OPTICALLY GUIDED SUPRAPUBIC CYSTOSTOMY

Abstract

A medical instrument and associated functionality are described for performing a cystostomy with optical guidance. A cystostomy device (10) includes a sound (12) including a distal portion (18) and a proximal portion (20), a front handle (14) and a rear handle (16). A physician or other user can grip the handles (14 and 16) to guide the distal portion (18) of the sound (12) through the urethra and into a bladder of the patient. The device (10) includes an optical unit (32) mounted at the tip (22) of the sound (12). The optical unit (32) generally includes a distal sound tip cap (34) with a lens opening and an optical lens (36) mounted on the opening. The optical unit (32) may further include one or more illumination sources, such as LEDs, for illuminating a volume forward of the tip (22) of the sound (12).

Claims

1. A method for use in cystostomy, comprising: providing a medical instrument including an instrument body having a proximate portion and a distal portion, and an optical assembly supported on said instrument body, said optical assembly including an optical element, directed forwardly in relation to said distal portion of said instrument body, for use in providing image information for a volume forward of said distal portion of said instrument body, and a light source, directed forwardly from said distal portion of said instrument body, for use in providing illumination of said volume forward of said distal portion of said instrument body; connecting said medical instrument to a display device for displaying images based on said image information; and using said display device to monitor a cystostomy.

2. The method of claim 1, wherein said medical procedure involves moving said medical instrument on a procedure pathway between a first position, where said distal portion is outside of a bladder of a patient, and a second position, wherein said distal portion is inside of said bladder.

3. The method of claim 1, wherein said using involves monitoring movement of a device separate from said medical instrument relative to a bladder of a patient.

4. The method of claim 2, wherein said medical instrument comprises a trocar having a cutting end and said medical procedure involves advancing said cutting end from said first position to said second position.

5. The method of claim 2, wherein said medical instrument comprises a boom supporting a retractable cutting blade, and said medical procedure involves employing said cutting blade to advance said boom from said second position to said first position.

6. The method of claim 1, wherein said medical instrument further comprises a supply line supported on said instrument body for providing a supply of a substance at said volume forward of said distal portion of said instrument body. The supply line of water used to cleanse surgical pathway from blood and/or tissue to provide visual acuity, such that tissue identification is not impeded, during advancement of trocar through abdomen into bladder.

7. The method of claim 6, wherein said substance comprises water for flushing a procedure pathway.

8. The method of claim 6, wherein said substance comprises a gel for improving imaging by said optical element.

9. The method of claim 1, wherein said cystostomy involves inserting a guide wire through said medical instrument into said patient's bladder.

10. The method of claim 9, wherein said cystostomy further involves using said (Original) guide wire to guide a further medical instrument to said patient's bladder.

11. The method of claim 10, wherein said further medical instrument comprises a catheter.

12. The method of claim 1, wherein said optical assembly functions as a guide wire for guiding insertion of a further device along a surgical path defined by said medical instrument.

13. The method of claim 12, wherein said further device comprises an obturator for widening said surgical path.

14. An apparatus for use in cystostomy, comprising: a medical instrument including an instrument body having a proximate portion and a distal portion, and an optical assembly supported on said instrument body, said optical assembly including an optical element, directed forwardly in relation to said distal portion of said instrument body, for use in providing image information for a volume forward of said distal portion of said instrument body, and a light source, directed forwardly from said distal portion of said instrument body, for use in providing illumination of said volume forward of said distal portion of said instrument body, said medical instrument being adapted for performing a medical procedure involving movement of said medical instrument on a procedure pathway between a first position, where said distal portion is outside of a bladder of a patient, and a second position, wherein said distal portion is inside of said bladder; a display device for displaying images based on said image information.

15. The apparatus of claim 14, wherein said display device is operative for monitoring movement of a device separate from said medical instrument relative to a bladder of a patient.

16. The apparatus of claim 15, wherein said medical instrument comprises a trocar having a cutting end for cutting a pathway from said first position to said second position.

17. The apparatus of claim 15, wherein said medical instrument comprises a boom supporting a retractable cutting blade operative to advance said boom from said second position to said first position.

18. The apparatus of claim 14, wherein said medical instrument further comprises a supply line supported on said instrument body for providing a supply of a substance at said volume forward of said distal portion of said instrument body.

