U.S. patent application number 15/238668 was filed with the patent office on 2016-12-08 for vascular access configuration.
This patent application is currently assigned to Arstasis, Inc.. The applicant listed for this patent is Arstasis, Inc.. Invention is credited to Brian Andrew Ellingwood, D. Bruce Modesitt.
Application Number | 20160354583 15/238668 |
Document ID | / |
Family ID | 49622157 |
Filed Date | 2016-12-08 |
United States Patent
Application |
20160354583 |
Kind Code |
A1 |
Ellingwood; Brian Andrew ;
et al. |
December 8, 2016 |
VASCULAR ACCESS CONFIGURATION
Abstract
One embodiment is directed to a system for creating translumenal
vascular access, comprising a dilator adaptor member having
proximal and distal ends and defining a dilator adaptor lumen
therethrough, wherein the dilator adaptor lumen is defined by an
inner diameter profile sized to accommodate insertion of one or
more portions of a guidewire, and wherein the dilator adaptor is
further defined by an outer diameter profile sized to accommodate
at least partial insertion of the proximal end of the dilator
adaptor into a dilator member lumen formed through a dilator
member, the dilator member being coupleable to an introducer
catheter member through an introducer member lumen formed through
the introducer member.
Inventors: |
Ellingwood; Brian Andrew;
(Sunnyvale, CA) ; Modesitt; D. Bruce; (San Carlos,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Arstasis, Inc. |
Redwood City |
CA |
US |
|
|
Assignee: |
Arstasis, Inc.
Redwood City
CA
|
Family ID: |
49622157 |
Appl. No.: |
15/238668 |
Filed: |
August 16, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14940109 |
Nov 12, 2015 |
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15238668 |
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13902579 |
May 24, 2013 |
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14940109 |
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61652104 |
May 25, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0069 20130101;
A61M 25/0662 20130101; A61M 25/09 20130101; A61B 17/3415 20130101;
A61M 2025/0293 20130101; A61M 2039/0273 20130101; A61M 29/00
20130101; A61M 39/0247 20130101; A61M 2039/0258 20130101; A61M
25/02 20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 29/00 20060101 A61M029/00; A61M 25/09 20060101
A61M025/09; A61B 17/34 20060101 A61B017/34 |
Claims
1. A system for creating translumenal vascular access, comprising:
a. a dilator-introducer assembly comprising a dilator member having
proximal and distal ends and defining a dilator lumen therethrough,
and an introducer member having proximal and distal ends and
defining an introducer lumen therethrough, wherein the introducer
lumen is defined by an inner diameter profile sized to accommodate
insertion of one or more portions of the dilator member; b. a
guidewire having an outer shape defined by a guidewire outer
diameter profile; c. a dilator adaptor having proximal and distal
ends and defining a dilator adaptor lumen therethrough, wherein the
dilator adaptor lumen is defined by an inner diameter profile sized
to accommodate insertion of one or more portions of the guidewire,
and wherein the dilator adaptor is further defined by an outer
diameter profile sized to accommodate at least partial insertion of
the proximal end of the dilator adaptor into the dilator member
lumen; wherein the guidewire may be advanced at least in part
through the dilator adaptor lumen, the dilator adaptor may be
advanced at least in part through the dilator member lumen, and the
dilator member may be advanced at least in part through the
introducer lumen to form an instrument assembly capable of forming
substantially atraumatic outer shape profile configuration defined
by longitudinally sequential increases in overall outer diameter
from exposed distal ends of the guidewire, dilator adaptor, dilator
member, and introducer.
2. The system of claim 1, wherein a maximum outer diameter of the
guidewire is substantially smaller than a minimum inner diameter of
the dilator member.
3. The system of claim 2, wherein without the dilator adaptor
interposed between the guidewire and dilator member, an annular gap
would be defined at the intersection of the guidewire and the
distal end of the dilator member.
