U.S. patent application number 14/101013 was filed with the patent office on 2014-06-12 for implantable sealing device.
This patent application is currently assigned to PETER OSYPKA STIFTUNG. The applicant listed for this patent is PETER OSYPKA STIFTUNG. Invention is credited to Peter Osypka.
Application Number | 20140163608 14/101013 |
Document ID | / |
Family ID | 47602714 |
Filed Date | 2014-06-12 |
United States Patent
Application |
20140163608 |
Kind Code |
A1 |
Osypka; Peter |
June 12, 2014 |
IMPLANTABLE SEALING DEVICE
Abstract
An implantable sealing device is disclosed herein and includes
an elongated elastic member having distal and a proximal ends, at
least one sealing element including braiding having outside and
inside faces. The braiding can include of a plurality of fine
threads of a memory metal alloy and wherein at least one face of
the braiding is coated by a membrane. The braiding can also include
a fixing member positioned at one of the distal and proximal ends
of the elastic member and being positioned opposite to the
braiding.
Inventors: |
Osypka; Peter;
(Grenzach-Wyhlen, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PETER OSYPKA STIFTUNG |
Grenzach-Wyhlen |
|
DE |
|
|
Assignee: |
PETER OSYPKA STIFTUNG
Grenzach-Wyhlen
DE
|
Family ID: |
47602714 |
Appl. No.: |
14/101013 |
Filed: |
December 9, 2013 |
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00243
20130101; A61B 2017/00575 20130101; A61B 17/0057 20130101; A61B
2017/00615 20130101; A61B 2017/00597 20130101; A61B 2017/00592
20130101; A61B 2017/00867 20130101; A61N 1/0587 20130101; A61B
2017/00579 20130101; A61B 2017/00623 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 10, 2012 |
EP |
EP12008240.9 |
Claims
1. An implantable sealing device comprising: a) an elongated
elastic member having a distal end and a proximal end; b) at least
one sealing element comprising a braiding including an umbrella
shape and having outside and inside faces, the braiding being
positioned respectively at one of the distal and proximal ends of
the elastic member, wherein the braiding includes a plurality of
fine threads of a memory metal alloy and wherein at least one face
of the braiding is coated by a membrane; and c) a fixing member
being positioned respectively at the distal and proximal ends of
the elastic member and being positioned opposite to the
braiding.
2. The sealing device according to claim 1, wherein the braiding
includes at least 30 threads made of Nitinol.
3. The sealing device according to claim 1, wherein said threads
are about 0.03 mm to about 0.15 mm in diameter
4. The sealing device according to claim 1, wherein the braiding is
configured to adapt to an anatomical shape of an apex of a left
ventricle when in use.
5. The sealing device according to claim 2, wherein the braiding
includes 30 to 100 threads.
6. The sealing device according to claim 2, wherein the braiding
includes about 70 to about 90 threads and wherein the threads are
about 0.05 mm to about 0.13 mm in diameter.
7. The sealing device according to claim 2, wherein the braiding
includes about 70 to about 90 threads and wherein the threads are
about 0.1 mm in diameter.
8. The sealing device according to claim 1, wherein the braiding is
positioned at the distal end of the elastic member.
9. The sealing device according to claim 1, wherein the membrane is
a biocompatible plastic.
10. The sealing device according to claim 1, wherein the
biocompatible plastic is silicone or polyurethane.
11. The sealing device according to claim 1, wherein the outside
face of the braiding is membrane coated.
12. The sealing device according to claim 1, wherein the elastic
member is a coil spring.
13. The sealing device according to claim 1, wherein the fixing
member includes radially expandable arms.
14. The sealing device according to claim 1, wherein the device is
folded inside the tube of the trocar.
