U.S. patent application number 15/680952 was filed with the patent office on 2018-02-01 for devices and methods for catheter placement within a vein.
This patent application is currently assigned to Velano Vascular, Inc.. The applicant listed for this patent is Velano Vascular, Inc.. Invention is credited to Richard T. Briganti, Pitamber Devgon, Kevin J. Ehrenreich.
Application Number | 20180028800 15/680952 |
Document ID | / |
Family ID | 59654710 |
Filed Date | 2018-02-01 |
United States Patent
Application |
20180028800 |
Kind Code |
A1 |
Devgon; Pitamber ; et
al. |
February 1, 2018 |
DEVICES AND METHODS FOR CATHETER PLACEMENT WITHIN A VEIN
Abstract
An apparatus includes an introducer defining a lumen and a
catheter movably disposed in the lumen. The introducer has a distal
end portion configured to operably couple to an indwelling
peripheral intravenous line at least partially disposed in a vein.
The catheter is configured to be moved between a first position, in
which the catheter is proximal to the peripheral intravenous line
when the introducer is operably coupled thereto, and a second
position, in which a distal surface of the catheter is distal to
the introducer and disposed at a predetermined distance from a
distal tip of the peripheral intravenous line. The predetermined
distance defined between the distal surface of the catheter and the
distal tip of the peripheral intravenous line is based at least in
part on a venous anatomy associated with the vein.
Inventors: |
Devgon; Pitamber;
(Philadelphia, PA) ; Ehrenreich; Kevin J.; (San
Francisco, CA) ; Briganti; Richard T.; (Bala Cynwyd,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Velano Vascular, Inc. |
San Francisco |
CA |
US |
|
|
Assignee: |
Velano Vascular, Inc.
San Francisco
CA
|
Family ID: |
59654710 |
Appl. No.: |
15/680952 |
Filed: |
August 18, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15199290 |
Jun 30, 2016 |
9744344 |
|
|
15680952 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2039/0258 20130101;
A61M 2039/0282 20130101; A61B 8/0891 20130101; A61M 2039/027
20130101; A61M 25/0097 20130101; A61M 2039/0202 20130101; A61M
25/0113 20130101; A61B 8/0841 20130101; A61M 39/0247 20130101 |
International
Class: |
A61M 39/02 20060101
A61M039/02; A61M 25/00 20060101 A61M025/00; A61B 5/15 20060101
A61B005/15; A61B 8/08 20060101 A61B008/08 |
Claims
1.-30. (canceled)
31. An apparatus, comprising: an introducer defining a lumen, a
distal end portion of the introducer configured to couple to an
indwelling peripheral intravenous line at least partially disposed
in a vein; and a catheter at least partially disposed in the lumen
of the introducer, the catheter configured to be moved relative to
the introducer between a first position, in which the catheter is
proximal to the indwelling peripheral intravenous line when the
introducer is coupled thereto, and a second position, in which a
distal surface of the catheter is distal to the introducer, the
catheter having a length sufficient to place the distal surface of
the catheter a distance from a distal tip of the indwelling
peripheral intravenous line, the distance based at least in part on
a predetermined average distance between the distal tip of the
indwelling peripheral intravenous line and a branch vessel coupled
to the vein.
32. The apparatus of claim 31, wherein at least one of a valve or
the branch vessel is disposed at a position along the vein between
the distal surface of the catheter and the distal tip of the
indwelling peripheral intravenous line.
33. The apparatus of claim 31, wherein the branch vessel has a
volumetric flow rate greater than a volumetric flow rate
threshold.
34. The apparatus of claim 31, wherein the distance is between
about 0.0 millimeters (mm) and about 50.0 mm.
35. The apparatus of claim 34, wherein the distal surface of the
catheter is distal to the distal tip of the indwelling peripheral
intravenous line when the catheter is in the second position.
36. The apparatus of claim 34, wherein the distal surface of the
catheter is proximal to the distal tip of the indwelling peripheral
intravenous line when the catheter is in the second position.
37. The apparatus of claim 31, wherein the catheter is in a distal
most position relative to the introducer when the catheter is in
the second position such that the distance is about 30.0 mm.
38. The apparatus of claim 31, wherein the catheter is in a distal
most position relative to the introducer when the catheter is in
the second position such that the distance is about 15.0 mm.
39. The apparatus of claim 31, wherein the indwelling peripheral
intravenous line includes a hub opposite the distal tip of the
indwelling peripheral intravenous line, the distal surface of the
catheter being disposed in a distal position relative to the hub
and one of a proximal position relative to the distal tip of the
indwelling peripheral intravenous line or flush with the distal tip
of the indwelling peripheral intravenous line when the catheter is
in the second position.
40. The apparatus of claim 31, further comprising: an actuator
movably coupled to the introducer, a portion of the actuator
disposed in the lumen of the introducer and coupled to a proximal
end portion of the catheter, the actuator configured to be moved
relative to the introducer to move the catheter between the first
position and the second position.
41. The apparatus of claim 31, wherein the distal tip of the
indwelling peripheral intravenous line is disposed in a first
portion of the vein and the branch vessel is coupled to a second
portion of the vein, the distal surface of the catheter being
disposed in the second portion of the vein when the catheter is in
the second position, wherein a volume of blood accessible via the
second portion of the vein is greater than a volume of blood
accessible via the first portion of the vein.
42. An apparatus, comprising: an introducer defining a lumen, a
distal end portion of the introducer configured to be coupled to an
indwelling peripheral intravenous line at least partially disposed
in a vein; a catheter having a proximal end portion and a distal
end portion and defining a lumen extending through the proximal end
portion of the catheter and the distal end portion of the catheter,
at least a portion of the catheter being movably disposed in the
lumen of the introducer; and an actuator movably coupled to the
introducer, a portion of the actuator disposed in the lumen of the
introducer and coupled to the proximal end portion of the catheter,
the actuator configured to be moved relative to the introducer to
move the catheter between a first position, in which the catheter
is proximal to the indwelling peripheral intravenous line when the
introducer is coupled thereto, and a second position, in which a
distal surface of the catheter is distal to the indwelling
peripheral intravenous line and within the vein such that at least
one valve of the vein is disposed between a distal tip of the
indwelling peripheral intravenous line and the distal surface of
the catheter.
43. The apparatus of claim 42, wherein the distal surface of the
catheter is disposed a predetermined distance from the distal tip
of the indwelling peripheral intravenous line when the catheter is
in the second position.
44. The apparatus of claim 43, wherein the predetermined distance
is between about 0.0 millimeters (mm) and about 50.0 mm.
45. The apparatus of claim 43, wherein the catheter is in a distal
most position relative to the introducer when the catheter is in
the second position such that the predetermined distance is at
least 15.0 mm.
46. The apparatus of claim 42, wherein the distal surface of the
catheter is disposed a predetermined distance from the distal tip
of the indwelling peripheral intravenous line when the catheter is
in the second position, the predetermined distance is based at
least in part on a length of the indwelling peripheral intravenous
line.
47. The apparatus of claim 42, wherein the distal end portion of
the introducer is coupled to a lock, the lock is configured to be
coupled to at least one of a hub of the indwelling peripheral
intravenous line or an adapter coupled to the hub of the indwelling
peripheral intravenous line to couple the introducer to the
indwelling peripheral intravenous line.
48. The apparatus of claim 47, wherein the catheter has a length
sufficient to dispose the distal surface of the catheter at a
predetermined distance from the distal tip of the indwelling
peripheral intravenous line when the lock is coupled to the
adapter.
49. An apparatus, comprising: an introducer defining a lumen, a
distal end portion of the introducer configured to couple to an
indwelling peripheral intravenous line at least partially disposed
in a first portion of a vein; and a catheter at least partially
disposed in the lumen of the introducer, the catheter configured to
be moved a distance relative to the introducer between a first
position, in which the catheter is proximal to the indwelling
peripheral intravenous line when the introducer is coupled thereto,
and a second position, in which a distal surface of the catheter is
distal to and spaced apart from a distal tip of the indwelling
peripheral intravenous line such that the distal surface of the
catheter is disposed in a second portion of the vein, a volume of
blood accessible via the second portion of the vein being greater
than a volume of blood accessible via the first portion of the
vein.
50. The apparatus of claim 49, wherein the first portion of the
vein is a first compartment of the vein and the second portion of
the vein is a second compartment of the vein, the vein including a
valve separating the first compartment from the second compartment,
and the distal surface of the catheter is spaced apart from the
distal tip of the indwelling peripheral intravenous line when in
the second position such that the valve is disposed between the
distal tip of the indwelling peripheral intravenous line and the
distal surface of the catheter.
51. The apparatus of claim 50, wherein a portion of the peripheral
intravenous line dwelling in the first compartment of the vein
results in a reduction in the volume of blood accessible via the
first compartment of the vein.
52. The apparatus of claim 50, wherein the second compartment of
the vein is in fluid communication with a branch vessel such that a
volume of blood flowing through the branch vessel results in an
increase in the volume of blood accessible via the second
compartment of the vein, the branch vessel having a volumetric flow
rate greater than a volumetric flow rate threshold.
53. The apparatus of claim 49, wherein the vein includes at least
one branch vessel, a portion of the indwelling peripheral
intravenous line is disposed within the vein such that the distal
tip of the peripheral intravenous line is spaced apart from the
branch vessel, the first portion of the vein being a portion closer
to the distal tip of the peripheral intravenous line and the second
portion of the vein being a portion closer to the branch
vessel.
54. The apparatus of claim 49, wherein the distal surface of the
catheter is spaced apart from the distal tip of the indwelling
peripheral intravenous line by about 0.0 millimeters (mm) and about
50.0 mm when the catheter is in the second position.
55. The apparatus of claim 49, wherein the catheter is in a distal
most position relative to the introducer when the catheter is in
the second position such that the distal surface of the catheter is
spaced apart from the distal tip of the indwelling peripheral
intravenous line by about 30.0 mm.
56. The apparatus of claim 49, wherein the catheter is in a distal
most position relative to the introducer when the catheter is in
the second position such that the distal surface of the catheter is
spaced apart from the distal tip of the indwelling peripheral
intravenous line by about 15.0 mm.
57. The apparatus of claim 49, further comprising: an actuator
movably coupled to the introducer, a portion of the actuator
disposed in the lumen of the introducer and coupled to a proximal
end portion of the catheter, the actuator configured to be moved
relative to the introducer to move the catheter the distance
between the first position and the second position.
58. The apparatus of claim 49, wherein the distal end portion of
the introducer is coupled to a lock, the lock is configured to be
coupled to a hub of the indwelling peripheral intravenous line.
59. The apparatus of claim 49, wherein the distal end portion of
the introducer is coupled to a lock, the lock is configured to be
coupled to an adapter coupled to a hub of the indwelling peripheral
intravenous line to couple the introducer to the indwelling
peripheral intravenous line, the distance that the catheter is
moved is sufficient to place the distal surface of the catheter in
a distal position relative to the distal tip of the indwelling
peripheral intravenous line when the catheter is placed in the
second position.
60. The apparatus of claim 49, wherein the distance that the
catheter is moved is based at least in part on a combined length of
the indwelling peripheral intravenous line and a predetermined
average length between the distal tip of the indwelling peripheral
intravenous line and at least one of the valve or the branch
vessel.
Description
BACKGROUND
[0001] The embodiments described herein relate generally to fluid
transfer medical devices. More particularly, the embodiments
described herein relate to devices and methods for placing a
catheter within a vein, via an indwelling peripheral intravenous
catheter, at a position suitable for blood aspiration.
[0002] The cutaneous veins of the forearm and hand are the most
accessed sites for intravenous catheter insertions and
venipunctures for infusing fluid into and/or aspirating bodily
fluid from a patient. The standard procedure for blood extraction
(i.e. phlebotomy), for example, involves percutaneous insertion of
a metal needle ("butterfly needle") into a patient to gain access
to that patient's vein. The typical hospitalized patient encounters
a needle every time a doctor orders a lab test. Repeated needle
"sticks" are not only painful and a major source of patient
dissatisfaction, but can lead to significantly higher material and
labor costs (needles and tubing must be disposed of after every
attempt).
[0003] While most hospitalized patients receive a peripheral
intravenous (PIV) catheter that is configured to dwell within a
vein for an extended period, PIVs are generally used for infusing
fluids and medications rather than blood extraction. In some
instances, for example, the failure rates for aspiration reach
20-50% when a PIV has been indwelling (e.g., disposed in a vein)
for more than a day. Blood extracted from PIVs is often hemolyzed
(i.e., the red blood cells are often ruptured and their contents
released), which can result in an unusable sample and a need to
repeat the blood collection.
[0004] Several barriers can contribute to the shortcomings of
extracting blood through a PIV. Such barriers can include, for
example, catheter malfunctions, occlusion of the vein resulting
from the indwelling of the PIV, debris forming around the PIV,
collapse of the PIV or vein in response to the negative pressure
during aspiration, and/or the like. In addition, the venous anatomy
of the forearm and hand have not been well studied or described
and, as such, the venous anatomy itself and/or characteristics of
blood flow paths therethrough can further present barriers to
phlebotomy through an indwelling PIV.
[0005] Thus, a need exists for improved understanding of the venous
anatomy and for devices and methods for placing a catheter within a
vein, via an indwelling PIV, at a position suitable for blood
aspiration.
SUMMARY
[0006] Devices and methods for placing a catheter within a vein,
via an indwelling peripheral intravenous catheter, at a position
suitable for blood aspiration are described herein. In some
embodiments, an apparatus includes an introducer and a catheter.
The introducer has a distal end portion configured to be
operatively coupled to an indwelling peripheral intravenous line at
least partially disposed in a vein. The catheter is configured to
be moved between a first position, in which the catheter is
proximal to the peripheral intravenous line when the introducer is
operably coupled thereto, and a second position, in which a distal
surface of the catheter is distal to the introducer and disposed at
a predetermined distance from a distal tip of the peripheral
intravenous line. The predetermined distance defined between the
distal surface of the catheter and the distal tip of the peripheral
intravenous line is based at least in part on a venous anatomy
associated with the vein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is an illustration of a human forearm and human hand
showing the vasculature thereof.
[0008] FIG. 2 is a schematic illustration of a portion of a
peripheral intravenous line and a portion of a blood aspiration
catheter disposed within a portion of a vein according to an
embodiment.
[0009] FIGS. 3-7 are schematic illustrations of a portion of a
peripheral intravenous line and a portion of a blood aspiration
catheter disposed within a portion of a vein, each of which having
a different anatomic characteristic.
[0010] FIG. 8 is a perspective view of a fluid transfer device in a
first configuration, according to an embodiment.
[0011] FIGS. 9-11 are each cross-sectional views of the fluid
transfer device of FIG. 8 taken along the line 9-9 in the first
configuration, a second configuration, and a third configuration,
respectively.
[0012] FIG. 12 is a top view of a fluid transfer device in a first
configuration, according to an embodiment.
[0013] FIGS. 13 and 14 are cross-sectional views of the fluid
transfer device of FIG. 12 taken along the line 13-13, in the first
configuration and a second configuration, respectively.
[0014] FIGS. 15-18 are graphs illustrating data associated with a
diameter of a branch vessel in fluid communication with a vein and
a distance from a distal surface of a peripheral intravenous
catheter disposed in the vein to the branch vessel, according to
various embodiments of the peripheral intravenous catheter.
[0015] FIG. 19 is a graph illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein and
a distance from a distal surface of a peripheral intravenous
catheter disposed in the vein to a branch vessel in fluid
communication with the vein, according to an embodiment.
[0016] FIG. 20 is a graph illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein and
a distance from a distal surface of a peripheral intravenous
catheter disposed in the vein to a branch vessel in fluid
communication with the vein, according to an embodiment.
[0017] FIG. 21 is a graph illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein of
the hand, a portion of a vein of the forearm, and a portion of the
antecubital region and a distance from a distal surface of a
peripheral intravenous catheter disposed in the vein to a branch
vessel in fluid communication with the vein, according to an
embodiment.
[0018] FIG. 22 is a graph illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein and
a distance from an insertion point of a peripheral intravenous
catheter into the vein to a branch vessel in fluid communication
with the vein, according to an embodiment.
[0019] FIGS. 23-28 are graphs illustrating data associated with a
distance within a vein from a distal surface of a peripheral
intravenous catheter to a distal surface of a blood aspiration
catheter extending therethrough and predicted success rate
associated with placing the distal surface of the blood aspiration
catheter in a portion of the vein having a desired set of
characteristics, according to various embodiments.
