U.S. patent application number 16/793967 was filed with the patent office on 2020-06-11 for iv catheter with integral extension set and a spring powered needle safety.
The applicant listed for this patent is Becton, Dickinson and Company. Invention is credited to Stephanie J. Branson, Weston F. Harding, S Ray Isaacson.
Application Number | 20200179613 16/793967 |
Document ID | / |
Family ID | 61692150 |
Filed Date | 2020-06-11 |
United States Patent
Application |
20200179613 |
Kind Code |
A1 |
Branson; Stephanie J. ; et
al. |
June 11, 2020 |
IV CATHETER WITH INTEGRAL EXTENSION SET AND A SPRING POWERED NEEDLE
SAFETY
Abstract
Catheter and needle assemblies with spring-powered retractable
needles are described. The assemblies can include a hollow handle,
a grip portion, a catheter hub with a catheter, and a needle. The
needle can have a first position in which the needle is slidably
disposed within the catheter and a second position in which the
needle is slidably removed from the catheter and retracted at least
in part into the hollow handle. The grip portion can include a
trigger portion that activates a spring to move the needle from the
first position into the second position. In the second position, a
sharp distal point of the needle is shielded by the grip portion to
prevent accidental needle sticks.
Inventors: |
Branson; Stephanie J.;
(Sandy, UT) ; Harding; Weston F.; (Lehi, UT)
; Isaacson; S Ray; (Layton, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Becton, Dickinson and Company |
Franklin Lakes |
NJ |
US |
|
|
Family ID: |
61692150 |
Appl. No.: |
16/793967 |
Filed: |
February 18, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15477256 |
Apr 3, 2017 |
10603446 |
|
|
16793967 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/3232 20130101;
A61M 25/0606 20130101; A61M 25/0043 20130101; A61M 5/3221 20130101;
A61M 25/0097 20130101; A61M 2039/1072 20130101; A61M 25/0631
20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32; A61M 25/00 20060101 A61M025/00; A61M 25/06 20060101
A61M025/06 |
Claims
1. A catheter and needle assembly comprising: a hollow handle
coupled to a grip portion, the hollow handle and grip portion
comprising an elongate cavity; a catheter hub comprising: a
catheter; a septum; and a fluid junction in fluid communication
with an extension tubing; and an elongate needle mounted on a
needle carriage, wherein the needle carriage is slidably disposed
within the elongate cavity, and wherein the elongate needle
comprises a first position in which the elongate needle is slidably
disposed within the catheter and a second position in which the
elongate needle is slidably removed from the catheter and retracted
at least in part into the hollow handle.
2. The assembly of claim 1, wherein the grip portion comprises a
trigger portion configured to activate a spring to slidably drive
the needle carriage along the elongate cavity to move the elongate
needle from the first position into the second position.
3. The assembly of claim 1, wherein the septum is configured to be
traversed by the elongate needle when the elongate needle is in the
first position and configured to form a fluid-tight seal when the
elongate needle is slidably removed from the septum as the elongate
needle moves to the second position.
4. The assembly of claim 1, wherein the needle carriage comprises a
carriage extension configured to detachably couple with a proximal
fitting of the catheter hub when the elongate needle is in the
first position.
5. The assembly of claim 1, wherein the needle carriage comprises a
needle carriage cavity in fluid communication with an open bore of
the elongate needle.
6. The assembly of claim 1, wherein the needle carriage comprises a
neck configured to engage a trigger tab to maintain the elongate
needle in the first position.
7. The assembly of claim 6, wherein depressing a trigger button
slides the trigger tab to disengage the neck to retract the
elongate needle to the second position.
8. The assembly of claim 1, wherein a sharp distal point of the
elongate needle is shielded by the grip portion when the elongate
needle is in the second position.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 15/477,256, filed on Apr. 3, 2017, and entitled IV
CATHETER WITH INTEGRAL EXTENSION SET AND A SPRING POWERED NEEDLE
SAFETY, which is incorporated herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] This disclosure relates generally to intravenous catheters
(e.g., vascular access devices). More specifically, this
application discloses various methods for using and systems of
catheter and needle assemblies with spring-powered needle safeties.
