U.S. patent application number 15/856488 was filed with the patent office on 2018-05-03 for transapical introducer.
This patent application is currently assigned to St. Jude Medical, Cardiology Division, Inc.. The applicant listed for this patent is St. Jude Medical, Cardiology Division, Inc.. Invention is credited to Tracee Eidenschink, Gregory R. Furnish, John Miser, Brian K. Wells.
Application Number | 20180116796 15/856488 |
Document ID | / |
Family ID | 51211317 |
Filed Date | 2018-05-03 |
United States Patent
Application |
20180116796 |
Kind Code |
A1 |
Wells; Brian K. ; et
al. |
May 3, 2018 |
TRANSAPICAL INTRODUCER
Abstract
A transapical introducer includes a housing near a proximal end
of the introducer, a first valve in the housing, a proximal tube
coupled to the housing, and a distal tube coupled to a distal end
of the proximal tube.
Inventors: |
Wells; Brian K.; (La Grange,
KY) ; Miser; John; (Crestwood, KY) ; Furnish;
Gregory R.; (Louisville, KY) ; Eidenschink;
Tracee; (Wayzata, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical, Cardiology Division, Inc. |
St. Paul |
MN |
US |
|
|
Assignee: |
St. Jude Medical, Cardiology
Division, Inc.
St. Paul
MN
|
Family ID: |
51211317 |
Appl. No.: |
15/856488 |
Filed: |
December 28, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14899491 |
Dec 17, 2015 |
9883942 |
|
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PCT/US2014/042494 |
Jun 16, 2014 |
|
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15856488 |
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61836440 |
Jun 18, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00907
20130101; A61B 2017/00247 20130101; A61B 17/3417 20130101; A61B
2017/3488 20130101; A61B 17/3498 20130101; A61B 2017/3441 20130101;
A61F 2/2427 20130101; A61B 17/3462 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61B 17/34 20060101 A61B017/34 |
Claims
1. An introducer comprising: a housing near a proximal end of the
introducer; a foam seal located in the housing; a flexible proximal
tube coupled to the housing; and a rigid distal tube coupled to a
distal end of the proximal tube; wherein the proximal tube is more
flexible than the distal tube and is capable of being clamped to
prevent fluid flow therethrough.
2. The introducer of claim 1, wherein the proximal tube is
translucent.
3. The introducer of claim 1, wherein the foam seal includes a
first slit on a first surface of the foam seal and a second slit on
a second surface of the foam seal, the first surface being opposite
the second surface and the first slit being generally perpendicular
to the second slit.
4. The introducer of claim 1, wherein the housing further comprises
a shoulder and a housing cap, the foam seal being positioned
between the shoulder and the housing cap.
5. The introducer of claim 4, wherein the housing further comprises
at least one foam seal retaining element.
6. The introducer of claim 5, wherein the at least one foam seal
retaining element is a spike extending radially inward from the
housing.
7. The introducer of claim 4, wherein the housing further comprises
a plurality of spikes spaced circumferentially around an inside of
the housing, each of the plurality of spikes extending radially
inward from the housing.
8. The introducer of claim 1, wherein the proximal tube is formed
of a material selected from the group consisting of
polytetrafluoroethylene, polyfluoroethylene, polyurethane, and
polyethylene.
9. The introducer of claim 1, wherein the distal tube is formed of
a material selected from the group consisting of stainless steel,
carbon reinforced nylon, and composite wound tubing.
10. The introducer of claim 1, wherein the distal tube is formed of
a material with a modulus of elasticity greater than about 10
GPa.
11. The introducer of claim 10, wherein the modulus of elasticity
of the material forming the distal tube is greater than about 40
GPa.
12. The introducer of claim 11, wherein the modulus of elasticity
of the material forming the distal tube is greater than about 100
GPa.
13. The introducer of claim 1, wherein the proximal tube is formed
of a material with a modulus of elasticity between about 0.35 GPa
and about 1.75 GPa.
14. The introducer of claim 13, wherein the modulus of elasticity
of the material forming the proximal tube is between about 0.5 GPa
and about 1 GPa.
15. An introducer comprising: an introducer housing near a proximal
end of the introducer; a first tube coupled to the introducer
housing; a valve housing on the first tube; and a flap hingedly
connected to the valve housing, the flap having a first closed
position and a second open position; wherein, when in the first
closed position, a proximal end of the first tube is fluidly sealed
from a distal end of the first tube and, when in the second open
position, the proximal end of the first tube is in fluid
communication with the distal end of the first tube.
16. The introducer of claim 15, wherein the flap is connected to
the valve housing by a pin.
17. The introducer of claim 15, wherein a biasing mechanism biases
the flap toward the first closed position.
18. The introducer of claim 17, wherein the biasing mechanism
comprises a spring.
19. The introducer of claim 15, further comprising a second tube
coupled to a distal portion of the first tube.
20. The introducer of claim 19, wherein the first tube is
translucent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 14/899,491, filed on Dec. 17, 2015, which is a
national phase entry under 35 U.S.C. .sctn. 371 of International
Application No. PCT/US2014/042494 filed Jun. 16, 2014, published in
English, which claims priority from U.S. Provisional Application
No. 61/836,440, filed Jun. 18, 2013, entitled "TRANSAPICAL
INTRODUCER," the disclosures of which are all hereby incorporated
herein by reference.
BACKGROUND
[0002] During a cardiac valve repair or replacement procedure,
access to the interior of the heart may be necessary. To access the
interior of the heart, physicians often conduct a median
sternotomy. In a median sternotomy, the physician makes an incision
along the center of the chest to divide the patient's sternum,
thereby creating an access to the heart. Sternotomies may result in
long recovery times and involve a high risk of complications (e.g.,
infections) due to the lengthy surgery required for these unstable
patients.
[0003] Rather than performing the more invasive median sternotomy,
a less invasive thoracotomy introducer device may be used to access
the interior of the heart and to provide a conduit through which
other devices may be passed during the procedure. Such miniaturized
introducers aid the physician in inserting the necessary repair or
replacement materials into the heart while also limiting the level
of physical invasiveness and the amount of blood loss.
BRIEF SUMMARY
[0004] In one embodiment, an introducer includes a housing near a
proximal end of the introducer, a first valve in the housing, a
flexible proximal tube coupled to the housing, and a rigid distal
tube coupled to a distal end of the proximal tube. The proximal
tube may be more flexible than the distal tube and may be capable
of being clamped to prevent fluid flow therethrough.
