U.S. patent application number 16/520813 was filed with the patent office on 2020-01-16 for methods and devices for vascular access.
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 Clint SOLOMON.
Application Number | 20200016375 16/520813 |
Document ID | / |
Family ID | 65436466 |
Filed Date | 2020-01-16 |
View All Diagrams
United States Patent
Application |
20200016375 |
Kind Code |
A1 |
SOLOMON; Clint |
January 16, 2020 |
METHODS AND DEVICES FOR VASCULAR ACCESS
Abstract
Methods and devices to facilitate positioning of a catheter into
a vessel. Devices include axially concentric assemblies of a
piercing needle and a dilator that guides an outer catheter into a
vessel, such as a blood vessel. The assemblies described herein can
include retraction mechanisms and/or lock mechanisms to control
needle positioning during catheterization processes as well as
improved valves that prevent leakage of fluid from the proximal end
of the devices. The devices and method include the use of novel
valves to prevent undesired leakage of fluids through the proximal
end of the catheter.
Inventors: |
SOLOMON; Clint; (Morgan
Hill, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
I-V Access Technology, Inc. |
Los Osos |
CA |
US |
|
|
Assignee: |
I-V Access Technology, Inc.
Los Osos
CA
|
Family ID: |
65436466 |
Appl. No.: |
16/520813 |
Filed: |
July 24, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16004970 |
Jun 11, 2018 |
10406326 |
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16520813 |
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62552663 |
Aug 31, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0097 20130101;
A61M 39/26 20130101; A61M 39/1011 20130101; A61M 25/0625 20130101;
A61M 25/0606 20130101; A61M 25/0631 20130101; A61M 29/00 20130101;
A61M 2025/0687 20130101 |
International
Class: |
A61M 25/06 20060101
A61M025/06; A61M 39/10 20060101 A61M039/10 |
Claims
1. A needle assembly comprising: a housing having a projection
located therein; a first tubular member having a first hub slidably
engaged with the housing; a needle having a needle hub, the needle
extending through the first tubular member, the needle hub
positioned within the assembly housing, the needle hub including a
stop material positioned in a fluid path of the needle hub such
that fluids passing through the needle into the needle hub contacts
the stop material; a biasing element in contact with the needle hub
applying a biasing force against the needle hub; where the needle
assembly comprises an unloaded configuration where the stop
material and the projection are adjacent without the biasing force
acting therebetween; where the first hub and needle hub are
moveable relative to each other to assume a loaded configuration
where the biasing force drives the needle hub proximally to force
the stop material against the projection such that the stop
material prevents further proximal movement of the needle hub; and
wherein when fluid in the needle hub contacts the stop material,
the stop material weakens causing proximal movement of the needle
hub such that a distal end of the needle retracts within the first
tubular member.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/004,970 filed Jun. 11, 2018, which claims
priority to U.S. Provisional Patent Application No. 62/552,663
filed Aug. 31, 2017, the contents of which are incorporated herein
by reference in their entireties.
FIELD OF THE INVENTION
[0002] The invention is directed to methods and devices to
facilitate positioning of a catheter into a vessel. Devices include
axially concentric assemblies of a piercing needle and a dilator
that guides an outer catheter into a vessel, such as a blood
vessel. The assemblies described herein can include retraction
mechanisms and/or lock mechanisms to control needle positioning
during catheterization processes as well as improved valves that
prevent leakage of fluid from the proximal end of the devices.
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.
[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.
[0008] 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 by incorporating a dilator to
expand the passage 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. The sytems described herein also permit a fully passive or
active needle retraction to withdraw the needle tip safely within
the dilator or other member. This retraction method allows for
positioning of the catheter in the vein with less risk of vascular
damage that could otherwise lead to hematoma or infiltration.
[0009] 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.
[0010] In addition, the needle assembly described herein includes
an improved needle assembly. For example, such a needle assembly
can include a housing having a projection located therein; a first
tubular member having a first hub slidably engaged with the
housing; a needle having a needle hub, the needle extending through
the first tubular member, the needle hub positioned within the
assembly housing, the needle hub including a stop material
positioned in a fluid path of the needle hub such that fluids
passing through the needle into the needle hub contacts the stop
material; a biasing element in contact with the needle hub applying
a biasing force against the needle hub; where the needle assembly
comprises an unloaded configuration where the stop material and the
projection are adjacent without the biasing force acting
therebetween; where the first hub and needle hub are moveable
relative to each other to assume a loaded configuration where the
biasing force drives the needle hub proximally to force the stop
material against the projection such that the stop material
prevents further proximal movement of the needle hub; and wherein
when fluid in the needle hub contacts the stop material, the stop
material weakens causing proximal movement of the needle hub such
that a distal end of the needle retracts within the first tubular
member.
