U.S. patent application number 17/658001 was filed with the patent office on 2022-09-22 for catheter needle assembly with enclosable needle.
This patent application is currently assigned to I-V Access Technology, Inc.. The applicant listed for this patent is I-V Access Technology, Inc.. Invention is credited to James HALE, Jacob HENTZLER, Vincent LESKOWICH, Thomas SUTTON.
Application Number | 20220296859 17/658001 |
Document ID | / |
Family ID | 1000006391042 |
Filed Date | 2022-09-22 |
United States Patent
Application |
20220296859 |
Kind Code |
A1 |
SUTTON; Thomas ; et
al. |
September 22, 2022 |
CATHETER NEEDLE ASSEMBLY WITH ENCLOSABLE NEEDLE
Abstract
Methods and devices to facilitate positioning of a catheter into
a vessel. Devices include axially concentric assemblies of a
piercing cannula, a shield and tubing such as a catheter where the
shield can be passively or actively locked into position over the
cannula tip to prevent inadvertent needle sticks.
Inventors: |
SUTTON; Thomas; (Summit,
NJ) ; HENTZLER; Jacob; (Morgan Hill, CA) ;
HALE; James; (Los Osos, CA) ; LESKOWICH; Vincent;
(Oakhust, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
I-V Access Technology, Inc. |
San Francisco |
CA |
US |
|
|
Assignee: |
I-V Access Technology, Inc.
San Francisco
CA
|
Family ID: |
1000006391042 |
Appl. No.: |
17/658001 |
Filed: |
April 5, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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17208962 |
Mar 22, 2021 |
11318286 |
|
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17658001 |
|
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63037841 |
Jun 11, 2020 |
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62993493 |
Mar 23, 2020 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0693 20130101;
A61M 25/0606 20130101; A61M 25/0612 20130101; A61M 25/0097
20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 25/00 20060101 A61M025/00 |
Claims
1. (canceled)
2. A medical assembly comprising: a cannula extending from a
cannula hub to a cannula distal end; a shield member extending from
a shield hub to a shield distal end, the shield member positioned
over the cannula and comprising a seat and a locking arm, the seat
configured to receive a tubing hub, and the locking arm comprising
a fixed portion and a free portion, where the free portion is
biased away from the shield hub; a tubing extending from the tubing
hub to a tubing distal end, the tubing positioned over the shield
member; and wherein in a first configuration the free portion
engages a surface feature of the tubing hub causing the shield hub
to be releasably locked to the tubing hub.
3. The medical assembly of claim 2, wherein opposite relative
movement between the cannula hub and the shield hub positions the
cannula distal end within the shield member to produce a protected
position.
4. The medical assembly of claim 2, wherein separation of the
shield hub and the tubing hub causes the locking arm to engage the
cannula hub causing locking together of the cannula hub and the
shield hub.
5. The medical assembly of claim 2, wherein the locking arm further
comprises one or more locking surfaces.
6. The medical assembly of claim 2, wherein the locking arm further
comprises one or more guide surfaces.
7. The medical assembly of claim 2, wherein the locking arm further
comprises an opening configured to allow movement of the shield
member within the cannula hub.
8. The medical assembly of claim 2, wherein the locking arm further
comprises a living hinge.
9. The medical assembly of claim 2, wherein the locking arm further
comprises a joining surface configured to provide support for the
locking arm.
10. The medical assembly of claim 2, wherein the shield distal end
further comprises a tapered distal portion.
11. A medical assembly, comprising: a cannula extending from a
cannula hub to a cannula distal end; a shield member extending from
a shield hub to a shield distal end, the shield member positioned
over the cannula and comprising a locking arm, the locking arm
comprising a fixed portion and a free portion, where the free
portion is biased away from the shield hub; a tubing extending from
a tubing hub to a tubing distal end, the tubing positioned over the
shield member; and a valve in fluid communication with the tubing
hub, the valve comprising a barrier layer at a distal end of the
valve, the barrier layer comprising one or more slits and a wall
portion extending proximally from the barrier layer defining a
valve cavity.
12. The medical assembly of claim 11, wherein the valve further
comprises a flange portion formed around the wall portion, wherein
the flange portion comprises a diameter greater than that of the
wall portion.
13. The medical assembly of claim 11, wherein the barrier layer
further comprises a plurality of leaflet structures.
14. The medical assembly of claim 11, wherein the valve is affixed
to the catheter hub at the wall portion.
15. The medical assembly of claim 12, wherein the valve is affixed
to the catheter hub at the flange portion.
16. The medical assembly of claim 12, wherein the flange portion
encircles the valve.
17. The medical assembly of claim 12, wherein the flange portion
further comprises openings such that the flange portion is not
circumferentially continuous about the wall.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 17/208,962 filed Mar. 22, 2021, which claims
the benefit of U.S. Provisional Application Nos. 62/993,493 filed
Mar. 23, 2020 and 63/037,841 filed Jun. 11, 2020, the entireties of
each of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] Methods and devices to facilitate positioning of a catheter
into a vessel. Devices include axially concentric assemblies of a
piercing needle, a shield and catheter where the shield can be
passively or actively locked into position over the needle tip to
prevent inadvertent needle sticks.
BACKGROUND
[0003] Intravenous venous catheterization involves the insertion of
a small catheter into a peripheral blood vessel, typically for the
administration of medication, fluids or drawing of blood. The act
of inserting an intravenous catheter presents risks to both
healthcare workers and patients. For example, healthcare workers
face a risk of infection upon being exposed to a patient's bodily
fluids. In addition, when the healthcare worker removes a needle
used during catheterization of the patient, the healthcare worker
must take significant care to prevent the sharp needle from
inadvertently penetrating the skin of the healthcare worker.
[0004] Another concern involves the patient. Namely, to
successfully access veins, even small, fragile or traumatically
stressed ones, there is a desire to minimize the trauma and
minimize the size of the introducer needle. This concern is
balanced against the need for the needle to allow for introduction
of a catheter over the needle and into the vessel.
