DISTENSIBLE KNITTED WIRE MESH FOR A CARDIAC SLEEVE

Abstract

Heart failure (HF) is a global pandemic affecting at least 26 million people worldwide. Thus, methods and devices that reduce the clinical and economic burden of HF are critical. The present invention features an adjustable cardiac sleeve comprising a basal ring structure and an apical hub couple together, wherein the basal ring structure comprises a plurality of interconnected loops made from a distensible wire.

Claims

1. An adjustable cardiac sleeve (100) comprising a basal ring structure (130) coupled to an apical hub (120), wherein the basal ring structure (130) comprises a plurality of interconnected loops, wherein a first loop end (131) is connected to a second loop end (132) of the interconnected loops to form a ring.

2. The cardiac sleeve (100) of claim 1, wherein the basal ring structure (130) and the apical hub (120) are coupled to each other by non-overlapping fibers (110).

3. The cardiac sleeve (100) of claim 1, wherein the basal ring structure (130) and the apical hub (120) are coupled to each other by a plurality of adjacent ring structures, each ring structure comprising a plurality of interconnected loops, wherein adjacent rows of ring structures are interconnected.

4. The cardiac sleeve (100) of claim 1, wherein the interconnected loops are made from a distensible wire, wherein the distensible wire comprises a super elastic wire.

5. The cardiac sleeve (100) of claim 1, wherein the plurality of interconnected loops is connected via a connection component.

6. The cardiac sleeve (100) of claim 5, wherein the connection component is welded, soldered, or crimped or wherein the connection component is filled with an adhesive.

7. The cardiac sleeve (100) of claim 1, wherein the plurality of interconnected loops is interlaced and secured with twists, or wherein the plurality of interconnected loops is interlaced and forms crossing points.

8. The cardiac sleeve (100) of claim 1, wherein the cardiac sleeve (100) is adjustable to the size of a heart.

9. The cardiac sleeve (100) of claim 1, wherein each loop of the plurality of interconnected loops of the basal ring structure (130) is adjustable and/or expandable.

10. The cardiac sleeve (100) of claim 9, wherein each loop of the plurality of interconnected loops of the basal ring structure (130) is circular.

11. The cardiac sleeve (100) of claim 9, wherein each loop of the plurality of interconnected loops of the basal ring structure (130) expands to an elliptical shape.

12. The cardiac sleeve (100) of claim 1, further comprising a membrane.

13. The cardiac sleeve (100) of claim 12, wherein the membrane partially or fully covers the cardiac sleeve (100).

14. The cardiac sleeve (100) of claim 13, wherein the membrane comprises natural or synthetic fiber.

15. The cardiac sleeve (100) of claim 12, wherein the membrane allows the cardiac sleeve (100) to avoid direct contact with a heart.

16. The cardiac sleeve (100) of claim 1, further comprising an actuator (130) operably connected to the apical hub (120), wherein a drive shaft (150) connects the actuator (140) to the apical hub (120).

17. The cardiac sleeve (100) of claim 1, wherein the cardiac sleeve (100) is configured to externally wrap over the epicardium of a native, intact heart.

18. The cardiac sleeve (100) of claim 1, wherein the cardiac sleeve (100) is attached to the heart by an anchoring mechanism, wherein the basal ring structure is attached to the heart by an anchoring mechanism.

19. A method of treating heart failure in a subject in need thereof, the method comprising obtaining a cardiac sleeve (100) comprising a basal ring structure (130) coupled to an apical hub (120), wherein the basal ring structure (130) comprises a plurality of interconnected loops, wherein a first loop end (131) is connected to a second loop end (132) of the interconnected loops to form a ring and externally wrapping over the epicardium of a native, intact heart of the subject, wherein the cardiac sleeve (100) cycles between a diastolic position and a systolic position.

