U.S. patent application number 17/575332 was filed with the patent office on 2022-05-05 for catheter insertion device.
The applicant listed for this patent is TELEFLEX MEDICAL INCORPORATED. Invention is credited to Chris KORKUCH, Jeffrey P. KUEHN, Drew PIEPRZYK.
Application Number | 20220134058 17/575332 |
Document ID | / |
Family ID | 1000006081269 |
Filed Date | 2022-05-05 |
United States Patent
Application |
20220134058 |
Kind Code |
A1 |
KORKUCH; Chris ; et
al. |
May 5, 2022 |
CATHETER INSERTION DEVICE
Abstract
A catheter insertion device that allows for insertion of a
catheter within vasculature of a patient is disclosed. The catheter
insertion device includes a handle and a needle cannula held within
the handle. A guidewire is partially disposed within the needle
cannula. The guidewire is slidable within a lumen of the needle
cannula. A first actuator is connected to the handle and the
guidewire, and is movable relative to the handle to move the
guidewire relative to the handle. A catheter and catheter hub are
configured to move relative to the handle and slide over the
cannula during deployment of the catheter into the vasculature of
the patient. A needle safety clip covers a sharp distal tip of the
cannula following removal of the needle cannula from the catheter
hub.
Inventors: |
KORKUCH; Chris; (Chester
Springs, PA) ; KUEHN; Jeffrey P.; (Schuylkill Haven,
PA) ; PIEPRZYK; Drew; (Reading, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TELEFLEX MEDICAL INCORPORATED |
Morrisville |
NC |
US |
|
|
Family ID: |
1000006081269 |
Appl. No.: |
17/575332 |
Filed: |
January 13, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16247249 |
Jan 14, 2019 |
11224724 |
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17575332 |
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14306698 |
Jun 17, 2014 |
10357635 |
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16247249 |
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14205307 |
Mar 11, 2014 |
9717886 |
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14306698 |
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61778302 |
Mar 12, 2013 |
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61865944 |
Aug 14, 2013 |
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Current U.S.
Class: |
604/510 |
Current CPC
Class: |
A61M 25/0113 20130101;
A61M 25/0618 20130101; A61M 25/0606 20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06 |
Claims
1. A catheter insertion device, comprising: a handle comprising a
top arm and a bottom arm, the top arm and the bottom arm formed in
a distal region of the handle; a needle cannula having a sharp
distal tip, the needle cannula held within the handle and at least
partially disposed between the top arm and the bottom arm; a
guidewire at least partially disposed within a lumen of the needle
cannula, the guidewire configured to slide within the lumen of the
needle cannula; a first actuator connected to the guidewire, the
first actuator being movable relative to the handle to move the
guidewire relative to the handle; a catheter group comprising a
catheter and a catheter hub, the catheter hub connected to a
proximal end of the catheter, the catheter and the catheter hub at
least partially disposed between the top arm and the bottom arm,
and the catheter and the catheter hub are configured to move
relative to the handle and slide over the cannula during deployment
of the catheter into vasculature of a patient; and a needle safety
clip configured to cover the sharp distal tip of the needle cannula
following removal of the needle cannula from the catheter hub.
2. The catheter insertion device according to claim 1, wherein the
first actuator comprises an arm secured to the guidewire, the arm
extending from a bottom surface of the first actuator.
3. The catheter insertion device according to claim 2, wherein the
arm is connected to a proximal end of the guidewire.
4. The catheter insertion device according to claim 1, wherein the
first actuator is a slider operable to slide over a portion of the
handle.
5. The catheter insertion device according to claim 4, wherein the
slider is operable to slide over the top arm formed in the distal
region of the handle.
6. The catheter insertion device according to claim 1, further
comprising a second actuator connected to the handle, the second
actuator being movable relative to the handle to push the catheter
group relative to the handle.
7. The catheter insertion device according to claim 6, wherein the
second actuator is configured to receive a portion of the catheter
hub.
8. The catheter insertion device according to claim 6, wherein the
second actuator comprises an enlarged proximal end operable to
engage the handle to limit movement of the second actuator relative
to the handle.
9. The catheter insertion device according to claim 6, wherein the
second actuator comprises a lip extending outward from a distal end
of the second actuator, the lip configured to prevent a finger of a
practitioner from slipping past the distal end of the second
actuator during operation.
10. The catheter insertion device according to claim 1, further
comprising a needle support coupled to the top arm, wherein the
needle support is configured to move relative to the handle upon
abutment of the catheter hub to the needle support.
11. The catheter insertion device according to claim 10, wherein
the needle support is configured to stabilize a portion of the
needle cannula during insertion of the needle cannula into a
patient.
12. The catheter insertion device according to claim 11, wherein
the needle support comprises a top portion that abuts a bottom
surface of the first actuator to prevent movement of the needle
support relative to the handle.
13. A method of accessing a vasculature of a patient, comprising:
providing the catheter insertion device of claim 1; grasping the
handle using a first hand of the practitioner; navigating the
handle until the sharp distal tip of the needle cannula is within
the vasculature of the patient; actuating the first actuator using
a first finger of the first hand of the practitioner to cause a
distal tip of the guidewire to move in a distal direction relative
to the handle and within the vasculature of the patient; and moving
the catheter group in a distal direction relative to the handle
such that the distal end of the catheter is inserted within the
vasculature of the patient.
14. The method according to claim 13, wherein the first actuator is
actuated in a proximal direction using the first finger of the
first hand of the practitioner to cause a distal tip of the
guidewire to move in a distal direction relative to the handle and
within the vasculature of the patient
15. The method according to claim 13, further comprising actuating
a second actuator of the catheter insertion device using the first
finger of the practitioner to cause the catheter group to move in a
distal direction relative to the handle so that the distal end of
the catheter is inserted within the vasculature of the patient.
16. The method according to claim 13, further comprising gripping a
first side of the handle using a second finger of the first hand of
the practitioner, and gripping the second side of the handle using
a third finger of the first hand of the practitioner, the second
finger and the third finger being different from the first finger
used to actuate the first actuator.
17. The method according to claim 16, further comprising gripping
the catheter hub with a second hand of the practitioner while
pulling the handle in a proximal direction using the first hand of
the practitioner to separate the catheter group from the
handle.
18. The method according to claim 17, further comprising pulling
the handle in the proximal direction to the point where the needle
safety clip covers the sharp distal tip of the needle cannula.
19. The method according to claim 13, wherein the practitioner
grips the handle overhand, and the first finger is the index finger
of the first hand of the practitioner.
20. The method according to claim 13, wherein the practitioner
grips the handle underhand, and the first finger is the index
finger of the first hand of the practitioner.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/247,249, filed Jan. 14, 2019, which is a
divisional of U.S. patent application Ser. No. 14/306,698, filed
Jun. 17, 2014, now U.S. Pat. No. 10,357,635, which claims the
benefit of U.S. Provisional Application No. 61/865,944, filed on
Aug. 14, 2013, and which is a continuation-in-part of U.S. patent
application Ser. No. 14/205,307, filed Mar. 11, 2014, now U.S. Pat.
