U.S. patent application number 11/364965 was filed with the patent office on 2006-11-30 for hemostatic system for body cavities.
This patent application is currently assigned to ArthroCare Corporation. Invention is credited to Alberto Bauer, John Overton Hudson Hudson.
Application Number | 20060271094 11/364965 |
Document ID | / |
Family ID | 46278516 |
Filed Date | 2006-11-30 |
United States Patent
Application |
20060271094 |
Kind Code |
A1 |
Hudson; John Overton Hudson ;
et al. |
November 30, 2006 |
Hemostatic system for body cavities
Abstract
Bleeding is controlled on an inner surface of a body cavity by
inserting into the cavity an expandable balloon which is covered by
a hemostatic shroud, expanding the balloon, and compressing the
shroud against the site of bleeding. The balloon may be disposed
around a central tube to supply inflation medium. The tip of the
device is soft to aid with insertion. The invention includes the
corresponding devices and systems for such control of bleeding
within a body cavity or passageway, as well as a method of making
the devices.
Inventors: |
Hudson; John Overton Hudson;
(Glenfield, GB) ; Bauer; Alberto; (Malaga,
ES) |
Correspondence
Address: |
ARTHROCARE CORPORATION
680 VAQUEROS AVENUE
SUNNYVALE
CA
94085-3523
US
|
Assignee: |
ArthroCare Corporation
Austin
TX
|
Family ID: |
46278516 |
Appl. No.: |
11/364965 |
Filed: |
February 28, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09998524 |
Nov 28, 2001 |
7018392 |
|
|
11364965 |
Feb 28, 2006 |
|
|
|
09927864 |
Aug 10, 2001 |
6706051 |
|
|
09998524 |
Nov 28, 2001 |
|
|
|
09406166 |
Sep 27, 1999 |
6306154 |
|
|
09927864 |
Aug 10, 2001 |
|
|
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09057414 |
Apr 8, 1998 |
|
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09406166 |
Sep 27, 1999 |
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Current U.S.
Class: |
606/196 |
Current CPC
Class: |
A61M 25/10184 20131105;
A61M 2025/1081 20130101; A61B 2017/00632 20130101; A61B 17/12136
20130101; A61M 25/10183 20131105; A61B 2090/065 20160201; A61M
29/02 20130101; A61B 17/12104 20130101; A61M 25/10187 20131105;
A61B 2017/00893 20130101; A61B 2017/1205 20130101; A61B 17/1219
20130101; A61B 2017/00898 20130101; A61B 17/0057 20130101; A61B
17/24 20130101; A61M 25/1011 20130101; A61B 2017/00818 20130101;
A61B 2017/0053 20130101; A61B 34/76 20160201; A61M 2210/0618
20130101 |
Class at
Publication: |
606/196 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1-15. (canceled)
16. A device for controlling bleeding on an inner wall of a body
cavity or passageway comprising: a central tube having a distal
end; a hemostatic shroud comprising a gel-forming absorbent
composition, said hemostatic shroud disposed around said central
tube; and an expandable balloon having an unexpanded state and
expanded state, said balloon disposed between said central tube and
said hemostatic shroud; wherein said balloon, in its unexpanded
position, is rolled around said central tube.
17. The device of claim 16 wherein said rolled balloon extends
beyond the distal end of said central tube.
18. A device for controlling bleeding on an inner wall of a body
cavity or passageway comprising: a central tube having a central
longitudinal axis, a wall, a proximal end, and a hole disposed in
said tube wall; a cylinder of fabric disposed around said central
tube; and an expandable balloon having an unexpanded state and an
expanded state, said balloon disposed between said central tube and
said fabric cylinder; said hole allowing fluid communication
between said central tube and said balloon.
19. The device of claim 18 wherein said balloon, in its unexpanded
state, is rolled around said central tube.
20. The device of claim 18 wherein said hole is disposed
perpendicular to the longitudinal axis of said central tube.
21. The device of claim 18 wherein said balloon wall thickness is
between 0.03 mm and 0.15 mm.
22. The device of claim 18 wherein said fabric is comprised of two
layers of a hemostatic shroud comprising a gel-forming absorbent
composition.
23-27. (canceled)
28. A method for controlling bleeding on a surface of a passageway
comprising: inserting into said passageway an inflatable member,
said member comprising an outermost, hemostatic gel forming
absorbent composition; expanding said inflatable member; and
compressing the composition against said inner surface of the
cavity where bleeding is to be accorded.
29. The method of claim 28 wherein said passageway is a nasal
passageway.
30. A method of controlling bleeding on a surface of a body cavity
comprising inserting a device as recited in claim 16.
Description
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/921,864 filed Aug. 10, 2001, which in turn
is a continuation-in-part of U.S. patent application Ser. No.
09/406,166 filed Sep. 27, 1999, which in turn is a
continuation-in-part of U.S. patent application Ser. No.
09/057,414, filed on Apr. 8, 1998.