4. The system of claim 2, wherein the maximum outer diameter of the
guidewire is at least about 25% smaller than the minimum inner
diameter of the dilator member.
5. The system of claim 2, wherein the maximum outer diameter of the
guidewire is about 0.018 inches.
6. The system of claim 5, wherein the minimum inner diameter of the
dilator member is between about 0.035 inches and about 0.040
inches.
7. The system of claim 3, wherein the dilator adaptor inner and
outer diameter profiles are configured to substantially make up the
difference in fit between the guidewire and dilator member.
8. The system of claim 6, wherein the dilator adaptor has a minimum
inner diameter of about 0.018 inches, and a maximum outer diameter
of about 0.050 inches.
9. The system of claim 1, wherein the introducer member distal end
has a tapered geometry with an outer diameter minimum at its distal
tip.
10. The system of claim 1, wherein the dilator member distal end
has a tapered geometry with an outer diameter minimum at its distal
tip.
11. The system of claim 1, wherein the distal end of the dilator
adaptor has a tapered geometry with an outer diameter minimum at
its distal tip.
12. The system of claim 1, wherein at least a portion of the
dilator adaptor has a proximally tapered geometry with an outer
diameter minimum located adjacent its proximal end.
13. The system of claim 12, wherein a friction fit may be formed
between the proximally tapered geometry of the dilator adaptor and
the dilator lumen of the dilator member when loading the dilator
adaptor into the dilator lumen.
14. The system of claim 13, wherein the proximally tapered geometry
is selected such that one size of dilator adaptor can form a
friction fit with a range of dilator lumen geometries.
15. The system of claim 1, wherein the dilator adaptor, when viewed
from distal end to proximal end, comprises a distal section with a
substantially constant outer diameter for a distal section length,
tapering up to a midsection with a substantially constant outer
diameter for a midsection length, tapering down to a proximal
section with a substantially constant outer diameter for a proximal
section length, ending in the proximal end.
16. The system of claim 15, wherein the substantially constant
outer diameter of the proximal section is greater than that of the
distal section and less than that of the midsection.
17. The system of claim 16, wherein each of the distal section,
midsection, and proximal sections has a substantially homogeneous
inner diameter defining the dilator adaptor lumen.
18. The system of claim 2, wherein the maximum outer diameter of
the guidewire is at least about 0.01 inches smaller than the
minimum inner diameter of the dilator member.
19. The system of claim 1, wherein the dilator adaptor comprises a
polymer selected from the group consisting of: polyethylene
terepthalate, polyethylene, high density polyethylene,
polypropylene, polytetrafluoroethylene, expanded
polytetrafluoroethylene, poly (ethylene-co-vinyl acetate),
poly(butyl methacrylate), and co-polymers thereof.
Description
RELATED APPLICATION DATA
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/940,109, filed on Nov. 12, 2015, which is a
continuation of U.S. patent application Ser. No. 13/902,579, filed
on May 24, 2013, which claims the benefit under 35 U.S.C. .sctn.119
to U.S. Provisional Application Ser. No. 61/652,104, filed May 25,
2012. The foregoing applications are hereby incorporated by
reference into the present application in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to vascular access
systems and techniques, and more particularly to configurations for
providing and/or facilitating elongate instrument access across a
vascular wall with minimal disruption to surrounding tissue
structures.
BACKGROUND
[0003] A number of diagnostic and interventional vascular
procedures are now performed translumenally, where an elongate
instrument such as a catheter is introduced to the vascular system
at a convenient access location--such as the femoral, brachial, or
subclavian arteries--and guided through the vascular system to a
target location to perform therapy or diagnosis. When vascular
access is no longer required, the catheter and other vascular
access devices must be removed from the vascular entrance and
bleeding at the puncture site must be stopped. One common approach
for providing hemostasis is to apply external force near and
upstream from the puncture site, typically by manual compression.