No. 9,717,886, which claims the benefit of U.S. Provisional
Application No. 61,778,302, filed on Mar. 12, 2013, the disclosures
of which are hereby incorporated by reference in their
entireties.
TECHNICAL FIELD
[0002] This disclosure generally relates to medical devices for use
in insertion of catheters or other medical equipment into the
vasculature of a patient. More particularly, this disclosure
relates to a catheter insertion device for at least partial
insertion of a catheter within the vasculature of the patient.
BACKGROUND
[0003] Different types of medical devices, such as needles,
introducers, trocars, catheters, stents, angiography balloons,
cutting tools, and imaging tools can be introduced into the body
for various medical procedures. For example, catheters are used to
introduce or remove fluids from vessels in the body for a variety
of medical procedures. In a typical procedure, to insert a catheter
in a vessel, the vessel access is first verified by aspiration
using a long hollow needle, such as a syringe needle. A guidewire
is then passed through the needle into the vessel. The guidewire
acts as a track for the catheter to pass over to reach a target
location within the vessel. A catheter is finally passed over the
guidewire to the target location in the vasculature of the patient.
With the catheter in place, the needle and the guidewire are
removed, leaving only the catheter in the vessel. Fluids are then
introduced or removed from the vessel through the catheter by
connecting a fluid source or aspiration device to the catheter
hub.
[0004] Various devices are known for placement of a catheter in the
vasculature of a patient. The maintenance of sterility of the
various components of the device by, for example, preventing the
contact of the fingers of the operator with the various parts of
the needle, the guidewire and the catheter itself during operation,
is important for use of these devices. However, known catheter
placement devices typically require the use of two hands for the
insertion of the guide wire and advancement of the catheter into
the vasculature, which increases the risk of contamination,
increases the risk of inadvertently damaging the vessel due to
unintended needle point movement, prevents the continuous use of
ultrasound from the point of skin penetration, vessel access, wire
guide insertion, through to having the first distal portion of the
catheter in the vessel and needle point shielded, and makes the
device less convenient for use.
[0005] Therefore, a need exists for a novel catheter insertion
device that allows for single-handed insertion of the catheter
within the vasculature of the patient.
SUMMARY
[0006] The foregoing needs are met, to a great extent, by
implementations of the catheter insertion device according to this
disclosure. In accordance with one implementation, a catheter
insertion device includes a handle, a needle cannula partially
within the handle, a guidewire partially within the handle and the
needle cannula, and a first actuator connected to the handle and
the guidewire. The needle cannula includes a sharp distal tip
extending distally from the handle. The first actuator is movable
relative to the handle to move the guidewire relative to the
handle, such that moving the first actuator in a proximal direction
relative to the handle causes a distal end of the guidewire to move
in a distal direction away from the handle, and moving the first
actuator in a distal direction relative to the handle causes the
distal end of the guidewire to move in a proximal direction towards
the handle.
[0007] In some implementations, the first actuator can be a slider
which is moved by sliding over a portion of the handle, and the
first actuator can include an arm extending downward from the
bottom surface of the first actuator. The arm can be connected to a
proximal end of the guidewire. The arm can include a through hole,
where the proximal end of the guidewire can be secured within the
through hole. The proximal end of the guidewire can include a ball,
where the diameter of the ball can be greater than the diameter of
the through hole, such that the guidewire can secured within the
through hole by an interference fit.
[0008] In some implementations, the handle can include a looped
proximal end portion that can define a channel that holds a portion
of the guidewire. The catheter insertion device can also include a
catheter assembly removably connected to the handle, where the
catheter assembly can include an elongated catheter connected to a
catheter hub. The catheter insertion device can also include a
needle safety clip that can cover the sharp distal tip of the
needle cannula following removal of the needle cannula from the
catheter hub. The catheter hub can house a hemostasis valve. The
hemostasis valve can include a distal piece and a proximal piece
that when mated define a closed inner cavity. The volume of the
closed inner cavity defined by the proximal piece can be greater
than any volume of the inner cavity defined by the distal
piece.
[0009] In some implementations, the catheter insertion device can
also include a second actuator connected to the handle, where the
second actuator can be movable relative to the handle to push the
catheter group relative to the handle. The second actuator can
include a notch to receive a portion of the catheter hub. The
second actuator can include an enlarged proximal end that engages
with the handle to limit travel of the second actuator relative to
the handle.
[0010] In some implementations, the catheter insertion device can
also include a needle support connected to the handle, where the
needle support can stabilize an intermediate portion of the needle
cannula during insertion of the needle cannula into a patient. The
intermediate portion of the needle cannula can freely extend from
the handle. The needle support can include a top portion that abuts
a bottom surface of the first actuator to prevent movement of the
needle support relative to the handle.
[0011] According to another implementation, a catheter insertion
device includes an insertion group including a handle, a needle
cannula partially within the handle, and a needle support connected
to the handle. The catheter insertion device also includes a
catheter group comprising an elongated catheter and a catheter hub
connected to the proximal end of the elongated catheter. The needle
support includes two parallel features separated by a distance
greater than an outer diameter of the elongated catheter to
stabilize the needle cannula during insertion of the needle cannula
into a patient. The needle cannula has a cantilever portion
extending from the handle, where the needle support supports the
needle cannula on the cantilever portion.
[0012] In some implementations, the needle support can move
relative to the handle upon abutment of the catheter hub to the
needle support. The needle support can move relative to the handle
by swinging upward or downward relative to the handle. The two
parallel features can be two parallel walls. The handle can include
a top arm, and the needle support can be connected to a distal
region of the top arm of the handle.
[0013] According to another implementation, a method of using a
catheter insertion device is disclosed. Initially, a practitioner
receives the catheter insertion device. The catheter insertion
device includes a handle, a needle cannula partially within the
handle, a guidewire partially within the handle and the needle
cannula, a first actuator connected to the handle and the
guidewire, a catheter group removably connected to the handle, and
a second actuator connected to the handle. The needle cannula
includes a sharp distal tip extending distally from the handle. The
first actuator is movable relative to the handle to move the
guidewire relative to the handle. The catheter group includes an
elongated catheter and a catheter hub connected to the proximal end
of the elongated catheter. The second actuator is movable relative
to the handle to move the catheter group relative to the
handle.
[0014] Next, the practitioner grips the handle using a hand of the
practitioner. The practitioner then navigates the handle until the
sharp distal tip of the needle cannula is within the vasculature of
a patient. Next, the practitioner actuates the first actuator using
a first finger to cause a distal tip of the guidewire to move in a
distal direction relative to the handle and within the vasculature
of the patient. Finally, the practitioner actuates the second
actuator using the first finger of the practitioner to cause the
catheter group to move in a distal direction relative to the handle
so that the distal end of the elongated catheter is inserted within
the vasculature of the patient.
[0015] In some implementations, the handle can include a first side
and a second side opposite the first side. The practitioner can
then grip the first side using a second finger of the hand of the
practitioner and grip the second side using a third, different
finger of the hand of the practitioner. The first actuator can be
actuated in a proximal direction using the first finger of the hand
of the practitioner to cause a distal tip of the guidewire to move
in a distal direction relative to the handle and within the
vasculature of the patient, and the second actuator can be actuated
in a distal direction using the first finger of the practitioner to
cause the catheter group to move in a distal direction relative to
the handle so that the distal end of the elongated catheter is
inserted within the vasculature of the patient.
