CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the priority benefit of U.S. Provisional Patent Application Serial No. 62/792, 159, filed January 14, 2019, entitled ENDOLUMINAL ACCESS TUBE, incorporated by reference in its entirety herein.

BACKGROUND

Field of the Invention

The present invention relates generally to gastrostomy tubes. More specifically, embodiments of the present invention concern an endoluminal access tube for placement in a gastrointestinal tract.

Discussion of Related Art

Gastrointestinal tract (GI tract) access tubes are commonly used to gain percutaneous access to a lumen of the GI tract during an interventional procedure. Examples of GI tract access tubes include a Cecostomy tube and a button gastrostomy tube (G-tube). In known embodiments, the Cecostomy tube generally includes an exposed proximal port and a distal coiled end secured within the lumen. The button G-tube generally has an exposed proximal port and a distal balloon end mounted in the lumen. In yet another conventional access tube embodiment, a G-tube for antegrade placement includes a distal end with a foam retention disc.

However, conventional GI tract access tubes have various deficiencies. For instance, Cecostomy tubes and button G-tubes have predefined, fixed stomal lengths. That is, such access tubes are provided in discrete sizes. Cecostomy tubes are also problematic because the distal coiled end can be readily dislodged within the lumen, which can cause patient discomfort and abscess formation. Button G-tubes are similarly problematic because the distal balloon end can deflate or pop, rendering the G-tube prone to dislodgement. Furthermore, the distal balloon end of button G-tubes is known to increase the risk of leakage through the tract wall. Yet further, the distal balloon end is known to cause a gastric outlet obstruction, particularly with smaller patients. A G- tube with a foam retention disc is deficient because the tube is difficult to remove and causes significant patient discomfort. SUMMARY

The following brief summary is provided to indicate the nature of the subject matter disclosed herein. While certain aspects of the present invention are described below, the summary is not intended to limit the scope of the present invention.

Embodiments of the present invention provide an endoluminal access tube that does not suffer from the problems and limitations of the prior art access tubes set forth above.

In one or more embodiments, an endoluminal access tube is described herein, which is configured to be removably secured to extend through a wall defining a patient lumen. The access tube broadly includes a tubular portion and a radially extendable internal retention device. The tubular portion presents opposite external and internal tube ends, with the tubular portion configured to extend axially through the wall to position the tube ends on respective external and internal sides of the wall. The access tube presents an access lumen extending through the tubular portion and between the tube ends to permit communication with the patient lumen. The internal retention device is shiftably attached relative to the tubular portion adjacent the internal tube end and presents a movable distal margin. The internal retention device is shiftable into and out of a deployed position within the patient lumen where the distal margin is spaced radially outwardly from the tubular portion to engage the wall and thereby restrict tube egress relative to the patient lumen.

In one or more embodiments, an endoluminal access tube is described herein which is configured to be removably secured to extend through a wall defining a patient lumen. The access tube broadly includes a tubular portion, a stop, and an external retention clamp. The tubular portion presents opposite external and internal tube ends, with the tubular portion configured to extend axially through the wall to position the external and internal tube ends on external and internal sides of the wall, respectively. The access tube presents an access lumen extending through the tubular portion and between the tube ends to permit communication with the patient lumen. The stop is attached to the tubular portion adjacent the internal tube end and is configured to be deployed within the patient lumen to engage the wall and thereby restrict tube egress relative to the patient lumen. The external retention clamp is slidably received on the tubular portion to slide axially therealong. The external retention clamp is operable to be adjustably secured on the tubular portion adjacent the external end and external to the patient lumen to engage the wall and thereby restrict tube ingress relative to the patient lumen.

Also described herein are methods of installing an endoluminal access tube according to various embodiments of the invention. The methods broadly include the steps of extending a tubular portion through a wall defining a patient lumen so that external and internal tube ends are located on respective external and internal sides of the wall, where the extending step includes the step of engaging an access tube stop adjacent the internal end with the wall to restrict tube egress relative to the patient lumen; and positioning an external retention clamp on the tubular portion to engage the wall and thereby restrict tube ingress relative to the patient lumen.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other aspects and advantages of the present invention will be apparent from the following detailed description of the embodiments and the accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Preferred embodiments of the invention are described in detail below with reference to the attached drawing figures, wherein:

FIG. 1 is a cross section of an endoluminal access tube constructed in accordance with a preferred embodiment of the present invention, where the access tube is configured to be removably secured to extend through a wall defining a patient lumen, with the access tube including a tubular portion, an internal retention device, and an axially-adjustable external retention clamp;

FIG. 2 is a fragmentary cross section of the endoluminal access tube shown in FIG. 1, showing the tubular portion and the retention device operably mounted on the tubular portion, with the retention device including arms, a deployment device, and elastic membrane, and showing the retention device in a retracted position;

FIG. 3 is a fragmentary cross section of the endoluminal access tube similar to FIG. 2, but showing the retention device in a deployed position;

FIG. 4 is a fragmentary side elevation of the endoluminal access tube shown in FIGS. 1-3, showing the tubular portion, the retention device operably mounted on the tubular portion, an absorbable end cap, and a flexible pusher to remove the absorbable end cap, with the access tube configured for insertion into the patient lumen;

FIG. 5 is a fragmentary side elevation of the endoluminal access tube similar to FIG. 4, but showing the absorbable end cap partially removed from the arms by the pusher; FIG. 6 is a fragmentary side elevation of the endoluminal access tube similar to FIG. 5, but showing the absorbable end cap entirely removed from the arms by the pusher;

FIG. 7 is a fragmentary side elevation of the endoluminal access tube similar to FIG. 6, but showing the pusher removed from the tubular portion;

FIG. 8 is a fragmentary side elevation of the endoluminal access tube similar to FIG. 7, but showing the arms shifted out of the retracted position by distal retraction of the deployment ring;

FIG. 9 is a fragmentary side elevation of the endoluminal access tube similar to FIG. 8, but showing the arms shifted into the deployed position by the deployment ring;

FIG. 10 is a fragmentary perspective of the endoluminal access tube similar to FIG. 9, but viewed from a different angle;

FIG. 11 is a fragmentary cross section of the external retention clamp shown in FIG. 1, showing a clamp body, clamp fingers, release elements, and springs of the external retention clamp, and showing the clamp located for positioning onto the tubular portion;

FIG. 12 is an enlarged fragmentary cross section of the external retention clamp shown in FIGS. 1 and 11, showing the clamp finger in the closed position;

FIG. 13 is an enlarged fragmentary cross section of the external retention clamp similar to FIG. 12, but showing the release element depressed so that a catch of the clamp finger is moved out of engagement with a shoulder of the clamp body;

FIG. 14 is an enlarged fragmentary cross section of the external retention clamp similar to FIG. 13, but showing the clamp finger shifted into an open position;

FIG. 15 is a fragmentary cross section of an endoluminal access tube similar to the access tube shown in FIGS. 1-14, showing a tubular portion, a retention device, and an axially-adjustable external retention clamp, and further showing line clamps to secure flexible lines of the retention device, with one of the line clamps being opened prior to securement of one flexible line and the other one of the line clamps being closed to secure another flexible line; and

FIG. 16 is another fragmentary cross section of the endoluminal access tube shown in FIG. 15, but taken in a direction perpendicular to the cross section of FIG. 15, showing fingers of the external retention device clamped to the tubular portion in a closed position, and also showing the clamp body of the external retention device including wing-shaped walls located adjacent a cut end of the tubular portion, wherein a cone-shaped tip of a tube feed is inserted between and retained by the walls. The drawing figures do not limit the present invention to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the preferred embodiment.

DETAILED DESCRIPTION

Turning initially to FIG. 1, an endoluminal access tube 20 is constructed in accordance with a preferred embodiment of the present invention. The access tube 20 is preferably configured as a gastrostomy access tube that provides access to a patient’s gastrointestinal tract (GI tract) 22. In particular, the access tube 20 is configured to extend through a wall W that at least partly defines a lumen L of the GI tract 22.

However, the principles of the present invention are applicable where the access tube 20 is removably secured to extend through another wall structure that defines a patient lumen. For example, the access tube could be configured for installation in a bladder (not shown) to drain urine, similar to a Foley catheter. The access tube could also be configured for installation to drain fluid from an abscess.

The access tube 20 broadly includes a tubular portion 24, an internal retention device 26, and an axially-adjustable external retention clamp 28.