TECHNICAL FIELD
[0002] This invention relates generally to medical devices and
methods of use, and more specifically, to materials, apparatus, and
methods for facilitating hemostasis within a body cavity or
passageway.
BACKGROUND OF THE INVENTION
[0003] Nasal passageways, for example, are often susceptible to
uncontrolled bleeding caused by various forms of trauma, disease or
cellular dysfunction. Methods and devices for controlling, limiting
or stopping such bleeding would be useful in a variety of
situations, ranging from emergency room care to long term care.
[0004] Bleeding is typical after nasal related surgeries or
procedures, and epistaxis related to a patient's nasal passageway
can be difficult to control. Hemostatic agents, such as
carboxymethyl cellulose (CMC) and woven knit or matted fabrics
thereof, are known for use in the control of bleeding, such as
post-trauma and post-surgical bleeding. CMC is defined as a
polycarboxylmethyl ether of cellulose or the sodium salt thereof.
It is sometimes referred to as cellulose ether,
carboxymethylcellulose, or sodium caramellose. Insertion,
application, and subsequent removal of these materials, however,
can be difficult in small body passageways, such as nasal
cavities.
SUMMARY OF THE INVENTION
[0005] The present invention comprises methods and devices for the
control of bleeding from an inner wall of a body passageway or
cavity. Briefly, the invention comprises an inflatable, expandable
balloon, usually covered by a hemostatic shroud, which is inserted
into a body cavity, such as a nasal passageway. The shroud is
composed of a hemostatic agent; that is, the shroud acts to
facilitate or enhance blood clot formation. The balloon component
of the present invention is expanded, or inflated, within the
cavity in order to press the shroud against the site of bleeding,
thereby allowing it to absorb blood and facilitate hemostasis. In
specific embodiments, the shroud is composed of a woven or knitted
fabric of a hemostatic fiber (such as carboxymethylcellulose) or a
reinforced hemostatic fiber. Optionally, this shroud may include an
"extension" or "tail" fiber, which upon balloon deflation and
removal, facilitates the later removal of the shroud which has been
intentionally left in vivo.
[0006] The device construction, particularly the balloon
construction, may vary according to the particular body cavity.
Although a range of different materials can be used for any of the
embodiments, there are particular materials which work better than
others, depending upon the particular application. For a nasal
application, one embodiment includes an inflatable balloon made
from a relatively inelastic material.
[0007] A particular embodiment of the invention comprises a device
for insertion of a shrouded balloon into a nasal passageway by a
catheter configured such that the balloon encircles the catheter
tube. The lumen of the catheter tube thereby serves as a passageway
for breathing. The inflated balloon compresses the shroud against
the bleeding nasal wall, thereby facilitating or enhancing
hemostasis. The balloon is deflatable such that, upon balloon
deflation, the shroud may be left in place on the cavity wall and
may be removed at a later time, such as by an attached extension on
the shroud.
[0008] In another embodiment, there is no central lumen. This gives
the catheter a much smaller overall diameter. In patients with
small nasal cavities, the lack of the breathing passageway is more
than compensated for by the small profile which is far less
traumatic and painful during insertion.
[0009] The shroud used in the present invention may comprise a
woven or knitted fabric combining hemostatic (e.g.,
carboxymethylcellulose (CMC)) fibers with reinforcing fibers.
Alternatively, the shroud may be just a hemostatic agent disposed
on the balloon in a film-like covering.
BRIEF DESCRIPTION OF DRAWINGS
[0010] For a better understanding of the present invention,
reference may be made to the detailed description which follows,
taken in conjunction with the drawings, in which:
[0011] FIG. 1 is a side view of a component adapted for insertion
in a nasal passageway;
[0012] FIG. 2 is a side view of the component shown in FIG. 1
covered with a hemostatic shroud;
[0013] FIG. 3a is a cross-sectional view of a device as shown in
FIGS. 1 and 2;
[0014] FIG. 3b is a cross-sectional view of a device as shown in
FIGS. 1 and 2;
[0015] FIG. 4 is a schematic view of a knitted fabric structure
useful in the present invention;
[0016] FIG. 5 illustrates another embodiment of the invention which
uses a pressure-indicating pilot balloon;
[0017] FIG. 6 illustrates a close-up, cross-sectional view of the
inflatable balloon and shroud in accordance with the present
invention;
[0018] FIG. 7 illustrates the same embodiment as illustrated in
FIG. 5 with the pilot balloon deflated and turned 90.degree.;
[0019] FIG. 8 illustrates the same embodiment as illustrated in
FIG. 7 but with the system inflated;
[0020] FIG. 9 is a partial cross-sectional view of a device
according to one embodiment of the present invention using a clamp
ring;
[0021] FIG. 10 is a partial cross-sectional view of the device of
FIG. 9 having a balloon disposed between the central tube and the
shroud;
[0022] FIG. 11a is a side view of one embodiment of the present
invention where the balloon is rolled around a central tube;
[0023] FIG. 11b is a side view of one embodiment of the present
invention where the balloon is rolled around a central tube and is
only partly covered by a hemostatic shroud;
[0024] FIG. 12a is a cross-sectional view of the balloon rolled
around the central tube;
[0025] FIG. 12b is a cross-sectional view of the balloon unrolled
and deflated around the central tube;
[0026] FIG. 12c is a cross-sectional view of the balloon inflated
around the central tube;
[0027] FIG. 13 is a cross-sectional view of the balloon rolled
around the central tube, with a shroud disposed therearound in
accordance with the present invention;
[0028] FIG. 14 is the cross-sectional view of FIG. 13 but with the
system inflated;
[0029] FIG. 15 is a side-view of the device shown in FIG. 11 but
without the central tube;
[0030] FIGS. 16a-16e show the steps for forming a device in
accordance with the present invention using a tube tool;
[0031] FIGS. 17a and 17b show an deflation hole in a central tube
in accordance with one embodiment of the present invention;
[0032] FIG. 18 shows a side, partial cross-sectional view of a
central tube without a deflation hole during deflation;
[0033] FIG. 19 is a cross-sectional view of the device with an
inflation/deflation hole; and
[0034] FIG. 20 shows a device in accordance with the present
invention where the inflation tube is not coaxial with a breathing
lumen, and the inflation tube has an inflation/deflation hole.