[0005] Once the catheter is properly inserted, it is important to
minimize fluid or blood leakage from the proximal end of the
catheter while a connector is coupled to the inserted catheter. It
is also important to protect caregivers and other individuals from
used needles.
[0006] The devices, methods and systems described herein provide
for an improved catheter and/or needle assembly.
SUMMARY
[0007] The illustrations and variations described herein are meant
to provide examples of the methods and devices of the invention. It
is contemplated that combinations of aspects of specific
embodiments or combinations of the specific embodiments themselves
are within the scope of this disclosure. The devices and methods
described herein are discussed as an exemplary embodiment of a
catheter needle assembly. However, with catheters or other medical
devices/introducers including but not limited to catheters,
introducers, tubes, lines, ports that can be used for vascular or
other devices.
[0008] The present disclosure includes medical assemblies for
insertion into tissue. In one example, a variation of a medical
assembly includes a cannula assembly comprising a cannula hub and a
cannula member extending to a cannula distal end; a shield assembly
comprising a shield hub and a shield member extending to a shield
distal end, where the shield hub is configured to be received in
the cannula hub and the shield member is configured to
concentrically receive the cannula member, where the shield
assembly is configured to move from a ready configuration to a safe
configuration; a tubing assembly comprising a tubing hub and a
tubing extending to a tubing distal end, where the tubing assembly
is configured to be received in the cannula hub over the shield hub
and where the tubing is configured to concentrically receive the
shield member; wherein in the ready configuration the shield hub is
releasably locked to the tubing hub, the cannula distal end extends
beyond both the shield distal end and the tubing distal end to
permit insertion into tissue, and the shield distal end remains
within the tubing; where, when in the ready configuration, relative
movement between the tubing hub and the cannula hub by a first
distance causes movement of the shield assembly to the safe
configuration; and wherein in the safe configuration, the shield
hub is released from the tubing hub and mechanically interferes
with the cannula hub to become locked thereto, and the shield
distal end now extends distally to the cannula distal end while
remaining within the tubing.
[0009] The relative movement described herein can include advancing
the tubing hub distally while the cannula hub remains stationary or
is moved proximally. In some variations where the assembly is
positioned in a small vessel, the tubing hub can remain stationary
while the cannula hub is withdrawn proximally.
[0010] Variations of the medical assembly described herein can
include a blunted distal end of the cannula or a sharp tip.
[0011] The medical assemblies described herein can include a
locking arm that is spring biased away from the shield hub and the
cannula hub comprises a first guide surface within an interior of
the cannula hub, wherein in the ready configuration the locking arm
is urged against the tubing hub by the first guide surface to
releasably lock the shield hub to the tubing hub.
[0012] In additional variations, the interior of the cannula hub
can further include a first locking surface spaced from the first
guide surface and wherein in the safe configuration, the locking
arm disengages from the first guide surface causing the locking arm
to bias away from the tubing hub towards the cannula hub such that
a second locking surface of the locking arm mechanically interferes
with the first locking surface to prevent distal movement of the
shield hub out of to the cannula hub. Any number of locking and
guiding surfaces are within the scope of the disclosure.
[0013] Variations of the medical assembly include a safe
configuration where the locking arm entirely disengages from the
first guide surface. Furthermore, in the safe configuration the
locking arm can mechanically interfere with the first guide surface
to prevent proximal movement of the shield hub within the cannula
hub.
[0014] Variations of the devices described herein also include a
shield member that reinforces the tubing to permit the tubing to
have a gauge difference of at least 3 sizes between the tubing and
the cannula. Moreover, the tubing distal end can comprise a
plurality of openings to allow for increased flow through a distal
end in view of the greater size differential between the lumen
diameter and the diameter of a distal opening of the tubing.
[0015] In variations of the devices, the tubing can comprise a
catheter tubing and the cannula can comprise a needle.
[0016] In additional variations, the shield distal end can comprise
a blunted distal end. However, variations include a shield distal
end that presents less of a risk of accidental penetration into
tissue as compared to the cannula distal end.
[0017] Variations of the devices can include a portion of the
cannula hub that comprises a flash chamber configured to visually
confirm fluids in the cannula hub.
[0018] An additional variation of a medical assembly for insertion
into tissue includes: a cannula assembly having a cannula hub and a
cannula having a cannula distal end, the cannula hub having an
interior chamber with a first guide surface and a first locking
surface; a shield assembly comprising a shield hub and a shield
member having a shield distal end, the shield hub configured to be
received within the interior chamber of the cannula hub such that
the cannula is coaxially received in the shield member, the shield
hub comprising a locking arm having a second locking surface and a
second guide surface, the locking arm also having an intermediate
portion extending between a fixed portion and a free portion, where
the fixed portion is coupled to the shield hub and the free portion
is spring-biased away from the shield hub, the shield assembly
being moveable between a ready configuration and a safe
configuration; a tubing assembly comprising a tubing hub and a
tubing member having a tubing distal end, wherein the tubing hub is
configured for positioning on the shield hub and the tubing member
coaxially receives the shield member, the tubing hub comprising a
surface feature; wherein in the ready configuration the cannula
distal end extends distally beyond both the shield distal end and
the tubing distal end and where the first guide surface engages the
second guide surface to constrain the free portion of the locking
arm against the surface feature of the tubing hub to releasably
lock the shield hub to the tubing hub; wherein, when in the ready
configuration, axial separation of the tubing hub from the cannula
hub over a first distance causes the shield assembly to assume the
safe configuration where the second guide surface disengages from
the first guide surface causing the free portion to bias away from
and disengage the tubing hub, and where the shield distal end is
now positioned distal to the cannula distal end, and where
interference between the second locking surface against the first
locking surface prevents further axial separation of the shield hub
from the cannula hub to permit separation of the tubing assembly
from the shield assembly and the cannula assembly.
