Development of a Disposable Spray Canister for Talc Pleurodesis*

Development of a Disposable Spray
Canister for Talc Pleurodesis*
A Preliminary Report
Henri G. Colt, MD, FCCP; and Jean-Francois Dumon, MD, FCCP
Talc pleurodesis has been used for more than 50 years
in both the United States and in Europe, and it has
proven to be safe and effective in patients with malignant
pleural effusions as well as recurrent pneumothorax.
In this preliminary report, we describe a disposable,
single-use spray canister that allows intrapleural administration
of sterile, asbestos-free Luzenac talc, thus
facilitating thoracoscopic talc insufflation for pleurodesis,
particularly in patients with recurrent malignant
effusions. The talc is delivered ready to use, administered
via a hollow plastic delivery catheter that can be
pleurodesis is usually recommended when patients
with persistent or recurrent pleural effusions have
failed multiple drainage procedures. The vast majority
of these patients have malignant pleural effusions
(MPE), often with pleural metastases, and are
no longer responsive to systemic therapy. Others have
paramalignant effusions or effusions related to massive
ascites or peritoneal carcinomatosis.1 During the
last 100 years, surgeons and chest physicians have
searched for an effective means of pleurodesis, and
many chemical, as well as other agents have been
employed with varying degrees of success.2 Although
never approved for intrapleural use by the Food and
Drug Administration, tetracycline has been most
frequently used in the recent past, but is no longer
available.3 Bleomycin, a cytotoxic agent ropprtedly
successful in up to 70% of instances, is costly and has
systemic adverse effects.4 With the recent resurgence
of thoracoscopy, talc pleurodesis, once quite popular,
is increasingly used, and several investigators have
shown that talc is superior to other agents in both
clinical and experimental settings.5-7
DESCRIPTION OF SPRAY CANISTER
The purpose of this report is to describe a spray
canister that allows intrapleural administration of
sterile, asbestos-free talc powder (developed in collaboration
with Luzenac Europe [Toulouse, France]
*From the Pulmonary and Critical Care Medicine Division,
University of California, San Diego Medical Center, San Diego
(Dr. Colt); and the Centre Laser du CHU Sud, St. Marguerite
Hospital, Marseille, France (Dr. Dumon).
Manuscript received January 24, 1994; revision accepted April 19,
1994.
Reprint requests: Dr. Colt, Pulmonary Special Procedures UCSD
Medical Center, 200 W. Arbor Drive, San Diego, CA 92103
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inserted through the pleural trocars used during thoracoscopy.
Use of this spray canister allows practitioners
to avoid complex handling and sterilization procedures
required for bulk talc powder. (Chest 1994; 106:1776-80)
MPE=malignant pleural effusions
Key words: canister; pleurodesis; talc; thoracoscopy
and Axion [Aubagne, France] and distributed by
Bryan Corp. [Woburn, Mass.] as aerosolized talc). The
talc is from Luzenac, a small town located in the area
of Ariege, France, the site of one of the largest
open-air talc mines in the world. Luzenac talc is
known for its relative purity: the canister contains 4
g of Luzenac PR 7841 white talc powder (talc and
chlorite concentration greater than or equal to 95%)
with a pH of 9, a real density of 2.58 to 2.83, and a
solubility in water less than 0.1%. Associated minerals
include dolomite (less than 3%), calcite (trace
elements only), and quartz (less than 3%). No amphiboles
have ever been detected (x-ray diffraction as
described in the Cosmetic, Toiletry, and Fragrance
Association J4-1 norms of the American cosmetic industry).
Products have been systematically controlled
since 1978 (information supplied by the manufacturer).
Additional elements include soluble calcium
(0.17%), soluble magnesium (0.09%) soluble iron (60
ppm), chloride (> 140 ppm), and insoluble calcium
(

FIGURE 1. Disposable talc spray canister with nozzle and 15-cm
delivery catheter. Also shown is a standard pneumatic talc atomizer
with bellows applicator (Richard Wolf Co.), 2.5 g of talc in
sterile test tube, and atraumatic lOF silicone catheter.
by gamma radiation and marketed in a sterile peel
pack in which are also enclosed 15- and 25-cm hollow
plastic delivery catheters. The propellant is
dichlorodifluoromethane.
