Patent Grant
10632292
All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The present teachings relate to devices and methods of use thereof for treating heart failures. An aspect of the present teachings relates to a device that can be used to change (e.g., reduce) the blood pressure in a heart chamber, for example, by creating a shunt, and optionally regulating the flow of blood through the shunt in order to enhance the therapeutic effect of the shunt. The present teachings further relate to a method of utilizing such a device, for example, in treating congestive heart failure and its related conditions, for example, acute cardiogenic pulmonary edema caused by an elevated pressure in a left side chamber in the heart.
Congestive heart failure (CHF) is a condition that affects millions of people worldwide. CHF results from a weakening or stiffening of the heart muscle that commonly is caused by myocardial ischemia (due to, e.g., myocardial infarction) or cardiomyopathy (e.g., myocarditis, amyloidosis). CHF causes a reduced cardiac output and inadequate blood to meet the needs of body tissues.
Treatments for CHF include: (1) pharmacological treatments, (2) assisting systems, and (3) surgical treatments. Pharmacological treatments, e.g., with diuretics, are used to reduce the workload of a heart by reducing blood volume and preload. While pharmacological treatments can improve quality of life, they have little effect on survival. Assisting devices, e.g., mechanical pumps, are used to reduce the load on a heart by performing all or part of the pumping function normally done by the heart. However, in a chronic ischemic heart, high-rate pacing may lead to an increased diastolic pressure, calcium overload, and damages to the muscle fibers. There are at least three surgical procedures for treating a heart failure: (1) heart transplant, (2) dynamic cardiomyoplasty, and (3) the Batista partial left ventriculectomy. These surgical treatments are invasive and have many limitations.
CHF is generally classified into systolic heart failure (SHF) or diastolic heart failure (DHF). In SHF, the pumping action of a heart is reduced or weakened. A normal ejection fraction (EF), the volume of blood ejected out of the left ventricle (stroke volume) divided by the maximum volume remaining in the left ventricle at the end of the diastole or relaxation phase, is greater than 50%. In a systolic heart failure, EF is decreased to less than 50%. A patient with SHF may have an enlarged left ventricle because of cardiac remodeling developed to maintain an adequate stroke-volume. This pathophysiological phenomenon is often associated with an increased atrial pressure and an increased left ventricular filling pressure.
DHF is a heart failure without any major valve disease even though the systolic function of the left ventricle is preserved. Generally, DHF is a failure of the ventricle to adequately relax and expand, resulting in a decrease in the stroke volume of the heart. Presently, there are very few treatment options for patients suffering from DHF. DHF afflicts between 30% and 70% of patients with CHF.
Devices to treat elevated left atrial pressure have been described. For example, U.S. Pat. Nos. 8,740,962 and 8,460,372 both describe prostheses that may be implanted in an opening in the septal wall of the heart to provide a shunt or channel permitting blood to flow from the left atrium into the right atrium. These devices collapse to a smaller configuration for delivery to the heart via a catheter and expand to a larger configuration (e.g., through self-expansion) upon deployment across an opening in the septal wall. Some of these devices have central cores with sufficient radial strength to maintain the patency of the septal wall opening and flexible anchors on both sides of the central core to contact the septal wall for atraumatic anchoring of the device. Some of these devices have retrieval legs and other features providing attachment points for delivery and/or retrieval for possible removal or redeployment.
During delivery of cardiac pressure-relief devices into openings in the septal wall of the heart, it may be desirable for the clinician to be able to observe the deployed configuration of elements of the device within the heart, such as the anchoring or retention features, prior to releasing the device from the delivery system. In addition, once released from the delivery system, it may be desirable for the portions of the prosthesis that attach to the delivery system to move out of the blood flow path through the prosthesis. If an implanted device must be retrieved after deployment, it may also be desirable for the prosthesis attachment elements to be movable back toward the center of the prosthesis so that the prosthesis can be collapsed and drawn into the retrieval catheter. Also, because the delivery catheter may need to approach the implantation site along an acute angle with respect to the septal wall, it may be desirable for the implant attachment features to be flexible enough to permit the implant to bend away from the longitudinal axis of the catheter during deployment of the implant into the septal wall. Finally, it may be useful for any retrieval features on the device to operate in combination with a strong central core and flexible anchors or retention segments.
One aspect of the invention provides a device for implanting into an atrial septum of a patient, the device having a core region with a plurality of core segments surrounding a central opening, the core region being adapted and configured to be disposed in an opening in the atrial septum; a distal retention region with a plurality of distal retention segments extending from the core segments, the distal retention segments being adapted to engage tissue on a left atrial side of the septal wall; a proximal retention region having a plurality of proximal retention segments extending from the core segments, the proximal retention segments being adapted to engage tissue on a right atrial side of the septal wall; and a retrieval region with a plurality (e.g., two or four) of retrieval members extending from the proximal retention segments, each retrieval member having a connector at a proximal end, the connector being adapted to connect to a delivery system; the device further having a delivery configuration and a deployed configuration, the core region, distal retention region and proximal retention region each having a smaller diameter in the delivery configuration than in the deployed configuration, the retrieval member connectors being disposed proximal to and radially outward from the opening in the deployed configuration.
In some embodiments, the connectors are disposed more radially inward in the delivery configuration than in the deployed configuration. The connectors may be, e.g., eyelets.
In some embodiments, the connectors may extend radially inward from an end of the retrieval members in the deployed configuration. In some embodiments, the connectors may extend distally from an end of the retrieval members in the deployed configuration.
In some embodiments the device also has a retrieval configuration in which the connectors are disposed radially inward from deployed configuration positions and the proximal and distal retention segments are each in substantially same positions as in the deployed configuration. The retrieval members may extend further proximally from the proximal retention region in the delivery configuration than in the retrieval configuration.
Another aspect of the invention provides a method of implanting a pressure relief device in an atrial septum of a patient's heart, in which the device has a distal retention region, a proximal retention region, a core region disposed between the distal retention region and the proximal retention region, an opening through the distal retention region, the core region and the proximal retention region, and a plurality of retrieval members disposed proximal to the proximal retention region. In such embodiments, the method includes the steps of expanding the distal retention region in a left atrium of the patient's heart from a collapsed delivery configuration to a deployed configuration; expanding the core region within an opening in the septal wall between the left atrium and a right atrium of the patient's heart from a collapsed delivery configuration to a deployed configuration; expanding the proximal retention region in the right atrium from a collapsed delivery configuration to a deployed configuration; releasing the retrieval members from a delivery system; and moving the retrieval members to a position radially outward from the opening after the releasing step.