[0005] In another embodiment, an introducer includes a housing near
a proximal end of the introducer, a foam seal located in the
housing, a flexible proximal tube coupled to the housing, and a
rigid distal tube coupled to a distal end of the proximal tube. The
proximal tube may be more flexible than the distal tube and may be
capable of being clamped to prevent fluid flow therethrough.
[0006] In a further embodiment, an introducer includes an
introducer housing near a proximal end of the introducer, a first
tube coupled to the introducer housing, a valve housing on the
first tube, and a flap hingedly connected to the valve housing. The
flap may have a first closed position and a second open position.
When in the first closed position, a proximal end of the first tube
may be fluidly sealed from a distal end of the first tube and, when
in the second open position, the proximal end of the first tube may
be in fluid communication with the distal end of the first
tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1A is a side plan view of one embodiment of a
transapical introducer.
[0008] FIG. 1B is a front plan view of the transapical introducer
of FIG. 1A.
[0009] FIG. 1C is a cross sectional view of the transapical
introducer of FIG. 1B taken along line 1C-1C.
[0010] FIG. 1D is an exploded view of the transapical introducer of
FIG. 1A with an obturator.
[0011] FIG. 1E is a perspective view of a duckbill valve according
to the prior art.
[0012] FIG. 1F is a perspective view of another embodiment of a
duckbill valve according to an aspect of the disclosure.
[0013] FIG. 1G is a side plan view of a wiper seal according to the
prior art.
[0014] FIG. 1H is a cross sectional view of the wiper seal of FIG.
1G taken along the line 1H-1H.
[0015] FIG. 1I is a perspective view of a hemostatic clamp
according to the prior art.
[0016] FIG. 1J is a side plan view of a transapical delivery device
according to the prior art.
[0017] FIG. 2A is a side plan view of another embodiment of a
transapical introducer.
[0018] FIG. 2B is a front plan view of the transapical introducer
of FIG. 2A.
[0019] FIG. 2C is a cross sectional view of the transapical
introducer of FIG. 2B taken along line 2C-2C.
[0020] FIG. 3A is a cross sectional view of a further embodiment of
a transapical introducer.
[0021] FIG. 3B is a front plan view of the transapical introducer
of FIG. 3A.
[0022] FIGS. 3C-E show multiple views of a foam seal of the
transapical introducer of FIG. 3A.
[0023] FIGS. 3F-3I show multiple views of an obturator passing
through the foam seal of FIGS. 3C-E.
[0024] FIG. 3J shows a front plan view of the transapical
introducer of FIG. 3A after an obturator has been withdrawn.
[0025] FIG. 3K is a cross sectional view of an alternate embodiment
of a transapical introducer with a foam seal.
[0026] FIG. 4A is a side plan view of a transapical introducer
according to a further embodiment.
[0027] FIG. 4B is a top plan view of the transapical introducer of
FIG. 4A.
[0028] FIG. 4C is a cross sectional view of the transapical
introducer of FIG. 4B taken along the line 4C-4C.
[0029] FIG. 4D is a side plan view of an obturator.
DETAILED DESCRIPTION
[0030] As used herein, the term "proximal," when used in connection
with an introducer device, refers to an end of the device closer to
the user of the device. On the other hand, the term "distal," when
used in connection with an introducer device, refers to an end of
the device farther away from the user. In the figures, like numbers
refer to like or identical parts.
[0031] The present disclosure generally relates to transapical
introducers for use in procedures repairing or replacing heart
valve (e.g. mitral or aortic valves, such as percutaneous mitral
valve repair ("PMVR")). However, the transapical introducers
disclosed herein may be used with other transapical devices and
procedures.
[0032] Generally, during a transapical procedure, a surgeon gains
access to the heart by sewing a purse string suture at the apex of
the heart and creating an access opening, as is known in the art.
An introducer is inserted into the heart and the purse string
suture is cinched, or drawn, about the introducer. The particular
treatment procedure, such as PMVR, is performed, inserting devices
as necessary through the introducer and into the heart. Once the
particular treatment procedure is concluded, any remaining devices
are removed through the introducer, and the introducer itself is
removed. The incision in the heart is closed, completing the
treatment procedure.
[0033] Some less invasive introducers have been developed over the
years. Improvements to these introducers are nonetheless still
possible and desirable. Such improvements may be directed at, for
example, reducing the likelihood of forming air bubbles within the
introducer that could potentially, and dangerously, enter the
heart, or providing a user with more intuitive control of the
introducer. For example, providing a clear introducer may help a
user visualize air bubbles trapped inside the introducer. Further,
introducers that include flexible portions may be clamped shut to
fluidly seal an introducer after a device has been removed from the
introducer. This may help ensure that no air enters the introducer
between the time after a user removes a first device from the
introducer seal and before the user inserts a second device into
the introducer. Still further, providing a biased valve that opens
only when a device is inserted through the introducer and closes
after the device is removed from the introducer may help reduce the
likelihood of air bubbles becoming trapped in the introducer.
[0034] Now referring to FIGS. 1A-D, various views of one embodiment
of a transapical introducer 100 are illustrated. The introducer 100
generally includes a hollow distal tube 110 connected to a hollow
proximal tube 130 by a connector 120. The connector 120 may, for
example, be generally tubular with a through-hole extending from a
proximal connector end 121 to a distal connector end 122. The
proximal and distal connector ends 121, 122 may each be
frustoconical and may be separated by a groove 132. A distal end
131 of the hollow proximal tube 130 may be configured to stretch
over the proximal connector end 121 and to snap or otherwise mate
with the groove 132 in the connector 120. A proximal end 111 of the
hollow distal tube 110 may be inserted into the through-hole of the
connector 120 via the distal connector end 122. Connected to the
proximal tube 130 is a housing 140. The housing 140 may include a
number of additional components, including, for example, a flush
port 150, a duckbill valve 160, a wiper seal 170, and a housing cap
180 (see FIGS. 1C and 1D). An obturator 190 or similar device may
be used with the introducer 100.
[0035] The distal tube 110 may be formed of a rigid material to
provide radial strength during apex introduction and also during
insertion of devices through the distal tube. The distal tube 110
may include one or more depth markers 112 to indicate the distance
from the distal end of the distal tube 110. A distal end 131 of the
proximal tube 130 is attached to the proximal end 111 of the distal
tube 110. The proximal tube 130 may be flexible to allow the
proximal tube to be clamped, for example with a hemostatic clamp,
to seal fluid from flowing through the introducer 100. An exemplary
hemostatic clamp is described more fully below with reference to
FIG. H. One or both of the distal tube 110 and proximal tube 130
may be formed from a translucent, transparent, or otherwise clear
material. As used herein, the terms "translucent," "transparent,"
and "clear" refer generally to the ability of light to pass through
a first object such that a second object may be seen through the
first object. The terms are intended to be interchangeable as used
in this disclosure. By forming the proximal tube 130 from a
translucent material, a user will be able to see, for example, air
bubbles in the proximal tube, as well as devices inserted through
the proximal tube, such as the obturator 190 or other devices.
