U.S. patent application number 13/587396 was filed with the patent office on 2012-12-06 for valved introducer assembly and method therefor.
This patent application is currently assigned to Greatbatch Ltd.. Invention is credited to Mark C. Kraus, Grant A. Mauch.
Application Number | 20120310167 13/587396 |
Document ID | / |
Family ID | 35212061 |
Filed Date | 2012-12-06 |
United States Patent
Application |
20120310167 |
Kind Code |
A1 |
Kraus; Mark C. ; et
al. |
December 6, 2012 |
Valved Introducer Assembly and Method Therefor
Abstract
An introducer assembly includes a sheath having a sheath
proximal end and distal end, and a passage therethrough. The
introducer assembly further includes a valve assembly that is
sealingly associated with the passage of the sheath. The valve
assembly includes a valve having a first seal and a second seal,
where the first and second seal optionally have different sealing
properties. For example, the first seal and the second seal have
different thicknesses, different sealing durometers, or otherwise
different sealing features. In another option, the sheath is
removable from the instrument disposed therethrough. In yet another
option, the valve of the valve assembly further includes a chamber
disposed between the first and second seals. The seals are spaced
to accommodate devices with multiple flow holes therein.
Inventors: |
Kraus; Mark C.;
(Independence, MN) ; Mauch; Grant A.; (Delano,
MN) |
Assignee: |
Greatbatch Ltd.
Clarence
NY
|
Family ID: |
35212061 |
Appl. No.: |
13/587396 |
Filed: |
August 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13174863 |
Jul 1, 2011 |
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13587396 |
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11198871 |
Aug 5, 2005 |
7972307 |
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13174863 |
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60598999 |
Aug 5, 2004 |
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Current U.S.
Class: |
604/167.03 |
Current CPC
Class: |
A61M 2039/0633 20130101;
A61M 2039/062 20130101; A61B 17/3462 20130101; A61M 25/0662
20130101; A61B 17/3474 20130101; A61B 17/3498 20130101; A61M
39/0606 20130101 |
Class at
Publication: |
604/167.03 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Claims
1. A method comprising: a) disposing an instrument through an
introducer, the introducer having a sheath extending from a sheath
proximal end to a sheath distal end, the sheath having a passage
therethrough, the introducer having a valve assembly sealingly
associated with the passage; b) sealing a valve of the valve
assembly against the instrument, the valve including a first seal,
a second seal, and a chamber disposed between the first and second
seals; c) disposing the instrument includes disposing the
instrument through at least the first seal, the chamber, and the
second seal; and d) separating the valve assembly and the
introducer from around a cross-sectional perimeter of the
instrument.
2. The method as recited in claim 1 wherein sealing the valve
against the instrument includes sealing the first seal having one
or more first properties and sealing the second seal having one or
more second properties, where the first properties are different
than the second properties.
3. The method as recited in claim 2 wherein sealing the first seal
and the second seal includes sealing the first seal with a thinner
seal than the second seal.
4. The method as recited in claim 2 wherein sealing the first seal
and the second seal includes sealing the first seal with a greater
durometer material than the second seal.
5. The method as recited in claim 1 wherein disposing the
instrument through the first and second seals includes disposing
the instrument through a circular opening of the first seal and at
least one slit of the second seal.
6. The method as recited in claim 1 wherein disposing the
instrument includes disposing the instrument through at least the
first seal and the second seal, the first seal having a first
sealing thickness and the second seal having a second sealing
thickness, and the first sealing thickness is different from the
second sealing thickness.
7. A method comprising: a) disposing a medical instrument within an
introducer, the introducer including at least two valves having a
chamber therebetween, the medical instrument having at least two
intake/discharge openings; and b) positioning the at least two
intake/discharge openings within the chamber.
8. The method as recited in claim 7 further comprising removing the
at least two valves from the introducer.
9. The method as recited in claim 7 further comprising positioning
the at least two valves a distance D apart from each other, and the
at least two intake/discharge openings are positioned apart from
each other less than D.
10. The method as recited in claim 7 further comprising positioning
a first intake/discharge opening within a chamber and positioning a
second intake/discharge opening outside the chamber without causing
an air embolism.
Description
RELATED APPLICATION
[0001] This application claims priority under 35 U.S.C. 119(e) to
U.S. Provisional Patent Application No. 60/598,999, filed Aug. 5,
2004, which application is incorporated herein by reference and
made a part hereof.
TECHNICAL FIELD
[0002] Introducers and introducing assemblies, and more
specifically a valved introducer assembly and method.