[0019] The present disclosure also includes a method of inserting a
medical assembly into tissue and removing the medical assembly from
tissue in a safe condition, the method comprising: positioning the
medical assembly adjacent to tissue where a cannula end of a
cannula extends distally from a tubing end of a tubing and where a
shield member is located between the cannula and the tubing, the
shield member having a shield end that is located within the
tubing, and where medical assembly includes a cannula hub joined to
the cannula, a tubing hub joined to the tubing, and a shield hub
joined to the shield member, where the tubing hub is seated on the
shield hub and releasably locked thereto, and the shield hub is
seated on the cannula hub; inserting the cannula end and the tubing
end into tissue to a desired location; moving the tubing hub
relative to the cannula hub such that the shield hub moves with the
tubing hub causing the shield end to be positioned distally to the
tubing end while remaining within the tubing, and causing the
shield hub to release from the tubing hub while mechanically
locking with the cannula hub; and removing the shield member and
the cannula from the tubing and the tubing hub such that the shield
member covers the cannula to establish the safe condition.
[0020] The method can further include visually identifying a fluid
within the cannula hub prior to removing the shield member and the
cannula from the tubing.
[0021] In an additional variation, the medical assemblies described
herein can include a cannula extending from a cannula hub to a
cannula distal end; a shield member extending from a shield hub to
a shield distal end, the shield member positioned over the cannula,
where shield distal end member is located proximally to the cannula
end; a tubing extending from a tubing hub to a tubing distal end,
the tubing positioned over the shield member, where the tubing
distal end extends distally to the shield distal end such that
tubing distal end tapers to contact the cannula at a location
distally to the shield member; wherein the cannula includes a
protected position when the cannula is moved proximally relative to
both the shield member and tubing such that the cannula distal end
is located within the shield member; and wherein the shield member
and the cannula are removable from the catheter tubing.
[0022] An additional variation of the devices can include a needle
assembly having a cannula extending from a cannula hub to a cannula
distal end, the cannula comprising a first gauge size; a shield
member extending from a shield hub slidably to a shield distal end,
the shield member positioned over the cannula, where the shield
distal end is located proximally to the cannula distal end; a
tubing having a second gauge size and extending from a tubing hub
to a tubing distal end, the tubing positioned over the shield
member, where the tubing distal end extends distally to the shield
distal end such that the tubing distal end tapers to contact the
cannula at a location distal to the shield distal end; and wherein
the first gauge size is smaller than the second gauge size by at
least a three gauge differential.
[0023] The methods, devices, and systems described herein provides
several benefits over conventional needle systems. For example, the
needle assemblies described herein allow for insertion of the
catheter using a small gauge needle that is undersized relative to
a larger size catheter as compared to conventional catheter needle
assemblies. The catheter assemblies of the current disclosure
incorporate a dilator or similar support member between the
catheter tubing and needle cannula as a support rather than to
dilate tissue. Such a configuration allows passage of the assembly
into the vessel allowing for an easy introduction of the catheter
into the vein or other body target. The use of a smaller needle and
dilator can reduce pain and/or anxiety of the patient as well as
reduce the risk of vascular damage. In addition, the devices
described herein can allow for active or passive covering of the
sharp cannula tip through movement of the tubing assembly.
[0024] In addition, the catheters described herein can employ a one
way, blood control valve that reduces the risk of blood leakage,
until catheter is fluidly coupled to a separate line.
[0025] The present disclosure is related to the following commonly
assigned patents and applications, the entirety of each of which is
incorporated by reference: U.S. Pat. No. 8,105,288 issued on Jan.
31, 2012, U.S. Pat. No. 8,591,469 issued on Nov. 26, 2013, U.S.
Pat. No. 9,775,973 issued on Oct. 3, 2017, U.S. Pat. No. 9,604,035
issued on Mar. 28, 2017, U.S. Pat. No. 10,828,465 issued on Nov.
10, 2020, U.S. Pat. No. 10,052,474 issued on Aug. 21, 2018, U.S.
Pat. No. 10,406,326 issued on Sep. 10, 2019, U.S. Pat. No.
10,850,069 issued on Dec. 1, 2020, U.S. Patent Publication no.:
US20190038889 published on Feb. 7, 2019, U.S. Patent Publication
no.: US20190351210 published on Nov. 21, 2019, U.S. Patent
Publication no.: US20200016375 published on Jan. 16, 2020, U.S.
Patent Publication no.: US20210031009 published on Feb. 4, 2021,
and PCT publication WO2020191228 published on Sep. 24, 2020.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] Each of the following figures diagrammatically illustrates
aspects and variations to better understand the invention.
Variation of the invention from the aspects shown in the figures is
contemplated.
[0027] FIG. 1A illustrates an example of an improved
needle-catheter assembly with a removable wing used for securing
the catheter to a surface of tissue when the catheter is positioned
within a vessel.
[0028] FIG. 1B shows a magnified view of a distal end of the
section 1B of the needle-catheter assembly in FIG. 1A.
[0029] FIG. 2A illustrates an exploded view of a variation of a
catheter needle assembly 100 having a needle assembly, a
support/shield assembly, a catheter and a safety cap.
[0030] FIGS. 2B to 2D illustrate an improved valve for use with
catheter.
[0031] FIG. 3A also shows the support/shield assembly including a
locking arm having a plurality of locking surfaces and guide
surfaces.
[0032] FIG. 3B illustrates a bottom oblique perspective view of the
support/shield assembly of FIG. 3A.
[0033] FIG. 3C illustrates the support/shield assembly of FIG. 3A
with the locking arm bending at the hinge to assume a natural,
unrestrained position away from the support/shield hub.
[0034] FIG. 4A shows an oblique view of a needle assembly to
illustrate the internal chamber of the needle hub.
[0035] FIG. 4B illustrates a side view of the needle assembly of
FIG. 4A with a portion of a wall of the needle hub removed.
[0036] FIG. 5A shows a partial view of a proximal end of a
needle-catheter assembly to illustrate a position of the catheter
hub and support/shield hub when the needle-catheter assembly is in
a ready configuration.