[0036] Illustrative materials that may be used for the distal tube
110 include, for example, biocompatible materials such as stainless
steel, carbon reinforced nylon, or composite wound tubing. The
material used for the distal tube 110 may be chosen based, in part,
on the stiffness of the material. For example, materials with a
modulus of elasticity of greater than about 190 GPa, including
steel, may be suitable. Further, materials with a modulus of
elasticity of greater than about 100 GPa, such as titanium alloys,
may be suitable for the distal tube 110. Still further, materials
with a modulus of elasticity of greater than about 40 GPa, such as
magnesium alloys, may be suitable for the distal tube 110. In one
embodiment, the distal tube 110 is formed of a material with a
modulus of elasticity greater than about 10 GPa.
[0037] Illustrative materials that may be used for the proximal
tube 130 include, for example, biocompatible materials such as
polytetrafluoroethylene ("PTFE"), polyfluoroethylene ("PFE"),
polyurethane ("PU"), or polyethylene ("PE"). The material used for
the proximal tube 130 may be chosen based, in part, on the
stiffness of the material. For example, materials with a modulus of
elasticity of between about 0.35 GPa and about 1.75 GPa may be
suitable for the proximal tube 130. In another example, materials
with a modulus of elasticity of between about 0.5 and about 1 GPa
may be suitable for the proximal tube 130. Other materials may be
suitable for the proximal tube 130, particularly materials that are
pliable enough to allow the proximal tube 130 to close on itself
under clamping force and recover to its original shape without
cracking, splitting, or otherwise breaking.
[0038] The housing 140 may take the form of a general hollow tube
with an extension 142 extending from a distal end of the housing
140. The extension 142 may be generally frustoconical with a
circular groove 143 at a proximal end of the extension 142. The
distal end of the housing 140 may be attached to a proximal end 132
of the hollow proximal tube 130. For example, the proximal end 132
of the hollow proximal tube 130 may be stretched over the extension
142 of the housing 140 and snap or otherwise mate with the groove
143 to secure the proximal tube 130 to the housing 140. The housing
140 may include a flush port 150 proximal to the extension 142. The
housing 140 may include a duckbill valve 160 proximal to the flush
port 150, a wiper seal 170 proximal to the duckbill valve 160, and
a housing cap 180 proximal to the wiper seal 170. An interior of
the housing 140 may take forms other than a tube or cylinder. For
example, the housing 140 may include a shoulder 141 in the form of
an annulus to help keep components of the housing 140 in place. For
example, the duckbill valve 160 may include an annular flange 161
that abuts the shoulder 141 of the housing 140 to help the duckbill
valve 160 from shifting positions.
[0039] In the embodiment illustrated in FIGS. 1A-D, a first seal
takes the form of duckbill valve 160. More specifically, the
duckbill valve takes the form of the quad-slit duckbill valve 160.
Duckbill valves are known in the art. A traditional duckbill valve
12, as illustrated in FIG. 1E, generally is made of pliable
material, shaped like the beak of a duck, and is configured with a
duckbill portion 16 and a base portion 18. The duckbill portion 16
is configured with a flattened end 20 having a slit 22 to flex open
so as to allow and provide fluid to pass through, and to close to
prevent the backflow of the fluid. For example, in operation when a
fluid is pumped through the duckbill portion 16, the flattened end
20 opens to permit the pressurized fluid to pass; and when internal
pressure is removed, the duckbill end 20 returns to its flattened
shape, closing the slit 22, thus preventing backflow. The operation
of the duckbill valve 12 is similar to a mitral valve. Further, the
base portion 18 may be configured with an external circumferential
protruding portion, such as a sealing ring or bead, for coupling
the duckbill valve 12 to another device, such as a supply line or
pump (not shown) that provides fluid.
[0040] The quad-slit duckbill valve 160 is similar to the duckbill
valve 12, but has four flaps instead of two, the four flaps coating
together to close the valve. The duckbill valve 160 may be
configured with a duckbill portion 162 and a base portion or flange
161. The duckbill portion 162 includes four leaflets or flaps 165,
and is configured with a flattened end 163 having a slit 164 to
flex open so as to allow and provide fluid to pass through, and to
close to prevent the backflow of the fluid. The duckbill valve 160
operates in essentially the same manner as duckbill valve 12, with
the flattened end 163 opening to permit pressurized fluid to pass;
and when internal pressure is removed, the duckbill end 163 returns
to its flattened shape, closing the slit 164, thus preventing
backflow. The flange 161 may, for example, be used in combination
with the shoulder 141 of the housing 140 to help keep the duckbill
valve 160 in place.
[0041] For a given diameter, the traditional duckbill valve 12 may
require a certain length of each flap in order to effectively
function as a one-way valve. For that same diameter, the duckbill
valve 160 may require a shorter length for each flap 165 to
effectively function as a one-way valve. The use of the duckbill
valve 160 provides for less dead-space within the housing 140, and
generally allows for the housing to be a shorter overall length.
Although illustrated as a quad-slit duckbill valve 160, other
valves, including traditional duckbill valves 12 or three-sided
duckbill valves may be used with the introducer 100.
[0042] Proximal to the duckbill valve 160 is a second seal, which
takes the form of a wiper seal 170. Wiper seals are known in the
art. For example, FIGS. 1G and 1H illustrate a wiper seal 70
according to the prior art. The prior art wiper seal 70 includes a
partial sealing and cleaning mechanism 71 located at the center of
a lumen 72 which allows a device to pass with little drag or
frictional force on the device. The sealing and cleaning mechanism
71 can be pre-treated with a sterilizing agent or an
anti-coagulant, e.g., heparin. As a device, such as the obturator
190, is passed through the wiper seal 70, the sealing and cleaning
mechanism 71 remains closed around the device and may
simultaneously "wipe" or scrape the device to prevent air from
seeping into the introducer 100, while further preventing dirt or
other contaminants on the device from entering the introducer 100.
Although one particular embodiment of a prior art wiper seal 70 is
illustrated in FIGS. 1G and 1H, the wiper seal 170 of the
introducer 100 may take other configurations.