[0016] In some implementations, the practitioner can grip the
catheter hub with his other hand while pulling the handle in a
proximal direction to separate the catheter group from the handle.
The practitioner can grip the handle overhand, such that the first
finger can be the index finger of the hand of the practitioner. The
practitioner can grip the handle underhand, such that the first
finger can be the index finger of the hand of the practitioner.
[0017] According to another implementation, a method of inserting a
catheter is disclosed. Initially, a catheter insertion device is
received. The catheter insertion device includes a handle, a needle
cannula partially within the handle, a guidewire partially within
the handle and the needle cannula, a first actuator connected to
the handle and the guidewire, a catheter group removably connected
to the handle, and a second actuator connected to the handle. The
needle cannula includes a sharp distal tip extending distally from
the handle. The first actuator is movable relative to the handle to
move the guidewire relative to the handle. The catheter group
includes an elongated catheter and a catheter hub connected to the
proximal end of the elongated catheter. The second actuator is
movable relative to the handle to move the catheter group relative
to the handle.
[0018] Next, the first actuator is actuated using a finger to cause
a distal tip of the guidewire to move in a distal direction
relative to the handle and within the vasculature of the patient.
The second actuator is actuated using the same finger to cause the
catheter group to move in a distal direction relative to the handle
so that the distal end of the elongated catheter is inserted within
the vasculature of the patient.
[0019] Certain implementations of the catheter insertion device
have been outlined so that the detailed description below may be
better understood. There are, of course, additional implementations
that will be described below and which will form the subject matter
of the claims.
[0020] In this respect, before explaining at least one
implementation in detail, it is to be understood that the catheter
insertion device is not limited in its application to the details
of construction and to the arrangements of the components set forth
in the following disclosure or illustrated in the drawings. Also,
it is to be understood that the phraseology and terminology
employed herein, as well as in the Abstract, are for the purpose of
description and should not be regarded as limiting.
[0021] As such, those skilled in the art will appreciate that the
conception upon which this disclosure is based may readily be
utilized as a basis for the designing of other structures, methods,
and systems for carrying out the several purposes of the catheter
insertion device. It is understood, therefore, that the claims
include such equivalent constructions insofar as they do not depart
from the spirit and scope of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 illustrates a perspective view of an implementation
of a catheter insertion device including a catheter group and an
insertion group.
[0023] FIG. 2A illustrates an exploded view of the separate
components of the catheter group of the catheter insertion device.
FIG. 2B illustrates a partially transparent perspective view of the
assembled catheter group of the catheter insertion device.
[0024] FIG. 3A illustrates an exploded view of the separate
components of the insertion group of the catheter insertion device.
FIG. 3B illustrates a perspective view of the assembled insertion
group of the catheter insertion device. FIG. 3C illustrates a
perspective view of an assembled insertion group of the catheter
insertion device having another implementation of the needle
guard.
[0025] FIG. 4 illustrates a side view of a right housing of an
assembled catheter insertion device.
[0026] FIG. 5 illustrates a cross-sectional view of a handle of an
assembled catheter insertion device.
[0027] FIG. 6 illustrates a transparent side view of a portion of a
slider of the insertion group of the catheter insertion device.
[0028] FIG. 7A illustrates the left side of a release of the
insertion group of the catheter insertion device. FIG. 7B
illustrates the right side of the release of the insertion group of
the catheter insertion device.
[0029] FIG. 8A illustrates a partially transparent perspective view
of a region of the assembled catheter insertion device. FIG. 8B
illustrates a partial cross-sectional view of the region of the
assembled catheter insertion device along the center longitudinal
plane of the handle. FIG. 8C illustrates a partial cross-sectional
view of the region of the assembled catheter insertion device along
the center longitudinal plane of the handle following actuation of
the slider by the practitioner. FIG. 8D illustrates a partial
cross-sectional view of the region of the assembled catheter
insertion device along the center longitudinal plane of the handle
following actuation of the release by the practitioner.
[0030] FIG. 9A illustrates a perspective view of a needle safety
clip mounted to a catheter hub of the catheter group of the
catheter insertion device. FIG. 9B illustrates a rear view of the
needle safety clip. FIG. 9C illustrates a front view of the needle
safety clip. FIG. 9D illustrates a perspective view of the needle
safety clip released from the catheter hub of the catheter group of
the catheter insertion device. FIG. 9E illustrates a perspective
view of a sharp needle tip of the needle. FIG. 9F illustrates the
sharp needle tip being withdrawn from the needle safety clip.
[0031] FIG. 10A illustrates the insertion group being pulled
proximally such that the catheter group is distal of the handle.
FIG. 10B illustrates the insertion group being pulled proximally to
the point where the sharp needle tip of the needle is between two
distal walls of the needle safety clip. FIG. 10C illustrates the
insertion group being pulled proximally to the point where the
sharp needle tip of the needle is proximal of both the two distal
walls of the needle safety clip and is tilted relative to the
needle safety clip.
[0032] FIG. 11A illustrates a perspective view of a rigid hub of
the catheter group of the catheter insertion device. FIG. 11B
illustrates a cross-sectional view of the rigid hub of the catheter
group of the catheter insertion device.
[0033] FIG. 12A illustrates a perspective view of a first
implementation of a valve. FIG. 12B illustrates a partial
cross-sectional view of the first implementation of the valve
within the catheter hub of the catheter group.
[0034] FIG. 13A illustrates a perspective view of a second
implementation of a valve having two parts. FIG. 13B illustrates a
proximal part of the two-part valve. FIG. 13C illustrates a distal
part of the two-part valve. FIG. 13D illustrates a partial
cross-sectional view of the second implementation of the valve
within the catheter hub of the catheter group.
[0035] FIG. 14 illustrates a partial cross-sectional view of a
third implementation of a valve within the catheter hub of the
catheter group.
[0036] FIG. 15 illustrates a partial cross-sectional view of a
fourth implementation of a valve within the catheter hub of the
catheter group.
[0037] FIG. 16 illustrates a perspective view of a distal region of
the needle showing a plurality of echogenic features.
[0038] FIGS. 17-25 each illustrate an alternative implementation of
catheter insertion device.
[0039] Implementations of the catheter insertion device are
described with reference to the drawings, in which like reference
numerals refer to like parts throughout.
DETAILED DESCRIPTION
[0040] Referring to FIG. 1, a perspective view of an implementation
of a catheter insertion device 100 including a catheter group 102
and an insertion group 104 is illustrated. The insertion group 104
can be separated from the catheter group 102 following partial
insertion of a catheter 106 in the vasculature of a patient. The
catheter group 102 also includes an extension line assembly 108 in
fluid communication with the catheter 106. The extension line
assembly 108 can be connected to a fluid source or an aspiration
device. The insertion group 104 includes a handle 110 that is
initially connected to the catheter group 102 and that facilitates
the insertion of the catheter 106 in the vasculature of the
patient.