[0020] FIG. 29 is a flowchart illustrating a method of using a
fluid transfer device to place a catheter within a vein, via an
indwelling peripheral intravenous catheter, at a position suitable
for blood aspiration, according to an embodiment.
[0021] FIGS. 30-43 illustrate various aesthetic and/or industrial
designs of a fluid transfer device each according to a different
embodiment.
[0022] FIGS. 44 and 45 are various views of a locking mechanism
configured for use with a fluid transfer device each according to a
different embodiment.
[0023] FIGS. 46-61 illustrate various fluid transfer devices each
with a different color and/or labeling scheme according to
particular embodiments.
DETAILED DESCRIPTION
[0024] In some embodiments, an apparatus includes an introducer and
a catheter. The introducer has a distal end portion configured to
be operatively coupled to an indwelling peripheral intravenous line
at least partially disposed in a vein. The catheter is configured
to be moved between a first position, in which the catheter is
proximal to the peripheral intravenous line when the introducer is
operably coupled thereto, and a second position, in which a distal
surface of the catheter is distal to the introducer and disposed at
a predetermined distance from a distal tip of the peripheral
intravenous line. The predetermined distance defined between the
distal surface of the catheter and the distal tip of the peripheral
intravenous line is based at least in part on a venous anatomy
associated with the vein.
[0025] In some embodiments, an apparatus includes an introducer, a
catheter, and an actuator. The introducer defines a lumen. A distal
end portion of the introducer is configured to be operably coupled
to an indwelling peripheral intravenous line at least partially
disposed in a vein. The catheter has a proximal end portion and a
distal end portion and defines a lumen extending through the
proximal end portion of the catheter and the distal end portion of
the catheter. At least a portion of the catheter is movably
disposed in the lumen of the introducer. The actuator is movably
coupled to the introducer. A portion of the actuator is disposed in
the lumen and coupled to the proximal end portion of the catheter.
The actuator is configured to be moved relative to the introducer
to move the catheter between a first position, in which the
catheter is proximal to the indwelling peripheral intravenous line
when the introducer is operably coupled thereto, and a second
position, in which a distal surface of the catheter is distal to
the indwelling peripheral intravenous line and within the vein such
that at least one of a valve of the vein or a branch vessel in
fluid communication with the vein is disposed between a distal tip
of the indwelling peripheral intravenous line and the distal
surface of the catheter.
[0026] In some embodiments, a method includes coupling a fluid
transfer device to an indwelling peripheral intravenous line at
least partially disposed in a vein of a patient. The fluid transfer
device includes at least a catheter configured to be moved relative
to the indwelling peripheral intravenous line. The catheter is
moved from a first position, in which the catheter is proximal to
the indwelling peripheral intravenous line, to a second position,
in which at least a portion of the catheter is disposed within the
indwelling peripheral intravenous line such that a distal surface
of the catheter is disposed at a predetermined distance from a
distal tip of the indwelling peripheral intravenous line. The
predetermined distance is based at least in part on a venous
anatomy associated with the vein. A volume of blood is transferred
via the catheter from the vein to a fluid reservoir in fluid
communication with the catheter. The catheter is moved from the
second position toward the first position after transferring a
desired volume of blood to the fluid reservoir. The fluid transfer
device is then decoupled from the indwelling peripheral intravenous
line after moving the catheter from the second position toward the
first position.
[0027] As used in this specification, the singular forms "a," "an"
and "the" include plural referents unless the context clearly
dictates otherwise. Thus, for example, the term "a member" is
intended to mean a single member or a combination of members, "a
material" is intended to mean one or more materials, or a
combination thereof.
[0028] As used herein, the terms "about" and "approximately"
generally mean plus or minus 10% of the value stated. For example,
about 0.5 would include 0.45 and 0.55, about 10 would include 9 to
11, about 1000 would include 900 to 1100.
[0029] As used herein, the terms "catheter" and "cannula" are used
interchangeably to describe an element configured to define a
passageway for moving a bodily fluid from a first location to a
second location (e.g., a fluid passageway to move a bodily fluid
out of the body). While cannulas and/or catheters can receive a
trocar, a guide wire, or an introducer to deliver the cannula
and/or catheter to a volume inside the body of a patient, the
cannulas and/or catheters referred to herein need not include or
receive a trocar, guide wire, or introducer. Similarly, the terms
"peripheral intravenous catheter" and "peripheral intravenous line"
are used interchangeably to describe a device configured to
percutaneously access a vein via venipuncture.
[0030] As used herein, the term "indwelling" when characterizing a
catheter or the like generally refers to a catheter that is at
least partially disposed within a portion of the body. For example,
an "indwelling peripheral intravenous catheter" (also referred to
as "indwelling peripheral intravenous line," "PIV catheter," "PIV
line," or "PIV") can be a peripheral intravenous catheter that is
percutaneously inserted into the body and at least partially
disposed within a vein. In general, the methods of using the
devices and/or embodiments described herein include gaining access
to a vein of a patient via an indwelling peripheral intravenous
catheter. In other words, the methods and/or embodiments described
herein involve gaining access to a vein of a patient via a
peripheral intravenous catheter previously inserted through the
skin of the patient and partially disposed within the vein.
[0031] As used herein, the words "proximal" and "distal" when used
in the context of a device refer to the direction closer to and
away from, respectively, a user who would place the device into
contact with a patient. Thus, for example, an end of the device
first touching the body of the patient would be a distal end of the
device, while an opposite end of the device (e.g., the end of the
device being manipulated by the user) would be a proximal end of
the device. The terms "proximal" and "distal" when used to describe
a portion of the body refer to positions and/or directions closer
to and away from, respectively, a central portion of the body.
Thus, for example, a patient's hand is distal to the patient's
forearm.
[0032] In some instances, the words "proximal" or "distal" can be
relative terms and do not necessarily refer to universally fixed
positions or directions. For example, a distal end portion of a
peripheral intravenous (PIV) catheter is configured to be inserted
into a vein of a patient's forearm while a proximal end portion of
the PIV catheter can be substantially outside of the body. Veins,
however, carry a flow of oxygen-poor blood from distal portions of
the body back to the heart and, as a result, PIV catheters are
generally inserted into a vein such that a distal tip of the PIV
catheter is disposed within the vein in a position proximal to the
insertion point (e.g., extending relative to the vein in a proximal
direction). Thus, a distal position relative to the PIV catheter
can refer to, for example, a proximal position relative to the vein
(e.g., closer to the heart).
[0033] The devices and methods described herein can be used to
advance a blood draw catheter at least partially through, for
example, an indwelling PIV to place a distal end of the blood draw
catheter in a desired position relative to a vein and/or the PIV.
As used herein, the terms "predetermined distance" and "desired
distance" generally refer to a distance defined between a distal
end of a blood draw catheter and a distal end of a PIV in which the
blood draw catheter is at least partially disposed. When describing
a "predetermined distance" and/or a "desired distance" defined
between the distal end of the catheter and the distal end of the
IV, it should be understood that such a distance is within, for
example, an acceptable range of predetermined distances. For
example, an acceptable range of predetermined distances can be
between, for example, 0.0 millimeters (mm) and about 50.0 mm. Thus,
in some instances, a predetermined distance between a distal end of
a first catheter and a distal end of a first PIV can be about 15.0
mm while in other instances, a predetermined distance between a
distal end of a second catheter and a distal end of a second PIV
can be above 30.0 mm. Furthermore, a predetermined distance can
refer to a positive distance in which a distal end of a catheter is
distal to a distal end of a PIV or a negative distance in which a
distal end of a catheter is proximal to a distal end of a PIV.
[0034] The devices and methods described herein generally relate to
the aspiration of blood from a vein of a patient, which is accessed
via an indwelling peripheral intravenous (PIV) catheter. The
cutaneous veins of the antecubital arm region, forearm, and hand
are the most accessed sites for intravenous catheterization. For
reference, FIG. 1 is illustrates a human forearm 10 and human hand
30 showing the vascular system thereof. While specific vascular
structures are identified, it is to be understood that the
proceeding identified regions do not constitute the entire vascular
system of the forearm and/or hand; rather, the regions of the
forearm 10 and the hand 30 are presented in FIG. 1 as a simplified
example suitable for the discussion of the embodiments and methods
herein. Moreover, it is to be understood that the vasculature
represented in FIG. 1 is but one example and that while serving
substantially the same function, the arrangement of an individual's
vascular system in the forearm and hand can vary from what is shown
in FIG. 1.
[0035] The venous system of the forearm 10 includes a basilic vein
11 and a cephalic vein 12, each of which extend distally to the
hand 30. The basilic vein 11 and the cephalic vein each provide a
flow of oxygen-depleted blood from distal portions of the hand 30
and forearm 10 to the vascular system of the upper arm (i.e., the
subclavian vein, not shown). A median cubital vein 13 branches from
the basilic vein 11 and establishes fluid communication between the
basilic vein 11 and a median vein 15 as well as fluid communication
between the basilic vein 11 and a median cephalic vein 16.
Similarly, an accessory cephalic vein 14 joins the median cubital
vein 13 to establish fluid communication between the cephalic vein
12 and the median cephalic vein 16. The median vein 15 and the
median cephalic vein 16 branch collectively to form perforating or
anastomotic veins 17. The basilic vein 11 and the cephalic vein 12
are each in fluid communication with the metacarpal veins 31 of the
hand 30, which in turn, are in fluid communication with the dorsal
digital veins 32. As shown in FIG. 1, the forearm 10 and the hand
30 can also include any number of veins and/or branches that
combine or divide the veins into a fewer number of veins or a
greater number of veins, respectively.
[0036] The arterial system of the forearm 10 includes a brachial
artery 21 and an ulnar artery 22, each of which extend distally to
the hand 30. The brachial artery 21 and the ulnar artery 22 each
provide a fluid of oxygen-rich blood from the vascular system of
the upper arm (i.e., the subclavian artery, not shown) to the
distal portions of the forearm 10 and hand 30. The brachial artery
21 branches into a median artery 23 and a radial artery 24. The
radial artery 24, in turn, branches into a metacarpal artery branch
25. The ulnar artery 22 and the metacarpal artery branch 25 supply
oxygen-rich blood to the hand 30. As shown in FIG. 1, the forearm
10 and the hand 30 can also include any number of arteries and/or
branches that combine or divide the arteries into a fewer number of
arteries or a greater number of arteries, respectively.
[0037] FIG. 2 is a schematic illustration of a blood draw catheter
160 and a peripheral intravenous catheter 180 partially disposed
within a vein 40 according to an embodiment. The vein 40 can be any
suitable vein such as those included in the forearm or hand of a
patient as described above with reference to FIG. 1. As shown, the
vein 40 defines a lumen that includes a set of valves V1, V2, and
V3. The vein 40 is in fluid communication with a set of branch
vessels (veins) B1, B2, B3. While the vein 40 is particularly shown
in FIG. 2, it should be understood that the arrangement of the vein
40 is presented by way of example and not limitation. Specifically,
while the valves V1, V2, and V3, and the branch vessels B1, B2, B3
(also referred to herein as "branches") are shown in a particular
arrangement relative to the vein 40, the arrangement illustrated in
FIG. 2 is intended to present a general schematic of known anatomic
structures of the vascular system. While the vascular structures
are schematically presented with reference to FIG. 2, specific
characterizations and/or data associated with these structures--at
least as it relates to blood draw via catheterization through a
peripheral intravenous catheter dwelling therein--is/are described
in further detail hereinbelow.
[0038] The valves V1, V2, and V3 (referred to collectively as
"valves V") disposed within the lumen of the vein 40 substantially
control the flow of blood through the lumen. Any of the valves V,
for example, can transition from a closed configuration to an open
configuration to allow a selective flow of blood therethrough. When
referring to the valve(s) V and/or any other valve(s) described
herein it should be understood that the valve(s) can be anatomic
structures within the vein or can be any other suitable form of
flow control serving a function similar to anatomical valves and/or
acting in a valve-like manner to obstruct and/or control blood flow
in one or more directions. For example, a vein can include any
number of anatomical valves formed of tissue and disposed in a
given position within the vein. Such a valve(s) typically control a
flow of blood within the vein in a single direction (e.g., in a
proximal direction or in a direction toward the heart). In other
words, valves generally limit and/or substantially prevent a
backflow of blood within the vein (e.g., in a distal direction or
in a direction away from the heart).
[0039] In other instances, however, an event can trigger or
otherwise can result in a valve-like response within a portion of
the vein that can selectively control a flow of blood through that
portion. For example, in some instances, a vasospasm of a portion
of the vein can result in a constriction of a lumen defined by the
portion of the vein sufficient to restrict and/or otherwise limit a
flow of blood therethrough (e.g., in a proximal and/or a distal
direction). In such instances, a relaxing of the portion of the
vein after the vasospasm can result in a dilation of the vein
and/or otherwise a return to a non-spastic arrangement, which in
turn, removes the limitation on the blood flow resulting from the
vasospasm. As such, the occurrence of a vasospasm along a portion
of a vein can effectively result in a valve-like response (albeit
in a proximal and/or distal direction) within that portion of the
vein sufficient to selectively control (e.g., limit or obstruct) a
flow of blood therethrough. In some instances, the presence of a
catheter within the vein and/or a contact between a portion of the
catheter and a portion of the vein wall can result in a vasospasm
of at least a portion of the vein. In other instances, a vein,
debris (e.g., thrombus), muscle response, constriction, and/or any
other structure, event, and/or response can act in a valve-like
function within the vein and/or can otherwise restrict a flow of
blood through the vein (e.g., in a proximal and/or distal direction
within the vein). By way of example, the flexing of a muscle, the
bending of a joint or appendage (e.g., elbow, arm, fingers, etc.),
the presence of an externally applied force (e.g., pressure applied
by a blood pressure cuff, pressure applied by a medical
professional's hand or finger(s), pressure applied by an ultrasound
probe), coughing or valsalva resulting in a temporary reversal of
blood flow, injection of substances resulting in vaso-inflammation,
and/or the like. Thus, the devices and methods described herein can
be configured and/or used to insert a blood draw catheter (e.g.,
the blood draw catheter 160) into a vein (e.g., the vein 40) and to
advance the blood draw catheter to a position within the vein that
is beyond and/or through any of the flow restrictions described
above, thereby placing the blood draw catheter in a position within
the vein that receives a substantially unrestricted flow of blood,
as described in further detail herein.
[0040] In some instances, one or more of the valves V can
transition between an open or closed configuration to, for example,
divert a flow of blood through a branch or the like. In some
instances, compartments defined between two adjacent valves in the
closed configuration can result in a significantly reduced flow of
blood through that compartment. In some instances, a flow of blood
can enter and/or exit a compartment defined by adjacent closed
valves via one or more branch vessels. The vascular system of a
person can include multiple veins that can branch from the vein 40
and/or join the vein 40, thereby forming a bypass or the like that
can define a flow path within which blood can flow around
occlusions of the vein 40 (see e.g., FIG. 1).
[0041] The flow characteristics associated with the vein 40 are
based at least in part on the arrangement of the vascular structure
thereof and/or in fluid communication therewith. For example, as
shown in FIG. 2, the vein 40 has a diameter D1 and each of the
branches B1, B2, and B3 (collectively referred to as "branches B")
has a diameter D2. In some instances, the volumetric flow rate of
blood through the vein 40 can be based at least in part on the
diameter D1 of the vein 40. Similarly, the volumetric flow rate of
blood through the vein 40 can be based on the diameter D2 of the
branches B, in which branches with a smaller diameter deliver a
smaller volume of blood to the vein 40 and branches with a larger
diameter deliver a larger volume of blood to the vein. Thus, when
the branches B in fluid communication with the vein 40 have a
larger diameter D2, the volumetric flow rate through the vein 40 is
greater than when the branches B have a smaller diameter. Although
the branches B1, B2, and B3 are shown in FIG. 2 as having the same
diameter, it should be understood that the diameter of each
branches B1, B2, or B3 can vary. As such, the vein 40 and/or
compartments of the vein 40 defined between adjacent valves V can
have localized areas of higher or lower volumetric flow rates.
[0042] As described above, a portion of the peripheral intravenous
catheter 180 and a portion of the blood draw catheter 160 are
disposed in the lumen of the vein 40. The peripheral intravenous
catheter 180 (also referred to herein as "peripheral intravenous
line" or simply "PIV") can be any suitable peripheral intravenous
catheter such as any suitable known PIV. The PIV 180 can have any
suitable length between a hub (not shown) and a distal surface of
the PIV catheter. For example, the length can be between about 19
millimeters (mm) (about 0.75 inches (in)) and about 45 mm (about
1.75 in). Similarly, the PIV 180 can have any suitable diameter D3.
