U.S. patent application number 16/847375 was filed with the patent office on 2020-08-13 for catheter device and method for delivery of medical devices in the aorta.
This patent application is currently assigned to ITSO Medical AB. The applicant listed for this patent is ITSO Medical AB. Invention is credited to Anders Jonsson.
Application Number | 20200254227 16/847375 |
Document ID | 20200254227 / US20200254227 |
Family ID | 1000004784586 |
Filed Date | 2020-08-13 |
Patent Application | download [pdf] |
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United States Patent
Application |
20200254227 |
Kind Code |
A1 |
Jonsson; Anders |
August 13, 2020 |
Catheter Device And Method For Delivery Of Medical Devices In The
Aorta
Abstract
A catheter device and method are disclosed for transvascular
delivery of a medical device to a cardiac valve region of a
patient. The catheter device comprises an elongate sheath with a
lumen and a distal end for positioning at a target site e.g. a
heart valve.
Inventors: |
Jonsson; Anders; (Bromma,
SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ITSO Medical AB |
Helsingborg |
|
SE |
|
|
Assignee: |
ITSO Medical AB
Helsingborg
SE
|
Family ID: |
1000004784586 |
Appl. No.: |
16/847375 |
Filed: |
April 13, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16467008 |
Jun 5, 2019 |
10688288 |
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PCT/SE2017/051221 |
Dec 5, 2017 |
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16847375 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/1095 20130101;
A61M 25/1002 20130101; A61F 2/2436 20130101; A61F 2/011 20200501;
A61M 2025/1047 20130101; A61F 2/013 20130101 |
International
Class: |
A61M 25/10 20060101
A61M025/10; A61F 2/24 20060101 A61F002/24; A61F 2/01 20060101
A61F002/01 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 5, 2016 |
SE |
1651598-3 |
Claims
1-17. (canceled)
18. A catheter device for transvascular delivery of a medical
device to a target region, such as a heart valve region, of a
patient, comprising an elongate sheath with a lumen, a proximal
end, a distal end, and a distal end portion including said distal
end is configured to be positioning at, or in the vicinity to, or
adjacent to said target region, such as said heart valve region,
wherein said elongate sheath has an increasing flexibility towards
said distal end.
19. The catheter device according to claim 18, comprising at least
one, preferably a plurality of expandable units being arranged for
temporarily positioning said elongate sheath in relation to said
cardiac valve when in an expanded state.
20. The catheter device according to claim 18, comprising an
elongate member with a distal end portion comprising said plurality
of radially expandable units, wherein said elongate member is
retractably insertable into said lumen.
21. The catheter device of claim 18, wherein said plurality of
radially expandable units comprises expandable balloons, preferably
three balloons positioned radially equidistant around a
longitudinal axis of said elongate sheath.
22. The catheter device of claim 21, wherein said plurality of
radially expandable units comprises expandable mechanical levers,
or swellable units, such as sponges, retractable into said
sheath.
23. The catheter device of claim 18, wherein said medical device is
an artificial replacement valve or a valve repair device, wherein
said cardiac valve preferably is an aortic valve of said
patient.
24. A kit of a catheter device of claim 18 and a medical device for
a cardiac valve, such as an artificial replacement valve.
25. A catheter device for transvascular delivery of a medical
device to a target region, such as a heart valve region, of a
patient, comprising an elongate catheter sheath with a lumen, a
proximal end, a distal end, and a distal end portion including said
distal end is configured to be positioning at, or in the vicinity
to, or adjacent to said target region, such as said heart valve
region; said catheter having an elongate sheath with a distal end
configured to transvascularly navigate through said vascular system
upstream the aorta to a position at and/or downstream said aortic
cardiac valve; wherein said elongate sheath has an increasing
flexibility towards said distal end.
26. The catheter device of claim 25, comprising a cover sheath
arranged coaxially outside of said elongate catheter sheath; said
cover sheath including at least one or a plurality of radially
expandable units proximate said distal end of said catheter sheath
and at an exterior of said catheter sheath; wherein at least one of
said radially expandable units is configured to be in apposition
with the interior vessel wall in the ascending aorta downstream
said aortic valve and upstream all side branch vessels of said
aortic arch; wherein said radially expandable units are arranged
for expanding to temporarily position said distal end in relation
to said cardiac valve; whereby said expandable units are arranged
to allow for blood flow outside said sheath and past lobes of said
radially expandable units when in a position for delivering said
artificial aortic valve; and wherein said cover sheath ends
proximal of said catheter sheath distal end.
27. The device of claim 26, wherein said cover sheath has a higher
flexibility than said elongate catheter sheath.