In general, vascular access devices are inserted into veins via
peripheral or central vessels for diagnostic or therapeutic
reasons. Vascular access devices can be used for infusing fluid
(e.g., saline solution, blood, medicaments, and/or total parenteral
nutrition) into a patient, withdrawing fluids (e.g., blood) from a
patient, and/or monitoring various parameters of the patient's
vascular system. Additionally, a convention is followed in this
disclosure using the term "proximal" to refer to a portion of a
device closest to the medical practitioner and the term "distal"
for the portion of the device toward a patient or away from the
medical practitioner.
[0003] Intravenous (IV) catheter assemblies are among the various
types of vascular access devices. Over-the-needle peripheral IV
catheters are a common IV catheter configuration. As its name
implies, an over-the-needle catheter is mounted over an introducer
needle having a sharp distal tip. The introducer needle is
generally a venipuncture needle coupled to a needle assembly that
helps guide the needle and facilitates its cooperation with the
catheter. At least the inner surface of the distal portion of the
catheter tightly engages the outer surface of the needle to prevent
peelback of the catheter and, thereby, to facilitate insertion of
the catheter into the blood vessel. The catheter and the introducer
needle are often assembled so that the sharp distal tip of the
introducer needle extends beyond the distal tip of the catheter.
Moreover, the catheter and needle are often assembled so that
during insertion, the bevel of the needle faces up, away from the
patient's skin. The catheter and introducer needle are generally
inserted at a shallow angle through the patient's skin into a blood
vessel.
[0004] Following insertion of the catheter and introducer needle
into the blood vessel at the catheterization site, the introducer
needle is removed leaving the catheter in the blood vessel. The
catheter can then be used to infuse fluids into the vasculature of
the patient. The removed introducer needle is considered a
"blood-contaminated sharp" and must then be properly handled and
discarded.
[0005] Although conventional over-the-needle catheters may provide
a variety of benefits, they are not without their shortcomings. For
example, after the introducer needle is removed, it can present a
needle stick hazard to the medical practitioner and/or patient.
Also, as a blood-contaminated sharp, the removed introducer needle
can covered with blood and/or tissue and can present a
contamination hazard to the medical practitioner and/or other
patients. The needle stick and contamination hazards can be
exacerbated in certain situations (e.g., where the catheterized
patient is uncooperative or where catheterization takes place in a
moving ambulance).
[0006] Thus, while a variety of over-the-needle catheters currently
exist, challenges still exist, including those listed above.
Accordingly it would be an improvement in the art to augment or
even replace current systems and techniques with other systems and
techniques.
BRIEF SUMMARY OF THE INVENTION
[0007] This disclosure relates generally to catheter and needle
assemblies with retractable needles. More specifically, this
disclosure discusses catheter and needle assemblies with
retractable needles that prevent accidental needle sticks. Methods
of using these catheter and needle assemblies are also
discussed.
[0008] Some exemplary catheter and needle assemblies can comprise a
hollow handle, a grip portion, a catheter hub comprising a
catheter, and an elongate needle having a first position in which
the elongate needle is slidably disposed within the catheter and a
second position in which the elongate needle is slidably removed
from the catheter and retracted at least in part into the hollow
handle. In some cases, the catheter hub can further comprise a
septum configured to form a fluid-tight seal when the elongate
needle is in the second position. In other cases, the grip portion
can comprise a trigger portion configured to activate a spring to
move the elongate needle from the first position into the second
position. In yet other cases, the assembly can include a needle
carriage selectively coupled to the elongate needle. In some
instances, a spring can drive the needle carriage along elongate
cavities within the grip portion and hollow handle to retract the
needle from the first position to the second position. In other
instances, the needle carriage can comprise a carriage extension
configured to detachably couple with a proximal fitting of the
catheter hub. In yet other instances, needle carriage can comprise
a needle carriage cavity in fluid communication with an open bore
of the elongate needle. In some cases, the needle carriage can
comprises a neck configured to engage a trigger tab to maintain the
elongate needle in the first position. In other cases, the catheter
hub comprises a Y-port.
