阅读说明：本技术 用于造口术的连接装置 (Connection device for ostomy ) 是由 A·V·V·L·N·S·默西·阿拉瓦利 苏雷什·库马尔·普雷玛·莫哈纳孙达拉姆 于 2019-07-31 设计创作，主要内容包括：本发明涉及一种用于造口术的连接装置。本发明的用于术后手术程序的连接和转移装置包含管状构件,所述管状构件具有近侧部分、远侧部分以及限定内表面和外表面的壁。所述远侧部分收纳在患者的内部身体器官内。所述外表面被配置成与所述内部身体器官的内壁介接。所述管状构件的所述内表面限定通孔,所述通孔被定尺寸以允许体液通过。至少一个可扩大构件设置在所述管状构件的所述外表面上,并且被配置和定尺寸以收纳在所述内部身体器官内以接合所述内壁,以将所述管状构件保持在所述内部身体器官内并且防止所述体液绕开所述管状构件并且与所述患者的外部皮肤接触。(The present invention relates to a coupling device for ostomy. The present invention is an attachment and transfer device for post-operative surgical procedures comprising a tubular member having a proximal portion, a distal portion, and a wall defining an inner surface and an outer surface. The distal portion is received within an internal body organ of a patient. The outer surface is configured to interface with an inner wall of the internal body organ. The inner surface of the tubular member defines a through-hole sized to allow passage of bodily fluids. At least one expandable member is disposed on the outer surface of the tubular member and is configured and dimensioned to be received within the internal body organ to engage the inner wall to retain the tubular member within the internal body organ and prevent the bodily fluids from bypassing the tubular member and coming into contact with the patient's external skin.)

1. A connection and transfer device, comprising:

a tubular member having a proximal portion, a distal portion, and a wall defining an inner surface and an outer surface, the distal portion of the tubular member configured and dimensioned to be received within an internal bodily organ of a patient, the outer surface of the tubular member configured to interface with an inner wall of the internal bodily organ, the inner surface of the tubular member defining a through-hole sized to allow passage of bodily fluids; and

at least one expandable member disposed on the outer surface of the tubular member, the at least one expandable member configured and dimensioned to be received within the internal body organ to engage the inner wall to retain the tubular member within the internal body organ and prevent the bodily fluids from bypassing the tubular member and contacting the patient's external skin.

2. The connection and transfer device of claim 1, further comprising a threaded cap, wherein the proximal portion and the distal portion of the tubular member define a proximal open end and a distal open end, the proximal portion comprising a threaded surface extending along the outer surface of the wall, the threaded surface configured to engage the threaded cap to secure the threaded cap on the tubular member to close the proximal open end.

3. The connection and transfer device of claim 2, wherein the tubular member includes a serrated surface having protruding ridges protruding from at least a portion of the outer surface, the protruding ridges configured to engage the inner wall of the internal body organ to retain the proximal portion of the tubular member within the internal body organ.

4. The connecting and transferring device of claim 3, further comprising

An expansion channel including an inlet port and an outlet port, the expansion channel extending circumferentially from the outer surface of the tubular member and distally along the wall of the tubular member to interface with the at least one expandable member, wherein the at least one expandable member includes an expandable member.

5. The connection and transfer device of claim 2, further comprising a partial loop structure member configured to extend around the proximal portion of the outer surface of the wall, the partial loop structure member configured to engage the external skin of the patient to prevent the proximal portion of the tubular member from passing into a body lumen of the patient.

6. The connection and transfer device of claim 4, wherein said at least one expandable member is configured and disposed about said projecting ridge to seal against the inside of said internal body organ when said at least one expandable member is expanded.

7. The connecting and transfer device of claim 1, wherein the tubular member comprises:

a first tubular member and a second tubular member movable relative to each other,

each of the first and second tubular members including a proximal portion and a distal portion and defining an inner surface and an outer surface,

the first tubular member defines a central axis,

the second tubular member is configured to extend around the outer surface of the first tubular member,

wherein the at least one expandable member includes a first set of movable links and a second set of movable links, at least two of the first set of movable links are operably coupled to the proximal portion of the first tubular member and at least two of the second set of movable links, the at least two of the second set of movable links are operably coupled to a distal portion of the second tubular member, such that upon proximal movement of the first tubular member along the inner surface of the second tubular member, the first and second sets of movable links move outwardly relative to the central axis to engage the inner wall, to retain the first and second tubular members within the internal body organ and prevent the bodily fluid from bypassing the first and second tubular members and coming into contact with the patient's external skin.