For example, the diameter D3 can be between about 26-gauge (or
about 0.45 mm) and about 14-gauge (or about 2.0 mm). In some of the
embodiments described herein, the PIV 180 can be a Jelco.RTM. 1.0
in, 20-gauge catheter manufactured by Smiths Medical, St. Paul,
Minn., USA (referred to herein as "Jelco.RTM. 1.0 in, 20-gauge
catheter" or "Jelco.RTM. 1.0 in, 20-gauge PIV").
[0043] In use, the size of the PIV 180 is generally based, at least
in part, on a size of the vein in which the PIV 180 will be
disposed. For example, in some instances, the PIV 180 is inserted
into a portion of the basilic vein 11 of the forearm 10 (see FIG.
1). In some such instances, a diameter of the portion of the
basilic vein 11 (e.g., the diameter D1 of the vein 40) can be
sufficiently large to use, for example, a 20-gauge PIV (e.g., the
diameter D3 of the PIV 180). In other instances, such as when the
PIV 180 is inserted into a portion of a vein of the hand (e.g., the
metacarpal vein 31 of the hand 30 in FIG. 1), the diameter of the
vein (e.g., the diameter D1 of the vein 40) can preclude the use of
a PIV with a diameter larger than, for example, 26-gauge or
24-gauge.
[0044] In some instances, the positioning of the portion of the PIV
180 within the vein 40 results in at least a partial occlusion of
the lumen of the vein 40. That is to say, the presence of the PIV
180 within the vein reduces and/or restricts a flow of blood around
the PIV 180. For example, as shown in FIG. 2, the PIV 180 can be
inserted into the vein 40 such that a distal end portion is
disposed in a compartment defined between the valve V1 (e.g., a
proximal valve) and the valve V2 (e.g., a distal valve), which in
turn, receives a limited flow of blood due to the presence of the
PIV 180. In some instances, the distal surface of the PIV 180 (also
referred to as the "distal tip") can be distal to the branch B1 and
spaced apart from the branch B1 by a distance or length L1. In
other instances, the distal surface of the PIV 180 can be proximal
to the branch B1. In some instances, the flow of blood through the
compartment can be reduced despite the compartment receiving a flow
of blood from the branch B1 (FIG. 2) and/or regardless of the
position of the distal surface of the PIV 180 relative to the
branch B1. In some instances, the flow of blood into the
compartment can be reduced by about 10%, about 20%, about 30%,
about 40%, about 50%, about 60%, about 70%, about 80%, about 90%,
or about 99%. In other instances, the presence of the PIV 180 can
restrict the flow of blood through the compartment by 100%. In
still other instances, the presence of the PIV 180 can restrict the
flow of blood through the compartment by less than 10%.
[0045] In general, peripheral intravenous catheters such as the PIV
180 are used to infuse fluids into the body and are not used to
aspirate blood because of, for example, low blood return levels,
debris surrounding the distal tip of the PIV, kinks in the PIV,
hemolysis of blood samples, vein collapse, and/or the like. As
shown in FIG. 2, however, the blood draw catheter 160 (also
referred to herein as "catheter") can be inserted through a lumen
defined by the PIV 180 and used to aspirate blood. The catheter 160
can be any suitable size that is based at least in part on the size
of the PIV 180. For example, the catheter 160 can have a diameter
that is smaller than an inner diameter of the PIV 180, thereby
allowing the catheter 160 to be inserted therethrough.
[0046] The catheter 160 can be positioned at a predetermined
distance or length L2 from the distal surface of the PIV 180. As
described in further detail herein, the distance or length L2
between the distal tip of the PIV 180 and a distal surface of the
catheter 160 can be based at least in part on information
associated with the vascular structure of the vein 40 (e.g., number
and position of valves, number and position of branches, diameter
of the vein 40 or branches B, etc.). In some instances, the length
L2 can be sufficient to dispose the distal surface of the catheter
160 in a compartment defined between the valve V2 and the valve V3.
That is to say, the distal surface of the catheter 160 can be
disposed in a compartment of the vein 40 that is distal to the
compartment in which the distal tip of the PIV 180 is disposed, as
shown in FIG. 2. In some instances, the distal surface of the
catheter 160 can be disposed in a position within the vein 40
having a volumetric flow rate that is greater than a volumetric
flow rate through the compartment in which the distal tip of the
PIV 180 is disposed. In this manner, the catheter 160 can be used
to aspirate a volume of blood.
[0047] In some instances, the distal surface of the catheter 160
can be disposed at a distance or length L3 from the branch B3, as
shown in FIG. 2. In some instances, the distance or length L3 can
be a "buffer zone" or the like. As described in further detail
herein, in some instances, it may be desired to reduce the distance
or length L3 of the buffer zone to increase a likelihood of a
successful blood draw through the catheter 160. In other instances,
the distance of length L3 of the buffer zone may not substantially
impact the likelihood of a successful blood draw. Similarly, while
the distal surface of the catheter 160 is shown in FIG. 2 as being
proximal to the valve V3 in other instances the catheter 160 can be
positioned such that the distal surface of the catheter 160 is
distal to the valve V3. Thus, the placement of the catheter 160
within the vein 40 and relative to the PIV 180 can increase or
decrease a likelihood of successful blood draw therethrough, as
described in further detail herein. In some instances, for example,
it can be desirable to position the distal surface of the catheter
160 between about 1.0 in and about 1.25 in from the distal tip of
the PIV 180, as described in further detail herein.
[0048] While the vein 40 is shown in FIG. 2 as having a number of
valves V and branches B, a catheter can be inserted through a
peripheral intravenous line at least partially dwelling in a vein
having any suitable anatomical features and/or structures. In
general, the vascular structures of a person vary, at least
slightly, from the vascular structures of other people. The varying
vascular structures, in some instances, can impact the size, shape,
arrangement, and/or efficacy of blood aspiration via a PIV and/or
via standard phlebotomy methods. Thus, as described in further
detail herein, determining characteristics of vascular structures
and providing devices having a configuration based at least in part
on the characteristics of the vascular structures, in some
instances, can result in an increased success rate associated with
blood aspiration in general, and more specifically, with blood
aspiration through an indwelling PIV.
[0049] FIGS. 3-6 are schematic illustrations of a blood draw
catheter 260 and a peripheral intravenous catheter 280 partially
disposed within a vein 40 according to an embodiment. The blood
draw catheter 260 (also referred to herein as "catheter") and the
peripheral intravenous catheter 280 (also referred to herein as
"peripheral intravenous line" or simply "PIV") can be any suitable
catheter device or devices. For example, in some embodiments, the
catheter 260 and the PIV 280 can be substantially similar to the
catheter 160 and the PIV 180, respectively, described above with
reference to FIG. 2. In some embodiments, the catheter 260 can be
included in a fluid transfer device such as those described in
further detail herein. In some embodiments, the PIV 280 can be, for
example, a standard, commercially available peripheral intravenous
catheter such as a Jelco.RTM. 1.0 inch, 20-gauge catheter (as
described above with reference to the PIV 180). As such, the
catheter 160 and the PIV 180 are not described in further detail
herein.
[0050] As shown in FIG. 3, in some instances, the PIV 280 can be
inserted into and/or can be otherwise dwelling within a vein 40
having a branch vessel B in fluid communication with the vein 40
and a valve V formed proximally (e.g., downstream) of the branch
vessel B. That is to say, the arrangement of the catheter 260, PIV
280, and vein 40 is such that the branch vessel B is between a
distal end portion of the catheter 260 and the valve V. In some
instances, the presence of the PIV 280 and/or catheter 260 within
the vein 40 can result in a blockage and/or occlusion of the vein
40 distal to the PIV insertion point, which in some instances, can
result in an at least partial reduction in volumetric flow rate of
the blood therethrough. In some instances, the branch vessel B
(also referred to as "branch") can provide an inlet flow of blood
into the vein 40. Thus, in this arrangement, the distal end of the
catheter 260 can be disposed in a portion of the vein 40 receiving
a flow of blood from the branch B that is sufficient for blood
aspiration through the catheter 260.
[0051] While the flow of blood through the branch B is generally an
inlet flow of blood (e.g., a flow of blood from a distal position
to a proximal position of the branch and/or vein 40 and/or
otherwise in the direction of the heart), in some instances, the
branch vessel B can receive an outlet flow of blood from the vein
40. In some such instances, a negative pressure resulting from
aspiration through the catheter 260 can be sufficient to draw a
volume of blood into the catheter 260 despite the outlet flow of
blood from the vein 40 to the branch B. In other instances, the
outlet arrangement of the branch B can result in a portion and/or
compartment of the vein 40 being unsuitable for aspiration. In such
instances, a nurse, technician, phlebotomist, doctor, etc. can move
the catheter 260 (e.g., relative to the PIV 280 and the vein 40) to
place the distal tip of the catheter 260 in a different portion
and/or compartment of the vein 40 that is otherwise suitable for
aspiration. Thus, relocating the catheter 260 relative to the PIV
280 can place the catheter 260 in fluid communication with a
portion of the vein 40 receiving a flow of blood sufficient for
aspiration through the catheter 260 while maintaining access to the
vein 40 via the indwelling PIV 280. In other words, the catheter
260 can be relocated without performing a venipuncture otherwise
used to access the vein 40.
[0052] In some instances, the reduction in blood flow past the PIV
280 resulting from the at least partial occlusion of the vein 40
can be such that the success of aspirating a volume of blood is at
least partially dependent on the flow of blood from or through the
branch B. That is to say, in some instances, the absence of the
branch B can otherwise result in a volumetric flow rate within the
portion of the vein that is insufficient for blood aspiration
through the catheter 260. For example, FIG. 4 illustrates the PIV
280 and the catheter 260 dwelling within a vein 40 having a valve V
disposed between a distal tip of the catheter 260 and a branch
vessel B. In some instances, a volumetric flow rate associated with
a compartment of the vein 40 defined between, for example, a PIV
insertion site and the valve V (e.g., in which the distal tip of
the catheter 260 is disposed) can be insufficient for blood
aspiration through the catheter 260. In other instances, the
catheter 260 can be advanced relative to the PIV 280 such that at
least the distal tip of the catheter 260 extends through the valve
V, thereby placing the catheter 260 in fluid communication with a
flow of blood, for example, from the branch B. As described above,
the relocation of the catheter 260 relative to the PIV 280 can
place the catheter 260 in fluid communication with a portion of the
vein 40 receiving a flow of blood sufficient for aspiration through
the catheter 260 while maintaining access to the vein 40 via the
indwelling PIV 280.
[0053] In some instances, the reduction in blood flow past the PIV
280 resulting from the at least partial occlusion of the vein 40
can be such that the success of aspirating a volume of blood is not
dependent on the flow of blood from or through the branch B. For
example, FIG. 5 illustrates the PIV 280 and the catheter 260
dwelling within a vein 40 having a diameter that is sufficiently
large to allow blood to flow around the portion of the PIV 280
and/or catheter 260 dwelling in the vein 40. In some such
instances, the vein 40 is not in fluid communication with a branch
vessel that is between the catheter 260 and the valve V, yet a
volumetric flow rate through that portion of the vein 40 is
nonetheless sufficient for aspiration through the catheter 260.
Moreover, in some such instances, because a sufficient volume of
blood flows past the PIV 280, the location of the distal end of the
catheter 260 relative to a distal end of the PIV 280 can be
variable. That is to say, in such instances, the catheter 260
placement is not dependent on a position of a branch vessel and/or
a valve V. In some instances, for example, the distal tip of the
catheter 260 and the distal tip of the PIV 280 can be flush. In
other instances, the catheter 260 can remain within a portion of
the PIV 280 (e.g., the distal tip of the catheter 260 is proximal
to the distal tip of the PIV 280, relative to the user).
[0054] Conversely, in other instances, the PIV 280 and the catheter
260 can be dwelling within a vein 40 having a relatively small
diameter, as shown in FIG. 6. In such instances, the PIV 280 can
substantially block or occlude the lumen of the vein 40 such that
little or no flow of blood flows past the PIV 280. In such
instances, a portion of the vein 40 may also lack a branch vessel
and/or valve. As such, a negative pressure exerted through the
catheter 260 for aspiration, in some instances, can be sufficient
to collapse a portion of the vein 40. For example, the negative
pressure exerted through the catheter 260 can result in at least a
portion of the vein wall collapsing, which in turn, can at least
partially occlude an opening of the catheter 260, as illustrated by
the arrow AA in FIG. 7. In some instances, modulating a pressure
and/or a rate of pressure change can limit and/or reduce a
likelihood of vein collapse. Similarly, the catheter 260 and/or any
suitable portion of a fluid transfer device coupled to the catheter
260 can be configured to limit, modulate, cap, and/or control a
negative pressure exerted therethrough and/or can have a diameter
or design configured to limit a volumetric flow rate therethrough,
which in turn, can limit and/or reduce a likelihood of vein
collapse.
[0055] In some instances, the catheter 260 can be moved relative to
the PIV 280, for example, to place the distal end of the catheter
260 in a position within the vein 40 having a larger diameter
and/or that is otherwise able to resist collapse. For example, the
position within the vein 40 can be proximal to a branch vessel or
valve. In other instances, the catheter 260 can be removed from the
PIV 280 and can be replaced with, for example, a catheter having a
smaller gauge or the like, which in turn, can result in a decrease
in negative pressure associated with aspiration. In some instances,
after a vein collapse (e.g., as shown in FIG. 7), the catheter 260
can be advanced within the vein 40 to move the catheter 260 through
the collapsed portion, thereby disposing the opening of the
catheter 260 in a non-collapsed portion of the vein 40. As
described above, the relocation and/or replacement of the catheter
260 relative to the PIV 280 can allow for aspiration through the
catheter 260 while maintaining access to the vein 40 via the
indwelling PIV 280.
[0056] In some instances, any suitable fluid transfer device can be
used to insert a catheter though an indwelling PIV to draw a volume
of blood from a patient. For example, FIGS. 8-11 illustrate a fluid
transfer device 300 used for phlebotomy through a peripheral
intravenous line. The fluid transfer device 300 includes an
introducer 310, a catheter 360, an actuator 370, and an adapter
375. The fluid transfer device 300 can be any suitable shape, size,
or configuration and is configured to be coupled to, for example, a
peripheral intravenous line (NV). In some embodiments, the fluid
transfer device 300 can be similar to and/or substantially the same
as any of those described in U.S. Patent Publication No.
2014/0364766 entitled, "Systems and Methods for Phlebotomy Through
a Peripheral IV Catheter," filed Aug. 26, 2014 (referred to
henceforth as the "'766 publication"), the disclosure of which is
incorporated herein by reference in its entirety. As such, portions
of the fluid transfer device 300 (also referred to herein as
"transfer device" or "device") are not described in further detail
herein.
[0057] As described above, the transfer device 300 includes the
introducer 310, the catheter 360, the actuator 370, and the adapter
375. The adapter 375 can be any suitable adapter such as, for
example, a Y-adapter or a T-adapter. For example, in this
embodiment, the adapter 375 is a T-adapter including a first port
coupled to the introducer 310, a second port coupled to a cannula
(see e.g., FIG. 8), and a third port that can be coupled to the PIV
(not shown). In some embodiments, the ports can be and/or can
include a Luer Lok.TM. or the like that can fluidically seal the
ports when the adapter 375 is not coupled to a device (e.g., the
transfer device 300, a PIV, etc.).
[0058] The introducer 310 of the transfer device 300 includes a
first member 311 and a second member 313. The introducer 310 can be
any suitable shape, size, or configuration. For example, in some
embodiments, the introducer 310 can be disposed in and/or can have
a substantially telescopic arrangement (as shown in FIGS. 9-11). In
some embodiments, the introducer 310 can have a shape that is, for
example, similar to a syringe or the like. The first member 311
includes a proximal end portion and a distal end portion. The
proximal end portion of the first member 311 is configured to be
engaged by a user during operation (e.g., the proximal end portion
includes a flange or the like). The distal end portion of the first
member 311 includes and/or is otherwise coupled to a lock 350. For
example, the lock 350 can be a Luer Lok.TM. or the like configured
to couple the introducer 310 to the adapter 375 and/or an
indwelling PIV (not shown in FIGS. 8-11). Moreover, the lock 350
includes a seal member 320 that defines and/or forms a
substantially fluid tight seal with, for example, the first member
311. In addition, the seal member 320 receives a portion of the
second member 313 and/or the catheter 360 as the second member 313
and/or the catheter 360 is advanced beyond the seal member 320 in
the distal direction and maintains a substantially fluid tight seal
around the portion of the second member 313 and/or the catheter
360, thereby substantially preventing a backflow of fluid into the
introducer 310. The seal member 320 can be any suitable
configuration such as, for example, an O-ring, a one-way valve, a
diaphragm, a self-healing diaphragm, a check valve, or any other
suitable seal member.