19. The apparatus of claim 18, wherein said substance comprises water for flushing a procedure pathway.

20. The apparatus of claim 18, wherein said substance comprises a gel for improving imaging by said optical element.

21. The apparatus of claim 14, wherein said instrument body is configured for inserting a guide wire through said medical instrument into said patient's bladder.

22. The apparatus of claim 14, wherein said optical assembly functions as a guide wire for guiding insertion of a further device along a surgical path defined by said medical instrument.

23. The apparatus of claim 22, wherein said further device comprises an obturator for widening said surgical path.

24-33. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] For a more complete understanding of the present invention, and further advantages thereof, reference is now made to the following detailed description, taken in conjunction with the drawings, in which:

[0030] FIG. 1 is a side cross-sectional view of a T-SPeC® device with an optical unit in accordance with the present invention;

[0031] FIG. 2 shows a cable for connecting the optical unit to a display in accordance with the present invention;

[0032] FIG. 3 shows a display for displaying real time images for guiding a T-SPeC® procedure in accordance with the present invention;

[0033] FIG. 4 shows an optical unit for mounting on the sound of the T-SPeC® device of FIG. 1;

[0034] FIG. 5 shows an alternative display device and connection in accordance with the present invention;

[0035] FIGS. 6-7 show an optically guided medical instrument including a cannula assembly, dilatator set and a bladed trocar assembly in accordance with the present invention.

[0036] FIGS. 8-25 show a series of steps for executing an optically guided cystostomy in accordance with the present invention.

[0037] FIGS. 26-28 show a series of steps to widen or dilate the surgical pathway utilizing the optical tube as a guidewire.

DETAILED DESCRIPTION

[0038] The present invention relates to a medical instrument and associated functionality for performing a cystostomy with optical guidance. Such optical guidance may be provided in connection with inside-to-outside or outside-to-inside procedures for penetrating a patient's bladder. A system for executing an inside-to-outside procedure is first described below, followed by a description of an exemplary system for performing an outside-to-inside procedure. While these systems illustrate two important categories of cystostomy, it will be appreciated that other cystostomy-related procedures with optical guidance are possible in accordance with the present invention. Such procedures include procedures for imaging, diagnosis, treatment, training, catheter placement, and stone extraction, among other things. Accordingly, it will be appreciated that the instruments and functionality described herein should be understood as illustrative and not by way of limitation.

[0039] Referring to FIG. 1, a T-SPeC® device 10 with an optical unit is shown. The details of the device 10, and the operation thereof, is generally described in U.S. Pat. No. 8,574,256 which is incorporated herein by reference. Generally, the device 10 includes a sound 12 including a distal portion 18 and a proximal portion 20, a front handle 14 and a rear handle 16. A physician or other user can grip the handles 14 and 16 to guide the distal portion 18 of the sound 12 through the urethra and into a bladder of the patient. More specifically, the user guides the tip 22 of the sound 12 to the dome of the bladder, adjacent to the pubic symphysis in preparation for cutting a pathway through the bladder and the abdominal wall of the patient. Conventionally, proper positioning of the tip 22 of the sound 12 has been achieved due to the geometry and features of the device 10 together with the skill of users employing tactile feedback. However, as will be understood from the description below, the illustrated device 10 enables optical guidance to monitor proper positioning visually.

[0040] The illustrated device 10 further includes an alignment guide 24. The alignment guide 24 includes an alignment housing 30 mounted on an alignment guide arm 26. The alignment guide arm 26 is slidably mounted on a mast 28 extending from the front handle 14. As described in detail in the above noted U.S. Pat. No. 8,574,256, the device 10 is configured such that the housing 30 is axially aligned with the distal portion 18 of the sound 12, when the distal portion is inserted through the urethra and into the bladder of the patient and is positioned exterior to the patient against the patient's abdominal wall. When the distal portion 18 of the sound 12 is positioned against the dome of the patient's bladder, a cutting end can be deployed from the sound 12 to cut a pathway through the bladder and abdominal wall of the patient. In this regard, the housing 30 provides back pressure against the patient's abdominal wall to facilitate the cutting process.

