U.S. patent application number 14/618448 was filed with the patent office on 2015-06-04 for pressure actuated catheter seal and method for the same.
This patent application is currently assigned to BOSTON SCIENTIFIC LIMITED. The applicant listed for this patent is BOSTON SCIENTIFIC LIMITED. Invention is credited to MICHAEL J. BONNETTE, LASZLO T. FARAGO, LEIF E. LEIRFALLOM, ERIC J. THOR, ARTHUR E. UBER, III, STEPHEN E. WEISEL.
Application Number | 20150151101 14/618448 |
Document ID | / |
Family ID | 44477119 |
Filed Date | 2015-06-04 |
United States Patent
Application |
20150151101 |
Kind Code |
A1 |
BONNETTE; MICHAEL J. ; et
al. |
June 4, 2015 |
PRESSURE ACTUATED CATHETER SEAL AND METHOD FOR THE SAME
Abstract
A catheter includes a pressure actuated seal within a manifold.
A catheter body is coupled with the manifold, and a manifold lumen
and catheter lumen are configured to receive pressurized fluids.
The pressure actuated seal includes a pressure actuated seal
element having a seal element lumen. The seal element lumen is in
communication with the manifold and catheter lumens. The pressure
actuated seal element is deformable between an open configuration
and a sealed configuration. In the sealed configuration, the
pressurized fluid in the manifold presses on the pressure actuated
seal element along a first seal face. The pressure actuated seal
element compresses inwardly around the seal element lumen according
to the pressure of the pressurized fluid. In the open
configuration, the pressure actuated seal element relaxes in the
absence of the pressurized fluid, and the seal element lumen is
open and configured to allow passage of an instrument.
Inventors: |
BONNETTE; MICHAEL J.;
(MINNEAPOLIS, MN) ; THOR; ERIC J.; (ARDEN HILLS,
MN) ; WEISEL; STEPHEN E.; (BROOK PARK, MN) ;
UBER, III; ARTHUR E.; (PITTSBURGH, PA) ; LEIRFALLOM;
LEIF E.; (PLYMOUTH, MN) ; FARAGO; LASZLO T.;
(HUDSON, WI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BOSTON SCIENTIFIC LIMITED |
Hamilton HM11 |
|
BM |
|
|
Assignee: |
BOSTON SCIENTIFIC LIMITED
Hamilton HM11
BM
|
Family ID: |
44477119 |
Appl. No.: |
14/618448 |
Filed: |
February 10, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13032185 |
Feb 22, 2011 |
8951229 |
|
|
14618448 |
|
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|
61306645 |
Feb 22, 2010 |
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Current U.S.
Class: |
604/247 |
Current CPC
Class: |
A61M 39/0613 20130101;
A61M 2039/062 20130101 |
International
Class: |
A61M 39/06 20060101
A61M039/06 |
Claims
1. A pressure actuated seal assembly comprising: a manifold
including a seal cavity and a manifold lumen extending through the
manifold and the seal cavity; a pressure actuated seal element
positioned within the seal cavity, the seal element includes: a
first seal face in communication with the manifold lumen, a second
seal face opposed to the first seal face, and a seal element lumen
extending from the first seal face to the second seal face, wherein
the seal element lumen is in fluid communication with the manifold
lumen, wherein at least the first seal face tapers from an
intermediate seal portion toward a distal seal portion, and the
first seal face has a greater area than a cross-section of the seal
cavity; wherein the pressure actuated seal element is deformable
between an open configuration and a sealed configuration, wherein:
in the sealed configuration, pressurized fluid in at least the
manifold lumen presses on the pressure actuated seal element along
the first seal face, and the pressure actuated seal element
compresses inwardly around the seal element lumen, and in the open
configuration, the pressure actuated seal element relaxes in an
absence of the pressurized fluid, and the seal element lumen is
open and configured to allow passage of an instrument
therethrough.
2. The pressure actuated seal assembly of claim 1, wherein the
second seal face tapers from an intermediate seal portion toward a
proximal seal portion, and the seal cavity tapers from near the
intermediate seal portion toward the proximal seal portion, and the
tapered seal cavity is sized and shaped to receive the tapered
pressure actuated seal element.
3. The pressure actuated seal assembly of claim 2, wherein the
first and second seal faces are tapered at different angles
relative to the seal element lumen.
4. The pressure actuated seal assembly of claim 2, wherein the
second seal face has a greater area than the first seal face.
5. The pressure actuated seal assembly of claim 1, wherein the
pressure actuated seal element includes a first seal portion
including the first seal face, a second seal portion including the
second seal face and a third seal portion intermediate to the first
and second seal portions, and one or more of the first, second and
third seal portions has a hardness different from another of the
seal portions.
6. A catheter assembly comprising: a self-sealing manifold
including a seal cavity and a manifold lumen extending through the
manifold and the seal cavity; a tapered catheter body coupled with
the self-sealing manifold, the tapered catheter body includes a
taper over at least a portion of a catheter body length including a
catheter distal portion, the tapered catheter body includes a
catheter lumen in communication with the manifold lumen, wherein
the manifold lumen and the catheter lumen are configured to receive
pressurized fluids; and the self-sealing manifold includes a seal
assembly positioned within the seal cavity, the seal assembly
sealing the manifold lumen and the catheter lumen near the
self-sealing manifold in a presence of the pressurized fluids
within at least one of the manifold lumen and the catheter lumen,
wherein the seal assembly includes: a seal element within the seal
cavity, the seal element including first and second seal faces,
wherein at least the first seal face tapers from an intermediate
seal portion toward a distal seal portion, and the first seal face
has a greater area than a cross-section of the seal cavity, and the
second seal face is coupled to the first seal face.
7. The catheter assembly of claim 6, wherein the second seal face
tapers from an intermediate seal portion toward a proximal seal
portion, and the seal cavity tapers from near the intermediate seal
portion toward the proximal seal portion, and the tapered seal
cavity is sized and shaped to receive the tapered pressure actuated
seal element.
8. The seal assembly of claim 7, wherein the first and second seal
faces are tapered at different angles relative to the manifold
lumen.
9. The seal assembly of claim 7, wherein the second seal face has a
greater area than the first seal face.
10. The catheter assembly of claim 6, wherein the catheter distal
portion includes one or more fluid passages, and a fluid is
distributed from the one or more fluid passages when the
pressurized fluids are received within the manifold and catheter
lumens and the seal assembly seals the manifold lumen and the
catheter lumen near the self-sealing manifold.
11. The catheter assembly of claim 10, wherein the one or more
fluid passages include a plurality of fluid passages extending
through a catheter sidewall.
12. A catheter assembly comprising: a manifold, the manifold
includes a manifold lumen having a manifold lumen perimeter, the
manifold lumen extends through the manifold; wherein the manifold
includes an elongate seal cavity in communication with the manifold
lumen, the elongate seal cavity extends longitudinally from a seal
cavity proximal end to a seal cavity distal end, a seal cavity
perimeter circumscribes the elongate seal cavity, and the seal
cavity perimeter is larger than the manifold lumen perimeter; a
pressure actuated seal element within the elongate seal cavity, the
seal element includes: a first seal face, a second seal face
opposed to the first seal face, and a seal element lumen extending
from the first seal face to the second seal face, the seal element
lumen is in communication with the manifold lumen; wherein at least
the first seal face tapers from an intermediate seal portion toward
a distal seal portion, and the first seal face has a greater
surface area than a cross-section of the seal cavity.
13. The catheter assembly of claim 12, wherein the second seal face
tapers from an intermediate seal portion toward a proximal seal
portion, and the seal cavity tapers from near the intermediate seal
portion toward the proximal seal portion, and the tapered seal
cavity is sized and shaped to receive the tapered pressure actuated
seal element.
14. The catheter assembly of claim 13, wherein the first and second
seal faces are tapered at different angles relative to the seal
element lumen.
15. The catheter assembly of claim 13, wherein the second seal face
has a greater area than the first seal face.
16. The catheter assembly of claim 12, wherein the pressure
actuated seal element is configured to deform when an instrument is
positioned within the seal element lumen and the pressurized fluid
is within the manifold lumen, the seal element compresses inwardly
and seals around the instrument.
17. The catheter assembly of claim 12, wherein compressing the
first seal face toward the second seal face compresses the pressure
actuated seal element outwardly into sealing engagement with the
seal cavity perimeter.
18. The catheter assembly of claim 12, wherein the pressure
actuated seal element includes a first seal portion including the
first seal face, a second seal portion including the second seal
face and a third seal portion intermediate to the first and second
seal portions, and one or more of the first, second and third seal
portions has a hardness different from another of the seal
portions.
19. The catheter assembly of claim 18, wherein the first seal
portion includes a first portion hardness greater than a second
portion hardness of the second seal portion, and the first portion
hardness is greater than a third portion hardness of the first seal
portion.
20. The catheter assembly of claim 19, wherein the second portion
hardness is greater than the third portion hardness.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This present application is a continuation of U.S. patent
application Ser. No. 13/032,185, filed on Feb. 22, 2011, now U.S.
Pat. No. 8,951,229, which claims priority under 35 U.S.C.
.sctn.119(e) to U.S. Patent Application No. 61/306,645, filed Feb.
22, 2010, the entire contents of which are incorporated herein by
reference.
TECHNICAL FIELD
[0002] Catheter and catheter lumen seals.
BACKGROUND
[0003] Catheter assemblies include lumens for the delivery of
instruments and fluids to treatment areas within the body. It is
sometimes necessary to seal the lumen to prevent the escape of
fluids or provide a sealed environment isolated from exterior
contaminants. In some examples, catheters include manually operated
seal assemblies within catheter handles and manifolds. The manually
operated seal assemblies are operated with mechanisms that turn
nuts, close clamps, push pistons and the like to deform a seal
element and close a lumen. Each of these mechanisms require a free
hand or other device to seal the assembly. Further, the mechanisms
require additional manual operation to disengage the seal and allow
access to the lumen. Manually operated seals are particularly
difficult to use during a procedure where the user's hands are
dedicated to manipulating the catheter and other instruments. For
instance, where the user needs to direct full attention to
manipulation of a catheter including a manually operated seal the
user must disengage or adjust the position of at least one hand to
manipulate the seal and thereby may lose the previous orientation
of a catheter already navigated or partly navigated through
vasculature. Continued navigation or repositioning of the catheter
may be required with possible frustration to the purpose of the
procedure.
[0004] Additionally, the manual mechanisms fail to seal the lumen
according to the pressure developed within the catheter assembly.
Stated another way, the manually operated seal assemblies create a
seal according to the mechanism used, for instance, according to
the hand tightening of a nut without any assurance the seal will
withstand a pressurized environment, such as fluids under pressure.
These manual mechanisms may thereby be subject to complications
including fluid leaks from the pressurized environment of the
catheter or ingress of contaminants. Further, there is no clear
indication to a user--other than an ambiguous resistance to further
tightening--that a seal is formed. Without a clear indication of
the status of a seal, undesirable leaking of fluids (including body
fluids such as blood) and ingress of contaminants may occur without
the knowledge of the user.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a partially exploded view of one example of a
catheter assembly.
[0006] FIG. 2 is an exploded view of one example of a catheter
including a pressure actuated seal assembly having an
amplifier.
[0007] FIG. 3 is a cross-sectional view of the manifold of the
catheter shown in FIG. 2.
[0008] FIG. 4 is a detailed cross-sectional view of element A in
FIG. 3.
[0009] FIG. 5 is a cross-sectional view of another example of a
pressure actuated seal assembly including an amplifier.
[0010] FIG. 6 is a cross-sectional view of yet another example of a
pressure actuated seal assembly including an amplifier.
[0011] FIG. 7 is a cross-sectional view of one example of a
pressure actuated seal assembly including a diaphragm.
[0012] FIG. 8 is an exploded view of the pressure actuated seal
assembly shown in FIG. 7.
[0013] FIG. 9 is an exploded view of one example of a pressure
actuated seal assembly including a diaphragm and an amplifier.
[0014] FIG. 10 is a cross-sectional view of one example of a
pressure actuated seal assembly including a pliable seal
element.