8. The connecting and transferring device of claim 7, further comprising:

a retaining ring structure member for retaining the ring structure,

wherein the outer surface of the first tubular member defines a circumferential groove extending about the central axis, the circumferential groove being disposed such that when the first tubular member is internally inserted through the internal body organ, the circumferential groove is positioned outside a body lumen of the patient to receive the retaining ring structure member, the retaining ring structure member being positioned and configured to inhibit movement of the proximal portion of the connection and transfer device into the body lumen.

9. The connection and transfer device of claim 7, further comprising a flexible collection container member disposed on the proximal portion of the first tubular member.

Technical Field

The present disclosure relates to surgical devices, and more particularly, to surgical devices that may be used after an ostomy to transfer stool to an ostomy bag without irritating the patient's skin.

Background

A colostomy is a surgical procedure that passes a portion of the large intestine through the abdominal wall to carry fecal matter out of the body.

Colostomy is a means of treating various diseases of the large intestine, including cancer, obstruction, inflammatory bowel disease, diverticular rupture, ischemia (impaired blood supply) or traumatic injury. A temporary colostomy is created to redirect stool from an injured or diseased portion of the large intestine, allowing rest and healing. A permanent colostomy is performed when the distal bowel must be removed or blocked and inoperable. Although colorectal cancer is the most common indication for permanent colostomy, only about 10-15% of patients with this diagnosis need to have a colostomy.

In current colostomies, an ostomy bag or pouch is attached directly to the skin layer. Direct contact between feces and skin layers leads to serious post-operative care problems such as infection, skin irritation, leakage, cleaning problems and psychological complications.

Disclosure of Invention

To address the above-mentioned shortcomings of the prior art, the present disclosure is directed to a connection and transfer device comprising a tubular member having a proximal portion, a distal portion, and a wall defining an inner surface and an outer surface. The distal portion of the tubular member is configured and dimensioned to be received within an internal body organ of a patient. The outer surface of the tubular member is configured to interface with an inner wall of an internal body organ. The inner surface of the tubular member defines a through-hole sized to allow passage of bodily fluids. The device includes at least one expandable member disposed on an outer surface of the tubular member. The at least one expandable member is configured and dimensioned to be received within the internal body organ to engage the inner wall so as to retain the tubular member within the internal body organ and prevent bodily fluids from bypassing the tubular member and coming into contact with the external skin of the patient.

In one aspect, the device includes a threaded cap, wherein the proximal and distal portions of the tubular member define proximal and distal open ends, the proximal portion includes a threaded surface extending along an outer surface of the wall, and the threaded surface is configured to engage the threaded cap to secure the threaded cap on the tubular member to close the proximal open end.

In one aspect, the tubular member includes a serrated surface having a projecting ridge protruding from at least a portion of the outer surface. The raised ridge is configured to engage an inner wall of the internal bodily organ to retain the proximal portion of the tubular member within the internal bodily organ.

In one aspect, the device includes an expansion channel including an inlet port and an outlet port, the expansion channel extending circumferentially from an outer surface of the tubular member and distally along a wall of the tubular member to interface with the at least one expandable member, wherein the at least one expandable member includes an expandable member.

In one aspect, the device includes a partial loop structure member configured to extend around a proximal portion of the outer surface of the wall. The partial loop structure member is configured to engage the external skin of the patient to prevent the proximal portion of the tubular member from entering the body lumen of the patient.

In one aspect, the at least one expandable member is configured and disposed about the raised ridge to seal against an inside of the internal body organ when the at least one expandable member is expanded.

In another aspect, the tubular member comprises a first tubular member and a second tubular member that are movable relative to each other. Each of the first and second tubular members includes a proximal portion and a distal portion and defines an inner surface and an outer surface. The first tubular member defines a central axis. The second tubular member is configured to extend around an outer surface of the first tubular member. The at least one expandable member includes a first set of movable links and a second set of movable links. At least two of the first set of movable links are operably coupled to a proximal portion of the first tubular member and at least two of the second set of movable links are operably coupled to a distal portion of the second tubular member such that, upon moving proximally of the first tubular member along an inner surface of the second tubular member, the first and second sets of movable links move outwardly relative to the central axis to engage the inner wall to retain the first and second tubular members within the internal body organ and prevent bodily fluids from bypassing the first and second tubular members and contacting the external skin of the patient.