20. The method of claim 19, wherein the diastolic position comprises fibers (110) extending linearly around the heart from the basal ring structure (130) directly down to the apical hub (120), and wherein the systolic position comprises fibers (110) wrapping helically around the heart from the basal ring structure (130) directly down to the apical hub (120) and compresses the heart.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0010] The features and advantages of the present invention will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings in which:

[0011] FIGS. 1A, 1B, 1C, 1D, and 1E demonstrate how a wire is formed into a loop with a crossing point. In certain embodiments, the crossing point of said wire (FIG. 1A) is secured with a bead (FIG. 1B). The bead may further be secured by crimping said bead (FIG. 1C) or by applying an adhesive inside the bead (FIG. 1D). The crossing point of said wire may further be secured by welding (FIG. 1E).

[0012] FIGS. 2A, 2B, 2C, and 2D show, in accordance with embodiments herein, how a wire formed into a loop may be secured. The wire loops may be secured with an axial twist (FIG. 2A) or with a plurality of axial twists (FIG. 2B). The wire loop may additionally be secured with an orthogonal twist (FIG. 2C) or a plurality of orthogonal twists (FIG. 2D).

[0013] FIGS. 3A and 3B show a structure comprising multiple loops secured together. FIG. 3A shows the multiple loops secured together without tension. FIG. 3B shows how the loops secured together elongate under tension.

[0014] FIGS. 4A and 4B show a closed ring-like structure comprising a plurality of loops secured together, wherein a first loop end is connected to a second loop end. FIG. 4A shows a closed ring-link structure without tension. FIG. 4B shows a closed ring-like structure (e.g., a distensible ring) elongated under tension.

[0015] FIGS. 5A and 5B show closed sleeve-like structure comprising a plurality of closed ring-like structures. FIG. 5A shows a closed sleeve-like structure without tension and FIG. 5B shows a closed sleeve-like structure (e.g., distensible sleeve-like structure) elongated under tension.

[0016] FIGS. 6A and 6B show in accordance with embodiments herein, how the wire mesh allows for a precise fit around a body organ (e.g., a heart). FIG. 6A shows a closed ring-like structure comprising a plurality of loops secured together (see FIGS. 4A and 4B) around a heart. FIG. 6B shows a closed sleeve-like structure comprising a plurality of closed ring-like structures (see FIGS. 5A and 5B) around a heart.

[0017] FIGS. 7A, 7B, and 7C show a closed ring-like structure comprising non-overlapping fibers connecting the closed ring-like structure (e.g., the basal ring structure) to an apical hub and motor. FIG. 7A shows a cardiac sleeve comprising a closed ring-like structure (e.g., the basal ring structure) coupled to an apical hub via non-overlapping fibers (e.g., linear members) and a motor in a diastole position (e.g., relaxed). FIG. 7B shows a cardiac sleeve comprising a closed ring-like structure (e.g., the basal ring structure) coupled to an apical hub via non-overlapping fibers (e.g., linear members) and a motor in a systole position (e.g., contracted). FIG. 7C shows the motor rotation angle alpha (α).

[0018] FIGS. 8A and 8B show a cardiac sleeve as described herein, comprising a closed ring-like structure (e.g., the basal ring structure) coupled to an apical hub via non-overlapping fibers (e.g., linear members) and a motor. In some embodiments, the cardiac sleeve described herein allows for a precise fit around a smaller body organ (e.g., a heart). For example, the non-overlapping fibers may be shortened to accommodate the smaller organ (e.g., the heart). FIG. 8A shows a closed ring-like structure (e.g., distensible ring) comprising linear members connecting the closed ring-like structure to an apical hub and motor around a smaller heart. FIG. 8B shows how the rotatable pins are positioned within the apical hub.

[0019] FIG. 9 shows, in accordance with embodiments herein, cardiac sleeves of the present invention.

[0020] FIG. 10 shows, in accordance with embodiments herein, an adjustable cardiac sleeve comprising a basal ring structure comprising a plurality of interconnected loops coupled to an apical hub, by a plurality of adjacent ring structure. In some embodiments, the plurality of adjacent ring structures may comprise a plurality of loops that align helically between the basal ring structure and the apical hub.