[0015] FIG. 11 is a cross-sectional view of another example of a
pressure actuated seal assembly having a pliable seal element
including a tapered seal element face.
[0016] FIG. 12 is a cross-sectional view of yet another example of
a pressure actuated seal assembly having a pliable seal element and
including a tapered seal element faces on first and second sides of
the seal element.
[0017] FIG. 13 is a cross-sectional view of still another example
of a pressure actuated seal assembly having a pliable seal element
including a deformable lip.
[0018] FIG. 14 is a cross-sectional view of a further example of a
pressure actuated seal assembly having a pliable seal element with
a deformable lip and a tapered seal element face
[0019] FIG. 15 is a cross-sectional view of one example of a
pressure actuated seal assembly having a pliable seal element
coupled with a plunger.
[0020] FIG. 16 is a top view of one example of the slider shown in
FIG. 15.
[0021] FIG. 17 is a cross-sectional view of one example of a
pressure actuated seal assembly having a hinged seal element
coupled with a plunger
[0022] FIG. 18A is a side view of one example of a catheter distal
portion including a fluid jet manifold.
[0023] FIG. 18B is a cross-sectional view of another example of a
catheter distal portion including a distal fluid jet system.
[0024] FIG. 18C is a side perspective view of one example a
catheter including a tapering catheter shaft.
[0025] FIG. 19 is a block diagram showing one example of a method
for using a pressure actuated seal assembly.
[0026] FIG. 20 is a cross-sectional view of one example of a
pressure actuated seal assembly having a plurality of seal
portions.
DESCRIPTION OF THE EMBODIMENTS
[0027] 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 of the present
disclosure may be practiced. These embodiments are described in
sufficient detail to enable those skilled in the art to practice
aspects of this disclosure, 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 disclosure.
Therefore, the following detailed description is not to be taken in
a limiting sense, and the scope of the present disclosure is
defined by the appended claims and their equivalents.
[0028] FIG. 1 shows one example of a catheter 100, such as a
thrombectomy catheter. The catheter 100 includes a manifold 102,
the manifold 102 is sized and shaped for connection with a high
pressure fluid source. Optionally, the manifold 102 is configured
for coupling with an exhaust reservoir for collection of fluids and
thrombus removed from the body of a patient. A catheter body 104 is
connected with the manifold 102. As shown in FIG. 1, the catheter
body 104 extends between a catheter proximal portion 112 coupled
with the manifold 102 and a catheter distal portion 114. In one
example, a strain relief fitting 116 is coupled between the
catheter body 104 and the manifold 102 to provide support and
facilitate the connection of the catheter body with the manifold.
Referring again to the manifold 102, as shown in FIG. 1, the
manifold includes a high pressure passage 108 extending into the
manifold 102. An introducer 110 is shown at a manifold proximal
portion 122. The introducer 110 facilitates the introduction of
instruments including guide wires, catheters and the like into the
manifold 102 and from the manifold into the catheter body 104. One
example of a guidewire 126 is shown in FIG. 1. As described in
further detail below, the catheter 100 includes a series of lumens
extending through the manifold 102 and the catheter body 104. For
instance, the manifold 102 includes a manifold lumen extending from
the manifold proximal portion 122 to a manifold distal portion 124.
The manifold lumen is in communication with a catheter lumen
extending through the catheter body 104 from the catheter proximal
portion 112 to the catheter distal portion 114. These passages,
including at least one of the manifold lumen and the catheter
lumen, are sealed with pressure actuated seal assemblies as
described in further detail below. In one example, the pressure
actuated seal assemblies seal around instruments, such as the guide
wire 126, and substantially prevent the flow of fluids out of the
manifold 102 and the introducer 110. Additionally, the overall
catheter is described below in operation (shown in FIGS. 18A-C) to
inject fluids through the catheter near the catheter distal portion
114. A variety of pressure actuated seals are described herein to
facilitate this fluid injection function.
[0029] One example of a pressure actuated seal assembly is shown in
FIG. 2. A catheter 200 is shown in FIG. 2 including the pressure
actuated seal assembly 202. The pressure actuated seal assembly 202
includes a seal element 206 and an amplifier 208. As shown in
further detail in FIG. 3 the amplifier 208 is positioned within a
seal cavity 204 to assist in deforming the seal element 206 to
close the seal element lumen 302 (shown in FIG. 3) through inward
compression of the seal element 206 around the seal element lumen.
In one example, the amplifier 208 includes an O-ring 210 coupled
with the amplifier. The O-ring 210 slides along an interior surface
of the seal cavity 204 and substantially prevents the passage of
fluids around the amplifier 208. Pressurized fluids incident on the
amplifier 208 thereby press the amplifier 208 into engagement with
the seal element 206 without loss of pressure on the seal element
206 by flow of the fluid around the amplifier.
[0030] Referring again to FIG. 2, in one example, the pressure
actuated seal assembly 202 includes a biasing element 212 such as a
spring. The biasing element 212 is interposed between at least the
amplifier 208 and the manifold 102. The biasing element 212 is
sized and shaped to bias the amplifier 208 away from the seal
element 206 in a relaxed state where pressurized fluids are not
incident against the amplifier. The amplifier is thereby biased
away from the seal element 206 allowing the seal element 206 to
relax into its undeformed (e.g., open) orientation and allow smooth
passage of instruments through the seal element and the amplifier
208. Depending upon the internal diameter of the seal element 206
and the outer diameter of the instrument (e.g., the guidewire 126),
there is a seal formed and some friction between the instrument and
the seal element 206 when the element 206 is in the undeformed
orientation. As previously described in FIG. 1, the catheter 100
includes an introducer 110. The biasing element 212 is optional to
the seal elements described herein. For instance, a biasing element
is excluded where the seal element is inherently lubricious and
readily resumes the undeformed configuration without sticking to
manifold surfaces.
[0031] Referring now to FIG. 2, the catheter 200 includes an
introducer guide 222 sized and shaped for coupling within a portion
of the seal cavity 204. As shown in greater detail in FIG. 3, the
introducer guide 222 engages with the manifold 102 (e.g., through
snap fitting, threading and the like) and ensures the amplifier 208
and the seal element 206 are retained within the seal cavity 204 to
hold the pressure actuated seal assembly 202 within the manifold
102.
[0032] The amplifier 208 includes a first amplifier face 214 and a
second amplifier face 216. As shown in FIG. 2, the first and second
amplifier faces 214, 216 are opposed to each other with the first
amplifier face 214 directed toward the catheter body 104 and the
second amplifier face 216 directed toward the seal element 206. The
second amplifier face 216 is sized and shaped for engagement with
the first seal face 218 of the seal element 206. A second seal face
220 is on an opposing side of the seal element 206 and directed
toward the introducer guide 222. During operation pressurized
fluids within the catheter body 104 and the manifold 102 exert
pressure on the amplifier 208 and press the amplifier 208 into
engagement with the seal element 206. Engagement of the amplifier
208 with the seal element 206 deforms the seal element and
compresses it within the seal cavity 204. Compression of the seal
element 206 within a correspondingly shaped recess within the seal
cavity (e.g., the introducter guide 222) forces the seal element
206 to inwardly compress around the seal element lumen 302 shown in
FIG. 3 because the seal element 206 has nowhere to expand. The
pressurized fluids within the catheter body 104 that operate the
seal element 206 include, but are not limited to, contrast media,
saline, drugs, blood and other body fluids and the like.
[0033] Referring now to FIG. 3, the pressure actuated seal assembly
202 is shown in cross-section with the seal element 206 and
amplifier 208 assembled in the seal cavity 204. The amplifier 208
is movable within the seal cavity 204 in proximal and distal
directions according to the presence or absence of a pressurized
fluid within the catheter body 104 and manifold 102. As shown in
FIG. 3, a series of lumens extend through the catheter 200
including an amplifier lumen 300, the seal element lumen 302, the
manifold lumen 304 and a catheter lumen 306. The lumens 300-306 are
aligned and capable of fluid communication. Instruments including
guide wires and the like are fed into the catheter 200 through the
introducer guide 222 and received within the seal cavity 204 before
being fed through the catheter body 104. For instance, in operation
a guide wire is back loaded through the introducer guide 222
through the seal element lumen 302 (in the seal cavity), amplifier
lumen 300, manifold lumen 304, catheter lumen 306 and through the
catheter distal portion 114 shown in FIG. 1. In still another
example, an instrument such as guide wire is front loaded through
the catheter 200, for instance, through the catheter distal portion
114 into the catheter body 104, manifold 102 and through the
amplifier lumen 300 and seal element lumen 302 and then out of the
introducer guide 222.
[0034] In operation, at least the manifold 102 receives a
pressurized fluid within the manifold lumen 304 through the high
pressure passage 108. The pressurized fluid is distributed into the
manifold 102 toward the amplifier 208. The pressurized fluid
engages with the amplifier 208 and forces the amplifier proximally
toward the seal element 206. The biasing force provided by the
biasing member 212 is overcome by the force of the pressurized
fluid allowing the proximal movement of the amplifier 208. In one
example, because of the O-ring 210 pressurized fluid is
substantially prevented from moving around the amplifier 208 and
into the remainder of the seal cavity 204. As the amplifier 208 is
moved proximally toward the seal element 206 by the pressurized
fluid the seal element 206 is deformed by the amplifier 208.
Because the seal element 206 is held within a seal element cavity
310 (e.g., formed in the introducer guide 222 in one example)
having a shape corresponding to the seal element deformation of the
seal element 206 forces the seal element to constrict the seal
element lumen 302 and tightly seal the seal element 206.
Optionally, the fluid is pressurized gradually to slowly close the
seal element 206. As the seal element 206 gradually closes some of
the fluid including entrained air bubbles leaks through the seal
element 206 out of the catheter lumen 306 and manifold lumen 304.
Gradually applying pressure to the seal element 206 minimizes air
bubbles within the system and correspondingly reduces the risk of
emboli. Alternatively, the inner diameter of the seal element
(e.g., the surface defining the seal element lumen 302) is sized to
provide a residual seal around an instrument disposed therein when
the fluid is not pressurized within catheter lumen 306. Optionally,
the inner diameter of the seal element is sized to residually seal
the seal element lumen 302 without pressurized fluid, and more
tightly seal the lumen when pressurized fluid is present.
[0035] In another example, where one or more instruments are
present within the seal element lumen 302 the seal element 206
constricts around the one or more instruments thereby closing the
seal element lumen and preventing passage of the pressurized fluid
beyond the seal element. In yet another example, where an
instrument is not present within the seal element lumen 302, the
seal element 206 is deformed by the amplifier 208 and compresses
around the seal element lumen 302 to constrict and close the seal
element lumen and substantially prevent passage of the pressurized
fluids beyond the seal element. The seal element 206 is constructed
with a pliable material including, but not limited to rubber,
silicone, polyurethane, PEBAX (a registered trademark of the Ato
Chimie Corp., France), synthetic latex, polyvinyl chloride, TEFLON
(a registered trademark of E.I. DuPont de Nemours and Company,
Corp. Delaware) and the like. The pliable material of the seal
element is selected with a particular durometer to seal around one
or more of an instrument, multiple instruments or close the seal
element lumen without an instrument present. In another example,
the amplifier 208 is constructed of a more rigid material than the
seal 206 for instance, including, but not limited to, hard resins,
such as polycarbonate, metals and the like.
[0036] The first amplifier face 214 has a first surface area and
the second amplifier face 216 has a second surface area less than
the first surface area of the first amplifier phase 214 (See FIGS.
2 and 3). Force transmitted to the seal element by the amplifier
208 where the amplifier is pressed into the seal element by
pressurized fluid is an amplified force based on the ratio of the
first and second surface areas of the first and second amplifier
faces 214, 216. The amplifier 208 thereby provides enhanced
deformation and corresponding enhanced constriction of the seal
element 206 around the seal element lumen 302 to provide a tight
seal that reliably prevents the passage of the pressurized fluid
through the seal element 302 whether an instrument is present or
not. The seal element 206 is capable of sealing the seal element
lumen 302 against fluid pressures of around 10 to 1200 psi.