Turning to FIGS. 1-3, the tubular portion 24 is configured to extend axially through the wall W to permit fluid communication with the lumen L. The tubular portion 24 preferably includes a tubular wall structure that extends continuously about a tube axis A and presents opposite external and internal tube ends 30,32 (see FIGS. 2 and 3). As used herein, the external and internal tube ends 30,32 are respectively located externally and internally relative to the lumen L when the access tube 20 is inserted through the wall W. However, for certain aspects of the present invention, it will be appreciated that the access tube 20 could be alternatively positioned. For instance, the access tube could be axially shifted from the depicted position so that the external tube end 30 or the internal tube end 32 is positioned within the opening defined by the wall W. In any event, it is preferable that the external tube end 30 is more externally located than the internal tube end 32. In other words, relative to the person installing the access tube 20, the external tube end 30 is relatively proximal, while the internal tube end 32 is relatively distal.

The tubular portion 24 also presents inner and outer tube surfaces 34,36 (see FIGS. 2 and 3). The inner tube surface 34 defines an access lumen 38 extending axially through the tubular portion 24 and between the tube ends 30,32 to permit communication with the patient lumen L. The tubular portion 24 also presents a pair of through-holes 40 on opposite sides of the access lumen 38 (see FIGS. 2 and 3). The through-holes 40 are configured to slidably receive lines of the retention device 26. As will be discussed, the through-holes 40 receive a deployment device having a deployment ring and permit distal retraction of the deployment ring to deploy the arms of the internal retention device 26 and lock them in place until released. However, the through- holes could be alternatively configured without departing from the scope of the present invention. For some aspects of the present invention, the tubular portion 24 could be devoid of holes other than the access lumen 38 (e.g., where the lines of the retention device 26 extend through the lumen 38).

The tubular portion 24 preferably comprises a flexible synthetic silicone or polyurethane resin material, but could include, additionally or alternatively, one or more other materials consistent with the principles of the present invention.

The tubular portion 24 has an axial length that is preferably configured to be selectively shortened to a desired final axial length dimension D1 for installation in the wall W. The tubular portion 24 is initially provided with a supplied axial length dimension greater than the final length dimension Dl . This enables a user to selectively shorten the tubular portion for use in different access applications.

The internal retention device 26 comprises a stop mechanism that is operable to engage the wall W of the GI tract 22 to restrict tube egress relative to the lumen L. As will be explained, the internal retention device 26 is shiftably attached relative to the tubular portion 24 adjacent the internal tube end 32 and presents a movable distal margin 42. The retention device 26 is shiftable into and out of a deployed position (see FIG. 1) within the patient lumen L where the distal margin 42 is spaced radially outwardly from the tubular portion 24 to engage the wall W and thereby restrict tube egress relative to the patient lumen L. The retention device 26 preferably includes a plurality of extendable arms 44, a shiftable deployment device 46, and preferably also includes elastic membrane 48. As will be discussed, the retention device 26 is temporarily received by an absorbable end cap 49 (see FIGS. 4-7).

The extendable arms 44 each include an elongated arm structure that presents proximal and distal arm ends 50,52 (see FIGS. 2 and 3). The proximal arm end 50 of each arm 44 preferably presents a notch 54 (see FIGS. 1 and 2). The arms 44 also include a tip 44a formed on the arm structure to provide the distal arm end 52. In the illustrated embodiment, the arms 44 are spaced circumferentially about the tube axis A. The proximal arm ends 50 are swingably mounted to the tubular portion 24 adjacent the internal tube end 32 at pivot joints 56 to pivot about corresponding transverse arm axes (see FIGS. 2 and 3). The illustrated arms 44 cooperate with the elastic membrane 48 to provide and support the distal margin 42.

Preferably, the arms 44 are pivotal to shift the distal margin 42 into and out of a retracted position (see FIGS. 2 and 6) where the arms 44 extend primarily axially and distally away from the tubular portion 24. In the retracted position, the arms 44 extend generally parallel to one another and cooperatively present a maximum retracted diameter dimension D2 that is about the same size as the outer diameter dimension of the tubular portion 24 (see FIG. 2). In various alternative embodiments, the arms 44 could also be configured so that the maximum retracted diameter dimension D2 is less than the outer diameter dimension. For some aspects of the present invention, the retracted diameter dimension D2 could be greater than the outer diameter dimension.

