U.S. patent application number 17/173853 was filed with the patent office on 2021-06-10 for percutaneous heart pump.
The applicant listed for this patent is THE PENN STATE RESEARCH FOUNDATION, TC1 LLC. Invention is credited to Robert L. Campbell, Jeremy J. Koncoski, Thomas M. Mallison, Mark W. McBride, Daniel Metrey, Eric C. Myer, Kevin J. Powell, William James Repka, Adam Roslund, Daniel A. Walters, Phyllis Yuen.
Application Number | 20210170162 17/173853 |
Document ID | / |
Family ID | 1000005406078 |
Filed Date | 2021-06-10 |
United States Patent
Application |
20210170162 |
Kind Code |
A1 |
Campbell; Robert L. ; et
al. |
June 10, 2021 |
PERCUTANEOUS HEART PUMP
Abstract
Disclosed herein are heart pumps that can include a catheter
body and an impeller coupled with a distal end of the catheter
body. The impeller can include a tip that is resealable or that
includes a resealable member. The heart pump can also include a
diffuser disposed between the distal end of the catheter body and
the impeller, wherein the diffuser includes a flow directing
surface.
Inventors: |
Campbell; Robert L.; (Port
Matilda, PA) ; Koncoski; Jeremy J.; (Pennsylvania
Furnace, PA) ; Mallison; Thomas M.; (State College,
PA) ; McBride; Mark W.; (Bellefonte, PA) ;
Metrey; Daniel; (Blacksburg, VA) ; Myer; Eric C.;
(Spring Mills, PA) ; Powell; Kevin J.; (Glen
Gardner, NJ) ; Roslund; Adam; (Monroeville, PA)
; Walters; Daniel A.; (Rockaway Twp., NJ) ; Repka;
William James; (Parsippany-Troy Hills, NJ) ; Yuen;
Phyllis; (Fremont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TC1 LLC
THE PENN STATE RESEARCH FOUNDATION |
Pleasanton
University Park |
CA
PA |
US
US |
|
|
Family ID: |
1000005406078 |
Appl. No.: |
17/173853 |
Filed: |
February 11, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16281695 |
Feb 21, 2019 |
10960116 |
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17173853 |
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15623575 |
Jun 15, 2017 |
10265447 |
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16281695 |
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14858354 |
Sep 18, 2015 |
9962475 |
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15623575 |
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13345597 |
Jan 6, 2012 |
9138518 |
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14858354 |
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61430537 |
Jan 6, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 60/205 20210101;
A61M 60/40 20210101; A61M 60/818 20210101; A61M 60/148 20210101;
A61M 60/135 20210101; A61M 60/414 20210101; A61M 60/122 20210101;
A61M 60/857 20210101; A61M 60/824 20210101; A61M 60/896
20210101 |
International
Class: |
A61M 60/205 20210101
A61M060/205; A61M 60/414 20210101 A61M060/414; A61M 60/857 20210101
A61M060/857; A61M 60/40 20210101 A61M060/40; A61M 60/896 20210101
A61M060/896 |
Claims
1-23. (canceled)
24. A heart pump configured to be applied percutaneously,
comprising: a catheter assembly comprising a proximal end, a distal
end, and an elongate body extending therebetween; an impeller
assembly comprising an impeller and a housing in which the impeller
is disposed; and a sheath assembly disposed over at least a portion
of the distal end of the catheter body, the sheath assembly
comprising an expandable distal end operable to facilitate
collapsing and expanding the impeller housing.
25. The heart pump of claim 24, wherein the expandable distal end
is configured to expand when a radial force is applied, and
contract when the radial force is removed.
26. The heart pump of claim 24, wherein the expandable distal end
has a conical configuration in an expanded position, and a
cylindrical configuration in a non-expanded position.
27. The heart pump of claim 24, wherein the expandable distal end
includes at least one axial slit.
28. The heart pump of claim 24, wherein the expandable distal end
includes a plurality of elongate members.
29. The heart pump of claim 28, wherein each of the plurality of
elongate members has a length that is greater than an axial length
of an outlet portion of the impeller housing.
30. The heart pump of claim 28, wherein the plurality of elongate
members are made of an elastic material.
31. The heart pump of claim 28, wherein the expandable distal end
includes a deformable webbing extending between the plurality of
elongate members.
32. The heart pump of claim 28, wherein the plurality of elongate
members have a first stiffness that is greater than a second
stiffness of a proximal portion of the sheath assembly.
33. The heart pump of claim 24, wherein the expandable distal end
includes an integral funnel layered over an outer surface and an
inner surface of a non-expandable portion of the sheath
assembly.
34. The heart pump of claim 33, wherein the integral funnel is
slidable relative to the inner surface and the outer surface of the
non-expandable portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/345,597, filed on Jan. 6, 2012, entitled
Percutaneous Heart Pump, which claims priority to U.S. Provisional
Application Ser. No. 61/430,537 filed Jan. 6, 2011, entitled
Percutaneous Heart Pump, the contents of each of which are hereby
incorporated by reference herein for all purposes.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This application is directed to heart pumps that can be
applied percutaneously.
Description of the Related Art
[0003] Heart disease is a major health problem that claims many
lives per year. After a heart attack, only a small number of
patients can be treated with medicines or other non-invasive
treatment. However, a significant number of patients can recover
from a heart attack or cardiogenic shock if provided with
mechanical circulatory support.
[0004] In a conventional approach, a blood pump having a fixed
cross-section is surgically inserted a heart chamber, such as into
the left ventricle of the heart and the aortic arch to assist the
pumping function of the heart. Other known applications involve
providing for pumping venous blood from the right ventricle to the
pulmonary artery for support of the right side of the heart. The
object of the surgically inserted pump is to reduce the load on the
heart muscle for a period of time, which may be as long as a week,
allowing the affected heart muscle to recover and heal. Surgical
insertion, however, can cause additional serious stresses in heart
failure patients.
[0005] Percutaneous insertion of a left ventricular assist device
("LVAD"), a right ventricular assist device ("RVAD") or in some
cases a system for both sides of the heart (sometimes called
"biVAD") therefore is desired. Conventional fixed cross-section
ventricular assist devices designed to provide near full heart flow
rate are too large to be advanced percutaneously, e.g., through the
femoral artery. There is an urgent need for a pumping device that
can be inserted percutaneous and also provide full cardiac rate
flows of the left, right, or both the left and right sides of the
heart when called for.
SUMMARY OF THE INVENTION
[0006] In one embodiment, a heart pump is provided that includes a
catheter body, a housing, an impeller, and a diffuser. The catheter
body includes a proximal end, a distal end, and an elongate body
extending therebetween. The housing is coupled with the distal end
of the catheter body and comprises a distal opening and a proximal
opening. The impeller assembly is coupled with the distal end of
the catheter body and positioned within the housing. The diffuser
can include a flow directing surface. The diffuser is disposed
between the distal end of the catheter body and the impeller. The
diffuser is configured to be positioned within the housing and
adjacent the proximal opening.
[0007] In another embodiment, a heart pump is provided that
includes a catheter body comprising a proximal end, a distal end,
and an elongate body extending therebetween. The pump also includes
an impeller coupled with the distal end of the catheter body and
comprising an axial lumen passing through a distal end of the
impeller. The impeller comprises a tip positioned at the distal end
of the impeller, the tip comprising a resealable member having a
resealable path.
[0008] In another embodiment, a heart pump is provided that
comprises a catheter body, an impeller, and a sheath. The catheter
body has a proximal end, a distal end, and an elongate structure
extending therebetween. The impeller is coupled with the distal end
of the catheter body. The sheath is disposed over at least a
portion of the distal end of the catheter body. The sheath also has
an expandable distal end.
[0009] In another embodiment, a catheter assembly is provided that
includes a catheter body, an impeller, and a deployment device. The
catheter body comprises a proximal end, a distal end, and an
elongate structure extending therebetween. The impeller is
configured for relative motion in an axial direction, and is
located at the distal end of the catheter body. The deployment
device is located at the proximal end of the catheter assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] A more complete appreciation of the subject matter of the
present inventions 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:
[0011] FIG. 1 illustrates one embodiment of a heart pump configured
for percutaneous application and operation;
[0012] FIG. 1A is a plan view of one embodiment of a catheter
assembly adapted to be used with the heart pump of FIG. 1;
[0013] FIG. 2 is a detail view of a distal portion of the catheter
assembly illustrated in FIG. 1A;
[0014] FIG. 3 is an exploded view of a portion of an impeller
assembly of the catheter assembly of FIG. 1A;
[0015] FIG. 4A is a cross-sectional view of a distal portion of the
catheter assembly, taken through the section plane 4A-4A shown in
FIG. 2;
[0016] FIG. 4B is a detail view of the distal portion of the
catheter assembly, taken at 4B-4B shown in FIG. 4A;
[0017] FIG. 5 is a cross-sectional perspective view of a bearing
assembly of the catheter assembly of FIG. 1A;
[0018] FIG. 6 is a cross-sectional view of a bearing housing of the
bearing assembly of FIG. 5;
[0019] FIG. 7 is a perspective view of one embodiment of a catheter
body that can be used to house a drive shaft and to convey an
infusant to the bearing housing of FIG. 5;
[0020] FIGS. 7A-7C show variations of the catheter body of FIG.
7;
[0021] FIG. 8 illustrates a surface configuration of one embodiment
of a bearing adapted to enhance or control flow of an infusant in
the bearing assembly of FIG. 5;
[0022] FIG. 9 illustrates one embodiment of an impeller
assembly;
[0023] FIGS. 9A, 9B-1, 9B-2, 10 and 10A illustrate details of
further embodiments of impeller blades;
[0024] FIG. 11 is a cross-sectional view of a proximal portion of
the catheter assembly, taken through the section plane 11-11 on
FIG. 1A;
[0025] FIGS. 12, 12A, and 12B are cross-section views similar to
that of FIG. 11, illustrating an infusant outflow path;
[0026] FIGS. 13A-B are cross-sectional views of two embodiments of
a blood pump that includes a diffuser;
[0027] FIGS. 14A-B are partial cross-sectional views illustrating
one embodiment of a blood pump including a retractable impeller
assembly in deployed and retracted configurations,
respectively;
[0028] FIGS. 15A-B illustrate a deployment device disposed at the
proximal end of a catheter assembly illustrated in FIGS. 14A-B in
deployed and retracted configurations, respectively;
[0029] FIG. 15C is a cross-sectional view of a structure for
actuating the deployment device illustrated in FIGS. 15A-B;
[0030] FIGS. 15D-F illustrate further embodiments of deployment
devices that can actuate the catheter assembly between deployed and
retracted configurations;
[0031] FIGS. 16A-C are cross-sectional views of three embodiments
of a self-sealing impeller tip; and
[0032] FIGS. 17A-D are perspective views of variations of a sheath
assembly having an expandable distal portion.
[0033] A more detailed description 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
[0034] Major components of heart pumps that can be applied
percutaneously to a patient are described below in Section I.
Section II describes various structures that facilitate the
rotatable support of a cantilevered impeller. Section III describes
various structures that facilitate deployment and/or retrieval of
one or more components of the distal end 108 of the heart pump 10
within the cardiovascular system. Section IV describes various
methods and techniques in connection with specific structures of
heart pumps
I. Overview of Heart Pumps
[0035] FIG. 1 illustrates one embodiment of a heart pump 10 that
includes a catheter assembly 100 having a proximal end 104 adapted
to connect to a motor 14 and a distal end 108 (see FIG. 1A) adapted
to be inserted percutaneously into a patient. The motor 14 is
connected by a signal line 18 to a control module 22 that provides
power and/or control signals to the motor 14. As discussed further
below, the heart pump 10 in various embodiments has an infusion
system 26 and a patient monitoring system 30.
[0036] The infusion system 26 can provide a number of benefits to
the heart pump 10 which are discussed below. In one embodiment, the
infusion system 26 includes a source of infusant 34, a fluid
conduit 38 extending from the infusant source 34 to the proximal
end 104 of the catheter assembly 100 and a fluid conduit 42
extending from the proximal end of the catheter assembly 100 to a
waste container 46. The flow of infusant to and from the catheter
assembly 100 can be by any means, including a gravity system or one
or more pumps. In the illustrated embodiment, the infusant source
34 includes an elevated container 50, which may be saline or
another infusant as discussed below. Flow from the elevated
container 50 can be regulated by a pressure cuff 54 to elevate the
pressure of the fluid in the container 50 to increase flow or by a
pinch valve 58 or by other means.
[0037] The patient monitoring system 30 can be used to monitor the
operation of the patient and/or the pump 10. For example, the
patient monitoring system 30 can include a user interface 60
coupled with a source of data 64. The data source 64 can include
one or more patient conditions sensors, such as pressure sensors 68
that are in pressure communication with the patient and/or
operating components within the patient. In one embodiment, the
pressure sensors 68 fluidly communicate by a conduit 72 that
extends between the sensors and a proximal portion of the catheter
assembly 100. The conduit 72 can include a plurality of separable
segments and can include a valve 76 to enable or disable the
pressure communication to the sensors 68.
[0038] The heart pump 10 is adapted to provide an acute or other
short-term treatment. A short-term treatment can be for less than a
day or up to several days or weeks in some cases. With certain
configurations the pump 10 can be used for a month or more.
[0039] The catheter assembly 100 extends between the proximal end
104 and the distal end 108. An impeller assembly 116 disposed at
the distal end 108 is configured to pump blood to convey blood from
one body cavity to another. In one arrangement, the impeller
assembly 116 conveys blood proximally through or along a portion of
the catheter assembly 100 to provide assistance to the left
ventricle of the heart. In another embodiment, the impeller
assembly 116 conveys blood distally through or along a portion of
the catheter assembly 100 to provide assistance to the right
ventricle of the heart. The heart pump 10 is useful as a heart
assist device for treating patients with acute heart failure or
other heart maladies. The heart pump 10 also can be used in
connection with a surgical treatment to support the patient without
providing full cardiovascular bypass. A patient could be supported
on the device for longer term with proper controls and design.
