Source: https://patents.google.com/patent/US8353953B2/en
Timestamp: 2019-04-20 15:04:25+00:00

Document:
2013-03-04 Assigned to SORIN GROUP ITALIA S.R.L. reassignment SORIN GROUP ITALIA S.R.L. MERGER (SEE DOCUMENT FOR DETAILS). Assignors: SORIN BIOMEDICA CARDIO S.R.L.
A device for deploying a cardiac valve prosthesis includes a distal valve holder portion and a shaft extending towards the valve holder portion. The shaft is selectively bendable to a curved shape to vary the spatial orientation of the valve holder portion with respect to the desired implantation site.
The present invention relates to devices for the in situ delivery of heart valves. More specifically, the invention relates to delivery devices for cardiac valve prostheses using minimally-invasive surgical techniques or endovascular delivery techniques.
Expandable prosthetic valves typically include an expandable and collapsible anchoring structure or armature, which is able to support and fix the valve prosthesis in the implantation position, and prosthetic valve elements, generally in the form of leaflets or flaps, which are stably connected to the anchoring structure and are able to regulate blood flow.
These expandable prosthetic valves enable implantation using various minimally invasive or sutureless techniques. Exemplary applications for such an expandable valve prosthesis include aortic and pulmonary valve replacement. Various techniques are generally known for implanting an aortic valve prosthesis and include percutaneous implantation (e.g., transvascular delivery), dissection of the ascending aorta using minimally invasive thoracic access (e.g., mini-thoracotomy or mini-sternotomy), and transapical delivery wherein the aortic valve annulus is accessed through an opening near the apex of the left ventricle. The percutaneous and thoracic access approaches involve delivering the prosthesis in a direction opposing blood flow (i.e., retrograde), whereas the transapical approach involves delivering the prosthesis in the same direction as blood flow (i.e., antegrade).
The present invention, according to one embodiment, is a device for delivering a cardiac valve prosthesis to an implantation site. The device includes a distal valve holder portion defining a cavity adapted to receive and radially constrain the valve prosthesis therein; a shaft coupled to the valve holder portion, the shaft including a tubular sleeve and a core disposed partially within the tubular sleeve, the core adapted to move axially with respect to the sleeve; a valve support disposed at or near a distal end of the shaft, the valve support including an annular recess adapted to mate with a portion of the valve prosthesis; a deployment mechanism adapted to axially translate the valve support with respect to the distal valve holder, such that the valve prosthesis is selectively deployed at the implantation site; and a deflection mechanism coupled to shaft, the deflection mechanism adapted to selectively vary the spatial orientation of the valve holder portion with respect to the implantation site.
The present invention, according to another embodiment, is a device for delivering a cardiac valve prosthesis to an implantation site, which includes a distal valve holder portion and a shaft coupled to the valve holder portion. The shaft is selectively bendable to a curved shape to selectively vary the spatial orientation of the valve holder portion with respect to the implantation site.
FIG. 1 is a general perspective view of a valve delivery device according to an exemplary embodiment.
FIGS. 2 a and 2 b are longitudinal sectional views of the device of FIG. 1 according to exemplary embodiments. FIGS. 2 a and 2 b show an exploded view, wherein the components shown in FIG. 2 b are intended to be located within the components shown in FIG. 2 a.
FIG. 3 is a partial sectional view of some of a portion of the device shown in FIG. 2.
FIG. 5 is a cross-sectional view taken along line V-V of FIG. 3.
FIG. 6 is a perspective view showing a portion of the device indicated by an arrow VI in FIG. 2 b.
FIG. 7 is a perspective view showing a portion of the device indicated by an arrow VII in FIG. 2 b.
FIG. 8 is a perspective view of a valve delivery device according to another exemplary embodiment.
FIG. 9 is a perspective view of an exemplary component of an embodiment.
In the following description, numerous specific details are given to provide a thorough understanding of embodiments. The embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
FIGS. 1 and 8 are perspective views of exemplary embodiments of a valve delivery device 100. The device 100 includes a handle 1 for manipulation by a practitioner and a holder unit 10 for a valve V to be delivered. As shown, the handle 1 and the holder unit 10 are generally located at proximal and distal ends of the device 100.