[0037] Once the pressurized fluid within the catheter 200 is
removed or depressurized the amplifier 208 relaxes within the seal
cavity 204 and moves distally toward the catheter body 104 allowing
the seal element 206 to assume a relaxed orientation and open the
constricted seal element lumen 302 for passage of instruments and
the like through the seal element lumen. To assist the distal
movement of the amplifier 208 away from the seal element 206 the
biasing element 212 coupled between the amplifier 208 and manifold
102 pushes the amplifier 208 away from the seal element 206.
Without the pressurized fluid engaged against the amplifier 208,
the biasing element 212 overcomes any residual seating of the
amplifier against the seal element 206 through friction,
interference fitting and the like. Stated another way, the biasing
element 212 urges the amplifier 208 away from the seal element 206
thereby allowing the seal element to relax. The relaxed seal
element 206 opens the seal element lumen 302 permitting the free
passage of instruments including guide wires and the like through
the lumens of the catheter 200.
[0038] The pressure actuated seal assembly 202 including the seal
element 206 automatically seals the seal element lumen 302 in the
presence of a pressurized fluid without requiring hand operation
from a catheter operator or separate actuation of different
mechanism to effect a seal. Stated, another way, the operator does
not operate the seal or observe an indicator separately from the
operation of the catheter (e.g., for a thrombectomy procedure).
Instead, the seal element lumen 302 is closed by the seal element
206 as the working environment within the catheter body and the
manifold is pressurized for the medical procedure. By consolidating
the sealing function with the operation of the catheter 100 during
the procedure, the operator does not need to confirm a seal is
present or remove a hand from the catheter 100 for operation of a
seal mechanism to confidently know the pressure actuated seal
assembly 202 is sealed and closing the seal element lumen 302.
Operator error including failure to operate a separately operable
seal and undesirable non-therapeutic movement of the catheter as
the operator adjusts a hand grip on the catheter or fully removes a
hand to operate a seal are substantially avoided.
[0039] Moreover, because the seal element 206 is actuated according
to the fluid pressure within the catheter 100 the seal becomes
correspondingly tighter with increasing fluid pressures. A seal is
thereby maintained within the seal element lumen 302 across a range
of pressures. For instance, the pressure actuated seal assemblies
described herein provide a complete seal from at least 10 to 1200
psi. Optionally a complete seal is maintained with pressures
greater than 1200 psi. Similarly, the pressure actuated seal
elements automatically unseal in the absence of a pressurized fluid
freeing the operator from manipulating a seal element into an open
configuration.
[0040] As described above, the pressure actuated seal assembly 202
including the seal element 206 is configured to automatically seal
the seal element lumen 302 when the working environment within the
catheter and manifold is pressurized. Similarly, each of the seal
elements and the corresponding pressure actuated seal assemblies
described herein automatically seal according to pressure increases
within the manifold lumen and catheter lumens.
[0041] Additionally, the seal element 206 is described above as
configured to seal around an instrument or instruments positioned
within the seal element lumen 302. Further, the seal element 206 is
described as configured to constrict around an empty seal element
lumen 302 and thereby seal the seal element 206. Each of the seal
elements and corresponding pressure actuated seal assemblies
described herein are similarly capable of at least one or both of
sealing around one or more instruments and sealing an empty seal
element lumen.
[0042] Referring again to FIG. 3, the pressure actuated seal
assembly 202 is assembled within a seal cavity 204 and held therein
by the introducer guide 222. Referring now to FIG. 4, one example
of the engagement features retaining the introducer guide 222
within the seal cavity of the manifold 102 is shown. The manifold
102 includes a manifold locking ridge 400 and the introducer guide
222 includes an introducer locking ridge 402. The manifold locking
ridge 400 and introducer locking ridge 402 engage with each other
to substantially prevent the proximal movement of the introducer
guide 222 and decoupling of the guide from the manifold 102. A
tapered barrel 404 is provided with the introducer guide 222 to
facilitate sliding of the introducer guide 222 into the seal cavity
204 to assist in the temporary deformation of the manifold 102 to
allow the distal passage of the introducer locking ridge 402 into
the seal cavity 204 for engagement with the manifold locking ridge
400. Once assembled with the manifold locking ridge 400 engaged
with the introducer locking ridge 402 the amplifier 208 and seal
element 206 are positioned and held in the seal cavity 204 in the
orientation shown in FIG. 3.
[0043] FIG. 5 shows another example of pressure actuated seal
assembly 500. The manifold 102 includes a seal cavity 501
containing the seal element 502 and an amplifier 510. The seal
element 502 is coupled with the amplifier 510, for instance, the
seal element 502 is over-molded onto the amplifier 510. Molding the
seal element 502 on an interior surface of the amplifier 510 allows
the seal element lumen 512 and amplifier lumen 514 to automatically
align. Assembly of the seal element 502 and amplifier 510 thereby
provides a single feature with aligned lumens that automatically
guide instruments such as a guide wires through both the seal
element and the amplifier.
[0044] Referring again to FIG. 5, the seal element 502 includes a
seal element ring 504 positioned near a manifold proximal portion
122. A seal element flange 508 of the seal element 502 includes,
for instance, a diaphragm extending across the seal cavity 501 near
the manifold distal portion 124. A seal element barrel 506 extends
between the seal element ring 504 and the seal element flange 508.
As shown in FIG. 5, the seal element barrel 506 extends along and
is coupled with an interior surface of the amplifier 510. Unitary
assembly of the seal element 502 and amplifier 510 automatically
aligns the seal element lumen 512 and amplifier lumen 514, as
previously discussed above.
[0045] In operation, where the manifold lumen 304 receives a
pressurized fluid, the fluid presses against the seal element
flange and the amplifier 510 positioned adjacent to the seal
element flange. The amplifier 510 is constructed of a rigid
material, such as a plastic resin, and is pushed toward the seal
element ring 504. Pressing of the amplifier 510 against the seal
element ring 504 deflects the seal element ring. As the seal
element ring 504 is deflected the pliable material of the seal
element 502 is compressed toward the manifold proximal portion 122.
Compression of the seal element at the seal element ring 504 forces
the pliable material in the seal element ring to compress inwardly
around the seal element lumen 512. Where an instrument is present
within the seal element lumen 512 the seal element ring 504 engages
around the instrument and provides a tight seal against the
instrument. Where an instrument is absent from the seal element
lumen 512 the seal element ring 504 presses inwardly around the
seal element lumen 512 and closes the seal element lumen to provide
a tight seal that substantially prevents the pressurized fluid in
the manifold lumen 304 from moving proximally beyond the manifold
proximal portion 122. Stated another way, as the pressure of the
working environment within the manifold lumen 304 (and the catheter
lumen 306) is increased for a medical procedure, the seal element
502 automatically constricts around the seal element lumen 512 to
seal the lumen. Where one or more instruments are present within
the seal element lumen 512, the seal element 502 automatically
seals around the instruments.
[0046] FIG. 6 shows another example of a pressure actuated seal
assembly 600 including a seal element 602 and an amplifier 604 as a
unitary assembly with the amplifier 604 engaged with the seal
element 602. In the example shown in FIG. 6, the amplifier 604 is
an amplifier ring formed along a surface of the seal element 602
near the manifold proximal portion 124. For instance, the amplifier
604 is over-molded with the pliable material of the seal element
602. In a similar manner to the pressure actuated seal assembly 500
shown in FIG. 5, the seal element lumen 610 and amplifier lumen 612
are automatically aligned with pressure actuated seal assembly 600
because the amplifier 604 is at least partially positioned within
the seal element 602. The amplifier lumen 612 is aligned with the
seal element lumen 610 without needing guide features formed within
the manifold 102 to otherwise align the seal element 602 with the
amplifier 604. The seal element 602 extends away from the amplifier
604 toward the manifold proximal portion 122. The seal element 602
shown in FIG. 6 includes a tapered seal surface 606 sized and
shaped to correspondingly engage with a tapered seal cavity surface
608 of the seal cavity 601.
[0047] In operation, where a pressurized fluid is provided within
the catheter, such as the catheter 200 including the manifold lumen
304 and catheter lumen 306, the pressurized fluid engages against
the amplifier 604. The rigid amplifier 604 is driven into the seal
element 602 and pushes the seal element 602 into tight engagement
with the tapered seal cavity surface 608. The tapered seal surface
606 is received along the tapered seal cavity surface 608.
Compression of the seal element 602 by the amplifier 604
correspondingly compresses the seal element 602. The tapered seal
cavity surface 608 biases the compressed seal element 602 along the
tapered seal surface 606 to compress inwardly around the seal
element lumen 610. Inward compression of the seal element 602
closes the seal element lumen 610 with the pliable material of the
seal element 602. In a similar manner to the amplifier 208 shown in
FIGS. 2 and 3 the seal element 602 has a greater distal
cross-sectional area near the manifold distal portion 124 compared
to the cross-sectional area of the seal element 602 near the
manifold proximal portion 122. As the cross-sectional area of the
seal element 602 decreases from the manifold distal portion 124 to
the manifold proximal portion 122 the force transmitted through the
seal element 602 by way of the amplifier 604 is correspondingly
multiplied. The multiplied force urges the pliable material of the
seal element 602 into the seal element lumen 610 according to the
shape of the tapered seal cavity surface 608 and tapered seal
surface 606.
[0048] In another example shown in FIG. 6, the seal element 602
includes a fluid reservoir 616. The fluid reservoir 616 is filled
with a fluid such as saline, silicone and the like. The fluid
reservoir 616 and fluid held within the cavity enhances the
pliability of the seal element 602 and increases the
compressibility of the seal element 602. With a pressurized fluid
within the manifold lumen 614 the seal element 602 is more easily
compressed to close the seal element lumen 610. While the fluid
reservoir 616 is shown in FIG. 6 a seal element fluid reservoir is
also an option with the other exemplary seal elements described
herein where increased pliability of the seal element 602 is
advantageous to increase the compressibility of the seal element
602 and thereby more easily form a tight seal within the seal
element lumen. The seal element 602 (as well as other seal elements
described herein) is optionally constructed with other materials or
configurations. For example, the seal element 602 is constructed
with, but not limited to, a sponge, closed cell foam, open cell
foam with a sealed skin and the like.
[0049] FIGS. 7 and 8 show another example of pressure actuated seal
assembly 700. As described in other examples, the pressure actuated
seal assembly 700 is retained within the manifold 102. As shown in
FIGS. 7 and 8, the pressure actuated seal assembly 700 is retained
within a seal cavity 702 and a diaphragm 708 and a seal element
704. Referring to FIG. 7, an amplifier 706 is interposed in between
the diaphragm 708 and the seal element 704, in one example. A
series of lumens are in communication within the catheter (e.g.,
the catheter 200) including the pressure actuated seal assembly
700. For instance, as shown in FIG. 7, the manifold 102 includes a
manifold lumen 710. The diaphragm includes a diaphragm lumen 738.
The amplifier includes an amplifier lumen 712. The seal element
includes a seal element lumen 714. Each of these lumens are in
communication with each other and provide a continuous path for the
introduction of instruments through the manifold 102 and into the
catheter body (e.g., the catheter body 104 shown in FIG. 1).
[0050] Referring again to FIGS. 7 and 8, an introducer guide 716 is
coupled with the manifold 102 to retain the pressure actuated seal
assembly 700 within the manifold. For instance, the introducer
guide 716 acts as retainer and is fixedly coupled with the manifold
102. The introducer guide 716 is coupled with the manifold 102 with
one or more features including but not limited to a mechanical
fitting, an interference fit, adhesives, welding, and the like. As
shown in FIG. 7, the introducer guide 716 includes an outer guide
barrel 718 coupled with the adjacent manifold 102 and an inner
guide barrel 720 extending around the seal element 704 and a
portion of the amplifier 706. The amplifier 706 includes an
amplifier base 722 interposed between the inner guide barrel 720
and the diaphragm 708. The amplifier 706 further includes in the
example shown an amplifier ring 724 extending around the inner
guide barrel 720. The amplifier ring 724 is retained within an
amplifier ring recess 728 formed between the outer guide barrel 718
and inner guide barrel 720 of the introducer guide 716. An
amplifier piston 726 extending from the amplifier base 722 includes
at least a portion of the amplifier lumen 712 extending therein.
