U.S. patent application number 17/107500 was filed with the patent office on 2021-03-18 for fluid handling system.
The applicant listed for this patent is TC1 LLC. Invention is credited to Peter W. Bristol, Keif M. Fitzgerald, Michael L. Green, Richard L. Keenan, Paul C. Leonard, Jeffrey Paul Mills, Paul F. Muller, Alan Schenck, Keith Schubert, Joseph P. Sullivan.
Application Number | 20210077690 17/107500 |
Document ID | / |
Family ID | 1000005240246 |
Filed Date | 2021-03-18 |
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United States Patent
Application |
20210077690 |
Kind Code |
A1 |
Schenck; Alan ; et
al. |
March 18, 2021 |
FLUID HANDLING SYSTEM
Abstract
A system for coupling a motor assembly to a control console is
disclosed. The motor assembly is configured to drive a percutaneous
heart pump. The system includes a motor coupling comprising a first
end having an electrical connection and a fluid connection coupled
to a respective electrical conduit and fluid conduit of the motor
assembly, and a second end spaced apart from the first end
including an interface coupling coupled to the electrical conduit
and fluid conduit. An interface member is configured to be
removably coupled to the control console, the interface member
comprising a corresponding connector coupleable to the interface
coupling of the second end of the motor coupling, wherein the
interface member is configured to provide a sterile attachment of
the fluid conduit to the control console.
Inventors: |
Schenck; Alan; (Sunnyvale,
CA) ; Green; Michael L.; (Pleasanton, CA) ;
Fitzgerald; Keif M.; (San Jose, CA) ; Muller; Paul
F.; (San Carlos, CA) ; Sullivan; Joseph P.;
(Issaquah, WA) ; Schubert; Keith; (Redmond,
WA) ; Bristol; Peter W.; (Seattle, WA) ;
Mills; Jeffrey Paul; (Barrington, IL) ; Leonard; Paul
C.; (Woodinville, WA) ; Keenan; Richard L.;
(Livermore, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TC1 LLC |
Pleasanton |
CA |
US |
|
|
Family ID: |
1000005240246 |
Appl. No.: |
17/107500 |
Filed: |
November 30, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16849700 |
Apr 15, 2020 |
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17107500 |
|
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|
15198342 |
Jun 30, 2016 |
10632241 |
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16849700 |
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14203978 |
Mar 11, 2014 |
9381288 |
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15198342 |
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61780656 |
Mar 13, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 60/857 20210101;
A61M 1/3659 20140204; A61M 60/871 20210101; A61M 60/135 20210101;
A61M 60/414 20210101; A61M 5/142 20130101; A61M 60/148 20210101;
A61M 5/172 20130101; A61M 60/50 20210101; A61M 60/205 20210101 |
International
Class: |
A61M 1/12 20060101
A61M001/12; A61M 1/10 20060101 A61M001/10; A61M 1/36 20060101
A61M001/36; A61M 5/142 20060101 A61M005/142; A61M 5/172 20060101
A61M005/172 |
Claims
1. A system for coupling a motor assembly to a control console, the
motor assembly configured to drive a percutaneous heart pump, the
system comprising: a motor coupling comprising a first end having
an electrical connection and a fluid connection coupled to a
respective electrical conduit and fluid conduit of the motor
assembly, and a second end spaced apart from the first end
including a interface coupling coupled to the electrical conduit
and fluid conduit; an interface member configured to be removably
coupled to the control console, the interface member comprising a
corresponding connector coupleable to the interface coupling of the
second end of the motor coupling, wherein the interface member is
configured to provide a sterile attachment of the fluid conduit to
the control console.
2. The system according to claim 1, wherein the interface member is
configured to provide a simultaneous connection of the fluid
conduit and the electrical conduit to the control console.
3. The system according to claim 1, wherein the interface member
further comprises a locking mechanism configured to lock the
interface member to the control console such that the fluid conduit
and electrical conduit of the motor assembly are releasably secured
to the control console.
4. The system according to claim 1, wherein the interface member is
configured to place the fluid conduit in communication with a
roller pump of the control console when coupled to the control
console.
5. The system according to claim 1, wherein the motor assembly
includes a driving assembly and a driven assembly, and wherein the
electrical conduit is coupled to the driving assembly and the fluid
conduit is coupled to the driven assembly.
6. The system according to claim 1, wherein the interface member
comprises a plurality of electrical contacts configured to engage a
respective plurality of electrical console contacts, at least one
of the electrical contacts of the interface member configured to
receive electrical power to drive the motor assembly.
7. The system according to claim 1, wherein the electrical conduit
includes at least one conductor for carrying a signal between the
interface member and a temperature sensor.
8. The system according to claim 1, wherein the motor assembly
includes a driving assembly and a driven assembly, and wherein the
driven assembly is configured to power an impeller of a
percutaneous heart pump.
9. The system according to claim 1, wherein the interface member
further comprises a locking mechanism configured to lock the fluid
conduit and electrical conduit of the motor assembly to the control
console, and wherein the locking mechanism includes a manually
actuatable release to unlock the fluid conduit and electrical
conduit from the control console.
10. The system according to claim 1, wherein the electrical conduit
includes at least one conductor for providing instructions to the
motor assembly.
11. The system according to claim 10, wherein the electrical
conduit further comprises at least one conductor for transmitting a
signal between a fluid sensor that measures at least one parameter
of a fluid within the fluid conduit and the control console.
12. The system according to claim 1, wherein the interface member
provides a fluid tight connection to the interface coupling.
13. A method of coupling a motor assembly to a control console of a
percutaneous heart pump, the method comprising: coupling a motor
coupling to an interface member, the motor coupling comprising a
first end having an electrical connection and a fluid connection
coupled to a respective electrical conduit and fluid conduit of the
motor assembly, and a second end spaced apart from the first end
including an interface coupling coupled to the electrical conduit
and fluid conduit; coupling the interface member to the control
console, wherein the the interface member is configured to provide
a sterile attachment of the fluid conduit to the control console,
and coupling the interface member to the control console provides
electrical power to the motor assembly via the electrical
conduit.
14. The method according to claim 13, wherein coupling the
interface member to the control console further comprises
simultaneously connecting the fluid conduit and the electrical
conduit to the control console.
15. The method according to claim 13, wherein coupling the
interface member to the control console further comprises placing
the fluid conduit in communication with a roller pump of the
control console.
16. The method according to claim 13, wherein coupling the
interface member to the control console further comprises
connecting a sensor conductor of the electrical conduit in
electronic communication with the control console, the sensor
carrying a signal between the interface member and a temperature
sensor.
17. The method according to claim 13, wherein coupling the
interface member to the control console forms a fluid tight
seal.
18. The method according to claim 13, wherein coupling the
interface member to the control console further comprises coupling
at least one conductor of the electrical conduit in electronic
communication with the control console, the at least one conductor
for providing instructions to the motor assembly from the control
console.
19. The method according to claim 13, wherein coupling the
interface member to the control console further comprises placing
at least one conductor of the electrical conduit in electronic
communication with the control console, the at least one conductor
for transmitting a signal between a fluid sensor that measures at
least one parameter of a fluid within the fluid conduit and the
control console.
20. The method according to claim 13, wherein coupling the
interface member to the control console further comprises using a
locking mechanism to lock the interface member to the control
console such that the electrical conduit and the fluid conduit
remain connected to the control console until a manually actuable
release is activate to release the interface member from the
control console.
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 16/849,700 filed on Apr. 15, 2020, which is a
Continuation of U.S. patent application Ser. No. 15/198,342 filed
on Jun. 30, 2016, now issued U.S. Pat. No. 10,632,241, which is a
Divisional of U.S. patent application Ser. No. 14/203,978, filed
Mar. 11, 2014, now issued U.S. Pat. No. 9,381,288, which claims the
benefit of priority to U.S. Provisional Patent Application No.
61/780,656, filed Mar. 13, 2013, each of which is hereby
incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This application is directed to pumps for mechanical
circulatory support of a heart. In particular, this application is
directed to a console and controller for a catheter pump and a
fluid handling system configured to convey and remove fluids to and
from the catheter pump.
