at one or more depths within the pneumostoma depending
upon the length of the pneumostoma. When the dilation is complete
the dilator is removed (step 756). A new larger PMD should then be
promptly inserted into the pneumostoma by the physician, or by the
patient under the observation of the physician (step 758).
[0143] In some cases, treatment with the sound/ultrasound device is
made in conjunction with inspection of the pneumostoma with a
pneumoscope. In such case, the pneumoscope may be used before and
after treatment to observe effects of the treatment upon the tissue
of the pneumostoma and to ensure all deleterious materials have
been removed from the pneumostoma. It may also be desirable to
clean the pneumostoma with suction/irrigation prior to reinsertion
of the PMD in order to remove any materials that may have been
dislodged during the treatment.
[0144] Alternative means may be used to dilate the pneumostoma in
alternative embodiments. FIG. 7F shows an alternative mechanical
dilator 760 and FIG. 7G shows a balloon dilator 780. Referring to
FIG. 7F, mechanical dilator 760 comprises first handle 761
connected to inner shaft 762 which extends to the distal tip of the
mechanical dilator 760. A second handle 763 is connected to an
outer shaft 764 which rides on inner shaft 762. At the distal end
of mechanical dilator 760 is expander 766. Expander 766 includes a
plurality of flexible elements 767 covered by a polymer shell 768.
The distal end of each flexible element 767 and polymer shell 768
is connected to the distal end of inner shaft 762. The proximal end
of each flexible element 767 and polymer shell 768 is connected to
the distal end of outer shaft 764. When outer shaft 764 is pushed
distally along inner shaft 762 (as shown by arrow 770), flexible
elements 767 bend or bow outwards (as shown by arrows 771).
Elements 767 push on polymer shell 768 causing it to also bow
outwards (in the direction of arrows 771). Thus mechanical dilator
760 transitions from the collapsed configuration to the expanded
configuration by pushing handle 763 distally relative to handle
761. Both outer shaft 764 and inner shaft 762 have markings 765 on
the exterior surface so the physician may assess the depth of
insertion of mechanical dilator 760 and the diameter of expansion
of mechanical dilator 760. Mechanical dilator 760 may be used in
the same way as dilator 700 of FIGS. 7A-7D, either for dilating the
pneumostoma or assessing the diameter of the pneumostoma.
Mechanical dilator 760 may additionally be provided with a locking
device to hold it in an expanded position and/or a limit device to
control expansion of the expander 766.
[0145] FIG. 7G shows a balloon dilator 780. Referring to FIG. 7F,
mechanical dilator 780 comprises first handle 781 connected to a
hollow shaft 782 which extends to the distal tip of the balloon
dilator 780. At the distal end of mechanical dilator 780 is balloon
786. Balloon 786 is sealed to the hollow shaft at the proximal end
787 and distal end 788 of balloon 786. An aperture in hollow shaft
782 communicates between the lumen of the hollow shaft 782 and the
interior of balloon 786. A syringe 792 is connected to the proximal
end of hollow shaft 782. When syringe 792 is compressed (as shown
by arrow 790), a liquid such as sterile saline is pushed through
hollow shaft 782 into balloon 786 causing balloon 786 to inflate
(as shown by arrows 791). Thus balloon dilator 780 transitions from
the collapsed configuration to the expanded configuration by
compressing syringe 792. Hollow shaft 782 has markings 785 on the
exterior surface so the physician may assess the depth of insertion
of balloon dilator 780. Syringe 792 has exterior markings 795 so
that the physician may assess the volume of balloon 786 and hence
the diameter to which it has been expanded. Balloon dilator 780 may
be used in the same way as dilator 700 of FIGS. 7A-7D, either for
dilating the pneumostoma or assessing the diameter of the
pneumostoma.
[0146] Balloon 786 may be formed of a relatively inelastic
material. In such case, injection of the liquid into the balloon
will expand the balloon to a preset size. This ensures that the
balloon does not stretch the pneumostoma more than desired.
