U.S. patent application number 17/395825 was filed with the patent office on 2021-11-25 for vascular access site management system.
The applicant listed for this patent is NP Medical Inc.. Invention is credited to Todd Chelak, John Damarati, Nicholas Dennis, Nicholas Illsley.
Application Number | 20210361922 17/395825 |
Document ID | / |
Family ID | 1000005764445 |
Filed Date | 2021-11-25 |
United States Patent
Application |
20210361922 |
Kind Code |
A1 |
Chelak; Todd ; et
al. |
November 25, 2021 |
VASCULAR ACCESS SITE MANAGEMENT SYSTEM
Abstract
A vascular access site management system includes a
stabilization body and a flow housing that is rotatable relative to
the stabilization body. The flow housing may have a flow path
extending through it to allow fluids to be introduced into or
extracted from a patient via a catheter connected to the vascular
access site management system. The vascular access site management
system may also include a needle free connector fluidly connected
to the flow housing via a section of tubing.
Inventors: |
Chelak; Todd; (Westborough,
MA) ; Damarati; John; (Marlborough, MA) ;
Dennis; Nicholas; (Sterling, MA) ; Illsley;
Nicholas; (Sterling, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NP Medical Inc. |
Clinton |
MA |
US |
|
|
Family ID: |
1000005764445 |
Appl. No.: |
17/395825 |
Filed: |
August 6, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16298175 |
Mar 11, 2019 |
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17395825 |
|
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62641649 |
Mar 12, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2039/0273 20130101;
A61M 2039/027 20130101; A61M 2039/0282 20130101; A61M 39/0247
20130101; A61M 2039/0036 20130101; A61M 2039/0258 20130101; A61M
2039/0261 20130101; A61M 39/10 20130101; A61M 2025/028 20130101;
A61M 25/02 20130101 |
International
Class: |
A61M 39/02 20060101
A61M039/02; A61M 39/10 20060101 A61M039/10; A61M 25/02 20060101
A61M025/02 |
Claims
1. A vascular access site management system for transfer of fluid
to and/or from a patient, the vascular access site management
system comprising: a stabilization body having a first portion and
a base portion, the first portion having a connector configured to
connect to a vascular access device inserted into the patient's
vasculature, the first portion having an inlet and an outlet and an
internal fluid path extending through at least a portion of the
stabilization body and between the inlet and outlet, the base
portion having a stabilization surface located on an underside of
the base portion and configured to stabilize the vascular access
site management system when placed upon the patient, the base
portion extending from the first portion; a flow portion moveably
secured to the stabilization body, the flow portion being moveable
relative to the stabilization body and between a first position and
at least a second position, the flow portion having a flow path
extending at least partially there through and a flow portion
outlet; and a valve mechanism located between the flow portion
outlet and the inlet of the internal fluid path, the valve
mechanism being in an open mode to allow fluid flow between the
flow path and the internal fluid path when the flow portion is in
the first position, the valve mechanism being in a closed mode to
prevent fluid flow between the flow path and the internal fluid
path when the flow portion is in the second position, wherein the
stabilization surface is configured to remain adjacent to the
patient during connection of the connector to the vascular access
device and/or movement of the flow portion between the first
position and the second position, thereby restricting movement of
the vascular access device relative to the patient.
2. A vascular access site management system according to claim 1,
wherein the connector includes a cannula configured to connect to
the vascular access device.
3. A vascular access site management system according to claim 2,
wherein the cannula is a male luer connector.
4. A vascular access site management system according to claim 1,
further comprising a locking mechanism configured to lock the flow
portion in the first position and/or the second position.
5. A vascular access site management system according to claim 1,
further comprising a protrusion located on the flow portion and a
detent located on the stabilization body, the protrusion located
within the detent at least when the flow portion is in the first
and/or second position.
6. A vascular access site management system according to claim 5,
wherein the protrusion and detent are configured to lock the flow
portion in the first and/or second position.
7. A vascular access site management system according to claim 1,
further comprising a protrusion located on the stabilization body
and a detent located on the flow portion, the protrusion located
within the detent at least when the flow portion is in the first
and/or second position.
8. A vascular access site management system according to claim 7,
wherein the protrusion and detent are configured to lock the flow
portion in the first and/or second position.
9. A vascular access site management system according to claim 1,
wherein the connector includes at least one locking arm configured
to secure the vascular access site management system to the
vascular access device.
10. A vascular access site management system according to claim 1,
wherein the stabilization surface is oriented at an angle with
respect to the fluid path.
11. A vascular access site management system for transfer of fluid
to and/or from a patient, the vascular access site management
system comprising: a stabilization body having a first portion and
a base portion, the first portion having a connector configured to
connect to a vascular access device inserted into the patient's
vasculature, the first portion having an inlet and an outlet and an
internal fluid path extending through at least a portion of the
stabilization body and between the inlet and outlet, the base
portion having a stabilization surface located on an underside of
the base portion and configured to stabilize the vascular access
site management system when placed upon the patient, the base
portion extending from the first portion; and a flow portion
moveably secured to the stabilization body, the flow portion
moveable relative to the stabilization body between a first
position and at least a second position, the flow portion having a
flow path extending at least partially there through and a flow
portion outlet, the flow portion outlet in fluid communication with
the internal fluid path when the flow portion is in the first
position to allow fluid flow between the flow path and the internal
fluid path, the flow portion outlet fluidly disconnected from the
internal fluid path when the flow portion is in the second position
to prevent fluid flow between the flow path and the internal fluid
path, wherein the stabilization surface is configured to remain
adjacent to the patient during connection of the connector to the
vascular access device and/or movement of the flow portion between
the first position and the second position, thereby restricting
movement of the vascular access device relative to the patient.
12. A vascular access site management system according to claim 11,
wherein the connector includes a cannula configured to connect to
the vascular access device.
13. A vascular access site management system according to claim 12,
wherein the cannula is a male luer connector.
14. A vascular access site management system according to claim 11,
further comprising a locking mechanism configured to lock the flow
portion in the first position and/or the second position.
15. A vascular access site management system according to claim 11,
further comprising a protrusion located on the flow portion and a
detent located on the stabilization body, the protrusion located
within the detent at least when the flow portion is in the first
and/or second position.
16. A vascular access site management system according to claim 15,
wherein the protrusion and detent are configured to lock the flow
portion in the first and/or second position.
17. A vascular access site management system according to claim 11,
further comprising a protrusion located on the stabilization body
and a detent located on the flow portion, the protrusion located
within the detent at least when the flow portion is in the first
and/or second position.
18. A vascular access site management system according to claim 17,
wherein the protrusion and detent are configured to lock the flow
portion in the first and/or second position.
19. A vascular access site management system according to claim 11,
wherein the connector includes at least one locking arm configured
to secure the vascular access site management system to the
vascular access device.
20. A vascular access site management system according to claim 11,
wherein the stabilization surface is oriented at an angle with
respect to the fluid path.
Description
PRIORITY
[0001] This application is a continuation of and claims priority
from co-pending U.S. application Ser. No. 16/298,175, filed Mar.
11, 2019, entitled "Vascular Access Site Management System,"
assigned attorney docket number 130974-04503, and naming Todd
Chelak, John Damarati, Nicholas Dennis and Nicholas Illsley as
inventors, the disclosure of which is incorporated herein, in its
entirety, by reference
[0002] U.S. application Ser. No. 16/298,175, in turn, claims
priority from U.S. Provisional Application No. 62/641,649 filed
Mar. 12, 2018, entitled "Vascular Access Site Management System,"
assigned attorney docket number 130974-04501 (formerly 1600/A45),
and naming Todd Chelak, John Damarati, Nicholas Dennis and Nicholas
Illsley as inventors, the disclosure of which is incorporated
herein, in its entirety, by reference.
RELATED UNITED STATES APPLICATIONS
[0003] This patent application is related to U.S. patent
application Ser. No. 16/298,501 entitled "Vascular Access Site
Management System," filed on Mar. 11, 2019, assigned attorney
docket number 130974-04502, now U.S. Pat. No. 11,013,902, and
naming Todd Chelak, John Damarati, Nicholas Dennis and Nicholas
Illsley as inventors, the disclosure of which is incorporated
herein, in its entirety, by reference.
TECHNICAL FIELD
[0004] The present invention relates to vascular access sites, and
more particularly to devices and systems that manage a vascular
access site inclusive of an associated indwelling catheter such as
a peripheral intravenous (IV) catheter.
BACKGROUND ART
[0005] In instances in which a patient will need regular
administration of fluid or medications (or regular withdrawal of
fluids/blood), catheters are often inserted into the patient and
used to administer the fluids/medications. The catheter may remain
in the patient for extended periods of time (several hours to
several days or longer). Additionally, an extension tube may be
connected to the catheter to facilitate use of the catheter and
connection of a medical implement (e.g., a syringe). To ensure that
the catheter and/or extension tube remain in place and are not
accidentally removed, some prior art systems secure the catheter
and/or extension tube to the patient using tape or similar adhesive
materials (e.g., a film dressing).
[0006] Tapes and adhesive film dressings can be problematic in that
they may not firmly secure the catheter in place, which can lead to
local trauma to the vein and a medical condition referred to as
phlebitis requiring removal of the catheter. Additionally, in some
instances, the manner in which the tape is applied and the
positioning/location of the catheter and/or extension tube may
cause the catheter and/or extension tube to be bent. This, in turn,
increases the risk of kinking (which can reduce/stop flow through
the catheter and/or extension tube) and makes it more difficult to
connect the medical implement required to introduce the
fluid/medication.
[0007] Other prior art systems attempt to manage the extension set
tubing and include various ways to secure the indwelling IV
catheter during the final stages of placement. However, these
systems either require cumbersome manipulation of the tubing to fit
a desired "J-loop" configuration or present a "hard-wired"
configuration that may not adapt to the available space surrounding
the insertion site. Additionally, the structure used to secure the
catheter to the patient is often a separate component that requires
maneuvering of several pieces to reach a final state of deployment.
This further burdens the clinician's time and skill level.
SUMMARY OF THE INVENTION
[0008] In accordance with one embodiment of the invention, a
vascular access site management system for transfer of fluid to
and/or from a patient has a stabilization body and a flow housing.