28. The device of claim 25 comprising at least one radially
expandable unit that is configured to be in apposition with the
interior vessel wall in the ascending aorta downstream said aortic
valve and upstream all side branch vessels of said aortic arch.
29. The device of claim 25, including a cover sheath that has an
increasing flexibility towards said distal end.
30. The device of claim 25, including a cover sheath that is
elastic and has a lesser inner lumen diameter than an outer
diameter of said elongate catheter sheath, wherein said cover
sheath is arranged outside said delivery catheter by stretching
over said elongate catheter sheath outside and along said delivery
catheter outside.
31. The device of claim 30, wherein said cover sheath has a length
shorter than a length of said elongate catheter sheath.
32. The device of claim 25, combined with an introducer device
configured to provide vascular, such as femoral access to said
patients vascular system, said introducer having a shorter length
than said elongate catheter sheath, and a lower flexibility than
said elongate catheter sheath.
33. The device of claim 25, including a cover sheath having a
distal end with an attachment unit to the delivery catheter at the
distal end of said cover sheath.
34. The device of claim 25, including a slotted crown unit having a
plurality of slots for passage of a portion of an interior
inflation balloon and configured to produce lobes of said balloon
through said slots and radially outside said slots.
35. The device of claim 25, said elongate catheter sheath having a
reinforcement braiding to avoid kinking.
36. The device of claim 25, comprising multiple sets of anchoring
units at a longitudinal distance from each other at said elongate
catheter sheath.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/467,008 filed Jun. 5, 2019 entitled
Catheter Device And Method For Delivery Of Medical Devices In The
Aorta, which is the U.S. National Phase of and claims priority to
International Patent Application No. PCT/SE2017/051221,
International Filing Date Dec. 5, 2017, entitled Catheter Device
And Method For Delivery Of Medical Devices In The Aorta; which
claims benefit of Swedish Application No. 1651598-3 filed Dec. 5,
2016; all of which are incorporated herein by reference in their
entireties.
FIELD OF THE INVENTION
[0002] This invention pertains in general to the field of medical
devices and medical procedures applying such medical devices. More
particularly, the invention relates to a catheter device for
inserting medical devices into a lumen of a patient. such as the
aortic arch, as well as related medical procedures and methods. In
particular the invention relates to the positioning of catheters
for the delivery of medical devices and the procedures, and more
specifically to the transvascular delivery of a medical device to a
cardiac valve.
BACKGROUND OF THE INVENTION
[0003] The human heart is a hollow muscular organ, responsible for
pumping a large volume of blood around the human body every day.
The ability to pump the blood is facilitated by several heart
valves which open and close appropriately to allow blood passage
through the heart. Heart valve dysfunction through natural defects
or through the increasing incidence of heart disease, often
requires the dysfunctional valve to be treated, with the main
treatment modalities being mechanical adjustment of the valve or
replacing the valve altogether. Current medical techniques are
aimed at moving away from the major open heart surgery procedure,
which is very traumatic for the patient, to more minimally invasive
catheter based procedures, which are less traumatic, although more
complicated procedures.
[0004] Catheter based procedures require precise positioning of the
catheter, used to deliver for example the replacement valve, in an
optimal position in relation to the cardiac valve to be treated.
This is especially important as misalignment has the potential to
damage adjacent cardiac structures leading to severe coronary
complications. Placement of the catheter adjacent to a heart valve
is hampered by the fact that the heart continues to pump throughout
the procedure, giving rise to significant levels of turbulence
which the catheter has to overcome to maintain its position.
[0005] Hence, improved or alternative medical devices and
procedures for stabilizing the introducer sheath during cardiac
valve replacement would be advantageous, in particular allowing for
increased cost-effectiveness, and/or patient safety.
SUMMARY OF THE INVENTION
[0006] Accordingly, embodiments of the present disclosure
preferably seek to mitigate, alleviate or eliminate one or more
deficiencies, disadvantages or issues in the art, such as the
above-identified, singly or in any combination by providing a
medical device and a method according to the appended patent
claims.
[0007] The present disclosure is an introducer sheath that
overcomes the positional problems that current catheters face. In
addition to maintaining the position, the disclosure is so devised
so that interference with the blood flow is minimal.
[0008] Aspects of the disclosure are described in the appended
patent claims.
[0009] According to a first aspect, a catheter device is provided
for transvascular delivery of a medical device to a target region
of a patient is disclosed.
[0010] In another aspect, a method of transvascularly delivering a
medical device to a target region of a patient is provided. The
method comprises providing and minimally invasively introducing a
catheter comprising an elongate sheath with a lumen to said target
site.
[0011] Further embodiments of the disclosure are defined in the
dependent claims, wherein features for the second and subsequent
aspects of the disclosure are as for the first aspect mutatis
mutandis.
