1. Field
Embodiments of the present invention relate to valve prostheses and, particularly, to frames for valve prostheses.
2. Background
Patients suffering from valve regurgitation or stenotic calcification of the leaflets can be treated with a heart valve replacement procedure. A traditional surgical valve replacement procedure requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma and discomfort. Traditional surgical valve procedures can also require extensive recuperation times and may result in life-threatening complications.
One alternative to a traditional surgical valve replacement procedure is delivering the replacement heart valve prosthesis using minimally-invasive techniques. For example, a heart valve prosthesis can be percutaneously and transluminally delivered to an implantation location. In such methods, a heart valve prosthesis can be compressed to be loaded within a sheath of a delivery catheter or crimped on a delivery catheter; advanced to the implantation location; and re-expanded to be deployed at the implantation location. For example, a catheter loaded with a compressed heart valve prosthesis can be introduced through an opening in the femoral artery and advanced through the aorta to the heart. At the heart, the prosthesis can be re-expanded to be deployed at the aortic valve annulus, for example.
In some embodiments, a prosthesis can include a collapsible, expandable frame that has a longitudinal axis. The frame can include first, second, and third sets of struts. The first and second sets of struts can be connected at a first plurality of nodes to define a first row of expandable cells. The second and third sets of struts can be connected at a second plurality of nodes to define a second row of expandable cells. The first row of expandable cells can be proximal to the second row of expandable cells. Each strut of the first set of struts can include a first proximal segment with a first width, a first intermediate segment with a second width, and a first distal segment with a third width. Each strut of the second set of struts can include a second proximal segment with a fourth width, a second intermediate segment with a fifth width, and a second distal segment with a sixth width. Each strut of the third set of struts can include a third proximal segment with a seventh width, a third intermediate segment with an eighth width, and a third distal segment with a ninth width. The second width can be smaller than each of the first and third widths. The fifth width can be smaller than each of the fourth and sixth widths. The eighth width can be smaller than each of the seventh and ninth widths.
In some embodiments, a prosthesis can include an expandable frame that has a longitudinal axis. The frame can include an intermediate section and an inflow section that is proximal to the intermediate section. The inflow section can include a concave saddle portion that is adjacent the intermediate section, and an outwardly flared portion.
Further features and advantages of the invention, as well as the structure and operation of various embodiments of the invention, are described in detail below with reference to the accompanying drawings. It is noted that the invention is not limited to the specific embodiments described herein. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein.
The accompanying drawings, which are incorporated herein and form part of the specification, illustrate embodiments of the present invention and, together with the description, further serve to explain the principles of the invention and to enable a person skilled in the relevant art(s) to make and use the invention.
The features and advantages of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, like reference numbers generally indicate identical, functionally similar, and/or structurally similar elements. The drawing in which an element first appears is indicated by the leftmost digit(s) in the corresponding reference number.
This specification discloses embodiments that incorporate the features of this invention. The disclosed embodiments merely exemplify the invention. The scope of the invention is not limited to the disclosed embodiments. The invention is defined by the claims appended hereto.
The embodiments described, and references in the specification to “one embodiment,” “an embodiment,” “an example embodiment,” “some embodiments,” etc., indicate that the embodiments described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is understood that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
In this application, the term “proximal” means situated nearer to the upstream or inflow side of the valve prosthesis, and the term “distal” means situated nearer to the downstream or outflow side of the valve prosthesis.
A valve prosthesis according to various embodiments can be used to replace the function of a native cardiac valve, for example, the tricuspid valve, the pulmonary valve, the mitral valve, and the aortic valve. In some embodiments, the heart valve prosthesis can be configured to be collapsed to a small diameter condition such that the valve prosthesis can be delivered into a patient's body using minimally invasive techniques. For example, the heart valve prosthesis can be collapsed to a small diameter condition that allows the valve prosthesis to be loaded within a delivery sheath of delivery catheter or crimped on the delivery catheter. In some embodiments, the valve prosthesis can be delivered using a catheter, a laparoscopic instrument, or any other suitable delivery device. In some embodiments, the valve prosthesis can be delivered to the heart using a transfemoral, transapical, transaxial, transaortic, or transseptal approach.