[0037] FIGS. 5B and 5C illustrate a state of the distal end of the
catheter-needle assembly in the ready configuration when advanced
into a vessel.
[0038] FIG. 6A shows a partial view of a proximal end of a
needle-catheter assembly to illustrate a position of the catheter
hub and support/shield hub as well as the locking arm when the
needle-catheter assembly is moved to the safe configuration.
[0039] FIGS. 6B and 6C illustrate a state of the distal end of the
catheter-needle assembly after the catheter assembly of FIG. 6A
moves from the ready configuration to the safe configuration.
[0040] FIG. 7A illustrates the state of the catheter-needle
assembly in the safe configuration as the needle hub retracts from
the catheter hub.
[0041] FIG. 7B illustrates a state of the distal end of the
catheter needle assembly of FIG. 7A, where the needle cannula is
locked together with the support/shield tubing.
[0042] FIG. 7C shows a top view of the support/shield hub located
within the needle hub when in the safe configuration.
[0043] FIG. 8A shows a magnified partial view a distal end of a
catheter assembly similar to that shown in FIG. 1A.
[0044] FIGS. 8B and 8C illustrate additional possible variations of
distal end of needle assemblies.
[0045] FIG. 9A shows a partial view of the distal end of the needle
assembly of FIG. 8A where the needle cannula is withdrawn relative
to the catheter tubing and support/shield member.
[0046] FIGS. 9B and 9C show catheter tubing as faded/hidden to
better illustrate the location of the needle relative to the
support/shield member and catheter tubing.
[0047] FIGS. 10A and 10B illustrate partial cross-sectional views
of the catheter and support/shield member of FIGS. 9B and 9C
respectively.
[0048] FIG. 11A shows a table conventional needle and catheter
sizes.
[0049] FIG. 11B shows a table of configurations of catheter needle
assemblies constructed in accordance with the present
disclosure.
DETAILED DESCRIPTION
[0050] For a better understanding of the present invention,
reference will be made to the following Description of the
Embodiments, which is to be read in association with the
accompanying drawings, which are incorporated in and constitute a
part of this specification, show certain aspects of the subject
matter disclosed herein and, together with the description, help
explain some of the principles associated with the disclosed
implementations.
[0051] The terms "a" or "an", as used herein, are defined as one or
as more than one. The term "plurality", as used herein, is defined
as two or as more than two. The term "another", as used herein, is
defined as at least a second or more. The terms "including" and/or
"having", as used herein, are defined as comprising. (i.e., open
language). The term "coupled", as used herein, is defined as
connected, although not necessarily directly, and not necessarily
mechanically.
[0052] Reference throughout this document to "some embodiments",
"one embodiment", "certain embodiments", and "an embodiment" or
similar terms means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
the appearances of such phrases or in various places throughout
this specification are not necessarily all referring to the same
embodiment. Furthermore, the particular features, structures, or
characteristics may be combined in any suitable manner in one or
more embodiments without limitation.
[0053] FIG. 1A illustrates an example of an improved
needle-catheter assembly 100 with a removable wing 240 used for
securing the catheter 130 to a surface of tissue when the catheter
is positioned within a vessel. The needle-catheter assembly 100
shown in FIG. 1A includes a needle assembly 220 having a needle hub
222 coupled to the catheter 130 through an intermediate
support/shield hub (not shown in FIG. 1A). The catheter 130
includes a catheter tubing/extrusion 132 terminating proximally to
an end of a needle cannula 172 as shown in FIG. 1B, which is a
magnified view of area 1B from FIG. 1A. Any portion of the needle
assembly 220 and components positioned therein (such as the
support/shield hub and/or catheter hub) can include transparent or
translucent sections to allow for visual detection of blood or
fluid flow therein. In one example a proximal portion 234 if a
needle hub 222 can comprise a visually transparent/translucent
flashback chamber.
[0054] As shown in FIG. 1B, variations of the device include a
distal end of the catheter tubing 132 directly contacting the
needle cannula 224 at a distal end of the assembly. As discussed
below, the use of an intermediate member (not shown in FIG. 1A or
1B) as a support structure allows for an increased step in diameter
or gauge size between the needle cannula 224 and catheter tubing
132. Traditional devices typically employ a dilator allow for a
size difference between a needle and catheter when inserting an
assembly into a blood vessel. However, variations of the assemblies
100 described herein can Such a step can include a 3- or 4-gauge
size difference between the size (outer diameter) of the catheter
and the size of the needle. Alternate variations allow for a
conventional 2-gauge size between the needle cannula 224 and
catheter tubing 132. The support/shield member can serve a second
purpose as a shielding element that covers the distal tip of the
needle cannula to render the used needle assembly in a safe
non-stick configuration. Accordingly, the intermediate member can
function as a support/shield assembly. Variations of the present
disclosure can also include conventional needle assembly tip
designs where the distal end of the catheter tubing terminates on a
support/shield cannula or tubing, which then terminates on a needle
cannula.
[0055] FIG. 2A illustrates an exploded view of a variation of a
catheter needle assembly 100 having a needle assembly 220, a
support/shield assembly 250, a catheter 130 and a safety cap 110.
Variations of the devices and methods under the present invention
can include needle assemblies that do not include a cap 110.
[0056] In the variation shown by FIG. 2A, the needle-catheter
assembly 100 includes a needle assembly 220 that seats a
support/shield assembly 250. The shield assembly then couples to a
catheter 130. As discussed below, the needle-catheter assembly 100
can include a ready configuration where the support/shield assembly
250 is initially releasably joined to the catheter 130 such that
the needle tip 225 is exposed. This configuration permits a
caregiver to insert the needle-catheter assembly 100 into tissue of
a patient and ultimately into a blood vessel. Actuation of the
needle-catheter assembly 100 by the caregiver causes the
support/shield assembly 250 to release from the catheter 130 while
becoming locked to the needle assembly 220. In this locked
configuration, the sharp tip 225 of the needle cannula 224 moves
within the support/shield tubing 254, which then functions as a
shield. In such variations, the support/shield tubing 254 can also
be described as a shield tubing or shield element. In some
variations of the assembly 100, the distal end of the
support/shield tubing 254 is rounded or blunt to further protect
the caregiver. Alternatively, the distal end of the support/shield
254 tubing can have a taper to match to an internal taper of the
catheter tip.