[0011] In one variation, the needle assembly, in the unloaded
configuration and in the loaded configuration, the distal end of
the needle extends beyond a distal end of first tubular member.
[0012] The first tubular member can comprise a dilator with a
catheter positioned exterior to the dilator. In one variation, the
needle assembly is actuatable by rotation of the first hub relative
to the needle hub.
[0013] The assembly can comprise a first hub having a slotted
opening and where the needle hub comprises a protruding element
within the slotted opening, where in the unloaded configuration, a
surface of the slotted opening prevents rearward movement of the
protruding element, and upon rotation of the first hub relative to
the needle hub the slotted opening permits proximal movement of the
protruding element and the needle hub. In one variation, a portion
of the slotted opening is angled to permit gradual proximal
movement of the protruding element and the needle hub during
rotation of the first hub.
[0014] Variations of the device can include a needle assembly where
the first hub comprises a locking surface, such that upon rotation
of the first hub, a locking arm enters the locking surface to
prevent further rotation of the first hub. For example, the
assembly can include a protective cap positioned exterior to the
first tubular member and the needle.
[0015] In variations of the device, in the unloaded configuration,
the needle hub can be touching or can be spaced from the
projection.
[0016] The devices described herein can include one or more slider
arms extending exterior to the housing, where the slider arm is
moveable from an exterior of the housing such that proximal
movement of the slider arm moves the needle hub proximally
sufficient to force the projection through the stop material to
retract the needle within the first tubular member.
[0017] Variations of the housing include an end cap at a proximal
end, and where the projection comprising a tapered projection
extending distally from the end cap.
[0018] The stop material can comprise any structure such as a
membrane positioned within a proximal end of the needle hub or over
a proximal end of the needle hub. In alternate variations, the stop
material comprises a plug positioned in a proximal end of the
needle hub.
[0019] The needle assembly can include one or more visually
transparent or visually translucent sections to permit visual
detection of fluid entering or passing through the needle hub.
[0020] In another example, the present disclosure includes a
medical assembly comprising an assembly housing having a projection
located therein; a first tubular member having a first hub coupled
with the assembly housing; a needle having a needle hub, the needle
extending through the first tubular member, the needle hub
positioned within the assembly housing, the needle hub including a
positioned in a fluid path of the needle hub such that fluids
passing through the needle into the needle hub engage the stop
material; where the needle assembly is actuatable from an unloaded
configuration to a loaded configuration during which a distal end
of the needle extends beyond a distal end of the first tubular
member, where in the unloaded configuration a mechanical stress
restrains the needle assembly from moving in a proximal direction
without increasing mechanical stress on the stop material wherein
in the loaded configuration a biasing element moves the needle hub
proximally until the stop material engages the projection increases
mechanical stress on the stop material, which prevents further
proximal movement of the needle hub and; wherein as fluid from the
needle hub contacts the stop material, a structural integrity of
the stop material reduces eventually permitting proximal movement
of the needle hub such that the distal end of the needle retracts
within the first tubular member.
[0021] The present disclosure also includes methods of preparing an
injection into a vessel of an individual and methods of
catheterization.
[0022] For example, such methods can comprise providing a needle
assembly having a needle extending through an outer tubular member,
where the needle comprises a stop material coupled to a needle hub,
where the needle assembly is in an unloaded configuration such that
a mechanical stress of the stop material is at a first level, where
the stop material reduces a structural integrity when exposed to
fluids; moving the needle hub and a hub of the outer tubular member
relative to each other resulting in an increase in the mechanical
stress of the stop material to a second level, while a distal end
of the needle extends beyond a distal end of the outer tubular
member.