DETAILED DESCRIPTION OF THE INVENTION
[0035] The present invention comprises systems, devices, and
methods for the control of bleeding in body cavities, such as nasal
passageways. Generally, the terms "cavity" and "passageway" may
include any bodily cavity, recess, passageway, etc., other than a
blood vessel or other component of the vasculature system, and it
encompasses those which are healthy and normal as well as those
which are abnormal and/or pathological (meaning, diseased or
unhealthy).
[0036] The term "hemostatic" agent (or material) refers to any
agent or material that is capable of arresting, stemming, or
preventing bleeding by means other than inducing tissue growth
alone. In other words, something other than tissue growth is at
least partially responsible for retarding or preventing bleeding.
Preferably, the agent or material will be one that enhances blot
clot formation. It will, of course, be appreciated that the agent
or material may have the beneficial property of inducing tissue
growth in addition to retarding or preventing bleeding. Examples of
preferred hemostatic agents which enhance blood coagulation include
carboxymethylcellulose (CMC), oxidized cellulose, calcium alginate,
gelatine, or collagen. CMC can be purchased from Acordis Special
Fibres, PO Box 111, 101 Lockhurst Land, Coventry, England, CV6 5RS.
Oxidized cellulose such as Tabotamp.TM., which is sold by Johnson
& Johnson, New Brunswick, N.J., U.S.A., is another example of a
hemostatic agent. Combinations of different hemostatic agents or
materials may be used within the scope of the invention.
[0037] The hemostatic agent may be a part of an expansible shroud
or may make up the shroud itself. In this later case, the
hemostatic agent is either a film or fabric comprised of the
hemostatic agent. In the former case, the hemostatic agent is
combined with another material, such as a reinforcing fiber
material. Typically, the hemostatic agent-containing shroud covers
an expansible device such as a balloon. The shroud may be in the
form of an expandable tube or in the form of an expandable sheet.
In specific embodiments disclosed, the preferred hemostatic agent
is a fibrous CMC, which is hemostatic and so will cause blood to
clot while at the same time absorbing any exudate. A fabric of CMC
fiber is preferred because, aside from its hemostatic properties,
it swells and forms a gel, absorbing many times its own weight in
fluid when it contacts water (or blood or exudate). Because the CMC
material is so hygroscopic, it does not dry into the clotted blood,
and therefore can be removed easily without tearing the clot and
causing re-bleeding.
[0038] Other hemostatic agents which may be used should have
absorptive and hemostatic properties similar to those of CMC. In
one embodiment, the hemostatic agent fibers are woven or knitted
together with reinforcing fibers, such as continuous multifilament
polyester or nylon. Such a knitted fabric is illustrated in FIG. 4,
and is more fully described and claimed in separate patent
applications (U.S. Ser. No. 09/406,490 filed Sep. 27, 1999,
pending; and Ser. No. 09/612,038 filed Jul. 7, 2000, pending; both
of which are incorporated by reference herein). The use of
reinforcing fibers provides increased strength to the shroud. This
increased strength is important for successful removal of a
blood-soaked fabric, where the CMC or gellable material has formed
a gel and therefore lost much of its strength.
[0039] Examples of some other hemostatic materials include oxidized
cellulose, which is conventionally used in knitted form as a
hemostatic agent during surgery, and calcium alginate, which is a
textile fiber derived from seaweed and is also commonly used as a
wound dressing. Furthermore, there are other polysaccharides which
are available with similar chemistry and properties to CMC. For
purposes of the present invention, the essential properties of the
hemostatic material are the ability to absorb large quantities of
liquid without becoming enmeshed in the clotted blood. The material
must be non-toxic and biocompatible.
[0040] Preferably, the shroud is provided in the form of a woven or
knitted, especially a weft knitted, textile fabric in which is
incorporated the hemostatic material, and which envelops the
balloon. The woven or knitted textile material may be permanently
or releasably fixed to the balloon.