[0041] Referring to FIG. 2A, an exploded view of the separate
components of the catheter group 102 of the catheter insertion
device 100 is illustrated. Referring to FIG. 2B, a partially
transparent perspective view of the assembled catheter group 102 of
the catheter insertion device 100 is illustrated. At its proximal
region, the catheter group 102 includes an extension line assembly
108 that includes an elongated extension line 112, an extension
line clamp 114, and an extension line hub 116. The elongated
extension line 112 defines an elongated lumen that is in fluid
communication with the lumen defined by the catheter 106 through
the lumen defined by a rigid hub 120. The extension line clamp 114
is received around the elongated extension line 112 and can be slid
in a direction perpendicular to the longitudinal axis of the
elongated extension line 112 to pinch the elongated extension line
112 closed. When the extension line clamp 114 pinches the elongated
extension line 112, fluid is prevented from flowing beyond the
extension line clamp 114 either distally towards the catheter 106
or proximally towards the extension line hub 116. The extension
line hub 116 defines a lumen that is in fluid communication with
the lumen defined by the elongated extension line 112.
[0042] In some implementations, the lumen defined by the extension
line hub 116 can be tapered from its proximal end towards its
distal end, while in other implementations, the lumen defined by
the extension line hub 116 can have a uniform diameter. The
proximal end of the extension line hub 116 includes a connector,
such as a threaded luer lock illustrated in FIG. 2, for connection
to a fluid source or an aspiration device. The fluid source can be,
for example, a syringe or an intravenous bag.
[0043] At its distal end, the catheter group 102 includes the
elongated catheter 106 that is connected to a juncture hub 118. In
particular, the proximal end of the elongated catheter 106 connects
to the distal end of the juncture hub 118. The rigid hub 120 is
partially received within the proximal end of the juncture hub 118.
The rigid hub 120 receives a seal, such as a valve 122, within an
internal cavity defined by the rigid hub 120. The proximal end of
the rigid hub 120 is sealed by a rigid hub cap 124. The proximal
end of the rigid hub cap 124 has an opening that allows the needle
cannula 130 and the guidewire 132 to pass through the rigid hub cap
124 to the valve 122. The elongated catheter 106 defines an
elongated lumen that is at least partially received within the
vasculature of the patient. The juncture hub 118 defines a tapered
cavity that is in fluid communication with the lumen defined by the
elongated catheter 106 and the lumen defined by the rigid hub 120.
The rigid hub 120 also includes a side port 121 for receiving the
elongated extension line 112 of the extension line assembly 108.
The lumen defined by the side port 121 is in fluid communication
with the lumen defined by the elongated extension line 112.
[0044] The valve 122 can be a one-piece valve or a multiple piece
valve, as described in greater detail below. When the catheter
group 102 is assembled, the valve 122 is enclosed by the rigid hub
120 and the rigid hub cap 124. In some implementations, the
catheter group 102 may not include the extension line assembly 108
and the fluid source or aspiration device can be connected to a
proximal end of the rigid hub 120.
[0045] Referring to FIG. 3A, an exploded view of the separate
components of the insertion group 104 of the catheter insertion
device 100 is illustrated. Referring to FIG. 3B, a perspective view
of the assembled insertion group 104 of the catheter insertion
device 100 is illustrated. The insertion group 104 includes the
handle 110 that is made up of a right housing 126 and a left
housing 128 that are connected together. Top arm 127 and bottom arm
129 are formed in the distal region of the handle 110. A needle
cannula 130 is held within the handle 110 and a guidewire, which
slides through the lumen defined by the needle cannula 130, is also
held within the handle 110. The needle cannula 130 can be anchored
within the handle 110 by an interference fit within an inner
channel defined by the handle 110, by an adhesive, by a threaded
connection, or the like. In some embodiments, the needle cannula
130 can be, for example, a 24 gauge needle.
[0046] A needle safety clip 134 is placed around the outer surface
of the needle cannula 130 to cover the sharp needle tip 131
following separation of the insertion group 104 from the catheter
group 102. A needle guard 136 covers the portion of the needle
cannula 130 extending from the handle 110 before initial use of the
catheter insertion device 100. A first actuator, such as a slider
138, is connected to the top of the handle 110 and to the guidewire
132 and slides the guidewire 132 relative to the handle 110 in both
proximal and distal directions. In some embodiments, the guidewire
132 can be a spring wire guide, such as a coiled or a coil-less
spring wire guide. The length of the guidewire 132 is selected such
that, before the slider 138 is actuated, the distal end of the
guidewire does not extend beyond the sharp needle tip 131 of the
needle cannula 130.
[0047] In some embodiments, the guidewire 132 can have an outer
diameter that is substantially uniform and less than or equal to
0.010 inches (0.0254 centimeters). Preferably, the guidewire 132
has an outer diameter that is less than or equal to 0.010 inches
when the needle cannula 130 is a 24 GA needle and the elongated
catheter 106 is a 22 GA catheter, so that the guidewire 132 can fit
within the lumen defined by the 22 GA catheter. In other
embodiments, the guidewire 132 can have a varying diameter that
narrows distally, such that the diameter of the guidewire 132 is
the smallest at a distal end of the guidewire 132. In some
embodiments the guidewire 132 can be made of, for example, a metal,
such as a metal alloy. For example, the guidewire 132 can be made
of an alloy of nickel and titanium. In some embodiments, the
guidewire 132 can be coated with polysulfones, polyfluorocarbons,
polyolefins, polyesters, polyurethanes, blends and/or
copolymers.
[0048] A second actuator, such as a release 140, is also connected
to the handle 110 and to the catheter group 102 and slides the
catheter group 102 relative to the handle 110 in a distal
direction. The release 140 includes a proximal arm 174 having an
enlarged proximal end 141. A needle support 142 is attached to a
proximal region of the handle 110 and swings upward and downward
relative to the handle 110 rotationally coupled to the top arm 127.
The needle support 142 includes two parallel walls 143 separated by
a distance slightly greater than the outer diameter of the
elongated catheter 106 in which the needle cannula 130 passes to
stabilize lateral movement of the needle cannula 130 during
insertion of the needle in the vasculature of the patient. This
stabilization is especially important for insertion of the needle
relatively deep in the tissue of the patient, such as within an
organ of the patient. The needle support 142 also includes a top
portion 147 that abuts the bottom surface of the slider 138 before
the slider 138 is slid proximally to prevent swinging of the
release 140 while the catheter insertion device 100 is being
inserted in the vasculature of the patient.
[0049] Referring to FIG. 3C, a perspective view of an assembled
insertion group 104 of the catheter insertion device 100 having
another implementation of the needle guard 137 is illustrated. The
needle guard 137 includes an open channel 260 defined by two
parallel side walls 262. A bottom longitudinal feature 264 and a
top longitudinal feature 266 between the parallel side walls 262
secure around the needle cannula 130. As such, the bottom
longitudinal feature 264 and the top longitudinal feature 266 are
spaced apart by a distance slightly greater than the outer diameter
of the needle cannula 130. The needle guard 137 also includes a tab
268 at the proximal end of the needle guard 137 to allow the
practitioner to initially lift the needle guard 137 out of contact
with the slider 138 and then push the needle guard 137 distally
until the proximal ends of the bottom longitudinal feature 264 and
the top longitudinal feature 266 are distal of the sharp needle tip
131. At this point, the needle guard 137 disengages from the
insertion group 104 and can be removed to expose the sharp needle
tip 131.
