JP7280401B2 - System and method for conveying piping - Google Patents

Description

The subject matter of this disclosure relates to delivery tube assemblies, including systems and techniques for placing percutaneous tubing into a patient.

Certain delivery tube assemblies are known and used in the medical arts, including for enteral and parenteral indications. For example, percutaneous endoscopic gastrostomy (PEG) is an endoscopic medical procedure in which a tube (“PEG tube” or “G-tube”) is passed through the abdominal wall into a patient's stomach, etc. placed within the gastrointestinal system of PEG tubes can be utilized to treat or feed patients when oral ingestion is not appropriate (eg, due to difficulty swallowing or sedation). PEG tubes may also be used to administer medications through tubes, for example, when beneficial absorption of medications is not adequate by oral administration. A tubing system may be used, for example, by passing a jejunal extension tube (“PEG-J tube” or “J tube”) through the PEG tube and into the jejunum through the pylorus to bypass the stomach and administer medication directly to the jejunum. , may extend further into the gastrointestinal system, such as the small intestine.

PEG may involve puncturing the abdominal wall, creating a fistula, and feeding a G-tube through the fistula into the stomach. A J-tube may be fed through the stomach and duodenum into the jejunum through the G-tube. An inner bumper can be placed inside the stomach and attached around the G-tube, for example to prevent or impede migration of the G-tube out of the stoma.

The plumbing system may include an outer bumper secured to the G-tube and positioned at or near the skin proximate the stoma, for example to protect the stoma and guide the G-tube and J-tube exiting the stoma. . The outer bumper can also prevent or impede the outer portion of the G-tube and J-tube from traveling through the stoma and into the stomach. Additionally or alternatively, a tubing system may be provided at the ends of the outer portions of the G and J tubes to facilitate attachment of the G and J tubes to external devices such as, for example, food or drug delivery devices. It may include an attached patient-side connector. The patient-side connector can also facilitate cleaning of the G and J tubes, including cleaning each tube separately.

However, a need still exists for further improvements to known percutaneous tubing systems, such as the PEG-J tubing system. For example, it may be desirable for a connector to provide a simple connection to an external device while also preventing or hindering accidental disconnection and/or movement of the J-tube. Also, it may be desirable for the bumper to allow flexible movement and rotation of the G-tube and J-tube. For example, the G and J tubes can be placed outside the fistula into the stomach to facilitate proper fistula healing while still allowing the G and J tubes to lie generally flat and parallel to the abdominal cavity. It may be even more desirable for the bumper to guide substantially perpendicular to it. This may reduce the visibility of the tube. These and other advantages may be provided by plumbing systems and methods in accordance with the disclosed subject matter.

Objects and advantages of the disclosed subject matter will be set forth in the following detailed description, become apparent, and may be learned by practicing the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the accompanying drawings.

To obtain these and other advantages, and in accordance with the purposes of the disclosed subject matter, as practiced and broadly described, the disclosed subject matter is a percutaneous tube, including an outer G-tube and an inner J-tube. Includes a connector assembly for A connector assembly generally includes a male connector assembly having a shell, a connector body, and a plug. the shell has a sidewall forming an interior, a first shell end having a first opening formed therein, and a second shell end having a second opening formed therein; Each of the first opening and the second opening communicate with the interior to receive percutaneous tubing therethrough, and the shell further has an engaged portion. The connector body has a first body end and a second body end with a tube lumen formed therethrough, the first body end receiving an inner J-tube therethrough and an outer J-tube. It has a connector tip sized to mate with a G-tube, and the connector body has an engaging portion that engages an engaged portion of the shell. A plug is configured to be coupled to the connector body and has a first plug end and a second plug end with a fluid lumen formed therethrough, the first plug end extending therefrom. It has a plug tip and the tip is sized to mate with the inner J-tube.

In some embodiments, the engaged portion can be located inside the shell. A sidewall of the shell may have an aperture formed therein, and the connector assembly may include a valve sized to be positioned within the aperture and in communication with the connector body. The valve may have a first end with a fluid fitting. The valve may be configured to engage the shell and connector body to prevent or impede movement of the shell relative to the connector body.

Additionally or alternatively, the connector tip can be tapered as implemented herein. The connector tip can be sized to receive the plug tip therein. The engaging portion can be engaged with the engaged portion by screw engagement.

Additionally, as embodied herein, a connector assembly may include a female connector with a lever having a locking extension. The locking extension may be sized to be received within a groove formed in the second plug end. The female connector is rotatable relative to and maintains axial engagement with the male connector when the locking extension is received in the groove. The connector assembly may include a removable cap for closing the fluid lumen at the second plug end of the plug. A cap can be coupled to the connector assembly.

