U.S. patent application number 17/805640 was filed with the patent office on 2022-09-22 for hemostatic device for a heart.
This patent application is currently assigned to Syntach AG. The applicant listed for this patent is Syntach AG. Invention is credited to Daniel ENGVALL, Jan Otto SOLEM, Kristian SOLEM, Martin WOLFF.
Application Number | 20220296272 17/805640 |
Document ID | / |
Family ID | 1000006381481 |
Filed Date | 2022-09-22 |
United States Patent
Application |
20220296272 |
Kind Code |
A1 |
SOLEM; Jan Otto ; et
al. |
September 22, 2022 |
Hemostatic Device For A Heart
Abstract
An access device for a heart chamber, a removable hemostatic
valve unit, and a system including a cardiac assist unit are
disclosed. In examples, the access device) includes an apical base
plate and a sealing unit configured to provide a separation of a
wet zone from a heart chamber and a dry zone with a gaseous
environment outside of said heart chamber inside a patient body at
the same time.
Inventors: |
SOLEM; Jan Otto;
(Schaffhausen, CH) ; SOLEM; Kristian;
(Schaffhausen, CH) ; ENGVALL; Daniel;
(Schaffhausen, CH) ; WOLFF; Martin; (Schaffhausen,
CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Syntach AG |
Schaffhausen |
|
CH |
|
|
Assignee: |
Syntach AG
Schaffhausen
CH
|
Family ID: |
1000006381481 |
Appl. No.: |
17/805640 |
Filed: |
June 6, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/EP2020/088064 |
Dec 30, 2020 |
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17805640 |
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16990903 |
Aug 11, 2020 |
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PCT/EP2020/088064 |
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PCT/EP2019/087182 |
Dec 30, 2019 |
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16990903 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/3425 20130101;
A61B 2017/00243 20130101; A61B 17/3498 20130101; A61B 17/00234
20130101; A61B 17/3423 20130101; A61B 2017/3464 20130101; A61B
2017/06019 20130101; A61B 2017/3419 20130101 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61B 17/00 20060101 A61B017/00 |
Claims
1. A hemostatic valve assembly for placement on a heart comprising:
a first housing; a second housing; the first and second housing
being splittable relative each other; a through-port extending
though the first and second housing; and, the through-port sized
and shaped for directing a medical device at least partially to an
interior of the heart.
2. The hemostatic valve assembly of claim 1, further comprising a
connection interface disposed on the valve assembly and configured
to mate with a heart access device.
3. The hemostatic valve assembly of claim 1, wherein the
through-port includes a controllable orifice size.
4. The hemostatic valve assembly of claim 1, further comprising a
seal for engaging the medical device.
5. The hemostatic valve assembly of claim 1, wherein the medical
device is a cardiac assist unit.
6. The hemostatic valve assembly of claim 2, further comprising a
sealing element matable with the access device.
7. The hemostatic valve assembly of claim 1, wherein the first
housing and the second housing are adjoinable to one another.
8. The hemostatic valve assembly of claim 1, further comprising a
pneumatic valve.
9. The hemostatic valve assembly of claim 8, further comprising a
reservoir unit in fluid communication with the pneumatic valve.
10. The hemostatic valve assembly of claim 1, further comprising an
inflatable member.
11. The hemostatic valve assembly of claim 1, wherein splittable is
constituted by the first housing and the second housing being
peeled off from each other.
12. A hemostatic valve for mounting on a heart comprising: first
housing and a second housing; the first housing and second housing
being separable from each other; a port providing an instrument
access to an interior of a heart, the port extending through the
first and second housings; a sealing mechanism located in the
port.
13. The hemostatic valve of claim 12, further comprising a
connection interface disposed on the hemostatic valve and
configured to mate with a heart access device.
14. The hemostatic valve of claim 12, wherein the sealing mechanism
includes a controllable orifice size.
15. The hemostatic valve of claim 12, wherein the instrument is a
cardiac assist unit.
16. The hemostatic valve of claim 13, further comprising a sealing
element matable with the heart access device.
17. The hemostatic valve of claim 12, wherein the sealing mechanism
is comprised of a pneumatic valve.
18. A hemostatic valve for attachment to a heart comprising: first
housing separable from a second housing; a port sized for allowing
a therapeutic instrument access to an interior of a heart, the port
extending through the first and second housings; a sealing
mechanism located in the port.
19. The hemostatic valve of claim 18, further comprising a
connection interface disposed on the hemostatic valve and
configured to mate with a heart access device.
20. The hemostatic valve of claim 18, wherein the sealing mechanism
includes a controllable orifice size.
Description
RELATED APPLICATIONS
[0001] This application is a bypass continuation of and claims
priority to International Patent Application No. PCT/EP2020/088064,
International Filing Date Dec. 30, 2020, entitled An Access Device
For A Heart, A Removable Hemostatic Valve Unit, And A System
Including A Cardiac Assist Unit, which claims priority to U.S.
application Ser. No. 16/990,903 filed Aug. 11, 2020 entitled An
Access Device For A Heart, A Removable Hemostatic Valve Unit, And A
System Including A Cardiac Assist Unit, which is a bypass
continuation of and claims priority to International Patent
Application No. PCT/EP2019/087182, International Filing Date Dec.
30, 2019, entitled An Access Device For A Heart, A Removable
Hemostatic Valve Unit, And A System And A Method Of Creating A
Transapical Passage On A Beating Heart, all of which are hereby
incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This disclosure pertains in general to the field of cardiac
medical devices. More particularly the disclosure relates to access
devices for a heart, in particular transapical access devices being
transapical ports to and from a heart's chambers. Also, the
disclosure relates to hemostatic valve units, in particular
hemostatic valve units for delivery of medical devices via a
cardiac apex to a heart, and even more particularly to such
hemostatic valve units with variable orifices and preferably
removable from the heart after use. In addition, the disclosure
relates to medical procedures, methods and systems of and for
creating a transapical passage on a beating heart. Moreover, the
disclosure relates to medical systems including cardiac assist
units to be transapically implanted. Furthermore, the disclosure
relates to apical base plates including a connection interface. In
addition, the disclosure relates to medical procedures, methods and
systems of and for transapically implanting a cardiac assist
system.
Description of Prior Art
[0003] This section is intended to introduce the reader to various
aspects of art that may be related to various aspects of the
present disclosure, which are described and/or claimed below. This
discussion is believed to be helpful in providing the reader with
background information to facilitate a better understanding of the
various aspects of the present disclosure. Accordingly, it should
be understood that these statements are to be read in this light,
and not as admissions of prior art.
[0004] In international patent publication number WO2009100198A2,
transapical heart ports, methods for making transapical heart
ports, and methods for using transapical heart ports are provided.
However, these heart ports may be further improved.
[0005] In British patent specification number GB1514019 a
hemostatic valve with a fluid pressure controllable cross section
is disclosed. However, these hemostatic valves may be further
improved.
[0006] In international patent publication WO 2018/167059 A1, a
transapical heart port is disclosed. The heart port is for use
during cardiac surgery to access the interior of a heart via its
apex. The heart port is removed after the surgical procedures are
performed (page 8 lines 9 to 10). During the procedure it has a
hemostatic valve attached to its housing, more precisely it is
screwed onto the proximal part of the port. The valve is not
disclosed as removable during use. The valve cannot be removed,
i.e. disassembled, from the port during use as this would cause
undesired blood loss. The port is also not disclosed providing a
dry zone in the patient when permanently implanted (i.e. surgery is
ended, and the patient body is closed again) as it is removed from
the patient.
[0007] In international patent publication WO 2011/017440 A1, organ
ports are disclosed, such as transapical heart ports and methods
and materials for implanting such organ ports. The ports are for
use during medical surgical procedures and can include a hemostatic
valve attached to a housing of such port and located within a
channel for instance to reduce blood loss from a heart through the
channel. However, such ports are not disclosed providing a dry zone
in the patient when permanently implanted (i.e. surgery is ended,
and the patient body is closed again).
[0008] In United States Patent Application Publication US
2016/0081715 A1, a surgical access device is disclosed for
introduction of surgical instrumentation into a patient's body. The
device includes a lateral moving seal cooperating with a bellows.
The bellows is arranged between an inner and an outer seal housing
and establishes a biasing relationship with the seal. The device is
not suited for permanent implantation, e.g. for use with a cardiac
assist device. It is also not suited as a cardiac transapical heart
port.
[0009] A similar seal assembly with a bellows is disclosed in U.S.
Pat. No. 5,492,304. A bellows allows reduction of the overall axial
dimension of the seal assembly. However, the device is not suited
for permanent implantation, e.g. for use with a cardiac assist
device. It is also not suited as a cardiac transapical heart
port.
[0010] For instance, it would be desired to provide a permanent
separation of a wet zone from a heart chamber and a dry zone with a
gaseous environment outside of said heart chamber inside a closed
patient body at the same time.
[0011] A transapical access device is desired that prevents blood
leakage while working on a beating heart and which allows for
attachment of other units than hemostatic valves, and in
particular, other units that have a larger dimension than an
opening of a through channel in a hemostatic valve.
[0012] It is also desired to be able to transfer a movement
longitudinally across the apex without bleeding and easy
installation of a sealing unit at the apex.
[0013] Another desired property is that access to a heart chamber
at a later point is facilitated, e.g. for repair or replacement of
components installed inside the heart.
SUMMARY OF THE INVENTION
[0014] 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 devices, systems and
methods according to the appended patent claims.
[0015] The present invention is defined by the appended claims
only, in particular by the scope of appended independent claim(s).
Reference(s) to "embodiments" throughout the description which are
not under the scope of the appended claims merely represents
possible exemplary executions and are therefore not part of the
present invention.
[0016] According to aspects of the disclosure, access devices for a
heart, removable hemostatic valve units, a system and a method of
creating a transapical passage on a beating heart, and a method of
transapically implanting a cardiac assist system are provided,
medical systems including cardiac assist units to be transapically
implanted, and apical base plates, are provided herein. An apical
base plate is a plate for attachment to an apex region of a
heart.
[0017] As mentioned above, this document relates to medical
devices. For example, this document provides transapical heart
ports and methods for using transapical heart ports. The
transapical heart ports provided herein can be inserted and secured
to the apex of a beating heart to provide secure access to the
inside or interior of the heart. The devices provided herein
provide access to the inside of the heart via the apex without
blood loss around instruments being introduced into the heart. The
transapical heart ports provided herein can be used during
surgeries where the patient's heart remains beating. The
transapical heart ports provided herein can be used for inserting
instruments of various types into the heart. For example,
annuloplasty rings, artificial valves, valve clips, cardiac assist
components, can be inserted into the heart, such as by using an
exemplary delivery system 7 shown in FIGS. 20A and 20B.
[0018] In examples, the access device includes an apical base plate
and a sealing unit 3 configured to provide a separation of a wet
zone 30 from a heart chamber 20 and a dry zone 32 with a "gaseous
environment" such as outside of said heart chamber inside a patient
body at the same time, as defined below.
[0019] The sealing unit 3 is not included in a hemostatic valve, or
part of a hemostatic valve but rather a separate entity, as
elucidated herein.
