U.S. patent application number 17/242665 was filed with the patent office on 2021-11-04 for cannula insertion system and methods of using the same.
The applicant listed for this patent is The Children's Hospital of Philadelphia. Invention is credited to Spencer Brown, Philip Bussone, JR., Marcus Graeme Davey, Alan W. Flake, Dustin Gaidos, Joseph Gordon, Joseph W. Jackson, Ryan Christopher Meers, Dylan J. Paproski.
Application Number | 20210338270 17/242665 |
Document ID | / |
Family ID | 1000005740761 |
Filed Date | 2021-11-04 |
United States Patent
Application |
20210338270 |
Kind Code |
A1 |
Flake; Alan W. ; et
al. |
November 4, 2021 |
Cannula Insertion System And Methods Of Using The Same
Abstract
A cannula insertion system for cannulating a blood vessel
includes a cannula system having a cannula that defines a cannula
lumen and has a distal and proximal end. The system includes a
cannula insertion device for coupling with the system that includes
a dilator having a dilator body and a dilator lumen; a needle
having a needle body and a needle lumen, the needle being
translatable within the dilator lumen along a first direction; a
movable dilator actuator configured to cause the dilator to move
along the first direction; a movable needle actuator configured to
cause movement of the needle along the first direction; and a
housing defining a housing recess. The housing recess is configured
to receive the cannula system, the dilator, and the needle. The
needle and the dilator are configured to be moved within the
cannula lumen along the first direction.
Inventors: |
Flake; Alan W.;
(Philadelphia, PA) ; Davey; Marcus Graeme;
(Ardmore, PA) ; Jackson; Joseph W.; (Wilmington,
DE) ; Paproski; Dylan J.; (Littleton, CO) ;
Meers; Ryan Christopher; (West Chester, PA) ; Gordon;
Joseph; (Mansfield, MA) ; Gaidos; Dustin;
(Milton, MA) ; Brown; Spencer; (Cranston, RI)
; Bussone, JR.; Philip; (Ipswich, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The Children's Hospital of Philadelphia |
Philadelphia |
PA |
US |
|
|
Family ID: |
1000005740761 |
Appl. No.: |
17/242665 |
Filed: |
April 28, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
63017204 |
Apr 29, 2020 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/3659 20140204;
A61B 2017/3466 20130101; A61B 17/3403 20130101; A61B 17/3421
20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61M 1/36 20060101 A61M001/36 |
Claims
1. A cannula insertion system for cannulating a blood vessel in a
tissue, the cannula insertion system comprising: a cannula system
including a cannula that defines a cannula lumen therethrough, the
cannula having a distal end and a proximal end opposite the distal
end; and a cannula insertion device configured to couple with the
cannula system, the cannula insertion device including: a dilator
having a dilator body that defines a dilator lumen therethrough; a
needle having a needle body that defines a needle lumen
therethrough, the needle being translatable within the dilator
lumen along a first direction; a dilator actuator configured to be
moved such that movement of the dilator actuator causes movement of
the dilator along the first direction; a needle actuator configured
to be moved such that movement of the needle actuator causes
movement of the needle along the first direction; and a housing
defining a housing recess therein, the housing recess being
configured to receive the cannula system, the dilator, and the
needle, wherein the needle and the dilator of the cannula insertion
device are configured to be moved within the cannula lumen along
the first direction.
2. The cannula insertion system of claim 1, wherein the actuator is
configured to translate the needle from a first position, in which
a distal end of the needle is positioned distally of a distal end
of the dilator, to a second position, in which the distal end of
the needle is positioned proximally of the distal end of the
dilator.
3. The cannula insertion system of claim 1, wherein the cannula
system includes a Y-connector adjacent to the proximal end of the
cannula, the Y-connector having a first proximal portion, which
defines a first proximal channel, and a second proximal portion,
which defines a second proximal channel, wherein the first and
second proximal channels are configured to be in fluid
communication with the cannula lumen.
4. The cannula insertion system of claim 3, wherein the first
proximal portion defines a slit seal that separates the first
proximal channel from the second proximal channel, the slit seal
having an open configuration, in which the dilator and the needle
are inserted therethrough, and a closed configuration, in which the
needle and the dilator are not extending therethrough, wherein when
the slit seal is in the closed configuration, liquid from the
cannula lumen is precluded from moving into the first proximal
channel.
5. The cannula insertion system of claim 3, further comprising a
plug configured to be removably inserted into the first proximal
channel.
6. The cannula insertion system of claim 1, wherein the cannula
system further includes a locking element thereon, and the housing
includes a locking element thereon, wherein the locking element of
the cannula system is configured to releasably engage with the
locking element of the housing such that the cannula system is
affixed to the housing.
7. The cannula insertion system of claim 1, further comprising a
collet jaw configured to releasably secure the cannula to the blood
vessel, the collet jaw being affixed to the cannula, the collet jaw
having a base, a deformable arm, and a head, wherein when the
collet jaw is in an open position, the head is spaced away from the
blood vessel and the cannula, and when the collet jaw is in a
closed position, the head is in contact with the tissue such that
the blood vessel is held in place between the collet jaw and the
cannula.
8. The cannula insertion system of claim 7, wherein the collet jaw
further comprises a tine on the head that extends towards the blood
vessel, wherein the tine is configured to dig into the tissue when
the collet jaw is in the second position.
9. The cannula insertion system of claim 1, wherein the housing
includes a translucent portion configured to allow visibility
through the housing into the housing recess.
10. The cannula insertion system of claim 1, wherein the cannula
system is configured to be operatively connected to an
extracorporeal membrane oxygenation (ECMO) system.
11. The cannula insertion system of claim 1, wherein the tissue
includes an umbilical cord of a neonate.
12. A method of cannulating a blood vessel in a tissue, the method
comprising the steps of: creating an opening in a wall of the blood
vessel by piercing the wall with a distal end of a needle by moving
the needle towards the vessel and through the wall of the vessel;
inserting a dilator into the opening and expanding the opening;
retracting the needle such that the needle is moved out of the
blood vessel; retracting the dilator such that the dilator is moved
out of the blood vessel; inserting a cannula into the opening in
the wall of the blood vessel; and securing the cannula in the blood
vessel, wherein the cannula defines a cannula lumen therethrough
extending between a distal end and a proximal end, and wherein the
dilator and the needle are movable within the cannula lumen.
13. The method of claim 12, wherein the needle defines a distal end
and a proximal end opposite the distal end, wherein the dilator
defines a dilator lumen extending through the dilator between a
distal end and a proximal end, and wherein the step of retracting
the needle includes moving the needle in the dilator lumen from a
first position, in which the distal end of the needle is outside of
the dilator lumen and is distal to the distal end of the dilator,
to a second position, in which the distal end of the needle is in
the dilator lumen and is proximal to the distal end of the
dilator.
14. The method of claim 12, wherein the step of securing the
cannula to the blood vessel includes moving a collet jaw from an
unlocked position, in which the collet jaw does not contact the
tissue, to a locked position, in which the collet jaw forcefully
clamps the tissue such that the blood vessel is held between the
collet jaw and the cannula such that at least a portion of the
blood vessel is precluded from translating relative to the
cannula.
15. The method of claim 14, further including the step of digging
into the tissue with a tine disposed on the collet jaw.
16. The method of claim 12, further comprising connecting the
cannula to an extracorporeal membrane oxygenation (ECMO)
system.
17. The method of claim 16, wherein the cannula is connected to a
Y-connector that splits into a first proximal portion and a second
proximal portion separate from the first proximal portion, and
wherein the step of connecting the cannula to the ECMO system
includes connecting the second proximal portion of the Y-connector
to the ECMO system.
18. The method of claim 12, further comprising moving the dilator
and the needle out of the cannula lumen after the step of securing
the blood vessel to the cannula.
19. The method of claim 18, wherein the cannula is connected to a
Y-connector that splits into a first proximal portion and a second
proximal portion separate from the first proximal portion, and
wherein the step of moving the dilator and the needle out of the
cannula lumen includes moving the dilator and the needle through
the first proximal portion.
20. The method of claim 19, further comprising moving the needle
and the dilator through a slit seal defined in the first proximal
portion of the Y-connector.
21. The method of claim 19, further comprising inserting a plug
into a first proximal channel of the Y-connector to prevent blood
flow out of the first proximal portion.
22. A cannula system comprising: a cannula having a distal end and
a proximal end opposite the distal end; a cannula lumen extending
through the cannula between the distal end and the proximal end;
and a slit seal disposed on the cannula, the slit seal being
configured to receive a cannula insertion device, wherein the
cannula system is configured to be in fluid communication with a
blood vessel and with an oxygenator.
23. The cannula system of claim 22, wherein the cannula further
includes: a Y-shaped connector having a first proximal portion and
a second proximal portion; and a slit seal disposed on the cannula,
the slit seal being configured to receive a cannula insertion
device therethrough, wherein the cannula lumen extends through the
second proximal portion of the Y-shaped connector, and wherein the
slit seal is configured to allow fluid communication between the
first proximal portion and the cannula lumen.
24. A cannula for fluidly communicating with a vessel of a tissue,
the cannula comprising: a distal end; a proximal end opposite the
distal end; a cannula lumen extending through the cannula between
the distal end and the proximal end; a Y-shaped connector having a
first proximal portion and a second proximal portion; and a slit
seal disposed on the cannula, the slit seal being configured to
receive a cannula insertion device therethrough, wherein the
cannula lumen extends through the second proximal portion of the
Y-shaped connector, and wherein the slit seal is configured to
allow fluid communication between the first proximal portion and
the cannula lumen.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 63/017,204, filed Apr. 29, 2020, the entirety of
which is incorporated herein for any and all purposes.
TECHNICAL FIELD
[0002] The present disclosure is related to embodiments of a
cannula insertion system, including a cannula system and a cannula
insertion device.
BACKGROUND
[0003] Extreme prematurity is the leading cause of infant morbidity
and mortality in the United States, with over one third of all
infant deaths and one-half of cerebral palsy diagnoses attributed
to prematurity. Respiratory failure represents the most common and
challenging problem associated with extreme prematurity, as gas
exchange in critically preterm neonates is impaired by structural
and functional immaturity of the lungs. Advances in neonatal
intensive care have achieved improved survival and pushed the
limits of viability of preterm neonates to 22 to 24 weeks
gestation, which marks the transition from the canalicular to the
saccular phase of lung development. Although survival has become
possible, there is still a high rate of chronic lung disease and
other complications of organ immaturity, particularly in neonates
born prior to 28 weeks gestation. The development of a system that
could support normal neonatal growth and organ maturation for even
a few weeks could significantly reduce the morbidity and mortality
of extreme prematurity, and improve quality of life in
survivors.
SUMMARY
[0004] The above deficiencies are addressed by cannula insertion
systems and methods of using them described throughout this
specification. According to an aspect of this disclosure, a cannula
insertion system for cannulating a blood vessel of a tissue
includes a cannula system having a cannula that defines a cannula
lumen therethrough. The cannula has a distal end and a proximal end
opposite the distal end. The cannula insertion system further
includes a cannula insertion device configured to couple with the
cannula system. The coupling between the cannula insertion device
and the cannula system may be releasable. The cannula insertion
device includes a dilator having a dilator body that defines a
dilator lumen therethrough; a needle having a needle body that
defines a needle lumen therethrough, the needle being translatable
within the dilator lumen along a first direction; a dilator
actuator configured to be moved such that movement of the dilator
actuator causes movement of the dilator along the first direction;
a needle actuator configured to be moved such that movement of the
needle actuator causes movement of the needle along the first
direction; and a housing defining a housing recess therein. The
housing recess is configured to receive the cannula system, the
dilator, and the needle. The needle and the dilator of the cannula
insertion device are configured to be moved within the cannula
lumen along the first direction.
[0005] The actuator may be configured to translate the needle from
a first position, in which a distal end of the needle is positioned
distally of a distal end of the dilator, to a second position, in
which the distal end of the needle is positioned proximally of the
distal end of the dilator.
[0006] The cannula system may include a Y-connector adjacent to the
proximal end of the cannula, the Y-connector having a first
proximal portion, which defines a first proximal channel, and a
second proximal portion, which defines a second proximal channel.
The first and second proximal channels may be configured to be in
fluid communication with the cannula lumen. In some aspects, the
first proximal portion may define a slit seal that separates the
first proximal channel from the second proximal channel. The slit
seal has an open configuration, in which the dilator and the needle
are inserted therethrough, and a closed configuration, in which the
needle and the dilator are not extending therethrough. When the
slit seal is in the closed configuration, liquid from the cannula
lumen is precluded from moving into the first proximal channel. In
some aspects, the cannula insertion system may include a plug
configured to be removably inserted into the first proximal
channel.
[0007] The cannula system may include a locking element thereon,
and the housing may include a locking element thereon as well. The
locking element of the cannula system can be configured to
releasably engage with the locking element of the housing such that
the cannula system is affixed to the housing.
[0008] The system may further include a collet jaw configured to
releasably secure the cannula to the blood vessel. The collet jaw
may be affixed to the cannula system. The collet jaw may have a
base, a deformable arm, and a head. When the collet jaw is in an
open position, the head is spaced away from the blood vessel and
the cannula, and when the collet jaw is in a closed position, the
head is in contact with the tissue such that the blood vessel is
held in place between the collet jaw and the cannula.
[0009] The tissue may be physiological tissue, such as an organ. In
some aspects, the tissue may include an umbilical cord of a
neonate. The head of the collet jaw may contact an umbilical sheath
of the umbilical cord, Wharton's jelly of the umbilical cord, or
the blood vessel itself. In some aspects, the collet jaw may
include a tine on the head that extends towards the blood vessel.
The tine may be configured to dig into the tissue (e.g., the
umbilical cord) when the collet jaw is in the second position.
[0010] In some aspects, the housing of the system may include a
translucent portion configured to allow visibility through the
housing into the housing recess.