DETAILED DESCRIPTION OF THE INVENTION

[0021] Following is a list of elements corresponding to a particular element referred to herein: [0022] 100 Cardiac Sleeve [0023] 110 Fiber [0024] 120 Apical Hub [0025] 130 Basal Ring Structure [0026] 131 First Loop End [0027] 132 Second Loop End [0028] 140 Actuator [0029] 150 Drive Shaft

[0030] Referring now to the figures, the present invention features an adjustable cardiac sleeve (100). In some embodiments, the cardiac sleeve (100) comprises a basal ring (130) structure coupled to an apical hub (120). In some embodiments, the basal ring structure (130) comprises a plurality of interconnected loops made from a distensible wire. In some embodiments, a first loop end (131) is connected to a second loop end (132) of the interconnected loops to form a ring. In some embodiments, the basal ring structure (130) and the apical hub (120) are interconnected (e.g., coupled) to each other. The cardiac sleeves (100) described herein may be adjustable to the size of a heart.

[0031] In some embodiments, the adjustable cardiac sleeve (100) wraps around the heart and assists in the pumping function of the heart. In some embodiments, the adjustable cardiac sleeve (100) externally wraps around the still-intact heart and provides an additional pumping force via contraction and expansion of the adjustable cardiac sleeve (100). In some embodiments, the adjustable cardiac sleeve (100) externally wraps around the still-intact heart and mechanically helps contract the heart to sync with the cardiac cycle.

[0032] In some embodiments, the adjustable cardiac sleeve (100) wraps the heart externally and does not modify the native heart, and therefore, avoids direct blood contact. Because the heart remains totally intact, the patient will not die even in cases of device malfunction.

[0033] In some embodiments, the cardiac sleeve (100) is controlled by a pacemaker system (e.g., a commercially-available pacemaker; e.g., a biventricular pacemaker) to match the pace of the native, intact heart. In some aspects, a pacemaker system synchronizes the cardiac sleeve (100) and the heart to a new desired pace. In some embodiments, the cardiac sleeve (100) works only on demand in conjunction with the pacemaker system, which may conserve battery energy.

[0034] In some embodiments, the present invention describes a distensible knitted wire mesh comprising a wire curved into circular loops (see FIG. 2A) and secured where said wire crosses itself (i.e., the wire is secured at a crossing point), thus fixing the loop in place (see FIG. 1A).

[0035] In some embodiments, the basal ring structure (130) and the apical hub (120) are coupled to each other by non-overlapping fibers (110). In some embodiments, the basal ring structure (130) and the apical hub (120) are coupled to each other by helically-arranged, non-overlapping fibers (110). The non-overlapping fibers (110) may be adjustable. For example, the non-overlapping fibers (110) may be shortened or lengthened between the basal ring structure (130) and the apical hub (120) to accommodate various heart sizes (FIGS. 8A and 8B).

[0036] In some embodiments, the plurality of interconnected loops is connected via a connection component (e.g., a bead). In some embodiments, the plurality of interconnected loops is connected via a bead, e.g., a snug-fitting bead. In some embodiments, the connection component (e.g., a bead) is welded, soldered, or crimped. In some embodiments, the bead is welded, soldered, or crimped. In other embodiments, the connection component (e.g., a bead) is filled with an adhesive. In other embodiments, the bead is filled with an adhesive. As used herein, a “connection component” may refer to a cylindrical-shaped object comprising a lumen through which a wire may be passed therethrough.

[0037] In some embodiments, the plurality of interconnected loops is interlaced and secured with twists. The interlace plurality of interconnected loops may be heat set at the point at which the twist was formed. In some embodiments, interlace twists are heat set. In some embodiments, the plurality of interconnected loops is interlaced, forming crossing points. In some embodiments, the crossing points may be welded.

[0038] In certain embodiments, the wire is fixed at the crossing point (see FIG. 1A) by constraining said crossing point through a snug-fitting bead (FIG. 1B). In some embodiments, the bead (FIG. 1B) may further be filled with an adhesive (FIG. 1D), welded, soldered, or crimped (FIG. 1C). In other embodiments, the wire is fixed at the crossing point by welding (FIG. 1E).

[0039] In other embodiments, the wire is fixed by predominantly axial twist(s) around itself (FIGS. 2A and 2B). In further embodiments, the wire is fixed by predominantly orthogonal twist(s) around itself (FIGS. 2C and 2D). In some embodiments, the shape of the twist (e.g., axial or orthogonal) may be locally heat set to fix the twist in place. For example, for a super elastic or shape-memory wire (e.g., nitinol), the shape of the twist may be locally heat set to fix the twist and thus fix the loop.