[0020] In some cases, a transapical heart port provided herein can
be inserted at the apex of the heart, for example, using an open
surgical incision or percutaneously. In some cases, a transapical
heart port itself can provide secure access such that instruments
can be exchanged during the intracavitary surgery without concern
that one would lose control of the apex of the heart (e.g., to
prevent bleeding through or around the transapical heart port and
to maintain blood pressure in the patient).
[0021] The transapical heart port provided herein is intended to
remain permanently implanted in place after completion of the
operation being performed on the heart. A sealed access to the
interior of the heart is provided in some configurations.
[0022] The access device 1 has for instance in examples a first,
open patient (body) configuration. An open patient configuration
means that the patient body is opened for a surgical procedure,
often by a section through the patient skin, and during the
surgical procedure--in contrast to a closed patient (body)
configuration. In the example of the open patient body
configuration, a removable hemostatic valve unit 2 is removably
attached to a proximal side of said apical base plate 100. In the
first configuration, examples include that only the hemostatic
valve unit 2 is mated with the apical base 100.
[0023] The access device 1 has for instance in examples a second,
closed patient (body) configuration, A closed patient (body)
configuration means that the patient body is closed after
conclusion of the surgical procedure. In the closed patient
configuration, the sealing unit 3, that optionally includes a
feed-through port 320, is preferably distally attached to said base
plate 100 for providing the separation of wet and dry zones. In the
first configuration, examples include that the sealing unit 3 is
mated with the apical base 100.
[0024] In a third configuration of the access device 1, both the
hemostatic valve unit 2 and the sealing unit 3 are mated to the
apical base 100. This third configuration is also an open patient
(body) configuration. A transition configuration from the first to
the second configuration may include the sealing unit 3 inserted
into the hemostatic valve unit 2 for delivery to the apical base
plate 100.
[0025] The access device, including the apical base plate (100)
includes preferably a tubular through port 120 adapted to be
arranged across cardiac tissue.
[0026] According to one aspect of the disclosure, access devices
for a heart are provided. The devices include an apical base plate
that has a tubular through port to be arranged across cardiac
tissue. "Across" means in the present context through cardiac
tissue and between an inside and an outside of the heart. The
cardiac tissue at the apex is thus provided with a tubular port
extending from the outside of the heart tissue to the inside of a
heart chamber at the apex region of the heart. This port can be
to/from the left or the right chamber.
[0027] The access device has a first configuration wherein a
removable hemostatic valve unit is attached to the base plate. The
port is thus open for fluid communication and is closable to
prevent bleeding, controllable by the valve.
[0028] Advantages of a removable hemostatic valve include for
instance one or more of the following technical effects. It
prevents blood leakage while working on a beating heart. Being
removable, it allows for attachment of other units than hemostatic
valves--instead of the valve but also in addition to the valve
before removal of the valve. Other units can have a larger
dimension than an opening to a through channel in the hemostatic
valve, in particular if the valve housing is provided as splittable
for providing a peel off valve. It may be a re-usable valve. It may
be re-attached if needed. In particular if the re-attached valve
housing is provided as splittable for providing a peel on valve. It
provides for attachment of a driving unit in a transition
configuration of a drive unit, valve, base plate, sealing unit. It
provides for temporary sealing of a cardiac access channel, e.g.
for installing examples of a permanent sealing unit 3 that is
adapted to remain implanted. It provides for creation of a wet dry
zone separation. A re-attachable hemostatic valve, e.g. in the form
of a peel on valve, provides the possibility to exchange, replace,
reposition, repair, and/or improve single and/or multiple
components or entire modules such as a bellows 310 or products such
as a drive unit of a cardiac support system. An example of a
removable and re-attachable hemostatic valve is seen in FIGS. 25A
to 25E. In FIG. 25A or 25D examples is a hemostatic valve are
illustrated in assembled state and FIGS. 25B, 25C and 25E show
examples of a hemostatic valve illustrated in dissembled state,
respectively. Parts 202, 204 illustrate some of the splittable
parts of the hemostatic valve.
[0029] A "wet dry zone" as used in this disclosure includes a
separation of a wet zone, i.e. containing blood, in a heart
chamber, from a dry zone, i.e. a gaseous or in particular air
containing environment, such as outside of the heart chamber, but
in any case inside an intact human body, at the same time.
[0030] The gaseous environment may for instance be provided outside
of the heart chamber, see an example illustrated in FIG. 23 with a
gaseous environment inside the drive unit 6.
[0031] Additionally, or alternatively, the gaseous environment may
be provided inside the heart chamber, sealed from the wet zone, see
e.g. FIG. 11C or FIG. 23, where the sealing unit 3 has a gaseous
environment in its interior securely sealed from the blood in the
chamber, i.e. away from the wet zone.
[0032] Additionally, or alternatively, the gaseous environment may
be provided inside the transapical hole, see e.g. FIG. 11C or FIG.
23, where the sealing unit 3 provides for a gaseous environment
inside the transapical hole.
[0033] Alternatively, or in addition, the gaseous environment may
at least partly contain a liquid to provide a "gaseous" environment
containing a medium different than blood, such as a biocompatible
lubricant medium e.g. for mechanical parts to enhance operational
life, and/or a protective gas, or a mixture thereof, such as
aerosol particles in gas. As long as the "gaseous" environment of
the dry zone is securely sealed inside the patient body from the
wet zone containing blood, it is a "gaseous" environment as used in
this disclosure.
[0034] The wet dry zone is thus providable during permanent
implantation of a medical device, such as an apical base plate, in
a closed patient's body.
[0035] The access device has a second configuration wherein a
sealing unit with a feed-through port 320 is attached to the base
plate. The feed through port is provided with separation of the wet
zone and dry zone. A membrane, like including a silicone (or other
synthetic material like PVC, Polyurethane, etc.) bellow is provided
for separating the wet zone from the dry zone. The membrane may
consist of more than one membrane or bellow in order to create a
membrane in membrane solution or bellow in bellow solution. The
different bellows, in a bellow in bellow solution, may consist of
different materials. The different materials may have different
properties, like different permeability of particles. In this way,
a more efficient "total" membrane may be costumed and/or created.
The different bellows may also consist of the same material, e.g.
in order to create an extra safety if one bellow may break and/or
leak. This may prevent gas leakage from dry zone into blood stream.
The feed-through port means that devices may cross the dry zone
to/from the wet zone. The feed through port 320 is for instance
provided at the distal end portion of the sealing unit 3. A sealing
member, like an O-ring, 326 may be provided to provide sealing at
the feed through port. Alternatively, the feed through port may be
without a sealing member but a closed membrane, e.g. for magnetic
couplings as shown in FIGS. 24A, 24B and 24C. In this second
configuration, the port is closed for fluid communication by means
of the sealing unit. A feed-through port, e.g. for medical devices
is however provided in this configuration. The sealing unit
provides for the wet/dry zone separation.
[0036] Some examples of the sealing unit 3 provide for a possible
movement of mechanical parts via/across the apex and a separation
of a wet zone, e.g. blood in heart chamber, and a dry zone, i.e.
gaseous/air environment outside of heart chamber, at the same time
without leakage of blood or gas over the separation by e.g. a
membrane for instance including a bellows 310. Such a sealing unit
3 may include a detaining unit 330 to provide a detainment of blood
and/or gas in order to delay and/or prevent an exchange of blood or
gas over the separation e.g. in case of a membrane malfunction. In
examples, the detaining unit may delay and/or prevent a leakage of
blood or gas over a membrane if for instance a bellows 310 would
break or malfunction. In examples, the detaining unit is a sponge,
or consists of sponge-like material, which allows for slow or
inhibited leakage of gas into blood, or vice versa. In other
examples, the detaining unit may include a three-dimensional maze
that allows for gas to freely pass through but can provide a delay
and/or entirely prevent blood from passing through the maze. The
detaining unit may be positioned inside the sealing unit 3. For
instance, the interior channel of the bellows 310 may be provided
with the detaining unit. Alternatively, or in addition, the
detaining unit may be provided in the top of the sealing unit 3
(when assembled positioned in tubular through port 120), see e.g.
in the interior space of the tubular through port 120 inside
sealing unit 3 such as illustrated in FIG. 22B. A detaining unit
consisting of a maze would provide a detainment of blood causing a
detainment of gas and thus would delay and/or prevent an exchange
of blood or gas over the separation. In other examples, the
detaining unit may provide a controlled leakage and/or dissolvement
of gas in blood, or vice versa, due to the costumed design of the
detaining unit. The detaining unit may be constructed as a diffusor
for spreading gas into liquid in a controlled way, e.g. in order to
dissolve in blood. The detainment unit improves patient safety as
it avoids or slows down potential gas leakage into the blood stream
of the patient, or as it avoids, or slows down potential blood
leakage into the device. In this context it should be noted that
small amounts of gas released over time are either not harmful or
can be dissolved in the blood, which is not critical for the
patient. On the other hand, the same amount of gas released
instantaneously could be life threatening, but this is avoided by
the detaining unit.
[0037] A sealing unit with bellows allows for a, e.g. longitudinal
and/or axial, movement of medical device parts relative each other,
e.g. for piston or rods' movements. A sealing unit with bellows
allows in addition or alternatively for radial movement of device
parts relative each other, in particular from outside the heart to
the inside of the heart, while the wet/dry separation is
maintained.
[0038] The sealing unit provides in an advantageous manner a
separation of a wet zone from a dry zone.
[0039] The sealing unit may be provided with a magnetic coupling,
as shown in an example in FIGS. 24A, 24B and 24C. A magnetic
coupling provides for easy assembly of components of a system to be
implanted, and/or easy detachment of components such as for
replacement, addition, removal or repair of such components. It
provides for a total sealing of the feed through port without a
through channel.
[0040] According to another aspect of the disclosure, a hemostatic
valve unit is provided. The valve unit has a housing with a distal
end and a proximal end. It is removably connectable at the distal
end to an apical base plate of an access device for a heart. The
valve unit includes a pneumatic valve in a through channel of the
valve unit between the distal end and the proximal end. The valve
is re-attachable if needed, e.g. for later access such as for
replacing/repairing components of a cardiac assist system.
Advantages of a removable valve are already described above and
also apply for this aspect.
[0041] According to yet another aspect of the disclosure,
applicator tools are provided for creating a transapical passage on
a beating heart. The applicator tool (in short herein referred to
as the "tool") includes in examples a harpoon insertable through a
tube of the applicator tool. The harpoon has a distal tip for
penetrating cardiac tissue at an apex of a heart. The tube has a
sharpened edge at a distal end for cutting the cardiac tissue at
the apex. The harpoon has an expandable flange for preventing
withdrawal of the harpoon through the cardiac tissue, in particular
while cutting with the tube and providing a clean cut because it
provides in use a counterforce against the tube's cutting edge,
wherein the flange is configured to keep the cut cardiac tissue
within the tube.