[0011] The cannula system may be configured to be operatively
connected to an extracorporeal membrane oxygenation (ECMO)
system.
[0012] In some aspects, the cannula insertion system may be used
outside of the cardiovascular system, for example, in the urinary
system, in the digestive system, in the lymphatic system, or in
another portion of the body. In some aspects, the cannula insertion
system may be used with a ureter. In other aspects, the cannula
insertion system may be used with a bile duct.
[0013] According to another aspect of the disclosure, a method of
cannulating a blood vessel in a tissue includes the steps of:
creating an opening in a wall of the blood vessel by piercing the
wall with a distal end of a needle by moving the needle towards the
vessel and through the wall of the vessel; inserting a dilator into
the opening and expanding the opening; retracting the needle such
that the needle is moved out of the blood vessel; retracting the
dilator such that the dilator is moved out of the blood vessel;
inserting a cannula into the opening in the wall of the blood
vessel; and securing the cannula in the blood vessel. The cannula
defines a cannula lumen therethrough extending between a distal end
and a proximal end. The dilator and the needle are movable within
the cannula lumen. The steps described herein need not be performed
in the listed order.
[0014] In some aspects of the method, the needle may define a
distal end and a proximal end opposite the distal end and the
dilator may define a dilator lumen extending through the dilator
between a distal end and a proximal end. The step of retracting the
needle may include moving the needle in the dilator lumen from a
first position, in which the distal end of the needle is outside of
the dilator lumen and is distal to the distal end of the dilator,
to a second position, in which the distal end of the needle is in
the dilator lumen and is proximal to the distal end of the
dilator.
[0015] The step of securing the cannula to the blood vessel may
include moving a collet jaw from an unlocked position, in which the
collet jaw does not contact the tissue, to a locked position, in
which the collet jaw forcefully clamps the tissue such that the
blood vessel is held between the collet jaw and the cannula such
that at least a portion of the blood vessel is precluded from
translating relative to the cannula. In some aspects, the method
may further include the step of digging into the tissue with a tine
disposed on the collet jaw.
[0016] The tissue may be physiological tissue, such as an organ. In
some aspects, the tissue may include an umbilical cord of a
neonate.
[0017] The method may include the step of connecting the cannula to
an extracorporeal membrane oxygenation (ECMO) system.
[0018] In some aspects, the cannula may be connected to a
Y-connector that splits into a first proximal portion and a second
proximal portion separate from the first proximal portion. The step
of connecting the cannula to the ECMO system may include connecting
the second proximal portion of the Y-connector to the ECMO
system.
[0019] The method may further include the step of moving the
dilator and the needle out of the cannula lumen after the step of
securing the blood vessel to the cannula. In some aspects, the
cannula may be connected to a Y-connector that splits into a first
proximal portion and a second proximal portion separate from the
first proximal portion, and the step of moving the dilator and the
needle out of the cannula lumen may include moving the dilator and
the needle through the first proximal portion. In some aspects, the
method may further include moving the needle and the dilator
through a slit seal defined in the first proximal portion of the
Y-connector.
[0020] In some aspects, the method may further include the step of
inserting a plug into a first proximal channel of the Y-connector
to prevent blood flow out of the first proximal portion.
[0021] According to another aspect of the disclosure, a cannula
system includes a cannula having a distal end and a proximal end
opposite the distal end; a cannula lumen extending through the
cannula between the distal end and the proximal end; and a slit
seal disposed on the cannula, the slit seal being configured to
receive a cannula insertion device. The cannula system is
configured to be in fluid communication with a blood vessel and
with an oxygenator. The blood vessel may be in a tissue. The tissue
may be physiological tissue, such as an organ. In some aspects, the
tissue may include an umbilical cord of a neonate, and the cannula
system may be configured to be in fluid communication with a blood
vessel of the umbilical cord and with the oxygenator.
[0022] In some aspects, the cannula of the cannula system may
further include a Y-shaped connector having a first proximal
portion and a second proximal portion; and a slit seal disposed on
the cannula. The slit seal may be configured to receive a cannula
insertion device therethrough. The cannula lumen may extend through
the second proximal portion of the Y-shaped connector. The slit
seal may be configured to allow fluid communication between the
first proximal portion and the cannula lumen. The cannula system
may optionally include one or more features of cannula systems
described throughout this application.
[0023] According to another aspect of the disclosure, a cannula for
fluidly communicating with a vessel of a tissue includes a distal
end; a proximal end opposite the distal end; a cannula lumen
extending through the cannula between the distal end and the
proximal end; a Y-shaped connector having a first proximal portion
and a second proximal portion; and a slit seal disposed on the
cannula, the slit seal being configured to receive a cannula
insertion device therethrough. The cannula lumen extends through
the second proximal portion of the Y-shaped connector. The slit
seal is configured to allow fluid communication between the first
proximal portion and the cannula lumen. The tissue may be
physiological tissue, such as an organ. In some aspects, the tissue
may include an umbilical cord of a neonate. The cannula may
optionally include one or more features of cannulas described
throughout this application.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The foregoing summary, as well as the following detailed
description of illustrative embodiments of the application, will be
better understood when read in conjunction with the appended
drawings. For the purposes of illustrating the present disclosure,
the drawings depict illustrative embodiments. It should be
understood, however, that the application is not limited to the
specific embodiments and methods disclosed, and reference is made
to the claims for that purpose. In the drawings:
[0025] FIG. 1 is an isometric view of a cannula insertion system
according to one aspect of the disclosure;
[0026] FIG. 2 is a cross-sectional view of the cannula insertion
system of FIG. 1;
[0027] FIG. 2A is a close-up cross-sectional view of a portion of
the cannula insertion system of FIG. 2;
[0028] FIG. 3 is an isometric view of a cannula insertion device
according to an aspect of the disclosure;
[0029] FIG. 4 is a cross-sectional view of the cannula insertion
device of FIG. 3;
[0030] FIG. 5 is close-up cross-sectional view of portion A of the
cannula insertion device of FIGS. 3 and 4;
[0031] FIG. 5A is a close-up cross-sectional view of a portion of
the cannula insertion device depicted in FIG. 5;
[0032] FIG. 6 is a close-up cross-sectional view of portion B of
the cannula insertion device of FIGS. 3-5;
[0033] FIG. 6A is a close-up cross-sectional view of the portion of
FIG. 6 but depicting the actuator spaced apart from the blocking
surface;
[0034] FIG. 7 is an isometric cross-sectional view of another
portion of the cannula insertion device of FIGS. 3-6A;
[0035] FIG. 7A is a cross-sectional view of the housing of the
cannula insertion device of FIGS. 3-7;
[0036] FIG. 8 is a side perspective view of a needle assembly
according to an aspect of this disclosure;
[0037] FIG. 9 is a side cross-sectional view of a portion of the
needle assembly of FIG. 8;
[0038] FIG. 10 is an isometric view of a dilator assembly according
to an aspect of this disclosure;
[0039] FIG. 11 is a side perspective view of the dilator assembly
of FIG. 10;
[0040] FIG. 11A is a side cross-sectional view of a portion of the
cannula insertion device showing a retention member inside the
housing;
[0041] FIG. 11B is a side cross-sectional view of the portion of
FIG. 11A showing the retention member in line with a dilator
assembly blocking surface on the housing;
[0042] FIG. 12 is a side cross-sectional view of a dilator
according to an aspect of this disclosure;
[0043] FIG. 12A is a side cross-sectional view of a dilator
according to an aspect of this disclosure;
[0044] FIG. 12B is a side cross-sectional view of a dilator
according to another aspect of the disclosure;
[0045] FIG. 13 is an isometric view of a cannula system according
to another aspect of this disclosure;
[0046] FIG. 14 is a side cross-sectional view of the cannula system
of FIG. 13;
[0047] FIG. 15 is an isometric cross-sectional view of a portion of
the cannula system of FIGS. 13 and 14;
[0048] FIG. 16 is a side perspective view of a portion of the
cannula system of FIGS. 13-15, depicting collet jaws in an open
position and a vessel (shown in phantom);
[0049] FIG. 17 is a cross-sectional view of a portion of the
cannula system of FIGS. 13-16, depicting collet jaws in a closed
configuration securing a vessel (shown in phantom);
[0050] FIG. 17A is an isometric view of the cannula system of FIGS.
13-17 with the collet jaws shown in the closed configuration and
showing the spring lock;
[0051] FIG. 18A is a side cross-sectional view of a cannula
insertion device with the needle and the dilator in the extended
positions according to an aspect of this disclosure;
[0052] FIG. 18B is a side cross-sectional view of a cannula
insertion device with the needle in the retracted position and the
dilator in the extended position according to an aspect of the
disclosure;
[0053] FIG. 18C is a side cross-sectional view of a cannula
insertion device with the needle and the dilator in the retracted
positions according to an aspect of the disclosure;
[0054] FIG. 18D is a close-up cross-sectional view of a portion of
the cannula insertion device shown in FIG. 18A;
[0055] FIG. 18E is a close-up cross-sectional view of a portion of
the cannula insertion device shown in FIG. 18B;
[0056] FIG. 18F is a close-up cross-sectional view of a portion of
the cannula insertion device shown in FIG. 18C;
[0057] FIG. 19 is a side cross-sectional view depicting the step of
piercing a vessel with a needle according to an aspect of the
disclosure;
[0058] FIG. 20 is a side cross-sectional view depicting the step of
inserting the dilator into the vessel of FIG. 19 according to an
aspect of the disclosure;
[0059] FIG. 21 is a side cross-sectional view depicting the step of
inserting the cannula into the vessel of FIGS. 19 and 20 according
to an aspect of the disclosure;
[0060] FIG. 22 depicts a process of cannulating a vessel with a
cannula insertion system according to an aspect of the
disclosure;
[0061] FIG. 23 depicts an exemplary view of a user holding the
cannula insertion device in a hand;
[0062] FIG. 24A depicts a step of cannulating an arterial vessel
according to an aspect of the disclosure;
[0063] FIG. 24B depicts a step of cannulating a venous vessel
according to an aspect of the disclosure; and
[0064] FIG. 25 depicts a schematic showing an external circulation
circuit connected to the cannula system.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0065] Certain terminology is used in the following description for
convenience only and is not limiting. The term "aligned" as used
herein in reference to two elements along a direction means a
straight line that passes through one of the elements and that is
parallel to the direction will also pass through the other of the
two elements.
[0066] Aspects of the disclosure will now be described in detail
with reference to the drawings, wherein like reference numbers
refer to like elements throughout, unless specified otherwise.
Certain terminology is used in the following description for
convenience only and is not limiting. The term "plurality," as used
herein, means more than one. The terms "a portion" and "at least a
portion" of a structure include the entirety of the structure.
Certain features of the disclosure that are described herein in the
context of separate embodiments may also be provided in combination
in a single embodiment. Conversely, various features of the
disclosure that are described in the context of a single embodiment
may also be provided separately or in any subcombination. The terms
"proximal" and "distal" can refer to the position of a portion of a
device relative to the remainder of the device or the opposing end
as it appears in the drawing. The proximal end can be used to refer
to the end manipulated by the user. The distal end can be used to
refer to the end of the device that is inserted and advanced and is
furthest away from the user. As will be appreciated by those
skilled in the art, the use of proximal and distal could change in
another context, e.g., the anatomical context in which proximal and
distal use the patient as reference, or where the entry point is
distal from the user.
[0067] One of the challenges associated with existing systems that
could support normal neonatal growth and organ maturation is
connection of the neonate's circulatory system to an oxygenator
configured to oxygenate the neonate's blood supply once the neonate
is removed from the womb. Cannulation of small vessels, such as the
arteries and vein in an umbilical cord, requires precise
manipulation of the device being used in the cannulation procedure.
In addition, the blood supply within the neonate is small, so
cannulation of the vessels within an umbilical cord must be done
quickly and with as little neonatal blood loss as possible to
maximize the chance of a successful outcome. Further, lowering the
time required to cannulate an umbilical cord and reducing the
amount of stimuli applied to the umbilical cord can reduce or
prevent the umbilical cord from spasming, as well as decrease the
time the neonate is not receiving oxygen, thus lowering the chance
of adverse effects due to hypoxia.
[0068] Accordingly, a cannula insertion system configured to
quickly, efficiently, and safely create an opening into a vessel,
such as a vein or artery within an umbilical cord, attach a cannula
to the vessel to provide a passageway into and out of the vessel,
and establish a blood flow between the neonate and an oxygenator
may result in an increase in successful outcomes of cannulation
procedures.
[0069] Generally, a cannula insertion system can include a cannula
insertion device configured to open a passageway into a vessel and
insert a cannula into the vessel, such that blood can move from the
vessel into the cannula, or vice versa. The cannula insertion
system may also include a needle assembly, a dilator assembly, and
a cannula. The vessel can be inside a body, such as a human body.
According to one aspect of the disclosure, the vessel can form a
portion of an external blood circuit outside of a body, such as an
umbilical cord of a full-term or premature neonate.
[0070] The disclosed aspects can be utilized with various humans or
animals. Specifically, these embodiments can be used to cannulate a
blood vessel in the umbilical cord of a child, such as a premature
neonate. When the vessel is cannulated, blood can flow from the
umbilical cord through the cannula and to a desired destination,
such as an external blood circulation circuit. Some of the
disclosed allow for the cannulation process to be performed
single-handedly and without additional tools or assistance, thus
improving simplicity and reducing the need for extra components or
people in the cannulation space. This lowers the risk of using an
incorrect medical tool or improperly combining various tools in an
attempt to achieve cannulation. By allowing the user to operate the
cannula insertion system with one hand, the user's other hand is
free to perform other tasks.
[0071] In some aspects, the systems disclosed throughout this
application may be used outside of the cardiovascular system. In
some aspects, the systems may be used for cannulating a lumen or
vessel in the urinary system, in the digestive system, in the
lymphatic system, or in another portion of the body. For example,
in some aspects, the systems and methods described herein may be
used with a ureter or with a bile duct.
