U.S. patent application number 12/857493 was filed with the patent office on 2011-02-24 for everting device and method for tracheostomy.
Invention is credited to Julia Suzanne Rasor, Ned Shaurer Rasor.
Application Number | 20110041854 12/857493 |
Document ID | / |
Family ID | 43604298 |
Filed Date | 2011-02-24 |
United States Patent
Application |
20110041854 |
Kind Code |
A1 |
Rasor; Julia Suzanne ; et
al. |
February 24, 2011 |
EVERTING DEVICE AND METHOD FOR TRACHEOSTOMY
Abstract
An integrated device and improved method for tracheostomy which
includes the placement of an everted film sheath into a patent's
trachea, through which the tracheal tube is inserted.
Inventors: |
Rasor; Julia Suzanne; (Los
Gatos, CA) ; Rasor; Ned Shaurer; (Cupertino,
CA) |
Correspondence
Address: |
Jill L. Robinson
95 Shuey Drive
Moraga
CA
94556
US
|
Family ID: |
43604298 |
Appl. No.: |
12/857493 |
Filed: |
August 16, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61274478 |
Aug 18, 2009 |
|
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61280409 |
Nov 4, 2009 |
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Current U.S.
Class: |
128/207.15 |
Current CPC
Class: |
A61M 16/0488 20130101;
A61B 17/3415 20130101; A61M 16/0472 20130101 |
Class at
Publication: |
128/207.15 |
International
Class: |
A61M 16/04 20060101
A61M016/04 |
Claims
1. A medical device for establishing an airway in a patient
comprising: a guide, said guide defining a first end adapted to be
placed on the outer skin of a patient's neck at an appropriate
insertion location for a tracheal tube, and a second end opposite
the first end; a pushing means, defining a distal end, a proximal
end, a storage space and an opening near the distal end of the
pushing means in communication with the storage space; wherein said
pushing means is held in moveable relation to the guide such that
as the proximal end of the pushing means is moved toward the second
end of the guide, the distal end of the pushing means moves away
from the first end of the guide; a first everting film sheath
defining a distal end and a proximal end; wherein a portion of the
first everting film sheath is stored within the storage space of
the pushing means, a portion of the first everting film sheath near
the distal end of the first everting film sheath extends from the
opening and is attached near the first end of the guide; whereby as
the proximal end of the pushing means is moved toward the first end
of the guide, the first everting film sheath everts from the
opening.
2. The medical device of claim 1 further comprising cutting means
for cutting tissue of the patient.
3. The medical device of claim 1 wherein the pushing means
comprises a separate pusher.
4. The medical device of claim 1 further comprising a needle
defining a proximal end and a sharp distal end adapted for piercing
the tissue of the patient, said needle held in movable relation to
the guide such that as the proximal end of the needle is moved
toward the second end of the guide, the sharp distal end of the
needle moves away from the first end of the guide.
5. The medical device of claim 1 further comprising a tracheal tube
defining a proximal end and a distal end, held in movable relation
to the guide such that as the proximal end of the tracheal tube is
moved toward the second end of the guide, the distal end of the
tracheal tube moves away from the first end of the guide.
6. The medical device of claim 5 wherein the pushing means is
positioned to lie inside the tracheal tube.
7. The medical device of claim 5 wherein the pushing means
comprises the tracheal tube.
8. The medical device of claim 1 wherein the storage space is a
lumen and further comprising a needle defining a proximal end and a
sharp distal end adapted for piercing the tissue of the patient,
said needle held in movable relation to the guide such that as the
proximal end of the needle is moved toward the second end of the
guide, the sharp distal end of the needle moves away from the first
end of the guide, and further comprising a tracheal tube defining a
proximal end and a distal end, held in movable relation to the
guide such that as the proximal end of the tracheal tube is moved
toward the first end of the guide, the distal end of the tracheal
tube moves out of and away from the first end of the guide, and
wherein the pushing means is positioned to lie inside the tracheal
tube and the needle is positioned to lie inside the lumen.
9. The medical device of claim 1 wherein the storage space is a
lumen and further comprising a cutting means defining a proximal
end and a sharp distal end adapted for piercing the tissue of the
patient, said cutting means held in movable relation to the guide
such that as the proximal end of the cutting means is moved toward
the second end of the guide, the sharp distal end of the cutting
means moves away from the first end of the guide, and further
comprising a tracheal tube defining a proximal end and a distal
end, held in movable relation to the guide such that as the
proximal end of the tracheal tube is moved toward the first end of
the guide, the distal end of the tracheal tube moves out of and
away from the first end of the guide.
10. The medical device of claim 9 wherein the pushing means
comprises the tracheal tube.
11. The medical device of claim 5 further comprising: a hollow
needle, said needle defining a proximal end and a distal end, said
needle held in the lumen in movable relation to the pushing means
such that as the proximal end of the needle is moved toward the
distal end of the pushing means, the distal end of the needle moves
away from the distal end of the pushing means; a piercing wire
defining a distal end and a proximal end adapted to pierce the skin
of the patient; and a second everting film sheath wherein the
second everting film sheath defines a distal end and a proximal
end; wherein a portion of the second everting film sheath is stored
within the hollow needle, a portion of the second everting film
sheath near the distal end of the second everting film sheath
extends from the distal end of the hollow needle and is attached to
the outside of the needle near the proximal end of the needle,
whereby as the proximal end of the needle is moved toward the
second end of the guide, the second everting film sheath everts
from the distal end of the hollow needle.
12. The medical device of claim 11 wherein the pushing means
comprises a pusher and is positioned to lie inside the tracheal
tube.
13. The medical device of claim 4 wherein the first everting film
sheath is wrapped in an axial spiral around the needle.
14. The medical device of claim 8 wherein the first everting film
sheath is wrapped in an axial spiral around the needle.
15. The medical device of claim 9 wherein the first everting film
sheath is wrapped in an axial spiral around the cutting means.
16. The medical device of claim 4 wherein the first everting film
sheath is rolled around the needle.
17. The medical device of claim 8 wherein the first everting film
sheath is rolled around the needle.
18. The medical device of claim 9 wherein the first everting film
sheath is rolled around the cutting means.
19. The medical device of claim 16 wherein the first everting film
sheath is defines a first longitudinal edge and a second
longitudinal edge and wherein at least a portion of the first
longitudinal edge overlaps the second longitudinal edge.
20. The medical device of claim 17 wherein the first everting film
sheath is defines a first longitudinal edge and a second
longitudinal edge and wherein at least a portion of the first
longitudinal edge overlaps the second longitudinal edge.
21. The medical device of claim 18 wherein the first everting film
sheath is defines a first longitudinal edge and a second
longitudinal edge and wherein at least a portion of the first
longitudinal edge overlaps the second longitudinal edge.
22. The medical device of claim 1 wherein an outwardly facing
portion of the first everting film sheath has a textured
surface.
23. The medical device of claim 1 wherein the pushing means is
flexible and defines a preformed shape of a curve, and wherein a
portion of the pushing means is held in a straight position by the
guide.
24. The medical device of claim 5 wherein the pushing means is
flexible and defines a preformed shape of a curve, and wherein a
portion of the pushing means is held in a straight position by the
guide; and wherein the tracheal tube defines a preformed shape of a
curve, and wherein a portion of the tracheal tube is held in a
straight position by the guide.