[0040] In some embodiments, a plurality of loops can be constructed in sequence to create a structure of loops, where each loop will proportionately elongate in response to applied tension (e.g., a plurality of interconnected loops; see FIGS. 3A and 3B).

[0041] In some embodiments, each loop of the plurality of interconnected loops of the basal ring structure (130) is adjustable. In other embodiments, each loop of the plurality of interconnected loops of the basal ring structure (130) is expandable. In some embodiments, each loop of the plurality of interconnected loops of the basal ring structure (130) is circular (FIG. 3A). In other embodiments, each loop of the plurality of interconnected loops of the basal ring structure (130) elliptical (FIG. 3B). In other embodiments, each loop of the plurality of interconnected loops of the basal ring structure (130) expands to an elliptical shape (FIG. 3B).

[0042] In some embodiments, the structure of loops can be closed to form a distensible ring-like structure (e.g., a basal ring structure (130)) with a first loop end (131) being fixed (i.e., connected) to a second loop end (132) (FIGS. 4A and 4B).

[0043] In some embodiments, the basal ring structure (130) and the apical hub (120) are interconnected to each other by a plurality of adjacent ring structures comprising a plurality of interconnected loops, e.g., made from a distensible wire (FIG. 6B). In some embodiments, the plurality of adjacent ring structures may comprise a plurality of loops that align helically between the basal ring structure (130) and the apical hub (120)(FIG. 10). In some embodiments, the adjacent rows of ring structures are interconnected. In some embodiments, the interconnected loops are made from a distensible wire. In some embodiments, the basal ring structure (130) and the apical hub (120) are interconnected to each other by non-overlapping, helically-arranged fibers, e.g., that are enclosed within the sleeve (e.g., enclosed within a membrane).

[0044] In some embodiments, the basal ring structure (130) is coupled to the apical hub (120) by a plurality of adjacent ring structures, each ring structure comprising a plurality of interconnected loops. In some embodiments, the adjacent rows of ring structures are interconnected. In some embodiments, the basal ring structure (130) is coupled to the apical hub (120) by a plurality of adjacent ring structures (e.g., interconnected adjacent ring structures). In some embodiments, the basal ring structure (130) is coupled to the apical hub (120) via a non-overlapping fiber (e.g., helically arranged non-overlapping fibers). In some embodiments, the basal ring structure (130) is coupled to the apical hub (120) via a plurality of adjacent ring structures and non-overlapping fibers.

[0045] In some embodiments, multiple rows of ring-like structures can be interconnected to adjacent rows by techniques described herein or by interlacing the wire through the adjacent loops, allowing the construction of distensible sleeve-like structures (FIGS. 5A and 5B).

[0046] In some embodiments, the distensibility of the ring-like structure (e.g., the basal ring structure (130)) or sleeve-like structure allows the structures to distend to fit the intended purpose (FIGS. 6A and 6B). In some embodiments, the material and diameter of the loop wire and the diameter of the circular loops will affect the distention force.

[0047] In some embodiments, the structures (e.g., ring-like structure (e.g., the basal ring structure (130)) or sleeve-like structure) are made from distensible wire. In some embodiments, the distensible wire comprises a super elastic wire, e.g., that enables fiber recoil. In some embodiments, the super elastic wire is nitinol. Non-limiting examples of materials that may be used as distensible wire include but are not limited to nitinol, titanium, cobalt-chromium, stainless steel, sutures, or multifilament sutures.

[0048] In some embodiments, the cardiac sleeve (e.g., the distensible wire or fibers (110)) is coated by a soft material (e.g., polyurethane, ePTFE, etc.) to ensure bare wire/fiber does not come in contact with the heart. Non-limiting examples of a soft material that may encapsulate the sleeve (e.g., the distensible wire or fibers (110)) include but are not limited to fabric, polyurethane, expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), elastomeric polymer, or silicone. In some embodiments, the soft material may comprise a hydrophilic material. In some embodiments, the soft material encapsulates the distensible wire or fibers (110).