In some embodiments, the moving step includes the step of moving the retrieval members from a position proximal to the opening and radially inward from an outer boundary of the opening to a position radially outward from the outer boundary of the opening. In some embodiments in which the device also has a retrieval configuration in which the retrieval members are in a position in front of the opening and the proximal and distal retention segments are each in substantially same positions as in the deployed configuration, the method includes the further step of expanding the device to the retrieval configuration prior to the releasing step, the steps of expanding the distal retention region, core region and proximal retention region to the deployed configurations being performed after the releasing step.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
The present teachings are described more fully herein with references to the accompanying drawings, which show certain embodiments of the present teachings. The present teachings may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided to illustrate various aspects of the present teachings. Like numbers refer to like elements throughout.
The present teachings provide a device and methods of use thereof. For example, the device can be used to regulate the pressure in a heart chamber. Specifically, the device can be used to (a) change an elevated chamber pressure and (b) prevent embolization from the right to left atria in a patient who suffers from CHF or has a Patent Foramen Ovale (PFO) or an Atrial Septal Defect (ASD) but needs a residual flow between the atria so as not to traumatize the heart hemodynamics.
As used herein, when terms “distal” and “proximal” are used to refer portion of the device, they mostly refer to a device in its elongated deliver configuration. The term “proximal” shall mean close to the operator (less into the body) and “distal” shall mean remote from the operator (further into the body). In positioning a medical device from a downstream access point, “distal” is more upstream and “proximal” is more downstream. As used in this application, unless otherwise indicated, the term “aperture” refers to any anatomical anomalies such as PFO, ASD, VSD, or an anatomical feature (such as an opening in the septal wall) created for the purpose of creating a shunt. As used herein, “substantially” means plus or minus 10%.
As explained in further detail below, various embodiments of the present teachings provide methods and devices for regulating the pressure in a heart chamber. In some embodiments, a medical device according to the present teachings includes an open central core region and two retention regions. In some embodiments, the medical device is positioned through an aperture in a septum, creating a shunt, for example, between the left and right atria. In some embodiments, the two retention regions of the medical device are disposed on the opposite sides of the septum. In some embodiments, a medical device according to the present teachings is extended into an elongated profile for a percutaneous delivery and resumes a preset profile in vivo after deployment.
An embodiment of the device in the present teaching has a distal retention portion configured to be positioned against the left atrial side of the septum, a proximal retention portion configured to be positioned against the right atrial side of the septum, and a central core portion disposed between the distal and proximal retention portions and configured to create a conduit for blood to flow through. An embodiment of the device in the present teaching has an elongated configuration for delivering through a catheter system and an expanded configuration securing the device across the septum. In some embodiments, the device is configured to transition from a delivery configuration to a deployed configuration through self-expansion or mechanical actuations. In some embodiments, during deployment, both the distal and proximal retention portions of the device are delivered in radially contracted configurations and expand radially while the device contracts longitudinally. In some embodiments, the central core portion is delivered in a radially contracted configuration and expands radially during deployment. In certain embodiments, one or both of the distal and proximal retention portions of the device contract longitudinally. In various embodiments, one of or both of the deployed distal and proximal retention portions has a generally flange-like profile. In various embodiments, the generally flange-like profile is made of a multiple segments or elements extending in a generally radial configuration from the central core portion. In some embodiments, the deployed distal retention portion is configured to be positioned against one side of the atrial septum. In some embodiments, the deployed proximal retention portion is configured to be positioned against one side of the atrial septum. In certain embodiments, both the deployed distal retention portion and the deployed proximal retention portion are configured to be positioned against both sides of the atrial septum. According to some embodiments, both the deployed distal and proximal retention portions apply a compression force against the septum from both sides, thereby securing the device across the septum.
In the deployed configuration shown in
In some embodiments, the radial span of the distal retention region 12 in the deployed configuration may be the same as the radial span of the proximal retention region 20. In other embodiments, the radial span of the distal retention region 12 may be greater than the radial span of the proximal retention region to, e.g., account for the typically greater pressure in the left atrium compared to the pressure in the right atrium. In some embodiments, the distal retention region has a general diameter of 8-20 mm upon deployment. In another embodiment, the deployed proximal retention region has a general diameter of 8-20 mm upon deployment. According to some embodiments, upon deployment, the diameter of the deployed core region of the device is about 25-50% of the overall diameter of the deployed distal retention region.
The retrieval region 22 includes retrieval legs 74 extending proximally and radially inwardly from the radially outward ends of the proximal retention segments 60, optionally via intermediate legs 76 disposed between the retrieval leg 74 and the proximal retention segments 60. According to some embodiments, each secondary retrieval leg 76 extends proximally from the proximal end 64 of a proximal retention segment 60. As illustrated, a distal end 78 of a secondary retrieval leg 76 joins the proximal end 64 of a proximal retention segment 60 where two adjacent proximal retention struts 66 join. Loops or eyelets 72 at the proximal ends of the retrieval legs 74 serve as connectors for the delivery and/or retrieval system. As shown in
When deploying the device 10 into the septal wall, a delivery system advances device 10 through and out of a catheter. As it emerges from the catheter, the distal retention region 14 of device 10 begins to self-expand in the left atrium. Subsequently, the core region 16 and proximal retention region 20 expand as they emerge from the catheter in the septal wall opening and right atrium, respectively, all while the eyelets 72 of the retrieval legs 74 are still connected to the delivery system. As shown in
When retrieving device 10 for redeployment or removal, the retrieval device grasps eyelets 72, moving them radially inward to the retrieval configuration. Device 10 is then pulled proximally into the retrieval catheter.
Additionally, although a wavy pattern with hairpin turn, or “U” turns, has been described in detail in relationship to the core region, other strut designs can also be used without departing from the scope of the present teachings. For example, the wavy pattern could adopt turns closely resembling a “V” shape or other profile. According to alternative embodiments, the core region could adopt either open-cell or closed-cell designs of any patterns known to those skilled in the art. In some embodiments, as the core region transitions from its delivery configuration to its deployed configuration, the diameter of the core region increases and the core region reduces in length, sometimes slightly. In other embodiments, as the diameter of the core region increases, the overall length of the core region remains the same.