[0041] In some embodiments, particularly those used in nasal
applications, the balloon will be made of a relatively inelastic
material, such as polyurethane or PVC. Alternatively, for other
uses and embodiments, the balloon can be made from an elastomeric
material, such as a thin silicone polymer. These balloons can be
made by methods known to those skilled in the art, such as by dip
molding. As noted above, it is generally desired in nasal
applications that the balloon have a fixed volume and be made of an
inelastic material. In such a case, the balloon is effectively a
bag that can be filled or emptied with an inflation medium. A fixed
volume, inflatable, inelastic balloon does not require the
inflating medium to first stretch the elastic material of the
balloon (as would be the case where the balloon is made from an
elastomeric material). All inflation medium pressure is used to
fill the cavity. This is essential when the device is used with a
pilot balloon to give a tactile feedback of the pressure inside the
catheter balloon. With an inelastic, fixed volume balloon, the
tactile feedback is truly representative of the pressure applied to
the inner surface of the nasal cavity.
[0042] For particular non-nasal applications, an elastic material
such as silicone rubber can be used for the balloon. Such a balloon
may be inflated with a liquid medium such as water or saline
solution and the volume controlled by monitoring the volume of
fluid inserted. Silicone rubber has the property of being permeable
to air but not to water or saline solution.
[0043] One specific embodiment of the present invention which is
designed for insertion within a nasal passageway is depicted in
FIGS. 1-3. As shown there, a balloon catheter 50 consists of a soft
flexible central tube 41, with a long non-elastomeric balloon 48
adhered to the outside wall of central tube 41 along the end
sections 49 of balloon 48. The wall of central tube 41 includes an
inflation lumen 51 (inflation passageway) which is in
communication, through a thin tube 42, with a valve and luer 43 at
one end and an inflation port 52 at the other end. The valve 43 is
opened by the tip of a standard syringe by which the balloon 48 may
be inflated or deflated at will. Tube 41 includes a central
breathing lumen 53 which serves as an air passage for
breathing.
[0044] In a specific exemplary embodiment, central tube 41 has an
approximate outside diameter of 10 mm, and an inside diameter of
4-5 mm. The active length is typically between 40 and 100 mm,
although shorter or longer lengths may be required for special
applications. One end of catheter 46 may have a reduction in the
outer diameter in order to provide a shoulder 40. This shoulder is
used to locate and maintain the position of an outer hemostatic
shroud, (seen in FIG. 2 and discussed in more detail below), during
insertion of the device of FIG. 2 into a nasal passageway. In
another method of construction the glued neck of the balloon
supplies the shoulder and in yet another construction method no
shoulder is used and the fabric is retained by a ring and glue or s
merely by glue alone. Catheter tube 41 typically is comprised of a
silicone elastomer or PVC. In the embodiment of the present
invention for use in a nasal passageway, the balloon is typically
of fixed volume with an expanded diameter of approximately 25 mm
and is expanded by inflation with air.
[0045] FIG. 2 illustrates the balloon catheter component of FIG. 1
covered by a hemostatic shroud 44 which envelopes a portion of
catheter tube 41. Hemostatic shroud 44 can be a soft knitted or
woven fabric tube made from a hemostatic material with a high
absorption ability. The shroud material is discussed in more detail
below. Shroud 44 is draped around the balloon catheter 50 and is
positioned by a sewn ring or ligature 45, which locates over
shoulder 40 at the distal end 46 of the balloon catheter. The "ring
over shoulder" mounting allows shroud 44 to be located precisely
over balloon 48 when the device is inserted into the nasal cavity,
but permits balloon 48 to be released from shroud 44 by simply
withdrawing the catheter. Other methods of locating the shroud may
also be used, such as a glued grommet, a welded ring, or by
actually shaping the knitted shroud for retention on the balloon.
The fabric shroud is highly elastic and deformable which allows it
to stretch and/or deform as the balloon is inflated. An extension
tail 47 to shroud 44 may be provided as a means to remove the
hemostatic element separately after balloon 48 has been
removed.
[0046] FIG. 3a shows a cross section, in the plane A-A, of nasal
catheter 50 of FIG. 1 with hemostatic shroud 44 shown disposed
thereon. As shown in FIG. 3, balloon 48 is covered by hemostatic
shroud 44, encircling central tube 41 and the non-adhered underside
thereof is in communication with inflation port 52.
[0047] In service, balloon 48 is inflated by filling material,
typically compressed air, from a syringe in communication with
valve 43 and the inflation lumen 42 which terminates in port 52 at
the inner surface of balloon 48 between the ends of the balloon
which are adhered at tube surface areas 49.