25. A medical device for establishing an airway in a patient
comprising: a pushing means, defining a distal end adapted to be
pushed into an incision formed on a patient's neck, a proximal end,
a storage space and an opening near the distal end of the pushing
means in communication with the storage space; an everting film
sheath defining a distal end and a proximal end; wherein a portion
of the first everting film sheath is stored within the storage
space of the pushing means, a portion of the everting film sheath
near the distal end of the everting film sheath extends from the
opening and is attached near the first end of the guide; wherein as
the distal end of the pushing means is pushed into the incision,
the everting film sheath everts from the opening.
26. A method of establishing an airway in a patient comprising the
steps of: everting a film sheath into a patient's trachea through
an incision; inserting a tracheal tube into the film sheath.
27. The method of claim 26 further comprising the step of: making
an incision at a predetermined location on the patient's neck.
28. The method of claim 27 further comprising, before the step of
making an incision: predetermining the location at a point between
the patient's first and second tracheal rings.
29. The method of claim 27 further comprising, before the step of
making an incision: predetermining the location at a point between
the patient's second and third tracheal rings.
30. The method of claim 27 wherein the everting step further
comprises: dilating the patient's skin and pre-tracheal tissue by
blunt dissection.
31. The method of claim 26 further comprising the steps of:
inserting a guide wire into the incision; and the step of inserting
the tracheal tube further comprises advancing the tracheal tube
over the guide wire.
32. The medical device of claim 1 wherein the first everting film
sheath is wrapped in an axial spiral in the storage space.
33. The medical device of claim 1 wherein the first everting film
sheath is rolled in the storage space.
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates to an improved method and related
devices for percutaneous placement of airway tubes into the
tracheas of living bodies, a procedure known as a tracheostomy, and
subsequent supportive maintenance tracheostomy.
[0002] Trachesotomies are the most common surgical procedure
performed on critically ill patients. The procedure involves
multiple steps to create and dilate a stoma and insert a
tracheostomy tube, each additional step creating the possibility
for error. Standard dilators, such as the BLUE RHINO manufactured
by Cook Critical Care, and serial dilators, are inserted with a
substantial, axially-inward force to dilate the patient's tissue,
which, in addition to requiring significant physical strength on
the part of the surgeon, may result in surgery-related
complications such as bleeding; perforation of the adjacent
vasculature, esophagus, and thyroid; pneumothorax and
pneumomediastinum; subcutaneous and mediastinal emphysema;
cartilage fractures; and suprastomal collapse. Further, dilatators
drag against the patient's tissue with a shear force and
considerable friction, causing tissue trauma resulting in pain,
slow healing, as well as, potentially, dysphagia, extensive
scarring and disfiguration. Finally, insertion of a dilator may
cause infection as a result of dragging or "tracking" microbes into
the trachea from the skin of the entry site or from subcutaneous
layers.
[0003] After the patient's tissues are dilated, insertion of a
standard tracheostomy tube, such as the SHILEY manufactured by
Covidien, creates a similar shear force and friction, with the same
potential for complications, as the insertion of a dilator.
Additionally, while in use, the tracheostomy tube can create
additional complications such as tissue erosion, fibrotic, scar and
granulation tissue formation and necrosis, which can result in
tracheal stenosis necessitating surgical repair. Also, the interior
of the trachea includes a layer of potentially infectious material
known as biofilm. Biofilm may adhere to and build up on the
tracheostomy tube leading to device and airway bacterial
colonization, subsequent local infection, and, finally, systemic
infection such as the frequent and often fatal complication of
ventilator-associated pneumonia.
[0004] It is an object of this invention to simplify the procedure
and reduce the number of components and steps required for
tracheostomy.
[0005] It is a further object of this invention to provide a device
and method that require less axial force to dilate patient tissue
and less shear and frictional force to insert an airway into the
patient's trachea.
[0006] It is a further object of this invention to provide a device
and method that reduce the potential of infection and other
complications associated with tracheostomy.
[0007] It is a further object of this invention to provide a device
and method that reduce tissue trauma such as rubbing frictional and
pressure necrosis, scarring, and granulation produced by a
tracheostomy tube while in situ in a trachea.
BRIEF SUMMARY OF THE INVENTION
[0008] The present invention utilizes everting technology, in
combination with novel means for placement and maintenance of
airway tubes, to simplify tracheostomy, reduce trauma to the
intervening and adjacent tissue and minimize the potential for
microbial infection. While it is anticipated that the invention
would be used for tracheostomy, the claimed device could also be
used for cricothyrotomy.
[0009] Everting is the laying down of a thin-walled "film" sheath
along the tissue entrance path wall during advancement of a
placement device, somewhat like tank treads being laid down along
the ground. The film sheath is pre-loaded inside a placement device
and as the film sheath emerges it everts, with the inside of the
film sheath becoming the outside. The extremely thin-walled film
sheath is made of a biomaterial that is lubricious, strong,
flexible, and resilient. Use of such an everting film sheath
virtually eliminates the drag, shear force, and friction generally
associated with placement, maintenance and removal of standard
tracheostomy devices, minimizing trauma and the potential for
microbial infection. The chance of infection is further reduced by
appropriate selection of biomaterial to reduce or eliminate biofilm
buildup.
[0010] An everting film placement device may stand-alone or be
integrated with a tracheostomy tube. If stand-alone, the device
places and secures the protective film sheath into a patient's
trachea to facilitate subsequent placement, maintenance and removal
of a standard tracheostomy tube. If the placement device and
tracheostomy tube are integrated, the device, simultaneously with
the placement of the film sheath, places and secures the
tracheostomy tube into the patient's trachea. The device can be
used to place film, alone or in combination with the tracheostomy
tube, into the trachea through an incision, which could include a
pre-existing stoma or a new tracheostomy site created by
conventional surgical procedures, blunt dissection or other means.
Alternatively, the device can include a cutting means and/or other
features that allow for percutaneous placement of the film and
device. In particular, the everting of the film sheath may provide
a means of blunt dissection which spreads and dilates the
tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIGS. 1 a-f show an embodiment of the current invention
suitable for placing film into an existing stoma and illustrate the
method steps for placement of the film and a conventional
tracheostomy tube, and their subsequent removal.
[0012] FIGS. 2 a-b show an embodiment of the current invention
suitable for placing film and an integrated tracheostomy tube into
an existing stoma and illustrate the method steps for placement of
the film and tracheostomy tube
[0013] FIG. 3 shows an embodiment of the current invention
including a cutting means.
[0014] FIG. 4 shows the detail of a preferred embodiment of the
cutting means.
[0015] FIGS. 5 a-e show in cutaway a preferred embodiment of the
current invention suitable for placing film and an integrated
tracheostomy tube percutaneously into a patient and illustrate the
method steps for placement of the film and tracheostomy tube using
dilation and blunt dissection.
[0016] FIGS. 6 a-g show a perspective view of a preferred
embodiment and steps similar to those shown in FIGS. 5 a-e, with
additional detail and including the use of a guide wire.
[0017] FIG. 7 shows a detail of the embodiment and step shown in
FIG. 6a.
[0018] FIG. 8 shows a detail of the embodiment and step shown in
FIG. 6b
[0019] FIG. 9 shows a cross-sectional view of the device position
shown in FIG. 5c.
[0020] FIG. 10 shows a cross-sectional view of the device position
shown in FIG. 5d.