Moreover, the balloon can be expanded at high pressure without risk
of over-expansion. However, a number of different balloon dilators
may be required having different sizes in order to treat different
pneumostomas or to incrementally expand a single pneumostoma. In
alternative embodiments, a relatively elastic material may be used
to make balloon 786. In such case, the balloon will have a larger
diameter for larger amounts of liquid allowing broader application.
However, the pressure applied by the balloon to the tissue will be
lower than for an inelastic balloon.
Pneumostoma Treatment Using Localized Thermotherapy
[0147] The treatment modalities available for treating a
pneumostoma include the application of heat (thermotherapy) or cold
(cryotherapy). Thermotherapy and cryotherapy can be used to affect
physical characteristics of tissues and cell proliferation and also
to treat infection. For example, the tissues of the pneumostoma
tend to encroach into the lumen of the pneumostoma thereby
impairing the function of the pneumostoma. One way to reduce tissue
encroachment is through the use of thermotherapy or cryotherapy
thereby maintaining or enhancing the patency of the pneumostoma. In
some embodiments a pneumostoma treatment device may be used to heat
the tissue in others the pneumostoma treatment device may be used
to cool the tissue to achieve the desired effects.
[0148] In one method of thermotherapy, a surface of a pneumostoma
treatment device is brought into contact with a target tissue of
the pneumostoma. The surface of the pneumostoma treatment device is
then heated to raise the temperature of the target tissue (e.g. by
electrical heating, laser heating, or by circulating a heated
medium). Other methods of thermotherapy include application of
focused ultrasound, infrared light, radio or microwave-frequency
radiation to the target tissue to induce the desired temperature
rise in the target tissue. For example, thermotherapy treatment
device may direct energy at the tissue to heat the target tissue.
The energy may be supplied as ultrasound, electrical energy,
electromagnetic energy (for example IR or laser energy). The
treatment is applied for a selected period of time. After the
treatment the tissue is reassessed and treated again as necessary.
The treatment may be applied to the pneumostoma tissue using a
range of treatment devices and modalities as described in more
detail below. In preferred embodiments, the temperature and
duration of the heat treatment are selected to affect physical
characteristics of tissues, reduce cell proliferation and/or treat
infection but not to kill tissues of the pneumostoma.
[0149] Methods of cryotherapy include placing the target tissues in
thermal contact with a cooled device or medium to lower the
temperature of the target tissue. Cryotherapy may be used in two
modes. The first mode of cryotherapy is cryogenic ablation in which
cryotherapy is used to freeze tissue. A device is used to lower the
temperature of the target cells to temperatures below freezing for
short periods of time. The cells in the frozen tissue die and the
tissue is removed. However, it is a disadvantage of tissue ablation
that the cell necrosis stimulates the healing response. The healing
response causes cell proliferation and generation of more cells in
the form of scar tissue. As a result, cryogenic ablation may
ultimately lead to greater tissue encroachment rather than less
tissue encroachment. Cryogenic ablation may however still be useful
for treating regions where tissue is encroaching into the
pneumostoma.
[0150] A second mode of cryotherapy is cryogenic cooling in which
cells are cooled below physiologic temperatures without freezing
the cells. A device is used to lower the temperature of the target
cells to temperatures between normal physiologic temperatures and a
temperature above freezing for short periods of time. Cryogenic
cooling has been found to reduce hyperplasia in blood vessels. See
e.g. U.S. Pat. No. 6,811,550 entitled "Safety Cryotherapy Catheter"
to Holland et al. Cryogenic cooling may also be used to his mode of
cryotherapy to treat larger areas of the pneumostoma including up
to the entire pneumostoma. In preferred embodiments, the
temperature and duration of the cryotherapy are selected to affect
physical characteristics of tissues, reduce cell proliferation
and/or treat infection but not to kill tissues of the
pneumostoma.