[0048] FIG. 4 illustrates a schematic view of a preferred fabric
for the hemostatic shroud. Specifically, spun CMC yarn 60 is
knitted in parallel with a polyester reinforcing yarn 61, as more
specifically described in the aforementioned U.S. patent
applications incorporated by reference. In this preferred
embodiment, the knitted fabric tube is manufactured first by
knitting a tube from Lyocell yarn in combination with the
reinforcing filament. Lyocell is the generic name for solvent spun
cellulose fiber. A brand thereof, "Tencel," (a registered
trademark), is available from Accordis Fibres, Coventry UK. Lyocell
is produced from the natural cellulose in wood pulp by dissolving
the wood pulp in a solvent and then extruding the product through a
die called a spinneret. The solvent is then evaporated therefrom,
thereby leaving a fiber which is composed of pure cellulose. After
knitting, the fabric tube is subjected to a sodium reactant,
according to known techniques, which serves to convert the pure
cellulose at least partially, into sodium carboxymethylcellulose.
The chemical conversion process is similar to that used to make
carboxymethylcellulose sodium USP, except that the raw cellulose is
in fiber form rather than the more normal powder form. Other
cellulosic raw materials can also be used such as cotton or viscose
rayon.
[0049] One use of the hemostatic nasal device of FIGS. 1-3 involves
inserting into a nasal cavity the shroud-covered balloon catheter
50 illustrated in FIG. 2. Balloon 48 is then inflated. Because the
shroud is deformable, it is able to expand and not limit the
balloon in its ability to inflate and fill the cavity. The
hemostatic fabric is pressed against the vessel wall and into
contact with the blood. On contact with blood, the hemostatic
shroud, typically CMC (or other similar material), adheres to the
cavity wall and swells to form a gel. It absorbs blood and exudate
while its hemostatic properties facilitate and enhance blood clot
formation. The lumen of the large (catheter) tube provides for
normal breathing, while the inflated balloon provides an anchor for
the device. After hemostasis is achieved, the balloon 48 is
deflated, and then the catheter is removed. In one embodiment the
balloon and tube only are removed and the gelled fabric is left in
situ.
[0050] Where the gelled fabric alone has been left in situ, the
fabric may be removed at any later time by means of the withdrawal
string or "tail" 47. Since the hygroscopic nature of the hemostatic
fabric prevents the material from sticking to the clotted blood,
removal is simple and with minimal chance of restarting the
bleeding process.
[0051] In an alternative embodiment, the outer surface of the
balloon itself is coated with an agent that facilitates blood
coagulation. In such an embodiment, the shroud does not comprise a
fabric of any kind, but is the hemostatic agent itself, provided in
the form of a flexible film that coats the outer surface of the
balloon. Examples of coating material include gelatin and collagen,
but the invention is not limited to these. Such an embodiment is
shown in FIG. 3b, which is identical to FIG. 3a except that the
shroud 70 is comprised only of a film of hemostatic agent (no
fabric). In slight distinction, FIG. 3a shows shroud 44 which is
comprised, as described above, of a soft knitted or woven fabric
made from a hemostatic material with a high absorption ability.
Pilot Balloon Tactile Pressure Indicator
[0052] In another embodiment, the device of this invention may
include a tactile pressure-indicating pilot balloon in fluid
communication with the balloon by which pressure is exerted on the
hemostatic shroud. In such an embodiment, both the shroud
compressing balloon and the pilot balloon are expandable.
Preferably, both balloons are inflatable but made of a
non-stretchable material. In this embodiment, the "balloons" are
really more like bags or plastic sacks which receive an inflation
medium such as air. Once the balloon is fully inflated, its volume
no longer changes because the material of which it is made does not
stretch. In use the balloon will typically not be inflated to its
maximum volume because the cavity into which the balloon is
inflated will preferably be smaller than the theoretical maximum
volume of the balloon. This is because the maximum volume and
dimensions of the balloon are typically chosen to be larger than
the cavity in order that the balloon always has the capacity to
fill the cavity. In this way, the hemostatic shroud, which
surrounds the balloon, is pressed against the complete inner
surface of the cavity.
[0053] Such a pilot balloon may be disposed at the end of the
inflation tube opposite the inflatable balloon of a nasal device as
shown in FIG. 5. In this embodiment, pilot balloon 190 is connected
to first inflatable balloon 191 via inflation tube 195. Thus, the
external tactile pressure sensing pilot balloon 190 does not enter
the passageway but allows the user to feel the pressure (usually by
grasping the pilot between thumb and finger) within the system as
the first inflatable balloon 191 is inflated. In this embodiment,
the pilot balloon 190 inflates along with inflatable balloon 190
during placement of hemostatic shroud 196 because the two balloons
are in fluid communication with each other. Thus, during placement,
the doctor is able to touch the pilot balloon and feel the pressure
increase as the system inflates. As discussed above, this may be
particularly important in nasal passageway applications, for
example, because too little inflation pressure may result in a lack
of blood flow stopage, and too great an inflation pressure may
damage the passageway. Thus, through a careful tactile
determination of system pressure during inflation and placement of
the hemostatic fabric, proper and effective use of the device is
insured.