For example, as embodied herein, a connector assembly may include fasteners that couple a connector body to a plug. The fastener may be integral with at least one of the connector body and the plug. The fastener may include at least one locking projection extending from at least one of the connector body and the plug. The fastener may include at least one locking recess formed in the other of the connector body and the plug. The fastener may include a clip having notches formed therein for receiving respective portions of the connector body and the plug. The clip may include a first clip portion and a second clip portion. The clip can be a member separate from the connector body and the plug. The clip may include a first clip portion hinged to a second clip portion. Alternatively, the clip may include a first clip portion spaced apart from a second clip portion. The connector body and plug may each have grooves formed therein, and the notch of the clip may form a flange that is received within the respective grooves of the connector body and plug.

Additionally, in some embodiments, the connector assembly may include a bumper configured to be placed about the percutaneous tubing to impede or prevent axial movement of the percutaneous tubing. The bumper may include a base having an aperture formed therethrough. A plurality of ridges can be formed on the bottom surface of the base. The base may include an arcuate perimeter. The base may include a first bumper base portion and a second bumper base portion, and in some embodiments each of the first bumper base portion and the second bumper base portion form a portion of the aperture. can have a notch for The bumper may include a bumper base connector for connecting together the first bumper base portion and the second bumper base portion. The bumper base connector includes a protrusion extending from one of the first bumper base portion and the second bumper base portion, and a first bumper base portion and a second bumper base portion for receiving the protrusion. and a receptacle formed in the other of the two. Additionally or alternatively, the bumper base connector includes a support wall located proximal to a notch in each of the first bumper base portion and the second bumper base portion; and a hood hinged to each support wall with the bumper base portion. Each support wall forms a portion of a U-shaped channel extending from the aperture and is sized to receive the percutaneous tubing when the first bumper base portion and the second bumper base portion are connected together. may have curved walls. The hood may have a U-shaped surface sized to receive a portion of the percutaneous tubing. The hood may be movable between an open position in which the bumper is freely movable relative to the percutaneous tubing and a closed position in which the bumper is fixed relative to the percutaneous tubing. When the hood is in the open position, the bumper can rotate freely around the percutaneous tubing.

Additionally or alternatively, the base may include a base portion received at least partially within the substrate portion. The base portion may include support walls forming opposite tracks with respect to each other on each side of the support walls. A bumper engages the base and moves along the track between an open position in which the bumper is freely movable relative to the percutaneous tubing and a closed position in which the bumper is fixed relative to the percutaneous tubing. It may include a hood that is slidable.

In accordance with another aspect, the disclosed subject matter includes a bumper for percutaneous tubing. The bumper is configured to prevent or impede axial movement of the percutaneous tubing. a bumper having an aperture formed therethrough and sized to receive the percutaneous tubing; an open position secured to the base in which the bumper is freely movable relative to the percutaneous tubing; a hood movable proximal to the aperture between a closed position in which the bumper is fixed relative to the percutaneous tubing. The bumper can include any of the features described herein.

In accordance with another aspect, the disclosed subject matter includes a method of assembling a tubing system including percutaneous tubing. The percutaneous tubing includes an outer G-tube and an inner J-tube. The method includes a shell having a sidewall defining an interior, a first shell end having a first opening formed therein, and a second shell end having a second opening formed therein. inserting percutaneous tubing through the first and second openings in the shell; and first and second body ends having a tube lumen formed therethrough. a first body end having a connector tip; inserting an inner J-tube into the connector tip and through the connector body; Mating with the connector tip and providing a plug having a first plug end and a second plug end with a fluid lumen formed therethrough, the first plug end comprising: coupling the inner J-tube with the plug tip; coupling the connector body with the plug; coupling the connector body with the shell.

Additionally or alternatively, the sidewall of the shell may have an aperture formed therein, and the method may further include inserting the valve into the aperture and in fluid communication with the connector body. The method may further include engaging a cap with the second plug end to close the fluid lumen.

Further, as embodied herein, the method includes providing a fluid source with a mated female connector, the female connector including a lever having a locking extension; inserting at least a portion of the second plug end into a female connector having a fluid lumen in fluid communication with a fluid source; and releasably coupling a locking extension of the female connector with the second plug end. and actuating the lever to.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the claimed subject matter of the disclosure.