The amplifier piston 726 is shown in FIGS. 7 and 8 and is sized and
shaped for reception within the inner guide barrel 720.
[0051] Referring to the assembled view shown in FIG. 7, the
amplifier 706 is sized and shaped for movable coupling within the
introducer guide 716. For instance, the amplifier ring 724 is sized
and shaped for movable or slidable coupling within the amplifier
ring recess 728 between the outer guide barrel 718 and the inner
guide barrel 720 of the introducer guide 716. The amplifier piston
726 is sized and shaped for slidable coupling within the inner
guide barrel 720. In one other example, the inner guide barrel 720
snuggly extends around the amplifier piston 726 allowing the
amplifier piston 726 to move proximally and distally according to
pressure incident on the diaphragm 708 while still providing
lateral support to the amplifier 706 to substantially prevent
misalignment of the amplifier piston relative to the seal element
704. Stated another way, the introducer guide 716 including the
outer guide barrel 718 and the inner guide barrel 720 maintains the
amplifier 706 and the amplifier lumen 712 in proper alignment with
the diaphragm lumen 738 and the seal element lumen 714.
Misalignment of the lumens extending through the manifold 102 is
thereby substantially avoided through the guiding function provided
by the interfitting between the introducer guide 716 and the
amplifier 706.
[0052] In operation, where a pressurized fluid is present within
the manifold lumen 710 the seal element 704 automatically closes
the seal element lumen 714. The pressurized fluid engages against
the diaphragm 708 including a first diaphragm surface 734. The
second diaphragm surface 736, opposed to the first diaphragm
surface 734, correspondingly engages against the amplifier 706. For
instance, the second diaphragm surface 736 engages with the
amplifier base 722 and pushes the amplifier 706 proximally toward
the seal element 704 retained within the amplifier piston recess
730 along with the amplifier piston 726. Proximal movement of the
amplifier piston 726 into engagement with the seal element 704
compresses the seal element 704 linearly within the amplifier ring
recess 728. As shown in FIG. 7, the seal element 704 is snuggly
received within the amplifier piston recess 730 and linear
compression of the seal element 704 correspondingly compresses the
pliable seal element 704 inwardly around the seal element lumen
714. The amplifier piston recess 730 substantially prevents the
seal element 704 from expanding away from the seal element lumen
714. Compression of the seal element 704 closes the seal element
lumen 714 to substantially seal the manifold lumen 710, diaphragm
lumen 738 and amplifier lumen 706 from outside access through the
introducer guide 716. In another example, where one or more
instruments is present within the seal element lumen 714, pressing
of the amplifier piston 726 on the seal element 704 compresses the
seal element 704 on the one or more instruments thereby creating a
tight seal around the one or more instruments and sealing lumens
710, 738, and 712 by way of the seal element 704.
[0053] In one example, the inner guide barrel 720 includes an inner
barrel stop 732 sized and shaped to engage with the amplifier base
722 after the amplifier 706 is moved proximally within the seal
cavity 702. The inner barrel stop 732 engages with the amplifier
706 to arrest additional proximal movement of the amplifier and
prevent damage to the seal element 704 by over-compression of the
seal element 704. Stated another way, the inner barrel stop 732
substantially prevents movement of the amplifier 706 past a
specified position within the seal cavity 702 thereby preserving
the structural integrity of the seal element 704 over the
operational lifetime of the pressure actuated seal assembly
700.
[0054] When the pressurized fluid is no longer present within the
manifold lumen 710 or is no longer pressurized the seal element 704
is free to relax and resume an undeformed state with the seal
element lumen 714 open to freely pass fluids, instruments, guide
wires and the like therethrough and provide access to the amplifier
lumen 712, diaphragm lumen 738, manifold lumen 710, and the
catheter lumen (e.g., catheter lumen 306 shown in FIG. 3).
Optionally, the amplifier 706 is coupled along the second diaphragm
surface 736, for instance by adhesives, welds, and the like.
Removal of the pressure within the manifold lumen 710 allows the
pliable diaphragm 708 to resume a relaxed position shown in FIG. 7.
Where the amplifier 706 is coupled with the diaphragm 708,
relaxation of the diaphragm returns it to its relaxed position and
correspondingly pulls the amplifier 706 out of compressing
engagement with the seal element 704 thereby allowing the seal
element 704 to resume a relaxed state with the seal element lumen
714 open to allow the passage of fluids, instruments and the
like.
[0055] In the pressure actuated seal assembly 700 described above
the seal element 704 and diaphragm 708 are constructed with, but
not limited to, pliable materials capable of deflecting and
compressing according to a pressurized fluid within at least the
manifold lumen 710. The diaphragm 708 and seal element 704 include,
for instance, pliable polymers including silicon, butyl rubber and
the like. The amplifier 706, in at least one example, is
constructed with a more rigid material, including but not limited
to, resins such as polycarbonate, DELRIN plastic (a trademarked
product of DuPont), polyvinyl chloride and the like.
[0056] In one example, the diaphragm 708 is retained within the
seal cavity 702 between the introducer guide 716 and the inner
surface of the seal cavity 702 within the manifold 102. For
instance, as shown in FIG. 7 the introducer guide 716 including the
outer guide barrel 718 is engaged with a portion of the diaphragm
708 thereby squeezing the diaphragm 708 between the introducer
guide 716 and the manifold 102. The diaphragm 708 is therefore held
in a position within the seal cavity 702 by the tight engagement
between the introducer guide 716 and the manifold 102. In another
example, the diaphragm 708 is coupled to the manifold 102 with a
feature, including but not limited to, a mechanical interfitting,
adhesives, welds, and the like. Retention of the diaphragm 708 in
the orientation shown in FIG. 7 substantially prevents the movement
of pressurized fluids around the diaphragm 708 and facilitates the
transmission of forced from the diaphragm 708 to the seal element
704 to achieve closure of the seal element lumen 714.
[0057] Referring now to FIG. 9, another example of a pressure
actuated seal assembly 900 is shown. The pressure actuated seal
assembly 900 is similar in at least some regards to the pressure
actuated seal assembly 700 shown in FIGS. 7 and 8. For example, the
pressure actuated seal assembly 900 includes the seal element 704
positioned adjacent to the amplifier 706, and the amplifier 706 is
positioned adjacent to the diaphragm 708 within the seal cavity
702. The pressure actuated seal assembly 900 includes as an option
a rolling diaphragm 902 extending from the diaphragm 708 to an
interior surface of the manifold 102 forming the seal cavity 702.
As with the diaphragm 708 described above and shown in FIGS. 7 and
8, the diaphragm 708 including the rolling diaphragm 902
substantially prevents the movement of pressurized fluids around
the diaphragm 708 and ensures engagement of the pressurized fluids
along the surfaces of the diaphragm 708 correspondingly moves the
diaphragm into engagement with the amplifier 706 to compress the
seal elements 704. The amplifier 706 shown in FIG. 9 includes an
optional tapered guide surface 904. The tapered guide surface 904
is shown in phantom lines in FIG. 9 and tapers from the manifold
proximal portion 122 towards the manifold distal portion 124. The
amplifier tapered guide surface 904 provides a tapered surface
sized and shaped to guide an instrument, such as a guide wire, from
the seal element lumen 714 to the amplifier 706. The tapered guide
surface, such as the tapered guide surface 904, shown in FIG. 9 is
equally applicable to any of the pressure actuated seal assemblies
discussed herein to facilitate the movement of an instrument
through the pressure actuated seal assemblies during loading of the
instrument into the manifold 102.
[0058] FIG. 10 shows another example of a pressure actuated seal
assembly 1000. The pressure actuated seal assembly includes a seal
element 1004 contained within an elongate seal cavity 1002 of the
manifold 102. As shown in FIG. 10, the seal element 1004 fills a
large portion of the seal cavity 1002. The elongate seal cavity
1002 includes a seal cavity perimeter 1022 extending between a seal
cavity proximal end 1024 and a seal cavity distal end 1020. The
elongate seal cavity 1002 is larger than the manifold lumen 1012 of
the manifold 102. As described in further detail below, the
elongate seal cavity 1002 provides a large volume for reception of
the seal element 1004 having a corresponding large volume elongated
shape. The seal element is able to readily deflect axially toward
the seal cavity distal end 1020 (and compress all of the seal
material therebetween) when under pressure and thereby inwardly
compress and close a seal element lumen 1014.
[0059] As previously described with respect to other seal elements,
the seal element 1004 is constructed with a pliable material
configured to axially compress under pressure and correspondingly
inwardly compress around the seal element lumen 1014. As shown in
FIG. 10, the seal element 1002 has a cylindrical shape extending
around the seal element lumen 1014. The seal element 1004 includes
a first seal face 1006 directed distally toward the manifold distal
portion 124 and a second seal face 1008 directed toward a manifold
proximal portion 122. In one example, the seal element 1004 is
retained within the seal cavity 1002 with an introducer guide 1010
acting as a retainer. The introducer guide 1010 is coupled with the
manifold 102 (e.g., through snap fitting, threading and the like)
and encloses the seal cavity 1002 thereby retaining the seal
element 1004 therein. The manifold inner surface 1018 defines the
seal cavity 1002 with the seal cavity perimeter 1022 and ensures
the seal element lumen 1014 of the seal element 1004 is aligned
with an introducer lumen 1016 of the introducer guide 1010 and the
manifold lumen 1012 within the manifold 102. That is to say a seal
element perimeter 1028 is substantially identical to the seal
cavity perimeter 1022 and thereby aligns the seal element lumen
1014 with the manifold lumen 1012. As will be described below, a
minimal gap 1030 is formed between the seal cavity perimeter 1022
and the seal element perimeter 1028 to facilitate axial deflection
of the seal element 1004.
[0060] In operation, where a pressurized fluid is present within
the manifold lumen 1012, the seal element 1004 is engaged by the
fluid across the first seal face 1006 and compresses to
automatically seal the seal element lumen 1014. As shown in FIG.
10, the first seal face 1006 is, in one option, spaced a small
distance from the distal end 1020 of the seal cavity 1002 to
facilitate engagement of the fluid along the first seal face 1006.
Stated another way, as shown in FIG. 10 a slit 1032 is formed
between the first seal face 1006 positioned immediately adjacent to
the distal seal cavity end 1020 to ensure pressurized fluid is
directed across the first seal face 1006.
[0061] The pressurized fluid engages with the seal element 1004
along the first seal face 1006 and presses the seal element
proximally toward the manifold proximal portion 122. Because of the
proximal compression of the seal element 1004 the seal element
deforms and compresses inwardly around the seal element lumen 1014
thereby closing the seal element lumen. In another example, where
an instrument (or instruments), such as a guide wire, is positioned
within the seal element lumen 1014 application of a pressurized
fluid along the first seal face 1006 presses on the seal element
1004 and compresses the seal element 1004 around the seal element
lumen 1014 to seal the seal element 1004 around the instrument
therein. The large pliable seal element 1004 under the influence of
a pressurized fluid is thereby able to close the seal element lumen
1014 with or without an instrument in the lumen. Optionally, the
seal element 1004 closes around instruments and closes the lumen
1014 under high pressures or flow rates (e.g., 100 psi or greater).
At lower pressures (e.g., 6 psi), the seal element lumen 1014
remains open to allow for purging of air from the manifold 102 and
a catheter coupled with the manifold 102.
[0062] Referring again to the first seal face 1006 (shown in FIG.
10), the first seal face 1006 acts as an amplifier to facilitate
the deflection and generate a tight seal in the seal element 1004.