[0072] In one preferred embodiment, a cannula insertion system
includes a cannula insertion device and a cannula system. The
cannula system can be used to transport blood from a neonate
between one or more external medical devices. The cannula system
can be removably connected to the umbilical cord of the neonate.
For example, the cannula insertion system can have a plurality of
cannula systems that are each connected to a separate blood vessel
in the umbilical cord. In the preferred embodiment, two cannula
systems may be connected to separate arteries, and one cannula
system can be connected to a vein in the umbilical cord, thus
forming a circulation loop, where blood leaves the neonate, moves
into the cannula system, moves into a connected circulation
circuit, and then returns to the neonate. In some aspects, if the
cannulation process should be repeated, the cannula system is
disengaged from the vessel and surrounding tissue and the cannula
insertion system is reset (as explained in detail later). The
cannula system can then be introduced to a different portion of the
umbilical cord, and the initially used portion of the umbilical
cord may be severed.
[0073] Continuing with the preferred embodiment, the cannula system
may releasably engage with a cannula insertion device, which
facilitates connecting and securing the cannula system to each
respective blood vessel. The cannula insertion system may be
handheld and designed to be operated by the user with the same hand
that is holding it. Such one-handed operation allows the user the
ability to use the second hand for other tasks. In general, in the
preferred embodiment, the cannula insertion system can be
configured to penetrate a targeted blood vessel, expand the opening
in the vessel wall, connect the cannula system to the vessel (e.g.,
by inserting a portion of the cannula system into the blood vessel
through the created opening), and securing the cannula system to
the vessel. Once the necessary steps have been performed and the
cannula system is secured to the vessel, the cannula insertion
device may be disconnected from the cannula system.
[0074] Referring to FIGS. 1-7A, a cannula insertion system 10
includes a cannula insertion device 20. The cannula insertion
device 20 has a housing 220 that defines a housing recess 222
therein (see FIGS. 7 and 7A). The recess 222 may receive a cannula
system 28 therein. In some aspects, the housing 220 may define a
transparent or translucent portion 230, through which the user may
observe the movement of components and flow of blood through the
cannula system 28. The transparent or translucent portion 230
includes a transparent or translucent portion to permit a user to
view at least a portion of the housing recess 222.
[0075] A flashback chamber 231 (see FIG. 2) can be disposed in the
recess 222 and visible through the transparent or translucent
portion 230 and can be configured to provide information to a user
of the cannula insertion device 20. For example, the cannula
insertion device 20 can be configured to indicate successful entry
of a needle into a blood vessel. Upon connection of the cannula
insertion system with the vessel to be cannulated, liquid from the
vessel (for example blood) can travel through the cannula insertion
device 20 and into the flashback chamber 231. The flashback chamber
231 defines an opening 232, through which the blood may drip into
the portion of the recess 222 that is visible through the
transparent or translucent portion 230, thus indicating that the
vessel has been successfully cannulated. In some aspects, before
cannulating the vessel, the user may place a predetermined amount
of liquid (e.g., saline) into the flashback chamber 231 through the
opening 232 (e.g., by injecting the liquid). The cannula system may
be primed with a suitable material before use (e.g., blood, saline,
or known composition, such as PlasmaLyte). The blood moving through
the flashback chamber 231 upon successful insertion of the needle
can then expedite time for flashback with the liquid in the
flashback chamber 231, and a droplet of the mixture can drip out of
the opening 232. Visualization of the flashback serves as an
indication the needle puncturing the vessel wall and entering the
blood vessel. If blood does not drip from the flashback chamber
231, this may be an indication that, for example, the needle did
not properly enter the vessel, the needle inadvertently punctured
an opposing vessel wall and exited the vessel, and/or there is a
mechanical blockage in the cannula insertion device 20. An
elastomeric plug 233 may be removably positioned in the opening
232. The plug 233 may be moved away from the opening 232 when the
cannula system is primed. After the needle has been retracted, the
plug 233 is disposed in the opening 232 and prevents the fluid from
exiting the needle lumen, thus decreasing blood loss. The plug may
further serve as a physical barrier to prevent debris from entering
the flashback chamber 231 through the opening 232.
[0076] The housing 220 can be sized such that the cannula insertion
device 20 can be held in one hand by the user. It will be
appreciated that the housing 220 need not fit entirely into the
palm of the user's hand and can extend out of the hand in one or
more directions (see, e.g., FIG. 23). The housing 220 extends
between a distal end 221 and a proximal end 223 opposite the distal
end 221. The housing 220 has a maximum length L extending along an
axis parallel to D1 from the distal end 221 to the proximal end
223, a maximum width W extending along an axis perpendicular to the
length L, and a maximum height H extending along an axis
perpendicular to both the length L and the width W (see FIG. 3). In
some aspects, the housing 220 may have a length L up to about 300
mm, up to about 250 mm, up to about 235 mm, up to about 200 mm, or
up to another suitable length. In some aspects, the housing 220 may
have a width W up to about 50 mm, up to about 40 mm, up to about 30
mm, or up to another suitable width. In some aspects, the housing
220 may have a height H up to about 50 mm, up to about 40 mm, up to
about 30 mm, or up to another suitable height. In some specific
embodiments, the housing 220 may have a length L of between about
150 mm to about 300 mm, preferably between about 175 mm to about
275 mm, and more preferably between about 175 mm to about 250 mm, a
width W between about 20 mm to about 40 mm, preferably between
about 25 mm to about 35 mm, and a height H between about 25 mm to
about 35 mm, and in one embodiment a length L of about 200 mm, a
width W of about 28 mm, and a height H of about 31 mm. It will be
further appreciated that the housing 220 may have different or
additional dimensions, and that the specific sizes and shapes
thereof would depend on the intended use. The precise dimensions of
the housing 220, as well as of the cannula insertion device 20 or
the cannula insertion system 10 as a whole, can be selected to
allow for single-handed use by the user. For example, the housing
220 can be sized in such a way that an average user can perform the
anticipated discrete functions of the cannula insertion system
(e.g., retracting the needle, retracting the dilator, and
disengaging the cannula from the cannula insertion device) without
substantially relocating the housing 220 in the hand between
functions and, in some preferred embodiments, being able to perform
all functions with the same digit (e.g., with the thumb of the hand
holding the housing).
[0077] Referring to FIGS. 8 and 9, the cannula insertion system 10
can include a needle assembly 22. The housing recess 222 can be
configured to receive the needle assembly 22. The needle assembly
22 can include a needle 40, which is configured to pierce a vessel
thereby creating a passage into the vessel. According to one aspect
of the disclosure, the needle 40 can be configured to pierce and
open a passage into a blood vessel, for example a blood vessel
located in an umbilical cord of a neonate. The needle 40 can
include a needle body 42 that extends from a proximal end 44 of the
needle 40 to a distal end 46 of the needle 40. The proximal end 44
of the needle 40 can be spaced from the distal end 46 of the needle
40 in a proximal direction PD, and the distal end 46 can be spaced
from the proximal end 44 of the needle 40 in a distal direction DD.
As shown in the illustrated embodiment, the needle body 42 can be
elongate along a first direction D1 extending from the proximal end
44 to the distal end 46 or vice versa. The first direction D1 is
bidirectional, and can include both the proximal direction PD and
the distal direction DD. The first direction D1 can be used for
reference with other components of the cannula insertion system
described throughout this specification.
[0078] The needle 40 defines a length L1 measured between the
proximal end 44 and the distal end 46 of the needle 40. According
to one embodiment, the length L1 can be between about 25 mm and
about 305 mm. According to one embodiment, the length L1 can be
between about 150 mm and about 180 mm, and preferably between about
100 mm and about 200 mm.
[0079] As shown in FIG. 9, the needle 40 can further include a
needle lumen 48 defined by the needle body 42 and extending along
the entirety of the length L1 between the proximal end 44 and the
distal end 46. The needle lumen 48 may have a circular
cross-section. The needle 40 can define a central axis 49, along
which the needle lumen 48 extends. The central axis 49 can be
parallel to the first direction D1. The needle 40 defines a gauge
determined by a size of the needle lumen 48, specifically by a
cross-sectional area J1 that is perpendicular to the first
direction D1. The lumen 48 of the needle 40 can define a
cross-sectional area between about 0.05 mm.sup.2 and about 0.8
mm.sup.2, or between about 0.2 mm.sup.2 and about 0.45 mm.sup.2.
The needle 40 can be between a 20 gauge needle and a 25 gauge
needle. According to another aspect, the needle 40 can be larger
than a 20 gauge needle, for example, if the needle 40 is configured
for use in vessels larger than vessels typically found in an
umbilical cord. In some aspects, the needle 40 can be solid such
that the needle 40 is devoid of a needle lumen 48. In some
exemplary embodiments, the needle 40 may be a 20 gauge needle
having an outer diameter of about 0.603 mm.
[0080] Referring still to FIG. 9, the needle 40 can include a
bleedback reduction mechanism 45, configured to provide restriction
to blood flow through the needle lumen 48, while still allowing
some amount of blood flow, which can be used to identify when the
needle 40 has entered a vessel. According to one embodiment, the
needle 40 can include a micro hole 47, which is smaller than the
needle lumen 48. The bleedback reduction mechanism 45 can be
positioned in the needle lumen 48, for example in or near the
distal end 46, in or near the proximal end 44, or between the
distal end 46 and the proximal end 44. A portion of the bleedback
reduction mechanism 45 can be positioned outside the needle lumen
48, for example around an exterior portion of the proximal end 44.
In some exemplary embodiments, the bleedback reduction mechanism 45
may be in liquid communication with the flashback chamber 231, such
that blood is configured to move through the needle 40, and
specifically through the bleedback reduction mechanism 45, and into
the flashback chamber 231. Liquid may pass through the micro hole
47 and into the flashback chamber 231 as described above. In one
embodiment, the bleedback reduction mechanism 45 effectively
reduces the inner diameter of the needle lumen 48. In some aspects,
the bleedback reduction mechanism 45 can include a feature on the
needle 40 configured to reduce the inside diameter of the needle
lumen 48 locally to define the micro hole 47.
[0081] As shown in FIG. 9, the tip of needle 40 can include a bevel
64 having a base end 65 and a tip end 66. As the bevel 64 extends
from the base end 65 to the tip end 66, the cross-sectional area J1
decreases. The needle 40 can define a bevel angle .alpha. measured
from the central axis 49 to the bevel 64. According to one
embodiment, the bevel angle .alpha. may be between about 1 degree
and about 60 degrees. According to another embodiment, the bevel
angle .alpha. may be between about 5 degrees and about 45 degrees.
According to yet another embodiment, the bevel angle .alpha. can be
between about 10 degrees and about 25 degrees. According to yet
another embodiment, the bevel angle .alpha. can be between about 12
degrees and about 22 degrees. A smaller bevel angle .alpha. can
result in easier piercing of a vessel and insertion of the needle
40, however decreasing the bevel angle .alpha. increases a length
of the bevel 64 measured from the base end 65 to the tip end 66.
According to one aspect of the disclosure, the needle 40 can
include a plurality of bevels such that the bevel 64 is one of the
plurality of bevels. The needle may be manufactured from a medical
grade material, such as surgical stainless steel, for example SAE
316, 420, or 440 stainless steel.
[0082] According to one embodiment, a successful insertion of the
needle 40 is achieved when both the tip end 66 and the base end 65
are positioned within the vessel. An increase in the length of the
bevel 64 can result in a greater insertion depth of the needle 40
needed to achieve a successful insertion, which may result in a
higher likelihood of "backwalling" or piercing the far side of the
vessel. Thus, according to one embodiment, the needle 40 is
configured to balance ease of insertion into an umbilical cord,
while maintaining an insertion depth that minimizes the chance of
backwalling the umbilical cord.
[0083] Referring again to FIGS. 1-7A, as shown in one aspect, the
cannula insertion device 20 includes a mechanism to translate the
needle 40 relative to the housing 220. A needle actuator 50 is
connected to or disposed on the housing 220 (see, specifically,
FIGS. 6-7). In some aspects, the needle actuator 50 is movable
within the recess 222. The needle actuator 50 is operably coupled
to the needle assembly 22 (see FIG. 8) such that actuation of the
needle actuator 50 transitions the needle 40 from a first position
to a second position. Referring to FIGS. 4-7, the needle actuator
50 is affixed to a hub 52 and a boom arm 54 disposed between the
needle actuator 50 and the hub 52. The hub 52 can include a recess
56 configured to receive the needle 40. The recess 56 defines a
shape that corresponds to an outer surface 59 of the needle body
42. The needle assembly 22 can be configured such that the needle
40 is permanently or temporarily secured to the hub 52. For
example, the needle 40 and the hub 52 can be secured with adhesive,
overmolding, welding, corresponding threads, etc.
[0084] According to one embodiment, the needle 40 and the needle
actuator 50 are configured to be secured such that movement,
including translation, rotation, or both, of the needle 40 relative
to the hub 52 is prevented without plastic deformation of the
needle assembly 22.
[0085] The boom arm 54 extends from the hub 52 to the needle
actuator 50, for example at least partially in the distal direction
DD, as shown in the illustrated embodiment. The boom arm 54 can
include a proximal end 55 adjacent to the hub 52 and a distal end
57 opposite the proximal end 55 and positioned such that the boom
arm 54 terminates at the distal end 57 at the needle actuator 50.
The needle actuator 50 can include an actuation surface 58
configured to be contacted by the user. As shown in FIG. 6, the
actuation surface 58 can face in the second direction D2. In other
aspects, the actuation surface 58 can be oblique or normal to the
second direction D2. The user can push on the actuation surface 58,
for example with a finger or a thumb, to cause the needle actuator
50 to move the needle 40.
[0086] As seen in FIGS. 6 and 6A, the needle actuator 50 can
include a stop surface 60, for example positioned adjacent the
distal end 57. According to one embodiment, the stop surface 60
faces in the proximal direction PD. The stop surface 60 is
configured to selectively abut another surface of the cannula
insertion device 20, for example, a blocking surface 124 defined by
the housing 220. FIG. 6 shows the stop surface 60 abutting the
blocking surface 124, while FIG. 6A shows the stop surface 60
spaced away from the blocking surface 124.