[0041] Once the tip 22 of the sound 12 passes through the patient's abdominal wall, the alignment guide 24 can be removed from the device 10. Then, a urinary catheter can be attached to the tip 22 of the sound 12 and the user can manipulate the sound 12 to draw the tip 22 together with the end of the urinary catheter into the patient's bladder. As discussed above, proper positioning of the sound 12 is required at the various stages of this process. For example, proper positioning is required as the sound 12 passes through the patient's urethra, as the tip on 22 is positioned against the dome of the patient's bladder, as the cutting end is used to penetrate the patient's bladder and abdominal wall, as the urinary catheter is drawn through the abdominal wall and into the bladder, and as the sound 12 is withdrawn from the patient. In accordance with the present invention, proper positioning throughout this process is facilitated by optical guidance.

[0042] The illustrated device 10 includes an optical unit 32 mounted at the tip 22 of the sound 12. The optical unit 32 generally includes a distal sound tip cap 34 with a lens opening and an optical lens 36 mounted on the opening. Although not shown in FIG. 1, the optical unit 32 may further include one or more illumination sources, such as LEDs, for illuminating a volume forward of the tip 22 of the sound 12; that is, a volume extending along axis 38 away from the tip 22 towards the housing 30 as illustrated in FIG. 1. The lens 36 is operative to direct light from the illuminated volume onto an end of an optical cable 16. In this regard, the distal end of the cable 16 may be registered in relation to the lens 36 such that light from the lens 36 is received within the acceptance angle of the cable 16. Thus, in the illustrated embodiment, the cable 16 may be a light guide such as a fiber-optic cable. Alternatively, a detector may be disposed between the lens 36 and the cable 16 to detect light and provide an electrical signal representative of the detected light.

[0043] An optical connector 40 is provided at the proximal end of the device 10 in the illustrated embodiment. The connector 40 may include an optical detector for detecting light transmitted through the cable 16 and providing an electrical signal representative thereof. In addition, the connector 40 may provide electrical power through the cable 16 to the illumination sources of the optical unit 32. As will be described below, and electrical cable and/or a wireless connection may be used to connect the connector 40 of the device 10 to a display and/or another power source.

[0044] FIG. 3 illustrates a display device 60 that may be used to display images captured by the optical unit for guiding a transurethral medical procedure. The illustrated display device 60 includes a base 62 and a display 64 pivotally mounted on the base 62. The display 64 provides real-time video images of the volume forward of the sound based on information transmitted from the optical unit. The display 64 can be pivoted to an optimal viewing angle for viewing by the user as the user is guiding the sound during the transurethral procedure. The illustrated device 60 further includes a cable port 66 for connecting the display device 60 to the T-SPeC® device. As shown in FIG. 2, a cable 50 can be plugged into the port 66 at the display device and also plugged into a connector of the T-SPeC® device associated with the optical cable. In this regard, the cable 50 can convey imaging information from the optical device to the display device 300 and can also provide electrical power and control signals from the display device 60 to the optical unit, e.g., to turn on and off the optical unit. FIG. 5 shows an alternative display device and connection.

[0045] FIG. 4 shows an optical unit 70 that may be mounted on the tip of the sound. The optical unit generally includes a cable 72 having a distal end thereof mounted in a proximal end of housing 74. A lens 76 is mounted on a distal end of the housing 74 in alignment with the distal end of the cable 72 such that light from the lens 76 is received within the cable 72. It will thus be appreciated that the housing 74 maintains the alignment and spacing between the lens 76 and the distal end of the cable 72. Captures imaging information for a volume in front of the lens 76. For example, clear images may be provided on the display of a volume between about 5-100 mm in front of the lens and having a diameter at least equal to that of the sound. The optical unit 70 may further include light sources 78 and 80 disposed about the lens 78 for illuminating the volume to be imaged. For example, the sources 78 and 80 may comprise LEDs and may have the same or different illumination parameters, e.g., power, wavelength and the like. Optionally, the sources 78 and 80 may be individually operable to provide the desired lighting. The optical unit 70 may be mounted on the sound in any appropriate manner such as, for example, an adhesive or sonic welding. In this regard, a complementary mounting structure may be provided on the sound to ensure proper mounting positioning and alignment. It will be appreciated that the dimensions of the optical unit 70 allow for mounting on the sound without interfering with operation of the cutting end and other components of the T-SPeC® device.