The stabilization body may have an inlet, an outlet (e.g., a male
luer that may connect to a catheter) configured to be connected to
a vascular access device, and an internal fluid path extending
through at least a portion the stabilization body and between the
inlet and outlet. The stabilization body may also have a
stabilization surface located on an underside of the stabilization
body to stabilize the vascular access site when on the patient. The
flow housing may have a sleeve portion and a pathway portion
extending from the sleeve portion. The pathway portion may have a
flow path extending through at least a portion of it. The sleeve
portion may be rotatably coupled to the stabilization body such
that the flow housing is rotatable with respect to the
stabilization body. The stabilization base may be oriented at an
angle (e.g., between 5 and 10 degrees) with respect to a
longitudinal axis of the outlet.
[0009] In some embodiments, the flow housing may be able to rotate
relative to the stabilization body between a first position and at
least a second position. The flow path may be fluidly disconnected
from the inlet of the stabilization body when in the first portion,
and fluidly connected to the inlet of the stabilization body when
in the second position. The system may also include an o-ring
located between a portion of the stabilization body and a portion
of the flow housing.
[0010] On the underside of the stabilization surface, the system
may have a first securement portion that secures the vascular
access site management system to the patient. The system may also
have a second securement portion located on a portion of the
underside of the stabilization surface. The second securement
portion may further secure the vascular access site management
system to the patient. The first securement portion may have a
first tack adhesive and the second securement portion may have a
second tack adhesive. The second tack adhesive may be stronger than
the first tack adhesive. The first securement portion may have a
first liner covering the first tack adhesive and the second
securement portion may have a second liner covering the second tack
adhesive. The liners may be removed prior to securing the vascular
access site management system to the patient. Additionally or
alternatively the first securement portion may include a gripping
and/or conforming structure.
[0011] In further embodiments, the system may have a valve
mechanism located in the fluid path. The valve mechanism
selectively prevents and allows fluid flow through the internal
fluid path. The stabilization body may have an inlet body and an
outlet body and the valve mechanism may be positioned between the
inlet body and outlet body. The valve mechanism may be a two way
pressure activated valve that deforms in the presence of a forward
pressure within the internal fluid path (e.g., to allow fluid flow
around the valve mechanism from the inlet to the outlet). To help
support the valve mechanism within the stabilization body, the
outlet body may have a plurality of support arms. The valve
mechanism may deform over the support arms in the presence of the
forward pressure. Additionally or alternatively, the valve
mechanism may include a slit extending through it. The slit may
open in the presence of a back pressure within the internal fluid
path to allow fluid flow through the slit and from the outlet to
the inlet. Additionally or alternatively, the pressure required to
open the slit may be above the venous pressure of the patient.
[0012] In additional embodiments, the system may have a tube with a
first end that is fluidly connected to the flow path of the pathway
portion and a second end. The device may also have a female luer
connector located at the second end of the tube. Alternatively, the
inlet of the flow path within the pathway portion may fluidly
connect to a medical implement.
[0013] To reduce pressure over a vein of the patient, the
stabilization body may include a vein relief zone. The vein relief
zone may have an adhesive portion that lifts the patient's skin
when the vascular access site management system is on the patient.
The relief zone may be axially aligned with the outlet of the
stabilization body. In some embodiments, the stabilization body may
have a protrusion extending from a surface of the stabilization
body, and the flow housing may have a recess. The recess may snap
over the protrusion such that the protrusion enters the recess to
axially secure the flow housing to the stabilization base.
[0014] In accordance with further embodiments, a method for
managing a vascular access site for transfer of fluid to and/or
from a patient includes providing a vascular access site management
system. The system may include a stabilization body and a flow
housing. The stabilization body may include an inlet, an outlet,
and an internal fluid path extending through a portion the
stabilization body and between the inlet and outlet. The
stabilization body may also have a stabilization surface located on
an underside of the stabilization body. The flow housing may have a
sleeve portion and a pathway portion extending from the sleeve
portion. The pathway portion has a flow path extending through a
portion it. The sleeve portion may be rotatably coupled to the
stabilization body such that the flow housing is rotatable with
respect to the stabilization body.
[0015] The method may also include connecting the outlet of the
stabilization body to a vascular access device, and placing the
stabilization body on the patient. The stabilization surface may
stabilize the vascular access site management system on the
patient. Once on the patient, the method may then rotate the sleeve
portion of the flow housing relative to the stabilization body to a
second position. The flow path in the pathway portion may be
fluidly disconnected from the inlet of the stabilization body when
in the first portion, and fluidly connected to the inlet of the
stabilization body when in the second position.
[0016] In some embodiments, the system may include a valve
mechanism located in the fluid path. The valve mechanism may have a
slit through it and may selectively prevent and allow fluid flow
through the internal fluid path. For example, the valve mechanism
may deform in the presence of a forward pressure within the
internal fluid path to allow fluid flow around the valve mechanism
from the inlet to the outlet. Additionally or alternatively, the
slit may open in the presence of a back pressure within the
internal fluid path to allow fluid flow through the slit and from
the outlet to the inlet. The vascular access site management system
may have a first and second securement portion located on the
underside of the stabilization surface. The first and second
securement portions may secure the vascular access site management
system to the patient.
[0017] In accordance with further embodiments, a vascular access
site management system includes a stabilization body having a base,
and an upper portion having a first end configured to be connected
to a vascular access device and a second end configured to receive
a medical implement. The stabilization body may also have a flow
path connecting the first end and the second end along a
substantially linear pathway. At the second end, the device may
have a port that may connect with the medical implement. The
medical implement may have a distal tip and a passage extending
through a portion of the medical implement to the distal tip. The
passage allows a medical article to pass through the medical
implement. A valve mechanism may be located within the flow path to
selectively prevent and allow fluid flow through the flow path. The
base may be oriented at an angle (e.g., between 5 and 10 degrees)
with respect to an outlet of the system.
[0018] The device may also have a first engagement element located
on a surface of the vascular access site management system. The
first engagement element may engage with a second engagement
element located on the medical implement to couple the medical
implement with the vascular access site management system and
position the distal tip at a predetermined longitudinal position in
the flow path (e.g., when coupled to the vascular access site
management system). The distal tip may interact with the valve
mechanism when in the predetermined longitudinal position to allow
passage of the medical article into the vascular access site
management system. For example, the distal tip of the medical
implement may at least partially open the valve mechanism when in
the predetermined longitudinal position. In some embodiments, the
valve mechanism may be supported in the vascular access site
management system such that the longitudinal movement of an outer
portion of the slit toward the first end is minimized.
[0019] In some embodiments, the valve mechanism may be a two way
pressure activated valve. In such embodiments, the valve mechanism
may deform in the presence of a forward pressure within the flow
path to allow fluid flow around the valve mechanism from the inlet
to the outlet. The upper portion may have a plurality of support
arms that support the valve mechanism within the flow housing and
the valve mechanism may deform over the support arms in the
presence of the forward pressure.
[0020] The valve mechanism may have a slit extending through it.
The slit may open in the presence of a back pressure within the
flow path to allow fluid flow through the slit and toward the
second end. The back pressure required to open the slit may be
above a venous pressure of the patient, and/or the distal tip of
the medical implement may partially open the slit when in the
predetermined longitudinal position.
[0021] The first engagement element may include at least one
protrusion and the second engagement element may include at least
one recess. The protrusion(s) may enter the recess(es) when the
medical implement is connected to the vascular access site
management system. Additionally or alternatively, the first
engagement element may include at least one recess and the second
engagement element may include at least one protrusion. Similarly,
the at least one protrusion may enter the at least one recess when
the medical implement is connected to the vascular access site
management system. The medical implement may have at least one
flexible arm, and the second engagement element may be on the at
least one flexible arm.
[0022] In further embodiments, the vascular access site management
system may include a septum located within the port. The septum
normally obstructs the port, and at least a portion of the medical
implement may extend through the septum when connected to the
vascular access site management system. For example, the septum may
include a slit extending through it, and the distal tip of the
medical implement may open and extend through the slit when the
medical implement is connected to the vascular access site
management system.
[0023] Additional embodiments of the vascular access site
management system may have a flow housing with a sleeve portion and
a pathway portion extending from the sleeve portion. The pathway
portion may have a fluid path extending through at least a portion
of the pathway portion, and the sleeve portion may be rotatably
coupled to the upper portion of the stabilization body such that
the flow housing is rotatable with respect to the stabilization
body. The flow housing may rotate with respect to the stabilization
body between a first position, a second position and, perhaps, a
third position. The fluid path may be in fluid communication with
the flow path of the upper portion when the sleeve portion is in
the first position and/or the third position, and fluidly
disconnected when in the second position. The upper portion may
have a first and second hole extending through a wall of the upper
portion. The first hole may fluidly connect the fluid path and the
flow path when the sleeve portion is in the first position, and the
second hole may fluidly connect the fluid path and the flow path
when the sleeve portion is in the third position.
[0024] Further embodiments may include a tube having a first end
and a second end. The first end may be fluidly connected to an
inlet of the vascular access site management system and/or there
may be a needle free connector located at the second end of the
tube. The upper portion may include a male luer lock connector that
may be connected to a catheter/or alternatively an access device
such as a needleless connector. Additionally or alternatively, the
upper portion may have a contact surface within the flow path. The
contact surface may contact an outer surface of the medical
implement during connection of the medical implement to prevent
further longitudinal movement of the distal tip within the flow
path and/or radially align the distal tip with the flow path. The
upper portion may also have a crushable or deformable guide rib
within the flow path to keep the distal tip concentric within the
flow path during connection of the medical implement.
[0025] In accordance with additional embodiments, a method for
managing a vascular access site and introducing a medical article
includes providing a vascular access site management system with a
stabilization body having a base, an upper portion with a first end
and a second end, and a flow path connecting the first end and the
second end along a substantially linear pathway. The system may
also include (1) a port located at the second end of the upper
portion of the stabilization body, (2) a valve mechanism located
within the flow path that selectively prevents and allows fluid
flow through the flow path, and (3) a first engagement element
located on a surface of the vascular access site management system.
The method may also include connecting a vascular access device to
the first end of the upper portion and connecting a medical
implement to the port at the second end of the upper portion.