Prior to pleurodesis, the sterile talc canister and
nozzles should be removed from the sterile packaging,
after which the protective cap on the canister
may be removed and the canister shaken. The nozzle
and delivery catheter are then securely attached
to the canister. Usage of the shorter 15-cm catheter
is recommended for application through pleural
trocars or at the thoracotomy site. The distal extremity
should not be in close proximity to lung parenchyma.
It is somewhat sharp and may cause parenchymal
damage. In addition, the talc is delivered
under pressure. Although no pressure-related damage
has yet been seen, it is a potential danger of
pressurized talc spray administration. While firmly
holding the nozzle and delivery catheter together in
one hand, pressure is applied to the nozzle on the
canister. The distal extremity of the delivery catheter
should be pointed in several different directions
to ensure equal and extensive delivery over all pleural
surfaces. The talc canister is kept vertical to
maximize distribution. In case of limited talc pleurodesis,
talc is applied only to the area of interest.
During talc delivery, the canister becomes cold, signaling
near total talc evacuation. If talc is delivered
through a pleural trocar during thoracoscopy, care
should be taken to keep the distal extremity of the
delivery catheter about 0.5 cm beyond the tip of the
pleural cannula. Otherwise, talc will adhere to the
sides of the cannula, and intrapleural distributions
will be unsatisfactory. After application, the talc
canister and delivery catheters should be discarded.
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Preliminary Clinical Experience
We have used this device in 12 patients with MPE
and in 9 patients with spontaneous pneumothoraxes
(in addition to bleb or bulla resection). Pleurodesis
was successful at 90 d (defined as absence of symptoms
attributable to effusions, clinically insignificant
increase of pleural effusion evidenced on chest x-ray
film compared with baseline films, and requiring no
further thoracentesis) in 11 of 12 patients and in all
patients with pneumothorax (the follow-up was 1
year). No complications of talc administration occurred,
although about 30% of patients had lowgrade
temperatures after thoracoscopy. A prospective
study comparing talc pleurodesis using this device
and routine talc powder administration using a
standard pneumatic atomizer (Richard Wolf Co.) is
underway.
Possible Benefits and Pitfalls
Overall, this disposable canister is effective and
practical. Complex in-hospital sterilization and handling
procedures of bulk talc powder are avoided,
and talc administration is simple, rapid, and clean.
The canister is expensive, however, when compared
with other talc preparations. For example, at University
of California, San Diego, Medical Center,
routine talc preparation, including purchase, sterilization,
packaging, and handling, costs only $4.00.
Another drawback of the canister is the inability to
quantify talc administration. For example, we use the
entire contents of a canister for patients with MPE
and extensive neoplastic parietal pleura involvement,
but we use only a few spray applications for limited
pleurodesis in patients with benign disease or pneumothorax.
Unfortunately, there is no way of quantifying
the amount of talc delivered is less than the
entire contents is used. This is quite different from the
way standard talc powder is packaged in our institutions
(in sterile plastic test tubes containing either
1.2 or 2.5 g of sterile talc powder).
Some minor pitfalls relate to the delivery catheters.
Their tips are too sharp and could tear lung parenchyma.
We have easily done this in experimental
animal models. Also, talc tends to clump if the
delivery catheter is held too close to the lung or to the
chest wall parietal pleura. We believe that thoracoscopic
administration of talc with the canister through
a single point of entry is more difficult than through
two points of entry, where the delivery catheter's
position can be easily verified thoracoscopically. The
delivery catheter also may detach from the nozzle as
pressure is applied. For this reason, the canister,
nozzle, and catheter should be held firmly during
application. In regard to previous suggestions of
aerosolized talc delivery through an indwelling chest
tube, we find this totally unsatisfactory. Talc clumps
CHEST / 106 / 6 / DECEMBER, 1994 1777

up inside the chest tube, even when the longer 25-cm
delivery catheter is used. Therefore, we do not
believe that aerosolized talc delivery through an indwelling
chest tube can replace talc slurry administration.