[0040] The catheter assembly 100 is provided with a low profile
configuration for percutaneous insertion. For example, the distal
end 108 of the catheter assembly 100 can be configured to have
about an 11 French (approximately 3.5 mm) size in a first
configuration for insertion and an expanded configuration, such as
up to about 21 French (approximately 7 mm), once positioned in the
body. The larger size facilitates greater flow rates by the
impeller assembly 116 as discussed below.
[0041] The catheter assembly 100 is configured to enable the distal
end 108 to reach a heart chamber after being inserted initially
into a peripheral vessel. For example, the catheter assembly 100
can have a suitable length to reach the left ventricle and
sufficient pushability and torquability to traverse the intervening
vasculature. The catheter assembly 100 may includes a multilumen
catheter body 120 that is arranged to facilitate delivery and
operation of the impeller assembly 116. Further details concerning
various embodiments of the catheter body 120 are discussed below in
connection with FIGS. 7-7C.
[0042] A drive system is provided to drive an impeller within the
impeller assembly 116. The drive system includes a motor 14 and a
suitably configured drive controller (not shown) disposed within
the control module 22. The motor 14 is in various embodiments is
configured to be disposed outside the patient, e.g., adjacent to
the proximal end 104 of the catheter assembly 100. In one
advantageous embodiment, the drive system employs a magnetic drive
arrangement. The motor 14 is arranged to generate magnetic fields
that will be sensed by permanent magnets disposed within the
proximal end 104 of the catheter assembly 100. This arrangement
facilitates very efficient generation of torque used to drive the
impeller assembly 116, as discussed below.
[0043] Some embodiments described herein could be incorporated into
a system in which a motor is miniaturized sufficiently to be
inserted into the patient in use, including into the vasculature.
Such an embodiment could be operated by disposing control signal
lines within the proximal portion of the catheter body 120. Also,
it may be useful to provide the capability to measure blood
pressure at the distal end 108 using a device disposed at the
proximal end 104. For example, a pressure sensor at the distal end
can communicate with a device outside the patient through a lumen
of the catheter body 120. Various details of these optional
features are described in U.S. Pat. No. 7,070,555, which is
incorporated by reference herein for all purposes and in its
entirety.
[0044] In another embodiment, a mechanical interface can be
provided between the motor and the proximal end 104 of the catheter
assembly 100. The mechanical interface can be between the motor 14
and a drive shaft positioned at the proximal end of the catheter
assembly 100.
[0045] A torque coupling system is provided for transferring torque
generated by the drive system to the impeller assembly 116. The
torque coupling system is discussed further in Section
II(C)--Torque Coupling System (as discussed below), but in general
can include magnetic interface between the motor 14 and a drive
assembly 146 disposed at the proximal end 104 of the catheter
assembly 100. The drive assembly 146 is coupled with a proximal end
of an elongate drive shaft 148 in one embodiment. The drive shaft
148 extends between the drive assembly 146 and the impeller
assembly 116. A distal portion of the drive shaft 148 is coupled
with the impeller assembly 116 as discussed below in connection
with one embodiment illustrated in FIGS. 4A and 4B. FIG. 11 shows
one manner of coupling the proximal end of the drive shaft 148 with
the drive assembly 146.
[0046] As discussed above, the heart pump 10 may also includes an
infusion system 26. Figure lA shows that the infusion system 26 can
include an infusion inflow assembly 150 provided adjacent to the
proximal end 104 in one embodiment. The infusion assembly 150 can
be one component of an infusion system that is configured to convey
one or more fluids within the catheter assembly 100. The fluids can
be conveyed distally within the catheter assembly 100, e.g., within
the catheter body 120, to facilitate operation of the impeller
assembly 116, some aspect of a treatment, or both. In one
embodiment, the infusion system is configured to convey a
lubricant, which can be saline, glucose, lactated Ringer's
solution, acetated Ringer's solution, Hartmann's solution (e.g.,
including compound sodium lactate), and D5W dextrose solution. In
another embodiment, the infusion system is configured to convey a
medication, or a substance that both acts as lubricant and
medication. As sometimes used herein "infusant" is intended to be a
broad term that includes any fluid or other matter that provides
performance enhancement of a component of the heart pump 10 or
therapeutic benefit, and can be wholly or partly extracted from the
system during or after operation of the pump.
[0047] In one embodiment, the infusion inflow assembly 150 includes
a catheter body 154 having a luer or other suitable connector 158
disposed at a proximal end thereof and an inflow port in fluid
communication with one or more lumens within the catheter assembly
100. A lumen extending through the catheter body 154 is adapted to
be fluidly coupled with a fluid source connected to the connector
158 to deliver the fluid into the catheter assembly 100 and through
one or more flow paths as discussed below in connection with FIGS.
4A, 4B, and 7-7C.
[0048] FIGS 1A and 12 show that the catheter assembly 100 in
various embodiments also includes an outlet positioned at a
location that is outside the patient when the heart pump 10 is in
use to allow infusant to be removed from the pump and from the
patient during or after the treatment. The outlet can be fluidly
coupled with an infusant return flow path in the catheter body 120
through a fluid port 144 disposed at the proximal end 104.
[0049] The catheter assembly 100 can also include a sheath assembly
162 configured to constrain the impeller assembly 116 in a low
profile configuration in a first state and to permit the impeller
assembly 116 to expand to the enlarged configuration in a second
state. The sheath assembly 162 has a proximal end 166, a distal end
170, and an elongate body 174 extending therebetween. In one
embodiment, the elongate body 174 has a lumen extending between the
proximal and distal ends 166, 170, the lumen being configured to be
slidably disposed over the catheter body 120. The arrangement
permits the sheath assembly 162 to be actuated between an advanced
position and a retracted position. The retracted position is one
example of a second state enabling the impeller assembly 116 to
expand to an enlarged configuration. The advanced position is one
example of a first state that enables the impeller assembly 116 to
be collapsed to the low profile configuration. In some embodiments,
a luer 102 or other suitable connector is in fluid communication
with the proximal end 166 of the sheath assembly 162. The luer 102
can be configured to deliver fluids to the catheter assembly 100,
such as priming fluid, infusant, or any other suitable fluid.
[0050] FIG. 1A illustrates a retracted position, in which the
distal end 170 of the elongate body 174 is at a position proximal
of the impeller assembly 116. In an advanced position, the distal
end 170 of the elongate body 174 is positioned distal of at least a
portion of the impeller assembly 116. The sheath assembly 162 can
be configured such that distal advancement of the distal end 170
over the impeller assembly 116 actuates the impeller assembly 116
from an enlarged state to a more compact state (or low profile
configuration), e.g., causing a change from the second state to the
first state, as discussed above.
[0051] FIGS. 4A & 4B show the elongate body 174 as a single
layer structure from the inner surface to the outer surface
thereof. In another embodiment, the elongate body 174 has a
multilayer construction. In one arrangement, the elongate body 174
has a first layer that is exposed to the catheter body 120 and a
second layer exposed that corresponds to an outer surface of the
catheter assembly 100. A third layer can be disposed between the
first and second layers to reinforce the elongate body 174,
particularly adjacent to the distal end thereof to facilitate
collapse of the impeller assembly 116. In another construction, a
reinforcing structure can be embedded in an otherwise continuous
tubular structure forming the elongate body 174. For example, in
some embodiments, the elongate body 174 can be reinforced with a
metallic coil.
[0052] FIG. 2 show that an impeller housing 202 is disposed at the
distal end 108. The impeller housing 202 can be considered part of
the impeller assembly 116 in that it houses an impeller and
provides clearance between the impeller and the anatomy to prevent
any harmful interactions therebetween. The housing 202 and the
impeller are also carefully integrated to maintain an appropriate
flow regime, e.g., from distal to proximal or from proximal to
distal within the housing.
[0053] FIGS. 1A and 2 also show that the distal end 108 of the
catheter assembly 100 includes an atraumatic tip 182 disposed
distal of the impeller assembly 116 in one embodiment. FIG. 1A
shows that the atraumatic tip 182 can have an arcuate configuration
such that interactions with the vasculature are minimally
traumatic. The tip 182 can also be configured as a positioning
member. In particular, the tip 182 can be rigid enough to help in
positioning the impeller assembly 116 relative to the anatomy. In
one embodiment, the tip 182 is rigid enough that when it is urged
against a heart structure such as the ventricle wall, a tactile
feedback is provided to the clinician indicating that the impeller
assembly 182 is properly positioned against the heart
structure.
II. Impeller Rotation and Support
[0054] The impeller assembly 116 can take any suitable form, but in
various embodiments includes an impeller 200 adapted to move a
fluid such as blood from an inlet to an outlet of the catheter
assembly 100. In certain embodiments the impeller 200 can be
cantilevered or otherwise supported for rotation primarily at one
end.
[0055] FIG. 3 shows that the impeller 200 includes a shaft 204, a
central body or hub 208, and one or more blades 212.
[0056] The shaft 204 and hub 208 can be joined in any suitable
fashion, such as by embedding a distal portion of the shaft within
the hub 208. The blades 212 can be spaced out proximal to distal
along the axis of the shaft. In some embodiments, the blades 212
are provided in blade rows. FIG. 9 shows that the distal end of the
shaft 204 can extend at least to an axial position corresponding to
one of the blade rows. In some embodiments, the shaft 204 can be
solid. In other embodiments, the shaft 204 has a lumen extending
axially through the hub so that a guidewire can be passed through
the catheter assembly 100. Details of variations with a lumen are
discussed further in U.S. application Ser. No. 12/829359, filed
Jul. 1, 2010, titled Blood Pump With Expandable Cannula, which is
hereby incorporated by reference herein in its entirety and for all
purposes.
A. Infusant Delivery and Removal System
[0057] The operation and duty cycle of the impeller assembly 116
can be lengthened by providing a hydrodynamic bearing for
supporting the shaft 204. A hydrodynamic bearing can be supported
by a lubricant, such as isotonic saline, which can be delivered in
a continuous flow. The lubricant can be delivered through the
infusion system to an outside surface of the shaft 204. The
infusant may be directed onto the shaft from a radially outward
location. In some arrangements, the lubricant flow is controlled
such that of a total lubricant volume introduced into the proximal
end of the cannula, a first portion of the total volume of the
lubricant flows proximally along the shaft 204. In some
embodiments, a second portion of the total volume flows distally
along the shaft, the first volume being different from the second
volume. The second portion of the total volume can be substantially
equal to the total volume introduced into the proximal end of the
cannula less the first volume.
[0058] FIGS. 3 to 8 show various structures for providing
rotational support of a proximal portion of the shaft 204 within
the distal portion of the catheter assembly 100. For example, as
shown in FIG. 3, a bearing assembly 220 can be disposed at a distal
end 224 of the multilumen catheter body 120. In one embodiment, the
bearing assembly 224 includes a housing 228 (as shown in FIG. 4B)
and one or more bearings configured to support the proximal portion
of the shaft 204. The bearing assembly 224, as illustrated in more
detail in FIG. 4B, includes a plurality of bearings 232a, 232b
disposed within the bearing housing 228. Various materials that can
be used for the bearings are discussed below.
[0059] FIG. 6 shows that the bearing housing 228 has a lumen 234
extending therethrough with a proximal enlarged portion 236a and a
distal enlarged portion 236b. The housing 228 comprises a shoulder
defining a narrow portion 240 of the lumen 234 disposed between the
enlarged portions 236a, 236b. The first and second bearings 232a,
232b can be disposed within the enlarged portions 236a, 2366b of
the bearing housing 228.
[0060] In one arrangement, the proximal end of the shaft 204 (e.g.,
as shown in FIG. 4A) is received in and extends proximally of the
second bearing 232b. In some embodiments there can be one bearing
(e.g., only bearing 232a), while in other embodiments both bearings
232a and 232b can be used. In some embodiments, the bearing(s),
e.g., bearings 232a and/or 232b, can be friction fit or
interference fit onto the impeller shaft 204. Accordingly, the
shaft 204 can be supported for rotation by the bearings 232a, 232b
as well as in the narrow portion 240 of the housing 228. In
embodiments where the bearing(s) 232a, 232b are friction or
interference fit onto the shaft, the bearing(s) 232a, 232b can be
configured to rotate with the shaft 204 relative to the bearing
housing 228. Further, the bearing(s) 232a, 232b can have a
relatively large clearance with the bearing housing 228. The
clearance between the shaft 204 and the bearing housing 228, at
regions that are not coupled with the bearing, can be in the range
of about 0.0005 to about 0.001 inch. In certain embodiments, the
clearance can be within a larger range, such as at least about
0.0005 inches, about 0.001 inches or up to about 0.005 inches. In
embodiments with multiple bearing(s) 232a, 232b, the clearance can
be different for the bearings 232a, 232b, such as providing a
larger clearance at the proximal bearing 232a.
[0061] In other embodiments, such as in FIG. 5, the bearing(s)
232a, 232b may not be friction or interference fit onto the shaft
204. In these embodiments, the bearing(s) 232a, 232b may be
disposed within the bearing housing 228, for example by an
interference or press fit. The shaft 204 may then rotate with
respect to the bearing(s) 232a, 232b, and there can be a clearance
between the shaft 204 and the bearing(s) 232a, 232b. The clearance
between the shaft 204 and the bearings 232a, 232b can be in the
range of about 0.0005 to about 0.001 inch. In certain embodiments,
the clearance can be within a larger range, such as at least about
0.0005 inches, about 0.001 inches or up to about 0.005 inches. The
clearance can be different for the bearings 232a, 232b, such as
providing a larger clearance at the proximal bearing 232a. In
certain embodiments, the bearing housing 228 may provide a thrust
surface for bearing axial loads. In other embodiments, there may be
other bearings located either distally or proximally of the bearing
housing 228 that are configured to bear axial loads. In other
embodiments, the fit between the bearings 232a, 232b and the shaft
204 can be tight, which can also assist in bearing axial loads in
some aspects.