[0087] The needle assembly 22 can further include a biasing member
62, for example a spring or a resilient elastic (see FIGS. 5 and
5A). The biasing member 62 is configured to apply a biasing force
on the needle assembly 22. According to one embodiment, the biasing
member 62 is configured to apply a force on the hub 52 in the
proximal direction PD.
[0088] The needle assembly 22 may have a loaded and an unloaded
configuration. In the loaded configuration, the needle 40 is in a
first position, and the biasing member 62 is exerting a biasing
force on the hub 52 in the proximal direction PD. The boom arm 54
may be held in place against the biasing force by the contact
between the stop surface 60 and the blocking surface 124, which
serves as a physical stop to prevent the needle assembly 22 from
being moved by the biasing member 62 (see FIGS. 6 and 6A). It will
be appreciated that the force exerted by the biasing member 62 is
sufficient to move the needle assembly 22 when there is no
resistance to this movement, but insufficient to cause deformation
or damage to either the boom arm 54, the hub 52, the needle 40, or
the housing 220 when the biasing force is kept static due to the
engagement of the stop surface 60 and the blocking surface 124.
[0089] In the unloaded configuration, the stop surface 60 is not in
contact with the blocking surface 124, and the needle assembly 22
is positioned more proximally than when it is in the loaded
configuration. To transition the needle assembly 22 from the
unloaded configuration to the loaded configuration, the needle
assembly 22 is moved in the distal direction DD against the biasing
force exerted by the biasing member 62 onto the needle assembly 22
as explained below. The transition may be actuated manually by the
user. The user may apply a force onto the needle assembly 22 (for
example, at the flashback chamber 231) and push the needle assembly
22 in the distal direction DD. In some aspects, the housing 220 may
be open at the proximal end 221, such that a user can insert a
finger or thumb into the housing 220 to contact the flashback
chamber 231. It will be appreciated that the force applied by the
user should be greater than the biasing force exerted by the
biasing member 62. In some aspects, the user can apply the loading
force by pressing on the flashback chamber 231 in the distal
direction DD. When the needle assembly 22 is in the loaded
configuration, the user may hear an audible click that indicates
successful transition of the needle assembly 22 from the unloaded
configuration to the loaded configuration.
[0090] In the loaded configuration, the needle assembly 22 is
configured such that as the user contacts (e.g., pushes on) the
actuation surface 58, the distal end 57 of the needle actuator 50
moves relative to the hub 52. This movement may cause the boom arm
54 to elastically deform. As shown, for example, in FIGS. 18A and
18B, the user input can include an activation force F applied to
the actuation surface 58 in a third direction D3. The third
direction D3 can be opposite the second direction D2, normal to the
actuation surface 58, both, or neither. The boom arm 54 may be
moved by applying a force to the actuation surface 58, for example
in the third direction D3, such that the stop surface 60 disengages
from the blocking surface 124. Without this engagement, the biasing
force causes needle assembly 22 to move in the proximal direction
PD. The needle 40 is at a first position within the cannula
insertion device 20 when the stop surface 60 and the blocking
surface 124 are engaged (FIGS. 18A and 18D) and in a second
position when the stop surface 60 and the blocking surface 124 are
not engaged and the biasing force exerted by the biasing member 62
on the hub 52 has caused the needle assembly 22 to move in the
proximal direction PD such that the stop surface 60 is located
proximally to the blocking surface 124 (FIGS. 18B and 18E).
[0091] Referring to FIGS. 10-12, the cannula insertion system can
further include a dilator assembly 25. In one embodiment, the
dilator assembly 25 functions to house the needle 40 and create a
larger opening in the blood vessel after the end of the needle
pierces the wall of the blood vessel. Expanding the opening in the
blood vessel can help insert a cannula into the vessel, as
explained further below. The dilator assembly 25 includes a dilator
26, a dilator hub 246 configured to fixedly retain the dilator 26
therein, and a dilator movement mechanism 240. Referring
specifically to FIG. 12, the dilator 26 may include a distal end
90, a proximal end 92, and a dilator body 94 that extends from the
proximal end 92 to the distal end 90. The dilator 26 further
includes a dilator lumen 96 defined by the dilator body 94. As
shown in the illustrated embodiment, the dilator lumen 96 can
extend through the entirety of the dilator body 94 between the
proximal end 92 and the distal end 90. The dilator lumen 96 has a
slightly larger cross-sectional area than the outer surface area of
the needle 40 and is configured to receive the needle 40 therein.
The needle 40 is slidably movable within the dilator lumen 96 and
can extend, at least in part, out of the dilator lumen 96 at the
distal end 90, out of the dilator lumen 96 at the proximal end 92,
or out of both ends of the dilator lumen 96. In some aspects, the
needle 40 may be longer than the dilator 26.
[0092] The dilator body 94 can define a tapered portion 98 adjacent
the distal end 90. The dilator 26 can define an outer
cross-sectional area J2, which decreases as the tapered portion 98
extends in the distal direction DD. As shown in the illustrated
embodiment, the minimum cross-sectional area J2 of the tapered
portion 98 can be located at the distal end 90 of the dilator 26.
In some aspects, the dilator 26 may have an outer diameter 91 of
between about 2 mm and about 6 mm. In some exemplary aspects (see
FIG. 12B), the dilator 26 may have an outer diameter 91 of between
about 4 mm and about 5 mm. In other exemplary aspects (see FIG.
12A), the dilator 26 may have an outer diameter 91 of between about
2 mm and about 3 mm. It will be appreciated that the specific sizes
of the dilator 26 will depend on the intended use with the cannula
insertion system 10. In some aspects, the specific dilator 26 that
will be used will depend on the vasculature of the umbilical
cord.
[0093] The tapered portion 98 may have a specific length 93
measured from the distal end 90 to the beginning of the taper
located at the position on the dilator body 94 where the outer
cross-sectional area J2 begins to decrease relative to outer
cross-sectional area J2 of the rest of the dilator body 94. In some
aspects, the length 93 of the tapered portion 98 may be between
about 1 mm and about 12 mm, between about 2 mm and about 11 mm,
between about 3 mm and about 10 mm, between about 4 mm and about 9
mm, or another suitable length. In some exemplary aspects (see FIG.
12A), the length 93 of the tapered portion 98 may be about 4 mm. In
other exemplary aspects (see FIG. 12B), the length 93 of the
tapered portion 98 may be about 9 mm.
[0094] The tapered portion 98 may have an inner diameter 95 that is
different from the inner diameter of the rest of the dilator body
94 not at the tapered portion 98 or, alternatively, the inner
diameter 95 may be the same throughout the entire dilator body 94,
including the tapered portion 98. In some exemplary aspects, the
inner diameter 95 of the tapered portion 98 may be between about
0.5 mm and about 2 mm. In some specific exemplary embodiments, the
inner diameter 95 of the tapered portion 98 may be about 0.96
mm.
[0095] The dilator 26 may be sized and shaped according to a
particular aspect described above based on its intended application
in the cannula insertion system 10. Since the cannula insertion
system 10 can be utilized to cannulate an arterial vessel or a
venous vessel, different parameters of the dilator 26 may be
preferable. For example, in aspects where the cannula insertion
system 10 will be used to cannulate an arterial vessel, it may be
preferable to utilize a smaller dilator than the dilator used for
cannulating a venous vessel. In some aspects, when the cannula
insertion system 10 is intended to cannulate an arterial vessel,
the dilator 26 may have a tapered portion 98 having a length 93 of
about 4 mm (see, e.g., FIG. 12A). The dilator 26 may be between
about 3 Fr and about 17 Fr, between about 5 Fr and about 15 Fr, or
in another suitable size range. The dilator size may be determined
relative to the size of the cannula 104. In some aspects, the
dilator can be 3, 4, 5, . . . , 17 Fr or another suitable size. In
some exemplary aspects, where the cannula insertion system 10 is
intended to cannulate an arterial vessel, the dilator 26 may be
between about 4 Fr and about 11 Fr. In other aspects, where the
cannula insertion system 10 is intended to cannulate a venous
vessel, the dilator 26 may have a tapered portion 98 having a
length 93 of about 9 mm (see, e.g., FIG. 12B). The dilator 26 in
these examples can be between about 9 Fr and about 17 Fr. The
difference in dilator tip sizes and geometry allows for the desired
ease of entry of the dilator into the vessel and for reduced risk
of unintended piercing of the opposing vessel wall.
[0096] Referring to FIGS. 10 and 11, the dilator 26 may be
translated by the dilator movement mechanism 240, which includes a
dilator actuator 242 disposed on or within the housing 220. When
the dilator actuator 242 is moved in a first direction, the dilator
hub 246 and the dilator 26 therein are moved towards the vessel
that is to be cannulated, for example in the distal direction DD.
When the dilator actuator 242 is moved in a second, opposite
direction, the dilator hub 246 and the dilator 26 therein are moved
away from the vessel, for example in the proximal direction PD. In
some aspects, movement of the dilator actuator 242 results in
movement of the dilator hub 246 and the dilator 26 in the opposite
direction, for example, where moving the dilator actuator 242 in
the distal direction DD causes the dilator 26 to move in the
proximal direction PD, and moving the dilator actuator 242 in the
proximal direction PD causes the dilator 26 to move in the distal
direction DD.
[0097] In some aspects, the dilator movement mechanism 240 further
includes a rack and pinion gear system 260 that is disposed in the
housing 220 and is configured to engage and operate with the
dilator hub 246. A first pinion 262 is disposed on the housing 220
and is rotatable along its axis. The first pinion 262 engages with
a first rack 264 and is configured to cause the first rack 264 to
move along the first direction D1. A second pinion 266 is disposed
on the housing 220 and is rotatable along its axis. The second
pinion 266 is engaged with a second rack 268 and is configured to
cause the second rack 268 to move along the first direction D1. In
some aspects, the first pinion 262 may be affixed to the second
pinion 266, such that when the when one of the pinions rotate, the
other pinion also rotates. It will be appreciated that the rack and
pinion gear system 260 may include a single pinion that engages
with both racks, or, alternatively, may include more than two
pinions and more than two racks.
[0098] Referring to FIGS. 18A-18F, the position of the dilator 26
along the first direction D1 may be controlled by movement of the
dilator actuator 242, for example also along the first direction
D1. When the dilator actuator 242 is in a first position, for
example its most proximal position, the dilator 26 is in its
extended configuration, for example, its most distal position
(FIGS. 18A and 18B). As the dilator actuator 242 is moved in the
distal direction DD, the rack and pinion gear system 260 in the
dilator movement mechanism 240 described above may cause the
dilator 26 to move in the proximal direction PD (FIGS. 18C and
18F). Movement of the dilator hub 246 and the dilator 26 may also
cause movement of the needle assembly 22 (with the needle) in the
proximal direction PD (FIGS. 18C and 18F). As best seen in FIGS. 5
and 5A, the needle hub 52 may contact the dilator hub 246 in such a
way that when the dilator hub 246 moves in the distal direction DD
or in the proximal direction PD, the needle hub 52 also moves in
the same respective direction. As shown in FIG. 18C, for example,
both the dilator hub 246 and the needle hub 52 are more proximal to
their respective positions in FIG. 18B.
[0099] As shown in FIGS. 10-11B, the dilator assembly 25 may
include a retention member 241 disposed thereon, for example on the
dilator movement mechanism 240. The retention member 241 is
elastically deformable, for example in the second or third
directions D2, D3. Referring to FIGS. 11A and 11B, the retention
member 241 is configured to releasably engage with a corresponding
dilator assembly blocking surface 225 defined on the housing 220 to
prevent inadvertent movement of the dilator assembly 25. The
retention member 241 defines a retention surface 243 that is
configured to contact the dilator assembly blocking surface 225.
For example, when the dilator assembly 25 is disposed such that the
dilator 26 is in its extended configuration (such as FIGS. 18A and
18B), the retention member 241 is inside the housing 220, for
example in the recess 222, such that the retention surface 243 is
not in contact with the housing 220 (see FIG. 11A). When the
dilator assembly 25 is moved such that the dilator 26 is in its
retracted configuration (such as in FIG. 18C), the retention member
241 is moved outside of the recess 220 such that the retention
surface 243 is positioned in line with the dilator assembly
blocking surface 225 along the first direction D1 (see FIG. 11B).
If the user attempts to move the dilator actuator 242 backwards in
the opposite direction after the dilator 26 has been retracted, the
retention surface 243 contacts the dilator assembly blocking
surface 225 and precludes such movement. This prevents inadvertent
extension of the dilator 26 after the dilator 26 has already been
retracted. If such movement is still desired, or if the cannulation
process is complete, the dilator assembly 25 may be moved back to
its original position where the dilator 26 is extended by
simultaneously moving the dilator actuator 242 in the proximal
direction PD and applying a force on the retention member 241 in
the third direction D3 (e.g., pressing down) such that the
retention surface 243 is no longer in line with the dilator
assembly blocking surface 225 along the first direction D1.
[0100] The cannula insertion system 10 can further include a
cannula system 28 that is configured to fluidly connect to the
vessel to be cannulated at one end and to a circulation system at
another end. Referring to FIGS. 13-17A, the cannula system 28 can
include a cannula 104 that has a distal end 100 a proximal end 102
opposite the distal end 100. The cannula 104 includes a cannula
lumen 106 defined by the cannula 104. As shown in the illustrated
embodiment, the cannula lumen 106 can enter the cannula 104 at one
of the proximal end 102 and the distal end 100, extend through an
entirety of the cannula 104, and exit the cannula 104 at the other
of the proximal end 102 and the distal end 100.