This method is time-consuming, frequently requiring one-half hour
or more of compression before hemostasis. This procedure is
uncomfortable for the patient and frequently requires administering
analgesics. Excessive pressure can also present the risk of total
occlusion of the blood vessel, resulting in ischemia and/or
thrombosis. After hemostasis is achieved by manual compression, the
patient is required to remain recumbent for six to eighteen hours
under observation to assure continued hemostasis. During this time
bleeding from the vascular access wound can restart, potentially
resulting in major complications. These complications may require
blood transfusion and/or surgical intervention.
[0004] Bioabsorbable fasteners have also been used to stop
bleeding. Generally, these approaches rely on the placement of a
thrombogenic and bioabsorbable material, such as collagen, at the
superficial arterial wall over the puncture site. This method
generally presents difficulty locating the interface of the
overlying tissue and the adventitial surface of the blood vessel.
Implanting the fastener too far from the desired location can
result in failure to provide hemostasis. If, however, the fastener
intrudes into the vascular lumen, thrombus can form on the
fastener. Thrombus can embolize downstream and/or block normal
blood flow at the thrombus site. Implanted fasteners can also cause
infection and auto-immune reactions/rejections of the implant.
[0005] Suturing methods also have used to provide hemostasis after
vascular access. The suture-applying device is introduced through
the tissue tract with a distal end of the device located at the
vascular puncture. Needles in the device draw suture through the
blood vessel wall on opposite sides of the punctures, and the
suture is secured directly over the adventitial surface of the
blood vessel wall to close the vascular access wound. Generally, to
be successful, suturing methods need to be performed with a precise
control. The needles need to be properly directed through the blood
vessel wall so that the suture is well anchored in tissue to
provide for tight closure. Suturing methods also require additional
steps for the physician.
[0006] In view of the deficiencies of the above methods and
devices, a new generation of "self-sealing" closure devices and
methods has been developed to avoid the need for implantation of a
prosthesis member, and also to minimize the steps and time required
for closure of the vascular site. Such self-sealing configurations
are available, for example, from Arstasis, Inc., of Redwood City,
Calif. under the tradename Axera.TM., and are described in
publications such as U.S. Pat. Nos. 8,083,767, 8,012,168,
8,002,794, 8,002,793, 8,002,792, 8,002,791, 7,998,169, and
7,678,133, each of which is incorporated by reference herein in its
entirety.
[0007] With self-sealing and other configurations of closure
devices, it may be desirable to achieve vascular access with
relatively small instruments before dilation up to larger working
lumens for subsequent diagnostic or interventional steps. For
example, rather than starting with a Seldinger access technique
wherein a needle and guidewire set configured to place a
conventional 0.035'' diameter guidewire are utilized, a
self-sealing access technique may be employed to place a much
smaller guidewire, such as an 0.018'' diameter guidewire. With a
relatively small guidewire, such as an 0.018'' diameter guidewire,
in place by the Seldinger technique, a subsequent process step may
be to install an introducer catheter assembly, generally comprising
an introducer catheter defining an introducer lumen, and a dilator
member configured to fit with in the introducer lumen. The dilator
member generally will define its own dilator member lumen through
which the guidewire may be threaded, to facilitate an
"over-the-wire" installation of the distal portions of the
introducer catheter and dilator member into the vascular lumen.
[0008] One of the challenges with an over-the-wire installation of
a conventional introducer-dilator assembly over a relatively small
guidewire, such as an 0.018'' diameter guidewire, is that many
readily available off-the-shelf introducer-dilator sets are
configured to fit more conventional guidewire diameters through the
dilator member lumen, such as diameters in the range of 0.035
inches. The geometric mismatch between a 0.018'' diameter guidewire
and a distal end of a dilator member sized for a 0.035'' diameter
guidewire, for example, can result in what may be termed an
"annular gap" that may form a mechanical edge at the interface
between these structures, and insertion of this gap or edge
relative to the vascular tissue to place the dilator member and
associated introducer catheter distal tips within the vascular
lumen may result in unwanted localized tissue trauma, heightened
insertion forces, and undesirable localized stress concentrations
on portions of the guidewire, dilator member, and/or introducer
catheter. There is a need to address this challenge so that
conventionally-sized dilator-introducer assemblies, such as those
designed for 0.035'' diameter guidewires, may be more optimally
utilized with relatively small guidewires, such as those having
diameters in the range of 0.018 inches, which may be desirable with
procedures such as self-sealing vascular access and closure
procedures.