[0012] It should be emphasized that the term "comprises/comprising"
when used in this specification is taken to specify the presence of
stated features, integers, steps or components but does not
preclude the presence or addition of one or more other features,
integers, steps, components or groups thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] These and other aspects, features and advantages of which
embodiments of the disclosure are capable of will be apparent and
elucidated from the following description of embodiments of the
present disclosure, reference being made to the accompanying
drawings, in which
[0014] FIG. 1A is a schematic illustration of an elongate sheath
connected to a hemostatic valve;
[0015] FIG. 1B is a schematic illustration of an elongate member,
with the radially expandable units in the collapsed
configuration;
[0016] FIG. 2A is a schematic illustration of the distal end
portion of the elongate member with the radially expandable units
in the collapsed configuration;
[0017] FIG. 2B is a schematic illustration of the distal end
portion of the elongate member with the radially expandable units
in the expanded configuration;
[0018] FIG. 2C is a schematic illustration frontal view of the
distal end portion of the elongate member with the radially
expandable units in the collapsed configuration;
[0019] FIG. 2D is a schematic illustration frontal view of the
distal end portion of the elongate member with the radially
expandable units in the expanded configuration;
[0020] FIG. 3A, 3B, 3C, 3D are schematic illustrations of
embodiments of the elongate sheath in the flexible, unlocked
configuration;
[0021] FIG. 3E is a schematic illustration of the cross sectional
view of the elongate sheath in the unlocked state;
[0022] FIG. 3F is a schematic illustration of one embodiment of the
cross sectional view of the elongate sheath in a locked state;
[0023] FIG. 3G is a schematic illustration of another embodiment of
the cross sectional view of the elongate sheath in the locked
state;
[0024] FIG. 4A is a schematic illustration of the elongate sheath
delivered transaxillary to a cardiac valve, where an embolic
protection filter is deployed, and the sheath is in a relaxed
state;
[0025] FIG. 4B is a schematic illustration where the relaxed sheath
is positioned in relation to the cardiac valve by expandable units
of an elongate member extending outside the distal end of the
sheath;
[0026] FIG. 4C is a schematic illustration of the cross sectional
view of the elongate sheath incorporating a second channel for
delivering the embolic protection filter;
[0027] FIG. 4D is a schematic illustration of the elongate sheath
delivered transaxillary to a cardiac valve, and the sheath is in
the locked configuration arranged relative to an aortic cardiac
valve, and the expandable units being withdrawn after positioning
the sheath;
[0028] FIG. 4E is a schematic illustration of the elongate sheath
delivered transfemorally to a cardiac valve, where an embolic
protection filter is deployed and the sheath in the locked
configuration;
[0029] FIG. 4F is a schematic illustration of the elongate sheath
delivered transaxillary to a cardiac valve, and where the relaxed
sheath is positioned in relation to the cardiac valve by expandable
units of the sheath;
[0030] FIG. 4G is a schematic illustration of the elongate sheath
delivered transaxillary to a cardiac valve, and where an embolic
protection filter is deployed over the vessels in the aortic arch
via a second channel of the sheath;
[0031] FIG. 4H is a schematic illustration of the elongate sheath
delivered transfemorally to a cardiac valve, and where an embolic
protection filter is deployed over the vessels in the aortic arch
via a second channel of the sheath; and
[0032] FIG. 5 is a flowchart for a method of implanting a medical
device.
[0033] Further figures are enclosed herein, wherein
[0034] FIG. 6 is is a schematic illustration of a "TAVI" introducer
installed in the aortic arch in two cross sectional views;
[0035] FIG. 7 is a cross-sectional view of a sheath with anchor
units in a lumen;
[0036] FIG. 8 is an illustration of a TAVI procedure with a
transfemoral approach using a Corevalve as an example;
[0037] FIG. 9 are two cross-sectional views similar to FIG. 6
showing two different embodiments of introducers having multiple
sets of anchr units;
[0038] FIG. 10 is a schematic illustration of advantages for
patients, clinicians and healthcare providers;
[0039] FIG. 11 is a cross-sectional view of an introducer inserted
in a femoral approach to the aortic valve having a sheath according
to the invention;
[0040] FIG. 12 are two cross sectional views of an introducer
inserted over wire with a dilator to the aortic arch and the
dilator removed and balloons inflated, respectively;
[0041] FIG. 13 are schematic illustrations of a distal part of an
introducer with un-inflated balloons and inflated balloons,
respectively, as well as a schematic illustration of an
introducer/CoreValve pushed into the aorta of a pig;
[0042] FIG. 14 is a schematic illustration of an introducer with
un-inflated balloons and a protruding dilator tip;
[0043] FIG. 15 is a schematic illustration of an introducer with a
cover-sheath and inflated balloons and a protruding dilator
tip;
[0044] FIG. 16 is a schematic illustration of user holding an
introducer with a cover-sheath and balloons and a protruding
dilator tip as well as a guidewire inserted into the dilator and
distally protruding from the dilator;
[0045] FIG. 17 is cross section through an example of multi-lumen
tube with fluid inflation channels for anchor units;
[0046] FIG. 18 is a cross-sectional view of an introducer inserted
in a femoral approach to the aortic arch with anchor units, a
dilator and guidewire;
[0047] FIG. 19 is a schematic illustration of a "crown" positioned
over a single lobe balloon to create lobes expandable from
interspaces of the crown when the balloon is inflated; and
[0048] FIG. 20 is schematic illustration of a crown in a
perspective view.