[0023] Another method includes a method of preparing an injection
into a vessel of an individual. For example, the method can
comprise providing a needle assembly having a needle extending
through an outer tubular member, where the needle comprises a stop
material that reduces a structural integrity when exposed to
fluids, the stop material being coupled to a needle hub, where the
needle assembly is in an unloaded configuration such that such that
the needle hub is prevented from proximal movement without
increasing mechanical stress on the stop material; moving the
needle hub and a hub of the outer tubular member relative to each
other such that a bias force forces the needle hub in a proximal
direction until the stop material engages a portion of the needle
assembly resulting in a state of increased mechanical stress on the
stop material, where a distal end of the needle extends beyond a
distal end of the outer tubular member when in the stop material is
in the state of increased mechanical stress.
[0024] Another variation of devices described herein includes
catheter assemblies for use with a male luer having a distal end
and a lateral surface, the male luer having a connector portion,
the catheter assembly comprising: a catheter hub having a chamber
with a proximal surface defining an open proximal end; a catheter
tubing coupled the catheter hub and having a lumen in fluid
communication with the chamber; a septum valve comprising: a
barrier layer at a distal end, the barrier layer having at least
one slit, a wall portion extending proximally from the barrier
layer, the wall portion defining a valve cavity therein, a flange
portion at a proximal end of the septum valve, the flange portion
having a diameter greater than a diameter of the wall portion; the
septum valve is coupled to the catheter hub such that the flange
portion engages the proximal surface of the catheter hub exterior
to the chamber and the wall portion engages a surface of the
chamber; and wherein insertion of the male luer into the cavity of
the septum valve causes the distal end of the male luer to open the
slit, while the lateral surface of the male luer engages the wall
portion within the cavity causing the wall portion to engage an
interior surface of the chamber, and where the connector portion
engages the flange portion against the proximal surface of the
catheter hub.
[0025] Variations of the catheter assembly include a catheter
assembly positioned about the needle assemblies described
herein.
[0026] Variations of the catheter assembly of can include a flange
portion of a septum valve being affixed to the proximal surface of
the catheter hub and where the wall portion of the septum valve
contacts the interior surface of the chamber of the catheter hub.
The slit in the barrier layer of the septum valve is normally
closed and opened upon the application of a force. The slit in the
barrier layer of the septum valve comprises a tri-slit that forms
three leaflet portions in the barrier layer.
[0027] 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. application Ser. No. 12/319,715 now
U.S. Pat. No. 8,105,288 issued on Jan. 31, 2012; U.S. application
Ser. No. 13/331,910 now U.S. Pat. No. 8,591,469 issued on Nov. 26,
2013; U.S. application Ser. No. 15/169,717 now U.S. Pat. No.
9,604,035 issued on Mar. 28, 2017; U.S. application Ser. No.
14/062,124 published as US20140058357 on Feb. 27, 2014; U.S.
application Ser. No. 13/759,643 published as US20130204226 on Aug.
8, 2013; and U.S. application Ser. No. 14/660,151 published as
US20150265827 on Sep. 24, 2015.
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Each of the following figures diagrammatically illustrates
aspects and variation to better understand the invention. Variation
of the invention from the aspects shown in the figures is
contemplated.
[0029] FIG. 1A illustrate an example of an improved needle assembly
with a protective cap covering a catheter.
[0030] FIG. 1B shows an exploded view of the needle assembly of
FIG. 1A.
[0031] FIG. 2 illustrates a variation of a catheter having an
extrusion or tubing coupled to a hub.
[0032] FIG. 3 illustrate an example of a dilator including a
dilator tubing coupled to a dilator hub where a biasing element is
nested within the dilator hub.
[0033] FIGS. 4A and 4B illustrate a side view and cross sectional
view of a needle having a needle cannula affixed with a needle
hub.
[0034] FIG. 5 illustrates a variation of a housing for the needle
assembly.
[0035] FIG. 6A illustrates a needle assembly having an optional
protective cap over a catheter 130, where the catheter is
positioned onto a dilator with a needle extending therethrough.
[0036] FIG. 6B illustrates a partial cross sectional view of the
dilator hub, needle hub, and housing.
[0037] FIGS. 6C and 6D illustrate top and side views respectively
of the needle assembly of FIG. 6A.
[0038] FIG. 6E illustrates the assembly of FIG. 6A with the cap and
body removed to demonstrate the interaction between the dilator hub
and the needle hub.
[0039] FIG. 7A shows rotation of cap in a direction to cause
rotation of the dilator hub via engagement of protrusion with a
slot or opening in cap.