BACKGROUND
[0003] Introducer devices provide for access to the venous system
and are employed for inserting medical devices such as catheters,
guidewires, leads, infusion ports, dialysis ports, dialysis
catheters, and others. A typical procedure for gaining access to
the central venous system or the arterial system with an introducer
is the Seldinger Introduction Method. The Seldinger Method provides
for insertion of a needle into the vasculature of a patient. Once
the needle is in the vessel, the physician aspirates the needle to
assure that the needle is in the vessel, and to draw out air
present in the bore of the needle. The syringe is removed and
discarded. A guide wire is inserted through the needle, and the
needle is removed over the guide wire. The introducer, which
includes a dilator and the sheath, is placed over the guidewire and
inserted into the vessel. With the introducer and wire guide in the
vessel, the dilator and wire guide are removed leaving only the
sheath in the vessel. The desired medical device is implanted
through the passage of the sheath. The sheath is optionally removed
from the medical device. The introducer device provides access to
the vein or artery, and therefore control of bleeding and the
intake of air is necessary, for example, through use of a
valve.
[0004] The introducer devices are designed to be used with both
large and small instruments, such as dilators and guidewires.
However, it can be difficult to effectively seal against
instruments over such a wide variety of diameters. Furthermore,
seals which are effective against larger diameter instruments are
often ineffective in allowing smaller, or relatively softer
devices, or devices having relatively lower column strength to pass
through the seal. In addition, devices which have fragile features
may be difficult to transfer through the seal without damage to the
features and/or device.
[0005] Accordingly, what is needed is an introducer assembly which
can effectively seal against a wide variety of instruments without
inhibiting the throughput of the instrument, or damaging the
instrument. What is also needed, is an introducer assembly which
does not distract or interfere with the implantation process.
SUMMARY
[0006] An introducer assembly is provided herein. The introducer
includes a sheath having a sheath proximal end and distal end, and
a passage therethrough. The introducer assembly further includes a
valve assembly that is sealingly associated with the passage of
this sheath. The valve assembly includes a valve having a first
seal and a second seal, where the first and second seal optionally
have different sealing properties. For example, the first seal and
the second seal have different thicknesses, different sealing
hardness qualities, or otherwise different sealing features. In
another option, the sheath is removable from the instrument
disposed therethrough. In yet another option, the valve of the
valve assembly further includes a chamber disposed between the
first and second seals, where the chamber includes a side exit that
can optionally be sealingly closed. The sealing thickness, chamber
thickness or diameter, or the dialator outer diameter can be
modified as further discussed below.
[0007] During use of the device, a method includes disposing an
instrument through an introducer, for example, the introducer
having the qualities discussed above. For example, the introducer
has a sheath extending from a sheath proximal end to a sheath
distal end, and the sheath has a passage therethrough. The
introducer further includes a valve assembly that is sealingly
associated with the passage. The method further includes sealing a
valve of the valve assembly against the instrument, where the valve
includes at least a first seal on a second seal and optionally a
chamber disposed between the first and second seals. The first seal
may have one or more first properties which are different than the
second seal which has one or more second properties. For example,
the first and second seals have different thicknesses, and/or
different hardnesses.
[0008] Advantageously, the introducer assembly described above
provides many benefits. For example, the introducer assembly allows
for a removable introducer assembly to seal against very soft
instruments such as soft tipped leads or soft and delicate
instruments. Another benefit is that the introducer allows for
passing instruments through a seal with delicate features and/or
tips through such sealing features, yet allowing for effective
sealing against such devices. Examples of such delicate features
include fasteners, electrodes, coatings, devices having low column
strength, fiber optics, and lead attachment features such as tines
or an active fixation device, such as a helix. Furthermore, the
various features described above further allow for
manufacturability of such a device and further allow for multiple
seals having multiple different sealing properties to be
incorporated with such a device.
[0009] These and other embodiments, aspects, advantages, and
features of the present invention will be set forth in part in the
description which follows, and in part will become apparent to
those skilled in the art by reference to the following description
of the invention and referenced drawings or by practice of the
invention. The aspects, advantages, and features of the invention
are realized and attained by means of the instrumentalities,
procedures, and combinations particularly pointed out in the
appended claims and their equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1A illustrates a perspective view of an introducing
assembly as constructed in accordance with at least one
embodiment;
[0011] FIG. 1B illustrates a perspective view of an introducing
assembly as constructed in accordance with at least one
embodiment;
[0012] FIG. 1C illustrates a perspective view of an introducing
assembly as constructed in accordance with at least one
embodiment;
[0013] FIG. 2A illustrates an exploded perspective view of a valve
assembly as constructed in accordance with at least one
embodiment;
[0014] FIG. 2B illustrates a perspective view of a valve assembly
as constructed in accordance with at least one embodiment;
[0015] FIG. 3 illustrates a side elevational view of a portion of
an introducing assembly as constructed in accordance with at least
one embodiment;
[0016] FIG. 4 illustrates side cross-sectional view of a portion of
an introducing assembly taken along 4-4;
[0017] FIG. 5 illustrates side cross-sectional view of a portion of
an introducing assembly as constructed in accordance with at least
one embodiment;
[0018] FIG. 6 illustrates a perspective view of a valve
cross-section as constructed in accordance with at least one
embodiment;
[0019] FIG. 7A illustrates a perspective view of a valve as
constructed in accordance with at least one embodiment;
[0020] FIG. 7B illustrates a cross-sectional view of a portion of a
valve assembly as constructed in accordance with at least one
embodiment;
[0021] FIG. 7C illustrates a cross-sectional view of a portion of a
valve assembly as constructed in accordance with at least one
embodiment;
[0022] FIG. 8 illustrates a perspective view of a valve assembly
cross-section as constructed in accordance with at least one
embodiment;
[0023] FIG. 9 illustrates an end view of a valve as constructed in
accordance with at least one embodiment;
[0024] FIG. 10 illustrates a top view of a valve as constructed in
accordance with at least one embodiment.