[0151] FIGS. 8A-8C show a catheter which may be used for
cryotherapy or thermotherapy of a pneumostoma tissues. As shown in
FIG. 8A, catheter 800 includes a shaft 802, a balloon 804 and a
flange 806. Flange 806 slides on the exterior of shaft 802 and acts
as a mechanical stop for insertion of shaft 802 into a pneumostoma.
The positioning of flange 806 on shaft 802 allows the physician to
control the depth of balloon 804 and thus the location of the
treatment area. The shaft 802 is provided with external markings
805 to indicate the distance between the treatment area and flange
806 thereby facilitating application of the treatment to the
desired target tissues.
[0152] As shown in FIG. 8B, shaft 802 has two lumens in inner lumen
808 and outer lumen 810. In some embodiments shaft 802 may be
coated with an insulating layer 803 so that treatment is limited to
the region of the balloon 804. The balloon may then be moved to
different locations in the pneumostoma to treat different areas. In
other embodiments, shaft 802 is not insulated and is also designed
to treat the tissues of the pneumostoma in addition to the balloon.
In such cases, it is preferable that treatment is performed at a
single position (because to do otherwise would treat areas along
the shaft 802 multiple times). As shown in FIG. 8C, at the proximal
end of shaft 802 are an inlet 809 which communicates with inner
lumen 808 and an outlet 811 which communicates with outer lumen
810.
[0153] As used for cryotherapy, catheter 800 is introduced in to
the pneumostoma 110 to a depth limited by flange 806 as shown in
FIG. 8C. Cryotherapy catheter 800 is connected to a cryotherapy
coolant system 819 which supplies a temperature-controlled coolant
fluid to cryotherapy catheter 800. A coolant fluid is introduced
through inlet 809 into inner lumen 808. The coolant passes through
inner lumen 808 to the distal end of cryogenic catheter 800. The
coolant passes through an aperture out of inner lumen 808 into the
balloon 804. The coolant inflates balloon 804 to bring it into
contact with the tissue of the pneumostoma 110. The coolant
circulates around balloon 804 and cools the surface of balloon 804
to the desired temperature. The coolant then returns through the
outer lumen 810 and exits the catheter via the outlet 811. In some
embodiments, a temperature sensor may be included in the distal tip
of cryotherapy catheter 800 in order to monitor the temperature of
the balloon. However, in other embodiments, temperature regulation
is performed by regulating the temperature of the coolant supplied
by the cryotherapy coolant system.
[0154] The coolant fluid is preferably a non-toxic liquid such as
saline. However, liquids other than saline may be used and in some
cases the coolant fluid may be a temperature-controlled gas. One
system for supplying coolant is described in U.S. Pat. No.
6,432,102 entitled "Cryosurgical Fluid Supply" to Joye et al. If
thermotherapy of the tissues is desired, a fluid heated to above
body-temperature may be used in place of the coolant.
[0155] FIG. 8D shows an alternative cryotherapy probe 820.
Cryotherapy probe 820 includes a shaft 821 and tip 822. Tip 822 is
of fixed size and is preferably made of a heat conductive material.
Tip 822 may be made in whole or in part of a biocompatible metal,
for example surgical steel. Tip 822 may be made in one piece with
shaft 821 or may be made separately and joined to shaft 821. As
shown in FIG. 8E, shaft 821 (shown in FIG. 8D) includes two lumens
824, 826 for supplying coolant to tip 822 (in FIG. 8D). Tip 822 has
a cavity 828 in which the coolant circulates. At the proximal end
of cryotherapy probe 820 is an inlet 834 which communicates with
lumen 824 and an outlet 836 which communicates with lumen 826. In
some embodiments, shaft 820 may be coated with an insulating layer
823 so that treatment is limited to the region of the tip 822.
Shaft 821 may be coated with an insulating material 823 in order
that the cryotherapy treatment is localized to the region of tip
822. The tip 822 may then be moved to different locations in the
pneumostoma to treat different areas.