[0042] Some examples of the disclosure provide for applicator tools
with improved patient safety as embolization of cut cardiac tissue
is prevented. The tissue that is cut is safely kept in the tube
with the harpoon flanges or wire mesh holding back the tissue in
the tube. Complications like stroke are minimized or avoided by
such examples of applicator tools for creating a transapical
passage on a beating heart, which is a particular challenge because
of the heart movements and related difficulties to contain cut
tissue and prevent it from being entrained with the blood flow of
the beating heart for instance. The tool is advantageous as it
provides that leakage of blood from the chamber is prevented when
creating a transapical passage. The penetration through the cardiac
tissue to the chamber, e.g. at the apex, is recognized by the
operator as complete, e.g. by an integrated blood indicator 490.
Also, an access device is deliverable over the same tool preparing
the puncture, thus a shortened and more safe medical procedure is
provided. The tool provides a reproducible desired hole size. The
applicator tool avoids undesired, e.g. too large or small cutting
of transapical holes. The applicator tool provides for a
reproducible medical procedure, in a pre-configured sequence
assisting medical personal during implantation. The tool provides
for a safe medical procedure with reduced overall patient risk
compared to manual cutting of a hole in cardiac muscle tissue with
a scalpel.
[0043] According to yet another aspect of the disclosure,
applicator tools for creating a transapical passage include a
harpoon insertable through a co-axial dilator of the tool. The
harpoon has a distal tip for penetrating cardiac tissue at an apex
of a heart. The dilator provides dilating of the cardiac tissue.
The applicator tool furthermore includes an access device for a
heart that has a tubular through port to be arranged across the
cardiac tissue when advanced over the dilator.
[0044] The applicator tool has the same advantages as mentioned
above for the previous tool, except tissue that is cut is not kept
in the tube with the harpoon flanges or wire mesh holding back the
tissue in the tube.
[0045] According to yet another aspect of the disclosure, a
transapical access system for creating a transapical passage on a
beating heart is provided. The system includes an access device for
a heart according to the afore described aspect of the disclosure.
In addition, the system includes an applicator tool for creating a
transapical passage and delivering the access device to an apex of
the heart, as described above according to the afore described
aspects of the disclosure. The system may provide all or some of
the advantages and technical effects of its components described
herein.
[0046] According to yet another aspect of the disclosure a medical
system includes a cardiac assist unit to be transapically
implanted. The cardiac assist unit is attachable to a sealed access
device. The access device provides for the wet/dry zone separation
inside the body. The assist unit is arranged on the dry side.
Assembly of the system and implantation is advantageously easy as
bleeding is avoided upon and after implantation. As blood cannot
enter the assist device, it can be implanted inside the body.
Mechanical parts of the assist device arranged in the dry zone are
protected from blood, leading to increased time of life, reduced
risk for complications, like blood clotting, infections etc.
Electronics inside the assist device is protected from short
circuits when arranged in the dry zone.
[0047] According to yet another aspect of the disclosure, a sealed
apical base plate is provided, which includes a connection
interface for matingly engagement of multiple medical devices that
in turn have mating connection interfaces for connection to the
apical base plate, respectively.
[0048] The connection interface may include a freely rotatable
connection of a system including a medical device relative the
apical base plate. Freely rotatable may include three-dimensional
movement around a pivot point. Free rotation provides for
flexibility for instance when positioning a medical (assist) device
during implantation. The free rotation allows for movement of parts
relative each other when implanted after ingrowth. This avoids
injuries like necrosis e.g. in connecting tissue at the
implantation site. Mounting spikes of the base plate are optional
and omitted for instance in a free rotation design as these
mounting spikes could otherwise prevent the free rotation. The free
rotation avoids tension in the implanted system since the devices
of the system connected at the connection interface will
continuously strive towards a stress-free position. The system has
thus a long lifetime and is highly biologically compatible.
[0049] According to yet another aspect of the disclosure, a method
of creating a transapical passage on a beating heart is provided.
The method or medical procedure include determining a position on
an apex region for creating a transapical passage. This may for
instance be done imaging modality providing suitable image data for
processing and analysis, e.g. CT based, MR based, Ultrasonic based.
Alternatively, or in addition, the position may be determined by
tactile sensing and/or visual inspection of the heart, e.g. during
surgery. The method further includes creating a transapical hole at
the determined apex region through cardiac tissue, such as by
punching and/or cutting through the tissue. The method further
includes delivering an access device, such as an apical base plate,
which has a tubular through port to the transapical hole. The
method further includes attaching a flange unit of the access
device to an outside of the heart, and removably connecting a
hemostatic valve unit to the access device. The method provides for
an advantageous creation of a wet zone/dry zone separation inside a
body. The method provides for ease of access to a heart chamber for
various procedures and/or medical devices. The method and related
devices provide for safe creation of a passage through cardiac
tissue, e.g. a transapical passage, while preventing embolies of
tissue removed for the passage, e.g. of a punched hole through
cardiac tissue. The method and used devices effectively prevent
bleeding. The method and used devices provide for reproducible hole
sizes. The method and used devices avoid too large cutting of
transapical holes, which is an issue difficult to remedy. A
reproducible medical procedure is provided as the method needs to
be done in a pre-configured sequence, as given by the devices used,
assisting medical personal during implantation. Overall, the method
provides for a safe medical procedure with reduced risk for
patients.
[0050] According to yet another aspect of the disclosure, a method
of transapically implanting a medical device like a cardiac assist
system on a beating heart is provided. The method or medical
procedure includes attaching the medical device like a cardiac
assist unit to a sealed access device. The medical device like an
assist unit is removably attached to the sealed access device,
which has a number of advantages. For instance, removable devices
provide for extended life of the entire implanted system with
replaceable and/or repairable units. The implanted system may
easily be updated with improved or enhanced future devices.
Repeated access to heart chambers is provided through a permanently
implanted access device. Also, the removable medical device can be
removed when no longer required (patient treatment successful)
[0051] Further embodiments are defined in the dependent claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0052] FIGS. 1A-B illustrate an example of access devices for a
heart;
[0053] FIG. 2 is a top view of a template 190 for positioning an
access device 1;
[0054] FIGS. 3A-B illustrate a hemostatic valve unit 2;
[0055] FIGS. 4A-B illustrate inflatable balloon configurations of
hemostatic valve units;
[0056] FIGS. 5A-C illustrate a first configuration of the access
device 1;
[0057] FIG. 6 illustrates an implanted access device 1 in a first
configuration;
[0058] FIGS. 7A-B illustrate a sealing unit for mounting in an
access device 1 for providing a second configuration;
[0059] FIGS. 8A-B and 9A-B illustrate a transition from a first
configuration to a second configuration of an access device 1;
[0060] FIGS. 10A-B and 11A-B illustrate a second configuration of
the access device 1, in particular an example of a sealed access
device 1, which includes a connection interface 110 for matingly
engagement of multiple medical devices;
[0061] FIG. 11C illustrates an implanted access device in a second
configuration;
[0062] FIGS. 12A-B illustrate an example of an applicator tool for
creating a transapical passage on a beating heart with a tube that
for instance has a sharpened edge at an end thereof, while a grip
with open lock is shown;
[0063] FIGS. 13A-D illustrate a harpoon needle, rod with a
retaining unit in form of expandable barbs and a punch tube with
sharp end edge assembly in different configurations;
[0064] FIGS. 14A-C illustrate creation of a transapical puncture in
a heart with an applicator tool shown in FIGS. 12 and 13;
[0065] FIGS. 15 and 16 illustrate a detail of the applicator
tool;
[0066] FIG. 17 illustrates the applicator tool in a configuration
where the transapical puncture is made and a tissue plug is safely
contained in the tube of the tool;
[0067] FIG. 18 illustrates an applicator tool with a dilator;
[0068] FIGS. 19A-B illustrate an example of a transapical access
system 5 assembled and ready for use including an applicator tool,
an access device for a heart and a hemostatic valve;
[0069] FIGS. 20A-B illustrate a delivery device for a medical
device to the interior of the heart, insertable through a
hemostatic valve and an access device in a first configuration;
[0070] FIG. 21 illustrates the delivery device of FIGS. 20A-B
transapically inserted into a heart through a hemostatic valve and
an apical access device in a first configuration as described
herein;
[0071] FIGS. 22A-B illustrate an example of a medical system
including a cardiac assist unit to be transapically implanted
attachable to a sealed apical base plate;
[0072] FIG. 23 illustrates an implanted access device with sealed
apical base plate and attached cardiac assist unit;
[0073] FIGS. 24A-C illustrate an alternative sealing unit with a
magnetic coupling;
[0074] FIGS. 25A-E illustrate a splittable hemostatic valve
unit;
[0075] FIG. 26 illustrate steps of an example of a method of
creating a transapical passage on a beating heart;
[0076] FIG. 27 illustrate steps of an example of a method of
transapically implanting a cardiac assist system;
[0077] FIG. 28A-F illustrate examples of an apical base plate.
DETAILED DESCRIPTION
[0078] Specific examples of the disclosure will now be described
with reference to the accompanying drawings. Inventions comprised
herein may, however, be embodied in many different forms and should
not be construed as limited to the examples set forth herein;
rather, these examples are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of an
invention to those skilled in the art. The terminology used in the
detailed description of the examples illustrated in the
accompanying drawings is not intended to be limiting of an
invention. In the drawings, like numbers refer to like
elements.
[0079] Now turning to the figures, FIGS. 1A and 1B illustrate an
example of an access device 1 for a heart, wherein FIGS. 5 and 6
illustrate a first configuration of the access device; and FIGS. 10
and 11 illustrate a second configuration of the access device
1.
[0080] The access device 1 include an apical base plate 100 that
has a tubular through port 120 to be arranged across cardiac tissue
at an apex 12 of a heart 10. The cardiac tissue at the apex 12 is
thus provided with a tubular through port 120 extending from the
outside 14 of the heart tissue to the inside 15 of a heart chamber
at the apex region of the heart 10. This port can be to/from the
left or the right chamber of the heart 10, depending on the
position at the apex region.
[0081] Mounting spikes 150, 151 are provided on the access device
for receiving mating apertures or recesses 250, 251 of e.g. a valve
unit 2 or a cardiac assist drive unit 6. If having different shape
of mating pairs of spikes and apertures, this provides for a
rotational correct mounting of units to the access device.
[0082] Alternatively, or additionally, locking members may be
provided such as bayonet joints 155 to lock units to the access
device 1, once mounted thereto or in combination with mounting
thereto.
[0083] The apical base plate is preferably made of a rigid,
preferably biocompatible, material. A flexible flange 160 of the
access device 1 allows for attachment to the cardiac tissue at the
outside of the heart 10. The flange 160 is for instance made of a
biocompatible fabric material, like a woven or nonwoven material. A
suitable biocompatible material is for instance Dacron or PTFE. The
flange unit 160 is attachable to an outside of the cardiac tissue
by suitable attachment elements. The attachment elements are
preferably sutures, hooks, clips, staples, and/or screws, etc. The
flange includes for example eyelets for receiving sutures for
stitching attachment of the access device 1 to the heart. Stitches
165 are schematically illustrated in FIG. 11C. The access device 1
is thus reliable attached to the heart while bleeding from the
heart chamber between heart tissue and the tubular through port
120, outside the tube, is prevented by the sealed flange. Bleeding
through the tubular through port 120 is prevented initially by the
tube 410 while suturing or by the hemostatic valve, when the
transapical access system is retracted from the hemostatic
valve.