[0040] FIG. 7B illustrates the assembly of FIG. 7A with the cap
removed as well as with the housing removed.
[0041] FIG. 7C illustrates a partial cross sectional view of the
dilator hub, needle hub, and housing after rotation of the cap.
[0042] FIG. 7D illustrates a view of the device assembly after the
rotation shown in FIG. 7A with the cap removed.
[0043] FIG. 7E illustrates a magnified view of a distal end of the
device assembly of FIG. 7D.
[0044] FIG. 8A shows the needle hub having moved proximally
relative to the projection resulting from the biasing element
driving the needle hub rearward.
[0045] FIG. 8B illustrates a condition where a device assembly is
inserted into a vessel after being activated in the loaded
configuration.
[0046] FIG. 8C illustrates a magnified view of box 8C in FIG.
8B.
[0047] FIGS. 9A and 9B illustrate the housing with a manual
retraction component.
[0048] FIG. 9C illustrates removal of a dilator from a catheter
130, where the catheter remains inserted within the target vessel
or area.
[0049] FIG. 10 illustrates a variation of a dilator with a tapered
or beveled distal end to match a bevel of an accompanying
needle.
[0050] FIGS. 11A to 11C illustrate an improved valve for use with
catheter.
[0051] FIGS. 12A to 12C show a luer fitting inserted into the
catheter valve assembly of FIG. 11C.
DETAILED DESCRIPTION
[0052] 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.
[0053] 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.
[0054] 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.
[0055] FIG. 1A illustrate an example of an improved needle assembly
with a protective cap 110 covering a catheter 130. Where the
catheter is coupled to a dilator 150 that is engaged with a housing
200. Any portion of the housing 200 and components positioned
therein can include transparent or translucent sections to allow
for visual detection of blood or fluid flow therein.
[0056] Variations of the devices and methods under the present
invention can include needle assemblies that do not include a cap
110 or catheter 130. In addition, alternate embodiments of the
methods and devices can include the use of a sheath or other
tubular member in place of a dilator 150.
[0057] FIG. 1B shows an exploded view of the needle assembly 100 of
FIG. 1A. In this variation, the cap 110 is not shown for purposes
of illustrating the assembly. As shown, a catheter 130 comprising a
catheter extrusion or tubing 132 and catheter hub is positioned
over a dilator 150. The dilator 150 can include a dilator tubing
152 coupled to a dilator hub. Variations of the dilator tubing 152
can be flexible, stiff, or a tubing that has varying properties
along its length. The dilator 150 is slidably positioned over a
needle 170 comprising a cannula 172 and needle hub 175 with a
biasing element 120 positioned between the dilator hub 154 and
needle hub 174 to apply a biasing force as described below. The
biasing element 120 in the illustrated example comprises a coil
spring. However, variations of the device can include any elastic
or resilient member that can provide a biasing force. For example,
an elastic resin, or other type of spring can be used to provide a
biasing force that drives the needle 170 in a proximal direction
relative to the dilator 150. The dilator hub 154, biasing element
120, and needle hub 174 can be slidably engaged within a housing
200. As described below, the housing 200 can include a projection
stop, projection or punch member 202 that is used to resist
rearward movement of the needle 170. The projection 202 is
illustrated as being part of an insert 204 that seats in a proximal
end of the housing 200. However, variations can include a
projection 202 that is integrally formed with the housing.
Likewise, the illustrated projection comprises a tapered shape.
However, alternate shapes are within the scope of this
disclosure.
[0058] As described above, the assembly illustrated in FIG. 1B
includes a catheter 130 and a dilator 150. However, variations of
the invention can include embodiments without a catheter and/or
embodiments where a generic tubular member with a hub is used in
place of dilator 150.
[0059] As described herein, for variations of the system 100 that
use a catheter 130, using a dilator 150 over a needle 170 allows
the use of a small needle size as compared to a catheter size. For
example, the use of dilator 150 allows for placement of a 20 GA
catheter using a 24 GA needle. However, alternate variations of the
devices can include catheters of any gauge, where the gauge is
selected based on the desired medical procedure. FIG. 2 illustrates
a variation of a catheter 130 having an extrusion or tubing 132
coupled to a hub 134. The hub 134 can include any number of
features that allow for joining of the catheter 130 with fittings
to deliver or remove fluids, medicine, or blood to/from the body.