The accompanying drawings, which are incorporated in and constitute a part of this specification, are included to illustrate and facilitate a further understanding of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.

1 is a plan view of an exemplary plumbing system including an exemplary male connector assembly, according to an exemplary embodiment of the disclosed subject matter; FIG. 2 is a perspective view of the exemplary plumbing system of FIG. 1 having a male connector assembly coupled to a female connector; FIG. 2 is a top perspective view of an exemplary male connector assembly of the exemplary plumbing system of FIG. 1; FIG. 3B is a side view of the exemplary male connector assembly of FIG. 3A; FIG. 3B is a front view of the exemplary male connector assembly of FIG. 3A; FIG. 3B is a rear view of the exemplary male connector assembly of FIG. 3A; FIG. 3B is an exploded top perspective view of the exemplary male connector assembly of FIG. 3A; FIG. 3B is an exploded bottom perspective view of the exemplary male connector assembly of FIG. 3A; FIG. 3B is an exploded side view of the exemplary male connector assembly of FIG. 3A; FIG. FIG. 3 is a perspective view of a percutaneous tubing inserted through an exemplary shell in accordance with the disclosed subject matter; 6 is a perspective view of the percutaneous tubing of FIG. 5 with a J-tube inserted through an exemplary connector body and a G-tube coupled with an exemplary connector tip in accordance with the disclosed subject matter; FIG. 7 is a perspective view of the percutaneous tubing of FIG. 6 with a J-tube mated with an exemplary plug tip and an exemplary plug mated with a connector body in accordance with the disclosed subject matter; FIG. 8 is a perspective view of the percutaneous tubing of FIG. 7 with the connector body coupled to the shell in accordance with the disclosed subject matter; FIG. 2 is a perspective view of an exemplary bumper of the exemplary piping system of FIG. 1; FIG. 9B is a front view of the exemplary bumper of FIG. 9A; FIG. 9B is a bottom view of the exemplary bumper of FIG. 9A; FIG. 9B is an exploded perspective view of the exemplary bumper of FIG. 9A; FIG. 9B is a perspective view of the exemplary bumper of FIG. 9A with percutaneous tubing inserted therethrough and the hood in the open position; FIG. 9B is a perspective view of the exemplary bumper of FIG. 9A with the hood in the closed position; FIG. 2 is a top view of an exemplary female connector of the plumbing system of FIG. 1 with a removable cap disposed thereon, according to an exemplary embodiment of the disclosed subject matter; FIG. 13B is a bottom view of the female connector of FIG. 13A; FIG. 13B is a left side view of the female connector of FIG. 13A; FIG. 13B is a right side view of the female connector of FIG. 13A; FIG. 13B is a front view of the female connector of FIG. 13A; FIG. 13B is an exploded perspective view of the female connector of FIG. 13A; FIG. 13B is a cross-sectional view of the female connector of FIG. 13A engaged with an exemplary second plug end; FIG. 2 is a top perspective view of another embodiment of an exemplary male connector assembly of the exemplary plumbing system of FIG. 1; FIG. 16B is a side view of the exemplary male connector assembly of FIG. 16A; FIG. 16B is a front view of the exemplary male connector assembly of FIG. 16A; FIG. 16B is a rear view of the exemplary male connector assembly of FIG. 16A; FIG. 16B is an exploded top perspective view of the exemplary male connector assembly of FIG. 16A; FIG. 16B is an exploded bottom perspective view of the exemplary male connector assembly of FIG. 16A; FIG. 16B is an exploded side view of the exemplary male connector assembly of FIG. 16A; FIG. 2 is a perspective view of another embodiment of an exemplary bumper of the exemplary piping system of FIG. 1; FIG. 18B is a front view of the exemplary bumper of FIG. 18A; FIG. 18B is a bottom view of the exemplary bumper of FIG. 18A; FIG. 18B is an exploded top perspective view of the exemplary bumper of FIG. 18A; FIG. 18B is an exploded bottom perspective view of the exemplary bumper of FIG. 18A; FIG. 18B is a perspective view of the exemplary bumper of FIG. 18A with percutaneous tubing inserted therethrough and the hood in a first position; FIG. 18B is a perspective view of the exemplary bumper of FIG. 18A with the hood in a second position; FIG.

Reference will now be made in detail to various exemplary embodiments of the disclosed subject matter. Exemplary embodiments of the disclosed subject matter are illustrated in the accompanying drawings. The structure and corresponding methods of operation of the disclosed subject matter, as well as methods of treatment using the disclosed subject matter, are described in connection with the detailed description of the present system.