[0009] In some embodiments, methods of catheterization comprise
providing a catheter and needle assembly comprising a hollow
handle, a grip portion, a catheter hub comprising a catheter, and
an elongate needle having a first position in which the elongate
needle is slidably disposed within the catheter and a second
position in which the elongate needle is slidably removed from the
catheter and retracted at least in part into the hollow handle,
inserting the elongate needle and catheter at a catheter insertion
site, activating a trigger portion to activate a spring to move the
elongate needle from the first position to the second position, and
removing the grip and handle portions containing the retracted
elongate needle. In some cases, the catheter hub can further
comprise a septum configured to form a fluid-tight seal when the
elongate needle is in the second position. In other cases,
activating the trigger portion can include depressing a trigger
button that disengages a trigger tab that maintains the elongate
needle in the first position.
[0010] In some embodiments, catheter and needle assemblies comprise
a hollow handle coupled to a grip portion, the hollow handle and
grip portion comprising an elongate cavity, a catheter hub
comprising a catheter, and an elongate needle mounted on a needle
carriage, where the needle carriage is slidably disposed within the
elongate cavity, and where the elongate needle comprises a first
position in which the elongate needle is slidably disposed within
the catheter and a second position in which the elongate needle is
slidably removed from the catheter and retracted at least in part
into the hollow handle. In some cases, the grip portion can
comprise a trigger portion configured to activate a spring to
slidably drive the needle carriage along the elongate cavity to
move the elongate needle from the first position into the second
position. In other cases, the catheter hub can further comprise a
septum traversed by the elongate needle when the elongate needle is
in the first position and configured to form a fluid-tight seal
when the elongate needle is slidably removed from the septum as the
elongate needle moves to the second position. In yet other cases,
the needle carriage can comprise a carriage extension configured to
detachably couple with a proximal fitting of the catheter hub when
the elongate needle is in the first position. In some instances,
the needle carriage can comprise a needle carriage cavity in fluid
communication with an open bore of the elongate needle. In other
instances, the needle carriage can comprise a neck configured to
engage a trigger tab to maintain the elongate needle in the first
position. In yet other instances, depressing a trigger button can
slide the trigger tab to disengage the neck to retract the elongate
needle to the second position. In some cases, a sharp distal point
of the elongate needle can be shielded by the grip portion when the
elongate needle is in the second position.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0011] In order that the manner in which the above-recited and
other features and advantages of disclosed embodiments are obtained
and will be readily understood, a more particular description of
the systems and methods briefly described above will be rendered by
reference to specific embodiments thereof, which are illustrated in
the appended drawings. Understanding that these drawings depict
only typical embodiments and are not, therefore, to be considered
to be limiting of its scope. Exemplary embodiments of the disclosed
systems and methods will be described and explained with additional
specificity and detail below through the use of the accompanying
drawings in which:
[0012] FIG. 1 illustrates a top view of a catheter and needle
assembly;
[0013] FIG. 2 illustrates a top cutaway view of a catheter and
needle assembly;
[0014] FIG. 3 illustrates a top cutaway view of a catheter hub and
grip portion;
[0015] FIG. 4A illustrates a top cutaway view of a catheter hub and
grip portion with a needle in a retracted position;
[0016] FIG. 4B illustrates a top cutaway view of a hollow handle
with a needle in a retracted position;
[0017] FIG. 5 illustrates a side cutaway view of a trigger portion
in relation to a grip portion;
[0018] FIG. 6A illustrates a front cutaway view of a trigger
portion in an engaged position; and
[0019] FIG. 6B illustrates a front cutaway view of a trigger
portion in a disengaged position.
