U.S. patent application number 17/262430 was filed with the patent office on 2022-04-07 for biological low profile, balloon expandable prosthetic heart valve, particularly aortic, for transcatheter implantation and the method of its manufacturing.
The applicant listed for this patent is Innovations for Heart and Vessels Sp. z o.o.. Invention is credited to Marzena Bialek-Brodocz, Pawel Buszman, Piotr Buszman, Jacek Gnilka, Piotr Hirnle, Wojciech Klein, Arkadiusz Mezyk, Krzysztof Milewski, Jerzy Nozynski, Mariusz Pawlak, Jonanna Sliwka, Marian Zembala, Michal Zembala.
Application Number | 20220104939 17/262430 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-07 |
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United States Patent
Application |
20220104939 |
Kind Code |
A2 |
Buszman; Pawel ; et
al. |
April 7, 2022 |
BIOLOGICAL LOW PROFILE, BALLOON EXPANDABLE PROSTHETIC HEART VALVE,
PARTICULARLY AORTIC, FOR TRANSCATHETER IMPLANTATION AND THE METHOD
OF ITS MANUFACTURING
Abstract
A biological low profile balloon expandable prosthetic heart
valve, particularly aortic for transcatheter implantation
comprising a valve frame of cylindrical design which consists of a
valve section, a supporting section and a biological material sewn
thereto. The upper part of the cylindrical cuff made of the
biological material is attached to the valve frame in the
supporting section on the outside and the cuff is folded to the
interior of the frame and it is attached to the posts in the valve
section. The upper parts of the cuff which are not attached to the
posts, on each side of the post are connected with each other on
the valve frame establishing commissures for the valve
leaflets.
Inventors: |
Buszman; Pawel; (Katowice,
PL) ; Pawlak; Mariusz; (Zabrze, PL) ; Klein;
Wojciech; (Knurow, PL) ; Gnilka; Jacek;
(Gliwice, PL) ; Mezyk; Arkadiusz; (Gliwice,
PL) ; Zembala; Marian; (Tarnowskie Gory, PL) ;
Sliwka; Jonanna; (Zabrze, PL) ; Bialek-Brodocz;
Marzena; (Bielsko-Biala, PL) ; Milewski;
Krzysztof; (Katowice, PL) ; Buszman; Piotr;
(Katowice, PL) ; Hirnle; Piotr; (Warszawa, PL)
; Nozynski; Jerzy; (Zabrze, PL) ; Zembala;
Michal; (Zabrze, PL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Innovations for Heart and Vessels Sp. z o.o. |
Katowice |
|
PL |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20210290377 A1 |
September 23, 2021 |
|
|
Appl. No.: |
17/262430 |
Filed: |
July 26, 2018 |
PCT Filed: |
July 26, 2018 |
PCT NO: |
PCT/PL2018/050037 PCKC 00 |
371 Date: |
January 22, 2021 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 24, 2018 |
PL |
P.426429 |
Claims
1. A biological low profile balloon expandable prosthetic heart
valve, particularly aortic for transcatheter implantation
comprising a valve frame of cylindrical design which consists of a
valve section, a supporting section and a biological material sewn
thereto characterised by the fact that the upper part of the
cylindrical cuff made of the biological material is attached to the
valve frame in the supporting section on the outside and the cuff
is folded to the interior of the frame and it is attached to the
posts in the valve section, and the upper parts of the cuff which
are not attached to the posts, on each side of the post are
connected with each other on the valve frame establishing
commissures for the valve leaflets.
2. The biological prosthetic aortic valve of claim 1 characterised
by the fact that attaching the biological cuff to the valve frame
and to the posts for attaching the cuff in the valve section is
done by sewing, favourably by use of surgical suture.
3. The biological prosthetic aortic valve of claim 1 characterised
by the fact that sewing the commissure in the frame area and in the
area of the post for attaching the cuff is done with a monofilament
suture, whose both ends alternately conducted through the adjacent
edges of the formed valve leaflets move towards the frame, and on
the first suture line between the valve leaflets there is a
protrusion made on the suture, favourably in the form of a
knot.