15. A method for sealing a tissue opening, especially a trocar tube
opening in a myocardium at an apex of a left ventricle comprising
the steps of: a) inserting a trocar tube including a folded sealing
device and guiding the trocar tube through an opening in a
myocardium into a patient's left ventricle, the sealing device
comprising: i) an elongated elastic member having a distal and a
proximal end; ii) at least one sealing element comprising a
braiding extending radially from the elongated elastic member
having outside and inside faces, the braiding being positioned
respectively at one of the distal and proximal ends of the elastic
member, wherein the braiding includes a plurality of fine threads
of a memory metal alloy and wherein at least one face of the
braiding is coated by a membrane; and iii) a fixing member being
positioned respectively at the distal and proximal ends of the
elastic member and being positioned opposite to the braiding; b)
pushing the braiding out of the trocar tube so that the umbrella
moves from a folded position into a deployed position whereas the
fixing member remains inside the trocar tube; c) stretching the
elastic member by means of a tensioning cord and pulling the
pre-stretched elastic member out of the opening in a myocardium
whereby the fixing member is placed against a tissue of a
myocardium and moves from a folded position into a deployed
position; d) removing the trocar tube whereby the elastic member
remains stretched; and e) removing tension from the elastic member
whereby the fixing member anchors in a tissue of a myocardium.
16. A tissue sealing device, comprising: a) an elongated elastic
member having a first end and a second end; b) a braided sealing
member disposed on at least one of the first and second ends, the
braided sealing member configured to radially extend upon release
from an insertion device; c) an anchor member disposed on the at
least one of the first and second ends, the anchor member
configured to anchor the elongated member to tissue, wherein the
elongated elastic member provides a compressive force between the
braided sealing member and the anchor member such that tissue is
compressed therebetween upon anchoring of the tissue sealing
device.
17. The sealing device according to claim 16, wherein the braided
sealing member includes threads of a shape memory material.
18. The sealing device according to claim 17, wherein the threads
are about 0.03 mm to about 0.15 mm in diameter.
19. The sealing device according to claim 16, wherein the braided
sealing member includes an umbrella shape.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority under 35 U.S.C.
.sctn.119(a) to European Patent Application No. EP12008240, filed
with the European Patent Office on Dec. 10, 2012, the content of
which is incorporated by reference herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present disclosure relates to an implantable sealing
device for sealing a tissue opening, more specifically a trocar
tube opening in the left ventricle of the heart.
[0004] 2. Description of Related Art
[0005] Deficient heart valves can be repaired or replaced using a
variety of different types of heart valve surgeries. One general
type of heart valve surgery involves an open-heart surgical
procedure during which the heart is stopped and blood flow is
controlled by a heart-lung bypass machine. This type of valve
surgery is highly invasive and exposes the patient to a number of
potential risks associated with use of the heart-lung machine.
[0006] Due to the drawbacks of open-heart surgical procedures,
there has been an increased interest in minimally invasive and
percutaneous replacement of cardiac valves. Such surgical
techniques involve making a relatively small opening in the chest
of the patient into which a valve assembly is inserted and
delivered into the heart via the operating device of a so-called
trocar tube. The minimally invasive methods include reduced pain
due to smaller incisions and less bleeding, shorter recovery time,
and, especially, avoid the use of a heart-lung machine.
[0007] Minimally invasive surgical procedures such as transcatheter
aortic valve implantation (TAVI) and transapical aortic valve
implantation (TAAVI) have become feasible alternatives to open
techniques in high risk patients.
[0008] In the TAVI process, the artificial valve is attached to a
compressed stent, the stent being attached to a balloon catheter.
The balloon catheter is inserted in the femoral artery and guided
into the heart to the area of the aortic valve. Once in position,
the balloon is inflated to secure the valve in place.
[0009] In the TAAVI approach, the replacement valve is inserted
through a small incision in the chest wall of a patient and the
catheter is advanced through the apex of the heart. Like in the
TAVI approach, a balloon catheter is inserted through an
introducer, e.g. a trocar tube and guided into the heart to the
area of the aortic valve. After valve deployment, the trocar tube
is removed and the opening in the ventricular apex is sutured.
[0010] A problem in the transapical procedure is the haemostatic
closure of the left ventricular apex. Frequently, a purse string
suture is placed in the tissue prior to insertion of the trocar
tube to facilitate closure after the procedure is complete. After
removing the trocar tube the ends of the suture are drawn tight to
close the wound. Due to the high pressure created by the
contraction of the heart severe problems may occur when the suture
is not tight or disrupts.