As used herein, “proximal” and “distal” refer to the conditions of handling of the device 100 by a practitioner who manipulates the device via the handle 1 at the “proximal” end in order to permit delivery of the valve V at the “distal” end of the device 100. Thus “proximal” and “distal,” as used herein, have no direct relationship to the approach (retrograde or antegrade) adopted for delivering the valve V.
In one exemplary embodiment, the valve V is of the type disclosed in U.S. Publication 2006/0178740, which is incorporated herein by reference. Such a prosthetic valve includes two annular end portions V1, V2 (i.e. inflow and outflow with respect to the direction of unimpeded flow of blood through the valve).
As shown in FIG. 1, the valve is arranged in the holder unit 10 at the distal delivery end of the device 100 with the annular portions V1, V2 in a radially contracted condition.
In the exemplary illustrated arrangement, the annular portions V1 and V2 are located “distally” and “proximally,” respectively of each other with reference to the orientation of the device 100. In the following it will be assumed that the valve V is delivered by releasing the annular portion V1 first and then by causing the valve V to gradually expand (e.g. due to its elastic or superelastic nature), starting from the portion V1 and continuing to the portion V2, until expansion is complete.
As further shown in FIG. 1, the device 100 includes a shaft 6, which is adapted to be selectively shaped into a curved pattern as further described below. The shaft 6 extends from the handle 1 to the holder unit 10 for the valve.
In various embodiments, the holder unit 10 includes an inner body or valve support 9 integral with or coupled to the tubular core 16 and including an annular groove or similar recessed 90 formation (see FIGS. 2 b) adapted to receive the (proximal) annular portion V2 of the valve V in a radially contracted condition.
In the embodiments shown in FIGS. 2 to 7, the shaft 6 includes a tubular sheath or sleeve 8 slidably arranged over the tubular core 16. The sleeve 8 is adapted to couple with or fit into a proximal sleeve 4, fixed in rotation with respect to the handle 1. The sleeve 4 has an outer threaded surface 40 to cooperate with a complementary threaded formation 30 provided at the inner surface of a tubular rotary actuation member 3 arranged around the sleeve 4. The actuation member 3 is fixed in translation with respect to the shaft 6. In an embodiment, a tapered sheath 2 a acts as an interface between the proximal sleeve 4 and the sleeve 8.
The sleeve 8 extends over the tubular core 16 and terminates with a distal portion including a terminal enlarged portion 800 adapted to extend around the distal portion of the core 16 to form an external tubular member of the holder unit 10, which is adapted to radially constrain and retain the valve V when disposed therein.
The terminal enlarged portion 800 may be either one-piece with the rest of the sleeve 8 or, as shown in FIG. 2 a, may include a separate tubular member coupled (e.g., adhesively or by means of screws, rivets, protrusions, etc.) to a funnel-shaped formation 800 a located at the terminal end of the distal portion 80 of the sleeve 8. In an embodiment, a tapered sheath 2 b acts as an interface between the sleeve 8 and the funnel shaped element 800 a.
According to various embodiments, the threaded surface/formations 30, 40 comprise a “micrometric” device actuatable by rotating the actuation member 3 to produce and precisely control axial displacement of the sleeve 8, 800 over the core 16. Such a controlled movement may take place along the core 16 starting from an extended position, as shown in FIG. 1, where the outer member 800 of the holder unit 10 radially constrains and retains the valve V.
As the sleeves 4, 8 are gradually retracted towards the handle 1 (by operation of the actuation device 30, 40, which are controlled by the rotary member 3), the outer member 800 gradually releases first the annular portion V1 of the valve V, then the portion of the valve located between the annular portion V1 and the annular portion V2, and finally the annular portion V2 of the valve V, thus permitting gradual radial expansion of the valve V. According to other embodiments, the device 100 includes a two-part actuation mechanism of the type disclosed in co-pending, commonly assigned U.S. application 12/465,262, now published as U.S. 2010/0292782, filed on May 13, 2009, entitled “DEVICE FOR THE IN SITU DELIVERY OF HEART VALVES,” which is incorporated herein by reference.
In an exemplary delivery procedure of the valve V, the practitioner introduces the device 100 into the patient's body and advances it through the delivery route or path until the outer member 800 is located at the annulus of the natural valve to be substituted by the valve V. The practitioner may use any of a variety of known techniques for delivering the device 100 to the valve annulus site.