In one aspect, the device further comprises a retaining ring structure member, wherein the outer surface of the first tubular member defines a circumferential groove extending about the central axis. The circumferential groove is disposed such that when the first tubular member is internally inserted through the internal body organ, the circumferential groove is positioned outside the body lumen of the patient to receive the retaining ring structure member, the retaining ring structure member being positioned and configured to inhibit movement of the proximal portion of the connection and transfer device into the body lumen.

In one aspect, the device includes a flexible collection container member disposed on a proximal portion of the first tubular member.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the detailed description of the embodiments given below, serve to explain the principles of the disclosure in which:

FIG. 1 is an exploded view of one aspect of an attachment and transfer device according to an exemplary embodiment of the present disclosure, including a serrated sleeve and related components that enable direct transfer of feces to an ostomy bag or pouch without contacting the patient's skin;

FIG. 2 is a cross-sectional view of the attachment and transfer device of FIG. 1 taken along section line 2-2 in FIG. 1, illustrating the attachment and transfer device passing through the abdominal wall of a patient with the sealing balloon in an unexpanded position;

FIG. 3 is a cross-sectional view of the connection and transfer device of FIG. 2 with the sealing balloon in an expanded position to seal the serrated cannula against the abdominal wall of the patient;

FIG. 4 is a perspective view of another exemplary embodiment of a connection and transfer device according to the present disclosure including an articulating connector link positioned around a cannula that enables direct transfer of stool to an ostomy bag or pouch without contacting the patient's skin;

FIG. 5 is an exploded perspective view of the connecting and transfer device of FIG. 4;

FIG. 6 is a cross-sectional view of the attachment and transfer device taken along section line 6-6 of FIG. 4, illustrating the attachment and transfer device passing through the abdominal wall of a patient with the articulating connector links in a straight, unextended position;

FIG. 7 is a perspective view of the connecting and transfer device of FIG. 4 with the hinge connector links in an extended position; and

FIG. 8 is a cross-sectional view taken along section line 6-6 of FIG. 4 with the articulating connector links of the connection and transfer device in an extended position to seal the cannula with respect to the abdominal wall of the patient.

Detailed Description

Aspects of the present disclosure relate to attachment and transfer devices that provide significant but unobvious advantages in the area of ostomy bags or pouches by enabling the transfer of stool through a stoma without the stool contacting the patient's skin.

Throughout the specification, the term "proximal" refers to the portion of the device closest to the operator, and the term "distal" refers to the portion of the device furthest from the operator.

The present disclosure addresses the problems present in current colostomies where the ostomy bag/pouch is attached directly to the skin layer, causing serious post-operative care problems such as infection, skin irritation, leakage, cleanliness issues when feces are in direct contact with the patient's skin layer, and psychological complications. The present disclosure relates to a meaningful, but not obvious, device that produces the major non-obvious advantages of preventing feces from coming into contact with the skin layer, thereby avoiding the serious post-operative care problems described above.

More particularly, the present disclosure relates to connector devices, each of which serves as a bridge to transfer feces directly into an ostomy bag or pouch without contacting the skin layer.

Referring to fig. 1-3, an attachment and transfer device 100 for use in post-operative surgical procedures includes a tubular member 102 including a wall 104 defining an inner surface 104a and an outer surface 104 b. The tubular member 102 defines a proximal open end portion 106 and a distal open end portion 108. The outer surface 104b includes a first portion 104b1, a second portion 104b2 extending from the first portion 104b1, and a third portion 104b3 extending from the second portion 104b 1.

The first portion 104b1 of the outer surface 104b includes a convex engagement surface 110 that extends from the proximal end portion 106 to define a first length L1 along the outer surface 104b of the wall 104. The male engagement surface 110 is configured to engage with a female engagement cap 112. In aspects of the present disclosure, the male and female engagement surfaces 110, 112 comprise interengaging threaded surfaces, although other engagement structures may be used, such as bayonet couplings, snap caps, and the like. The cap 112 seals the end of the tubular member 102 to prevent feces from leaving the connection and transfer device 100.