Description of the Related Art
[0003] Heart disease is a major health problem that has high
mortality rate. Physicians increasingly use mechanical circulatory
support systems for treating heart failure. The treatment of acute
heart failure requires a device that can provide support to the
patient quickly. Physicians desire treatment options that can be
deployed quickly and minimally-invasively.
[0004] Intra-aortic balloon pumps (IABP) are currently the most
common type of circulatory support devices for treating acute heart
failure. IABPs are commonly used to treat heart failure, such as to
stabilize a patient after cardiogenic shock, during treatment of
acute myocardial infarction (MI) or decompensated heart failure, or
to support a patient during high risk percutaneous coronary
intervention (PCI). Circulatory support systems may be used alone
or with pharmacological treatment.
[0005] In a conventional approach, an IABP is positioned in the
aorta and actuated in a counterpulsation fashion to provide partial
support to the circulatory system. More recently,
minimally-invasive rotary blood pumps have been developed in an
attempt to increase the level of potential support (i.e., higher
flow). A rotary blood pump is typically inserted into the body and
connected to the cardiovascular system, for example, to the left
ventricle and the ascending aorta to assist the pumping function of
the heart. Other known applications pumping venous blood from the
right ventricle to the pulmonary artery for support of the right
side of the heart. An aim of acute circulatory support devices is
to reduce the load on the heart muscle for a period of time, to
stabilize the patient prior to heart transplant or for continuing
support.
[0006] There is a need for improved mechanical circulatory support
devices for treating acute heart failure. Fixed cross-section
ventricular assist devices designed to provide near full heart flow
rate are either too large to be advanced percutaneously (e.g.,
through the femoral artery without a cutdown) or provide
insufficient flow.
[0007] There is a need for a pump with improved performance and
clinical outcomes. There is a need for a pump that can provide
elevated flow rates with reduced risk of hemolysis and thrombosis.
There is a need for a pump that can be inserted
minimally-invasively and provide sufficient flow rates for various
indications while reducing the risk of major adverse events. In one
aspect, there is a need for a heart pump that can be placed
minimally-invasively, for example, through a 15FR or 12FR incision.
In one aspect, there is a need for a heart pump that can provide an
average flow rate of 4 Lpm or more during operation, for example,
at 62 mmHg of head pressure. While the flow rate of a rotary pump
can be increased by rotating the impeller faster, higher rotational
speeds are known to increase the risk of hemolysis, which can lead
to adverse outcomes and in some cases death. Accordingly, in one
aspect, there is a need for a pump that can provide sufficient flow
at significantly reduced rotational speeds. These and other
problems are overcome by the inventions described herein.
[0008] Furthermore, in various catheter pump systems, it can be
important to provide fluids to an operative device of a catheter
assembly (e.g., for lubrication of moving parts and/or treatment
fluids to be delivered to the patient), and to remove waste fluids
from the patient's body. A controller may be provided to control
the flow into and out of the catheter assembly. It can be
advantageous to provide improved mechanisms for engaging the
catheter assembly with the controller, which may be housed in a
console.
[0009] Additionally, there is a need to reduce the time to
implantation and treatment. In the case of therapy for acute heart
failure in particular, the time it takes to start therapy can be
critical to survival and good outcomes. For example, a difference
of several minutes can be the difference between recovery and
permanent brain damage for patients suffering myocardial infarction
or cardiogenic shock. Accordingly, a continuing need exists to
provide pump systems that can be set up, primed, and inserted
faster, easier, and more effectively.
[0010] These and other problems are overcome by the inventions
described herein.
SUMMARY
[0011] There is an urgent need for a pumping device that can be
inserted percutaneously and also provide full cardiac rate flows of
the left, right, or both the left and right sides of the heart when
called for.
[0012] In one embodiment, a system for priming a catheter assembly
is disclosed. The system can include a catheter assembly including
an elongate body having a distal portion and an operative device
coupled at the distal portion. The system can also include a
priming vessel configured to receive insertion of the operative
device therein. The priming vessel can include a proximal portion
secured to the distal portion of the elongate body such that the
elongate body is in fluid communication with the priming vessel.
The priming vessel can also include a distal end through which air
is expelled when a fluid is channeled through the elongate body and
into the priming vessel to expel air from within the catheter
assembly.
[0013] In another embodiment, an infusate system for priming a
catheter assembly is disclosed. The system includes a catheter
assembly including an elongate body and an operative device, a
fluid reservoir configured to store an infusate fluid, and a luer
coupled in flow communication with the fluid reservoir. The
infusate system also includes a priming vessel configured to
receive insertion of the operative device therein. The priming
vessel is coupled in flow communication with the elongate body and
the luer such that the luer is configured to deliver the infusate
fluid to the priming apparatus to expel air from the catheter
assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] A more complete appreciation of the subject matter of this
application and the various advantages thereof can be realized by
reference to the following detailed description, in which reference
is made to the accompanying drawings in which:
[0015] FIG. 1 is a schematic view of an operative device of a
catheter assembly in position within the anatomy for assisting the
left ventricle.
[0016] FIG. 2 is a three-dimensional perspective view of a catheter
assembly, according to some embodiments.
[0017] FIG. 3A is a three-dimensional perspective view of a fluid
handling system that includes a console and catheter assembly.
[0018] FIG. 3B is a three-dimensional perspective view of an
interface region of the console shown in FIG. 3A.
[0019] FIG. 4 is a three-dimensional perspective view of an
interface member, according to one embodiment.
[0020] FIG. 5A is a three-dimensional perspective view of a
cap.
[0021] FIG. 5B is a three-dimensional perspective view of an
interface member in an unlocked configuration.
[0022] FIG. 5C is a three-dimensional perspective view of an
interface member in a locked configuration.
[0023] FIG. 6A is a three-dimensional perspective view of a first
side of an electrical component, according to one embodiment.
[0024] FIG. 6B is a three-dimensional perspective view of a second,
opposite side of the electrical component of FIG. 6A.
[0025] FIG. 7 is a schematic diagram of an infusate system,
according to one embodiment.
[0026] FIG. 8 is an enlarged view of a priming apparatus shown in
FIG. 2.
[0027] More detailed descriptions of various embodiments of
components for heart pumps useful to treat patients experiencing
cardiac stress, including acute heart failure, are set forth
below.
DETAILED DESCRIPTION
[0028] This application is directed to fluid handling systems that
are configured to control and/or manage fluid and electrical
pathways in a catheter assembly, such as a catheter assembly of a
percutaneous heart pump system. In particular, the disclosed
percutaneous heart pump systems may include a catheter assembly and
a console that includes a controller configured to control the
fluid and electrical pathways that pass through the catheter
assembly. Some of the disclosed embodiments generally relate to
various configurations for coupling and engaging the catheter
assembly with the console. For example, the console may be
configured to control the flow rate of the pump and to monitor
various physiological parameters and pump performance through the
various electrical and fluid pathways of the catheter assembly. In
some arrangements, the catheter assembly may be disposable, such
that the catheter assembly can be discarded after use, while the
console and controller are reusable. In embodiments with a reusable
console and a disposable catheter assembly (or, indeed, in any
embodiments where consoles and catheter assemblies may be coupled),
it can be desirable to provide an effective interface between the
catheter assembly and the console that completes the various fluid
and electrical connections between the catheter assembly and the
console.
[0029] In particular, it can be advantageous to provide an
interface member at a proximal portion of the catheter assembly
that is removably engageable with the console. Furthermore, to
enhance usability and to minimize mistakes in making the
connections, it can be important to make the interface easy to use
so that users can easily connect the catheter assembly to the
console before use and easily remove the catheter assembly from the
console after use. Moreover, it can be important that the interface
provides a secure connection between the interface member of the
catheter assembly and an interface region of the console to ensure
that the catheter assembly remains connected to the console
uninterrupted during treatment.
[0030] As explained herein, one example of a catheter assembly is
used in a percutaneous heart pump system having an operative device
(e.g., an impeller assembly) that is configured to assist the
patient's heart in pumping blood. The heart pump system may be
configured to at least temporarily support the workload of the left
ventricle in some embodiments. The exemplary heart pump can be
designed for percutaneous entry through the femoral artery to a
patient's heart. In particular, the exemplary impeller assembly can
include a collapsible impeller and cannula, which can be inserted
into the patient's vasculature at a catheter size of less than 13
FR, for example, about 12.5 FR in some arrangements. During
insertion through the patient's vascular system to the heart, a
sheath may maintain the impeller and cannula assembly in a stored
configuration. When the impeller assembly is positioned in the left
ventricle (or another chamber of a patient's heart), the impeller
and cannula can expand to a larger diameter, for example to a
catheter size of about 24 FR when the sheath is removed from the
impeller assembly. The expanded diameter of the impeller and
cannula may allow for the generation of higher flow rates,
according to some embodiments.
