U.S. patent application number 11/910223 was filed with the patent office on 2009-09-03 for vascular access.
Invention is credited to Aaron Abroff, Janelle Anderson, Joshua Druker, James R. Flom, Carl Gandarillas, John F. Lapetina, Robert Yuen Lee Ang, John P. Marano, JR., Michael Tal, Michael F. Wei.
Application Number | 20090221961 11/910223 |
Document ID | / |
Family ID | 37962946 |
Filed Date | 2009-09-03 |
United States Patent
Application |
20090221961 |
Kind Code |
A1 |
Tal; Michael ; et
al. |
September 3, 2009 |
VASCULAR ACCESS
Abstract
A device may include a hollow needle, a dilator mounted
coaxially on the needle, and a sheath mounted coaxially on the
dilator. The dilator may be slideably displaceable relative to the
sheath.
Inventors: |
Tal; Michael; (Woodbridge,
CT) ; Marano, JR.; John P.; (Madison, CT) ;
Flom; James R.; (San Mateo, CA) ; Lapetina; John
F.; (San Francisco, CA) ; Lee Ang; Robert Yuen;
(Cupertino, CA) ; Abroff; Aaron; (San Carlos,
CA) ; Gandarillas; Carl; (Beacon Falls, CT) ;
Wei; Michael F.; (Redwood City, CA) ; Druker;
Joshua; (Redwood City, CA) ; Anderson; Janelle;
(New York, NY) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET, FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
37962946 |
Appl. No.: |
11/910223 |
Filed: |
March 30, 2006 |
PCT Filed: |
March 30, 2006 |
PCT NO: |
PCT/US2006/011624 |
371 Date: |
June 19, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60666547 |
Mar 30, 2005 |
|
|
|
60743285 |
Feb 14, 2006 |
|
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Current U.S.
Class: |
604/103.06 |
Current CPC
Class: |
A61M 25/0097 20130101;
A61M 25/0618 20130101; A61M 2025/0687 20130101; A61M 25/0606
20130101; A61M 29/00 20130101 |
Class at
Publication: |
604/103.06 |
International
Class: |
A61M 29/02 20060101
A61M029/02; A61M 25/09 20060101 A61M025/09 |
Claims
1. A device comprising: a hollow needle defining a side hole and
having: a bore so sized as to receive a guidewire; and a sharpened
distal tip distal to the side hole; a dilator coaxially mounted on
the needle thereby defining a first space between the dilator and
needle, the first space communicating with the hollow needle bore
through the side hole so that a fluid, if any, exiting the side
hole may flow to the first space; and a sheath coaxially mounted on
the dilator; wherein: at least one of the dilator and sheath is
clear, semi-opaque, or translucent, so that fluid, if any, inside
the device, may be visualized through the dilator and/or sheath to
confirm proper placement of the needle in a cavity containing the
fluid; the dilator is slideably displaceable relative to the
sheath; and the dilator includes a proximal portion and a distal
portion, the distal portion having a larger cross-sectional area
than the proximal portion.
2. The device of claim 1, wherein the dilator further comprises a
transition region between the proximal portion and the distal
portion, and wherein the transition region defines a dilator side
hole.
3. The device of claim 2, wherein the transition region has a
constant cross-section.
4. The device of claim 1, wherein the dilator is formed as a single
piece.
5. The device of claim 1, wherein the distal portion of the dilator
is solid, and the proximal portion defines a dilator side hole.
6. The device of claim 1, wherein the proximal portion of the
dilator comprises a shaft, the distal portion of the dilator is
affixed to the shaft, and the distal portion of the dilator defines
the first space.
7. The device of claim 6, wherein the first space cross-sectional
area is no smaller than about 25% of the needle bore
cross-sectional area.
8. (canceled)
9. A device comprising: a hollow needle defining a side hole and
having: a bore so sized as to receive a guidewire; and a sharpened
distal tip distal to the side hole; a needle hub attached to a
proximal end of the needle and defining a lumen sized and
positioned to receive a guidewire; a dilator coaxially mounted on
the needle thereby defining a first space between the dilator and
needle, the first space communicating with the hollow needle bore
through the side hole so that a fluid, if any, exiting the side
hole may flow to the first space; and a sheath coaxially mounted on
the dilator; wherein: at least one of the dilator and sheath is
clear, semi-opaque, or translucent, so that fluid, if any, inside
the device, may be visualized through the dilator and/or sheath to
confirm proper placement of the needle in a cavity containing the
fluid; the dilator is slideably displaceable relative to the
sheath; and wherein the needle hub is transitionable between a
first state in which the lumen is so patent as to allow the
guidewire to slide freely through the needle hub and a second state
in which the lumen is so obstructed as to clamp the guidewire in
the needle hub.
10. The device of claim 9, wherein the needle hub further comprises
a sealing member configured to seal on a guidewire, if any,
positioned in the lumen.
11. The device of claim 9, further comprising a dilator hub
attached to a proximal end of the dilator, the dilator hub being
slideably displaceable over the needle and releasably attachable to
the needle hub by complementary mating elements of the dilator hub
and the needle hub.
12. The device of claim 9, wherein the needle hub comprises two
finger grips separated from one another in a rest condition,
wherein at least one finger grip is so coupled to the needle hub
mating element as to cause the needle hub mating element to move
when the at least one finger grip is moved in at least one
direction.
13. The device of claim 9, wherein the needle hub lumen tapers
distally.
14. A device comprising: a hollow needle defining a side hole and
having: a bore so sized as to receive a guidewire; and a sharpened
distal tip distal to the side hole; a guidewire having a distal end
and being so preloaded that the guidewire distal end terminates
proximal to the needle side hole and does not obstruct the needle
side hole; a dilator coaxially mounted on the needle thereby
defining a first space between the dilator and needle, the first
space communicating with the hollow needle bore through the side
hole so that a fluid, if any, exiting the side hole may flow to the
first space; and a sheath coaxially mounted on the dilator;
wherein: at least one of the dilator and sheath is clear,
semi-opaque, or translucent, so that fluid, if any, inside the
device, may be visualized through the dilator and/or sheath to
confirm proper placement of the needle in a cavity containing the
fluid; and the dilator is slideably displaceable relative to the
sheath.
15. The device of claim 14, further comprising: a wedging member
removably so pressing against the guidewire as to immobilize the
guidewire with respect to the needle.
16. The device of claim 14, wherein the sheath has a distal tip
with a parabolic curve.
17. The device of claim 14, wherein: the dilator has a distal tip
with a parabolic curve.
18. A device comprising: a hollow needle defining a side hole and
having: a bore so sized as to receive a guidewire; and a sharpened
distal tip distal to the side hole; a pressure gauge in fluid
communication with the needle side hole; a dilator coaxially
mounted on the needle thereby defining a first space between the
dilator and needle, the first space communicating with the hollow
needle bore through the side hole so that a fluid, if any, exiting
the side hole may flow to the first space; and a sheath coaxially
mounted on the dilator; wherein: at least one of the dilator and
sheath is clear, semi-opaque, or translucent, so that fluid, if
any, inside the device, may be visualized through the dilator
and/or sheath to confirm proper placement of the needle in a cavity
containing the fluid; and the dilator is slideably displaceable
relative to the sheath.
19. The device of claim 14, wherein the guidewire includes a
movement-impeding member.
20. The device of claim 19, wherein the movement-impeding member
comprises a handle or a stopper.
21. The kit device of claim 19, wherein the movement-impeding
member comprises a covering over at least a portion of the
guidewire.