The depicted arms 44 are also pivotal to shift the distal margin 42 into and out of the deployed position (see FIGS. 1, 3, 9, and 10). In the deployed position, the arms 44 extend primarily radially away from the tubular portion 24. In the deployed position, the arms 44 cooperatively present a maximum deployed diameter dimension D3 (see FIG. 1) that is greater than the outer diameter dimension of the tubular portion 24.

The arm structure preferably includes a synthetic resin material that comprises a relatively stiff material to prevent bending or breaking of the arms 44. The tips 44a preferably include a relatively soft synthetic resin material that comprises a material relatively softer than the material of the arm structure. The material of the tips 44a preferably includes a silicone material. However, the arm structure and/or the tips 44a could include one or more other materials consistent with the principles of the present invention. For instance, the arm structure and/or the tips 44a (or any other part of the access tube 20) could include a radiopaque material in order to permit visualization of the access tube 20 with fluoroscopy or radiography to confirm position.

Although the arms 44 preferably pivot between the retracted and deployed positions, the arms 44 could be alternatively shiftably mounted and/or configured for deployment. For instance, the arms could be constructed of a flexible material so that the arms can be flexed between the retracted and deployed positions. In alternative embodiments, the arms could be alternatively shiftably attached relative to the tubular portion. For example, alternative arms could be mounted to pivot about arm axes that are parallel to the tube axis.

Although the illustrated retention device includes four (4) arms, the device could have five (5) or more arms. Similarly, the device could have three (3) or fewer arms.

The illustrated elastic membrane 48 comprises a continuous layer of elastomeric material to cover the arms 44 and cooperate with the arms 44 to provide the distal margin 42. In depicted embodiment, the elastic membrane 48 presents the distal margin 42. The elastic membrane 48 has a generally toroidal shape and presents opposite inner and outer margins 58,60 that are attached to and sealingly engaged with the tubular portion 24 along corresponding seams (see FIGS. 2 and 3). In particular, the inner margin 58 is attached to the inner tube surface 34 and the outer margin 60 is attached to the outer tube surface 36. The margins 58,60 are preferably attached to the tubular portion 24 by being welded and/or adhered thereto, although other attachment methods could also be used.

The elastic membrane 48 is secured around the arms 44 so that the arms 44 can pivot between the retracted position (see FIG. 2) and the deployed position (see FIG. 3). The elastic membrane 48 also receives the deployment device 46 and accommodates shifting movement of the deployment device 46 to position the arms 44.

The elastic membrane material preferably comprises an elastomeric silicone or polyurethane material. However, the elastic membrane material could include, alternatively or additionally, one or more other synthetic resin materials, such as an alternative elastomeric material, without departing from the scope of the present invention.

In alternative embodiments, the membrane could be alternatively configured without departing from the scope of the present invention. For some aspects of the present invention, the retention device could be devoid of membrane. For example, the distal margin of the retention device could be provided solely by the depicted arms.

The deployment device 46 is shiftably supported by the tubular portion 24 and is shiftable to move the retention device 26 into and out of the deployed position. The deployment device 46 preferably includes a circular deployment ring 62 and a pair of flexible lines 64 attached to the ring 62 (see FIGS. 2 and 3).

The deployment device 46 is preferably positioned and configured so that the ring 62 is located adjacent the internal end 32 and the lines 64 are slidably received by the holes 40. Furthermore, the deployment device 46 is preferably positioned and configured so that the lines 64 extend proximally beyond the proximal end 30 of the tubular portion 24.

The lines 64 preferably have sufficient rigidity so that each line 64 can be pushed and pulled through the holes 40. The lines 64 are preferably moved in the same axial direction at the same time so that the lines 64 cooperatively move the ring 62 in the axial direction. In this manner, the deployment device 46 is slidably mounted in the tubular portion 24 to slide axially along the length of the tubular portion 24. The lines 64 preferably comprise a synthetic resin material. However, the lines could include a metallic material, such as stainless steel, without departing from the scope of the present invention.

Again, the lines 64 preferably extend proximally beyond the external end 30 of the tubular portion 24. In this manner, the lines 64 can be selectively grasped by the user at a location spaced proximally relative to the tubular portion 24 to permit manual shifting of the deployment device 46. However, the lines could be alternatively configured for adjustable shifting of the deployment device.