That is to say, the large surface area of the first seal face 1006
(relative to the area of the seal element lumen 1014 or the
manifold lumen 1012) exposed by the slit 1032 provides an amplifier
surface that transmits compressive force generated along its entire
surface through engagement with pressurized fluid in the manifold
lumen 1012. Stated another way, by exposing a large surface area of
the seal element 1004 (e.g., the first seal face 1006) to the
pressurized fluid all of the pliable material beneath the face 1006
is compressed. In contrast, where a smaller seal face is exposed
(relative to the face 1006 exposed with the slit 1032) only the
material beneath the face is compressed. In other words, by
increasing the size of the seal element 1004 and correspondingly
increasing the size of the first seal face 1006 a large quantity of
pliable seal material is squeezed outward and inward to readily
close the seal element lumen 1014 and any gaps 1030 between the
seal element perimeter 1028 and the surfaces defining the seal
element cavity 1002 (e.g, the seal cavity perimeter 1028).
[0063] The pressure actuated seal assembly 1000 closes the seal
element lumen 1014 without an amplifier, such as a separate
amplifier 208 shown in FIG. 2. The pliable material of the seal
element 1004 including, but not limited to, silicone, butyl rubber
and the like deflects under the pressure from the fluid. The
pliable material of the seal element 1004 along with the relatively
large size of the seal element at the first seal face 1006 compared
to the material of the seal element surrounding the seal element
lumen 1014 enhances the deflection of the seal element 1004. The
enhanced deformation of the seal element under the influence of the
pressurized fluid permits removal of the amplifier.
[0064] Furthermore, in examples where the seal element is
positioned around an instrument (e.g., a guide wire and the like)
the gap between the seal element 1004 and the instrument in the
seal element lumen 1014 is small. A fluid flow into the catheter
will have a difficult time leaking through this gap and the
pressure builds across the seal element 1004. Correspondingly,
tighter gaps between the seal element and the instrument seal
quickly and easily. Further the durometer of the seal 1004 is
important. A readily deformable low durometer seal rapidly deforms
under pressure and correspondingly quickly and tightly seals the
seal element lumen 1014. Moreover, the surface area and volume of
the seal affect the quality of the seal and the speed a seal is
formed. Seals with relatively large surface areas and volumes
relative to the seal element lumen 1014 deform quickly and easily.
Similarly, a thick seal element 1004 with a long seal element lumen
1014 has a correspondingly long and difficult to pass gap between
the instrument and the seal element. A longer gap path allows more
pressure to build at the seal element 1004 and thereby deforms the
seal element to close the seal element lumen 1014. Further still,
greater flow rates (e.g., under pressure) build pressure more
quickly and readily deform the seal element 1004 to create a
tighter seal relative to seals created with lower flow rates.
Infusate fluids with high viscosity also build pressure at the seal
element 1004 because of the difficulty in moving viscous fluids
through the seal element 1004 prior to deformation. Based on these
specifications, the seal 1004 (or the seal examples described
herein) are tailored via mechanical properties, dimensions, and
tolerances to achieve a successful seal during periods of
infusion.
[0065] Referring now to FIG. 11, another example of a pressure
actuated seal assembly 1100 is shown including a seal element 1106
having a tapered seal face 1108. As in some previous examples, the
seal element 1106 is positioned within a seal cavity 1102 of a
manifold 102. As shown in FIG. 11, the seal cavity 1102 includes a
tapered seal cavity surface 1104 sized and shaped to correspond to
the tapered seal face 1108 of the seal element 1106. The seal
element 1106 further includes a proximal seal face 1110 positioned
near the manifold proximal portion 122. The tapered seal face 1108
of the seal element 1106 is shown in FIG. 11 on a distal side of
the seal element near the manifold distal portion 124. In another
option, the tapered seal face 1108 is on the proximal seal face
1110 near the manifold proximal portion 122. The seal element 1106
is positioned within the seal cavity 1102 so the seal element lumen
1112 is substantially aligned with a manifold lumen 1114, as shown
in FIG. 11.
[0066] In operation, where a pressurized fluid is present within
the manifold lumen 1114 the pressurized fluid engages with the
tapered seal face 1108 of the seal element 1106. The tapered seal
face 1108 provides a larger surface area for the pressurized fluid
to engage against thereby enhancing the force applied to the seal
element 1106 and correspondingly enhancing the deflection of the
seal element 1106 and its inward compression around the seal
element lumen 1112. The pressurized fluid engaged along the tapered
seal face 1108 presses the seal element 1106 proximally, and the
seal cavity 1102 substantially prevents expansion of the seal
element 1106 outwardly. Instead, proximal compression of the seal
element 1106 forces the seal element 1106 to compress inwardly
around the seal element lumen 1112 thereby closing the seal element
lumen 1112 and providing a tight seal that substantially prevents
the passage of the pressurized fluid past the seal element 1106. As
in previous examples, where an instrument, such as a guide wire, is
present within the seal element lumen 1112 application of the
pressurized fluid along the tapered seal face 1108 compresses the
seal element 1106 around the instrument within the seal element
lumen thereby closing the seal element 1106 around the instrument
and providing a tight seal that substantially prevents the passage
of fluids beyond the seal element 1106. FIG. 12 shows yet another
example of a pressure actuated seal assembly 1200.
[0067] The pressure actuated seal assembly 1200 includes a seal
element 1204 positioned within a seal cavity 1202. As shown in FIG.
12, the seal element 1204 includes a distal tapered seal face 1206
and a proximal tapered seal face 1208. The tapered seal faces 1206,
1208 are sized and shaped for reception within the seal cavity 1202
having a corresponding distal tapered cavity surface 1210 and a
proximal tapered cavity surface 1212. The tapered cavity surfaces
1210, 1212 are configured in substantially the same shape as the
tapered seal faces 1206, 1208 of the seal element 1204. In another
example, at least one of the tapered seal faces and tapered cavity
surfaces are tapered at different angles relative to the
corresponding seal face or cavity surface. One of the seal cavity
1202 or the seal element 1204 thereby has a distinct shape from the
other of the seal cavity and the seal element. A manifold lumen
1214 extends through the manifold 102 and is in substantial
alignment with the seal element lumen 1216 extending through the
seal element 1204. Optionally, the seal element 1204 includes at
least one guide such, as a proximal instrument guide 1218 and a
distal instrument guide 1220 (each of which is shown in phantom
lines). The proximal and distal instrument guides 1218, 1220
facilitate passage of an instrument, for instance a guide wire,
through the seal element lumen 1216 and into the manifold lumen
1214. In another example, the distal instrument guide 1220
facilitates movement of an instrument proximally, such as a front
loaded guide wire, through the manifold lumen 1214, into the seal
element 1204 and proximally out of the seal element 1204.
[0068] In operation, pressurized fluid within the manifold lumen
1214 applies a force across the distal tapered seal face 1206 and
forces the seal element 1204 proximally within the seal cavity
1202. As described in the example shown in FIG. 11, the distal
tapered seal face 1206 provides enhanced surface area and provides
a larger surface for the pressurized fluid to act upon the seal
element 1204. The seal element 1204 thereby experiences greater
forces and corresponding greater deflection as the seal element
1204 is urged proximally. The proximal tapered seal face 1208 on
the seal element is engaged against the proximal tapered cavity
surface 1212 and guides compression of the seal element 1204
inwardly around the seal element lumen 1216. The engagement between
the proximal tapered seal face 1208 and the proximal tapered cavity
surface 1212 thereby acts as an amplifier substantially directing
the seal element 1204 to compress inwardly as opposed to outwardly
and enhances the inward deformation of the seal element around the
seal element lumen 1216. Compression of the seal element 1204
inwardly closes the seal element lumen 1216 with or without an
instrument present to substantially prevent passage of the
pressurized fluid beyond the seal element 1204. When the fluid
within the manifold lumen 1214 is no longer under pressure, the
natural elasticity of the seal element 1204 allows the seal element
to resume its undeformed state thereby allowing the seal element
1204 to expand and open the seal element lumen 1216 for passage of
fluids, instruments and the like.
[0069] Another example of a pressure actuated seal assembly 1300 is
shown in FIG. 13, and includes a seal element 1304 having a
deformable lip 1306. The seal element 1304 is disposed within the
seal cavity 1302 of the manifold 102. The deformable lip 1306 of
the seal element 1304 includes, in one example, a distal tapered
lip portion 1308 and proximal tapered lip portion 1310. The tapered
lip portions 1308, 1310 are sized and shaped to guide an instrument
fed through the manifold 102 proximally or distally. The tapered
lip portions 1308, 1310 thereby guide an instrument into the seal
element lumen 1312 of the seal element 1304. As shown in FIG. 13,
the seal element lumen 1312 of the seal element 1304 is
substantially aligned with the manifold lumen 1314 of the manifold
102. The seal base 1316 is coupled across a seal cavity proximal
surface 1318 and positions the seal element 1304 within the seal
cavity 1302 to align the seal element lumen 1312 with the manifold
lumen 1314. Optionally, the seal element 1304 is spaced from the
seal cavity distal surface 1320. Spacing of the seal element 1304
from the seal cavity distal surface 1320 allows for fluid,
including pressurized fluid, within the manifold lumen 1314 to move
around the seal element 1304. Pressurized fluid surrounding the
exterior of the deformable lip 1306 forces the deformable lip 1306
to compress inwardly thereby closing the seal element lumen 1312,
as described further below.
[0070] In operation, a pressurized fluid present within the
manifold lumen 1314 enters the seal cavity 1302. The pressurized
fluid at least partially surrounds the exterior of the deformable
lip 1306 of the seal element 1304. The pressurized fluid compresses
the deformable lip 1306 inwardly around the seal element lumen
1312. Compression of the deformable lip 1306 around the seal
element lumen 1312 closes the seal element lumen to substantially
prevent the passage of the pressurized fluid beyond the seal
element 1304. In another example, where an instrument is present
within the seal element lumen 1312 compression of the deformable
lip 1406 around the instrument forces the deformable lip 1306 to
tightly engage around the instrument and thereby create a seal that
substantially prevents the passage of pressurized fluids between
the instrument and the deformable lip 1306. The seal element 1304
including the deformable lip 1306 is constructed with a pliable
material including, but not limited to, butyl rubber, silicone and
the like. The deformable lip 1306 is constructed with the pliable
material to ensure rapid deflection of the deformable lip and
inward compression around the seal element lumen 1312 to provide a
tight seal through the manifold 102. In another example, at least a
portion of the deformable lip 1306 is coupled with another portion
of the surfaces defining the seal cavity 1302. That is to say a
distal portion of the deformable lip 1306 is coupled with a distal
portion of the seal cavity 1302. In such an example, passages
through the deformable lip 1306, for instance, from the seal
element lumen 1312 to the exterior of the deformable lip 1306 allow
the transmission of pressurized fluid out of the seal element lumen
and into the area surrounding the deformable lip 1306. The
deformable lip 1306 is thereby engaged by the pressurized fluid on
the exterior surfaces of the seal element 1304 to deflect the
deformable lip 1306 of the seal element to close the seal element
lumen 1312.
[0071] Referring now to FIG. 14, still another example of a
pressure actuated seal assembly 1400 is shown. As in previous
examples, the pressure actuated seal assembly 1400 includes a seal
element 1404 disposed within a seal cavity 1402 of the manifold
102. The seal element 1404 includes an exterior lip portion 1406.
The exterior lip portion 1406 is near a seal element distal portion
1420 and seal element exterior portion 1424. The exterior lip
portion 1406 is sized and shaped to engage with the surface
defining the seal cavity 1402. The seal element 1404 further
includes an interior lip portion 1408 extending from the seal
element distal portion 1420 near the seal element interior portion
1426 and the seal element lumen 1416. As further shown in FIG. 14,
the seal element 1404 further includes a tapered seal element
surface 1412 sized and shaped for engagement with the tapered
cavity surface 1410. In yet another example, the seal element 1404
includes a biasing projection 1414 along the tapered seal element
surface 1412. The biasing projection 1414 is sized and shaped to
ensure the seal element 1304 disengages from the tapered cavity
surface 1410 after fluid within the manifold lumen 1418 is no
longer pressurized to allow the seal element 1404 to resume a
relaxed configuration where the seal element lumen 1416 is capable
of passing instruments and fluids.