In some embodiments, the valve prosthesis can be configured to be re-expandable such that once the collapsed heart valve prosthesis is delivered to a desired implantation site the valve prosthesis can be deployed by re-expanding the valve prosthesis to a larger diameter condition to securely engage the surrounding anatomy. For example, an aortic valve prosthesis may be expanded to engage the aorta, the aortic annulus, the left ventricle outflow tract, or combinations thereof. After deployment, the valve prosthesis can function as a one-way valve, permitting blood flow in one direction (a downstream or distal direction) and preventing blood flow in an opposite direction (an upstream or proximal direction).
In some embodiments, the valve prosthesis can be configured to be fully or partially recaptured within a sheath of a delivery catheter. Such recapturing can occur during or after deployment at the implantation site. For example, after partially or fully deploying the valve prosthesis, a clinician may wish to reposition or remove the prosthesis. The clinician can recapture the valve prosthesis within a sheath of a catheter and reposition or remove the valve prosthesis.
In some embodiments, the valve prosthesis includes a frame and a valve assembly coupled thereto. The frame supports the valve assembly. In some embodiments, the frame can be configured to be self-expandable or balloon expandable. The frame can be made from any suitable biocompatible metal and synthetic material. For example, suitable biocompatible metals can include nickel, titanium, stainless steel, cobalt, chromium, alloys thereof (e.g., nitinol), or any other suitable metal. And for example, suitable biocompatible synthetic materials can include thermoplastics or any other suitable synthetic material.
In some embodiments, the valve assembly includes a plurality of leaflets. In some embodiments, the valve assembly can also include a skirt. The valve assembly can be made from any suitable synthetic or biological material. For example, suitable biological materials can include mammalian tissue such as porcine, equine, or bovine pericardium.
Frame 1000 can have an inflow section 1008, an intermediate section 1010, and an outflow section 1012. In some embodiments, inflow section 1008 can include a saddle portion 1014 and an outwardly flared portion 1016. Saddle portion 1014 can be concave—curving or bending inward towards longitudinal axis 1002 as shown in
In some embodiments, a portion 1015 of outwardly flared portion 1016 at inflow edge 1004 extends towards longitudinal axis 1002 as shown in
As shown in
Intermediate section 1010 can be adjacent inflow section 1008. In some embodiments, intermediate section 1010 can be adjacent saddle portion 1014 of inflow section 1008. In some embodiments, the contour of intermediate section 1010 is generally parallel to longitudinal axis 1002. For example, the contour of intermediate section 1010 can taper slightly inward (as shown in
Outflow section 1012 can be adjacent intermediate section 1010. In some embodiments, outflow section 1012 includes a first portion 1018 that is adjacent the distal edge of intermediate section 1010, and a second portion 1020 that is adjacent first portion 1018. In some embodiments, first portion 1018 is outwardly flared—the contour surface of first portion 1018 extends away from longitudinal axis 1002 as first portion 1018 extends in the distal direction. In some embodiments, a second portion 1020 is inwardly flared—the contour surface of second portion 1020 extends towards longitudinal axis 1002 as second portion 1020 extends in the distal direction. In some embodiments, inwardly flared portion 1020 defines outflow edge 1006. In some embodiments, the transition between outwardly flared portion 1018 and inwardly flared portion 1020 forms a smooth curve.
In some embodiments, the diameter of outflow portion 1012 at an intermediate section, for example, the transition between first portion 1018 and second portion 1020, is greater than the diameter of outflow portion 1012 at its outflow edge 1006 and at its proximal edge.