[0050] Referring to FIG. 4, a side view of the right housing 126
including the slider 138 and the guidewire 132 is illustrated. The
handle 110 includes a looped proximal end 144 through which the
guidewire 132 passes. In particular, the guidewire 132 passes
through the channel 145 defined by the handle 110. The diameter of
the channel 145 is slightly greater than the diameter of the
guidewire 132 so that the guidewire 132 stably passes through the
channel 145. The slider 138 can be slid by a finger, such as the
index finger in overhand operation or the thumb in underhand
operation, of a practitioner proximally and distally within a
chamber 146 defined by the handle 110. The chamber 146 is sized to
be slightly larger than the slider 138 to stabilize the movement of
the slider 138 within the chamber 146.
[0051] Due to the looping of the guidewire 132 within the looped
proximal end 144, proximal movement of the slider 138 translates
into distal movement of the distal tip of the guidewire 132 and
vice versa. The looping of the guidewire 132, as opposed to a
linear geometry, also enables one-handed operation of the catheter
insertion device 100 while maintaining continuous grip of the
gripping features 148 of the handle 110. In addition, the looping
of the guidewire 132 reduces the likelihood of piercing the
vasculature of the patient during advancement of the guidewire 132
due to the force of the practitioner being indirectly applied to
the guidewire 132.
[0052] Referring to FIG. 5, a cross-section view of the assembled
handle 110 with the guidewire 132 and the slider 138 is
illustrated. The handle 110 includes gripping features 148 that
help the practitioner grip the handle 110 of the catheter insertion
device 100. A right-handed practitioner can, for example, grip the
gripping feature 148 on the left housing 128 using his thumb and
grip the gripping feature 148 on the right housing using his middle
finger or left-handed practitioner can, for example, grip the
gripping feature 148 on the left housing 128 using his middle
finger and grip the gripping feature 148 on the right housing using
his thumb. The handle 110 can be gripped by the practitioner
overhand or underhand using the same fingers. Although depressed
lines are shown as the gripping features 148, any gripping feature
can be formed on the outer surface of the handle 110. For example,
raised lines can be formed in place of the depressed lines, a
textured surface can be formed, a plurality of bumps can be formed,
or a different material, such as rubber, can be formed over the
region of the handle 110 corresponding to the gripping features
148.
[0053] Three openings are defined by the front face 150 of the
handle 110. The bottom opening 152 is sized to receive the rigid
hub cap 124 of the catheter group 102. In particular, the diameter
of the bottom opening 152 is slightly greater than the diameter of
the rigid hub cap 124. The middle opening 154 is sized to receive
the guidewire 132 and the needle cannula 130, and the top opening
156 is sized to receive the slider 138 and the proximal arm of the
release 140 (not shown). The top opening 156 includes a wider
bottom region that receives the slider 138 and a narrower top
region that receives the proximal arm of the release 140. The
bottom opening 152 and the middle opening 154 are separated by a
portion of the handle 110, whereas the middle opening 154 and the
top opening 156 are not separated to allow a bottom arm 158 (not
shown) of the slider 138 to slide within middle opening 154, as
explained in greater detail below.
[0054] In particular, referring to FIG. 6, a transparent side view
of a portion of the slider 138 is illustrated. The slider 138
includes a bottom arm 158 extending from the bottom of the slider
138 in a direction perpendicular to the longitudinal axis of the
slider 138. The bottom arm 158 includes a through hole 160 that
receives the proximal end 133 of the guidewire 132. The through
hole 160 has an internal diameter that is slightly larger than the
outer diameter of the guidewire 132 but slightly smaller than the
diameter of the ball 162 formed at the end of the guidewire 132.
The guidewire 132 is therefore secured within the through hole 160
by a interference fit. The through hole 160 does not extend along
the entirety of the length of the bottom arm 158, such that the
distal end of the through hole 160 is closed. Although the ball 162
is secured within the through hole 160 by a interference fit, in
some implementations, the ball 162 can be secured by an adhesive,
by a threaded connection, or the like.
[0055] Due to the interference fit between the through hole 160 and
the guidewire 132, as the slider 138 is moved in a longitudinal
direction for a given distance, the guidewire will also move in the
opposite direction for the same distance and vice versa. The slider
138 includes one or more grips 164 that allow a finger, such as the
index finger in an overhand operation or the thumb in an underhand
operation, of the practitioner to predictably actuate the slider
138 in either a distal or proximal direction. In some embodiments,
as shown in FIG. 6, the grips 164 can be shaped like arrows that
point in the proximal direction. Adjacent to each grip 164 can be
an indicator 166, such as a number, that indicates a relative
extension of the guidewire 132 distally from the sharp needle tip
131.
[0056] Referring to FIG. 7A, the left side of the release 140
includes a notch 168 that receives the side port 121. The release
140 is sized to be received from around the bottom arm 129 to the
slider 138. The notch 168 is sized to be slightly larger than the
diameter of the side port 121 to stably secure the side port 121.
When the practitioner actuates the release 140 in a distal
direction using, for example, his index finger, the catheter group
102 is also actuated in the distal direction by the same distance
through the interface between the notch 168 and the side port
121.
[0057] Referring to FIG. 7B, the right side of the release 140
includes a continuous side wall 170. If the practitioner's finger
were to push down onto the slider 138 or top arm 127 of the handle
110 while the needle cannula 130 is still in the vasculature of the
patient, the resulting downward movement of the needle cannula 130
may cause damage to the vasculature of the patient. As such, to
help prevent the practitioner's finger from slipping past the
distal end of the release 140, the release 140 includes a distal
lip 172 that extends radially outward from the release 140.
[0058] The release 140 also includes a proximal arm 174 having an
enlarged proximal end 141 (not shown). The proximal arm 174 slides
within the top opening 156 of the handle 110. The enlarged proximal
end of the release 140 is dimensioned to be larger than the top
opening 156 so that distal movement of the release 140 is limited
to the length of the proximal arm 174 and so that the release 140
does not separate from the handle 110. The release 140 can also
include a grip 176 that allow a finger, such as the index finger in
an overhand operation or the thumb in an underhand operation, of
the practitioner to predictably actuate the release 140 in either a
distal or proximal direction.
[0059] Referring to FIG. 8A, a partially transparent perspective
view of a region of the assembled catheter insertion device 100 is
illustrated. The bottom arms 129 of the right housing 126 and the
left housing 128 abut against one another to support the weight of
the juncture hub 118. The top arms 127 of the right housing 126 and
the left housing 128 are spaced apart by a distance slightly
greater than the width of the needle support 142 to allow the
needle support 142 to swing upwards during removal of the catheter
group 102. The needle support 142 includes two parallel walls 143
that are perpendicular to the plane of the top surface of the
bottom arms 129. As explained above, the parallel walls 143 are
spaced apart by a distance slightly greater than the outer diameter
of the elongated catheter 106 to stabilize the needle cannula 130
during insertion into the vasculature of the patient. Both top arms
127 also include a groove 178 that received a corresponding tongue
of the needle guard 136. The tongue and groove connection stably
secures the needle guard 136 to the handle 110 before use of the
catheter insertion device 100.