During connection, the first engagement element may engage with a
second engagement element located on the medical implement. The
medical implement may have distal tip and a passage extending
through a portion of the medical implement to the distal tip. The
distal tip may be positioned at a predetermined longitudinal
position in the flow path and may interact with the valve mechanism
when the first engagement element is engaged with the second
engagement element. The method may then pass a medical article
through the passage of the medical implement and into the vascular
access site management system. The distal tip of the medical
implement may partially open the valve mechanism (e.g., a slit
within the valve mechanism) when in the predetermined longitudinal
position.
[0026] In some embodiments, the method may also include fluidly
connecting a second medical implement to an inlet of the system,
and transferring fluid through the vascular access site management
system, The pressure applied to the valve mechanism by the fluid
may deform the valve mechanism to allow fluid flow around the valve
mechanism from the inlet to the outlet. Additionally or
alternatively, the vascular access site management system may also
include a flow housing having a sleeve portion and a pathway
portion extending from the sleeve portion. The pathway portion may
have a fluid path extending through at least a portion of the
pathway portion, and the sleeve portion may be rotatably coupled to
the upper portion of the stabilization body. In such embodiments,
the method may also include rotating the flow housing from a first
position to a second position. The fluid path may be in fluid
communication with the flow path of the upper portion when the flow
housing is in the second position, and fluidly disconnected when in
the first position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The foregoing features of embodiments will be more readily
understood by reference to the following detailed description,
taken with reference to the accompanying drawings, in which:
[0028] FIGS. 1A-1B schematically show various views of a vascular
access site management system in an undeployed state, in accordance
with various embodiments of the present invention.
[0029] FIGS. 1C-1D schematically show various views of a vascular
access site management system in a deployed state, in accordance
with various embodiments of the present invention.
[0030] FIG. 2 schematically shows an exploded view of the vascular
access site management system shown in FIGS. 1A-1D, in accordance
with some embodiments of the present invention.
[0031] FIG. 3 schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 1A-1D, in
accordance with some embodiments of the present invention.
[0032] FIG. 4A-4D schematically show a camming mechanism within the
vascular access site management system shown in FIGS. 1A-1D, in
accordance with some embodiments of the present invention.
[0033] FIG. 5A schematically shows an alternative embodiment of a
vascular access site management system in a closed mode, in
accordance with some embodiments of the present invention.
[0034] FIG. 5B schematically shows the alternative embodiment of a
vascular access site management system shown in FIG. 5A in an open
mode, in accordance with some embodiments of the present
invention.
[0035] FIG. 5C schematically shows an exploded view of the
alternative embodiment of a vascular access site management system
shown in FIG. 5A, in accordance with some embodiments of the
present invention.
[0036] FIG. 5D schematically shows a cross-sectional view of the
alternative embodiment of a vascular access site management system
shown in FIG. 5A in the closed mode, in accordance with some
embodiments of the present invention.
[0037] FIG. 5E schematically shows a cross-sectional view of the
alternative embodiment of a vascular access site management system
shown in FIG. 5A in the open mode, in accordance with some
embodiments of the present invention.
[0038] FIG. 6A schematically shows a further alternative embodiment
of a vascular access site management system, in accordance with
some embodiments of the present invention.
[0039] FIG. 6B schematically shows the alternative embodiment of a
vascular access site management system shown in FIG. 6A in a first
deployed position, in accordance with some embodiments of the
present invention.
[0040] FIG. 6C schematically shows the alternative embodiment of a
vascular access site management system shown in FIG. 6A in a second
deployed position, in accordance with some embodiments of the
present invention.
[0041] FIG. 6D schematically shows a cross-sectional view of the
flow housing of the alternative embodiment of a vascular access
site management system shown in FIG. 6A, in accordance with some
embodiments of the present invention.
[0042] FIG. 6E schematically shows a cross-sectional view of the
alternative embodiment of a vascular access site management system
shown in FIG. 6A, in accordance with some embodiments of the
present invention.
[0043] FIGS. 7A-7D schematically show an additional embodiment of a
vascular access site management system in a first position, in
accordance with further embodiments of the present invention.
[0044] FIGS. 8A-8C schematically show the vascular access site
management system of FIGS. 7A-7D in a second position, in
accordance with further embodiments of the present invention.
[0045] FIGS. 9A-9C schematically show the vascular access site
management system of FIGS. 7A-7D in a third position, in accordance
with further embodiments of the present invention.
[0046] FIG. 10A schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 7A-7D with a
valve mechanism in the closed mode, in accordance with additional
embodiments of the present inventions.
[0047] FIG. 10B schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 7A-7D with a
valve mechanism in an open mode for retrograde flow, in accordance
with additional embodiments of the present inventions.
[0048] FIG. 11 schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 7A-7D with a
medical implement connected to the vascular access site management
system, in accordance with additional embodiments of the present
inventions.
[0049] FIGS. 12A-12D schematically show an additional embodiment of
a vascular access site management system in a first position, in
accordance with further embodiments of the present invention.
[0050] FIGS. 13A-13D schematically show the vascular access site
management system of FIGS. 12A-12D in a second position, in
accordance with further embodiments of the present invention.
[0051] FIGS. 14A-14D schematically show the vascular access site
management system of FIGS. 12A-12D in a third position, in
accordance with further embodiments of the present invention.
[0052] FIG. 15 schematically shows an exploded view of the vascular
access site management system of FIGS. 12A-12D, in accordance with
some embodiments of the present invention.
[0053] FIG. 16A schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 12A-12D with
a valve mechanism in the closed mode, in accordance with additional
embodiments of the present inventions.
[0054] FIG. 16B schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 12A-12D with
a valve mechanism in an open mode for retrograde flow, in
accordance with additional embodiments of the present
inventions.
[0055] FIG. 16C schematically shows a cross-sectional view of the
vascular access site management system shown in FIGS. 12A-12D with
a valve mechanism in an open mode for forward flow, in accordance
with additional embodiments of the present inventions.
[0056] FIGS. 17A-17C schematically show the vascular access site
management system of FIGS. 12A-12D with a vein relief area, in
accordance with some embodiments of the present invention.
[0057] FIG. 18 schematically shows an additional embodiment of a
vascular access site management system with an alternate base
direction, in accordance with further embodiments of the present
invention.
[0058] FIGS. 19A-19D schematically show an alternative embodiment
of a locking mechanism for locking the vascular access site
management system to the catheter, in accordance with some
embodiments of the present invention.
[0059] FIGS. 20A-20D schematically show an additional alternative
embodiment of a locking mechanism for locking the vascular access
site management system to the catheter, in accordance with some
embodiments of the present invention.
[0060] FIGS. 21A-21D schematically show a further alternative
embodiment of a locking mechanism for locking the vascular access
site management system to the catheter, in accordance with some
embodiments of the present invention.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0061] In illustrative embodiments, a vascular access site
management system includes a stabilization body and a flow housing
that is rotatable relative to the stabilization body. The flow
housing may have a flow path extending through it to allow fluids
to be introduced to or extracted from a patient via a catheter
connected to the vascular access site management system.
Additionally, in some embodiments, the vascular access site
management system may include a needle free connector or other
medical connector fluidly connected to the flow housing via a
section of tubing. Details of illustrative embodiments are
discussed below.
[0062] FIGS. 1A-1D schematically show a vascular access site
management system 100 in both an undeployed state (FIGS. 1A and 1B)
and a deployed state (FIGS. 1C and 1D), in accordance with some
embodiments of the present invention. FIG. 2 shows an exploded view
of the vascular access site management system 100. The management
system 100 may include a stabilization base 110 (e.g., an adherent
substrate) that may be secured to the patient to hold the
management system 100 in place during use. More specifically, the
stabilization base 110 may include one or more adhesive layers on
its underside to secure the management system 100 to the patient.
For example, as discussed in greater detail below, the
stabilization base may include two sections of adhesive (FIG. 2).
The first section 112 may be a light tack adhesive that allows the
user to position and re-position the management system 100 as
needed. The second section of adhesive 114 may be stronger adhesive
that allows the user to firmly secure management system 100 once
the system 100 is in place.
[0063] The locations of the adhesive sections 112/114 may vary
depending on the application. For example, in some embodiments, the
first section adhesive 112 may be located at the leading end (e.g.,
the end closed to the catheter) of the stabilization base 110 (see
FIG. 2), and the second section 114 of adhesive may be located on
the remainder of the underside of the stabilization base 110.
However, in other embodiments, the first section of adhesive 112
may be located at the trailing end of the stabilization base 110
(e.g., the end farthest from the catheter). Additionally or
alternatively, the stronger adhesive (e.g., the second section of
adhesive 114) may be located on the entire underside of the
stabilization base 110 and the first section of adhesive 112 may be
located on top of a portion of the stronger adhesive (e.g., one or
more areas on the underside of the stabilization base 110 will have
multiple layers of adhesive--a layer of stronger adhesive and a
layer of lighter tack adhesive on top of the stronger
adhesive).
[0064] To prevent the sections of adhesive 112/114 from
inadvertently sticking to the wrong surface and/or to prevent
bacteria and other contamination from sticking to the adhesive, the
stabilization base 110 may include one or more liners covering the
adhesive. Each of the liners may include a tab so that the liner
can be easily removed. For example, the stabilization base 110 can
include a first liner 111 for the first section of adhesive 112 and
a second liner 113 for the second section of adhesive 114.
Alternatively, a single liner may be used for both sections of
adhesive 112/114 or each section 112/114 may have multiple
liners.
[0065] Although any number of adhesives may be used to secure the
management system 100 to the patient, the adhesive used for the
first section 112 should be easily peelable (e.g., to allow the
user to reposition the device 100), but be able to resist shear
loads so that the weight of the device 100 and any attached medical
implements (e.g., a syringe) do not cause the device 100 to
inadvertently move or fall off. The adhesive used for the second
section 114 should be strong enough such that the stabilization
base 110 and the management system 100 do not peel off the
patient's skin during regular movement by the patient (e.g.,
manipulation of the hand, arm etc.).