[0025] FIG. 11A illustrates a perspective view of a valve as
constructed in accordance with at least one embodiment;
[0026] FIG. 11B illustrates a top view of a valve as constructed in
accordance with at least one embodiment.
[0027] FIG. 11C illustrates a perspective view of an introducing
assembly as constructed in accordance with at least one
embodiment;
[0028] FIG. 11D illustrates a cross-sectional view of a portion of
an introducing assembly as constructed in accordance with at least
one embodiment;
[0029] FIG. 12 illustrates a cross-sectional view of a valve taken
along 12-12 of FIG. 11B;
[0030] FIG. 13 illustrates a cross-sectional view of a valve taken
along 13-13 of FIG. 11B;
[0031] FIG. 14 illustrates an exploded perspective view of an
introducing assembly as constructed in accordance with at least one
embodiment;
[0032] FIG. 15 illustrates an enlarged exploded perspective view of
FIG. 14;
[0033] FIG. 16 illustrates a side elevational view of an example
medical instrument for use with the introducing assembly;
[0034] FIG. 17 illustrates a side elevational view of a portion of
an introducing assembly with a medical instrument disposed
therethrough;
[0035] FIG. 18 illustrates a side elevational view of a portion of
an introducing assembly with a medical instrument disposed
therethrough;
[0036] FIG. 19 illustrates a side elevational view of a portion of
an introducing assembly with a medical instrument disposed
therethrough; and
[0037] FIGS. 20A-20E illustrate various examples of a valve and
slit configurations.
DESCRIPTION OF THE EMBODIMENTS
[0038] In the following detailed description, reference is made to
the accompanying drawings which form a part hereof, and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
the invention, and it is to be understood that other embodiments
may be utilized and that structural changes may be made without
departing from the scope of the present invention. Therefore, the
following detailed description is not to be taken in a limiting
sense, and the scope of the present invention is defined by the
appended claims and their equivalents.
[0039] An introducer assembly 100 is illustrated in FIGS. 1A, 1B,
and 1C. The introducer assembly includes an introducer 110 having a
sheath 112 with a passage 114 therethrough. The sheath extends from
a sheath proximal end 116 to a sheath distal end 118. Near the
sheath distal end 118 is a tapered portion, allowing for a more
tapered transition portion to taper to the dilator disposed
therethrough.
[0040] The introducer assembly further includes an instrument such
as a dilator 120 that is coupled with the introducer, for example,
with a rotatable coupler. The dilator 120 is removably disposed
within a passage of the sheath 112. The sheath 112 includes a
support diameter 113 which is sized to receive a dilator 120 having
a dilator diameter 117 therethrough. It should be noted that other
instruments such as leads and/or guidewires can be disposed through
the sheath and sheath passage 114, as will further be described
below. The dilator 120 extends from a dilator distal end 122 to a
dilator proximal end 124, where the dilator distal end 122 is
insertable into a patient, for example, over a needle or a
guidewire. The dilator distal end 122 optionally ends in a tapered
end, allowing for ease of transition within tissue of a patient.
The dilator proximal end 124 optionally includes features, such as
a luer hub or threads, that allows for other devices to be coupled
thereto.
[0041] Referring again to the sheath 112, the sheath 112 includes
various types of sheaths, for instance, the sheath 112 can comprise
a sheath which has a strengthening material, such as a
strengthening braid of material. Alternatively, the sheath 112
includes a sheath which is modified to assist in preventing bends
and/or kinks along the sheath. The sheath 112 is defined in part by
a longitudinal axis, and the sheath 112 is, in one option, coaxial
with the dilator 120.
[0042] In one embodiment, the introducer 110 and the sheath 112 are
removable from around instruments disposed therein, such as a lead
disposed with the sheath 112. For example, the sheath 112 is
removable from around the instrument without having to slide or
otherwise manipulate the introducer and/or the sheath over a
proximal end of the instrument. In one option, the introducer
and/or sheath are removed from an outer perimeter along a
cross-section of an instrument disposed therethrough.
[0043] The sheath 112, for example, can be removed from the
instrument disposed therethrough in a number of different manners.