[0057] FIG. 2A further illustrates the support/shield assembly 250
including a support/shield hub 252 having a locking arm 256. The
locking arm can include any number of features to facilitate the
configurations described above. The locking arm 256 can have a
biased configuration such that it biases away a hub 252 of the
support/shield assembly 250. As shown, the locking arm 256 is
parallel or near parallel to the support/shield hub 252, which is
the position of the locking arm 256 when nested within the needle
hub 222. The variation of the support/shield assembly 250 shown in
FIG. 2A includes a locking arm having a slot or opening 258 and
provides any number of locking features and/or mating features to
facilitate the locking positions discussed herein. Locking features
262 can lock against locking feature 226 of the needle hub 222 to
lock the support/shield assembly 250 to the needle assembly
220.
[0058] As described above, the assembly illustrated in FIG. 2A (or
any assembly disclosed herein) includes a catheter 130. However,
variations of the invention can include embodiments without a
catheter.
[0059] FIG. 2A also illustrates the catheter 130 including a
catheter hub 134 having a catheter tubing 132 extending from the
hub 134. The catheter hub 134 includes proximal threading 136 as
well as any number of surfaces 135 that can be used by a caregiver
to manipulate or handle the catheter 130. The internal opening of
the catheter hub 134 at a proximal end (e.g., adjacent to the
threading 136) can include a standard luer taper to accommodate
male luer fittings as well as any type of valve 190 to prevent
leakage of blood from the catheter 130. As discussed below, the
threading 136 of the catheter hub 134 can also serve as a surface
feature or locking surfaces during deployment and positioning of
the catheter tube 132 in a vessel. In alternate variations, the
catheter can include any number of surface features 137, other than
threading, where such features function as locking surfaces.
[0060] FIGS. 2B-2D illustrate an improved valve for use with
catheters, including a catheter as described herein. Typically,
such a catheter 130 is used with a male luer that is inserted into
the catheter body 134 through the valve 190. The catheter 130
includes a catheter hub 134 having a chamber 140 with a proximal
surface 138 defining an open proximal end. The chamber 140 is in
fluid communication with a catheter tubing 132 that is coupled to
the catheter. The tubing includes one or more lumens in fluid
communication with the chamber 140. The valve or septum valve 190
includes a barrier layer (or septum) 192 at a distal end. The
barrier layer 192 can have one or more slits 194. The illustrated
variation shows a barrier layer 192 with 3 slits 194 that form
three leaflet structures 197 or flaps. However, variations of the
valve 190 include any number of slits forming any number of
leaflets. The barrier layer 192 generally includes a flexible or
semi-flexible material that is compatible with exposure to blood,
medicaments, and other fluids commonly encountered during
catheterization/infusion procedure.
[0061] As shown in FIG. 2C, the valve includes a wall portion 196
extending proximally from the barrier layer 192 and defines a valve
cavity 199. A flange portion 198 is formed around the wall 196 at a
proximal end of the valve 190. The flange portion comprises a
diameter greater than a diameter of the wall portion. Variations of
the valve 190 include a flange portion 198 that encircles the valve
190. Alternatively, the flange portion 198 can include openings or
segments such that it is not circumferentially continuous about the
wall.
[0062] FIG. 2D shows the valve 190 coupled to the catheter hub 134
such that the flange portion 198 engages the proximal surface 138
of the catheter hub 134 and is exterior to the chamber 140 of the
hub 134. The wall portion 196 of the valve 190 engages a surface of
the chamber. The valve 190 can be affixed to the catheter at
various points. For example, variations of the assembly include a
valve 190 that is only affixed to the catheter hub 134 at the
flange portion 198 using an adhesive or joining material where the
wall portion 196 is simply positioned against a wall of the chamber
140. Alternatively, or in combination, the valve 190 can be affixed
to the catheter hub 134 at the exterior wall portion 196. In an
alternate variation, the valve 190 can simply be press-fit into the
catheter hub 134. Any number of features known to those in the art
can be used to facilitate seating of the valve 190 within the
catheter hub 134 (e.g., pockets, ribs, increased frictional
resistance of the surface of the valve or chamber, etc.)
[0063] FIGS. 3A to 3C illustrate a variation of a support/shield
assembly 250 for use with the catheter assemblies disclosed herein.
FIG. 3A illustrates a top oblique perspective view of a
support/shield assembly 250 having a seat 260 that receives a
catheter hub (not shown in FIGS. 3A to 3C). The seat 260 can
comprise any standard male luer tapered shape or the shape can be
any shape that allows seating of the catheter hub. A support/shield
254 extends from the support/shield hub 252 and/or seat 260. The
support/shield 254 can comprise any material that both supports a
wall of the catheter tubing during insertion of the catheter-needle
assembly as well as shields the sharp tip of the cannula upon
removal of the needle assembly. For example, the support/shield can
comprise any medically approved material used for
catheters/sheaths/dilators/etc. In addition, variations of the
support/shield can comprise polymers, shape memory alloys, metals
and metallic alloys including stainless steel.
[0064] FIG. 3A also shows the support/shield assembly 250 including
a locking arm 256 having a plurality of locking surfaces 262, 266
and guide surfaces 264. In this variation, the locking arm 256
includes an opening 258 that allows movement of the support/shield
assembly 250 within the needle assembly 220 to transition from the
ready configuration to the safe configuration disclosed herein. The
locking arm 256 of FIG. 3A is shown in a ready configuration, where
the locking arm 256 is relatively parallel to the support/shield
hub 252. As noted below, the locking arm 256 has a natural
position, when unrestrained, to deflect away from the
support/shield hub 252. In the variation illustrated in FIG. 3A,
the locking arm 256 includes a living hinge 259 that biases the
locking arm 256 away from the support/shield hub 252. However,
variations of the support/shield assembly 250 can include any
number of spring biased constructions to bias the locking arm 256
away from the support/shield hub 252.