[0101] The cannula 104 can define a tapered portion 108 adjacent
the distal end 100. The cannula system 28 can define a
cross-sectional area J3 (see FIG. 17), which decreases as the
tapered portion 108 extends in the distal direction DD. The minimum
cross-sectional area J3 of the tapered portion 108 can be located
at the distal end 100 of the cannula system 28.
[0102] The cannula 104 can define a reinforced portion 110 that is
configured to be resistant to deformation. The reinforced portion
110 may be adjacent to the distal end 100. The reinforced portion
110 may include a component that is configured to resist
stretching, for example a polyethylene wire or thread or a
stainless steel wire. This prevents the reinforced portion 110 from
stretching when the cannula 104 is being inserted into the vessel
and the clamping mechanism is activated to secure the vessel to the
cannula system 28. The reinforced portion 110 may be a portion of
the cannula 104 or may comprise the entirety of the cannula 104
between the distal end 100 and the proximal end 102. The reinforced
portion 110 may include one or more materials that resist
stretching, such as nitinol, stainless steel, poly-aramid synthetic
mesh, such as KEVLAR.RTM. (available from E.I. Du Pont de Nemours
and Company of Wilmington, Del.), high-modulus polyethylene (e.g.,
DYNEEMA.RTM.), or other suitable materials. In this way, the
cannula 104 may be less flexible nearer its distal end 100 to
provide increased rigidity near the vessel, and thus, in one
embodiment, the distal 25%, more preferably 50% of the cannula 104,
is less flexible than the remaining proximal portion of the cannula
104.
[0103] In some embodiments, the dilator 26 and the cannula 104 may
be a single component having a tapered distal end. The inside
diameter of the tapered distal end may be approximately the same
as, or nominally greater than, the outside diameter of needle body
42, such that the needle body 42 can be disposed therein. The
tapered distal end of the combined dilator and cannula component in
such embodiments may be configured to be deformable such that the
tapered end can be expanded to produce a near-constant inside
diameter bore along its length when the combined dilator and canula
component is placed within the vessel. It will be appreciated that
the combined component may provide comparable functionality to the
functionality of separate dilators 26 and cannulas 104 as described
throughout this application.
[0104] The cannula system 28 may include a Y-connector 190
configured to connect to the cannula 104. The Y-connector divides
the cannula system 28 into two proximal portions. A first proximal
portion 194 defines a first proximal channel 206 extending
therethrough and is configured to interface and connect with the
cannula insertion device 20. A second proximal portion 196 defines
a second proximal channel 208 extending therethrough and is
configured to connect to one or more components of an external
circulation circuit 400 (see FIG. 25), for example an
extracorporeal membrane oxygenation (ECMO) system. The second
proximal portion 196 may connect to a tube 28b, which can then
connect to the external circulation circuit 400. A distal portion
192 of the Y-connector 190 defines a distal channel 210 and is
disposed opposite the first and second proximal portions 194, 196
and communicates with the cannula 104, for example at the proximal
end 102. The distal channel 210 is in fluid communication with the
cannula lumen 106 and with the second proximal channel 208. Fluid
communication between the distal channel 210 and the first proximal
channel 206 is reversible and may be opened or closed during using.
Although FIG. 14 depicts an embodiment in which the second proximal
channel 208 is coaxial with the cannula lumen 106, other
embodiments can place the first proximal channel 206 to coaxial
with the cannula lumen 106. Also, the needle 40 and dilator 26 can
be sufficiently flexible (e.g., resiliently flexible) to bend to
follow an insertion path from first proximal channel 206 to cannula
lumen 106.
[0105] The Y-connector 190 may be a separate component from the
cannula 104 or, in some aspects, the Y-connector 190 and the
cannula 104 may be formed as a monolithic unitary piece. Utilizing
a Y-shaped connector allows for the needle 40 and the dilator 26 to
be introduced through a first channel, while the liquid (e.g.,
blood) from the cannulated vessel is moved through a different
channel. This prevents blood loss, leaks, infections, or damage to
the cannula system 28 or any connected tubing. It also creates an
easier transition between the cannulation process and having the
blood flow through the cannula and allows for at least a portion of
the assembly to be connected to an external flow circuit during the
cannulation process. In some aspects, at least a part of the
Y-connector 190 may include the reinforced portion 110.
[0106] In some aspects, the entire cannula 104, the Y-connector
190, and the tube 28b may all be a single unitary piece that has
been molded (e.g., dip molded) as one component. Such unitary
construction could be beneficial to blood health by removing
transitions along the blood flow path, thus decreasing instances of
clot formation, leakage, or bacterial growth sites. The Y-connector
190 can include one or more materials that resist stretching, such
as nitinol, stainless steel, poly-aramid synthetic mesh, such as
KEVLAR.RTM. (available from E.I. Du Pont de Nemours and Company of
Wilmington, Del.), high-modulus polyethylene (e.g., DYNEEMA.RTM.),
or other suitable materials. Specifically, in some aspects, the
distal portion 192 may include the stretch-resistant materials
listed above, while the first and second proximal portions 194, 196
may be devoid of the stretch-resistant materials.
[0107] The first proximal portion 194 defines a seal 198 (see FIG.
15) through which the needle 40 and/or the dilator 26 may removably
pass when the cannula insertion device 20 is engaged with the
cannula system 28. It will be appreciated that the seal 198 is
configured to be reversibly opened to allow the needle 40 and the
dilator 26 to pass through while also being configured to be closed
when the needle 40 and dilator 26 are removed from the cannula
system 28. The seal 198 may include a resilient or elastic material
that is configured to deform in response to the forces of the
needle 40 or dilator 26 and to return to its undeformed state when
the needle 40 or dilator 26 are removed. The seal 198 should be
manufactured such that liquid in the cannula is precluded from
passing therethrough when the seal 198 is closed. When the seal 198
is open, the distal channel 210 may fluidly communicate with both,
the first proximal channel 206 and the second proximal channel 208.
When the seal 198 is closed, the distal channel 210 may only
communicate with the second proximal channel 208. In some
embodiments the seal 198 may be a slit seal 198 in the wall of the
Y-connector 190 within the first proximal portion 194. In some
embodiments, the seal 198 may be a septum seal in the wall of the
Y-connector 190 within the first proximal portion 194 that is
configured to be pierced by the needle 40 and the dilator 26.
[0108] A rigid casing 200 may be disposed on the Y-connector 190 to
provide structure to the Y-connector 190. The casing 200 may be any
suitable shape, for example a Y-shape that complements the shape of
the Y-connector 190. The casing 200 may be a unitary piece or, in
some aspects, it may include separate components, for example a
first casing component disposed on the first proximal portion 194
and a second casing component disposed on the second proximal
portion 196. The rigid casing 200 may be formed of a plastic, such
as polycarbonate.
[0109] As shown, for example, in FIG. 13, the rigid casing 200 may
include a locking component 202 disposed thereon for releasably
engaging the cannula system 28 with the cannula insertion device
20. The cannula insertion device 20 includes a complementary
locking component 224 (see FIGS. 6 and 7) that is configured to
interact with the locking component 202 to releasably lock the
cannula system 28 to the housing 220 of the cannula insertion
device 20 to prevent inadvertent dislodging, disconnecting,
relative translation, or relative rotation. The locking components
202, 224 may be any suitable locking mechanism, such as a
protrusion, a rail, a hook, a latch, or another mechanism. The
locking engagement may be reversed to de-couple the cannula system
28 from the cannula insertion device 20.
[0110] Referring back to FIGS. 1-7A showing the cannula insertion
device 20, a release mechanism 226 may be disposed on the housing
220 of the cannula insertion device 20 and be configured to actuate
movement of the locking component 224 on the housing 220. When the
locking component 224 on the housing 220 is moved, it disengages
from the locking component 202 on the casing 200, thus allowing the
cannula system 28 to be removed from the cannula insertion device
20. The release mechanism 226 may be a button, a switch, a latch,
or another suitable mechanism. In some aspects, a second release
mechanism 226b may be disposed on the housing. The second release
mechanism 226b may be used in case the primary release mechanism
226 does not sufficiently de-couple the components or in case of
another emergency.
[0111] In some aspects, the casing 200 may further include a guide
270 on one of the first proximal portion 194, the second proximal
portion 196, or both proximal portions (see, for example FIGS.
13-15). The guide 270 corresponds to the shape of the recess 222
such that the cannula system 28 is insertable therein only in the
desired orientation. For example, the guide 270 may be disposed on
the second proximal portion 196, such that the second proximal
portion 196 cannot be inadvertently inserted into the recess 222
and engaged with the needle assembly 22 or the dilator 26. This
prevents user error and decreases the chances of damaging the
cannula system 28 or the cannula insertion device 20, and prevents
incorrect connections, which can lead to improper blood
circulation, blood loss, intrusion of air bubbles, or leakage.
[0112] In some aspects, it is advantageous to secure the cannulated
vessel to the cannula 104 once the cannula 104 has been inserted
into the vessel. A clamping mechanism may be used to releasably
secure the cannula 104 to the vessel. It will be appreciated that
the cannula 104 may be secured to the vessel indirectly, for
example by contacting a portion of the umbilical cord. In some
aspects, the clamping mechanism may contact the umbilical sheath,
the Wharton's jelly within the umbilical cord, or the vessel
itself. In some aspects, the clamping mechanism is affixed to the
cannula system 28 or, specifically, to the cannula 104. Referring
again to FIGS. 13-17A, one or more collet jaws 170 may be disposed
on or adjacent to the cannula 104. The collet jaws 170 may include
a base 172 (seen in FIG. 14), at which the collet jaws 170 are
affixed to the cannula 104, a head 174 opposite the base 172, and a
deformable arm 176 extending between the base 172 and the head 174.
The deformable arms 176 may be curved, such that when the base 172
is attached to and contacts the cannula 104, the head 174 is spaced
away from the cannula 104. In this arrangement, the collet jaws 170
are biased open. In some aspects, the collet jaws 170 may be formed
from titanium. In other aspects, the collet jaws 170 may be formed
from a stainless steel, such as 306 stainless steel or 316
stainless steel.
[0113] As depicted in the exemplary aspect of FIG. 17, during
engagement, the deformable arm 176 may be flexed and straightened
along its length, such that the head 174 is moved towards the
cannula 104. A portion of the cannulated vessel 2 (shown in
phantom) may be disposed between the cannula 104 and the head 174,
and when the deformable arm 176 is flexed toward the cannula 104,
the inner wall of the vessel 2 is pressed against the outer surface
of the cannula 104 by the inner surface of the head 174. This
secures the vessel 2 in place relative to the cannula 104. As noted
above, it will be understood that the head 174 may press the vessel
2 against the cannula 104 by pressing on another portion of the
umbilical cord 1, for example the umbilical sheath, rather than
contacting the vessel 2 directly.
[0114] Referring still to FIGS. 13-17A, in some aspects, the
flexing of the deformable arm 176 may be actuated by a collet
sleeve 178 that is configured to slidably move along the cannula
104. The deformable arm 176 may be disposed between the cannula 104
and the collet sleeve 178. As the collet sleeve 178 is moved
towards the distal end 100, it slides over the deformable arm 176
and applies a force thereon, causing the deformable arm 176 to
deform and straighten. The forced applied by the collet sleeve 178
should be greater than the inherent resistance to bending in the
deformable arms 176. When the collet sleeve 178 is moved away from
the distal end 100, the force on the deformable arm 176 is removed,
and it returns to its undeformed configuration. In some aspects, a
physical stop 180 may extend from a portion of the collet jaw 170
to preclude the collet sleeve 178 from moving past it. In some
aspects, a stop 180 may be disposed on the head 174, on the
deformable arm 176, on the base 172, or on the cannula 104.
[0115] The collet jaws 170 include features to facilitate retention
of the cannulated vessel. In some aspects, one or more tines 182
(see FIGS. 16 and 17) may be disposed on the head 174, such that
when the collet sleeve 178 deforms the deformable arms 176 and
contacts the head 174 with the vessel, the tines 182 dig into,
pierce, or bite the umbilical cord 1. The tines 182 may dig into
the umbilical sheath of the umbilical cord, the blood vessel
itself, or another connecting tissue present in the umbilical cord.
It will be appreciated that the tines 182 need not dig into or bite
entirely through the umbilical cord. Such biting or digging into
further secures the vessel and prevents the vessel from translating
or rotating relative to the collet jaws 170 or the cannula 104, for
example, if the cannula 104 is pulled in the proximal direction PD
after it has been inserted into the vessel and secured to the
tissue. In some aspects, the tines 182 may be substantially
orthogonal to the head 174 or, instead, may be disposed at an angle
relative to the head 174, for example, such that the tines 182
extend from the head 174 away from the distal end 100 of the
cannula 104. The tines 182 may dig into the tissue surrounding the
vessel 2 (e.g., the umbilical sheath) or into the vessel 2 itself
and prevent the vessel 2 from dislodging or pulling away from the
cannula system 28 during the cannulation process or subsequent use.
It will be understood that although exemplary aspects herein are
directed to blood vessels in an umbilical cord, the disclosed
systems may be utilized in other parts of a human or other animal
body. It will be further appreciated that "tissue" may refer to
umbilical tissue or other physiological tissue, including an
organ.
[0116] In some aspects, it may be preferable to secure the vessel 2
as close to the distal end 100 of the cannula 104 as possible to
decrease the space between the distal end 100 and the portion of
the vessel 2 that is secured to the cannula system 28. This would
decrease collection of blood in that space and would reduce
ballooning of the vessel 2, where blood builds up between the
distal end 100 and the portion of the vessel 2 that is secured and
increases pressure while stretching and expanding the vessel. This
may lead to undesired de-coupling of the vessel 2 from the cannula
system 28, as well as stagnant blood, clotting, infections, poor
blood flow, blood loss, and/or leaks. FIG. 16 depicts the collet
jaws 170 in an unlocked position, where the head 174 is spaced away
from the cannula 104, and FIG. 17 depicts the collet jaws 170 in a
locked position, where the head 174 clamps the vessel 2 to the
cannula 104 between the head 174 and the cannula 104. The collet
jaws 170 may have 1, 2, 3, 4, or another suitable number of
deformable arms 176 and respective heads 174. In some exemplary
aspects, the collet jaws 170 have two deformable arms 176 and
respective heads 174. It will be understood that the collet jaws
170 may be used to apply a clamping action on the vessel 2 by way
of clamping down on the external tissue (e.g., umbilical cord or
Wharton's jelly) surrounding the vessel 2 and are not required to
clamp the vessel walls directly.