[0059] The first member 311 slidably receives at least a portion of
the second member 313 and/or the actuator 370. The first member 311
defines a channel 312 that is configured to define a range of
motion for the second member 313 relative to the first member 311.
The channel 312 extends along a length of the first member 311
between the proximal end portion 3151 and the distal end portion
3152, as shown in FIGS. 9-11. More particularly, the channel 312
does not extend through the proximal end portion and/or the distal
end portion of the first member 311 (i.e., the channel 312 does not
extend the entire length of the first member 311). Thus, at least a
distal end portion the channel 312 is bounded by an inner surface
of the first member 311. The channel 312 can have any suitable
shape and/or size. For example, in some embodiments, the channel
312 has a first cross-sectional area at or near the proximal end
portion of the first member 311 and a second cross-sectional area
at or near a distal end portion of the first member 311. In some
embodiments, the channel 312 can be configured to fan-out, flare,
and/or otherwise widen along a length of the first member 311 in
the distal direction. As described in further detail herein, a
portion of the second member 313 can be movably disposed in the
channel 312, which in turn, defines, for example, a range of motion
associated with the second member 313 relative to the first member
311.
[0060] The second member 313 of the introducer 310 includes a
proximal end portion and a distal end portion. The distal end
portion of the second member 313 has a protrusion 314 extending
from an outer surface that is movably disposed within the channel
312 of the first member 311. The distal end portion of the second
member 313 includes and/or is coupled to a guide member 330 that
receives at least a portion of the catheter 360. The guide member
330 is configured to support and/or otherwise guide at least the
portion of the catheter 360 as the catheter 360 is advanced through
the introducer 310. For example, in some embodiments, the guide
member 330 can be formed from a metal or hard plastic (e.g., with a
higher durometer that the catheter 360), which can allow the guide
member 330 to advance through the introducer 310, a PIV (not
shown), and/or any obstruction or kink included therein. Moreover,
the second member 313 can include a seal member 315 disposed in a
distal position within an inner volume of the second member 313 and
about a portion of the guide member 330. The seal member 315 forms
a substantially fluid tight and/or substantially hermetic seal
about the guide member 330. In some embodiments, the seal member
315 can be formed from an absorbent material such as POREX.RTM. or
the like.
[0061] The arrangement of the introducer 310 is such that when the
second member 313 is moved relative to the first member 311, the
protrusion 314 is moved within the channel 312. As such, the
channel 312 (and/or the portion of the inner surface defining the
channel 312) defines a range of motion for the second member 313
relative to the first member 311. For example, with the channel 312
extending along the length of the first member 311, the range of
motion associated with the second member 313 as defined by the
channel 312 includes an axial motion (e.g., a distal and/or
proximal direction) of the second member 313 within the first
member 311 between its proximal position and its distal position.
Similarly, the increased width associated with the second
cross-sectional area can define, for example, a rotational range of
motion about a longitudinal centerline of the first member 311,
thereby allowing the second member 313 to at least partially rotate
within and/or relative to the first member 311 (as described in
detail in the '766 publication).
[0062] As shown in FIGS. 8-11, the actuator 370 of the transfer
device 300 includes a proximal end portion and a distal end
portion. In some instances, a user can engage the proximal end
portion to manipulate at least the actuator 370 of the transfer
device 300 to transition the transfer device 300 between, for
example, a first configuration (FIGS. 8 and 9), a second
configuration (FIG. 10), and a third configuration (FIG. 11). The
proximal end portion is coupled to a secondary catheter 378 that
includes a coupler 379, which in turn, can be coupled to a fluid
reservoir (e.g., an evacuated container, sample reservoir, syringe,
etc.). As described in further detail herein, the actuator 370
couples to the catheter 360 and places a lumen of the catheter 360
in fluid communication with a lumen of the secondary catheter 378.
Thus, when the coupler 379 is coupled to the fluid reservoir, the
catheter 360 is placed in fluid communication with the fluid
reservoir.
[0063] The actuator 370 can have any suitable shape, size, or
configuration. At least a portion of the actuator 370 can be
inserted into the second member 313 and can be moved between, for
example, a proximal position and a distal position (e.g., in a
telescopic motion). In some embodiments, the actuator 370 can
define a slot or the like configured to receive a portion of the
second member 313. In such embodiments, a length of the slot can
define a range of motion of the actuator 370 relative to the second
member 313.
[0064] The catheter 360 of the transfer device 300 can be any
suitable shape, size, or configuration. For example, in some
embodiments, the catheter 360 can be about a 20-gauge catheter or
the like. In other embodiments, the catheter 360 can be greater
than or less than a 20-gauge catheter. Moreover, the catheter 360
can be formed of any suitable biocompatible material having any
suitable stiffness and/or Shore durometer such that the catheter
360 has a desired flexibility, which in turn, can allow the
catheter 360 to elastically deform without, for example, kinking or
the like.
[0065] The catheter 360 has a proximal end portion and a distal end
portion. The proximal end portion of the catheter 360 is coupled to
the actuator 370 such that the lumen defined by the catheter 360 is
in fluid communication with the secondary catheter 378. The distal
end portion of the catheter 360 can be arranged in any suitable
manner. For example, in some embodiments, the distal end portion of
the catheter 360 can include a substantially open end-surface
configured to place the lumen 3209 in fluid communication with, for
example, a vein. In some embodiments, the distal end portion can
include the open end-surface and any number of openings disposed on
the side (e.g., circumference) of the catheter 360, as described in
the '766 publication.
[0066] As shown in FIGS. 8 and 9, prior to use, the transfer device
300 can be disposed in a first configuration (e.g., an expanded
configuration), in which the second member 313 is disposed in a
proximal position relative to the first member 311 and the actuator
370 is disposed in a proximal position relative to the second
member 313. In this manner, the guide member 330 is disposed within
the first member 311 of the introducer 310 and at least the distal
end portion of the catheter 360 is disposed within the guide member
330. Said another way, the catheter 360 is at least partially
disposed in the introducer 310 when the transfer device 300 is in
the first configuration. In some embodiments, the inner volume of
the second member 313 and the inner volume of the first member can
be substantially fluidically sealed such that the inner volumes are
each substantially sterile. As a result, at least a portion of the
catheter 360 is maintained in a substantially sterile environment
prior to use.
[0067] While in the first configuration, a user (e.g., a
phlebotomist) can manipulate the transfer device 300 to couple the
first member 311 of the introducer 310 to the adapter 375. In other
embodiments, the transfer device 300 can be pre-assembled with the
adapter 375. In still other embodiments, the transfer device 300
can be used without the adapter 375. Although not shown in FIGS.
8-11, the third port of the adapter 375 can be coupled to a PIV. As
a result, the introducer 310 is coupled (e.g., indirectly via the
adapter 375 or directly when used without the adapter 375) to the
PIV. Likewise, although not shown in FIGS. 8-11, the coupler 379
disposed at the end of the secondary catheter 378 can be coupled to
a fluid reservoir or the like to place the lumen of the catheter
360 in fluid communication with the fluid reservoir.
[0068] Once coupled to the PIV and the fluid reservoir, the user
can manipulate the transfer device 300 by engaging the first member
311 and the actuator 370 and exerting a force on the actuator 370.
The force exerted on the actuator 370 moves the actuator 370 and
the second member 313 in the distal direction relative to the first
member 311, thereby placing the transfer device 300 in the second
configuration, as indicated by the arrow BB in FIG. 10. More
specifically, the actuator 370 moves the second member 313 from a
proximal position to a distal position relative to the first member
311, while the actuator 370 remains in a relatively fixed position
(e.g., its proximal position) relative to the second member 313.
For example, in some embodiments, the arrangement of the first
member 311, the second member 313, and/or the actuator 370 can be
such that a relative movement thereby is controlled in a desired
manner. Specifically, the second member 313 can be maintained
substantially in the proximal position relative to the first member
311 until the force is applied (e.g., either directly or
indirectly) to the second member 313 that is sufficient to move the
second member 313 relative to the first member 311. In a similar
manner, the actuator 370 can be maintained substantially in the
proximal position relative to the second member 313 until a force
is applied on the actuator 370 that is sufficient to move the
actuator 370 relative to the second member 313.
[0069] As shown in FIG. 10, the actuator 370 and the second member
313 are collectively moved relative to the first member 311 in
response to the applied force on the actuator 370. As such, a
portion of the force moves the second member 313 within the first
member 311 (e.g., the protrusion 314 within the channel 312), while
the actuator 370 is retained in a substantially fixed position
relative to the second member 313. Thus, a force sufficient to move
the second member 313 relative to the first member 311 is less than
a force sufficient to move the actuator 370 relative to the second
member 313. Such an arrangement can, for example, ensure that the
second member 313 is relative to the first member 311 prior to the
actuator 370 being moved relative to the second member 313.
[0070] As shown in FIG. 10, the movement of the second member 313
to the distal position relative to the first member 311 advances
the guide member 330 (coupled thereto) in the BB direction to a
position in which at least the distal end portion of the guide
member 330 is disposed in and extends past an end of the PIV. More
specifically, as the second member 313 is moved to its distal
position, the guide member 330 is concurrently advanced through a
port or "basket" of the PIV (not shown). As described above, the
guide member 330 is configured to have a stiffness and/or is formed
from a material(s) with a hardness or durometer that is sufficient
to pass through the port of the PIV substantially without kinking,
breaking, bending, plastically deforming (e.g., permanently
deforming), etc. Moreover, the guide member 330 can have a length
and hardness that is sufficient to pass through any suitable PIV to
dispose at least the distal end portion in a distal position
relative to the end of the PIV. In some instances, the guide member
330 can be arranged such that when the second member 313 is in its
distal position relative to the first member 311, the distal end
portion of the guide member 330 is disposed in a vascular structure
and at least partially outside of the PIV. Furthermore, with the
actuator 370 maintained in a relatively fixed position relative to
the second member 313, the distal end portion of the catheter 360
is maintained within the guide member 330, as shown in FIG. 10.
[0071] Once the second member 313 in its distal position, the
applied force exerted on the actuator 370 can move the actuator 370
from its proximal position to its distal position relative to the
second member 313. For example, the portion of the applied force
that was operable in moving the second member 313 relative to the
first member 311 is instead operable in moving the actuator 370
from its proximal position to its distal position relative to the
second member 313, as indicated by the arrow CC in FIG. 11. The
movement of the actuator 370 to its distal position advances the
catheter 360 in the CC direction to a position in which at least
the distal end portion of the catheter 360 is disposed in and
extends past the PIV (e.g., a second position and/or a desired or
predetermined position). The catheter 360 can be advanced such that
the distal end portion of the catheter 360 extends beyond the
distal end portion of the guide member 330 to be disposed in the
vascular structure and at least partially outside of the PIV and
the guide member 330 (e.g., at a predetermined position). With the
catheter 360 advanced, for example, to the second position (e.g.,
the predetermined position), the lumen of the catheter 360 can
receive a flow of bodily fluid, which can flow therethrough and
into the fluid reservoir. For example, in some embodiments, the
fluid reservoir can be an evacuated reservoir such as a
Vacutainer.RTM. tube, which can exert a suction force through the
lumen of the catheter 360. Thus, the bodily fluid (e.g., blood) is
drawn through the lumen of the catheter 360 and the lumen of the
secondary catheter 378 and into the fluid reservoir. In this
manner, a phlebotomist can collect (e.g., draw) a given amount of
blood through an existing peripheral intravenous line without the
need for additional needle sticks.
[0072] As described herein, in some embodiments, the predetermined
distance can be based on, for example, one or more characteristics
associated the vasculature anatomy of the patient. In some
instances, for example, the PIV can be a Jelco.RTM. 1.0 in,
20-gauge catheter and the catheter 360 can be advanced to a
position such that a distance between the distal tip of the
catheter 360 and the distal tip of the PIV is between about 0.0 mm
and about 50.0 mm. In the embodiment shown in FIGS. 8-11, for
example, the predetermined distance can be about 15.0 mm beyond the
distal end of the PIV when the catheter 360 is in the second
position. As described above with reference to FIGS. 3-7, in some
instances, the successful aspiration of a volume of blood from the
vein through the catheter 360 can be based at least in part on one
or more characteristics associated with the vascular anatomy. For
example, in some instances, disposing the distal end of the
catheter 360 at about 15.0 mm from the distal end portion of the
PIV can, in some instances, place the distal end of the catheter
360 in position within the vein receiving a desired volumetric flow
of blood (e.g., a branch is disposed between the catheter 360 and a
valve and/or any other suitable venous arrangement).
[0073] In some instances, however, the second position of the
catheter 360 may be such that the distal end of the catheter 360 is
disposed in a portion of the vein having a flow of blood
insufficient for aspiration. As such, the user can engage the
actuator 370 to move the catheter 360 in the distal direction or
the proximal direction to place the distal end of the catheter 360
in a portion of the vein having a flow of blood sufficient for
aspiration through the catheter 360. In other words, the
predetermined distance can be any suitable distance within, for
example, a predetermined range of distances (e.g., between about
0.0 mm and about 50.0 mm).
[0074] Once a desired volume of blood is transferred to, for
example, a fluid reservoir such as an evacuated fluid reservoir or
tube (e.g., coupled to the coupler 379), the user can retract the
actuator 370, which in turn moves the catheter 360 in a proximal
direction from the second position toward the first position. The
user can then decouple the device 300 from the adapter 375 and/or
the PIV and decouple the fluid reservoir from the coupler 379. In
some instances, the device 300 can then be safely discarded.
[0075] In some instances, it may be desirable to rotate the
catheter 360 relative to the first member 311, thereby rotating the
distal end portion within the vascular structure (e.g., to prevent
a suctioning of the distal end portion to a wall of the vascular
structure). In such instances, the user can, for example, rotate
the actuator 370 and the second member 313 relative to the first
member 311. More specifically, manipulation of the actuator 370 by
the user can result in a rotation of both the actuator 370 and the
second member 313 relative to the first member 311. As described
above, the channel 312 can have a cross-sectional shape and/or area
at or near the proximal end portion of the first member 311 that is
associated with and/or slightly larger than a size of the
protrusion 314, thereby defining the rotational range of motion of
the second member 313 when disposed in the proximal position (e.g.,
about 30 degrees, about 60 degrees, about 90 degrees, about 120
degrees, about 180 degrees, about 210 degrees, or more). In some
instances, such rotation of the actuator 370 and the second member
313 can, for example, reduce a likelihood of the distal end portion
of the catheter 360 forming suction against a wall of the vascular
structure (e.g., a vein). In some instances, it may be desirable to
rotate the second member 313 as the actuator 370 is being moved
toward its distal position, as described in the '799
publication.
[0076] While the fluid transfer device 300 is particularly shown
and described above with reference to FIGS. 8-11, in other
embodiments, any suitable fluid transfer device can be used to
access a vein via a PIV and to place a catheter in a desired
position within the vein or within the PIV to aspirate a volume of
blood from the patient. For example, FIGS. 12-14 illustrate a fluid
transfer device 400 for phlebotomy through a peripheral intravenous
line or catheter in a first configuration and second configuration,
respectively, according to an embodiment. The fluid transfer device
400 (also referred to herein as "transfer device") is configured to
couple to and/or otherwise engage an indwelling peripheral
intravenous catheter (PIV) to transfer fluid from (e.g., aspiration
of blood) and/or transfer fluid to (e.g., infusion of a drug or
substance) a vein of a patient, as described in further detail
herein. The transfer device 400 can be any suitable shape, size,
and/or configuration. For example, as shown in FIGS. 12-14, the
transfer device 400 includes at least an introducer 410, a catheter
460 (or cannula), and an actuator 470. In some embodiments, the
transfer device 400 can be similar to and/or substantially the same
as any of those described in U.S. patent application Ser. No.