The devices and methods provided herein can be used to administer any of a variety of suitable therapeutic agents or substances, such as drugs or biological agents, to a patient. For example, as embodied herein, a plumbing system can be coupled to a therapeutic agent delivery device, such as a pump, to deliver a therapeutic agent through the plumbing system. As used herein, a "therapeutic agent delivery device" or "delivery device" (used interchangeably herein) generally conveys a liquid or gel composition through a plumbing system to a patient. It is intended to refer to a device capable of administering a dose of a fluid substance, such as a therapeutic agent, including. In some embodiments, fluid therapeutic agents may include one or more pharmaceutical or biological agents. For example, without limitation, one such liquid therapeutic agent can be a central nervous system agent such as levodopa. Central nervous system agents can be administered alone or in combination with decarboxylase inhibitors such as, but not limited to, carbidopa.

In accordance with the subject matter disclosed herein, connector assemblies for percutaneous tubing are provided that include an outer tube, such as a G-tube, and an inner tube, such as a J-tube. A connector assembly generally includes a male connector assembly having a shell, a connector body, and a plug. the shell has a sidewall forming an interior, a first shell end having a first opening formed therein, and a second shell end having a second opening formed therein; Each of the first opening and the second opening communicate with the interior to receive percutaneous tubing therethrough, and the shell further has an engaged portion. The connector body has a first body end and a second body end with a tube lumen formed therethrough, the first body end receiving an inner J-tube therethrough and an outer J-tube. It has a connector tip sized to mate with a G-tube, and the connector body has an engaging portion that engages an engaged portion of the shell. A plug is coupled to the connector body and has a first plug end and a second plug end having a fluid lumen formed therethrough, the first plug end having a plug tip extending therefrom. However, the tip is sized to mate with the inner J-tube.

The accompanying drawings, in which like reference characters denote the same or functionally similar elements through separate views, further illustrate various embodiments, all of which serve to explain various principles and advantages in accordance with the disclosed subject matter. For purposes of description and illustration, but not limitation, an exemplary embodiment of a piping assembly and associated components in accordance with the disclosed subject matter are shown in FIGS. 1-21. Although the subject matter of the present disclosure has been described in terms of using a tubing system having a delivery device for administering dosages of therapeutic agents, those skilled in the art will appreciate that the subject matter of the disclosure is not limited to the illustrated embodiments, It will be appreciated that the connector assembly may be a component of any suitable plumbing system for conveying any suitable substance therethrough. Additionally, the components and methods of using the connector assembly are not limited to the exemplary embodiments described or shown herein. For example, the bumpers embodied herein can be used with other piping assemblies to similar benefits and advantages. Similarly, the connector assembly can be configured for use with other device connectors, including conventional adapters, and is not limited to use with the device connectors herein.

Referring to the exemplary embodiment of FIG. 1, tubing system 100 includes a percutaneous tubing 110 having an outer G-tube 112 and an inner J-tube 114 extending therethrough, as shown for example in FIG. . Referring to FIG. 1, the end of the percutaneous tubing 110 external to the patient can have a connector assembly 200 coupled thereto, which connector assembly 200 can be, for example, as embodied herein. , can be configured as a male connector assembly. As further described below, the tubing system 100 embodied herein includes a bumper 300 positioned around the percutaneous tubing 110 spaced a distance from the connector assembly 200 . As further described below, connector assembly 200 is configured to mate with device connector 400 . This device connector 400 may be configured as a female connector, eg, as implemented herein. Device connector 400 is coupled to a delivery device or fluid source, thus coupling percutaneous tubing 110 to such delivery device or fluid source. For example, as shown in FIG. 1, fluid source connector 420 may be coupled with device connector 400 via tubing 410 . Fluid source connector 420 may be configured as, for example, without limitation, an oral/enteral connector, luer connector, or any other fluid tight connector, for example, without limitation, for dispensing fluid through percutaneous tubing 110. can be used to couple to a fluid source, such as the injector 430 of the Additionally or alternatively, as shown in FIG. 1, a pump device 450 may be coupled with device connector 400 via tubing 410, pump device 450 pumping fluid through percutaneous tubing 110, for example, without limitation. Can be used for pumping.

Referring to FIG. 2, percutaneous tubing 110 is shown with connector assembly 200 coupled thereto. Connector assembly 200 is mated in-line with device connector 400 that can be mated to any device or fluid source as described herein. Bumper 300 is placed on or near the patient's skin, proximal to the stoma, and percutaneous tubing 110 extends through bumper 300 and the stoma into the stomach, as described further below. .

