U.S. patent number 3,810,474 [Application Number 05/290,922] was granted by the patent office on 1974-05-14 for tubing.
This patent grant is currently assigned to Smiths Industries Limited. Invention is credited to David Edward Cross.
United States Patent |
3,810,474 |
Cross |
May 14, 1974 |
TUBING
Abstract
An endotracheal tube has an inflatable cuff of undulatory
bellows-like configuration to provide spaced circumferential
convolutions, whereby cuff contact in establishing a labyrinth seal
with the intubated patient's trachea is restricted to narrow bands
so as to reduce the extent, and consequential healing-time, of any
pressure-induced necrosis. A cuff convoluted over only part of its
length is provided on a tracheostomy tube, and alternative
configurations of cuff of partially-convoluted form and involving
cylindrical shoulders of different lengths, are used for
endotracheal and tracheostomy tubes. The cuff in each case is
inflated from an air-line that includes a pilot balloon and is
coupled into a passageway which is incorporated in the tube wall
and which opens through the wall into the cuff.
Inventors: |
Cross; David Edward
(Folkestone, Kent, EN) |
Assignee: |
Smiths Industries Limited
(London, EN)
|
Family
ID: |
10434167 |
Appl.
No.: |
05/290,922 |
Filed: |
September 21, 1972 |
Foreign Application Priority Data
|
|
|
|
|
Sep 24, 1971 [GB] |
|
|
44638/71 |
|
Current U.S.
Class: |
128/207.15;
604/916 |
Current CPC
Class: |
A61M
16/04 (20130101); A61M 25/1002 (20130101); A61M
16/0465 (20130101); A61M 16/0443 (20140204); A61M
16/0445 (20140204); B29C 2049/0089 (20130101); B29L
2031/753 (20130101); B29L 2023/007 (20130101); A61M
2205/32 (20130101); B29K 2105/258 (20130101); A61M
16/0497 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61M 25/10 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348-351 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Pollock; Elliott I.
Claims
I claim:
1. In a medico-surgical device having an inflatable balloon cuff
for introduction into the body to effect a seal therein, the
improvement wherein the cuff includes means for providing a
convoluted external surface to the inflated cuff to restrict cuff
contact with the body throughout said seal to discrete bands, the
convolution of said external surface in said inflated cuff
comprising a series of at least three mutually-spaced crest
portions with intervening recess portions to provide said bands of
contact occluding the intervening recesses from one another in the
seal.
2. A device according to claim 1 wherein the cuff has a wall of
regularly configuration.
3. A device according to claim 1 including a length of tubing, and
wherein the cuff encompasses a portion of the tubing and has said
crest portions spaced axially of the tubing from one another with
each crest portion encircling the tubing.
4. A device according to claim 3 wherein the said crests portions
occupy only part of the cuff length.
5. A device according to claim 3 wherein the tubing wall
incorporates a passageway communicating with the interior of the
cuff for inflation purposes.
6. An endotracheal tube comprising a length of tubing, a convoluted
sleeve surrounding a portion of the tubing coaxially near one end
of said tubing, said sleeve being sealed at both of its ends to
said tubing to provide a balloon cuff encompassing said portion of
the tubing with axially-spaced circumferential convolutions, and
means coupled to the interior of the cuff for conveying fluid to
inflate the cuff, said cuff at least when inflated having by virtue
of said convolutions a series of at least three circumferential
outwardly-directed crest portions spaced axially from one another
for contacting the tracheal wall in discrete bands.
7. An endotracheal tube according to claim 6 wherein one of said
crest portions of said cuff comprises a cylindrical shoulder
portion located beyond the others of said circumferential crest
portions towards said one end of the tubing, and wherein the
shoulder portion and the said others of said crest portions have
substantially the same diameter as one another.
8. A tracheostomy tube comprising a curved length of tubing having
a distal end for insertion into a patient's trachea through the
neck, attachment means coupled to the other, proximal end of the
tubing for use in securing the tube externally at the patient's
neck, an inflatable cuff encompassing a portion of the tubing near
the said distal end, and means coupled to the interior of the cuff
for conveying air to inflate the cuff, said cuff having a
convoluted wall surrounding said portion of the tubing and
including a series of at least three axially-spaced circumferential
crest portions for contacting the patient's trachea at discrete
positions to provide a labyrinth seal therewith when the cuff is
inflated.
9. A tracheostomy tube according to claim 8 wherein the cuff wall
includes a cylindrical shoulder portion and a plurality of narrow
circumferential crests, said shoulder portion being located
distally of the said narrow circumferential crests, and wherein the
shoulder portion and the said narrow crests have substantially the
same diameter as one another.
Description
BACKGROUND OF THE INVENTION
This invention relates to medical or surgical devices, and in
particular to such devices of the kind having an inflatable balloon
or cuff for introduction into the body to effect a seal
therein.