[0066] In some instances, it may be beneficial for the
stabilization base 110 to be folded up prior to use/deployment (see
FIGS. 1A and 1B) such that a portion of the stabilization base 110
interfaces with the stabilization body 120 (or flow housing 140).
For example, the stabilization base 110 (or the liners 111/113) may
be bi-stable such that it is stable in either the folded up
position or in the folded down position (e.g., it will not revert
to the folded down position when it is folded up and vice versus).
Alternatively, the system 100 may include a mechanism that holds
that stabilization base 110 in the folded up position (e.g., the
body 120 may include a protrusion that extends through the base 110
when in the folded up configuration and prevents the base 110 from
returning to the folded down position).
[0067] As discussed in greater detail below, when the stabilization
base 110 is in the folded up position, the underside of the base
110 provides a surface on each side of the management system 100
where the user may grab and manipulate the device. To further
improve the user's ability to grip and manipulate the device 100,
the release liners 111/113, the adhesive 112/114, or the
stabilization base 110 may be a material that deforms in the
presence of a pressure such that it conforms to the user's fingers,
the shape of the stabilization body 120 and/or flow housing
140.
[0068] Located on and secured to the stabilization base 110, the
management system 100 has a stabilization body 120 with an opening
122 extending through it. For example, the stabilization body 120
may have a bottom portion 124 that is secured to the stabilization
base 110 and a proximally extending portion 126 that extends upward
from the bottom portion 124 and through which the opening 122
extends. The bottom portion 124 may be secured to the stabilization
base 110 in any number ways (e.g., via adhesive, ultrasonic
welding, bonding, etc.). In some embodiments, it may be beneficial
for the stabilization body 120 to conform to the patient. To that
end, the stabilization body 120 may include living hinges 121
(FIGS. 4A and 4B) that allow the bottom portion 124 of the
stabilization body 120 to flex (e.g., with respect to portion
126).
[0069] As mentioned above, the management system 100 may be
connected to a catheter 210 that has been inserted into the
patient. To that end, the stabilization body 120 may include a pair
of locking arms 130A/130B that extend from the body 120 and toward
the catheter 210. Each of the locking arms 130A/130B may have an
inwardly projection protrusion 132A/132B that engages with a luer
thread 212 on the catheter 210 to lock the catheter 210 in place.
For example, during connection of the catheter 210, the user may
push the management system 100 against the catheter 210 (while
holding the catheter 210 to ensure that it does not move) such that
the end of the catheter 210 and the luer thread 212 contact the
locking arms 130A/B. As additional force is applied by the user,
the locking arms 130A/B will begin to flex outward until the luer
thread 212 is located between the arms 130A/B, at which point the
arms 130A/B will snap back to their original position. Once the
arms 130A/B have "snapped" back, the protrusions 132A/B will engage
the luer thread 212 and lock the catheter 210 to the management
system 100.
[0070] As best shown in FIGS. 2 and 3, the management system 100
may also include a flow housing 140 that essentially acts as the
hub of the management system 100, and through which fluid being
transferred to/from the patient flows. The flow housing 140
includes a main housing 150 and a housing extension 160 that
extends outward from the main housing 150 and through the opening
122 in the stabilization body 120. At least a portion of the
housing extension 160 may be a male luer (e.g., male luer portion
164) that connects with the catheter 210 during use. The extension
160 and/or the opening 122 may be sized such that the extension 160
and, thus the flow housing 140 is free to rotate with respect to
stabilization body 120. Additionally, as discussed in greater
detail below, the extension 160 may have one or more protrusions
162 that interact with a camming surface on the stabilization body
120 to further secure the extension 160 (e.g., the male luer
portion 164) to the catheter 210.
[0071] The main housing 150 of the flow housing 140 may have a port
152 (e.g., an inlet) that fluidly connects to tubing 170 leading to
a needle free connector 180 (discussed in greater detail below).
Within the interior of the main housing 150, the flow housing 140
may have an internal fluid path 154 that extends through the body
of main housing 150/flow housing 140 and the extension 160. As
discussed in greater detail below, during use, fluid may flow
through the flow housing 140 as fluid is transferred to the
patient. It should be noted that, although much of the discussion
herein refers to the port 152 as an inlet, the port 152 also may be
used as an outlet. In other words, if fluid is to be drawn from the
patient (as opposed to transferred to the patient), the fluid may
flow into fluid path 154 via the extension 160 and male luer
connector 164, through the internal fluid path 154, and out of the
port 152.
[0072] In some instances the catheter 210 may extend out of the
patient at an angle (e.g., at a 7 degree angle with respect to the
patient). To reduce the forces/pressure on the catheter 210, make
it easier for the user to connect the catheter 210 to the device
100 and keep the fluid path 154 in line with the catheter 210, the
fluid path 154 (e.g., the portion extending through the housing
extension 160/male luer) may also be at an acute angle with respect
to the surface of the patient. To that end, as shown in FIG. 3, the
proximally extending portion 126 may not be perpendicular with
respect to the bottom portion 124 of the stabilization base.
Rather, it may be angled back slightly to create the acute angle
between the fluid path 154 and the surface of the patient's skin.
Additionally or alternatively, the portion of the fluid path 154
extending upward through the fluid housing 140 may be not be at a
right angle with respect to the portion that extends through the
extension 160.
[0073] To control fluid flow through the management system 100 and
the flow housing 140, the interior of the flow housing 140 may
include a valve mechanism 142 within the internal fluid path 154.
For example, the flow housing 140 may include a two-way pressure
activated valve 142 (PAV) that includes a flat diaphragm 143 with a
slit 144. Alternatively, at least a portion of the diaphragm 143
may have a curvature with the slit 144 positioned within the curved
portion. The valve mechanism 142 prevents fluid flow through the
flow housing 140 (e.g., through the internal fluid path 154) until
it is exposed to a large enough pressure to open the slit through
the diaphragm 143 (e.g., a cracking pressure). It is important to
note that a diaphragm 143 and slit 144 configuration should be
chosen such that the patient's venous pressure is below the
backward (i.e. proximally-directed) cracking pressure of the valve
mechanism 142 to prevent the venous pressure from opening the slit
144/pressure activated valve 142. Additionally, the
distally-directed cracking pressure may be different than the
proximally-directed cracking pressure.
[0074] Although a diaphragm 143 with a slit 144 may achieve the
functionality of a two-way pressure activated valve, other two-way
PAVs known in the art may also be used within the flow housing 140.
Additionally or alternatively, the flow housing 140 may include a
one-way PAV valve that only allows a one directional flow through
the flow housing 140 (e.g., from the port 152 and towards the
catheter 210). For example, in some embodiments, the diaphragm 143
may not have a slit 144 (e.g., it may be a solid diaphragm). In
such embodiments, the diaphragm may deform (e.g., it may deform
over a protrusion within the flow housing 140) in the presence of a
pressure within the flow housing 140 to open the internal fluid
path 154 and allow the fluid to flow past the diaphragm and through
the flow housing 140.
[0075] To secure the valve 142 within the flow housing, the device
100 may include a cap 145 that may be inserted to an open end of
the flow housing 140. The cap 145 may have a skirt 146 that extends
inward into the interior of the flow housing 140 and traps the
valve 142 between the skirt 146 and an inner wall of the flow
housing 140. To ensure that the fluid path 154 through the flow
housing 140 is not blocked, the cap 145 may include an opening 147
through the skirt 146. In some instances, connection and
disconnection of a medical implement to the needle-free connector
180 may cause a pressure increase and/or decrease within the flow
housing 140 (e.g., within the fluid path 154). To compensate for
these pressure changes and to help prevent blood from being pulled
into the fluid path 154 (e.g., past the valve 142), the cap 145 may
include a diaphragm or bellows (not shown) that deforms with the
changes in pressure. For example, if the pressure within the fluid
path 154 increases (e.g., due to connection of the medical
implement), the diaphragm or bellows may deform outward with
respect to the fluid path 154. Conversely, if the pressure within
the fluid path 154 decreases (e.g., upon disconnection of the
medical implement) the diaphragm or bellows may deform inward with
respect to the fluid path 154 (e.g., into the interior of the flow
housing 140).
[0076] As noted above, the extension 160 may have one or more
protrusions 162 that interact with a camming surface on the
stabilization body 120 to further secure the extension 160 (e.g.,
the male luer portion 164) to the catheter 210. For example, as
shown in FIGS. 4A-4D, the stabilization base 120 (e.g., in the
proximally extending portion 126) may have slots 310 that allow the
protrusions 162 on the extension 160 to pass through the
stabilization base 120 (e.g., when the flow housing 140 is in the
upright position shown in FIG. 2). The slots 310 provide a
diametric interference with the effective diameter of the
protrusions 162 such that they provide a one-way, snap-style
insertion of the flow housing 140 into the stabilization body 120.
This allows for proper initial positioning and capturing of the
protrusions 162 relative to the camming surfaces 128 on the
stabilization body 120.
[0077] Once in place, a camming surface 163 on the protrusions 162
will contact a camming surface 128 on the stabilization body 120.
Upon rotation of the flow housing 140 toward the deployed position
(see FIGS. 1C and 1B), the camming surface 163 on the protrusions
162 will slide along and advance up the camming surface 128 on the
stabilization body 120. This, in turn, will cause the flow housing
140 and extension 160 to move towards the catheter 210 such that
the male luer portion 164 of the extension 160 moves further into
the female luer of the catheter hub 214. In some embodiments, the
protrusions 162/lugs may travel into a detent within the
stabilization body 120 to lock the flow housing 140 in the
cammed/fully connected position. It is important note that, as
discussed above, the catheter 210 is restrained by the pair of
locking arms 130A/B and therefore is held in place as the male luer
portion 164 is connected.
[0078] As mentioned above, the vascular access site management
system 100 also includes a needle-free connector 180 that is
fluidly connected to the flow housing 140 via a tube 170. The
needle-free connector 180 (e.g., a medical valve) is connectable to
a medical implement and is used to control fluid flow to and from
the patient. Although any number of needle-free connectors 180 or
medical valves can be used (e.g., positive displacement valves,
negative displacement valves, neutral displacement valves, etc.),
some embodiments may use a simple split septum valve. As is known
in the art, a split septum valve includes a septum 182 obstructing
the inlet 184 of the valve 180. To allow flow through the valve
180, the septum 182 may include an aperture or a slit extending
through it. To that end, connection of the medical implement (e.g.,
a needleless syringe) to the valve 180 deforms the septum, thus
opening the aperture/slit. Once connected, the medical implement
may transfer fluid to/from the patient. In order to help reduce
potential kinking, the tube 170 may be pre-formed with the
arcuate/curved shape shown in the figures. For example, the tube
170 may be initially formed in this shape (e.g., prior to assembly)
or the tube 170 may take that curved shape during the sterilization
process after assembly.