4. A way of manufacturing a biological low profile balloon
expandable prosthetic heart valve, particularly aortic for
transcatheter implantation comprising a valve frame of cylindrical
design which consists of a valve section, a supporting section and
a biological material sewn thereto characterised by the fact that
the upper part of the cylindrical cuff made of the biological
material is attached to the valve frame in the supporting section
on the outside and the cuff is folded to the interior of the frame
and it is attached to the posts in the valve section, and the upper
parts of the cuff which are not attached to the posts, on each side
of the post are connected with each other on the valve frame
establishing commissures for the valve leaflets.
5. The way of claim 4 characterised by the way that sewing the
commissure in the frame area and in the area of the post for
attaching the cuff is done with a monofilament suture, whose both
ends alternately conducted through the adjacent edges of the formed
valve leaflets move towards the frame on the distance of 2 mm, and
on the first suture line between the valve leaflets there is a
protrusion specifically made on the suture, favourably in the form
of a knot.
Description
[0001] The present invention relates to a biological low profile,
balloon expandable prosthetic aortic valve for transcatheter
implantation and the method of its manufacturing. The invention
relates to medical devices and developments used in treatment of
cardiovascular system valve defects.
[0002] Use of this type of device involves its manufacturing and
implantation by minimally invasive percutaneous method in the place
of a native valve which is impaired due to a congenital or acquired
defect. Implantation is carried out under fluoroscopy by means of a
low profile delivery system. This procedure is a recommended method
of treating valvular disfunctions in a chosen group of patients
with left arterial outflow tract stenosis, allowing to restore its
functionality.
[0003] Aortic stenosis (AS) which is left arterial outflow tract
obstruction is nowadays the most frequently occurring valve defect
posing a serious clinical challenge for doctors. The reason is the
growing number of elderly patients who cannot undergo a standard
cardiac surgery due to surgical risks. It is estimated that with
age the prevalence of aortic stenosis rises from 0,7% in patients
18-44 years old up to 13,3% in patients after >75 years old
(publications: Nkomo V. T., Gardin J. M., Skelton T. N., et al.,
Burden of valvular heart disease: a population-based study. Lancet,
2006. 368(9540): p. 1005-11 DOI: 10.1016/S0140-6736(06)69208-8).
European Society of Cardiology (ESC) in the recommendations from
2012 estimates that 2-7% Europeans and Americans over 65 years of
age suffer from this condition. (Joint Task Force on the Management
of Valvular Heart Disease of the European Society of C., European
Association for Cardio-Thoracic Surgery, Vahanian A., et al.,
Guidelines on the management of valvular heart disease (version
2012). Eur Heart J, 2012. 33(19): p. 2451-96 DOI:
10.1093/eurheartj/ehs 109). In the event that concomitant symptoms
appear with impaired blood flow surgical treatment is
indispensible, since without it the prognosis worsens
significantly. Currently the basic method of treatment (gold
standard) is the surgical aortic valve replacement (SAVR) which
comprises implantation of a biological or mechanical prosthesis.