[0072] In operation, where a pressurized fluid is present within
the manifold lumen 1418 the pressurized fluid engages with the seal
element 1404. The pressurized fluid engages against the exterior
lip portion 1406 and deflects the lip portion outwardly to seal the
exterior lip portion along the surfaces defining the seal cavity
1402 and substantially prevent passage of pressurized fluids around
the seal element 1404. The pressurized fluid also engages with the
interior lip portion 1408 and deflects the interior lip portion
inwardly. Deformation of the interior lip portion 1408 inwardly
assists in sealing the seal element lumen 1416 as the interior lip
portion 1408 compresses around the seal element lumen 1416. The
pressurized fluid further compresses the seal element 1404
proximally into the manifold 102 thereby forcing the tapered seal
element surface 1412 into engagement with the tapered cavity
surface 1410. The tapered seal element surface 1412 cooperates with
the tapered cavity surface 1410 to exert an inward compressive
force on the seal element 1404 toward the seal element lumen 1416.
The pliable material in the seal element 1404 is pressed inwardly
into the seal element lumen 1416 creating a tight seal and
substantially preventing the passage of the pressurized fluid
through the seal element 1404. Stated another way, the tapered seal
element surface 1412 and tapered cavity surface 1410 cooperate and
act as an amplifier to enhance the deformation of the seal element
1404 inwardly toward the seal element lumen 1416. Once the fluid is
no longer pressurized, the seal element 1404 resumes a relaxed
orientation because of its natural elasticity. In the relaxed
orientation the seal element lumen 1416 is open and an instrument
may pass through the seal element. The biasing projections 1414
shown in FIG. 14 provide a biasing force to the seal element 1404
and push the seal element 1404 out of engagement with the tapered
cavity surface 1410. The biasing projections 1414 thereby prevent
the seal element 1404 from interlocking with the tapered cavity
surface 1410 and remaining in a compressed orientation after the
fluid is no longer pressurized.
[0073] FIG. 15 shows another example of a pressure actuated seal
assembly 1500. The pressure actuated seal assembly 1500 includes a
plunger 1504 and a seal element 1510 positioned within a seal
cavity 1502. The plunger 1504 is movably coupled within the seal
cavity 1502 and is moved proximally and distally to seal and unseal
the seal element 1510, respectively. In one example, the plunger
1504 includes a plunger barrel 1506 and plunger face 1508. The
plunger barrel 1506 is coupled with a biasing member 1516 and the
biasing member 1516 is coupled between the plunger and a proximal
seal cavity portion 1512. The biasing member 1516 (e.g., a spring,
elastomer or the like) is configured to bias the plunger 1504 away
from the proximal seal cavity portion 1512 toward the distal seal
cavity portion 1514 near the manifold lumen 1522. The seal element
1510 is coupled between the plunger face 1508 and the proximal seal
cavity portion 1512. The plunger 1504 is sized and shaped to fit
within the seal cavity 1502, and aligns a seal element lumen 1520
extending through the seal element 1510 with the manifold lumen
1522 extending through the manifold 102. Alignment of the seal
element lumen 1520 with the manifold lumen 1522 assists in ensuring
that instruments, including guide wires, are reliably fed through
the lumens from the manifold 102 to the catheter body 104 (or from
the catheter body 104 to the manifold 102). In one example, the
pressure actuated seal assembly 1500 includes a rolling diaphragm
1518 extending from the manifold 102 through the seal cavity 1502
to the plunger face 1508. As described in previous examples, the
rolling diaphragm 1518 substantially prevents passage of
pressurized fluids around the plunger 1504 while allowing the
plunger 1504 to move within the seal cavity 1502 to create a seal
with the seal element 1510. The seal element 1510 is constructed
with a pliable material including but not limited to butyl rubber,
silicone, and the like. The pliable material of the seal element
1510 cooperates with movement of the plunger 1504 to deflect the
seal element 1510 around the seal element lumen 1520.
[0074] In operation, where a pressurized fluid is present within
the manifold lumen 1522 the pressurized fluid engages against the
plunger 1504 and moves the plunger proximally toward the proximal
seal cavity portion 1512. The pressurized fluid incident on the
plunger face 1508 provides sufficient pressure against the plunger
1504 to overcome the biasing force of the biasing member 1516
allowing the plunger 1504 to move proximally within the seal cavity
1502. Movement of the plunger 1504 is transmitted to the seal
element 1510. The pliable material of the seal element 1510 allows
the seal element 1510 to deflect inwardly upon movement of the
plunger 1504. As the plunger 1504 moves proximally the seal element
1510 deflects inwardly and closes the seal element lumen 1520.
Where an instrument is present within the seal element lumen 1520
the deflecting pliable material of the seal element 1510 closes
around the instrument within the seal element lumen and seals
around the instrument preventing the passage of pressurized fluid
through past the seal element 1510. Once the fluid within the
manifold lumen 1522 and the seal cavity 1502 is no longer
pressurized the plunger 1504 is moved distally toward the distal
seal cavity portion 1514 by the biasing member 1516. As the plunger
1504 moves distally the seal element 1510 coupled between the
plunger 1504 and the proximal seal cavity portion 1512 is pulled
apart opening the seal element 1520. As the seal element 1510 is
opened fluid may pass through the seal element lumen 1520.
Similarly, an instrument may pass through the seal element lumen
1520 after the plunger 1504 is moved distally and the seal element
1510 relaxes to the orientation shown in FIG. 15.
[0075] Optionally, with the pressure actuated seal assembly 1500
and any of the pressure actuated seal assemblies described herein,
an introducer is fed through the seal element lumen 1520 prior to
closure of the seal element 1510 by the pressurized fluid. The
introducer includes a lumen capable of passing an instrument, such
as a guide wire. Once the seal element 1510 is sealed around the
introducer (e.g., because of pressurized fluid within the manifold
lumen) the instrument is fed through the lumen of the introducer as
desired by the operator. The introducer thereby facilitates feeding
of the instrument through the catheter body while a pressurized
fluid is present within the catheter body and the seal element 1510
is compressed inwardly into the seal element lumen 1520.
[0076] FIG. 16 shows another example of a plunger 1600 sized and
shaped for use with the pressure actuated seal assembly 1500. The
plunger 1600 is disposed within a seal cavity 1602 and the plunger
is sized and shaped to move proximally and distally (relatively
into and out of the page) according to the presence or absence of
pressurized fluid within the manifold lumen 1522. Similarly to the
seal element lumen 1520 extending through the plunger 1504 in FIG.
15 a seal element lumen 1604 extends through the plunger 1600 in
FIG. 16. A seal element, such as seal element 1510, is coupled with
the plunger 1600 and coupled with a seal cavity portion, (e.g., the
proximal seal cavity portion 1512 shown in FIG. 10). Referring
again to FIG. 16, the plunger 1600 is shown with one or more
plunger edges 1606 in close proximity to the seal cavity wall 1608.
The plunger edges 1606, in one example, minimize contact between
the plunger 1600 and the seal cavity wall 1608 thereby freely
allowing the plunger 1600 to move proximally and distally within
the seal cavity 1602 without interference with the seal cavity wall
1608. The plunger 1600 is thereby able freely move proximally and
distally without the plunger 1600 snagging along the seal cavity
wall 1608 and frustrating the ability of the seal element 1510 to
open or close. In another example, the plunger edges 1606 are
points sized and shaped to ride along the seal cavity wall 1608 to
further minimize the friction between the plunger 1600 and the seal
cavity wall 1608.
[0077] Referring now to FIG. 17, another example of a pressure
actuated seal assembly 1700 is shown, including a plunger 1704 and
a seal element 1706. The pressure actuated seal assembly 1700 is
positioned within a seal cavity 1702 with the plunger 1704
positioned adjacent to a distal seal cavity surface 1738 and the
seal elements 1706 positioned adjacent to a proximal seal cavity
surface 1736. The seal element 1706 includes a proximal seal
portion 1708 coupled along the proximal seal cavity surface 1736. A
distal seal portion 1710 is positioned within the seal cavity 1702
and extends from near the seal element lumen 1716 toward the
perimeter of the seal cavity 1702.
[0078] In one example shown in FIG. 17, the seal element 1706
includes a rolling diaphragm 1718 coupled between the distal seal
portion 1710 and the perimeter of the manifold 102 defining the
seal cavity 1702. The rolling diaphragm 1718 allows the distal seal
portion 1710 to move proximally and distally within the seal cavity
1702 during sealing and unsealing of the pressure actuated seal
assembly 1700. Where the pressure actuated seal assembly 1700
includes the rolling diaphragm 1718 a seal element chamber 1734 is
within the seal element 1706. The seal element chamber 1734 is
substantially sealed away from the remainder of the seal cavity
1702. In another example, the manifold 102 includes a vent 1730
extending from the exterior of the manifold into the seal element
chamber 1734. The vent 1730 allows passage of gases within the seal
element chamber 1734 during compression of the seal element 1706 by
the plunger 1704.
[0079] A biasing member (e.g., a spring, elastomer and the like),
is positioned between the proximal seal portion 1708 and the distal
seal portion 1710. The biasing member 1732 biases at least the
distal seal portion 1710 away from a proximal seal cavity surface
1736. The biasing member 1732 expands the seal element 1706 in a
manner similar to an accordion and positions a pinching portion
1712 of the seal element 1706 outwardly from the seal element lumen
1716 to open the seal element lumen 1716 in the absence of
pressurized fluid within the manifold 102. The seal element 1706
further includes, in another example, seal element hinges 1714. The
seal element hinges 1714 permit deflection of the seal element 1706
(including the pinching portion 1712) inwardly into the seal
element lumen 1716 during actuation by the plunger 1704.
[0080] The plunger 1704 shown in FIG. 17 includes a plunger
proximal face 1720 positioned adjacent to the proximal seal portion
1708. The plunger 1704 further includes a plunger distal face 1722
directed in an opposing direction to the plunger proximal face
1720. The plunger 1704 includes a plunger recess 1724 extending
around the plunger lumen 1726, as described in further detail
below. In one example, the plunger recess 1724 is sized and shaped
to receive a pressurized fluid and transform force from the
pressurized fluid into proximal movement of the plunger 1704 to
deflect the seal element 1706 and close the seal element lumen
1716.
[0081] In operation, when a pressurized fluid is present within the
manifold lumen 1728 the pressurized fluid engages against the
plunger 1704. For instance, at least a portion of the pressurized
fluid is received within the plunger recess 1724. The plunger 1704
is moved proximally away from the distal seal cavity surface 1738
toward a proximal seal cavity surface 1736. Proximal movement of
the plunger 1704 deflects the seal element 1706. Pressure applied
to the seal element 1706 through the plunger 1704 overcomes the
bias provided by the bias member 1732 to the seal element 1706. The
distal seal portion 1710 of the seal element 1706 is deflected
proximally toward the proximal seal cavity surface 1736. The seal
element 1706 acts as a linkage around the seal element hinges 1714
as the distal seal portion 1710 is moved proximally. The pinching
portion 1712 compresses around the seal element lumen 1716 and the
opposed surfaces of the pinching portion 1712 engage to seal the
seal element lumen 1716 and prevent the passage of pressurized
fluids through the seal element lumen 1716 and out of the manifold
102. In a similar manner, where an instrument, such as a guide
wire, is present within the seal element lumen 1716 pressure upon
the plunger 1704 correspondingly deflects the seal element 1706 and
moves the pinching portions 1712 inwardly to engage around the
instrument. The pinching portions 1712 engage around the instrument
and create a seal preventing the passage of pressurized fluids
around the instrument and through the seal element lumen. After the
pressure is released on the within the manifold lumen 1728 the bias
of the biasing member 1732 is no longer opposed by a pressure
within the seal cavity 1702. The biasing member 1732 presses the
distal seal portion 1710 distally toward the distal seal cavity
surface 1738. The plunger 1704 is correspondingly moved toward the
distal seal cavity surface 1738 with distal movement of the distal
seal portion 1710. The pinching portion 1712 of the seal element
1706 moves outwardly as the biasing member distally moves the
distal seal portion 1710 thereby opening the seal element lumen
1716 and allowing passage of the fluids and instruments.