[0079] During use, the user (e.g., the medical personnel) may first
connect a medical implement to the needle-free connector 180 and
flush (e.g., prime) the device 100, for example, with saline. Once
the device 100 is flushed/primed, the user may insert the catheter
210 into the patient (e.g., into the patient's arm). It is
important to note that prior to inserting the catheter 210, the
insertion site should be properly cleaned per acceptable medical
practice. Additionally, to preserve the injection site after
insertion of the catheter 210, the user may place gauze over the
injection site and the location where the management device 100
will be placed.
[0080] The user may then connect the catheter 210 to the management
device 100. When attaching the catheter 210 and securing the
stabilization device 100, the user may grab the stabilization body
120 (or the underside of the stabilization base 110 if it is folded
up) and press the device 100 against the catheter 120. As the user
presses the device 100 against the catheter 120, the locking arms
130A/B will begin to deform until the catheter 210 (e.g., the
thread 212 on the catheter hub 214) snaps into place. At this
point, the catheter 210 is, at least partially connected to the
male luer connector portion 164 on the extension 160. Once the
catheter 210 is attached, the user may then remove the liner 111 on
the first section 112 of adhesive and stick the stabilization base
110 to the patient.
[0081] Once the first section 112 of adhesive is adhered to the
patient, it is desirable to check that the fluid flow through the
system 100 and in the vein is acceptable/adequate. To that end, the
user may gently inject 1-2 ml of saline into the vein to confirm
adequate fluid flow. If the fluid flow is not adequate, the user
may adjust the positioning of the catheter 210 within the vein by
gently lifting the first section 112 of adhesive to release the
system 100 from the patient's skin, and move the catheter 210
forward into the vein while gently injecting another 1-2 ml of
saline solution. Once the flow is adequate, the user may, once
again, secure the system 100 to the patient's skin using the first
section 112 of adhesive. Additionally, if the user is satisfied
with the placement, the user may remove the liner 113 for the
second section 114 of adhesive to further secure the system 100 to
the patient.
[0082] After the vascular access site management system 100 is
secured (or re-secured) and there is adequate flow within the vein,
the user rotate the flow housing 140, tube 170 and needle-free
connector 180 to either the right or the left (e.g., from the
upright position to the position shown in FIG. 1C or 1D). As the
flow housing 140 is rotated, the camming action of the lug 162
camming surface 128 on the stabilization body 120 will cause the
flow housing 140 (including the extension 160 and male luer
connector portion 164) to move towards the catheter 210 and further
secure the male luer connector portion 164 and the catheter 210.
The user may then place a dressing over the connection site to
maintain the cleanliness and sterility of the connection and
connection site. It should be noted that, by allowing the user to
choose either a left or right configuration, embodiments of the
present invention allow the user to choose the best configuration
for the given application based, for example, the user's
preference, the amount of available space on either side of the
catheter 210, the location of the catheter 210, etc.
[0083] Once the system 100 is fully secured to the patient, the
catheter 210 cannot be inadvertently moved. Additionally, the
medical implement (e.g., the syringe) may be connected and
disconnected as needed without impacting the placement/location of
the catheter 210. This, in turn, helps to prevent injury to the
patient and ensures that adequate fluid flow through the device
100, catheter 210, and vein is maintained. Furthermore, because the
device 100 includes a needle-free connector 180, the medical
implement can be easily re-attached to the device 100 at a later
time to introduce fluids into the patient and/or withdraw fluids
from the patient.
[0084] It should be noted that, some embodiments of the present
invention may have various features that help the user
know/determine the distance from the system 100 to the tip of the
catheter 210 so that the user can determine when the tip of the
catheter 210 is located within the vein. For example, returning to
FIGS. 1C and 1D, the stabilization body 120 and/or the flow housing
140 may have a dressing deployment surface 220 on which the
dressing may be placed/secured and the edge of the dressing (not
shown) may be aligned with a line or a marking on the stabilization
body 120 or flow housing. Additionally, in such embodiments, the
dressing may have a series of graduations or a grid pattern that
corresponds to the length of the catheter 210. In this manner, when
the user applies the dressing such that it is aligned with the
line/marking, the user will be able to tell where in the vein the
end of the catheter 210 is by the graduations on the dressing. To
accommodate multiple types of catheters 210, the dressing may have
multiple sets of graduations that correspond to different types and
lengths of catheters 210.
[0085] Although the embodiments described above have a flow housing
140 with a main housing 150 and a housing extension 160 (with male
luer portion 164) that all rotate relative to the stabilization
body 120, other embodiments may have different rotational
configurations. For example, as shown in FIGS. 5A-5E, in some
embodiments, the vascular access site management system 400 may
have stabilization body 410 with a male luer connector 420
extending from one side of the stabilization body 410 (e.g., the
side facing the catheter 210) and a stabilization body extension
430 extending from the other side. Like the male luer portion 164
discussed above, the male luer connector 420 extending from the
stabilization body 410 connects to the catheter 210 during use.
Additionally, although not shown, the stabilization device can also
include a locking mechanism, for example, locking arms like those
described above to lock the catheter 210 to the device 400.
[0086] The stabilization body extension 430 may have one or more
holes 440 (e.g., opposing side holes) (FIG. 5C) that extend through
the wall of the stabilization body extension 430 and to the fluid
path 450 (FIG. 5D) extending through the stabilization body 410
(e.g., through both the stabilization body extension 430 and the
male luer connector 420). In some embodiments, the end of the
stabilization body extension 430 may be a female luer lock 460.
However, in other embodiments, the stabilization body extension 430
may have any other type of medical port or it may simply have a
closed end or a capped port. In embodiments having a closed end or
capped port, the stabilization body extension 430 may have a
diaphragm or bellows that flexes/deforms with changes in the
pressure, in a manner similar to that described above.
[0087] Located on the stabilization body extension 430, the device
400 may have a flow sleeve 470 having a flow portion 472 with a
fluid path 480 extending (FIG. 5D) through it, and a ring portion
474 that may snapped over (or otherwise secured) to the
stabilization body extension 430. The flow sleeve 470 is rotatable
with respect to the stabilization body extension 430 between a
closed mode and one of two open modes. For example, in the closed
mode, the flow portion may be in the vertical orientation (FIGS. 5A
and 5D) and the fluid path 480 within the flow portion 472 may be
fluidly disconnected from the holes 440 and the fluid path 450
extending through the stabilization body 410. During use, to
transition the flow sleeve 470 to the one of the open modes (FIGS.
5B and 5D), the user may rotate the flow sleeve 470 to the left or
right (depending on the user's preference and the configuration of
the catheter 210) until it reaches the horizontal orientation
(FIGS. 5B and 5E). To prevent leakage between the flow sleeve 470
and the stabilization body extension 430, the flow sleeve 470 (or
the stabilization body extension 430) may include a seal 485.
[0088] When in the open mode, the fluid path 480 extending through
the flow portion 472 is fluidly connected to the holes 440 and the
fluid path 450 extending through the stabilization body 410.
Although not shown, like the embodiments described above, the
device 400 may also have a tube and a needle-free connector that
are fluidly connected to the flow portion 472 and, in particular,
the fluid path 480 (e.g., via port 482). Therefore, in a manner
similar to that described above, when the flow sleeve 470 is in the
open mode, the user may transfer fluid to and from the patient.
[0089] To ensure that the flow sleeve 470 does not inadvertently
rotate back to the closed mode, some embodiments may have a locking
mechanism that holds the flow sleeve 470 in the open position. For
example, in some embodiments, the flow sleeve 470 may have a
protrusion that enters a detent within the stabilization body
extension 430. Additionally or alternatively, the stabilization
body extension 430 may have protrusion that enters a detent in the
flow sleeve 470 when in the open mode.
[0090] Additionally, although the embodiment described above and
shown in FIGS. 5A-5E has opposing holes 440 that create discreet
open modes, other embodiments may allow for fluid communication
between the fluid path 480 in the flow sleeve 470 and the fluid
path 450 extending through the stabilization body 410 in any
orientation of the flow sleeve 470. For example, rather than
opposing holes 440, some embodiments may have a channel within
stabilization body extension 430 that connects the two holes 440.
Therefore, the fluid path 480 in the flow sleeve 470 is fluidly
connected to the fluid path 450 in the stabilization body 410 when
the flow sleeve 470 is in the vertical orientation, horizontal
orientation or anywhere in between.
[0091] It should be noted that in the embodiment shown in FIGS.
5A-5E, the catheter and the male luer connector 420 are
rotationally decoupled from the rotation of the flow sleeve 470.
Therefore, any rotation of the flow sleeve 470 does not rotate the
male luer connector 420 and/or the catheter.
[0092] FIGS. 6A-6E show an additional embodiment of a vascular
access site management system 500. Like the management systems
100/400 described above, the management system 500 shown in FIGS.
6A-6E may have a needle-free connector 180 that is fluidly
connected to a flow housing 540 via a tube 170. The needle-free
connector 180 can be any number of needle-free connectors and/or
medical valves. For example, in some embodiments, the needle-free
connector may be a swabbable luer activated such that those
described in U.S. Pat. Nos. 6,755,391, 7,014,169, 6,039,302,
7,100,890, and 7,789,864, the disclosures of which are incorporated
herein by reference.