In some embodiments of the present teachings, the device 10 in its delivery configuration, such as illustrated in
In some embodiments of the present invention, the device 10 in its delivery configuration, such as illustrated in
Referring again to
According to some embodiments, as illustrated in
Continuing referring to
According to one embodiment, while the device 10 is in its delivery configuration, the distal retention region 12 radially collapses with each distal retention segment 46 orienting longitudinally along the longitudinal axis of the core region 16. According to one embodiment, while the device 10 is in its deployed configuration, the distal retention segments 46 expand radially with each distal retention segment 46 forming a plane at an angle, for example, perpendicular, to the longitudinal axis of the core region 16. Upon deployment in vivo, the distal retention region 12 is configured to be deployed inside the left atrium with each of the distal retention segments 46 located at the left atrial side of the atrial septum. In certain embodiments, the distal retention opposes the left atrial side of the atrial septum. According to some embodiments, upon deployment, the distal retention region 12 forms a disc-like configuration, with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 46 contacting the atrial septum. In another embodiments, the distal retention region 12 forms an umbrella-like configuration with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 46 doming away from the atrial septum. For example, one or more distal ends of the distal retention segments 46 can contact the atrial septum. In yet another embodiment, the distal retention region 12 forms a generally straight slope profile with at least a portion, sometimes a substantial portion, of the surface area of each distal retention segment 46 not contacting the atrial septum. In this particular embodiment, one or more distal ends of the distal retention segments 46 remain furthest away from the atrial septum. One skilled in the art should understand that other suitable profile could also be used. Thus the exemplary embodiments discussed, shown, or mentioned herein should not be viewed as limiting.
According to some embodiments, the distal ends 50 of each distal retention segment 46 includes a foot 52, as illustrated in
Continuing referring to
According to some embodiments, as illustrated in
Similar to the distal retention region 12, the device 10 can also have a proximal retention region 20. In some embodiments, the proximal retention region 20 of the device 10 has an expanded umbrella-like profile when deployed, as illustrated in
According to one embodiment, when the device 10 is in its delivery configuration, the proximal retention portion 20 radially collapses with the proximal retention segments 60 orienting longitudinally along the longitudinal axis of the core region 16, and when the device 10 is in its deployed configuration, the proximal retention portion 20 radially expands with the proximal retention segment 60 curving distally, for example as illustrated in
The curved deployment configuration of the proximal retention region 20 allows the device to accommodate various atrial septum thickness. For example, for a thin atrial septum, the curved proximal retention segments 60 can fully assume its pre-defined curved deployment configuration. For a thick atrial septum, the curved proximal retention segments 60 can oppose the atrial septum, and when the septum pushes back, the curved proximal retention segments 60 can deflect at their first curve while maintaining the device 10 in place.
According to some embodiments, curving the second section of the deployed proximal retention region 20 away from the atrial septum enlarges the contacting surface area with the septal tissue, thereby preventing any trauma to the tissue. One skilled in the art should understand, the second curve of the proximal retention segments 60 can start at any location near or at the proximal ends 64 of each retention segment 60.
According to some embodiments, in a delivery configuration, the proximal retention region struts 66 have a similar width as the distal retention struts 40. In other embodiments, the proximal retention struts 66 have a different width than the distal retention struts 40. In yet another embodiment, the width of the strut 26 of the core region 16 is greater than that of the proximal retention struts 66 and that of the distal retention struts 40, so that the core region 16 is more rigid than the proximal and distal retention portions 12, 20. According to one embodiment of the present teachings, upon deployment, the stiff core region 16 pushes the surrounding tissue radially outwardly, thereby maintaining the size of the opening for the treatment, while the relative pliable proximal and distal retention portions 12, 20 gently contact the septal tissue without penetration.
According to some embodiments, at least some of the proximal retention struts 66 are longer than some of the distal retention struts 40. In some embodiments, all of the proximal retention struts are longer than the distal retention struts. In some embodiments, the distal retention struts 40 have a length of about 2-7 mm. In some embodiments, the proximal retention struts 66 have a length of about 2-14 mm. One skilled in the art should understand that the specific length of the distal retention struts 40 and/or proximal retention struts 66 should be determined by, inter alia, the overall size of the device, which in turn is determined by the needs of a patient. According to some embodiments, the proximal retention struts 66 are configured so that, upon full deployment, its first section curves toward the septum, forming a space between a portion of the strut and septum, and the most radially outward portion of the proximal retention struts 66 is at or near the most radially outward portion of the distal retention struts 40 on the opposite side of the septum.
In various embodiments, the device 10 is fabricated from a tube. Thus, all portions of the device 10, such as the distal retention portion 12, the distal transitional portion 14, the core region 16, the proximal transitional portion 18, the proximal retention portion 20, and proximal retrieval portion 22, have a same thickness. In one embodiment, the thickness of the tube, and thus the thickness of each portion of the device, is from 0.005-0.007 inch. In another embodiment, at least one portion of the device 10 has a different thickness than the rest of the device. This, in some circumstances, can be achieved by removing material from other portions.
According to one embodiment, as illustrated in
In one embodiment, the width of each portion, such as the distal retention portion 12, the distal transitional portion 14, the core region 16, the proximal transitional portion 18, the proximal retention portion 20, and proximal retrieval portion 22, of the device 10 is the same as the thickness of the portion. In another embodiment, the width of the distal retention portion 12, the distal transitional portion 14, the core region 16, the proximal transitional portion 18, and the proximal retention portion 20, are greater than the thickness of these portions. In some embodiments, the width of the proximal retrieval portion 22 is the same as the thickness. According to some embodiments, for portions of the device having a width greater than the thickness, the curving and bending of such portions can be achieved in a controlled manner, without risking the struts being twisted during the process. For other portions of the device where twisting is expected, or less concerning, such as the proximal retrieval portion, the thickness and width can be the same. According to some embodiments, the thickness of each portion of the device ranges from about 0.003″ to about 0.09″.