For some aspects of the present invention, the deployment device could have structure alternative to the lines for shifting the deployment device and thereby moving the retention device 26. For instance, alternative embodiments of the deployment device could include rigid sliding elements instead of the flexible lines.

The ring 62 is generally rigid and has a unitary toroidal shape. In various alternative embodiments, the ring could be alternatively configured within the ambit of the present invention.

The ring 62 is configured to be shifted axially by the lines 64 so that the deployment device 46 can be moved into and out of engagement with the arms 44. More specifically, the deployment device 46 can be axially shifted by movement of the lines 64 between a distal location (see FIGS 2 and 6) and a proximal location (see FIGS. 1, 3, 9, and 10).

The retracted position of the arms 44 is generally associated with the deployment device 46 being in the distal location (see FIGS. 2 and 6). To deploy the arms 44, the deployment device 46 is shifted proximally so that the ring 62 engages the arms 44 and pivots the arms 44 radially outwardly (see FIG. 8). As the deployment device 46 is shifted into the proximal location, the ring 62 engages the notches 54 to restrict pivoting of the arms 44 out of the deployed position (see FIGS. 1, 3, 9, and 10).

To retract the arms 44, the deployment device 46 is shifted distally so that the ring 62 is moved out of engagement with the notches 54, which permits the arms 44 to be pivoted radially inwardly, generally when an external force is applied to the distal margin 42 in a distal direction. As the deployment device 46 is shifted into the distal location, the ring 62 permits the arms 44 to be returned to the retracted position.

Although the illustrated deployment device 46 is preferred, the principles of the present invention are applicable where an alternative deployment device is used to move the arms 44.

Turning to FIGS. 2-10, installation of the access tube 20 generally involves retrograde placement of the access tube 20, although the access tube 20 can be installed via antegrade placement through the esophagus. Retrograde placement of the access tube 20 includes the steps of inserting the tubular portion 24 and the retention device 26 through the wall W and into the lumen L. Prior to insertion, the tubular portion 24 and the retention device 26 are preferably arranged so that the arms 44 are in the retracted position (see FIGS. 2 and 6).

In the retracted position, and prior to insertion, the tubular portion 24 and the retention device 26 are configured to receive the absorbable end cap 49 (see FIGS. 4-7). The absorbable end cap 49 presents a socket to slidably receive the tubular portion 24 and the retention device 26 and is preferably formed of a conventional resorb material, such as gelatin, Hypromellose, or pullulan.

The tubular portion 24, the retention device 26, and the absorbable end cap 49 are configured to be inserted through the wall W so that the arms 44 are located in the lumen L (see FIGS. 2 and 4). The user can then insert a flexible pusher 65 into the tubular portion 24 and slide the pusher 65 distally into engagement with the absorbable end cap 49 (see FIGS. 4-7). By further sliding the pusher 65 distally, the pusher 65 can shift the absorbable end cap 49 distally out of engagement with the retention device 26 to permit deployment of the arms 44 (see FIG. 6). Construction of the absorbable end cap 49 with resorb material permits the absorbable end cap 49 to be absorbed by the GI tract 22 or other tissues of the patient.

The user can then grasp and move the lines 64 proximally to shift the deployment device 46 from the distal location (see FIGS. 2, 6, and 7) to pivot the arms 44 radially outwardly (see FIG. 8). As the deployment device 46 is shifted proximally, the ring 62 engages the arms 44 and pivots the arms 44 radially outwardly. The deployment device 46 can be further shifted into the proximal location so as to pivot the arms 44 into the deployed position (see FIGS. 3, 9, and 10). With the arms 44 deployed, the tubular portion 24 and the retention device 26 can be moved proximally so that the arms 44 are moved into engagement with the wall W.

Once the tubular portion 24 and the retention device 26 are inserted, the user can trim the length of the tubular portion 24 prior to attachment of the external retention clamp 28. More specifically, the user can selectively remove a proximal part of the tubular portion 24 so that the tubular portion 24 has a desired final length dimension Dl . The user can also remove proximal parts of the lines 64, as needed, for customized installation. In this manner, the access tube 20 has a customizable length for universal application. The tubular portion 24 is preferably trimmed to a length associated with a desired stomal length S of the access tube 20 (see FIG. 1), which is generally associated with the thickness of the wall W. As will be described below, once the tubular portion 24 has been trimmed to the desired length, the clamp 28 can then be secured on the tubular portion 24.