[0031] For example, FIG. 1 illustrates one use of the disclosed
catheter pump system. A distal portion of the pump, which can
include an impeller assembly 116A, is placed in the left ventricle
(LV) of the heart to pump blood from the LV into the aorta. The
pump can be used in this way to treat patients with a wide range of
conditions, including cardiogenic shock, myocardial infarction, and
other cardiac conditions, and also to support a patient during a
procedure such as percutaneous coronary intervention. One
convenient manner of placement of the distal portion of the pump in
the heart is by percutaneous access and delivery using the
Seldinger technique, or other methods familiar to cardiologists.
These approaches enable the pump to be used in emergency medicine,
a catheter lab and in other non-surgical settings. Modifications
can also enable the pump 10 to support the right side of the heart.
Example modifications that could be used for right side support
include providing delivery features and/or shaping a distal portion
that is to be placed through at least one heart valve from the
venous side, such as is discussed in U.S. Pat. Nos. 6,544,216;
7,070,555; and US 2012-0203056A1, all of which are hereby
incorporated by reference herein in their entirety for all
purposes.
[0032] Turning to FIG. 2, a three-dimensional perspective view of a
catheter assembly 100A is disclosed. The catheter assembly 100A may
correspond to the disposable portion of the heart pump systems
described herein. For example, the catheter assembly 100A may
include the impeller assembly 116A near a distal portion of the
catheter assembly 100A, an elongate body 174A extending proximally
from the impeller assembly 116A, an infusion system 195 configured
to supply infusate to the catheter assembly 100A, a motor assembly
comprising a driven assembly 101 and a drive assembly 103, one or
more conduits 302 (e.g., electrical and/or fluid conduits)
extending proximally from the motor assembly, and an interface
member 300 coupled at a proximal portion of the conduits 302.
[0033] Moving from the distal end of the catheter assembly 100A of
FIG. 2 to the proximal end, the impeller assembly 116A may be
disposed at a distal portion of the catheter assembly 100A. As
explained above, the impeller assembly 116A can include an
expandable cannula or housing and an impeller with one or more
blades. As the impeller rotates, blood can be pumped proximally (or
distally in some implementations) to function as a cardiac assist
device. A priming apparatus 1400 can be disposed over the impeller
assembly 116A. As explained herein with reference to FIGS. 7-8, the
priming apparatus 1400 can be configured to expedite a process of
expelling air from the catheter assembly 100A before insertion of
the operative device of the catheter assembly into the patient.
[0034] With continued reference to FIG. 2, the elongate body 174A
extends proximally from the impeller assembly 116A to an infusion
system 195 configured to allow infusate to enter the catheter
assembly 100A and waste fluid to leave the catheter assembly 100A.
A catheter body 120A (which also passes through the elongate body
174A) can extend proximally and couple to the driven assembly 101
of the motor assembly. The catheter body 120A can pass within the
elongate body 174A, such that the elongate body 174A can axially
translate relative to the catheter body 120A. Axial translation of
the elongate body 174A relative to the catheter body 120A can
enable the expansion and collapse of the impeller assembly 116A.
For example, the impeller assembly 116A, coupled to a distal
portion of the catheter body 120A, may expand into an expanded
state by moving the elongate body 174A proximally relative to the
impeller assembly 116A. The impeller assembly 116A may self-expand
into the expanded state in some embodiments. In the expanded state,
the impeller assembly 116A is able to pump blood at high flow
rates. After the treatment procedure, the impeller assembly 116A
may be compressed into a collapsed state by advancing a distal
portion 170A of the elongate body 174A distally over the impeller
assembly 116A to cause the impeller assembly 116A to collapse.
[0035] As explained above, the catheter body 120A can couple to the
driven assembly 101 of the motor assembly. The driven assembly 101
can be configured to receive torque applied by the drive assembly
103, which is shown as being decoupled from the driven assembly 101
and the catheter assembly 100A in FIG. 2. The drive assembly 103
can be coupled to the driven assembly 101 by engaging a proximal
portion of the driven assembly 101 with the drive assembly, e.g.,
by inserting the proximal portion of the driven assembly 101 into
an aperture 105 of the drive assembly 103.
[0036] Although not shown in FIG. 2, a drive shaft can extend from
the driven assembly 101 through the catheter body 120A to couple to
an impeller shaft at or proximal to the impeller assembly 116A. The
drive assembly 103 can electrically communicate with a controller
in a console (see, e.g., FIGS. 3A-3B), which can be configured to
control the operation of the motor assembly and the infusion system
195 that supplies a flow of infusate in the catheter assembly 100A.
The impeller of the impeller assembly 116A may thus be rotated
remotely by the motor assembly during operation of the catheter
pump in various embodiments. For example, the motor assembly can be
disposed outside the patient. In some embodiments, the motor
assembly is separate from the controller or console, e.g., to be
placed closer to the patient. In other embodiments, the motor
assembly is part of the controller. In still other embodiments, the
motor assembly is miniaturized to be insertable into the patient.
Such embodiments allow the drive shaft to be much shorter, e.g.,
shorter than the distance from the aortic valve to the aortic arch
(about 5 cm or less). Some examples of miniaturized motors catheter
pumps and related components and methods are discussed in U.S. Pat.
Nos. 5,964,694; 6,007,478; 6,178,922; and 6,176,848, all of which
are hereby incorporated by reference herein in their entirety for
all purposes.
[0037] As shown in FIG. 2, the motor assembly (e.g., the drive
assembly 103 and the driven assembly 101) is in electrical
communication with the controller and console by way of the
conduits 302, which may include electrical wires. In particular, as
shown in FIG. 2, the electrical wires may extend from the motor
assembly proximally to the interface member 300. To enable the
controller in the console to electrically communicate with the
motor assembly and/or other sensors in the catheter assembly 100A
(such as pressure sensors, flow sensors, temperature sensors,
bubble detectors, etc.), it can be advantageous to provide a
reliable electrical connection between the interface member 300 and
the console. In various embodiments disclosed herein, therefore,
the removable interface member 300 may include electrical
components configured to couple to one or more electrical contacts
(sometimes referred to herein as interconnections) in the console.
The electrical connections may be achieved in a simple,
user-friendly manner. In various embodiments disclosed herein, for
example, the electrical connections may be made substantially at
the same time, e.g., substantially simultaneously, as fluid
connections are made between the interface member 300 and console.
These and other structures incorporated to reduce the complexity of
operating the pump system are provided to reduce the chance of
errors in set-up and delays, which for the emergency conditions in
which the pump may be implemented could be life-threatening.
[0038] The mechanical components rotatably supporting the impeller
within the impeller assembly 116A permit high rotational speeds
while controlling heat and particle generation that can come with
high speeds. The infusion system 195 may deliver a cooling and
lubricating solution to the distal portion of the catheter assembly
100A for these purposes. As shown in FIG. 2, the infusion system
195 may be in fluid communication with the interface member 300 by
way of the conduits 302, which may also include fluid conduits or
tubes. Because the catheter assembly 100A may be disposable and/or
removable from a console, it can be important to securely couple
interface member 300 to the console. Furthermore, it can be
important to provide an easy-to-use interface such that users can
easily complete fluid connections that remain secure during a
treatment procedure. Maintaining security of the connection is
important because the fluids and signals carried by the conduits
302 enable the impeller to operate in a continuous manner. Stoppage
of the pump system may require the catheter assembly 100A to be
removed from the patient and replaced in certain circumstances,
which may be life-threatening or extremely inconvenient at a
minimum.