[0093] The management system 500 also includes a rotatable
stabilization pad 520 that is rotatable about the flow housing 540
that is secured/retained within the stabilization pad 520. The
stabilization pad 520 may have base 522 that may be placed on the
patient during use and may support the flow housing 540. To retain
the flow housing 540, the stabilization pad 520 may also include a
proximally extending portion 524 that extends upward from the base
522, and an opening 526 extending through the proximally extending
portion 524. The flow housing 540 may be pushed through the opening
526 such that the portion of the proximally extending portion 524
surrounding the opening 526 snaps into a recess 541 within the flow
housing 540. As noted above, the stabilization pad 520 should be
able to rotate about the flow housing 540. Therefore, the opening
526 should be sized such that the connection between the pad 520
and flow housing 540 does not interfere with the rotation. In some
embodiments, the stabilization pad 520 may be elastomeric.
[0094] At one end, the flow housing 540 may include a male luer
lock connector 550 that connects to the catheter 210 within the
patient. To help the user during connection of the catheter 210,
the stabilization pad 520 may include a retention feature 528 (FIG.
6E) that holds the collar/ring 552 of the male luer lock connector
550 back during initial connection with the catheter 210. For
example, the retention feature 528 may be a ridge or protrusion
that contacts the ring 552 and essentially interferes with the
forward and backward movement of the ring 552. Once the initial
connection has been made (e.g., the male luer portion has been
inserted into the female luer on the catheter 210), the user may
rotate the ring 552 to release it from the retention feature 528
and allow the user to screw the ring 552 onto the catheter 210.
[0095] Like the flow housings described above, the flow housing 540
shown in FIGS. 6A-6E has a flow path 542 extending through it to
allow fluid to be transferred to and/or from the patient during
use. The tube 170 may be fluidly connected to the flow path 542 via
port 543. To control fluid flow through the management system 500
and the flow housing 540, the interior of the flow housing 540 may
include a valve mechanism 544 within the internal fluid path 542
(FIGS. 6D and 6E). For example, the flow housing 540 may include a
two-way pressure activated valve 544 (PAV) like that described
above. The valve mechanism 544 prevents fluid flow through the flow
housing 540 (e.g., through the internal fluid path 154) until it is
exposed to a large enough pressure to open the slit through the
diaphragm (e.g., a cracking pressure).
[0096] In some applications, it may be necessary to introduce a
medical article into the catheter 210. For example, the user may
need to access to a peripheral vein through the indwelling catheter
210 to introduce sensors for detecting a patient condition,
introduce delivery lines for certain medicaments/agents, and/or
introduce tubing for direct blood withdrawal. To that end, the flow
housing 540 may have a split septum port 560 for receiving a
medical implement 610 (e.g., a blunt cannula or other medical
device or connector). As the name suggests, the split septum port
560 includes a septum 562 that obstructs the port 560 and normally
seals off the interior of the flow housing 540 (e.g., it seals off
the flow path 542 from the environment/exterior of the flow housing
540. To allow for connection of the medical implement 610, the
septum 562 may include an aperture or a slit extending through it.
To that end, during connection of the medical implement 610 to the
flow housing 540, the end 612 (e.g., the distal tip) of the medical
implement 610 deforms the septum 562, thus opening the
aperture/slit to allow the medical implement 610 to extend through
the septum 562.
[0097] As shown in FIG. 6E, the medical implement 610 may have a
channel 614 extending through it to allow the medical article (not
shown) to be introduced into the catheter 210 and/or vein through
the system 500. However, it should be noted that any obstructions,
bends, turns, etc. within the path between the channel 614 and the
catheter 210/vein may make it difficult to introduce the medical
article. For example, if the valve mechanism 544 is closed, it will
obstruct the pathway and, potentially prevent the medical article
from being introduced. In view of the above, some embodiments may
have various features that help to provide a clear path for the
introduction of the medical article by positioning the medical
implement 610 such that the end 612 of the medical implement 610 is
near the valve mechanism 544 and, in some cases, partially opens or
fully opens the valve mechanism.
[0098] For example, the flow housing 540 can include one or more
protrusions 546 that extend out from the flow housing 540 and enter
a recess 617 within the arms 616 of the medical implement 610 when
it is connected to the flow housing 540. The location of both the
protrusions 546 and the recesses 617 may be such that the end 612
of the medical implement 610 is located at the valve mechanism 544
or, as shown in FIG. 6E opens the valve mechanism 544. Additionally
or alternatively, to help appropriately position the medical
implement 610, the flow path 542 may include a contact surface 543
that contacts the outer surface of the medical implement 610 and
acts as a stop for the medical implement 610 (e.g., the outer
diameter of the medical implement 610 may contact the inner
diameter of the flow path 542 so that the medical implement 610
stops in the desired position). In addition to acting as a stop for
the medical implement 610, the contact surface 543 may also keep
the tip/end 612 of the medical implement 610 (and therefore the
channel 614) concentric with the opening through the valve
mechanism 544 and the male luer connector 550.
[0099] In other embodiments, the medical implement 610 and/or the
flow path 542 may also have a guide ribs extending along at least a
portion of its length (e.g., along the outer diameter of the
medical implement 610 and/or the inner diameter of the flow housing
540). The guide ribs guide the medical implement 610 into the flow
housing 540 and keep it concentric within the flow path 542 and,
perhaps help position the medical implement 610 longitudinally
within the flow housing 540. The ribs may be deformable or
crushable.
[0100] Although the vascular access site management system shown in
FIGS. 6A-6E includes a stabilization pad 520 that rotates with
respect to the flow housing 540, other embodiments may have
different configurations. For example, as shown in FIGS. 7-11, some
embodiments may include a stabilization body 1010 and a flow
housing 1090 that is rotatable about the stabilization body 1010
(and not just a stabilization pad 520). It should be noted that,
like the management systems described above, the management system
1000 shown in FIGS. 7-11 may have a needle-free connector that is
fluidly connected to the flow housing 1090 via a tube. The
needle-free connector can be any number of needle-free connectors
and/or medical valves.
[0101] The stabilization body 1010 has a base 1020 and an upper
portion 1030 extending from the base 1020. During use, the base
1020 may be placed on the patient to support and stabilize the
device 1000 on the patient. At one end, the upper portion 1030 may
include a male luer lock connector 1032 that connects to the
catheter 210 within the patient. Like the other embodiments
described herein, the base 1020 may be oriented at an angle (e.g.,
between 5 and 10 degrees) with respect to a longitudinal axis of
the outlet 1031 (e.g., the outlet of the male luer lock connector).
To help the user during connection of the catheter 210, the base
1020 may include a retention feature 1022 (FIGS. 10A and 10B) that
holds the collar/ring 1033 of the male luer lock connector 1032
back during initial connection with the catheter 210. For example,
like the retention feature described above, the retention feature
1022 may be a ridge or protrusion that contacts the ring 1033 and
essentially interferes with the forward and backward movement of
the ring 1033.
[0102] As shown in FIG. 10A, the upper portion 1030 has a flow path
1040 extending through it (e.g., to outlet 1031) to allow fluid to
be transferred to and/or from the patient during use. To control
fluid flow through the management system 1000 and the upper portion
1030, the interior of the upper portion 1030 may include a valve
mechanism 1060 (e.g., a two-way pressure activated valve (PAV) with
a slit 1062) within the internal flow path 1040 (FIGS. 10A and
10B). The valve mechanism may deform in the presence of a forward
pressure (e.g., toward the outlet 1031) to allow fluid to flow
around the valve mechanism 1060 and through the upper portion 1030.
Additionally, in the presence of a retrograde pressure (e.g., from
the outlet 1031), the slit 1062 may open to allow fluid flow
through the upper portion 1030 from the outlet 1031 toward an inlet
1114 in the flow housing 1090 (described in greater detail below).
It should be noted that, to avoid low pressure flow (e.g. blood
reflux) through the valve mechanism 1060, the pressure required to
open the slit in the retrograde direction should be greater than
the venous pressure of the patient.
[0103] To help support the valve mechanism 1060 within the flow
path 1040, the upper portion 1030 of the stabilization body 1010
may include a number of support arms 1036. In the presence of the
forward pressure and as the valve mechanism 1060 deforms, the valve
mechanism 1060 may deform away from a seating/sealing surface 1037
within the upper portion 1030 and over the support arms 1036 to
allow the fluid flow toward the outlet 1031, around the valve
mechanism 1060 and between the spaces between the support arms
1036. Additionally, the support arms 1036 may be located radially
inward from the seating/sealing surface 1037 to promote deformation
(e.g. bending) of the valve mechanism 1060 around the support arms
1036 in the presence of the forward pressure. It should be noted
that, although the figures show eight support arms 1036, other
embodiments may have more or less than eight support arms 1036. For
example, some embodiments may have seven or less support arms 1036
and other embodiments may have nine or more support arms 1036.
Furthermore, the number of support arms 1036, their width(s) and
contact area(s), and the amount of open space between each support
arm 1036 will at least partially influence the degree that the
valve mechanism 1060 bends around the support arms 1060 and the
size of the opening between the seating/sealing surface 1037 and
valve mechanism 1060 (e.g. size of flow path).
[0104] As shown in FIGS. 9A-9C and 10A-10B, the flow housing 1090
has a sleeve portion 1100 and a pathway portion 1110 extending from
the sleeve portion 1100. The sleeve portion 1100 is located
on/around the upper portion 1030 of the stabilization body 1010
such that the flow housing 1090 can rotate with respect to the
stabilization body 1010, for example, between a closed mode (e.g.,
the position shown in FIGS. 8A-8C) and at least one open mode
(e.g., the positions shown in FIGS. 7A-7C and 9A-9C). The pathway
portion 1110 has a fluid path 1112 that extends through it and that
is fluidly connected to the flow path 1040 within the upper portion
1030 when in the open mode(s). The inlet 1114 of the fluid path
1112 may be connected to the tube leading to the needle free
connector (discussed above). Alternatively, a medical implement
(e.g., for fluid transfer in/out of the patient) may be connected
directly to the inlet 1114. It should be noted that the catheter
210 and the stabilization body 1010 are rotationally decoupled from
the rotation of the flow housing 1090. Therefore, any rotation of
the flow housing 1090 does not rotate the stabilization body 1010
and/or the catheter.