[0054] In order for the tactile pressure sensing pilot balloon to
give a more accurate indication of the pressure inside the nasal
cavity, it is preferred that the first inflatable balloon (catheter
balloon) be non-stretchable. In accordance with this aspect of the
invention, the balloon is made of a relatively inelastic material
(such as polyurethane or PVC) in order to have the ability of
completely filling a cavity without any energy being used to
stretch the wall of the balloon. In such a case, the balloon is
effectively a bag that can be filled or emptied with an inflation
medium. The inflatable, non-stretchable balloon does not require
the inflating medium to first stretch the elastic material of the
balloon (as would be the case where the balloon is made from an
elastomeric material). This is preferred when the device is used
with a pilot balloon to give a tactile feedback of the pressure
inside the catheter balloon. With a non-stretchable balloon, the
tactile feedback is more representative of the pressure applied to
the inner surface of the nasal cavity.
[0055] FIG. 5 also illustrates hemostatic shroud 196 disposed on
first inflatable balloon 191. As discussed above, various means for
introducing air or other suitable pressurizing fluid into the
system can be used. FIG. 5 shows a Luer slip valve 197 attached to
one end of a pilot balloon 190 the opposite end of which is
connected via inflation tube 195. Such slip valves are known to
those skilled in the art to provide the introduction of an
inflating medium, typically air, into the system. Also shown in
FIG. 5 is fabric clamp ring 198 used to hold the hemostatic shroud
196 to the inflation tube and/or base of inflatable balloon 191. In
this embodiment, which includes no central tube, inflation tube 195
ends where inflatable balloon 191 and inflation tube 195 connect at
clamp ring 198. In the alternative embodiment shown in FIG. 6, an
inflation tube 200 actually extends into inflatable balloon
191.
[0056] FIG. 6 illustrates a close-up, partially cross sectional
view of inflation balloon 191 within hemostatic shroud 196. Within
inflation balloon 191 is internal inflation tube 200. Internal
inflation tube 200 as shown in FIG. 6 is either an integral
extension of an inflation tube 195 as seen in FIG. 5, or is a
separate piece of tubing in fluid communication with an inflation
tube 195 as seen in FIG. 5. Internal inflation tube 200 is shown as
open at its end 205 in FIG. 6.
[0057] In FIG. 6, the hemostatic shroud 196 is shown folded back
over itself along the length of the inflation balloon 191. In
assembling the shroud 196 over the balloon 191, half the fabric
length is first placed over the balloon and the excess fabric is
given a complete turn (or 360.degree. twist) before inverting the
twisted excess fabric over the balloon to give the second layer of
fabric. This has the effect of closing the fabric over the distal
end of the balloon as shown in FIG. 6.
[0058] FIG. 7 illustrates the embodiment shown in FIG. 5 with pilot
balloon 190 turned 90.degree. from the view shown in FIG. 5. FIG. 6
is presented to illustrate the deflated pilot balloon which
accompanies deflated inflatable balloon 191. After an inflation
medium (preferably air) is introduced into the system, the
resultant configuration of pilot balloon 190 is shown in FIG. 8.
This inflated pilot balloon 190, as shown in FIG. 8, when touched
or gripped by the doctor using the device, qualitatively indicates
the pressure in the system.
[0059] In one embodiment, the pilot balloon as illustrated in FIGS.
5-8, has a wall thickness of about 0.09 mm (0.0035 inches) and is
comprised of polyvinyl chloride (PVC). Typically, the pilot balloon
is approximately 0.5 to 2 inches in length.
[0060] In its nasal embodiments, the method comprises the steps of
inserting into a nasal cavity a first inflatable balloon surrounded
at least in part by a hemostatic shroud comprising a gel-forming
absorbent composition. The inflatable balloon is then expanded
which compresses the shroud against the inner surface of the cavity
where bleeding is to be controlled. Where the device includes a
pilot balloon, the pressure inside the inflatable balloon is
monitored, during expansion of the inflatable balloon and shroud,
by touching the pressure-indicating pilot balloon which is in fluid
communication with the first inflatable balloon.
Nasal Applications
[0061] Soft Tip
[0062] When it is desired to use the present invention in a narrow
body cavity, such as in a nasal application, several embodiments
are particularly advantageous. One such embodiment includes a soft
tip to allow easier insertion into the nasal cavity as compared to
a device not having a soft tip. The soft tip allows for less damage
and irritation to the wall of the nasal cavity during insertion,
particularly where the cavity does not exhibit smooth or straight
walls. For this purpose, a soft tip can be formed on the distal end
of a shaft which is configured to be inserted into a particular
body cavity.
[0063] In one such soft-tip embodiment, shown in FIG. 9, central
tube 230 is covered along its length by a suitable fabric 232, such
as a CMC fabric, or a woven CMC-reinforcing filament fabric as
described above. Fabric clamp ring 234, composed for example of
medical grade PVC, is disposed longitudinally on the distal end 235
of central tube 230 and pinches fabric 232 to tube 230. Clamp ring
234 is not positioned completely onto tube 230, however, but
extends longitudinally beyond distal end 235 of tube 230.