[0049] In some embodiments, the distensible knitted mesh can be used where a structure needs to be reversibly collapsed into a smaller shape to be further expanded for a variety of uses, such as during the delivery process from a catheter or delivery device around the heart into the thoracic cavity.

[0050] In some embodiments, the cardiac sleeves (100) described herein are compressible. In some embodiments, the cardiac sleeves (100) described herein are compressed into a catheter for delivery. In other embodiments, the cardiac sleeve (100) comprising an actuator (140), as described herein, is delivered via a delivery system.

[0051] In some embodiments, the cardiac sleeve (100) is folded and/or compressed to fit into a delivery system and brought to and/or near the heart apex. Then, the cardiac sleeve (100) may be pushed out of the delivery system and maneuvered into position around the heart. In some embodiments, the delivery system is large enough to accommodate an actuator (140) which may be also loaded into the delivery system, e.g., before the sleeve. In some embodiments, the actuator (140) is preconnected to the cardiac sleeve (100) before implant.

[0052] In some embodiments, the basal ring structure (130) and the apical hub (120) are interconnected by fibers (110). In other embodiments, the basal ring structure (130) and the apical hub (120) are interconnected by non-overlapping fibers (110). In some embodiments, the basal ring structure (130) and the apical hub (120) are interconnected by helically arranged, non-overlapping fibers (110). In one embodiment, fibers (110) are incorporated into the distensible ring-like structure (i.e., the basal ring structure (130)) and attached to an apical hub (120).

[0053] In some embodiments, the non-overlapping fibers (110) are adjustable. In other embodiments, the non-overlapping fibers (110) are adjustable by rotating pins in the apical hub (120). In some embodiments, rotating the pins in the apical hub (120) changes the length of the non-overlapping fibers (110) between the basal ring structure (130) and the apical hub (120) (i.e., the length of the non-overlapping fibers (110) engaged with the heart). In some embodiments, rotating the pins in the apical hub (120) increases the length of the non-overlapping fibers (110) between the basal ring structure (130) and the apical hub (120). In other embodiments, rotating the pins in the apical hub (120) decreases the length of the non-overlapping fibers (110) between the basal ring structure (130) and the apical hub (120).

[0054] In some embodiments, the cardiac sleeve (100) described herein further comprises a membrane. In some embodiments, the membrane attaches to the basal ring structure (130) and/or the non-overlapping fibers (110). In some embodiments, the membrane is integrated with the cardiac sleeve (100). In some embodiments, the membrane may be bonded or sutured to the basal ring structure (130) and/or the non-overlapping fibers (110). In some embodiments, the cardiac sleeve (100) may encapsulate the basal ring structure (130) and/or the non-overlapping fibers (110).

[0055] In some embodiments, the membrane partially covers the cardiac sleeve (100). In other embodiments, the membrane fully covers the cardiac sleeve (100). In some embodiments, the membrane comprises natural or synthetic fiber including, but not limited to, ePTFE or Polyurethane. In some embodiments, the membrane allows the cardiac sleeve (100) to avoid direct contact with a heart. In other embodiments, the cardiac sleeve (100) described herein is partially or fully covered by a membrane to avoid direct contact with a heart.

[0056] In some embodiments, the cardiac sleeve (100) described herein further comprises an actuator (140) operably connected to the apical hub (120). In some embodiments, a drive shaft (150) connects the actuator (140) to the apical hub (120). In some embodiments, the actuator (140) is suitable for cyclic rotational or twisting motion.

[0057] The adjustable cardiac sleeves (100) described herein advantageously allow for minimally invasive surgical implantation of the sleeve.

[0058] In some embodiments, the adjustable cardiac sleeve (100) described herein only assists the heart as needed. In some embodiments, the adjustable cardiac sleeve (100) described herein continuously assists the heart.

[0059] In some embodiments, the non-overlapping fibers (110; non-overlapping, helically-arranged fibers) change their orientation from straight (FIG. 7A) to helical (FIG. 7B) according to the relative motion/twist of the cardiac sleeve (100) (i.e., according to the relative motion/twist of the actuator (140) attached to the apical ring hub (120)). As used herein, “straight,” refers to a fiber that is as direct as possible between the basal ring structure (130) and the apical hub (120) while still following the contour of the surface of the heart over which the cardiac sleeve is wrapped.