3A-4C, an exemplary connector assembly 200 is shown. Connector assembly 200 generally includes shell 210, connector body 230, plug 250, and clip 270, for example, as shown in FIGS. 4A-4C. The shell has sidewalls 212 that form the interior. As embodied herein, the shell has a first shell end 214 with a first opening formed therein and a second shell end 216 with a second opening formed therein. have. An opening in first shell end 214 and an opening in second shell end 216 communicate with the interior for receiving percutaneous tubing 110 therethrough.

4A-4C, the shell further has an engaged portion 218. As shown in FIG. As implemented herein, the engaged portion 218 may be configured for threaded engagement. However, any suitable engagement configuration may be used, such as, but not limited to, snap-fit engagements, latching engagements, or any other suitable engagement. Further, as implemented herein, the engaged portion 218 may be positioned inside the shell 210 .

Additionally, as embodied herein, sidewall 212 of shell 210 may have aperture 220 formed therein. Apertures 220 may allow access to the interior of shell 210 through sidewalls 212 . For example, as embodied herein, aperture 220 is configured to allow fluid to selectively access the interior of shell 210 through aperture 220, as further described herein. Additionally, it may be sized to receive valve 280, or other suitable fluid regulating component.

Referring to FIGS. 4A-4C, connector assembly 200 includes connector body 230 . As embodied herein, the connector body 230 has a sidewall 232 forming a first body end 234 and a second body end 236 with a tube lumen formed therethrough. First body end 234 has a connector tip 237 . As embodied herein, connector tip 237 has an inner diameter sized to receive inner J-tube 114 therethrough. Further, as embodied herein, connector tip 237 has an outer diameter sized to mate with outer G-tube 112 . Additionally, in some embodiments, the connector tip 237 can be tapered. Alternatively, connector tip 237 may have uniform cross-sectional dimensions. Additionally, connector body 230 may include a recessed portion 231 formed in sidewall 232 thereof. Recessed portion 231 provides a more formable structure, for example, by reducing the amount of surface area susceptible to surface depression.

As embodied herein, connector assembly 200 may also include ferrule 235 sized to receive G-tube 112 therethrough. Additionally, as embodied herein, connector body 230 may include rim 239 that surrounds connector tip 237 . G-tube 112 can thus extend through connector body 230 between connector tip 237 and rim 239 . Accordingly, ferrule 235 may be sized to engage connector body 230 and be positioned over connector tip 237 to cover G-tube 112 entering connector body 230 . In this manner, ferrule 235 can radially compress G-tube 112 into engagement with connector tip 237 . When connector body 230 is inserted into shell 210, first shell end 214 further compresses ferrule 235 to further engage G-tube 112 with connector tip 237, as described herein. can do.

For example, as embodied herein, connector body 230 has an engaging portion 238 that engages engaged portion 218 of shell 210 . As implemented herein, the engagement portion 238 may be configured for threaded engagement. However, any suitable engagement configuration, such as, but not limited to, snap fit engagement, latch engagement, or any other suitable engagement, allows engagement portion 238 to engage shell 210. It can be used to complement portion 218 . Further, as practiced herein, engagement portion 238 may be spaced inwardly along connector body 230 from connector tip 237 .

Additionally, as embodied herein, sidewall 232 of connector body 230 may have aperture 240 formed therein. Apertures 240 may allow access to the interior of connector body 230 through side walls 232 . For example, as embodied herein, aperture 240 allows fluid to selectively access the interior of connector body 230 through aperture 240, as further described herein. As such, it can be sized to receive a valve 280, or other suitable fluid regulating component. Additionally, connector body 230 may have an engaged portion 242 proximal to aperture 240 for engaging valve 280 with connector body 230, for example. For example, as implemented herein, the engaged portion 242 may be threadedly engaged. However, any suitable engagement can be used, such as, but not limited to, a snap fit engagement, latch engagement, or any other suitable engagement.

Additionally, as implemented herein, second body end 236 may include flange 244 . This flange 244 surrounds the aperture in the second body end 236 and forms a groove 245 between the flange 244 and the side wall 232 . Flange 244 and groove 245 may form part of a fastener for connector body 230, as further described herein. Further, as embodied herein, flange 244 may include projections 246 projecting therefrom that extend connector body 230 into the second position, as further described herein. Corresponding receptacles can be mated to lock in proper rotational alignment to the mounted component at the body end 236 of the.