15/014,834 entitled, "Devices and Methods for Fluid Transfer
Through a Placed Peripheral Intravenous Catheter," filed Feb. 3,
2016 (referred to henceforth as the "'834 application"), the
disclosure of which is incorporated herein by reference in its
entirety. As such, some aspects of the transfer device 400 are not
described in detail herein and should be considered substantially
similar to such aspects of the transfer devices described in the
'834 application unless explicitly expressed otherwise.
[0077] The introducer 410 of the transfer device 400 can be any
suitable configuration. For example, in some embodiments, the
introducer 410 can be an elongate member having a substantially
circular cross-sectional shape. The introducer 410 has an outer
surface 435 and defines an inner volume 413 within which at least a
portion of the catheter 460 and at least a portion of the actuator
470 are movably disposed. Although not shown in FIGS. 12-14, a
proximal end portion of the introducer 410 can include an opening
or port configured to movably receive a portion of the catheter
460. As such, a first portion of the catheter 460 can be disposed
within the inner volume 413 and a second portion of the catheter
460 can be disposed outside of the inner volume 413. A distal end
portion of the introducer 410 includes and/or is coupled to a lock
450 configured to physically and fluidically couple the introducer
410 to the PIV, as described in further detail herein.
[0078] As shown in FIGS. 12-14, the outer surface 435 of the
introducer 410 includes a set of ribs 436 distributed along at
least a portion of the introducer 410. More particularly, each rib
436 extends widthwise along at least a portion of the introducer
410 with each rib 436 successively distributed lengthwise along at
least the portion of the introducer 410. In this manner, the outer
surface 435 defines alternating local minima and local maxima
arranged along the portion of the length of the introducer 410, as
described in detail in the '834 application. The arrangement of the
transfer device 400 is such that a portion of the actuator 470 is
configured to be advanced along the outer surface 435 forming the
set of ribs 436 as a user moves the actuator 470 relative to the
introducer 410, which in turn, vibrates the actuator 470 (and the
catheter 460 coupled thereto). In some instances, this vibration
can, for example, facilitate the advancing of the catheter 460
through a portion or the transfer device 400, a portion of the PIV,
and/or a portion of the vasculature. Moreover, in some instances,
the vibration can provide a user with a haptic, tactile, and/or
audible indicator associated with a position of the catheter 460
relative to the introducer 410 and/or PIV, as described in detail
in further detail herein.
[0079] As described above, the inner volume 413 is configured to
receive a portion of the catheter 460 and a portion of the actuator
470, as shown in FIGS. 13 and 14. In some embodiments, an inner
surface of the introducer 410 that defines the inner volume 413 can
have, for example, a tortuous cross-sectional shape (not shown in
FIGS. 12-14) such that an axis defined by a first portion of the
inner volume 413 is parallel to and offset from an axis defined by
a second portion of the inner volume 413. In such embodiments, the
first portion of the inner volume 413 can be spaced apart from the
second portion of the inner volume 413 without being fluidically
isolated therefrom. In some embodiments, the introducer 410 can
define a slot, channel, track, opening, and/or the like that is in
fluid communication with the inner volume 413. In some embodiments,
the tortuous cross-sectional shape of the inner volume 413 is such
that the second portion cannot be viewed (e.g., is out of the line
of sight) via the slot or the like in fluid communication with the
first portion of the inner volume 413, which in turn, can limit
and/or substantially prevent contamination of at least the catheter
460 disposed therein, as described in detail in the '834
application.
[0080] As described above, the lock 450 of the transfer device 400
is included in and/or coupled to the distal end portion of the
introducer 410. The lock 450 can be any suitable shape, size, or
configuration. In some embodiments, the lock 450 is substantially
similar to those described in detail in the '834 application. As
such, the lock 450 can selectively engage and/or contact the PIV to
couple the introducer 410 thereto. In some embodiments, the shape,
size, and/or arrangement of the lock 450 is such that the lock 450
forms three points of contact with the PIV 405. In some
embodiments, such an arrangement can provide structural rigidity
and/or support to the PIV as a portion of the lock 450 (e.g., a
proboscis or the like) is inserted into a portion of the PIV as
well as, structural rigidity and/or support to the catheter 460 as
the catheter 460 is moved therethrough.
[0081] The catheter 460 of the transfer device 400 is movably
disposed within the inner volume 413 defined by the introducer 410
(e.g., the second portion of the inner volume 413) and is coupled
to the actuator 470. In some embodiments, the catheter 460 can be
moved (e.g., via movement of the actuator 470) between a first
position and a second position to transition the transfer device
400 between the first configuration and the second configuration,
respectively. More specifically, at least a portion of the catheter
460 is disposed within the inner volume 413 and/or the lock 450
when the catheter 460 is in the first position (FIG. 13) and at
least a portion of the catheter 460 extends beyond the introducer
410 and lock 450 to place a distal end of the catheter 460 in a
position within the PIV or a position distal to the PIV when the
catheter 460 is in the second position (FIG. 14), as described in
further detail herein. As shown in FIGS. 12-14, a proximal end
portion of the catheter 460 and/or a secondary catheter coupled to
the actuator 470 and in fluid communication with the catheter 460
is configured to extend through the opening and/or port defined by
the proximal end portion of the introducer 410. In this manner, a
proximal end portion of the catheter 460 and/or the secondary
catheter can be coupled to a fluid reservoir, fluid source,
syringe, and/or the like, which in turn, places the catheter 460 in
fluid communication therewith.
[0082] The catheter 460 can be any suitable shape, size, and/or
configuration. In some embodiments, the catheter 460 can be
substantially similar to the catheters described in detail in the
'834 application. In some embodiments, at least a portion of the
catheter 460 can have an outer diameter (e.g., between a 16-gauge
and a 26-gauge) that is substantially similar to or slightly
smaller than an inner diameter defined by a portion of the lock
450. In this manner, an inner surface of the portion of the lock
450 can guide the catheter 460 as the catheter 460 is moved between
the first position and the second position. In some embodiments,
such an arrangement can limit and/or can substantially prevent
bending, deforming, and/or kinking of the catheter 460 as the
catheter 460 is moved between the first position and the second
position. In some embodiments, the catheter 460 can have a length
that is sufficient to place a distal surface of the catheter 460 in
a desired position relative to a distal surface of the PIV when the
catheter 460 is in the second position, as described in further
detail herein.
[0083] The actuator 470 of the transfer device 400 can be any
suitable shape, size, and/or configuration. In some embodiments,
the actuator 470 can be substantially similar to the actuators
described in detail in the '834 application. For example, the
actuator 470 can include a first portion movably disposed within
the inner volume 413 and a second portion movably disposed outside
of the inner volume 413 and in contact with the outer surface 435
of the introducer 410. In this manner, a user can engage the second
portion of the actuator 470 and can move the actuator 470 relative
to the introducer 410 to move the catheter 460 coupled to the first
portion of the actuator 470 between the first position and the
second position. With the second portion of the actuator 470 in
contact with the outer surface 435, the actuator 470 can be moved
along the set of ribs 436 when the actuator 470 is moved relative
to the introducer 410, which in turn, produces a haptic, tactile,
and/or audible output or feedback. In some instances, the haptic,
tactile, and/or audible output and/or feedback can provide an
indication to the user that is associated with a position of the
distal end of the catheter 460 relative to, for example, a distal
end of the PIV and/or the introducer. Although not show in FIGS.
12-14, in some embodiments, the introducer 410 and/or the actuator
470 can include indicia or the like configured to provide to the
user a visual indication associated with the position of the distal
end of the catheter 460. For example, in some embodiments, the
introducer 410 can include a gradation or the like that can
indicate a distance between, for example, a distal end of the
catheter 460 and a distal tip of the PIV.
[0084] In some embodiments, the transfer device 400 can be disposed
in the first configuration prior to use (e.g., shipped, stored,
prepared, etc. in the first configuration). In use, a user can
manipulate the transfer device 400 to couple the lock 450 to an
indwelling PIV. For example, the PIV can be percutaneously inserted
into any suitable vein of the forearm 10 or hand 30 described above
with reference to FIG. 1. As described above, the size and/or
configuration of the PIV can be based at least in part on the vein
in which the PIV is inserted. For example, in some instances, a
portion of the PIV can be disposed within a vein of the forearm 10
(e.g., the basilic vein 11 or the like) that is sufficiently large
to receive a 20-gauge PIV. Similarly, the size and/or configuration
of the transfer device 400 can be based at least in part on the
size of the PIV. For example, in embodiments in which the
indwelling PIV is and/or has a 20-gauge catheter, the catheter 460
of the transfer device 400 can be between, for example, 22-gauge
and 26-gauge.
[0085] With the lock 450 coupled to the indwelling PIV, the user
can engage the actuator 470 to move the actuator 470 relative to
the introducer 410, which in turn, moves the catheter 460 from the
first position (e.g., disposed within the introducer 410 and/or the
lock 450) toward the second position. In some embodiments, the
arrangement of the actuator 470 and the introducer 410 is such that
advancing the actuator 470 relative to the introducer 410 produces
a haptic output and/or feedback configured to provide and indicator
to the user that is associated with position of the distal end of
the catheter 460 relative to the introducer 410 and/or the PIV. For
example, based on the haptic feedback or the any other suitable
indicator, the user can place the catheter 460 in the second
position such that the distal surface of the catheter 460 extends a
desired distance beyond the distal surface of the PIV.
[0086] With the catheter 460 in the second position (e.g., with the
transfer device 400 in the second configuration shown in FIG. 14),
the user can establish fluid communication between a fluid
reservoir, fluid source, syringe, and/or the like and the catheter
460. For example, in some embodiments, the user can couple the
catheter 460 (or a secondary catheter not shown) to the fluid
reservoir, fluid source, syringe, and/or the like. With the
catheter 460 in fluid communication with the fluid reservoir and/or
fluid source, the transfer device 400 can then transfer a fluid
from the patient or transfer a fluid to the patient via the
catheter 460 extending through and beyond the PIV.
[0087] As shown in FIG. 14, in some instances, the catheter 460 can
be in the second position when the actuator 470 is in a distal most
position. In this manner, the distal surface of the catheter 460 is
positioned within the vein at a predetermined distance beyond the
distal surface of the catheter 460. In some embodiments, the length
of the catheter 460 can be sufficient to define a predetermined
and/or desired distance or length L4 between the distal surface of
the catheter 460 and the distal surface of the PIV when the
catheter 460 is in the second position. In some instances, placing
the distal surface of the catheter 460 the predetermined and/or
desired distance or length L4 from the distal surface of the PIV
can, for example, place the distal surface of the catheter 460 in a
desired position within the vein. For example, in some instances,
placing the distal surface of the catheter 460 at the predetermined
and/or desired distance length L4 from the distal surface of the
PIV can, for example, place the distal surface of the catheter 460
in a position within a vein that is substantially free from debris
(e.g., fibrin/blood clots) otherwise surrounding the distal end
portion of the PIV.
[0088] In some instances, the indwelling PIV can substantially
occlude at least a portion of the vein within which the PIV is
disposed (e.g., either the PIV itself and/or debris forming around
the PIV). As such, PIVs are often suited for delivering a fluid
rather than aspirating blood. The venous system, however, is a
capacitance system and thus, reroutes blood flow through a
different vein (e.g., forms a bypass around the occlusion or
substantial occlusion). Moreover, the alternate venous structures
(i.e., branches) typically rejoin the vein in which the PIV is
disposed at a given distance downstream of the PIV and thus,
deliver at least portion of the flow of blood that would otherwise
be flowing through the vein in which the PIV is disposed.
[0089] Thus, in some embodiments, the length of the catheter 460
and/or transfer device 400 when in the position and/or second
configuration can be based at least in part on characteristics
associated with the vascular structure (e.g., vein) within which
the PIV and catheter 460 are disposed. For example, in some
instances, the distal surface of the catheter 460 is placed within
a compartment and/or portion of the vein that receives a flow of
blood sufficient to aspirate a volume of the blood through the
catheter 460. In some instances, the compartment and/or portion of
the vein can be based on an existence of one or more valves and/or
branch vessels in fluid communication vein and/or a position of the
one or more valves and/or branch vessels relative to the distal
surface of the PIV and/or the distal surface of the catheter
460.
[0090] In some instances, for example, the predetermined and/or
desired distance can be between about 0.0 millimeters (e.g., the
distal surfaces are flush) and about 100 millimeters (mm). In other
embodiments, the predetermined and/or desired distance can be
between about 10 mm and about 90 mm, between about 20 mm and about
80 mm, between about 30 mm and about 70 mm, between about 30 mm and
about 60 mm, between about 40 mm and about 50 mm, or between any
other suitable range and subranges therebetween. In some
embodiments, for example, the transfer device 400 can be configured
such that the actuator 470 can move about 95 mm along the
introducer 410 (e.g., the transfer device 400 has a 95 mm stroke)
to position the distal surface of the catheter 460 at about 40 mm
beyond the distal surface of the PIV to which the transfer device
400 is coupled. In other embodiments, for example, the transfer
device 400 can have a 47 mm stroke that positions the distal
surface of the catheter 460 at about 20 mm beyond the distal
surface of the PIV to which the transfer device 400 is coupled. In
still other embodiments, the transfer device 400 can have any
suitable stroke length to position the distal surface of the
catheter 460 at the predetermined and/or desired distance from the
distal surface of the PIV. As described in further detail herein,
the stroke length and thus, the predetermined and/or desired
distance and/or length L4 can be based at least in part on the
arrangement of the vascular structure in which PIV and catheter 460
are disposed.
[0091] Vascular Structure Analysis
[0092] As described above with reference to FIGS. 1-5, a portion of
a PIV dwelling within a vein obstructs, at least partially, a lumen
defined by the vein and thus, restricts a flow of blood
therethrough. In addition, an amount of debris such as blood
clots/thrombus or fibrin tails, etc. formed around the portion of
the PIV often increases with PIV dwelling time, thereby further
limiting blood flow through at least a portion of the vein. In some
instances, the blood flow through the vein can be restricted to an
extent that renders aspiration of blood through the PIV and/or
through a catheter disposed at or near a distal end of the PIV
unsuccessful or at least impractical. In addition, the obstructions
within the vein and/or the restrictions of the flow can increase a
turbulence of the blood flow, which in turn, can increase the
likelihood of hemolysis (i.e., the shearing of red blood cells).
Similarly, the application of more negative pressure through a
blood draw catheter to overcome the restrictions in flow can
increase a stress on or in the red blood cells that can result in
hemolysis. As described herein, however, it is contemplated that
vascular structures such as valves and/or branches disposed in the
vein and/or in fluid communication with the vein can, for example,
sufficiently mitigate the effects of the indwelling PIV, thereby
allowing aspiration of blood through a catheter that gains access
to the vein via the indwelling PIV as well as reducing a likelihood
of hemolyzed blood samples.
[0093] As described above with reference to the devices 200 and/or
300, in some instances, advancing a blood draw catheter through an
indwelling PIV such that a distal end of the catheter is disposed
within, for example, a predetermined range of distances from a
distal end of the PIV can place the catheter in a position relative
to the vein that receives a volumetric flow of blood sufficient for
blood aspiration. For example, the device 200 is configured to
couple to the PIV 280 (e.g., dwelling within a vein) and to advance
the catheter 260 to, for example, a distal most position (e.g., the
second position) such that the distal end of the catheter 260 is
disposed approximately 15.0 mm from the distal end of the PIV 280.
In some instances, advancing the catheter 260 relative to the PIV
280 (e.g., by placing the catheter 260 in the second position), an
average success rate (or a predicted average success rate)
associated with blood aspiration through the catheter 260
increased.
[0094] In general, it is contemplated and further described herein
that the increased success rate associated with blood aspiration
through the catheter 260 when the catheter 260 is disposed, for
example, in the second position is indicative of one or more
relationships between the venous anatomy and a position of a blood
draw catheter relative to the venous anatomy and/or an indwelling
PIV. Accordingly, a prospective single-center study of the lower
arm venous anatomy including the antecubital, forearm, and
hand/wrist region was conducted. The venous anatomy of thirty-five
(35) healthy adults was imaged using ultrasonic imaging and data on
location and frequency of valves, the valves locations and
frequency of branches or collateral vessels, and vessel diameters
was recorded in areas where intravenous (IV) catheter placement is
common. The first 5 subjects served as validation of study methods
and ultrasound technique consistency. Data for the subsequent 30
subjects was collected and analyzed.
[0095] A nurse marked hypothetical IV insertion locations (e.g.,
locations that would likely be used to access a vein for
aspiration) in each subject's hand/wrist, forearm, and antecubital
regions, on each arm--six (6) total sites marked per subject. The
nurse and/or a medical technician took 1-2 photographs of each
subject's arms to document where the hypothetical IV insertion site
marks were placed.