[0043] The housing 140 may also include a flush port 150 distal of
the duckbill valve 160. Flush ports are known in the art. The flush
port 150 brings the distal tube 110 and proximal tube 130 in fluid
communication with the outside of the housing 140 distally of the
duckbill valve 160. The flush port 150 allows a user to introduce a
fluid, such as saline, into the proximal tube 130 and distal tube
110 after a device, such as the obturator 190, has been inserted
through the proximal and distal tubes. This may be done, for
example, to remove air trapped within the introducer. Similarly,
the flush port 150 may be used to withdraw fluid, such as saline,
blood, and/or air.
[0044] The proximal end of the housing 140 includes a housing cap
180. The housing cap 180 closes off the proximal end of the housing
140, with the exception of a central opening 182 that allows for
devices, such as the obturator 190, to be inserted into the
introducer 100. The housing cap 180 may have a chamfered surface
that may direct devices, such as the obturator 190, to the central
opening 182.
[0045] In practice, the obturator 190 is advanced through the
central opening 182 in the housing cap 180 prior to inserting the
introducer 100 into the heart. This may be accomplished, for
example, by grasping a handle 192 of the obturator 190 and manually
pushing the obturator through the introducer until a lip 194 of the
obturator makes contact with the housing cap 180, limiting further
distal movement of the obturator. The shaft 196 of the obturator
may be sized to substantially match an inner diameter of the distal
tube 110 and/or proximal tube 130. This sizing allows the obturator
190 to limit the ability of fluid, such as blood, to flow out of
the heart and through the introducer 100 after the introducer has
been inserted into the heart. However, it should be understood that
the obturator 190, as well as other devices, may not fit perfectly
within the introducer 100. Even when the obturator 190 or other
device is inserted fully within the introducer 100, gaps may remain
along at least some of the length of the introducer 100 between the
outside of the obturator 190 (or other device) and the inside of
the distal tube 110 and/or proximal tube 130 of the introducer 100.
Fluids, such as air, may reside in these gaps if not purged from
the introducer 100. The tip 198 of the obturator 190 may be
tapered. The tapered shape of the tip 198 may aid the user in
guiding the obturator 190 through the housing 140 and components
therein.
[0046] With the obturator 190 inside the introducer 100, the user
may flush the introducer to remove air trapped in the housing 140,
the proximal tube 130, or the distal tube 110. In one example, the
user may attach a 40 cc syringe to the flush port 150 and flush the
introducer 100 with sterile saline. Flushing may be continued until
a saline stream comes out of the distal end of the distal tube 110
of the introducer 100. This first flush is performed prior to
inserting the introducer 100 into the heart.
[0047] After flushing, the introducer 100 is inserted into the
heart far enough that a portion of the distal tube 110 crosses the
heart tissue, with the entire proximal tube 130 and the housing 140
remaining outside of the heart. The introducer 100 may be inserted
into the heart at an angle, such that the proximal end of the
introducer 100 is higher than the distal end of the introducer. In
this position, air bubbles trapped in the introducer tend to move
away from the heart.
[0048] Once the introducer 100 is at the desired position in the
heart, the obturator 190 is slowly withdrawn from the introducer.
Because the obturator 190 is sized to fill much of the space within
the distal tube 110 and proximal tube 130, withdrawal of the
obturator may create negative pressure causing blood to flow from
the heart into the introducer 100. The proximal tube 130 may
include one or more indicia to provide a user with, for example, a
visual marking corresponding to a desired distance to withdraw the
obturator 190. If a marking is provided on the proximal tube 130,
the user may remove the obturator 190 until the distal end of the
tip 198 of the obturator aligns with the marking. As described
above, the proximal tube 130 may be translucent to facilitate the
ability of the user to determine the position of the obturator 190
in the proximal tube 130.
[0049] When the obturator 190 has been withdrawn to the desired
position within the introducer 100, the user may clamp the proximal
tube 130, for example with a hemostatic clamp. This clamping is
made possible, at least in part, due to the proximal tube 130 being
flexible, as described above. Further, because the proximal tube
130 is translucent, the user may accurately determine a desired
location for clamping. This location may be based, in part, on the
location of the obturator 190 in the proximal tube 130. Even
further, any air bubbles created during clamping may be able to be
visually identified and dealt with, for example, by clamping in a
different location or taking other appropriate actions. After
clamping, a user may also flush the introducer 100, using the flush
port 150 as described above to minimize the likelihood of any air
bubbles being trapped within the introducer 100. If the user is
satisfied with the clamping of the proximal tube 130, he may fully
remove the obturator 190 from the introducer 100 and begin the
treatment procedure.
[0050] Referring to FIG. 1I, a hemostatic clamp 40 according to the
prior art is illustrated. The hemostatic clamp 40 may be made of,
for example, titanium alloy. The hemostatic clamp 40 may include a
left clamp body 41 and a right clamp body 42 which are joined by a
hinge and may be divided into jaws 43 and handles 44 by the hinge.
The jaws 43 of the left and right clamp bodies 41, 42 may have a
curved configuration with ends extending upwardly. A serrated
portion 48 with serrations projecting from an engaging surface are
respectively formed on both ends of the jaw 43 of the left clamp
body 41 and the jaw 43 of the right clamp body 42. The handles 44
of the left and right clamp bodies 41, 42 respectively may have a
clamping force adjustment mechanism acting in cooperation with each
other. The adjustment mechanism may include a ratchet means 46
formed on one of the left clamp body 41 and the right clamp body 42
and a pawl 47 formed on the other of the left clamp body 41 and the
right clamp body 42. Other hemostatic clamps, such as those with
different shapes, different force adjustment mechanisms, and with
or without serrations may alternately be used in conjunction with
the introducer 100.
[0051] Treatment procedures that may be performed using the
introducer 100 include PMVR or transcatheter aortic valve repair
("TAVR"). It should be noted, however, that the introducer 100 may
be used with a number of other procedures, including other
minimally invasive heart procedures.
[0052] One exemplary delivery device that could be used with the
introducer 100 is a transapical heart valve delivery device 30,
illustrated in FIG. 1J. The transapical delivery device 30 for a
collapsible prosthetic heart valve 31 extends from an atraumatic
tip 32 at the distal end of the device to a proximal end (not
shown), and includes a catheter assembly 33 for delivering the
heart valve to, and deploying the heart valve at, a target
location. The catheter assembly 33 is adapted to receive the
collapsible prosthetic heart valve 31 in an assembled condition in
a compartment 34 defined around a support shaft 35. A distal sheath
36 is operable for sliding movement between a closed position
covering the prosthetic heart valve 31 and maintaining it in a
collapsed condition, and an open position for deployment of the
valve.
