This U.S. patent application Ser. No. 12/336,950 entitled Hand-Actuated Articulating Surgical Tool, by Mark C. Doyle, attorney docket number 029714-00394, assigned to the assignee of the present invention, filed Dec. 18, 2008.
The invention relates generally to surgical instruments. More particularly, the invention relates to a shaft.
Current laparoscopic surgical tools are limited in accessibility of certain regions of the human body. Existing tools can perform invasive surgery without making a substantial incision, but these tools are incapable of bending within the body to reach.
Additionally, existing tools rely on use of cables to manipulate the surgical tip of the tool. These tools have the disadvantage of requiring extensive sterilization of the internal components. The cleaning of internal metal cables can be a lengthy and expensive process. This process must be repeated prior to each procedure. Alternatively, disposable components may be used with a substantial increase in recurring costs.
Certain embodiments of the invention will now be described in detail with reference to the figures.
The control portion 110, 112 may be any device that can translate the movements of the user's hand and fingers into hydraulic, mechanical, or electrical signals to actuate the corresponding parts of the slave portion 120 of the device. For example, two such devices are shown in
In certain embodiments, the control portion 110, 112 uses hydraulic fluid to transfer pressure from a control cylinder to a slave cylinder. The fluid is preferably sterilized distilled water, however a saline solution, a perfluorinated hydrocarbon liquid, or any other physiologically compatible fluid could also be used. A “physiologically compatible fluid” is a fluid that once exposed to tissues and organs, does not create any intolerable reaction, such as a rash or immune response, in the patient, and does not adversely interfere with the normal physiological function of the tissues or organs to which it is exposed. In addition, a physiologically compatible fluid can remain in a patient's body or in contact with a tissue or an organ without the need to remove the fluid.
In one embodiment, the control portion 112 clamps onto the arm of the user by way of a clamp 115. The control portion 112 features finger loops 117, into which the user inserts the user's fingers. By squeezing each finger loop 117, the user creates hydraulic pressure or an electrical signal that results in a corresponding motion at the distal end 120 of the device. The user may then “open” the squeezed finger to create the opposite motion.
Each finger loop 117 is connected with a control cylinder 310 (shown in
Another embodiment of the invention includes a control portion 110 that is clamped to the side of a surgical bed using clamps 130. In this embodiment, the user grasps the control portion 110 much in the same way that a motorcycle driver grasps the handles of a motorcycle. The user may turn the handles, push them in, pull them out, pivot them about their axes, or, with the aid of a thumb loop, squeeze them. As detailed below, each of these motions creates a corresponding motion at the distal end 120 of the device.
In another embodiment, the control portion 110 is clamped to an object other than the surgical bed, such as a table or a cart. In yet another embodiment, the control portion 110 is clamped to the user's arms or hand. In still another embodiment, the control portion 110 is held by the user, without it being clamped to anything.
The movements of the control portion 110 are translated into hydraulic motion through the use of control cylinders 214, 216, 218, 220. When the user squeezes the thumb loop 212 towards the handle 210, a bend cam 222 is turned about a vertical axis. The bend cam 222 is shown in
The control portion 110 may be attached to the side of a surgical bed using a clamp 130. However, the control portion is free to rotate about a vertical axis 226, shown in
A user may also push the handle 210 forward, in which case, the top portion of the control portion 110 moves forward over a slide 232. The side 232 is connected to an outer cylinder 312 of a control cylinder 218 via an attachment point 330. The outer cylinder 312 is in turn attached to the piston 320 via a shaft 318. The forward movement of the shaft 318 extends the piston 320 forward, thereby creating the hydraulic pressure needed to actuate a slave cylinder in the distal end 120 of the device. In one embodiment of the invention, the forward movement of the handle results in an extension of the distal end 120 of the device through an extension module, described in detail below.
The handle part of the control portion 110 may also rotate along a longitudinal axis coinciding with the shaft 234, as shown in
In certain embodiments of the invention, the movements of the different parts of the control portion 110 creates electrical signals that are sent through wires in the intermediate portion 190 to the slave cylinders in the distal end 120 of the device. The electrical signal is sufficient to actuate motor in the corresponding slave cylinder, which in turn results in the slave module being actuated. Thus, for example, a forward movement of the handle 210 creates an electrical signal that actuates a motor in an extend module, which results in the extension of that module. Similarly, the rotation of the handle 210, the bending of the handle 210, and the squeezing of the thumb loop 212, result in the rotate module, the bend module, and the grasp module, respectively, being actuated. The slave modules having a motor are described in greater detail below.