Again, although the tubular portion 24 and the retention device 26 are disclosed as being inserted by retrograde placement, the access tube 20 could also be positioned by antegrade placement through the patient’s esophagus. During antegrade placement, the external end of the tubular portion 24 is preferably covered by a tapered end cap.

Turning to FIGS. 1 and 11-14, the external retention clamp 28 is operable to be adjustably frictionally engaged with the tubular portion 24 adjacent the external tube end 30. When secured to the tubular portion 24, the clamp 28 is positioned externally to the patient lumen L to engage the wall W and thereby restrict tube ingress relative to the patient lumen L. Preferably, the external retention clamp 28 is adjustably axially positionable along the tubular portion 24 to provide the desired stomal length S. Again, the stomal length S is generally associated with the thickness of the wall W (see FIG. 1).

The external retention clamp 28 preferably includes a clamp body 66, shiftable clamp fingers 68, release elements 70, springs 72, and a covering 76. The retention clamp more preferably also includes a powered electronic circuit 74 (see FIGS. 11-14).

The clamp body 66 presents an axial central opening 78, lateral openings 80 that communicate with the central opening 78, and release openings 82 (see FIG. 11). Adjacent to each of the lateral openings 80, the clamp body 66 also presents an upper shoulder 84 to engage the clamp finger 68 (see FIG. 12). The clamp body 66 further presents a channel 86 to receive the spring 72 (see FIG. 12).

The depicted clamp body 66 is slidably mounted on the tubular portion 24. Preferably, the central opening 78 is slightly undersized relative to the tubular portion 24 so that the clamp body 66 frictionally engages the tubular portion 24 when slidably received thereon.

The clamp body 66 preferably includes a synthetic resin material. More preferably, the clamp body includes a material that is at least partly translucent. As will be discussed, the clamp body 66 preferably has a translucent construction to facilitate light transmission from LED lights.

Each clamp finger 68 is unitary and includes a head 88, a catch 90, a boss 92, and a tube- engaging end 94 (see FIGS. 12-14). The clamp fingers 68 are slidably received in the lateral openings 80 and are slidable between open and closed positions. The catch 90 is configured to flex relative to the rest of the clamp finger 68 to permit shifting of the clamp finger 68 between the open and closed positions. In the closed position, the end 94 frictionally engages the tubular portion 24 when the clamp 26 is mounted on the tubular portion 24. The catch 90 preferably engages the upper shoulder 84 to restrict movement of the clamp finger 68 out of the closed position.

The spring 72 is positioned in the channel 86 to engage the boss 92 and a shoulder 96 of the clamp body 66. The spring 72 generally urges the clamp finger 68 toward the open position. The spring 72 flexes to permit movement of the clamp finger 68 toward the closed position.

The release element 70 is slidably mounted in the corresponding release opening 82 to slide vertically between upper and lower positions. When the clamp finger 68 is in the closed position, the catch 90 generally urges the release element 70 into the upper position. The release element 70 can be depressed by the user to shift the catch 90 downwardly out of engagement with the shoulder 84. With the catch 90 disengaged, the spring 72 preferably urges the clamp finger 68 to shift from the closed position toward the open position.

The powered electronic circuit 74 preferably includes LED lights 98, 100, pairs of contacts 102, 104, a timer 106, and a battery 108. Because the boss 92 has a metallic surface to slidably engage the contacts 102,104, each set of contacts can be selectively closed by the boss 92. The contacts 102 are closed by the boss 92 to turn on the LED light 98 when the clamp finger 68 is partly depressed and located in an intermediate position (not shown) between the open and closed positions. When the contacts 102 are closed, the timer 106 keeps the LED light 98 on for a predetermined amount of time. In this manner, the LED light 98 provides visible indicia to the user that the clamp finger 68 has been partly depressed and located in the intermediate position.

The contacts 104 are closed by boss 92 to turn on the LED light 100 when the clamp finger 68 is depressed and located in the closed position (see FIG. 12). In this manner, the LED light 100 provides visible indicia to the user that the clamp finger 68 is in the closed position. The LED light 100 only remains on when the contacts 104 are closed. Thus, when the clamp finger 68 is moved out of the closed position, the LED light 100 turns off.