SUMMARY
[0009] One embodiment is directed to a system for creating
translumenal vascular access, comprising: a dilator-introducer
assembly comprising a dilator member having proximal and distal
ends and defining a dilator lumen therethrough, and an introducer
member having proximal and distal ends and defining an introducer
lumen therethrough, wherein the introducer lumen is defined by an
inner diameter profile sized to accommodate insertion of one or
more portions of the dilator member; a guidewire having an outer
shape defined by a guidewire outer diameter profile; and a dilator
adaptor having proximal and distal ends and defining a dilator
adaptor lumen therethrough, wherein the dilator adaptor lumen is
defined by an inner diameter profile sized to accommodate insertion
of one or more portions of the guidewire, and wherein the dilator
adaptor is further defined by an outer diameter profile sized to
accommodate at least partial insertion of the proximal end of the
dilator adaptor into the dilator member lumen; wherein the
guidewire may be advanced at least in part through the dilator
adaptor lumen, the dilator adaptor may be advanced at least in part
through the dilator member lumen, and the dilator member may be
advanced at least in part through the introducer lumen to form an
instrument assembly capable of forming substantially atraumatic
outer shape profile configuration defined by longitudinally
sequential increases in overall outer diameter from exposed distal
ends of the guidewire, dilator adaptor, dilator member, and
introducer. A maximum outer diameter of the guidewire may be
substantially smaller than a minimum inner diameter of the dilator
member. Without the dilator adaptor interposed between the
guidewire and dilator member, an annular gap may be defined at the
intersection of the guidewire and a distal end of the dilator
member. The maximum outer diameter of the guidewire may be at least
about 25% smaller than the minimum inner diameter of the dilator
member. The maximum outer diameter of the guidewire may be about
0.018 inches. The minimum inner diameter of the dilator member may
be between about 0.035 inches and about 0.040 inches. The dilator
adaptor inner and outer diameter profiles may be configured to
substantially make up the difference in fit between the guidewire
and dilator member. The dilator adaptor may have a minimum inner
diameter of about 0.018 inches, and a maximum outer diameter of
about 0.050 inches. The introducer member distal end may have a
tapered geometry with an outer diameter minimum at its distal tip.
The dilator member distal end may have a tapered geometry with an
outer diameter minimum at its distal tip. The distal end of the
dilator adaptor may have a tapered geometry with an outer diameter
minimum at its distal tip. At least a portion of the dilator
adaptor may have a proximally tapered geometry with an outer
diameter minimum located adjacent its proximal end. A friction fit
may be formed between the proximally tapered geometry of the
dilator adaptor and the dilator member lumen of the dilator member
when loading the dilator adaptor into the dilator member lumen. The
proximally tapered geometry may be selected such that one size of
dilator adaptor can form a friction fit with a range of dilator
member lumen geometries. The dilator adaptor, when viewed from
distal end to proximal end, may comprise a distal section with a
substantially constant outer diameter for a distal section length,
tapering up to a midsection with a substantially constant outer
diameter for a midsection length, tapering down to a proximal
section with a substantially constant outer diameter for a proximal
section length, ending in the proximal end. The substantially
constant outer diameter of the proximal section may be greater than
that of the distal section and less than that of the midsection.