However, this procedure affects major organs, especially in case of
elderly patients (>70 years of age)among whom perioperational
mortality rises with age from 1-3% to 4-8%, which is quoted in
Guidelines on the management of valvular heart disease. It
translates into a high percentage of patients disqualified from
surgical treatment (1/3 of patients>75 years of age). It
particularly refers to patients with concomitant afflictions of
other organs and with high surgical risk (Euroscore 2>10%)(lung
B., Cachier A., Baron G., et al., Decision-making in elederly
patients with severe aortic stenosis: Why are so many denied
surgery? Eur Heart J, 2005. 26(24): p. 2714-20 DOI:
10.1093/eurheart/ehi471). The alternative for such patients is a
minimally-invasive method introduced into clinical setting in 2002,
so-called Transcatether Aortic Valve Replacement (TAVR). The
efficacy of this method compared to conventional (surgical) method
has been confirmed by the outcomes of numerous completed and
ongoing trials in both high risk and lower risk patients
(publications:Mack M. J., Leon M. B., Smith C. R., et al. 5-year
outcomes of transcatheter aortic valve replacement or surgical
aortic valve replacement for high surgical risk patients with
aortic stenosis (PARTNER 1): a randomized controlled trial. The
Lancet, 2015. 385(9986): p. 2477-2484 DOI:
10.1016/s0140-6736(15)60308-7; Deeb G. M., Reardon M. J., Chetcuti
S., et al., 3-Year Outcomes in High-Risk Patients Who Underwent
Surgical or Transcatheter Aortic Valve Replacement. J Am Coll
Cardiol, 2016.67(22): p. 2565-74 DOI: 10.1016/j.jacc.2016.03.506;
Leon M. B., Smith C. R., Mack M. J., et al., Transcatheter or
Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N
Engl J Med, 2016. 374(17): p. 1609-20 DOI: 10.1056/NEJMoa1514616;
Sondergaard L., Steinbruchel D. A., Ihlemann N., et al., Two-Year
Outcomes in Patients With Severe Aortic Valve Stenosis Randomized
to Transcatheter Versus Surgical Aortic Valve Replacement: The
All-Corners Nordic Aortic Valve Intervention Randomized Clinical
Trial. Circ Cardiovasc Interv, 2016. 9(6) DOI:
10.1161/CIRCINTERVENTIONS.115.003665)-7)
[0004] Despite undisputed benefits, TAVR is not free from
significant constraints. Relatively frequently occurring vascular
injuries (4-13%) are caused mainly by large delivery systems, which
although much smaller than the ones used originally (average drop
from 24 F to 18 F), still need miniaturization (da Gama Ribeiro V.,
Vouga L., Markowitz A., et al., Vascular access in transcatheter
aortic valve implantation. Int J Cardiovasc Imaging, 2011.27(8): p.
1235-43 DOI: 10.1007/s10554-011-9900-8; Cribier A., The Odyssey of
TAVRfrom Concept to Clinical Reality. Tex Heart Inst J, 2014. 41(2)
DOI: 10.14503/THIJ-14-4137; Halapas A., Chrissoheris M., Bouboulis
N., et al., Update on current TAVI 3 technology, indications,
screening, and outcomes. Continuing Cardiology Education, 2016.
2(1): p. 37-46 DOI: 10.1002/cce2.20).
[0005] Another essential issue is the higher frequency of
paravalvular leakage (PVL) occurring in patients after TVR
procedure in comparison to patients after a classical surgical
procedure. The complex valve anatomy and imperfect expandable
systems cause the risk of uneven opening of the prosthetic heart
valve as well as its impaired apposition to the native annulus and
bulb. Connected with the above mentioned issue inability to
subsequent implantation of a prosthesis and its movement in case of
malpositioning poses a serious challenge for scientists and
constructors. These problems are addressed in detail in the
publication Mollmann H., Kim W. K., Kempfert J., et al.,
Complications of transcatheter aortic valve implantation (TAVI):
how to avoid and treat them. Heart, 2015. 101(11): p. 900-8 DOI:
10.1136/heartjnl-2013-304708.
[0006] Applying biological materials for manufacturing currently
used TAVI prostheses rises the problem of durability. The implant
like any other tissue degenerates with time and is subject to
processes such as calcification or vegetation. It is essential to
find methods which can improve durability and immunity of currently
used materials preserving their flexibility and biocompatibility.