[0065] FIG. 3B illustrates a bottom oblique perspective view of the
support/shield assembly 250 of FIG. 3A. As shown, the locking arm
256 can include a joining surface 261 that provides support for the
locking arm and/or FIG. 3C illustrates the support/shield assembly
250 of FIG. 3A with the locking arm 256 at the hinge 259 to assume
a natural, unrestrained position away from the support/shield hub
252. In additional variations, the locking arm 256 can bend along a
surface of the locking arm 256 rather than just at the hinge 254.
As discussed below, alternate variations of the support/shield
assembly will have a locking arm where any portion of the locking
arm disengages from a locking surface of a catheter hub and engages
a locking surface of a needle hub.
[0066] FIG. 4A shows an oblique view of a needle assembly 220 and
illustrates the internal chamber of the needle hub 222. The distal
end of the needle hub 222 includes an opening 230 for receiving the
support/shield hub 252 and catheter hub 134 (both of which are not
shown in FIG. 4A see FIGS. 1A and 2A). The needle hub 222 includes
a seat 232 for receiving the support/shield hub 252. The seat can
be any structure that receives a hub of the support/shield or
catheter. Variations of the needle hub 222 include a male luer. The
needle cannula 224 can be coupled through the seat 232 and is
secured to the needle hub 222 such that the internal lumen of the
cannula 224 can be fluidly coupled to a flash chamber 234. The
flash chamber 234 or any part of the needle hub 222 can be
transparent to allow a caregiver to observe the presence of blood
therein for confirmation that a distal tip of the cannula 224
penetrated a blood vessel. FIG. 4A also shows the needle hub 222
including one or more locking surfaces 226. The needle hub 222 also
includes a guide surface 228 that engages a portion of the shield
hub. As discussed below, the locking surface 226 and guide surface
228 allow for locking and/or guiding of the components of the
needle-catheter assembly between a ready configuration and a locked
configuration.
[0067] FIG. 4B illustrates a side view of the needle assembly 220
with a portion of a wall of the needle hub 222 removed. In the
illustrated variation, the guiding surface 228 extends at an
incline such that a height 227 of the guide surface 228 at a distal
end is greater than a height 227 of the guide surface 228 at the
proximal end. Variations of the hub can include inclining the guide
surface 228 or inclining the bottom surface of the hub 222. As
described below, the incline maintains engagement of the locking
arm (256 in FIG. 3A) against a catheter hub until in the ready
configuration until the assembly is moved into the safe
configuration. FIG. 4B also illustrates the locking surface 226 as
being spaced from a distal end of the guide surface 228.
[0068] FIG. 5A shows a partial view of a proximal end of a
needle-catheter assembly 100 with a portion of the needle hub 222
removed to illustrate a position of the catheter hub 134 and
support/shield hub 252 when the needle-catheter assembly 100 is in
a ready configuration. In this particular variation of the
needle-catheter assembly 100, the needle hub 222 prevents the
caregiver from contacting the support/shield hub 252. Since the
assembly 100 is in the ready configuration, the entire assembly 100
can be advanced distally into tissue to insert a tip 225 of the
needle 224 into a vessel 1 as shown in FIG. 5B. Once the caregiver
confirms placement of the needle 224 into a vessel 1 lumen, the
caregiver can actuate the assembly 100, to the safe configuration.
As discussed herein, in the ready configuration, the locking arm
256 is maintained/restrained towards the catheter hub 134 and away
from its natural position because the guide surface 264 of the
locking arm 256 contacts the guide surface 228 of the needle hub
222 (FIG. 5A). By being held against the catheter hub 134 the
locking arm 256 engages a surface feature 137 of the catheter hub
134. Accordingly, in this position, the support/shield hub 252 and
catheter hub 134 move together as the surface feature 137 of the
catheter hub 134 engages a locking surface 266 of the locking arm
256. Therefore, opposite relative movement between the needle hub
222 and the catheter hub 134 causes the support/shield hub 252 to
remain engaged with the catheter hub 134. As noted above, alternate
variations of the device include the use of the threading 136 of
the catheter hub 134 as a locking surface FIG. 5A also shows that a
slot 258 (FIGS. 3A and 3B) prevents interference between the
locking arm 256 and the guide surface 228 of the needle hub 222
except at the interface between surfaces 228 and 264.
[0069] FIGS. 5B and 5C illustrate a state of the distal end of the
catheter-needle assembly 100 in the ready configuration when
advanced into a vessel 1. The catheter tubing 132, support/shield
254, and needle cannula 224 are partially shown to better
illustrate the configuration of these components when the
catheter-needle assembly 100 is in the ready configuration. As
shown in both FIGS. 5B and 5C, the needle cannula 224 extends
through both the support/shield tubing 254 and the catheter tubing
132 but the sharp tip 225 of the cannula 224 extends beyond the
support/shield tubing 254, which allows the catheter 132 to end
directly onto the cannula 224 adjacent to the tip 225. As noted
herein, this configuration allows for 3-4-gauge steps in size
difference between the needle cannula 224 and catheter tubing 132.
This configuration also permits the support/shield tubing 254 to
function as a dilator or reinforcement of the catheter tubing wall
132 given the size differential with the needle cannula 224. FIG.
5C shows the catheter tubing 132 being hidden for purposes of
illustrating the end of the support/shield tubing 254, which
remains proximal to both the sharp tip 225 and end of the catheter
tubing 132.