SUMMARY OF THE INVENTION
[0011] An object of the present disclosure is therefore to provide
an improved device for sealing a tissue opening, especially a
trocar tube opening in the myocardium after the transapical
procedure of valve replacement. The device can not only seals the
tissue opening itself, such that the primary bleeding is stopped,
but also prevent secondary bleeding from occurring. The tissue
opening should be tightly closed. Furthermore, the device is
filigree and flexible in order to be able to follow the movement of
the heart without the occurrence of structural damage such as e.g.
cracks. The beating of the heart and the heart rate of the patient
should not be affected. Due to its filigree construction the
braiding can take the anatomical shape of the apex of the left
ventricle, the place where the trocar is introduced.
[0012] A further object of the disclosure is to provide the above
required device and to simultaneously provide a possibility to
place heart wires in minimally invasive heart surgery
procedures.
[0013] The sealing device can include a membrane coated braiding of
fine threads. Furthermore a tensioning member and a fixing member
are present for placing and anchoring the sealing device into the
myocardium.
[0014] In some embodiments, a sealing device according to the
present disclosure comprises an elongated elastic member having a
distal and a proximal end, at least one sealing element in form of
an umbrella shaped braiding having outside and inside faces, the
braiding being positioned respectively at the distal and proximal
ends of the elastic member, wherein the braiding includes a
plurality of fine threads of a memory metal alloy and wherein at
least one face of the braiding is coated by a membrane, and a
fixing member being positioned respectively at the distal and
proximal ends of the elastic member and being positioned opposite
to the braiding.
[0015] The braiding may be very soft and flexible in order to avoid
injuring the very soft heart tissue. The braiding is able to follow
the movement of the heart. The braiding is adapted to the
anatomical shape of the apex of the left ventricle and includes at
least 30 fine threads, preferably 30 to 100 threads, more
preferably 70 to 90 threads. The threads are 0.03 to 0.15 mm in
diameter, preferably 0.05 to 0.13 mm in diameter; more preferably
circa 0.1 mm in diameter. Due to the number of fine threads the
device fulfills the requirement of flexibility and softness.
[0016] The umbrella shaped braiding is preferably made out of
Nitinol threads thus allowing the self-deployment of the membrane
coated braiding whereby the braiding is adapted to the shape of the
apex of the left ventricle due to the shape memory properties of
Nitinol.
[0017] The interaction of the sealing member, the elastic member,
and the fixing member allows the immediate closure of the opening
in the apex of the left ventricle. The immediate closure is
beneficial due to the high pressure in the left ventricle created
by the contraction of the heart and the strong movement of the
heart. The sealing of the trocar tube opening in the myocardium
starts immediately after the placing and fixing of the membrane
coated braiding.
[0018] A preferred sealing device comprises an elongated elastic
member having distal a and a proximal end, at least one sealing
element in form of an umbrella shaped braiding having outside and
inside faces, the braiding being positioned respectively at the
distal and proximal ends of the elastic member, wherein the
braiding includes at least 30 threads made of Nitinol, said threads
being 0.03 to 0.15 mm in diameter and wherein at least one face of
the braiding is coated by a membrane, and whereby in a position in
use the braiding is adapted to the anatomical shape of the apex of
the left ventricle, and a fixing member positioned respectively at
the distal and proximal ends of the elastic member and being
positioned opposite to the braiding.
[0019] At least one membrane coated braiding can be present. When
additional sealing may be necessary a second membrane coated
braiding may be present positioned opposite to the first membrane
coated braiding.
[0020] The membrane coated braiding is preferably positioned at the
distal end of the elastic member, thus being positioned at the
inner side of the opening in the myocardium in the position of use
as shown in FIG. 2.
[0021] Suitable membranes are made out of biocompatible plastic
such as e.g. silicone or polyurethane, preferably silicone. It is
important that the membrane is biocompatible and impervious to
blood.
[0022] The coating is positioned respectively at the outside face
or at inside face of the braiding, preferably at the outside face.
If desired, both sides of the braiding may be coated.
[0023] The elongated elastic member is a tensioning element and may
be a spring or a member made from elastic biocompatible material
like rubber. The spring is preferably a coil spring made, for
example, from stainless steel, MP35N or Nitinol.