[0021] FIGS. 11 a-f show an embodiment of the current invention
including a trocar and utilizing the everting film to effect
dilation and blunt dissection.
[0022] FIG. 12 shows an alterative embodiment of the current
invention suitable for percutaneously placing film and a
tracheostomy tube utilizing an everting guide needle.
[0023] FIG. 13 shows a means of packing the everting film sheath in
the lumen of the pusher.
[0024] FIG. 14 shows an improved means of packing the everting film
sheath in which the everting film is wrapped around a guide
needle.
[0025] FIG. 15 shows an alternative view of the means of packing
the everting film sheath shown in FIG. 14.
[0026] FIG. 16 shows an additional improved means of packing the
everting film sheath in which the everting film's longitudinal
edges are unconnected and the film is rolled around a guide
needle.
[0027] FIG. 17 shows an embodiment of an everting film with an
integral inflatable cuff at its distal end.
[0028] FIG. 18 shows the embodiment of FIG. 17 in use in the
trachea.
[0029] FIG. 19 shows an embodiment of an everting film with an
inflatable cuff at its distal end and lumens.
[0030] FIG. 20 shows a first example of tissue-engaging film
surface structures.
[0031] FIG. 21 shows a second example of tissue-engaging film
surface structures.
[0032] FIG. 22 shows a third example of tissue-engaging film
surface structures.
[0033] FIG. 23 shows a fourth example of tissue-engaging film
surface structures.
[0034] FIG. 24 shows the tissue-engaging film surface structure
spreading and dilating tissue by blunt dissection.
[0035] FIG. 25 shows a schematic of the anatomical landmarks and
markings on a patient's neck to be used for correctly locating
airway access devices.
[0036] FIG. 26 shows a locator strip to be used to appropriately
locate the flange on a patient's neck.
DETAILED DESCRIPTION OF THE INVENTION
[0037] The everting placement device of the invention, shown with
various modifications in the figures includes a pushing means,
which may comprise a pusher 110 or be integrated with another
component, a guide 130, which is positioned and held at the
appropriate location on the neck of the patient, and a first
everting film sheath 120.
[0038] The pusher 110 has a proximal end 111 and a tapered distal
nose 115 through which a longitudinal lumen 125 or other storage
space opens. The pusher 110 is preferably flexible and pre-formed
to be curved so as to allow the pusher 110 to curve caudally into
the trachea 101.
[0039] The guide 130 includes connector means, which may be a
tube-like connector 139 structure as shown, with a distal end 131
and proximal end 132, and also preferably includes an extension 135
or stand-off guide 460 for supporting the pusher 110. The guide
also preferably includes a flange 137 that may be positioned at the
appropriate location on the patient's neck and that is shaped to
conform to the topography of that location. The flange 137 may be
held to the patient's neck using a strap or other conventional
means, is preferably v-shaped and is made of a clear material to
facilitate proper placement. The connector means should be adapted
for attachment to conventional ventilator tubing (not shown). The
guide 130 also preferably includes finger rests 138 similar to
those of a syringe. The finger rests 138 may be extensions from the
connector 139, or alternatively from the extension 135 or stand-off
guide 460. The outwardly facing portion of the flange 137 may also
include upper and lower guide marks 1870, 1871 suitable for easy
alignment with corresponding marks on the patient's neck or on a
locator strip 1910 to ensure correct placement of the guide 130
using methods and devices further described below.
[0040] Alternative embodiments of the guide are possible provided
certain functions are retained. There must be an external element
or elements like the flange 137 near the neck of the patient, such
as a ring or similar structure, to which the distal end 123 of the
film sheath 120 is attached so as to absorb the force necessary to
keep the distal end 123 stationary and to keep the everted portion
of the film from moving while the stored portion is being deployed.
There must be a connector means to connect the tracheal tube to
ventilator tubing after the tracheal tube has been inserted into
the patient and the film sheath. Additionally, if the pusher 110 is
flexible, it preferably must be maintained by the guide in a
nominally straight or otherwise axially movable configuration so as
to allow a nominally axial force to be applied during use. Persons
of ordinary skill in the art will appreciate that a number of
alternatives, including tube-like structures that only partly
enclose the pusher and guides employing slits and/or are curved,
could be designed. However, it should be noted that if the pusher
110 is initially curved with the right nominal curvature for
entering the trachea, the pusher 110 could be used to place the
film sheath 120 in the trachea by hand using a caudally arcing
motion without being maintained in a straight position or requiring
any guide other than a ring or other short structure used as the
connector means, positioned at the appropriate point on the
patient's neck. Finally, the structure of the guide should
preferably be such that, when in use, equal and opposite axial
forces are applied to the guide 130 and to the pusher 110 in order
to minimize the axial placement force applied to the patient's
tissue during the placement process.
[0041] The film sheath 120 is composed of a highly flexible and
high strength polymer film, such as skived PTFE D/W 200, a modified
homopolymer PTFE manufactured by DeWAL Industries, that is
generally inelastic, biocompatible and resists adhesion of bodily
elements, tissue and potentially infectious contaminating material
such as biofilm. Such film has been used in catheter devices. The
distal end 123 of the film sheath 120 initially extends out from
the lumen 125 opening formed in the tapered distal nose 115 of the
pusher 110 and may be attached to the guide 130. Such attachment
may be effected by permanently affixing the distal end 123 of the
film sheath 120 to the appropriate portion of the guide 130 or by
trapping the distal end 123 of the film sheath 120 between
appropriate components of the guide 130 such as between the
connector 139 and the flange 137. The remaining bulk of the film
sheath 120 is initially stored inside the lumen 125. The proximal
end 124 of the film sheath 120 may be free.
[0042] The embodiment shown in FIG. 1 is suitable for use in
patients with a stoma 102 formed by conventional means and either
already existing or newly created at the time the device 100 is to
be used. It will be understood that normal surgical procedures
would be followed in the usage of all of the embodiments of the
device described; for example, if appropriate, the patient's tissue
would be properly prepped for sterile surgery and numbed by local
anesthetic before beginning the procedure. Initially, in a
preferred embodiment, the flexible pusher 110 is constrained to be
straight by the guide 130, which includes an attached extension
135.
[0043] To place the film sheath 120 through the stoma 102 into the
tracheal lumen 101 the pusher 110 can be advanced into the guide
130 by means of an attached handle, not shown. Preferably, however,
force is applied controllably, expeditiously and reproducibly to
the proximal end 111 of the pusher 110 by means of the operator's
thumb, with the forefinger and middle finger placed on the finger
rests 138 of the guide 130, which are preferably located on the
extension 135 but which may instead extend from the connector 139,
as indicated in FIG. 1b, in the manner for operation of a
hypodermic syringe.
[0044] As the pusher 110 is advanced, the film sheath 120 everts
from the lumen 125 of the pusher 110, through the opening in the
nose 115 and radially across the tip of the nose 115, to cover the
exterior of the pusher 110. In this way the pusher 110 is advanced
into the stoma 102 with essentially no axial force applied to the
patient's tissue that can distort and damage tissue structures,
such as the pretracheal tissues, tracheal cartilage and anterior
and posterior tracheal wall, and structures distal to the distal
tracheal wall such as the esophagus and adjacent vasculature. The
stoma 102 is dilated radially from its initial relaxed or partially
healed diameter to the full diameter required for the tracheal tube
as the tapered distal nose 115 of the pusher 110 advances through
the film sheath 120, again with essentially no substantial axial
force applied to the patient's tissue.