[0053] The delivery device further includes an outer shaft 37, the
distal end of which is connected to a valve retainer, and the
proximal end of which can optionally be connected to a hub (not
shown) that can be held by a user when sliding the distal sheath 36
relative to the support shaft 35. An inner shaft 38 extends from
the proximal end of the delivery device through the outer shaft 37
and the support shaft 35 for connection to the atraumatic tip
32.
[0054] The distal sheath 36 surrounds the support shaft 35 when the
distal sheath is in the closed position, and is slidable relative
to the support shaft such that it can selectively cover or uncover
the compartment 34. The distal sheath 36 is connected at its distal
end to the atraumatic tip 34, such that sliding movement of the
inner shaft 38 controls the movement of the distal sheath both
proximally and distally, which in turn controls the expansion of
the heart valve 31.
[0055] If performing a transapical TAVR procedure, the transapical
delivery device 30 is inserted through the central opening 182 in
the housing 180, through the wiper seal 170, and through the
duckbill valve 160. The tip of the transapical delivery device 30
is advanced until it is near the clamped area of the proximal tube
130. The proximal tube 130 and housing 140 may be flushed with, for
example, saline using a 40 cc syringe coupled to the flush port
150. The saline fills the introducer 100 proximal to the clamped
area of the proximal tube 130, forcing air out of the introducer.
Depending on the particular device being used, the flushing step
may also flush the delivery device itself. For example, delivery
devices often contain lumens that should be purged of air with a
flushing step prior to the delivery device being inserted into a
patient. These delivery devices may include their own features for
flushing, such as additional flush ports and/or purge holes, which
may be used in conjunction with or separate to the flushing of the
introducer 100 as appropriate. For example, if the delivery system
includes purge holes on its shaft, the flush port 150 may be used
to remove any air from the proximal tube 130 and delivery device,
with flushing continued until saline runs out the purge holes on
the delivery system shaft that are positioned proximal to the wiper
seal 170.
[0056] After purging, the user may visually confirm that there are
no identifiable air bubbles remaining in the proximal tube 130.
Once confirmed, the hemostatic clamp 40 is removed from the
proximal tube 130, and the delivery device may be advanced into the
heart. If the delivery device contains purge holes, the purge holes
are advanced past the wiper seal 170 during advancement of the
delivery device such that air cannot enter the heart through the
purge holes. The particular treatment procedure, such as TAVR, is
performed as is known in the art. During the treatment procedure,
the delivery device may need to be removed and replaced, either
with the same or another device. If this replacement is required,
the user may repeat the flushing and clamping steps described above
to minimize the likelihood of introduction of air bubbles into the
heart. Once the treatment procedure is complete, the user may
remove any devices in the introducer 100, and remove the introducer
itself from the heart while using the purse string sutures to close
the incision.
[0057] Now referring to FIGS. 2A-C, various views of another
embodiment of a transapical introducer 200 are illustrated. The
introducer 200 generally includes a hollow distal tube 210
connected to a hollow proximal tube 230 by a connector 220. These
elements are substantially similar to the distal tube 110, the
proximal tube 130, and connector 120 described in relation to the
introducer 100 above. For example, the distal tube 210 may be
formed of a rigid material. Similarly, the proximal tube 230 may be
flexible to allow the proximal tube to be clamped, without
cracking, splitting, or otherwise breaking, in order to seal fluid
from flowing through the introducer 200. One or both of the distal
tube 210 and proximal tube 230 may be formed from a translucent,
transparent, or otherwise clear material. Connected to the proximal
tube 230 is a housing 240. The housing 240 is similar to the
housing 140 described in relation to the introducer 100, although
the housing 240 may be differently shaped to appropriately house
components contained therein. The components in the housing 240, as
illustrated in FIG. 2C, may include, for example, a flush port 250,
first and second duckbill valves 262, 264 proximal to the first
duckbill valve, a wiper seal 270 proximal to the first and second
duckbill valves, and a housing cap 280 proximal to the wiper seal.
Similar to the housing cap 180, the housing cap 280 may be
chamfered toward a central opening 282 in the housing cap to allow
devices to enter the introducer 200. The wiper seal 270 may be
similar or identical to the wiper seal 170 described above in
relation to FIGS. 1A-D and 1G-H.
[0058] In the embodiment illustrated in FIGS. 2A-C, first and
second seals take the form of duckbill valves. Although the
duckbill valves may take different forms, such as the two-sided,
three-sided or four-sided described above in relation to FIGS.
1A-F, the duckbill valves illustrated in FIGS. 2A-C take the form
of the first quad-slit duckbill valve 262 and the second quad-slit
duckbill valve 264. The structure of each quad-slit duckbill valve
262 and 264 is substantially similar to that described in relation
to the quad-slit duckbill valve 160 of the introducer 100. For
example, similar to the duckbill valve 160 illustrated in FIG. 1F
according to an embodiment of the disclosure, the duckbill valves
262, 264 may each have a duckbill portion and a base/flange
portion. The duckbill portion may include four leaflets or flaps
and be configured with a flattened end having a slit to flex open
so as to allow and provide fluid to pass through, and to close to
prevent the backflow of the fluid. In the current embodiment, the
first duckbill valve 262 is positioned in a similar manner as the
position of the duckbill valve 160 of the introducer 100, with the
first duckbill valve 262 being distal of both the housing cap 280
and the wiper seal 270. Stated another way, the first duckbill
valve 262 may be positioned with a base or flange portion closer to
the housing cap 280 and the flaps farther away from the housing
cap. In this position, the first duckbill valve 262 allows fluid to
pass from the proximal end of the introducer 200 toward the distal
end, but not from the distal end to the proximal end. The second
duckbill valve 264 is positioned distal to the first duckbill valve
262, as well as being distal to the housing cap 280 and the wiper
seal 270, and faces the opposite direction of the first duckbill
valve 262. In other words, the flaps of the first duckbill valve
262 face the flaps of the second duckbill valve 264. More
specifically, the flaps of the second duckbill valve 264 are closer
to the housing cap 280 than the base of the second duckbill
valve.
[0059] The duckbill valve 262 functions substantially similar to
the duckbill valve 160 described in relation to the introducer 100.