[0117] In some aspects, a spring lock 179 may be disposed on the
deformable arms 176 (see FIG. 17A). The spring lock 179 is held in
compression by the collet sleeve 178 when the collet jaws 170 are
in the unlocked configuration. When the collet sleeve 178 is moved
in the distal direction DD and causes the deformable arms 176 to
deform and to secure the cannula 104 to the vessel 2, the collet
sleeve 178 passes over and past the spring lock 179, allowing the
spring lock 179 to un-compress. The spring lock 179 is then
positioned proximal to the collet sleeve 178 (not shown) and acts
as a physical barrier to prevent the collet sleeve 178 from moving
in the proximal direction PD. The spring lock 179 may be moved back
to the compressed configuration by pushing it towards the cannula
104 and sliding the collet sleeve 178 back in the proximal
direction PD over the spring lock 179. Moving the spring lock 179
and sliding the collet sleeve 178 back allows the cannula insertion
device 20 to be "reset" to disengage the collet jaws 170 from the
tissue, for example, if the cannula 104 needs to be removed from
the vessel.
[0118] The housing 220 may include a mechanism for moving the
collet jaws 170. In some aspects, the mechanism may be part of or
connected to the dilator actuator 242 described above. Referring
again to FIGS. 1-7A, the dilator actuator 242 that is disposed on
the housing 220 may be movable in the distal direction DD and the
proximal direction PD relative to the housing 220 to cause movement
of the collet jaws 170. When the dilator actuator 242 is moved in
the distal direction DD, it may cause the collet jaws 170 to move
from an unlocked position, in which the vessel 2 is not secured
between the collet jaws 170 and the cannula system 28, to a locked
position, in which the vessel 2 is secured between the collet jaws
170 and the cannula system 28. The dilator actuator 242 may be
configured to contact the collet sleeve 178 such that movement of
the dilator actuator 242 causes movement of the collet sleeve 178.
The collet sleeve 178 may also be moved from the locked position to
the unlocked position, and this movement may be accomplished by
moving the dilator actuator 242 in the opposite direction than
described above or, alternatively, moving the collet sleeve 178
manually (i.e., having the user move the collet sleeve 178).
[0119] In some aspects, the collet sleeve 178 may include a handle
184 that may be gripped, pushed, or pulled to translate the collet
sleeve 178. In some aspects, the dilator actuator 242 may be
configured to contact and move the handle 184, which is affixed to
the collet sleeve 178 (see FIGS. 13-15). In some aspects, the
dilator actuator 242 includes a collet engagement surface 252 that
is configured to contact the handle 184 (see, for example, FIGS. 1,
2, 6, and 7). The collet engagement surface 252 may also serve as a
blocking surface to prevent movement of the handle 184 too far in
the proximal direction PD. The reinforced portion 110 may prevent
stretching when the collet sleeve 178 is moved along the cannula
104, which helps maintain the desired size and shape of the cannula
system 28 and lowers chances of damage or inadvertent
disconnections of components.
[0120] The collet jaws 170 may be disposed on or adjacent the
reinforced portion 110 of the cannula system 28, such that when the
collet jaws 170 are in the closed position and the vessel 2 is
secured to the cannula system 28, the clamping forces applied by
the collet jaws 170 onto the cannula system 28 through the vessel 2
do not deform the cannula system 28 at the reinforced portion 110.
According to one aspect of the disclosure, the reinforced portion
110 is configured to receive the collet jaws 170 while maintaining
a cylindrical shape.
[0121] A method of assembling the cannula insertion system 10 can
include the step of coupling the needle 40 to the needle actuator
50 such that the needle 40 and the needle actuator 50 are at least
one (or both) of translationally locked and rotationally locked.
The step of coupling the needle 40 to the needle actuator 50 can
include the step of positioning at least a portion of the needle 40
in the recess 56 of the hub 52. The step of coupling the needle 40
to the needle actuator 50 can further include the step of securing
the at least a portion of the needle 40 in the recess 56. The step
of securing the at least a portion of the needle 40 in the recess
56 can include using adhesive, overmolding, welding, threading,
etc.
[0122] The method of assembling the cannula insertion system 10 can
include the step of coupling the dilator 26 to the dilator hub 246,
such that the dilator 26 and the dilator hub 246 are at least one
of translationally locked and rotationally locked. The step of
securing the at least a portion of the dilator 26 to the dilator
hub 246 can include using adhesive, overmolding, welding,
threading, etc.
[0123] The method of assembling the cannula insertion system 10 can
include the step of coupling the needle 40, the needle actuator 50,
the dilator 26, the dilator actuator 242, and the housing 220 such
that the needle 40 and the needle actuator 50 are translatable
relative to both the dilator 26 and the housing 220. According to
one aspect of the disclosure, the step of coupling the needle 40,
the needle actuator 50, the dilator 26, the dilator actuator 242,
and the housing 220 is performed after the step of coupling the
needle 40 to the needle actuator 50, and after the step of coupling
the dilator 26 to the dilator hub 246. The step of coupling the
needle 40, the needle actuator 50, the dilator 26, the dilator
actuator 242, and the housing 220 can include the step of inserting
the needle 40 into the dilator lumen 96 and translating the needle
40 within the dilator lumen 96 in the distal direction DD relative
to the dilator 26.
[0124] The method of assembling the cannula insertion system 10 can
include the step of compressing the biasing member 62, for example,
in such aspects where the biasing member 62 is a compressible
spring or elastic element.
[0125] The method of assembling the cannula insertion system 10 can
include the step of blocking movement of the needle assembly 22
relative to the housing 220 in the proximal direction PD. According
to one aspect of the disclosure, this step can include abutting the
stop surface 60 with the blocking surface 124 as described above.
This step may be performed by applying a force to the needle
assembly 22 in the distal direction DD. The flashback chamber 231
can be pushed on by the user to cause the needle assembly 22 to
move in the distal direction DD.
[0126] The method of assembly can include the step of coupling the
cannula system 28 to the housing 220. According to one aspect of
the disclosure, the step of coupling the cannula system 28 to the
housing 220 may include coupling the cannula system 28 to the
housing 220 such that movement of the housing 220 relative to the
cannula system 28 in the distal direction DD is blocked, and
movement of the housing 220 relative to the cannula system 28 in
the proximal direction PD is not blocked. According to one aspect
of the disclosure, the step of coupling the cannula system 28 to
the housing 220 includes coupling the cannula system 28 to the
housing 220 such that movement of the housing 220 relative to the
cannula system 28 in both the distal direction DD and the proximal
direction PD is blocked. The step of coupling the cannula system 28
to the housing 220 can include the step of inserting the dilator 26
into the cannula lumen 106 and translating the dilator 26 within
the cannula lumen 106 in the distal direction DD relative to the
cannula system 28.
[0127] The step of coupling the cannula system 28 to the housing
220 may include orienting the cannula system 28 such that it is
insertable into the recess 222 of the housing. In some aspects,
where a particular orientation of the cannula system 28 relative to
the housing 220 is desired, the step may further include aligning
the guide 270 with opening in the recess 222 defined, for example,
by the shape of the housing 220, such that the cannula system 28 is
permitted to pass into the recess 222.
[0128] The method of assembly may also include engaging the first
proximal portion 194 of the Y-connector 190 with the housing 220.
The needle 40, the dilator 26, or both may be inserted into the
first proximal channel 206, through the seal 198 (e.g., the slit
seal 198), into the distal channel 210, and into the cannula lumen
106. In some aspects, the method of assembling may further include
engaging the casing 200 with the housing 220 such that the cannula
system 28 is precluded from translating or rotating relative to the
housing. In some aspects where the casing 200 includes one or more
locking components 202 and the housing includes complementary
locking components 224, the step of engaging the casing 200 with
the housing 220 may further include the step of securing the
locking components 202 on the casing 200 with their respective
counterpart locking components 224 on the housing 220 to lock the
cannula system 28 to the housing 220. In some aspects, engaging the
locking components 202 with locking components 224 may result in an
audible click, thus providing auditory feedback to the user that
the coupling action was completed successfully.
[0129] The cannula system 28 may be primed with the necessary
liquid and be ready for connection to a blood vessel. The method of
assembly may further include a step of priming the cannula system
28. Priming the cannula system 28 may include introducing into the
cannula 104 blood, plasma, saline, PlasmaLyte, and/or a solution
having a composition that mimics human physiological plasma
electrolyte concentrations, osmolality, and pH. The introduces
liquid or liquids may be brought to, and maintained at, the desired
temperatures, pressures, and gas concentrations. It will be
appreciated that the specific values of the above parameters will
depend on the specific requirements of the intended use. The
priming step may include a step of removing air bubbles from the
cannula 104 such that the cannula 104 is entirely filled with
liquid.
[0130] After completion of the method of assembling the cannula
insertion system 10, the cannula insertion device 20 and the
cannula system 28 can define an assembled configuration, as shown,
for example, in FIGS. 1 and 2. According to one aspect of the
disclosure, in the assembled configuration: 1) the needle 40 is
coupled to the needle actuator 50 such that the needle 40 and the
needle actuator 50 are translationally locked; 2) the dilator 26
and the housing 220 are coupled such that the dilator 26 and the
housing 220 are translationally locked; 3) the needle assembly 22
is coupled to the dilator such that the needle assembly 22 is
translatable relative to the dilator 26; and 4) the cannula system
28 is coupled to the housing 220 such that the cannula system 28 is
translatable relative to the housing 220 in the distal direction
DD, and the cannula system 28 is translationally locked relative to
the housing 220 in the proximal direction PD.
[0131] After the desired use, the method may further include the
step of de-coupling the cannula system 28 from the housing 220. The
step of de-coupling may include actuating the release mechanism 226
to disengage the locking component 202 on the casing 200 from the
corresponding locking component 224 on the housing 220. In some
aspects, the method may include an alternative step of de-coupling
the cannula system 28 from the housing 220 by actuating a second
release mechanism 226b instead of the primary release mechanism
226. This may be done in cases when the release mechanism 226 does
not, or cannot, de-couple the cannula system 28 from the housing
220, for example, in an emergency situation. In some aspects,
actuating the release mechanism 226 or the second release mechanism
226b results in an audible click, thus providing auditory feedback
to the user that the de-coupling action was completed successfully.
After disengaging the locking components 202, 224 from each other,
the cannula system 28 may be removed from the recess 222 and out of
the housing 220. The needle 40 may be removed from the cannula
lumen 106, pulled out through the seal 198, and removed out of the
first proximal channel 206. The dilator 26 may be removed from the
cannula lumen 106, pulled out through the seal 198, and removed out
of the first proximal channel 206.
[0132] In some aspects, the method of assembly may further include
inserting a fitting 212 into the first proximal channel 206 (see
FIGS. 13 and 15, showing the fitting 212, and FIG. 14, showing the
first proximal channel 206). The fitting 212 can be a cap or plug
to block blood flow out of the first proximal channel 206. In some
aspects, the first proximal portion 194 may include a sealing
element 204 configured to engage with the fitting 212 to create a
liquid-tight seal between the fitting 212 and the first proximal
portion 194. The sealing element 204 may be a cross-slit seal. The
sealing element 204 and the fitting 212 together may form a
liquid-tight seal. The seal 198 and the seal formed between the
sealing element 204 and the fitting 212 help prevent any liquid
from moving into the first proximal channel 206 from the cannula
lumen 106, or any debris from moving into the cannula lumen 106
from the first proximal channel 206, after the cannulation process
is completed.
[0133] The cannula insertion device 20 can be configured such that,
in the assembled configuration, the housing 220 abuts the cannula
system 28 such that movement of the housing 220 in the third
direction D3 relative to the cannula system 28 is prevented.
[0134] The assembled configuration of the cannula insertion system
10 can include an extended configuration (as shown in FIGS. 18A and
18D, for example), in which the needle 40 and the dilator 26 are
extended in the distal direction DD. The assembled configuration
may further include a first retracted configuration (FIGS. 18B and
18E), in which the needle 40 is in a retracted position as
explained above and the dilator 26 is in the extended position. The
assembled configuration may further include a second retracted
configuration (FIGS. 18C and 18F), in which both the needle 40 and
the dilator 26 are in the retracted positions as explained
above.
[0135] In the first and second retracted configurations, the distal
end 46 of the needle 40 is positioned within the dilator lumen 96,
such that the distal end 46 of the needle 40 is positioned
proximally of the distal end 90 of the dilator 26. According to one
aspect of the disclosure, the cannula insertion system 10 is
configured such that a user can transition the cannula insertion
system 10 from the extended configuration to the first retracted
configuration, and vice versa, with one hand. The user may further
be able to transition the cannula insertion system 10 from the
first retracted configuration to the second retracted
configuration, and vice versa, with one hand. The cannula insertion
system 10 being configured to transition with one hand allows the
user's other hand to remain free to, for example, hold the
umbilical cord during the insertion procedure.
[0136] In the first and second retracted configurations, the stop
surface 60 can be spaced away from the blocking surface 124. In the
retracted configurations, a biasing force applied by the biasing
member 62 resists movement of the needle 40 in the distal direction
DD relative to the housing 220. Applying a force to the cannula
insertion device 20 greater than the biasing force applied by the
biasing member 62, and in a direction opposite the direction of the
biasing force can move the needle 40 in the distal direction DD
relative to the housing 220, and thereby transition the cannula
insertion device 20 from the retracted configuration to the
extended configuration.