Medical or surgical devices of this kind are known in the treatment
of humans and also animals, and commonly take the form of a tube
that is provided with an inflatable cuff encompassing a portion of
its length. Examples of such tubes are to be found in the various
forms of cuffed endotracheal tube that are commonly used in
anaesthesia. The tube in this case is for introduction into a
patient's trachea through the mouth or nose, and carries a cuff
near the distal end so that inflation causes the cuff to distend
into contact with the tracheal wall and thereby effect sealing of
the tube in the trachea. Similar practice applies in tracheostomy,
but the cuffed tube used in this case is specially adapted for
insertion into the trachea through a surgical opening in the
patient's neck.
The purpose of the seal provided with both the cuffed endotracheal
and tracheostomy tubes is to ensure that all air or other gas
administered to the patient is routed through the tube, and also to
prevent mucous, vomit or other material from the upper respiratory
tract, entering the lungs. However, there is the risk of injury
resulting from the inflation pressure exerted by the cuff on the
tracheal wall, in that blood-carrying capillaries in the wall may
become occluded and this may lead to necrosis of the tracheal
tissue. The cuff used is generally of a uniform-cylindrical or
barrel-shape configuration and contacts the tracheal wall over an
area of such an extent that healing of the necrosis, by natural
growth from adjacent undamaged areas and restoration of blood
supply, is usually very slow. The injury may, however, take the
more serious form of stenosis, resulting from an invasion of the
affected area by fibrous tissue, and relief of consequential
tracheal-restriction may necessitate surgery.
A proposal (Dr. P. D. Salpekar, British Medical Journal, 29th Jan.
1966, page 296) for reducing the risk of tracheal-wall injury in
tracheostomy, involves the use of two axially-spaced and
independently-inflatable cuffs. With this arrangement the two cuffs
are inflated alternately with one another, so that each is in use
to provide the desired seal for only half the period of intubation.
Although this reduces the time of capillary occlusion at any
position on the tracheal wall, it does not fully avoid the
fundamental possibility of there being extensive areas of necrosis
that are slow to heal and rejuvenate.
The risks and difficulties of necrosis and possible stenosis
referred to above in connection with cuffed endotracheal and
tracheostomy tubes, apply correspondingly to other cuffed devices
(such as for example catheters) used elsewhere in the body, and it
is an object of the present invention to provide a cuffed device
for medical or surgical use that will enable such risks and
difficulties to be reduced.
SUMMARY OF THE INVENTION
According to the present invention there is provided a medical or
surgical device having an inflatable balloon or cuff for
introduction into the body to effect a seal therein, wherein the
cuff presents a convoluted external surface when inflated so as to
contact the body at discrete positions therein.
With the cuffed device of the present invention contact with the
body is made only at the discrete positions so that the possibility
of extended and unbroken areas of necrosis with the long recovery
time required, is substantially reduced.
The balloon or cuff may have a wall of undulatory configuration,
and may encompass a portion of a length of tubing, for example the
tubing of an endotracheal or tracheostomy tube of plastics or
rubber. In these latter circumstances the cuff may have
convolutions which each encircle the tubing and which are spaced
from one another axially of it. The cuff may be convoluted along
the whole, or only a part, of its length.
BRIEF DESCRIPTION OF THE DRAWINGS
Cuffed medical and surgical devices in accordance with the present
invention will now be described, by way of example, with reference
to the accompanying drawings, in which:
FIG. 1 shows an endotracheal tube provided with a convoluted cuff,
in accordance with the present invention;
FIGS. 2 and 3 illustrate respectively and for comparison purposes,
the circumstances applicable to tracheal intubation of an
endotracheal tube of the prior art and the endotracheal tube of
FIG. 1;
FIG. 4 shows a cuffed tracheostomy tube according to the present
invention; and
FIGS. 5 and 6 illustrate two alternative configurations of cuff
that are applicable to the endotracheal and tracheostomy tubes of
FIGS. 1 and 4.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to FIG. 1, the endotracheal tube includes tubing 1 that
is of constant bore or lumen 2 throughout its length and has a
bevelled, distal, tip 3. An elongate cuff 4 encompasses a portion
of the tubing 1 near the bevelled tip 3, being formed by a short
length of convoluted sleeving of uniform wall thickness that is
bonded or otherwise sealed at both ends to the tubing 1. The cuff
4, of regularly undulating external surface with circumferential
crests 5 space axially from one another by the valley recesses,
provides a balloon of bellows-like configuration enclosing a
portion of the tubing wall 8 around an opening 6 from a passageway
7. The passageway 7, which runs lengthwise of the tube within the
wall 8, is closed at the tip 3, and at some two-thirds of the
length of the tubing 1 along from the tip 3 is in air-tight
communication with an external air-line 9 sealed into the wall
8.
Air to inflate the cuff 4 through the opening 6 from the passageway
7, is supplied to the air-line 9 via a standard coupling 10. Supply
of air to the air-line 9 in this way distends the convoluted cuff 4
to urge the smoothly-curved crests 5 into contact with the internal
wall of the intubated patient's trachea. This contact establishes
an effective labyrinth seal with occluded recesses intervening the
crests 5, that withstands efficiently the ventilation pressure
administered to the patient via the lumen 2, and blocks aspiration
of pharyngeal secretions and any other material from his upper
respiratory tract. The cuff-inflation pressure is maintained using
a stopper plug 11 inserted in the coupling 10 as shown, and can be
checked by reference to the distension of a pilot balloon 12
included in the air-line 9.