For example, the sheath 112 can include structure integral
therewith or non-integral that allows for the sheath to be
separated from around the instrument without damaging the
instrument, and/or allows for the sheath to be removed from the
outer perimeter of the cross-section of the instrument. In some
non-limiting examples, the structure includes one or more tabs that
are connected with the sheath to tear the sheath off of the
instrument. In another example, the structure includes a tear
strip, molecularly orientated material within the sheath, one or
more openings in the sheath allowing the sheath to separate at one
or more locations that each can be used alone or in combination to
separate the sheath from around the instrument. In another option,
the sheath is at least partially dissolvable within a body,
allowing the sheath to be removed from the instrument. In another
option, a slitting or splitting device such as a slitter can be
used to removed the sheath, where the sheath is removed by
slitting. In yet another option, the sheath further includes one,
two or more tabs which can be used to separate the sheath away from
the instrument. Further options include a pre-weakened or scored
sheath, allowing for the sheath to be manually removed by tearing,
separating, or slitting, for example. In yet another example, the
sheath includes molecularly oriented material allowing for the
sheath to be removed from around the instrument.
[0044] The introducer assembly 100 further includes a valve
assembly 130 which is sealingly associated with the passage of the
sheath, allowing for substantial sealing of the passage preventing
fluids to exit from a patient when the sheath is disposed within
the patient. The valve assembly 130 assists in preventing fluids
from exiting, yet permits passage of instruments through the valve
assembly 130, and substantially seals against the instruments that
are disposed therethrough. The valve assembly 130, as further
described below, allows for sealing against instruments that have a
wide variety of diameters, and/or features, or soft tipped
devices.
[0045] The valve assembly 130 is coupled with a portion of the
introducer 110, for example, along one or more tabs of the
introducer. The valve assembly 130 is removable from around an
outer cross-sectional perimeter of an instrument disposed through
the introducer, similar to the manner suggested above for the
introducer and/or sheath. In one option, the valve assembly has a
U-shaped housing structure, where it has an open end on its housing
such that it can be removed a way from an instrument without having
to split apart the valve assembly. In another option, a valve
membrane of the valve assembly 130 includes tear away features,
allowing for the valve membrane to be removed from instruments
disposed therein. The valve of the valve assembly 130 further
allows for the valve assembly 130 to be removed from around an
instrument, as further described below.
[0046] The valve assembly 130, as shown in more detail in FIGS. 2A
and 2B includes a housing 140 which provides support to the valve
assembly 130. The housing 140, in one option, is secured along a
portion of the introducer 110 (FIG. 1B) that is offset from the
introducer passage, and the housing 140 is cantilevered over the
passage of the introducer.
[0047] In one option, the housing 140 includes a first housing
portion 142 and a second housing portion 144 where a valve 150 for
sealing the instruments 150 is disposed between the two portions
142 and 144. It should be noted that the housing 140 can
alternatively includes only the first housing portion 142 or only
the second housing portion 144, other housing combinations are
suitable as well.
[0048] The first portion 142 of the housing 140 and a second
portion 144 of the housing are disposed about the valve 150 forming
a sandwich, where the first portion 142 is coupled with the second
portion 144. Examples of ways in which the first portion 142 is
coupled with the second portion 144 include, but are not limited
to, ultrasonic welding, interference fit, snap-fit coupling,
mechanical fasteners, adhesive, or compression fit. The housing
140, in one option, forms a U-shaped structure such that it can be
removed from around instruments disposed therethrough without
having to separate the housing 140. In another option, the housing
140 includes a hub structure 146 allowing for other devices, such
as a dilator, to be coupled therewith. In one option, the structure
146 includes a luer hub with features such as those illustrated in
FIG. 2A, which allows for another threaded component to be
threadingly coupled therewith.
[0049] The valve assembly 130 is coupled with the introducer 110
(FIG. 1B), for example, along a tab of the introducer 110 (FIG.
1B). In one option, the housing 140 is wrapped around a portion of
the introducer 110 (FIG. 1B), and optionally is snap-fittedly
coupled with the introducer 110 (FIG. 1B). Alternatively, the valve
assembly 130 can be made integral with the introducer 110 (FIG.
1B). In yet another option, the valve assembly 130 forms an adaptor
that is attachable and removable by the user before, during, or
after an implant procedure. For example, the user can remove or
attach the valve assembly 130 with a fitting or other coupling.
[0050] FIGS. 3, 4 and 5 illustrate the valve assembly 130 in
greater detail. The valve 150 includes multiple valves therein, for
example, in one option, a first seal 152 and a second seal 154. The
first seal 152 is defined by a first seal thickness 156, and the
second seal 154 is defined in part by a second seal thickness 158.
The first seal thickness 156, in one option, is lesser than the
second seal thickness 158. In another option, the ratio of the
first seal thickness 156 to the second seal thickness 158 includes,
but is not limited to Table 1 (see below).
[0051] In one option, the first seal thickness 156 is approximately
0.020 inches (0.508 mm) or 0.040 inches (1.016 mm). The second
valve thickness 158, in one option, is approximately 0.035 inches
(0.889 mm). It should be noted that the first seal 152 and the
second seal 154 can be further modified to provide different
sealing properties to the instruments disposed therethrough. For
instance, the first seal 152 and the second seal 154 have different
sealing thicknesses, as listed in Table 1, and can be combined with
other variations, such as material hardness properties.