[0060] Before the practitioner slides the slider 138 proximally,
the distal end 139 of the slider 138 extends beyond the distal end
of the top arm 127 and, as such, extends distally beyond the needle
support 142. As shown in FIG. 8B, which illustrates a partial
cross-sectional view of the region of the assembled catheter
insertion device 100 along the center longitudinal plane of the
handle 110, the bottom surface of the slider 138 abuts against the
top portion 147 before the slider 138 is slid proximally to prevent
swinging of the release 140 while the catheter insertion device 100
is being inserted in the vasculature of the patient.
[0061] FIG. 8C illustrates a partial cross-sectional view of the
region of the assembled catheter insertion device 100 along the
center longitudinal plane of the handle 110 following actuation of
the slider 138 by the practitioner. As shown in FIG. 8C, the distal
end 139 of the slider 138 is proximal of the needle support 142 so
that the top portion 147 no longer abuts the bottom surface of the
slider 138 and is free to swing upwards as the catheter group 102
is separated from the insertion group 104.
[0062] FIG. 8D illustrates a partial cross-sectional view of the
region of the assembled catheter insertion device 100 along the
center longitudinal plane of the handle 110 following actuation of
the release 140 by the practitioner. As shown in FIG. 8D, the
release 140 pushes the rigid hub 120 distally so that the distal
end of the juncture hub 118 extends distally beyond the needle
support 142. As the juncture hub 118 initially abuts and distally
moves past the needle support 142, the needle support 142 swings
upward to provide clearance for full deployment of the catheter
group 102.
[0063] Referring to FIG. 9A, a perspective view of the needle
safety clip 134 mounted to the rigid hub 120 is illustrated.
Referring to FIG. 9B, a rear view of the needle safety clip 134 is
illustrated. Referring to FIG. 9C, a front view of the needle
safety clip 134 is illustrated. The needle safety clip 134 includes
a proximal wall 180 that includes a round aperture 182 having a
diameter slightly greater than the outer diameter of the needle
cannula 130. In some implementations, the round aperture 182 can
have a sharp inner surface to grip the outer surface of the needle
cannula 130 when the needle cannula 130 is at an angle with respect
to the central axis of the round aperture 182. In other words, the
sharp inner surface of the round aperture 182 digs into the outer
surface of the needle cannula 130 when the needle cannula 130 is
tilted with respect to the needle safety clip 134, as shown in FIG.
9D, to prevent movement of the needle cannula 130 with respect to
the needle safety clip 134.
[0064] Referring back to FIG. 9A, a top wall 184 extends distally
of the proximal wall 180 and defines a top opening 186. The top
opening 186 allows the spring arm 188 to extend partially above the
top wall 184 in its compressed state, as shown in FIG. 9A. The
spring arm 188 is illustrated to be C-shaped. However, the spring
arm 188 can be designed to have other shapes that are resilient and
can be shaped to be, for example, stepped, blocked, jagged, or
amorphous. The top distal portion of the spring arm 188 is
connected to the distal bottom surface of the top wall 184 to
secure the spring arm 188 to the rest of the needle safety clip
134. The spring arm 188 can be made of any flexible material, such
as, for example, plastic, stainless steel, aluminum or titanium.
The spring arm 188 can be made of the same material as the rest of
the needle safety clip 134 or made of a different material having
the desired characteristics.
[0065] A first distal wall 190 extends downward from the distal end
of the top wall 184 and defines a first distal channel. A second
distal wall 194 curves upward from the first distal wall 190 and
defines a second distal channel. A narrow tab 198 extends distally
from the distal end of the second distal wall 194 and a broad tab
200 extends distally from the narrow tab 198. The narrow tab 198 is
received within a narrow recess 202 at the top of the rigid hub cap
124 and the broad tab 200 is received within a broad recess 204 at
the top of the rigid hub cap 124 to mount the needle safety clip
134 to the rigid hub cap 124. When the needle safety clip 134 is
mounted to the rigid hub cap 124, the narrow tab 198 prevents
lateral movement of the needle safety clip 134 while broad tab 200
prevents longitudinal movement of the needle safety clip 134.
[0066] Referring back to FIG. 9C, the first distal wall 190 defines
a channel having a round top region 191 and a rectangular bottom
region 192. The diameter of the round top region 191 is slightly
larger than the outer diameter of the needle cannula 130 to allow
the needle cannula 130 to slide through the round top region 191
with low friction and to prevent lateral movement of the needle
cannula 130. The rectangular bottom region 192 has a width that is
less than the outer diameter of the needle cannula 130 to block the
needle cannula 130 from being able to extend distally past the
second distal wall 194, as explained in greater detail below. The
second distal wall 194 also includes a round top region 195 that
has a diameter that is greater than the outer diameter of the
needle cannula 130 and a rectangular bottom region 196. The width
of the rectangular bottom region 196 can be equal to the diameter
of the round top region 195 to allow the needle cannula 130 to move
downward relative to the needle safety clip 134 under force of the
spring arm 188.
[0067] Referring to FIG. 9D, a perspective view of the needle
safety clip 134 released from the rigid hub 120 is illustrated.
After the needle cannula 130 is withdrawn from the rigid hub 120,
it passes proximally through the round top region 195 of the second
distal wall 194 and then through the round top region 191 of the
first distal wall 190. Once the round top region 191 does not
stabilize the needle cannula 130, the needle cannula 130 is free to
tilt relative to the needle safety clip 134. The spring arm 188
then decompresses, as shown in FIG. 9D, to push the needle safety
clip 134 upward. Because the needle cannula 130 is still within the
round aperture 182, it is gripped by the sharp inner edges of the
round aperture 182, which prevents longitudinal movement of the
needle cannula 130 with respect to the needle safety clip 134. As
such, the first distal wall 190 and the second distal wall 194
cover the sharp needle tip 131 and protect the practitioner from
potential needle pricks.
[0068] Referring to FIG. 9E, a perspective view of the sharp needle
tip 131 of the needle cannula 130 is illustrated. As shown in FIG.
9E, the sharp needle tip 131 can have a lancet tip or, in other
implementations, the sharp needle tip 131 can be formed by back
grinding. The sharp needle tip 131 tapers in the distal direction
such that the width W.sub.n of the sharp needle tip 131 at a plane
along the sharp needle tip 131 is equal to the width of the
rectangular bottom region 192. As such, the needle cannula 130
cannot extend distally past the first distal wall 190 beyond that
plane where the sharp needle tip 131 has the width W.sub.n when the
needle safety clip 134 is released from the rigid hub 120 because
the needle cannula 130 is wider than the rectangular bottom region
192 proximal of that plane. However, the length L.sub.n can still
extend distally beyond the first distal wall 190 because the needle
cannula 130 is thinner than the rectangular bottom region 192
distal of that plane. Therefore, as shown in FIG. 9F, to prevent
exposure of the sharp needle tip 131 beyond the second distal wall
194, the needle safety clip 134 is designed so that the distance
D.sub.c between the first distal wall 190 and the second distal
wall 194 in the axis aligned with the longitudinal axis of the
needle cannula 130 is greater than the length L.sub.n.