According to some embodiments, the retrieval eyelets 72 are configured to be attached to a flexible delivery mechanism. In one embodiment (not shown), a delivery filament, such as a wire or a suture, extends through one or more retrieval attachment mechanisms with both ends of the filament being controlled by a clinician. Upon deployment, one end of the delivery filament is loosened and the other end of the delivery filament is retracted proximally so that the entire flexible delivery filament is removed from the body. One skilled in the art would understand that a flexible delivery filament allows the device fully deploy at a treatment location, while still under the control of the clinician, so that the deployment can be assessed and the device can be retrieved if necessary.
According to some embodiments, the retrieval eyelets 72 are configured to be attached to a relatively rigid delivery mechanism. In one embodiment (not shown), a delivery shaft with notches at its distal end for hosting the retrieval eyelets 72. During delivery, the retrieval eyelets 72 is secured inside the notch, and upon deployment, the retrieval eyelets 72 are released from the notch. One skilled in the art would understand that a relatively rigid delivery shaft can push the device distally inside the delivery catheter and to deploy device.
According to some embodiments, the device 10 includes eight proximal retention segments 60, eight secondary retrieval legs 76, four primary retrieval legs 74, and two retrieval attachment mechanisms 72. Each retrieval attachment mechanism 72 joins a proximal junction formed by two adjacent primary retrieval legs 74. Each distal end 82 of the two adjacent primary retrieval legs 74 further joins a proximal junction 80 formed by two adjacent secondary retrieval legs 76. Each distal end 78 of the said two adjacent secondary retrieval legs 76 joins a proximal end 64 of a proximal retention segment 60. Although
According to one embodiment of the present teachings, the device 10 is pre-set into its deployed profile and stretched into an elongated profile, such as shown in
Similar to previously described embodiments, the device 100 includes a distal retention portion 112, a distal transition portion 114, a core region 116, a proximal transition portion 118, a proximal retention portion 120, and a proximal retrieval portion 122. Core region 116, distal transition struts 134, and distal retention portion 112, proximal transition portion 118, proximal retention portion 120, and secondary retrieval struts 176 and retrieval attachment mechanisms 172 shown in
In the deployed configuration shown in
In some embodiments, the radial span of the distal retention region 112 in the deployed configuration may be the same as the radial span of the proximal retention region 120. In other embodiments, the radial span of the distal retention region 112 may be greater than the radial span of the proximal retention region to, e.g., account for the typically greater pressure in the left atrium compared to the pressure in the right atrium. In some embodiments, the distal retention region has a general diameter of 8-20 mm upon deployment. In another embodiment, the deployed proximal retention region has a general diameter of 8-20 mm upon deployment. According to some embodiments, upon deployment, the diameter of the deployed core region of the device is about 25-50% of the overall diameter of the deployed distal retention region.
The retrieval region 122 includes retrieval legs 174 extending proximally and radially inwardly from the radially outward ends of the proximal retention segments 160 via intermediate legs 176 disposed between the retrieval leg 174 and the proximal retention segments 160. According to some embodiments, each secondary retrieval leg 176 extends proximally from the proximal end of a proximal retention segment 160. As illustrated, a distal end of a secondary retrieval leg joins the proximal end of a proximal retention segment 160 where two adjacent proximal retention struts join. Loops or eyelets 172 at the ends of the retrieval legs 174 serve as connectors for the delivery and/or retrieval system. As shown in
When deploying the device 100 into the septal wall, a delivery system advances device 100 through and out of a catheter. As it emerges from the catheter, the distal retention region 114 of device 100 begins to self-expand in the left atrium. Subsequently, the core region 116 and proximal retention region 120 expand as they emerge from the catheter in the septal wall opening and right atrium, respectively, while the eyelets 172 of the retrieval legs 174 are still connected to the delivery system. As shown in
When retrieving device 100 for redeployment or removal, the retrieval device grasps eyelets 172, moving them radially inward. Device 100 is then pulled proximally into the retrieval catheter.
As in the earlier embodiments, portions of device 100 are arranged and configured to provide the desired bending behavior as device 100 emerges from and is drawn back into a delivery catheter, as shown in
In some embodiments of the present teachings, the device 100 in its delivery configuration, such as illustrated in
In some embodiments of the present invention, the device 100 in its delivery configuration, such as illustrated in
According to some embodiments, as illustrated in
Upon deployment in vivo, the distal retention region 112 of device 100 is configured to be deployed inside the left atrium with each of the distal retention segments 146 located at the left atrial side of the atrial septum. In certain embodiments, the distal retention opposes the left atrial side of the atrial septum. According to some embodiments, upon deployment, the distal retention region 112 forms a disc-like configuration, with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 146 contacting the atrial septum. In another embodiments, the distal retention region 112 forms an umbrella-like configuration with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 146 doming away from the atrial septum. For example, one or more distal ends of the distal retention segments 146 can contact the atrial septum. In yet another embodiment, the distal retention region 112 forms a generally straight slope profile with at least a portion, sometimes a substantial portion, of the surface area of each distal retention segment 146 not contacting the atrial septum. In this particular embodiment, one or more distal ends of the distal retention segments 146 remain furthest away from the atrial septum. One skilled in the art should understand that other suitable profile could also be used. Thus the exemplary embodiments discussed, shown, or mentioned herein should not be viewed as limiting.
According to some embodiments, the distal ends of each distal retention segment 146 include a foot 152. The foot 152 is configured to prevent the distal ends of the distal retention segments 146 from penetrating, piercing, or eroding into the septal tissues. According to some embodiments, the foot is configured to provide a larger surface area for contacting the tissues and/or reducing the force that the distal retention segments 146 apply onto the tissues. In some embodiments, the foot 152 is also configured to incorporate a radiopaque marker.
When the device 100 is at its delivery configuration, the proximal transition portion 118 has a small generally tubular profile, such as illustrated in
According to some embodiments, as illustrated in
Similar to the distal retention region 112, the device 100 can also have a proximal retention region 120. In some embodiments, the proximal retention region 120 of the device 100 has an expanded umbrella-like profile when deployed, as illustrated in
According to one embodiment, when the device 100 is in its delivery configuration, the proximal retention portion 120 radially collapses with the proximal retention segments 160 orienting longitudinally along the longitudinal axis of the core region 116, and when the device 100 is in its deployed configuration, the proximal retention portion 120 radially expands with the proximal retention segment 160 curving distally. When the device is deployed in vivo, according to some embodiments, for example as illustrated in
The curved deployment configuration of the proximal retention region 120 allows the device to accommodate various atrial septum thickness. For example, for a thin atrial septum, the curved proximal retention segments 160 can fully assume its pre-defined curved deployment configuration. For a thick atrial septum, the curved proximal retention segments 160 can oppose the atrial septum, and when the septum pushes back, the curved proximal retention segments 160 can deflect at their first curve while maintaining the device 100 in place.
