Source: https://patents.google.com/patent/EP2484309A1/en
Timestamp: 2018-07-16 18:59:33
Document Index: 600854417

Matched Legal Cases: ['art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110']

EP2484309A1 - Heart valve prosthesis - Google Patents
EP2484309A1
EP2484309A1 EP20110153114 EP11153114A EP2484309A1 EP 2484309 A1 EP2484309 A1 EP 2484309A1 EP 20110153114 EP20110153114 EP 20110153114 EP 11153114 A EP11153114 A EP 11153114A EP 2484309 A1 EP2484309 A1 EP 2484309A1
EP20110153114
A heart valve prosthesis includes a supported valve (16) including a biological valve portion (76) mounted within a support structure (12). The supported valve is configured to provide for substantially unidirectional flow of blood through the supported valve. The supported valve has inflow (78) and outflow (80) ends that are spaced axially apart from each other. A fixation support member (14) includes inflow (40) and outflow (42) portions. The inflow portion of the fixation support member extends from a radially inner contact surface (44) of the fixation support member radially outwardly and axially in a direction of the inflow end of the supported valve. The outflow portion of the fixation support member extends from the radially inner contact surface radially outwardly and axially in a direction away from the inflow portion of the fixation support member. The radially inner contact surface (44) is attached to a radially outer surface of the supported valve adjacent the inflow end of the supported valve. The supported valve (16) and the fixation support member (14) are deformable between a reduced cross-sectional dimension and an expanded cross-sectional dimension thereof, whereby implantation of the heart valve prosthesis is facilitated.
Various types of heart valve prostheses have been developed to replace the patient's native valve exhibiting valvular disease or dysfunction. Valve replacement offers requires open heart surgery, although more minimally invasive procedures (e.g., percutaneous implantation) may be utilized for replacing certain valves. Heart valve prostheses typically are either mechanical valve designs or biological designs.
When the prosthesis 18, which includes support structures 10 and 12, is heated to its transformation temperature, which may vary according to the alloy composition, it quickly reverts to its high-temperature (austenitic) form. The prosthesis thus may retain the compressed condition by keeping it cooled. Alternatively, the stent and valve may be retained in the compressed position, such as with sutures circumscribing the structure, a cylindrical enclosure (e.g, barrel of an implanter) around the structure, etc. The prosthesis 18 will then return toward its high-temperature (or original) position upon removal of the retaining element.
In the cross-sectional view of Fig. 5, it is shown that a longitudinal cross-section through the prosthesis 18 demonstrates a substantially V-shaped cross-sectional configuration of the fixation support member 14 in its expanded cross-sectional dimension. For instance, the radially inner contact surface 44 defines an apex and each of the inflow and outflow portions of the fixation support member define legs of the V-shaped cross-sectional configuration. It will be appreciated that the term "substantially" as used in relation to the V-shaped configuration is intended to encompass that the apex of the "V" can be curved or arcuate (as shown in FIG. 5) as well as being pointed. Additionally, the legs of the V-shaped configuration do not need to perfectly straight, but can be curved provided that distal ends of the inflow and outflow portions are axially spaced apart to enable tissue to be received therebetween when implanted. The space between the legs of the V-shaped cross-sectional configuration defines a receptacle, indicated at 102, dimensioned and configured for receiving tissue therein. For the example of FIGS. 2-5, the receptacle 102 has a generally toroidal shape. It will be understood that the fixation support member 14 may be implemented with or without the web or other covering or with a different covering that is not continuous, as in the examples of FIGS. 3-5.
As also depicted in the example of FIG. 5, the inflow portion 54 is separated from the outflow portion 56 in its expanded condition by an angle equal to the sum of angles θ1 and θ2, each of which is drawn relative to a plane 104 that extends through the prosthesis 18 transverse to the longitudinal axis thereof. The combined angle of θ1 + θ2 is greater than 40°, and typically ranges between 70 and 100°. Additionally, θ2 can be greater than θ1 to better accommodate receiving native tissue for implantation of the prosthesis 18 at the mitral position.
FIGS. 6 and 7 depict an example of the prosthesis 18 implanted at the mitral position in a patient's heart 110. FIG. 7 is an enlarged view of the implanted prosthesis 18 from FIG. 6. As shown in FIGS. 6 and 7, the space 102 between the inflow and outflow portions 54 and 56 of the fixation support member 14 provides a receptacle for receiving therein tissue at the mitral valve annulus 112. Thus, the annulus 112, including portions of the patient's native valve 114, can fit within the corresponding receptacle space 102 formed between the opposing surfaces of the inflow and outflow portions 54 and 56 to help hold the prosthesis 18 at the desired mitral position without requiring the use of sutures. Of course, one or more sutures (not shown) can be applied to further affix the prosthesis.