In various embodiments, the radial dimensions of portion 800 are slightly less than the radial dimensions of the annulus of the natural valve intended to be substituted. In these embodiments, the outer member 800 will not unduly move about or “dance,” while being positioned within the natural annulus. In various exemplary embodiments, these radial dimensions are in the range of between about 10 mm and about 27 mm.
In the exemplary case of aortic valve replacement, this may involve the outer member 800 being located immediately distally (with respect to the flow direction blood pumped from the left heart ventricle) of the aortic annulus so that the annular portions V1 and V2 are located on opposite sides (i.e. astride) of the Valsalva sinuses. In other words, the portion V1 is located on one of the ventricle side and the aortic root side of the Valsalva sinuses, and the portion V2 is located on the opposite side of the Valsalva sinuses.
Once the portion 800 is disposed properly at the annulus site, the practitioner will actuate the rotary actuation member 30 by rotating it in such a way that cooperation of the threaded sections 30 and 40 will cause the outer sleeve 8 and the proximal sleeve 4 to start gradually retracting towards the handle 1. As a result of this retraction of the outer sleeve, the outer member 800 will gradually disengage the annular portion V1 of the valve V. The annular portion V1 will thus be allowed to radially expand.
Gradual withdrawal of the sleeves 4, 8 proceeds until the outer member 800 has almost completely disengaged the valve V, while the annular formation V2 is still securely retained by the tubular member 800 of which still forces the annular formation V2 of the valve within the inner body 9 of the a holder portion.
This deployment mechanism of the annular formation V1 and the valve V may be controlled very precisely by the practitioner via the screw-like mechanism 30, 40 actuated by the rotary member 3. Deployment may take place in a gradual and easily controllable manner by enabling the practitioner to verify how deployment proceeds.
Also, so long as the annular formation V2 of the valve V is still constrained within the formation 9 by the tubular member 800, the practitioner still retains firm control of the partially (e.g., “basket-like”) expanded valve V. The practitioner will thus be able to adjust the position of the valve V both axially and radially, that is by rotating the valve V around its longitudinal axis, e.g. to ensure that radially expanding anchoring formations of the valve V are precisely aligned with the Valsalva sinuses to firmly and reliably retain in place the valve V once finally delivered.
In various embodiments, the portion 800 has a marginal outer edge provided with one or more notches 802 providing a reference in angular positioning of the valve V at the implantation site. In various embodiments, these notches are visible during implantation (e.g., using radiography or other common implantation techniques).
According to various embodiment, the annular portion V2 of the valve V is received in the formation 9 and is thus blocked against any significant axial movement, during the retraction of the sleeve 8 and the sleeve 4 over the core 16. In other words, the valve V will not experience any significant axial displacement with respect to the shaft 6. The retraction of the outer sleeve 8 continues until the annular formation V2 (and the valve V as a whole) become disengaged from the device 100 and thus completely deployed at the implantation site.
While a cardiac valve prosthesis including two self-expandable annular portions has been considered herein for exemplary purposes, this disclosure similarly applied to cardiac valve prostheses including further expandable annular portions and/or one or more annular portions that are expandable via an expansion means such as an inflatable balloon.
In various embodiments, the device 100 includes an illuminator device 300 located at the holder unit 10 to provide illumination of the implantation site of the valve V. In minimally-invasive surgical procedures the operation site is observed directly by the practitioner via the (minimally-invasive) access path gained through the thorax of the patient. The action of the illuminator 300 is beneficial in that penetration of ambience light to the implantation site may be reduced or impeded by the body structures of the patient. In various embodiments, the illuminator device 300 is adjustable.
In the exemplary embodiment shown in FIG. 1, the illuminator 300 is fed with light radiation produced by a source 1000 via fiber optical element 2000 which extends through the shaft 6 (for instance by extending in an axial cavity 60 provided in the tubular core 16). Preferably (see also FIG. 2 b), the fiber optical element 2000 enters the shaft 6 by means of a connector 7 (e.g, a Luer-Lock female connector). In other embodiments, such an axial cavity 60 of the shaft 6 may be also be employed for other reasons as detailed below.