22. A method comprising: providing a device comprising: a hollow
needle defining a side hole and having: a bore so sized as to
receive a guidewire; and a sharpened distal tip distal to the side
hole; a guidewire having a distal end and being so preloaded that
the guidewire distal end terminates proximal to the needle side
hole and does not obstruct the needle side hole; a dilator
coaxially mounted on the needle thereby defining a first space
between the dilator and needle, the first space communicating with
the hollow needle bore through the side hole so that a fluid, if
any, exiting the side hole may flow to the first space; and a
sheath coaxially mounted on the dilator; wherein: at least one of
the dilator and sheath is clear, semi-opaque, or translucent, so
that fluid, if any, inside the device, may be visualized through
the dilator and/or sheath to confirm proper placement of the needle
in a cavity containing the fluid: and the dilator is slideably
displaceable relative to the sheath; introducing the distal tip of
the hollow needle into a cavity; advancing the guidewire through
the distal tip of the needle into the cavity; advancing the dilator
and sheath together over the needle into the cavity; and removing
the needle and the dilator, thereby leaving the sheath in place to
provide access to the cavity.
23. The method of claim 22, further comprising immobilizing the
guidewire relative to the needle before advancing the dilator and
sheath.
24. The method of claim 22, wherein the cavity is a vein, and the
method further comprises aspirating blood through the device to
confirm that access has been obtained to the vein.
25. The method of claim 22, wherein the cavity is an artery, and
the method further comprises observing blood color or pulsatile
flow of blood in the device to confirm that access has been
obtained to the artery.
26. The method of claim 22, further comprising removing the
guidewire together with the needle and the dilator.
27. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/666,547, filed Mar. 30, 2005, and of U.S.
Provisional Application No. 60/743,285, filed Feb. 14, 2006, both
of which are hereby incorporated herein by this reference.
BACKGROUND
[0002] A preferred non-surgical method for inserting a catheter or
vascular sheath into a blood vessel involves the use of the
Seldinger technique, which includes an access needle that is
inserted into a patient's blood vessel. A guidewire is inserted
through the needle and into the vessel. The needle is removed, and
a dilator and sheath combination are then inserted over the
guidewire. The dilator and sheath combination is then inserted a
short distance through the tissue into the vessel, after which the
dilator is removed and discarded. The catheter is then inserted
through the sheath into the vessel to a desired location.
[0003] Alternatively, with microaccess techniques, an access needle
is inserted into a patient's blood vessel. A guidewire is inserted
through the needle and into the vessel. The needle is removed, and
a dilator is then inserted over the guidewire. The dilator
combination is then inserted a short distance through the tissue
into the vessel, after which the guidewire is removed and
discarded. The dilator is left in place, and a separate sheath kit
is used. A larger guidewire is inserted into the dilator and the
dilator is removed. A dilator and sheath combination is inserted.
Then the dilator and guidewire are removed. The catheter is then
inserted through the sheath into the vessel to a desired
location.
[0004] A number of vascular access devices are known. See, for
example, U.S. Pat. Nos. 4,581,019, 4,629,450, 4,772,264, 4,978,334,
5,158,544, 5,424,410, 5,312,355, 5,512,052, 5,728,132, 5,885,217,
5,919,160, 6,120,494, 6,179,823, and 6,210,366, each of which is
incorporated herein by reference, wherein various devices for
vascular access are described. However, none of these devices has
the ease and safety of use that physicians would prefer, and there
is thus a need for an easier-to-use and safer vascular access
device, especially one that would clearly indicate when a blood
vessel has been punctured.
SUMMARY
[0005] Preassembled vascular access devices may include a hollow
needle, a dilator coaxially disposed on at least a portion of the
needle, and a sheath coaxially mounted on at least a portion of the
dilator. Spaces may be defined between the needle and dilator and
between the dilator and the sheath. The hollow needle bore may
communicate with one or more of the spaces through apertures
defined in the needle and/or dilator. The sheath may be translucent
or transparent, thereby allowing a user to see a blood flash and
confirm that vascular access is achieved.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIGS. 1 and 2 are each a schematic representation of one
embodiment of a vascular access device.
[0007] FIGS. 3 and 4 are each a schematic representation of another
embodiment.
[0008] FIG. 5 is a partly cross-sectional view of a further
embodiment.
[0009] FIG. 5A is a cross-section along line 5A-5A.
[0010] FIG. 6 is a partly cross-sectional view of another
embodiment.
[0011] FIG. 7 is a partly cross-sectional view of yet another
embodiment.
[0012] FIG. 8 is a partly cross-sectional view of an embodiment in
which the distal portion of the dilator extends distally.
[0013] FIGS. 9A-C are schematic representations of use of the
disclosed vascular access devices.
[0014] FIGS. 10A-B are schematic representations of an embodiment
having a coaxial dilator system.
[0015] FIG. 11 is a schematic cross-sectional view of the proximal
portion of the system of FIGS. 10A-B.
[0016] FIGS. 12 and 12A depict embodiments of dilators.
[0017] FIG. 13 depicts a longitudinal cross-section of an
embodiment of a needle-dilator-sheath assembly.
[0018] FIGS. 13A-C depicts the transverse cross-sections indicated
in FIG. 13.
[0019] FIGS. 13D-E depict another embodiment of a dilator.
[0020] FIGS. 14-16 depict additional embodiments of
needle-dilator-sheath assemblies.
[0021] FIG. 17 depicts a hub assembly for a vascular access
device.
[0022] FIG. 18 depicts a perspective longitudinal cross-section of
the FIG. 2 embodiment.
[0023] FIG. 19 depicts an elevation longitudinal cross-section of
the FIG. 1 embodiment.
[0024] FIG. 20 depicts another embodiment of a
needle-dilator-sheath hub assembly.
[0025] FIGS. 20B-D depict additional features of access
devices.
[0026] FIGS. 21-27 depict various embodiments of guidewire grabbers
or stoppers.
[0027] FIGS. 28-32 depict an embodiment of an asymmetric needle hub
and a corresponding dilator hub.
[0028] FIGS. 33-34 depict transverse cross-sections of exemplary
sheaths.
[0029] FIG. 35 depicts another embodiment of needle-dilator-sheath
hub assemblies.
[0030] FIGS. 36-39 depict various components of the FIG. 21
embodiment. FIG. 39 depicts the components of FIGS. 37 and 38
assembled.
[0031] FIGS. 40-43 depict various views of another embodiment of a
needle-dilator-sheath hub assembly.
[0032] FIGS. 44-48 depict various component of an exemplary dilator
hub.
[0033] FIGS. 49-51 depict various views of an exemplary sheath.
[0034] FIG. 52 depicts an exploded view of an exemplary embodiment
of a sheath valve.
[0035] FIGS. 53-58 depict various views and operation of another
exemplary embodiment of a needle-dilator-sheath assembly.
[0036] FIGS. 59-68 depict various views and operation of a further
exemplary embodiment of a needle-dilator-sheath assembly.
[0037] FIGS. 69-75 depict various views and operation of yet
another exemplary embodiment of a needle-dilator-sheath
assembly.
[0038] FIGS. 76-79 depict various embodiments and views of devices
having trapping mechanisms.
[0039] FIGS. 80-84 depicts various embodiments and views of devices
having blunting mechanisms.
[0040] FIGS. 85-87 depict various embodiments of devices having
attachments between a needle hub and a dilator hub.
DETAILED DESCRIPTION
[0041] U.S. Patent Applications 60/343,814 and 10/329,173 describe
vascular access devices and are hereby incorporated herein by
reference.