There is another significant aspect influencing spreading of TAVR
method in the world that should be noted, namely its price. Wealthy
countries such as Germany and Switzerland are able to cover costs
of only 34,5% and 36,2% of the demand for the therapy respectively
while the European average is around 17,9%. The ideal prosthetic
heart valve should be made of durable materials resistant to
degradation, with biophysical properties to the greatest extent
similar to native leaflets or of natural materials modified
properly so that their mechanical parameters are reinforced and
improved.
[0007] The prosthetic heart valve known from the patent description
WO2018011592 has leaflets made of a biological material sewn into a
frame, a sewing ring. The ring comprises elements for attaching the
leaflets with a suture or other attaching materials. However, this
construction does not allow perfect stabilization of the whole
valve construction as well as for its appropriate and stable
apposition to vascular walls. Additionally, this method does not
allow to form the valve leaflets without cutting and preliminary
forming the material in order to form the leaflet structures, which
can cause impaired apposition and closing (coaptation) of the
leaflets and as a result leakage and defective closure. This way of
fabricating is time-consuming. What is more, intrusion into the
structure of the leaflet material may cause its damage, which
contributes to formation of leakages or coagulation on the material
edges undergoing treatment.
[0008] The prosthetic heart valve known from the patent description
WO2018004871 comprises a metal stent with longitudinal and
transverse meshes. The construction resembling commercially
available valves of metal frame connected with bovine or porcine
pericardium which undergoes various processes of chemical and
biological modification with sowing stem cells. The above mentioned
modification methods improve the quality of a biological material
and decrease the risk of calcification and coagulation. These
methods do not affect the quality of valve activity, hence ruling
out the risk of improper leaflet motion and in consequence
defective closure of the valve. However, introducing so many
modifications significantly rises the costs of fabricating and
increases the time of production.
[0009] The prosthetic heart valve known from the patent description
U.S. Pat. No. 5,984,973 is made of a natural material, it consists
of a metal frame to which a biological material forming the
leaflets is sewn by a continuous suture line with a monofilament
suture. In the upper part of the frame there are 3 vertical posts
evenly located in relation to the diameter of the frame, on which
the biological material is wound and sewn by circular suture line
creating commissures which form the leaflets. Continuous sewing
with a single commissure suture is less resistant to mechanical
damage and destruction. Damage in any place of such mounting may
cause untwisting of the commissure, stripping of the material and
damage of the valve. Additionally, pulling the material onto
vertical posts located in the upper part of the valve frame may
cause damage and ripping of the delicate biological material used
for forming leaflets due to valve activity and mechanical
overload.
[0010] The aim of the invention is to eliminate the defects of the
existing prosthetic heart valves as well as to reduce the cost of
manufacturing by use of an improved (optimized) method of
manufacturing the valve leaflets and a manner of sewing them.
[0011] The invention refers to a biological low profile balloon
expandable prosthetic heart valve, particularly aortic, for
transcatheter implantation, comprising a cylindrical valve frame
which consists of a valve section, supporting section and a
biological material sewn thereto. The upper part of a cylindrical
cuff made of a biological material is attached to the valve frame
in its supporting section on the outside and the cuff is folded to
the interior of the frame from below and it is attached to the
attaching posts in the valve section, and the upper parts of the
cuff which are not fastened to the supporting posts, on each side
of the post, are connected with each other on the valve frame
establishing commissures for the valve leaflets. Attaching the
biological cuff to the valve frame and to the posts for attaching
the cuff in the valve section is done by sewing, favourably with
use of a surgical suture. Sewing commissures in the frame area and
in the area of the post for attaching the cuff is made with a
monofilament suture, whose both ends alternately conducted through
the adjacent edges of the created valve leaflets move towards the
frame, and on the first suture line between the valve leaflets
there is a protrusion made on the suture, favourably in the form of
a knot.