DESCRIPTION OF EMBODIMENTS
[0049] Specific embodiments of the disclosure will now be described
with reference to the accompanying drawings. This disclosure may,
however, be embodied in many different forms and should not be
construed as limited to the embodiments set forth herein; rather,
these embodiments are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
disclosure to those skilled in the art. The terminology used in the
detailed description of the embodiments illustrated in the
accompanying drawings is not intended to be limiting of the
disclosure. In the drawings, like numbers refer to like
elements.
[0050] In an embodiment of the disclosure according to FIG. 1A, a
catheter device 1 for transvascular delivery of a medical device to
a cardiac valve region 6 (see e.g. FIG. 4D) of a patient is shown.
The catheter device comprises an elongate sheath 2 with a lumen and
a distal end 3. In addition in FIG. 1B an elongate member 4 is
provided with a distal end portion 9 comprising a plurality of
radially expandable units 5. The end portion 9 may include an
obturator. The expandable units 5 are arranged for temporarily
positioning the elongate sheath 2 in relation to the cardiac valve
6, FIGS. 4B and 4F. The elongate member 4 is retractably insertable
into the lumen of the elongate sheath 2.
[0051] The elongate sheath 2 depicted in FIG. 1A is designed to be
deliverable transvascularly in the relaxed state which facilitates
optimal flexibility when transiting through the vasculature. When
at the desired anatomical location the elongate sheath 2 is able to
be secured in position by means of the anchoring unit(s)
stabilizing the sheath at the target location. The expandable
anchoring units 5, facilitate optimal stabilization of the catheter
1 for subsequently affixing the medical device to the heart valve
6.
[0052] FIG. 4A shows the elongate sheath inserted in its relaxed
shape. FIG. 4B shows the radially expandable units 5 in their
expanded configuration, i.e. outside the elongate sheath 2, which
positions the elongate sheath 2 centrally over the valve 6. The
expandable units 5 expand out of the elongate member 4, which
extends beyond the distal end of the sheath 2.
[0053] The sheath 2 is now positioned and stabilized over the valve
6. This overcomes the problems in prior art with insufficient
stabilization and lack of accurate positioning.
[0054] Alternatively, or in addition, expandable units, such as
balloons may be arranged on the outside of the sheath 2. The sheath
may be provided as a separate "condom" like sheath to be arranged
outside an interior delivery catheter.
[0055] Arrangement may be made coaxially.
[0056] The expandable unit may be integrally formed with the
sheath, as seen in FIG. 4F.
[0057] Thus, the expandable units do not affect the cross section
of the lumen of sheath 2. Upon returning to the unexpanded state,
e.g. by deflating balloons of the expandable units 5, a delivery of
a medical device through the catheter lumen may be made without the
need to retract the expandable units 5.
[0058] The expandable units provide for a defined positioning of
the distal en of the catheter sheath 2 in an anatomical structure,
like a blood vessel, an atrium or cardiac chamber, relative a
cardiac valve. This allows for a precision delivery of a medical
device through the catheter device.
[0059] Movements of certain anatomical structures are very limited
over the cardiac cycle. For instance the aortic arch is relatively
stable and the locked catheter will stay substantially in the same
spatial orientation, direction, and distance to the cardiac valve
as during the final positioning provided by the expanded expandable
units 5.
[0060] The catheter may thus be positioned relative a cardiac valve
in an anatomical structure.
[0061] The catheter may be locked in the locked configuration along
its entire length by having sets of expandable anchoring units at a
longitudinal distance from each other, see example in the
figures.
[0062] A distal portion may for instance be the portion arranged in
the ascending aorta, the aortic arch and the descending aorta, as
shown in FIG. 4E.
[0063] FIG. 4D is a schematic illustration of the elongate sheath
delivered transaxillary to a cardiac valve, here the aortic valve
6, and relative to an aortic cardiac valve 6.
[0064] FIG. 4E is a schematic illustration of the elongate sheath
delivered transfemorally to a cardiac valve.