[0084] Alternatively, or in addition to using the tool 4 for
creating a transapical hole, the hole may be prepared in a
conventional surgical procedure using a scalpel. However, this will
cause more bleeding than using the tool 4.
[0085] The tubular through port 120 is protruding from the apical
base plate 100 and plugged into the transapical hole created in a
suitable manner. Preferably the tube of the tubular through port
120 has an outer diameter slightly larger than the transapical
hole, for improved sealing when in place.
[0086] The flange 160 is for instance attached to the apical base
plate 100. The base plate may be made of two plates between which
the flange can be clamped upon mounting of the plates together (see
also FIG. 11B), such as indicated by the screws in the base plate
100 in the illustrating Figures.
[0087] An example of an apical base plate is illustrated in FIGS.
28A, 28B, 28, C, 28D, 28E, and 28F. FIGS. 28A and-28B illustrate
the apical base plate. FIG. 28C illustrates a top view of an apical
base plate. FIG. 28D illustrated a close-up view of an apical base
plate. FIG. 28E illustrates a cross section of an apical base
plate. FIG. 28F illustrates an apical base plate having two holders
connected thereto.
[0088] In the example, the apical base plate comprises suture holes
170 to facilitate attachment therebetween. The flange 160 may be
attached to the apical base plate by sutures.
[0089] The access device may thus in use be attached to cardiac
tissue while sealing the interior from the exterior of the heart.
The flange 160 may be sewn to the cardiac tissue, e.g. in a
parachute procedure, i.e. the sutures are first fixed to the
tissue, e.g. by means of a template 190 at the desire apex
location. Then the access device's flange is threaded to the
sutures and pushed along the sutures to the cardiac tissue. The
access device is then advanced over the tube 410 which occupies the
hole on the heart wall until the plate and the flange has contact
with the heart surface, and the distal opening of the tube of the
tubular through port 120 is inside the heart chamber. The
hemostatic valve 2 is connected to the apical base plate 100 during
its attachment to the heart. Finally, the sutures are knotted, and
the flange 160 is thus tightened to the tissue, such that blood
inside the heart does not leak past the access device 1, bleeding
through the access device 1 is prohibited by the hemostatic valve.
Alternatively, or in addition, to sutures and/or to the parachute
procedure described, tissue glue, staples, hooks, clips, or other
fixation means may be provided for sealingly affixing the flange
160 to cardiac tissue. The port 120 is the only fluid communication
when access device 1 is correctly attached to the apex.
[0090] The access device 1 may then be left permanently in place,
avoiding the need to close the transapical hole after a surgical
procedure. The access device allows for advantageous access to the
heart chamber as described herein.
[0091] The template 190 shown in FIG. 2 has an exterior perimeter
corresponding to the perimeter of the flange unit 160. In this
manner, a suitable cardiac surface at the apex can be determined by
applying the template 190 to the apex region. The template 190 has
markings, e.g. in the form of cut-outs 191, corresponding to
elements of the access device 1, e.g. a hole corresponding to the
tubular through ports outer diameter. Such cut-outs or similar
markings provide that the access device will be oriented correctly
at the apex when attached thereto, e-g- by sutures stitched to the
cardiac tissue and affixed to the access device 1, e.g. at flange
160. The template 190 preferably includes holes 192 for suture
stitching for reliably attaching the access device 1 to the apex at
the suitable surface for creating the transapical passage through
the cardiac tissue.
[0092] Alternatively, or in addition to a template 190, the correct
position for implanting the access device 1 may be found manually
by tactile sensing of a surgeon and/or imaging, e.g. ultrasonic,
based guidance.
[0093] The access device 1 has a first configuration wherein a
removable hemostatic valve unit 2 is attached to the base plate.
The first configuration is illustrated for instance in FIGS. 5A, 5b
and 5C and FIG. 6. The port 120 is thus open for fluid
communication, controllable by the valve 2 when attached thereto.
The valve 2 is (re-)attachable or mountable to the base plate 100
by suitable attachment means. For instance, the mounting can be
done by threaded attachment (rotation of the devices relative each
other), screws, bayonet locks, or similar. The valve 2 is
re-attachable removable from the base plate, e.g. at an end of a
procedure done through the valve and access device 1, or when the
access device 1 has transited to a second configuration where the
valve is not needed as for instance sealing is provided by other
units such as a sealing unit 3. The removable hemostatic valve 2
has a valve through port with proximal and distal openings
providing a communication channel with controllable orifice size,
e.g. for delivery of various sized medical device, to and from the
interior of the heart (chamber).
[0094] The access device has a second configuration wherein a
sealing unit 3 with a feed-through port 320 is attached to the base
plate 100. The second configuration is illustrated for instance in
FIGS. 10A and 10B and FIGS. 11A, 11B and 11C. In this
configuration, the port 120 is closed for fluid communication by
means of the sealing unit. A feed-through port 320, e.g. for
medical devices is however provided in this second configuration of
the access device 1. The through port has preferably a sealing 326
to prevent blood from leaking out of the heart. A sealing surface
at the tubular through port's inner portion, like at the proximal
end illustrated e.g. in FIGS. 1A and 1B, may provide sealing
against a sealing member 325, such as at the outside of the sealing
unit, e.g. at its proximal end. This prevents blood leakage through
the through port when the sealing unit 3 is inserted and affixed to
the access device 1.
[0095] The second configuration of the access device 1 is provided
as an alternative or in addition to the first configuration
thereof. The second configuration of the access device 1 may be
provided in addition to the first configuration during a transition
from the first configuration to the second configuration only, e.g.
when the sealing unit 3 is delivered to the apical base plate 100
through the hemostatic valve unit attached to the apical base plate
100. This has the advantage of avoiding blood leakage when changing
configuration of the access device 1. A transition from the first
to the second configuration is illustrated for instance in FIGS. 8A
and 8B. A co-existent first and second configuration is illustrated
for instance in FIGS. 9A and 9B.
[0096] As can be seen in FIGS. 8A and 8B and 9A and 9B, the sealing
unit 3 of the access system is in examples configured to be
delivered through the hemostatic valve unit 2 for a transition from
the first configuration to the second configuration. In the second
configuration, the separation is provided between the wet zone and
the dry zone.
[0097] The hemostatic valve unit 2 may include one or more units to
control the opening cross-section or aperture of a port 210 of the
valve. These one or more units to control the aperture may, like
housing 200, be splittable for instance for peel-on and/or peel-off
of the units as described herein. Splittable is preferably provided
by a construction of at least two parts joined together to form one
unit. For instance, mechanical, or magnetic, preferably releasable
joints may be provided for the joints. In particular, as
illustrated in the Figures, the housing parts are preferably
splittable in an axial/longitudinal direction of the valve unit 2.
In this manner, the housing parts are preferably removable radially
outwards, herein called "peel-off" operation. Other unit(s) may
then be providing sealing of the wet dry zone of the apical base
plate, such as the bellows described herein. Re-assembly may be
made in a reverse radially inward assembly of such housing parts of
a valve unit 2, herein also called "peel-on" operation.
[0098] Such unit may move or size suitably for such control.
Examples of units include inflatable balloons, leaflets (moveable
or fixed), and/or flaps (moveable or fixed). The aperture may be
controlled by units similar to camera lens aperture diaphragms or
iris like units. The units may alternatively or additionally
include directional flow control elements, such as valves. The
controlled directional flow may be uni-directional, i.e. in one
direction only, or bi-directional, i.e. in two directions (forward,
backward flow).
[0099] FIGS. 3A and 3B illustrate a hemostatic valve unit 2 while
FIGS. 4A and 4B illustrate example of two different inflatable
balloon configurations of hemostatic valve units 2. The removable
hemostatic valve is connectable to the through port 120, i.e. a
fluid communication channel is provided through the hemostatic
valve to the through channel 120. The hemostatic valve 2 may for
instance include one or more sealing elements (not shown) suitably
arranged against the access device 1. For instance, such sealing
elements may be provided as pressing against the apical base plate
proximal side and/or a proximal end portion of the tubular through
port 120.
[0100] The hemostatic valve unit 2 includes a housing 200 with
approximal end and a distal end. The housing 200 may be splittable
for instance for peel-on and/or peel-off of the hemostatic valve
unit 2 as described herein. The distal end is affixable to the
access device 1. The ends include an opening for access to a
through channel of the valve 2. The though channel includes an
inflatable balloon, via an inflation port 210. The inflation
pressure provides a more or less restricted passage through the
through channel of valve 2, i.e. the orifice of the valve through
port 225 is variable by the inflation pressure (as illustrated by
the double headed arrow in FIG. 4A). Devices inserted through the
through channel may have varying diameter or cross-sectional shape,
wherein the balloon pressure is adapted to this cross section to
provide a reliable sealing. In this manner, the through channel of
valve 2 accommodates a large range of devices diameters and
cross-sectional shapes. As shown in FIG. 4B, the balloon 220 may
have multiple lobes to further improve the adaptability to and
range of different diameters or cross-sectional shapes of devices
accommodatable for passage through the through channel of the valve
2 while safely providing reliable sealing and leakage protection of
blood from the interior of the heart to the outside of the
heart.
[0101] The hemostatic valve unit 2 is illustrated removably affixed
to an access device 1 for instance in FIGS. 5, 6, 8, and 9. A
sealing surface 230 is provided for fluid tight sealing against a
sealing surface 130 of access device 1, such as at the apical base
plate 100. The sealing may include a sealing member, such as an
O-ring for improved sealing.
[0102] The hemostatic valve can for instance be reliably removably
affixed to an access device's 1 via a bayonet joint 155 including
bayonet pins 255.
[0103] As shown in FIGS. 25A, 25B, 25C, 25D, and 25E, the housing
200 of valve 2 is in examples splittable, with 202, 204 splittable
housing parts of the valve 2 as mentioned above. In this manner,
the valve 2 can be disassembled from parts that are positioned in
its through port 225. Blood leakage may effectively be prevented by
other parts, e.g. as shown in FIG. 24A. An access device 1 with
affixed sealing unit 3 provides bleeding prevention as described
above. With a medical device having a larger proximal diameter than
the through port 225, the valve 2 cannot be withdrawn proximally
for removal from the aggregate. There can be mechanical obstacles
preventing that the valve 2 is retracted. For instance, a drive
unit 6 may be affixed proximally to the aggregate of access device
1 and sealing unit 3 as shown in FIG. 24A. The splittable valve 2
may then advantageously removed from the aggregate upon assembly of
the other parts by deflating the balloon 220 and splitting the
valve 2. The valve 2 is arranged to be peeled off. The split parts
of valve 2 can then be removed from the patient as valve 2 is no
longer needed. Alternatively, or in addition, the splittable valve
2 may be opened only while parts still are connected to each other.
For instance, two adjoining parts of a splittable valve with
several parts may be separated from each other for opening the
splittable valve 2, while still having part being adjoined, e.g. by
a hinge, splint, string, or similar joint (like an open ring).