[0096] A separate ultrasound technician performed an ultrasonic
imaging study capturing the information in a study worksheet.
Two-hundred ten (210) vessels were imaged and the information was
recorded, including: [0097] Position of the IV mark site on
anatomic diagram of arm, including distance from crease of the
wrist (whether positive or negative). [0098] Distances from each IV
mark site to vein valves up to 8 centimeters (cm) centrally. [0099]
Distances from each IV mark site to vein branches or collateral
vessels up to 8 cm centrally. [0100] Vessel diameters at the IV
mark site and immediately central to every vein branch or
collateral vessel up to 8 cm centrally.
[0101] The data is set forth in Table 1, below:
TABLE-US-00001 TABLE 1 Branch Distance and Diameter PIV Length PIV
Length PIV Length PIV Length 0.00 in/0.00 mm 1.00 in/25.4 mm 1.16
in/29.46 mm 1.25 in/31.75 mm Length Past Tip (mm) 64.5 39 35 32.7
Length Past Hub (mm) 64.5 64.4 64.5 64.5 No Branches within 23 11%
37 18% 41 20% 44 21% 80.0 mm Branch >= 64.5 mm 11 5% 23 11% 25
12% 28 13% Branch <= 64.5 mm 176 84% 150 71% 144 69% 138 66%
Totals 210 100% 210 100% 210 100% 210 100% Dist. <= 64.5 mm 148
70% 134 64% 131 62% 128 61% Diam. >=1 mm Dist. <= 64.5 mm 28
13% 16 8% 13 6% 10 5% Diam. < 1 mm No/Unsuitable Branch 62 30%
76 36% 79 38% 82 39%
[0102] Specifically, as shown in Table 1 and FIGS. 15-18, data
associated with branch vessel characteristics relative to a
hypothetical PIV having an effective length of 0.00 in (FIG. 15),
an effective length of 1.00 in (FIG. 16), an effective length of
1.16 in (FIG. 17), and an effective length of 1.25 in (FIG. 18) was
determined. For example, an ultrasound image of each vein was taken
from the hypothetical IV insertion point to 8.0 cm (80 mm)
centrally (e.g., in a proximal or downstream direction). Commonly
used PIV lengths were considered, in which the PIV having the
length of 0.00 in (0.00 mm) would place the distal end of the PIV
at the hypothetical insertion site; the PIV having the length of
1.00 in (25.4 mm) would place the distal end of the PIV at about
1.00 in (25.4 mm) from the hypothetical insertion site; the PIV
having the length of 1.16 in (29.46 mm) would place the distal end
of the PIV at about 1.16 in (29.46 mm) from the hypothetical
insertion site; and the PIV having the length of 1.25 in (31.75 mm)
would place the distal end of the PIV at about 1.25 in (31.75 mm)
from the hypothetical insertion site.
[0103] The use of a fluid transfer device such as, for example, the
transfer devices 300 and/or 400 to aspirate a volume of blood
through the indwelling PIV was considered. As described above, the
length of the catheter (e.g., the catheter 360) can be based at
least in part on the venous anatomy. For example, for the transfer
device 300, the distal end of the catheter 360 can extend
approximately 15 mm beyond a distal end of, for example, 1.16 in
(29.46 mm) PIV, when the catheter 360 is in the distal most
position (e.g., a second position). The transfer device 400 is
configured such that the catheter 460 extends approximately 30.0 mm
beyond a distal end of, for example, the 1.16 in (29.46 mm) PIV,
when the catheter 460 is in the distal most position (e.g., a
second position). That is to say, the distal surface of the
catheter 360 is configured to extend approximately 40 mm beyond a
hub of the PIV and/or beyond a hypothetical insertion point while
the catheter 460 is configured to extend approximately 64.5 mm
beyond the hub of the PIV and/or beyond the hypothetical insertion
point. Therefore, when considering the transfer device 400, for
example, the length of the distal surface of the catheter 460 from
the distal tip of the PIV catheter (also referred to herein as "L")
when the catheter 460 is in a distal most position and when the
effective length of the PIV is 0.00 in (0.0 mm) is approximately
64.5 mm; the length L when the catheter 460 is in the distal most
position and when the effective length of the PIV is 1.00 in (25.4
mm) is approximately 39.0 mm; the length L when the catheter 460 is
in the distal most position and when the effective length of the
PIV is 1.16 in (29.46 mm) is approximately 35.0 mm; and the length
L when the catheter 460 is in the distal most position and when the
effective length of the PIV is 1.25 in (31.75 mm) is approximately
32.7 mm, as shown in Table 1.
[0104] An effect on blood flow and/or successful aspiration
produced by branch vessels beyond 80.0 mm was not considered. For
example, in some instances, a flow rate through the lumen of a
catheter has an inverse relationship with the overall length of the
catheter. In other words, a catheter having a given inner diameter
and a first length can be associated with and/or otherwise produce
a lower flow rate that is lower than a flow rate of a catheter
having the same given diameter and a second length, less than the
first length. Thus, in this example, a flow rate associated with a
catheter length of 80.0 mm (8.0 cm or about 3.15 in) beyond the
hypothetical insertion point was not considered suitable for use
with, for example, a 20-gauge PIV and/or otherwise for use in this
study. In other instances, however, a flow rate through a catheter
having such a length or a greater length can be sufficient for
blood aspiration. In some instances, the catheter 460 of the
transfer device 400 can have a length that is associated with a
minimal desired flow rate therethrough (e.g., a length such that
the distal end of the catheter 460 is about 64.5 mm beyond a PIV
hub and/or beyond an insertion point of a PIV. In other instances,
a catheter having an inner diameter substantially similar to an
inner diameter of the catheter 460 can have a length greater than
the length of the catheter 460 while still allowing for a
sufficient flow rate therethrough.
[0105] In a similar manner, and for the purposes of the study
described herein, branch vessels having a diameter of 1.0 mm or
less were not considered to contribute sufficient blood flow to the
vein and thus, were not considered suitable. That is to say, branch
vessels having a diameter of 1.0 mm or less were considered to have
a volumetric flow rate of blood below a volumetric flow rate
threshold. In other instances, however, a branch vessel having a
diameter of 1.0 mm can provide a sufficient flow of blood to the
vein, such as, for example, in pediatric cases and/or when a PIV is
disposed within a vein of the hand or other small vein. Thus, while
described above as being based on a size of a branch vessel, in
other instances, a branch vessel having any suitable size but
having a volumetric flow rate below, for example, the volumetric
flow rate threshold may not be suitable.
[0106] FIG. 15 illustrates a graph 590 showing data associated with
a distance of a first branch vessel from the distal tip of the PIV
catheter and the branch vessel diameter when the effective length
of the PIV is 0.00 in. In this instance, 23 veins (or 11%) were not
in fluid communication with branch vessels within the 8.0 cm (80.0
mm or about 3.15 in), as indicated by region 591 in FIG. 15; 11
veins (or 5%) were in fluid communication with branch vessels
beyond approximately 64.5 mm, as indicated by region 592 in FIG.
15; and 28 veins (or 13%) were in fluid communication with branch
vessels within approximately 64.5 mm but with a diameter of less
than 1.0 mm, as indicated by region 593 in FIG. 15. As such, for a
PIV catheter having an effective length of 0.00 in (0.00 mm), 62
veins (or 30%) were not in fluid communication with a branch vessel
or were in fluid communication with an unsuitable branch vessel. In
other words, 138 veins (or 70%) were in fluid communication with at
least one suitable branch vessel (at least as it relates to blood
aspiration via an indwelling PIV catheter).
[0107] FIG. 16 illustrates a graph 690 showing data associated with
a distance of a first branch vessel from the distal tip of the PIV
catheter and the branch vessel diameter when the effective length
of the PIV is 1.00 in. In this instance, 37 veins (or 18%) were not
in fluid communication with branch vessels within the 8.0 cm (80.0
mm or about 3.15 in) from the hypothetical insertion site, 23 veins
(or 11%) were in fluid communication with branch vessels beyond
approximately 64.5 mm, and 16 veins (or 8%) were in fluid
communication with branch vessels within approximately 64.5 mm but
with a diameter of less than 1.0 mm, as indicated by regions 691,
692, and 693, respectively, in FIG. 16. As such, for a PIV catheter
having an effective length of 1.00 in (25.4 mm), 76 veins (or 36%)
were not in fluid communication with a branch vessel or were in
fluid communication with an unsuitable branch vessel. In other
words, 124 veins (or 64%) were in fluid communication with at least
one suitable branch vessel (at least as it relates to blood
aspiration via an indwelling PIV catheter).
[0108] FIG. 17 illustrates a graph 790 showing data associated with
a distance of a first branch vessel from the distal tip of the PIV
catheter and the branch vessel diameter when the effective length
of the PIV is 1.16 in. In this instance, 41 veins (or 20%) were not
in fluid communication with branch vessels within the 8.0 cm (80.0
mm or about 3.15 in) from the hypothetical insertion site, as 25
veins (or 12%) were in fluid communication with branch vessels
beyond approximately 64.5 mm, and 13 veins (or 6%) were in fluid
communication with branch vessels within approximately 64.5 mm but
with a diameter of less than 1.0 mm, as indicated by regions 791,
792, and 793, respectively, in FIG. 17. As such, for a PIV catheter
having an effective length of 1.16 in (29.46 mm), 79 veins (or 38%)
were not in fluid communication with a branch vessel or were in
fluid communication with an unsuitable branch vessel. In other
words, 121 veins (or 62%) were in fluid communication with at least
one suitable branch vessel (at least as it relates to blood
aspiration via an indwelling PIV catheter).
[0109] FIG. 18 illustrates a graph 890 showing data associated with
a distance of a first branch vessel from the distal tip of the PIV
catheter and the branch vessel diameter when the effective length
of the PIV is 1.25 in. In this instance, 44 veins (or 21%) were not
in fluid communication with branch vessels within the 8.0 cm (80.0
mm or about 3.15 in) from the hypothetical insertion site, 28 veins
(or 13%) were in fluid communication with branch vessels beyond
approximately 64.5 mm, and 10 veins (or 5%) were in fluid
communication with branch vessels within approximately 64.5 mm but
with a diameter of less than 1.0 mm, as indicated by regions 891,
892, and 893, respectively, in FIG. 18. As such, for a PIV catheter
having an effective length of 1.25 in (31.75 mm), 82 veins (or 39%)
were not in fluid communication with a branch vessel or were in
fluid communication with an unsuitable branch vessel. In other
words, 118 veins (or 61%) were in fluid communication with at least
one suitable branch vessel (at least as it relates to blood
aspiration via an indwelling PIV catheter).
[0110] The mean branch distance and branch diameter were determined
and the standard deviations were calculated for effective PIV
lengths of 1.00 in (25.4 mm), 1.16 in (29.46 mm), and 1.25 in
(31.75 mm), as shown in Table 2 below:
TABLE-US-00002 TABLE 2 Mean Branch Distance and Diameter PIV Length
PIV Length PIV Length 1.00 in/25.4 1.16 in/29.46 1.25 in/31.75 mm
mm mm Std. Std. Std. Mean Dev. Mean Dev. Mean Dev. Branch Distance
32 mm 20 34 mm 21 35 mm 22 Branch Diameter 1.6 mm 1.1 1.6 mm 1.2
1.6 mm 1.2
[0111] FIG. 19 is a graph 990 illustrating data associated with a
predicted flow rate (by percentage) within a portion of the vein
and a distance from the distal tip of the PIV catheter disposed
therein to a branch vessel in fluid communication with the vein. In
this instance, a length of 40.0 mm between a distal surface of a
catheter (e.g., the catheter 460) and the distal tip of the PIV
when the catheter is in the distal most position was proposed
(e.g., based at least in part on a flow rate through the catheter),
as indicated by line 991 in FIG. 19. Moreover, in this instance, a
predicted flow rate of more than 50% through the vein was
considered sufficient to support aspiration without branch vessels
in fluid communication with the vein (e.g., within the 8.0 cm (80.0
mm or about 3.15 in) from the hypothetical insertion site), as
indicated by line 992 and region 993 in FIG. 19.
[0112] FIG. 20 is a graph 1090 illustrating another relationship
between the predicted flow rate (by percentage) within a portion of
the vein and a distance from the distal tip of the PIV catheter
disposed therein to a branch vessel in fluid communication with the
vein. In this instances, the length of 40.0 mm and the flow
threshold of 50% were maintained (from the graph in FIG. 19), as
indicated by the lines 1091 and 1092, respectively, in FIG. 20.
Veins that were not in fluid communication with a branch vessel
(e.g., within the 8.0 cm (80.0 mm or about 3.15 in) from the
hypothetical insertion site) and that had a predicted flow rate of
less than 50% are indicated by region 1094 in FIG. 20. Veins that
were in fluid communication with branch vessels that were further
than 40.0 mm beyond the distal tip of the PIV catheter and within
the 80.0 mm from the hypothetical insertion site are indicated by
region 1095 in FIG. 20.
[0113] FIG. 21 is a graph 1190 illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein of
the hand (e.g., the hand 30 in FIG. 1), a portion of a vein of the
forearm (e.g., the forearm 10 in FIG. 1), and a portion of the
antecubital (AC) region (e.g., an antecubital region 28 in FIG. 1)
and a distance from the distal tip of the PIV catheter disposed
therein to a branch vessel. As shown in the graph 1190, branches in
fluid communication with the vein in the AC region were further
from the distal tip of the PIV and the vein had an overall higher
predicted flow rate than the vein of the forearm, which in turn,
had an overall higher predicted flow rate and was in the fluid
communication with branches that were further from the distal tip
of the PIV than the vein of the hand. Such results were predictable
based at least in part on decreasing vein diameter as the vein
extends distally from the AC region to the hand.
[0114] FIG. 22 is a graph 1290 illustrating data associated with a
predicted flow rate (by percentage) within a portion of a vein and
a distance from the hypothetical insertion point of the peripheral
intravenous catheter into the vein to a branch vessel in fluid
communication with the vein. As described above with reference to
Table 1 and the graph 590 in FIG. 15, 23 veins (or 11%) were not in
fluid communication with a branch vessel within the 8.0 cm (80.0 mm
or about 3.15 in) from the hypothetical insertion site, as
indicated by the region 1291 in FIG. 22. Branch vessels within 1.0
in (25.4 mm) of the hypothetical point of PIV catheter insertion
were found in 70 veins (or 33%), as indicated by region 1292 in
FIG. 22. Moreover, 187 veins (or 89%) were in fluid communication
with at least one branch vessel; 121 veins (or 58%) were in fluid
communication with at least two branch vessels; and 43 veins (or
20%) were in fluid communication with a third branch vessel.
[0115] As shown in FIGS. 15-22 and described above in at least
Table 1, a predicted flow rate through a vein can be based at least
in part on a size and/or diameter of the vein (e.g., whether the
vein is in the antecubital region, the forearm, or the hand), the
existence of one or more branch vessels in fluid communication with
the vein (e.g., within a predetermined distance such as, for
example, 8.0 cm), the distance between the branch vessels and the
distal tip of the PIV catheter, and a diameter of the branch
vessels. Moreover, the success of blood aspiration via a blood draw
catheter accessing a vein through an indwelling PIV catheter can be
based at least in part on the venous anatomy (just described) and
the distance between a distal surface of the blood draw catheter
(e.g., the catheters 360 and/or 460) and the distal tip of the PIV
catheter.
[0116] For example, FIGS. 23-28 are graphs illustrating data
associated with a predicted rate of success for blood aspiration
and a distance within a vein from a distal tip of a PIV catheter to
a distal surface of the blood draw catheter (e.g., a hypothetical
and/or modeled distance--no catheters were inserted into the body
during the study described herein). Scenarios were modeled each of
which reflected different inputs and/or characteristics and the
predicted rate of success associated with each scenario was
calculated, as shown below in Table 3 and Table 4,
respectively:
TABLE-US-00003 TABLE 3 Inputs 1 2 3 4 5 6 Flow Threshold (%) 33 33
33 33 33 33 Applied Tourniquet 0 30 0 30 0 30 Diameter Change (%)
Diameter (%) 150 150 150 150 150 150 Insert Angle 30 30 30 30 30 30
PIV Exposed 4 4 4 4 4 4 Central Buffer Std. Std. 40.0 40.0 0.0 0.0
Peripheral Buffer Std. Std. Std. Std. 0.0 0.0
TABLE-US-00004 TABLE 4 Success Rates (Percentage) 1 2 3 4 5 6 15 mm
70% 82% 78% 88% 66% 80% 25 mm 75% 86% 81% 90% 73% 86% 30 mm 78% 87%
82% 90% 75% 87% 35 mm 81% 89% 83% 91% 79% 89% 40 mm 81% 90% 83% 91%
81% 90%
[0117] Characteristics associated with a PIV catheter such as, for
example, a Jelco.RTM. 1.0 in, 20 gauge catheter and/or
characteristics associated with how such a PIV catheter is inserted
into a vein were modeled (e.g., simulated, etc.). For example, as
shown in Table 3, a PIV insertion angle of approximately 30.degree.