[0062] At least the proximal portion of the shaft 204 can be made
of a material that will not corrode or otherwise be made to be
inert when immersed in the lubricant or other infusant. The
material may be one that will not corrode in isotonic saline.
Suitable materials may include a wide variety of metals, including
alloys, and at least saline-resistant stainless steel and
nickel-based alloys. Also, the shaft 204 could be made as a
composite to include advantageous properties of a plurality of
materials. In some cases the shaft 204 could be formed as a
polymer. The class of polymers selected would include those that
can form a shaft 204 of a certain stiffness suitable in this
application. For example, polycarbonate or PEEK could be used. In
certain configurations, the polycarbonate, PEEK, or other suitable
polymer can provide enhanced performance by being combined with a
second material or structure. A glass or carbon filled
polycarbonate or other stiff polymer could also be used.
[0063] As discussed above, a hydrodynamic bearing between the shaft
204 and the bearings 232a, 232b may be utilized in various
embodiments. In one such arrangement, a continuously replenished
fluid film is provided at least between the inner wall of the
bearing housing and an adjacent moving structure, such as the
impeller shaft or an outer surface of a bearing. For example, the
bearing housing 228 can be configured to permit a lubricant to be
delivered therethrough into the lumen 234. The bearing housing 232
can include a plurality of channels 260 disposed therein extending
proximally from a plurality of ports 264 located at the narrow
portion 240 of the housing 228. Each port 264 can communicate with
one of the channels 260 to provide fluid communication into the
lumen 234.
[0064] As shown in FIG. 5, the channels 260 can be formed in the
wall of the housing 228. In one embodiment, the channels 260 are
formed as open depressions, e.g., as flutes, extending along the
housing 228. In this embodiment, the channels 260 can be enclosed
by a separate structure, such as a separate outer sleeve, that is
disposed around the housing 228. FIG. 4B shows that a proximal
portion 268 of the impeller housing 202 can be sized to tightly fit
over the outer surface of the bearing housing 228, enclosing the
radially outward portion of the channels 260. In this arrangement,
at least a portion of a flow path is formed between an outer
surface of the bearing housing 232 and a separate outer sleeve.
[0065] Fluid communication between the port 264 in the bearing
housing 228 and the infusion inflow assembly 150 can be by any
suitable combination of lumens within the catheter assembly 100.
For example, in one embodiment, each of the channels 260 has a
proximal port 272 that communications with an annular space 274
formed in the catheter assembly 100. The annular space 274 can be
formed between a plurality of separate overlaid structures in the
catheter assembly 100. FIG. 4A and 4B show that the annular space
274 is formed between an outer surface 278 of the multilumen
catheter body 120 and an inner surface of the proximal length 268
of the housing 202.
[0066] Fluid communication is provided in the catheter assembly 100
between the space 274 and the infusion inflow assembly 150. For
example, a plurality of lumens 282 formed in the multi-lumen
catheter body 120 can be dispersed circumferentially about the
catheter body 120 at a peripheral circumferential region 284, as
illustrated in FIGS. 7-7C. The peripheral position of the lumens
282 enables a central area of the catheter body 120 to be dedicated
to a central lumen 286. By providing a plurality of smaller lumens
282 located at the periphery, a relatively large flow rate can be
delivered through a relatively small circumferential band (when
considered in cross-section) of the catheter body 120. Each of the
lumen 282 has a distal port 290 that communicates with the space
274.
[0067] A proximal portion of the lumens 282 can take any suitable
form. For example, the lumens 282 can communicate at their proximal
end with a flow diverting structure (not shown) that is in fluid
communication with the infusion inflow assembly 150. As described
herein, in some embodiments the lumen 282 can be disposed
circumferentially about the central lumen 286. The catheter
assembly 100 can include a flow diverting structure or connector,
e.g., disposed about the proximal end of the catheter body 120 that
is configured to divert the infusant into the lumens 282 for
distally directed flow therein. In other embodiments, the catheter
assembly 120 can include a flow diverting structure disposed
adjacent the distal end thereof that is configured to divert the
infusant into the lumens 282 from the central lumen 286 for
proximally directed flow in the lumens 282.
[0068] FIG. 5 includes arrows that illustrate the flow of infusant
into the bearing assembly 220. In one arrangement, the inflow of
infusant is indicated by an arrow 300 which is shown pointing
distally within one of the channels 260 of the bearing housing 228.
The infusant flow enters the bearing housing through the ports 264.
Although flow is shown in one channel 260, corresponding flow may
be provided in each of a plurality of channels 260 disposed around
the central lumen 234. An arrow 304 illustrates that at least a
portion of the infusant delivered through the port 264 may flow
generally proximally within the bearing housing 228. An arrow 308
illustrates that at least a portion of the infusant delivered
through the port 264 may flow generally distally within the bearing
housing 228.
[0069] FIG. 5 illustrates the arrows 304, 308 as proximally and
distally directed, respectively. However, the high speed rotation
of the impeller shaft 204 within the housing 228 will create a thin
film of lubricant spacing the impeller shaft 204 from the surfaces
of the bearings 232a, 232b. This thin film will extend all the way
around the shaft 204 and thus each portion of the flow will have a
spiral or helical flow direction.
[0070] The bearings 232a, 232b can have different configurations to
enhance the performance of the pump 10. For example, the proximal
bearing 232a can be longer along the longitudinal axis of the
bearing housing 228 than the distal bearing 232b. A longer proximal
bearing 232a is believed to better control runout of the shaft 204.
Better runout control on the shaft 204 is believed to enhance the
control of the position of the blades 212 relative to the housing
202. Less runout reduces excessive variation in the gap between the
blades 212 and the housing 202, providing biocompatibility benefits
such as reduced hemolysis.
[0071] In some embodiments, such as those in FIG. 5 where the
bearings 232a, 232b are not friction fit or interference fit onto
the shaft 204, the distal bearing 232b has a smaller inner diameter
than the proximal bearing 232a. If the shaft 204 has a constant
diameter, the smaller inner diameter should provide greater control
of angular deflection of the shaft. Controlling angular deflection
can enhance relative position control of the blades 212 and housing
202, providing blood handling benefits such as reduced hemolysis. A
smaller clearance could also be provided by enlarging the diameter
of the shaft 204 at the axial position of the distal bearing. In
some embodiments, the larger inner diameter of the bearing 232b
enables a larger volume of lubricant to flow proximally and a
lesser volume to flow distally in the lumen 234.
[0072] The continuous introduction of lubricant maintains a
constant, predictable and durable rotational bearing state between
stationary component, e.g., the bearing housing 282, and a moving
component, e.g., the shaft 204, a component of the bearings 232a,
232b, or both the shaft 204 and a component of the bearings 232a,
232b. Also, continuous lubricant inflow provides a means for
removing heat generated by the relative motion between the shaft
204 and the bearings. Also, the infusant can create fluid pressure
within the catheter assembly 100 that can push debris generated
within or by the pump 10 out of the bearing housing 220. Enhancing
the volume of infusant that flows along the path indicated by the
arrow 304 enhances the likelihood that debris generated by or
present in the pump will be removed from the proximal end rather
than to be trapped inside the distal portion of the catheter
assembly 100.
[0073] Another technique for controlling infusant flow in the lumen
234 is to locate the port 264 between the bearings 232a, 232b and
closer to one of the bearing. For example, the ports 264 can be
located adjacent to the proximal bearing 232a in one embodiment.
This provides a shorter path of egress out of the narrow portion
240 of the bearing housing 228 in the proximal direction.
[0074] Other strategies for controlling the flow of infusant within
the bearing housing 228 include modifying a surface within one or
more of the bearings 232a, 232b. FIG. 8 shows a surface
modification 233 provided in a bearing 232a to enhance proximally
directed flow. The surface modification 233 comprises a plurality
of axially oriented grooves 235 in one embodiment. In another
embodiment, the surface modification 233 includes one or more
spiral grooves. The spiral grooves can be formed with a groove
entrance that is substantially parallel with a flow direction of
infusant between the bearings 232a, 232b such that a reduction of
velocity of the flow is minimized. In one embodiment, each spiral
groove includes at least about 3 turns disposed on the inner
surface of the bearing between the proximal and distal ends of the
bearing. In another embodiment, each spiral groove has adjacent
turns that are spaced apart by a minimum pitch of 0.125 inches (3.2
mm). In another embodiment, each spiral groove has an axial density
of about 32 turns per inch (about 1.3 turns per mm). The grooves
are formed in the surface 237 of the bearing 232a upon which the
impeller shaft 204 is supported. The grooves 235 locally enlarge
the clearance between the shaft 204 and the surface 237 so that a
greater volume of infusant can flow distal-to-proximal across the
bearing 232a. The surface modification 233 reduces back-pressure
limiting the distal-to-proximal flow across the bearing 232a.
[0075] In other embodiments, it may be desirable to enhance
distally directed flow. For example, the infusant may be provided
with a fluid intended to be delivered to the patient. In such
embodiments, the surface modification 233 can be provided on the
distal bearing 232b. In certain embodiments, both proximal and
distal bearings 232a, 232b are provided with flow enhancing
modifications to enhance heat transfer or purging of the bearing
assembly 220. In such embodiments, one of the bearings may have a
greater degree of flow enhancement provided on the bearing
surface.
[0076] The arrangement of the bearing assembly 220 can be a factor
in selecting an appropriate infusant. Saline is a preferred
infusant, but other sufficiently biocompatible infusants could be
used. Other embodiments are configured such that little or no
infusant flows out of the pump into the patient. For such
embodiments, other infusant fluids can be used, such as
glucose.
[0077] FIG. 7 illustrates further features of the catheter body
120. The catheter body 120 comprises an inner most portion 320 that
defines the central lumen 286. The inner most portion 320 is
disposed within, e.g., circumferentially surrounded by, the
peripheral circumferential region 284. A continuous outer
circumferential region 324 can be provided around the peripheral
circumferential region 284 to fully enclose the lumens 282,
discussed above. FIGS. 4A and 4B illustrate that a distal end of
the inner most portion 320 is configured to be received and secured
within a proximal portion of the lumen 234 within the bearing
housing 228. FIG. 4B illustrates that a region of overlap can be
provided between a distal portion of the inner most portion 320 and
a proximal portion of the bearing housing 228. This construction
provides a continuous lumen defined in part by the central lumen
286 of the catheter body 120 and in part by the lumen 234 of the
bearing housing. In another arrangement, the bearing housing 228
and the catheter body 120 are joined by a coupler that enhances the
sealing between infusant inflow through the lumens 282 and the
channels 260 and the infusant outflow through the central lumen
286. As discussed further below, this continuous lumen provides a
space for the rotation of the shaft 204 of the impeller assembly
116 and the drive shaft 148 of the torque coupling system.
[0078] The physical connection between the bearing housing 228 and
the catheter body 120 can be achieved in any suitable manner. FIG.
3 illustrates that in one arrangement, a slideable connection is
provided. In this arrangement, a rod 332 is provided between the
bearing housing 228 and the catheter body 120. The rod 332 can have
any suitable configuration, but may have a proximal end configured
to be received in a recess or lumen formed in the catheter body 120
and a distal end 340 configured to couple with the bearing housing
228. FIG. 3 shows that the distal end 340 of the rod 332 can be
configured to engage with a feature of the bearing housing 228 so
that a limited range of sliding is permitted.
[0079] In one embodiment, the bearing housing 228 has an elongate
channel 342 configured to receive a middle portion of the rod 332
and an enlarged depression 344 located at the distal end of the
channel 342. The depression 344 has a width W that is sufficient to
receive a wide distal end of the rod 332. The depression 344 can be
configured to have an axial length along the housing 228 that can
define a range of motion of the bearing housing 228 relative to the
catheter body 120.
[0080] In one arrangement, the bearing housing 228 is positioned
relative to the catheter body 120 and the rod 332 such that the
distal portion of the rod 332 is located at the distal end of the
depression 344. Thereafter, the catheter assembly 100 can be
manipulated such that the bearing housing 228 moves distally
relative to the catheter body 120 and the rod 332 such that the
distal portion of the rod 332 is located at the proximal end of the
depression 344. In the distal position, the impeller assembly 116
is located more distally than in the proximal position. As
discussed further below, this enables a variety of techniques for
unfurling the impeller blades 212 within the housing 202.
B. Bearing Configurations
[0081] Any suitable bearing can be used in the catheter assembly
100. The provision of an infusant for hydrodynamic support enables
a wide range of bearing materials to be used. If saline or other
more corrosive infusant is used, the bearing must be carefully
configured to not degrade within the expected duty cycle of the
pump 10. Some polymeric materials are advantageously not degraded
by isotonic saline, and are acceptable materials from this
perspective. Under the fluid-dynamic conditions, a hydrodynamic
bearing that is supported by a biocompatible infusant such as
isotonic saline is preferred. It is believed that certain polymer
bearings in combination with isotonic saline can support such
conditions as 35,000-50,000 psi-ft/min for an appropriate duty
cycle. Other aspects that can guide the choice of bearing
configurations include minimizing thermal expansion, given the heat
that could be generated in the heart pump 10, and minimizing
moisture absorption.