Each of the distal section, midsection, and proximal sections may
have a substantially homogeneous inner diameter defining the
dilator adaptor lumen. The maximum outer diameter of the guidewire
may be at least about 0.01 inches smaller than the minimum inner
diameter of the dilator member. The dilator adaptor may comprise a
polymer selected from the group consisting of: polyethylene
terepthalate, polyethylene, high density polyethylene,
polypropylene, polytetrafluoroethylene, expanded
polytetrafluoroethylene, poly (ethylene-co-vinyl acetate),
poly(butyl methacrylate), and co-polymers thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1A illustrates a geometric misfit scenario wherein a
relatively small guidewire is interfaced with a
conventionally-sized dilator-introducer assembly.
[0011] FIG. 1B illustrates an assembly featuring a dilator adaptor
to address a geometric misfit scenario such as that depicted in
FIG. 1A.
[0012] FIG. 2A illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0013] FIG. 2B illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0014] FIG. 2C illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0015] FIG. 2D illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0016] FIG. 2E illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0017] FIG. 2F illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0018] FIG. 2G illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0019] FIG. 2H illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0020] FIG. 2I illustrates one aspect of a vascular access
configuration in accordance with the present invention wherein a
relatively small guidewire may be utilized in concert with a
conventionally-sized dilator-introducer assembly.
[0021] FIG. 3A illustrates a longitudinal cross sectional view of
one embodiment of a dilator adaptor in accordance with the present
invention.
[0022] FIG. 3B illustrates a longitudinal cross sectional view of
another embodiment of a dilator adaptor in accordance with the
present invention.
[0023] FIG. 4 illustrates a technique conducting a procedure
involving a vascular access configuration in accordance with the
present invention wherein a relatively small guidewire may be
utilized in concert with a conventionally-sized dilator-introducer
assembly.
[0024] FIG. 5 illustrates a technique conducting a procedure
involving a vascular access configuration in accordance with the
present invention wherein a relatively small guidewire may be
utilized in concert with a conventionally-sized dilator-introducer
assembly.
DETAILED DESCRIPTION
[0025] Referring to FIG. 1A, a geometric mismatch scenario is
depicted wherein a relatively small guidewire (6), such as a
guidewire having a diameter in the range of 0.018 inches, is being
utilized in concert with a conventionally-sized dilator-introducer
assembly comprising a dilator member (4) coupled through an
introducer catheter (2). The dilator member (4) may define a lumen
therethrough which has a diameter sized for larger guidewires, in
the range of 0.035 inches. As shown in FIG. 1A, and as described
above, the geometric mismatch between the guidewire (6) and the
inner diameter of the dilator member (4) creates an annular gap (8)
or step in geometry, which may unfavorably affect the function of
the overall apparatus relative to the nearby pertinent tissue
structures. Referring to FIG. 1B, with an appropriate sized and
shaped tubular dilator adaptor (10) intercoupled between the
dilator member (4) and guidewire (6), the mismatch issue may be
substantially, if not completely, mitigated, to produce a desired
closely-toleranced fit at the junction (12) between the guidewire
(6) and adaptor (10), and at the junction (14) between the adaptor
(10) and the dilator member (4).
[0026] Referring to FIGS. 2A-2I, various aspects of a vascular
access system and procedure related thereto are illustrated. FIGS.
3 and 4 illustrate in a flowchart fashion various embodiments of
medical procedures involving such vascular access technology.