According to some embodiments, curving the second section of the deployed proximal retention region 120 away from the atrial septum enlarges the contacting surface area with the septal tissue, thereby preventing any trauma to the tissue. One skilled in the art should understand, the second curve of the proximal retention segments 160 can start at any location near or at the proximal ends of each retention segment 160.
According to some embodiments, in a delivery configuration, the proximal retention region struts have a similar width as the distal retention struts. In other embodiments, the proximal retention struts have a different width than the distal retention struts. In yet another embodiment, the width of the strut of the core region 116 is greater than that of the proximal retention struts and that of the distal retention struts, so that the core region 116 is more rigid than the proximal and distal retention portions 112, 120. According to one embodiment of the present teachings, upon deployment, the stiff core region 116 pushes the surrounding tissue radially outwardly, thereby maintaining the size of the opening for the treatment, while the relative pliable proximal and distal retention portions 112, 120 gently contact the septal tissue without penetration.
According to some embodiments, at least some of the proximal retention struts are longer than some of the distal retention struts. In some embodiments, all of the proximal retention struts are longer than the distal retention struts. In some embodiments, the distal retention struts have a length of about 2-7 mm. In some embodiments, the proximal retention struts have a length of about 2-14 mm. One skilled in the art should understand that the specific length of the distal retention struts and/or proximal retention struts should be determined by, inter alia, the overall size of the device, which in turn is determined by the needs of a patient. According to some embodiments, the proximal retention struts are configured so that, upon full deployment, its first section curves toward the septum, forming a space between a portion of the strut and septum, and the most radially outward portion of the proximal retention struts is at or near the most radially outward portion of the distal retention struts on the opposite side of the septum.
In various embodiments, the device 100 is fabricated from a tube. Thus, all portions of the device 100, such as the distal retention portion 112, the distal transitional portion 114, the central core region 116, the proximal transitional portion 118, the proximal retention portion 120, and proximal retrieval portion 122, have a same thickness. In one embodiment, the thickness of the tube, and thus the thickness of each portion of the device, is from 0.005-0.007 inch. In another embodiment, at least one portion of the device 100 has a different thickness than the rest of the device. This, in some circumstances, can be achieved by removing material from other portions.
In one embodiment, the width of each portion, such as the distal retention portion 112, the distal transitional portion 114, the core region 116, the proximal transitional portion 118, the proximal retention portion 120, and proximal retrieval portion 122, of the device 100 is the same as the thickness of the portion. In another embodiment, the width of the distal retention portion 112, the distal transitional portion 114, the core region 116, the proximal transitional portion 118, and the proximal retention portion 120, are greater than the thickness of these portions. In some embodiments, the width of the proximal retrieval portion 122 is the same as the thickness. According to some embodiments, for portions of the device having a width greater than the thickness, the curving and bending of such portions can be achieved in a controlled manner, without risking the struts being twisted during the process. For other portions of the device where twisting is expected, or less concerning, such as the proximal retrieval portion, the thickness and width can be the same. According to some embodiments, the thickness of each portion of the device ranges from about 0.003″ to about 0.09″.
According to some embodiments, the retrieval eyelets 172 are configured to be attached to a flexible delivery mechanism. In one embodiment (not shown), a delivery filament, such as a wire or a suture, extends through one or more retrieval attachment mechanisms with both ends of the filament being controlled by a clinician. Upon deployment, one end of the delivery filament is loosened and the other end of the delivery filament is retracted proximally so that the entire flexible delivery filament is removed from the body. One skilled in the art would understand that a flexible delivery filament allows the device fully deploy at a treatment location, while still under the control of the clinician, so that the deployment can be assessed and the device can be retrieved if necessary.
According to some embodiments, the retrieval eyelets 172 are configured to be attached to a relatively rigid delivery mechanism. In one embodiment (not shown), a delivery shaft with notches at its distal end for hosting the retrieval eyelets 172. During delivery, the retrieval eyelets 172 is secured inside the notch, and upon deployment, the retrieval eyelets 172 are released from the notch. One skilled in the art would understand that a relatively rigid delivery shaft can push the device distally inside the delivery catheter and to deploy device.
According to one embodiment of the present teachings, the device 100 is pre-set into its deployed profile and stretched into an elongated profile, such as shown in
In the delivery configuration (not shown), device 410 (including distal retention region 412, central core region 416 and proximal retention region 420) is radially compressed and axially elongated compared to the deployed configuration shown in
In the deployed configuration shown in
In some embodiments, the radial span of the distal retention region 412 in the deployed configuration may be the same as the radial span of the proximal retention region 420. In other embodiments, the radial span of the distal retention region 412 may be greater than the radial span of the proximal retention region to, e.g., account for the typically greater pressure in the left atrium compared to the pressure in the right atrium. In some embodiments, the distal retention region has a general diameter of 8-20 mm upon deployment. In another embodiment, the deployed proximal retention region has a general diameter of 8-20 mm upon deployment. According to some embodiments, upon deployment, the diameter of the deployed core region of the device is about 25-50% of the overall diameter of the deployed distal retention region.
The retrieval region 422 includes retrieval legs 474 extending proximally and radially inwardly from the radially outward ends of the proximal retention segments 460, optionally via intermediate legs 476 disposed between the retrieval legs 474 and a junction 464, and the proximal retention segments 460. As illustrated in
When deploying the device 410 into the septal wall, a delivery system advances device 410 through and out of a catheter. As it emerges from the catheter, the distal retention region 414 of device 410 begins to self-expand in the left atrium. Subsequently, the core region 416 and proximal retention region 420 expand as they emerge from the catheter in the septal wall opening and right atrium, respectively, all while the eyelets 472 of the retrieval legs 474 are still connected to the delivery system. Distal retention segments 446, core region 416 and proximal retention segments 460 are substantially in their deployed configurations even while retrieval legs 474 and 476 extend proximally into the delivery catheter (not shown). After they emerge from the delivery catheter, retrieval legs 474 and 476 begin moving toward their expanded at-rest shapes, while eyelets 472 remain radially inward (in the device's retrieval configuration) from their at-rest positions because they are still connected to the delivery system. After release from the delivery system, eyelets 472 move radially outward to their at-rest positions radially outside of the device's opening 424 (i.e., the deployed configuration shown in
When retrieving device 410 for redeployment or removal, the retrieval device grasps eyelets 472, moving them radially inward. Device 410 is then pulled proximally into the retrieval catheter.