Cylinders 214, 216, 218, and 220 are control cylinders. A typical control cylinder 310 is shown in its retracted position in
A piston 320, attached to a shaft 318, moves within the inner cylinder 314, within a distance defined by the two inlet points 322, 324 for the hydraulic fluid. The distal end of the shaft 318 is configured to be capable of attachment to the piston 320, while the proximal end of the shaft 318 is configured to be capable of attachment to the outer cylinder at a site dose to the attachment point 330. The outer cylinder or the handle assembly may be provided with ratchet teeth. The ratchet teeth are adapted to engage with a locking mechanism to secure the piston 320 at a desired position relative to the cylinder body. Alternatively, a locking mechanism may employ a friction lock to secure the piston 320 at a desired position.
The piston 320 has a solid front face and is movable along the longitudinal axis of the inner cylinder 314. The front face of the piston 320 is identical in shape to the cross section of the cylindrical cavity. The outer surface of the piston 320 forms an airtight seal with the inner surface of the inner cylinder 314. Thus, the portion of the cavity on one side of the piston 320 does not communicate with the portion of the cavity on the other side of the piston 320. At the same time, the piston 320 must be allowed to move smoothly back and forth along the longitudinal axis of the inner cylinder 314.
The proximal end of the inner cylinder 314 is sealed with a seal 316, comprising an opening there through, through which the shaft 318 can slide. The distal end of the inner cylinder 314 is sealed with another seal 328, optionally comprising an O-ring 326.
Thus, in the extended position of the control cylinder 310,
The cannula 190 comprises hydraulic tubings, connecting the control cylinders of the control portion 110 with the slave cylinders at the distal end 120, and housings for the hydraulic tubings.
The distal end 120 comprises modular components. The components can be selected from, for example, an extend module, a rotate module, a bend module, and a grasp module. Other functions can be included as well and activated in the manner described in detail below. Each module is individually describe in greater detail below. The invention is adapted such that the user can pick the combination of modules and the quantity of each individual module that is best suitable for the user's needs and assemble them conveniently.
The extend module 410 is depicted in both its retracted position,
Additional modules can be attached to the extend module either at its distal end, through the distal attachment point 430, or at its proximal end, through the proximal attachment point 431.
In another embodiment, the extend module may be extended using electrical power instead of hydraulic power. In this embodiment, by pushing forward on the handle 210 of the control portion 110, the user causes an electrical connection to be formed, whereby electrical signal is sent from the control portion 110 through wires in the intermediate portion 190 to the extend module 432,
In another embodiment,
The rotate module 510,
Additional modules can be attached to the rotate module either at its distal end, through the distal attachment point 532, or at its proximal end, through the proximal attachment point 534.
In another embodiment, the rotate module may be rotated using electrical power instead of hydraulic power. In this embodiment, by turning the handle 210 of the control portion 110, the user causes an electrical connection to be formed, whereby an electrical signal is sent from the control portion 110 through wires in the intermediate portion 190 to the rotate module 540,
The bend module 610 is depicted in
In some embodiments, the bending of the distal end 628 of the module is through an angle of at least 110°, i.e., when the piston 620 moves from the proximal end of the hydraulic portion completely to the distal end of the hydraulic portion, the distal end 628 of the module bends at least 110°. In other embodiments, the rotation is an angle of at least 110°, at least 150°, at least 200°, at least 250°, at least 300°, or an angle of at least 350°.
Additional modules can be attached to the bend module either at its distal end, through the distal attachment point 630, or at its proximal end, through the proximal attachment point 632.
In another embodiment, the bend module may be bent using electrical power instead of hydraulic power. In this embodiment, by turning the handle 210 of the control portion 110, the user causes an electrical connection to be formed, whereby electrical signal is sent from the control portion 110 through wires in the intermediate portion 190 to the bend module. The electrical signal causes an electrical motor to turn. The electrical motor is attached to a shaft which in turn is attached to the rack 624. The movement of the shaft 618 moves the rack 624, which in turn causes the gear 626 to rotate, which in turn causes the distal end 628 of the module to bend.