[0082] Any suitable polymeric material may be used for the bearings
232a, 232b. The polymeric material can include a homopolymer, a
copolymer, or a mixture of polymers. The polymeric material can
include thermoplastic or thermoset polymers. Examples of polymers
that can be used for bearings 232a, 232b include, but are not
limited to, one or more of a polyketone, a polyether, a polyacetal,
a polyamide-imide, a polyacetal, polyether ether ketone (PEEK),
polytetrafluoroethylene (PTFE), and polyphenylene sulfide
(PPS).
[0083] The polymeric material can also include (e.g., can be mixed,
combined, and/or filled with) one or more additives such as a
reinforcer and a lubricant. Specific additives include, but are not
limited to, graphite, carbon fiber, glass fiber, and PTFE. Those of
ordinary skill in the art may appreciate that the additives may be
polymeric or non-polymeric. In some embodiments, the polymeric
material used for bearings 232a and/or 232b can include PEEK,
carbon fiber, PTFE, and graphite. In other embodiments, the
polymeric material can include PPS and glass fiber. In yet other
embodiments, the polymeric material can include a polyamide-imide
polymer, carbon fiber, and graphite. The polymeric material can
include any suitable amount of additive(s). For example, the
polymeric material can include a total amount of additive(s) in the
range of from about 1 wt % to about 50 wt %, based on the total
weight of the polymeric material. In other embodiments, the
polymeric material used for bearings 232a, 232b may not include any
additives.
[0084] The polymeric material chosen for bearings 232a, 232b can
have particular characteristics that advantageously affect the
performance of the bearings. For example, in order to minimize
thermal expansion caused by the heat generated in the heart pump
10, a preferred material would be subject to a minimum of
dimensional change, and can have a coefficient of thermal expansion
in the range of from about 1.2.times.10.sup.-5 .degree. F.sup.-1 to
about 25.2>10.sup.-5 .degree. F.sup.1. In other embodiments, the
polymer used for bearings 232a, 232b has a coefficient of friction
in the range of from about 0.15 to about 0.3. In another example,
in order to minimize or prevent water absorption, the selected
polymeric material can have a water adsorption in the range of from
about 0.01% to about 0.4% over a 24 hour period. In yet another
example, the polymeric material can be suitable for high pressure
and velocity performance, and can have a limiting pressure-velocity
(PV) in the range of from about 20,000 psi-ft/min to about 50,000
psi-ft/min.
[0085] The polymeric material used for bearings 232a, 232b may be
commercially available. Examples of suitable,
commercially-available polymeric materials include, but are not
limited to, Ketron PEEK-HPV, Turcite A, Turcite X, Turcite T X,
Rulon L R, Rulon J, Rulon 641, Rulon A R, Techtron HPV PPS, Ryton
PPS, Torlon 4301, and Torlon 4501. In some embodiments, the
polymeric material used for bearings 232a, 232b is Ketron
PEEK-HPV.
[0086] Of course, other bearing configurations and/or materials
would be suitable under other conditions, e.g., with less corrosive
infusants or if a hydrostatic or non-hydraulic bearing is used.
C. Torque Coupling Systems
[0087] A torque coupling system is provided to rotate the impeller
200 at a high rate to move blood from inside a heart camber to a
location within a patient's vasculature in amounts sufficient to
sustain the patient or provide treatment to the patient. The torque
coupling system couples the impeller 200 with the motor 136, which
may be disposed outside the patient. It is expected that the
impeller 200 and the drive shaft 148 are to be rotated at
25,000-30,000 revolutions per minute for a period of seven to ten
days. To provide reliable performance under these conditions,
isotonic saline or other lubricant is provided between the drive
shaft 148 and stationary components therearound.
[0088] FIGS. 11 and 4B illustrate proximal and distal portions 400,
404 of the drive shaft 148. The proximal portion 400 is coupled
with the drive assembly 146 such that rotation of the drive
assembly 146 rotates the drive shaft 148. The distal portion 404 of
drive shaft 148 is coupled with the impeller shaft 204 such that
rotation of the drive shaft 148 causes rotation of the impeller
shaft 204. The drive shaft 148 also includes an elongate body 408
that extends between the proximal and distal portions 400, 404. The
elongate portion 408 comprises a lumen 412 extending
therethrough.
[0089] The size of the elongate body 408 may be as small as
possible to minimize the cross-sectional profile of the catheter
assembly 100. The cross-sectional profile of the catheter assembly
100 corresponds to the crossing profile of the catheter assembly,
which limits where the system can be inserted into the vasculature.
The lumen 412 is sized to permit a guidewire to be advanced
therethrough in some embodiments. The use of a guidewire is
optional, but may simplify insertion.
[0090] In one embodiment, the elongate body 408 comprises a
multi-layer construction. In some embodiments, each layer can
include at least one coil wire or a plurality of coil wires all
wound in a same orientation. For example, a two-layer,
counter-wound wire construction is particularly advantageous. A
first layer (e.g., an inner layer) of the elongate body 408 is
provided by a coiled wire of nickel-molybdenum-chromium alloy, such
as 35NLT or MP35N. In other embodiments, the wire material can be
MP35N LT. In one embodiment, the wire has a 0.008 inch diameter and
the coil has a 5 filar right-hand wound construction. The outer
diameter of the first layer may be about 0.071 inch. A second layer
(e.g., an outer layer) of the elongate body 408 can include the
same material as the first layer, disposed on the outside of the
first layer. The first and second layers can be wound in the same
direction, or in opposite directions. For example, in some
embodiments the first layer (e.g., an inner layer) can be left-hand
wound and the second layer (e.g., an outer layer) can be right-hand
wound, or vice versa. In other embodiments, both the first and
second layers can be left-hand wound. In yet other embodiments,
both the first and second layers can be right-hand wound. The wound
coil wire construction can advantageously facilitate proximal
and/or distal flow of infusant along the outer layer of the
elongate body 408. For example, the outer layer can be constructed
such that the infusant travels along the coil and/or in the
direction of the winding. Those skilled in the art may appreciate
that, depending on the direction of rotation of the elongate body
408, the infusant flow can advantageously be directed either
proximally or distally. The second layer may be a 5 filar left-hand
wound construction. In one embodiment, each layer is formed using a
0.008 inch diameter wire, in the above-noted coiled configuration.
In other embodiments, the elongate body 408 can include three or
more coil wire layers, wherein the layers are wound in alternating
directions. In some embodiments, the outer diameter of the second
layer can be between about 0.072 inch and about 0.074 inch, while
in other embodiments the diameter can be much larger or smaller. In
some aspects, for example, the outer diameter of the second layer
can be about 0.073 inch. The inner diameter of the elongate body
408 can be at least about 0.039 inch in some implementations. In
some embodiments, one or more ends of the elongate body 408 can be
welded and square cut, for example, with a 0.1 inch maximum weld
length on each end. The length of the elongate body 408 can vary,
but in some embodiments, the length can be between about 47 inches
and 48 inches, for example, about 47.5 inches.
[0091] Other materials and other constructions are possible. The
elongate body 408 can be made of other non-ferrous metals or other
corrosion resistant material or constructions with appropriate
modulus. Other materials that could meet the corrosion requirements
include stainless steel (e.g., 302, 304, or 316). In certain
embodiments, the elongate body 408 can have a structure that
enables other materials to be used. For example varying at least
one of coil layers, filars, wire diameter, and coil diameter may
enable an otherwise less robust material to operate below the
fatigue stress of that material.
[0092] In another embodiment, a four layer construction is
provided. The four layers comprise three wire-wound layers, e.g.,
similar to the arrangement described above, but included a third
wound layer on the outer surface of the second layer. A low
friction layer can be disposed on the outside surface of the
elongate body 408. One material that could be used as a
low-friction layer is PTFE, known commercially as Teflon.RTM.. The
low-friction layer should be configured to have sufficient wear
resistance, such as by selection of the appropriate PTFE material,
e.g. polyphenylene sulphone-filled PTFE, and/or by insuring
appropriate infusant flow is maintained during the entire duration
of use of the device in order to prevent undesirable local elevated
temperature of the PTFE material.
[0093] The drive shaft 148 operates within the multilumen catheter
body 120. Because the drive shaft 148 is rotated at a very high
rate when in use within the multilumen catheter body 120, the
configuration of the surface forming the central lumen 286 is
important. In some embodiments, this inner surface has high
lubricity and high wear resistance. One material that can be used
for the inner surface of the catheter body 120 is high density
polyethylene (HDPE), which provides sufficient lubricity and wear
resistance. In one embodiment, the entire multilumen catheter body
120 is formed of HDPE. PTFE provides good lubricity and could be
used if made sufficiently wear resistant. One way to increase the
wear resistance of PTFE is to impregnate it with polyphenylene
sulphone (PPSO.sub.2), another is to gamma irradiate the material.
One way to increase the lubricity of Polyimide materials is to
impregnate it with Graphite, another is to impregnate it with
Graphite and PTFE.
[0094] FIG. 4B shows a clearance 412 between the elongate body 408
of the drive shaft 148 and the inner surface of the multilumen
catheter body 120. The clearance 412 may be about 0.005 inch. Along
a diameter between opposite sides of the inner surface of the
central lumen 286 and outer surface of the elongate body 408
includes about 0.010 inch of space or diametric clearance. A larger
minimum clearance may be desirable if the crossing profile can be
enlarged or if other structures of the catheter assembly 100 can be
made thinner or eliminated to allow more room between the elongate
body 408 and the central lumen 286.
[0095] FIGS. 11 and 12 show further details of the drive assembly
146, which is disposed at the proximal end 104 of the catheter
assembly 100. The drive assembly 146 includes a drive housing 450
having a recess or cavity 454 disposed therein. The cavity 454 is
configured for mounting a rotor support shaft 458 for rotation
therein. The support shaft 458 has a proximal end and a distal end
and a plurality of components mounted thereon. The distal end of
the support shaft 458 has a recess 462 formed therein to receive a
proximal end of the drive shaft 148. The support shaft 458 may also
have a lumen 466 disposed therein for slideably receiving a
guidewire.
[0096] A rotor 470 is mounted on an outer surface of the support
shaft 458 between sleeve bearings 474a, 474b, as shown in FIG. 12.
The rotor 470 can take any suitable form, but in one embodiment
includes an elongate magnet 476 disposed between proximal and
distal flywheels 478a, 478b.
[0097] The proximal end of the support shaft 458 has a tapered port
480 for receiving the guidewire. The proximal end can be configured
for engaging the motor 136 in some embodiments. In other
embodiments, a magnetic field is induced by the motor 136 in a
manner that creates torque and rotation of the shaft 458.
[0098] An infusant outflow path 482 is provided within the drive
assembly 146. The outflow path 482 is provided between an outer
surface of the support shaft 458 and an inner surface 486 of the
distal bearing. The flow path 482 continues from the distal bearing
474b. radially outwardly along thrust surfaces 490a. The flow path
continues proximally between the outer surface of the rotor 470 and
the inner surface defining the cavity 454. The flow path 482
continues radially inwardly along the thrust surface 490a toward
the support shaft 458. The flow path 482 continues proximally
between the support shaft 458 and the proximal bearing 474a.
Proximal of the bearing 474a, the flow of infusant exits the
catheter assembly 100 through an outflow port 144 through which it
can be directed to the waste container 46 or discarded. The flow
path is shown in more detail in FIGS. 1, 12, 12A, and 12B.
III. Structures that Facilitate Deployment and Retreival
[0099] The catheter assembly 100 can include one or more features
that facilitate the deployment and/or retrieval of one or more
components of the distal end 108 of the heart catheter assembly 100
(e.g., the impeller assembly 116 or a portion thereof).
A. Optionally-Expandable Diffuser
[0100] As shown in FIGS. 13A and 13B, the pump can include a
diffuser 502a, 502b. As illustrated in FIG. 13A, in some
embodiments the diffuser 502a is connected to the impeller hub 208.
For example, the diffuser 502a can be integral, or form a unitary
structure, with the impeller hub 208. In another example, the
proximal end of the impeller hub 208 can include the diffuser 502a.
As illustrated in FIG. 13B, in other embodiments, the diffuser 502b
is separate from (e.g., not connected to) the impeller hub 208.
[0101] The diffuser 502a, 502b can be disposed between the distal
end of the elongate body of the catheter body and the impeller. The
diffuser 502a, 502b can be configured to be positioned within the
housing 202 and adjacent to the proximal opening of the housing. In
some embodiments, the diffuser 502a, 502b can be axially aligned
with the proximal opening of the housing 202. Advantageously, this
configuration can maximize the flow directing capabilities of the
diffuser 502a, 502b, as discussed further herein. The diffuser
502a, 502b can be located adjacent the proximal end of the hub 208.
The diffuser 502a, 502b can include a proximal end 504a, 504b. and
a distal end 505a, 505b. The proximal end 504a, 504b. of the
diffuser 502a, 502b can be positioned adjacent the distal end of
the bearing housing 228 (e.g., over a bearing 516 and/or a front
thrust washer 518). As shown in FIG. 13A, the proximal end 504a can
be separated from the bearing 516 by a gap 522. The gap 522 can
have an axial length generally equal to the length of the bearing
516. The gap 522 can also be generally cylindrical with a
longitudinal axis that is aligned with the longitudinal axis of the
impeller shaft 204. The distal end 505a, 505b can be located
adjacent the proximal end of the impeller hub 208. The diffuser
502a, 502b can include a flow directing surface. For example, an
outer surface 513 of the diffuser 502a, 502b can form a curved line
from the proximal end 504a, 504b. to the distal end 505a, 505b, as
illustrated in FIGS. 13A-B. As viewed from the proximal or distal
end, the diffuser 502a, 502b can have a generally circular cross
sectional shape. As shown in FIGS. 13A and 13B, the diameter of the
diffuser 502a, 502b can be greatest in the mid section and can
taper to a smaller diameter in the distal and/or proximal
directions. The diffuser 502a, 502b can have a maximum diameter
that is generally greater than the diameter of the hub 208 and/or
the bearing housing 228. The diameter of the proximal end 504a,
504b. can be generally equal to the diameter of the bearing housing
228. The diameter of the distal end 505a, 505b can be generally
equal to the diameter of the hub 208. The diffuser 502a, 502b may
be referred to herein as a bulge, and in various embodiments can
have a radially enlarged portion disposed downstream of the
impeller.