DISCUSSION
Talc pleurodesis was first suggested in 1935 by
Bethune,8 a Canadian surgeon who investigated
methods of achieving adherence of lung parenchyma
to the chest wall prior to performing lobectomy. In
this study, Bethune actually credits a deceased Canadian
physician, R. U. Harwood, for suggesting the
use of commercial talc for this technique because of
the known fibrogenic properties of silicate powders.
Bethune also describes the first thoracoscopic administration
of talc powder using a specially designed
"return-air" blower made by the Pilling Company.
Subsequently, thoracoscopic talc poudrage (poudrage,
which is French for powdering, consists of
spraying sterile talc powder over the visceral and
parietal pleura surfaces) was used for pleurodesis
in patients with tuberculosis as well as in
patients with spontaneous pneumothorax,9,10 although
several surgeons later preferred talc administration
via thoracotomy, even in patients with malignant
pleural effusions.11"'5 In 1958, Chambers,'6 a
thoracic surgeon from San Diego, revived the technique
of talc slurry pleurodesis (by talc slurry, one
usually means that sterile talc powder is diluted in 50
to 200 mL of normal saline solution and instilled via
pleural trocar or chest tube), reporting an 85% success
rate after instillation through an indwelling chest
tube. Similar results were reported in 1967 by Jones17
using thoracoscopic application of talc slurry, and in
1976 by Adler and Sayek.18 This thoracic surgeon
from New York also described a novel talc powder
aerosol delivery system developed in cooperation
with the Union Carbide Corporation in 1967.19 Microcel
B, an amorphous calcium silicate used to fluidify
talc and avoid clumping, was added in small
amounts to US Pharmacopoeia-approved talc inside
a metal container. A small Teflon delivery catheter
was employed for administration into the body cavity
during thoracotomy. Although successful, this
product was not commercialized owing to lack of
interest by the company (verbal communication, R.
Adler, MD, December 1993).
Although talc was repeatedly used for pleurodesis
in patients with MPE in both Europe and the United
States throughout the 1960s,20-24 it was largely abandoned
in the 1970s, especially in the United States.
Indeed, there had been suggestions that proportional
mortality from carcinoma of the lung and pleura
among talc workers was four times that of a control
population.25 In addition, tetracycline was becoming
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a most popular agent since the first report of its successful
use for pleurodesis by Rubinson and Bolooki
in 1972.26
A potential problem of intrapleural talc administration,
therefore, is the carcinogenicity of the talc.
The issue surrounding talc use is particularly confusing
because many mineral talcs, especially those
previously mined from New York, were heavily
contaminated with tremolite or anthrophyllite.27'28
Talc asbestosis, produced by inhalation of talc with
asbestos fibers, is a well recognized medical illness.29
Talc is, after all, a hydrous magnesium silicate
(Mg6Si8020[OH]4), sometimes containing a small
amount of aluminum silicate. Its formula is similar to
that of asbestos. The formula for chrysotile asbestos,
for example, is Mg6Si4010(0H)8, and contamination
of talc with asbestos, especially tremolite, has
been reported.3032 Other minerals such as dolomite
(calcium magnesium carbonate) may also "contaminate"
talc.33 The results of experimental studies of
Wagner et a134 and Rubinoet et al,35 as well as those
of retrospective studies performed by the Research
Committee of the British Thoracic Association36 in
England and by Leophonte et a137 in France show
that pure talc (containing no asbestos) is not carcinogenic.
Both the European and American Pharmacopoeia,
therefore, have instituted strict guidelines for
medical-grade and cosmetic-grade talc composition,38-40
not only addressing requirements for asbestos-free
talc, but also limiting its contamination with
bacteria or other minerals. Although further research
is required in this area, current evidence suggests that
fears of asbesto-free, pure talc-induced neoplasms are
unfounded. To our knowledge, no cases of neoplasm
caused by intrapleural administration of sterile,
asbestos-free talc have been reported.
Many studies have demonstrated that talc pleurodesis
is a safe and effective means of achieving apposition
of the pleural surfaces in patients with MPE.