[0020] The Figures illustrate specific aspects of exemplary
catheter securement dressing and methods for making and using such
devices as described below. Together with the following
description, the Figures demonstrate and explain the principles of
the structures, methods, and principles described herein. In the
drawings, the thickness and size of components may be exaggerated
or otherwise modified for clarity. The same reference numerals in
different drawings represent the same element, and thus their
descriptions will not be repeated. Furthermore, well-known
structures, materials, or operations are not shown or described in
detail to avoid obscuring aspects of the described devices.
Moreover, the Figures may show simplified or partial views, and the
dimensions of elements in the Figures may be exaggerated or
otherwise not in proportion for clarity and instruction.
DETAILED DESCRIPTION OF THE INVENTION
[0021] The following description supplies specific details to
provide a thorough understanding of the described catheter and
needle assemblies. Nevertheless, the skilled artisan would
understand that the described catheter and needle assemblies and
methods of making and using them can be implemented and used
without employing these specific details. Indeed, the catheter and
needle assemblies can be placed into practice by modifying the
illustrated devices and methods and can be used in conjunction with
any other apparatus and techniques conventionally used in the
industry.
[0022] In general, this disclosure relates to systems of catheter
and needle assemblies and methods of catheterization using such
catheter and needle assemblies. In some instances, a catheter and
needle assembly can comprise a hollow handle, a grip portion, and a
catheter hub, arranged in that order along a longitudinal axis. The
catheter hub can comprise an over-the-needle-catheter configured
for catheterization of a patient. The needle can be configured
retract into the grip portion and hollow handle via a spring. Using
the grip portion to manipulate the catheter and needle assembly, a
medical practitioner can insert the over-the-needle-catheter into a
vasculature of the patient at a catheter insertion site. The
medical practitioner can then activate a trigger on the grip
portion to retract the spring-loaded needle into the grip portion
and the hollow handle. The spring-loaded needle retracts into the
grip portion and hollow handle to sheath the needle to avoid a
needle stick from the retracted needle. The grip portion and hollow
handle can then be removed as a single unit from the catheter hub
and safely discarded with minimized risk of needle stick and/or
contamination.
[0023] Referring to FIGS. 1-2, a catheter and needle assembly 1 is
shown. While the catheter and needle assembly 1 can comprise any
suitable component and/or suitable structure, at least in some
embodiments, it comprises a hollow handle 10, a grip portion 30,
and a catheter hub 60. In some instances, the hollow handle 10, the
grip portion 30, and the catheter hub 60 can be aligned along a
longitudinal axis "A". The hollow handle 10 can comprise an
elongate cavity 12 aligned along the longitudinal axis "A". The
hollow handle 10 can comprise a proximal end 14 and a distal end
16. The proximal end 14 of the hollow handle 10 can comprise an
axial opening 18 that includes a vent 20. In some cases, the vent
20 can be configured to selectively allow air transmission into and
out of cavity 12 and/or to substantially prevent fluid flow into or
out of cavity 12.
[0024] In some embodiments, the grip portion 30 comprises a
proximal end 32 and a distal end 34. The proximal end 32 of the
grip portion 30 can selectively couple with the distal end 16 of
the hollow handle 10. The distal end 34 of the grip portion 30 can
selectively and detachably couple with a proximal end 62 of the
catheter hub 60. The grip portion 30 can also comprise an elongate
cavity 36 that extends from the distal end 34 to the proximal end
32 and into the elongate cavity 12 of the hollow handle 10. The
grip portion 30 can also comprise gripping surfaces 38 configured
to allow the medical practitioner to manipulate the assembly 1
during catheterization. The grip portion 30 can also comprise a
trigger portion 130. In some cases, the trigger portion 130 is
configured to allow the medical practitioner to retract the
spring-loaded needle into the grip portion 30 and hollow handle
10.
[0025] In some embodiments, the catheter hub 60 comprises the
proximal end 62, a distal end 64, and an open passageway 66
therethrough. In some cases, the proximal end 62 of the catheter
hub 60 can be configured to selectively and detachable couple with
the distal end 34 of the grip portion 30. In other cases, the
catheter hub 60 can comprise a catheter 68 extending distally from
the catheter hub 60. In yet other cases the catheter hub 60 can
comprise a fluid junction 70 in fluid communication with the
catheter 68, tubing 72, and fluid connector 74. In some instances,
the tubing 72 can comprise one or more pinch clamps. In other
instances, the fluid connector 74 can comprise one or more Luer
fittings, a needleless connection, or other means of connecting a
fluid line.