[0012] The invention also refers to a method of manufacturing a
biological low profile, balloon expandable prosthetic aortic valve
for transcatheter implantation comprising the cylindrical valve
frame which consists of a valve section, supporting section and a
biological material sewn thereto. The upper part of a cylindrical
cuff made of a biological material is attached to the valve frame
in its supporting section on the outside, and the lower unattached
part of the cuff is folded and it is inserted to the interior of
the frame from below and it is attached to the attaching posts in
the valve section, and the upper parts of the cuff which are not
attached to the supporting posts, on each side of the post, are
connected with each other on the valve frame establishing
commissures for the valve leaflets. Sewing commissures in the frame
area and in the area of the post for attaching the cuff is made
with a monofilament suture, whose both ends alternately conducted
through the adjacent created valve leaflets move towards the frame
for the distance of 2 mm. On the first suture line between the
valve leaflets there is a protrusion made on the suture, favourably
in the form of a knot.
[0013] The prosthetic heart valve of the present invention is
characterised by high biocompatibility and of a low profile, which
enables applying the delivery system of the smallest diameter
possible. It adheres well to the aortic annulus in the supporting
section for eliminating the risk of leakages. It is possible to
reposition the valve with use of a special implantation system
including a balloon of a "dog bone" type.
[0014] The method of forming the prosthetic heart valve and its
leaflets takes less time than currently used methods of fabricating
biological prosthetic heart valves, which is approximately 3 hours.
So far the whole process has taken a few days. Furthermore,
applying the method of forming the cylinder folded into the
interior of the valve frame for forming its leaflets by creating
commissures, allows to eliminate the need to form them from a
number of separate elements, thanks to which the whole construction
and the material are more durable and resistant to damage and tear.
This method also allows to eliminate a big number of places of
sewing which are most prone to be damaged. Moreover, use of
alternate interlacing of sutures in the place of commissure allows
to avoid tearing of the whole mounting in the event of one thread
being torn and the whole bicuspid or tricuspid structure is still
preserved--a commissure is still supported by the other part of the
suture. Additionally, the unique manner of sewing allows to create
pockets between a frame and a valve leaflet, which further improves
apposition of leaflets to each other (coaptation) and they prevent
the leakage as well as allow free blood circulation as they do not
cause build-up of blood between the valve leaflet material and the
frame. Additionally, direct apposition of the cuff to the valve
frame lowers the risk of occurrence of free space, by means of
which paravalvular leakages are eliminated.
[0015] Adopting the above mentioned solutions significantly reduces
the time of valve fabricating, which in turn should relevantly
lower the costs of production and increase competitiveness of the
product. It should translate into the widest possible use and
further development of minimally invasive methods of repairing the
aortic valve and other valves.
[0016] The invention is presented in the examples of realization in
the drawings, in which
[0017] FIG. 1 shows the stent shoulder of the bicuspid heart valve
with the biological material sewn thereto and formed in the shape
of a cylinder,
[0018] FIG. 2 shows the stent shoulder of the tricuspid valve with
the biological material sewn thereto and formed in the shape of a
cylinder,
[0019] FIG. 3 shows the projection view from the front of the valve
stent with the biological material sewn thereto and with the marked
place of mounting in the valve section of the valve frame,
[0020] FIG. 4 shows the projection view from the front of the valve
stent with the biological material folded inwards with the marked
place of mounting in the valve section of the valve frame,
[0021] FIG. 5 shows a bicuspid valve formed by folding the
biological material previously sewn into and formed into the shape
of a cylinder into the interior of the frame and by sewing the
commissures,
[0022] FIG. 6 shows a tricuspid valve formed by folding the
biological material previously sewn into, formed into the shape of
a cylinder into the interior of the frame and by sewing the
commissures,
[0023] FIG. 7 shows the manner of creating commissures,
[0024] FIG. 8 shows the commissures in a bicuspid valve in the
closed and open position and
[0025] FIG. 9 shows the commissures in a tricuspid valve in the
closed and open position.
[0026] Shown below is an innovative model of the biological valve,
particularly aortic, intended for treatment of cardiovascular
system valve defects with the use of minimally invasive method.