[0065] In FIGS. 4D and 4E, the expandable units 5 are not shown, as
they are either retracted from the sheath, or returned to their low
profile unexpanded/collapsed configuration in the sheath.
[0066] In FIG. 4G-H the sheath of the device passes alongside
branch vessels in the aortic arch.
[0067] In embodiments, such as illustrated in FIG. 4A-H a catheter
1 having a second channel 7 that extends parallel on the outer
portion or the inner portion of the elongate sheath 2 is depicted.
This channel 7 allows for the delivery of further units or liquids
to aid the procedure to place the medical device, when the lumen of
the elongate sheath 2 is used for the elongate member 4 or medical
device.
[0068] The second channel 7 may be an integral part on the inside
or outside of the elongate sheath 2. This has the advantage of
being relatively cheap to manufacture by an extrusion method.
[0069] In FIGS. 4A-H, a sheath device is depicted. Interaction with
the side walls in the aortic arch is therefore also kept at the
minimum, avoiding scraping off further debris to be transported
with the blood stream. Simultaneously, the aortic arch is kept open
for unrestricted navigation of the sheath 2.
[0070] By having a second channel in the sheath 2, the distal end
of the sheath can be positioned appropriately at the valve, by the
stabilizing and anchoring effect of the protection unit 8 extending
from the second channel, while medical device can be delivered
through the lumen of the sheath without any hindrance from the
protection unit 8 or e.g. expandable units such as balloons.
[0071] Blood flow is kept open efficiently by such a compact
device.
[0072] The elongate member 4 may be comprised of three balloons
positioned radially equidistant around the longitudinal axis (See
FIGS. 2C and D). Fewer or more balloons are possible, as well as
alternative expansion units such as expandable mechanical levers,
or swellable units for example retractable sponges. The expansion
units 5 allow for optimal positioning of the elongate sheath 2 in
relation to the aforementioned cardiac valve 6. The multiple
balloon expansion unit can be expanded (See FIG. 2D) using a
variety of means for example using a fluid means or where
appropriate gaseous means. The balloons can also be individually or
simultaneously expanded as well as inflated to differing pressures
independently of the other expanding units.
[0073] Alternatively, the elongate member 4 is retractably inserted
into the elongate sheaths 2 lumen to a length equal to the distance
between the distal end 9 and the second proximal marker 10. In this
embodiment proximal markers 10 and 11 are used to guide the
positional orientation of the distal end portion 9 and thus provide
for optimal alignment of the expandable units 5 with the portion of
the elongate sheath 2 to be expanded. This facilitates safe
positioning at the desired valve region.
[0074] In a further embodiment the elongate sheath 2 is comprised
of radiopaque material, facilitating visualization of the elongate
sheath 2 which provides for optimal positioning of the elongate
sheath 2 for delivery of the medical device. Alternatively
radiopaque fiducial markers on the elongate sheath 2 can be used
for optimal positioning of the sheath 2 within the body of the
patient.
[0075] The embodiment shown in FIGS. 2A and B, includes a guide
wire 12 which is firstly positioned within the patient which
facilitates optimal transit of the elongate sheath 2 and elongate
member 4 to the desired anatomical site.
[0076] The locked elongate sheath 2 may be used in medical
procedures to delivery of a medical device to the cardiac valve 6,
which could include an artificial heart valve prosthesis, or
similar devices.
[0077] The elongate sheath 2 maybe a constituent of a medical
system devised for transvascularly delivering a medical device to a
cardiac valve 6 of a patient. The method as depicted in FIG. 5
initially comprises 100 minimally invasively either transfemorally
(See FIG. 4E) or transaxillary (See FIG. 4D) introducing a catheter
1 comprising an elongate sheath 2 with a lumen in a relaxed state
into the patients vascular system. Step 110 involves the distal end
3 of said elongate sheath 2 being navigated through the vascular
system to the desired cardiac valve, FIG. 4A. The next step in the
system 120, involves the elongate member 4 with a distal end
portion 9 comprising a plurality of radially expandable units 5,
being inserted into the lumen of the elongate sheath 2, whereupon
it is advanced through the elongate sheath 2 to the distal end of
the elongate sheath 2, FIG. 4B. Alternatively, expandable units 5
of the sheath may be expanded at this stage (without introducing an
elongate member 4 into the sheath, FIG. 4F. Whereupon step 130 is
initiated which involves the plurality of radially expandable units
5, being radially expanded to temporarily position in relation to
the cardiac valve 6 the elongate sheath 2, (See FIGS. 4B and
F).
[0078] After delivery of the medical device, or similar, the
expandable units 5 of a sheath 2 are brought back to the
non-expanded state.