[0102] Advantageously, the relatively large diameter and/or the
curved outer surface can assist in directing (e.g., diffusing)
fluid flow out of the housing 202. The geometry of the diffuser
502a, 502b (e.g., the radius of curvature of the outer surface) can
be optimized to control desired fluid properties such as boundary
layer flow, laminar flow, and pressure gradients and to reduce
outlet flow losses.
[0103] The diffuser 502a, 502b can include a wall 511. The wall 511
can include an inner surface 512 and the outer surface 513,
described above. The wall 511 can have a thickness extending from
the inner surface 512 to the outer surface 513. In some
embodiments, the wall 511 can have a generally uniform thickness
along the axial length of the diffuser 502a, 502b. One advantage of
a generally uniform wall thickness is that the diffuser 502b can be
more easily expanded and/or collapsed, as described herein. In
other embodiments, the wall 511 can have a variable thickness along
the axial length of the diffuser 502a, 502b. For example, as
illustrated in FIG. 13A, the thickness of the wall 511 can increase
in the distal direction. One advantage of a variable thickness wall
is that it can have variable structural strength. For example, a
wall having a thickness that increases distally can advantageously
have greater strength in areas that are most exposed to oncoming
blood flow.
[0104] The inner surface 512 can define a chamber 506 through which
the impeller shaft 204 can pass. As shown in FIG. 13A, the diffuser
502a can form part of the proximal end of the hub 208 of the
impeller 200 (e.g., the hub 208 can be connected to the diffuser
502a). Thus, the diffuser 502a can rotate with the rotating hub
208. The diffuser 502a can also include a proximal cavity outlet
508. As shown in FIG. 13B, the diffuser 502b can be a component
separate from the impeller 200. In this embodiment, the diffuser
502b can be stationary when the hub 208 is rotating. The diffuser
502b can also include a distal cavity outlet 510.
[0105] There can be many advantages to including a diffuser 502a
that is connected to the impeller hub 208. For example, the unitary
construction can be easier to manufacture and/or assemble. As
described herein, the distal end of the diffuser 502a can be
relatively thick and strong (e.g., stiff). In addition, it can be
advantageous for the infusant to exit the catheter assembly 100 at
the proximal outlet 508, which is generally at the downstream end
of the diffuser 502a.
[0106] There can also be advantages to including a diffuser 502b
that is a structure separate from and not directly attached to the
impeller hub 208. In some embodiments, the diffuser 502b can be
made from a material that is different from the material used to
make impeller hub 208. For example, the diffuser 502b can be made
from a material that is relatively more flexible (softer) than the
material of the impeller hub 208. In other embodiments, the wall
511 of diffuser 502b can have a generally uniform thickness. These
features of diffuser 502b can facilitate the expansion and/or
contraction of the diffuser 502b, described further herein.
[0107] As shown in FIGS. 13A and 13B, the diffuser 502a, 502b can
be generally hollow, as defined by the chamber 506. The diffuser
502a, 502b can be sufficiently hollow and can be made of a
relatively flexible material (e.g., a polymer or elastomer) to be
expandable and/or collapsible. For example, the maximum diameter of
the diffuser 502a, 502b can expand from a first diameter to a
second diameter. Advantageously, the collapsible diffuser 502a,
502b can have a deployed, expanded configuration, and a retracted,
collapsed configuration. In the deployed, expanded configuration,
the diffuser 502a, 502b can have a maximum diameter (e.g., as
measured at the mid-section or bulge) that is generally greater
than the diameter of the hub 208 and/or the bearing housing 228. In
the retracted, collapsed configuration, the diffuser 502a, 502b can
have a reduced diameter. For example, in the retracted, collapsed
configuration, the diffuser 502a, 502b can have a maximum diameter
that is generally less than or equal to the diameter of the hub 208
and/or the bearing housing 228. Although described as having a
diameter, those skilled in the art may appreciate that while
retracted and/or collapsed, the diffuser 502a, 502b may not have a
generally circular cross section. A collapsible diffuser can be
advantageous compared to a non-collapsible diffuser because a
collapsible diffuser can allow the overall structure to maintain
and low profile for the purpose of retracting back into a sheath
and for insertion into and/or removal from a patient.
[0108] In some embodiments, the relatively flexible material itself
may not be significantly expandable (e.g., stretchable and/or
elastic). Rather, the terms "expandable" and "collapsible" can
refer to the overall expansion and/or collapse of the chamber 506
of the diffuser 502a, 502b. In other embodiments, the relatively
flexible material itself may be significantly expandable (e.g.,
balloon-like).
[0109] The chamber 506 can be configured (e.g., sized) to allow
fluid (e.g., infusant) flow through the diffuser 502a, 502b. The
diffuser 502a, 502b can be configured for fluid communication with
a fluid, such as an infusant, that passes through the bearing
assembly 220. The bearing assembly 220 illustrated in FIGS. 13A and
13B can have many, if not all, of the same features as described
with respect to the bearing assembly 220 illustrated in FIG. 5. As
shown in FIGS. 13A and 13B, the infusant can follow an infusant
path 514a, 514b. out of the bearing assembly 220 and into the
diffuser 502a, 502b via a passage or cavity 520 between the bearing
516 and the washer 518. For at least a portion of the infusant path
514a, 514b, the infusant can travel distally. In some embodiments,
at least a portion of the infusant path 514a, 514b. can be
non-helical (e.g., generally linear). In other embodiments, at
least a portion of the infusant path 514a, 514b. can be generally
helical. The helical shape of the infusant path 514a, 514b. can be
caused at least in part by rotation of one or more components of
the impeller assembly 116 (e.g., the impeller shaft 204 and/or
impeller hub 208).
[0110] As illustrated in FIG. 13A, the infusant path 514a can
extend from the proximal end 504a to the distal end 505a and can
return back to the proximal end 504a to exit the proximal outlet
508 via the gap 522. The portion of the infusant path 514a that
extends from the proximal end 504a to the distal end 505a is
helical (e.g., can encircle the impeller shaft 204 one or more
times along the axial length of the path). The return portion of
the infusant path 514a can be non-helical (e.g., generally linear).
The return portion of the infusant path 514a can be non-helical at
least in part because the return portion can follow the curved
interior surface 512 of the diffuser wall 511. In use, the infusant
can exit the bearing assembly 220 at the cavity 520 to enter the
chamber 506. At least a portion of the infusant can then follow
infusant path 514a to travel helically around the impeller shaft
204 in the distal direction until the distal end 505a is reached.
The infusant then changes direction and turn around to flow
proximally along the non-helical return portion of the infusant
path 514a and through the gap 522 to exit the pump via the proximal
cavity outlet 508. Although shown as a single distal-to-proximal
line, in some embodiments, exit flow can be induced along and
generally following the shape of the inner surface 512 to the
proximal cavity outlet 508. In use, as the infusant passes through
the gap 522, the infusant can act as a hydrodynamic bearing (e.g.,
in addition to the hydrodynamic bearing that may be present between
the impeller shaft and the bearing housing as described herein).
This hydrodynamic bearing can generally be in the shape of a
cylinder that extends axially, as defined by the gap 522.
Advantageously, this hydrodynamic bearing can reduce friction
between the diffuser 502a and the bearing housing 228.
[0111] As illustrated in FIG. 13B, the infusant path 514b. can
extend from the proximal end 504b. to the distal end 505b. As
illustrated in FIG. 13B, the infusant path 514b. is helical (e.g.,
can encircle the impeller shaft 204 one or more times along the
axial length of the path). In use, as shown in FIG. 13B, generally
all of the infusant flows proximally to distally within a distal
portion of the bearing assembly 220 and exits the bearing assembly
at the cavity 520 to enter the chamber 506. In various embodiments,
a portion of the infusant flows proximally within a proximal
portion of the bearing assembly 220 through a space between the
drive shaft 148 and the catheter body 120. This return flow is
discussed above, e.g., in connection with arrow 304 in FIG. 8. At
least a portion of the infusant then follows the infusant path
514b. to travel helically around the impeller shaft 204 in the
distal direction and out through the distal cavity outlet 510. As
illustrated in FIG. 13B, the distal cavity outlet 510 defines a gap
between the distal end 505b of diffuser 502b and the proximal end
of impeller hub 208. In use, as the infusant passes through the
distal cavity outlet 510, the infusant can act as a hydrodynamic
bearing. This hydrodynamic bearing can generally be in the shape of
a cylinder having a length extending axially along the length of
the gap and a radius corresponding to the cross sectional radius of
the gap. Advantageously, this layer of infusant between the
diffuser and the impeller hub can reduce friction between the
diffuser 502b and the impeller hub 208 when the pump is in
operation.
[0112] As described herein, the diffuser 502a, 502b can be
expandable. In some embodiments, one or more forces exerted by the
infusant can be used to expand the diffuser 502a, 502b. The flow
rate of the infusant can be sufficient to establish an area of
positive pressure within the diffuser 502a, 502b, thereby allowing
at least a portion of the infusant to exit adjacent to a distal end
of the device. In some embodiments, the static pressure of the
infusant entering the chamber 506 can cause the diffuser 502a, 502b
to expand. In any of these embodiments, an inflated diffuser 502a,
502b can be deflated by interrupting and/or discontinuing the flow
of infusant into the diffuser 502a, 502b and by allowing the
infusant to exit the diffuser via the proximal outlet 508 or the
distal outlet 510. In some embodiments, the wall is elastic but the
pliability is relatively low such that upon removal of the infusant
flow a transition from expanded to low profile is rapid. The
diffuser 502a, 502b self-collapses displacing the infusant out of
the chamber 506 through one or more small apertures. In addition to
promoting quick deflation, the relatively low pliability will
provide a uniform diffuser profile, e.g., will not be deformed or
deflected by any varying pressure or flow rate of the blood from
the impeller 200. A lower infusant pressure configuration can also
be provided by increasing the pliability of the structure forming
the diffuser 502a, 502b. The structure can be of enhanced
pliability by material selection or constructions (e.g., by being
thinner or adopting other balloon-like features).
[0113] In other embodiments, the centrifugal force exerted by the
infusant as it travels along the helical path 514a, 514b. can be
used to expand the diffuser 502a, 502b. As illustrated in FIG. 13A,
the diffuser 502a can be connected to the impeller assembly
116.
[0114] In these embodiments, the diffuser 502a and the impeller
assembly 116 can be rotated. In use, when the impeller assembly 116
and the diffuser 502a are rotated, the infusant can also rotate due
to, e.g., shear forces generated from the fluid contact with the
rotating diffuser 502a and/or the rotating impeller shaft 204. The
rotating infusant can exert a pressure on the inner surface 512 to
thereby expand the diffuser 502a from the collapsed configuration
to the expanded configuration. Thus, in some embodiments, the
diffuser 502a can be centrifugally expanded. In yet other
embodiments, the diffuser 502a can be expanded using a combination
of static and centrifugal forces.
[0115] As illustrated in FIG. 13B, the diffuser 502b may not be
rotatable. In these embodiments, when the impeller shaft 204 is
rotated, the infusant can also rotate due to, e.g., shear forces
generated from the fluid contact with the rotating impeller shaft
204. As described herein, the rotating infusant can exert a
pressure on the inner surface 512 to thereby expand the diffuser
502b from the collapsed configuration to the expanded
configuration. Thus, in some embodiments, the diffuser 502b can be
centrifugally expanded. In yet other embodiments, the diffuser 502b
can be expanded using a combination of static and centrifugal
forces.
[0116] Infusant exiting the diffuser 502a, 502b can be continuously
replenished with additional infusant via the flow path 514. If the
impeller shaft 204 stops rotating, the pressure generated from
rotation can decrease to match the pressure acting on the outside
of the diffuser 502a, 502b, thereby allowing the diffuser 502a,
502b to collapse.
[0117] In yet other embodiments, the diffuser 502a, 502b can be
expanded and/or inflated by a combination of static and centrifugal
forces. For example, the diffuser 502a, 502b can be expanded and/or
inflated by a combination of the static force of the infusant as it
enters the chamber 506 and the centrifugal force of the infusant as
it travels along the helical path 514.
B. Relatively Axially-Moveable Impeller Housing
[0118] As illustrated in FIG. 14B, when the impeller and the
diffuser 502 are in the proximal position, at least a portion of
the impeller (e.g., the blades 212 and/or the hub) and/or the
diffuser 502 may be relatively positioned in a portion of the
housing 202 having minimal or no coating, such as an outlet 802 of
the housing 202 (e.g., the outlet through which blood is pumped).
In some embodiments, the housing 202 can be moved axially relative
to the impeller and/or the diffuser 502. In some embodiments, the
housing 202 is moved axially over the impeller and the impeller is
stationary. Those skilled in the art may appreciate that in some
embodiments, the housing 202 may not be configured to move axially
relative to the impeller and/or the diffuser 502 (e.g., housing 202
is fixed or stationary relative to impeller and/or the diffuser
502). For example, the housing 202 and the diffuser 502 can be
spaced apart by a relatively constant axial distance in all
operational states, or at least in a collapsed and an expanded
state.