A second portion 104b2 of the outer surface 104b of the wall 104 extends distally from the terminal end of the male engagement surface 110 to define a second length L2 that extends to the beginning of the serrated surface of the projecting ridge 114 that projects from the outer surface 104b (and portions thereof) toward the distal open end portion 108. The serrated surface of the raised ridge 114 defines a third length L3 along the outer surface 104b of the wall 104 that corresponds to a third portion of the outer surface 104b 3. The tubular member 102 is configured to be inserted internally through a stoma "S" extending from the outside 20' of the patient incision 22, through the skin 20 and through the inside 20 "of the patient incision 22 and into an internal organ" I ", such as the large or small intestine. The inlet port 116a of the expanding channel 116 extends circumferentially from the second portion 104b2 of the outer surface 104b and extends distally a distance D within the wall 104 to extend circumferentially to define the outlet port 116b of the expanding channel 116. The outlet port 116b is configured to interface with an expandable circumferential member 118 that is configured and disposed to seal the inside 20 "of the patient incision 22 when the expandable member 118 is in an expanded, pressurized configuration. Distance D is sufficient to enable the inflation channel 116 to extend distally from the lateral side 20' and distally from the medial side 20 "of the patient incision 22 and interface with the expandable circumferential member 118 to enable expansion and pressurization of the member 118.

The partial loop structure member 120 is configured to extend around a second portion 104b2 of the outer surface 104b of the wall 104 to secure the attachment and transfer device 100 on the lateral side 20' of the patient incision 22. More specifically, the outer diameter "D1'" (defined by the sum of the inner diameter "D1" plus twice the width thickness "w 1") of the structural member 120 is selected to prevent the attachment and transfer device 100 from passing into the incision 22. Inner diameter "D1" is selected to substantially match the outer diameter defined by second portion 104b2 of outer surface 104b of wall 104 to enable partial ring structure member 120 to be securely mated or joined to wall 104.

Referring to fig. 2, a method of applying the connector and transfer device 100 according to one aspect of the present disclosure includes inserting a tubular member 102 configured and dimensioned to have a serrated surface of projecting ridges 114 into a stoma "S" in the direction of arrow Y.

An ostomy bag or pouch (not shown) would be attached to the outer surface 104b of the wall 104 at the proximal first portion 104b1 containing the convex engagement surface 110.

The step of inserting the tubular member 102 into the stoma "S" includes retaining the tubular member 102 within the stoma "S" with the expandable circumferential member 118 and the serrated surface of the projecting ridges 114 in the abdominal cavity.

Referring to fig. 3, in some embodiments, the method comprises injecting a liquid 122 (e.g., water or saline solution) into the expandable circumferential member 118 via the inlet port 116a and sealing the inlet port 116a with a one-way valve (not shown) such that the expandable circumferential member 118 expands and grips the serrated surface of the raised ridge 114 to secure the connector and transfer device 100 within the stoma "S".

The method may further comprise installing partial ring structure member 120 in the direction of arrow R to extend around second portion 104b2 of outer surface 104b of wall 104 of tubular member 102 to secure attachment and transfer device 100 on outside 20' of patient incision 22. The outer diameter "D1" of partial ring structure member 120 is sufficient to inhibit passage of tubular member 102 into incision 22.

In addition to the width thickness "w 1", the height thickness "h 1" of the structural member 120 also serves to inhibit movement of the attachment and transfer device 100 into the incision 22.

In some embodiments, the method comprises mounting the female engagement member 112 on the male engagement surface 110 or mounting a stoma pouch or bag (not shown) on the proximal open end portion 106 of the tubular member 102.

Thus, those skilled in the art will appreciate that the connector and transfer device 100 is intended to be inserted into a stoma (temporary or permanent ileostomy or colostomy) and includes a cap or female engagement member on its exterior portion, which will enable the user or patient or caregiver to avoid the stoma pouch or bag for a period of time as desired.

The device 100 is anchored or secured within the stoma "S" and the internal organ "I" using the raised ridge 114 on the tubular member 102 and the expandable circumferential member 118. When a user injects a liquid or water 122 through the outer orifice 116a, the expandable circumferential member 118 expands.

The enlarged expandable circumferential member 118 engages the serrations of the tubular member 102 and holds the device 100 in place within the stoma "S" and the internal body organ "I".