[0156] The size of tip 822 may differ between different cryotherapy
probes 820. A physician may have a range of cryotherapy probes
available and choose the cryotherapy probe based upon the anatomy
of the pneumostoma and the size and location of the tissues to be
treated. Cryotherapy probe 820 may optionally be provided with a
flange 830 positionable along shaft 821 in order to limit insertion
of tip 822 into the pneumostoma and thereby control the location of
tip 822 and the location of the cryotherapy treatment site.
[0157] In use, cryotherapy probe 820 is introduced into a
pneumostoma to a position indicated by the markings on the exterior
of the shaft 821 or position of the flange 830. Tip 822 is brought
into thermal contact with the pneumostoma tissues to be treated.
Cryotherapy probe 820 is connected to a cryotherapy coolant system
819. A coolant fluid is introduced through inlet 834 into lumen
824. The coolant passes through lumen 824 to the distal end of
cryotherapy probe 820. The coolant passes through an aperture out
of lumen 824 into the cavity 828. The coolant circulates around
cavity 828 and cools the surface of tip 822 to the desired
temperature. The coolant then returns through lumen 826 and exits
the probe via the outlet 836. In some embodiments a temperature
sensor may be included in the tip 822 of cryotherapy probe 820 in
order to monitor the temperature of the tip. However, in other
embodiments, temperature regulation is performed by regulating the
temperature of the coolant supplied by the cryotherapy coolant
system. For thermotherapy, a heated fluid may be circulated through
the probe in place of the coolant.
Pneumostoma Treatment Using Electromagnetic Radiation
[0158] The treatment modalities available for treating a
pneumostoma include the application of energy in the form of
electromagnetic radiation, for example, infrared, ultraviolet,
visible light, RF, microwaves. Such energy treatment can be used to
affect physical characteristics of tissues and cell proliferation
and also to treat infection. For example, the tissues of the
pneumostoma tend to encroach into the lumen of the pneumostoma
and/or thicken the walls of the pneumostoma thereby impairing the
function of the pneumostoma. One way to reduce tissue encroachment
and/or thickness is through the application of energy to the
tissues, either to kill the cells or to reduce their proliferation
thereby maintaining or enhancing the patency of the pneumostoma. In
some embodiments a pneumostoma treatment device may be used to
direct energy to particular localized regions of the pneumostoma
tissue, in other embodiments, the pneumostoma treatment device may
apply energy equally in all directions. In other embodiments, the
electromagnetic radiation may be selected to kill or damage
bacteria to reduce infection while minimizing damage to the cells
of the pneumostoma. Some frequencies of visible light, for example,
have been shown to kill certain bacteria without causing
significant damage to human cells.
[0159] FIG. 9A illustrates a pneumostoma treatment device 900 for
treatment of pneumostoma tissues with electromagnetic radiation.
The device includes a shaft 902 having at its distal end a
treatment head 904. The treatment head has a tapered or rounded tip
920 to facilitate introduction into the pneumostoma. The treatment
head 904 may generate electromagnetic radiation in situ, or the
electromagnetic radiation may be transmitted from an external
source to the treatment head 904. The treatment head may in some
cases have a window 905 which is either open or covered with a
material transparent to the electromagnetic radiation to be
transmitted. In other cases the entire treatment head 904 may be
enclosed in a material which is transparent to the delivered
electromagnetic radiation.
[0160] At the proximal end the pneumostoma treatment device 900 has
a coupling 912 for connecting the pneumostoma treatment device 900
to a power source which may provide the electromagnetic radiation
directly or provide electrical power to create electromagnetic
radiation in the treatment head 904. Coupling 912 may be connected
to shaft 910 by a flexible cable 914. The proximal end of shaft 902
may also provide access to lumens 916 which communicate with
apertures 918 adjacent treatment head 904. Lumens 916 and apertures
918 optionally provide suction, irrigation and/or cooling to the
region adjacent treatment head 904 as necessary and/or desirable
for a particular treatment modality.