Examples of Sealing Variables
TABLE-US-00001 [0052] TABLE 1 Examples 1 2 3 4 5 6 7 8 1.sup.st
0.020 0.020 0.040 0.040 0.020 0.020 0.040 0.040 Sealing Surface
thickness (inches), 156 2.sup.nd 0.035 0.035 0.035 0.035 0.035
0.035 0.035 0.035 Sealing Surface thickness (inches), 158 Chamber
0.050 0.070 0.050 0.070 0.050 0.070 0.050 0.070 thickness (inches),
171 1.sup.st Seal 40 40 40 40 70 70 70 70 Hardness (Shore A) 152
2.sup.nd Seal 40 40 40 40 70 70 70 70 Hardness (Shore A) 158
[0053] In another option, the first and second seals 152, 154 have
different sealing properties as the material properties, such as
sealing hardness, where the sealing properties are different for
the first and second seals 152 and 154. For example, in one option,
the first seal has a durometer of approximately 20 or 30 Shore A
hardness, and the second seal has a hardness of approximately 40
Shore A hardness. In another example, the first sealing hardness is
about 40-70 Shore A. In another example, the second sealing
hardness is about 40-70 Shore A. In an example, the first sealing
hardness is different than the second sealing hardness. In another
example, the first sealing hardness is lesser than the second
sealing hardness. In yet another example, the first sealing
hardness is greater than the second sealing hardness. Other
examples and combinations of material hardnesses and/or
seal/chamber thicknesses are listed in Table 1 above. Suitable
materials for the first and/or second seals 152, 154 include, but
are not limited to, silicone, thermoplastic rubbers (TPR), or
thermoplastic urethane (TPU).
[0054] In yet another option, the first and/or second seals 152,
154 are provided with features that allow for the first and/or
second seals 152 and 154 to be sealed against non-circular
instruments, or non-circular instruments and/or circular
instruments. The first and/or second seals 152, 154, in another
option, have features that allow for sealing against multiple
instruments disposed through the first and second seals 152, 154
simultaneously. In one option, the first seal 152 includes a single
slit, or a plurality of slits 160, such as an asterisk pattern, as
illustrated in FIG. 7A. The first seal 152 can include other shapes
and sizes as well. For example, FIG. 7B illustrates an example
where the first seal 152 has a circular opening shape 153. In
another option, the second seal 154 has a single slit of material,
and/or a plurality of slits. In another option, the first and
second seals 152, 154 includes features such as the slits 160 that
extend to the outer edge 141 (FIG. 2A) of the valve 150. This
provides for a path for an instrument disposed therethrough to
travel as the valve assembly is removed from around the instrument.
Alternatively, in another option, at least one of the first or
second seals 152, 154 include slits 160 that do not extend to the
outer edge 141. For example, a web 161 of material is included near
the outer edge 141, providing additional structural and/or sealing
support for the valve assembly, as illustrated in FIG. 7C.
[0055] Referring to FIG. 5, the first seal 152, is formed for
example, by a slit on the first outer surface 162 of the valve and
the second seal 154 forms a slit structure on the second outer
surface 164 of the valve, the slit structure extends through the
valve from the first outer surface 162 to the second outer surface
164.
[0056] In another option, as illustrated in FIG. 7B, a hole 153 is
formed as the first seal 152, where the hole 153 optionally
includes tapered features 155. Referring again to FIG. 5 or 7A, the
slit structure, optionally, extends through the valve from the
first outer surface 162 to the second outer surface 164, and
extends from an intermediate portion to the outer edge 141 (FIG.
2A) of the valve 150. In another option, as illustrated in FIG. 7C,
the slit structure of the first seal 152 extends through the first
outer surface 162 to the second outer surface 164, but does not
extend through edge 141.
[0057] The valve 150, in another option, includes a chamber 170
therein. The chamber 170, which in one option is non-symmetrical,
is disposed between the first seal 152 and the second seal 154. In
another example, the chamber 170 has an elliptical shape. The
chamber 170 allows for the two sealing surfaces to be provided with
one valve assembly, and further serves to provide back bleed
prevention. The chamber further allows for the first and second
seals 152 and 154 to be formed of two different sealing
properties.
[0058] The chamber 170 is defined in part by a chamber thickness
171. The chamber thickness 171, in one option, is greater than the
first sealing thickness and/or the second sealing thickness 158.
Other variations for the chamber thickness 171, and the chamber
thickness relative to the first and/or second sealing thickness
156, 158, are listed above in Table 1.
[0059] The chamber 170, in one option, has a side exit 172 where in
an unassembled structure the side exit 172 has a slightly open
structure position. The side exit 172 allows for the chamber 170 to
be formed within valve assembly, while allowing for multiple
different types of seals to be formed in the first and second seals
152 and 154. For example, the valve 150 can be molded into the
shape illustrated in FIG. 5, where the insert for the chamber 170
can be removed during the molding process, and the slits can be
formed by secondary operations.
[0060] Referring to FIG. 6, the chamber 170 is defined in part by
an upper surface 180, side surfaces 182 and a bottom surface 184.