As in the earlier embodiments, portions of device 410 are arranged and configured to provide the desired bending behavior as device 410 emerges from and is drawn back into a delivery catheter, as shown in
In some embodiments of the present teachings, the device 410 in its delivery configuration is configured to be delivered and deployed through a 5 French-12 French catheter. In one embodiment, the elongated device 410 has a diameter ranging from about 1 mm to about 4 mm, and the central core region 416 in a deployed configuration has a diameter ranging from about 3 mm to about 12 mm, or from about 110% to about 300% of that of the core region 416 in its delivery configuration. In other embodiments, the struts of the shunt portion 416 have a width of about 0.005 inch to about 0.030 inch. In a delivery configuration, the gap between two adjacent portions of the core portion struts is from about 0″ to about 0.010″, and upon deployment, the gap between two adjacent portions of the struts is up to about 0.075″.
In some embodiments of the present invention, the device 410 in its delivery configuration has an overall length of about 5-25 mm, with the length of the core region 416 being 0.5-5 mm. In one embodiment, for a deployed device 410, the length of the core region 416 ranges from about 1 mm to about 7 mm, with the overall length of the device 410 ranging from about 3 mm to about 12 mm. In another embodiment, the length of the core region 416 of a deployed device ranges from about 30 to about 70% of the length of the device in the deployed profile.
According to some embodiments, as illustrated in
Upon deployment in vivo, the distal retention region 412 of device 410 is configured to be deployed inside the left atrium with each of the distal retention segments 446 located at the left atrial side of the atrial septum. In certain embodiments, the distal retention opposes the left atrial side of the atrial septum. According to some embodiments, upon deployment, the distal retention region 412 forms a disc-like configuration, with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 446 contacting the atrial septum. In another embodiments, the distal retention region 412 forms an umbrella-like configuration with at least a portion, sometimes a substantial portion, of the surface area of each retention segment 446 doming away from the atrial septum. For example, one or more distal ends of the distal retention segments 446 can contact the atrial septum. In yet another embodiment, the distal retention region 412 forms a generally straight slope profile with at least a portion, sometimes a substantial portion, of the surface area of each distal retention segment 446 not contacting the atrial septum. In this particular embodiment, one or more distal ends of the distal retention segments 446 remain furthest away from the atrial septum. One skilled in the art should understand that other suitable profile could also be used. Thus the exemplary embodiments discussed, shown, or mentioned herein should not be viewed as limiting.
According to some embodiments, the distal ends of each distal retention segment 446 include a foot 451. The foot 451 is configured to prevent the distal ends of the distal retention segments 446 from penetrating, piercing, or eroding into the septal tissues. According to some embodiments, the foot is configured to provide a larger surface area for contacting the tissues and/or reducing the force that the distal retention segments 446 apply onto the tissues. In some embodiments, the foot 451 is also configured to incorporate a radiopaque marker.
When the device 410 is at its delivery configuration, the proximal transition portion 418 has a small generally tubular profile, with adjacent struts packed closely and parallel to each other. The proximal transition portion 418 is also configured to transform from a delivery configuration to a deployed configuration. During such transition, a proximal section of the struts extends radially outwardly, and a distal section of the struts expands as the core region 416 expands radially into its deployed configuration. Thus, while the device 410 is in its deployed configuration, the proximal transition struts bend at a location so that the core region 416 of the device has a tubular profile at the distal end of the proximal transition struts, and the proximal retention region 420 of the device 410 have a radially outward umbrella-shaped profile that is generally at an angle, sometimes perpendicular, to the longitudinal axis of the core region 416 at the proximal end of the proximal transition struts.
Similar to the distal retention region 412, the device 410 can also have a proximal retention region 420. In some embodiments, the proximal retention region 420 of the device 410 has an expanded umbrella-like profile when deployed, as illustrated in
According to one embodiment, when the device 410 is in its delivery configuration, the proximal retention portion 420 radially collapses with the proximal retention segments 460 orienting longitudinally along the longitudinal axis of the core region 416, and when the device 410 is in its deployed configuration, the proximal retention portion 420 radially expands with the proximal retention segment 460 curving distally. When the device is deployed in vivo, according to some embodiments, for example as illustrated in
The curved deployment configuration of the proximal retention region 420 allows the device to accommodate various atrial septum thickness. For example, for a thin atrial septum, the curved proximal retention segments 460 can fully assume its pre-defined curved deployment configuration. For a thick atrial septum, the curved proximal retention segments 460 can oppose the atrial septum, and when the septum pushes back, the curved proximal retention segments 460 can deflect at their first curve while maintaining the device 410 in place.
According to some embodiments, curving the second section of the deployed proximal retention region 420 away from the atrial septum enlarges the contacting surface area with the septal tissue, thereby preventing any trauma to the tissue. One skilled in the art should understand, the second curve of the proximal retention segments 460 can start at any location near or at the proximal ends of each retention segment 460.
According to some embodiments, in a delivery configuration, the proximal retention region struts have a similar width as the distal retention struts. In other embodiments, the proximal retention struts have a different width than the distal retention struts. In yet another embodiment, the width of the strut of the core region 416 is greater than that of the proximal retention struts and that of the distal retention struts, so that the core region 416 is more rigid than the proximal and distal retention portions 412, 420. According to one embodiment of the present teachings, upon deployment, the stiff core region 416 pushes the surrounding tissue radially outwardly, thereby maintaining the size of the opening for the treatment, while the relative pliable proximal and distal retention portions 412, 420 gently contact the septal tissue without penetration.