[0161] The shaft 902 and treatment head 904 are of suitable
diameter for insertion into a pneumostoma. Typically the shaft 902
and treatment head 904 will be less than approximately 10 mm in
diameter. In some cases the shaft and treatment head may be
approximately 5 mm in diameter. The shaft 902 is flexible enough to
allow insertion of the treatment head 904 into a pneumostoma even
when the pneumostoma is not entirely straight. The shaft 902 should
however be stiff enough that it can provide adequate force to push
the treatment head 904 to the correct location in the
pneumostoma.
[0162] The pneumostoma treatment device carries a flange 906 which
can slide on shaft 902. The flange 906 has a locking collar 908 to
fix the flange 906 at an adjustable position along the shaft 902,
other locking means may be used, for example, a suture, tape glue
or mechanical lock. The physician will typically adjust the
location of the flange 906 along the shaft 902 so that when the
treatment head 904 and shaft 902 are inserted to the desired depth
into a pneumostoma, the flange contacts the chest of the patient
and prevent further insertion. Correct pre-positioning of the
flange 906 on shaft 902 serves to guide treatment depth and protect
against over insertion. The shaft 902 may also be provided with
external markings 910 so that the physician may determine the
correct location for flange 906 and the corresponding depth of
treatment head 904.
[0163] FIG. 9B shows a sectional view of pneumostoma treatment
device 900 inserted into a pneumostoma 110. Note that flange 906 is
in contact with the skin 114 of the chest 100 of the patient and
thus acts as a mechanical stop to prevent further insertion. Flange
906 may additionally be provided with an adhesive (not shown) to
temporarily secure the flange 906 to the skin 114 of the chest 100
of the patient thereby securing the treatment head 904 at the
desired depth within the pneumostoma 110. Coupling 912 connects
controller 922 via cable 914 to the proximal end of shaft 902 and
via shaft 902 to treatment head 904. Controller 922 may be used to
control the provision of electromagnetic radiation by treatment
head 904. Controller may control one or more of: the location,
intensity, wavelength and/or duration of the application of the
electromagnetic radiation as directed by a physician.
[0164] The treatment head 904 may be designed so that it delivers
electromagnetic radiation equally in all directions thereby
treating uniformly all of the tissues adjacent the treatment head.
In alternative embodiments treatment head 904 may be designed such
that it applies the electromagnetic radiation in a directional
manner--this adds additional complexity in that a mechanism needs
to be provided for aligning the electromagnetic radiation with the
target tissues. However, the directional solution allows for
different tissues within the pneumostoma to be treated differently
and also different regions to be treated differently from other
regions. Directionality may be provided, for example, using
scanning optics to aim a beam of electromagnetic radiation provided
by controller 922 through a fiber optic cable.
[0165] FIG. 9C shows a sectional view of a pneumostoma treatment
device 930 for treatment of pneumostoma tissues with
electromagnetic radiation. The device includes a shaft 932 having
at its distal end a treatment head 934. The shaft 932 carries a
flange 936 which can slide on shaft 932. One or more lumens 946
passes along the length of shaft 932 to one or more aperture 948
adjacent treatment head 934. Lumens 946 and apertures 948
optionally provide suction, irrigation and/or cooling to the region
adjacent treatment head 934 as necessary and/or desirable to
enhance treatment or protect tissue during treatment. At the
proximal end the pneumostoma treatment device 930 has a coupling
942 for connecting the pneumostoma treatment device 930 to a power
source 940 which provides electrical power through cable 944 to
create electromagnetic radiation in the treatment head 934.
