Patent Grant
11559188
The present invention relates generally to medical devices used for visualizing and/or treating regions of tissue within a body. More particularly, the present invention relates to methods and apparatus for directly visualizing tissue regions via imaging systems which are off-axis relative to a longitudinal axis of a deployment catheter and/or treating the issue regions under visualization.
Conventional devices for accessing and visualizing interior regions of a body lumen are known. For example, ultrasound devices have been used to produce images from within a body in vivo. Ultrasound has been used both with and without contrast agents, which typically enhance ultrasound-derived images.
Other conventional methods have utilized catheters or probes having position sensors deployed within the body lumen, such as the interior of a cardiac chamber. These types of positional sensors are typically used to determine the movement of a cardiac tissue surface or the electrical activity within the cardiac tissue. When a sufficient number of points have been sampled by the sensors, a “map” of the cardiac tissue may be generated.
Another conventional device utilizes an inflatable balloon which is typically introduced intravascularly in a deflated state and then inflated against the tissue region to be examined. Imaging is typically accomplished by an optical fiber or other apparatus such as electronic chips for viewing the tissue through the membrane(s) of the inflated balloon. Moreover, the balloon must generally be inflated for imaging. Other conventional balloons utilize a cavity or depression formed at a distal end of the inflated balloon. This cavity or depression is pressed against the tissue to be examined and is flushed with a clear fluid to provide a clear pathway through the blood.
However, such imaging balloons have many inherent disadvantages. For instance, such balloons generally require that the balloon be inflated to a relatively large size which may undesirably displace surrounding tissue and interfere with fine positioning of the imaging system against the tissue. Moreover, the working area created by such inflatable balloons are generally cramped and limited in size. Furthermore, inflated balloons may be susceptible to pressure changes in the surrounding fluid. For example, if the environment surrounding the inflated balloon undergoes pressure changes, e.g., during systolic and diastolic pressure cycles in a beating heart, the constant pressure change may affect the inflated balloon volume and its positioning to produce unsteady or undesirable conditions for optimal tissue imaging.
Accordingly, these types of imaging modalities are generally unable to provide desirable images useful for sufficient diagnosis and therapy of the endoluminal structure, due in part to factors such as dynamic forces generated by the natural movement of the heart. Moreover, anatomic structures within the body can occlude or obstruct the image acquisition process. Also, the presence and movement of opaque bodily fluids such as blood generally make in vivo imaging of tissue regions within the heart difficult.
Other external imaging modalities are also conventionally utilized. For example, computed tomography (CT) and magnetic resonance imaging (MRI) are typical modalities which are widely used to obtain images of body lumens such as the interior chambers of the heart. However, such imaging modalities fail to provide real-time imaging for intra-operative therapeutic procedures. Fluoroscopic imaging, for instance, is widely used to identify anatomic landmarks within the heart and other regions of the body. However, fluoroscopy fails to provide an accurate image of the tissue quality or surface and also fails to provide for instrumentation for performing tissue manipulation or other therapeutic procedures upon the visualized tissue regions. In addition, fluoroscopy provides a shadow of the intervening tissue onto a plate or sensor when it may be desirable to view the intraluminal surface of the tissue to diagnose pathologies or to perform some form of therapy on it.
Moreover, many of the conventional imaging systems lack the capability to provide therapeutic treatments or are difficult to manipulate in providing effective therapies. For instance, the treatment in a patient's heart for atrial fibrillation is generally made difficult by a number of factors, such as visualization of the target tissue, access to the target tissue, and instrument articulation and management, amongst others.
Conventional catheter techniques and devices, for example such as those described in U.S. Pat. Nos. 5,895,417; 5,941,845; and 6,129,724, used on the epicardial surface of the heart may be difficult in assuring a transmural lesion or complete blockage of electrical signals. In addition, current devices may have difficulty dealing with varying thickness of tissue through which a transmural lesion desired.
Conventional accompanying imaging devices, such as fluoroscopy, are unable to detect perpendicular electrode orientation, catheter movement during the cardiac cycle, and image catheter position throughout lesion formation. Without real-time visualization, it is difficult to reposition devices to another area that requires transmural lesion ablation. The absence of real-time visualization also poses the risk of incorrect placement and ablation of critical structures such as sinus node tissue which can lead to fatal consequences.