Various embodiments include features to facilitate spatial orientation of the valve V with respect to the implantation site. In various embodiments, the shaft 6 is flexible and adapted to be imparted specific curved shapes. The shaft 6 being flexible and selectively bendable makes it possible to deflect or “steer” the holder unit 10 with respect to the handle 1. Due to such delectability or steerability the practitioner can select a desired spatial orientation of the holder unit 10 (and thus of the valve V) which facilitates positioning the valve V at the implantation site with a desired spatial orientation. This orientation may correspond to an orientation that avoids or minimizes the application of undesired mechanical stresses to the implantation site (i.e. to the heart tissues of the patient), while achieving the desired orientation of the valve V.
Steerability of the holder unit 10 permits a main axis X10 of the holder unit 10 to be arranged at a desired orientation which is generally skew or bent with respect to the axis X1 of the proximal portion of the device. The axis X1 essentially corresponds to the main axis of the handle 1 and the parts of the device adjacent thereto (i.e. the proximal sleeve 4 and the rotary actuation member 3). FIG. 1 is exemplary of the main axis X10 of the holder portion 10 being steered (i.e. bent) to an angle α with respect to the axis X1.
It will likewise be appreciated that any desired “radial” or “polar” orientation of the axis X10 with respect to the axis X1 may be simply achieved by the practitioner by rotating the device 100, as a whole, around the axis X1, by rotating the handle 1 within the practitioner's hand.
In various embodiments, the shaft 6 is made adjustable or “steerable” by means of a wire member 12 extending through the axial cavity 60 in the tubular core 16 and cooperating with a tensioning mechanism (see FIG. 7). In an embodiment, the tensioning mechanism includes a fixed tubular member 13, a rotary member 14 and an anchoring member 15.
The tubular member 13 includes a distal end 130 coupled and integral with a proximal end of the core 16, a radially expanded portion 132 and a proximal portion 134 provided with an outer thread 136.
The rotary element 14 is coupled to the outer thread 136 by means of an inner thread. The second tubular element 15 is slidably mounted over the outer thread 136 of the member 13 and is fixed in rotation (e.g., by means of a radial pin engaging a groove provided in the member 13).
The wire member 12 is anchored at the distal portion of the core 16 (e.g. in proximity of the inner body 9 carrying the annular portion 90 into which the portion V2 of the valve V is constrained) and extends within the shaft towards the mechanism 13, 14, 15.
With reference to FIGS. 2 a, 2 b, in some embodiments, the actuation mechanism 13, 14, 15 extends through the proximal sleeve 4, the rotary actuation member 3 and the handle 1. The distal portion 30 of the actuation mechanism may also extend partially into the sleeve 8 and the core 16. In some embodiments, the distal portion 130 is inserted in the sleeve 4 with the radially expanded portion 132 providing an abutment surface to the sleeve 4.
Moreover, in various embodiments, the member 13 is provided with a longitudinal groove 1300 (see FIG. 7) adapted to rotationally fix the sleeve 4 with respect to the member 13 (e.g., by means of a radial pin or screw). In these embodiments, the length of the groove 1300 determines the longitudinal (i.e., axial) range of relative motion of the member 13 with respect to the sleeve 4. In other embodiments, the expanded portion 132 has an annular groove 1320, which is adapted to fix the rotating actuation member 3 in translation with respect to the member 13 (e.g., by means of a radial pin or screw engaging groove 1320), which allowing partial or complete rotational movement therein.
In various embodiments, the radially expanded portion 132, which is surrounded by the rotary actuation member 3 and the outer thread 136, as well as the whole proximal portion 134, is located inside the handle 1. In various embodiments, the member 13 has an elongated shape permitting it to extend within the handle 1 to be secured thereto (e.g., by means of radial screws), while also acting as a support member for the shaft 6. This ensures no rotation of the member 13 inside the device 100, since the handle 1 is firmly held by the practitioner's hand.
The mechanism 13, 14, 15 is intended to pull (i.e., to apply a longitudinal, tensile force to) the wire member 12 towards the handle 1 so that a longitudinal tensile force is applied to the core 16 to produce controlled bending of the shaft 6.