The side exit 172, in one option, as formed in one or more the side
surfaces 182 of the chamber 170. In another option, the chamber 170
further includes a tapered portion 186, which allows for further
manufacturability, for example, when removing an insert of the
mold.
[0061] The valve 150 optionally further includes structure 190 for
sealing the chamber 170, as illustrated in FIG. 8. In one option,
the structure includes a crush ring 192 that allows for an upper
portion of the valve 150 to be sealingly engaged with a lower
portion of the valve. In one option, the structure 190 includes a
crush ring 192 that engages with a lower ring 198 of the valve 150.
In another option, the crush ring 192 can be formed on upper and/or
lower surfaces of the side exit. The structure 190 such as the
crush ring allows for the chamber 170 to be effectively sealed
during use. Furthermore, the crush ring features aid in
manufacturability of the valve assembly.
[0062] In another option, the chamber 170 is sealed in other
manners. For example, the chamber 170 can be bonded, for example,
with adhesive, sealer, or filler. In another option, the valve 150
is formed of two separate pieces that are bonded together. In yet
another option, the valve 150 is formed of two separate pieces that
mate together, and are laminated together.
[0063] Referring to FIGS. 7 and 8, the valve 150 further includes a
channel 200 with ramped portions 202 that allow for the housing 140
to compress the upper and lower portions of the valve 150 together,
to seal the chamber within the valve. For example, a projection 204
of the housing 140 engages the ramped portion to compress the valve
150, and seal the chamber 170. When the first part 142 and the
second part 144 of the housing 140 are coupled together, portions
of the housing engage with the ramp 202 of the channel 200 of the
valve 150, to compress and seal the chamber 170, as further shown
in FIGS. 6, 7 and 8.
[0064] Further variations for the valve assembly include relative
sizes for the valve minor diameter 175 and the chamber diameter
177, as illustrated in FIGS. 9 and 10. For example, Table 2
illustrates examples of relative dimensions for a dilator to be
used with a sheath (see FIG. 1C), and the relative valve minor
diameter 175, support diameter 113, and chamber diameter 177.
Assembly Dimensions
TABLE-US-00002 [0065] TABLE 2 Ratio 1 9atio 2 Ratio 3 Valve Dilator
Dilator O Dilator O Support O Minor O Chamber O O % of % of % of
Dilator O 113 175 177 Valve Valve Valve (Fr/inches) (Fr/inches)
(inches) (inches) Minor O Chamber O Support O 7FR 0.092 7FR 0.173
0.179 0.174 51% 53% 53% 8FR 0.111 8FR 0.192 0.179 0.174 62% 64% 58%
9FR 0.118 9FR 0.199 0.179 0.174 66% 68% 59% 10FR 0.137 10FR 0.218
0.179 0.174 77% 79% 63% 11FR 0.145 11FR 0.226 0.179 0.174 81% 83%
64% 12FR 0.158 12FR 0.239 0.179 0.174 88% 91% 66%
[0066] FIGS. 11A, 11B, 11C, 11D, 12, and 13 illustrate another
embodiment for the introducer or valve. FIG. 11C illustrates an
introducer assembly 100 and a dilator disposed therethrough. The
introducer assembly 100 includes a handle assembly 200 that houses
a valve assembly 130 therein, and for example, forms a housing 140
for the valve assembly. The handle assembly 200 includes separable
tabs used to tear away the valve assembly 130, for example, when a
component such as a dilator is disposed within the sheath. Other
methods or structures can be used to separate or otherwise remove
the introducer from components disposed therethrough. A side port
assembly 212 is coupled with the handle assembly 200 and allows for
the valve assembly 130 to be flushed with fluid, such as saline.
The side port assembly 212 further allows for medicine to be
introduced therein. The handle assembly 200 further includes
structure that couples with the valve assembly, and further allows
for the valve assembly 130 to be removed. For example, the handle
assembly 200 includes one or more posts 210 that are received
within a portion of the valve assembly 130, as illustrated in FIG.
11D.
[0067] The valve assembly 130 is further shown in FIGS. 11A, 11B,
12, and 13. The valve assembly 130 includes a valve 150 having
multiple sealing structures. For example, the valve 150 includes
two or more sealing structures, such as a first seal 152 and a
second seal 154. The first and second seals form a chamber 170
therebetween. In an example, the first seal 152 includes a opening
153 such as a circular opening, where the opening has an opening
diameter. In an example, the opening diameters include, but are not
limited to about 0.070 inches, 0.090 inches, or 0.120 inches. The
circular opening allows for the valve assembly to seal against
components disposed therethrough. Other structures for the first
seal 152 are possible as discussed above, for example, including,
but not limited to one or more slits.
[0068] The chamber 170 in an option, has an elliptical shape and
has a width 157. The width dimensions include, but are not limited
to, 0.215 inches, 0.270 inches, or 0.310 inches. The chamber can
have other shapes and cross sections, including, but not limited to
circular, square, or rectangular shapes, or those discussed
above.