That is, the enlarged expandable circumferential member 118 is configured and dimensioned to be received within the internal body organ "I" to engage and retain the inner or peritoneal wall against the peritoneal wall (the inner side 20 of the patient's skin 20 relative to the incision 22 ") to thereby retain the tubular member 102 within the internal body organ" I "and prevent bodily fluids from bypassing the tubular member 102 and coming into contact with the patient's external skin.

The expandable circumferential member 118 can be made of a biocompatible, flexible material to avoid injury to the inner surface of the body organ "I".

Fig. 4-8 illustrate another exemplary embodiment of the presently disclosed connecting and transfer device, generally designated 200. The connecting and transfer device 200 includes a first tubular member 202 having a wall 204 defining an inner surface 204a and an outer surface 204 b. The first tubular member 202 defines a central axis X-X.

The tubular member 202 and the wall 204 include a first portion 2041, a second portion 2042 extending from the first portion 2041, and a third portion 2043 extending from the second portion 2042.

Referring to fig. 6, the first portion of wall 2041 has a wall thickness t 1. Similarly, the second portion of wall 2042 has a wall thickness t 2. The third portion of the wall 2043 has a wall thickness t3 that varies distally from a maximum t3' at the intersection with the second portion of the wall 2042 to a minimum t3 "at the distal open end portion 2022.

The first tubular member 202 defines a proximal open end portion 2021 of the first portion 2041 and a distal open end portion 2022 of the third portion 2043.

The proximal open end portion 2021 of the first portion 2041 of the wall comprises a concentric outwardly extending portion 2041' extending along the first portion 2041 relative to the central axis X-X such that the wall thickness t1 of the first portion 2041 is greater than the wall thickness t2 of the second portion 2042.

The second portion 2042 extends to the third portion 2043. The distal open end portion 2022 of the third portion 2043 comprises a concentric outwardly extending inclined portion 2043' extending along the third portion 2043 relative to the central axis X-X such that the wall thickness t3 of the third portion 2043 is greater than the wall thickness t2 of the second portion.

The third portion 2043 includes a proximal end portion 2043 "that defines the intermittent projections 206 that extend further proximally and concentrically about the centerline axis X-X to further define a series of gaps 206' between the intermittent projections 206.

The gaps 206' between the intermittent projections 206 are each configured to receive a first plurality of movable links 208a. The set of a plurality of movable links 208a.. n are operably coupled to proximal end portion 2043 "of third portion 2043. At least two (if not each) of the plurality of movable links 208a.. n are configured to interconnect with at least two (if not each) of the second plurality of movable links 210a.. n. Movable links 210a.. n extend from a distal end portion 2102 of second tubular member 210. The second tubular member 210 having a proximal end portion 2101 is configured to extend around the outer surface 2042' of the second portion 2042 of the first tubular member 202. Thus, the second tubular member 210 includes an inner surface 210 'that interfaces with the outer surface 2042' of the first tubular member 202.

As with the connection and transfer device 100, the first tubular member 202 is configured and dimensioned for insertion into the stoma "S" and a portion of the internal body organ "I" (e.g., the small or large intestine) that extends from the lateral side 20' of the patient incision 22, through the skin 20, and through the medial side 20 "of the patient incision 22.

A first plurality of movable links 208a.. n are received in gaps 206' between the intermittent projections 206 and are operably coupled with a proximal end portion 2043 "of the third portion 2043.

A second plurality of movable links 210a.. n are operably connected with distal end portion 2102 of second tubular member 210 and are made of a biocompatible, flexible material. Links 210a.. n are configured such that upon movement proximal of first tubular member 202 in a direction along centerline axis X-X of inner surface 210' of second tubular member 210 (as indicated by arrow a), at least two, if not each, of the plurality of movable links 210a.. n move outwardly in the direction of arrow B relative to central axis X-X. The outward movement of links 210a.. n effects a joint outward movement of a plurality of movable links 208a.. n operatively coupled with the proximal end portion 2043 "of the third portion 2043 of the first tubular member 202.

A plurality of movable links 210a.. n operably coupled with a distal end portion 2102 of second tubular member 210 extend along an inner side 20 "of patient incision 22 and into an internal organ" I "upon insertion of first tubular member 202 via stoma" S ".