[0027] The aortic valve comprises a metal stent of a cylindrical
design covered by a cuff made of a biological material (modified
pericardium). The method used for forming the cuff and for
attaching the biological material to the frame finally gives the
basis to form a biological aortic valve either bicuspid or
tricuspid.
[0028] The metal frame of the valve sized 16-29 mm of a cylindrical
design with the possibility for radial expansion comprising two
parts:
[0029] The lower part (supporting) made of the posts 0.4 mm thick
which are connected with each other in the manner ensuring
durability and enabling sewing the modified biological material
onto the valve frame. The posts of the supporting section are
connected with each other in a right-handed or left-handed design.
The size of the basal meshes of the supporting section is in the
range of 4-5 mm while the meshes of the middle section and the
section connected with the valve frame are sized 3-4 mm.
[0030] The upper part (valve) consists of the posts located
parallel to the axe of the supporting frame. The valve frame is
made of two kinds of basal posts and the posts onto which the
material is attached in order to form the valve leaflets.
[0031] The first (lower) ends of the valve frame posts are
connected with the supporting frame struts while the others (upper)
being connected to each other create the upper border of the
valve.
[0032] The height of the valve frame mesh (in the direction
parallel to the frame axe) is between 17 and 18 mm, branching off
they connect with the adjacent struts of the valve frame also in a
right-handed or left-handed design.
[0033] The design of the valve frame ensures fixed length of the
frame in the process of compression and expansion. Additionally, it
allows obtaining a low profile and coherent structure similar to a
tube after tightening the stent.
[0034] Thanks to the post thickness change in the lower part and
thanks to application of appropriate parameters the effect of "dog
bone" is obtained in the scaffolding. The frame design ensures low
traumatization of tissues during implantation and thanks to high
radial strength enables obtaining optimal hemodynamic
parameters.
[0035] The biological material in the form of sheets of porcine
pericardium from which the valve leaflets are formed is widely used
in the valves admitted to trading on a regulated market. The sheets
are obtained from breeding pigs kept on a special diet, which
allows their proper growth. Thereafter pericardium is purified and
carefully selected by a qualified staff so as to choose the best
quality some (taking into consideration flexibility, smoothness of
the texture and cohesion). The material is cut in the shape of a
square with a side length of the range 8-11 cm. Afterwards two
opposite sides are connected to each other creating a cylinder
(cuff) which is placed onto the supporting section of the valve
frame from the outside and it is sewn thereto by a continuous
suture line either single or double. The other part of the cuff is
folded into the interior of the stent. The surplus of the material
which stands out in the frame valve section is used to create
commissures which properly made constitute the valve leaflets
either bicuspid or tricuspid. The edges of the valve leaflets are
attached along the vertical axis to the frame valve section which
contains attaching posts. For the bicuspid valve there are two
posts, for the tricuspid valve there are three posts. The coupling
formed this way enables coherence and ensures undisturbed work of
the valve with full coaptation (apposition) of the leaflets which
translates into a favourable hemodynamic profile of the prosthetic
heart valve mentioned thereover.
[0036] A surgical suture with needles on both ends is used for
creating a commissure. In the middle section of the suture between
two ends a protrusion is made, favourably a knot, which is
afterward located inside a pocket which is formed by pressing the
edge of a material surplus in the place of vertical attachment of
the valve frame in the valve section. The knot is located in the
distance of 1-2 mm from the frame edge. By turns each suture is led
with a needle through the edges of the formed pocket from the two
opposite sides towards the valve frame. Each suture by turns goes
through the inner part of the formed pocket. Then it is led from
the outer part back into the inside of the pocket, afterwards it
goes through the opposite edge. This manner of dragging is repeated
several fold for each of the sutures in order to approximate two
edges tightly, thanks to which a commissure is formed and the valve
leaflet is formed. Consecutively the other unattached suture ends
on the valve frame are mounted by means of surgical knots to the
attaching elements in the valve section of the valve frame.
* * * * *