[0026] In some embodiments, the catheter and needle assembly 1
comprises an elongate needle 100 with an open bore 102 therethrough
and a sharp distal point 104. The needle 100 can be slidably
disposed within the catheter 68. The needle 100 can be selectively
coupled to a needle carriage 106. The needle carriage 106 can be
configured to slidably translate within and along the elongate
cavity 36 of the grip portion 30 and into the elongate cavity 12 of
the handle. The needle 100 can have a first position, best seen in
FIGS. 1-3, with needle 100 disposed within the catheter hub 60
within the open passageway 66 and slidably disposed within the
catheter 68. In this first position, the needle carriage 106 is
disposed within the grip portion 30. The needle 100 can also have a
second position, best seen in FIGS. 4A and 4B, with the needle 100
retracted by a helical spring 108 into the grip portion 30 and the
hollow handle 10. In this second position, the needle carriage 106
is disposed within the handle 10.
[0027] With continued reference to FIGS. 1-2, in some embodiments,
the catheter and needle assembly 1 comprises a cover 140. The cover
140 can comprise a distal portion 142 configured to shield the
catheter 68 and/or the needle 100. The cover 140 can also comprise
a proximal portion 144 configured to shield at least a portion of
the catheter hub 60 and the grip portion 30. The proximal portion
144 can also be configured to cover and/or to shield the trigger
portion 130 to prevent accidental activation of the trigger portion
130.
[0028] Referring now to FIG. 3, a cutaway view of some embodiments
of the grip portion 30 and the catheter hub 60 are shown with the
needle carriage 106 in the first position. In the first position,
the needle carriage 106 can be slidably disposed within the
elongate cavity 36 of the grip portion. Also, in this first
position, the helical spring 108 can be coiled around a portion of
the needle carriage 106 and compressed between a spring tab 110 on
the needle carriage 106 and a spring tab 40 on the grip portion 30.
The needle carriage 106 can be maintained in this first position
with the compressed spring 108 by trigger tabs 132 that slidably
engage a neck 112 of the needle carriage 106. The trigger tabs 132
can slidably engage along trigger tab slots 42 in the grip portion
30. The needle 100 can be coupled to the needle carriage 106 by a
needle mount 114. The open bore 102 of the needle 100 can open into
a needle carriage cavity 116. The needle carriage cavity 116 can
open into a needle carriage opening 118. In some cases, the needle
carriage opening 118 can further comprise a filter 120.
[0029] In some embodiments, the grip portion 30 comprises a distal
wall 44. In some cases, the distal wall 44 can comprise wall
extensions 46. The distal wall 44 can comprise a distal opening 48.
In other cases, the distal wall 44 can be configured to receive a
needle carriage extension 122 of the needle carriage 106 such that
the needle carriage extension 122 extends at least in part through
the distal opening 48 when the needle 100 is in the first position.
The needle carriage extension 122 can be configured to extend into
and/or be received by a proximal fitting 76 on the catheter hub 60
when the needle 100 is in the first position. The needle carriage
extension 122 can also be configured to detachably couple with the
proximal fitting 76 on the catheter hub 60 when the needle 100 is
in the first position. In some cases, the proximal fitting 76 can
comprise a Luer style fitting. In other cases, the distal wall 44
can be configured to receive the proximal fitting 76. In yet other
cases, the needle carriage extension 122 can be configured to
extend at least in part into an opening in the proximal fitting
76.