[0039] When activated, the catheter pump system can effectively
increase the flow of blood out of the heart and through the
patient's vascular system. In various embodiments disclosed herein,
the pump can be configured to produce a maximum flow rate (e.g. low
mm Hg) of greater than 4 Lpm, greater than 4.5 Lpm, greater than 5
Lpm, greater than 5.5 Lpm, greater than 6 Lpm, greater than 6.5
Lpm, greater than 7 Lpm, greater than 7.5 Lpm, greater than 8 Lpm,
greater than 9 Lpm, or greater than 10 Lpm. In various embodiments,
the pump can be configured to produce an average flow rate at 62
mmHg pressure head of greater than 2 Lpm, greater than 2.5 Lpm,
greater than 3 Lpm, greater than 3.5 Lpm, greater than 4 Lpm,
greater than 4.25 Lpm, greater than 4.5 Lpm, greater than 5 Lpm,
greater than 5.5 Lpm, or greater than 6 Lpm.
[0040] Various aspects of the pump and associated components are
similar to those disclosed in U.S. Pat. Nos. 7,393,181; 8,376,707;
7,841,976; 7,022,100; and 7,998,054, and in U.S. Pub. Nos.
2011/0004046; 2012/0178986; 2012/0172655; 2012/0178985; and
2012/0004495, the entire contents of each of which are incorporated
herein for all purposes by reference. In addition, this application
incorporates by reference in its entirety and for all purposes the
subject matter disclosed in each of the following concurrently
filed applications: application Ser. No. 13/802,556, which
corresponds to attorney docket no. THOR.072A, entitled "DISTAL
BEARING SUPPORT," filed on Mar. 13, 2013; application Ser. No.
13/801,833, which corresponds to attorney docket no. THOR.089A,
entitled "SHEATH SYSTEM FOR CATHETER PUMP," filed on Mar. 13, 2013;
application Ser. No. 13/802,570, which corresponds to attorney
docket no. THOR.090A, entitled "IMPELLER FOR CATHETER PUMP," filed
on Mar. 13, 2013; application Ser. No. 13/801,528, which
corresponds to attorney docket no. THOR.092A, entitled "CATHETER
PUMP," filed on Mar. 13, 2013; and application Ser. No. 13/802468,
which corresponds to attorney docket no. THOR.093A, entitled "MOTOR
ASSEMBLY FOR CATHETER PUMP," filed on Mar. 13, 2013.
Fluid Handling System
[0041] FIG. 3A is a three-dimensional perspective view of a fluid
handling system 350 that includes a console 301 and the catheter
assembly 100A of FIG. 2. The console 301 can provide electrical
power, control signals, medical fluids (e.g., saline) for infusion,
and fluid waste extraction to the catheter assembly 100A by way of
its interface with the interface member 300. In this manner, a
plurality of fluid connections can advantageously be made with a
single interface. As illustrated in FIG. 2, for example, the
removable interface member 300 may be disposed at a proximal
portion of the catheter assembly 100A and may be configured to
couple to the console 301 at an interface region 303.
[0042] In some embodiments, the fluid handling system 350 can be
configured to deliver fluids to and/or remove fluids from the
catheter assembly 100A. As discussed above and in the incorporated
patent references, saline and/or other medical solutions can
lubricate and/or cool component between the motor assembly and the
operative device. If desired, waste fluids can be removed from the
catheter assembly 100A using the fluid handling system 350. In some
embodiments, the fluid handling system 350 can include a multilumen
catheter body having a proximal end and a distal end. The catheter
body can include one or more lumens through which medical solutions
(e.g., saline), waste fluids, and/or blood can flow. To drive fluid
through the catheter assembly 100A (e.g., into and/or out of the
catheter assembly 100A), the console 301 may include one or more
pump(s) configured to apply positive or negative pressure to the
catheter assembly 100A when the catheter assembly 100A is coupled
to the console 301 and engages the pump(s).
[0043] In addition, the fluid handling system 350 may also be
configured to provide electrical communication between the console
301 and the catheter assembly 100A. For example, the console can
include a controller (e.g., a processor) that is programmed to
control and/or manage the operation of the motor assembly. The
console 301 may also include electrical interfaces configured to
supply power to the motor assembly and/or other components that are
driven by electrical power when the interface member 300 is coupled
to the console 301. Moreover, one or more electrical or electronic
sensors may be provided in the catheter assembly 100A and may
electrically couple to the console 301 by way of the fluid handling
system 350. The embodiments disclosed herein may thereby provide
fluid and electrical connections between the catheter assembly 100A
and the console 301.
[0044] As explained above, the fluid handling system 350 may
provide a removable interface between the catheter assembly 100A
and the console 301, which may include various components,
including, e.g., one or more pump(s), processors (e.g., the
controller), electrical interconnections, etc. For example, to
activate one or more pumps in the console 301 and/or to engage one
or more electrical connections between the console 301 and the
interface member 300, a user may simply insert a distal portion of
the interface member 300 (e.g., including a closure member) along
the illustrated Z-direction into an aperture 304 of the interface
region 303 until the pump(s) are engaged and the electrical
connection(s) are formed. In some aspects, the insertion of the
interface member along the Z-direction may engage the pump(s) and
complete the electrical connection(s) substantially
simultaneously.
[0045] In some embodiments, the interface member 300 may be secured
to the console 301 by engaging a locking device between the
interface region 303 and the interface member 300. One convenient
way to engage a locking device is by rotating a portion of the
interface member 300 relative to another portion of the interface
member or relative to the console 301, as explained herein. For
example, rotation of an outermost structure (opposite the direction
Z), sometimes referred to herein as a "cap" relative to the console
may engage a locking mechanism configured to mechanically secure
the interface member 300 to the console 301 to prevent the
interface member 300 from being accidentally disengaged during a
treatment procedure.
[0046] The console 301 may also include a user interface 312, which
may comprise a display device and/or a touch-screen display. The
user may operate the percutaneous heart pump system by interacting
with the user interface 312 to select, e.g., desired flow rates and
other treatment parameters. The user may also monitor properties of
the procedure on the user interface 312.
[0047] FIG. 3B is a three-dimensional perspective view of the
interface region 303 of the console 301 shown in FIG. 3A. The
interface region 303 can include the aperture 304 configured to
receive the distal portion of the interface member 303. The
aperture 304 may include a generally circular cavity shaped and
sized to receive a portion of the interface member 300. A bubble
detector 308 (e.g., an optical sensor in some embodiments) can be
positioned at a back wall of the aperture 304. The bubble detector
308 may include a recess portion defined by two walls sized and
shaped to receive a segment of tubing. When fluid flows through the
tubing (see, e.g., bubble detector tube segment 326 in FIG. 4), the
bubble detector 308 may monitor the fluid to determine whether or
not the fluid includes unwanted matter, e.g., bubbles of air or
other gas. In some embodiments, the bubble detector 308 may measure
the amount (number or volume) of bubbles in the fluid passing
though the tube segment. It should be appreciated that it can be
important to detect bubbles in the treatment fluid to avoid
inducing embolisms in the patient. The bubble detector 308 may
electrically communicate with the controller in the console 301 and
can indicate the amount of bubbles in the treatment fluid. The
console 301, in turn, can alert the user if there are bubbles in
the treatment fluid.
[0048] The interface region 303 can also include one or more pumps,
e.g., peristaltic pumps in some embodiments. The peristaltic pumps
can be used to pump fluid into or out of the catheter assembly 100A
to deliver medical fluids and to remove waste fluids, respectively.
Such pumps may employ one or more rollers 306 to control delivery
of a fluid within a respective tube (see, e.g., pump tube segments
324a, 324b of FIG. 4). For example, the one or more pump rollers
306 can be housed within the console 301. As shown, two pump
rollers 306 are mounted about their rotational axes (e.g., the
Y-direction illustrated in FIG. 3B) at the back wall of the
aperture 304. The pump rollers 306 can be rotated by a peristaltic
pump motor within the console (not shown in FIGS. 3A-3B). As
explained in more detail herein with respect to FIG. 4 below, the
rollers 306 can engage pump tube segments 324a, 324b to pump fluid
into or out of the catheter assembly 100A. The pump rollers 306 may
be configured to be received within occlusion bed regions of the
interface member 300 (see, e.g., occlusion beds 322a and 322b of
FIG. 4) to pump fluid through the catheter assembly 100A.