Alternatively, or in addition, the valve 2 can be subsequently
re-assembled and for instance re-attached to an apical base plate
as desired (e.g. peel-on), either during the same procedure or at a
later time after adequate sterilization.
[0104] Examples for peel-on and peel-off of a hemostatic valve 2
may be applied in reverse for each of these operations,
respectively.
[0105] A valve 2 may later be re-attached, for instance to a
configuration as shown in FIG. 24A if sealing is desired again,
e.g. for repair or replacement of components of the aggregate or
other parts of the system. The access device 1 thus provides for a
re-access to the inside of the heart 15 at a later point in
time.
[0106] The access device 1 may comprise a drive unit 6 of a cardiac
assist device connected to the base plate in the second
configuration. A rod 610 (FIG. 11A and FIG. 23) may transfer a
movement generated by the drive unit into the heart chamber for
cardiac assist. The distal end of the rod 610 may be connected to
an anchor at a heart valve region, like anchor unit 650 in the
example of an annuloplasty implant.
[0107] An anchor unit in the form of an annuloplasty implant is
described in unpublished PCT application of the same applicant with
PCT application number PCT/EP2019/068597 filed 10 Jul. 2019, which
is incorporated herein by reference in its entirety for all
purposes, but in particular the description of the chain
annuloplasty ring and delivery system shown in FIGS. 24 to 42 and
the corresponding description.
[0108] Coupling of the rod may be made magnetically, e.g. with a
sealing unit 3 shown in FIGS. 24A, 24B and 24C. A magnetic coupling
340 at the distal end of the sealing unit may provide advantageous
coupling with a firm link at the coupling point that allows for
rotational movement and adaptation of the movement. A hollow in the
magnetic coupling may be provided as a hollow funnel for receiving
a spherical ball coupling to allow for this movement and
geometrical adaptation during assembly and operation of the assist
unit. Such a magnetic clutch coupling provides a number of
advantages, for instance an overload protection. The magnetic
connection can be configured such that it uncouples at pre-defined
threshold forces to avoid tissue damage. The uncoupling possibility
of the magnetic clutch coupling also allows for easy repair of
components of an assist system, e.g. for repair, replacement or
removal thereof.
[0109] Coupling means are described in unpublished PCT application
of the same applicant with PCT application number PCT/EP2019/068595
filed 10 Jul. 2019, which is incorporated herein by reference in
its entirety for all purposes, but in particular the description of
the coupling unit 200 and extension units 400, including magnetic
and linked joint couplings as for instance shown in FIGS. 5 and 6
thereof as well as the corresponding description.
[0110] In FIGS. 7, 8, 9, 10, 11, 22, 23 and 24 examples of sealing
unit 3 are illustrated in various configurations.
[0111] The sealing unit includes in examples a membrane or bellow
310 and a feed through port 320. The feed through port may be
completely sealed with no through going opening, such as for
magnetic couplings. Alternatively, or in addition, a feed through
port may have a distal opening for feeding through an element like
a rod 610. The distal opening is then provided with a sealing
member 326, such as an O-ring, for sealing the feed through port
and providing the separation of the wet zone and the dry zone while
allowing for a movement transferred between the zones. The sealing
unit thus allows for instance reciprocal movement, e.g. in a
cardiac assist/driving unit arrangement for safe reciprocal
movement over millions of repeated cycles without leakage.
[0112] The membrane or bellows is preferably in examples made of an
elastic and/or flexible material, such as silicone or the like.
Bellows may be made of metal material like biocompatible metal
materials such as Titanium or Nitinol. The bellows is movable in a
longitudinal direction, e.g. for reciprocal cyclic movements. It is
also moveable radially allowing for free motion or rotation as
described herein. In examples, the bellows is rotating
simultaneously as the bellows moves in operation in a longitudinal
direction. In this way, there will be a rotation of a bellows upon
forward and backward reciprocal movement, causing the bellows to
have a type of threaded motion or corkscrew like motion. This
combined motion is for instance providable by such elastic and/or
flexible material of the bellows. A bellows which allows for
rotation may have beneficial features since it would mimic the
natural muscle contraction causing a helix heart movement. Such
advantage features may e.g. be lower friction of the bellows. Other
advantage features may e.g. be less stress and tension on the
bellows causing a longer lifetime of the bellows.
[0113] In case the through channel is desired to be closed, this
may be done by means of a plug (not shown) insertable into the
through port 120.
[0114] FIGS. 3, 4, 5, 6, 8, 9, 19, 20, 21, 24 and 25 illustrate
example of a hemostatic valve unit 2 in various configurations.
[0115] A hemostatic valve unit 2 has a housing 200 with a distal
end and a proximal end. It is removably connectable at the distal
end thereof to an apical base plate 100 of an access device 1 for a
heart 10. The valve unit 2 includes a pneumatic valve in a through
channel 225 of the valve unit 2 between the distal end and the
proximal end thereof.
[0116] The pneumatic valve is for instance a balloon valve or a
tube coil for controlling an inner passage in a through channel of
the valve. A balloon valve has generally a larger range than a tube
coil, which in turn can be provided with reduced height of the
valve. A balloon valve is schematically shown in FIG. 4, while the
valve shown in FIG. 25 may have a tube coil, for controlling the
passage in the through channel.
[0117] The housing 200 has a proximal end with an opening to the
through port 225 of the valve unit 2, such as for receiving a
medical device to be passed through the inner passage of the valve
unit 2.
[0118] The hemostatic valve unit 2 can in examples include a
pneumatic reservoir unit (not shown) for maintaining a
substantially constant pressure on the pneumatic valve.
[0119] In some examples the housing 200 is splittable. It has for
instance multiple splittable housing parts 202, 204. As shown in
FIG. 25. This allows for the herein described advantageous peel off
when the valve is split.
[0120] The valve unit 2 may be re-usable.
[0121] In FIG. 4A a single lobe "donut" balloon is illustrated.
[0122] In FIG. 4B a balloon with multiple lobes 222 is
illustrated.
[0123] An inflation port 210 is connectable to a pressure
regulation source for controlling the pressure in the balloon.
Various pressures provide for various expansions of the balloon,
and also for varied pressure on devices introduced into the through
port 225 and in apposition to the balloon's exterior wall. Sealing
is thus secured over a wide range of cross sections of devices to
be entered through the port 225. For instance, a small needle or
comparatively large tube can be entered through the valve without
bleeding.
[0124] In FIG. 5, the valve 2 is illustrated attached to an access
device 1. This assembly is illustrated in FIG. 6 being attached to
the heart 10 creating a transapical access to a heart chamber.
[0125] In FIGS. 19A and B, the hemostatic valve 2 is illustrated
attached to the applicator tool 4 over the tube 410, and in FIGS.
20A and B attached to a delivery system 7 for delivering medical
devices into the heart, as illustrated in FIG. 21. A delivery tube
70 of the delivery system is configured to be inserted into the
heart chamber 20. The delivery tube 70 is in the example shown
inserted through the access device 1 with attached valve 2 (see
FIG. 6). The distal end of the delivery tube 70 is in the example
advanced through the left ventricular chamber towards the left
atrial chamber. A pusher 74 may be used to advance medical devices
or other medical system assembly components through the delivery
tube 70 to the inner of the heart. The delivery system may include
a funnel shaped inserter unit 72 for facilitating insertion of such
devices and components into the proximal end of the delivery tube
70. For instance, an anchor unit 650 may be delivered through the
delivery tube 70 to the cardiac valve area as illustrated in FIG.
21 (at distal end of delivery tube 70) and in FIG. 23 (delivered
and attached to valve area and also a rod 610). The anchor unit is
for instance the annuloplasty chain implant mentioned above and
described in PCT application number PCT/EP2019/068597, and in
particular the chain annuloplasty ring and its delivery system
shown in FIGS. 24 to 42 and the corresponding description therein.
A chain annuloplasty ring may be affixed to a cardiac annulus, like
the mitral valve annulus as illustrated, by means of multiple
anchor screws (not shown). These screws may be rotated into the
annulus tissue by suitably attached screwdrivers (not shown) having
proximal ends accessible for rotation passed through a lock of the
inserter unit 72.
[0126] Once, the anchor unit 650 is installed, a driving rod 610
can be attached to the anchor unit 650 via the access device 1. The
rod 610 may for instance be pre-installed through a sealing units'
3 feed-through port 320 and installed together into the access
device 1 through a hemostatic valve 2 as described herein. The rod
610 may also be installed first and then the sealing unit 3 is then
installed with its bellows over the rod 610 through the valve 2.
The valve 2 can then be removed while drive unit 6 becomes
connected to the driving rod 610 and access device 1, leaving a wet
dry zone separation implanted in the patient with the cardiac
assist system installed.
[0127] In FIGS. 12-19 examples of applicator tools 4 for
advantageously creating a transapical passage on a beating heart
are illustrated, for instance with a tube 410 that has a sharpened
edge at a distal end thereof.
[0128] The applicator tool includes in examples a harpoon 450
insertable through a tube of the applicator tool. The harpoon 450
includes a rod member 470 that is housed inside a hollow
penetration needle 460 that has a distal tip for penetrating
cardiac tissue at an apex of a heart. The rod 470 member is
preferably a solid rod with an expandable retention member 473 at
the distal end 472 of the rod. The rod 470 is arranged
longitudinally movable in the penetration needle. The penetration
needle is inserted into the tube 410 and arranged longitudinally
movable in the tube 410. The rod is preferably kept longitudinally
stationary with the penetration needle 460 when it is
longitudinally moved. The tube 410 has preferably a sharpened edge
at a distal end for cutting the cardiac tissue at the apex.
[0129] In a first step, tube 410 is brought with its distal end
into apposition at the desired location of the apex. The
penetration needle 460 may be pushed at that location, such as
determined with template 190, out of the tube 410 through the
cardiac tissue to the chamber. The needle has a small enough
diameter that substantially no bleeding occurs across the cardiac
tissue at the puncture site. The harpoon 450 is stored in the
penetration needle with expandable flanges in a collapsed
configuration within the needle lumen and proximal to the sharp tip
thereof, see FIG. 13A
[0130] The distal end of the tube 410 may be brought into
apposition at the desired apex region and then the penetration
needle may be pushed through the apex. For instance, the
penetration needle may be releasably activated by a trigger 465.
The trigger releases the needle and it is pushed forward by a
spring 466 released by the trigger 465. The needle is "shot"
through the cardiac tissue in a quick and reliable manner.
[0131] FIGS. 15 and 16 illustrate a detail of the applicator tool
4. More precisely, the proximal end portion of the penetration
needle 460 housing the proximal portion of the rod 470 are shown.
The rod 470 has a shoulder 471 such that the rod can be
longitudinally moved relative the penetration needle 460. The
shoulder provides a stop in the proximal direction, such that the
relative position of the rod 470 to the penetration needle 460 in
its retracted position is provided, see e.g. FIG. 13A for the
distal end of the rod 470 retracted into the distal tip of the
penetration needle 460. The seat 461 of the needle provides that
upon triggering a forward push of the needle 460 and rod 470
aggregate can be shot together forward, e.g. by releasing the
needle spring 466 in tension by activating the needle trigger 465,
see e.g. FIG. 15, 17 or 19A and 19B. A safety pin 467 may be
provided preventing unintended activation of the trigger 465. The
rod 470 can then be moved in the distal direction with its distal
end out of the penetration needle's 460 distal end for expanding
the one or more retaining units 473.