[0046] FIGS. 6-7 illustrate an optically guided cystostomy medical instrument 100 in accordance with the present invention. The illustrated instrument includes a bladed trocar assembly 102 and a cannula assembly 104. FIG. 7 shows the assemblies 102 and 104 separated and FIG. 6 shows the assemblies 102 and 104 assembled. The instrument 100 further includes a communications cable 106 for connecting the instrument 102 a display device, as will be described below, and a water valve 116 for connecting the instrument 100 to a supply of water such as a syringe, a tank, water bag, gravity fed from an IV pole, or water tap.

[0047] The cannula assembly 104 includes a cannula body 112, an optical unit 120, and the communications cable 106. The cannula housing 112 has a proximal portion adjacent the cable 106 and a distal portion adjacent the optical unit 120. The body 112 defines a hollow internal passageway for receiving the bladed trocar assembly 102. Appropriate connectors extend between the optical unit 120 and the cable 106 for transmitting optical information from the optic unit 120 to the cable 106, e.g., within the hollow center of the cannula body or within the walls of the body 112. The optical unit 120 captures real-time images of a volume forward of the distal end of the instrument 100. These images can be used to monitor the progress of the instrument as the instrument is used to form a surgical pathway from the patient's abdominal wall to the bladder. Simultaneously, video and pictures can be captured and stored for further review, while providing for archival of patient records. In this regard, the optical unit 120 may include one or more LEDs for providing illumination and imaging equipment. For example, the imaging equipment may include a miniature camera unit such as a camera tip or other optical elements, such as one or more lenses and optical fibers for use in transmitting optical information to a remotely located sensor or camera. In the illustrated embodiment, the optical unit 120 includes an LED and a 1.6 mm camera tip. It will be appreciated that other sizes for the camera tip, including smaller dimensions are possible and potentially desirable.

[0048] The bladed trocar assembly 102 includes a trocar blade tip 122, a trocar obturator body 114 and an obturator handle 108. The trocar blade tip 122 has a sharp, pointed end for penetrating tissue and is configured to surround the optical unit 120 as well as a water port 124. The trocar obturator body 114 extends between the trocar blade tip 122 and the obturator handle 108 with a groove 118 to accommodate the optical unit 122 housing internal to the cannula body 112. Alternatively, the optical unit 122 (including the fiber optic cable thereof) may be positioned directly into the obturator body/trocar assembly (proximal end) with the distal end in the same position as shown in FIG. 6. In such a case, when the physician removes the obturator/trocar to position a catheter as described below, the operator can then slip the fiber optic cable could be removed from the obturator and slipped down the cleared cannula body. The body 114 has a generally cylindrical configuration and includes an interior water lumen for delivering water from the valve 116 to the water port 124. It will be appreciated that the valve 116 can be opened to allow water to flow from the water port 124 to flush the surgical pathway and improve imaging or closed to terminate water flow. The obturator handle 108 rotates freely on the body 114 and can be gripped by a practitioner to advance or retract the body 114 and trocar blade tip 122 in relation to the cannula assembly 104. The illustrated trocar assembly 102 further includes a fluid seal 110 that forms a seal against the finger pull 107 of the cannula assembly 104 to prevent flow of water or other fluids at the proximal end of the cannula assembly 104 when the handle 108 is fully depressed.

[0049] It will be appreciated that the dimensions of the various components of the instrument 100 may vary in accordance with the present invention. In the illustrated embodiment, the handle 108 has a width or diameter of about 4 cm. The instrument 100 may have a length of about 17 cm from the distal end of the trocar assembly 102 to a collar area of the cannula assembly 104 when the trocar assembly 102 is fully inserted. The cannula may have a range of sizes with an outside diameter ranging from of 14 to 28 French, dependent on patient size and need. Moreover, as shown in FIG. 1 and described in more detail below, the cannula may be formed in two pieces to separate along a longitudinal axis of the cannula. This may be desired, for example, to enable removal of the cannula after a catheter has been installed via the cannula. In this regard, the cannula assembly 104 may be configured to separate by pulling on opposite halves of the cannula assembly or by operating a slider or clip to release the two halves.