[0049] An electrical interconnect 307 can also be provided in the
back wall of the aperture 304. The electrical interconnect 307 can
be configured to provide power to the motor assembly and/or
electrical signals or instructions to control the operation of the
motor assembly. The electrical interconnect 307 can also be
configured to receive electrical signals indicative of sensor
readings for monitoring pressure, flow rates, and/or temperature of
one or more components in the catheter assembly 100A. A recessed
channel 309 can extend from the bottom of the aperture 304 along
the side to the lower edge of the console 301. The recessed channel
309 can be shaped and sized to receive one or more of the conduits
302 (e.g., electrical and/or fluid conduits) extending between the
interface member 300 and the motor assembly. In one embodiment, all
of the conduits 302 can be received within the channel 309
providing a flush side surface when the interface member 300 is
disposed in the interface aperture 304.
[0050] In addition, it can be important to ensure that the
interface member 300 is controllably secured within the console 301
such that it is engaged and disengaged only when the user desires
to engage or disengage the interface member 300 from the console
301. For example, as explained in more detail herein relative to
FIGS. 5A-5C, the interface region 303 can include a groove 313
sized and shaped to receive a locking mechanism (e.g., a tab or
flange projecting in the X direction) on the interface member 300.
In one embodiment, a disengaging member 305 includes a
spring-loaded release mechanism 310 provided above the aperture 304
and a pin 311 that can be inserted into a hole in the interface
member 300 (see, e.g., FIGS. 5A-5C and the accompanying disclosure
below). As explained below with respect to FIGS. 5A-5C, the pin 311
can assist in releasing the interface member 300 relative to the
console 301. The spring-loaded release mechanism 310 can be pressed
to release the pin 311 and unlock the interface member 300 from the
console 301. As explained herein, the spring-loaded release
mechanism 310 can therefore act as a further safety mechanism to
ensure that the cassette is not accidentally disengaged by the
user.
Removable Interface Member
[0051] FIG. 4 is a three-dimensional perspective view of the
interface member 300, according to one embodiment. The interface
member 300 can comprise a body that is shaped and sized to fit into
the interface region 303 of the console 301. As shown in FIG. 4,
the interface member 300 can have a substantially circular profile,
and is sometimes referred to as a puck. In some embodiments, the
interface member 300 can include an outer body 333 operably coupled
to a manual interface 320, sometimes referred to as a cap. The
manual interface 320 is generally palm-sized so that a user can
receive it in their hand and operate it comfortably, e.g., with
finger pressure on the outer rim of the cap. One or more occlusion
beds can be formed or provided at the interface between the
interface member 300 and the console 301, e.g., in or on the
interface member 300. For example, first and second occlusion beds
322a and 322b may be formed in the interface member 300. As shown
in FIG. 4, for example, the occlusion beds 322a, 322b, can include
arcuate recessed regions formed in the interface member 300.
[0052] The interface member 300 can further include first and
second pump tube segments 324a, 324b positioned along the occlusion
beds 322a, 322b formed in the interface member 300. When the
interface member 300 is inserted into the console 301, the pump
rollers 306 can engage with the interface member 300 and compress
the tube segment(s) 324a, 324b against the occlusion bed(s) 322a,
322b, respectively. As the pump motor(s) in the console 301 rotate
the rollers 306, fluid flows into uncompressed portions of the tube
segment(s) 324a, 324b and continues flowing throughout the catheter
assembly 100A. For example, by compressing the tube segments 324a,
324b, the fluid may be pumped into or out of the catheter assembly
100A by way of the conduits 302 extending from the interface member
300 to the motor assembly and distally beyond the motor
assembly.
[0053] Because the tolerances for the peristaltic pump can be
rather tight, the body of the interface member 300 (e.g., the outer
body 333 and/or an inner body, such as inner body 339 illustrated
in FIGS. 5B-5C) can be formed with precise tolerances (e.g., molded
from a unitary structure in some implementations) such that when
the interface member 300 is inserted into the console 301, the pump
rollers 306 precisely and automatically engage with the tube
segments 324a, 324b and occlusion beds 322a, 322b to reliably
occlude the tube segments 324a, 324b and pump fluids through the
catheter assembly 100A. Thus, when the interface member 300 is
inserted sufficiently far into the interface region 303, the pump
in the console 301 can automatically engage the interface member
300.
[0054] For example, the gap between the rollers 306 and the
occlusion beds 322a, 322b can be less than about two wall
thicknesses of the tube segments 324a, 324b in some arrangements,
such that the tubes 324a, 324b can be effectively occluded. Due to
the precise tolerances of the interface member 300, the pump can be
engaged by simply inserting the interface member 300 into the
console 301. There is no need to separately activate the pump in
some embodiments. The dimensions of the interface member 300 may be
selected such that the occlusion bed(s) 322a, 322b automatically
engages the respective pump rollers 306 upon insertion of the
interface member 300 into the console 301.
[0055] The above configuration provides several advantages. As one
of skill in the art will appreciate from the description herein,
the interface member 300 and interface region 303 provide an
easy-to-use, quick connection of the tubing segments to one or more
respective rollers 306. Moreover, the components can be
manufactured easily and cost-effectively because only certain
components require tight tolerances and the interface of member 300
to region 303 is essentially self-aligning. The interface also
eliminates any need to engage the pump through a second mechanism
or operator step, streamlining operation of the heart pump and
simplifying the engagement of the catheter assembly 100A to the
console 301. Also, in implementations where the console 301 is
mounted on an IV pole with rollers, or another type of lightweight
cart, for example, the simplified engagement mechanisms disclosed
herein can be advantageous because there is only a minimal applied
force against the pole, which prevents the pole from rolling or
tipping when the pump is engaged.
[0056] The pump tube segments 324a, 324b can be mounted on the
interface body 300 near or in the respective occlusion beds 322a,
322b. As illustrated, the first and second pump tube segments 324a,
324b can be configured to engage with the pump rollers 306 in the
console 301, as explained above. The first and second pump tube
segments 324a, 324b can have an arcuate shape (which may be
pre-formed in various arrangements) that generally conforms to the
curved shape of each respective occlusion bed 322a, 322b. The pump
rollers 306 within the console 301 can thereby be positioned within
the occlusion beds 322a, 322b to compress the tube segments 324a,
324b against the wall of the occlusion beds 322a, 322b. In
addition, a bubble detector tube segment 326 can also be mounted in
or on the interface member 300 and can be configured to engage with
or be positioned adjacent to the bubble detector 308 illustrated in
FIG. 3B. The bubble detector tube segment 326 can be any suitable
shape. As illustrated, the bubble detector tube segment can be
substantially straight and can be sized and shaped to be received
by the bubble detector 308 within the console 301. As explained
above with respect to FIGS. 3A-3B, the bubble detector 308 (which
may be an optical sensor) can be used to detect air bubbles in the
treatment or lubricating fluid being supplied to the patient.
[0057] The tube segments can be fluidly connected to the remainder
of the catheter assembly 100A, including, e.g., one or more lumens
of the catheter body, by way of the conduits 302. In operation,
therefore, the removable interface member 300 may allow fluid to be
pumped into and out of the patient within a controlled system,
e.g., such that the fluids within the catheter assembly 100A can be
pumped while maintaining a sterile environment for the fluids.
Depending on the implementation, the volume of medical solution
into the catheter body can be equal to, or can exceed by a minimum
amount, the volume of medical solution out of the catheter body to
assure that blood does not enter a blood-free portion of the heart
pump.
[0058] In addition, one or more electrical contacts 328 can be
provided in the interface member 300. The electrical contacts 328
can be any suitable electrical interface configured to transmit
electrical signals between the console 301 and the catheter
assembly 100A (e.g., the motor assembly and/or any suitable
sensors). For example, the electrical contacts 328 can be
configured to electrically couple to the electrical interconnect
307 disposed in the console 301. Electrical control signals and/or
power may be transmitted between the console 301 and the catheter
assembly 100A by way of the electrical connection between the
electrical contacts 328 and the electrical interconnect 307.
Advantageously, the electrical connection between the electrical
contacts 328 and the electrical interconnect 307 may be formed or
completed when the interface member 300 is inserted into the
interface region 303 of the console 301. For example, in some
embodiments, the electrical connection between the electrical
contacts 328 and the electrical interconnect 307 may be formed
substantially simultaneously with the fluid connection (e.g., the
engagement of the pump) when the interface member 300 is inserted
into the interface region 303. In some aspects, for example, the
electrical connection can be formed by inserting electrical pins
from the electrical contacts 328 into corresponding holes of the
electrical interconnect 307 of the console 301, or vice versa.