In this variation, the catheter hub 134 includes projections 136
that allow for a threaded engagement of another hub onto the
proximal end of the catheter. 130. As shown, variations of the
catheter 130 can include an improved septum valve 190 as discussed
below.
[0060] FIG. 3 illustrate an example of a dilator 150 including a
dilator tubing 152 coupled to a dilator hub 154 where a biasing
element 120 is nested within the dilator hub 154. In alternate
variations, a biasing element can be positioned external to the
dilator hub. Alternatively, the biasing element can be positioned
in another part of the needle assembly 100 as long as it provides a
direct or indirect biasing force on the needle to urge the needle
in a proximal direction. In the broadest example, a dilator hub 154
can comprise an ordinary hub as commonly used in medical catheters.
Alternatively, a variation of a hub (for a dilator or any other
tubular member, or generic sheath), can include features to improve
the operability of the needle assembly 100. For instance, the
illustrated hub 154 can include one or more locking surfaces 156 to
prevent rotation of the hub 154 when moved from an unloaded
configuration to a loaded configuration as shown below. The hub 154
can also include one or more projections/protrusions/tab features
158 that, when used with a cap 110 (shown in FIG. 1A) provide for
alignment and rotation of the hub 154 with the cap. The hub 154 can
also optionally include a groove or recess 160 that can be used
with one more retaining clips to assist in preventing rotation of
the hub 154. FIG. 3 also illustrates a slotted opening 162 that can
serve multiple functions. For example, the slotted opening 162 can
be used to help prevent rearward movement of the needle/needle hub
as well as to permit controlled proximal movement of the needle hub
as described below.
[0061] FIGS. 4A and 4B illustrate a side view and cross sectional
view of a needle 170 having a needle cannula 172 affixed with a
needle hub 174. The needle hub 174 receives a portion of the
biasing element (shown in FIG. 3) in a distal portion 178 of the
hub 174. However, in alternate variations, the biasing element can
engage an exterior portion of the needle as well. The needle hub
includes one or more protrusions or catch features 176 that can
engage with the slotted opening 162 (shown in FIG. 3) of the
dilator hub 154. The needle hub 174 also includes a chamber 180)
that is in fluid communication with a lumen of the cannula 172). A
stop material 182 is also coupled to the needle hub 174. The stop
material 182 can comprise a fluid sensitive material that degrades
in structural integrity upon contact with fluid. The stop material
182 can comprise a membrane, thin layer, or plug.
[0062] FIG. 5 illustrates a variation of a housing 200 for the
needle assembly 100. As shown, the housing 200 can include a
projection or punch member 202 that engages the stop material (as
discussed below). In the illustrated variation, the projection 202
is formed form an insert 204 that is inserted into a proximal end
of the housing 200. However, as noted above, the projection can be
integrally formed in the hub. The housing 200 can further include
one or more locking features 206 that engage the locking surface
(shown in FIG. 3) of the dilator hub. In this variation, the
locking features 206 extend from spring clips positioned about the
housing 200. In alternate variations, the locking features 206 can
be integrally formed with the housing 200. The housing can also
optionally include a slider or slider arm 208 that extends
exteriorly to the housing 200. The slider 208 includes a portion
(not shown) that engages the needle to allow for manual retraction
of the needle. Such a feature can serve as an added measure of
safety that the medical practitioner can check to ensure full
retraction of the needle. The housing 200 can also include one or
more alignment features 210 that require alignment of the cap with
the feature 210 prior to removal of the cap.
[0063] FIGS. 6A to 6E are intended to show a variation of a needle
assembly 100 in an unloaded, safe, or storage position. FIG. 6A
illustrates a needle assembly 100 having an optional protective cap
110 over a catheter 130, where the catheter is positioned onto a
dilator with a needle extending therethrough. In those variations
without a protective cap 110, the actuation of the needle assembly
into a loaded or ready position can be accomplished via movement of
the catheter, dilator, and/or needle.