In some embodiments, frame 1000 is configured to be implanted at the aortic valve. Accordingly, inflow section 1008 can be configured to have an expanded diameter such that inflow section 1008 engages the outflow tract of the left ventricle. Saddle portion 1014 can be configured to have an expanded diameter such that saddle portion 1014 engages the transition between the native aortic annulus and the left ventricle outflow tract. Intermediate section 1010 can be configured to have an expanded diameter such that intermediate section 1010 engages the native aortic annulus or leaflets. Second portion 1020 can be configured to have an expanded diameter such that second portion 1020 engages the aorta at a supra-coronary position. In some embodiments, the outwardly flared configuration of first portion 1018 of outflow section 1012 is configured to provide a radial gap between frame 1000 and the aorta. This radial gap can reduce the risk that the coronary arteries will be blocked.
In some embodiments, valve assembly 2024 includes a plurality of leaflets 2026. For example, valve assembly 2024 can include three leaflets 2026 (only two leaflets 2026 are shown in
In some embodiments, frame 2000 comprises a plurality of struts forming expandable cells. For example, as shown in
In some embodiments, valve assembly 2024 is mounted within frame 2000 such that nadirs 2030 of leaflets 2026 are positioned adjacent to the distal edge of saddle portion 2014 of inflow section 2008.
In some embodiments, saddle portion 2014 comprises first and second sets of struts defining only a single row of expandable cells. In some embodiments, saddle portion 2014 comprises more than two sets of struts defining two or more rows of expandable cells.
In some embodiments, first portion 2018 of outflow section 2012 is outwardly flared such that the contour extends away from longitudinal axis 2002. In some embodiments, commissures 2028 are coupled to outwardly flared portion 2018 of outflow section 2012. In some embodiments, valve assembly 2024 is mounted within frame 2000 such that the valve assembly 2024 has a high profile valve position. For example, a longitudinal length 2049 between commissures 2028 and outflow edge 2006 is about 20% to about 35% of longitudinal length 2047 of frame 2000. A high-profile valve position can improve hemodynamics and durability.
In some embodiments, frame 3000 includes an inflow section 3008, an intermediate section 3010, and an outflow section 3012. Outflow section 3012 can have a first portion 3018 that is adjacent intermediate portion 3010, and a second portion 3020. In some embodiments, first portion 3018 has a contour that is substantially parallel to longitudinal axis 3002. For example, the contour of first portion 3018 can taper slightly outward (as shown in
In some embodiments, second portion 3020 can include a plurality of V-shaped structures 3048. For example, second portion 3020 can include five V-shaped structures 3048 as shown in
In some embodiments, commissures 3028 are coupled to first portion 3018 of outflow section 3012 that has a contour surface that is substantially parallel to longitudinal axis 3002. Attaching commissures 3028 in this manner can improve valve assembly durability.
As shown in
In some embodiments, a longitudinal length 4074 between a center of third plurality of nodes 4073 and first plurality of nodes 4040 is about equal to a longitudinal length 4076 between a center of first plurality of nodes 4040 and a center of second plurality of nodes 4044. In some embodiments, longitudinal lengths 4074 and 4076 are within the range from about 3.75 mm to about 4.45 mm, for example, 4.10 mm. In some embodiments, a longitudinal length 4078 between a center of second plurality of nodes 4044 and a center of fourth plurality of nodes 4075 is greater than each of longitudinal length 4076 and longitudinal length 4074. In some embodiments, longitudinal length 4078 is within the range from about 4.50 mm to about 5.10 mm, for example, about 4.80 mm.
In some embodiments such as the one shown in
In some embodiments, each node of first plurality of nodes 4040 can have a length within the range from about 0.1 mm to about 5 mm. In some embodiments, each node of second plurality of nodes 4044 can have a length within the range from about 0.4 mm to about 0.45 mm.
As shown in
In some embodiments, width 5095 ranges from about 0.1 mm to about 1.2 mm. In some embodiments, width 5095 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm. In some embodiments, width 5096 ranges from about 0.05 mm to about 1.0 mm. In some embodiments, width 5096 ranges from about 0.15 to about 0.21 mm, for example, about 0.18 mm. In some embodiments, width 5097 ranges from about 0.10 mm to about 1.2 mm. In some embodiments, width 5097 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm.