[0042] In some embodiments, a dilator or a sheath and dilator are
mounted on a needle, which needle has a lateral opening proximal to
the needle distal tip. Prior to insertion, the needle is positioned
so that the distal end of the needle is distal to the distal end of
the dilator. After insertion of the needle into a blood vessel, the
needle opening permits blood to flow into an annular space between
the needle and the dilator to indicate that the distal end of the
needle has punctured the blood vessel. Additionally or
alternatively, blood flows into an annular space formed by the
sheath to indicate that the blood vessel has been punctured. In
addition, blood may flow to a transparent hub or an optional side
port to provide further indication access has been achieved and to
help the user to determine whether access has been gained to an
artery or a vein.
[0043] Once vascular access is achieved, that is, once the distal
tip of the needle punctures a blood vessel and blood flows through
a lateral opening in the needle to one of the annular spaces
described above and as appropriate, into a side port, a guidewire
is advanced or threaded through the needle, and then the entire
apparatus, including the needle, the dilator, and a sheath, can be
advanced over the guidewire into the blood vessel. Alternatively
the guidewire may be threaded through the needle, and then the
dilator and sheath can be advanced off the needle, over the
guidewire into the blood vessel. When the sheath is in position,
the inner dilator, needle and guidewire can be removed together.
Thus, the guidewire protects the needle tip, and the needle, with
the guidewire in it, can then be bent for added safety, to prevent
removal of the guidewire and consequential exposure of the needle
tip. Alternatively, the guidewire can be left in place for catheter
placement. In some embodiments, described in more detail below, the
distal tip of the needle can be contained within the dilator, which
also may contribute to safety.
[0044] In one embodiment, the dilator has a distal member that can
be advanced distally or the distal tip of the needle can be
retracted so that the distal tip of the dilator distal member
extends distally over the distal tip of the needle. The dilator
distal member then protects the blood vessel wall as the needle and
dilator, or the needle, dilator, and sheath, or the dilator and
sheath are advanced or withdrawn from a blood vessel, preferably
over a guidewire. In addition, when the needle, dilator, and/or
sheath are pulled out, the healthcare worker is protected.
[0045] In another embodiment, there is a coaxial dilator system,
with an inner dilator and an outer dilator. The inner dilator can
be advanced independently distally to the distal tip of the needle.
The inner dilator then covers the needle tip, the inner dilator
distal member then protects the blood vessel wall as the needle,
dilator or the needle, dilator, sheath are advanced or withdrawn
from a blood vessel, preferably over a guidewire. In addition, when
the needle or needle, dilator, and/or sheath are pulled out, the
worker is protected.
[0046] In another embodiment, the needle can be rotated relative to
the dilator or the dilator and sheath, so that the needle tip,
which is inserted into a blood vessel with the needle distal tip
bevel up, can be rotated 180.degree. in the vessel so that the
needle distal tip bevel is down. When the needle distal tip is in
this position, it is less likely that movement of the needle distal
tip will cause injury to the blood vessel. The proximate portion of
the needle member may have color coding, words, or other indicia to
indicate the relative position of the needle tip level. Also, the
needle member proximal portion may have a notch, pivot, indent, or
other mechanism to indicate relative position and/or to hold the
needle member in position relative to the dilator or the dilator
and sheath.
[0047] The disclosed vascular access devices have several uses,
including access to every vessel when a vascular sheath is needed
as in stent placement, percutaneous transluminal coronary
angioplasty (PTCA), etc. or when a peel-away sheath is needed, for
example, for inserting PICC lines, pacemaker leads, etc. In
addition, the disclosed vascular access devices would be useful for
access to dialysis grafts and fistulas, which are superficial
structures and where access is sometimes needed quickly, especially
during a de-clotting procedure. Another use would be for placement
of central lines (femoral, subclavian or internal jugular). Instead
of use of a large (18 G) needle (current technique), followed by
advancement of a dilator over a guidewire and exchanging it for a
triple lumen catheter or vascular sheath, a large needle or a small
needle can be used to gain vascular access with a vascular sheath
through which a triple lumen or any other catheter can be safely
placed.
[0048] The disclosed vascular access devices may provide several
advantages, the first of which is efficiency. Instead of the
current multi-step access method with an exchange of guidewires and
sheaths, these devices can reduce the number of steps and simplify
access. Another advantage is safety. After a vessel is accessed,
the guidewire can be left in to protect the needle tip. The needle,
dilator and guidewire can be removed together after the sheath is
in place. If no additional access is needed in the same procedure,
the needle can be bent for added safety. This is contrary to the
current technique where the unprotected bloody needle is removed
from the guidewire after vascular access is gained. Alternatively,
the guidewire can be left in place to provide further access
through the sheath and the dilator distal member protects the
distal tip of the needle and ultimately the user. Another advantage
is the reduction of infection. By minimizing the number of
guidewires and sheaths necessary to obtain vascular access, the
opportunities for inadvertent contamination are decreased. A
further advantage is that under non-hospital or field conditions,
use of the disclosed devices will decrease the possibility of
infection due to a non-sterile environment. A yet further advantage
in some embodiments is the added stiffness of the system. The added
stiffness provided by the needle may enable advancement of the
system without multiple dilatations and thereby reduce trauma to
the patient. In addition, the stiffness provided by the needle
and/or other internal components permits the use of softer
materials in forming the sheath, which may further reduce vascular
trauma. For example, the sheath of a 6 French device can be made of
a material having a hardness of about 55 durometer to about 75
durometer.
[0049] An even further advantage relates to the bleeding from the
needle, the dilator, and around the wires that occurs during
guidewire exchanges with current techniques. Such bleeding
increases the spread of blood over the surgical field and the
operator's gloves, thereby, increasing the chance of infection in
case an inadvertent needle stick happens. The disclosed devices can
decrease this risk of infection because the blood will flow into
the sheath rather than into the surgical field as in the current
technique.
[0050] Another and further advantage of some embodiments is that
there is no need for over-the-wire exchanges. The device can be
configured to eliminate the possibility of inadvertent guidewire
misplacement into the vascular system during the access procedure.
In the current technique, with exchange of the needle for a dilator
and then for the sheath, it is a known complication that the
operator fails to grasp the guidewire during those exchanges and
the guidewire is inadvertently advanced with the dilator or
catheter into the patient's vascular system. The guidewire then has
to be removed either surgically or snared percutaneously.
[0051] Lastly, the present devices can be cost-effective because
they may eliminate the need for an additional guidewire and coaxial
dilator to be used in gaining vascular access.
[0052] In FIGS. 1 and 2, a needle section 102 includes a needle 104
and a proximal portion 106 with a twist lock member 108, and a
dilator section 112 includes a dilator 114 and a hub 116. In one
embodiment, needle 104 has one or more openings 120. Dilator 114
may be clear, semi-opaque, or translucent so that when blood flows
into needle 104 and then through an opening 120 either (1) into an
annular space 122 between needle 104 and dilator 114 or (2) into or
through spaces (not shown) in dilator 114, the physician can see
the blood. This will indicate to the physician that the distal end
124 of needle 104 has punctured a blood vessel (not shown). The
ability to visualize a blood flash can provide other information as
well. For example, the user can tell whether an artery or vein has
been penetrated by the color of the blood (brighter red indicating
arterial blood, darker red or purple indicating venous blood), the
back pressure of the blood (higher pressure indicating arterial
access, lower pressure indicating venous access), the speed at
which the blood fills the device (slower filling being venous,
faster filling being arterial) and whether the blood is pulsatile
(pulsatile blood indicating arterial access, nonpulsatile blood
indicating venous access).