[0069] Referring to FIGS. 10A-C, partially transparent side views
of the catheter insertion device 100 during separation of the
catheter group 102 are illustrated. As explained above in
connection with FIG. 8D, the release 140 is initially slid distally
to allow the needle support 142 to swing upwards. The practitioner
then uses the hand that is not grasping the handle 110 to stabilize
the catheter group 102. For example, the practitioner can use his
non-dominant hand to grasp the juncture hub 118 and/or the rigid
hub 120 to stabilize the rigid hub 120 at a constant position
within the vasculature of the patient. The practitioner can then
pull the insertion group 104 proximally to remove the needle
cannula 130 from the catheter group 102.
[0070] As shown in FIG. 10A, the insertion group 104 is pulled
proximally such that the catheter group 102 is distal of the distal
end of the handle 110. At this point, the needle safety clip 134 is
still mounted to the rigid hub cap 124, as explained above. As
shown in FIG. 10B, the insertion group 104 is pulled proximally to
the point where the sharp needle tip 131 of the needle cannula 130
is proximal of the second distal wall 194, but still distal of the
first distal wall 190. As such, the plane where the sharp needle
tip 131 has the width W.sub.n is still distal of the first distal
wall 190 and the needle cannula 130 is stabilized within the round
top region 191. As shown in FIG. 10C, the sharp needle tip 131 is
proximal of the first distal wall 190 and, therefore, free to tilt
relative to the needle safety clip 134. The spring arm 188 then
decompresses to tilt the needle cannula 130 downward, so that the
first distal wall 190 and/or the second distal wall 194 cover the
sharp needle tip 131.
[0071] Referring to FIG. 11A, a perspective view of the rigid hub
120 is illustrated. The rigid hub 120 can include two or more
compression ribs 206 protruding radially inward along an inner
circumference of the proximal end of the rigid hub 120 to allow for
oversizing of the valve 122. The compression ribs 206 grip the
valve 122 within the rigid hub 120. The radial interference caused
by the compression ribs 206 on the valve 122 acts to seal the
puncture hole created by the needle cannula 130 with the valve 122
following separation of the catheter group 102 from the insertion
group 104. The areas between the compression ribs 206 provide a
region for the material of the valve 122 to displace when the valve
122 is compressed.
[0072] Referring to FIG. 11B, a cross-sectional view of the rigid
hub 120 taken along the plane defined by the diameter of the rigid
hub 120 and the longitudinal axis of the side port 121 is
illustrated. The smooth region 208 just distal of the compression
ribs 206 has a diameter that is smaller than the diameter of the
valve 122 to radially seal the valve 122 within the rigid hub 120.
The annular flange 210 abuts against the flat distal face 214 of
the valve 122 to prevent distal movement of the valve 122 when the
needle cannula 130 applies distal pressure to the valve 122.
[0073] Referring to FIG. 12A, a perspective view of a first
implementation of the valve 211 is illustrated. The valve 211
includes a flat proximal face 212 and a flat distal face 214. The
valve 211 has a substantially uniform outer diameter in the regions
that are received within the rigid hub 120 to allow for a
compression fit within the rigid hub cap 124. The proximal region
of the valve 211 has a wedged surface 216 that enlarges distally.
The valve 221 is solid and made of a resilient material, such as,
for example, silicon, rubber, polyisoprene, or the like.
[0074] Referring to FIG. 12B, a partial cross-sectional view of the
assembled rigid hub 120, valve 122, and rigid hub cap 124 taken
along the plane defined by the diameter of the rigid hub 120 and
the longitudinal axis of the side port 121 is illustrated. The
wedged surface 216 of the valve 211 is compressed within the rigid
hub cap 124 to force the valve material radially inward in response
to pressure applied to the flat distal face 214. As shown in FIG.
12B, the flat distal face 214 is flush with the distal end of the
rigid hub cap 124 to allow for complete evacuation of the inner
volume of the rigid hub 120 when flushing the catheter insertion
device 100.
[0075] Referring to FIG. 13A, a perspective view of a second
implementation of the valve 218 is illustrated. The valve 218 is a
two-part valve that includes a proximal part 220 and a distal part
222. Referring to FIG. 13B, the proximal part 220 has a flat
proximal face 224 and a proximal region 228 having a reduced
diameter. The proximal part 220 defines an inner cavity 230 that
extends along a majority of the longitudinal axis of the proximal
part 220. Relative to the valve 211, the inner cavity 230 reduces
the surface area of the valve 218 that the needle cannula 130 must
pass through, thereby reducing the force required to insert the
needle cannula 130.
[0076] Referring to FIG. 13C, the distal part 222 is solid and
includes a proximal region 232 of reduced diameter. The diameter of
the proximal region 232 is slightly smaller than the diameter of
the inner cavity at the distal end of the proximal part 220 to
prevent lateral movement of the distal part 222 relative to the
proximal part 220 when the valve 218 is assembled within the rigid
hub 120 and the rigid hub cap 124. The distal part 222 also has a
tapered distal region with a diameter that reduces distally. The
valve 218 can be made of a resilient material, such as, for
example, silicon, rubber, polyisoprene, or the like.
[0077] Referring to FIG. 13D, a partial cross-sectional view of the
assembled rigid hub 120, two-part valve 218, and rigid hub cap 124
taken along the plane defined by the diameter of the rigid hub 120
and the longitudinal axis of the side port 121 is illustrated. The
proximal region 228 having the reduced diameter is compressed
within the rigid hub cap 124 to force the valve material radially
inward in response to pressure applied to the flat distal face 226.
The flat distal face 226 is flush with the distal end of the rigid
hub cap 124 to allow for complete evacuation of the inner volume of
the rigid hub 120 when flushing the catheter insertion device
100.
[0078] Referring to FIG. 14, a cross-sectional view of the
assembled rigid hub 120, a third implementation of a two-part valve
236, and the rigid hub cap 124 taken along the plane defined by the
diameter of the rigid hub 120 and the longitudinal axis of the side
port 121 is illustrated. The valve 236 is a two-part valve that
includes a proximal part 238 and a distal part 240. The proximal
part 238 and the distal part 240 each define mirrored inner
cavities that together define the inner cavity 242. As is the case
with regard to the valve 218, the inner cavity 242 reduces the
surface area of the valve 236 that the needle cannula 130 must pass
through, thereby reducing the force required to insert the needle
cannula 130. Based on the shape of the valve 236, the inner cavity
of the proximal part 238 improves sealing when a vacuum is applied
to the distal face of the distal part 240 following removal of the
needle cannula 130. The inner cavity of the distal part 240
improves sealing when a high pressure is applied to the distal face
of the distal part 240 following removal of the needle cannula 130.