[0030] In some embodiments, when the needle 100 is in the first
position, the needle 100 extends through the catheter hub 60
through a septum 78 disposed in the open passageway 66 of the
catheter hub 60. The septum 78 can be retained within the open
passageway 66 by septum retaining tabs 80. The septum 78 can also
comprise one or more openings. In some cases, the septum 78
comprises a first septum opening 82 and a second septum opening 84
connected by a septum lumen 86. When in the first position, the
needle 100 can also extend through the catheter 68. The catheter 68
can be secured at least in part to the catheter hub 60 with a
grommet 88.
[0031] Referring now to FIGS. 4A and 4B, a cutaway view of some
embodiments of the needle and catheter assembly 1 are shown with
the needle 100 in the second position. As shown in FIG. 4A, in the
second position, the sharp distal point 104 of the needle 100 can
be retracted from the catheter hub 60 into the grip portion 30 to
prevent accidental needle sticks. In this second position the
needle 100 is no longer threaded through the catheter 68. The
needle 100 also no longer passes through the septum 78. The needle
100 also no longer passes through the first and second septum
openings 82, 84 and the first and second septum openings 82, 84 can
maintain a fluid-tight seal. The carriage extension 122 of the
needle carriage 106 can also retract from the proximal fitting 76
of the catheter hub 60. In some cases, the catheter hub 60 can
separate from the grip portion 30 when the needle 100 is in the
second position. In other cases, the catheter hub 60 can remain
coupled to the grip portion 30 when the needle 100 is in the second
portion and the medical practitioner can separately uncouple the
catheter hub 60 from the grip portion 30 after the needle 100 is
retracted to the second position.
[0032] As shown in FIG. 4B, in the second position, the spring 108
can uncompress and can drive the needle carriage 106 along the
elongate cavity 36 of the grip portion 30 and into and along the
elongate cavity 12 of the handle 10. Concomitantly, as the needle
carriage 106 is driven along the elongate cavities 36, 12, the
needle 100 can be slidably withdrawn from the catheter 68 through
the septum 78 and into the grip portion 30 and the handle 10. The
needle carriage 106 can then come to rest and can be biased against
the proximal end 14 of the handle 10. In some instances, the grip
portion 30 and handle 10 are then separated from the catheter hub
60 and discarded to prevent any cross-contamination.
[0033] Referring now to FIGS. 5, 6A, and 6B, some embodiments of
the trigger portion 130 are shown. While the trigger portion 130
can comprise any suitable component that allows it to function as
intended, at least in some embodiments it comprises the trigger tab
132, a trigger button 134, and a keyhole opening 136 on the trigger
tab 132. FIG. 5 shows a side cutaway view of the trigger portion
130 with respect to the grip portion 30. As shown in FIG. 5 and as
described above, the trigger tab 132 can be configured to be
disposed within the trigger tab slots 42 to engage the neck 112 of
the needle carriage 106. When the neck 112 is engaged by the
trigger tab 132, the needle 100 is held in the first position. The
trigger button 134 can be connected to the trigger tab 132. The
trigger button 134 can be configured to allow the medical
practitioner to activate the spring 108 to retract the needle 100
by pressing down on the trigger button 134 in the direction
indicated by the arrow labeled "B". By pressing on the trigger
button 134 in the direction indicated by the arrow labeled "B", the
medical practitioner can cause the trigger tab 132 to be slidably
translated along the trigger tab slots 42. As the trigger tab 132
slidably translates along the trigger tab slots 42, the neck 112
becomes disengaged. With the neck 112 disengaged, the spring 108 is
able to drive the needle carriage 106 along the elongate cavities
36, 12 to retract the needle 100.