[0079] A medical device can thus be delivered through the lumen of
the anchored and precisely positioned elongate sheath 2 to the
heart valve 6. This delivery is done with high spatial precision.
Blood flow in the lumen around the anchored sheath 2 is maintained
in-between the anchoring unit(s) or radially distally of some
anchoring units when not in lumen wall apposition. Partially
expanded anchoring units may contribute to mechanical stability of
the sheath in the lumen, a pulsatile movements of the sheath may be
dampened by intermittent apposition of the anchoring units to
interior wall tissue of the lumen.
[0080] The medical device may for instance be a cardiac valve
repair or replacement device.
[0081] When the medical device is delivered, release of the
anchoring unit(s) to return the elongate sheath 2 to the released
delivery state can now be performed (step 160) with the subsequent
withdrawal of the elongate sheath 2 from the vasculature of the
patient.
[0082] The embolic protection unit as shown in FIGS. 4A-H, may be
retracted after the release of the anchoring unit(s).
[0083] To ensure the optimal positioning of the elongate member 4
when it is inserted into the elongate sheath 2, the elongate member
4 is inserted to a length which is equal to the distance between
the distal end and the second proximal marker 10 of the elongate
member 4. Primarily the elongate sheath 2 will be centrally
positioned in relation to the cardiac valve 6, which facilitates
optimal delivery of the medical device, although other positions
off-center could also be desirable.
[0084] The medical system is primarily used for the delivery of a
medical device to be affixed to the particular cardiac valve 6,
which include the aortic and mitral valves of a patient. After
delivery of the medical device to the cardiac valve 6, the medical
device delivery system is withdrawn through the lumen of the
elongate sheath 2.
[0085] The device provides for a 1:1 response for the operator
thanks to long introducer channel
[0086] No problems with twisted aorta anatomy
[0087] No problems with plaque scraping
[0088] No problems with delivering the stiffer type aortic stent
valves to navigate around aortic arch with reduced stroke risk
[0089] The sheath is soft preferably in an example flexible, at
least the distal part. It is like a sloppy catheter in an
example.
[0090] The sheath may have a pre-shaped bend optionally, it bends
for instance when the introducer/dilator is withdrawn. It may bend
to an arc formed shape, circular.
[0091] A stiffer dilator may be provided to stiffen the introducer
during introductions from within
[0092] This prevents the introducer sheath from kinking or
collapsing, "simulates" a stiff (short) introducer. Then dilator
withdrawal and push forward long soft introducer up to aorta
descendens past side vessels and atop aortic valve is made.
[0093] A medical procedure is disclosed for positioning distal
orifice of introduction catheter adjacent aortic valve.
[0094] Balloon expansion is preferably provided for target
precision positioning of a distal orifice of the delivery device,
preferably centering thereof
[0095] A slotted Crown may be provided to produce partial/multiple
balloon segments as shown in the figures. The "crown" may be
positioned exterior to single lobe balloon to create multiple lobe
balloons (anchoring units). Rigid webs that resist inflation
pressure to create lobes expandable from interspaces between crowns
webs. It is particularly well working with latex/rubber/elastic
balloon(s) to create inflatable lobes. Inflatable lobes are
adaptable to be in apposition with inner lumen wall of tubular body
structures.
[0096] A single balloon with a single inflation channel may be
divided into one or more lobes depending on the slots of the crown.
The slots of the crown element may have a selected length and width
to provide a desired lobe. The balloon material is elastic, such
that the balloon can form expandable lobes upon inflation. The
material of the balloon is elastic, such as for instance elastic
rubber or latex. Balloon material, elasticity and thickness
determine together with inflation pressure (preferably saline
inflation liquid) the size and radial expansion of the lobe(s) to
provide advantageous apposition, positioning and potentially
securing of the catheter in the body lumen such as a vessel.
[0097] The crown is a tubular element than can be slid over the
catheter to the position of a balloon. It can be made of
sufficiently stiff material to resist inflation pressure at the one
or more web(s) between the one or more slot(s) allowing expansion
of balloon lobes.
[0098] As shown in the figures depicting the crown:
[0099] Thus, the system and catheter create a working channel to an
aortic valve.
[0100] Alternative access may be made through artery, left arm,
down to the aortic valve (not shown).
[0101] Some embodiments of the sheath include a thin condom type
sheath having an open distal end orifice. The sheath of this
example is preferably not stiff. It is preferably highly Flexible.
It has preferably a low profile. It is thus atraumatic. It is
preferably hydrophilic or coated with a hydrophilic agent. It is
preferably elastic.
[0102] The sheath ends proximally of the distal end of the device
sheath to be delivered, e.g. an artificial heart valve sheath over
which the condom type sheath with at least one expansion element is
positioned (coaxially). The sheath may be pre mounted, part of a
delivery system.