With continued reference to FIGS. 4A-4C, as embodied herein, connector assembly 200 includes plug 250 . Plug 250 has a plug body 252 forming a first plug end 254 and a second plug end 256 with a fluid lumen formed therethrough. First plug end 254 has a plug tip 257 extending therefrom. As embodied herein, plug tip 257 is sized to mate with inner J-tube 114 . For example, the plug tip 257 forms a lumen whose outer diameter is sized to fit within the J-tube 114, and is made of stainless steel, as embodied herein. It can be formed as a tube or a molded plastic tube. First plug end 254 may have a rim 259 sized to receive plug tip 257 therein. As embodied herein, the connector assembly 200 is sized to receive the plug tip 257 received within the second body end 236 of the connector body 230 and the second body end 236 of the connector body 230 . A ferrule 255 that engages end 236 may also be included. Accordingly, ferrule 255 may be sized to engage connector body 230 and be positioned over plug tip 257 to cover J-tube 114 entering connector body 230 . In this manner, ferrule 255 can radially compress J-tube 114 into engagement with plug tip 257 .

Additionally, second plug end 256 may include flange 264 as implemented herein. This flange 264 surrounds the aperture of the second plug end 256 and forms a groove 265 between the flange 264 and the side wall 252 . Flange 264 and groove 265 may form part of a fastener for fastening plug 250 to connector body 230 . For example, as implemented herein, flange 264 can be sized similarly to flange 244 . Further, as embodied herein, flange 264 forms a recess 266 to receive protrusion 246 of connector body 230 to engage plug 250 with connector body 230 in proper rotational alignment. be able to.

As noted above, fasteners may be provided to couple connector body 230 to plug 250 . Fasteners may be integrally formed with connector body 230 and/or plug 250 . For example, the fastener can be a threaded arrangement, snap fit, or the like. 4A-4C, a fastener may include a clip 270 as embodied herein. For example, clip 270 is positioned within groove 265 of plug 250 and notch 275 a configured to be positioned within groove 245 of connector body 230 to secure plug 250 to connector body 230 . It may have a notch 275b configured to. As embodied herein, clip 270 may be configured as two semi-circular clip portions 272,274. Two semi-circular clip portions 272 , 274 are each configured to be positioned in groove 245 and groove 265 to form clip 270 . In some embodiments, the two clip portions 272,274 may be hinged together at the ends of each clip portion 272,274. Alternatively, clip 270 can be constructed as a single piece component.

Further, second plug end 256 can form a connector to mate with device connector 400, as embodied herein. Second plug end 256 may include a ring portion 267 and a frustoconical portion 269 forming a groove 268 therebetween. Accordingly, groove 268 may facilitate engagement between device connector 400 and connector assembly 200, as further described herein. Additionally, an open plug nub 263 can extend from the frusto-conical portion 269 to form a second groove 261 therebetween. Second groove 261 may be sized to receive gasket 273 to seal between plug 250 and device connector 400 .

With continued reference to FIGS. 4A-4C , as embodied herein, connector assembly 200 is sized to be positioned within apertures 220 and 240 and has valve 280 in communication with connector body 230 . can include For example, as embodied herein, valve 280 may have an engaging portion 285 that engages engaged portion 242 of connector body 230 . As implemented herein, the engagement portion 285 may be configured for threaded engagement. However, any suitable engagement configuration, such as, but not limited to, snap-fit engagement, latch engagement, or any other suitable engagement, complements engaged portion 242 of connector body 230. can be used to Valve 280 may have, for example, a hexagonal head or any other suitable fastening to allow valve 280 to be gripped against connector body 230 or to engage or disengage connector body 230, for example. It may include a grip portion 284 that may be configured as a tool or driver head. Referring to FIG. 4B, valve 280 may include slot 286 for receiving fitting 287 . A slot 286 may extend from valve 280 and be positioned within connector body 230 to secure valve 280 within connector body 230 . An O-ring 288 may be positioned around valve 280 proximal engagement portion 285 to provide a fluid-tight seal between valve 280 and connector body 230 . Additional or alternative sealing techniques may be employed.

Additionally, as embodied herein, valve 280 may include port 282 for receiving a fluid injection device, such as, but not limited to, injector 430 . For example, without limitation, as embodied herein, port 282 may be an oral/enteral connector, luer connector, or any other suitable fluid tight connector for receiving a corresponding syringe. can be configured. In this manner, fluid can be introduced into the connector body through G-tube 112 while bypassing J-tube 114 . This configuration can be utilized, for example, to flush the G-tube 112 with liquid or to administer liquids through the G-tube 112 directly into the stomach.