[0069] The second seal 154 provides a second sealing surface for
components disposed therethrough. In an example, the second seal
154 includes a slitted portion 163. In an example, the slitted
portion 163 extends partially through the valve 150. In another
example, the slitted portion 163 extends through the entire valve
150, as illustrated in FIG. 11A. In another example, a web 161 of
material is disposed between the slitted portion 163 and the first
seal 152. The web 161, in one embodiment, is sized to allow for the
valve 150 to be torn as the introducer is removed or torn apart.
The valve 150 includes additional structure allowing for the valve
150 to be separated or torn away from components therethrough. For
example, the valve 150 optionally further includes one or more post
openings 179 that receive posts 210 (FIG. 11D) therein. As the
handle assembly 200 (FIG. 11D) is separated, the posts 210 (FIG.
11D) assist in separating the valve 150. FIGS. 20A-20E illustrate
further examples of slit configurations for valve 150. The seals
have respective seal thicknesses, and the chamber has a chamber
thickness. Furthermore, medical instruments, such as dilators, have
an outer diameter. The ratios of the relative seal thicknesses, and
chamber thickness, and seal properties include, but are not limited
to, those shown in Tables 1 and 3 above and below. The first seal,
in an option, includes a hole having a hole diameter 191. The hole
diameter 191 can include the diameters, and relative diameters
shown in Table 3. Furthermore, in an example, a sum of the hole
diameter 191, the first sealing thickness, and the second sealing
thickness is less than two times an outer diameter of a medical
instrument disposed through the sheath. Further examples include a
hole having a stretch listed in Table 3. Other examples include a
hole having a stretch of about 30-60%, or a hole having a stretch
of about 20-50%. One example of calculating the hole stretch is
(Dilator O.D.--Valve Hole .theta.)/Valve Hole .theta.). In another
example, in a valve having a first seal, a second seal, and a
chamber therebetween, the sum of the first seal and the second seal
is less than an outer diameter of the dilator.
EXAMPLES
TABLE-US-00003 [0070] TABLE 3 Valve 1st 2nd Total Seal Dilator
Valve Chamber Chamber Seal Seal Thickness FR OD Hole O Width (B)
Height Thickness Thickness (1st + 2nd) % Hole Size (in) (in) (in)
(in) (in) (in) (in) Stretch 7 0.092 0.070 0.215 0.070 0.020 0.035
0.055 31% 8 0.111 0.070 0.215 0.070 0.020 0.035 0.055 59% 9 0.118
0.090 0.270 0.070 0.020 0.035 0.055 31% 10 0.137 0.090 0.270 0.070
0.020 0.035 0.055 52% 11 0.144 0.090 0.270 0.070 0.020 0.035 0.055
60% 12 0.158 0.120 0.310 0.070 0.020 0.035 0.055 32% 13 0.171 0.120
0.310 0.070 0.020 0.035 0.055 43% 14 0.189 0.120 0.310 0.070 0.020
0.035 0.055 58% 15 0.197 0.150 0.320 0.070 0.020 0.035 0.055 31% 16
0.208 0.150 0.320 0.070 0.020 0.035 0.055 39% 7 0.092 0.070 0.215
0.050 0.040 0.035 0.055 31% 8 0.111 0.070 0.215 0.050 0.040 0.035
0.055 59% 9 0.118 0.090 0.270 0.050 0.040 0.035 0.055 31% 10 0.137
0.090 0.270 0.050 0.040 0.035 0.055 52% 11 0.144 0.090 0.270 0.050
0.040 0.035 0.055 60% 12 0.158 0.120 0.310 0.050 0.040 0.035 0.055
32% 13 0.171 0.120 0.310 0.050 0.040 0.035 0.055 43% 14 0.189 0.120
0.310 0.050 0.040 0.035 0.055 58% 15 0.197 0.150 0.320 0.050 0.040
0.035 0.055 31% 16 0.208 0.150 0.320 0.050 0.040 0.035 0.055
39%
[0071] FIGS. 14 and 15 illustrates another embodiment of an
introducer assembly 300, including an introducer 310, such as a
splittable or removable introducer, and a medical instrument 350
disposed therethrough. Examples of the medical instrument 350
include, but are not limited to, catheters, central venous
catheters for a hemodialysis process, or dilators. The introducer
310 includes a passage therethrough that allows for the medical
instrument 350 to be received therein, and allows for the
introducer 310 to introduce the medical instrument 350 to be
introduced into a patient. The introducer 310 further seals against
the medical instrument 350.
[0072] The medical instrument 350, shown in greater detail in FIG.
16, extends from a proximal end portion 352 to a distal end portion
354. In an example, the medical instrument 350 includes a number of
openings 356, such as intake/discharge openings or flow holes that
allow for fluids and/or gases to pass therethrough. In an example,
the openings 356 are spaced apart a distance D' along a
longitudinal axis of the medical instrument. In another example,
the openings 356 are positioned near a distal end portion 354 of
the medical instrument 350. In an example, the two or more openings
356 are spaced about 3 centimeters apart.