In various embodiments, the core 16 includes a proximal portion 20 and a distal portion 21. The proximal portion 20 (see, e.g., FIG. 3) includes an external sheath 22 and a coil element 24, helically wound therein. The coil element 24 is intended to provide a certain amount of flexibility to the core 16 (i.e., to the shaft 6), particularly to the proximal portion 20.
The distal portion 21 (see, e.g., FIG. 6) includes an external sheath 32 and a braided tubular element 34 located therein. A pair of longitudinal formations 36 is constrained between the external sheath 32 and the braided tubular element 34, and partially extends also between the coil element 24 and external sheath 24 of the proximal portion 20. In some embodiments, the longitudinal formations 36 are made of metallic material. The longitudinal formations 36 are intended to give a certain amount of stiffness to the distal portion 21 of the shaft 6, avoiding at the same time any undesired lateral bending thereof.
The coil element 24 and the braided tubular element 34 define an axial cavity, such as, for instance, the axial cavity 60, wherein the wire 12 extends from the distal portion of the core 6 to the member 15, where a proximal portion 120 of the wire member 12 is securely fixed.
In various embodiments, the wire 12 includes a proximal portion 120 which passes through a slot 1340 provided in the member 13 (see FIG. 7) and is anchored (for instance by mechanical clamping or crimping) to the member 15. In various embodiments, the wire 12 may be a tendon, a string, a suture, a wire, or a variety of other elements adapted to transmit a tensile force.
In various embodiments, the member 14 is a rotary ring-like member. Rotating the member 14 will thus cause the element 15 to slide axially relative to the member 1 in either direction depending on the direction the member 14 is rotated.
When rotated, the member 14 moves longitudinally in a proximal or distal direction, depending on the direction of rotation, along the outer thread 136 of member 13, thereby producing displacement of the member 15 over the member 13, proximally or distally depending on the direction of rotation of member 14.
In the case of a displacement of the member 14 in the proximal direction (i.e., towards or into the handle 1), the element 15 will be urged proximally to produce/increase longitudinal tensioning of the wire-like member 12, which, in turn, will translate into (increased) bending of the shaft 6.
In the case of a displacement of the member 14 in the distal direction (i.e., away or outwardly of the handle 1), the member 15 will correspondingly be able to slide distally thus releasing the tensile force on the wire-like element 12. This will gradually release its longitudinal tension, thereby reducing the amount of bending between the axes X10 and X1. The members 14, 15 will remain in contact with each other as long as there is a longitudinal tension in the wire-like element 12, acting as a sort of bias on members 14, 15. This ensures correspondence between the displacements of members 14 and 15 (i.e., smooth adjustment of the amount of bending). The amount of bending (i.e., the resulting angle a between the axes X10 and X1 in FIG. 1) can thus be selectively adjusted by the practitioner by acting on the rotary member 14.
In the embodiments considered herein the distal portion 21 of the tubular core 16 is intended to achieve the desired amount of bending with respect to the axis X1 having a minimum flexibility, while the proximal portion 20 is given a certain amount of flexibility substantially without being angularly displaced from the axis X1.
In various embodiments, the handle 1 is provided with an opening or window 140 through which the rotary member 14 can be actuated by the practitioner (e.g., by alternate action of the thumb). This exemplary mechanism provides the benefit of being actuatable by the practitioner by rotating the rotary member 14 while retaining a firm hold of the handle 1.
Rotation can be, as previously described, in either direction, so that the amount of longitudinal tension applied on the member 12 can be selectively varied while the bending angle of the shaft 6 will correspondingly vary based an the amount of tension applied by the member 12. The angle between the axes X10 and X1 (i.e. the spatial orientation of the holder portion 10 and the valve V located therein) can thus be selectively varied depending on the practitioner's needs and preferences during the intervention.
Those skilled in the art will appreciate that the action of applying a longitudinal tension onto the member 12 can be achieved by resorting to different mechanisms (e.g., by means of screw mechanism actuated by rotating the handle 1).
The embodiment of FIGS. 8 and 9 may adopt, insofar as the release/delivery mechanism of the valve V is concerned, the same “micrometric” mechanism actuated via the rotary member 3 as discussed above. In the embodiments of FIGS. 8 and 9, the desired “steering” of the holder portion 10, causing the angle X10 to form an adjustable angle α to the axis X1, can be achieved by coupling to the shaft a shaping member 5 (see FIG. 9) such as, for instance, a wire-like shaping member 5 inserted into an axial cavity of the shaft 6. In various embodiments, such a cavity may be the cavity 60 already provided for the fiber optic element 2000 to extend through the core 16 (as shown, e.g., in FIG. 2 b).