[0024] The fixing member may be any known fixing member which may
be deployed from a retracted to an extended position. Preferably
the fixing member includes radially expandable arms, e.g. a pair of
radially expandable arms which extend from the elongated elastic
member. The arms are formed from a bio-compatible material, such as
stainless steel, MP35N or Nitinol, preferably Nitinol. The fixing
member is operatively associated with the elongated elastic member
and is mounted for movement between a retracted position wherein
the arms are disposed within the interior lumen of the trocar tube
and an extended position wherein the arms extend radially outwardly
to anchor the elastic member and thus to anchor the umbrella shaped
membrane coated braiding in the myocardium thus sealing the opening
in the myocardium. The radially expandable arms may be different in
shape, whereby the shape may influence the anchor effect. Before
use, the sealing device is folded and is disposed within the
interior lumen of the trocar tube.
[0025] The disclosure further relates to a method for sealing a
tissue opening, especially a trocar tube opening in the myocardium
at the apex of the left ventricle comprising inserting a trocar
tube including a folded sealing device as described herein and
guiding the trocar tube through an opening in the myocardium into
the patient's left ventricle, pushing the folded umbrella shaped
and membrane coated braiding out of the trocar tube so that the
umbrella moves from a folded into a deployed position whereas the
fixation member remains inside the trocar tube, stretching the
elastic member by means of a tensioning cord and pulling the
pre-stretched elastic member out of the opening in the myocardium
whereby the fixing member is placed against the tissue of the
myocardium and moves from a folded into a deployed position,
removing the trocar tube whereby the elastic member remains
stretched, and removing the tension from the elastic member whereby
the fixing member anchors in the tissue of the myocardium.
[0026] These and other features of the systems and methods of the
subject disclosure will become more readily apparent to those
skilled in the art from the following detailed description taken in
conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] So that those skilled in the art to which the subject
disclosure appertains will readily understand how to make and use
the devices and methods of the subject disclosure without undue
experimentation, embodiments thereof will be described in detail
herein below with reference to certain figures, wherein:
[0028] FIG. 1 is a schematic illustration of the transapical valve
insertion technique;
[0029] FIG. 2 shows the sealing device, sealing the inner
myocardium;
[0030] FIG. 3 show the sealing device, sealing the outer
myocardium;
[0031] FIG. 4 is a view corresponding to FIG. 1 and in addition
shows temporary electrodes inserted for heart stimulation;
[0032] FIGS. 5a to 5d show the placing and the affixing of the
stimulation electrodes;
[0033] FIG. 6 shows a stimulation electrode in detail;
[0034] FIGS. 7a, 7b and 7c show the sealing system in detail;
and
[0035] FIGS. 8, 8a, 9, 9a and 10, 10a, show the steps of placing
and affixing the sealing system.
DETAILED DESCRIPTION OF THE INVENTION
[0036] Reference will now be made to the drawings wherein like
reference numerals identify similar structural features or aspects
of the subject disclosure. FIG. 1 is a schematic illustration of
the transapical valve insertion technique and shows the balloon
catheter used to insert new artificial heart valves during
Transapical Aortic Valve Implantation (TAAVI) according to the
state of the art. Trocar tube 1 is inserted into the left ventricle
3 of the heart through the myocardium 2. A compressed valve
prosthesis constructed from a stainless steel stent with an
attached artificial valve 4 is placed on the balloon catheter 5,
inserted into the apex of the left ventricle, and positioned
directly inside the diseased aortic valve. Once in position, the
balloon is inflated to secure the valve in place. The balloon is
then deflated and removed leaving the new valve to function
immediately.
[0037] FIG. 2 shows the sealing device sealing the opening in the
myocardium. Trocar tube 1, via which the sealing device had been
inserted, is retracted behind the ventricular apex. The opening in
the tissue is tightly sealed by the membrane coated braiding 7
which is positioned at the inner myocardium at the distal end of
the elastic member 6. As shown in the embodiment of FIG. 2, the
elastic member 6 includes a coil spring. The braiding 7 is adapted
to the anatomical shape of the apex of the left ventricle.
[0038] The flexible braiding 7 tightly closes the inner tissue of
the heart and is anchored by the fixing member which is operatively
associated with the coil spring of elastic member 6. The coil
spring is stretched by pulling the double thread 9 down. After the
placement of the sealing device, the thread 9 may be removed by
pulling down one side of the thread 9 so that the thread 9 may slip
out.
[0039] FIG. 3 shows the sealing device sealing the outer
myocardium. The sealing device can be positioned the other way
around as described above should the anatomical shape of the left
ventricular apex not allow sealing of the inner myocardium. In this
case the membrane coated braiding 7 is positioned at the outer
myocardium.