[0073] In another example, the medical instrument 350 includes an
input 360 and an output 362 portion near the proximal end portion
352. For example, the output 362 allows for fluid such as blood to
be removed from a body, and the input 360 allows for fluid such as
blood to be returned or input into the body. The output 362 and the
input 360 communicate with separate tubing lumens, in an option. In
another option, each tubing lumen includes one or more openings
356. Further options include one or more clamp locations 366 which
can be used to prevent air or blood from passing through the tubing
unintentionally.
[0074] FIGS. 17, 18, and 19 illustrate greater details of the
introducer 310, and illustrate the relative positions of the valves
314 and openings 356 on the medical instrument 350 as the medical
instrument 350 is moved within the introducer 310. The introducer
310 is adapted to seal against the medical instrument 350, and also
seals the passage 312 of the introducer 310 when the medical
instrument 350 is not disposed within the introducer 310. The
introducer 310 includes two or more valves 314 therein.
[0075] The two or more valves 314 are spaced along a longitudinal
axis of the introducer 310, and are separated a distance D. The
distance D, in an example, is at least is great, or in another
example, is greater than distance D'. In an example, D is greater
than 0.010 inches. In another example, D is less than about 2.0
inches. The two or more valves 314 define in part a chamber 320
therebetween. The valve spacing and/or the chamber volume is such
that the openings 356 can be between the valves 314, and there is a
limited opportunity for air to be introduced into the body via the
introducer. For example, when the medical instrument 350 is
disposed relative to the valves 314 as shown in FIG. 17, only the
air between the valves 314 or in the chamber 320 can be potentially
introduced into the patient. However, the volume of air contained
between the two valves 314 or within the chamber 320 is
significantly less than a volume of air that would be considered
clinically significant as an air embolism.
[0076] The valves 314, in an example, are self-sealing membranes,
such as a slitted membrane. In another example, the valves 314 are
one or more members disposed adjacent to each other to form a
valve. In an example, one or more of the valves 314 include
multiple valves, such as the double valves discussed above. It
should be noted that one, two, or more of the valves 314 can
include any of the valves discussed above, or illustrated in the
figures. The valves, in an example, provide a hemostatic seal at
venous pressures of at least +/-12 mm Hg.
[0077] During use of the device, a method includes disposing an
instrument through an introducer, for example, the introducer
having the qualities and/or incorporating any of the seals or
valves discussed above. For example, the introducer has a sheath
extending from a sheath proximal end to a sheath distal end, and
the sheath has a passage therethrough. The introducer further
includes a valve assembly that is sealingly associated with the
passage. The method further includes sealing a valve of the valve
assembly against the instrument, where the valve includes at least
a first seal on a second seal and optionally a chamber disposed
between the first and second seals. The first seal may have one or
more first properties which are different than the second seal
which has one or more second properties. For example, the first and
second seals have different thicknesses, and/or different
hardnesses. The first and second seals may include one or more
slits, which for example, allows for non-symmetrical instruments to
be sealed therein. In another option, disposing an instrument
includes disposing an instrument with two or more flow holes spaced
apart a distance D'. The seals or valves are spaced apart from one
another a distance greater than D'.
[0078] The method further includes disposing the instrument through
the first and second seals, in the optional chamber. The method
further includes separating the valve assembly and the introducer
from around a cross-sectional perimeter of the instrument, for
example, without damaging the instrument that is disposed therein.
For example, suitable methods for splitting the valve assembly
include splitting the sheath, for example, along a weakened section
along the sheath from the tabs and removing the u-shaped valve from
around the instrument, or removing the sheath along scored sections
of the sheath.
[0079] Additional options for the method including providing a
chamber with a side exit, and sealing the side exit with a portion
of the valve. In one option, a crush ring is provided with the
valve assembly to close off a portion of the chamber and providing
a sealed chamber portion. In one option, the method includes
compressing a crush ring and compressing it with a ramped portion
of the valve from pressure of the housing.
[0080] Advantageously, the introducer assembly described above
provides many benefits. For example, the introducer assembly allows
for a removable introducer assembly to seal against very soft
instruments such as soft tipped leads or soft and delicate
instruments, or devices with relatively low column strength.
Another benefit is that the introducer allows for passing up
instruments through a seal with delicate features and/or tips
through such sealing features, yet allowing for effective sealing
against such devices. Examples of such delicate features include
fasteners, electrodes, or coatings. Furthermore, the various
features described above further allow for manufacturability of
such a device and further allow for multiple seals having multiple
different sealing properties to be incorporated with such a device.
The multiple seals further allow for a first seal to seal against
instruments disposed therethrough, and a second seal to seal a
passage of the introducer when no instruments, or very small
instruments are disposed therethrough. The introducer assembly
further allows for removal of the introducer without disruption to
the procedure or placement of the medical device such as a
lead.
[0081] It is to be understood that the above description is
intended to be illustrative, and not restrictive. Many other
embodiments will be apparent to those of skill in the art upon
reading and understanding the above description. It should be noted
that embodiments or portions thereof discussed in different
portions of the description or referred to in different drawings
can be combined to form additional embodiments of the present
invention. The scope of the invention should, therefore, be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled.
* * * * *