[0119] As illustrated in FIGS. 14A and 14B and as described herein,
the rod 332 provided between the catheter body 120 and the bearing
housing 228 enables a slideable engagement between the catheter
body 120 and the bearing housing 228. The distal end of the
catheter body 120 can be connected to the proximal portion 268 of
the impeller housing 202. The catheter body 120 can translate
distally from a proximal position to a distal position, and vice
versa, by the application of an axial force described further
herein. As described herein, for example with respect to FIGS.
4A-4B, the catheter body 120 can be coupled to the proximal portion
268 of the impeller housing 202. For example, the proximal portion
268 of the impeller housing 202 can be fitted over the distal end
of the catheter body 120.
[0120] In the proximal position, illustrated in FIG. 14A, the axial
position of the outlet 802 can be proximal of the axial position of
the proximal-most blade 212. In the distal position, illustrated in
FIG. 14B, the axial position of the outlet 802 can generally
correspond to the axial position of the proximal-most blade 212.
Advantageously, the rod 332 and the enlarged depression 344 can
control the axial distance over which the impeller housing 202 is
capable of sliding. The rod 332 can also advantageously prevent the
bearing housing 228 from rotating with the impeller shaft 204.
[0121] Those skilled in the art may appreciate that the axial
movement of the catheter body 120 and the impeller housing 202
relative to the impeller and/or the diffuser 502 can have the same
relative effect as axially moving the impeller and/or the diffuser
502 relative to the catheter body 120 or the impeller housing 202,
even if the impeller and/or the diffuser are not actually moved
axially. Accordingly, in some embodiments the catheter body 120 in
the proximal position can be referred to as the deployed position
of the impeller and/or the diffuser 502. The catheter body 120 in
the distal position can be referred to as the retracted position of
the impeller and/or the diffuser 502.
[0122] The ability of the impeller and/or the diffuser 502 to be
retracted and deployed relative to the impeller housing can have
many advantages. For example, axial movement of the impeller
housing relative to the impeller and/or the diffuser can reduce the
profile of the pump to ease insertion and retrieval. In some
embodiments, in the retracted position, the impeller hub 208,
blades 212, and/or diffuser 502 can be positioned at the same axial
location as a portion of the housing 202 that does not have a
covering (e.g., the outlet 802). Accordingly, the cross-sectional
area of the catheter assembly 100 measured at the axial position of
the diffuser 502 in the retracted position, for example, is
comparatively smaller than when it is in the deployed position. The
smaller cross sectional area can be advantageous for minimizing
trauma to a user during insertion into and/or retrieval from the
body.
[0123] In other embodiments, the retracted position of the impeller
and/or the diffuser can be distal of the deployed position of the
impeller and/or the diffuser. In some embodiments, the impeller
housing can have a rigidity that varies axially. For example, the
impeller housing can have a proximal portion that is more rigid
(e.g., less flexible) than a distal portion. In these embodiments,
the impeller and/or the diffuser can reside in the proximal, rigid
portion while in the deployed position. The impeller and/or the
diffuser can reside in the distal, flexible portion while in the
retracted position. Advantageously, when the impeller and/or the
diffuser reside in the flexible portion of the impeller housing,
this portion of the pump may be collapsed to a lower profile than
would otherwise be achievable if the impeller and/or the diffuser
remained in the rigid portion of the impeller housing.
[0124] As described herein, the catheter body can be coupled to the
impeller housing. The retraction and deployment (e.g., movement
between proximal and distal positions) of the impeller housing can
be controlled by manipulation of a proximal end of the catheter
assembly that results in an application of axial force to the
catheter body. For example, the impeller housing can be moved
axially by the rotational force applied by a nut disposed at the
proximal end of the catheter assembly. A section of the proximal
end of the catheter assembly is illustrated in FIGS. 15A and
15B.
[0125] In some embodiments, axial force is applied to the catheter
body via an impeller deployment assembly 800. The impeller
deployment assembly includes a nut 804 that is engaged with a
portion of the catheter assembly, such as a flow diverter 806. As
described herein, the flow diverter 806 can be a part of the
infusion inflow assembly 150, illustrated in FIG. 1. The distal end
of the flow diverter 806 can be connected to a proximal portion of
the catheter body. In some embodiments, the nut 804 can be engaged
with a pin 808. The pin 808 can penetrate through the wall of the
drive housing 450 and can be coupled with or fixedly attached to
the flow diverter 806. The nut 804 can be disposed over at least a
portion of the drive housing 450 and/or the flow diverter 806. The
nut 804 can include an internal engagement structure that is
configured to engage the flow diverter 806 (e.g., via the pin 808).
In some embodiments, the internal engagement structure can include
internal threading. In other embodiments, the internal engagement
structure can include a cam track 812 having first and second ends
(e.g., a proximal end and a distal end), as illustrated in FIG.
15C. In these embodiments, the pin 808 can be configured to travel
along the cam track 812. The internal engagement structure can be
generally helical. The drive housing 450 can also include a
longitudinal channel 810 along which the pin 808 can travel.
[0126] As illustrated in FIGS. 15A and 15B, the drive housing 450
can contain the support shaft 458 and the drive shaft 148. The
drive housing 450 can also capture the nut 804. For example, a
retention structure can be formed in the outside surface of the
housing 450 to prevent the nut 804 from slipping proximally or
distally relative to the housing 450. One embodiment of a retention
structure is illustrated below in connection with the deployment
device of FIGS. 15D-F but can be included with the deployment
device 800 as well. The pin 808 can penetrate the wall of the drive
housing 450 and permit axial translation of the flow diverter 806
by acting as a cam. In some embodiments, the support shaft 458 and
the thread advance nut 804 may be rotatable but not translatable
relative to the drive housing 450.
[0127] In use, a rotational force can be applied to the nut 804.
This application of rotational force can be converted into an axial
force that is applied to the flow diverter 806 and the catheter
body. As described herein, the pin 808 can be fixedly attached to
the flow diverter 806 at one end and have a second end disposed
within the inner surface of the nut 804 along the cam track
thereof. The rotation of the nut 804 in a first direction (e.g.,
clockwise or counter-clockwise) can cause the pin 808 to translate
from a proximal position (e.g., proximal end) to a distal position
(e.g., distal end) in the longitudinal channel 810. Accordingly,
the flow diverter 806, the catheter body, and the impeller housing
can also translate from a proximal position to a distal position.
As described herein, the distal translation of the catheter body
and the impeller housing can improve the ease of the retraction of
the impeller hub and the blades into the impeller housing. In
embodiments where the outlet 802 is generally free of a polymeric
coating, relative movement of at least a portion of the impeller
and/or the diffuser proximally into the outlet 802 or distally into
a more flexible region of the impeller housing (i.e., mid section
of the housing where there is less strut material) can
advantageously reduce the profile of the pump upon collapsing into
the sheath. In addition, axial adjustment of the impeller housing
relative to the impeller can advantageously promote more efficient
flow dynamics. In some embodiments, the impeller is positioned
closer to the outlet 802 than the middle portion of the housing in
order to improve flow dynamics.
[0128] A rotational force applied to the nut 804 in a second
direction (e.g., counter-clockwise or clockwise) can cause the pin
808 to translate from the distal position to the proximal position.
Accordingly, the flow diverter 806, the catheter body 120, and the
impeller housing 202 can also translate from a distal position to a
proximal position. As described herein, the proximal translation of
the catheter body 120 and the impeller housing 202 can effectively
result in the deployment of the impeller hub 208 and the blades
212.
[0129] FIGS. 15D-F illustrate another embodiment of a deployment
device 850 that can be used to manipulate or deploy a distal
structure of the catheter assembly and/or the impeller housing. As
with the deployment device 800, the deployment device 850 can be
used to actuate the impeller 200 between retracted and deployed
configurations.
[0130] As discussed above, the catheter assembly can include a flow
diverter 852 that is part of the infusion system. The flow diverter
852 may be coupled with a proximal portion 122 of the catheter body
120. In one embodiment, the proximal end of the proximal portion
122 is inserted into a recess 854 formed at a distal 852a end of
the flow diverter 852. The connection between the proximal portion
122 of the catheter body 120 the flow diverter 852 can be further
made secure by a strain relief 856 disposed at the junction and
extending distally thereof. The strain relief 856 overlaps a
proximal length of the proximal portion 122 and absorbs movements
of the portions of the catheter assembly to isolate the connection
between the flow diverter 852 and the catheter body. A cap 860 can
be used to securely couple strain relief 856 to the flow diverter
852. A proximal portion 862 of the flow diverter 852 is received
within a recess 864 of the housing 450. A seal device 866, such as
an 0-ring, may be provided between the proximal portion 862 of the
flow diverter 852 and inside surface of the recess 864 to prevent
infusion from exiting the housing 450 in an undesirable manner.
[0131] The flow diverter 852 also includes a lumen 868 that extends
from a proximal end 852b to the distal end 852a thereof. The lumen
868 is configured to permit a proximal portion of the drive shaft
148 to reside therein. In some embodiments, flow diverter 852 is
configured to cause some infusant to flow proximally in the lumen
868 between the drive shaft 148 and the inner surface of the flow
diverter 852 that forms the lumen 868 to lubricate and cool the
drive shaft. The flow diverter 852 can be configured to cause most
or substantially all of the infusant entering the diverter through
the lumen in the catheter body 154 to flow distally between the
catheter body 120 and the drive shaft 148. In one arrangement, the
lumen 868 is enlarged from a location proximal of where the
catheter body 154 couples with the flow diverter 852 toward the
distal end 852a of the flow diverter. This enlargement creates a
path of least resistance toward the distal direction to divert the
flow distally. In one embodiment, the lumen 868 is further enlarged
at a location between where the catheter body 154 couples with the
flow diverter 852 and the recess 854 such that a substantially
continuous lumen can be formed to keep flow resistance at the
junction between the flow diverter 852 and the proximal portion 122
of the catheter body 120 to a minimum.
[0132] The deployment device 850 includes a guide track 872 on a
proximal portion 862 of the flow diverter 852, a guide member 874,
and an actuator 876. The guide track 872 can comprise an axially
oriented slot or recess formed in the outside surface of the
proximal portion 862. The guide track 872 may be configured to
slidably receive a guide member 874 such that relative movement can
be provided between the guide track 872 and a guide member 874. A
portion of the guide member 874 may extend through sidewall of the
drive housing 450 such that the axial position of the guide member
874 can be fixed and relative movement is provided by movement of
the flow diverter 852 relative to the guide member. In one
embodiment the guide member 874 is a pin that has one end received
in a small hole in the drive housing 450 and the other end disposed
in the guide track 872.
[0133] The actuator 876 is configured to translate rotational
motion thereof into axial motion of the flow diverter 852. For
example, the actuator 876 can comprise a nut that includes internal
threads that are engaged with external threads on the outside
surface of the flow diverter 852. In various embodiments, a
proximal portion of the actuator 876 is anchored to the drive
housing 450 to prevent the actuator 876 from moving axially along
the drive housing. In one embodiment a retention structure 882 is
provided between the actuator 876 and the drive housing 450. One
embodiment of the retention structure 882 is illustrated in detail
B of FIG. 15D. In particular, the retention structure 882 includes
an inwardly protruding member 884 that is received in an annular
recess formed in the outside surface of the drive housing 450. The
protruding member 890 can include an inwardly protruding ring
having n diameter that is less than the diameter of the actuator
876 distally and proximally of the protruding member 884.
[0134] FIGS. 15E-F illustrate operation of the deployment device.
FIG. 15E corresponds to an expanded configuration of the catheter
assembly 100. In this position, the pin 874 is positioned at the
distal end of the guide track 872 and the flow diverter 852 is in a
proximal position. Because the flow diverter 852, the catheter body
120, and the impeller housing are coupled together so that they
move in unison, the catheter body 120 and the impeller housing are
also positioned in a relatively proximal position. Relative axial
movement is permitted between the impeller and the catheter body,
as well as between the diffuser and the catheter body. Also,
because the catheter body 120, the flow diverter 852, and the
impeller housing move in unison, relative axial movement is
permitted between the impeller (and/or diffuser) and the impeller
housing. As a result, the impeller will be in a more distal
position relative to the impeller housing when the catheter
assembly 100 is in the configuration of FIG. 15E. The more distal
position moves the impeller into the largest volume portion of the
impeller housing enabling the impeller to expand.
[0135] FIG. 15F corresponds to a collapsed configuration of the
catheter assembly 100. In this position, the pin 874 is positioned
at the proximal end of the guide track 872 and the flow diverter
852 is in a distal position. This causes the impeller to be in a
more proximal position relative to the housing when the catheter
assembly is in the configuration of FIG. 15F. This more proximal
position moves the impeller into engagement with the inside surface
of the housing tending to collapse the impeller.
[0136] To move from the expanded configuration of FIG. 15E to the
collapsed configuration of FIG. 15F, the actuator 876 is rotated in
a manner that causes the threads to act upon each other which
creates axial movement of the catheter body 120 and the impeller
housing 202.
C. Impellers Having Self-Sealing Impeller Tips and Lumens With
Valves
[0137] In some embodiments, the tip 602 of impeller hub 208 can be
self-sealable or resealable (e.g., configured to automatically
effectively form a seal to substantially stop the flow of a fluid
in the absence of direct action by a user or operator to form the
seal), as illustrated in FIGS. 16A-C. As illustrated in FIGS.
16B-C, the tip 602 of impeller hub 208 can include a resealable
member having a resealable path therethrough.
[0138] As shown in FIG. 16A, the impeller tip 602 can be made of an
elastomeric material (e.g., a silicone or polyisoprene polymer). As
shown in FIG. 16A, the tip 602 can include a resealable path 604
that extends along the length of the tip. The resealable path 604
can extend from the outer surface at the distal end of tip 602 to
the impeller shaft, which can be hollow. The hollow shaft extension
606 is shown in FIGS. 16A and 16B connected by the resealable path
604 to the tip 602 and is connected at its proximal end to the
impeller shaft 204. Thus, the resealable path 604 can extend from
the impeller shaft 204 to the outer surface of the tip 602. The
resealable path 604 can be configured for guidewire passage. The
resealable path 604 can generally pass through the center of
rotation of the impeller tip 602.