[0059] Further, as shown in FIG. 4, the manual interface 320 can be
mechanically coupled to a proximal portion of the outer body 333
and may be configured to rotate relative to the outer body 333 in a
constrained manner, as explained below relative to FIGS. 5A-5C. For
example, the outer body 333 can include one or more locking
apertures 331 configured to receive locking tabs 332 that are
configured to lock the manual interface 320 relative to the console
301. Moreover, as explained below relative to FIGS. 5A-5C, the
outer body 333 may include a pin hole 321 sized and shaped to
receive the pin 311 illustrated in FIG. 3B to releasably couple the
removable interface member 300 relative to the console 301.
[0060] One will appreciate from the description herein that the
configuration of the pump rollers, occlusion bed, and tubing can be
modified depending on the application in accordance with the
present inventions. For example, the configuration may be modified
to provide easier access for service and repair. In various
embodiments, the pump rollers may be disposed external to the
console. In various embodiments, the pump rollers and occlusion bed
may be both disposed within the cassette. In various embodiments,
the console includes a mechanism to actuate the pump rollers in the
cassette. In various embodiments, the rollers may be fixed. In
various embodiments, the rollers may be configured to rotate,
translate, or both. The rollers and/or the occlusion bed may be
positioned on a base that is configured to move. In some
embodiments, the console-cassette interface can include a positive
pressure interface to pump fluid (e.g., saline) into the patient's
vasculature and a negative pressure interface to pump fluid (e.g.,
waste fluid) out of the patient's vasculature.
Locking Mechanism
[0061] As discussed above, the interface member 300 advantageously
can be fully engaged with the console 301 by simply inserting it
into a correspondingly shaped aperture 304 in the housing of the
console 301. When interface member 300 is brought into adjacency
with a back wall of the interface region 303 of the console, e.g.,
when the interface member 300 is inserted into the aperture 304,
the fluid handling and electrical connections are made, and the
system 350 is operational. A locking mechanism in the interface
member 300 can be provided for additional security, which can be
particularly useful for patient transport and other more dynamic
settings. For example, it is desirable to ensure that the catheter
assembly 100A is secured to the console 301 during the entire
procedure to ensure that the procedure is not disrupted due to
accidental disengagement of the interface member 300 from the
console 301.
[0062] In one embodiment, the locking mechanism can be disposed
between the console 301 and the interface member 300 and can be
configured to be engaged by a minimal movement of an actuator. For
example, the manual interface 320 can be provided to cause
engagement of a locking device by a small rotational turn of the
manual interface 320 relative to the console 301.
[0063] FIG. 5A is a three-dimensional perspective view of the
manual interface 320. As shown in FIG. 5A, the manual interface 320
can include or be coupled with an internal cam 335. The cam 335 can
include one or more protruding lobes, such as lobes 336a and 336b.
Further, the cam 335 can include a recessed region 337 recessed
inwardly relative to the lobes 336a, 336b. The cam 335 can also
include a stepped region 338 which can enable the interface member
300 to be locked and unlocked relative to the console 301, as
explained herein.
[0064] FIG. 5B is a three-dimensional perspective view of an
interface member 300A in an unlocked configuration, and FIG. 5C is
a three-dimensional perspective view of an interface member 300B in
a locked configuration. It should be appreciated that the interface
members 300A, 300B of FIGS. 5B and 5C are illustrated without the
outer body 333, which has been hidden in FIGS. 5B and 5C for
purposes of illustration. Unless otherwise noted, the components of
FIGS. 5B and 5C are the same as or similar to the components
illustrated with respect to FIG. 4. As shown in FIGS. 5B and 5C,
the interface members 300A, 300B can include an inner body 339 that
can be disposed within the outer body 333 shown in FIG. 4. The
occlusion beds 322a, 322b can be formed in the inner body 339 of
the interface member 300A, 300B, as shown in FIGS. 5B-5C; however,
in other arrangements, the occlusion beds 322a, 322b may be formed
in the outer body 333 or other portions of the interface member
300A, 300B. In addition, as shown in FIGS. 5A and 5B, an electrical
component 340 can be disposed in a recess or other portion of the
inner body 339. Additional details regarding the electrical
component 340 are explained below with respect to FIGS. 6A-6B.
[0065] The inner body 339 of the interface member 300A, 300B can
further include a protrusion 330 that includes the tab 332 at a
distal portion of the protrusion 330. When the interface member
300A is in the unlocked configuration, the protrusion 330 can be
disposed in or near the recess 337 of the cam 335 in the manual
interface 320. The cam 335 may therefore not contact or apply a
force against the protrusion 330 when the interface member 300A is
in the unlocked configuration, as shown in FIG. 5B.
[0066] However, once the interface member 300 is inserted into the
console 301, the interface member 300 can be locked into place by
rotating the manual interface 320 relative to the inner body 339
and the console 301, e.g., rotated in the A-direction illustrated
in FIG. 5B. When the manual interface 320 is rotated, the internal
cam 335 is also rotated within the interface member 300A, 300B.
Once the cam is rotated, the lobes 336a, 336b of the cam 335 can
engage with the one or more protrusions 330 of the inner body 339
and can push the protrusions 330 outwardly relative to the inner
body 339. In one embodiment, the tabs 332 may extend outwardly
through the locking apertures 331 formed on the outer body 333.
When the tab(s) 332 are pushed through the locking aperture(s) 331,
the tabs 332 project laterally outward from the outer body 333. In
this position, in some embodiments, each of the tabs 332 can lock
into the groove(s) 313 in the console 301 (see FIG. 3B) to secure
the interface member 300B to the console 301. Thus, in the unlocked
position, the tab 332 can be substantially flush with the outer
surface of the interface member 300A, and in the locked position,
the tab 332 can extend through the locking aperture 331 and lock
into the grooves 313 in the console 301.
[0067] In some embodiments, the protrusion 330 can be a
cantilevered protrusion from the inner body 339. As mentioned
above, it can be important to maintain tight tolerances between the
occlusion beds 322a, 322b, which is also formed in the interface
member, and the pump rollers 306 when the interface member 300
engages with the console 301. Because the occlusion beds 322a, 322b
may be formed in the same body as the cantilevered protrusions 330,
conventional manufacturing processes, such as molding processes,
can be used to manufacture the interface member 300 (e.g., the
outer body 333 and/or the inner body 339) according to precise
dimensions. Thus, the protrusion(s) 330, tab(s) 332 and the
occlusion bed(s) 322a, 322b can be made within tight dimensional
tolerances, and the tab(s) 332 and/or protrusion(s) 330 can be
positioned relative to the occlusion bed(s) 322a, 322b with very
high precision such that when the interface member 300 is engaged
with the console 301, the tube segments 324a, 324b are optimally
occluded. Moreover, because the interface member 300 can be locked
by rotating the manual interface 320 on the interface member 300,
only minimal forces are applied to the console 301. This enhances
the advantages of minimizing disruption of a mobile cart or IV pole
to which the system may be coupled.
Disengagement Mechanism
[0068] It can also be important to provide a disengagement
mechanism configured to decouple the interface member 300 from the
console 301. With reference to FIGS. 3B, 4, 5B, and 5C, the
disengaging member 305 of the console 301 can be configured to
disengage and unlock the interface member 300 from the console 301.
For example, the pin 311 may be spring-loaded such that when the
interface member 300A is in the unlocked configuration, the pin 311
extends through the pin hole 321 of the outer body 333 but only
contacts a side surface of one of the lobes 336b of the cam 335.
Thus, in the unlocked configuration of the interface member 300A,
the pin 311 may simply slide along the cam surface, permitting
rotation of the manual interface 320 relative to the pin 311 and
the console 301.
[0069] As shown in FIGS. 3B and 5C, however, when the interface
member 300B is rotated into a locked configuration, the pin 311 can
engage with the stepped region 338 of the internal cam 335, e.g.,
the spring-biased pin 311 can extend into the stepped region 338 or
shoulder of the cam 335. By engaging the stepped region 338, the
pin 311 prevents the cam 335 from rotating from the locked
configuration to the unlocked configuration. A user can disengage
the cassette by pressing the spring-loaded release mechanism 310 to
release the spring and remove the pin 311 from the stepped region
338. The pin 311 can thereby be disengaged from the stepped region
338, and the internal cam 335 can rotate back into the unlocked
position. When the cam 335 is moved back into the unlocked
position, the tab 332 can be withdrawn from the groove 313 in the
console 301 to unlock the interface member 300.