[0082] Referring now to FIG. 18A, one example of a fluid jet
distributor 1801 is shown. As previously described in the examples
shown in FIGS. 1 through 17 the pressure actuated seal assemblies
are provided within the manifold 102 (FIG. 1). The pressure
actuated seal assemblies include seal elements that close a seal
element lumen according to the presence of a pressurized fluid
within the manifold lumen and the catheter lumen of the catheter.
By closing the seal element lumen the pressure actuated seal
assemblies maintain a pressurized environment within the catheter
100. A distal portion 114 of the catheter 100 is shown in FIG. 18.
The catheter distal portion 114 includes a catheter lumen tapered
portion 1808 tapering toward a guide wire orifice 1802 from an
interior surface of the catheter defining a catheter lumen
intermediate portion 1810. The catheter lumen intermediate portion
1810 extends proximally toward the manifold 102 shown in FIG. 1.
Optionally, the catheter lumen tapered portion 1808 gradually
tapers over a length of the catheter 100, for instance from near
the catheter proximal portion toward the catheter distal portion
114.
[0083] A guide wire 1800 is shown positioned within the catheter
lumen 306 and extending through the guide wire orifice 1802.
Positioning of a portion of the guide wire, for instance the guide
wire tip 1807, within the guide wire orifice 1802 partially closes
the interior of the catheter and assists in maintaining the
pressurized environment within the catheter lumen 306 created in
part through operation of the pressure actuated seal assembly
within the manifold 102. The guide wire orifice 1802 includes a
perimeter substantially matching the perimeter of the guide wire
tip 1807 with sufficient tolerance to allow movement of the guide
wire tip through the orifice. Positioning the guide wire tip 1807
within the guide wire orifice 1802 closely fits the catheter distal
portion 114 around the guide wire tip 1807 and minimizes fluid flow
through the guide wire orifice 1802 from the catheter lumen tapered
portion 1808 to the environment surrounding the catheter 100.
[0084] In one example, the catheter distal portion 114 includes
pressurized fluid passages 1804 provided in at least one of the
catheter lumen tapered portion 1808 and the portion of the catheter
body including the catheter lumen intermediate portion 1810.
Referring to FIG. 18, the pressurized fluid passages 1804 are shown
in broken lines in the catheter lumen intermediate portion 1810.
The guide wire 1800 is positioned within the guide wire orifice
1802 and acts as a plug to substantially prevent the passage of
pressurized fluid through the guide wire orifice. The pressure
actuated seal assemblies described herein ensure pressurized fluid
does not pass through the seal element lumen. The pressurized fluid
is instead forced through the pressurized fluid passages 1804 and
directed into fluid jets 1806. The fluid jets 1806 are used, in one
example, to engage with and break up thrombus material within a
vessel. In another example, the fluid jets 1806 marinate the
surrounding vasculature with medication, contrast fluid and the
like fed to the catheter distal portion. In one option, high
pressure delivery of fluids, for instance during thrombectomy
procedures, is halted while the medication or contrast fluid is
delivered through the catheter lumen 306 and the fluid passages
1804. The pressurized fluid is delivered through the fluid passages
over a range of pressures including, but not limited to, pressures
sufficient to deliver the fluids through the passages 1804 to the
vessel location, and higher pressures for delivery of the fluid and
removal of thrombus.
[0085] The pressurized environment within the catheter lumen 306
provides a substantially similar pressure at the catheter distal
portion 114 compared to the catheter proximal portion 112 in close
proximity to the pressure actuated seal assemblies. The catheter
body 104 maintains this pressurized environment throughout the
catheter body 104 without substantial pressure losses from the
catheter proximal portion 112 to the catheter distal portion 114
because the catheter body 104 is spaced away from the interior of
the catheter lumen 306. For instance, as shown in FIG. 18 the guide
wire 1800 near the center of the catheter body 104 is spaced from
the walls of the catheter body 104. The large diameter of the
catheter body 104 from the catheter proximal portion 112 to the
catheter distal portion 114 minimizes pressure losses due to
turbulent flow and other fluid behavior along the surfaces
circumscribing the catheter lumen 306. The catheter lumen 306 is
large enough to isolate pressure losses along the circumscribing
surfaces of the catheter lumen 306 and maintain a consistent
pressure within the interior of the catheter lumen 306 from the
catheter body proximal portion 112 to the catheter body distal
portion 114. The pressure actuated seal assemblies described
previously thereby cooperate with the catheter body 104 and the
catheter lumen 306 to provide a pressurized environment throughout
the catheter body including the catheter body distal portion 114.
The cooperation of the pressure actuated seal assemblies with the
catheter lumen 306 thereby maintains a high pressure at the
catheter body distal portion to produce the fluid jets 1806 through
the pressurized fluid passages 1804.
[0086] Another example of a fluid jet system 1812 is shown in FIG.
18B. The fluid jet system 1812 does not include the fluid passages
1804 shown in FIG. 18A for the fluid jet distributor 1801. Instead,
the fluid jet system 1812 uses the guide wire orifice 1802 as a
nozzle to deliver a fluid jet distally from the catheter distal
portion 114. As described above with regard to the fluid jet
distributor 1801, in one example, the guide wire orifice 1802 has a
tight tolerance relative to the guide wire tip 1807, and reception
of the guide wire tip 1807 within the guide wire orifice 1802 plugs
the orifice and prevents the distribution of fluids. In another
example, the guide wire orifice 1802 is larger than the outer
diameter of the guide wire tip 1807 and fluid is deliverable
between the guide wire tip 1807 and the surfaces defining the guide
wire orifice. Axial movement of the guide wire 1800 within the
catheter body distal portion 114 including movement of the guide
wire tip 1807 through the guide wire orifice 1802 controls the flow
rate and pressure of delivery according to the relative opening
between the guide wire tip and the surfaces defining the guide wire
orifice 1802. Stated another way, movement of the guide wire tip
1807 gradually into and out of the guide wire orifice 1802
correspondingly alters the spacing between the guide wire tip 1807
and the surfaces of the orifice (due in part to the taper of the
catheter lumen tapered portion 1808 and the varying distance
between the guide wire tip and the tapered portion).
[0087] In operation, the fluid jet system 1812 is positioned on the
catheter body distal portion 114 and positioned at a desired
location within the vasculature. For example, the catheter body 104
(see FIG. 1) is guided along the guide wire 1800. The specialist
may then deliver fluids including, but not limited to, medications,
contrast media and the like to the catheter body distal portion 114
under pressure. Procedures, including thrombectomy procedures,
making use of the catheter lumen 306 are arrested, while the fluid
is delivered. Because the fluid is delivered under pressure the
pressure actuated seal assemblies (described herein) seal the
catheter lumen 306 at the proximal portion of the catheter and
maintain a pressurized environment within the lumen for delivery of
the fluid to the catheter distal portion 114.
[0088] Where the guide wire orifice 1802 has a tight tolerance with
the guide wire tip 1807 the specialist withdraws the guide wire tip
from the orifice and the fluid is delivered through the guide wire
orifice. In the option having space between the guide wire tip 1807
and the surfaces of the guide wire orifice 1802 (e.g., where the
catheter includes one or more of the catheter lumen tapered portion
1808 and a gap between the guide wire tip and the orifice)
pressurized fluid is delivered through the space. The specialist
may adjust the delivery pressure and flow rate as needed according
to axial positioning of the guide wire tip 1807 relative to the
guide wire orifice 1802. For instance, fluids are delivered with
higher pressure and greater velocity (with a correspondingly strong
jet) where a small space is formed between the guide wire tip 1807
and the guide wire orifice 1802 surface. Greater flow rate is
achieved where the guide wire tip 1807 is withdrawn, at least
partially or more, from the guide wire orifice 1802 surfaces
thereby increasing the gap between the catheter and the guide wire
tip. As described above with regard to the fluid jet distributor
1801, the fluid jet system 1812 delivers fluids over a range of
pressures including, but not limited to, pressures sufficient to
deliver the fluids through the guide wire orifice 1802 to the
vessel location, and higher pressures for delivery of the fluid and
removal of thrombus.
[0089] Another example of a catheter 1814 is shown in FIG. 18C. The
catheter 1814 includes the previously described fluid passages 1804
for distribution of fluid from the catheter distal portion 114. The
catheter body 1816 is tapered from near the manifold 102 toward the
catheter distal portion 114. The tapered catheter body 1816
includes a corresponding tapered catheter lumen that gradually
tapers toward the catheter distal portion 114. The taper of the
catheter body 1816 ensures that there is a gap between the inner
wall of the catheter lumen and the guide wire 126 to permit fluid
flow along the catheter to the fluid passages 1804 and the guide
wire orifice 1802. Stated another way, by providing a tapered gap
in the catheter body 1816 pressure losses due to throttling of flow
around the guide wire 126 are minimized. Fluids (medication,
contrast and the like) are thereby readily delivered to the
catheter distal portion 114 and the surrounding vasculature even
while an instrument (e.g., guide wire 126) is present within the
catheter body 1816. Further, the catheter 1814 with the tapered
catheter body 1816 has enhanced deliverability because the distal
portion of the catheter (near the catheter distal portion 114 and
extending toward the catheter proximal portion 112) has a small
cross sectional area and is correspondingly more flexible and able
to easily navigate vasculature relative to the larger proximal
portion of the catheter body 1816.
[0090] Referring now to FIG. 19, one example of a method 1900 for
using a catheter including a pressure actuated seal assembly is
shown. Reference is made in the description of the method 1900 to
various elements previously shown in FIGS. 1-18. Where reference is
made to one element, the reference is intended to be exemplary and
implicitly includes other similar elements herein and their
equivalents. At 1902, a fluid is pressurized within at least one of
a manifold lumen 304 of a manifold 102 or catheter lumen 306 of a
catheter body 104. The catheter body 104 is coupled with the
manifold 102. At 1904, a seal element, such as a seal element
within a pressure actuated seal assembly (e.g., pressure actuated
seal assembly 202 shown in FIG. 2), is pressed by the pressurized
fluid within one or more of the catheter lumen 306 and manifold
lumen 304. At 1906 the pressurized fluid deforms the seal element
into a compressed sealed configuration. Deforming the seal element
206 includes constricting the seal element around the seal element
lumen 302 extending through the seal element 206. As previously
described above, the pressure exerted by the pressurized fluid on
the seal element compresses the seal element in a proximal
direction toward a manifold proximal portion 122. Proximal seal
element compression causes inward compression of the seal element
206 into the seal element lumen 302. The inward compression closes
the seal element lumen. In still another example, deforming the
seal element includes constricting the seal element 206 around an
instrument positioned within the seal element lumen 302 (e.g. a
guide wire, an introducer and the like) to provide a seal between
the seal element and the instrument. At 1908, the seal element 206
is relaxed in the absence of the pressurized fluid. The seal
element 206 resumes an initial undeformed configuration and the
seal element lumen is correspondingly opened and configured to
allow passage of an instrument. Stated another way, the seal
element 206 is biased from the compressed configuration into an
original undeformed configuration (e.g., by the natural elasticity
of the seal element, a biasing member and the like). In the
original configuration the seal element 206 withdraws from the seal
element lumen and opens the seal element lumen for passage of
instruments.
[0091] Several options for the method 1900 follow. In one example,
pressing the seal element 206 includes pressing an amplifier, such
as the amplifier 208, against the seal element 206. The amplifier
208 multiplies the force of the pressurized fluid transmitted to
the seal element 206. For instance, the amplifier includes a first
amplifier face 214 substantially larger than the second amplifier
face 216. The first amplifier face 214 is directed toward the
pressurized fluid and the second amplifier face 216 is directed
toward the seal element 206. Force applied to the first amplifier
face 214 by the pressurized fluid is transmitted through the
amplifier 208 to the second amplifier face adjacent to the seal
element 206 and smaller than the first amplifier face. The force
transmitted through the amplifier 208 from the large first
amplifier face is multiplied at the smaller second amplifier face
216 and is transmitted into the seal element 206. In another
example, deforming and constricting the seal element, such as the
seal element 1304 having at least one deformable lip 1306, includes
constricting the deformable lip 1306 around the seal element lumen
1312.