The LED lights 98, 100 are preferably positioned on top of the clamp body 66 and are retained in a housing 109 that is at least partly translucent (see FIG. 14). Again, the clamp body 66 also preferably includes a translucent material. As each LED light 98,100 is illuminated, the housing 109 and the clamp body 66 both preferably transmit light. More preferably, the translucent construction causes the housing 109 and clamp body 66 to become illuminated and glow. Thus, the housing 109 and clamp body 66 facilitate the transmission of visible indicia to the user, where the indicia is associated with the position of the clamp finger 68, as discussed above. Turning to FIGS. 1 and 11, the retention clamp 28 also preferably includes a receptacle 110 that fluidly communicates with the tubular portion 24. The receptacle 110 is fixed to the clamp body 66 and preferably includes a receptacle body 112, a receptacle cover 114, a removable port plug 116, and line connectors 118 (see FIG. 11).

The receptacle body 112 presents an access port 120 that fluidly communicates with the tubular portion 24 (see FIG. 11). In the usual manner, the port 120 of the receptacle body 112 is configured to receive a tube end (not shown) for introducing materials to the GI tract via the tubular portion 24. When the port 120 is not in use, the plug 116 can be removably inserted into the port 120

The line connectors 118 preferably comprise lugs that are removably engaged by the lines 64. The line connectors 118 are preferably recessed so as to be covered when the cover 114 is installed on the body 112.

Once the tubular portion 24 and the retention device 26 are inserted, and any trimming of the tubular portion 24 has been done, the retention clamp 28 can be secured on the tubular portion 24. The clamp 28 is mounted on the tubular portion 24 by inserting the tubular portion 24 into the central opening 78 while the clamp fingers 68 are in the open position.

Again, in preferred embodiments, the external retention clamp 28 is adjustably axially positionable along the tubular portion 24 to provide the desired stomal length dimension S (see FIG. 1), particularly after the access tube 20 has been inserted into the lumen L. The stomal length dimension S is an axial dimension measured between the arms 44 and the clamp body 66 (see FIG. 1). The stomal length dimension S is adjustable by moving the retention clamp 28 axially along the tubular portion 24 as needed. In preferred embodiments, the stomal length S is adjusted to correspond generally to the thickness of the wall W (see FIG. 1).

The clamp 28 is selectively removably secured on the tubular portion 24 by shifting both of the clamp fingers 68 into the closed position. Again, the clamp fingers 68 frictionally engage the tubular portion 24 in the closed position to restrict relative movement between the clamp 28 and the tubular portion 24.

With the clamp 28 secured on the tubular portion 24, the lines 64 can be secured to the receptacle 110 to hold the arms 44 in the deployed position. In particular, the lines 64 are engaged by corresponding connectors 118 so that the lines 64 are taut and hold the ring 62 against the arms 44. With the lines 64 secured to the receptacle 110, the cover 114 can be removably attached to the body 112 to cover the connectors 118 and the ends of the lines 64. The clamp 28 can also be selectively removed from the tubular portion 24 to permit removal of the access tube 20. The clamp 28 is removed by initially detaching the lines 64 from the connectors 118.

With the lines 64 detached, the access tube 20 can be removed from the lumen L. In the depicted embodiment, the lines 64 can be pushed distally so that the entire deployment device 46 can be moved distally, from the proximal location to the distal location, out of engagement with the arms 44. With the deployment device 46 in the distal location, the access tube 20 can be shifted proximally out of the lumen L. More specifically, as the access tube 20 moves proximally, the wall W engages the distal margin 42 and shifts the arms 44 and elastic membrane 48 from the deployed position to the retracted position. With the access tube 20 in the retracted position, the retention device 26 is sized to pass through the wall W.

As an optional step, once the lines 64 are detached from the connectors 118, the clamp 28 can be removed from the tubular portion 24. In particular, the clamp fingers 68 can be disengaged from the tubular portion 24. More specifically, both release elements 70 are depressed (i.e., moved to the lower position) so that the springs 72 can shift the clamp fingers 68 from the closed position to the open position. With the clamp fingers 68 disengaged, the clamp 28 can be moved proximally to a location spaced from the tubular portion 24. It will be appreciated that the clamp 28 can be removed from the tubular portion 24 either before or after removal of the access tube 20 from the lumen L.