[0103] The expandable members are expanded, e.g. when provided as
balloons they are Inflated, when in position at the target
site.
[0104] Several sets of expansion elements like one or more balloons
along length of catheter/sheath may be provided advantageously.
This provides better locking/securing to the vessel lumen at the
position of expansion. This multiple sets of expansion elements
prevents kinking of the delivery catheter when expandable members
are expanded. They also in addition or alternatively prevent
rotation of the delivery catheter in the vessel lumen when
expandable members are expanded.
[0105] It is provided in an example a catheter device for
transvascular delivery of a medical device to a target region, such
as a heart valve region, of a patient. It comprises an elongate
sheath with a lumen, a proximal end, a distal end, and a distal end
portion including said distal end is configured to be positioning
at, or in the vicinity to, or adjacent to said target region, such
as said heart valve region. The elongate sheath preferably has an
increasing flexibility towards said distal end. Increased
flexibility may be provided by a thinner material of the catheter
wall towards the distal end, e.g. at the distal end region.
[0106] The catheter device according to the example, has at least
one, preferably a plurality of expandable units being arranged for
temporarily positioning said elongate sheath in relation to said
cardiac valve when in an expanded state.
[0107] The catheter device according to the example may
additionally or alternatively have an elongate member with a distal
end portion comprising the plurality of radially expandable units,
wherein the elongate member is retractably insertable into the
lumen.
[0108] The catheter device according to the examples may
additionally or alternatively have the plurality of radially
expandable units in the form of one or more expandable balloons,
preferably three balloons positioned radially equidistant around a
longitudinal axis of the elongate sheath. The interspace between
the balloon(s) or lobes provides for continued flow of body fluid,
like blood, urine, air, past the set of one or more
balloons/lobes/expandable units to be expanded towards the lumen
wall at a target site of the catheter.
[0109] The catheter device according to the examples may
additionally or alternatively have the plurality of radially
expandable units comprise alternatively or in addition expandable
mechanical levers, or swellable units, such as sponges, collapsible
and/or retractable into the sheath.
[0110] The catheter device according to the examples may
additionally or alternatively have the medical device being an
artificial replacement valve or a valve repair device, wherein the
cardiac valve preferably is an aortic valve of the patient.
[0111] The catheter device according to the examples may be
provided in a kit of the catheter device and a medical device for
delivery to a cardiac valve region, such as an artificial
replacement valve.
[0112] Alternatively, or in addition, a system is provided for
transvascularly delivering a medical device to an aortic cardiac
valve region of a patient. The system includes a catheter
comprising an elongate catheter sheath with a lumen for minimally
invasively introducing into the vascular system, the catheter being
configured to transvascularly deliver an artificial heart valve to
the aortic cardiac valve region.
[0113] The catheter sheath has a distal end configured to
transvascularly navigate through the vascular system upstream the
aorta to a position at and/or downstream the aortic cardiac
valve.
[0114] A plurality of radially expandable units is provided at
least temporarily proximate the distal end of the catheter sheath
and at an exterior of the catheter sheath. At least one of the
radially expandable units is configured to be in apposition with
the interior vessel wall in the ascending aorta downstream the
aortic valve and upstream all side branch vessels of the aortic
arch.
[0115] The radially expandable units are arranged for expanding to
temporarily position the distal end in relation to the cardiac
valve.
[0116] The expandable units are arranged to allow for blood flow
outside the sheath and past lobes of the radially expandable units
when in a position for delivering the artificial aortic valve.
[0117] Alternatively, or in addition, a catheter device is provided
for transvascular delivery of a medical device to a target region,
such as a heart valve region, of a patient, comprising an elongate
catheter sheath with a lumen, a proximal end, a distal end, and a
distal end portion including the distal end is configured to be
positioning at, or in the vicinity to, or adjacent to the target
region, such as the heart valve region; and a cover sheath arranged
coaxially outside of the elongate catheter sheath.
[0118] The catheter sheath has distal end configured to
transvascularly navigate through the vascular system upstream the
aorta to a position at and/or downstream the aortic cardiac
valve.
[0119] The cover sheath includes at least one or a plurality of
radially expandable units proximate the distal end of the catheter
sheath and at an exterior of the catheter sheath. At least one of
the radially expandable units is configured to be in apposition
with the interior vessel wall in the ascending aorta downstream the
aortic valve and upstream all side branch vessels of the aortic
arch.
[0120] The radially expandable units are arranged for expanding to
temporarily position the distal end in relation to the cardiac
valve.
[0121] The expandable units are arranged to allow for blood flow
outside the sheath and past lobes of the radially expandable units
when in a position for delivering the artificial aortic valve.
[0122] The cover sheath ends proximal of the catheter sheath distal
end.