("Insert Angle" in Table 3) was assumed and approximately 4 mm of
the PIV catheter was assumed to be exposed or outside of the body
("NV Exposed" in Table 3). In these instances, a threshold diameter
of branch vessels as a percentage of a diameter of the blood draw
catheter was fixed at 150% ("Diameter (%)" in Table 3). As
described in further detail herein, a desired length of the blood
draw catheter (e.g., the catheter 360 of the device 300 and/or the
catheter 460 of the device 400) can be determined based at least in
part on a calculated success rate.
[0118] FIG. 23 is a graph 1390 illustrating the predicted rate of
success for blood aspiration under a first scenario (Scenario "1"
in Tables 3 and 4). In this example, a flow rate of about 33%
around the hypothetical indwelling PIV was assumed, as indicated by
the "Flow Threshold (%)" in Table 3. In other words, a 33%
occlusion of the lumen of the vein modeled. As shown in Table 3, in
this example, a standard buffer size associated with a central
branch and a standard buffer size associated with a peripheral
branch were modeled. Specifically, the standard buffer size (or
desired distance from the branch vessel) for a central branch
vessel having a diameter between about 0.0 mm and about 1.0 mm was
2.5 mm; the standard buffer size for a central branch vessel having
a diameter between about 1.0 mm and about 2.0 mm was 5.0 mm; the
standard buffer size for a central branch vessel having a diameter
between about 2.0 mm and about 3.0 mm was 10.0 mm; and the standard
buffer size for a central branch vessel having a diameter greater
than about 3.0 mm was 20.0 mm. Similarly, the standard buffer size
for a peripheral branch vessel having a diameter between about 0.0
mm and about 1.0 mm was 1.0 mm; the standard buffer size for a
peripheral branch vessel having a diameter between about 1.0 mm and
about 2.0 mm was 5.0 mm; the standard buffer size for a peripheral
branch vessel having a diameter between about 2.0 mm and about 3.0
mm was 5.0 mm; and the standard buffer size for a peripheral branch
vessel having a diameter greater than about 3.0 mm was 5.0 mm.
[0119] As described in detail above, the device 300 can be used to
aspirate a volume of blood from a vein via an indwelling PIV. In
such instances, the reach of the catheter 360 beyond a distal end
of an indwelling PIV catheter such as a Jelco.RTM. 1.0 in, 20-gauge
PIV (e.g., a hypothetical PIV catheter in this case) is about 15 mm
and is indicated in FIG. 23 by the dashed vertical line. The
modeled/predicted success rates associated with blood draw through
the catheter (e.g., the catheter 360) in such instances closely
matched empirical results associated with actual use of the
catheter for blood aspiration. The close matching of such results,
for example, provides validation for the accuracy of the model
and/or the assumptions associated with the model. Therefore, based
at least in part on the validation of the modeled and/or predicted
success rates of the catheter (e.g., the catheter 360) disposed at,
for example, 15.0 mm beyond the distal end of the PIV (either
empirically or hypothetical) it was determined that the model could
be used to calculate predicted success rates for aspiration of
blood through a hypothetical blood draw catheter based on a
distance between a distal surface of the catheter and the distal
tip of the PIV catheter (e.g., a hypothetical PIV catheter disposed
in the vein). By comparing the predicted success rates, a desired
distance between the distal surface of the catheter and the distal
tip of the PIV catheter can be determined. For example, in assuming
the parameters and/or characteristics shown in column 1 of Table 3,
the desired length between the distal surface of the catheter and
the distal tip of the PIV catheter was determined to be about 35.0
mm having a predicted overall success rate of about 81% (as
indicated in Table 4).
[0120] FIG. 24 is a graph 1490 illustrating the predicted rate of
success for blood aspiration under a second scenario (Scenario "2"
in Tables 3 and 4). In this example, the only change from scenario
"1" was the application of a tourniquet proximal to the PIV
catheter insertion site. In this example, the application of the
tourniquet was considered to increase the size of the vein by about
30%. More specifically, the application of a tourniquet downstream
of (e.g., proximal to) a PIV insertion point increases the pressure
within the vein, which in turn, results in a swelling or increase
in diameter of the vein. In some instances, the increase in the
diameter of the vein can be based at least in part on the gender of
the subject. For example, in some instances, the application of a
tourniquet on a male subject can increase a diameter of a vein, for
example, by about 25%, while the application of a tourniquet on a
female subject can increase a diameter of a vein, for example, by
about 45%. In some instances, the increase in diameter of the vein
can be based at least in part on a diameter of the vein without the
application of a tourniquet. When the application of a tourniquet
is considered, for example, to result in a percentage increase in
area of a vein, the percentage increase in area is substantially
the same for males and females. That is to say, an area increase of
a vein resulting from an application of a tourniquet is
substantially independent of gender (e.g., is independent of common
differences in the size of veins between males and females). In
other words, the resultant change on the vein diameter results in
an equivalent change in pressure or volume, thus a smaller vein
diameter distends to a larger percentage of diameter than a vein
having a larger diameter; however, the resultant change in the
cross sectional area is substantially equal. As shown in Tables 3
and 4, in this instance, the percentage of increase in the area of
the vein was assumed and/or modeled at 30%. Thus, with all other
inputs remaining the same, the predicted success rates for
aspiration of blood through the blood draw catheter were calculated
based on a distance between a distal surface of the catheter and
the distal tip of the PIV catheter, as shown in Table 4 and the
graph 1490 in FIG. 24. By comparing the predicted success rates, a
desired distance between the distal surface of the catheter and the
distal tip of the PIV catheter was determined to be about 35.0 mm
having a predicted overall success rate of about 89% (as indicated
in Table 4).
[0121] FIG. 25 is a graph 1590 illustrating the predicted rate of
success for blood aspiration under a third scenario (Scenario "3"
in Tables 3 and 4). In this example, the only change from scenario
"1" was the assumption that the distal surface of the catheter
reached, for example, a central branch vessel or the buffer zone.
Specifically, as shown in Table 3, the buffer zone for the central
branch was set to 40.0 mm. In other words, the distal end of the
catheter can be about 40.0 mm from the central branch while
remaining within the "buffer zone" and/or otherwise by being in
fluid communication with a vein having a positive effect on a
volumetric flow rate through at least a portion of the vein. Thus,
by comparing the predicted success rates, a desired distance
between the distal surface of the catheter and the distal tip of
the PIV catheter was determined to be about 25.0 mm having a
predicted overall success rate of about 81%, as indicated in Table
4.
[0122] FIG. 26 is a graph 1690 illustrating the predicted rate of
success for blood aspiration under a fourth scenario (Scenario "4"
in Tables 3 and 4). In this example, the only change from scenario
"3" was the application of a tourniquet proximal to the PIV
catheter insertion site--assuming an increase in the size of the
vein by about 30%, as described above. Thus, by comparing the
predicted success rates, a desired distance between the distal
surface of the catheter and the distal tip of the PIV catheter was
determined to be about 25.0 mm having a predicted overall success
rate of about 90%, as indicated in Table 4.
[0123] FIG. 27 is a graph 1790 illustrating the predicted rate of
success for blood aspiration under a fifth scenario (Scenario "5"
in Tables 3 and 4). In this example, the only change from scenario
"1" and/or "3" was the buffer zone associated with both central
branches and peripheral branches was decreased to 0.0 mm. That is
to say, all assumptions associated with one or more buffer zones
surrounding a branch vessel were set to zero. Said another way, in
this instance, a branch vessel can affect the likelihood of a
successful blood draw through a catheter when a distal end of the
catheter is disposed at or proximal to (e.g., beyond) the branch
vessel. Thus, by comparing the predicted success rates, a desired
distance between the distal surface of the catheter and the distal
tip of the PIV catheter was determined to be about 35.0 mm having a
predicted overall success rate of about 79%, as indicated in Table
4.
[0124] FIG. 28 is a graph 2490 illustrating the predicted rate of
success for blood aspiration under a sixth scenario (Scenario "6"
in Tables 3 and 4). In this example, the only change from scenario
"5" was the application of a tourniquet proximal to the PIV
catheter insertion site--assuming an increase in the size of the
vein by about 30%, as described above. Thus, by comparing the
predicted success rates, a desired distance between the distal
surface of the catheter and the distal tip of the PIV catheter was
determined to be about 35.0 mm having a predicted overall success
rate of about 89%, as indicated in Table 4.
[0125] With the predicted success rates calculated for scenarios
1-6, an overall desired distance between a distal surface of a
catheter and a distal tip of a PIV catheter dwelling within a vein
was determined to be about 30.0 mm. In other words, blood
aspiration via a blood draw catheter using an indwelling PIV
catheter is more likely to be successful when the distal surface of
the catheter (e.g., the catheter 460 of the device 400) is disposed
at a distance of about 30.0 mm from the distal tip of the
indwelling PIV catheter. While some predicted success rates
continued to increase with an increase in distance beyond, for
example, 30.0 mm, it was determined that 30.0 mm was desired based
on diminishing returns associated with increased lengths of the
catheter. Moreover, in some instances, a flow rate through a
catheter can be inversely proportional to a length of the catheter.
Thus, providing a catheter with a length that places the distal end
of the catheter at about 30.0 mm beyond the distal tip of the
indwelling PIV can, for example, balance a benefit of potential
increase in flow rate through the vein at a further distance with a
decreased flow rate through the catheter.
[0126] While the transfer device 300 is described above as being
configured to place the distal end of the catheter 360
approximately 15.0 mm beyond a distal end of a PIV (e.g., a 1.0 in
PIV such as a Jelco.RTM. 1.0 in, 20-gauge PIV) when the catheter
360 is in a distal most position, and the transfer device 400 is
described above as being configured to place the distal end of the
catheter 460 approximately 30.0 mm beyond a distal end of a PIV
(e.g., a 1.0 in PIV) when the catheter 460 is in a distal most
position, it should be understood, that the catheter 360 and the
catheter 460 can be placed in any suitable position proximal or
distal to the distal end of the PIV within the 15.0 mm and the 30.0
mm, respectively. For instance, a user may manipulate the transfer
device 400 by advancing the catheter 460 (or the transfer device
300 by advancing the catheter 360) relative to an indwelling 1.0 in
PIV to its distal most position. If, however, blood draw is
unsuccessful and/or a flow of blood through the catheter 460 is
below a desired threshold, the user can, for example, move the
catheter 460 in a proximal direction relative to the PIV to place
the catheter 460 in a position within the vein receiving a desired
flow of blood, as described above with reference to, for example,
FIGS. 2-6.
[0127] FIG. 29 is a flowchart illustrating a method 50 of using a
fluid transfer device to place a catheter within a vein, via an
indwelling peripheral intravenous catheter, at a position suitable
for blood aspiration, according to an embodiment. The method 50
includes coupling the fluid transfer device to an indwelling
peripheral intravenous line (PIV) at least partially disposed in a
vein of a patient, at 51. The fluid transfer device can be any
suitable device configured for fluid transfer through a PIV. For
example, in some embodiments, the fluid transfer device can be
substantially similar to the fluid transfer devices 300 and/or 400
described above with reference to FIGS. 8-11 and FIGS. 12-14,
respectively. In some embodiments, the fluid transfer device can be
substantially similar to any of the fluid transfer devices
described in the '834 application incorporated by reference above.
In other embodiments, the fluid transfer device can include only a
catheter or other suitable fluid conduit. As such, the fluid
transfer device can include at least an introducer defining a
lumen, a catheter movably disposed in the lumen of the introducer,
and an actuator coupled to the catheter. As described above with
reference to the transfer device 400, the lumen (or inner volume)
of the introducer can have a tortuous cross-sectional shape
configured to isolate, at least partially, the catheter disposed in
the introducer from a volume outside of the introducer.
[0128] With the fluid transfer device coupled to the PIV (and/or an
adapter coupled to the PIV), the catheter is moved from a first
position, in which the catheter is proximal to the indwelling PIV,
to a second position, in which at least a portion of the catheter
is disposed within the indwelling PIV such that a distal surface of
the catheter is disposed at a predetermined distance from a distal
tip of the indwelling PIV, at 52. As described above with reference
to the fluid transfer device 400 shown in FIGS. 12-14, the
introducer can have an outer surface that defines a set of ribs or
the like configured to be in contact with a portion of the actuator
such that moving the actuator relative to the introducer advances
the portion of the actuator along the ribs. In some embodiments,
the movement of the actuator along the ribs can produce a vibration
of the actuator, which in turn, can produce, for example, a haptic,
tactile, and/or audible output. In some instances, the haptic,
tactile, and/or audible output can provide to a user an indication
associated with a position of a distal end portion of the catheter
as the actuator moves the catheter from the first position toward
the second position (as described in detail in the '894 application
incorporated by reference above). In some embodiments, the
introducer can include indicia or the like that can indicate to the
user the relative position of the distal end portion of the
catheter (e.g., relative to a distal end portion of the PIV).
[0129] As described above with reference to the transfer device
400, the actuator is configured to move the catheter to the second
position such that the distal surface of the catheter is placed at
the predetermined distance from the distal tip of the indwelling
PIV. As described in detail above, the predetermined distance can
be based at least in part on the venous anatomy of the vein in
which the PIV and catheter are disposed. For example, in some
instances, the predetermined distance is based at least in part on
the existence and/or position of one or more valves within the vein
and/or one or more branch vessels in fluid communication with the
vein. In some instances, the method 50 can optionally include, for
example, determining the venous anatomy associated with the vein
prior to coupling the fluid transfer device to the indwelling
peripheral intravenous line. This determining of the venous anatomy
can be based on, for example, ultrasonic imaging, venogram, or
fluoroscopy and/or the like. Thus, based on data associated with
the venous anatomy, the distal surface of the catheter can be
placed at the predetermined distance from the distal tip of the
indwelling PIV. More particularly, the predetermined distance can
be a position within the vein and/or relative to the PIV that is
associated with a desired likelihood for successful aspiration of a
volume of blood through the catheter.
[0130] As described in detail above, in some instances, the
predetermined distance can be such that the distal surface of the
catheter is disposed within the vein at a desired distance (e.g., a
buffer zone) from a branch vessel in fluid communication with the
vein. In some instances, the predetermined distance can be such
that at least one of a valve or a branch vessel is in a position
along the vein that is between the distal tip of the indwelling PIV
and the distal surface of the catheter. That is to say, the distal
tip of the PIV can be in a position relative to the vein that is
distal to (e.g., upstream of) the valve and/or branch vessel and
the distal surface of the catheter can be in a position relative to
the vein that is proximal to (e.g., downstream of) the valve and/or
branch vessel. As such, the distal surface of the catheter can be
placed in a position within the vein that receives a desired
volumetric flow rate of blood that is suitable for blood aspiration
through the catheter and that would otherwise be reduced by
obstructions within the vein (e.g., debris such as fibrin or the
like) resulting from the indwelling portion of the PIV.
[0131] In some embodiments, the predetermined distance can be such
that the distal surface of the catheter is in a distal position
relative to the distal tip of the indwelling PIV. Similarly stated,
the distal surface can be in a position along and/or relative to
the vein that is proximal to a position along and/or relative to
the vein of the distal tip of the indwelling PIV. Said yet another
way, the distal surface of the catheter can be in a position within
the vein that is downstream of a position within the vein of the
distal tip of the indwelling PIV. As described in detail above, in
some embodiments, the predetermined distance can be within a
predetermined range of distances between, for example, about 0.0 mm
and about 50.0 mm. For example, in some embodiments, the
predetermined distance can be 30.0 mm. In some embodiments, the
haptic, tactile, audible, and/or visual indication resulting from
the movement of the actuator relative to the introducer can be
associated with and/or otherwise indicate a distance between the
distal surface of the catheter and the distal tip of the indwelling
PIV. Thus, when a user determines the distal surface of the
catheter is placed at the predetermined distance from the distal
tip of the PIV, the user can stop moving the actuator relative to
the introducer regardless of whether the actuator is in, for
example, a distal most position relative to the introducer.