According to some embodiments, at least some of the proximal retention struts are longer than some of the distal retention struts. In some embodiments, all of the proximal retention struts are longer than the distal retention struts. In some embodiments, the distal retention struts have a length of about 2-7 mm. In some embodiments, the proximal retention struts have a length of about 2-14 mm. One skilled in the art should understand that the specific length of the distal retention struts and/or proximal retention struts should be determined by, inter alia, the overall size of the device, which in turn is determined by the needs of a patient. According to some embodiments, the proximal retention struts are configured so that, upon full deployment, its first section curves toward the septum, forming a space between a portion of the strut and septum, and the most radially outward portion of the proximal retention struts is at or near the most radially outward portion of the distal retention struts on the opposite side of the septum.
In various embodiments, the device 410 is fabricated from a tube. Thus, all portions of the device 410, such as the distal retention portion 412, the distal transitional portion 414, the central core region 416, the proximal transitional portion 418, the proximal retention portion 420, and proximal retrieval portion 422, have a same thickness. In one embodiment, the thickness of the tube, and thus the thickness of each portion of the device, is from 0.005-0.007 inch. In another embodiment, at least one portion of the device 410 has a different thickness than the rest of the device. This, in some circumstances, can be achieved by removing material from other portions.
In one embodiment, the width of the distal retention portion 412, the distal transitional portion 414, the core region 416, the proximal transitional portion 418, and the proximal retention portion 420, are greater than the thickness of these portions. In some embodiments, the width of the proximal retrieval portion 422 is the same as the thickness. According to some embodiments, for portions of the device having a width greater than the thickness, the curving and bending of such portions can be achieved in a controlled manner, without risking the struts being twisted during the process. For other portions of the device where twisting is expected, or less concerning, such as the proximal retrieval portion, the thickness and width can be the same. According to some embodiments, the thickness of each portion of the device ranges from about 0.003″ to about 0.09″.
According to some embodiments, the retrieval eyelets 472 are configured to be attached to a flexible delivery mechanism. In one embodiment (not shown), a delivery filament, such as a wire or a suture, extends through one or more retrieval attachment mechanisms with both ends of the filament being controlled by a clinician. Upon deployment, one end of the delivery filament is loosened and the other end of the delivery filament is retracted proximally so that the entire flexible delivery filament is removed from the body. One skilled in the art would understand that a flexible delivery filament allows the device fully deploy at a treatment location, while still under the control of the clinician, so that the deployment can be assessed and the device can be retrieved if necessary.
According to some embodiments, the retrieval eyelets 472 are configured to be attached to a relatively rigid delivery mechanism. In one embodiment (not shown), a delivery shaft with notches at its distal end for hosting the retrieval eyelets 472. During delivery, the retrieval eyelets 472 is secured inside the notch, and upon deployment, the retrieval eyelets 472 are released from the notch. One skilled in the art would understand that a relatively rigid delivery shaft can push the device distally inside the delivery catheter and to deploy device.
According to one embodiment of the present teachings, the device 410 is pre-set into its deployed profile and stretched into an elongated profile for percutaneous delivery. Upon deployment, the device will recover to its pre-set deployed configuration once free from constraint of the delivery catheter. To minimize any deformation during the delivery process, according to one embodiment of the present teachings, the maximum ratio of the thickness (t) of a curved portion of the device (e.g., the transition from proximal retention segments 460 to secondary retrieval legs 476) over two times of the radius “R” of the curved portion is 0.12, i.e., t/2R≤12%. Maintaining this ratio will ensure the maximum recovery of the intended curvature.
The attachment points of between the elements forming the proximal retention region and the retrieval legs may affect the behavior of the device during deployment and retrieval.
According to one embodiment, the device of the present teachings is manufactured by laser cutting a biocompatible metal tube. According to some embodiments, the device is made of a biocompatible metal or polymer. In various embodiments, the entire device is made of a biocompatible metal or polymer. In some embodiments, the device in its entirely or portion(s) thereof, for example, those with curved/bent deployment configuration, is made of an elastic material, a super-elastic material, or a shape-memory alloy so that the above portions can be distorted into a generally straightened profile during the delivery process and resume and maintain its intended profile in vivo once it is deployed from a delivery catheter. In some embodiments, the device is made of stainless steel, nitinol, Titanium, Elgiloy, Vitalium, Mobilium, Ticonium, Platinore, Stellite, Tantalum, Platium, Hastelloy, CoCrNi alloys (e.g., trade name Phynox), MP35N, or CoCrMo alloys, any other metallic alloys, or a mixture thereof. Alternatively, in some embodiments, a part of the device or the entire device is made of a polymer, such as PTFE, UHMPE, HDPE, polypropylene, polysulfone, or other biocompatible plastic. The surface finish of the device can be textured to induce tissue response and tissue in-growth for improved stabilization. Alternatively, a part of or the entirely of the device can be fabricated from a resorbable polymer. In some embodiments, the resorbable polymer includes polyactic acid, polyglycolic acid, polycaprolactone, a combination of two or more of the above or a variety of other resorbable polymers that are well known to those skilled in the art.
According to one embodiment of the present teachings, the device is fabricated from a tubular form and then shaped to its final configuration. In one embodiment, if a sufficiently elastic and resilient material, such as nitinol, is used, the structure is preformed into the finished shape and elastically deformed. In some embodiments, the device is stowed in a delivery device during the delivery and the device elastically recovers its shape upon deployment. In some embodiments, one, some, or all portions of the device are manually expanded to the desired diameter and/or curved to a pre-set shape. In certain embodiment, one, some, or all portions of the device is heat set in an oven while constrained to the desired shape.
According to one embodiment of the present teachings, at least one portion of the device expands radially upon being deployed in vivo. According to one embodiment of the present teachings, upon deployment, the radial expansion of at least one portion of the device is due to the elastic nature of the material. According to another embodiment of the present teachings, upon deployment, the radial expansion of at least one portion of the device is due to its pre-set thermal shape memory of the material. According to yet another embodiment of the present teachings, during deployment, at least one portion of the device is manually expanded radially via a balloon.