16A-17C, an alternate embodiment of an exemplary connector assembly 600 is shown. Connector assembly 600 generally includes shell 610 , connector body 630 , and plug 650 , for example as shown in FIGS. 17A-17C. The shell has sidewalls 612 that form the interior. As embodied herein, the shell has a first shell end 614 with a first opening formed therein and a second shell end 616 with a second opening formed therein. have. An opening in first shell end 614 and an opening in second shell end 616 communicate with the interior for receiving percutaneous tubing 110 therethrough.

17A-17C, the shell further has an engaged portion 618. As shown in FIG. As implemented herein, the engaged portion 618 may be configured to engage with a right angle hang lock. However, any suitable arrangement of engagements may be used, such as, but not limited to, snap-fit engagements, threaded engagements, latching engagements, or any other suitable engagements. Further, as implemented herein, the engaged portion 618 may be located inside the shell 610 .

Additionally, as embodied herein, sidewall 612 of shell 610 may have aperture 620 formed therein. Apertures 620 may allow access to the interior of shell 610 through sidewalls 612 . For example, as embodied herein, aperture 620 is configured to allow fluid to selectively access the interior of shell 610 through aperture 620, as further described herein. Additionally, it may be sized to receive valve 680, or other suitable fluid regulation component.

17A-17C, connector assembly 600 includes connector body 630 . As embodied herein, connector body 630 has a sidewall 632 forming a first body end 634 and a second body end 636 with a tube lumen formed therethrough. First body end 634 has a connector tip 637 . As embodied herein, connector tip 637 has an inner diameter sized to receive inner J-tube 114 therethrough. Further, as embodied herein, connector tip 637 has an outer diameter sized to mate with outer G-tube 112 . Additionally, in some embodiments, the connector tip 637 can be tapered. Alternatively, connector tip 637 may have uniform cross-sectional dimensions.

As embodied herein, connector assembly 600 may also include ferrule 635 sized to receive G-tube 112 therethrough. Additionally, as embodied herein, connector body 630 may include rim 639 surrounding connector tip 637 . G-tube 112 can thus extend through connector body 630 between connector tip 637 and rim 639 . Accordingly, ferrule 635 may be sized to engage connector body 630 and be positioned over connector tip 637 to cover G-tube 112 entering connector body 630 . In this manner, ferrule 635 can radially compress G-tube 112 into engagement with connector tip 637 . Once the connector body 630 is inserted into the shell 610, the first shell end 614 causes the ferrule to compress the G-tube 112 further into engagement with the connector tip 637 as described herein. 635 can be further radially compressed.

For example, as embodied herein, connector body 630 has an engaging portion 638 that engages engaged portion 618 of shell 610 . As implemented herein, the engagement portion 638 may be configured for threaded engagement. However, any suitable engagement configuration, such as, but not limited to, snap fit engagement, latch engagement, or any other suitable engagement, allows engagement portion 638 to engage shell 610. It can be used to complement portion 618 . Further, as implemented herein, engagement portion 638 may be spaced inwardly along connector body 630 from connector tip 637 .

Additionally, as embodied herein, sidewall 632 of connector body 630 may have aperture 640 formed therein. Aperture 640 may allow access to the interior of connector body 630 through sidewall 632 . For example, as embodied herein, aperture 640 allows fluid to selectively access the interior of connector body 630 through aperture 640, as further described herein. As such, it can be sized to receive valve 680, or other suitable fluid regulation component. Further, when connector body 630 is engaged with shell 610, apertures 620 and 640 may be aligned. Additionally, shell 610 may have an engaged portion 617 proximal to aperture 620 for, for example, placing valve 680 in fluid communication with connector body 630 to engage shell 610 . For example, as embodied herein, the engaged portion 617 can be a key-like molded component to the valve body 685 and locking finger 687 to provide right-angle locking engagement. . However, any suitable engagement may be used, such as, but not limited to, threaded engagement, snap-fit engagement, latching engagement, or any other suitable engagement.

As implemented herein, connector body 630 may include one or more flange portions 646 proximal to second body end 636 . Flange portion 646 may be sized to engage a corresponding portion of plug body 652 to couple connector body 630 to plug 650 . Additionally or alternatively, as implemented herein, connector body 630 engages one or more locking projections 672 of plug 650, as further described herein. It may include one or more fixation surfaces 674, which may be sized as such.