[0132] With the catheter in the second position and/or with the
distal surface of the catheter being disposed at the predetermined
distance from the distal tip of the PIV, a volume of blood is
transferred via the catheter from the vein to a fluid reservoir in
fluid communication with the catheter, at 53. The fluid reservoir
can be any suitable fluid reservoir such as, for example, a
negative pressure container or an evacuated container, a syringe, a
sample bottle, and/or the like. In some instances, the method 50
can include establishing fluid communication between the catheter
and the fluid reservoir. In other instances, the fluid
communication between the catheter and the fluid reservoir can be
pre-established (e.g., pre-assembled and/or assembled in a separate
process or the like). Thus, with the distal surface of the catheter
being disposed within the vein at a position in which a volumetric
flow rate is not substantially restricted by obstructions otherwise
resulting from the indwelling portion of the PIV catheter, a volume
of blood can be transferred from the vein, through the catheter
(and thus, the PIV), and into the fluid reservoir.
[0133] The method 50 includes moving the catheter from the second
position toward the first position after a desired volume of blood
is transferred to the fluid reservoir, at 54. In some instances, an
actuator can be moved to move the catheter toward the first
position and/or to place the catheter substantially in the first
position. In other instances, the actuator can be moved to place
the catheter in a third position (e.g., a storage or disposal
position). The fluid transfer device is decoupled from the
indwelling PIV after the catheter is moved from the second position
toward the first position, at 55. Moreover, the fluid reservoir can
be removed from fluid communication with the catheter (e.g.,
decoupled or the like) prior to the catheter being moved toward the
first position, after the catheter is moved toward the first
position, or after the fluid transfer device is decoupled from the
indwelling PIV. With the fluid transfer device decoupled from the
indwelling PIV, the fluid transfer device can be safely discarded.
In this manner, the fluid transfer device can be used to aspirate a
volume of blood from a vein that is accessed via an indwelling
peripheral intravenous catheter.
[0134] While the distal surface of the catheter is described above
as being disposed at the predetermined distance from the distal tip
of the PIV when the distal surface of the catheter is in a distal
most position relative thereto, in other embodiments, the
predetermined distance can be a distance between the distal surface
of the catheter and the distal tip of the PIV when the distal
surface of the catheter is in a proximal position relative to the
distal tip of the PIV. For example, in some instances in which the
vein is in fluid communication with a branch vessel that is beyond
a reach of the catheter (e.g., downstream of the catheter when the
catheter is fully advanced relative to the introducer), it may be
desirable to advance the catheter to the second position in which
the distal surface of the catheter is disposed within the PIV
catheter. More particularly, in some such instances, the distal
surface of the catheter can be disposed at the predetermined
distance from the distal tip of the PIV when the distal surface of
the catheter is distal to, for example, a hub of the PIV but
proximal to, for example, the distal tip of the PIV. As such, the
catheter can be in the second position when the distal surface of
the catheter is in a distal position relative to one or more kinks
otherwise formed in the PIV catheter. In other instances, the
catheter can be in the second position when the distal surface of
the catheter is substantially flush with the distal tip of the PIV
(e.g., the predetermined distance is about 0.0 mm). Thus, in some
instances, the predetermined distance between the distal tip of the
PIV and the distal end or surface of the catheter can be, for
example, a predetermined range of distances that includes a
distance in a proximal direction (e.g., a negative distance) and a
distance in a distal direction (e.g., a positive distance), as
described in the '834 application incorporated by reference above.
Moreover, by passing the catheter through at least a portion of the
PIV, the catheter can be configured to "unkink" at least a portion
of the PIV whether the distal surface of the catheter is in a
proximal position relative to the distal tip of the PIV or a distal
position relative to the distal tip of the PIV. In other instances,
advancing the catheter to a position such that the distal end of
the catheter is distal to the distal tip of the PIV can, for
example, remove debris such as fibrin, clots, etc. from the distal
tip of the PIV, which in turn, may be sufficient to allow for
successful blood draw through the catheter.
[0135] The embodiments described herein can be used to transfer
fluid from a patient or to the patient by accessing a vein via an
indwelling PIV. In some instances, the embodiments described herein
can be used to aspirate a volume of blood efficiently while
maintaining the integrity of the sample. While extracting blood,
the transfer device 300 and/or 400, for example, can be configured
to receive and/or produce a substantially laminar (e.g.,
non-turbulent or low turbulent) flow of blood through the transfer
device 300 and/or 400, respectively, to reduce and/or substantially
prevent hemolysis of the blood as the blood flows through the
transfer device 300 and/or 400, respectively.
[0136] As described above, the transfer device 300 and/or 400, for
example, can be manipulated to place the distal surface of the
catheter 360 and/or 460, respectively, at a predetermined and/or
desired distance from a distal surface of the PIV. In some
instances, for example, the predetermined and/or desired distance
can be based at least in part on the venous anatomy (e.g., the
existence of one or more valves and/or branch vessels), as
described in detail above with reference to the vascular structure
analysis. Specifically, in some instances, the predetermined and/or
desired distance can be about 5.0 mm, about 10.0 mm, about 15.0 mm,
about 20.0 mm, about 25.0 mm, about 30.0 mm, about 35.0 mm, about
40.0 mm, about 45.0 mm, about 50.0 mm, and/or any suitable distance
or fraction of a distance therebetween. In other instances, a
predetermined and/or desired distance can be zero. That is to say,
in some instances, it may be desirable to position the distal
surface of the catheter 260 substantially flush to and/or with the
distal tip of the PIV catheter. Moreover, in some instances, the
predetermined and/or desired distance can be proximal to the distal
tip of the PIV catheter (e.g., the distal end of the blood draw
catheter is disposed within the PIV catheter) or the predetermined
and/or desired distance can be distal to the distal tip of the PIV
catheter (e.g., the distal end of the blood draw catheter is
disposed outside of the PIV catheter and within, for example, a
vein). As described above, it should be understood that when
referring to a predetermined and/or desired distance, such a
distance can be, for example, within a predetermined and/or desired
range of distances. In some instances, the predetermined and/or
desired range of distances can be based at least in part on the
venous anatomy and/or one or more characteristics associated with
an indwelling PIV such as, for example, a PIV length.
[0137] Although the predetermined and/or desired distance is
described above as being a positive distance, that is, the distal
surface of the catheter 360 and/or 460 is flush with or distal to
the distal tip of the PIV catheter, in other embodiments, a
predetermined and/or desired distance can be associated with a
distal surface of a catheter (e.g., the catheter 360 of the
transfer device 300 or the catheter 460 of the transfer device 400)
being in a proximal position relative to the distal tip of the PIV
catheter (e.g., a negative distance). For example, in some
instances, the predetermined and/or desired distance can be between
about 0.0 mm (e.g., the distal surfaces are flush) to about -50 mm,
between about -10 mm and about -40 mm, between about -20 mm and
about -30 mm, or between any other suitable range or subranges
therebetween. In some instances, the predetermined and/or desired
distance can be less than -50 mm (e.g., the distal surface of the
catheter 360 and/or 460 is more than 50 mm proximal to the distal
surface of the PIV). In some instances, the catheter 360 and/or
460, for example, can be placed in the second position such that a
distal end portion of the catheter 360 and/or 460 remains within
the PIV in a position distal to, for example, a kink or the like.
For example, an indwelling PIV can have one or more portions that
are kinked and/or bent (e.g., a portion of the PIV where the PIV
catheter couples to a hub). In such instances, the predetermined
and/or desired distance can be such that the distal surface of the
catheter 360 and/or 460 is distal to the portion of the PIV that
forms the kink while remaining within the PIV, which in turn, can
result in a fluid flow path being sufficiently unrestricted to
allow blood aspiration therethrough, as described in the '834
application incorporated by reference herein.
[0138] Although not shown in FIGS. 8-11 and/or 12-14, the transfer
device 300 and/or 400, respectively, can be coupled to any suitable
PIV while still being configured to place the distal surface of the
catheter 360 and/or 460, respectively, at the predetermined and/or
desired distance relative to the distal tip of the PIV catheter. In
some instances, use of a PIV can include coupling the PIV to an IV
extension set and/or an adapter (e.g., a single port adapter, a
Y-adapter, a T-adapter, or the like). Thus, while the transfer
devices 300 and/or 400 are described herein as being coupled to a
PIV, it should be understood that the transfer devices 300 and/or
400 can be coupled to either a PIV or an adapter coupled thereto
based on the situation and/or configuration. The transfer devices
300 and/or 400 can be configured to couple to any suitable
commercially available PIV, adapter, and/or extension set. For
example, the lock 450 of the transfer device 400 can have a size,
shape, and/or configuration that can allow the lock 450 to be
coupled to various PIVs, adapters, and/or extension sets, as
described in detail in the '834 application incorporated by
reference above. Moreover, the catheter 460 can have a length that
is sufficient to place the distal surface of the catheter 460 at a
desired position relative to the distal tip of the PIV when the
catheter 460 is in the second position regardless of the lock 450
coupling to an adapter (e.g., IV extension set) or directly to the
PIV.
[0139] The embodiments described herein can be used in a variety of
settings (ER, in-patient, etc.). The following scenario of
withdrawing a sample volume of blood from a patient is provided by
way of example. In some instances, a peripheral intravenous (PIV)
line and/or catheter is inserted into a vein of a patient following
standard guidelines and an extension set and/or adapter is
attached. The PIV catheter can remain within the vein for an
extended period and can provide access to the vein for the transfer
of fluids (e.g., saline, blood, drug compounds, etc.) to the
patient. That is to say, after placement, the PIV is an indwelling
PIV catheter. When it is time to draw a volume blood, a user (e.g.,
nurse, physician, phlebotomist, and/or the like) can stop the
transfer of fluid to the patient, if it is transferring fluid, for
approximately 1-5 minutes to allow the fluid to disperse from the
PIV insertion site. To draw the blood sample, the user attaches a
transfer device (e.g., the transfer device 400) to a port and/or
suitable portion of the extension set and/or adapter and
transitions the transfer device from a first configuration (e.g., a
storage configuration as shown in FIGS. 12 and 13) to a second
configuration, in which a portion of a catheter included in the
transfer device extends through the peripheral IV and into the vein
(e.g., as shown in FIG. 14).
[0140] As described in detail above with reference to the transfer
device 400, a distal surface of the catheter can be disposed at a
predetermined and/or desired distance from a distal tip of the PIV
catheter when the transfer device is in the second configuration to
place the catheter in fluid communication with a portion of the
vein that receives an unobstructed and/or uninhibited flow of
blood. For example, the distal surface of the catheter can be in a
distal position relative to the distal tip of the PIV catheter and
at least one branch vessel, valve, and/or the like in fluid
communication with the vein. Once the catheter is in the desired
position, the user can attach one or more negative pressure
collection containers, tubes, and/or syringes to the transfer
device to extract a volume of blood. In some instances, the volume
of blood can be a first volume of blood that can be discarded
and/or at least temporarily stored apart from a subsequent sample
volume of blood (e.g., typically a volume of about 1-3 milliliters
(mL) but up to 8-10 mL of blood can be a "waste" or "pre-sample"
volume). In some instance, the waste volume can include
contaminants, non-dispersed residual fluids, and/or the like. After
the collection of the waste volume, the user can couple, for
example, one or more negative pressure containers (e.g., sample
containers) to the transfer device to collect a desired blood
sample volume. Once the sample volume is collected, the transfer
device can be transitioned from the second configuration toward the
first configuration and/or a third configuration (e.g., a "used"
configuration). The transfer device can then be decoupled from the
extension set and/or adapter and safely discarded. In some
instances, after collecting the sample volume but prior to
transitioning the transfer device from the second configuration,
the waste or pre-sample volume, for example, can be reinfused into
the vein via the transfer device.
[0141] While various embodiments are described above, it should be
understood that they have been presented by way of example only,
and not limitation. Where schematics and/or embodiments described
above indicate certain components arranged in certain orientations
or positions, the arrangement of components may be modified.
Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any of embodiments as discussed above.
[0142] For example, FIGS. 30-61 illustrate various transfer device
configurations, each according to an embodiment. Each of the
embodiments shown in FIGS. 30 and 61 can be substantially similar
in form and/or function to, for example, the transfer device 400
described above with reference to FIGS. 12-14. As shown, for
example, in FIGS. 30-39 a transfer device that is substantially
similar in at least function to the transfer device 400 can have
any suitable configuration and/or arrangement that can enhance
and/or increase an aesthetic appeal and/or the ergonomics of the
transfer device. In some embodiments, a transfer device that is
substantially similar in at least function to the transfer device
400 can have a design configured to display indicia such as
instructions for use, company name, size and/or compatibility
(e.g., "20-gauge," "22-gauge," and/or the like, as shown in FIGS.
40-43. Similarly, as shown in FIGS. 44 and 45, a lock mechanism,
coupler, clip, and/or any other suitable portion can be configured
to display indicia and/or otherwise provide an indication to a user
of, for example, an intended use of the transfer device.
[0143] In some embodiments, any portion of the transfer devices
(e.g., including transfer devices 300 and 400 described above) can
have a color or the like configured to provide an indication of the
intended use of the transfer device. In some embodiments, the color
of at least a portion of any transfer device described herein can
be according to an industry standard, a U.S. Food and Drug
Administration (FDA) rule or standard, and/or the like. For
example, in some embodiments, any suitable portion of the transfer
devices described herein can be shaded and/or colored yellow,
indicating a 24-gauge catheter is included therein; blue,
indicating a 22-gauge catheter is included therein; pink,
illustrating a 20-gauge catheter is included therein; green,
illustrating a 18-gauge catheter is included therein; and/or any
other suitable color coding.
[0144] As shown, for example, in FIGS. 46-52, any suitable portion
of a transfer device such as, for example, the transfer device 400
described above, can have a substantially uncolored and at least
partially transparent (clear or light grey) introducer (e.g., the
introducer 410) and a color coded partially transparent or opaque
lock (e.g., the lock 450) and/or actuator (e.g., the actuator 470).
In some embodiments, a transfer device can also include a color
coded partially transparent or opaque coupler (e.g., the coupler
379 included in the transfer device 300), as shown in FIGS. 50-52.
In some embodiments, a transfer device can include a white, opaque
lock, as shown in FIG. 52. In some embodiments, such as those shown
in FIGS. 53-55, an introducer, lock, actuator, and/or coupler can
each be color coded and partially transparent or color coded and
opaque, or a combination thereof. In some embodiments, such as
those shown in FIGS. 56-61, a transfer device can include a white,
opaque introducer and any suitable combination of color-coding
described above.
[0145] While embodiments are particularly shown and described
herein, various changes in form and details may be made. Any of the
aspects and/or features of the embodiments shown and described
herein can be modified to affect the performance thereof. For
example, the ribs in the set of ribs 436 of the introducer 410 and
the actuator 470 can have any suitable shape, size, configuration,
and/or arrangement to produce a desired set of characteristics
associated with the movement of the actuator 470 relative to the
introducer 410, as described above. By way of another example, any
of the components of the transfer device 400 can be formed from any
suitable material that can result in a desired hardness, durometer,
and/or stiffness of that component. As another example, the size
and/or shape of the transfer device 400 can be increased or
decreased based on a desired usage. For example, in some
embodiments, a transfer device having a size that is smaller than
the transfer device 400, but otherwise being substantially similar
in form and/or function to the transfer device 400 can be used with
or for pediatric patients.
[0146] Where methods and/or schematics described above indicate
certain events and/or flow patterns occurring in certain order, the
ordering of certain events and/or flow patterns may be modified.
Additionally certain events may be performed concurrently in
parallel processes when possible, or may be performed sequentially.
Moreover, while the fluid transfer devices 300 and/or 400 are
described above as being used in the method 50, in other instances,
any suitable device can be used in any of the methods described
herein (including the method 50). For example, in some embodiments,
a user can manipulate a catheter to advance the catheter from a
first position to a second position relative to an indwelling
peripheral intravenous line, as described above with reference to
the method 50. In such instances, the catheter can be independent
of a fluid transfer device such as the fluid transfer devices 300
and/or 400. In other words, a separate and/or independent catheter
can be used in any of the methods described herein including, for
example, the method 50. Said another way, a fluid transfer device
that includes only a catheter can be used in any of the methods
described herein including, for example, the method 50.
* * * * *