[0123] The cover sheath has preferably a higher flexibility than
the flexibility of the delivery catheter.
[0124] At least one of the radially expandable units is for
instance configured to be in apposition with the interior vessel
wall in the ascending aorta downstream the aortic valve and
upstream all side branch vessels of the aortic arch.
[0125] The cover sheath has in an example an increasing flexibility
towards the distal end. This allows for better navigation around
the aortic arch. This also allows for a low profile catheter and
improved deliverability of a medical device, such as an artificial
heart valve through the sheath.
[0126] The cover sheath is for instance elastic. It may have a
lesser inner lumen diameter than an outer diameter of the delivery
catheter, wherein the sheath is arranged outside the delivery
catheter by stretching over the delivery catheter's outside an
along the delivery catheter outside.
[0127] The cover sheath has preferably a length shorter than a
length of the delivery catheter.
[0128] The device of these examples may be combined with an
introducer device configured to provide vascular, such as femoral
access to the patients vascular system, wherein the introducer has
a shorter length than the delivery catheter, and preferably a lower
flexibility than the delivery catheter and the cover sheath. This
allows for most advantageous delivery of a medical device over a
long distance to a position remote of the puncturing site entering
the vascular system (e.g. femoral approach).
[0129] The cover sheath includes in examples balloons/stabilizers
and has a distal end with an orifice that ends proximally of the
delivery catheter's distal end. The sheath may be arranged
coaxially outside of delivery catheter (preferably with low
profile/diameter increase of delivery catheter).
[0130] The cover sheath preferably has a distal end with an
attachment unit to the delivery catheter at the distal end of the
cover sheath. The attachment unit is preferably an adhesive unit, a
force fit unit (e.g. distal end contracting onto delivery
catheter), or a mechanical fixation unit (outside ring, clamp, lock
ring, hook, barb, interference fit).
[0131] The device of any of the examples may include one or more
slotted crown unit(s) having a plurality of slots for passage of a
portion of an interior inflation balloon and configured to produce
lobes of the balloon through the slots and radially outside the
slots.
[0132] A plurality of crown units may provide a plurality of sets
of expandable balloons along the length of the sheath on which the
crowns are attached.
[0133] Additionally or alternatively, the sheath and/or catheter
may have a lubricious inside, such as of Teflon or Teflon
coating.
[0134] Additionally or alternatively, the sheath and/or catheter
having a reinforcement braiding to avoid kinking.
[0135] The multiple sets of the anchoring units (expandable units)
may be provided at a longitudinal distance from each other at the
sheath. Sets may be configured to be arranged a) in the ascendens
aorta and b) in the descendens aorta besides other positions.
[0136] This may provide for improved hemodynamic stability during
positioning in the aortic arch. Each set of anchoring units allows
for blood flow in-between the anchoring units along the sheath
exterior. Hemodynamic pressure waves may be smoothed out and
improve hemodynamic stability having several sets of anchoring
units arranged in that manner, see Figures.
[0137] A method of transvascularly delivering a medical device to a
cardiac valve of a patient is provided. The method comprises at
least the steps of: introducing a catheter comprising an elongate
sheath with a lumen in a relaxed state into the vascular system;
navigating a distal end of the elongate sheath through the vascular
system to the cardiac valve; expanding an embolic protection unit
from a second channel in the sheath to cover ostia of the side
branch vessels in the aortic arch and to stabilize a distal end of
the sheath at the cardiac valve, and delivering a medical device
through the lumen of the locked elongate sheath to the heart valve
while the embolic protection unit covers the ostia.
[0138] The method may include radially expanding expandable units
of the catheter or an elongate member positioned beyond a distal
end of the sheath, to temporarily position in relation to the valve
the elongate sheath; and optionally delivering a medical device
through the lumen of the elongate sheath to the heart valve,
wherein the elongate sheath is preferably locked in position in the
lumen by expandable member(s).
[0139] The method may additionally include inserting an elongate
member with a distal end portion comprising a plurality of the
radially expandable units, into the lumen of the elongate sheath;
advancing the elongate member through the elongate sheath to the
distal end of the elongate sheath; retracting the expandable units
and withdrawing the elongate member from the lumen of the elongate
sheath.
[0140] The present invention has been described above with
reference to specific embodiments. However, other embodiments than
the above described are equally possible within the scope of the
invention. Different method steps than those described above, may
be provided within the scope of the invention. The different
features and steps of the invention may be combined in other
combinations than those described. The catheter may be positioned
and locked in other cardiac anatomical structures than illustrated.
Medical devices delivered through the catheter sheath may be any
medical device to be delivered to the cardiac valve tissue. The
scope of the invention is only limited by the appended patent
claims.
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