The second duckbill valve 264 provides an additional level of
sealing in the proximal direction. More specifically, the second
duckbill valve 264 allows fluid to pass from the distal end of the
introducer 200 toward the proximal end of the introducer, but not
from the proximal end toward the distal end. This may be useful,
for example, to help prevent air from being unintentionally forced
into the introducer 200 if negative pressure is created in the
proximal tube 230. Such negative pressure could be created, for
example, by changes in flow or pressure in the heart when the
distal tube 210 of the introducer 200 is in a ventricle of the
heart. For example, when expelling blood, the left ventricle builds
pressure prior to the aortic valve opening. Once the aortic valve
opens, the high pressure in the ventricle causes the blood to pass
from the left ventricle through the aorta. When the ventricle fills
with blood, the filling is caused by low/negative pressure in the
left ventricle, which causes blood to be drawn from the left
atrium. When the ventricle is undergoing this cycle of pressure
changes while the distal tube 210 of the introducer 200 is in the
ventricle, the portion of the introducer in fluid communication
with the ventricle may be affected by these pressure cycles. One
specific concern is that, when the ventricle is at low or negative
pressure, air may tend to be "sucked" into introducer 200 from the
environment outside the introducer. The addition of the second
duckbill valve 264 may alleviate or eliminate the tendency of air
being sucked into the introducer 200 in such circumstances.
[0060] Other than the inclusion of the second duckbill valve 264,
the remaining components of the introducer 200 may be similar or
identical to the corresponding components describe in relation to
the introducer 100. For example, the distal tube 210, the connector
220, the proximal tube 230, the flush port 250, the first duckbill
valve 262, the wiper seal 270 and the housing cap 280 may all be
similar or identical to the corresponding parts in the introducer
100. The housing 240, however, may be longer to accommodate the two
duckbill valves 262, 264, whereas the housing 140 may only need to
accommodate a single duckbill valve 160. Further, these components,
other than the additional/second duckbill valve 264, function in
the same or a similar fashion as described in relation to the first
embodiment of the introducer 100.
[0061] Now referring to FIGS. 3A-B, a further embodiment of a trans
apical introducer 300 is illustrated. The introducer 300 generally
includes a hollow distal tube 310 connected to a hollow proximal
tube 330 by a connector 320. These elements are substantially
similar to the distal tubes 110, 210, the proximal tubes 130, 230,
and connectors 120, 220 described in relation to the introducers
100 and 200 above. Connected to the proximal tube 330 is a housing
340. The housing 340 is similar to the housings 140, 240 described
in relation to the introducers 100, 200, although the housing 340
may be differently shaped to appropriately house components
contained therein. The components in the housing 340 may include,
for example, a flush port 350, a foam seal 366 abutting a shoulder
341 in the housing, and a housing cap 380. The shoulder 341 may
take the form of an annulus, with a first side of the foam seal 366
abutting the shoulder and a second side of the foam seal abutting
the housing cap 380.
[0062] The flush port 350, which is distal to the housing cap 380,
the foam seal 366, and the shoulder 341, may be similar or
identical in structure and function as the flush ports 150, 250
described in relation to the transapical introducers 100, 200,
respectively. Similarly, the housing cap 380, at the proximal most
end of the housing 340, may be similar or identical in structure
and function to the housing caps 180, 280 described in relation to
the transapical introducers 100, 200, having a chamfered surface
leading to a central opening 382.
[0063] The foam seal 366 is illustrated in more detail in FIGS.
3C-J. In the illustrated embodiment, and as best seen in FIGS.
3C-E, the foam seal 366 takes the form of a short cylinder flanked
by the housing shoulder 341 and the housing cap 380, as shown in
FIG. 3A. A first slit 367 is formed across a first surface 361 of
the foam seal 366, the first slit extending across a center area of
the first surface, which may be along a diameter of the foam seal.
The first slit 367 extends approximately half the thickness of the
foam seal 366. A second slit 368 is formed across a second surface
362 of the foam seal 366, the second slit extending across a center
area of the second surface, which may be along a diameter of the
foam seal. The second slit 368 also extends approximately half the
thickness of the foam seal 366. Neither the first slit 367 nor the
second slit 368 need extend completely across a complete diameter
of their respective surfaces 361, 362, but this configuration may
be the easiest to produce. For example, the slits 367, 368 may not
extend to the outer edge of the respective surfaces 361, 362, on
one or both sides of the slits.
[0064] The first slit 367 may be generally perpendicular to the
second slit 368. Note that in certain of FIGS. 3B-3J, the first
slit 367 or second slit 368 may be represented in phantom lines
when the particular slit would not otherwise be visible. With this
generally perpendicular configuration, the first slit 367 meets the
second slit 368 at approximately the center of the foam seal 366,
creating a passageway therethrough. Although the slits 367, 368 are
each described as extending across the center of the respective
surfaces 361, 362 of the foam seal 366 and approximately half the
thickness of the foam seal, variations are possible. For example,
one or both slits 367, 368 may be off-center and they need not be
perpendicular to each other. Similarly, one or both of the slits
367, 368 may extend more than half the thickness of the foam seal
366. Alternately, one of the slits 367, 368 may extend less than
half the thickness of the foam seal 366 if the other one of the
slits 367, 367 extends more than half the thickness of the foam
seal 366. However, the first slit 367 and second slit 368 should
overlap to at least some degree to allow for passage of a device
through the foam seal 366. In one example, the foam seal 366 has a
thickness of between approximately 0.125 and 0.25 inches (3.175 to
6.35 mm). Various materials, such as silicone or urethane open-cell
foam may be used for the foam seal 366.
[0065] As a device, such as an obturator 390, is passed through the
foam seal 366, as illustrated in FIGS. 3F-3I, the device first
passes through the first slit 367 and then through the second slit
368. To properly pass through both slits 367, 368, the device
should be inserted through the point at which the slits intersect
to form a passageway. The foam seal 366, having an amount of
elasticity, conforms around the device to create and maintain a
fluid seal while the device passes through the foam seal (see FIG.
3I). After the device is removed from the foam seal 366, as
illustrated in FIG. 3J, the foam seal, including first slit 367 and
second slit 368, self-close, maintaining a fluid seal across the
foam seal.
[0066] As the device passes through the foam seal 366, axial or
rotational friction may be created. Axial friction, causing the
foam seal 366 to be pulled somewhat in the direction of movement of
the device, is best illustrated in FIG. 3I. This movement may be at
least partially resisted by the housing shoulder 341 abutting the
foam seal 366, as described above in relation to FIG. 3A. It is
noted that FIGS. 3B and 3F-J omit elements within the housing 340
(including the shoulder 341) other than the foam seal 366 for
clarity of illustration. The amount of friction created depends on
a number of factors, including the size of the device, the material
of the foam seal 366 and the material of the particular device
passing through the foam seal. For example, if silicone foam is
used for the foam seal 366, it may be advantageous to use silicone
lubricant oil on the foam seal to minimize friction resulting from
normal use.