[0132] Thus, once the penetration needle is positioned through the
cardiac tissue, the harpoon 450 may be pushed forward out of the
penetration needle distal end. This may be done by pushing the
proximal end 455 of the harpoon 450 in the distal direction while
the penetration needle 460 is kept in position, for instance as
described in the previous paragraph. The expandable flange is then
expanded, e.g. by an elastic force thereof. The flange provides
thus a retainer element for preventing withdrawal of the harpoon
through the cardiac tissue, as illustrated in FIGS. 13B,C and 14B.
A moveable and lockable stop element 474 may be provided for
keeping the rod locked in position relative the grip 400 and/or
tube 410, as illustrated in FIGS. 18 and 19A.
[0133] The harpoon with expanded retainer unit is then withdrawn
towards the cardiac tissue, i.e. at the inner wall of the heart
chamber. The shoulder 471 at the proximal end portion of rod 470
and expanded retaining unit 473 are abutting against the
penetration needle. In this manner, the aggregate rod 470 and
penetration needle 460 can be withdrawn proximally as a unit, e.g.
by manually drawing the proximal end 455 in the proximal
direction.
[0134] The tube 410 is then pushed forward towards the retainer
unit through the cardiac tissue, wherein the flange is configured
to keep the cut cardiac tissue within the tube 410, as illustrated
in FIGS. 13D and 14C. Tube 410 is arranged longitudinally moveable
and is for instance pushed forward by using the trigger 415 in a
safe and reproducible manner. The trigger 415 may be arranged to
articulate a claw 417 that pushes the tube 410 when the trigger is
activated accordingly. When pushing the trigger, the claw tilt
slightly against the outside of the tube 410 and locks in place for
the pushing action. Releasing the trigger 415 removes the tilting
of the claw 417 which then can slide back over the tube 410 for the
next forward trigger movement. This provides for precise activation
of the movement with a compact mechanism. The cut cardiac tissue
from the transapical hole thus created is safely kept inside the
tube 410, as schematically illustrated in FIG. 14C as a tissue plug
475.
[0135] The tube 410 may be pushed forward, e.g. by operation of a
trigger 415 of the grip 400. The tube may be suspended freely
rotatable around its central axis. Cutting may be facilitated by
rotation of the tube when moving through the cardiac tissue.
Rotation of the tube may be provided by a control dial 420. In this
manner, a quick, precise and efficient transapical hole is made.
This is done with improved patient safety as embolization of cut
cardiac tissue is prevented. The tissue that is cut is safely kept
in the tube 410 with the harpoon flanges holding back the tissue in
the tube, as illustrated in FIG. 13D. Complications like stroke are
minimized or avoided by such examples of applicator tools for
creating a transapical passage on a beating heart, which is a
particular challenge because of the heart movements and related
difficulties to contain cut tissue and prevent it from being
entrained with the blood flow of the beating heart for
instance.
[0136] The tube 410 has an outer diameter thus substantially
corresponding to the diameter of the punched transapical hole in
the cardiac tissue. In case a tubular through port 120 is installed
in the transapical hole via said tube 410, the through port 120
outer diameter is slightly larger than the diameter of the
transapical hole. Tissue around the transapical hole may thus
elastically flex towards the outside of the through port's 120 tube
and thus improve both ingrowth and sealing of the access device
1.
[0137] The distal end of the tube 410 is in examples in fluid
communication with a proximal seal including a blood indicator 490.
Blood entering the blood indicator via the tube 410 indicates
penetration of the cardiac tissue into an interior/chamber 20 of
the heart 10. As illustrated in FIGS. 19A and 19B, the applicator
tool 4 can in examples also deliver a medical device. For instance,
the device is arranged over the tube's 410 outside and can slide
over the tube 410.
[0138] The medical device is arranged to be matingly received with
an inner channel of the device slidable over the tube's 410
outside. It can for instance be slid onto the tube from the distal
end thereof for assembly as shown in FIG. 19A. A conical protection
unit may temporarily be put on the distal end orifice of the tube
410 for sliding the medical device onto the tube, for instance to
cover a sharp edge 412 of the distal end of the tube 410.
[0139] In FIG. 19B the device is illustrated being slid
forward.
[0140] In an example, the device incudes an apical access device 1.
The device may include a hemostatic valve unit 2 removably
pre-attached thereto.
[0141] The apical base plate can be slid forward over tube 410 and
with its tubular through port 120 into the through hole, still with
the distal end of tube inserted through the cardiac tissue. When
the flange unit 160 is sealingly attached to the apex, the
applicator tool can be withdrawn out of the port 120 and the valve
unit 2. This leaves the aggregate of an access device with attached
valve unit 2 in position as shown in FIG. 6.
[0142] The transapical port is then usable, e.g. for delivery of
devices to the heart chamber or performing procedures as desired.
Eventually the sealing unit 3 may then be installed for providing
the wet/dry zone separation. A medical device like a driving unit
of a cardiac assist device can be installed at the dry zone of the
access device 1. The valve unit may be removed. The procedure can
then be concluded, leaving a wet/dry zone separated device
implanted in the closed patient body.
[0143] FIG. 18 illustrates an example of an applicator tool for
creating a transapical passage that includes a penetration needle
insertable through a co-axial dilator 480 of the tool. The
penetration needle 460 has a distal tip for penetrating cardiac
tissue at an apex of a heart.
[0144] This example does not include a harpoon. However, a tool 4
as described previously with a harpoon-based tissue retaining
member and cutting tube may provide for preparation of a hole
substantially lesser than a tubular through port 120 (not shown in
the Figures). The diameter of the hole may then be widened by a
dilator 480. The applicator tool 4 may furthermore include an
access device for a heart that has a tubular through port to be
arranged across the cardiac tissue when advanced over the dilator.
Also, a removable hemostatic valve unit 2 may be included in
examples of such a tool 4 attachable to the access device 1 and
slidable over the dilator 480.
[0145] Hence, a transapical access system 5 for creating a
transapical passage on a beating heart is provided. The system
includes an access device for a heart according to the afore
described aspect of the disclosure. In addition, the system
includes an applicator tool for creating a transapical passage and
delivering the access device to an apex of the heart, as described
above according to the afore described aspects of the
disclosure.
[0146] The system may include a fixture template 190 for targeted
puncture of the apex. The fixture may be provided in examples with
a patient specific shape for the apex of a particular patient's
heart 10. The specific shape may be selected from multiple
pre-manufactured fixtures of different shapes. The template 190 may
be manufactured with a specific shape based on imaging data of the
apex, for instance CT based imaging data.
[0147] FIG. 23 illustrates an example of a medical system including
a cardiac assist unit transapically implanted. A drive unit 6 of
the cardiac assist unit is illustrated attached to a sealed apical
base plate 1 which is implanted and providing a transapical passage
with a wet/dry zone separation as described above. Hence, the
mechanical and electronic parts in the drive unit are in a dry zone
(inside its housing and inside the sealing unit 3). A driving rod
610 is attached to an anchor unit 650. In FIG. 22A, B and FIG. 23
the electronic parts in the drive unit may have a cable
through-port for electrical connection 630 of a cable to e.g. an
external cell, battery or other power supply. An illustration of
such an electrical connection 630 is seen in FIGS. 22A, B and FIG.
23. Note that the tread shown at electrical connection 630 is
optional or alternative for securely connecting a cable. The cable
through-port typically ends up in an electrical connection for
instance in the form of e.g. a Bal Seal connector like a "Bal
Conn.RTM. Electrical Contact" or a "SYGNUS.RTM. implantable contact
system" or similar connection systems, such as on top of the
housing
[0148] The access device 1 is in examples a cardiac anchor unit as
part of an implantable medical device system. A cardiac anchor unit
and cardiac assist principles are for instance disclosed in WO
2011/119101A1 of the same applicant that the present application,
in particular in FIG. 11c thereof and related description regarding
a left ventricle arrangement for assisting the mitral valve piston
like movement. This document is incorporated herein by reference in
its entirety, and in particular regarding FIG. 11c. The access
device 1 provides a particular advantageous implementation of such
a cardiac assist system. Access device 1 may also be used in
cardiac assist systems involving other configurations than
disclosed in WO 2011/119101A1.
[0149] If further anchor units are present at the heart, like shown
in FIG. 23, a relative movement is providable by the driving unit,
e.g. via the rod 610. The access device 1 when implanted at the
apex may be regarded having a static position, and a second anchor,
like the chain annuloplasty anchor mentioned above, may be moved in
a push/pull movement, e.g. synchronized with the heart's ECG,
intracardiac pressure, cardiac output flow, or the like, for
assisting the heart's pump action and thus treatment of a
patient.
[0150] FIGS. 11A, 11B and 11C illustrate an example of a sealed
apical base plate 1, which includes a connection interface 110 for
matingly engagement of multiple medical devices. An example is the
hemostatic valve 2 and the drive unit 6 that may be attached
alternatively to the same connection interface. The multiple
medical devices have in turn a mating connection interface designs
for connection to the apical base plate, respectively.
[0151] In some examples, the connection interface is positioned on
a proximal side of the apical base plate 1, and the apical base
plate 1 is sealed on a distal side, opposite its proximal side.
[0152] The connection interface 110 may include a locking unit 115
in certain embodiments. The locking unit provides for secure mating
engagement of the apical base plate 1 with such multiple medical
devices when attached to each other. An example of a locking unit
115 is shown in FIG. 3A.
[0153] As is shown in the example of the apical base plate in FIGS.
28A, 28B, 28C, 28D and 28E, the apical base plate may comprise
various connection interfaces 110 for mating with a medical device.
In one example, a connection interface 110 may be an edge for e.g.
matingly engagement with e.g. a locking clip. In another example
the connection interface 110 may be a screwing hole e.g. for
screwing in a screw, for example of M2 size, any suitable size may
be used. In yet another example, the connection interface 110 may
be a connection hole or a connection loop e.g. for matingly
engagement with e.g. a suture, a wire, a thread, a fiber or
similar. By way of example, FIG. 28F illustrates the apical base
plate having two holders connected to one of the illustrated
connection interfaces 110. It is to be noted that the apical base
plate may comprise one or more connection interfaces 110. In some
examples, more than one different connection interfaces 110 may be
applied.
[0154] FIG. 26 illustrates steps of an example of a method 700 of
creating a transapical passage on a beating heart.
[0155] The method or medical procedure includes determining a
position 710 on an apex region for creating a transapical passage.
This may for instance be done using an imaging modality providing
suitable image data for processing and analysis, e.g. CT based, MR
based, Ultrasonic based. Alternatively, or in addition, the
position may be determined by tactile sensing and/or visual
inspection of the heart, e.g. during surgery.
[0156] The method further includes creating a transapical hole 720
at the determined apex region through cardiac tissue, such as by
punching and/or cutting through the tissue.