In another embodiment,
In another embodiment, the squeezing of the thumb loop 212 causes an electrical current to turn a motor 740,
The tynes 724 of the grasp module 710 are configured to accommodate a number of different tools. For example, in
All the above tools and other tools can fit individually and interchangeably on the grasp module 710. Therefore, during a surgical procedure, the user may attach one tool to the grasp module 710, use it, remove it, and then attach another tool to the same grasp module 710. This process can be repeated any number of times with any number of tools.
As mentioned above, the modules of the present invention are designed to be placed in order that the user deems most useful. For example,
As shown in
In certain embodiments, the present invention features a restraint 1110 that can be attached to the cannula 190 using a thumb screw 1112 (
As part of their normal physiological function, certain organs in the body have continuous motion. For example, the heart beats, the lungs expand and contract as the patient breathes, and the gastrointestinal tract also undergoes contractile motion. When performing surgery, it is often necessary stabilize the part of the organ undergoing surgery so that additional injury to the organ does not occur and the organ can be worked on. Aspects of the invention also feature a tissue restraint module 1210 (
A number of different mechanisms for separating the tynes 1214 are shown in
In certain embodiments, the tissue restraint module is held against a tissue or an organ during the surgical procedure. By doing so, in the space between the two tynes 1214, or a particular space created within a single tyne, a surface area of the tissue or organ becomes restrained, i.e., the local motion of the tissue or the organ is considerably reduced as compared with an unrestrained region of the tissue or the organ. The restraining of the tissue or the organ provides a relatively stable area on which the user can perform the surgical procedure.
In certain embodiments, the intermediate portion 190 of the cannula can be adapted to hold a number of different tools to be used during the operation. The cannula may be the cannula leading to the grasp module 710 at the distal end 120 of the device. During the operation, the user can retrieve a first tool from the cannula while within the patient's body and attach it to the grasp module 710. After using the first tool, the user can then return the first tool to the cannula, retrieve a second tool and attach it to the grasp module 710. Other tools may subsequently be used in a similar fashion.
The cannula 190 is held in place using a positioning arm 140 (see
In using the devices of the present invention, it is often the case that the tools at the distal portion of the device are to move a short distance. This distance is small enough that it would become difficult for the user to move his hands or fingers for that short a distance. Therefore, a system is needed to convert a longer movement of the user's hands and fingers at the proximal end of the device to a short movement of the tools at the distal end of the device. This is accomplished by having the control cylinder and the slave cylinder be of different diameters. Of importance, is the relationship between the piston area and the shaft area when using cylinders of different diameters, as generally described below.
At least a portion of the intermediate portion 190 of the laparoscopic tool is an articulation portion.
Another aspect of the present invention includes a double acting/double cylinder system. This system is depicted in
The slave cylinder comprises a piston 1314 and a shaft 1316 attached thereto. The piston 1314 is capable of moving within the slave cylinder 1310. The piston divides the slave cylinder into two cavities: a distal cavity, a wall of which is A3, and a proximal cavity, a wall of which is A4. The shaft 1316 passes through the proximal cavity. The piston 1314 prevents liquid communication between the distal cavity and the proximal cavity.
A control line provides hydraulic communication between the proximal cavity of the control cylinder and the proximal cavity of the slave cylinder. Another control line provides hydraulic communication between the distal cavity of the control cylinder and the proximal cavity of the slave cylinder. Thus, in the system, the two distal cavities are in hydraulic communication with each other, the two proximal cavities are in hydraulic communication with each other, but no proximal cavity is in hydraulic communication with any distal cavity.
If the control cylinder piston 1318 moves towards the distal end of the control cylinder 1320, hydraulic fluid is moved from the distal cavity of the control cylinder, through a control line, and into the distal cavity of the slave cylinder, thereby pushing the slave cylinder piston 1314 towards the proximal end of the slave cylinder 1310. The reverse may also happen. If the control cylinder piston 1318 moves towards the proximal end of the control cylinder 1320, hydraulic fluid is moved from the proximal cavity of the control cylinder, through a control line, and into the proximal cavity of the slave cylinder, thereby pushing the slave cylinder piston 1314 towards the distal end of the slave cylinder 1310. Further, while the control cylinder piston 1318 remains stationary, the salve cylinder piston 1314 also remains stationary.
In an embodiment, the double acting/double cylinder system of the invention comprises an overpressure reservoir. If the hydraulic pressure within the cylinders or the control lines exceeds a certain amount, some hydraulic fluid is transferred to the overpressure reservoir. The opening to the overpressure reservoir may comprise a pressure gauge device, which can become activated when the hydraulic pressure within a system surpasses a certain preset value. When the pressure gauge device is activated, the opening to the overpressure reservoir opens and hydraulic fluid can then enter the reservoir.