Also demonstrated in FIGS. 6 and 7, the spikes 34 can extend outwardly from the inflow and outflow portions 54 and 56 and, in turn, grippingly engage the respective native annulus tissue at the inflow end of the mitral valve and the patient's native valve leaflets 114 at the outflow portion. Additional spikes from the inflow end of the supported valve can also help fix and anchor the prosthesis 18 at the mitral position.
As described herein, the prosthesis 18 can be implanted in a low invasive procedure, which may include no cardio pulmonary bypass or may be implemented with a reduced amount of cardio pulmonary bypass relative to other mitral valve replacement procedures. Additionally, when implanted, the prosthesis 18 can be implanted without removing the patient's native mitral valve, as shown. However, the prosthesis can also be implanted if the patient's value is removed (wholly or partially).
At some time prior to implanting the valve at the desired implantation site, for each of the approaches of FIGS. 8 or 9, the heart valve prosthesis 18 is inserted into a barrel 120 of an implanter, such that the prosthesis has the reduced cross-sectional dimension relative to the expanded cross-sectional dimension of the prosthesis. The implanter can be of the type shown and described with respect to FIG. 19 of U.S. Patent Application Serial No. 10/266,380, filed on October 8, 2002 , and entitled HEART VALVE PROSTHESIS AND SUTURELESS IMPLANTATION OF A HEART VALVE, which is incorporated herein by reference. The implanter in the above-incorporated patent application provides a substantially linear barrel, which can have a flexible or bendable tip to facilitate direct implantation through the heart to the desired implantation site. This type of implanter is especially well-suited for mitral valve replacement over catheters or other percutaneous types of implanters due to the large diameter of typical native mitral valves. Other types of implanters may also be employed for performing the methods described herein.
Returning to the example of FIG. 8, before inserting the barrel 120 into the patient's heart 110, an opening 122 is created in the patient's heart 110 to provide a substantially direct path to a valve annulus 112 in the patient's heart 110. As used herein, the term "substantially" as modifier for "direct path" is intended to convey that the opening is intended to provide a line-of-sight path from the opening to the implantation site, although some deviation might exist. Such deviation can be compensated, for instance, by employing a bendable barrel 120 that can be inelastically deformed to a shape to facilitate implantation at the site or by deforming the heart manually during the procedure to provide the corresponding path along which the barrel can traverse. This is to be contrasted with percutaneous implantation procedures that are performed through femoral vein, for example.
As a further example, a mattress suture, or other type of purse string suture 127 can be applied at location in the patient's heart through which the implanter is to be inserted. In the example of FIG. 8, the location comprises the patient's heart muscle located at the apex 126 of the heart 110. Two ends of the purse string 127 suture extend from the apex tissue can be tightened around the barrel 120 to mitigate blood loss. Consequently, cardiopulmonary bypass is not required. However, it is to be understood that in certain situations, some bypass may be necessary, although usually for a much shorter period of time than with conventional procedures.
As shown in FIG. 8, the barrel 120 of the implanter has been inserted through the apex 126 of the patient's heart 110. For instance, the valve of the prosthesis 18, in its reduced cross-sectional dimension, can have a diameter of 15 mm to 20 mm for implanting a valve having a 24-35 mm fully expanded diameter. Those skilled in the art will appreciate that valve dimensions (e.g., ≥ 24 mm) are not suitable for percutaneous implantation procedures. However, such sizes of valves are deemed appropriate and sometimes necessary for replacement of the mitral valve. Additionally, many existing manufactured pericardial valve designs designed for minimally invasive percutaneous implantation are not effective at such large sizes and/or are not capable of operating under the hemodynamic conditions that typically exist for the mitral position.
During a closed heart procedure, the insertion of the implanter can be guided by a patient's finger (or other instrument) 128 that is introduced via the left atrial appendage 130. A purse string or mattress suture 132 can be applied around the atrial appendage to mitigate blood loss. The surgeon's finger can locate the patient's native valve and associated annulus 112 to help position and guide the distal end of the implanter to the desired implantation site. Once at the desired site, the valve can be discharged from the barrel 120 of the implanter and the implanter withdrawn from the heart 110. The finger (or other instrument) 128 can also be used help guide the valve to ensure its fixation and implantation at the appropriate position at the mitral annulus 112, such as shown in Figs. 6 and 7.
In order to facilitate proper positioning of the prosthesis 18, a positioning apparatus (e.g., a dilator or umbrella or other structure) 136 can be inserted through the heart muscle, such as the apex 126 of the patient's heart 110, and positioned to a desired location. A purse string suture 127 can be employed at the apex 126 and tightened around the instrument to control bleeding. The placement of the positioning apparatus 136 can be guided by fluoroscopy or other imaging modalities.