Thus, a tissue imaging system which is able to provide real-time in vivo access to and images of tissue regions within body lumens such as the heart through opaque media such as blood and which also provides instruments for therapeutic procedures are desirable.
The tissue-imaging apparatus described relates to variations of a device and/or method to provide real-time images in vivo of tissue regions within a body lumen such as a heart, which is filled with blood flowing dynamically therethrough. Such an apparatus may be utilized for many procedures, e.g., mitral valvuloplasty, left atrial appendage closure, arrhythmia ablation, transseptal access and patent foramen ovale closure among other procedures. Further details of such a visualization catheter and methods of use are shown and described in U.S. Pat. Pub. 2006/0184048 A1, which is incorporated herein by reference in its entirety.
A tissue imaging and manipulation apparatus that may be utilized for procedures within a body lumen, such as the heart, in which visualization of the surrounding tissue is made difficult, if not impossible, by medium contained within the lumen such as blood, is described below. Generally, such a tissue imaging and manipulation apparatus comprises an optional delivery catheter or sheath through which a deployment catheter and imaging hood may be advanced for placement against or adjacent to the tissue to be imaged.
The deployment catheter may define a fluid delivery lumen therethrough as well as an imaging lumen within which an optical imaging fiber or electronic imaging assembly may be disposed for imaging tissue. When deployed, the imaging hood may be expanded into any number of shapes, e.g., cylindrical, conical as shown, semi-spherical, etc., provided that an open area or field is defined by the imaging hood. The open area is the area within which the tissue region of interest may be imaged. The imaging hood may also define an atraumatic contact lip or edge for placement or abutment against the tissue region of interest. Moreover, the distal end of the deployment catheter or separate manipulatable catheters may be articulated through various controlling mechanisms such as push-pull wires manually or via computer control
In operation, after the imaging hood has been deployed, fluid may be pumped at a positive pressure through the fluid delivery lumen until the fluid fills the open area completely and displaces any blood from within the open area. The fluid may comprise any biocompatible fluid, e.g., saline, water, plasma, Fluorinert™, etc., which is sufficiently transparent to allow for relatively undistorted visualization through the fluid. The fluid may be pumped continuously or intermittently to allow for image capture by an optional processor which may be in communication with the assembly.
The imaging hood may be deployed into an expanded shape and retracted within a catheter utilizing various mechanisms. Moreover, the imaging element, such as a CCD or CMOS imaging camera, may be positioned distally or proximally of the imaging hood when collapsed into its low-profile configuration. Such a configuration may reduce or eliminate friction during deployment and retraction as well as increase the available space within the catheter not only for the imaging unit but also for the hood.
Moreover, the imaging element may be introduced along or within the hood into an off-axis position relative to a longitudinal axis of the catheter and/or hood for providing direct visualization of the underlying tissue to be visually examined and/or treated. For example, one variation may utilize a flexible section located at a distal end of the catheter which may be configured from various flexible materials coupled or integrated with a relatively rigid section located proximally of flexible section. The imaging element may be positioned and/or attached to a lateral inner wall of the flexible section such that when the section is collapsed within the sheath, the imaging element may be placed in an in-line or axially positioned relative to the catheter and hood to provide for a low-profile delivery configuration.
Upon deployment of the hood from the constraints of the sheath, the hood and flexible section may be advanced distal to the sheath such that the hood is free to expand or to be expanded and the flexible section is also unconstrained to expand or to be expanded as well such that a portion of the flexible section extends laterally relative to the hood and the catheter to form an imager retaining channel or pocket. The retaining channel or pocket may extend laterally a sufficient distance, either self-expanding or pushed open via the imager being urged laterally into the space, such that the space distal to the catheter is unobstructed by the imager or retaining channel. Alternatively, if the flexible section is self-expanding when pushed out of the sheath such that it expands to its original lateral configuration when not constrained by the sheath, the section may urge imager into its off-axis position if attached to one another.
Because the imager is positioned laterally, the catheter and hood may accommodate a variety of sizes for different types of imagers. For instance, relatively larger, more economical, and/or relatively more powerful CCD or CMOS imagers may be utilized with the system as the hood may accommodate a range of sizes and configurations for the imaging system. With the imager positioned in its off-axis location relative to the hood and/or catheter, the user may obtain a better angle of visualization of the entire operating landscape, including both the movements of the tools and the target tissue surface during any number of therapeutic and/or diagnostic procedures. Moreover, the unobstructed opening of the catheter may allow for various instruments, such as RF ablation probes, graspers, needles, etc., to be deployed through the catheter and past the imager into the open area defined by the hood for treatment upon the underlying imaged tissue.