[0137] In the extended configuration, the distal end 46 of the
needle 40 is positioned outside the dilator lumen 96, such that the
distal end 46 of the needle 40 is positioned distally of the distal
end 90 of the dilator 26. In the extended configuration, the stop
surface 60 abuts the blocking surface 124 of the housing 220, and
movement of the needle 40 in the proximal direction PD relative to
the housing 220 is blocked by interference of the stop surface 60
and the blocking surface 124.
[0138] According to one aspect of the disclosure, the cannula
insertion system 10 can be assembled and delivered to an operating
room in the retracted configuration. In the first or second
retracted configuration, the distal end 46 of the needle 40 is
enclosed by the dilator 26, thus lowering the chance of damaging
the distal end 46 of the needle 40, and also lowering the chance of
injury to a user of the cannula insertion system 10 by the sharp
distal end 46 of the needle 40. Alternatively, the cannula
insertion system 10 can be presented to the users such that the
cannula system 28 is separated from the cannula insertion device
20. In some aspects, the cannula system 28 may be prime before
being engaged with the cannula insertion device 20 as explained
above. In some aspects, the cannula insertion device 20 may be
delivered to the user in the first retracted configuration, wherein
the dilator 26 is in the extended position and the needle 40 is in
the retracted position such that the needle tip end 66 is inside
the dilator lumen 96.
[0139] A method of use can include the step of transitioning the
cannula insertion device 20 from the first retracted configuration
to the extended configuration. The user may apply a loading force
to the needle assembly 22 to move the needle 40 in the distal
direction DD until the distal end 46 of the needle 40 moves outside
of the dilator lumen 96 and is positioned distally of the distal
end 90 of the dilator 26 along the first direction D1 and until the
stop surface 60 on the needle actuator 50 is positioned distally of
the blocking surface 124 along the first direction D1. For example,
in some exemplary embodiments, the user may apply a force to the to
the flashback chamber 231 or the plug 233. As explained above, in
some aspects, the housing 220 may be open at the proximal end 221,
such that a user can insert a finger or thumb into the housing 220.
To apply a force to the flashback chamber 231 or the plug 233, the
user may insert one or more fingers into the housing 220 (e.g.,
into the portion of the housing 220 that includes the translucent
portion 230) and push on the flashback chamber 231. The applied
force should be greater than the force being applied in the
opposite proximal direction PD by the biasing member 62. The
biasing member 62 can be compressed or may be extended. When the
needle actuator 50 passes the blocking surface 124 in the distal
direction DD, the distal end 57 of the boom arm 54 and the needle
actuator 50 move in the second direction D2, thereby aligning the
stop surface 60 and the blocking surface 124 along the first
direction D1. The user may stop pushing the needle assembly 22
after the stop surface 60 has been moved in line with the blocking
surface 124. At this position, the cannula insertion device 20 is
in the extended configuration (FIGS. 18A and 18D). In some aspects,
the user may receive indication that the cannula insertion device
20 is in the proper extended configuration, such as an audible
click or tactile feedback.
[0140] The needle actuator 50, and the boom arm 54 specifically,
may be formed of deformable but elastic or resilient material, such
that the boom arm 54 may be deformed when force is applied thereto,
but also may return to its undeformed state when the force is
removed. As force F is applied to the actuation surface 58 at the
distal end 57 of the needle actuator 50, the boom arm 54 is
deformed, for example, in a third direction D3 opposite the second
direction D2. When the force is removed, the boom arm 54, which is
biased to return to its undeformed state, moves the distal end 57
and the attached needle actuator 50 in the second direction D2.
[0141] A method of use can include the step of advancing the
cannula insertion device 20 toward a vessel 2, for example a blood
vessel in an umbilical cord, while the cannula insertion device 20
is in the extended configuration with the needle 40 extended such
that the distal end 46 (i.e., the needle tip) extends distally past
the distal end 90 of the dilator 26. Referring to FIG. 19, the
method of use can further include the step of piercing a first wall
4 of the vessel 2, with the distal end 46 of the needle 40. As
shown, the assembled configuration of the cannula insertion device
20 can include the needle 40 being oriented "bevel down" such that
the tip end 66 is spaced from the base end 65 in the second
direction D2, such that the tip end 66 is closer to the actuation
surface 58 with respect to the second direction D2, than the base
end 65 is from the actuation surface 58 with respect to the second
direction D2. Alternatively, the cannula insertion system 10 can
include the needle being oriented "bevel up" (opposite bevel down)
when the cannula insertion device 20 is in the assembled
configuration. Alternatively, the cannula insertion system 10 can
include the needle being oriented at an orientation that neither
bevel up nor bevel down when the cannula insertion device 20 is in
the assembled configuration.
[0142] As shown, the step of piercing the first wall 4 of the
vessel 2 includes orienting the cannula insertion device 20
relative to the vessel 2 such that at an angle .theta. measured
from the central axis 49 of the needle 40 to the first wall 4 of
the vessel 2 is between about 5 degrees and about 60 degrees,
between about 10 degrees and about 45 degrees, or between about 15
degrees and about 30 degrees. The cannula insertion device 20 can
define a length L2 measured from the base end 65 to the distal end
90 of the dilator 26 along the first direction D1. According to one
aspect of the disclosure, the length L2 can be between about 1.5 mm
to about 2 mm. Alternatively, the length L2 can be less than 1.5 mm
or greater than 2 mm allowing the cannula insertion device 20 to be
configurable for vessels of various sizes. The cannula insertion
device 20 can be configured such that the length L2 is large enough
to allow insertion of an entirety of the bevel 64 into the vessel
while minimizing the chance of backwalling the vessel 2. It will be
appreciated that the angle of insertion of the needle 40 may vary
greatly from one application to another. For example, blood vessels
in umbilical cords can be oriented in a variety of different ways,
thus requiring different angles of insertion. Some exemplary and
non-limiting examples of such vessels are shown in FIGS. 24A and
24B. FIG. 24A, for example, depicts a step of cannulating an
arterial vessel, and FIG. 24B depicts a step of cannulating a
venous vessel. It will be understood that these figures are
graphical depictions and do not show all components involved in the
cannulation process. Regardless of the specific angle of insertion,
the cannulation process of each vessel preferably is performed such
that the vessel can be properly secured to the cannula 104 without
damaging the vessel itself.
[0143] The method of use can further include the step of advancing
the cannula insertion device 20 in the distal direction DD relative
to the vessel 2, until both the tip end 66 of the needle 40 and the
base end 65 of the needle 40 are positioned within the vessel 2.
The method of use can further include the step of stopping movement
of the cannula insertion device 20 in the distal direction DD,
relative to the vessel 2, prior to the tip end 66 of the needle 40
piercing a second wall 6 of the vessel 2.
[0144] The method of use can include the step of advancing the
cannula insertion device 20 in the distal direction DD relative to
the vessel 2, until the tip end 66 of the needle 40, the base end
65 of the needle 40, and the distal end 90 of the dilator 26 are
each positioned within the vessel 2. The step of advancing the
cannula insertion device 20 in the distal direction DD relative to
the vessel 2, until the tip end 66 of the needle 40, the base end
65 of the needle 40, and the distal end 90 of the dilator 26 are
each positioned within the vessel 2 can include inserting at least
a portion of the tapered portion 98 of the dilator 26 in the vessel
2. Next, as shown in FIG. 20, the needle 40 can then be retracted
such that the tip end 66 of the needle 40 is more proximal to the
distal end 90 of the dilator 26.
[0145] After at least a portion of the tapered portion 98 of the
dilator 26 is positioned within the vessel 2, the method of use can
include the step of retracting the needle 40. The step of
retracting the needle 40 can include the step of moving the needle
40 relative to the vessel 2 in the proximal direction PD. According
to one aspect of the disclosure, the step of retracting the needle
40 includes the step of moving the needle 40 in the proximal
direction PD until the needle 40 is no longer positioned within the
vessel 2. The step of retracting the needle 40 can be performed
while maintaining the relative positions of the dilator 26 and the
vessel 2.
[0146] According to one aspect of the disclosure, the step of
retracting the needle 40 includes the step of moving the needle
actuator 50, for example, by using a finger to push down on the
actuation surface 58. The user may push on the actuation surface 58
in a direction, for example a direction toward the needle 40, such
as the third direction D3. The force exerted on the actuation
surface 58 must be greater than any inherent resistance to bending
from the boom arm 54 itself and great enough to temporarily deform
the boom arm 54 and move the distal end 57 towards the needle.
According to one aspect of the disclosure, the boom arm 54 can be
designed with a flexed shape such that the boom arm 54 provides its
own biasing mechanism. In some aspects where additional biasing
forces are applied to the boom arm 54, the force exerted on the
actuation surface 58 must be greater than those biasing forces.
[0147] The step of retracting the needle 40 can include the step of
sliding the stop surface 60 along the blocking surface 124, for
example in the third direction D3, until the stop surface 60 and
the blocking surface 124 are no longer aligned along the first
direction D1. Once the stop surface 60 and the blocking surface 124
are no longer aligned along the first direction D1, the force
applied by the biasing member 62 (see for example FIG. 18B) moves
the needle actuator 50, the boom arm 54, the hub 52, and the
attached needle 40 in the proximal direction PD relative to the
housing 220. In some aspects, retracting the needle 40 may result
in an audible click, thus providing auditory feedback to the user
that the needle retraction was completed successfully.
[0148] Referring to FIG. 21, the method of use can include the step
of advancing the cannula insertion device 20 in the distal
direction DD relative to the vessel 2 until both, the distal end 90
of the dilator 26 and the distal end 100 of the cannula system 28,
are positioned within the vessel 2. As shown in the illustrated
embodiment, the step of advancing the cannula insertion device 20
as such can include inserting at least a portion of the tapered
portion 108 of the cannula system 28 into the vessel 2.
[0149] According to one embodiment, the step of advancing the
cannula insertion device 20 in the distal direction DD relative to
the vessel 2, until both the distal end 90 of the dilator 26 and
the distal end 100 of the cannula are positioned within the vessel
2, is performed after the step of retracting the needle 40. This
step can include inserting an entirety of the tapered portion 108
of the cannula system 28 into the vessel 2.
[0150] The method of use can include the step of retracting the
dilator 26. The step of retracting the dilator 26 can include the
step of moving the dilator 26 relative to the vessel 2 in the
proximal direction PD. According to one aspect of the disclosure,
the step of retracting the dilator 26 includes the step of moving
the dilator 26 in the proximal direction PD until the dilator 26 is
no longer positioned within the vessel 2. The step of retracting
the dilator 26 can be performed while maintaining the relative
positions of the cannula system 28 and the vessel 2. According to
one aspect of the disclosure, the step of retracting the dilator 26
is performed after the step of advancing the cannula insertion
device 20 in the distal direction DD relative to the vessel 2,
until both the distal end 90 of the dilator 26 and at least the
distal end 100 of the cannula are positioned within the vessel
2.
[0151] The step of retracting the dilator 26 may include applying a
force to the dilator actuator 242 to cause the dilator actuator 242
to move along the first direction D1. The dilator actuator 242 may
be connected to the rack and pinion gear system 260.
[0152] In some aspects, the step of moving the dilator actuator 242
may include moving the dilator actuator 242 in the distal direction
DD. This may cause the second rack 268, which is engaged with the
second pinion 266, to also move in the distal direction DD. The
second pinion 266 may be fixed to the housing 220 such that the
second pinion 266 may rotate but is precluded from translating
along the first direction D1. Movement of the second rack 268
causes rotation of the second pinion 266. In some aspects, the
second pinion 266 is connected to the first pinion 262, such that
when the second pinion 266 is rotated, the first pinion 262 is also
rotated. When the second pinion 266 is rotated, the first pinion
262 is rotated and causes movement of the first rack 264 that is
engaged with the first pinion 262. Such rotation may cause the
first rack 264 to move in the proximal direction PD. The dilator
assembly 25 and dilator 26 may be connected to the first rack 264,
such that when the first rack 264 is moved in the proximal
direction PD, the dilator 26 is also moved in the proximal
direction PD. In some aspects, retracting the dilator 26 may result
in an audible click, thus providing auditory feedback to the user
that the dilator retraction was completed successfully. The cannula
insertion device 20 with both the needle 40 and the dilator 26 in
the retracted positions is depicted in FIG. 18C.
[0153] The method of use can include the step of securing the
position of the cannula system 28 relative to the vessel 2. For
example, the cannula 104 can be clamped to the vessel 2. In some
aspects, one or more collet jaws 170, as described above, may be
disposed on the cannula system 28 for securing the cannula 104 to
the vessel 2.
[0154] The method of use can include the step of moving the collet
jaws 170 from an unlocked position, in which the vessel 2 is not
secured between the collet jaws 170 and the cannula 104 (see FIG.
16, showing a vessel 2 in phantom), to a locked position, in which
the vessel 2 is secured between the collet jaws 170 and the cannula
104 (see FIG. 17, showing a vessel 2 in phantom). The step of
moving the collet jaws 170 to the locked position may include
moving the collet sleeve 178 in the distal direction DD towards the
distal end 100 of the cannula 104, such that the collet sleeve 178
slides over the deformable arms 176 and causes the deformable arms
176 to deform, such that the head 174 is moved towards the cannula
104. The farther the collet sleeve 178 is moved in the distal
direction DD, the closer the head 174 moves to the cannula 104. The
portion of the vessel 2 that is to be secured may be positioned
between the cannula 104 and the head 174, such that when the collet
sleeve 178 is moved in the distal direction DD, the head 174
contacts the vessel 2 and compresses the vessel 2 between the head
174 and the cannula 104 (see FIG. 17).
[0155] The step of moving the collet sleeve 178 may include the
step of moving a collet handle 184. The handle 184 may be affixed
to the collet sleeve 178, such that when the handle 184 is moved in
the distal direction DD, the collet sleeve 178 is also moved in the
distal direction DD.
[0156] The step of moving the collet handle 184 may include moving
the dilator actuator 242 in the distal direction DD until the
collet engagement surface 252 contacts the handle 184 and pushing
the handle 184 in the distal direction DD with the collet
engagement surface 252.