[0045] As the pusher 110 emerges from the distal end 131 of the
guide 130 into the stoma 102 and trachea 101, it curves caudally
into the tracheal lumen, as shown in FIG. 1c, which may be as a
result of the pre-formed, memory curvature built into the flexible
pusher 110 during its manufacture. If the film-covered nose 115 of
the pusher 110 contacts the posterior wall of the trachea 101, the
motion of the first everting film sheath 120 impels it caudally
along the tracheal axis without applying a significant force
transverse to the tracheal wall.
[0046] After the film sheath 120 is fully everted from the pusher
110, the pusher 110 is removed as shown in FIG. 1d and a
conventional tracheal tube 103 may be inserted through the film
sheath 120 into the trachea 101 as shown in FIG. 1e and connected
to, or reside within, the connector 139. Alternatively, the pusher
110 itself may be designed to operate as a tracheal tube. In that
case, it may be advantageous to allow a portion of the film sheath
to remain inside the pusher 110, preferably attached at its
proximal end 124, so that both the outside of the pusher 110 and at
least a portion of the inside of the pusher are encased in the film
sheath 120, and protected from biofilm, while in use. It will be
understood that additional features could be added to any of these
embodiments, including, for example, a cuff.
[0047] If the conventional tracheal tube 103 includes an inflatable
cuff 105 at its distal end, the diameter of the film sheath 120
must be sufficient to pass the deflated cuff 105 and its inflation
means without impeding the placement motion. In this case the
length of the film sheath 120 is such that its proximal end 124
terminates above the cuff 105 as shown; however, it may be
desirable to allow for the distal end of the film sheath 120 to
terminate below the cuff 105, forming a protective lubricious
barrier between the tracheal tube 103 and cuff 105 and the
patient's tissue. In such case, as shown in FIG. 13, the diameter
of the film sheath 120 must be wide enough at the point where it
covers the cuff 105 to accommodate inflation of the cuff, and the
film 620 that ultimately everts to create the wider portion of the
sheath 120 may need to be "bunched" or folded longitudinally for
storage. It will also be noted that conventional practice requires
testing of the cuff before insertion into the trachea. Thus, the
guide would optimally include an enlarged or cutaway section to
accommodate inflation of the cuff during the test, which is further
described below in the text associated with FIG. 6.
[0048] Further, since the pusher 110 lays down the film sheath 120
as it advances, dragging against tissue is essentially eliminated
such that bacteria, cells, and cellular debris are not tracked from
the skin into the wound or trachea as may occur with standard
tracheal tube insertion methods.
[0049] Biofilm 106 will collect on any foreign object in the
trachea, such as a tracheal tube, forming large colonies of
bacteria which can lead to local and, ultimately, systemic
infections. However, the lubricious fluoropolymer material of the
film sheath 120, including, for example, PTFE D/W 200, is resistant
to biofilm adhesion. Although some buildup may occur, the colonies
are usually shed when they are small and before they can cause
infection.
[0050] The film sheath 120, which covers the outside portion of the
tracheal tube 103, prevents biofilm from collecting on most of the
outside portion of the tracheal tube 103 and provides an outward
facing biofilm resistant surface. The inside of the tracheal tube
103 will still collect biofilm, but acceptable standard methods of
cleaning the inside of the tracheal tubes currently exist,
including the use of brushes and replacement of an inner cannula.
As shown in FIG. 1e, upon removal of the tracheal tube 103, the
closely fitting proximal end 124 of the film sheath 120 is
preferably trapped behind the deflated cuff 105, and the film
sheath 120 reverts upon tracheal tube 103 removal as shown in FIG.
1f. Unlike conventional removal of a tracheal tube, the biofilm is
generally not scraped off and deposited in the trachea and stoma
wall during removal, thus reducing the potential of contamination
and infection.
[0051] The device may be modified to include an integrated tracheal
tube 210 as shown in FIGS. 2a and 2b. The pusher 110 is positioned
inside the integral tracheal tube 210, but the proximal ends 111
and 211 of the pusher 110 and integrated tracheal tube 210,
respectively, are structured for simultaneous movement when the
operator's fingers apply force in the manner described above in
connection with FIG. 1. In the embodiment shown this is achieved by
causing the proximal end 111 of the pusher 110 to have a stand-off
edge 214, which may function as a thumb rest, that is wider than
the opening to the lumen at the proximal end 211 of the integrated
tracheal tube 210, although other designs are possible. The
integrated tracheal tube 210 fits inside the guide 130. The distal
end 215 of the tracheal tube 210 terminates before the tapered nose
115 of the pusher 110, and may itself be tapered to allow for
easier insertion.
[0052] In operation, the film sheath 120 emerging from the nose of
the pusher 110 everts over both the pusher 110 and the integrated
tracheal tube 210 as shown in FIG. 2b. The pusher 110 and the first
everting film sheath 120 thereby direct and facilitate the placing
of the integrated tracheal tube 210 through the stoma 102 into the
tracheal lumen integrally. Both pusher 110 and integrated tracheal
tube 210 are flexible and may have a pre-formed curvature memory
that causes them to move caudally as they emerge from the guide
130, as described previously in the text associated with FIG. 1,
and to conform to the angle between the axes of the stoma 102 and
trachea 101 after placement. Accordingly, the identity and function
of the pusher 110 and film sheath 120, and the process of placing
the film-encased integrated tracheal tube 210 into the trachea 101,
are very similar to those described for the identity and function
of these components in placing a film sheath 120 alone through an
existing stoma 102 as shown in FIG. 1 during the placement of the
conventional tracheal tube 103. After full placement of the
integrated tracheal tube 210 and removal of the pusher 110, the
advantages of a film-encased integrated tracheal tube 210 and film
reversion during removal are obtained as illustrated in FIGS. 1e
and 1f. FIGS. 2a and 2b show placing of an integrated tracheal tube
210 without a cuff for clarity, but a cuff could be employed with
this embodiment of the invention.
[0053] The device 100 may also be modified to include cutting means
that would allow for percutaneous insertion of the tracheal tube
into a patient without a pre-existing stoma or a stoma newly
created by conventional means. FIG. 3 shows an embodiment of the
device 100 that can be percutaneously placed in the trachea in the
process of placing the film sheath 120. The device includes a
cutting means, an embodiment of which is shown in detail in FIG. 4,
located within the lumen 125 of the pusher 110 and within the
portion of the film sheath 120 stored there. The cutting means may
be a cutter 301, preferably comprising a sharp point 311 and three
or more blades 320 mounted on the distal end 305 of a support
member 310 that has an appropriate diameter and shape to fit within
the lumen 125. It will be understood that other arrangements of the
blades and cutter forms could be used, and it might be desirable to
include an opening through the cutter to allow for the use of a
guide wire as further described below. As an alternative, for
example, the cutter and member could be integrated, as with a guide
needle 410 shown in FIGS. 5 through 9. The member 310 or needle 410
may be pushed forward by the operator to extend through the nose
115, cutting the desired tissue, and then withdrawn back into the
lumen 125 when no longer needed.