In various embodiments, the shaping member 5 (FIG. 9) can be comprised of a bent steel rod rigid enough that, when inserted and advanced into the flexible shaft 6, the shaping member 5 will impart to the shaft 6 a bent shape which will correspond to the bent shape of the member. The composite shape of the bending member 5 and the flexible shaft 6 will depend on the bending resistance of each component.
In various embodiments, the shaping member 5 is one of an assortment of otherwise similar shaping member having different values for the “steering” angle α between X1 and X10 to be imparted to the shaft 6. Accordingly, once access to the implantation size is gained, the practitioner may evaluate the desired orientation of the holder portion 10 which will allow optimal delivery of the valve V at the implantation site. The practitioner will then select a positioning member 5 out of the assortment as the one providing such desired orientation. The shaping member thus selected will then be inserted into the shaft 6 to impart to the shaft the desired mutual orientation of the axes X10 to the axes X1.
a deflection mechanism coupled to shaft, the deflection mechanism adapted to selectively vary the spatial orientation of the valve holder portion with respect to the implantation site.
2. The device of claim 1, wherein the shaft is selectively bendable to a curved shape to selectively vary the spatial orientation of the valve holder portion with respect to the implantation site.
3. The device of claim 2, including a curved shaping member for coupling to the shaft to impart to the shaft a curved shape influenced by the shaping member.
4. The device of claim 3, wherein the shaft has an axial cavity for insertion of the curved shaping member.
5. The device of either of claim 4, wherein the curved shaping member is in the form of a curved rod.
6. The device of any of claim 5, wherein the curved shaping member for coupling to the shaft is selectable out of a plurality of shaping members each having a respective curved shape, whereby the shaft is imparted different curved shapes by coupling it to different shaping members in the assortment.
7. The device of claim 2, wherein the shaft is configured to bend when subjected to a longitudinal force.
8. The device of claim 7, wherein the shaft has a cavity and a wire-like member extending in the cavity, the wire-like member having associated tensioning members to apply a longitudinal force to the wire to produce a bending of the shaft.
an actuation member actuatable between the tubular member and the anchoring member, the actuation member operable to selectively produce relative movement of the tubular member with respect to the anchoring member to thereby apply a longitudinal tensile force to the wire-like member.
10. The device of claim 8, including a rotary actuation member adapted to apply a longitudinal force to the shaft.
11. The device of claim 10, including a handle with the shaft extending from the handle, the handle including the rotary actuation member located therein and open to access from outside the handle.
12. The device of claim 11, including an opening in the handle for access to the rotary actuation member.
13. The device of claim 12, for deploying a cardiac valve prosthesis including at least one radially expandable annular portion, wherein the valve holder portion includes at least one constraint member for radially constraining the at least one annular portion, the at least one constraint member actuatable to release the at least one annular formation constrained thereby to permit radial expansion thereof.
14. The device of claim 13, wherein the at least one constraint member includes at least one sleeve slidably actuatable along the shaft, whereby the at least one constraint member releases the at least one annular formation constrained thereby.
15. The device of claim 14, wherein the distal valve holder portion has a diameter of between about 10 mm and about 27 mm.
16. The device of claim 2, wherein the distal valve holder portion has a marginal outer edge provided with at least one notch providing reference in angular positioning of the cardiac valve prosthesis.
European Search Report issued in EP Application No. 08159301, mailed Dec. 30, 2008, 6 pages.
Extended European Search Report Issued in EP Application 07115960, dated Jan. 24, 2008, 8 pages.
Huber, Christoph H. et al., "Direct-Access Valve Replacement: A Novel Approach for Off-Pump Valve Implantation Using Valved Stents", Journal of the American College of Cardiology, vol. 46, No. 2, 2005, pp. 366-370.
Partial European Search Report issued in EP Application No. 10155332, dated Jun. 9, 2011, 7 pages.

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 Application No. 08159301
 Application No. 10155332