[0053] As can be seen in FIG. 2, dilator hub 116 releasably engages
needle proximal section 106. In some embodiments, the dilator hub
can include a conical recess that receives a conical member forming
a part of needle proximal section. Needle proximal section may
include an annular portion having threading that engages reciprocal
threading on the dilator hub. Other arrangements of threading,
detents, or other snap- or force-fit configurations that achieve
the same purpose of releasably engaging the proximal portions of
the needle and dilator sections are also contemplated.
[0054] Hub 116 may optionally have a porous vent 128. Needle
proximal portion 106 may optionally have a porous vent plug 130
that fits a channel 132 in fluid communication with lumen 134 of
needle 104, the optional conical recess, and needle proximal
portion 106 having lumen 136.
[0055] Needle proximal portion 106 may have color coding, words, or
other indicia, such as a pivot or notch, to indicate to the
operator the position of the bevel of distal tip 124 relative to
dilator 114. Also, there may be a mechanical fit between dilator
114 and needle 104 so that the operator would sense by feel or
sound when the needle has been rotated to change the position of
the needle tip bevel.
[0056] In the embodiment shown in FIGS. 3 and 4, a needle section
142 includes a needle 144 and a proximal portion 146 with a twist
lock member 148, a dilator section 150 includes a dilator 152 and a
hub 154, and a sheath section 160 includes a sheath 162 and a
proximal portion 164. In one embodiment, needle 144 has one or more
openings 149. Dilator 152 and sheath 162 may be clear, semi-opaque,
or translucent so that when blood flows into needle 144 and then
through opening 149 (1) into an annular space 170 between needle
144 and dilator 152, (2) into or through spaces (not shown) in
dilator 152, or (3) through an opening 172 into an annular space
174 between dilator 152 and sheath 162, the physician can see the
blood. As above, this will indicate to the physician that the
distal end 176 of needle 144 has punctured a blood vessel (not
shown). Dilator opening 172 may be positioned just proximal to
needle aperture 149, or proximal to the transition from tube (or
bullet) to conical tip. A dilator aperture 172 may also (or
additionally) be positioned as proximal as possible yet still
distal to seal 179. Alternatively, opening 172 may be positioned
inside the sheath proximal to portion 164. Sheath proximal portion
164 may have a port 178 so that blood can be aspired through a
syringe (not shown). The sheath may contain a hemostatic valve (not
shown) in the distal end 164 to prevent blood flow out the distal
end of the sheath. The sheath proximal portion 164 is shown as
having a frustoconical shape, but it may also have a distal
cylindrical region shaped to receive a tube-like cover for
packaging.
[0057] A drop of high-viscosity fluid may be placed in between the
needle internal diameter and the guidewire at the needle proximal
end. This can prevent the drawing of air into the device through
the space between the needle and guidewire when blood is aspirated
through the side port. Dow Corning 360 medical fluid, 12,500 cSt is
an example fluid but other similar materials can be used. Rubber
seals in the dilator hub can also help to seal the needle. The
fluid drop and/or airtight seals are particularly useful when the
device is being used to obtain venous access, because venous
placement is often confirmed by aspiration. Aspiration is usually
not necessary during arterial access, because the arterial blood
pressure is sufficient to cause the blood to enter the device.
[0058] Proximal sections 108 and 116 and 146 and 154, respectively,
may optionally have luer connecting members. For example, section
108 may have a male luer lock 129, and section 116 may have a
female luer connector 131. Sections 146 and 154 may have comparable
members, respectively.
[0059] As shown in FIG. 4 sections 142, 150, and 160 can be
inserted into one another. Proximal sections 146, 154, 164 can
twist or snugly fit together, such as with a luer connector,
threading, a pressure or snap fit, a detent/groove arrangement, a
post/hole arrangement, or a combination thereof. The structure
shown in FIG. 2 is especially applicable here.
[0060] In another embodiment shown in a partial cross-section in
FIG. 5, needle 180 has an opening or side hole 182. Dilator 184,
which is arranged coaxially to needle 180, has a substantially
hollow distal section 186 and a substantially solid proximal
section 188, which sections 186 and 188 are connected by rigid or
substantially rigid longitudinal members 190, to form an
interrupted or discontinuous structure. The space between sections
186 and 188 not occupied by members 190 constitutes an annular or
substantially annular space 194, into which blood can flow from
opening 182. Sheath 196 is transparent or translucent, so that the
blood in space 194 can be observed by the physician.
[0061] Dilator 184 may have one or more small openings, pores, or
porous material 200, for example, in sheath 196, to allow air or
gas to leave annular space 194 as blood enters. The openings
themselves, or the openings in the porous material, are small
enough that air will escape but blood will be retained. Suitable
porous materials include a porous polymer such as self-sealing,
white porous HDPE of pore size 2.5 microns.
[0062] The distal end 202 of a guidewire 204 may be preloaded, that
is, positioned within a lumen 206 of needle 180. In this way blood
will flow into needle 180 and out through opening 182, and not
proximally out lumen 206. Once the physician sees the blood in
annular space 194, guidewire 204 can be advanced distally through
lumen 206 into a blood vessel (not shown). Another view of the
relationship between needle 180, dilator longitudinal members 190,
and sheath 196 can be seen in the cross-sectional view shown in
FIG. 5A.
[0063] Separate configurations for a dilator member are shown in
more detail in FIGS. 6 and 7. In FIG. 6, a dilator 210 shown has
conical elements. A distal dilation section 212 includes a double
cone design with a passageway 214 extending from the tip of one
conical element 216 to the tip of another conical element 218. At
least two stabilizing longitudinal members 220 extend from distal
section 212 to a proximal section 222, which may include a single
conical element 224 with a passageway 226 and a proximal twist or
locking section 228.
[0064] The embodiment shown in FIG. 7 includes a dilator-needle
combination where the dilator device described in FIG. 6 also
includes a needle 232 that extends through passageway 214 to and
through passageway 226. Needle 232 has a proximal section 234 that
includes a twist or locking arrangement.
[0065] In the partial representation of an embodiment shown in FIG.
8, a dilator 240 is arranged circumferentially around a needle 242.
Dilator 240 has a distal portion 244 that extends distally toward
the distal tip 246 of needle 242. Alternatively, the inner,
elongated dilator is coaxially located within the larger outer
dilator. The inner elongated member can be advanced over the needle
to dilate the vessel and/or protect the tip. As depicted in FIGS.
9A to 9C, a needle 252 is positioned in a puncture opening 254 in a
blood vessel 256. A guidewire 258 extends distally from needle 252
into a lumen 260 of blood vessel 256. A dilator 262 positioned
circumferentially around needle 252 has a distal portion 264. As
shown in FIG. 9b, dilator distal portion 264 can be advanced over
needle 252 so that the distal tip 268 of dilator distal portion 264
extends distally of the distal tip 270 of needle 252. Then, when,
as shown in FIG. 9C, needle 252 and dilator 262 are advanced
distally over guidewire 258, needle distal tip 270 is protected by
dilator distal portion 264.
[0066] The embodiment shown in FIGS. 10A and 10B includes a coaxial
dilator system including inner dilator 276 and outer dilator 278.
Dilators 276 and 278 are arranged around needle 280, and the distal
end 282 of inner dilator 276 is initially slightly distal of the
distal end 284 of outer dilator 278. The proximal end (not shown)
of inner dilator 276 is advanced distally to cause inner dilation
distal end 282 to cover the distal end 288 of needle 280. Dilators
276 and 278 may interact or be held so that they retain their
relative positions with regard to each other and needle 280 as the
needle, dilator or needle, dilator, sheath combination is advanced
into or withdrawn from a blood vessel (not shown), optimally over a
guidewire (not shown).