[0027] Referring to FIG. 2A, a conventional dilator
member/introducer catheter set is depicted in a disassembled form,
comprising a dilator member (4) having proximal (22) and distal
(20) ends, a lumen (28) defined therethrough, and a fitting (36)
proximally to assist with manipulating and coupling the dilator
member (4). The conventional dilator member/introducer catheter set
also comprises an introducer catheter or introducer sheath (2)
having proximal (26) and distal (24) ends, a lumen (30)
therethrough, and a proximal valve assembly (16), to assist with
preventing leaks that may otherwise occur through the lumen (30)
and around small instruments, such as the dilator member (4) or
other diagnostic and/or interventional tools, which may be passed
through the lumen (30) and valve (16). Typical dilator
member/introducer catheter sets for vascular access, such as those
available from providers such as Boston Scientific Corporation,
Covidien, Inc., or St. Jude Medical, Inc., are designed to have
outer introducer catheter diameters (34) in the range of about 6
French, and have inner dilator member lumen diameters of between
about 0.035'' and about 0.038''. The outer diameter (32) of the
dilator member (4) typically is configured to be easily slideable
through the lumen (30) of the introducer (2), without significant
leakage between the two elongate bodies when assembled. Referring
to FIG. 2B, the distal end (20) of the dilator (4) may be advanced
through the proximal end valve fitting (16) of the introducer
catheter (2) and into the lumen (30) of the introducer catheter
(2), to form an assembly as shown in FIGS. 2C and 2D, wherein the
distal end (20) of the dilator member (4) may be configured to have
a tapered geometry and to extend distally past the distal end (24)
of the introducer catheter (2), which also may have a tapered
distal geometry. Preferably the fit (38) at the interface between
the dilator member (4) and introducer catheter (2) is manufactured
to be closely toleranced by the manufacturer of the
dilator/introducer set, as described above.
[0028] Referring to FIG. 2E, in a scenario wherein a relatively
small guidewire, such as one in the range of 0.018 inches, is to be
utilized in concert with a conventionally-sized dilator/introducer
set, such as one having a dilator member lumen diameter of about
0.035 inches, a tubular dilator adaptor member (10) may be added to
an assembly to mitigate the geometric mismatch. Generally the
dilator adaptor (10) has proximal (42) and distal (40) ends and
comprises a small lumen (44) defined therethrough to accommodate
passage of a small instrument such as a guidewire. As shown in FIG.
2F, in one embodiment, the dilator adaptor (10) is configured to be
inserted proximal end (42) first into the distal end (20) of the
dilator member (4), and this assembly may occur before or after the
dilator member is assembled into the working lumen of the
introducer catheter (2). Referring to FIG. 2G, a resulting assembly
is depicted, with the dilator adaptor (10) inserted through the
working lumen of the dilator member (4), which is inserted through
the working lumen of the introducer catheter (2). A small working
lumen (44) is maintained through the dilator adaptor (10) to
accommodate passage of a guidewire or other small instrument.
[0029] Preferably at least one portion of the proximal end geometry
of the dilator adaptor (10) comprises a proximal taper (tapering to
smaller outer diameter as one measures incrementally closer to the
proximal end of the dilator adaptor) which is configured to
interface with the inner lumen geometry of the working lumen of the
associated dilator member (4) in such a manner that the dilator
adaptor (10) may be pushed up into the distal end of the dilator
member (4) until a friction fit is established. Preferably the
proximal taper geometry of the dilator adaptor (10) is configured
to not only accommodate one guidewire/dilator mismatch scenario
(i.e., such as one wherein an 0.018'' outer diameter guidewire is
to be utilized with a dilator member having an inner lumen diameter
of about 0.035''), but also a substantially broad range of mismatch
scenarios (including one wherein an 0.018'' outer diameter
guidewire is to be utilized with a dilator member having an inner
lumen diameter of about 0.038'', as well as a myriad of other
mismatch scenarios which may be greater in mismatch
dimensions).
[0030] Referring to FIG. 2H, in practice, with a guidewire (6)
already installed into a position wherein the distal end of the
guidewire extends into a blood vessel lumen (48), and the remainder
of the guidewire (10) extends proximally across the vessel wall
(50), across other related tissue structures (52), and across the
skin (54) of the patient, to extend proximally, generally outside
of the patient, an assembly of the dilator adaptor (10), dilator
member (4), and introducer catheter (2) may be advanced in an
"over-the-wire" technique to place at least a portion of such
assembly within the vascular lumen (48). A closer view is presented
in FIG. 2I. The assembly may be further advanced until the distal
end of the introducer catheter is positioned within the vascular
lumen (48), after which the dilator member (4) and dilator adaptor
(10) may be withdrawn proximally to make room for other diagnostic
and/or interventional tools, such as catheters, imaging devices,
and prostheses such as stents which may be passed through the
working lumen of the introducer. Subsequently, the tools may with
withdrawn, as well as the guidewire and introducer sheath, to
complete closure of the trans-vascular access port or wound. As
described above, in one embodiment, the trans-vascular access point
across the vessel wall (50) may be configured to be a self-sealing
access point, which is designed to self-seal after withdrawal of
the pertinent instrumentation.