Electrical Interconnections, Components, and Cables
[0070] FIG. 6A is a three-dimensional perspective view of a first
side of the electrical component 340 illustrated in FIG. 4. FIG. 6B
is a three-dimensional perspective view of a second, opposite side
of the electrical component 340 of FIG. 6A. As shown in FIGS.
5B-5C, the electrical component 340 may be disposed in a recess of
the interface member 300. The electrical component 340 can be any
suitable electrical or electronic component, including, e.g., a
printed circuit board (PCB) configured to provide an electrical
interface between various components in the catheter assembly 100A
and the console 301. As explained herein, the electrical component
340 can form an electrical interface between the interface member
300 and the console 301 to provide electrical communication between
the console 301 and the catheter assembly 100A (such as the motor
assembly and/or various sensors).
[0071] For example, the electrical component 340 of the interface
member 300 can include the one or more electrical contacts 328
configured to mate with the corresponding electrical interconnect
307 in the console 301. The electrical contacts 328 and/or the
electrical interconnect 307 can be, for example, nine-pin
electrical interconnects, although any suitable interconnect can be
used. The motor assembly that drives the operative device (e.g.,
impeller) of the catheter pump can be electrically connected to the
interface member 300 by way of one or more electrical cables, e.g.,
the conduits 302. In turn, the console 301 can be coupled to a
power source, which can drive the catheter pump motor assembly by
way of the interface member's contacts 328 and the electrical
conduits 302 connecting the interface member 300 to the motor
assembly. The electrical component 340 can also include
communications interconnects configured to relay electrical signals
between the console 301 and the catheter pump motor assembly or
other portions of the catheter assembly 100A. For example, a
controller within the console 301 (or interface member) can send
instructions to the catheter pump motor assembly via the electrical
component 340 between the console 301 and the interface member 300.
In some embodiments, the electrical component 340 can include
interconnects for sensors (such as pressure or temperature sensors)
within the catheter assembly 100A, including sensors at the
operative device. The sensors may be used to measure a
characteristic of the fluid in one or more of the tubes (e.g.,
saline pressure). The sensors may be used to measure an operational
parameter of the system (e.g., ventricular or aortic pressure). The
sensors may be provided as part of an adjunctive therapy.
[0072] The electrical component 340 within the interface member 300
can be used to electrically couple the cable (and the motor
assembly, sensors, etc.) with the corresponding interconnects 307
in the console 301. For example, one or more internal connectors
346 and 348 on the second side of the electrical component 340 may
provide electrical communication between the contacts 328
(configured to couple to the interconnects 307 of the console 301)
and the catheter assembly 100. For example, electrical cables
(e.g., the conduits 302) can couple to a first internal connector
346 and a second internal connector 348. The internal connectors
346, 348 may electrically communicate with the contacts 328 on the
first side of the electrical component 340, which in turn
communicate with the interconnects 307 of the console 301.
[0073] In various embodiments, the electrical component 340 is
fluidly sealed to prevent the internal electronics from getting
wet. This may be advantageous in wet and/or sterile environments.
This may also advantageously protect the electronics in the event
one of the fluid tubes leaks or bursts, which is a potential risk
in high pressure applications.
[0074] In addition, the electrical component 340 (e.g., PCB) can
include various electrical or electronic components mounted
thereon. As shown in FIG. 6B, for example, two pressure sensors
344a, 344b can be mounted on the electrical component 340 to detect
the pressure in the pump tube segments 324a, 324b. The pressure
sensors 344a, 344b may be used to monitor the flow of fluids in the
tube segments 324a, 324b to confirm proper operation of the heart
pump, for example, confirming a proper balance of medical solution
into the catheter body and waste out of the catheter body. Various
other components, such as a processor, memory, or an
Application-Specific Integrated Circuit (ASIC), can be provided on
the circuit board. For example, respective pressure sensor ASICs
345a, 345b can be coupled to the pressure sensors 344a, 344b to
process the signals detected by the pressure sensors 344a, 344b.
The processed signals may be transmitted from the ASICs 345a, 345b
to the console 301 by way of internal traces (not shown) in the PCB
and the contacts 328.
Priming and Infusate System and Apparatus
[0075] One embodiment of an infusate system 1300 is illustrated in
FIG. 7. Various components described herein can be understood in
more detail by referencing the patent applications incorporated by
reference herein. The infusate system 1300 can be configured to
supply treatment and/or lubricating fluids to the operative device
of the catheter assembly (e.g., an impeller assembly 116), and to
remove waste fluid from the assembly. Furthermore, as explained
herein, an elongate body 174 can be slidably disposed over a
catheter body 120, such that there may be gaps or channels between
the outer surface of the catheter body 120 and the inner surface of
the elongate body 174. Such gaps or channels can contain air
pockets harmful to the patient during a medical procedure. In
addition, the lumen or lumens extending within the catheter body
120 also can contain air pockets harmful to the patient. Thus, it
is desirable to expel air from both the lumens within catheter body
120 and the gaps or channels disposed between the elongate body 174
and the catheter body 120 before conducting a treatment
procedure.
[0076] The system 1300 of FIG. 7 may be configured to supply fluid
to the catheter assembly during treatment, to remove waste fluid
during treatment, and/or to expel air from the elongate body 174,
e.g., between the inner surface of the elongate body 174 and the
outer surface of the catheter body 120 before treatment. In this
embodiment, an interface member 1313 (similar to or the same as the
interface member 300 described herein, in some aspects) may be
provided to connect various components of the catheter assembly, as
discussed herein. An outer sheath tubing 1303a can extend from a
fluid reservoir 1305 to a luer 102 configured to be coupled to an
infusate device. As shown in FIG. 7, the outer sheath tubing 1303a
can be configured to deliver fluid to the outer sheath, e.g., the
space between the elongate body 174 and the catheter body 120. The
fluid reservoir 1305 may optionally include a pressure cuff to urge
fluid through the outer sheath tubing 1303a. Pressure cuffs may be
particularly useful in fluid delivery embodiments using
gravity-induced fluid flow. The luer 102 can be configured to
deliver infusate or other priming fluid to the elongate body 174 to
expel air from the elongate body 174 as described herein in order
to "prime" the system 1300. In addition, a pressure sensor 1309a,
which may be disposed on a motor housing 1314, can be coupled to
the outer sheath tubing 1303a to measure the pressure of the
infusate or priming fluid flowing through the outer sheath tubing
1303a and into the luer 102. The motor housing 1314 illustrated in
FIG. 7 may be the same as or similar to the motor assembly
described above with reference to FIG. 2, for example, when the
drive assembly 103 is coupled to the driven assembly 101.
[0077] As illustrated in the embodiment of FIG. 7, inner catheter
tubing 1303b can extend between the motor housing 1314 and the
fluid reservoir 1305, by way of a T-junction 1320. The inner
catheter tubing 1303b can be configured to deliver fluid to the
lumen or lumens within catheter body 120 during treatment and/or to
expel air from the catheter 120 and prime the system 1300. A
pumping mechanism 1306a, such as a roller pump for example, can be
provided along inner catheter tubing 1303b to assist in pumping the
infusate or priming fluid through the system 1300. As explained
herein, the roller pump can be a peristaltic pump in some
arrangements. In addition, an air detector 1308 can be coupled to
the inner catheter tubing 1303b and can be configured to detect any
air or bubbles introduced into the system 1300. In some
embodiments, a pressure sensor 1309b can couple to inner catheter
tubing 1303b to detect the pressure of the fluid within the tubing.
Additionally, a filter 1311 can be employed to remove debris and
other undesirable particles from the infusate or priming fluid
before the catheter body 120 is infused or primed with liquid. In
some embodiments, the air detector 1308, the pressure sensor 1309b,
and the pumping mechanism 1306a can be coupled to the interface
member 1313 described above (such as the interface member 300). One
or more electrical lines 1315 can connect the motor housing 1314
with the cassette 1313. The electrical lines 1315 can provide
electrical signals for energizing a motor or for powering the
sensor 1309a or for other components. To expel air from the
catheter body 120, infusate or priming fluid can be introduced at
the proximal end of the catheter assembly. The fluid can be driven
distally to drive air out of the catheter body 120 to prime the
system.