[0050] FIGS. 8-25 show an illustrative process, in accordance with the present invention, for forming a surgical pathway to a patient's bladder and inserting a catheter or Dilation Cannula all under optical guidance. By way of overview, the percutaneous suprapubic cystostomy with SPC Vision™ procedure steps include: [0051] 1) Connect SPC Vision, device to vision display monitor [0052] 2) Connect water supply to SPC Vision, device for improved visualization [0053] 3) Prep skin surface above pubic symphysis with localized antiseptic [0054] 4) Palpate patient's abdomen to locate the pubic symphysis [0055] 5) Advance cannula with trocar at two finger breadths above pubic symphysis through skin into the bladder, visualizing passageway [0056] 6) After locating the cannula and trocar within the bladder, remove the trocar from cannula, leaving cannula in situ [0057] 7) Option 1. A Guidewire is placed through Cannula. Then remove Cannula and place catheter over Guidewire or “size-up” the surgical tract for a larger catheter, requiring further tract dilation, utilizing balloon dilation. Then place Catheter over Guidewire and complete procedure. [0058] a. Aspirate urine through Foley catheter to confirm placement [0059] b. Set Catheter at dome of bladder [0060] c. Dress the site [0061] 8) Option 2. Advance a small-bore catheter through the cannula and into the bladder. [0062] a. Aspirate urine through Foley catheter to confirm placement [0063] b. Inflate Foley catheter balloon [0064] c. Remove Cannula and withdraw from patient [0065] d. Dress the site [0066] 9) Option 3 (FIGS. 26-28). Advance dilation cannula over the optics tube as a “guide wire” to size-up the surgical pathway for desired use [0067] a. Repeat with increased diameter of dilation cannulas 2402 (16, 22, and 34 French shown in FIG. 28) as needed [0068] b. Perform surgical procedure or placement of catheter through dilation cannula [0069] c. Inflate Foley catheter balloon [0070] d. Remove dilation cannula and withdraw from patient [0071] e. Dress the site

[0072] FIG. 8 shows a medical instrument for use in the procedure which may be substantially as described in connection with FIGS. 6-7. As shown in FIG. 9, the process may be initiated by connecting the communications cord 106 to a display device 130 including a monitor 132. The display device 130 may include, for example, a laptop computer, a dedicated display device for the system, or another display device available in the procedure environment.

[0073] Next, a water supply 134 may be connected to the valve 116 (FIG. 10). Although not shown, it will be appreciated that the water supply 134 may be connected to a water source such as a water tank or water tap. It will be appreciated that the valve 116 may be operated to provide water at the distal end of the instrument 100 when needed to flush the surgical pathway or otherwise improve imaging.

[0074] As noted above, it is important to initiate an incision to access the patient's bladder at the proper location on the patient's abdominal wall. In this regard, it is generally desired to form the surgical pathway above the pubic symphysis while avoiding the peritoneum cavity and bowel so as to access the dome of the bladder. As shown in FIGS. 11-12, a practitioner 144 may locate the pubic symphysis via palpation and then initiate incision of the skin/abdominal wall, using the instrument 100, about two finger breadths cranial to the pubic symphysis.

[0075] The practitioner 144 can then view the imaging device 130 to monitor advancement of the distal end of the instrument 100 through the skin and fatty tissue (FIG. 13), through the subcutaneous tissue and fascia layer, and through the bladder wall into the interior of the bladder (FIGS. 14-15).

[0076] Once the distal end of the instrument 100 is properly positioned within the bladder and such positioning is confirmed on the monitor 132, the practitioner 144 may lift the trocar handle 108 while holding the cannula of the instrument 100 in place to remove the trocar assembly 102 as shown in FIGS. 16-18.

[0077] Once the trocar assembly 102 has been removed from the instrument 100, there are a couple of options for proceeding with insertion of a catheter. In a first option, as illustrated in FIGS. 19-21, a guide wire 150 is first inserted through the cannula assembly of the instrument 100 into the bladder 142. As shown in FIG. 19, proper positioning of the guide wire 150 within the bladder 142 can be confirmed on the monitor 132. The instrument 100 can then be withdrawn leaving the guide wire 150 in place (FIG. 20). As shown in FIG. 21, a catheter 160 can then be threaded over the guide wire 150 and through the surgical pathway formed by the instrument 100 so that the distal end of the catheter 160 is positioned within the bladder 142. The guide wire 150 can then be withdrawn through the catheter 160.