[0157] Creating the transapical hole may advantageously be
performed using an applicator tool 4 as described above and
illustrated in FIGS. 12 to 19. Creating the transapical hole may
include penetrating cardiac tissue at the apex with a penetration
needle 460 housing a distal tip of a harpoon 450 and through a tube
410. The forward penetration movement of the harpoon member and
penetration needle 460 may be released by a trigger 465 so that
these are "shot" forward as a unit in a one-shot movement, here
through the apex wall. The one-shot movement is quick and reliable
for making the initial puncture of the cardiac tissue.
[0158] When the harpoon is brought through the cardiac tissue, a
rod member may be further advanced out of the penetration needle
and one or more retention members may be expanded radially outwards
from the rod's 470 distal end 472. The retention member is then
withdrawn for apposition against the inner cardiac wall of the
heart chamber at the puncture made by the puncture needle 460
(which is also suitably withdrawn into the puncture).
[0159] The sharpened edge 412 of the tube 410 is then pushed
through the cardiac tissue towards the retention member. Pushing of
the tube relative the rod member distal end 472 may be done by
operating the trigger 415 of the pistol grip 400 in a safe and
repeatedly standardized manner. In addition, a control dial 420 may
be used by an operator for rotating the tube when cutting for
improved cutting.
[0160] The expanded diameter of the retention member is preferably
slightly smaller than the inner diameter of the tube 410 lumen so
that the tissue plug can be completely withdrawn into the tube's
410 inner lumen, as illustrated in FIG. 13D. The retention member
may also have a larger diameter. It may be brought into apposition
with the sharp edge 412 of the tube 410. Thus, both retaining the
tissue plug in the tube and covering the sharp edge, preventing
potential unintended cutting by the edge 412 and increasing safety
of the procedure both for patients and operators. In any case,
embolization of the cut tissue plug from the apex is securely
prevented.
[0161] The penetration of the cardiac tissue into the heart chamber
an interior of the heart may be indicated to the operator with a
blood indicator of the applicator tool 4. For instance, the blood
indicator 490 may be provided at distal end of a tube of an
applicator tool being in fluid communication with a proximal seal.
The seal may include a transparent portion blood passing from the
chamber into the distal end and the lumen of tube 410 passes
through the tube 410 to its proximal end and indicates penetration
of the cardiac tissue into an interior of the heart. The seal
provides also for feed through of the penetration needle and rod
member therein without leakage.
[0162] A dilator 480 may be used for widening the tissue hole
created by the penetration needle 460 and/or the tube 410
[0163] The method further includes delivering 730 an access device,
such as an apical base plate, which has a tubular through port to
the transapical hole. Delivery may be made by sliding the access
device distally over the outside of tube 410 and/or a dilator
480.
[0164] The method further includes attaching a flange unit of the
access device to an outside of the heart. The flange unit may be
attached around the transapical hole by a suture technique called
"parachute technique". For the parachute procedure, both ends of a
single suture 165 are sutured through the cardiac tissue around the
hole at a suitable distance to the hole. This may be done using a
suitable template for a number of sutures around the hole. For
instance, 8 to 10 sutures around the periphery of the flange 160
may be sufficient for providing reliable seat of the access device
in a sealed manner, i.e. without bleeding from the heart chamber
when the channel in tube 120 is suitably closed by e.g. a
hemostatic valve, sealing unit or a plug. The channel in tube 120
provides a transapical working channel to and from a heart chamber
on a beating heart.
[0165] Bleeding is prevented by keeping the tube 410 in the hole.
The two ends of each same suture are then passed through the flange
unit, which is held away from the heart surface on the outside of
the tube 410 of tool 4. The suturing pattern is repeated using
additional sutures, resulting in several suture "pairs" spaced
around the hole and tube 410. The access device 1 is then lowered
or parachuted down against the outer heart wall and advanced until
the plate 100 and the flange 160 are in contact with the heart
surface and the opening of the tube 120 of the access device 1 is
inside the heart chamber. After all the suture pairs are secured,
e.g. by suitable knots, the result is a blood tight flange with a
tubular port 120 in the transapical hole.
[0166] The method may further include removably connecting a
hemostatic valve unit 2 to the access device 1. The hemostatic
valve unit 2 may be pre-mounted on the tube 410 and positioned at
the access device 1 by sliding along the tube 410. Alternatively,
the hemostatic valve unit 2 may be pre-mounted and releasably
attached on the access device 1 and positioned in the transapical
passage by sliding along the tube towards the apical puncture hole
as described above.
[0167] The tube 410 of the applicator tool may then be retracted.
It is withdrawn out of the access device and valve that remain in
place at the heart, as shown in FIG. 6.
[0168] A medical procedure and/or delivery of medical devices may
be performed through the port of the valve 2 and the port 120. The
method may include for example transapically passing a driving rod
610 of a cardiac assist system into the heart through the
hemostatic valve 2 and access device 1.
[0169] Delivering medical devices to the heart chamber may include
deploying an annuloplasty chain ring at a cardiac valve annulus. A
delivery catheter of a delivery system may be introduced for this
purpose through the access device 1 with affixed valve 2. The
delivery catheter may then be removed out of the patient. Blood
leakage from the heart is continued prevented by the hemostatic
valve unit 2.
[0170] A sealing device may be slid over the driving rod 610
through the valve 2 and affixed at the access device 1 providing a
sealed access device 1 with a wet/dry zone separation. The proximal
end of the driving rod 610 may then be connected to a drive unit 6
while attaching the drive unit 6 to the access device 1.
[0171] The sealing device 3 may be introduced through the
hemostatic valve unit 2 to the access device 1 sealing the
transapical passage, e.g. as described above for creating the
wet/dry zone separation. An element like a rod may pass across the
through port of the sealing element 3. Alternatively, the distal
end port of sealing unit 3 may be provided as a closed element like
a membrane or hub. A magnetic coupling 340 to an element in the
heart chamber may be established with units shown in FIGS. 24A, 24B
and 24C.
[0172] The valve 2 may then be removed as well as a medical device
affixed to the access device prior to concluding the procedure. The
method 700 may include removing the hemostatic valve unit from the
apical base plate by disconnecting the hemostatic valve unit from
the apical base plate and withdrawing the hemostatic valve unit out
of the patient, or splitting or partitioning the hemostatic valve
unit.
[0173] In addition, examples of the disclosure may include one or
more sensors. For instance, the access device 1, the hemostatic
valve 2, the sealing unit 3, the drive unit for cardiac assist 6,
the transapical access system 5, or other medical devices (not
shown) attachable to the access device 1 may include such sensor(s)
thus implantable into a patient's body.
[0174] Sensors often need to be part of a wet zone and a dry zone,
since measurement is often performed in blood (wet zone) and
sensors often include electrical parts that need to be separated
from blood in a dry zone. Thus, it is important to have a
feed-through port 320 in order to facilitate this sensor wet and
dry zone separation.
[0175] Hence, some examples of the disclosure include in addition
one or multiple optional sensors 620.
[0176] Such sensor may go through the feed-through port 320 of the
bellows 310, instead of the driving rod 610 as previously
described. In another alternative/example, there may be more than
one (multiple) feed-through ports 320 so that multiple sensors
and/or the driving rod 610 could go through different feed-through
ports 320 at the same time. The feed-through port 320 does not need
to be part of the bellows 310, as previous described, but may be a
separate part/unit of the sealing unit 3 instead. An example of a
multiple feed-through, or multi-lumen, ports 320 is for instance
including a preferably separate channel for a sensor, such as a
pressure sensor, (not shown in the Figures).
[0177] In one example, the sensor 620 may include one or more
pressure sensors e.g. connectable to a port distally ending in the
chamber of the heart. This will provide intracardiac pressure of
e.g. the left and/or right ventricle of the heart. The pressure
data not only provides important clinical data but may also be used
in control algorithms of an implanted medical device. Other
relevant clinical parameters, e.g. the heart rate of the patient
and/or various heart arrhythmias, may also be extracted from the
pressure data.
[0178] In one example, the sensor 620 may include additionally, or
alternatively, one or more ECG electrodes e.g. connectable to a
port distally ending in the heart. This will provide intracardiac
electrical activity of the heart. The ECG data not only provides
important clinical data but may also be used in control algorithms
of an implanted medical device. Other relevant clinical parameters,
e.g. the heart rate of the patient and/or various heart
arrhythmias, may also be extracted from the ECG data.
[0179] In one example, the sensor 620 may include additionally, or
alternatively, one or more optical and/or electrical sensors used
for obtaining blood flow and/or blood volume measurements in the
heart. Such sensors may e.g. be placed in an optical port and/or
window (not shown) facing towards the wet zone of the heart. This
may e.g. provide measurement data for intracardiac blood volume of
the left ventricle of the heart. The blood flow/volume data not
only provides important clinical data but may also be used in
control algorithms of an implanted medical device. Other relevant
clinical parameters, e.g. the heart rate of the patient and/or
stroke volume and/or cardiac output and/or SpO2, may also be
extracted from the blood flow/volume data.
[0180] In one example, the sensor 620 may include in addition, or
alternatively, one or more movement sensors e.g. connectable to a
port distally ending in the heart and/or connected to the driving
rod 610. This will provide measurement data for intracardiac
movement and/or activity data of the heart. The movement data may
e.g. represent the up and down movement of the mitral valve and/or
the atria/ventricle plane. The movement data not only provides
important diagnostic clinical data but may also be used in control
algorithms of an implanted medical device. Other relevant clinical
parameters, e.g. the heart rate of the patient and/or various heart
arrhythmias, may also be extracted from the movement data. Examples
of movement sensors include magnetic based, such as a Hall effect
sensor, and/or optical based. Examples of movement sensors may also
include one or more accelerometers.
[0181] The measurement data obtained from the sensor(s) 620 may for
instance be used to control a medical device, e.g. be part of a
control algorithm implemented in the hardware and/or software of
the medical device such as a cardiac assist system. The data from
the sensors may for instance also be used to monitor important
physiological properties and/or use the sensor data to extract
and/or calculate critical clinical parameters that need to be
monitored. Besides from monitoring the physiological properties
and/or clinical parameters, they may be part of a surveillance
system. Obtaining and managing patient data is not only important
for e.g. the safety of the patient and the functionality of a
medical device, but also due to regulatory requirements for medical
devices since it will be mandatory to collect, retain, and analyze
post-market clinical data.
[0182] Such measurement data, providable by sensors 620, when
implanted with examples of devices described herein, has hitherto
been difficult to provide.
[0183] FIG. 27 illustrates steps of an example of a method 800 of
transapically implanting a cardiac assist system. The method 800 or
medical procedure includes attaching 810 a cardiac assist unit 6 to
an access device 1 including a sealed apical base plate 100. The
apical base plate 100 has a sealed tubular through port arranged
across cardiac tissue to a heart chamber. A flange unit is attached
to the base plate 100 and to the heart 10. The access device 1 has
a sealing unit 3 attached thereto. The method may include inserting
a delivery tube through a hemostatic valve attached to the access
device prior to sealing the access device for providing a wet/dry
zone as described above.
[0184] Some additional examples of the disclosure are given
below.