[0067] The coaxial dilator system shown in FIGS. 10A and 10B
requires an activation system that causes one dilator to move in
relation to the other dilator. It is preferred that the inner
dilator would be advanced distally to cover the distal end of the
needle while the outer dilator remains constant, or in place. The
dilator system may be configured so that the outer dilator would
remain relatively, substantially in place while the inner dilator
is pushed, pulled, or slid in the distal direction. In the
embodiment shown in FIG. 11, a proximal needle section 290 is
circumferentially surrounded by a proximal inner dilator section
292 and an outer dilator section 294. Tapered needle hub 296 has at
least one annular projection or ring 298 that is received in an
annular groove 302 in the tapered outer dilator proximal hub 304.
Inner dilator hub 306 has threading 308 that engages reciprocal
threading 310 on needle 290 or on a separate needle member attached
to needle 290 or needle hub 296. Inner dilator hub 304 has a
projection or wing 312 that moves within, and is guided by, a slot
316 that prevents rotation of inner dilator 292 with respect to
outer dilator 294. It is contemplated that other mechanical
arrangements known or discernible to those skilled in the art would
be acceptable, so long as they permitted advancement of the distal
portion of the inner dilator over the distal portion of the needle
without rotation of the inner dilator relative to the outer
dilator.
[0068] In some embodiments, an access device may include a
guidewire preloaded or preloadable in a needle and a dilator
preloaded or preloadable in a sheath. The device may be provided as
a kit in various stages of assembly. For example, a kit may include
separate needle, guidewire, dilator, and sheath. The guidewire may
be preloaded in the needle. The sheath may be preloaded on the
dilator. The sheath and dilator may be preloaded on the needle. The
sheath, dilator, and needle may be preloaded on the guidewire. The
guidewire may be preloaded in the needle and provided with a
separate sheath preloaded on a dilator. The dilator, needle, and
guidewire may be preassembled and provided with a separate
sheath.
[0069] In one embodiment, access may be obtained as follows: a
needle is advanced into a vessel. When access is achieved, a
guidewire (either preloaded in the needle or now introduced) is
advanced into the vessel. The needle is then removed or partly
retracted, and a dilator (with or without preloaded sheath) is
advanced over the guidewire into the vessel. If the dilator is
preloaded with a sheath, the dilator (and optionally the wire) are
then removed, leaving the sheath in place. If the dilator is not
preloaded with a sheath, then the dilator is removed, and a sheath
is advanced over the guidewire into the vessel.
[0070] FIG. 12 depicts an alternate embodiment of a dilator 400.
The dilator may be of unitary construction. It may include a
bulging portion (or "bullet") 410 at its distal end 404; this
portion performs the actual dilating. The distal end is tapered,
such as with the illustrated frustoconical shape, to reduce tissue
trauma during insertion. The bullet may include an aperture 412 to
allow blood to pass from the needle (not shown), through the
bullet, and into the sheath. The rest of the dilator, extending to
the proximal end 402, may be a narrow-diameter spine 408. This
configuration may be preferred because only the forward portion of
the dilator is necessary to perform dilation; reducing the proximal
diameter increases the volume of the sheath in that region and can
improve visibility of the blood flash and reduce clotting. The
bulging portion of the dilator may have a cylindrical region 413 of
approximately or exactly constant diameter to facilitate sealing of
a sheath taper against the cylindrical region.
[0071] FIG. 12A depicts an alternate embodiment of a dilator 400 in
which aperture 412 is positioned in the proximal transition of the
bulging portion.
[0072] This arrangement may be better appreciated in FIG. 13, which
shows an exemplary arrangement of needle 414, dilator 400, and
sheath 420. Blood entering the tip 415 of the needle travels
through the needle, emerges into the bullet through needle aperture
418, and then passes into the sheath space through dilator aperture
412. FIGS. 13A-C show the indicated transverse cross-sections of
the FIG. 13 embodiment to illustrate better the spatial
relationships. The spine may be so sized as not to define
substantial volume between the spine and the needle; in this case,
little or no blood flows between the spine and the needle proximal
to aperture 412 because the spine does not contribute substantially
to the space between the dilator and the needle.
[0073] Of course, the positions of apertures 412 and 418 may be
varied, so long as they ultimately permit blood to flow from the
tip of the needle to the sheath space and/or the sheath sidearm
(and, it is preferred, not outside the device). Aperture 412 (or
another aperture in addition to aperture 412) may be positioned on
the spine 408. Needle aperture 418 may be positioned 0.5 centimeter
or more from the dilator end, or proximal to the dilator tip, or
proximal to the transition from tube (or bullet) to conical tip.
Dilator aperture 412 may be positioned within the bullet just
proximal to the needle aperture 418 (FIG. 15). Alternatively,
needle aperture 418 and dilator aperture 412 positioned in the
spine can be aligned with one another (not shown).
[0074] As shown in FIGS. 13D-E, the bullet 410 can include a
recessed portion 411. The recessed portion contributes to the space
between the dilator and sheath and therefore effectively increases
the space between the bullet and the inner diameter of the sheath.
This permits higher blood flow and can facilitate visualization.
The benefit can be further enhanced by positioning aperture 412 in
the recessed portion 411. FIGS. 13D-E also depict the bullet 410 as
a separate piece mounted on spine 408 at mounting aperture 409.
Alternatively, the bullet and spine can be integrally formed.
[0075] FIG. 14 depicts another embodiment of a
needle-dilator-sheath assembly, in which the dilator aperture 412
is omitted. Instead, a channel 422 is so formed in the distal end
of the spine 408 that it extends from inside the bullet 410' to the
sheath space. In this embodiment, blood entering the needle tip 415
can flow into the bullet through needle aperture 418, into the
bullet, through the channel, and into the sheath space.
[0076] FIGS. 15 and 16 depict still further embodiments in which
the dilator spine (and, consequently, the dilator hub) are omitted.
Instead, a bullet 400'' (FIG. 15) or 400''' (FIG. 16) is attached
directly to the needle 414 or 414', respectively. With the FIG. 15
embodiment, blood entering the needle tip flows through aperture
418 into the bullet and through aperture 412 into the sheath space.
With the FIG. 16 embodiment, blood flows down the needle 414' to
aperture 418' and directly into the sheath space. The bullet may be
solid or hollow. When using either of these embodiments, the needle
may be inserted fully into the vein either by spinning it 180
degrees (described above) or blunting the needle with the
guidewire, with a stylet, or with a sleeve external to the needle
tip. These embodiments provide a high optical path length for blood
visualization and may be particularly well suited for especially
small device sizes, such as 4 French and below, because a constant
diameter dilator tube or spine may occupy too much of the sheath
space to permit a readily visualizable blood flash.
[0077] FIGS. 17-20 depict various views of a hub assembly 500 for a
vascular access device. The hub assembly may include a needle hub
502, a dilator hub 520, and a sheath hub 540. The depicted needle
hub includes finger grips 504 and 508, which may be provided with
depressions 510 and ridges 512 to improve grippability. The needle
hub may be hollow. The grips may be separated from one another in a
rest condition by a distance d, so that the grips may be squeezed
together and thereby change the shape of the needle hub (to be
described in more detail shortly). The grips 504, 508 may each
extend like arms from a distal hinge portion 514 and contribute
respective halves 515 and 516 to the distal shaft of the needle
hub. A hollow needle (not shown) may be affixed to the needle hub
in the distal portion 514. The distal portion 514 of the needle hub
may be received in a chamber 528 of the dilator hub 520. The needle
hub may include one or markings, such as a dot, to indicate the
orientation of the needle tip bevel to aid the user in positioning
the needle for puncture. The needle hub also includes a mating
feature 518, such as a ridge (shown) or a depression (not shown)
that coordinates with a complementary feature 530 on the proximal
part of the dilator hub. By this arrangement, the needle hub is
held to the dilator hub through the interaction of the mating
features. When the grips are squeezed toward one another, the
needle hub's mating feature 518 is so compressed that it clears the
dilator hub's mating feature 530, and the needle hub is thereby
released from the dilator hub. This may best be appreciated in FIG.