[0064] During manufacture of this embodiment, a cylindrical piece
of fabric 232 is slipped over central tube 230 and clamp ring 234
is slid over fabric 232 and part way on to central tube 230. Then,
fabric 232 is folded back, and inverted, around tube 230 to create
a double layer of fabric along tube 230. After fabric 232 is
folded, a folded section 236 is created. This folded region 236,
extending beyond the distal end of clamp ring 234, forms a soft tip
which reduces trauma as the device is inserted into a body
passageway.
[0065] In one embodiment, glue can be used to set clamp ring 234
into place. The glue would be placed between fabric 232 and tube
230 where the clamp ring overlaps tube 230. A preferred glue is a
cyanoacrylate based glue, a more preferred glue being Loctite 4011.
Loctite is a registered trademark of Loctite Corporation.
[0066] In a related embodiment, clamp ring 235 could also be made
of a soft material to add to the soft tip of the device. In such an
embodiment, clamp ring 234 would not be made of a rigid medical
grade polyvinyl chloride (PVC), but rather a soft polymer.
[0067] FIG. 10 shows the embodiment of FIG. 9 but with a balloon
240 disposed between shroud 232 and central tube 230. Balloon 240
is attached toward the distal end of central tube 230 by any of a
number of means, including the use of glue or heat sealing the
balloon directly to central tube 230 at its distal end 241. Means
for inflating balloon 240 are not shown in FIG. 10, but are
addressed in other parts of this specification.
[0068] A second way to achieve the soft tip of the invention is to
roll the balloon around the central tube or roll the balloon around
itself underneath the fabric. In the former embodiment, a
thin-walled balloon is disposed on a central tube and, when
deflated, is flattened and rolled around the tube around the same
longitudinal axis defined by the central tube, similar to how a
roll of paper towels are disposed around a cardboard tube. FIG. 11
shows such an embodiment where balloon 240 is rolled around central
tube 230. Balloon 240 is sized so as to extend beyond the distal
end of central tube 230. The region of extension 245 provides a
soft tip for the device which achieves the above described
advantages during placement. Preferably, the balloon is made from a
film welding technique to achieve a very thin walled balloon.
Typical materials for the balloon include PVC and polyurethane. Any
suitable polymer would work, so long as it is easily welded and
maintains adequate strength to allow expansion of an inflation
medium without breaking.
[0069] Film welding techniques (including radio frequency welding)
are well known to those skilled in the art and are used in a
variety of larger products such as blood bags, intravenous (IV)
drug bags, pouches for card or badge protection, etc. Generally,
the thinner the material, the better, so long as adequate strength
is insured. The preferred thickness for the balloon thin film
material is 0.09 mm. The combination of this very thin walled
balloon along with a thin inflation tube and thin fabric allows for
a very small diameter device. The smaller the diameter, the easier
the device can be inserted into a nasal passageway.
[0070] FIG. 11b shows an embodiment of the present invention where
the hemostatic shroud does not completely cover balloon 240. In
such a case, the hemostatic shroud 196 is disposed on only a part
of balloon 240. In this embodiment, the shroud would typically be
of the film-type, attached directly to the balloon, as discussed in
more detail above.
[0071] FIGS. 12a-12c show three cross sections of balloon 240 and
central tube 230. FIG. 12a shows the balloon rolled around central
tube 230. FIG. 12b shows the balloon 240 unrolled but not fully
inflated around central tube 230, and FIG. 12c shows the balloon
240 inflated around central tube 230. FIG. 13 shows the cross
section of FIG. 12a with shroud 232 shown disposed around the
balloon 240. When central tube 230 receives inflation medium
(typically air), the medium passes through a passageway, typically
a hole (not shown) in the wall of tube 230 and into the interior of
balloon 240. Balloon 240 then expands and unrolls within shroud 232
and expands to cause shroud 232 to contact the inner surface of the
body passageway or cavity where bleeding is to be controlled. FIG.
14 shows balloon 240 expanded within shroud 232. FIGS. 13 and 14
show the shroud 232 as a two layer shroud, consistent with the
embodiment shown in FIG. 10. The shroud could, however, be single
layered or have more than two layers.
[0072] The balloon rolling does not have to be rolled around a
central tube. As described above, no central tube is present in
some embodiments. In such a case, the fabric would be disposed
around a rolled balloon where the balloon is simply rolled up on
itself. An example of this later embodiment is shown in FIG. 15. A
tubular connection for introducing inflation media would obviously
be included.
[0073] Twisted Fabric Construction
[0074] In another embodiment, the shroud is attached to the
inflation lumen at only the proximal end of the device, as shown in
FIGS. 6 and 16e. Here, shroud 232 is doubled-up, back over itself
along the length of central tube 230. In this embodiment, however,
and unlike the embodiment shown in FIG. 9, the assembly of shroud
232 over balloon 240 involves the twisting of the fabric at its
distal end. Here, half the fabric length is first placed over the
balloon and the excess fabric is turned, preferably in a complete
turn (or 360.degree. twist) at its distal end before inverting the
twisted excess shroud back over the balloon and first layer of
shroud to provide the second layer of shroud. This has the effect
of closing the shroud over the distal end of the balloon as shown
in FIG. 6. In such an embodiment, balloon 240 is only secured to
central tube 230 at its proximal end. This allows for the use of
only one attachment means for the entire device, such as glue or a
clamp ring 257.