Various other configurations for positioning the imaging element off-axis may include us of instruments such as a dilator positioned proximal to the flexible segment. The dilator may be translatable through the deployment catheter and may also define one or more working lumens therethrough for the introduction of one or more instruments. With the imaging element attached laterally within the channel or pocket, the hood and flexible section may be advanced out of the sheath with the imaging element still in its low-profile axial position. The dilator may be pushed distally to expand the collapsed section to its expanded volume to form the channel or pocket, consequently pushing the imaging element laterally to the side where the imaging element may bulge out and stretch the channel or pocket.
Yet other variations may utilize an imager support member which is extendable through the deployment catheter and the collapsed imaging hood to position the imaging element distally of the hood. When the hood is deployed and expanded, the imaging element may be pulled proximally into the hood and into its off-axis position via the support member, which may include one or more curved or linked sections or which may be made from a shape memory alloy which reconfigures itself. In yet another variation, the imaging element may include a tapered or angled proximal surface which is forced to slide against an angled surface which is complementary to the imaging element surface. Proximal actuation of the imager may force the imaging element to slide into an off-axis position. In yet other variations, the imaging element may be urged into its off-axis position via an inflatable elongate balloon which pushes the imager along or within the hood.
A tissue-imaging and manipulation apparatus described below is able to provide real-time images in vivo of tissue regions within a body lumen such as a heart, which is filled with blood flowing dynamically therethrough and is also able to provide intravascular tools and instruments for performing various procedures upon the imaged tissue regions. Such an apparatus may be utilized for many procedures, e.g., facilitating transseptal access to the left atrium, cannulating the coronary sinus, diagnosis of valve regurgitation/stenosis, valvuloplasty, atrial appendage closure, arrhythmogenic focus ablation, among other procedures. Further examples of tissue visualization catheters which may be utilized are shown and described in further detail in U.S. patent application Ser. No. 11/259,498 filed Oct. 25, 2005, which has been incorporated hereinabove by reference in its entirety.
One variation of a tissue access and imaging apparatus is shown in the detail perspective views of
When the imaging and manipulation assembly 10 is ready to be utilized for imaging tissue, imaging hood 12 may be advanced relative to catheter 14 and deployed from a distal opening of catheter 14, as shown by the arrow. Upon deployment, imaging hood 12 may be unconstrained to expand or open into a deployed imaging configuration, as shown in
Imaging hood 12 may be attached at interface 24 to a deployment catheter 16 which may be translated independently of deployment catheter or sheath 14. Attachment of interface 24 may be accomplished through any number of conventional methods. Deployment catheter 16 may define a fluid delivery lumen 18 as well as an imaging lumen 20 within which an optical imaging fiber or assembly may be disposed for imaging tissue. When deployed, imaging hood 12 may expand into any number of shapes, e.g., cylindrical, conical as shown, semi-spherical, etc., provided that an open area or field 26 is defined by imaging hood 12. The open area 26 is the area within which the tissue region of interest may be imaged. Imaging hood 12 may also define an atraumatic contact lip or edge 22 for placement or abutment against the tissue region of interest. Moreover, the diameter of imaging hood 12 at its maximum fully deployed diameter, e.g., at contact lip or edge 22, is typically greater relative to a diameter of the deployment catheter 16 (although a diameter of contact lip or edge 22 may be made to have a smaller or equal diameter of deployment catheter 16). For instance, the contact edge diameter may range anywhere from 1 to 5 times (or even greater, as practicable) a diameter of deployment catheter 16.