[0092] In still another example, the method 1900 includes
distributing a fluid including, but not limited to, medication,
contrast, saline and the like through the catheter distal portion
114, for instance through pressurized fluid passages 1804 (see
18A). Optionally, a fluid is distributed through a guide wire
orifice 1802 as shown in FIG. 18B. The pressure actuated seal
assemblies close a seal lumen and optionally close the seal around
an instrument disposed in the seal lumen including a guide wire
(e.g., guide wire 126, shown in FIG. 1). The sealed environment
prevents the flow of the fluids through the manifold 102 and
instead directs flow of the fluids along the catheter body 104
toward a fluid jet distributor 1801 including the pressurized fluid
passages 1804 and the guide wire orifice 1802. In another example,
the fluid is distributed under high pressure to impinge upon
thrombus material and break up the material. In yet another
example, the fluid is distributed at a lower pressure to marinate
the vessel region surrounding the fluid jet distributor 1801. The
instrument, such as the guide wire, at least partially closes the
guide wire orifice 1802 to direct the flow of fluid into at least
one of the pressurized fluid passages 1804 and through the guide
wire orifice 1802 partially closed with the guide wire.
[0093] FIG. 20 shows another example of a pressure actuated seal
assembly 2000. As previously described in other examples, the
pressure actuated seal assembly 2000 is included within the
manifold, such as the manifold 102. The manifold 102 is
substantially similar to previously described manifolds. For
instance, the manifold 102 includes a manifold proximal portion 122
and a manifold distal portion 124. As shown in FIG. 20, the
manifold 102 includes a seal cavity 2002 sized and shaped to
receive a seal element 2004 therein. An introducer guide 1010, in
one example, is positioned within the manifold distal portion 124
and closes the seal cavity 2002 to retain the seal element 2004
therein. Further, in the example show the introducer guide 1010
provides the proximal end of the seal cavity 2022.
[0094] Referring again to FIG. 20, the seal element 2004 includes
first, second and third seal portion 2006A, B, C, respectively. The
first, second and third seal portions 2006A-C are orientated in a
series within the seal cavity 2002. As shown, each of the seal
portions includes a portion of the seal element lumen 2016
extending therethrough. As previously described, the seal element
lumen 2016 is aligned with the manifold lumen 1012 and the
introducer lumen 1016 to form a substantially continuous lumen
through the manifold 102 and the seal element 2004. The seal
element perimeter 2018 cooperates with the seal cavity perimeter
2020 to substantially align the first, second and third seal
portions 2006A, B, C within the seal cavity 2002 and thereby align
the seal element lumen (e.g., lumens of each of the portions) with
the manifold lumen 1012 and the introducer lumen 1016.
[0095] As described above, the seal element 2004 includes a
plurality of portions including, for instance first, second and
third seal portions 2006A, B, C. In one example, the first, second
and third seal portions 2006A-C are constructed with varying
materials with correspondingly different durometers. For instance,
each of the first, second and third seal portions are constructed
with pliable materials configured to deflect as pressure is applied
across, for instance, a first seal face 2008 of the first seal
portion 2006A through the slit 1032 between the distal end of the
seal cavity 2024 and the first seal face 2008. For instance, as
pressure is applied across the first seal face 2008 the first seal
portion 2006A is pressed toward the second and third seal portions
2006B, C and compresses each of the seal portions through
engagement of intermediate seal faces 2012 and thereby inwardly
compresses the first, second and third seal portions 2006A-C around
the seal element lumen 2016. Optionally, compression of the first,
second and third seal portions 2006A-C similarly expands the seal
portions outwardly and engages the seal element perimeter 2018 with
the seal cavity perimeter 2020 to substantially prevent the flow of
pressurized fluid around gaps otherwise formed between the first
through third seal portions 2006A-C and the seal element perimeter
2018.
[0096] As described above the first, second and third seal portions
2006A-C are each constructed with different materials having
different durometers. In one example, the first seal portion 2006A
is constructed with a first material having a first durometer while
the second and third seal portions 2006B, C include materials
having second and third respective materials each with different
durometers. Optionally, the first and second seal portions 2006A, B
include materials having a durometer greater than the durometer of
the intermediate third seal portion 2006C. The first and second
seal portions 2006A, B thereby form a seal chamber 2014 that
substantially contains the third seal portion 2006C therebetween.
In one example, the seal chamber 2014 including the first and
second seal portions 2006A, B maintains the third seal portion
2006C in the configuration shown in FIG. 20 and substantially
prevents the flow (extrusion) of the third seal portion 2006C
through either of the manifold lumen 1012 and the introducer of the
lumen 1016 (or the portions of the seal element lumen 2016
associated with the first and second seal portions). For instance,
where the third seal portion 2006C is constructed with a material
similar to a gel the seal chamber 2014 including more rigid seal
portions 2006A, B provides structural support to the seal portion
2006C and substantially prevents the flow of the third seal portion
through the seal element lumen 2016.
[0097] In another example, the first seal portion 2006A is
constructed with a material with a greater durometer than that of
the third seal portion 2006C and the first seal portion 2006A acts
as an amplifier when engaged with pressurized fluid, for instance,
along the first seal face 2008. The first seal portion 2006A is
pressed into engagement with the third seal portion 2006C and
compresses the more pliable third seal portion 2006C to collapse
the seal portion 2006C around the seal element lumen 2016.
Optionally, each of the first, second and third seal portion
2006A-C compresses inwardly (and outwardly in some examples) under
differing pressures. For instance, at lower pressures such as less
than 50 psi the intermediate third seal portion 2006C having a
lower durometer initially expands inwardly to close the seal
element lumen 2016 for instance around an instrument positioned
within the seal element lumen. At a higher pressure, for instance,
50 to 1200 psi the third seal portion 2006C as well as one of the
first and second seal portions 2006A, B (based on the durometers of
each of the seal portions) compresses with the third seal portion
2006C to compress the seal materials around the seal element lumen
2016 including, for instance, an instrument disposed therein. At
even higher pressures, such as at 1200 to 1500 psi each of the
first, second and third seal portions 2006A-C is compressed by the
pressurized fluid applied along the first seal face 2008, for
instance, through transmission of compression through intermediate
seal faces 2012 engaged between the seal portions. Each of the
seals compresses inwardly around the seal element lumen 2016 to
close the seal element lumen 2016 or engage the seal portions
around an instrument provided within the seal element lumen 2016.
Optionally, the seal portions 2006A-C are configured to only
provide a seal when an instrument is disposed within the seal
element lumen 2016 and otherwise allow throttled flow of fluid
(e.g., for purging of a catheter system) through the lumen.
[0098] In other examples, the materials of the first, second and
third seal portions 2006A-C are selected with a variety of
durometers to tune the response of the seal element 2004 to seal
with one or more of the seal portions 2006A-C under varying
pressures. One such example is provided immediately above. In one
prophetic example, the first seal portion 2006A includes a first
material having a durometer of approximately 60, the second seal
portion includes a durometer of approximately 30 and the third seal
portion 2006C includes a more pliable durometer of approximately
10.
[0099] The pressure actuated seal assemblies and methods for using
the same described herein automatically seal a seal element lumen
in the presence of a pressurized fluid without requiring hand
operation from a catheter operator. The operator does not need to
operate the seal or observe an indicator to know the pressure
actuated seal assembly is sealed and closing the seal element
lumen. Instead, when a pressurized fluid is introduced to the
catheter and manifold for use as part of a procedure the seal
assembly automatically closes because of the pressure. The operator
can thereby confidently operate the catheter without doubting
whether the seal has closed the seal element lumen or the seal was
not actuated because of operator error. Additionally, because the
seal element is actuated according to the fluid pressure within the
catheter the seal becomes correspondingly tighter with increasing
fluid pressures. A seal is thereby maintained within the seal
element lumen across a range of pressures. For instance, the
pressure actuated seal assemblies described herein provide a
complete seal from at least 10 to 1200 psi. Optionally a complete
seal is maintained over pressures greater than 1200 psi. Similarly,
the pressure actuated seal elements automatically unseal in the
absence of a pressurized fluid freeing the operator from
manipulating seal element into an open configuration.
[0100] Further, the seal element is capable of closing the seal
element lumen with or without an instrument therein. The seal
element seals around a variety of instrument sizes and
configurations (guidewires with varying diameters, multiple
instruments and the like). For instance, a single seal element will
seal around a variety of instruments with different perimeters when
under pressure from fluid in the catheter body. In another example,
the seal element material and seal element lumen size are chosen
according to the size of the instrument delivered through the seal
element. Stated another way, the seal element is chosen to ensure
tight sealing around a specified instrument when the seal element
is subjected to pressure from the pressurized fluid in the catheter
body.
[0101] If a procedure requires the presence of an instrument within
the catheter while the pressurized environment is maintained the
instrument is fed into the catheter through the seal element. As
the pressurized fluid applies pressure to the seal element the seal
element closes and seals around the instrument. Optionally, sealing
of the seal element fixes the instrument in place and
correspondingly retains the instrument in a desired orientation
according to the needs of the operator. In another example, the
instrument is slidable through the closed seal element if movement
of the instrument is necessary while the fluid is pressurized in
the catheter. In any case, when the fluid in the catheter body is
no longer pressurized and the seal element is open and the
instrument is easily slidable through the seal element lumen.
[0102] Moreover, the seal elements and the surrounding manifolds
are configured to permit back loading and front loading of
instruments (e.g., feeding the instrument into the catheter from
the manifold and feeding the instrument toward the manifold from
the catheter, respectively). For instance, one or more of the
manifold and the seal element include tapering surfaces that guide
the instrument through the seal element lumen when front or back
loaded.
[0103] In one example, the instrument includes an introducer having
its own lumen and a second instrument is fed through the introducer
into the pressurized environment of the catheter. Sealing the seal
element around the introducer thereby provides access through the
catheter to vasculature while pressure is maintained within the
catheter. Optionally, the instrument within the introducer is
snuggly engaged by the interior surface of the introducer and
slidable relative to the introducer. The instrument and introducer
are sized and shaped to minimize the space therebetween to
substantially prevent the passage of pressurized fluids through the
introducer while still allowing movement of the instrument through
the seal.
[0104] As previously described, the pressure actuated seal
assemblies maintain a pressurized environment within the catheter
lumen during operation of the catheter, for instance, during a
thrombectomy procedure where high pressure fluids are fed through
the catheter body. Pressurized fluid is transmitted through the
catheter lumen to the catheter distal portion. The catheter lumen
tapers into a fluid jet manifold and the pressurized fluid is
directed through pressurized fluid passages into fluid jets that
project from the catheter body. Because the catheter interior wall
only tapers near the catheter distal portion pressure losses are
minimized between the catheter proximal and distal portions. The
catheter lumen tapers near the catheter distal portion to enhance
the strength of the fluid jets projecting from the pressurized
fluid passages. Similarly, where an instrument is present within
the catheter lumen (e.g., a guide wire) the catheter interior wall
is spaced from the instrument to minimize pressure losses between
the wall and the instrument. Stated another way, flow
characteristics including turbulent flow extending between the
catheter interior wall and the instrument are avoided. The pressure
within the catheter lumen is thereby substantially maintained from
the catheter proximal portion to the catheter distal portion.
[0105] Although the present disclosure has been described in
reference to preferred embodiments and methods for use of those
embodiments, persons skilled in the art will recognize that changes
may be made in form and detail without departing from the spirit
and scope of the present disclosure. 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 discussed in
different portions of the description or referred to in different
drawings can be combined to form additional embodiments of the
present application. Further, the elements and features of one or
more of the pressure actuated seal elements and the associated
structures and functions of the seal elements is fully compatible
with other fluid delivery devices including, but not limited to,
handheld manifolds, access ports and independent catheters. Stated
another way, the pressure actuated seal elements are not limited to
direct or integral coupling or incorporation to a catheter. The
scope of the present disclosure should, therefore, be determined
with reference to the appended claims, along with the full scope of
equivalents to which such claims are entitled.
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