[0034] Referring now to FIGS. 6A and 6B, cross-sectional views of
some embodiments of the trigger portion 130 relative to the grip
portion 30 are shown. FIG. 6A illustrates embodiments of the neck
112 engaged by the trigger tab 132 and FIG. 6B illustrates
embodiments of the neck 112 disengaged from the trigger tab 132. In
some cases, the keyhole opening 136 on the trigger tab 132 can
comprise a narrow portion 137 and a larger portion 138. The narrow
portion 137 can be sized and/or shaped to engage the neck 112. The
larger portion 138 can be sized to permit the neck 112 to be
disengaged from the keyhole opening 136 and/or to permit the
carriage extension 122 to pass through the keyhole opening 136. As
shown in FIG. 6A, with the trigger tab 132 in the engaged position,
the neck 112 can be engaged by the narrow portion 137 of the
keyhole opening 136 and the needle 100 maintained in the first
position. As shown in FIG. 6B, as the medical practitioner presses
down on the trigger button 134 in the direction indicated by the
arrow labeled "B", the trigger tab 132 slides along the trigger tab
slots 42, the neck 112 disengages with the narrower portion 137,
and the larger portion 138 permits the carriage extension 122 to
pass through the keyhole opening 136 thereby allowing the spring
108 to retract the needle 100. While FIGS. 6A and 6B illustrate a
keyhole opening 136 mechanism to engage and disengage the neck 112,
any other suitable mechanism as is known in the art can be used.
For example, a pin or tab can be used to engage the neck 112 and
the trigger button 134 can be configured to remove the pin or tab
to disengage the neck 112.
[0035] In some embodiments, this application discloses methods of
catheterization using catheter and needle assemblies comprising
retracting needles. In some instances, these methods can include
providing a catheter and needle assemblies as described above. The
medical practitioner can begin by preparing a catheterization site
on a patient. The medical practitioner can then remove the catheter
and needle assembly 1 from any packaging. The medical practitioner
can then grasp the assembly 1 by the gripping surfaces 38 and
manipulate the assembly 1 so that the sharp distal point 104 of the
elongate needle 100 is at a catheter insertion site. The medical
practitioner can then insert the elongate needle 100 and the
catheter 68 into the patient at a shallow angle at the catheter
insertion site and access a blood vessel. In some cases, the
medical practitioner can further advance the catheter 68 to achieve
proper placement. The medical practitioner can confirm proper
placement of the catheter by observing blood flashback into the
open passageway 66 of the catheter and/or blood flashback along the
tubing 72. The medical practitioner can then depress the trigger
button 134 to activate the spring 108 to retract the elongate
needle 100 into the second position. As the elongate needle 100
retracts into the grip portion 30 and hollow handle 10, the
catheter hub 60 separates from the grip portion 30. The medical
practitioner can then discard the grip portion 30 and hollow handle
10 that contain the sheathed elongate needle 100 with minimized
risk of needle stick and/or contamination. When the elongate needle
100 retracts to the second position, the septum 78 seals the
catheter hub 60 to prevent fluid escaping from the patient through
the catheter 68. The medical practitioner can then infuse fluids to
the patient through the fluid junction 70 and/or through fluid
connection 74. Alternately, the medical practitioner can then
infuse fluids to the patient through the catheter 68 via the
proximal fitting 76 of the catheter hub 60 using a connector that
can traverse the septum 78.
[0036] Although the catheter and needle assembly 1 can be
manufactured and assembled in any suitable manner, at least in some
embodiments, the catheter and needle assembly 1 is assembled, cover
140 is positioned thereon, and the assembly 1 and cover 140 are
placed within a sealed package. The sealed package can be formed
from materials substantially resistant to contamination by
infectious agents such as viruses and microbes. The sealed package
can then be sterilized to render the infectious agents non-viable.
Suitable sterilization conditions that render the infectious agents
non-viable include chemical sterilants (e.g., ethylene oxide,
hydrogen peroxide vapor, and other similar chemicals) and exposure
to ionizing radiation (e.g., gamma rays, beta particles, and other
similar types of radiation). Suitable materials for the sealed
package include, but are not limited to, paper, waxed paper,
plastic, thermoplastic film, non-woven materials, and other similar
materials. After packaging and sterilization, the packaged assembly
is considered sterile until the package is opened.