In another embodiment, the overpressure reservoir comprises an opening, which communicates with rest of the hydraulic circuits when it is placed in storage mode. When in use mode, the hydraulic fluid in the reservoir is completely cut off form the rest of the circuits. The purpose of the reservoir is to rehydrate the circuit when in storage mode.
The reservoir further comprises a spring mechanism at the side opposite to the opening. When the hydraulic pressure within the system surpasses the pressure applied by the spring mechanism, hydraulic fluid enters the reservoir from the system. Conversely, when the pressure within the system falls below the pressure applied by the spring mechanism, for example due to a leak in the system, hydraulic fluid enters the system from the reservoir. Thus, the reservoir may also function as a fluid replacement reservoir.
In certain embodiments, the flow of the hydraulic fluid inside the system will move very easily so that not enough resistance is afforded. In these situations, it is difficult for a user to control the movement of the cylinders with fine precision. Therefore, certain embodiments of the invention feature a narrowing at a point in the hydraulic tubing, the purpose of which is to create resistance. In some embodiments, the user can change the amount of narrowing, and therefore, the amount of resistance in the hydraulic tubing.
The slave cylinder 1312 also has a piston 1318 and a shaft 1320. The volumes of displaced hydraulic fluid in front of and behind the piston 1318 must be equal to the volume of displaced hydraulic fluid in front of and behind the piston 1314. In other words,
A1I1=A3I2
and
A2I1=A4I2
where I1 is the distance traveled by the slave cylinder. Rearranging the equations results in
which result in the basic relationship between the various surface areas as
It is readily understood by those of skill in the art that the above relationship will also hold true if the control cylinder and the slave cylinder are configured such that small movements by the user's hands and fingers results in longer movements at the distal end of the device. In other words, in
In certain embodiments, when it is desirable to have a long range of movement or very fine movement at the distal end of the device, a full range of movement at a slave cylinder at the distal end of the device may be affected by using multiple strokes of a control cylinder. In these embodiments, the present invention features a multiple stroke cylinder system (
The system is also equipped with a “dump” valve 1416. The dump valve 1416 may be activated by the user at anytime. When the dump valve 1416 is activated, hydraulic fluid is transferred from the slave cylinder 1418 back to the reservoir 1422. The dump valve 1416 has three modes: use; storage; and brake. When the dump valve 1416 is place in storage mode, the reservoir 1422 is connected to the rest of the circuit and will replenish the water in the circuit. In the “use” mode the reservoir 1422 is completely cut off from the rest of the circuit and only the master cylinder is connected to the slave cylinders. In the “brake” mode, the master and slave cylinders are completely cut off from each other. The reservoir 1422 is also cut off form the rest of the circuit in the “brake” mode.
In some embodiments, to aid the removal of the hydraulic fluid from the slave cylinder 1418 a spring mechanism 1420 is placed behind the piston of the slave cylinder. Those of skill in the art know of other mechanisms that can be used to return the piston of the slave cylinder to its original position.
In other embodiments, the system is so configured that the user can reverse the flow of the hydraulic fluid. Therefore by additional strokes of the control cylinder the user can remove hydraulic fluid from the slave cylinder 1418 and transfer it back to the reservoir 1422.
Referring now to
The mechanical manipulation mechanism 1710 is configured for transmitting a first set of control signals 1770. The mechanical slave cylinder 1775 is positioned at a distal end of the surgical device 1705 and is configured for receiving the first set of control signals 1770. The mechanical slave cylinder 1775 comprises a piston 1725 and a detachable shaft 1740. The piston 1725 is configured for responding to the first set of control signals 1770 by moving between a proximal end 1730 and a distal end 1735 of the mechanical slave cylinder 1715. The detachable shaft 1740 is configured for detachably coupling with a distal end 1745 of the piston 1725 and for moving with the piston 1725.
In one embodiment, the mechanical manipulation mechanism 1710 comprises at least one manipulator 1750 coupled with at least one control cylinder 1755. For purposes of brevity and clarity, the reference to the manipulator 1750 and the control cylinder 1755 will be in the singular. However, it is understood that, in accordance with embodiments of the present invention, there may be more than one manipulator 1750 and control cylinder 1755.