[0070] FIG. 6A shows a partial view of a proximal end of a
needle-catheter assembly 100 with a portion of the needle hub 222
removed to illustrate a position of the catheter hub 134 and
support/shield hub 252 as well as the locking arm 256 when the
needle-catheter assembly 100 is moved to the safe configuration.
Typically, the caregiver will observe a flash chamber 234 in the
device for confirmation that a lumen of the needle cannula is in
fluid contact with a blood vessel. Once the caregiver is
comfortable with the placement of the needle-catheter assembly 100,
the caregiver manipulates the needle-catheter assembly 100 to
produce relative movement between the catheter (typically the
catheter hub 134) and the needle hub 222. Typically, the caregiver
advances the catheter hub 134 in a distal direction 12 to reduce
the possibility of pulling the assembly 100 out of the vessel.
However, proximal movement of the needle hub 222 relative to the
catheter hub 134 can also suffice. In the illustrated variation,
the caregiver can grasp the needle hub 222 and use a finger or
thumb to advance the catheter hub 134 using the push-tab or
protrusion 135.
[0071] Since the catheter-needle assembly 100 was initially in the
ready configuration at the start of relative movement between the
catheter hub 134 and needle hub 222 (i.e., the configuration shown
in FIG. 5A), the support/shield hub 252 is engaged with the
catheter hub 134 via interference between locking surfaces on the
locking arm 256 and surface feature 137 of the catheter hub 134.
Relative movement 12 of the catheter hub 134 to the needle hub 222
also moves the support/shield hub 252 to the condition shown in
FIG. 6A where the guide surface 264 of the locking arm 256 is no
longer engages the guide surface 228 of the needle hub 222. The
resiliency of the locking arm 256 causes locking arm 256 and
surface 264 to move towards an unrestrained position (e.g., the
surface 264 engages the wall of the needle hub 222). Doing so
causes disengagement between the locking arm 256 and catheter 134
hub and engagement between a locking surface 262 of the locking arm
256 and locking surfaces (e.g., 226) of the needle hub 222. In this
configuration, the locking arm 256 is completely disengaged from
the guide surface 228, which prevents the support/shield hub 222
from moving proximally and uncovering of the needle tip 225 (not
shown in FIG. 6A). It is noted that the support/shield hub 252 can
still be engaged with the needle hub 222. However, the catheter hub
134 and support/shield hub are no longer locked together.
[0072] Further distal advancement 12 of the catheter hub 134 causes
further separation between the catheter hub 134 and support/shield
hub 252 until the catheter hub 134 disengages the seat 260 of the
support/shield hub 252. At this stage (as shown in FIG. 6A), the
locking arm 256 now locks together the needle hub 222 and
support/shield hub 252. Accordingly, withdrawal of the needle hub
222 also causes withdrawal of the support/shield hub 252.
[0073] FIGS. 6B and 6C illustrate a state of the distal end of the
catheter-needle assembly 100 after the catheter assembly moves from
the ready configuration (FIG. 5A) to the safe configuration (FIG.
6A). As shown in FIG. 6B, the distal opening 144 of the catheter
132 are within the vessel 1. However, the sharp tip 225 of the
cannula 224 is withdrawn relative to the catheter tubing 132. FIG.
6C illustrates the state of the distal end of the catheter assembly
with the catheter tubing 132 in phantom view to better illustrate
the positioning of the sharp tip 225 relative to the support/shield
tubing 254. Movement of the catheter hub relative to the needle hub
from the ready configuration to the safe configuration will occur
over a distance that allows the catheter tube 132 and
support/shield tube 245 to a position that is distal to the sharp
tip 225. Again, as shown in FIG. 5A, which shows the ready
configuration, the catheter hub and support/shield hub are locked
together. Movement of the catheter hub from this position also
moves the support/shield hub until both enter the safe
configuration of FIG. 6A. The distance of the movement will be
enough to position the catheter hub 132 and support/shield tube 254
distal to the sharp tip 225 and cannula 224 as shown in FIG.
6C.
[0074] FIG. 7A illustrates the state of the catheter-needle
assembly 100 in the safe configuration as the needle hub 222
retracts from the catheter hub 134. As discussed above, the needle
hub 222 is locked with the support/shield hub 252 by interference
between locking surfaces 262 of the locking arm 256 and one or more
locking surfaces 226 of the needle hub 222. Withdrawal of the
needle hub 222 in a proximal direction 14 relative to the catheter
hub 134 causes the withdrawal of both the needle hub 222 and the
support/shield hub 252 such that the needle cannula remains secured
within the support/shield tubing 254 such that the blunted tip of
the support/shield tubing protects the caregiver or others from
skin penetration by the sharp tip of the cannula.
[0075] FIG. 7B illustrates a state of the distal end of the
catheter needle assembly 100 of FIG. 7A, where the needle cannula
224 is locked together with the support/shield tubing 254 thorough
locking of their respective hubs. As shown, the sharp tip 225 of
the needle cannula 224 remains secured within the support/shield
tubing 254. Ultimately, the support/shield tubing 254 and needle
cannula 224 are removed from the catheter tubing 132, which remains
in the vessel 1.
[0076] FIG. 7C shows a top view of the support/shield hub 252
located within the needle hub 222 when in the safe configuration.
As shown, dropping of the locking arm 256 from the guide surface
(not visible in FIG. 7C) of the needle hub 222 causes locking
surfaces 262 of the locking arm to engage locking surfaces 226 of
the needle hub 222. Any number of locking surfaces can be used in
alternate variations of the device. Once secured in the safe
configuration, the needle and support/shield assemblies can be
removed from the catheter.
[0077] FIG. 8A shows a magnified partial view a distal end of a
catheter assembly similar to that shown in FIG. 1A. As shown in
FIG. 8A, a support/shield member 254 is positioned between the
needle cannula 224 and catheter tubing 132.