[0040] FIG. 4 is a view corresponding to FIG. 1 and in addition
shows temporary electrodes (heart wires) inserted for heart
stimulation. Heart wires are normally placed in open heart surgical
procedures and are attached to the epicardium to synchronize the
heart after the surgery. The embodiment according to FIG. 4
provides a possibility to attach heart wires even if the heart is
not exposed.
[0041] An additional catheter 10 is slipped over the trocar tube 1.
The catheter 10 is a three-lumen device which comprises a tubular
body defining a first inner lumen extending longitudinally
there-through for slipping the catheter over the trocar tube and a
second and third lumen 11, 12 which run along each side of the
inner lumen allowing temporary electrodes to pass therethrough. A
Nitinol-stylet 13, which is preferably pre-shaped, is first
inserted within said lumen for assisting in steering of the
stimulation electrode when implanted.
[0042] FIGS. 5a to 5d show insertion of an electrode within the
myocardium of the heart. A pre-shaped stylet 13 is first inserted
within lumen 11 or 12 and guided from outside of the heart into and
through the myocardium. The tip of the stylet 13 leaves the tissue
of the myocardium. A coil 14 is then guided over the stylet towards
its tip. The stylet 13 is then withdrawn and the temporary
electrode 15 is inserted via the lumen of the coil 14. The proximal
portion of electrode 15 is connected to an external pacemaker. The
stimulating procedure is the same procedure as the placing of heart
wires which are used in open heart surgical procedures if it is
expected that the patient will need stimulation for a limited time
after the surgery. After completion of temporary stimulation the
heart wires are removed by pulling.
[0043] FIG. 6 shows a stimulation electrode comprising, at its
distal end, a loop 16 and a fixing member. The stimulation
electrode is inserted by means of coil 17.
[0044] FIGS. 7a, 7b and 7c show the sealing system in detail. FIG.
7a is a top view of the umbrella shaped braiding 7. In some
embodiments, the braiding can include about 80 Nitinol threads
having a diameter of about 0.1 mm. FIG. 7b is a side view of the
sealing device. Coil spring of elastic member 6 is attached to the
braiding 7 at its distal end. The fixing member 8 is operatively
associated with the coil spring at its proximal end. Loop 73 allows
double thread 9 to pass therethrough. Socket 72 may hold the ends
of the braiding threads. In unfolded condition the braiding 7 can
be umbrella shaped or any other suitable shape. The coating is
positioned at the outside face 70 or at the inside face 71 of the
braiding 7, preferably at the outside face. If desired, both sides
of the braiding 7 may be coated. FIG. 7c shows the braiding 7 in
the shape adapted to the anatomical shape of the apex of the left
ventricle as shown in use in FIG. 2.
[0045] FIGS. 8, 9, and 10 show the steps of placing and affixing
the sealing system. FIG. 8 shows the sealing device positioned
inside trocar tube 1 before placing the device into the left
ventricle. Braiding 7 and fixing member 8 are folded. The stick 20
is for pushing out the sealing device. The folding may be upwards
(FIG. 8) or downwards (FIG. 8a).
[0046] FIGS. 9 and 9a show the trocar tube placed in the myocardium
functioning as a portal for the subsequent placement of the sealing
device. The braiding 7 is pushed out of the trocar tube 1 and is
unfolded. The fixing member 8 is inside the tube 1 and thus still
protected. FIG. 9 and FIG. 9a differ in the anatomical shape of the
apex of the left ventricle and show the adaption of the shape of
the braiding 7 to the different anatomical shapes.
[0047] FIGS. 10 and 10a show the sealing device placed and the
trocar tube 1 removed. By pulling double thread 9 downwards coil
spring of the elastic member 6 is pre-stretched. The pre-stretched
coil spring is pulled downwards out of the opening in the
myocardium. After removing the trocar tube 1 whereby the double
thread is still stretched the fixing member 8 moves from a folded
into a deployed position and anchors in the myocardium tissue.
[0048] While the apparatus and methods of the subject disclosure
have been shown and described with reference to embodiments, those
skilled in the art will readily appreciate that changes and/or
modifications may be made thereto without departing from the spirit
and scope of the subject disclosure.
* * * * *