[0054] The incision, either as created by the arrangements of
blades 320 in a star-like shape or as created by the needle 410,
allows for entry of the nose 115 of the pusher 110 into the
patient. The first everting film sheath 120 then stretches the skin
open radially and allows the nose 115 to proceed into the
underlying tissue by blunt dissection. Everting blunt dissection
minimizes trauma and bleeding since it is accomplished by spreading
the affected tissue rather than by cutting it, and further
minimizes the axial force required to spread the tissue. When the
spreading action of the first everting film sheath 120 is
sufficient to permit progress by blunt dissection, the cutting
means may be retracted into the pusher 110. If a non-spreading
tissue structure is encountered which does not permit blunt
dissection, as might possibly be encountered at or near the
tracheal wall 330, the cutting means may again be deployed to
initiate the spreading action of the first everting film sheath 120
through that structure. In normal patients, however, additional
cutting should not be necessary since the radial stretching action
of the first everting film sheath 120 causes tissues that do not
spread to be pushed aside rather than being penetrated, for example
when the cartilaginous rings in the trachea wall 330 are
encountered.
[0055] FIGS. 5a-e, 6a-g, 7, 8, 9 and 10 show different views of an
embodiment of the current invention that include a pusher 110, film
sheath 120, guide 130, and an integrated tracheal tube 210. In the
embodiment, a needle 410 is employed as the cutting means, but it
will be understood that an alternative cutting means, such as the
blades described in connection with FIGS. 3 and 4, could be
substituted. In this embodiment of the device, the guide 130
includes a removable stand-off guide 460 with projections B and D.
Finger rests 138 which are attached to or integral with the guide
130, preferably as part of the stand-off guide 460, although they
might also be integral with the connector 139, function as
projections E. The proximal end 411 of the needle 410 includes a
projection A; while the proximal end of the pusher 111 includes a
projection C. The projections allow for operation of the device
with one hand. It will be understood, however, that the projections
described are optional, and that the steps described in connection
with the projections A through E could instead be performed using
more conventional methods. It will also be understood that for ease
of use the projections could be located at different angles
relative to the longitudinal axis of the device 100 and to each
other and could be shaped to conform comfortably accommodate the
operator's fingers.
[0056] To operate the embodiment shown in FIGS. 5 and 6, after
properly positioning the device 100 on the neck over the trachea
101, which may be accomplished using devices and methods described
in connection with FIGS. 25 and 26 below, the operator advances the
guide needle 410 through the patient's tissue into the trachea 101
by squeezing projections A and B together with the thumb and
forefinger from the position shown in FIGS. 5a and 6a to the
position shown in FIGS. 5b and 6b, respectively. Detail of the
guide needle 410 movement is shown in FIGS. 7 and 8. The distance
advanced into the trachea is limited by the standoff at projection
B.
[0057] Because the distance between the surface of the skin and the
trachea tissue can vary significantly between patients, it would be
advantageous to be able to appropriately adjust the distance the
guide needle 410 moves when projections A and B are squeezed
together. This could be accomplished by providing marks on the
guide 130, or more preferably by providing small protrusions with
detents that provide quantum "clicks" of movement corresponding to
a known distance, such as a millimeter. It will be understood that
with such a modification the projections A and B might not be
brought completely together. Before the procedure, an ultrasound
could be performed at the insertion site to determine the depth of
the tracheal tissues. The projections A and B would then be brought
together a distance equal to the measured depth, plus an additional
amount, on the order of a few millimeters, to ensure that the
distal end 412 of the guide needle 410 enters the tracheal lumen
101.
[0058] In addition, whether or not the penetration of the needle
410 is adjusted, the penetration into the trachea 101 may be
verified by a bronchoscope in the trachea 101 as is used in
conventional percutaneous dilational tracheostomies.
[0059] Next, the pusher 110 is advanced by the operator over the
guide needle 410 into the trachea by squeezing projections C and D
together with the thumb and forefinger to the position shown in
FIG. 5c. The distance advanced into the trachea is limited by the
standoff at projection D. As previously described, the wound is
dilated by purely radial force to the diameter of the tapered
distal end 215 of the tracheal tube 210 by the advancement of the
tapered nose 115 of the pusher 110 under the first everting film
sheath 120. Further, as was described in connection with the needle
410, similar structures could be used to adjust the penetration of
the pusher 110 by measuring and/or limiting the distance
projections C and D are moved together. Similar marks or detents
could be employed. The pusher 110 would be moved approximately the
same distance as the needle 410.
[0060] The guide needle 410 is then removed. The standoff guide 460
may be removed or, alternatively as shown, may be constructed with
a slot having a narrow portion 465 beginning at the proximal end
132 of the guide 130 and extending toward the distal end 131 of the
guide 130, and a wider portion 466 near the distal end 131 of the
guide 130 so as to allow Projection C at the proximal end 111 of
the pusher 110 to be relocated by twisting the standoff guide 460
around the pusher 110, so that Projection C is positioned to move
along the narrow portion of the slot 465, as shown in FIGS. 6d, 9
and 10. It will be noted that the Projection C may also be
removable and, if so, could be removed before advancement of the
pusher, thus eliminating the need to rotate the standup guide. The
pusher 110 and integral tracheal tube 210 are then advanced fully
by squeezing the proximal end 111 of the pusher 110 and the finger
rests 138, here shown as projections E, on the proximal end 132 of
the guide 130 between the thumb, index and middle fingers in the
manner of hypodermic syringe similar to that previously described
in connection with FIG. 1, resulting in the structures shown in
FIGS. 5d and 6e and the everted film sheath 120 covering the
integrated tracheal tube 210. It should be noted that the film
sheath is not shown in FIG. 6 to allow the integral tracheal tube
210 to be more clearly seen. If not previously removed, the
stand-off guide would be removed at this time, as shown in FIG. 6f.
Alternatively, pusher 110 and guide wire 2000, the use of which is
further described below, can be first removed followed by removal
of the standoff guide 460. After removal of the pusher 110 and
guide wire 2000, the integrated tracheal tube 210 becomes fully
functional as shown in FIGS. 5e and 6g with the advantages of being
clad in a film sheath as described previously in this document.
[0061] While the above discussions assume a separate pusher that
contains the everting film, other forms of pushing means are
possible. For example, the tracheal tube itself may perform the
pushing function as shown in FIGS. 11a-11f. As shown in FIG. 11a,
the film sheath 120 is stored in the lumen of the integrated
tracheal tube 210 rather than in a dedicated pusher. The distal end
123 of the film sheath 120 is attached to the guide in one of the
manners described above. However the proximal end 124 of the film
sheath 120 may be attached to the distal end 215 of the tracheal
tube 210 forming an air tight seal. A sliding tapered trocar 314 is
contained within the tracheal tube 210. The tapered trocar 314 may
be a cutting means or may include cutting device (not shown) at its
tapered tip or may contain another cutting means such as a hollow
needle or similar penetrator. Once the patient's skin is cut by the
cutting means as shown in FIG. 11b, the cutting means-initiated
opening is enlarged by blunt dissection by advancing the trocar 314
as shown in FIG. 11c. The tracheal tube 210 can then be advanced
over the trocar 314 everting the film sheath 120. It will be noted
that the tracheal tube 210 preferably includes rounded edges on the
opening of its distal end 215. The everting process further expands
the opening by blunt dissection. After the distal end 215 of the
tracheal tube 210 is advanced to be within the trachea of the
patient, the trocar 314 is removed and the tracheal tube 210 is
advanced further into the trachea. If the proximal end 124 of the
film sheath 120 is attached to the distal end 215 of the tracheal
tube 210, a film inflation means, such as a film-inflating bulb 390
or syringe, in operable attachment to the guide 130 may be used to
inflate the film sheath 120, sealing the space between the trachea
and the tracheal tube 210 and preventing air or other materials
from the esophagus from entering the lungs.