[0078] In some aspects, a waste fluid line 1304 can fluidly connect
the catheter body 120 with a waste reservoir 1310. A pressure
sensor 1309c, which may be disposed on or coupled to the interface
member 1313, can measure the pressure of the fluid within the waste
fluid line 1304. A pumping mechanism 1306b, such as a roller pump,
for example, can be coupled to the interface member 1313 and can
pump the waste fluid through the waste fluid line 1304 to the waste
reservoir 1310.
[0079] FIG. 8 is an enlarged view of the priming apparatus 1400
shown in FIG. 2. As explained above, the priming apparatus 1400 may
be disposed over the impeller assembly 116A near the distal end
170A of the elongate body 174A. The priming apparatus 1400 can be
used in connection with a procedure to expel air from the impeller
assembly 116A, e.g., any air that is trapped within the housing or
that remains within the elongate body 174A near the distal end
170A. For example, the priming procedure may be performed before
the pump is inserted into the patient's vascular system, so that
air bubbles are not allowed to enter and/or injure the patient. The
priming apparatus 1400 can include a primer housing 1401 configured
to be disposed around both the elongate body 174A and the impeller
assembly 116A. A sealing cap 1406 can be applied to the proximal
end 1402 of the primer housing 1401 to substantially seal the
priming apparatus 1400 for priming, i.e., so that air does not
proximally enter the elongate body 174A and also so that priming
fluid does not flow out of the proximal end of the housing 1401.
The sealing cap 1406 can couple to the primer housing 1401 in any
way known to a skilled artisan. However, in some embodiments, the
sealing cap 1406 is threaded onto the primer housing by way of a
threaded connector 1405 located at the proximal end 1402 of the
primer housing 1401. The sealing cap 1406 can include a sealing
recess disposed at the distal end of the sealing cap 1406. The
sealing recess can be configured to allow the elongate body 174A to
pass through the sealing cap 1406.
[0080] The priming operation can proceed by introducing fluid into
the sealed priming apparatus 1400 to expel air from the impeller
assembly 116A and the elongate body 174A. Fluid can be introduced
into the priming apparatus 1400 in a variety of ways. For example,
fluid can be introduced distally through the elongate body 174A
into the priming apparatus 1400. In other embodiments, an inlet,
such as a luer, can optionally be formed on a side of the primer
housing 1401 to allow for introduction of fluid into the priming
apparatus 1400.
[0081] A gas permeable membrane can be disposed on a distal end
1404 of the primer housing 1401. The gas permeable membrane can
permit air to escape from the primer housing 1401 during
priming.
[0082] The priming apparatus 1400 also can advantageously be
configured to collapse an expandable portion of the catheter
assembly 100A. The primer housing 1401 can include a funnel 1415
where the inner diameter of the housing decreases from distal to
proximal. The funnel may be gently curved such that relative
proximal movement of the impeller housing causes the impeller
housing to be collapsed by the funnel 1415. During or after the
impeller housing has been fully collapsed, the distal end 170A of
the elongate body 174A can be moved distally relative to the
collapsed housing. After the impeller housing is fully collapsed
and retracted into the elongate body 174A of the sheath assembly,
the catheter assembly 100A can be removed from the priming housing
1400 before a percutaneous heart procedure is performed, e.g.,
before the pump is activated to pump blood. The embodiments
disclosed herein may be implemented such that the total time for
infusing the system is minimized or reduced. For example, in some
implementations, the time to fully infuse the system can be about
six minutes or less. In other implementations, the infusate time
can be less than 5 minutes, less than 4 minutes, or less than 3
minutes. In yet other implementations, the total time to infuse the
system can be about 45 seconds or less. It should be appreciated
that lower infusate times can be advantageous for use with
cardiovascular patients.
Preparing a Percutaneous Heart Pump for Insertion into the
Vasculature
[0083] As discussed herein and in the incorporated patent
applications, in various embodiments the heart pump is inserted in
a less invasive manner, e.g., using techniques that can be employed
in a catheter lab.
[0084] Prior to insertion of the catheter assembly 100A of the
heart pump, various techniques can be used to prepare the system
for insertion. For example, as discussed in connection with FIG. 8,
the catheter assembly 100A can be primed to remove gas that could
be contained therein prior to any method being performed on the
patient. This priming technique can be performed by placing a
distal portion of the catheter assembly 100A in a priming vessel,
such as the apparatus 1400. Thereafter, a media is delivered into
the catheter assembly 100A under pressure to displace any
potentially harmful matter, e.g., air or other gas, out of the
catheter assembly 100A. In one technique, the apparatus 1400 is
filled with a biocompatible liquid such as saline. Thereafter, a
biocompatible liquid such as saline is caused to flow distally
through the catheter assembly 100 to displace air in any of the
cavities formed therein, as discussed above. A pressure or flow
rate for priming can be provided that is suitable for priming,
e.g., a pressure or flow rate that is lower than the operational
pressure or flow rate.
[0085] In one technique, the biocompatible liquid is pushed under
positive pressure from the proximal end through the catheter
assembly 100A until all gas is removed from voids therein. One
technique for confirming that all gas has been removed is to
observe the back-pressure or the current draw of the pump. As
discussed above, the priming apparatus 1400 can be configured to
permit gas to escape while preventing saline or other biocompatible
liquid from escaping. As such, the back-pressure or current draw to
maintain a pre-selected flow will change dramatically once all gas
has been evacuated.
[0086] In another technique, the priming apparatus 1400 can include
a source of negative pressure for drawing a biocompatible liquid
into the proximal end of the catheter assembly 100A. Applying a
negative pressure to the priming apparatus 1400 can have the
advantage of permitting the catheter assembly 100A to be primed
separate from the pumps that are used during operation of the heart
pump. As a result, the priming can be done in parallel with other
medical procedures on the patient by an operator that is not
directly working on the patient.
[0087] In another approach, a positive pressure pump separate from
the pump that operates the heart pump can be used to prime under
positive pressure applied to the proximal end. Various priming
methods may also be expedited by providing a separate inlet for
faster filling of the enclosed volume of the priming apparatus
1400.
Collapsing an Expandable Housing of a Fully Primed Catheter
Assembly
[0088] A further aspect of certain methods of preparing the
catheter assembly 100A for insertion into a patient can involve
collapsing the impeller housing 116A. The collapsed state of the
impeller housing 116A reduces the size, e.g., the crossing profile,
of the distal end of the system. This enables a patient to have
right, left or right and left side support through a small vessel
that is close to the surface of the skin, e.g., using catheter
lab-type procedures. As discussed above, in one technique the
priming apparatus 1400 has a funnel configuration that has a large
diameter at a distal end and a smaller diameter at a proximal end.
The funnel gently transitions from the large to the small diameter.
The small diameter is close to the collapsed size of the impeller
housing 116A and the large diameter is close to or larger than the
expanded size of the impeller housing 116A. In one method, after
the catheter assembly 100A has been primed, the impeller housing
116A can be collapsed by providing relative movement between the
priming apparatus 1400 and the impeller housing 116A. For example,
the priming housing 1400 can be held in a fixed position, e.g., by
hand, and the catheter assembly 100A can be withdrawn until at
least a portion of the impeller assembly 116A is disposed in the
small diameter segment of the priming apparatus 1400. Thereafter,
the elongate body 174A of the sheath assembly can be advanced over
the collapsed impeller assembly 116A.
[0089] In another technique, the catheter assembly 100A is held
still and the priming apparatus 1400 is slid distally over the
impeller assembly 116A to cause the impeller assembly 116A to
collapse. Thereafter, relative movement between the elongate body
174A and the impeller assembly 116A can position the distal end
170A of the elongate body 174A over the impeller assembly 116A
after the catheter assembly 100A has been fully primed.
[0090] Although the inventions herein have been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present inventions. It is therefore to be
understood that numerous modifications can be made to the
illustrative embodiments and that other arrangements can be devised
without departing from the spirit and scope of the present
inventions as defined by the appended claims. Thus, it is intended
that the present application cover the modifications and variations
of these embodiments and their equivalents.
* * * * *