[0037] In some embodiments, when assembly 1 is manufactured, needle
100 is rotationally oriented in the assembly 1 so that a beveled
surface of the sharp distal point 104 is substantially aligned with
the trigger button 134. When the assembly 1 is unshielded in
preparation for usage by the medical practitioner, the alignment of
the beveled surface of the needle 100 and trigger button 134
substantially directs the medical practitioner's grasp of the
hollow handle 10 to an intuitively proper position for insertion
into the patient with the beveled surface facing upward. Following
insertion of the needle 100 the medical practitioner is readily
able to confirm the proper placement in the patient's blood vessel
by observation of blood flashback in the open passageway 66 and/or
within the tubing 72.
[0038] In some embodiments, when assembly 1 is manufactured, a
lubricant can be applied to one or more parts of the assembly. For
example, the lubricant can be applied to one or more of the needle
100, the catheter 68, the carriage extension 122, the needle
carriage 106, and the spring 108. The lubricant can be applied to
reduce friction between the components and/or to permit the
lubricated components to slip more easily past each other. For
example, lubricant can be applied to the needle carriage 106 and
spring 108 to permit the needle carriage 106 to slide more easily
from the first position to the second position. Likewise, lubricant
can be applied to the needle 100 and or catheter 68 to ease entry
of the needle into the patient's blood vessel and/or to ease
removal of the needle 100 from the catheter 68. In some cases, the
lubricant can comprise an antimicrobial agent such as
chlorohexidine.
[0039] Although the catheter and needle assembly 1 can be
manufactured from any suitable materials, at least in some
embodiments, the hollow handle 10, the grip portion 30, the
catheter hub 60, and the cover 140 are formed from thermoplastic
polymeric resins such as polycarbonate, polystyrene, polypropylene,
and other similar materials. The hollow handle 10 and the grip
portion 30 can be formed from a substantially transparent material
to allow the medical practitioner to visibly ascertain whether the
needle 100 is in the first position or the second position. The
catheter 68 can be formed from thermoplastic resins such as
polytetrafluoroethylene (PTFE), polyurethane, and other similar
materials. In some cases, the catheter 68 can be formed from
thermoplastic hydrophilic polyurethane that softens with exposure
to physiological conditions within the patient's body. The elongate
needle 100, the spring 108, and the grommet 88 can be formed from a
stainless steel alloy or other similar material.
[0040] The present disclosure discusses catheter and needle
assemblies that can have many features. For example, some
embodiments of the catheter and needle assemblies comprise a septum
within the catheter hub. The septum is configured to seal when the
needle is retracted, thereby sealing the catheter from an outside
atmosphere to prevent fluid leakage. Also, in other embodiments,
the catheter hub comprises a Y-port, tubing, and connectors. The
Y-port can provide an access point for the medical practitioner to
infuse fluids into the patient. Also, the tubing can provide the
ability to observe blood flashback for a much longer time as a
blood flow front progresses up the tubing. Another feature is a
lower amount of drag when advancing the catheter. The lower amount
of drag when advancing the catheter can be enabled by one or more
of lubricating the needle and/or the catheter, the beveled surface
of the sharp distal point of the needle, sizing and shaping the
catheter and/or needle for reduced drag, and other similar
features.
[0041] Yet another feature is the adaptability of the disclosed
assemblies to other techniques known in the art. For example, the
described assembly can be modified to place a catheter within a
tortuous vessel anatomy by providing a flexible guidewire within
the open bore of the needle. The assembly is inserted at the
catheterization site as described above. Then the flexible
guidewire is advanced into the blood vessel. The catheter is then
further advanced into the blood vessel along the flexible
guidewire. Then the flexible guidewire is retracted. The needle is
then retracted as described above.
[0042] In addition to any previously indicated modification,
numerous other variations and alternative arrangements may be
devised by those skilled in the art without departing from the
spirit and scope of this description, and appended claims are
intended to cover such modifications and arrangements. Thus, while
the information has been described above with particularity and
detail in connection with what is presently deemed to be the most
practical and preferred aspects, it will be apparent to those of
ordinary skill in the art that numerous modifications, including,
but not limited to, form, function, manner of operation, and use
may be made without departing from the principles and concepts set
forth herein. Also, as used herein, the examples and embodiments,
in all respects, are meant to be illustrative only and should not
be construed to be limiting in any manner.
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