[0105] To create fluid communication between the flow path 1040 in
the upper portion 1030 of the stabilization body 1010 and the fluid
path 1112 in pathway portion 1110, the upper portion 1030 may have
one or more holes 1038A/B extending through the wall of the upper
portion 1030. For example, in the closed mode, the flow housing
1090 may be in the vertical orientation (FIGS. 8A-8C) and the fluid
path 1112 within the pathway portion 1110 may be fluidly
disconnected from the holes 1038A/B and the flow path 1040 in the
upper portion 1030. To transition the flow housing 1090 to one of
the open modes (FIGS. 7A-7C and 9A-9C), the user may rotate the
flow housing 1090 to the left or right (depending on the user's
preference and the location of the catheter 210 upon the patient).
When in one of the open modes, the fluid path 1112 extending
through the flow housing 1090 is fluidly connected to one of the
holes 1038A/B and the flow path 1040 in the upper portion 1030.
[0106] As discussed above, in some applications, it may be
necessary to introduce a medical article into the catheter 210. To
that end, the upper portion 1030 may have a port 1050 with split
septum 1080 for receiving a medical implement 610. The split septum
1080 obstructs the port 1050 and normally seals off the interior of
the upper portion 1030 (e.g., it seals off the flow path 1040 from
the environment/exterior of the upper portion 1030). As the name
suggests, the septum 1080 may include an aperture or a slit 1082
through which the end/distal tip 612 of the medical implement may
pass. For example, while engaging the medical implement 610 with
the upper portion 1030, the end/distal tip 612 will deform the
septum 1080, and opens the aperture/slit 1082 to allow the distal
tip 612 to enter the interior of the device 1000 (e.g., the flow
path 1040).
[0107] It should be noted that, although the figures show a split
septum-style sealing mechanism 1080, other embodiments may have
alternative valving mechanisms for sealing off the flow path 1040
from the environment/exterior of the upper portion 1030 and allow
the distal tip 612 to enter the interior of the device 1000. For
example, some embodiments may include a valve structure such as
that described in U.S. Pat. No. 9,079,005 (incorporated herein by
reference in its entirety). In such embodiments, the sealing
mechanism may have a proximal portion located within the port, a
wall that extends distally from the proximal portion within the
interior of the device 1000 (e.g., within the interior of the upper
portion) and an open distal end. The wall may form an interior
within the sealing mechanism. To support the sealing mechanism
within the device 1000, the device 1000 may include structures
against which the end of the wall may contact.
[0108] As also discussed above, obstructions, bends, turns, etc.
within the path between the channel 614 in the medical implement
610 and the catheter 210/vein may make it difficult to introduce
the medical article. To that end, like the flow housing 540
mentioned above, the upper portion 1030 can include one or more
engagement features (e.g., protrusions 1070) that extend out from
the device 1000 (e.g., from the flow housing 1090) and enter an
engagement feature (e.g., a recess 617) within the arms 616 of the
medical implement 610 when it is connected to the device 1000. The
location of both the protrusion(s) 1070 and the recess(es) 617 may
be such that the distal tip 612 of the medical implement 610 is
located at a predetermined longitudinal position within the flow
path 1040 and interacts with the valve mechanism 1060. For example,
the distal tip 612 may merely contact the valve mechanism 1060 to
make it easier for the medical article to open the slit 1062 or, as
shown in FIG. 11, the distal tip 612 of the medical implement 610
may partially or fully open the slit 1062 within the valve
mechanism 1060.
[0109] As shown in FIG. 11, in embodiments in which the medical
implement 610 partially opens the slit, when the distal tip 612 of
the medical implement 610 interacts with the valve mechanism 1060,
the inner portion 1064 of the valve mechanism 1060 around the slit
1062 may deform and/or move longitudinally towards the first
end/outlet 1031 and into the area between the support arms 1036.
Conversely, the longitudinal movement (e.g., towards the outlet
1031) of the outer portion 1066 of the slit 1062 may be minimized.
For example, as the distal tip 612 begins to interact with the
valve mechanism 1060, the outer portion 1066 may contact the
support arms 1036 which, in turn, prevent the outer portion 1036
from moving toward the outlet 1031.
[0110] It should be noted that, although the engagement member on
the device 1000 is described as a protrusion/projection and the
engagement member on the medical implement 610 is described as a
recess, other embodiments may have different configurations and
structures. For example, the engagement member on the medical
implement 610 may be a protrusion and the engagement member on the
device 1000 may be a recess. Additionally or alternatively, the
device 1000 and the medical implement 610 may each have both a
protrusion and a recess. In addition, the engagement member on the
medical implement 610 may not reside on the arm 616 but
alternatively or additionally on a feature or surface(s) that make
contact with an engagement member on or near an end 1034 (FIG. 10B)
of upper portion 1030, thereby coupling the medical implement 610
with the device 1000 to achieve placement of the distal tip 612 of
the medical implement 610 at a predetermined longitudinal position
within the flow path 1040.
[0111] It should be noted that the engagement between the
engagement feature 1070 on the upper portion 1030 and the
engagement feature 617 on the medical implement 610 and the contact
between the medical implement 610 and the septum 1080 may radially
align the distal tip 612 with the flow path (e.g., to keep the
distal tip 612 concentric with the flow path 1040). Additionally or
alternatively, to further help appropriately position the distal
tip 612 (e.g., longitudinally) and to radially align the distal tip
612 with the flow path 1040, the flow path 1040 may include a
contact surface 1042 that contacts the outer surface of the medical
implement 610. In addition to acting as a stop for the medical
implement 610, the contact surface 1042 may also keep the distal
tip 612 (and therefore the channel 614) concentric with the opening
through the valve mechanism 1060 and the male luer connector 1032.
To further help with the radial positioning and keep the distal tip
612 concentric, like the embodiments shown in FIGS. 6A-6E, the
device 1000 may have guide ribs (which may be crushable or
deformable) extending along a portion of the length of the flow
path 1040.
[0112] It is important to note that by positioning the medical
implement 610 in the manner described above, various embodiments of
the present invention provide unobstructed medical article
delivery, and like the other embodiments described herein, allow
the user to configure the J-loop to the left or right and lock the
J-loop in place. Additionally the elastomeric pad 520 and/or the
stabilization body 1010 allow for patient comfort and maintains a
proper catheter angle (e.g., in a manner similar to that described
above).
[0113] FIGS. 12-17 schematically show an alternative vascular
access site management system 1200 that also rotationally decouples
the rotation of a portion of the device (e.g., a flow housing) from
the rest of the device and the catheter to which it is connected.
In a manner similar to the embodiments described above, the device
1200 may have a stabilization body 1210 with a male luer connector
1211 extending from one side of the stabilization body 1210 and a
stabilization body extension 1213 extending from the other side.
For example, the stabilization body 1210 may have an inlet body
1214 that forms the stabilization body extension 1213 and an outlet
body 1212 that forms the male luer connector 1211. During use, the
male luer connector 1211 may connect to the catheter 210. The
stabilization device 1210 may include a locking mechanism (e.g., a
threaded ring 1222, locking arms, etc.) for securing the male luer
connector 1211 to the catheter 210.
[0114] As best shown in FIGS. 16A and 16B, the stabilization body
1210 may have an internal fluid path 1240 extending though the
stabilization body 1210. The inlet 1230 of the fluid path 1240 may
be located within the inlet body 1214 and the outlet 1220 of the
fluid path 1240 may be located within the outlet body 1212. Within
the fluid path 1240 and to control the flow of fluid through the
internal fluid path 1240, the stabilization body 1210 may have a
valve mechanism 1320 that is positioned within/between the inlet
body 1214 and the outlet body 1212. For example, the valve
mechanism 1320 may be a two-way pressure activated valve (PAV) with
a slit 1322 extending through it. As described in greater detail
below, the valve mechanism may deform in the presence of a forward
pressure (e.g., from the inlet 1230 towards the outlet 1220) to
allow fluid to flow around the valve mechanism 1320 and through the
stabilization body 1210. Additionally, in the presence of a
retrograde pressure (e.g., from the outlet 1220 toward the inlet
1230), the slit 1322 may open to allow fluid flow through the
stabilization body 1200 from the outlet 1220 toward the inlet 1230.
It should be noted that, to avoid low pressure flow (e.g. blood
reflux) through the valve mechanism 1320, the pressure required to
open the slit in the retrograde direction should be greater than
the venous pressure of the patient.
[0115] In addition to being positioned between the inlet body 1214
and the outlet body 1212, the stabilization body 1210 may include a
number of support arms 1217 within the fluid path 1240 that
mechanically support the valve mechanism 1320 within the fluid path
1240. To that end, as the valve mechanism 1320 deforms (e.g., in
the presence of the forward pressure), the valve mechanism 1320 may
deform away from a seating/sealing surface 1215 within the
stabilization body 1210 and over the support arms 1217 to allow the
fluid flow from the inlet 1230 toward the outlet 1220, around the
valve mechanism 1320 and between the spaces between the support
arms 1217. Additionally, the support arms 1217 may be located
radially inward from the seating/sealing surface 1215 to promote
deformation (e.g. bending) of the valve mechanism 1320 around the
support arms 1217 in the presence of the forward pressure. It
should be noted that, although the figures show eight support arms
1217 other embodiments may have more or less than eight support
arms 1217. For example, some embodiments may have seven or less
support arms 1217 and other embodiments may have nine or more
support arms 1217. Furthermore, the number of support arms 1217,
their width(s) and contact area(s), and the amount of open space
between each support arm 1217 will at least partially influence the
degree that the valve mechanism 1320 bends around the support arms
1217 and the size of the opening between the seating/sealing
surface 1215 and valve mechanism 1320 (e.g. size of flow path).
[0116] To help stabilize the device 1200 on the patient, the
stabilization body 1210 may include a base portion 1250 with a
stabilization surface 1252 located on an underside of the base
portion 1250 that stabilizes the device/system 1200 on the patient.
Additionally or alternatively, the base portion 1250 may include a
separate stabilization base 1300 that is located on the underside
of the base portion 1250. In some embodiments, the device 1200 may
have a first securement portion 1302 and, perhaps, a second
securement portion 1304 located on the underside of the
stabilization base 1300 (or the underside of the base portion
1250). In a manner similar to that described above for prior
embodiments, the first and/or second securement portion 1302/1304
may include an adhesive layer that secures the device 1200 to the
patient. For example, the first securement portion 1302 may have a
light tack adhesive layer and the second securement portion 1304
may have a stronger tack adhesive layer (e.g., an adhesive that is
stronger than the adhesive on the first securement portion 1302).