The imaging and manipulation assembly 10 may additionally define a guidewire lumen therethrough, e.g., a concentric or eccentric lumen, as shown in the side and end views, respectively, of
In operation, after imaging hood 12 has been deployed, as in
As seen in the example of
Although contact edge 22 need not directly contact the underlying tissue, it is at least preferably brought into close proximity to the tissue such that the flow of clear fluid 28 from open area 26 may be maintained to inhibit significant backflow of blood 30 back into open area 26. Contact edge 22 may also be made of a soft elastomeric material such as certain soft grades of silicone or polyurethane, as typically known, to help contact edge 22 conform to an uneven or rough underlying anatomical tissue surface. Once the blood 30 has been displaced from imaging hood 12, an image may then be viewed of the underlying tissue through the clear fluid 30. This image may then be recorded or available for real-time viewing for performing a therapeutic procedure. The positive flow of fluid 28 may be maintained continuously to provide for clear viewing of the underlying tissue. Alternatively, the fluid 28 may be pumped temporarily or sporadically only until a clear view of the tissue is available to be imaged and recorded, at which point the fluid flow 28 may cease and blood 30 may be allowed to seep or flow back into imaging hood 12. This process may be repeated a number of times at the same tissue region or at multiple tissue regions.
In desirably positioning the assembly at various regions within the patient body, a number of articulation and manipulation controls may be utilized. For example, as shown in the articulatable imaging assembly 40 in
Additionally or alternatively, an articulatable delivery catheter 48, which may be articulated via one or more push-pull wires and having an imaging lumen and one or more working lumens, may be delivered through the deployment catheter 16 and into imaging hood 12. With a distal portion of articulatable delivery catheter 48 within imaging hood 12, the clear displacing fluid may be pumped through delivery catheter 48 or deployment catheter 16 to clear the field within imaging hood 12. As shown in
Alternatively, rather than passing an articulatable delivery catheter 48 through the deployment catheter 16, a distal portion of the deployment catheter 16 itself may comprise a distal end 49 which is articulatable within imaging hood 12, as shown in
Visualization within the imaging hood 12 may be accomplished through an imaging lumen 20 defined through deployment catheter 16, as described above. In such a configuration, visualization is available in a straight-line manner, i.e., images are generated from the field distally along a longitudinal axis defined by the deployment catheter 16. Alternatively or additionally, an articulatable imaging assembly having a pivotable support member 50 may be connected to, mounted to, or otherwise passed through deployment catheter 16 to provide for visualization off-axis relative to the longitudinal axis defined by deployment catheter 16, as shown in
If one or more optical fibers are utilized for imaging, the optical fibers 58 may be passed through deployment catheter 16, as shown in the cross-section of
In accessing regions of the heart H or other parts of the body, the delivery catheter or sheath 14 may comprise a conventional intra-vascular catheter or an endoluminal delivery device. Alternatively, robotically-controlled delivery catheters may also be optionally utilized with the imaging assembly described herein, in which case a computer-controller 74 may be used to control the articulation and positioning of the delivery catheter 14. An example of a robotically-controlled delivery catheter which may be utilized is described in further detail in US Pat. Pub. 2002/0087169 A1 to Brock et al. entitled “Flexible Instrument”, which is incorporated herein by reference in its entirety. Other robotically-controlled delivery catheters manufactured by Hansen Medical, Inc. (Mountain View, Calif.) may also be utilized with the delivery catheter 14.
To facilitate stabilization of the deployment catheter 16 during a procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of catheter 16, as shown in
To further stabilize a position of the imaging hood 12 relative to a tissue surface to be imaged, various anchoring mechanisms may be optionally employed for temporarily holding the imaging hood 12 against the tissue. Such anchoring mechanisms may be particularly useful for imaging tissue which is subject to movement, e.g., when imaging tissue within the chambers of a beating heart. A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through deployment catheter 16 and into an expanded imaging hood 12. As the imaging hood 12 is brought into contact against a tissue surface T to be examined, anchoring mechanisms such as a helical tissue piercing device 84 may be passed through the tool delivery catheter 82, as shown in
The helical tissue engaging device 84 may be torqued from its proximal end outside the patient body to temporarily anchor itself into the underlying tissue surface T. Once embedded within the tissue T, the helical tissue engaging device 84 may be pulled proximally relative to deployment catheter 16 while the deployment catheter 16 and imaging hood 12 are pushed distally, as indicated by the arrows in
Although a helical anchor 84 is shown, this is intended to be illustrative and other types of temporary anchors may be utilized, e.g., hooked or barbed anchors, graspers, etc. Moreover, the tool delivery catheter 82 may be omitted entirely and the anchoring device may be delivered directly through a lumen defined through the deployment catheter 16.