[0060] In some embodiments, the cardiac sleeve (100) described herein is configured to externally wrap over the pericardium of a native, intact heart. In some embodiments, the cardiac sleeve (100) described herein is configured to externally wrap over the epicardium of a native, intact heart. In some embodiments, the cardiac sleeve (100) described herein is attached to the heart by a suture.

[0061] In some embodiments, the cardiac sleeve (100) is attached to the surface of the heart (e.g., to the epicardium or pericardium of the heart) via an anchoring mechanism, e.g., a suture. In some embodiments, the apical hub (120) and/or the basal ring structure (130) are attached to the surface of the heart (e.g., to the epicardium or pericardium of the heart) via an anchoring mechanism, e.g., a suture. In other embodiments, the cardiac sleeve (100) is attached to the surface of the heart by a hook or a suture. In other embodiments, the basal ring structure (130) of the cardiac device (100) is attached to the heart by hooks or sutures. In another embodiment, the distensible ring-like structure is attached to a heart, by means of sutures, as an example.

[0062] In some embodiments, an actuator (140) is synchronized to a heartbeat and cycles between a diastolic position (FIG. 7A) and a systolic position (FIG. 7B). In some embodiments, in the diastolic position (FIG. 7A), the fibers (110) extend around the heart from the basal ring structure (130) directly down to the apical hub (120) (e.g., the fibers are straight or linear). In some embodiments, in the systolic position (FIG. 7B), the fibers (110) are wrapped around the heart (FIG. 7B) as determined by the rotational or twist angle alpha (α; FIG. 7C) of the actuator (140) (i.e., the fibers are helical).

[0063] In some embodiments, the non-overlapping fibers (110) are designed so that they do not elongate under the loads encountered during service; thus, the length of the fibers (110) is constant. As the fibers (110) wrap around the heart (i.e., move into a systolic position (FIG. 7B)) due to the rotational/twist angle of a, the distance between the distensible ring-like structure (i.e., the basal ring structure (130)) and the apical hub (120) will be reduced, thereby compressing the heart. Alpha (a) can be varied to control the amount of compression.

[0064] In some embodiments, the cardiac sleeve (100) described herein is adjustable to the size of the heart. In certain embodiments, the attachment position of the fibers (110) to the apical hub (120) can be adjusted to increase or shorten the distance between the distensible ring-like structure (i.e., the basal ring structure (130)) and the apical hub (120) independent of rotation/twist of the actuator (140), e.g., to fit a larger or smaller heart when the device is being implanted. This may be accomplished, for example, by coiling the fibers (110) around rotatable pins that are positioned within the apical hub (120) (FIG. 8A smaller heart, and cutaway view FIG. 8B).

[0065] The present invention may further feature a method of treating heart failure in a subject in need thereof. The method may comprise obtaining a cardiac sleeve (100) as described herein and externally wrapping over the epicardium of a native, intact heart of the subject. In some embodiments, the cardiac sleeve cycles between a diastolic position and a systolic position. In some embodiments, the diastolic position comprises fibers (110) extending linearly around the heart from the basal ring structure (130) directly down to the apical hub (120). In some embodiments, the systolic position comprises fibers (110) wrapping helically around the heart from the basal ring structure (130) directly down to the apical hub (120) and compressing the heart.

[0066] The present invention may further feature a method of treating heart failure in a subject in need thereof. The method may comprise externally wrapping a cardiac sleeve (100) as described herein over the epicardium of a native, intact heart of the subject. In some embodiments, the cardiac sleeve cycles between a diastolic position and a systolic position.

[0067] Without wishing to limit the present invention to any theory or mechanism, it is believed that the configuration of the present invention is advantageous, wherein the rings change shape (shifting towards a more elliptical shape) to allow for an expansion of overall circumference around the heart (to accommodate various heart sizes), as opposed to the material itself expanding.

[0068] As used herein, the term “about” refers to plus or minus 10% of the referenced number.

[0069] Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase “comprising” includes embodiments that could be described as “consisting essentially of” or “consisting of,” and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase “consisting essentially of” or “consisting of” is met.

[0070] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.