According to various embodiments of the present teachings, one or more radio-opaque markers are used. Without attempting to limit to any particular function, these radio-opaque markers can be visualized by using radiographic imaging equipment such as X-ray, magnetic resonance, ultrasound, or other imaging techniques known to one of ordinarily skilled in the art. One or more markers as disclosed herein can be applied to any part of a device or a delivery system of the present teachings. A radio-opaque marker can be weld, sewed, adhered, swaged riveted, otherwise placed, and secured in or on the device. The radio-opaque marker may be made of tantalum, tungsten, platinum, irridium, gold, or alloys of these materials or other materials that are known to those skilled in the art. The radio-opaque marker can also be made of numerous paramagnetic materials, including one or more elements with atomic numbers 21-29, 42, 44, and 58-70, such as chromium (III), manganese (II), iron (III), iron (II), cobalt (II), copper (II), nickel (II), praesodymium (III), neodymium (III), samarium (III), ytterbium (III), gadolinium (III), terbium (III), dysprosium (III), holmium (III) and erbium (III), or other MR visible materials that are known to those skilled in the arts.
The devices described above may be delivered by delivery systems described, e.g., in US 2011/0071623.
In most cases, the treatment starts with a septal puncture which creates an aperture in the atrial septum, and device as described above is then deployed across the aperture. Since the resulting aperture is essentially a fresh wound, the body's natural healing process will start. In some cases, the tissue or cell growth can extend through the openings of the device and into the tubular opening of the shunt portion of the device. In some situation, the opening created by the shunt portion of the device may be blocked or otherwise re-occluded by the tissue growth. Thus, such healing process would then undo all intended treatment over time.
Thus, in some embodiments, the entirety or at least a portion of the device is covered with a biocompatible barrier, for example, to prevent excessive tissue ingrowth. According to one embodiment, only one side of the luminal surface is covered. Advantages of covering one side of the luminal surface include the possibility of enhanced healing. It is known that living cells infiltrate a sufficiently porous covering material, such as ePTFE, and that microcapillaries may form within and across the barrier wall so that a living intima is formed along the luminal surface.
In one embodiment, the luminal surface of the shunt portion of the device is covered with a biocompatible barrier not only to prevent tissue ingrowth but also provide a thrombi-resistant to the shunt lumen. The configuration may depend on the application of the device. In some applications, for example, where a large aperture with a greater pressure differential between the two atria is present or created, placing the covering on the luminal surface (facing the blood flow) may result in an advantageous laminar flow of the blood—blood flow without significant turbulence. Another advantage of using only luminal covering can be improved anchoring of the device within the aperture afforded by interactions between the bare structure of the shunt portion of the device and the tissue wall surrounding the aperture.
In another embodiment, the abluminal surface (facing the tissue) of the shunt portion of the device is covered with a biocompatible barrier in order to prevent tissue ingrowth. In another embodiment, placing barrier material only on the abluminal surface of the shunt portion has some benefit to patients. For example, contacting blood with a metal structure may result in local, limited thrombosis. Thus, by covering the abluminal surface of the shunt portion of the device could limit thrombosis, resulting in enhanced healing without occlusion of the shunt lumen.
In yet another embodiment, the covering is placed on both the luminal and abluminal surfaces of the shunt portion. One skilled in the art should understand that the covering must be attached to the device to prevent it from detaching and perhaps forming emboli in the heart. In some embodiments, the material used as a barrier could be attach to a device through direct bonding between the device and material. For material that does not adhere well to a device, it can be made to bond to itself. For example, one effective method of affixing the ePTFE cover is to place ePTFE covers in contact with both the abluminal and luminal surfaces of the shunt portion of the device so that one ePTFE covering can bond to the other where the ePTFE coverings come to contact through the openings in the shunt portion.
In the embodiment where both luminal and abluminal surfaces of the shunt portions is encapsulated with same or similar material, porosity of material can be selected to achieve the best treatment result. For example, material with small pores, or even no pores could be used to encapsulate the abluminal side so that tissue encroachment can be prevented, and material with a larger pore size than that of the material covering the abluminal surface of the shunt portion could be used to cover the luminal surface in order to facilitate cell coverage and endothelialization of the luminal side to produce a thromboresistent surface in direct blood contact.
One skilled in the art would understand that the optimal configuration of the covering will have to be determined by clinicians based on each patient's conditions. The specific embodiments discussed herein should not be viewed as limiting.
In some embodiments, the encapsulating layers are made of a flexible, biocompatible, non-absorbable polymeric material (i.e., a material that does not dissolve after implanted in the body). Examples of such materials include, without limitation, expanded polytetrafluoroethylene (ePTFE), unexpanded porous PTFE, woven or knitted polyester or expanded PTFE yarns, ultrahigh molecular weight polyethylene (UHMWPE), other polyolefins, composite materials such as ePTFE with PTFE fibers, or UHMWPE film with embedded UHMWPE fibers, polyimides, silicones, polyurethane, hydrogels, fluorinated ethylene polypropylene (FEP), polypropylfluorinated amines (PFA), other related fluorinated polymers. According to another embodiments, the encapsulating layer could also be made of other material such as polyurethanes, metallic materials, polyvinyl alcohol (PVA), extracellular matrix (ECM) isolated from a mammalian tissue, or other bioengineered materials, or other natural materials (e.g., collagen), or combinations of these materials. Suitable material also include nonwoven fabrics, electrospun, dry spun materials or various combinations thereof.
Furthermore, the surface of the encapsulation material can be modified with biological, pharmaceutical and/or other active ingredients, such as anti-coagulants, anti-thrombogenic agents, cells, growth factors and/or drugs to diminish calcifications, protein deposition, and thrombus, which control and direct tissue growth by stimulating an irritation response to induce cell proliferation in one area and discourage cell proliferation in the other.
The methods and devices disclosed herein are useful for treating various symptoms of heart failures, in particular diastolic heart failures, by reducing the pressure in the left atrium and pulmonary veins. One skilled in the art would further recognize that devices according to the present teachings could be used to regulate pressure in other parts of the heart and/or vascular portions of the body. For example, the devices disclosed herein can be deployed on the septum between the left and right atria, the left and right ventricles, the left atrium and the coronary sinus, and the like.
Various embodiments have been illustrated and described herein by way of examples, and one of ordinary skill in the art would recognize that variations can be made without departing from the spirit and scope of the present teachings. The present teachings are capable of other embodiments or of being practiced or carried out in various other ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present teachings belong. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present teachings. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
This application claims the benefit under 35 U.S.C. § 119 of U.S. Patent Appl. No. 62/028,286, filed Jul. 23, 2014, and U.S. Patent Appl. No. 62/167,624, filed May 28, 2015, the disclosures of which are incorporated by reference.
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