Turning to FIGS. 15 and 16, an access tube 200 is constructed in accordance with the present invention. The following description will primarily describe differences of the access tube 200 from the access tube 20. The access tube 200 broadly includes a tubular portion 204, an internal retention device 206, and an axially-adjustable external retention clamp 208. The retention device 206 includes a link with a circular keeper (not shown) and flexible lines 210 attached to the keeper.

The retention clamp 208 includes, among other things, a clamp body 212, shiftable clamp fingers 214, release elements 216, springs 218, line clamps 220, a covering 222, and a powered electronic circuit 224. The circuit 224 preferably includes batteries 226 mounted in the clamp body 212 and associated with the line clamps 220.

The line clamps 220 each include a fixed portion 228 and a movable portion 230 that present respective corrugated clamp faces 232 (see FIG. 15). The movable portion 230 is shiftable between an open position, where the clamp faces 232 of the portions 228,230 are disengaged, and a closed position, where the clamp faces 232 of the portions 228,230 are engaged to secure one of the lines 210. Prior to line securement, the user can open the respective line clamp 220 and position the line 210 between the portions 228,230 (see FIG. 15). With the line 210 located between the portions 228,230, the line clamp 220 can be closed to secure the line 210 in place between the clamp faces 232 (see FIG. 15). As depicted in FIG. 15, one line clamp 220 is open and ready to be closed, while another line clamp 220 is closed to secure the respective line 210.

The clamp body 212 preferably includes wing-shaped walls 234 located on opposite sides of the central opening 236 (see FIG. 16). The clamp body 212 is configured to be positioned so that the walls 234 are located adjacent an external tube end 238 of the tubular portion 204. The external tube end 238 may also be in abutting engagement with the walls 234. As depicted in FIG. 16, a port plug 240 can be removed from an access port 242 so that a tube feed 244 can be inserted into the port 242. In particular, a cone-shaped end 246 of the tube feed 244 is inserted into the port 242 so that shoulders 248 presented by the end 246 engage the walls 234 (see FIG. 16). In this manner, the tube feed 244 is removably retained by the clamp body 212 when inserted into the access port 242. Additional advantages of the various embodiments of the invention will be apparent to those skilled in the art upon review of the disclosure herein and the working examples below. It will be appreciated that the various embodiments described herein are not necessarily mutually exclusive unless otherwise indicated herein. For example, a feature described or depicted in one embodiment may also be included in other embodiments, but is not necessarily included. Thus, the present invention encompasses a variety of combinations and/or integrations of the specific embodiments described herein.

As used herein, the phrase "and/or," when used in a list of two or more items, means that any one of the listed items can be employed by itself or any combination of two or more of the listed items can be employed. For example, if a composition is described as containing or excluding components A, B, and/or C, the composition can contain or exclude A alone; B alone; C alone; A and B in combination; A and C in combination; B and C in combination; or A, B, and C in combination.

The present description also uses numerical ranges to quantify certain parameters relating to various embodiments of the invention. It should be understood that when numerical ranges are provided, such ranges are to be construed as providing literal support for claim limitations that only recite the lower value of the range as well as claim limitations that only recite the upper value of the range. For example, a disclosed numerical range of about 10 to about 100 provides literal support for a claim reciting "greater than about 10" (with no upper bounds) and a claim reciting "less than about 100" (with no lower bounds). Although the above description presents features of preferred embodiments of the present invention, other preferred embodiments may also be created in keeping with the principles of the invention. Such other preferred embodiments may, for instance, be provided with features drawn from one or more of the embodiments described above. Yet further, such other preferred embodiments may include features from multiple embodiments described above, particularly where such features are compatible for use together despite having been presented independently as part of separate embodiments in the above description.

The preferred forms of the invention described above are to be used as illustration only, and should not be utilized in a limiting sense in interpreting the scope of the present invention. Obvious modifications to the exemplary embodiments, as hereinabove set forth, could be readily made by those skilled in the art without departing from the spirit of the present invention.

The inventors hereby state their intent to rely on the Doctrine of Equivalents to determine and assess the reasonably fair scope of the present invention as pertains to any apparatus not materially departing from but outside the literal scope of the invention as set forth in the following claims.