In one embodiment, the manipulator 1750 is configured for being controlled by a human hand 1760 and for actuating the control cylinder 1755 by mechanically transmitting a second set of control signals 1775 from the manipulator 1750 to the control cylinder 1755. The control cylinder 1755 is positioned at a proximal end of the surgical device 1705 and is configured for transmitting the first set of control signals 1770 to the mechanical slave cylinder 1715.
In one embodiment, the mechanical slave cylinder 1715 is in hydraulic communication with the control cylinder 1755 and is configured for responding to hydraulic control signals of the first set of control signals 1770 transmitted by the control cylinder 1755. In one embodiment, the first set of control signals 1770 are transmitted via a cable and pulley system.
In one embodiment, the detachable shaft 1740 is configured to be reusable within the surgical device 1705. In one embodiment, the detachable shaft 1740 is configured to be sterilized after detachment. In yet another embodiment, the distal end 1742 of the detachable shaft 1740 is configured for detachably coupling with a surgical instrument 1765. In one embodiment, the surgical instrument 1765 is part of the detachable shaft 1740. In another embodiment, the surgical instruction 1765 is a instrument separate from the detachable shaft 1740.
Furthermore, in one embodiment, the detachable shaft 1740 is disposable. For example, in one embodiment, the detachable shaft 1740 is disposed after its use within a single patient. By being disposable, this eliminates the potential for cross contamination of bodily fluids from patient to patient.
In embodiments of the present invention, the detachable shaft 1740 may be made of any material that is suitable for being coupled with the piston 1725, for a sterile environment, and for being coupled with a surgical instrument 1765 such that the surgical instrument 1765 is operable for its intended purpose. For example, the detachable shaft 1740 may be plastic. In yet another example, the detachable shaft 1740 may be metal. In one embodiment, the detachable shaft 1740 is composed of a combination of materials. For example, the detachable shaft 1740 may be part plastic, and/or made primarily of plastic, in addition to other materials. In another embodiment, the detachable shaft 1740 may be part and/or made primarily of metal, in addition to other materials.
In one embodiment, the detachable shaft 1740 is hallow. In another embodiment, the detachable shaft 1740 that is hallow is configured for performing at least, but not limited to, one of the following: suctioning, illuminating, transporting gasses, irrigating, and providing a pathway for wires therein. In one embodiment, these wires are electrical wires.
Referring now to
In one embodiment, the instructing 1810 comprises one of more, but not limited to, of the following instructions: bending, rotating, pushing, pulling, changing to various degrees of lateral movement and changing to various degrees of vertical movement.
Referring now to
Referring now to
The draping material 1935 is configured for isolating a portion of the surgical device 1705 within a sterile environment 1930. The portion of the surgical device 1705 that is isolated within the sterile environment 1930 is the portion of the shaft 1945 that moves through the ring 1925 and is within the sterile environment 1930 side of the draping material 1935. The sterile environment 1930 refers to an environment intended to be maintained in a state that only contains the living organic material desired by the operator of the surgical device 1705.
On one side of the draping material 1935 lies the surgical device 1705, in the non-sterile environment 1940. On the other side of the draping material 1935 lies the sterile environment 1930. Additionally, a patient may also be within the sterile environment 1930, upon which the surgical device 1705 is being remotely controlled by a human hand 1760 to perform a surgery.
In one embodiment, the interface mechanism 1905 comprises a ring 1925 defining an opening 1920 through the draping material 1935 and configured for receiving the shaft 1945 there through as the shaft 1945 moves with the piston 1725. In one embodiment, the ring 1925 comprises: an inner portion 1910, and an outer portion 1915. The inner portion 1910 is sealingly coupled with a portion of the distal end 1735 of the mechanical slave cylinder 1715. In one embodiment, the outer portion 1915 is coupled with the inner portion 1910 and is sealingly coupled with the draping material 1935.
In one embodiment, the outer portion 1915 and the inner portion 1910 are two separate components that are coupled with each other. In another embodiment, the outer portion 1915 and the inner portion 1910 are part of a single component. In other words, the ring 1925 may be made up of one or more components.
In one embodiment, the interface mechanism 1905 is plastic. In another embodiment, the interface mechanism 1905 is metal. In yet another embodiment, the interface mechanism 1905 is made of a material selected from at least one of the following materials: metals, plastics and ceramics. Thus, the interface mechanism 1905, in one embodiment, is a combination of materials.