[0064] FIG. 6B illustrates a partial cross sectional view of the
dilator hub 154, needle hub 174, and housing 200. As shown, in the
unloaded configuration, the projection 202 of the housing 200 is
spaced from the stop material 182. Spacing of the stop material 182
from the projection was found to improve consistency of the
operation of the device assembly 100 by preventing loading of the
stop material 182 by the projection or punch 202 until a medical
practitioner is ready to use the device. Delaying loading of the
stop material 182 prevents variability in the structural integrity
of the stop material 182 due to such factors as fatigue or due to
the cyclical temperature and pressure conditions that a device
might experience during a sterilization process common to medical
devices. In some variations, the stop material 182 can be touching
the projection 202 in the unloaded configuration. However, in the
unloaded configuration, the stop material 182 will not be under
stress arising from the force applied by the biasing element 120.
Variations of the device include configurations where the biasing
element 120 applies a biasing force to the needle hub 174 in the
unloaded configuration. Alternatively, other variations can include
configurations where the biasing element 120 does not apply a
biasing force to the needle hub 174 when in the unloaded
configuration.
[0065] FIGS. 6C and 6D illustrate top and side views respectively
of the needle assembly 100 of FIG. 6A. As shown, the cap 110 can
include one or more slots/grooves 112 that mate with various
portions of the needle assembly 100 to prevent inadvertent loading
of the needle assembly 100. FIG. 6C shows a portion of the
slot/groove 112 as accommodating an alignment feature 210 of the
body 200. As shown, the alignment feature 210 bears against the
slot/groove 112, which prevents movement of the cap 110 in an axial
direction relative to the needle assembly 100. FIG. 6D illustrates
a side view of the assembly 100 where the slot/groove 112 engages a
protusion/projection of the dilator hub 158. The assembly 100 also
can include illustrated numerals (e.g., "1" and "2") along with
directional indicators (e.g., arrows"), which in the illustrated
variation are on the cap 110. The numerals can provide instructions
as to the sequence of operations for rotation of the cap 110. For
example, the depicted indicators show that the first operation is
rotation of the cap (via the "1") and removal of the cap (via the
"2").
[0066] FIG. 6E illustrates the assembly of FIG. 6A with the cap 110
and body 200 removed to demonstrate the interaction between the
dilator hub 154 and the needle hub 174. In the example illustrated
by FIG. 6E, the biasing element (shown in FIG. 6B) urges the needle
hub 174 in a proximal direction (away from the catheter 130.
However, the protrusions or catch feature 176 engages a side of the
slotted opening 162, which prevents the dilator from moving
proximally. This engagement between the catch 176 and the slotted
opening 162 allows for the spacing (or low stress state) between
the stop material 182 and the punch 202 (as shown in FIG. 6B). It
is also noted that when the device assembly is in the unloaded
configuration, a sharp distal tip of the needle can optionally
extend beyond a distal end of the catheter and/or dilator.
[0067] FIGS. 7A to 7E are intended to show a variation of a needle
assembly 100 actuated to a loaded or ready configuration. Again,
this example shows the optional use of a cap 110 as well as other
features. As shown in FIG. 7A, rotation of cap 110 in direction 10
causes rotation of the dilator hub 154 (not shown in FIG. 7A) via
engagement of protrusion 158 with a slot/groove 112 in cap 110.
Rotation 10 causes alignment of alignment feature 210 with
protrusion 158 in the slot/groove 112 of the cap 110. This permits
removal of the cap 110 from the device assembly 100. In alternate
variations, the dilator hub, sheath hub, or first hub can be
rotated without the use of a cap.
[0068] FIG. 7B illustrates the assembly 100 of FIG. 7A with the cap
removed as well as with the housing 200 removed to illustrate the
interaction of the various components. As shown, rotation of the
dilator hub 154 causes locking feature 206 to engage with locking
surface 156 of the dilator hub 154. This prevents further rotation
(in either direction) of the dilator hub 154. Rotation of dilator
hub 154 also causes the protrusion or catch feature 176 of the
needle hub 174 to move along the tapered surface 164 of the slotted
opening 162 in dilator hub 154 such that the protrusion or catch
feature 176 no longer prevents proximal movement of the needle hub
174. FIG. 7C illustrates a partial cross sectional view of the
dilator hub 154, needle hub 174, and housing 200 after rotation 10.
As shown, the proximal movement of the needle hub 174 causes stop
material 182 to engage the projection 202 such that the interaction
between the stop material 182 and the projection 202 prevents
further movement of the needle hub 174. This state represents a
high stress or loaded state of the stop material 182.