[0062] With reference to FIG. 12, the needle may optionally include
a separate everting film feature. In this embodiment, rather than
the bare needle 410, a hollow everting needle 510, optionally
enclosing a sharp-pointed wire 515 or similar device, is employed.
In the embodiment shown in FIG. 12, the wire 515 initiates the
incision, which is then expanded radially by the needle 510 as it
is pushed forward under the everting film 520 by means of blunt
dissection in the same manner as the pusher 110 and first everting
film sheath 120 expand the incision created by the needle 410. The
everting film 520 is initially stored within the needle 510, with
one end of the everting film 520 attached to the outside of the
needle 510, optimally at or near the proximal end of the needle.
The wire 515 may be fixedly attached by means of a holder 516 to
the inside of the everting needle 510 as shown, the needle 510 and
the wire 515 advancing together being used to initiate the
incision. But, alternatively, the wire might be attached to a wire
pusher that could be extended from and withdrawn into the everting
needle 510 and the nose 115 after use in the same manner that the
needle 410 or support member 310 are extended from and withdrawn
into the nose 115 and lumen 125 in descriptions of FIGS. 3 and 4.
The use of an everting needle 510 has the advantage of creating a
wound without the cutting and dragging action of the bare needle
410. Thereafter the everting needle 510 serves the same guide and
verification functions as does the bare needle 410 in the
embodiment shown in FIGS. 5 and 6 and is similarly withdrawn after
serving those functions.
[0063] With reference to FIGS. 3, 5, 6, 12 and 14, preferably, the
diameter of the nose 115 of the pusher 110 is of only slightly
larger diameter than that of the outside diameter of a conventional
14 or 15 gauge hypodermic needle, approximately 0.83 to 0.72
inches. It will be appreciated that the diameter of each subsequent
portion of the device to be inserted into the patient should be
only slightly larger than that of the previous portion of the
device so as to allow for easy advancement through the tissue.
Moreover, the tapered ends of the various portions should
preferably have rounded edges to decrease the resistance to
advancement. However, the minimum inside diameter of the lumen 125
of the pusher 110 and the outside diameter of the needle 510 is
limited by the volume required to store the first everting film
sheath 120. The volume required to store the film sheath 120
depends on the thickness of the film and the efficiency with which
it is packed. In the case where the sheath is longitudinally sealed
to form a tube, the volume required to store the film sheath will
also be affected by the outside diameter of the pusher or other
portion of the device over which it must evert.
[0064] The volume needed to store the film sheath can be
substantially reduced by more efficiently packing the film to
minimize the storage volume it occupies. Conventionally, everting
film is formed into a sheath 120 by welding or otherwise sealing
the film 620 along its length longitudinally. As shown in FIG. 13,
the everting film 620 can then be compressed and bunched up along a
particular length in longitudinal folds, and packed axially. This
method of packing the film may still be appropriate in certain
cases, for example, where a portion of the sheath has a larger
diameter than other portions in order to accommodate the inflation
of a cuff.
[0065] However, a more effective way of packing the film 620 is
shown in FIGS. 14 and 15 in which the film 620 is wrapped in an
axial spiral around a central diameter, such as around the support
member 310, the guide needle 410 or the wire 515. However, it may
be possible to have the central diameter used only during the
manufacturing process and removed, leaving the spiraled film in
place in the storage volume. This permits the cross-sectional area,
and usually the volume, occupied by the flattened wrapped film in
the lumen 125 or similar structure to be significantly reduced.
While the embodiment shows the longitudinal edges as welded or
sealed together, it will be noted that the edges can be free as
described below in connection with FIG. 16.
[0066] As an alternative, with reference to FIG. 16, a flat sheet
of film 920 may be rolled around a central diameter as shown at
910. The central diameter may be the guide needle 410 as shown, but
may alternatively be the support member 310 in FIG. 3, the guide
needle 410 in FIGS. 5 and 6, the trocar 314 in FIG. 11, or any
similar structure. As with the axial spiral storage device
described above, it may be possible to have the central diameter
used only during the manufacturing process and removed, leaving the
rolled film in place in the storage volume. The edges of the film
930 are not welded or otherwise sealed, but are designed to overlap
940 when fully everted, thus forming a tubular film conduit, such
as the film sheath 120 shown in FIGS. 1 through 6. This structure
permits the film sheet 920 to unroll to a much larger diameter
sheath without wrinkling as it is everted from the small diameter
opening. Also, a rolled film sheath is much easier and less
expensive to manufacture than a sheath comprising a sealed film
conduit, which requires welding together the edges of a film sheet.
The elimination of welding is especially advantageous in the
manufacture of the smallest film sheaths for which specialized
materials and high precision welding is required and the volume
occupied by the welded seams and their stiffness become limiting
factors for minimum diameter of the eversion system. The
elimination of the welding or bonding is also advantageous in that
there is no weld or bond to fail or leak.
[0067] It will be appreciated that while in the basic embodiment
shown the proximal end 124 of the film sheath 120 is open and the
film is attached at the distal end 123 and only attached to the
guide 130, for certain applications, including potentially the
hollow, everting needle, the proximal end 124 might be attached to
the interior lumen of the pushing element to allow for reversion of
the film upon removal of the pushing element. Alternatively, in the
case where the tracheal tube is the pushing element and a trocar is
used, as shown in FIG. 11, the proximal end 124 of the film might
be attached to the interior lumen of the pushing element to ensure
full containment of the pushing element within the film.
[0068] With reference to FIGS. 17 and 18, the first everting film
sheath 120 may optionally include an integrated inflatable cuff at
its proximal end shown deflated in FIG. 18 as 1045 and inflated as
1040. A thin elastic film sheet 1010 in the shape of the cuff 1040
and its inflation lumen 1020 are welded 1290 to an inelastic film
sheet 1030 composed of the polymer film used to create the film
sheath 120 in any of the embodiments previously discussed. The
elastic film must have sufficient elasticity to expand to fill the
space between the tracheal tube and the trachea wall when forming
the cuff, with sufficient strength and minimum thickness to contain
the pressure required to inflate it to the required size.
Additionally, the elastic film must be biocompatible and stable in
the tracheal environment.
[0069] Using an inflator bulb, similar to the bulb 390 described in
connection with FIG. 11, the cuff can be expanded like a balloon to
form an inflated cuff 1040 within the trachea 101 that prevents the
flow of ventilator gases from between the outside of the treacheal
tube and the treachal wall and out of the patient's mouth, and
prevents the patient from aspirating mucous and material from the
esophagus into the lungs. When the cuff is deflated 1045 for
removal of the tracheal tube, the elasticity of the deflated cuff
1045 holds the distal end of the inelastic film 1030 of the film
sheath 120 close to the outer wall of the tracheal tube 210.
[0070] A small ridge or groove 1060 on the outer wall of the
tracheal tube, whether integrated as shown as 210, or separate,
retains the distal end of the film sheath 120, and the cuff 1040,
1045, preventing it from slipping off the tracheal tube as the
tracheal tube is removed. In a manner similar to that shown in FIG.