[0157] In some alternate aspects, the step of clamping the vessel 2
can be performed with a vessel clamp that is configured as a single
handed, pinch-operated clip, which secures the thin and slippery
umbilical vessel to the cannula.
[0158] The step of securing the position of the cannula system 28
relative to the vessel 2 can include suturing the cannula 104 to
the vessel 2. According to one embodiment, a suture can be wrapped
around the reinforced portion 110 of the cannula 104.
[0159] The step of securing the position of the cannula system 28
relative to the vessel 2 can be performed after the step of
retracting the dilator 26.
[0160] The method of use may also include the step of de-coupling
the cannula system 28 from the cannula insertion device 20 as
described above. The step of de-coupling may include actuating the
release mechanism 226 to disengage the locking component 202 on the
casing 200 from the corresponding locking component 224 on the
housing 220. In some aspects, the method may include an alternative
step of de-coupling the cannula system 28 from the housing 220 by
actuating a second release mechanism 226b instead of the primary
release mechanism 226. This may be done in cases when the release
mechanism 226 is not sufficient in de-coupling the cannula system
28 from the housing 220 or in other emergency situations. In some
aspects, actuating the release mechanism 226 or the second release
mechanism 226b results in an audible click, thus providing auditory
feedback to the user that the de-coupling action was completed
successfully.
[0161] The method of use can further include the step of attaching
a fitting 212 to the first proximal portion 194 after the cannula
system 28 has been disconnected from the cannula insertion device
20. The fitting 212 may be moved through the sealing element 204,
which may be a trocar valve or a cross-slit valve, and block
passage of blood out of the first proximal channel 206. The fitting
212 may also displace any liquid between the seal 198 and the
sealing element 204 and prevent additional liquid from entering the
space between the two seals. Displacing (or evacuating) the liquid
between the seal 198 and the sealing element 204 removes stagnant
blood or priming fluid. The fitting 212 may also provide a physical
barrier adjacent to the seal 198 to prevent the seal 198 from being
forced open due to pressure in the cannula lumen 106. In some
aspects, the fitting 212 may be tethered to the rigid casing 200 or
to the cannula 104.
[0162] The cannula insertion system 10 can be part of a kit that
includes one or more of the cannula insertion devices 20, one or
more of the cannula systems 28, one or more of the needle
assemblies 22, one or more of the dilator assemblies 25, or any
combination thereof. The method of use can include repeating any of
the steps above two additional times, such that three of the
cannula insertion systems 10 are used to create a passage into
three vessels 2, for example. According to one aspect of the
disclosure, the three vessels can include a vein and two arteries,
the vein and two arteries being positioned in an umbilical cord of
a neonate. It will be appreciated that blood vessels in an
umbilical cord can have different sizes, and so appropriately-sized
components of the disclosed systems should be used with each
vessel. The method of use can include the step of securing the
cannula system 28 of each of the cannula insertion devices 20
relative to one another such that movement of any one of the
cannula systems 28 relative to any of the other cannula insertion
systems 28. Securing the cannulas 104 can include wrapping a suture
around each of the cannulas 104. The step of securing the cannulas
104 can result in each of the cannula system 28 remaining aligned
with their respective vessel 2 while reducing rubbing and friction
between the cannula system 28 and the respective vessel 2.
[0163] According to one aspect of the disclosure, the cannula
insertion system 10 can include wrapping, tape, sutures, or another
structure configured to secure the cannulas 104 of multiple cannula
insertion devices 20 together after the cannulas 104 are inserted
into respective vessels. According to one aspect of the disclosure,
the cannula insertion system 10 can include cannulas 104 of
different sizes. It will be appreciated that the size of the
cannula 104 may depend on the intended application of that cannula
104. For example, the size of the cannula 104 may be determined
based on which specific blood vessel is to be cannulated. In some
exemplary aspects, the cannula 104 may have a size in a range from
about 4 Fr to about 18 Fr. The cannula 104 may be 4, 5, 6, . . . ,
18 Fr, or another size that is suitable for the intended use. In
some exemplary applications where multiple cannulas 104 may be
introduced into differently sized blood vessels, the separate
cannulas 104 may have different sizes. For example, in aspects
where the cannula 104 is to be introduced into a first type of
blood vessel (e.g., an artery of an umbilical cord) the cannula 104
may be between about 5 Fr and about 12 Fr, and where the cannula
104 is to be introduced into a second type of blood vessel (e.g., a
vein of an umbilical cord) the cannula 104 may be between about 12
Fr and about 18 Fr.
[0164] FIG. 22 depicts an exemplary process 300 of cannulating a
vessel 2. In step 302, the cannula insertion system 10 is
positioned relative to the vessel 2 such that the needle 40 is at
the desired angle and location and in a position to pierce the
vessel 2. It will be appreciated that other surgical preparation
steps may be performed before or after step 302, such as
disinfecting, cleaning, or otherwise preparing the vessel 2, or
priming the cannula system 28.
[0165] In step 304, the cannula insertion device 20 is moved
towards the vessel 2 such that the needle 40 pierces the wall of
the vessel 2. It will be appreciated that the needle 40 is an
appropriate size and rigidity to pierce the desired vessel. After
the needle 40 pierces the wall of the vessel 2, blood from the
vessel 2 can flow through the cannula insertion system 10 and exit
at the flashback chamber 231 through the opening 232. The blood can
drip into the recess 222 of the housing 220, and the user can
visually detect the presence of blood in the recess 222 by looking
through the translucent portion 230 or through the open proximal
end 223 of the housing 220. This can indicate to the user that the
vessel 2 has been successfully pierced.
[0166] In step 306, after piercing the vessel 2, the dilator 26 is
moved into the vessel 2 through the opening created by the needle
40 in step 304. The dilator 26 is translated into the vessel 2 to
enlarge the opening in the wall of the vessel 2.
[0167] In step 308, the needle 40 may be retracted according to the
mechanisms described throughout this specification. This removes
the sharp needle tip from within the vessel 2 and reduces chances
of "backwalling" the vessel or otherwise piercing, scratching, or
irritating the vessel walls. This also allows for more space in the
vessel 2, into which the dilator 26 may be moved to further enlarge
the opening in the vessel wall.
[0168] In step 310, the dilator 26 may be retracted as described
throughout this specification. Retracting the dilator 26 provides
more room inside the vessel 2 for the cannula 104 and also
increases open space inside the cannula lumen 106, which allows for
more blood to flow from the vessel 2 into the cannula system
28.
[0169] In step 312, the tip of the cannula 104 is moved into the
vessel 2 through the enlarged hole in the vessel wall. Entry of the
cannula 104 may be facilitated by the tapered portion 108 at the
distal end 100 of the cannula 104. The blood in the vessel 2 may
now flow into the cannula lumen 106. The blood can flow through the
cannula lumen 106, through the second proximal portion 196 of the
Y-connector 190, and through the tube 28b that is connected to (or
is a part of) the cannula system 28.
[0170] In step 314, the cannula 104 may be secured to the vessel 2
to prevent de-coupling of the vessel and the cannula. The step of
securing the cannula 104 to the vessel 2 may be accomplished by
moving one or more collet jaws 170 from an unlocked position to a
locked position as described throughout this specification.
Specifically, the step may include moving the collet sleeve 178 to
cause the deformable arms 176 to deform and move the head 174
towards the cannula 104 and the vessel 2 between the cannula 104
and the head 174. This step may further include piercing the walls
of the vessel 2 with one or more tines 182.
[0171] It will be appreciated that some of the steps in process 300
may be done in a different order. For example, in some aspects, the
step 310 of retracting the dilator 26 may be done after the step
312 of moving the cannula 104 into the vessel 2.
[0172] The process 300 may further include an optional step of
connecting the cannula system 28 to an external circulation circuit
400 (see FIG. 25, for example), such as an extracorporeal membrane
oxygenation circuit. In some aspects, this connection may be made
at the second proximal portion 196 of the Y-connector 190. In some
aspects, an intermediate tubing 28b may be connected to the second
proximal portion 196, which can then in turn be connected to an
external circulatory system. The step of connecting the cannula
system 28 to an external circulatory system may be performed before
step 302, such that the cannula system 28 is already connected with
the external circulatory system when the vessel 2 is
cannulated.
[0173] The process 300 may further include a step of introducing a
liquid into the flashback chamber 231. The user may inject the
liquid into the flashback chamber 231 through the opening 232. This
step may include moving the plug 233 out of the opening 232 before
injecting the liquid therethrough.
[0174] The process 300 may include the step of checking whether the
needle 40 properly entered the vessel 2 by visually observing
whether blood or priming fluid drips out of the opening 232 into
the flashback chamber 231 when the needle has been retracted. This
step may be performed immediately after step 308.
[0175] In some aspects, the process 300 may further include an
optional step of de-coupling the cannula system 28 from the cannula
insertion device 20 after securing the cannula 104 to the vessel 2.
This step may include dis-engaging the locking components 202 on
the cannula system 28 from the corresponding locking components 224
on cannula insertion device 20 as described throughout this
specification. The step of de-coupling the cannula system 28 from
the cannula insertion device 20 may further include moving the
needle 40 and the dilator 26 through the seal 198 such that the
seal 198 no longer has components inserted therethrough and is thus
closed to prevent liquid from passing through.
[0176] In some aspects, the process 300 may further include an
optional step of inserting a fitting 212 into the first proximal
channel 206 of the first proximal portion 194 to displace any
liquid that is present in the first proximal channel 206 and to
prevent any liquid or debris from moving into the first proximal
channel 206.
[0177] As mentioned throughout this application, the cannula system
28 may fluidly connect the neonate with an external circulation
circuit. The external circulation circuit may include an oxygenator
configured to provide gas exchange for the blood passing
therethrough. It will be appreciated that the external circulation
circuit may include other components as well to help maintain the
blood that passes through the circuit at preferred parameters.
[0178] In some aspects, the cannulation process 300 can be
performed on multiple blood vessels to define a blood circuit
between the separate blood vessels (e.g., cannulating an arterial
vessel and cannulating a venous vessel). Cannulating a first blood
vessel though which blood flows from the first vessel into the
cannula system 28 allows the blood to flow through the cannula
lumen 106, into the second proximal portion 196 of the Y-connector
190, then into the tube 28b. The blood can then travel through an
external circulation circuit (including one or more components for
treating blood, such as an oxygenator). After the blood is treated
by any of the components in the external circulation circuit, the
blood may flow into and through a tube 28b of a second cannula
system 28 that can be connected to a second blood vessel. The blood
can then flow from the tube 28b of the second cannula system 28 to
the second proximal portion 196 and through the cannula lumen 106
of the second cannula system 28. From the second cannula system 28,
the blood can move to the second vessel that was cannulated by
process 300. By cannulating at least a first vessel and a second
vessel such that the cannula system 28 connected to the first
vessel and the cannula system 28 connected to the second vessel are
in fluid communication with one another allows the user to create a
blood circuit between the first and second vessels. In such
exemplary arrangements, blood can flow out of the first vessel,
travel through the external circulation circuit, and flow into the
second vessel. It will be appreciated that multiple first vessels
(i.e., vessels out of which blood flows) and/or multiple second
vessels (i.e., vessels into which the blood flows) can be
cannulated and connected to a single external circulation
circuit.
[0179] The components of various cannula insertion systems
described throughout this specification may be manufactured from
various materials that are suitable for use in a medical, surgical,
or otherwise sterile environment. The cannula insertion device 20
and the cannula system 28 may include medical grade plastic or
metal, or may have a combination of plastic and metal components.
Suitable materials include, but are not limited to, high-density
polyethylene (HDPE), polyether ether ketone (PEEK), polycarbonate,
polyamide, polypropylene, polytetrafluoroethylene (PTFE), silicone,
or another suitable. The material should be biocompatible and
non-toxic and should not adversely react with the liquids, bodily
fluids, gases, temperatures, or medicines being utilized. It will
be understood that the cannula system 28 and any tubing (e.g.,
cannula 104 or tube 28b) used with the cannula system 28 should be
non-hemolytic to avoid damaging the blood that will flow
therethrough. For example, in some aspects of the cannula insertion
system 10, the needle 40 may be formed from a stainless steel, the
dilator 26 may be formed from HDPE, and the housing 220 may be
formed from polycarbonate. The cannula 104 may be formed from a
urethane or silicone. The collet jaws 170 may be formed from
titanium or stainless steel, such as 304 stainless steel or 316
stainless steel.
[0180] It will be appreciated that the foregoing description
provides examples of the disclosed system and technique. However,
it is contemplated that other implementations of the disclosure may
differ in detail from the foregoing examples. All references to the
disclosure or examples thereof are intended to reference the
particular example being discussed at that point and are not
intended to imply any limitation as to the scope of the disclosure
more generally. All language of distinction and disparagement with
respect to certain features is intended to indicate a lack of
preference for those features, but not to exclude such from the
scope of the disclosure entirely unless otherwise indicated.
[0181] Recitation of ranges of values herein are merely intended to
serve as a shorthand method of referring individually to each
separate value falling within the range including the stated ends
of the range, unless otherwise indicated herein, and each separate
value is incorporated into the specification as if it were
individually recited herein. All methods described herein can be
performed in any suitable order unless otherwise indicated herein
or otherwise clearly contradicted by context.
[0182] Although the disclosure has been described in detail, it
should be understood that various changes, substitutions, and
alterations can be made herein without departing from the spirit
and scope of the invention as defined by the appended claims.
Moreover, the scope of the present disclosure is not intended to be
limited to the particular embodiments described in the
specification. As one of ordinary skill in the art will readily
appreciate from the disclosure of the present invention, processes,
machines, manufacture, composition of matter, means, methods, or
steps, presently existing or later to be developed that perform
substantially the same function or achieve substantially the same
result as the corresponding embodiments described herein may be
utilized according to the present disclosure.
* * * * *