[0166] In the embodiment shown in FIG. 9C, the treatment head 934
generates electromagnetic radiation in situ. The treatment head 934
is enclosed in a material which is transparent to the delivered
electromagnetic radiation. As shown in FIG. 9C the treatment head
934 radiates electromagnetic radiation in all directions uniformly
from source 935 located within head 934. Source 935, generates the
desired electromagnetic radiation from electrical power provided by
power source 940. The source may be for example, a source of IR, UV
visible light, X-rays or other electromagnetic radiation with which
it is desired to treat the tissue of the pneumostoma. Particular
devices suitable for use as source 935 include for example
incandescent light sources, LEDs, fluorescent lamps and miniature
X-ray sources. The source may be provided with additional features
to ensure uniformity of distribution of the selected
electromagnetic radiation including, for example a collimator,
diffuser, and or reflector.
[0167] FIG. 9D shows a sectional view of a pneumostoma treatment
device 950 for treatment of pneumostoma tissues with
electromagnetic radiation. The device includes a shaft 952 having
at its distal end a treatment head 954. The shaft 952 carries a
flange 956 which can slide on shaft 952. Flange 956 may be locked
to shaft 952 and secured to the chest of the patient so that head
954 may be secured in a fixed relation to the pneumostoma during
operation of pneumostoma treatment device 950. At the proximal end
the pneumostoma treatment device 950 has a coupling 962 for
connecting the pneumostoma treatment device 950 to a controller 960
which provides light and power through cable 964 to treatment head
954.
[0168] In the embodiment shown in FIG. 9D, the treatment head 954
does not generate electromagnetic radiation in situ. Instead, the
electromagnetic radiation is generated by controller 960 and
transmitted through an optical fiber 953 to treatment head 954. The
treatment head 954 is enclosed in a material which is transparent
to the delivered electromagnetic radiation. As shown in FIG. 9D,
the treatment head 954 includes scanning optics 958 which direct
the electromagnetic radiation in a particular direction under the
control of controller 960. Controller 960 generates the desired
electromagnetic radiation, transmits it to head 954 which directs
it to a particular region of tissue of the pneumostoma. Controller
960 is connected to a computer system 964 which provides the
physician with an interface 966 to operate controller 960 and
control head 954 to treat selected target tissues within a
pneumostoma.
[0169] Controller 960 may generate one or more selectable
frequencies of electromagnetic radiation. Controller 960 may, for
example include a tunable laser source cable of generating coherent
light over a range of different frequencies. The light frequency
and intensity may be selected based upon the effect desired. For
example, in some case the light frequency and intensity may be
selected to ablate certain target tissues in the pneumostoma.
Tissue ablation may be used to generate pores in the wall of the
pneumostoma to enhance patency of the pneumostoma and/or restore
pathways for gas to exit the pneumostoma.
[0170] In some embodiments, the scanning optics may also receive
light received back from the tissue, which light may pass back down
the fiber optic to controller 960. The received light may be
analyzed using tissue spectroscopy and/or tomography techniques to
determine properties of the particular tissue from which the light
is received. In such way the head 954 can be used to analyze the
tissue of the pneumostoma in addition to, or instead of, treating
the tissue. Tissue scanning may be used in order to select target
tissues for e.g. ablation to enhance the selectivity of treatment
and reduce damage to sensitive tissue. For example, tissue scanning
may be used to ensure that tissue ablation avoids blood vessels in
proximity to the pneumostoma when forming pores to restore or
enhance the exit of gas through the pneumostoma.
[0171] Because of the proximity of blood vessels to the surface of
the pneumostoma, the pneumostoma may also be used as a port for
analysis of compounds in the bloodstream. For example analysis of
blood gases, and/or glucose concentration. The analysis can be
performed by scanning the thin tissues of the pneumostoma and
analyzing the light received from the tissues. Information in the
received light at different frequencies and in a number of modes
(for example scattering, reflectance, absorption and fluorescence)
may be used to derive detailed information regarding the tissues of
the pneumostoma and blood in vessels immediately adjacent the
pneumostoma
[0172] 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. Embodiments of the present
invention may use some or all of the features shown in the various
disclosed embodiments where such features are not structurally or
functionally incompatible. It is intended that the scope of the
invention be defined by the claims and their equivalents.
* * * * *