[0078] Alternatively, as shown in FIG. 22, the catheter 160 may be threaded through the instrument 100 so that the distal end of the catheter 160 is disposed within the bladder 142 as confirmed via the display device 130. A balloon 162 near the distal end of the catheter 160 may then be inflated to prevent unintended withdrawal of the catheter 160 from the bladder 142 (FIG. 18). As shown in FIG. 19, the instrument 100 may then be withdrawn from the patient and longitudinally separated into halves to remove the instrument 100 from the catheter 160. Finally, the practitioner 144 may withdraw the catheter 160 until the balloon 162 is secured against the wall of the bladder 142. The practitioner 144 can then dress the incision to complete the procedure.

[0079] The SPC Vision device and technique is an enabling technology for replacing urethral catheterization with suprapubic catheterization in hospitalized patients with occluded urethras, when inside-to outside suprapubic catheterization (SPC) is contraindicated with the T-SPeC® instrument, allowing these patients access to SPC, further improving clinical outcomes, while simultaneously saving hospitals money due to reduced length of stay, all realized with this change in clinical practice. The utilization of SPC, replacing usage of urethral catheterization in select patients will reduce extended hospital stays, readmissions and complications associated with indwelling urethral catheters. The rationale for integrating illumination and visual guidance with the SPC Vision device is to replace the “blind” entry to the bladder when an inside-to-outside transurethral suprapubic cystostomy with the T-SPeC® device is contraindicated due to an occluded urethra. Inside-to-outside transurethral suprapubic cystostomy with the T-SPeC® device is contraindicated when there is severe stricture disease (urethral scar tissue), obstructing the urethra. Prior to initiating a cystostomy, utilizing an endoscope/cystoscope, may be used to inspect the health of the urethra passage and bladder, for detecting possible bladder cancer, a procedure called a Cystoscopy. Urologists are very familiar with these procedures. If passage of urethra is not available, the alternative outside-to-inside trocar punch technique or highly invasive open cystostomy is required. Failure to void the bladder of a patient in severe retention will lead to acute kidney injury, kidney failure, and mortality.

[0080] Due to the acute shortage of urologists, and limited availability to support hospital-based patient catheterization with SPC, mid-level clinicians such as PAs, RNPs and emergency physicians will be utilized to place suprapubic catheters. These clinicians are less experienced with SPC placement, especially with “blind SPC placement techniques where patient safety can be of concern. Thus, adding vision to SPC placement techniques can improve procedure safety. Over 70% of all critical care patients are transferred from the emergency department (E.D.), with the remainder coming from the Med/Surg area. In order to place suprapubic catheters in patients being transferred to the CCU, it is necessary to provide T-SPeC® and SPC Vision procedure training to mid-level clinicians, such as PAs and nurse practitioners and emergency physicians. Furthermore, U.S. men 40 to 83 years of age have an overall incidence of nearly 7 per 1,000 per year present to the E.D. with acute or severe urinary retention and an impassible urethra due to Benign Prostatic Hyperplasia (BPH), Infection and inflammatory issues or other penile trauma, fracture or laceration. To prevent injury, to increase the ease of passage and reduce the procedure time Physician Assistants (PAs), Registered Nurse Practitioners (RNPs), Emergency Physicians, Intensivists, or Hospitalists will require special training in the use of the SPC Vision procedure and device, to place suprapubic catheters in patients with compromised, occluded urethral passage. The use of vision during suprapubic catheter placement with SPC Vision will dramatically reduce the training required and improve the overall safety of cystostomy in patients contraindicated for urethral SPC placement with the T-SPeC® instrument.

[0081] The application of optics and lighting would include the placement of the optics camera lens and light source in the distal sound tip of the SPC Vision, cannula with the camera and light cable extending through the instrument sound, body and handle exiting at the posterior end of the instrument terminating with a connector plug. The posterior connection would interface with a detachable power supply to transmit the image to a display panel, monitor or screen with a live image, with additional capability of storing video and still picture images for retrieval and to be included in the medical records for patient.

[0082] The foregoing description of the present invention has been presented for purposes of illustration and description. Furthermore, the description is not intended to limit the invention to the form disclosed herein. Consequently, variations and modifications commensurate with the above teachings, and skill and knowledge of the relevant art, are within the scope of the present invention. The embodiments described hereinabove are further intended to explain best modes known of practicing the invention and to enable others skilled in the art to utilize the invention in such, or other embodiments and with various modifications required by the particular application(s) or use(s) of the present invention. It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the prior art.