Referring to fig. 8, the connection and transfer device 200 may further comprise a circumferential groove 212 defined in the outer surface 2042' of the second portion 2042 of the first tubular member 202 and extending about the central axis X-X. The circumferential groove 212 is provided such that when the first tubular member 202 is inserted through the stoma "S", the circumferential groove 212 is positioned on the outside 20' of the patient incision 22 to enable receipt of a retaining ring structure member 214 therein to inhibit further movement of the connection and transfer device 200 into the stoma "S".

In a similar manner with respect to the partial ring structure member 120 described above, the outer diameter "D2'" (defined by the sum of the inner diameter "D2" plus twice the width thickness "w 2") of the retaining ring structure member 214 is selected to inhibit the first wall portion 2041 of the wall 204 of the first tubular member 202 from entering the cutout 22. More specifically, the inner surface of the retaining ring structure member 214 includes a raised projection 214 'that is received in a circumferential groove 212 positioned on the outside 20' of the patient incision 22. Inner diameter "D2" of retaining ring structure member 214 is dimensioned to enable engagement with outer surface 2042', and thus retaining ring structure member 214 and its raised projections 214' inhibit movement of connecting and transfer device 200 into incision 22.

In addition to width thickness "w 2", the height thickness "h 2" of retaining ring structure member 214 also serves to inhibit movement of attachment and transfer device 200 into incision 22, as with respect to partial ring structure member 120 described above.

In some embodiments, the connection and transfer device 200 further comprises a flexible collection container member 216 disposed on the proximal open end portion 2021 of the first portion 2041 of the first tubular member 202 to enable transfer of fecal matter through the stoma "S" and to collect fecal matter within the flexible collection container member 216 without the fecal matter contacting the patient' S skin.

Referring to fig. 6, a method of applying a connector and transfer device 200 according to one aspect of the present disclosure includes inserting a distal open end portion 2022 of the device 200 into an internal organ "I" via a stoma "S" in the direction of arrow Y', with links 208a.. n and 210a.. n in a co-linear position flush with the second portion 2042 of the first tubular member 202, and with a flexible collection container member 216 (e.g., a stoma pouch or bag) connected to the proximal open end portion 2021 of the first portion 2041.

The method further comprises the user or patient or caregiver pulling the first tubular member 202 proximally outwardly along the inner surface 210' of the second tubular member 210 in the direction of arrow a, with or without an instrument, as shown in fig. 7-8, to move the first tubular member 202 relative to the second tubular member 210. This relative movement causes links 208a.. n and 210a.. n to shift or pivot in the direction of arrow B from the co-linear position to the extended position such that movable link 210a.. n, which extends from distal end portion 2102 of second tubular member 210, now extends from incision 22 generally along inner side 20 "of patient's skin 20. The translation or pivoting of links 208a.. n and 210a.. n from the collinear position to the extended position uniformly enlarges and enlarges the internal body organ "I" and holds it against the peritoneal wall (the inner side 20 of the patient's skin 20 relative to the incision 22).

That is, at least two movable links 210a.. n of the second set of movable links extend to be received within internal body organ "I" to engage the inner wall, thereby retaining first and second tubular members 202 and 210, respectively, within internal body organ "I" and preventing bodily fluids from bypassing tubular members 202 and 210 and coming into contact with the patient's external skin.

In an embodiment, the method generally includes inserting a retaining ring structure member 214 into a circumferential groove 212 in the first tubular 202 positioned on the outside 20 'of the patient incision 22 in the direction of arrow R', thereby securing the connection and transfer device 200 in a locked position in the stoma "S".

The attachment and transfer device 200 thereby reduces the likelihood of post-operative care procedures and infection because the fecal material does not come into direct contact with the stoma suture or the patient's skin.

In addition, the likelihood of allergic reactions is reduced because contact of the fecal material and pouch with the skin is reduced or eliminated. Reduce leakage and cleanliness problems and psychological complications, thereby improving the lifestyle of the patient.

While several embodiments of the disclosure have been illustrated in the accompanying drawings, the disclosure is not intended to be limited thereto, since the scope of the disclosure is intended to be as broad as the art will allow and the specification is likewise read in this manner. Accordingly, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Although the foregoing disclosure has been described in some detail by way of illustration and example, for purposes of clarity or understanding, it will be apparent that certain changes and modifications may be practiced within the scope of the appended claims.