[0139] The resealable path 604 can be created using a very small
diameter, e.g., a 32 gauge (0.00925 inch or 0.235 mm) wire or pin.
In some embodiments, the resealable path 604 can be created without
coring the impeller tip 602 (e.g., without punching out or
otherwise removing a cylinder of material). The resealable path 604
can be self-sealable. For example, the resealable path 604 can
close or seal automatically, without the use of additional tools or
implements. The resealable path 604 can be self-sealable due to the
elastomeric properties of the material used for impeller tip 602
(e.g., a silicone or polyisoprene polymer) and/or the diameter of
the resealable path 604. In some embodiments, circumferential and
radial forces of the tip material and/or external pressure forces
(illustrated with arrows at 612) exerted while the catheter
assembly 100 is implanted can also contribute to sealing the
resealable path 604.
[0140] In some embodiments, the tip 602 or resealable member 622,
624 can be made of the same material as the rest of the impeller
system (e.g., hub, blades, shaft, and/or shaft extension). In other
embodiments, the tip 602 or resealable member 622, 624 can be made
from a different material than the rest of the impeller system
(e.g., hub, blades, shaft, and/or shaft extension). For example,
the tip 602 or resealable member 622, 624 can be made of a material
that is more elastomeric (e.g., has greater elasticity) than the
material from which the impeller shaft 204 and/or shaft extension
606 are formed. In another example, the tip 602 or resealable
member 622, 624 can be made from a polyisoprene polymer and at
least a portion of the impeller shaft 204 (e.g., the distal end)
and/or shaft extension 606 are formed from an acrylonitrile
butadiene styrene (ABS) polymer or a polycarbonate polymer.
[0141] In some embodiments where the impeller tip 602 comprises a
resealable member 622 that is made separately from the rest of the
impeller system, the resealable member 622 can include one or more
proximally-extending tabs 616. The one or more tabs 616 can be
disposed about the proximal end of resealable member 622. In some
embodiments, the resealable member 622 can include one generally
cylindrical tab 616 that is disposed about the proximal end of the
resealable member 622. The one or more tabs 616 can be configured
to mate with (e.g., can engage and/or be disposed within) one or
more of the corresponding recesses 618 disposed on the distal end
of a portion of the impeller assembly 116 (e.g., the hub 208, shaft
204, and/or shaft extension 606). As illustrated in FIG. 16B, the
recess 618 can be bounded by the surfaces of the hub 208 and the
shaft extension 606. The one or more recesses 618 can be disposed
about the distal end of impeller assembly 116. In some embodiments,
the distal end of the impeller assembly 116 can include one recess
618. For example, the recess 618 can be a generally cylindrical
channel surrounding at least a portion of the shaft extension
606.
[0142] Engagement of the resealable member 622 with the distal end
of the impeller assembly 116 as illustrated in FIG. 16B can have
many advantages. For example, an interface 620 between the
resealable member 622 and the distal end of the impeller assembly
116 can be non-planar. Accordingly, a non-planar interface 620 can
have a greater surface area than an otherwise similar interface
that is planar. The increased surface area can advantageously
increase the connection strength between the resealable member 622
and the distal end of the impeller assembly 116. In one embodiment,
the interface 620 can be much longer than the radial distance from
the lumen 610 to the outer surface of the hub 208. For example, the
interface 620 can be at least about twice as long as this radial
distance.
[0143] As illustrated in FIG. 16B, resealable member 622 can
include a valve 608 that extends proximally into an axial lumen
610. One valve structure that can be used is a duck bill valve. The
lumen 610 can pass through one or more components of the distal end
of the impeller assembly 116, such as the impeller shaft 204, the
impeller shaft extension 606, and/or the hub 208. The lumen 610 can
have a diameter that is greater than the diameter of the resealable
path 604. The lumen 610 may also not be self-sealing. The valve 608
can be tapered or otherwise have a reduced cross section compared
to the lumen 610. As a result, the impeller tip can also include
one or more corners 614 where the lumen 610 extends distally to
overlap with the valve 608. The outer surface of valve 608 can be
separated by a distance from the inner surface of the resealable
member 622. Advantageously, where the pressure within the lumen 610
is greater than the pressure outside the catheter assembly 100, the
internal pressure can be exerted on valve 608 to close resealable
path 604. The proximal extension of the valve 608 into the lumen
610 can also promote easier entry of a guidewire into the lumen 610
when the guidewire is introduced from the distal end of the pump.
Other valves structures that may be used in place of the valve 608
are discussed in US application Ser. No. 12/829,359 and in U.S.
Pat. No. 7,022,100, which are incorporated by reference herein for
all purposes and in its entirety.
[0144] Another embodiment of an impeller tip 602 that includes a
resealable member 624 is illustrated in FIG. 16C. The resealable
member 624 can have a resealable path 630 therethrough. The
resealable member 624 can optionally include a distal tapered
portion. As described herein, the impeller can be coupled with the
catheter body through a drive shaft 148, which can be disposed or
received within the axial lumen of the impeller or within the
impeller shaft 204. As illustrated in FIG. 16C, a distal portion of
a shaft, e.g., the drive shaft 148 or the impeller shaft 204, can
be disposed or received within the resealable member 624. The
impeller tip 602 can further include a non-resealable portion 626
having a non-resealable path 628 extending therethrough (e.g., a
path that generally does not seal or close once it has been opened
or created, and/or remains permanently open allowing fluid to pass
therethrough). The resealable path 630 and the non-resealable path
628 can be co-linear (e.g., coaxial). As illustrated in FIG. 16C,
the non-resealable portion 626 can extend distally of the
resealable member 624. In some embodiments, the non-resealable
portion 626 can partially or fully surround an outer surface of the
resealable member 624. For example, the resealable member 624 can
be partially or entirely contained within the non-resealable
portion 626. As illustrated in FIG. 16C, the non-resealable portion
626 can include the distal-most portion of the impeller tip 602. In
some embodiments, the non-resealable portion 626 can be a unitary
structure that includes the hub and one or more blades of the
impeller. In one embodiment, the non-resealable portion 626 can
include the entire impeller body except for the resealable member
624. For example, as discussed above, the impeller can include a
hub disposed between the impeller blades and the impeller shaft
204. The impeller hub can surround the resealable member 624.
[0145] Advantageously, the impeller tip 602 can be configured to
receive a guidewire through both the resealable path and the
non-resealable path 628. In some embodiments, the resealable path
(when open) and/or the non-resealable path can have a diameter that
is no more than one-half the diameter of the guidewire. Where the
impeller tip 602 includes a resealable member 624 disposed therein,
the resealable member can be advantageously protected from the
trauma to which the outer surface of the impeller tip 602 may be
exposed. In addition, the distally-extending non-resealable path
can act as a guide or channel that directs the guidewire through
the impeller. Furthermore, as discussed herein, the tapered shape
of the distal portion of the resealable member 624 can help to
reseal the resealable member 624, as radial forces extending
inwards can surround the tapered portion and help to close the
resealable path. Note in this case that the non-resealable member,
also made of an elastomeric material (but different actual
material), retains a level of elasticity that can stretch to a
lesser degree than the resealable material to accommodate passage
of the guidewire.
[0146] The impeller tip 602 illustrated in FIG. 16C can be
manufactured by first molding a soft and/or elastomeric material
over at least a portion of the drive shaft 148 of the impeller
shaft 204 to form the resealable member 624. Some suitable
materials for forming the member 624 include polyurethane and
silicone. Some materials having low durometer, e.g., below 60A, can
be used for the resealable member 624. In some embodiments, the
material can have a durometer in the range of from about 25A to
about 55A. For example, the material can be a polyurethane or a
silicone polymer having a durometer below 60A (e.g., in the range
of from about 25A to about 55A). In some embodiments with a
polyurethane material, the hardness can be for example, about 25A,
about 35A, about 45A, or about 55A. In other embodiments, a
silicone material can be used for the tip 602 and/or the resealable
member 622, 624. The silicone material can have a hardness ranging
from about 20A to about 60A. In some embodiments, the hardness can
be about 38A. As described above, the resealable member 624 can
optionally be formed to include a distal tapered portion. The rest
of the impeller, or a portion thereof, can then be molded over the
resealable member 624 and the drive shaft 148. The remainder of the
impeller tip 602 can be formed from a second material (e.g., a
second polymer) that is different from the material used to form
the resealable member 624. The non-resealable path 628 and the
resealable path 630 can be created after the impeller is molded
over the drive shaft 148 or the impeller shaft 204. A variety of
methods and/or tools can be used to create these paths, including
but not limited to a drill, a needle, or a small gauge screw. In
some embodiments, the paths 628, 630 can be formed from a proximal
end to a distal end of a wall of the impeller hub, e.g., distal of
the distal most blade. In other embodiments, the paths 628 can be
formed from a distal end of the impeller toward a proximal end of
the impeller.
[0147] In use, those skilled in the art may appreciate that
non-sealable (e.g., non-resealable or non-self-sealing) devices may
require a constant flow of infusant in the distal direction to
prevent the proximal flow of fluid or blood into the device.
Advantageously, a resealable tip can allow for guidewire passage
through the center of the catheter assembly 100 to ease insertion
without requiring a constant flush of infusant. The tip in various
embodiments the resealable tip self-seals when the guidewire is
removed. Valves discussed herein provide the advantage of
preventing blood from entering other portions of the catheter
assembly 100, such as the impeller shaft 204 or the lumen 234 or
the bearing housing 228. In various embodiments, valves are
configured to be actuated from an at least partially open
configuration to a closed configuration, such as by application of
a force or pressure on one side thereof.
D. Sheath Having Expandable Distal End
[0148] As described herein, the pump can include a sheath assembly.
The sheath assembly can control the collapse and expansion of the
impeller and/or the impeller housing. In some embodiments, the
distal end of the sheath assembly can optionally include one or
more structures that aid in the deployment and/or retrieval of the
impeller assembly.
[0149] In some embodiments, as shown in FIGS. 17A to 17D, the
sheath assembly can include an expandable distal end 170a, 170b,
170c. For example, the distal end can expand when a radial force is
applied, and can contract when the radial force is removed. The
distal end may also be able to expand and/or contract repeatedly.
When expanded, the distal end 170a, 170b, 170c can have a conical
and/or funnel-like configuration. When not expanded, the distal end
170a, 170b, 170c can have a generally cylindrical (e.g., generally
constant diameter) configuration, for example as illustrated in
FIG. 17A. To assist with expansion and/or contraction, the distal
end 170a, 170b, 170c or portions thereof may be made from materials
having a different flexibility and/or elasticity (e.g., more or
less flexible and/or elastic) than the material(s) used for all or
a portion of the remainder of the sheath assembly. In some
embodiments, the sheath assembly 162 can have at least one
configuration where it is at least partially disposed over the
impeller housing, catheter assembly, and/or impeller assembly.
Advantageously, the conical and/or funnel-like configuration can
aid the deployment and/or retraction of the impeller assembly
and/or impeller housing as described herein.
[0150] As illustrated in FIG. 17A, the distal end 170a can include
one or more axial slits 702 (e.g., 2, 3, or 4 slits). Slit 702 can
extend proximally from the distal end 170a at least partially along
the length of the elongate body 174. The distal end 170a can also
include a plurality of elongate members 704 (e.g., 2, 3, or 4
elongate members). Each elongate member 704 can be joined at one
end (e.g., proximal end) to the sheath assembly. Each elongate
member 704 can also have a distal end 705 that is outwardly
deflectable away from axis 708. The elongate members 704 can be
separated from each other by the slits 702. Each elongate member
704 can have a width that is defined by the distance between slits
702 and a length defined by the length of each adjacent slit 702.
In some embodiments, the elongate members 704 and slits 702 can be
generally equally spaced circumferentially about the elongate body
174. In some embodiments, the elongate members 704 can each have a
length that is generally equal to or greater than the axial length
of the outlet portion of the impeller housing. For example, in some
embodiments, the elongate members 704 can each have a length in the
range of from about 0.25 in. up to about 2.0 in. In other
embodiments, the elongate members 704 can each have a length in the
range of from about 0.5 in to about 0.75 in. The elongate members
704 and/or at least a portion of the sheath assembly 162 (e.g., the
portion of the sheath assembly 162 that connects to elongate
members 704) can be made from a relatively elastic material (e.g.,
any of the elastomeric polymers described herein).
[0151] In use, an outwardly-acting radial force resulting from the
radial stiffness of the impeller housing can be applied to the
elongate members 704 which causes the elongate members 704 to
deflect outwards, as illustrated in FIG. 17B. For example, the
axial movement of the impeller housing in the proximal direction
into the sheath assembly (or distal movement of the sheath over the
expanded impeller housing) can cause the elongate members 704 to
deflect outwards. The outward deflection of the elongate members
704 can result in the conical or funnel-like configuration of the
distal end 170a when sheathed over an expanded section of the
impeller housing. When the elongate members 704 are deflected
outwards, the width of each slit 702 can increase at the distal end
to define a gap 709. In some embodiments, the elongate members 704
can be self-collapsing. For example, the elongate members 704 can
be configured to return to their original configuration when the
internal outward-acting radial forces are released (e.g., where the
elongate members 704 are made of a relatively elastic
material).