1f in which the tracheal tube itself has an inflatable cuff, this
results in reversion of the film sheath 120, capturing and removing
the biofilm that accumulates on the external surface of the film
sheath 120 without scraping the biofilm off into the trachea or
wound. As a result, infective agents and potential aspirates are
not deposited into the trachea during the removal of the tracheal
tube.
[0071] The elastic film sheet 1010 is positioned at that portion of
the inelastic film sheet 1030 intended to eventually form the
outwardly facing proximal end 124 of the first everting film sheath
120. The elastic film sheet 1010 is attached to the film sheet 1030
only at the edges, forming the sealed volume required for the cuff
1040 and allowing for the cuff's eventual inflation and expansion.
The elastic film sheet 1010 also includes a narrow portion that
forms the inflation lumen 1020, which extends longitudinally away
from the proximal end 124 of the sheath 120. This portion of the
elastic film sheet 1010 is also attached to the film sheet 1030
only at the edges to form a sealed volume connected to the sealed
volume that forms the cuff 1040, 1045, and is connected at its
distal end to a source of inflation fluid or gas which may be
introduced through a passage in the guide 130 or other appropriate
means. The inflation fluid or gas used to inflate the cuff can then
reach the uninflated cuff 1045 through the inflation lumen
1020.
[0072] As suggested above, the cuff 1040, 1045 may be added to any
of the embodiments of the film sheath 120 shown above such that the
sheath includes both elastic 1010 and inelastic 1030 film sheets.
To form a sheath comprising a sealed film conduit, the longitudinal
edges of the inelastic film sheet 1030 are welded such that the
elastic film 1010 is on the outside of the film sheath 120 when
fully everted.
[0073] With reference to FIG. 19, it is also possible to create
lumens 1110 in addition to the inflation lumen 1020 by attaching
the narrower portion of the elastic film sheet 1010 to the film
sheet 1030 longitudinally to form multiple channels. The lumens
1110 preferably extend from the distal end 123 of the film sheath
120 to ports 1112, 1113 near the proximal end 124 of the film
sheath 120, just above or below the deflated cuff 1045. Such access
lumens are useful for passing catheters into the trachea cranially
and caudally from the tracheal tube for diagnostic and drug
delivery purposes and for inserting suction tubes to remove
accumulations of mucous and phlegm or other matter that accumulates
above or below the inflated cuff 1040.
[0074] With reference to FIGS. 20 to 24, as noted above an
important function of the first everting film sheath 120 is to
spread tissue, either when entering pre-existing stoma or
initiating placement of a tracheal tube percutaneously by blunt
dissection. While the lubricious property of the film sheath 120
assists in the eversion process, it decreases the ability of the
film sheath 120 to spread tissue. Accordingly, it may be
advantageous if the film sheath 120 has a textured exterior surface
1310 where it is intended to engage and spread tissue 1340, while
the interior surface 1320 of the film sheath 120 and those portions
of the external surface that are not intended to engage tissue
retain the lubricious property required by the eversion
process.
[0075] The textured exterior surface 1310 can be composed of
various alternative tissue-engaging surface features: rounded
protrusions as shown in FIG. 20, square-edged as shown in FIG. 21,
and sharp-edged as shown in FIGS. 22 and 24. Indentations as
illustrated in FIG. 23 may also be used. The textured surface can
be formed on the film sheath 120 by molding during formation or by
indentation after formation. Persons of ordinary skill in the art
will appreciate that other alternative surfaces could be employed;
for example, a random variety of surface features can be formed on
the film sheath 120 by physical means (e.g., sand blasting),
chemical etching, or by engraving by pressing an etched surface
against the film sheath 120, or by embedding other materials into
the outer surface 1310 of the film sheath 120. Only that portion of
the film sheath 120 that engages tissue needs to be textured. It
should be noted that while biofilm likely adheres to textured film
more than it does to untextured film, generally the size at which
the debris sloughs off the textured film is still small enough so
as to reduce the potential for infection over use of an unsheathed
tracheal tube.
[0076] The method of using the current invention requires that the
guide 130 be affixed to the patient's neck, correctly positioned
over an existing or intended insertion site. Preferably the flange
137 of the guide 130 is shaped to conform to the topography of the
neck surface of the patient cranial to the sternal notch and caudal
to the thyroid cartilage, and includes means for holding the guide
in the correct position on the patient's neck such as a neck strap.
As is standard practice, the flange 137 may include holes or slots
1801 designed to accommodate a neck strap (not shown). The neck
strap prevents displacement of the guide 130 during the
tracheostomy operation and provides support to the devices attached
to the flange thus minimizing forces on those tissues in the
vicinity of the surgical site. It should be noted that conventional
cotton or other fabric neck ties may stretch after being tightened
into place, resulting in degradation of function. To avoid this,
the neck strap may be configured to resemble an orthopedic collar
used to hold the head in a backward-extending, forward-facing
position, but adapted to support and properly locate the flange 137
of the device 100 of the invention.
[0077] With reference to FIG. 25, showing a schematic
representation of the physiological configuration of a patient's
neck, the generally accepted optimum anatomical location of the
entrance site axis is perpendicular and directly anterior to the
trachea axis between the 1st and 2nd or 2nd and 3rd tracheal rings
below the cricoid cartilage 2010, approximately one finger breadth
above the sternal notch 2020. When a pre-existing stoma is not
present, this location is identified by palpation of the thyroid
cartilage 2040 and cricoid cartilage 2010 and, significantly,
placing a mark 2030 with a marking pen on the skin at the access
site between the 1st and 2nd or 2nd and 3rd tracheal rings.
[0078] Placement of the guide 130, specifically the flange 137, may
be facilitated by the use of a locator strip 1910, shown in FIG.
26. The locator strip 1910, is a strip of temporary,
easily-removed, preferably transparent, adhesive tape 1920. The
locator strip 1910 includes a hole 1940 marking the location or
desired location of the entrance site. The locator strip 1910
includes perforations 1925 transversally at or near its center,
preferably through the hole 1940, to allow it to be easily torn
apart for removal. The locator strip 1910 has a, preferably heavy,
line 1930 adapted to be aligned parallel with the longitudinal axis
of the trachea and has arrowheads 1945 or similar indicators
pointing to the hole 1940. Upper and lower indicator marks 1970,
1971 are adapted to be easily aligned with corresponding upper and
lower guide marks 1870, 1871 on the flange 137 to allow for correct
positioning of the device 100.
[0079] In addition to reducing tissue trauma and making the
insertion of the tracheal tube easier, the current device also
allows for a more simplified method of tracheostomy from the
current standard of care.