Success rates are reportedly greater than 85%.6,22,4147
In animal experiments as early as in 1941, Lelourd41
showed that pleurodesis was achieved by the 7th day
after talc administration. In a recent canine study,
Bresticker et a17 reported that pleural symphysis from
talc was comparable to that obtained by mechanical
abrasion. Mathlouti et a149 showed that talc caused an
inflammatory reaction confined to the pleural surfaces,
confirming previous work done by Frankel et
al.50 Controversy subsists, however, regarding the
ideal method of administration, and it is unclear
whether poudrage has any advantages over slurry.
Boutin et al5l, for example, has repeatedly advocated
thoracoscopic talc poudrage. Additional support for
this procedure, which may be safely performed with
the patient under local or general anesthesia, is provided
by several studies. Ohri et a143 reported 95.5%
Development of a Disposable Spray Canister for Talc Pleurodesis (Colt, Dumon)

success in 42 patients, and Aelony et al44 showed
success in 23 of 28 (82%) patients. Hartman et a16
compared the use of insufflation of talc under thoracoscopic
guidance with control populations who had
received either tetracycline or bleomycin pleurodesis,
reporting a 95% success rate of talc at 90 days
compared with 70%o for bleomycin and 47% for tetracycline.
Poudrage may be more effective than
simple administration of talc slurry through a previously
placed chest tube because adhesions and loculated
fluid collections seen during thoracoscopy can
be removed prior to pleurodesis. Additional, prospective,
multi-armed randomized protocols and animate
laboratory research are necessary, however, to further
define indications for the selected techniques of
talc administration.
In contrast to many favorable clinical reports of
talc pleurodesis, there are reports of immediate adverse
effects of intrapleural talc administration and
those suggesting potential restrictive ventilatory impairment
years after talc pleurodesis for recurrent
pneumothorax.52 Roujeau and Rose53 linked talc use
to pulmonary talcoma. Talc pachypleuritis (pleural
inflammation and thickenning), although not constant
radiographically,51 has been described.17'49
Acute pneumonitis54'55 and acute respiratory distress
syndrome56 also have occurred shortly after intrapleural
talc administration, although definite causal
relationships between respiratory insufficiency and
talc, however, have not been established. Whether
adverse effects of talc are related to dose or mode of
administration requires investigation. In regard to
potential long-term restrictive lung disease after
intrapleural talc administration in patients with
pneumothorax, Lange et a157 performed pulmonary
function tests on 114 patients during a 22- to 35-year
follow-up study. Only mild, statistically insignificant
differences in ventilatory function were discovered.
In the experimental setting, McCahren et a158 showed
that talc pleurodesis did not affect dynamic or static
lung compliance in growing swine. It appears, therefore,
that fears of decreased lung function due to talc
pleurodesis probably are unfounded.
In summary, if talc is to be recognized by medical
and surgical communities as an effective and safe
method of pleurodesis, clinical and laboratory studies
need to be performed to answer specific questions
regarding mode of administration, talc composition,
and effects of talc pleurodesis compared with other
methods of pleural symphysis. Practical problems
also must be addressed. Intrapleural talc administration
has not been formally recognized by the US Food
and Drug Administration, and lack of standardization
regarding dose, mode of administration, packaging,
and handling persists. Many practitioners,f or
example, use European or US Pharmacopoeia-
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approved talc in its "pure" form. It is unclear
whether the composition of talc obtained from
different sources can alter its fibrogenicity. Others
combine talc with thymol iodide, as originally described
by Bethune.8'46 Advantages of this mixture
over pure asbestos-free talc are undefined. It is noteworthy
that several different talc sterilization techniques
are available. For example, talc may be gamma-radiated
and placed into sterile peel packs,59
whereas, at the University of California, San Diego,
Medical Center, medical-grade asbestos-free US
Pharmacopoeia-approved talc powder is purchased
in bulk form, packaged in unit doses, and sterilized
using a combination of ethylene oxide and dry heat.
While some hospitals willingly share their handling
guidelines, others refuse to do so categorically. The
availability of a sterile, asbestos-free talc spray canister
could facilitate talc acquisition and provide an
alternative to institutionally prepared talc for pleurodesis.
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Development of a Disposable Spray Canister for Talc Pleurodesis (Colt, Dumon)