[0031] Referring to FIG. 3A, a longitudinal cross sectional view of
one embodiment of a dilator adaptor (10) is depicted with
dimensions in inches. The most distal portion starting from the
distal end (40) may comprise a tapered geometry (56) to ultimately
assist with pushing deployment into the pertinent tissue
structures. A mid-portion (60) may have a substantially homogeneous
outer diameter for a given length. Next a proximally tapered
portion (58) may assist with establishing a friction fit with an
associated inner lumen geometry of a dilator member, as described
above. A most proximal portion (62) up to the proximal end (42) may
have a substantially constant outer diameter for a given
length.
[0032] Referring to FIG. 3B, a longitudinal cross sectional view of
another embodiment of a dilator adaptor (10) is depicted with
dimensions in inches. The most distal portion starting from the
distal end (40) may comprise a tapered geometry (64), followed by a
portion (66) having a substantially constant outer diameter for a
given length, followed by another tapered portion (68), a
midportion (70) which may have a mild taper either proximally or
distally or be substantially constant in outer diameter for a given
length, followed by a proximally tapered portion (72) which may
assist with establishing a friction fit with an associated inner
lumen geometry of a dilator member, as described above. A most
proximal portion (74) up to the proximal end (42) may have a
substantially constant outer diameter for a given length. The
dilator adaptor may comprise a polymer selected from the group
consisting of: polyethylene terepthalate, polyethylene, high
density polyethylene, polypropylene, polytetrafluoroethylene,
expanded polytetrafluoroethylene, poly (ethylene-co-vinyl acetate),
poly(butyl methacrylate), and co-polymers thereof.
[0033] Referring to FIG. 4, after patient preparation and
preoperative diagnostics (80), access may be created (for example,
by crossing with an access needle and leaving behind a guidewire,
as in a Seldinger technique) (82). An operational assembly may be
formed which combines the at least a portion of the guidewire
through the dilator adaptor lumen, at least a portion of the
dilator adaptor through the dilator member lumen, and at least a
portion of the dilator member through the introducer catheter
lumen. Such an assembly may be accomplished by first assembling the
adaptor and dilator member together, then placing this assembly
into the introducer for further advancement over the guidewire into
the vessel, as shown in the embodiment of FIG. 4 (elements 84, 86);
referring to FIG. 5 (102), such a sub-process may comprise
combining the adaptor into an already-assembled dilator
member--introducer catheter subassembly. The
dilator-adaptor/dilator member/introducer assembly may then be
advanced in an "over-the-wire" configuration (i.e., with the
proximal end of the guidewire (and additional portions thereof
following) being advanced into the distal end of the
dilator-adaptor and associated dilator member and introducer as
this assembly is advanced over the guidewire) into a position
relative to the vessel wherein at least the distal end of the
dilator adaptor is positioned within the vessel lumen (88). With
the distal end of the introducer having access to the vascular
lumen (90), the dilator member and dilator adaptor may be withdrawn
(92) along with the guidewire, and other instrumentation may be
advanced through the working lumen of the introducer catheter or
sheath (94) to conduct a procedure (96), after which the
instrumentation may be withdrawn out of the introducer (98), and
the remaining introducer may be withdrawn to complete the closure,
which preferably has been set up to be a self-sealing closure
(100).