In some embodiments, a width 5098 of proximal segment 5083 is greater than a width 5099 of intermediate segment 5084, and a width 5100 of distal segment 5085 is greater than width 5099. In some embodiments, width 5098 ranges from about 0.10 mm to about 1.2 mm. In some embodiments, width 5098 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm. In some embodiments, width 5099 ranges from about 0.05 mm to about 1.0 mm. In some embodiments, width 5099 ranges from about 0.15 to about 0.21 mm, for example, about 0.18 mm. In some embodiments, width 5100 ranges from about 0.10 mm to about 1.2 mm. In some embodiments, width 5100 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm.
In some embodiments, a width 5102 of proximal segment 5086 is greater than a width 5104 of intermediate segment 5087, and a width 5106 of distal segment 5088 is greater than width 5104. In some embodiments, width 5102 ranges from about 0.10 mm to about 1.2 mm. In some embodiments, width 5102 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm. In some embodiments, width 5104 ranges from about 0.05 mm to about 1.0 mm. In some embodiments, width 5104 ranges from about 0.15 to about 0.21 mm, for example, about 0.18 mm. In some embodiments, width 5106 ranges from about 0.10 mm to about 1.2 mm. In some embodiments, width 5106 ranges from about 0.30 to about 0.36 mm, for example, about 0.33 mm.
In some embodiments, a length 5089 between a proximal end of proximal segment 5080 and a center of intermediate segment 5081 ranges from about 1.0 mm to about 2.5 mm. In some embodiments, length 5089 ranges from about 1.70 to about 1.62 mm, for example, about 1.66 mm. In some embodiments, a length 5090 between the center of intermediate segment 5081 and the distal end of distal segment 5082 ranges from about 1.0 to about 2.5 mm. In some embodiments, length 5090 ranges from about 1.74 to about 1.82 mm, for example, about 1.78 mm.
In some embodiments, a length 5091 between a proximal end of proximal segment 5083 and a center of intermediate segment 5084 ranges from about 1.0 to about 2.5 mm. In some embodiments, length 5091 ranges from about 1.72 to about 1.80 mm, for example, about 1.76 mm. In some embodiments, a length 5092 between the center of intermediate segment 5084 and the distal end of distal segment 5085 ranges from about 1.0 mm to about 2.5 mm. In some embodiments, length 5092 ranges from about 1.68 to about 1.76 mm, for example, about 1.72 mm.
In some embodiments, a length 5093 between a proximal end of proximal segment 5086 and a center of intermediate segment 5087 ranges from about 1.5 mm to about 3.0 mm. In some embodiments, length 5093 ranges from about 2.02 to about 2.10 mm, for example, about 2.06 mm. In some embodiments, a length 5094 between the center of intermediate segment 5087 and the distal end of distal segment 5088 ranges from about 1.5 mm to about 3.0 mm. In some embodiments, length 5094 ranges from about 2.04 to about 2.12 mm, for example, about 2.08 mm.
Tapered struts as described above with reference to
As shown in
Force curve 6109 of a valve prosthesis having tapered struts as described above with reference to
A valve prosthesis having tapered struts as described above with reference to
A valve prosthesis having tapered struts as described above with reference to
A valve prosthesis having tapered struts, such as those described above with reference to
Notably, force curves 6107 and 6108 are exemplary. Valve prostheses according to embodiments of the invention can have force curves that differ from the force curves 6107 and 6108 in
A valve prosthesis having tapered struts, such as those described above with reference to
In some embodiments, the valve prosthesis can be configured such that the strut gaps compress tissue of the valve assembly no more than about 70 percent of twice the tissue thickness. For example, if the tissue has a thickness of about 0.30 mm, the valve prosthesis can be configured such that the strut gaps compress the tissue no more than about 0.18 mm (0.60 mm−(0.7*(2*0.30 mm))=0.18 mm).
It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.
The present invention has been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.
The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.
The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.