In one embodiment, the ring 1925 of the interface mechanism 1905 is of a non-circular shape. For example, the ring 1925 may be round, oval, square, diamond shape, etc. Thus, in one embodiment, the shaft 1945 also may be of a non-cylindrical shape. For example, but not limited to, the shaft 1945 may be rectangular. Furthermore, in one embodiment, the shaft 1945 may be detachable, as explained herein. However, whatever the shape of the ring 1925 and the shaft 1945, both the ring 1925 and the shaft 1945 much be compatible, thereby enabling the shaft 1945 to move through the ring 1925, in a manner in which liquid does not flow from one side of the draping material 1935 to the other side.
Furthermore, it should be noted that the interface mechanism 1905 is designed in such a way as to maintain the sterility of the sterile environment 1930. Thus, as described herein, a liquid or other contaminants may not flow from one side of the draping material 1935 to the other side, through the interface mechanism 1905. In another embodiment, the interface mechanism 1905 is waterproof.
Referring now to
Furthermore, in one embodiment, the interface mechanism 1905 is reusable. For example, the interface mechanism 1905 is detachable from the sterile drape 1935. In one embodiment, after being detached, the interface mechanism 1935 may be sterilized. In another embodiment, the interface mechanism 1935 is reattached to the same sterile drape that was used before, or to different new sterile drape. In another embodiment, the interface mechanism 1905 is disposable.
The mechanical slave cylinder 1715 comprises a piston 1725 and a shaft 1945. The piston 1725 is configured for responding to the first set of control signals 1770 by moving between a proximal end 1730 and a distal end 1735 of the mechanical slave cylinder 1715. The shaft 1945 is configured for coupling with a distal end 1745 of the piston 1725 and is configured for moving with the piston 1725. Further, the distal end 1735 of the mechanical slave cylinder 1715 is sealingly coupled with a draping material 1935 via an interface mechanism 1905. The draping material 1935 is configured for isolating a portion of the surgical device 1705 within a sterile environment 1930.
The interface mechanism 1905 comprises a ring 1925. The ring 1925 defines an opening 1920 and is configured for sealingly receiving the shaft 1945 there through as the shaft 1945 moves with the piston 1725. The ring 1925 comprises an inner portion 1910 and an outer portion 1915. The inner portion 1910 is sealingly coupled with a portion of the distal end 1735 of the mechanical slave cylinder 1715. The outer portion 1915 is coupled with the inner portion 1910 and is sealingly coupled with the draping material 1935.
In one embodiment, the instructing 1910 comprises one or more, but not limited to, the following instructions: bending; rotating; pushing; pulling; changing to various degrees of lateral movement; and changing to various degrees of vertical movement. In response to these instructions, the shaft 1945 at least performs the following: bends, rotates, extends forward, extends backward, extends in a lateral direction, and extends in a vertical direction, respectively.
Thus, an operator, such as a surgeon, of the surgical device 1705 uses his hand 1760 to remotely control the surgical device 1705. The surgeon uses a manipulator 1750, such as finger loops, to give surgical instructions to the surgical device 1705. These instructions are translated into control signals (second set of control signals 1775), hydraulic or mechanical, that are sent to the control cylinder 1755. The control cylinder 1755 then sends control signals (first set of control signals 1770) to a mechanical slave cylinder 1715 that is attached to the shaft 1945. The shaft 1945 itself is coupled with a surgical instrument 1765 that moves within the patient. The instructions may ultimately guide the piston 1725 to move back and forth, while also guiding the surgical instrument 1765 to bend, grasp, turn, etc. within the patient.
Thus, those of skill in the art will appreciate that the devices described herein provide a relatively easy and economical instrument to perform minimally invasive surgery.
One skilled in the art will appreciate that these devices are and may be adapted to carry out the objects and obtain the ends and advantages mentioned, as well as those inherent therein. The methods, procedures, and devices described herein are presently representative of embodiments and are exemplary and are not intended as limitations on the scope of the invention. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the disclosure.
It will be apparent to one skilled in the art that varying substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention.
Those skilled in the art recognize that the aspects and embodiments of the invention set forth herein may be practiced separate from each other or in conjunction with each other. Therefore, combinations of separate embodiments are within the scope of the invention as disclosed herein.
All patents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.
The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising”, “consisting essentially of” and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions indicates the exclusion of equivalents of the features shown and described or portions thereof. It is recognized that various modifications are possible within the scope of the invention disclosed. Thus, it should be understood that although the present invention has been specifically disclosed by embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the disclosure.