[0034] Various exemplary embodiments of the invention are described
herein. Reference is made to these examples in a non-limiting
sense. They are provided to illustrate more broadly applicable
aspects of the invention. Various changes may be made to the
invention described and equivalents may be substituted without
departing from the true spirit and scope of the invention. In
addition, many modifications may be made to adapt a particular
situation, material, composition of matter, process, process act(s)
or step(s) to the objective(s), spirit or scope of the present
invention. Further, as will be appreciated by those with skill in
the art that each of the individual variations described and
illustrated herein has discrete components and features which may
be readily separated from or combined with the features of any of
the other several embodiments without departing from the scope or
spirit of the present inventions. All such modifications are
intended to be within the scope of claims associated with this
disclosure.
[0035] Any of the devices described for carrying out the subject
diagnostic or interventional procedures may be provided in packaged
combination for use in executing such interventions. These supply
"kits" may further include instructions for use and be packaged in
sterile trays or containers as commonly employed for such
purposes.
[0036] The invention includes methods that may be performed using
the subject devices. The methods may comprise the act of providing
such a suitable device. Such provision may be performed by the end
user. In other words, the "providing" act merely requires the end
user obtain, access, approach, position, set-up, activate, power-up
or otherwise act to provide the requisite device in the subject
method. Methods recited herein may be carried out in any order of
the recited events which is logically possible, as well as in the
recited order of events.
[0037] Exemplary aspects of the invention, together with details
regarding material selection and manufacture have been set forth
above. As for other details of the present invention, these may be
appreciated in connection with the above-referenced patents and
publications as well as generally known or appreciated by those
with skill in the art. For example, one with skill in the art will
appreciate that one or more lubricious coatings (e.g., hydrophilic
polymers such as polyvinylpyrrolidone-based compositions,
fluoropolymers such as tetrafluoroethylene, hydrophilic gel or
silicones) may be used in connection with various portions of the
devices, such as relatively large interfacial surfaces of movably
coupled parts, if desired, for example, to facilitate low friction
manipulation or advancement of such objects relative to other
portions of the instrumentation or nearby tissue structures. The
same may hold true with respect to method-based aspects of the
invention in terms of additional acts as commonly or logically
employed.
[0038] In addition, though the invention has been described in
reference to several examples optionally incorporating various
features, the invention is not to be limited to that which is
described or indicated as contemplated with respect to each
variation of the invention. Various changes may be made to the
invention described and equivalents (whether recited herein or not
included for the sake of some brevity) may be substituted without
departing from the true spirit and scope of the invention. In
addition, where a range of values is provided, it is understood
that every intervening value, between the upper and lower limit of
that range and any other stated or intervening value in that stated
range, is encompassed within the invention.
[0039] Also, it is contemplated that any optional feature of the
inventive variations described may be set forth and claimed
independently, or in combination with any one or more of the
features described herein. Reference to a singular item, includes
the possibility that there are plural of the same items present.
More specifically, as used herein and in claims associated hereto,
the singular forms "a," "an," "said," and "the" include plural
referents unless the specifically stated otherwise. In other words,
use of the articles allow for "at least one" of the subject item in
the description above as well as claims associated with this
disclosure. It is further noted that such claims may be drafted to
exclude any optional element.
[0040] As such, this statement is intended to serve as antecedent
basis for use of such exclusive terminology as "solely," "only" and
the like in connection with the recitation of claim elements, or
use of a "negative" limitation.
[0041] Without the use of such exclusive terminology, the term
"comprising" in claims associated with this disclosure shall allow
for the inclusion of any additional element--irrespective of
whether a given number of elements are enumerated in such claims,
or the addition of a feature could be regarded as transforming the
nature of an element set forth in such claims.
[0042] Except as specifically defined herein, all technical and
scientific terms used herein are to be given as broad a commonly
understood meaning as possible while maintaining claim
validity.
[0043] The breadth of the present invention is not to be limited to
the examples provided and/or the subject specification, but rather
only by the scope of claim language associated with this
disclosure.
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