19. The dilator hub, still connected to the sheath, may then be
advanced as a unit over the needle into the blood vessel to be
accessed. In addition, the needle hub could be moved into the
dilator hub, so that mating feature 518 engages recess 519 to clamp
the needle hub onto the guidewire and thereby provide a safe
starting/shipping configuration. (Alternatively, the needle can be
advanced with the dilator and sheath and rotated 180 degrees in the
vessel for safety, as described above.)
[0078] Mating feature 530 may be a hole, as shown in the figures.
This additionally provides a rotational lock to help ensure that
the needle bevel is correctly oriented. The post/hole configuration
also can allow the operator to remove the needle hub and reinsert
it at 180.degree. to the original orientation. This can help
left-handed users or facilitate positioning the device for
procedures in which space or anatomical constraints favor this
orientation. Alternatively, feature 530 can be a groove, to provide
rotational freedom where that is more desired or appropriate, such
as reorienting the sideport compared to its orientation in the
package.
[0079] The depicted dilator hub 520 has a distal portion 534 in
which a dilator (not shown) may be attached. The distal portion of
the dilator hub also has a distal mating feature 532 that interacts
with a complementary mating feature on the proximal portion of the
sheath 540 to keep the dilator engaged with the sheath. The
complementary features may together form, for example, a twist-lock
feature, so that the dilator is released from the sheath by
gripping the dilator (perhaps at depressions 522 and ridges 524)
and twisting it relative to the sheath. The mating feature between
the dilator and the sheath is described in more detail below.
[0080] The sheath 540 includes a main portion 541 and a cap 542,
between which is defines a valve space 554. The main portion
defines a chamber 558 that can receive the dilator and/or needle
and/or guidewire. The main portion may also define a distal channel
560. The sheath may also provide a port 544 for flushing, sampling,
etc. The sheath may also include grips, such as depressions 548 and
ridges 550 and a suture loop 551. FIG. 20 shows guidewire 568
passing through a channel defined through the device by the needle
hub, the dilator hub, and the sheath. The sheath can be a peelaway
sheath.
[0081] FIG. 20 also shows an alternate embodiment with some
exemplary modifications. In some embodiments, the outer surfaces of
grips 504' and 508' of needle hub 502' can diverge from one another
(instead of tapering toward one another as shown in FIG. 17); this
may help a user maintain a purchase on the needle hub while urging
the dilation/sheath combination forward and/or pulling the needle
hub backward. The sheath cap 542 may have one or more slots 564 to
provide a spring-like action to allow for the dilator hub to be
easily locked or unlocked (described in more detail below). A tube
may be attached and/or integrally formed with port 544. Dilator hub
520 may have a rubber seal near its distal end to seal the outer
diameter of the needle to the inner diameter of the dilator hub.
The seal may be especially useful when the device is used to venous
access procedures for the reasons given above. A drop of
high-viscosity fluid in the needle may also be included, as
described above. The sheath may include a ring 562 or other
protuberance for providing a grip surface to hold the sheath in
place while the dilator is withdrawn. The sheath main portion may
be smooth.
[0082] Some exemplary (but not required) dimensions for the
embodiment of FIGS. 17-20 are: [0083] needle bore ranging diameter
from 25 G to 14 G, preferably 21 G; [0084] exposed needle 3-7
centimeters long (3 cm for central access via radial artery; 5 cm
for typical applications; 6 cm for obese patients; 7 cm for femoral
access in obese patient); [0085] sheath length 3-15 cm, preferably
5-15 cm, more preferably 5.5 cm or 11 cm; [0086] sheath size 3-10
Fr, preferably 4-8 Fr, more preferably 4 Fr for radial access, or 6
Fr or 7 Fr for subclavian access; [0087] needle aperture 0.5
centimeter or more from dilator end, or proximal to the dilator
tip, or proximal to the transition from tube to conical tip; [0088]
needle may have second aperture 6 centimeters or less from needle
tip.
[0089] The sheath may have a radio-opaque tip.
[0090] In some embodiments, aspiration, flushing, or air-tightness
are necessary (such as central venous catheterization and various
procedures in interventional radiology). In such circumstances, it
may be important to block off the proximal end of the needle hub
where the wire sticks out and is open to atmosphere. Structures for
clamping the guidewire in the needle hub are described elsewhere
herein, but in some circumstances, the clamp should also provide an
air- or liquid-tight seal. One example of such a seal is a
Tuohy-Borst ("T-B") valve (an example of a Tuohy-Borst valve is
shown in FIG. 8 of U.S. Pat. No. 5,050,606, which is hereby
incorporated herein by this reference). A T-B valve or other
actuated valve (such as a duckbill-configured valve actuated by an
operator) may be included in the needle hub. In use, the valve may
be closed before use (the device may be shipped with the valve
closed, or the valve may be manually closed before a procedure).
This may serve to seal around the guidewire and to hold the
guidewire in place. When the vessel is punctured by the needle, the
valve may be opened (gently, to avoid jarring the needle tip) to
allow advancement of the guidewire. The valve may be left open or
may be closed to hold the guidewire in an advanced position.
[0091] As discussed above, confirmation that access has been
obtained in an artery versus a vein may be obtained by observing
the color of blood that flows into an access device. However,
simple color observation may not serve as sufficient confirmation.
A pressure gauge can be used to measure the pressure of
back-flowing blood to determine whether it has arterial pressure or
venous pressure. A pressure gauge, such as a transducer or column
2010 (FIG. 20B), may be attached to or form part of the side port
of an access device described herein. If a column is used, it may
be held vertically or at some other angle that includes a vertical
component. When the distal end of an access device has gained entry
to a blood vessel or other structure with a pressurized liquid, the
blood or pressurized liquid may pass through the device and into
the column; its height 2012 is indicative of the pressure of the
liquid. Comparatively high pressure indicates arterial access,
while comparatively low pressure indicates venous access. The
measurement of liquid column height may be made by an independent
instrument (ruler) or made directly if the sideport column is
graduated with markers 2014. The column may include a stopcock 2018
that controls access to a syringe connector 2020.
[0092] The side port may be clear, semi-opaque, or translucent to
permit visualization of blood or other substance in the side port.
In some embodiments, the sheath may be opaque and the side port
clear, semi-opaque, or translucent, so that blood or other liquid
is not visualized until it enters the side-port.
[0093] A covering may be placed over all or part of the guidewire,
such as over the portion of the guidewire that protrudes or would
protrude from the needle hub when the guidewire is loaded in the
needle (FIG. 20C). The covering may be flexible to facilitate
manual positioning of the guidewire and to preserve its tactile
"feel." The covering may provide an airtight or fluid-tight seal of
the proximal end of the device, particularly the needle hub. The
covering may also protect the sterility of the guidewire. The
covering may also prevent the wire from being advanced too far out
the distal end of the device (by being attached to the guidewire)
or from slipping out or being removed from the proximal end (by
being attached to some part of the device). It may also serve to
contain spillage of blood or other fluid, especially in the absence
of a side port. During use, when the guidewire is advanced, the
slack of the covering may "bunch up" around the guidewire (FIG.