The convoluted cuff 4 of the endotracheal tube described above with
reference to FIG. 1, contacts the wall or mucous membrane of the
trachea in discrete bands rather than throughout the extended area
characteristic of the known form of cuff with its
uniform-cylindrical or barrel-shape configuration. The
circumstances applicable to intubation using the barrel-shape
configuration of cuff for example, are illustrated in FIG. 2,
whereas those applicable to intubation using the convoluted cuff 4
of the present invention are illustrated in FIG. 3.
As illustrated in FIG. 2, the smooth barrel-shaped cuff 14 contacts
the ciliated columnar epithelium E of the mucous membrane M of the
trachea over a substantial unbroken area. The pressure applied
tends to occlude the mucosal capillaries C which pass from the
submucous layer L through the longitudinally-extending elastic
fibres F, and which serve to supply blood to the epithelium E at a
pressure of between 12 and 30 millimetres of mercury. The pressure
of inflation for efficient sealing of the cuff 14 in the trachea,
exceeds the ventilation pressure which is commonly set at between
14 and 15 millimetres of mercury, but which may occasionally reach
as high as 60 millimetres of mercury. Occlusion of the capillaries
C with consequent necrosis, and possible stenosis, is therefore
quite likely.
Similar considerations apply to the circumstances of the convoluted
cuff 4 illustrated in FIG. 3, but here the greater efficiency of
the labyrinth seal provided along the length of the cuff 4 by the
successive bands of contact of the crests 5 and their intervening
recesses occluded from one another, tends to enable use of a lower
inflation pressure. The likelihood of necrosis, and possible
stenosis, is therefore reduced, and is in any case confined to
spaced bands as distinct from an extended unbroken area. The repair
by healing or rejuvenation of any necrotic region is achieved by
natural growth of cells adjacent that region together with
restoration of capillary blood-supply to it. Accordingly if there
is necrosis with the convoluted cuff, the fact of confinement of
the damage to spaced bands is the more conducive to speedy natural
healing and rejuvenation.
Although the advantages of the convoluted cuff 4 have been referred
to above more particularly in connection with an endotracheal tube,
they are equally applicable to a cuffed tracheostomy tube. The
advantages, however, do not necessarily require the use of a cuff,
such as the cuff 4, that is convoluted along its whole length, but
may be realised with only partial convolution. A form of
tracheostomy tube incorporating a partially-convoluted cuff is
illustrated in FIG. 4.
Referring to FIG. 4, the curved tubing 21 of the tracheostomy tube
is terminated proximally by a conventional chimney 22 and
fixing-strap 23. The cuff 24 encompasses a portion of the tubing 21
near the distal end 25 and is inflatable from an air-line 26 that
includes a pilot balloon 27. The air-line 26 is coupled at the
chimney 22 into a passageway 28 that extends the length of the
tubing 21 and is closed at the distal end 25. The passageway 28
communicates with the interior of the cuff 24 via two openings 29
and 30 through the tubing wall.
The cuff 24 has two distinct proximal crests 31 and a narrow distal
crest or rounded shoulder 32 that is of the same diameter as the
two crests 31 and is smoothly contoured into a distal section 33 of
conical form. Contact with the trachea upon inflation of the cuff
24 is made at the shoulder 32 and the crests 31 so that any
necrosis is consequently confined to just three spaced and narrow
bands. In this respect also, however, the likelihood of necrosis is
reduced by the fact that the cuff 24 is formed of strong, but very
thin, plastics material so as to have a normally floppy nature and
enable full erection and efficient sealing to be achieved with a
low inflation-pressure.
Two modified configurations of `floppy` cuff that may alternatively
be used in place of the cuff 24 of FIG. 4, or the cuff 4 of FIG. 1,
are illustrated in FIGS. 5 and 6. As compared with the cuff 24 of
FIG. 4 each of these alternative cuffs has three proximal
convolution-crests 31' of equal diameter to one another and that of
FIG. 6 incorporates an extended, cylindrical crest or shoulder 32'
(of the same diameter) at its distal end.
The various convoluted cuffs illustrated in FIGS. 1 and 4 to 6 may
be formed of plasticized polyvinyl chloride (or possibly
polyurethane) by blow moulding. Alternatively, a dipping process in
which a suitably-shaped mandrel pre-heated to approximately
210.degree.C, is dipped into a paste of polyvinyl chloride, may be
used. The mandrel when coated with the paste, in the latter
process, is inserted in an oven at a temperature of some
280.degree.C for approximately 11/2 to 21/2 minutes (depending on
the cuff size), and is then allowed to cool to some lower
temperature at which the completed cuff can be rolled off ready for
sealing to the main tubing. This latter tubing may also be of
polyvinyl chloride, and may be extruded to include radio-opaque
material (conveniently confined to a longitudinal strip integral
with the tubing wall) and an appropriate plasticizer to provide for
slight softening at body temperature.
* * * * *