[0080] As an example, the method of using the embodiment described
in connection with FIGS. 5 and 6 is as follows. It is assumed in
this example that the patient has an endotracheal tube and is on a
ventilator, but a similar procedure could be used where the patient
was not on a ventilator. After preparation of the
patient--including sedation, appropriate positioning, and placement
on 100% oxygen with appropriate flow--the operator checks the
tracheal tube cuff and locates the anatomical landmarks of the
patient's neck, all in substantially the same manner as in current
procedures. The operator then makes a mark on the patient's skin
between the first and second or second and third tracheal rings,
approximately one finger breadth above the sternal notch,
indicating where the tracheal tube will be inserted. The operator
lays the locator strip on the patient's skin, aligning its line
parallel with the axis of the trachea and the hole directly over
the access site mark on the patient's skin. The flange 137 is then
positioned over the locator strip so that upper and lower guide
marks 1870, 1871 on the flange match to the upper and lower
indicator marks 1910, 1920, respectively, on the locator strip. The
neck strap secures the device to the patient, and the locator strip
is removed by tearing at the perforations. Use of the locator strip
is optional, as those more familiar with percutaneous dilational
tracheostomy or this device, may not require its use. At this point
in the process, a bronchoscope may be inserted through the
endotracheal tube and used in a conventional manner, being
withdrawn as a unit with the endotrachael tube until the light from
the bronchoscope transilluminates through the skin of the patient
at the point where the tracheal tube will ultimately be placed.
Finally, the endotracheal tube is reinflated. Conventional
adjustments to the respiration would also be made to account for
the bronchoscope and any air leak that might occur during the
procedure.
[0081] The device is then employed as previously described in
connection to penetrate the skin and pretracheal tissues, evert the
film sheath, and insert the tracheal tube into the patient. After
the pusher is removed, the process again follows standard
procedures for tracheostomy: the tracheal tube cuff is inflated and
the tracheal tube is connected via the connector to appropriate
ventilator tubing; and the endotracheal tube and bronchoscope are
removed. Preferably, a postoperative chest radiograph is performed
to rule out pneumothorax, after which the insertion site may be
cleaned and dry dressings applied as needed.
[0082] It will be understood that if the device is used for
cricothyrotomy the incision might include both a vertical and
transverse cut through the cricothyroid membrane, and the procedure
could be performed in a non-sterile environment (i.e, in an
emergency situation).
[0083] Any of the embodiments of the current invention may also be
adapted to include a guide wire 2000 which may preferably include a
conventional "j" tip. An integral or non-integral guide wire 2000
may be placed in or reside in the lumen of the needle 410, the
pusher 110, or of the trocar 314. The guide wire 2000 may be
advanced into the trachea to aid in guiding the pusher 110 and/or
the tracheal tube 210 caudally along the tracheal axis. The guide
wire 2000 can be advanced after the distal end 115 of the pusher
110 has been advanced to just enter the trachea. If a needle is
used, the guide wire 2000 is preferably advanced when the distal
end 115 of the pusher 110 is over the tip of the needle 410.
Alternatively, the guide wire could be passed down a lumen of the
pusher 110 and into the trachea after the needle 410 is removed
from the pusher 110, but before the pusher 110, and integral
tracheal tube 210 if a part of the device, are advanced fully into
the trachea. Use of a guide wire 2000 with a trocar 314 is
similarly effected, with the trocar 314 taking the place of the
pusher 110. It will be noted, however, that rather than advancing
fully into the trachea, the trocar 314 would remain in place while
the tracheal tube 210 was initially advanced, to be subsequently
removed once the tracheal tube 210 was sufficiently advanced into
the trachea. Subsequently, the guide wire 2000 is advanced into the
trachea to aid in guiding the tracheal tube 210 caudally along the
tracheal axis. The guide wire 2000 would then be removed.
[0084] The device allows the surgeon to use the following
simplified method for placing a tracheal tube into a patient. It is
to be assumed that the patient has an endotracheal tube and is on a
ventilator and that the device is as shown in FIG. 6 and includes
the use of a guide wire 2000. [0085] 1. Sedate patient. [0086] 2.
Monitor patient's airway pressures, exhaled tidal volumes, and
continuous pulse oximetry readings to assure adequate ventilation
prior to patient positioning [0087] 3. Place patient on 100% oxygen
with volume adjusted to compensate for future presence of the
bronchoscope [0088] 4. Position patient supine with hyperextended
neck and support shoulders with a transverse roll (towel or
pillow), the head of the patient's bed can be elevated 20 to 30
degrees [0089] 5. Perform a screening ultrasound of the neck which
may help identify aberrant vessels that may be within the predicted
path of the tracheal tube. [0090] 6. Verify the integrity of the
cuff by inflating it and checking for leaks. [0091] 7. Completely
deflate the cuff [0092] 8. Prep neck and upper chest and drape
anterior neck [0093] 9. Locate and mark anatomical landmarks:
thyroid cartilage, cricoid cartilage, sternal notch [0094] 10.
Infiltrate incision site with 1% lidocaine with epinephrine [0095]
11. Make a mark on the skin between 1st & 2nd or 2nd & 3rd
tracheal rings approximately one finger breadth above the sternal
notch where access and ultimate tracheal tube placement will be
made. [0096] 12. Position the device by holding it by the standoff
guide with one hand approximately vertical to the patient's neck
centering the device flange opening against the skin on the mark
previously made at the access site while palpating with a finger of
the other hand positioned in the "V" of the flange. [0097] 13.
Secure the tracheal tube with a neckstrap around the patient's
neck. [0098] 14. Insert bronchoscope through endotracheal tube and
align it. [0099] 15. Loosen the tapes of the endotracheal tube and
deflate the endotracheal tube cuff [0100] 16. Withdraw the
bronchoscope and endotracheal tube as a unit until the light from
the bronchoscope transilluminates through the skin where access and
ultimate tracheal tube placement will be made. [0101] 17. Reinflate
the endotracheal tube cuff [0102] 18. Adjust ventilator tidal
volume and frequency as necessary to accommodate the bronchoscope
and any air leak that may occur during dilation. [0103] 19. While
palpating as in step 12 advance central guide needle by squeezing
the guide needle and stand-off guide finger rests together,
penetrating the skin and pretracheal tissue and entering trachea
under direct bronchoscopic visualization by the
anesthesiologist/bronchoscopist. [0104] 20. Verify entrance of the
distal end of the guide needle into the tracheal lumen. [0105] 21.
Advance the outer coaxial everting pusher and tracheal tube with
surrounding film assembly over the guide needle by squeezing pusher
and standoff guide finger rests together thus dilating the skin and
pretracheal tissue and entering the trachea under direct
bronchoscopic visualization. The tip of the assembly will cover the
tip of the needle guide. [0106] 22. Remove the guide needle over
the guide wire. [0107] 23. Advance the central guide wire into the
trachea to the level of the carina. [0108] 24. Rotate the standoff
guide such that its slot aligns with the pusher and tracheal tube
assembly finger rests. [0109] 25. Advance the pusher and tracheal
tube assembly over the guide wire by squeezing the pusher and
standoff guide finger rests thus fully placing the film covered
assembly in the trachea under direct brochoscopic visualization.
[0110] 26. Remove the stand-off guide by popping it off the
tracheal tube connector. [0111] 27. Remove the pusher tube and
guide wire. [0112] 28. Inflate the tracheal tube cuff [0113] 29.
Connect the ventilator tubing to the connector of the tracheal
tube. [0114] 30. Deflate the endotracheal tube cuff and remove the
endotracheal tube and the bronchoscope [0115] 31. Postoperatively,
perform a chest radiograph to rule out pneumothorax [0116] 32.
Clean the site with sterile saline [0117] 33. Apply dry dressings
as needed.
[0118] While the present invention has been shown and described
with reference to the foregoing embodiments and methods, it will be
apparent to those skilled in the art that changes in form,
connection, and detail may be made therein without departing from
the spirit and scope of the invention as defined in the appended
claims.
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