20D).
[0094] In some embodiments, the dilator hub may be attached (FIG.
85) to the needle hub, such as by a filament (FIG. 87) or by a
membrane (FIG. 86) attached to the hubs and surrounding or
partially surrounding the needle. This attachment may prevent the
needle from being totally retracted from the dilator, thus exposing
the sharp needle tip. It may also provide blood containment.
[0095] In some embodiments, the dilator hub may interact with the
needle depending on their relative positions. One such embodiment
includes protrusions from the inner wall of the dilator hub into
the lumen. The solid needle cannula can pass between these
protrusions in either direction of motion. When the part of the
needle cannula interrupted by the side hole passes through the
dilator hub, however, the protrusions will catch on the hole. In
the example depicted in FIGS. 76-77, the protrusions are
directional, that is, they will prevent the dilator and needle from
separating, either by advancing the dilator, or equivalently by
pulling the needle back. However, they do not prevent the dilator
and needle from being pushed back together (either by retracting
the dilator or equivalently advancing the needle). In the example
depicted in FIGS. 78-79, the protrusions are not directional and
once one of them catches on, or protrudes into, the needle side
hole, neither sliding the dilator and needle further together, nor
separating them further, will be possible.
[0096] In some embodiments, the dilator hub may include a blunting
device that snaps onto the needle distal tip if and when the tip is
so retracted as to enter the dilator hub. FIGS. 80-84 illustrate
one example. In FIG. 80, the blunting device is held open by the
needle shaft. FIG. 81 shows the cross-section indicated in FIG. 80.
If the needle is retracted (FIGS. 82-83), the blunting device snaps
shut, cradling the needle distal tip. When the needle is fully
withdrawn from the device, its tip is protected (FIG. 84).
[0097] In some embodiments, the device may include a clip or other
obstructing piece that can be attached to, for example, the
guidewire, to prevent the guidewire from slipping distally while
packaged or during introduction of the needle. If not secured, the
guidewire may slip past the side aperture in the needle and thereby
impede the blood flash or might slip past the needle's bevel tip
and effectively blunt it. FIGS. 21-27 show examples of wire
grabbers or stoppers. As shown in FIGS. 21-22, a wire grabber 620
can be inserted in the needle hub slot 621 (FIG. 23, also FIGS.
28-29) so that guidewire 568 is held tightly between fingers 624
and 626. When the operator is ready to advance the guidewire, the
grabber is removed by pulling tab 622.
[0098] Alternatively, the wire stopper 630 shown in FIGS. 23-24 can
be used. The stopper similarly has fingers 636 and 638. These
extend from a body 632. The proximal end of the guidewire may be
affixed to the body 632, such as by being glued in hole 634. This
holds the guidewire in a loop and prevents the proximal end of the
guidewire from flailing about. When the guide is to be advanced,
the stopper is removed. The stopper then can be used as a handle to
control the guidewire and/or prevent advancement beyond the needle
hub. Other examples of handles/weights are shown in FIGS. 53, 59,
and 69. They do not necessarily include structures to grab or stop
the guidewire. The guidewire may also include markings at intervals
along its length, particularly along its proximal end, to indicate
how far the guidewire has been advanced during a procedure.
[0099] FIGS. 24A-C depict an embodiment of a wedge 660 that may be
positioned in the distal orifice of the needle hub 502 against the
guidewire to press it in place. In the depicted embodiment, the
wedge is an arc-shaped piece, but other shapes are possible, such
as round or cornered cross-sections. The wedge can include an
enlarged distal portion 662 that provides a surface more easily
grasped by a user. A vascular access device can be shipped with the
wedge in place to prevent movement of the guidewire during shipment
and to prevent movement of the guidewire during the initial steps
of gaining vascular access. When the user is ready to advance the
guidewire, the wedge can be removed, such as withdrawing from the
needle hub by grasping the distal portion.
[0100] FIGS. 25-27 depict a guidewire locking pin and a device
adapted to receive the locking pin. A hole 640 may be formed in the
device, such as in grip 508' (depicted) or in another portion of
the device. A pin, such as a hitch pin clip 642 may be positioned
in the hole such that one arm of the pin goes through the hole and
the other presses the guidewire onto the pincer face. The guidewire
can optionally be constrained by hooking its proximal end to the
pin, as shown in FIG. 27. A retaining mound may be formed in hole
640 complementary to the pin's shape so that the pin fits over this
mound and thereby is better retained in the hole.
[0101] FIGS. 28-32 depict an embodiment of an asymmetrical vascular
access hub assembly. FIGS. 28-29 depict the needle hub 502''. The
hub defines two grips 504'' and 508'' as before, but only one of
the grips (504'' in the drawing) is biased. When the grips are
pinched, then, grip 504'' moves toward grip 508'' to clamp the
guidewire (FIG. 32 depicts the flexed shape). This arrangement
reduces the number of moving parts and can thereby simplify the
manufacturing process and relax design tolerances. The needle hub
may include a mating feature 518' to mate with a complementary
feature 530' in the dilator hub. When the grips are pinched, grip
504'' is deformed, causing feature 518' to disengage complementary
feature 530'. The feature 518' may be omitted from the unbiased
grip 508''.
[0102] Any of the hub embodiments described herein may also include
a fin or fins 650 or pins that engage a complementary slot 652
(FIG. 31) in the dilator hub to prevent rotation before removal of
the dilator/sheath assembly from the needle hub.
[0103] FIGS. 32A-B show additional exemplary embodiments of a
needle hub 502''' and dilator hub 520A. The needle hub again may
have a single post 518'. In this case, one fin 650a is positioned
on one finger grip 508''', and the other fin 650b is on the other
grip 504'''. The dilator hub has complementary slots 652A, 652B
that line up with the grip-specific fins and do not line up with
one another.
[0104] As shown in FIGS. 33-34, the sheath tubing may be formed
ridges and/or depressions to improve grip during advancement. A
separate component that attaches or clamps reversibly onto the
sheath (e.g. from a material such as silicone rubber), in a
placement according to the preference of the operator, is another
way to improve grip for sheath advancement. Such a component could
be included in a kit.
[0105] FIG. 35 shows yet another embodiment of a hub assembly, and
FIGS. 36-39 show various portions thereof. This depicted embodiment
includes sheath 540 and needle hub 502' as previously described.
Dilator hub 520'' includes an insert 574 inside the dilator that
allows the dilator hub to interface with the needle hub and the
sheath. The insert includes a proximal end (shown in FIG. 36) that
may include mating feature 530' (FIG. 39) as described above for
mating feature 530. Insert 574 can be made from a single piece (not
shown) or from multiple pieces, such as major piece 578 (FIG. 37)
and minor piece 580 (FIG. 28). The major and minor pieces can be
fitted together in a variety of ways, such as by aligning
receptacles 582, 582 to receive bridging dowels. The insert may
include a distal interface feature 532', such as the depicted
recess, that interfaces with a complementary interface feature on
the sheath (shown, for example, in FIG. 35).