[0078] FIGS. 8B and 8C illustrate additional possible variations of
distal end of needle assemblies. In FIGS. 8B and 8C the catheter
tubing 132 is faded/phantom view to better illustrate the
support/shield member 254 located between the needle 224 and
catheter tubing 132. As shown, the support/shield member 254
extends along the needle 224 but terminates within the catheter
tubing 132. The distal end of the of the support/shield member 254
can be blunted as shown in FIG. 8B or can be tapered 166. In the
illustrated variation, the tapered portion 255 of the
support/shield member 254 is located within a taper of the catheter
tubing 132. However, alternate variations are within the scope of
this disclosure. For example, the support/shield member 254 can be
stepped or have any configuration as used by those skilled in the
art.
[0079] FIG. 8A also illustrates optional flow openings 146
extending through a wall of the catheter tubing 132. Such flow
openings 146 can assist in offsetting any restriction of flow
through the catheter 132 due to the reduced size of the distal
opening 144 relative to a lumen size of the catheter tubing
132.
[0080] FIG. 9A shows a partial view of the distal end of the needle
assembly 100 of FIG. 8A where the needle cannula 224 is withdrawn
relative to the catheter tubing 132 and support/shield member 254.
In FIGS. 9B and 9C the catheter tubing 132 is shown as faded/hidden
to better illustrate the location of the needle 224 relative to the
support/shield member 254 and catheter tubing 132. As shown, the
bevel 178 or sharp tip of the needle 224 is retracted within the
support/shield member 254 to shield the sharp tip upon removal of
the needle 224 from the catheter 132 as discussed above. FIG. 9C
illustrates another variation of the assembly 100 where the
support/shield member 254 includes a tapered distal portion 166
within a tapered distal end 142 of the catheter 132. As shown, a
bevel 178 is retracted within the support/shield member 224 to
shield the sharp tip of the needle 224.
[0081] FIGS. 10A and 10B illustrate partial cross-sectional views
of the catheter 132 and support/shield member 254 of FIGS. 9B and
9C respectively. FIG. 10A illustrates the needle 170 extending
through the support/shield member 254 and out through the catheter
132. The support/shield member 254 is slidable or retractable
relative to the catheter 132 but is prevented from moving distally
in the catheter 132 due to the presence of a shoulder 133 within
the catheter 132. The shoulder 133 is formed from an increase in a
thickness of the catheter wall at the tapered section 142. This
increased wall thickness reduces the risk of collapse at the
tapered section 142 when inserted into tissue. FIG. 10B illustrates
a variation where the support/shield member 254 includes a tapered
section 166 that is positioned within the tapered section 142 of
the catheter 132. In the illustrated variation, the taper 166 of
the support/shield member 254 can support the catheter 132 at the
tapered section 142 of the catheter 132 when inserted within
tissue.
[0082] Another benefit of the variations shown in FIGS. 8A to 10B
is that the intermediate member not only provides a needle guard
when the needle is retracted within the intermediate member, but
the intermediate member also reinforces the catheter, which allows
for a greater size differential between the catheter and needle.
This allows for the placement of a smaller gauge needle to insert a
given catheter.
[0083] The configurations disclosed herein not only allow for an
improved safety mechanism, but the configuration of needle cannula,
support/shield tubing, and catheter allow improved sizing between
the smaller needle and larger catheter than are otherwise
available. Hypodermic needles are available in a wide variety of
outer diameters described by gauge numbers. Smaller gauge numbers
indicate larger outer diameters. Inner diameter depends on both
gauge and wall thickness. Needles are routinely available in a
variety of gauge sizes, including 18, 21, 23, and 25 gauge.
[0084] For example, conventional needle catheter assemblies,
especially for peripheral catheters, are configured so that any
given catheter size uses a needle size that is two gauge sizes
removed from the catheter gauge (for purposes of discussion the
outer diameter size of the catheter and needle are measured by
gauge size but other measurements are within the scope of this
disclosure). FIG. 11A shows two tables, the first being a
conventional needle and catheter size comparison based on ISO
standards for needle that are 2-gauge sizes smaller than their
associated catheter. As shown, the configuration column indicates
catheter size with the associated needle size being 2-gauge sizes
smaller. The lower chart illustrates examples of various
conventional needle catheter devices from various medical device
manufacturers. Like the ISO standards, a measurement of the
commercially available needle catheter assemblies confirms a
2-gauge size differential between the catheter and needle.
[0085] In contrast, FIG. 11B illustrates various configurations of
catheter needle assemblies constructed in accordance with the
present disclosure. As shown, the construction of the catheter
needle assemblies described herein allow for a 4-gauge size
differential between the catheter and needle. The catheter
assemblies of the present disclosure can also allow for a 3-gauge
size differential as well.
[0086] The needle gauge becomes a consideration in certain cases
where the vein of the patient is narrow, fragile, or superficial.
In such cases, a gauge size with a larger number (e.g., 25 G) may
be preferred over a routine needle gauge (e.g., 21 G) to minimize
damage to the blood vessel, as well as minimize the associated pain
during insertion.
[0087] However, while a larger gauge size needle has a smaller
outer diameter, the needle also has a smaller bore and a smaller
internal diameter. When blood cells are forced by the vacuum
pressure of large volume evacuated and quickly enters the tight
space of a tiny needle gauge, hemolysis may occur. Hemolysis can
cause inaccurate results (slight to significant) when testing
several analytes. Potassium, for example, can be falsely increased
in a hemolyzed sample. Phlebotomists must exercise judgment between
maintaining patient comfort and maximizing sample integrity when
selecting an appropriate needle gauge for each patient.
[0088] The previous description of the disclosed embodiments is
provided to enable any person skilled in the art to make or use the
present invention. Various modifications to these embodiments will
be readily apparent to those skilled in the art, and the generic
principles defined herein can be applied to other embodiments
without departing from the spirit or scope of the invention. For
example, a wide variety of materials may be chosen for the various
components of the embodiments. It is therefore desired that the
present embodiments be considered in all respects as illustrative
and not restrictive, reference being made to the appended claims as
well as the foregoing descriptions to indicate the scope of the
invention.
* * * * *