[0185] Example 31. An applicator tool (4) for creating a
transapical passage on a beating heart, said applicator tool (4)
including
[0186] a harpoon (450) insertable through a tube (410) and having a
distal tip configured to penetrate cardiac tissue at an apex of
said heart; and
[0187] said tube (410) having a sharpened edge at a distal end
configured to cut said cardiac tissue at said apex to a transapical
hole in said heart, and said harpoon having an expandable flange
for preventing withdrawal of said harpoon through said cardiac
tissue, wherein said flange is configured to keep said cut cardiac
tissue within said tube (410).
[0188] 32. The applicator tool of example 31, wherein said distal
end of said tube is in fluid communication with a proximal seal
including a blood indicator (490).
[0189] 33. The applicator tool of example 31 or 32, wherein said
distal end of said tube (410) is configured for apposition to said
cardiac tissue at said apex.
[0190] 34. The applicator tool of any of examples 31 to 33,
comprising
[0191] an access device (1) for a heart having a tubular through
port (120) adapted to be arranged across said cardiac tissue when
advanced over said tube (410).
[0192] 35. The applicator tool of example 34, wherein a removable
hemostatic valve unit (2) is attachable to said access device (1)
and slidable over said tube (410).
[0193] 36. The applicator tool of any of examples 31 to 35, in
combination comprising a dilator having a larger diameter than said
transapical hole in use made in said heart by said tube (410) and
said dilator being configured to widen said transapical hole when
inserted therein.
[0194] Example 37. An applicator tool (4) for creating a
transapical passage on a beating heart, said applicator tool (4)
including
[0195] a penetration needle (460) insertable through a co-axial
dilator (480) having a distal tip configured to penetrate cardiac
tissue at an apex to provide an opening, and said dilator (480) to
widen said opening of said cardiac tissue; and
[0196] an access device (1) for a heart having a tubular through
port (120) adapted to be arranged across said cardiac tissue when
advanced over said dilator (480), and/or wherein said distal end of
said penetration needle is in fluid communication with a proximal
seal including a blood indicator.
[0197] 38. The applicator tool of example 37, wherein a removable
hemostatic valve unit (2) is attachable to said access device (1)
and slidable over said dilator (480).
[0198] Example 39. A transapical access system for creating a
transapical passage on a beating heart, said system including an
access device (1) for a heart according to any of originally filed
claims 1 to 21, and/or
[0199] an applicator tool (4) for creating a transapical passage
and delivering said access device (1) to an apex of said heart
according to any of examples 31 to 38.
[0200] 40. The system of example 39, comprising a fixture template
(190) for targeted puncture of said apex.
[0201] 41. The system of example 40, wherein said fixture (190) has
a patient specific shape for said apex, such as selected from
multiple fixtures or manufactured based on imaging data of said
apex.
[0202] Example 42. A method of creating a transapical passage on a
beating heart, said method including
[0203] determining a position on an apex region for creating a
transapical passage
[0204] creating a transapical hole at said determined apex region
through cardiac muscle tissue,
[0205] delivering an access device having a through port to said
transapical hole,
[0206] attaching a flange unit of said access device to said heart,
and
[0207] removably connecting a hemostatic valve unit to said access
device.
[0208] 43. The method of example 42, including arranging a
plurality of sutures at said transapical hole for said attaching
said flange unit of said access device to said heart.
[0209] 44. The method of any of examples 42 to 43, including
cutting said cardiac tissue at said apex with a sharpened edge at a
distal end of a tube.
[0210] 45. The method of any of examples 42 to 44, including
preventing withdrawal of a harpoon through said cardiac tissue by
expanding a flange of said harpoon.
[0211] 46. The method of any of examples 42 or 43, including
creating said transapical hole with an applicator tool including
penetrating cardiac tissue at said apex with a distal tip of a
harpoon member through a tube.
[0212] 47. The method of any of examples 45 or 46, including
keeping said cut cardiac tissue within said tube by said expanded
flange of said harpoon member.
[0213] 48. The method of any of examples 42 to 47, including
indicating penetration of said cardiac tissue into an interior of
said heart with a blood indicator at distal end of a tube of an
applicator tool being in fluid communication with a proximal seal
including a blood indicator.
[0214] 49. The method of example 42 or 43, including creating said
transapical passage with an applicator tool including penetrating
cardiac tissue at an apex with a penetration needle of said
applicator tool insertable through a co-axial dilator having a
distal tip dilating said cardiac tissue.
[0215] 50. The method of example 49, including arranging a tubular
through port of said access device across said cardiac tissue when
advanced over said dilator.
[0216] 51. The method of example 50, including removably attaching
a removable hemostatic valve unit to said access device and sliding
said removable hemostatic valve unit over said dilator.
[0217] 52. The method of any of examples 42 to 51, including
[0218] transapically passing a driving rod of a cardiac assist unit
into said heart through said hemostatic valve;
[0219] attaching a sealing unit to said access device through said
hemostatic valve unit and over said driving rod;
[0220] sealing said transapical passage through said access device
by said sealing unit;
[0221] removing said hemostatic valve unit from said access
device;
[0222] 53. The method of example 52 including said
[0223] removing said hemostatic valve unit from said access device
by
[0224] disconnecting said hemostatic valve unit from said access
device and withdrawing said hemostatic valve unit out of the
patient, or
[0225] splitting or partitioning said hemostatic valve unit.
[0226] 54. The method of any of examples 42 to 53, including
deploying an annuloplasty chain ring at a cardiac valve
annulus.
[0227] 55. The method of any of examples 42 to 54, including
removing a delivery tube out of patient and sealing against blood
leakage from said heart by a hemostatic valve unit.
[0228] 56. The method of any of examples 42 to 54, wherein said
applicator tool is the applicator tool of any of examples 22 to 29,
said access device is the access device of any of originally filed
claims 1 to 21, and/or said hemostatic valve is that of any of
claims 22 to 26.
[0229] Example 57. A method of transapically implanting a medical
device on a beating heart including
[0230] removably attaching said medical device to a sealed access
device (1) affixed to said heart.
[0231] 58. The method of example 57, said access device having a
sealed tubular through port adapted to be arranged across cardiac
tissue to a heart chamber,
[0232] and a flange unit sealingly affixing said access device to
said heart.
[0233] 59. The method of any of examples 57 to 58, including
attaching a sealing unit to said access device for creating a
separation of a wet zone and a dry zone inside a mammal body.
[0234] 60. The method of any of examples 57 to 59, including
inserting a delivery tube through a hemostatic valve attached to
said access device.
[0235] 61. The method of any of examples 57 to 60, including
attaching said medical device to said sealed access device while a
hemostatic valve and a sealing unit are attached to said access
device, and detaching said hemostatic valve by splitting or
peeling-off said hemostatic valve.
[0236] 62. The method of any of examples 57 to 61, wherein said
medical device is removably attached to said sealed access
device.
[0237] 63. The method of any of examples 57 to 62, wherein said
medical device is comprised in a cardiac assist system.
[0238] 64. The method of any of examples 57 to 63, wherein said
access device is the access device of any of claims 1 to 21, and/or
said hemostatic valve is that of any of claims 21 to 26.
[0239] 65. A method of accessing a heart of a patient
comprising:
[0240] accessing said heart of said patient;
[0241] accessing a heart chamber of said heart;
[0242] securing a base plate at an apex region of said heart and
extending to said heart chamber;
[0243] associating a sealing unit with said base plate and thereby
creating a dry zone isolated from said heart chamber;
[0244] It should be noted that the skilled person will understand
that some of the devices disclosed herein in combination with other
devices can be provided and implemented as standalone devices,
independent of the other devices or combined systems and methods
described herein. An example is the access device 1, which can be
provided as an access port to the inner of the heart for other
applications than described herein. Another example is the
application tool 4 that may be provided to safely puncture a tissue
wall and provide the tissue wall with a tissue passage. Also, the
removable hemostatic valve 2 may be provided for attachment to
other units than an access device 1.
[0245] Unless otherwise defined, all terms (including technical and
scientific terms) used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
invention belongs. It will be further understood that terms, such
as those defined in commonly used dictionaries, should be
interpreted as having a meaning that is consistent with their
meaning in the context of the relevant art and will not be
interpreted in an idealized or overly formal sense unless expressly
so defined herein.
[0246] 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, which is only limited by the appended patent claims.
LIST OF REFERENCE SIGNS
[0247] 1 access device for a heart [0248] 100 apical base plate
[0249] 110 connection interface [0250] 115 locking unit [0251] 120
tubular through port [0252] 125 sealing surface for sealing unit 3
[0253] 130 sealing surface for hemostatic valve 2 [0254] 150, 151
mounting spikes [0255] 155 bayonet joint [0256] 160 flange unit
[0257] 165 sutures [0258] 170 suture hole [0259] 190 template for
positioning an access device [0260] 191 cut-outs of template [0261]
192 cut-outs for suture stitching [0262] 2 hemostatic valve unit
(inflatable valve assembly) [0263] 200 housing [0264] 202, 204
splittable housing parts [0265] 210 inflation port [0266] 220
inflatable balloon member [0267] 222 balloon lobe [0268] 225 valve
through port [0269] 230 sealing surface for sealing against access
device 1 [0270] 250, 251 Mounting apertures (mating with 150,151)
[0271] 255 bayonet pins for joint 155 [0272] 260 sealing element
[0273] 3 sealing unit (bellows assembly) [0274] 310 bellows [0275]
320 feed-through port [0276] 325 first sealing member for sealing
against access device [0277] 326 second sealing member for sealing
feed through port [0278] 330 detaining unit [0279] 340 magnetic
coupling [0280] 4 applicator tool for creating a transapical
passage (apex punch assembly) [0281] 400 pistol grip [0282] 410
tube [0283] 412 sharp tip of tube [0284] 415 trigger for pushing
tube 410 forward [0285] 417 claw [0286] 420 control dial for
rotating tube [0287] 450 harpoon [0288] 455 proximal end of harpoon
450/rod 470 [0289] 460 penetration needle [0290] 461 seat [0291]
465 needle trigger [0292] 466 needle spring [0293] 467 safety pin
[0294] 470 rod [0295] 471 shoulder [0296] 472 head (distal end
portion) of rod with retaining unit [0297] 473 retaining unit e.g.
barb, hook or fluke or wire mesh [0298] 474 moveable and lockable
stop element [0299] 475 tissue plug [0300] 480 dilator [0301] 490
penetration/blood indicator [0302] 5 transapical access system
[0303] 6 drive unit for cardiac assist [0304] 610 driving rod
[0305] 620 sensor [0306] 630 electrical connection [0307] 650
anchor unit/annuloplasty implant [0308] 7 delivery system [0309] 70
delivery tube [0310] 72 inserter unit [0311] 74 pusher [0312] 700 a
method of creating a transapical passage on a beating heart [0313]
710-730 method steps [0314] 800 a method of transapically
implanting a cardiac assist system [0315] 810 method step [0316] 10
heart [0317] 12 apex region of heart 10 [0318] 14 outside of heart
[0319] 15 inside of heart [0320] 20 heart chamber [0321] 30 Wet
zone [0322] 32 Dry zone
* * * * *