[0106] The embodiments of FIGS. 17-39 are used as follows: the
needle is introduced into the blood vessel. A blood flash may be
observed. A guidewire stopper, grabber, clip, or wedge, if present,
can be removed, thereby freeing the guidewire for distal
advancement. The guidewire is advanced into the needle and into the
blood vessel. The guidewire thereby protects the needle tip and
helps to prevent trauma during later manipulation. The needle hub
grips are squeezed, thereby levering the proximal portion of the
needle hub to clamp on and restrain the guidewire, while the distal
portion of the needle hub, via mating feature 518, is freed from
dilator hub via mating feature 532. The sheath/dilator hub may then
be advanced into the blood vessel. The guidewire can be removed now
or at a later stage. At this point, the needle is covered by the
dilator and is thereby further protected. The dilator can be then
unlocked from the sheath (described in detail with reference to
FIGS. 32-37) and withdrawn. The needle remains protected within the
dilator, and the two can be removed, optionally with the guidewire,
and discarded. This leaves the sheath in place in the blood vessel,
ready for use, such as insertion of a catheter.
[0107] FIGS. 40-43 depict various views of still another embodiment
of a hub assembly. In this embodiment, the needle hub is formed by
a clamshell-like assembly 582. A pin 584 may be inserted through an
aperture in one shell so that legs 586 straddle a guidewire 603 and
restrain it under the bridge 585 of the pin. The guidewire may have
a handpiece 608 and/or stopper 610. Needle 601 is fixed in the
needle hub, e.g., by bolt or screw 602 or other readily recognized
ways.
[0108] A silicone tube 600 may surround the guidewire to provide
some cushioning. When the device is to be used, the needle is
introduced in the blood vessel. The pin is removed, thereby freeing
the guidewire to be advanced through the needle. Once the guidewire
is positioned, the proximal portions 590 of the clamshell are
squeezed together, causing them to rotate at pivot point 592, and
they may be held together by tab 588. The squeezing of the proximal
portions of the clamshell cause divots 598 to impinge on the
guidewire 603 and/or tubing 600, thereby immobilizing the guidewire
with respect to the needle hub. At the same time, the pivoting of
the clamshell causes retainers 604 on the clamshell to swing clear
of corresponding notches 605 on the sheath 540, thereby releasing
the dilator hub 520 and sheath 540 to slide with respect to the
needle hub 582. The dilator hub/sheath assembly can then be
advanced as described previously.
[0109] FIGS. 44-48 provide several views of components of another
embodiment of a dilator hub assembly. As before, the dilator may
include an insert (in this case, a single piece). After the dilator
and sheath are advanced, the outer dilator hub piece may be rotated
relative to its insert. This causes protrusions 4402 on the inner
aspect of the outer dilator hub piece ride into depressions 4502 in
the insert, causing the proximal end of the insert to flex at flex
point 4504 and compress onto the needle, thereby fixing it in
relation to the dilator hub (and thereby trapping the needle tip
within the dilator for safety). At the same time, a cam system at
the distal end of the dilator hub causes the dilator hub to
disengage from the sheath. For example, the distal end of the
dilator hub may include a slot 4503 that initially engages a
protrusion on the inner surface of the sheath cap; when the dilator
hub is rotated, the protrusion is freed from the slot, and the
dilator hub can slide off the sheath. As shown in FIG. 47, the
dilator hub can include its own seal 4702 to help maintain a fluid
and/or gas-tight seal.
[0110] FIGS. 49-52 show various views and detail of sheath 540. The
dilator hub interface can engage the dilator to prevent its release
until the dilator is affirmatively disengaged from the sheath as
described previously. The valve cap and valve body may include
complementary features 4902, 4904 to prevent cap rotation relative
to the body. A seal 5102 may be embedded between the valve body and
the valve cap. A wide variety of seals may be used, such as those
described in U.S. Pat. Nos. 2,022,369, 5,273,546, 4,000,739,
4,424,833, and 4,430,081, each of which is hereby incorporated
herein by this reference. An exploded view of one exemplary seal is
shown in FIG. 52, in which the seal includes one piece with a hole
and a second piece with a slit. A single piece construction may
also be desirable where one side incorporates a hole and the other
a slit. Such valves may be called "passive" valves because they are
not actuated by an operator. A sheath may further or alternately
include an actuated valve, such as a Tuohy-Borst valve. The
actuated valve can be used to control the effective internal
diameter of the sheath (so that devices inserted through the sheath
fit snugly) and/or to provide an air- or liquid-tight seal. An
actuated valve may be included in a sheath by way of a separate
piece that is fitted onto the sheath.
[0111] Alternatively, the lumen of the sheath can have a
frustoconical shape or other smooth shape, rather than the
transition depicted in FIG. 51.
[0112] FIGS. 53-58; 59-68; and 69-75 depict and describe three
additional embodiments of needle-dilator-sheath hub assemblies.
[0113] FIG. 53 shows a starting condition of an assembly. In FIG.
54, tabs are squeezed on the needle hub to release the needle hub
and allow the dilator and sheath to be advanced. In FIG. 55, the
dilator hub is rotated and retracted. In FIG. 56, The dilator,
needle, and wire are removed. FIGS. 57-58 provide additional views
showing tab latch 5802, drain port 5804, and living hinge tab
5806.
[0114] FIGS. 59-60 show a starting condition of another assembly.
In FIG. 61, the needle hub is rotatable 180 degrees to orient the
needle bevel and unlock the dilator hub. In FIG. 62, the dilator
hub and valve body are released from a keyed disk on the needle
hub. FIGS. 63-66 show detail of how the dilator hub releases from
the needle hub with 180-degree stops. In FIGS. 67-68, tabs are
pinched to release the dilator hub from the valve body for
removal.
[0115] FIG. 69 shows a starting condition of yet another assembly.
As shown in FIG. 71, the distal edge of the needle hub is angled to
correspond to the needle bevel, thereby providing the practitioner
with an indication of needle orientation. In FIG. 72, the needle
hub is twisted out of a detent to release it from the dilator hub
and valve body. In FIGS. 70 and 73, the dilator hub is revealed as
the needle hub is released and the sheath/valve is inserted in the
subject. FIGS. 74-75 show twisting of the dilator hub to detach it
from the valve body and to allow its removal with the needle and
wire.
[0116] One embodiment of an access device which may be particularly
well-suited for peripherally-inserted central catheterization
(PICC) includes a needle hub having no valve and a peelaway sheath
with no valve or side port.
[0117] The access devices disclosed herein can be used for a wide
variety of purposes other than gaining vascular access. For
example, the can be used for draining fluid from abscesses,
draining air from a pneumothorax, and accessing the peritoneal
cavity. Devices used for draining may include side holes in the
sheath, such as near the distal end of the sheath.
[0118] The disclosed devices may be made from conventional,
physiologically acceptable materials. For example, the needle may
be made of a rigid polymer or a metal such as stainless steel,
nitinol, or the like. The tubes, bullets, sheath, dilator, and/or
spine can be made of metals described above and/or suitable
polymeric materials such as polyethylene, polypropylene,
fluoropolymers and copolymers such as perfluoro
(ethylene-propylene) copolymer, polyurethane polymers, PEBAX.RTM.,
PEEK, Nylon co-polymers and coextrusions. The other elements can be
made of the metals described above and/or suitable polymeric
materials, such as polyethylene, polycarbonate, ABS, polypropylene,
fluoropolymers and copolymers such as perfluoro
(ethylene-propylene) copolymer, polyurethane polymers or
co-polymers.
[0119] Although various features may be depicted in isolation, they
may, of course, be combined in various embodiments. For example, a
vascular access device may include a hub assembly as shown in FIGS.
17-20 with a bullet dilator such as shown in FIGS. 12-16, and a
guidewire stopper, grabber, and/or wedge as shown in FIGS. 21-27. A
wide variety of other combinations are possible and readily
appreciated.
* * * * *