[0067] FIG. 3K illustrates a modified embodiment of an introducer
300' that is similar to the introducer 300 in most regards.
However, the introducer 300' includes an added retaining element
feature in the housing 340' to help further restrict the foam seal
366 from axial or rotational movement caused by friction. The
particular retaining element illustrated is a series of spikes 342'
extending radially inward from the housing 340'. One, two, or more
spikes 342' may be used with the housing, generally arranged
circumferentially around the housing 340' and equally spaced,
although variations in spacing and number of such retaining
elements is possible.
[0068] Now referring to FIGS. 4A-C, various views of a further
embodiment of a transapical introducer 400 are illustrated. The
introducer 400 generally includes a hollow distal tube 410
connected to a hollow proximal tube 430. The distal tube 410 may be
directly connected to the proximal tube 430 as illustrated. The
distal tube 410 and proximal tube 430 may alternately be formed as
a single elongate tube. Connected to the proximal tube 430 is a
housing 440. The housing 440 may include a number of additional
components, including, for example, a wiper seal 470, and a housing
cap 480. The housing cap 480 may be positioned on the proximal end
of the housing 440 and include a chamfered surface leading to a
central aperture 482, similar to the housing caps 180, 280, 380
described in relation to the transapical introducers 100, 200, 300,
respectively. The wiper seal 470 may be positioned distal to the
housing cap 480 and proximal to a flush port 450, the wiper seal
being similar or identical to the wiper seals 170, 270 described
above in relation to the transapical introducers 100, 200,
respectively. The flush port 450 may be included in the proximal
tube 430 distal of the housing 440. The flush port 450 may be
identical to the flush ports 150, 250, 350 described in relation to
the transapical introducers 100, 200, 300, respectively.
[0069] Similar to the distal tubes 110, 210, 310 described in
relation to the transapical introducers 100, 200, 300,
respectively, the distal tube 410 may be formed of a rigid material
to provide radial strength during apex introduction and also during
insertion of devices through the distal tube. Unlike the proximal
tubes 130, 230, 330, however, the proximal tube 430 may also be
formed of a rigid and translucent material.
[0070] The proximal tube 430 may also include a valve housing 460.
As best illustrated in FIG. 4C, the valve housing 460 may include a
pivotable or hinged flap or valve, such as a drop-leaf valve 461,
hingedly connected to the valve housing by, for example, a pin 462.
The drop-leaf valve 461 may take different shapes, such as the
general "U" shape illustrated, but should be large enough to be
capable of fluidly sealing the introducer 400. The drop-leaf valve
461 includes a biasing mechanism to bias the drop-leaf valve to a
closed position 461'. The biasing mechanism may be, for example, a
spring mechanism in the pin 462.
[0071] In practice, the introducer 400 is used similarly to the
embodiments described above. An obturator 190, illustrated in FIG.
4D (which may be identical to the obturators 190, 390 illustrated
in FIGS. 1D, 3I respectively), is advanced through the central
opening 482 of the housing cap 480 and further through the wiper
seal 470 prior to inserting the introducer 400 into the heart.
Initially, the drop-leaf valve 461 is biased shut in the closed
position 461'. As the tip 198 of the obturator 190 makes contact
with the drop-leaf valve 461, it pushes the drop-leaf valve 461
toward the open position 461''. Although the flush port 450 is
positioned distal to the housing 440 rather than within the housing
as shown in other embodiments, once the obturator 461 is inside the
introducer 400, the user may flush the introducer to remove air
trapped therein as described with previous embodiments.
[0072] After flushing, the introducer 400 is inserted into the
heart far enough that a portion of the distal tube 410 crosses the
heart tissue, with the entire proximal tube 430, including the
valve housing 460 and the housing 440 remaining outside of the
heart. The introducer 400 may be inserted into the heart at an
angle, such that the proximal end of the introducer 400 is higher
than the distal end of the introducer. In this position, air
bubbles trapped in the introducer tend to move away from the
heart.
[0073] Once the introducer 400 is at the desired position in the
heart, the obturator 190 is slowly withdrawn from the introducer.
Because the obturator 190 is sized to fill most or all of the space
within the distal tube 410 and proximal tube 430, withdrawal of the
obturator creates a pressure gradient causing blood to flow from
the heart into the introducer 400. As the tip 198 of the obturator
190 moves proximally past the drop-leaf valve 461, the biasing
force on the drop-leaf valve causes the drop-leaf valve to move
from the open position 461'' to the closed position 461'. After the
obturator 190 is fully removed, the distal tube 410 and the portion
of the proximal tube 430 distal to the drop-leaf valve should be
filled with blood
[0074] In the embodiment illustrated in FIGS. 4A-C, the valve
housing 460 is somewhat larger than the size of the proximal tube
430. This increased size is useful to allow the drop-leaf valve 461
to move through its full range of motion while still allowing a
device, such as the obturator 190, to substantially or completely
occupy the diameter of the proximal tube 430. This sizing results
in the potential for air bubbles to be trapped as the obturator 190
is being removed proximally across the valve housing 461,
particularly if any air is trapped between the drop-leaf valve 461
and the top of the valve housing 460 when the drop-leaf valve is in
the open position 461''. To minimize the possibility of trapping
air bubbles, the obturator 190 should be removed slowly from the
introducer 400. Additionally, the tapered tip 198 of the obturator
may help reduce the likelihood of air becoming trapped just
distally of the drop-leaf valve 461. As the obturator 190 is
removed, the drop-leaf valve 461 gently rides along the surface of
the tapered tip 198 of the obturator as the drop-leaf valve moves
to the closed position 461'. The configuration of the valve housing
461 and drop-leaf valve 461 eliminates the need to clamp the
proximal tube 430 after removal of the obturator 190.
[0075] The user may inspect the inside of the proximal tube 430, as
it is translucent, to check if air bubbles remain in the proximal
tube. If the user is satisfied, he may fully remove the obturator
190 from the introducer 400 and begin the treatment procedure.
[0076] Generally, the same procedures may be performed using the
introducer 400 as with other embodiments of introducers described
above. Depending on the specific procedure, as well as the
configuration of the obturator 190, it may be advantageous for the
valve housing 460 to be located more proximally on the proximal
tube 430 than shown. This is because it is desirable for a device
to occupy the full diameter of the wiper seal 470 prior to the
distal end of the device causing the drop-leaf valve to begin
opening. For example, some devices used in procedures compatible
with the introducer 400 may have a working tip at the distal end of
the device with a smaller diameter than the cylindrical shaft of
the device. If the working tip were to start to open the drop-leaf
valve 461 prior to the shaft of the device occupying the full
diameter of the wiper seal 470, the drop-leaf valve could open
before the wiper seal established a fluid seal.