In another variation where the tool delivery catheter 82 may be omitted entirely to temporarily anchor imaging hood 12,
An illustrative example is shown in
Optionally, processor 98 may also be utilized to coordinate the fluid flow and the image capture. For instance, processor 98 may be programmed to provide for fluid flow from reservoir 96 until the tissue area has been displaced of blood to obtain a clear image. Once the image has been determined to be sufficiently clear, either visually by a practitioner or by computer, an image of the tissue may be captured automatically by recorder 100 and pump 92 may be automatically stopped or slowed by processor 98 to cease the fluid flow into the patient. Other variations for fluid delivery and image capture are, of course, possible and the aforementioned configuration is intended only to be illustrative and not limiting.
Deployment of imaging hood 12 may be actuated by a hood deployment switch 120 located on the handle assembly 112 while dispensation of the fluid from reservoir 114 may be actuated by a fluid deployment switch 122, which can be electrically coupled to the controller 118. Controller 118 may also be electrically coupled to a wired or wireless antenna 124 optionally integrated with the handle assembly 112, as shown in the figure. The wireless antenna 124 can be used to wirelessly transmit images captured from the imaging hood 12 to a receiver, e.g., via Bluetooth® wireless technology (Bluetooth SIG, Inc., Bellevue, Wash.), RF, etc., for viewing on a monitor 128 or for recording for later viewing.
Articulation control of the deployment catheter 16, or a delivery catheter or sheath 14 through which the deployment catheter 16 may be delivered, may be accomplished by computer control, as described above, in which case an additional controller may be utilized with handle assembly 112. In the case of manual articulation, handle assembly 112 may incorporate one or more articulation controls 126 for manual manipulation of the position of deployment catheter 16. Handle assembly 112 may also define one or more instrument ports 130 through which a number of intravascular tools may be passed for tissue manipulation and treatment within imaging hood 12, as described further below. Furthermore, in certain procedures, fluid or debris may be sucked into imaging hood 12 for evacuation from the patient body by optionally fluidly coupling a suction pump 132 to handle assembly 112 or directly to deployment catheter 16.
As described above, fluid may be pumped continuously into imaging hood 12 to provide for clear viewing of the underlying tissue. Alternatively, fluid may be pumped temporarily or sporadically only until a clear view of the tissue is available to be imaged and recorded, at which point the fluid flow may cease and the blood may be allowed to seep or flow back into imaging hood 12.
The deployment catheter 16 may be then repositioned to an adjacent portion of mitral valve MV, as shown in
As mentioned above, when the imaging hood 12 is cleared by pumping the imaging fluid within for clearing the blood or other bodily fluid, the fluid may be pumped continuously to maintain the imaging fluid within the hood 12 at a positive pressure or it may be pumped under computer control for slowing or stopping the fluid flow into the hood 12 upon detection of various parameters or until a clear image of the underlying tissue is obtained. The control electronics 118 may also be programmed to coordinate the fluid flow into the imaging hood 12 with various physical parameters to maintain a clear image within imaging hood 12.
One example is shown in
The variations in fluid pressure within imaging hood 12 may be accomplished in part due to the nature of imaging hood 12. An inflatable balloon, which is conventionally utilized for imaging tissue, may be affected by the surrounding blood pressure changes. On the other hand, an imaging hood 12 retains a constant volume therewithin and is structurally unaffected by the surrounding blood pressure changes, thus allowing for pressure increases therewithin. The material that hood 12 is made from may also contribute to the manner in which the pressure is modulated within this hood 12. A stiffer hood material, such as high durometer polyurethane or Nylon, may facilitate the maintaining of an open hood when deployed. On the other hand, a relatively lower durometer or softer material, such as a low durometer PVC or polyurethane, may collapse from the surrounding fluid pressure and may not adequately maintain a deployed or expanded hood.
As mentioned above, an imaging element, e.g., a CCD or CMOS imager or optical fiber, may be connected to, mounted to, or otherwise passed through deployment catheter 16 to provide for visualization off-axis relative to the longitudinal axis 186 defined by deployment catheter 16. In yet other variations for providing off-axis visualization, an imaging element may be advanced through or along deployment catheter 16 such that the imaging element and hood 12 are arranged to be delivered in a low-profile configuration within sheath 14. Upon deployment of hood 12, the imaging element may be introduced along or within hood 12 into an off-axis position relative to the longitudinal axis of catheter 16 for providing direct visualization of the underlying tissue to be visually examined and/or treated.