By way of example, positioning apparatus 136 can include an umbrella-type distal end 138 that is attached to a shaft 140. The distal end 138 can be inserted in a closed condition through the apex 126 to a desired position the patient's heart valve and expanded to an open condition. In the open condition, the distal surface of the opened umbrella 138 provides a back stop against which the discharge end of the barrel 120 or prosthesis 18 can engage for defining an implantation position. For instance, once the barrel 120 of the implanter engages the distal end 138, which can be felt or otherwise perceived by the surgeon, the prosthesis 18 can be discharged from the barrel at the mitral valve annulus. When expanded, the inflow and outflow portions 54 and 56 of the fixation support member 14 can receive tissue at the mitral annulus and thereby hold the prosthesis 18 at a fixed axial position relative to the mitral annulus 112, as shown in FIGS. 6 and 7.
The angular relationship of the respective support structures 173 and 175 can also be implemented as discussed with respect to the example of FIG. 5. For instance, an angle between the facing surfaces of the respective inflow and outflow support portions 173 and 175 can be greater than 40°, typically ranging between 70 and 100°. Additionally, the angular contribution of the outflow portion 175 can be greater than that of the inflow portion, such as described with respect to FIG. 5, to better accommodate the dimensions and configurations of the mitral valve annulus, which may include the patient's native leaflets when the prosthesis 152 is implanted. Since according to one embodiment the prosthesis 152 can be implanted at the mitral position, the supported valve 16 can be provided with a diameter or size that is greater than 23 millimeters, such as ranging from about 25 millimeters to about 34 millimeters, or even larger. The prosthesis 174 thus can be configured to function and can be implanted as described with respect to FIGS. 8 and 9.
The prosthesis of claim 1, wherein the fixation support member further comprises:
The prosthesis of claim 2, wherein the flexible and deformable annular support comprises a continuous monolithic structure in which the support features alternate extending between the inflow and outflow directions along a circumferential path corresponding to the radially inner contact surface.
The prosthesis of claim 2, wherein the flexible and deformable annular support comprises separate inflow and outflow support portions supports that are connected together to define the radially inner contact surface of the fixation support member.
The prosthesis of claim 2, wherein at least some of the support features further comprise spikes that extend outwardly from respective support features toward the other of inflow or outflow portion of the fixation support member.
The prosthesis of claim 2, wherein the support structure of the supported valve further comprises a substantially cylindrical support extending between the axially spaced apart inflow and outflow ends thereof, the cylindrical support including a plurality of support features extend generally axially between the axially spaced apart inflow and outflow ends of the cylindrical support, adjacent pairs of the support features being interconnected so as to bias the cylindrical support radially outwardly toward the expanded cross-sectional dimension.
The prosthesis of claim 1, wherein a longitudinal cross-section axially through the prosthesis in its expanded cross-sectional dimension provides an angle between the inflow and outflow portions of the fixation support member that is greater than about forty degrees, space between axially opposed surfaces of the inflow and outflow portions defines an receptacle dimensioned and configured for receiving therein tissue at a valve annulus.
The prosthesis of claim 7, wherein the angle between the inflow and outflow portions of the fixation support member ranges between approximately 70 and approximately 100 degrees.
The prosthesis of claim 7, wherein an angle of the inflow portion of the fixation support member relative to a plane extending transversely through the prosthesis at the radially inner contact surface of the fixation support member is less than an angle of the outflow portion of the fixation support member relative to the plane.
The prosthesis of claim 1, wherein the fixation support member has a substantially V-shaped cross-sectional configuration for a longitudinal cross-section taken axially through the prosthesis in its expanded cross-sectional dimension, in which the radially inner contact surface defines an apex and each of the inflow and outflow portions of the fixation support member define legs of the V-shaped cross-sectional configuration, a space between the legs of the V-shaped cross-sectional configuration defines a generally toroidal receptacle channel dimensioned and configured for receiving a valve annulus.
The prosthesis of claim 1, wherein the supported valve has an expanded cross-sectional dimension that is greater than 24 mm, the inflow and outflow portions of the fixation support member extending outwardly beyond the expanded cross-sectional dimension of the supported valve to provide an annular receptacle between the inflow and outflow portions of the fixation support member dimensioned and configured for receiving a tissue at a valve annulus.
The prosthesis of claim 1, wherein a valve portion of the supported valve comprises an animal tissue heart valve.
The prosthesis of claim 12, wherein the animal tissue valve comprises a porcine valve.
EP20110153114 2011-02-02 2011-02-02 Heart valve prosthesis Pending EP2484309A1 (en)
EP20110153114 EP2484309A1 (en) 2011-02-02 2011-02-02 Heart valve prosthesis
EP2484309A1 true true EP2484309A1 (en) 2012-08-08
ID=44275694
EP20110153114 Pending EP2484309A1 (en) 2011-02-02 2011-02-02 Heart valve prosthesis
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