As noted above, the first securement portion 1302 with the light
tack adhesive allows the user to position and reposition the
system/device 1200 as needed. The second securement portion 1304
with the stronger adhesive allows the user to firmly secure the
system/device 1200 to the patient once the device/system 1200 is in
place.
[0117] In addition to or instead of the adhesive, the first
securement portion 1302 may include a gripping or conforming
structure that grips and/or conforms to the patient's skin to allow
the user to initially position the device 1200 and hold the device
1200 in place while the second securement portion is secured to the
patient or instead, no different than the first securement portion.
For example, the first securement portion 1302 may include silicone
structures (e.g., protrusions, ribs, etc.) that grip and/or conform
to the surface of the patient's skin.
[0118] Like the adhesive sections 112/114 described above, the
first securement portion 1302 may be located at the leading or
trailing edge of the stabilization base 1300 (or base portion 1250
of the stabilization body 1210) and the second securement portion
1304 may be located on the remainder of the stabilization base 1300
or base portion 1250. To prevent the securement portions 1302/1304
and their respective adhesives from inadvertently sticking to the
wrong surface and/or prevent bacteria/contamination from sticking
to the adhesive, the device 1200 may have one or more liners 1310
covering the adhesive. The liner 1310 may have a tab 1312 so that
the liner 1310 can be easily removed. In some embodiments, the
first and second securement portions 1302/1304 may have their own
liners that can be removed independently as needed.
[0119] As discussed above, it may beneficial to reduce the
force/pressure on the catheter 210 and keep the fluid path 1240 in
line with the catheter 210. To that end, the base portion 1250
and/or the stabilization base 1300 may be configured at an angle
with respect to the outlet 1220 of the stabilization body 1210
(e.g., with respect to the longitudinal axis of the outlet 1220).
For example, the stabilization base 1300 and/or base portion 1250
may be at an angle that complements the angle of the catheter 210
extending out of the patient (e.g., between 5-10 degrees).
[0120] Once the device/system 1200 is in place and secured to the
patient, it may be located over a portion of the vein in which the
catheter 210 is inserted. To help relieve the pressure applied to
the patient over the vein (and reduce any distortion of the vein by
the device 1200), some embodiments of the device/system 1200 may
include a vein relief zone 1254 within the base portion 1250 (as
shown in FIGS. 17A-17C). The vein relief zone 1254 has a recessed
surface and is axially aligned with the outlet 1220. Additionally,
the relief zone 1254 may include adhesive (e.g., on the base
portion 1250 and/or adhesive 1352 on the stabilization base 1300)
that lifts the patient's skin that is over the vein to further
reduce the pressure on the vein.
[0121] To facilitate the flow of fluids in and out of the patient,
the device 1200 may have a flow housing 1260 that is connected to
the stabilization body 1210 and has a sleeve portion 1270 and a
pathway portion 1280 extending from the sleeve portion 1270. As the
name suggests, the pathway portion 1280 may include a flow path
1282 that extends through it and that is fluidly connected to the
fluid path 1240 within the stabilization body 1210 to allow fluid
to pass through the device 1200. The inlet 1284 of the flow path
1282 may connect directly to a medical implement used to transfer
fluid to and/or from the patient through the device 1200.
Alternatively, the device 1200 may include a tube 1330 that is
connected to the inlet 1284 of the flow path 1282 at a first end
1332 and a medical connector (e.g., a female luer connector 1340),
a needle free connector (not shown) or other medical device such as
a luer activated valve (not shown) at the second end 1334.
[0122] As best shown in FIGS. 12A-12D, 13A-13D, and 14A-14D, the
flow housing 1260 may be rotatably connected to the stabilization
body 1210 such that flow housing 1260 can rotate between a first
position (FIGS. 12A-12D), a second position (FIGS. 13A-13D) and a
third position (FIGS. 14A-14D). To that end, the inlet body 1214 of
the stabilization body 1210 may have a protrusion 1232 extending
from a surface of the inlet body 1214. Conversely, the sleeve
portion 1270 may include a recess 1272 into which the protrusion
1232 may snap during assembly of the device 1200. To allow the flow
housing 1260 to rotate with respect to the stabilization body 1210,
the recess 1272 may be substantially larger/longer that the
protrusion 1232 such that the protrusion 1232 slides within the
recess 1272 during rotation. To further help rotation and prevent
leakage between the stabilization body 1210 and the flow housing
1260, the device 1200 may include an o-ring 1290 between an outer
diameter/surface of the stabilization body 1210 and an inner
diameter/surface of the flow housing 1260. The o-ring 1290 may also
provide some rotational resistance so that the flow housing 1260
does not accidentally rotate.
[0123] It should be noted that, although the stabilization body
1210 is described above as having a protrusion 1232 and the flow
housing 1260 is described as having a recess 1272 to facilitate the
rotation of the flow housing 1260 with respect to the stabilization
body 1210, other embodiments may have different configurations. For
example, in some embodiments, the stabilization body 1210 may have
a recess into which a protrusion extending inward from an inner
surface of the flow housing 1260 may snap into and slide within
during rotation.
[0124] In a manner similar to that described above, the device 1200
may be used to transfer fluids to and/or from a patient and
minimize the stress on the catheter 210 and access site. For
example, the user (e.g., the medical personnel) may first connect a
medical implement to the female luer connector 1340 (or other
needle-free connector) or directly to the inlet 1284 of the flow
path 1282 and flush (e.g., prime) the device 1200, for example,
with saline. Once the device 1200 is flushed/primed, the user may
insert the catheter 210 into the patient (e.g., into the patient's
arm).
[0125] The user may then connect the catheter 210 to the management
device 1200. When attaching the catheter 210 and securing the
stabilization device 1200, the user may grab the stabilization body
1210 and press the device 1200 against the catheter 210. If so
equipped, the user may then screw the ring 1222 of the male luer
connector 1212 onto the catheter 210 to secure the device 1200 to
the catheter 210. Once the catheter 210 is attached, the user may
then remove the liner 1310 stick the stabilization base 1210 to the
patient (e.g., via the securement portion(s) 1302/1304).
[0126] It should be noted that, if the device 1200 has more than
one securement portion (e.g., the first securement portion 1302 and
second securement portion 1304 discussed above) and each securement
portion has its own liner, the user may remove the liner for the
first securement portion 1302 first. Once the first securement
portion 1302 is adhered to the patient and the user has confirmed
that there is adequate flow through the system 1200 (e.g., as
described above), the user may remove the liner 1310 for the second
securement portion 1304 to further secure the system 1200 to the
patient.
[0127] After the vascular access site management system 1200 is
secured or at a time preferable to the user, the user may rotate
the flow housing 1260 (and the tube 1330 and female luer connector
1340 if equipped) to either the right or the left (e.g., from the
upright position shown in FIGS. 12A-12D to the position shown in
FIG. 13A-D or 14A-D). If needed, the user may then place a dressing
over at least the catheter insertion site to maintain the
cleanliness of the site. It should be noted that, like the
embodiments described above, the user may choose either a left or
right configuration based on what is the best configuration for the
given application.
[0128] Although the embodiment discussed above has a base portion
1250 that is a split base with two legs 1216A/B that extend out
from the base portion 1250 and toward the flow housing 1260 (e.g.,
and away from the male luer connector 1211), other embodiments may
have different base configurations. For example, as shown in FIG.
18, the base portion 1250 may have legs 1810A/B that extend toward
the male luer connector 1211 and away from the flow housing 1260.
Alternatively, some embodiments may have legs that extend in both
directions or may only have a single leg (e.g., as opposed to being
a split base with more than one leg).
[0129] It is important to note that the embodiments described
herein, provide numerous benefits. For example, because the devices
may be rotated in either direction, the embodiments described
above, allow the user to configure the J-loop to either the left or
right side and, in some embodiments, lock it in place. Various
embodiments also provide two stage stabilization. During the first
stage, the clinician has an important "extra hand" during the
venous access procedure and the second stage secures catheter to
the body to restrict catheter movement and reduce associated
clinical complications, such as phlebitis and
infiltration/extravasation. The embodiments described herein also
reduce the potential for kinking in the tube, reduces clinical
variation, and provide a means for the user to know the location of
the catheter tip relative to a datum on the device.
[0130] Although the embodiments described above utilize locking
arms (e.g., arms 130A/130) and/or a standard rotating collar/ring
(e.g., ring 552) to secure the catheter 210 to the vascular access
site management systems, other embodiments may utilize different
structures. For example, as shown in FIGS. 19A to 19D, the device
may have locking arms 710A and 710B within hinges 712A/B (e.g.,
living hinges) that allow the arms to flex between an open mode
(FIGS. 19B and 19D) and a closed mode (FIGS. 19A and 19C). One of
the arms 710A may have a protrusion 714 that enters a recess 716
(e.g., formed by two protrusion 718A/B) on the other arm 710B when
in the closed mode to secure the catheter 210 (FIG. 19C).
[0131] FIGS. 20A-20D show a further alternatively locking mechanism
for the catheter 210. Like the locking arms 130A/B described above,
the embodiment shown in FIGS. 20A-20D also has arms 810A/B
extending from the device. However, the arms 810A/B may be attached
to the rest of the device via hinges 812A/B. The hinges 812A/B
allow the arms 810A/B to transition between an open mode (FIG.
20A/20C) and a closed mode (FIGS. 20B and 20D).
[0132] FIGS. 21A-21D show a further embodiment of a locking
mechanism that may be used with the vascular access site management
systems described herein. This locking mechanism may include a
skirt 910 that can transition between an open mode (FIGS. 21A and
21C) and a closed mode (FIGS. 21B and 21D). For example, once the
catheter 210 is secured to the male luer connector 920, the skirt
910 may be collapsed to transition it to the closed mode. When in
the closed mode, the skirt 910 may surround a portion of the
catheter hub 214 to secure the catheter 210 to the device.
[0133] The embodiments of the invention described above are
intended to be merely exemplary; numerous variations and
modifications will be apparent to those skilled in the art. All
such variations and modifications are intended to be within the
scope of the present invention as defined in any appended
claims.
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