[0077] Although the disclosure herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present disclosure. It is therefore to be
understood that numerous modifications may be made to the
illustrative embodiments and that other arrangements may be devised
without departing from the spirit and scope of the present
disclosure as defined by the appended claims. It will be
appreciated that the various dependent claims and the features set
forth therein can be combined in different ways than presented in
the initial claims. It will also be appreciated that the features
described in connection with individual embodiments may be shared
with others of the described embodiments
[0078] The following Paragraphs summarize certain aspects of the
disclosure.
[0079] Paragraph A: An introducer comprises a housing near a
proximal end of the introducer, a first valve in the housing, a
flexible proximal tube coupled to the housing, and a rigid distal
tube coupled to a distal end of the proximal tube, wherein the
proximal tube is more flexible than the distal tube and is capable
of being clamped to prevent fluid flow therethrough.
[0080] Paragraph B: The introducer of Paragraph A, wherein the
proximal tube is translucent.
[0081] Paragraph C: The introducer of Paragraph A, wherein the
first valve is a duckbill valve.
[0082] Paragraph D: The introducer of Paragraph C, further
comprising a wiper seal in the housing disposed proximally of the
duckbill valve.
[0083] Paragraph E: The introducer of Paragraph D, further
comprising a second valve in the housing.
[0084] Paragraph F: The introducer of Paragraph E, wherein the
second valve is a duckbill valve.
[0085] Paragraph G: The introducer of Paragraph F, wherein the
first duckbill valve is oriented to allow fluid to flow across the
first duckbill valve only in a first direction and the second
duckbill valve is oriented to allow fluid to flow across the second
duckbill valve only in a second direction, the first direction
being opposite the second direction.
[0086] Paragraph H: The introducer of Paragraph A, wherein the
proximal tube is formed of a material selected from the group
consisting of polytetrafluoroethylene, polyfluoroethylene,
polyurethane, and polyethylene.
[0087] Paragraph I: The introducer of Paragraph A, wherein the
distal tube is formed of a material selected from the group
consisting of stainless steel, carbon reinforced nylon, and
composite wound tubing.
[0088] Paragraph J: The introducer of Paragraph A, wherein the
distal tube is formed of a material with am modulus of elasticity
greater than about 10 GPa.
[0089] Paragraph K: The introducer of Paragraph J, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 40 GPa.
[0090] Paragraph L: The introducer of Paragraph K, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 100 GPa.
[0091] Paragraph M: The introducer of Paragraph L, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 190 GPa.
[0092] Paragraph N: The introducer of Paragraph A, wherein the
proximal tube is formed of a material with a modulus of elasticity
between about 0.35 GPa and about 1.75 GPa.
[0093] Paragraph O: The introducer of Paragraph N, wherein the
modulus of elasticity of the material forming the proximal tube is
between about 0.5 GPa and about 1 GPa.
[0094] Paragraph P: An introducer comprises a housing near a
proximal end of the introducer, a foam seal located in the housing,
a flexible proximal tube coupled to the housing, and a rigid distal
tube coupled to a distal end of the proximal tube, wherein the
proximal tube is more flexible than the distal tube and is capable
of being clamped to prevent fluid flow therethrough.
[0095] Paragraph Q: The introducer of Paragraph P, wherein the
proximal tube is translucent.
[0096] Paragraph R: The introducer of Paragraph P, wherein the foam
seal includes a first slit on a first surface of the foam seal and
a second slit on a second surface of the foam seal, the first
surface being opposite the second surface and the first slit being
generally perpendicular to the second slit.
[0097] Paragraph S: The introducer of Paragraph P, wherein the
housing further comprises a shoulder and a housing cap, the foam
seal being positioned between the shoulder and the housing cap.
[0098] Paragraph T: The introducer of Paragraph S, wherein the
housing further comprises at least one foam seal retaining
element.
[0099] Paragraph U: The introducer of Paragraph T, wherein the at
least one foam seal retaining element is a spike extending radially
inward from the housing.
[0100] Paragraph V: The introducer of Paragraph S, wherein the
housing further comprises a plurality of spikes spaced
circumferentially around an inside of the housing, each of the
plurality of spikes extending radially inward from the housing.
[0101] Paragraph W: The introducer of Paragraph P, wherein the
proximal tube is formed of a material selected from the group
consisting of polytetrafluoroethylene, polyfluoroethylene,
polyurethane, and polyethylene.
[0102] Paragraph X: The introducer of Paragraph P, wherein the
distal tube is formed of a material selected from the group
consisting of stainless steel, carbon reinforced nylon, and
composite wound tubing.
[0103] Paragraph Y: The introducer of Paragraph P, wherein the
distal tube is formed of a material with a modulus of elasticity
greater than about 10 GPa.
[0104] Paragraph Z: The introducer of Paragraph Y, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 40 GPa.
[0105] Paragraph AA: The introducer of Paragraph Z, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 100 GPa.
[0106] Paragraph BB: The introducer of Paragraph AA, wherein the
modulus of elasticity of the material forming the distal tube is
greater than about 190 GPa.
[0107] Paragraph CC: The introducer of Paragraph P, wherein the
proximal tube is formed of a material with a modulus of elasticity
between about 0.35 GPa and about 1.75 GPa.
[0108] Paragraph DD: The introducer of Paragraph CC, wherein the
modulus of elasticity of the material forming the proximal tube is
between about 0.5 GPa and about 1 GPa.
[0109] Paragraph EE: An introducer comprises an introducer housing
near a proximal end of the introducer, a first tube coupled to the
introducer housing, a valve housing on the first tube, and a flap
hingedly connected to the valve housing, the flap having a first
closed position and a second open position, wherein, when in the
first closed position, a proximal end of the first tube is fluidly
sealed from a distal end of the first tube and, when in the second
open position, the proximal end of the first tube is in fluid
communication with the distal end of the first tube.
[0110] Paragraph FF: The introducer of Paragraph EE, wherein the
flap is connected to the valve housing by a pin.
[0111] Paragraph GG: The introducer of Paragraph EE, wherein a
biasing mechanism biases the flap toward the first closed
position.
[0112] Paragraph HH: The introducer of Paragraph GG, wherein the
biasing mechanism comprises a spring.
[0113] Paragraph II: The introducer of Paragraph EE, further
comprising a second tube coupled to a distal portion of the first
tube.
[0114] Paragraph JJ: The introducer of Paragraph II, wherein the
first tube is translucent.
* * * * *