In either case, imaging element 174 (e.g., CCD, CMOS, optical fiber, etc.) may be positioned and/or attached to a lateral inner wall of flexible section 170 such that when section 170 is collapsed within sheath 14, as shown, imaging element 174 may be placed in an in-line or axial positioned relative to the catheter 16 and hood 12 to provide for a low-profile delivery configuration, as also shown in the end view of
Upon deployment of hood 12 from the constraints of sheath 14, hood 12 and flexible section 170 may be advanced distal to sheath 14 such that hood 12 is free to expand or to be expanded and flexible section 170 is also unconstrained to expand or to be expanded as well such that a portion of flexible section 170 extends laterally relative to hood 12 and catheter 16 to form an imager retaining channel or pocket 178, as shown in the side and perspective views of
Because imager 174 is positioned laterally, catheter 16 and hood 12 may accommodate a variety of sizes for different types of imagers 174. For instance, relatively larger, more economical, and/or relatively more powerful CCD or CMOS imagers may be utilized with the system as hood 12 may accommodate a range of sizes and configurations for the imaging system. With the imager 174 positioned in its off-axis location relative to the hood 12 and/or catheter 16, the user may obtain a better angle of visualization of the entire operating landscape, including both the movements of the tools and the target tissue surface during any number of therapeutic and/or diagnostic procedures. Moreover, the unobstructed opening of catheter 16 may allow for various instruments, such as RF ablation probes 182, graspers, needles, etc., to be deployed through catheter 16 and past imager 174 into the open area defined by hood 12 for treatment upon the underlying imaged tissue.
Another variation for an off-axis visualization system is shown in the partial cross-sectional side views of
As shown in
A variety of dilators may also be used with deployment catheter 16 and/or sheath 14. Dilators may define single or multiple lumens according to the needs of the user and the size of the instruments to be used with the tissue visualization catheter. Accordingly, different dilators can be conveniently and quickly swapped while hood 12 is still in the patient's body. In addition, dilators which are preformed to have a curved or arcuate shape may also be used such that catheter 16 and/or sheath 14 may conform into the curved or arcuate shape imparted by the dilator, as shown in
In yet another variation,
Once hood 12 has been expanded, support member 200 may be pulled proximally to bring imaging element 174 into hood 12 and into its off-axis position. To receive imaging element 174 within hood 12, the flexible section proximal to hood 12 may define a longitudinal slit 202 at least partially along the section, as shown in the perspective and detailed perspective views of
Another variation is illustrated in the side views of
Yet another variation is illustrated in the partial cross-sectional side views of
Upon further tensioning of support member 234, imaging element 174 may be forced to slide proximally along the tapered interface and into its off-axis location, as indicated by the angled direction of travel 236 in the cross-sectional side view of
In yet another variation,
Another variation is illustrated in the partial cross-sectional side views of
To deploy hood 12, the process may be reversed where shaft 266 may be urged distally to push linkage member 268, which in turn may push imaging element 174 distally. As hood 12 is deployed, elastic member 260 may pull imaging element into its off-axis position along the inner surface of hood 12.
When hood 12 is retracted into sheath 14, magnet 284 may magnetically attract imaging element 174 such that hood 12 is collapsed proximally of imaging element 174 and is positioned distally of the collapsed hood 12 when retained within sheath 14, thus freeing up additional space within sheath 14.
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
This application is a continuation application of U.S. patent application Ser. No. 16/523,725, filed Jul. 26, 2019, which is a continuation application of U.S. patent application Ser. No. 14/959,109, filed Dec. 4, 2015 (issued as U.S. Pat. No. 10,390,685), which is a continuation application of U.S. patent application Ser. No. 11/961,995 filed Dec. 20, 2007 (issued as U.S. Pat. No. 9,226,648) which claims the benefit of and priority to U.S. Prov. Pat. Apps. 60/871,415 and 60/871,424 both filed Dec. 21, 2006, all of which are incorporated herein by reference in their entirety.
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| 20200305693 A1 | Oct 2020 | US |
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| 60871424 | Dec 2006 | US | |
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| Parent | 14959109 | Dec 2015 | US |
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| Parent | 11961995 | Dec 2007 | US |
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