[0075] The present invention also includes a method for manufacture
of a device as represented in FIG. 6. This method, as shown in
FIGS. 16a-16e, involves the use of an assembly tool 260 as shown in
FIG. 16b. This tool is a relatively thin-walled cylinder and is
made from a relatively rigid, or stiff, material.
[0076] The method first requires the placement of shroud 232 over
the balloon 240 and central tube 230, as shown in FIG. 16a. In the
next step, assembly tool 260 is pushed into shroud 232, which
shroud is simultaneously stretched around the outside surface of
assembly tool 260, as shown schematically in FIG. 16b. FIG. 16c
illustrates the third step, which requires rotating assembly tool
260, and shroud 232 along with it. The preferred rotation is
360.degree., although more rotation would achieve the same purpose.
The next step is shown in FIG. 16d, which illustrates the
progression of assembly tool 260 toward the proximal end of the
device, which causes shroud 232 to double over on itself, forming a
double layer of fabric along the outside surface of balloon 240.
FIG. 16e shows the result of this method, after a clamp ring 257 is
placed around shroud 232 at the proximal end of the device, thereby
securing the fabric in place. Any excess fabric that would extend
beyond the clamp ring 257 could then be trimmed from the
device.
[0077] Glue could also be used with this embodiment. During the
step of placing clamp ring 257, a small amount of glue could be
injected under the clamp ring at two spots, one each at 180.degree.
from the other around the circumference of the inflation tube where
clamp ring 257 will be secured. Because the fabric is meshed, in
the preferred embodiment, the glue will contact the fabric, the
inflation tube, and the inside of the clamp ring, binding all three
components together.
[0078] This method can also be used to place fabric around a device
which has no central inflation lumen, but which has only an
inflation balloon attached to the distal end of the inflation tube.
Such an embodiment is shown in FIG. 5. In such a case, only the
balloon and fabric extend beyond the distal end of the inflation
tube.
[0079] In some embodiments of the invention, particularly those not
including a breathing lumen, there is a risk that upon deflation,
the balloon and/or surrounding fabric will be sucked into the
passageway by which inflation medium passes from the central tube
into the balloon. This is illustrated in FIG. 18, wherein balloon
240 is shown sucked into a blocking position at distal end 275 of
central tube 230. This may result in preventing complete deflation
of balloon 240.
[0080] To prevent this potential problem, a hole may be formed in
the central tube wall as shown in FIGS. 17a, 17b, and 19. As shown
in FIGS. 17a and 17b, hole 261 is formed so that inflation medium
can enter and be withdrawn from a balloon surrounding the central
tube 230. The inflation medium can pass both at the distal end of
the central tube 230 and laterally through hole 261. This prevents
a deflation limitation or stopage which could result at the distal
end of central tube 230, as shown in FIG. 18. FIG. 19 shows a
cross-sectional view of central tube 230 having hole 261 with
balloon 240 and shroud 232 disposed therearound.
[0081] FIG. 20 illustrates an embodiment having a breathing tube
301 where inflation lumen 300 is disposed within the wall of
breathing tube 301. In this embodiment, balloon 302 is shown
disposed around breathing tube 301, and inflation lumen 300 is
disposed radially offset from the central axis of breathing tube
301. Here, inflation lumen 300 extends along the entire length of
breathing tube 301, and is blocked at its distal end by glue 303.
Alternatively, inflation lumen 300 could be formed so as not to
continue all the way to the end of the breathing tube 301 (as shown
in FIG. 1). The important aspect of inflation lumen 300 is that it
not be open at the breathing tube's distal end.
[0082] To allow delivery of inflation medium to balloon 302, a hole
304 is provided along inflation lumen 300. The hole could be formed
from a number of different techniques. A preferred method of making
the hole in this embodiment includes the use of a punch. The punch
is a metal tube, with one end sharpened like a circular knife,
which is inserted into the side of breathing tube 301 only far
enough to create the hole 304. The use of a punch, instead of a
conventionally drilled hole, helps insure that a conventional drill
does not continue into the breathing passageway and open a hole
there during manufacture of the device.
[0083] An additional advantage to using the punch, instead of a
conventional drill, is that, unlike a conventional drill, the punch
cuts a clean hole and does not create loose material or shavings
which could be difficult to remove from the device and could cause
a contamination hazard during later use of the device. By using the
punch, the punched material is removed within the shaft of the
punch and discarded.
[0084] The foregoing comprises a description of certain exemplary
embodiments of the present invention. The invention is not limited
to these embodiments, however, and the subjoined claims are
intended to be construed to encompass all embodiments of this
invention, and equivalents and variants thereof, which may be made
by those skilled in the art without departing from the true spirit
and scope of the essential concepts disclosed and claimed
herein.
* * * * *