[0152] As illustrated in FIG. 17C, the distal end 170b of the
sheath assembly can include an deformable structure 706 (e.g., a
webbing) that at least partially covers one or more slits 702. In
some embodiments, the deformable (e.g., stretchable, expandable,
flexible, and/or elastic) structure 706 can surround, coat, and/or
cover at least a portion of the distal end 170b (e.g., the elongate
members 704). As illustrated in FIG. 17C, the deformable structure
706 can be an elastomeric coating (e.g., incorporating those
elastomeric materials described herein). In other embodiments, the
deformable structure 706 can include a spring, such as a
semi-circular spring member having a straight or oscillatory
pattern. In use, the deformable structure 706 can be configured to
return the elongate members 704 to their original, non-conical
configuration and/or prevent over-deflection of the elongate
members 704 beyond their elastic limit.
[0153] In some embodiments, the elongate members 704 can be stiffer
(in the circumferential and/or axial direction(s)) than the
proximally-adjacent portion of the sheath assembly. Advantageously,
the stiffer material can prevent or inhibit the distal-most end of
the sheath assembly from folding over itself when it encounters
resistance (e.g., advancing the sheath over an expanded cannula
housing). In one embodiment, one or more elongate members 704 can
be reinforced with a plurality of wires that extend to the
distal-most tip of the elongate member 704. In another embodiment,
one or more elongate members 704 can be made from a polymer that is
stiffer than the material (e.g., a second polymer) of the
proximally-adjacent portion of the sheath assembly.
[0154] As illustrated in FIG. 17D, in some embodiments the distal
end 170c of sheath assembly 162 can include an integral funnel 710
having a distal, conically-shaped portion 711. As described further
herein, the integral funnel 710 can be expandable and/or
collapsible. Advantageously, the integral funnel 710 can assist in
deployment and retraction of the housing while minimally increasing
the profile of the pump. The integral funnel 710 can be connected
to a non-expandable portion 712 of the sheath, for example, at a
distal-most tip 714. The integral funnel 710 can include an outer
layer 713 and an inner layer 715 that converge at an interface 717.
The integral funnel 710 can be layered over an outer surface 716
and over an inner surface 718 of the non-expandable portion 712.
Accordingly, as illustrated in FIG. 17D, at least a portion of the
inner layer 715 can reside, at least temporarily, within the lumen
of the sheath assembly 162. The integral funnel 708 can be
connected to either the outer surface 716 or the inner surface 718
of the sheath. In some embodiments, the funnel 710 can be a distal
extension of distal end 170 that is folded over the non-expandable
portion 712.
[0155] The integral funnel 710 can be slideable over the outer
surface 716 and/or the inner surface 718 of the non-expandable
portion 712. The contact surfaces between the non-expandable
portion 712 and the integral funnel 710 and/or between the outer
layer 713 and the inner layer 715 can be lubricated, e.g., using a
silicone lubricant, to establish and/or maintain slideability
and/or low friction. The integral funnel 710 can be made from a
thin, flexible material, such as a polyurethane polymer. In some
embodiments, the integral funnel 710 can be made from a material
that is more flexible and/or elastic than the material that is used
for all or a portion of the remainder of the sheath assembly. In
some embodiments, the material used for the integral funnel 710 can
have one or more membrane-like qualities. In use, the axial
movement of the housing 202 (not shown) can frictionally engage the
integral funnel 710, causing the integral funnel 710 to deploy or
retract. For example, in embodiments where the outer layer 713 is
affixed to the non-expandable portion 712 of the sheath, axial
movement of the housing 202 in a distal direction can cause the
inner layer 715 to translate distally (e.g., slide distally along
the inner surface 718 of the sheath), thus deploying the conical
portion 711 (e.g., pulling the conical portion 711 out of the
sheath). Axial movement of the housing in a proximal direction can
cause the inner layer 715 to translate proximally (e.g., slide
proximally along the inner surface 718 of the sheath), thus
retracting the conical portion 711 into the sheath (e.g., pulling
the conical portion 711 into the sheath). The thin, flexible
material of the conical portion 711 can advantageously allow the
conical portion 711 to deform upon retraction into the sheath.
[0156] In embodiments where the inner layer 715 is affixed to the
non-expandable portion of the sheath, axial movement of the housing
202 can cause the outer layer 713 to translate. For example, distal
movement of the housing can cause the outer layer 713 to slide
distally along the outer surface 716 of the sheath. Proximal
movement of the housing can cause the outer layer 713 to slide
proximally along the outer surface 716 of the sheath.
[0157] In some embodiments where the funnel 710 is a distal
extension of the non-expandable portion 712 that is folded over the
non-expandable portion 712, the funnel 710 can slide distally as
the non-expandable portion 712 is moved proximally. In use, as the
non-expandable portion 712 is moved proximally, the funnel 710 can
slide distally to unfold and surround the impeller assembly
116.
IV. Methods
[0158] Various methods and techniques are discussed above in
connection with specific structures of heart pumps. The following
elaborates on some aspects of these techniques and methods. The
following discussion is to be read in light of and freely combined
with the foregoing discussion.
A. Retracting and Deploying the Impeller Housing By Way of the
Impeller Deployment Assembly at the Proximal End of the Catheter
Body
[0159] As discussed above, in various embodiments the heart pump 10
is inserted in a less invasive manner, e.g., using techniques that
can be employed in a catheter lab. Various general techniques
pertinent to the heart pump 10 are described in U.S. patent
application Ser. No. 12/829,359, filed on Jul. 1, 2010, and
entitled Blood Pump With Expandable Cannula, which is incorporated
by reference herein in its entirety and for all purposes.
[0160] Because the catheter assembly 100 is to be delivered through
a small access site, it can be important to ensure that the
impeller housing is reliably deployed and retracted, as described
above. A clinician may begin a heart pumping procedure by
introducing the catheter assembly 100 into the patient
percutaneously, e.g., by urging the catheter assembly through the
femoral artery and into a heart chamber. Because the impeller and
impeller housing are advanced through a narrow artery in some
embodiments, the impeller and impeller housing can initially be
inserted into the patient in a retracted, or collapsed (or low
profile), state, as described above. Once the distal end of the
catheter assembly 100 (including the impeller housing) has reached
the desired operating location (e.g., a heart chamber), the
clinician can deploy the impeller housing into an advanced or
expanded configuration.
[0161] One method of deploying the impeller and/or diffuser is by
using the impeller deployment assembly 800, which can be located
near the proximal end of the catheter assembly. As shown in FIGS.
15A and 15B, the clinician can rotate the nut 804 (clockwise or
counter-clockwise depending on the threading) such that the nut 804
translates from a distal position to a proximal position. In turn,
the flow diverter 806, the catheter body, and the impeller housing
can also translate from a distal position to a proximal position
and thereby advance the impeller distally into a wider portion of
the impeller housing to allow for deployment of the impeller hub
208 and blades 212. Thus, in some embodiments, the clinician can
deploy the impeller, located at a distal end of the catheter
assembly, by rotating a nut disposed near the proximal end of the
catheter assembly.
[0162] In some embodiments, the impeller 200 and housing 202 can be
axially displaced relative to their operational positions during
delivery of the distal end to the heart (e.g., the impeller and
housing can be delivered to the vasculature in an axially separated
configuration). As used in this context, "axially displaced"
includes configurations where there is axial movement of the
impeller 200 relative to any portion of the housing 202 prior to or
during the process of delivery. For example, axial displacement
includes conditions in which the impeller 200 is moved from a first
position near a proximal end port (outlet for left side support or
inlet for right side support) of the housing 202 to a second
position distal the first position. The second position can be one
that is still between the proximal end port and a distal end port
(inlet for left side support or outlet for right side support) of
the housing 202. The first position may be the operational position
of the impeller 200 relative to the housing 202. Axial displacement
also includes conditions in which the impeller is located proximal
of an operational position, e.g., at a location proximal of a
proximal end port of the housing 202, including being disposed
within a non-expandable portion of the heart pump. When the
clinician delivers the distal end of the heart pump to the heart
chamber, rather than delivering the distal end with the impeller
housing disposed over the impeller blades, the impeller housing can
be in a proximally displaced position or retracted configuration
(or distally displaced position or advanced configuration in other
embodiments) with respect to the impeller, such that it is axially
moved from the operational position, as discussed above.
[0163] In some embodiments, the impeller and the housing can be
delivered in series (with the impeller being delivered before the
housing, or vice versa). For example, in one embodiment, the
impeller housing 202 is first advanced into position, e.g., in the
heart. The housing 202 may then be expanded if the housing has
expanded and compressed configurations. Thereafter the impeller 200
may be positioned, e.g., advanced through a catheter body similar
to the catheter body 120 to be positioned within the impeller
housing 202. Thereafter the impeller 200 can be rotated by a source
of rotational energy. In various embodiments, the source of
rotational energy can comprise a motor positioned outside of the
patient to drive a shaft similar to the shaft 148. In other
embodiment, the source of rotational energy can comprise a motor
that is miniaturized to be positionable within the patient, as
discussed in U.S. Pat. No. 7,070,555, which is incorporated by
reference herein for all purposes and in its entirety. In another
embodiment, the distal end of the impeller 200 can be configured to
be advanced into position in the patient and, at a later stage of a
procedure, the impeller housing 202 can be positioned thereover. In
one technique, the impeller 200 is positioned in the heart chamber
(or wherever the procedure is to occur), the clinician can then
advance the impeller housing over the impeller blades and begin
operating the heart pump. For removal of the catheter assembly from
the patient after the procedure, the clinician can retract or
displace the impeller housing proximally to axially displace and/or
separate the impeller from the impeller housing.
[0164] The configurations enabling displaced or serial delivery
also can decouple the design of the impeller housing 202 from the
complexities of the design of the impeller 200. For example, the
impeller housing 202 can have a greater range of expansion from a
collapsed state to an expanded state. If no structures are disposed
inside the housing 202 in the collapsed state, greater compression
and a lower crossing profile can be achieved compared to where the
housing 202 must be sized in the collapsed state to accommodate the
impeller 200 in its collapsed state. This provides one or more of
the benefits of access through smaller vessels, in smaller
patients, or a larger expanded size in standard patients through
typical access (e.g., femoral vessel). Similarly, greater
compression of the impeller 200 may be possible if the impeller 200
is delivered using a dedicated compression sheath or device that is
not required to expand and/or to be present around the impeller
during operation. As a result, larger blades may be delivered from
the same collapsed profile, providing the advantages of higher flow
discussed above. More details of serial delivery of blood pumps are
discussed in U.S. Pat. No. 7,022,100, which is incorporated by
reference herein for all purposes and in its entirety.
[0165] Once the impeller is deployed, the clinician can conduct the
procedure, e.g., by running the heart pump within a heart chamber.
Once the procedure is finished, the clinician can remove the
catheter assembly from the patient by retracting the impeller. The
clinician can simply rotate the nut 804 in a direction opposite to
that rotated for deploying the impeller. The nut can then translate
from the proximal position to the distal position, which in turn
can cause the flow diverter 806, the catheter body, and the
impeller housing to also translate from the proximal position to
the distal position. The impeller can thereby be retracted
proximally into an area near the outlet 802 to reduce the profile
of the pump upon collapsing into the sheath. Thus, the clinician
can both deploy and retract the impeller by rotating a nut located
near the proximal end of the catheter assembly.
B. Controlling the Collapse and Deployment of the Impeller Housing
with the Sheath Assembly
[0166] As mentioned above in Section IV(A), it can be advantageous
in certain embodiments to enable a clinician to deploy and retract
the impeller assembly prior to and after a heart procedure. One
method of collapsing the impeller housing can be performed by
advancing the sheath assembly 162 distally over the impeller
housing to collapse the impeller assembly, e.g., for removal of the
catheter assembly from the patient after a heart procedure. As
mentioned above, elongate body 174 of the catheter assembly 162 can
be slidably disposed over the catheter body 120. The clinician can
distally advance the elongate body 174 over the impeller housing,
or alternatively proximally retract the catheter body 120 such that
the impeller housing collapses into the elongate body 174 of the
sheath assembly 162.
[0167] As FIGS. 17A-D illustrate, the sheath assembly can have
expandable distal ends 170a, 170b, 170c, that expand when a radial
force is applied. Thus, when the clinician advances the elongate
body 174 of the sheath over the impeller housing, the impeller
housing can contact the distal end 170 and can induce a radial
force that causes the distal ends 170a, 170b, 170c, to expand in
order to aid in retraction of the impeller assembly. Similarly,
when the clinician slides the elongate body 174 in a proximal
direction, the impeller assembly can deploy through the distal end
170 of the catheter assembly 162, because the distal ends 170a,
170b, 170c, can contract when a radial force is removed (or not
applied). Thus, the clinician can reliably deploy and retract the
impeller assembly by sliding the elongate body 174 of the sheath
relative to the catheter body 120. In other embodiments, the sheath
assembly need not have expandable distal ends as described above.
The clinician can therefore simply deploy the impeller assembly 116
by providing relative motion between the elongate body 174 of the
sheath and the impeller assembly, e.g., by retracting the elongate
body 174 from the impeller assembly, and can collapse the impeller
assembly by providing relative motion between the elongate body 174
of the sheath and the impeller assembly 116, e.g., by advancing the
elongate body over the impeller assembly. The distal end of the
elongate body 174 can therefore effectuate collapse of the impeller
assembly 116 without using the expandable distal ends described
above. In embodiments where the impeller assembly is
self-expanding, the retraction of the elongate body 174 from the
impeller assembly 116 or extension of the impeller assembly 116 out
of the elongate body 174 can release the impeller assembly to
self-expand.
[0168] It will be apparent to those skilled in the art that various
modifications and variations can be made in the present embodiments
without departing from the scope or spirit of the advantages of the
present application. Thus, it is intended that the present
application cover the modifications and variations of these
embodiments and their equivalents.
* * * * *