The valve 236 can be made of a resilient material, such as, for
example, silicon, rubber, polyisoprene, or the like.
[0079] Referring to FIG. 15, a partial cross-sectional view of the
assembled rigid hub 120, a fourth implementation of a two-part
valve 244, and the rigid hub cap 124 taken along the plane defined
by the diameter of the rigid hub 120 and the longitudinal axis of
the side port 121 is illustrated. The valve 244 is a two-part valve
that includes a proximal part 246 and a distal part 248. The
proximal part 246 defines a proximal inner cavity 250 and the
distal part 240 defines a relatively smaller distal inner cavity
252. Due to the compression provided by the rigid hub cap 124 on
the proximal part 246 and the rigid hub 120 on the distal part 248,
the valve 244 is sealed closed following removal of the needle
cannula 130 from the valve 244.
[0080] Moreover, because of the distal inner cavity 252, the distal
part 248 is forced radially inward to close the channel formed by
the needle cannula 130 under pressure applied to the distal face
254 of the distal part 248. The pressure applied to the distal face
254 pushes the proximal part 246 proximally, which causes the
wedged surface 256 of the valve 244 to compress within the rigid
hub cap 124 and for the valve material radially inward.
[0081] In contrast, when a vacuum is applied to the distal face 254
of the distal part 248, the channel formed by the needle cannula
130 in the distal part 248 is forced open. The inner cavity of the
proximal part 238, however, improves sealing when the vacuum is
applied to the distal face 254 of the distal part 248 following
removal of the needle cannula 130. In particular, the proximal part
246 is pulled distally which also causes the proximal part 246 to
compress radially inward, thereby preventing air from entering the
proximal inner cavity 250 from the outside environment. The valve
244 can be made of a resilient material, such as, for example,
silicon, rubber, polyisoprene, or the like.
[0082] Referring to FIG. 16, a perspective view of a distal region
of the needle cannula 130 is illustrated. The distal region of the
needle cannula 130 includes one or more and, preferably, eight
echogenic features. The echogenic features can be, for example,
through holes 258 drilled within opposite sides of the needle
cannula 130. Although the sharp needle tip 131 is echogenic when
observed under ultrasound, the through holes 258 improve the
echogenicity of the needle cannula 130. In particular, the through
holes 258 are visible through the wall thickness of the elongated
catheter 106 under ultrasound. In addition, through holes 258 allow
for blood flow from within the lumen of the needle cannula 130 to
the outer surface of the needle cannula 130. The blood then flows
to the inner surface of the catheter 106 to allow for visual
observation of the blood.
[0083] The through holes 258 are angled relative to one another.
For example, the through holes 258 are drilled 90 degrees apart
from one another, as shown in FIG. 16. The different angles of the
through holes 258 and the number of through holes 258 results in at
least two echogenic features being visible under ultrasound at all
times--one echogenic feature being the sharp needle tip 131 and the
other being at least one of the through holes 258. The two visible
echogenic features enable the practitioner to know the angle of
insertion of the needle cannula 130.
[0084] The many features and advantages of the catheter insertion
device 100 are apparent from the detailed specification, and thus,
the claims cover all such features and advantages within the scope
of this application. Further, numerous modifications and variations
are possible. For example, referring to FIGS. 17-25 various
alternative implementations of catheter insertion devices are
illustrated. In particular, the catheter insertion device 200
illustrated in FIG. 17 also includes a housing 202, a slider 204
that can be slid proximally to advance a guidewire distally and
that can be slid distally to advance the guidewire proximally, and
a release 206 to advance the catheter hub 208. Relative to the
release 140 of the catheter insertion device 100, the release 206
is actuated below the slider 204.
[0085] Referring to FIG. 18, the catheter insertion device 300
includes a housing 302, a wheeled actuator 304 that can be rotated
counter clockwise to advance a guidewire distally and that can be
rotated counter clockwise to advance the guidewire proximally, and
a release 306 to advance the catheter hub 308. The wheeled actuator
304 limits the longitudinal movement of a finger of the
practitioner to move the guidewire. In some implementations, the
wheeled actuator 304 can be geared to further limit the movement of
the practitioner to move the guidewire.
[0086] Referring to FIG. 19, the catheter insertion device 400
includes a housing 402, a linkage actuator 404 having links 405
that can be separately moved proximally to advance a guidewire
distally and that can be moved distally to advance the guidewire
proximally, and a release 406 to advance the catheter hub 408. The
linkage actuator 404 enables the practitioner to control the length
of advancement of the guidewire depending on the link 405 that is
actuated.
[0087] Referring to FIG. 20, the catheter insertion device 500
includes a housing 502 having grooves to receive the fingers of a
practitioner, a piston 504 that is actuated to advance a guidewire
distally, and a release 506 to disconnect the catheter hub 508. The
piston 504 can be actuated by the thumb of the practitioner in a
stepped manner.
[0088] Referring to FIG. 21, the catheter insertion device 600
includes a housing 602, a single flag actuator 604 that is actuated
to advance a guidewire distally or proximally, and a release 606 to
disconnect the catheter hub 608. The release 606 is connected to
the catheter hub 608 by a threaded connected and can be rotated
relative to the catheter hub 608 to disconnect from the catheter
hub 608. The single flag actuator 604 can be actuated by the thumb
of the practitioner.
[0089] Referring to FIG. 22, the catheter insertion device 700
includes a housing 702, a plunger 704 that is actuated to advance a
guidewire distally or proximally, and a release 706 to disconnect
the catheter hub 708. The release 706 is connected to the catheter
hub 708 through interference in the internal geometry of the
catheter hub 708 and disconnects from the catheter hub 708 upon
safety activation. The plunger 704 can be actuated by the thumb of
the practitioner.
[0090] Referring to FIG. 23, the catheter insertion device 800
includes a housing 802, a single flag indicator 804 that is
attached to the proximal end of a guide wire and shows the position
of the guidewire distally or proximally to the tip of the needle, a
partially exposed gearing mechanism 805 through which the guidewire
passes, and a release 806 to disconnect the catheter hub 808. The
gearing mechanism can be actuated by the finger of the practitioner
to move the guidewire. Referring to FIG. 24, the catheter insertion
device 900 includes a housing 902, a drum 904 that is directly
actuated to advance a guidewire distally or proximally, and a
release 906 to disconnect the catheter hub 908. The drum 904 can,
for example, be rotated counter clockwise to advance a guidewire
distally and that can be rotated counter clockwise to advance the
guidewire proximally.
[0091] Referring to FIG. 25, the catheter insertion device 1000
includes a housing 1002, a slider 1004 that can be slid proximally
to advance a guidewire distally and that can be slid distally to
advance the guidewire proximally, a gearing mechanism or linkage
configuration 1005 which can control the length of movement of the
slider relative to the length of advancement of the guidewire, and
a release 1006 to advance the catheter hub 1008.
[0092] As such, it is not desired to limit the catheter insertion
device 100 to the exact construction and operation described and
illustrated and, accordingly, all suitable modifications and
equivalents may fall within the scope of the claims.
* * * * *