[0069] FIG. 7D illustrates a view of the device assembly 100 after
the rotation 10 shown in FIG. 7A with the cap removed. As shown,
the protrusion 158 on the dilator hub 154 is aligned with the
alignment feature 210 of the housing 200. In addition, the locking
member 206 engages the locking surface of the dilator hub 154. FIG.
7E illustrates a magnified view of box 7E from FIG. 7D. As shown,
in the ready or loaded configuration, a distal tip of the needle
cannula 172 extends beyond a tip of the dilator tubing 158, which
extends beyond a tip of the catheter tubing 132 allowing the device
assembly 100 to be ready for use. Once inserted into a vessel blood
flow 20 enters a lumen of the needle cannula 172.
[0070] As blood or other fluid flow 20 enters the needle cannula
172 it ultimately enters a chamber 180 in the dilator hub 174 that
is in fluid communication with the stop material, this causes the
stop material to lose structural integrity causing the needle hub
174 to move proximally relative to the projection 202 resulting
from the biasing element 120 driving the needle hub 174 rearward as
shown in FIG. 8A.
[0071] FIG. 8B illustrates the condition where the device assembly
is inserted into a vessel 1 after being activated in the loaded
configuration. The flow of liquid 20 within the vessel 1 causes
retraction of the needle hub as discussed above. FIG. 8C
illustrates a magnified view of box 8C in FIG. 8B, as shown, the
rearward movement of the needle hub causes the needle cannula 172
to retract within the dilator tubing 152 and/or the catheter tubing
132.
[0072] FIG. 9A illustrates an additional optional feature for use
with the device assembly 100 described herein. In this example, the
housing 200 can include a manual retraction component 208. In the
illustrated variation, the retraction component comprises a sliding
arm 208 that is slidable with respect to the housing 200 and, as
shown in FIG. 9B, engages the protrusion or catch feature 176 of
the needle hub 174. Proximal movement of the slider arm 208 causes
proximal movement of the needle hub 174 to ensure that the needle
tip retracts within the dilator. The operation of the slider arm
208 can serve as a confirmation that the needle is retracted or can
be used as an added safety measure. Once retraction of the needle
occurs or is confirmed, FIG. 9C illustrates removal of the dilator
150 from the catheter 130, which can remain inserted within the
target vessel or area.
[0073] FIG. 10 illustrates a variation for use with the needle
assembly described herein. In this variation, the dilator 158 tip
is tapered to approximate a taper of a beveled needle 172 tip. In
some situations, a needle tip can penetrate the vessel cause fluid
flow but prior to full insertion of the dilator tip, which might be
proximally staggered from the needle tip. The tapering of the
dilator as shown increases the probability that the dilator enters
the penetrated vessel with the beveled needle tip. As illustrated,
the dilator tip can be rounded as well as non-rounded.
[0074] FIGS. 11A-11C illustrate an improved valve for use with
catheters, including a catheter as described above. Typically, such
a catheter 130 is used a male luer (as described in FIGS. 12A-12C
below). 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 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.
[0075] As shown in FIG. 11B, 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.
[0076] FIG. 11C 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.)
[0077] FIGS. 12A-12C show a cross sectional view of a catheter
valve assembly 130 to demonstrate an example of a luer fitting 50
being inserted into the valve 190 of the catheter assembly 130. The
figures do not show male or female threading on either the luer
fitting 50 or catheter hub 134 for purposes of clarity in showing
the interaction between a male luer 52 of the luer fitting 50 and
the catheter 130.
[0078] FIG. 12A illustrates insertion of a male luer 52 having a
taper into the cavity of the valve 190. As shown in FIG. 12B, as
the surface of the male luer 52 engages the wall portion 196, the
wall portion 196 is compressed against a surface of the catheter
chamber 140. As the male luer 52 advances, the slit 194 of the
valve 190 opens in a distal direction. Ultimately, as shown in FIG.
12C, insertion of the male luer 52 into the cavity of the valve 190
causes the distal end of the male luer 52 to open the slit, while
the lateral surface of the male luer 52 engages the wall portion
196 of the valve 190 causing the wall portion 196 to engage an
interior surface of the chamber 140. The connector portion 54 of
the luer fitting 50 engages the flange portion 198 against the
proximal surface 138 of the catheter hub 134. Removal of the luer
fitting 50 from the catheter hub 134 causes the leaflets 197 of the
valve formed by the slit to return to a closed configuration.
[0079] 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.
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