With continued reference to FIGS. 17A-17C, connector assembly 600 includes plug 650 as embodied herein. Plug 650 has a plug body 652 forming a first plug end 654 and a second plug end 656 with a fluid lumen formed therethrough. First plug end 654 has a plug tip 657 extending therefrom. As embodied herein, plug tip 657 is sized to mate with inner J-tube 114 . For example, the plug tip 657 forms a lumen whose outer diameter is sized to fit within the J-tube 114, and is made of stainless steel, as embodied herein. It can be formed as a tube or a molded plastic tube. First plug end 654 may have a rim 659 sized to receive plug tip 657 therein. As embodied herein, connector assembly 600 receives plug tip 657 and is received within and engages second body end 636 of connector body 630 . It may also include a ferrule 655 that is sized as such. Accordingly, ferrule 655 may be sized to engage connector body 630 and be positioned over plug tip 657 to cover J-tube 114 entering connector body 630 . In this manner, ferrule 655 can radially compress J-tube 114 into engagement with plug tip 657 .

Additionally, second plug end 656 may include flange 664 as implemented herein. The flange 664 surrounds the aperture of the second plug end 656 and has one or more locking projections 672 extending therefrom. The locking projection 672 can have one or more locking ribs 675 formed therein and can form part of a fastener for fastening the plug 650 to the connector body 630 . For example, as implemented herein, locking protrusions 672 and locking ribs 675 may be sized to be received within and engage locking surface 674 . Further, as embodied herein, flange 664 forms a recess 666 to receive protrusion 646 of connector body 630 to engage plug 650 with connector body 630 in proper rotational alignment. be able to. In this manner, fasteners may be provided to couple connector body 630 to plug 650 , which may be integrally formed with connector body 630 and/or plug 650 .

Additionally, second plug end 656 can form a connector to mate with device connector 400 as embodied herein. Second plug end 656 may include a ring portion 667 and a frustoconical portion 669 forming a groove 668 therebetween. Accordingly, groove 668 may facilitate engagement between device connector 400 and connector assembly 200, as further described herein. Additionally, an open plug nub 663 can extend from the frusto-conical portion 669 to form a second groove 661 therebetween. Second groove 661 may be sized to receive gasket 673 to seal between plug 650 and device connector 400 .

With continued reference to FIGS. 17A-17C, as embodied herein, connector assembly 600 is sized to be positioned within apertures 620 and 640 and includes valve 680 in communication with connector body 630. can include For example, as embodied herein, valve 680 may include valve body 685 having locking fingers 687 for press-fit engagement with engaged portion 617 of shell 610 . However, any suitable engagement configuration, such as, but not limited to, snap-fit engagement, latch engagement, or any other suitable engagement, complements engaged portion 617 of shell 610. can be used for Additionally or alternatively, as embodied herein, valve 680 engages connector body 630 with a press fit engagement, snap fit engagement, latch engagement, or any other suitable engagement. can do. Referring to FIG. 17A, valve body 685 may include slot 686 for receiving O-ring 688 that may provide a fluid tight seal between valve 680 and shell 610 . Additional or alternative sealing techniques may be employed. Further, as embodied herein, the engagement of valve 680 with shell 610 and connector body 630 causes shell 610 to retain connector body 630 and plug 650 at least partially within shell 610 . It can be fixed to the connector body 630 .

Additionally, as embodied herein, valve 680 may include port 682 for receiving a fluid injection device such as, but not limited to, injector 430 . For example, without limitation, port 682 may be configured as an oral/enteral connector, luer connector, or any other suitable liquid tight connector for receiving a corresponding syringe. In this manner, fluid may be introduced through port 682 and out port 689 into shell 610 and connector body 630 through G-tube 112 while bypassing J-tube 114 . This configuration can be utilized, for example, to flush the G-tube 112 with liquid or to administer liquids through the G-tube 112 directly into the stomach.

17A-17C, a fixation tool 690 can be used to fix the valve 680 to the shell 610 as embodied herein. The fixation tool 690 can have a perimeter 693 and a hollow projection 696 forming a notch 691 . Each of perimeter 693 and notch 691 may correspond to one or more slots 684 formed in the top of valve 680 . As such, the protrusion 696 of the fixation tool 690 may be inserted into the slot 684 to engage the fixation tool 690 with the valve 680 , whereby turning the fixation tool 690 causes the valve 680 to move. is adapted to rotate into engagement with shell 610 . The fixation tool may have a gripping portion 699 at its top, which may be wider than the protrusions 696 and substantially flat, as practiced herein. As embodied herein, fixation tool 690 may be removed after value 680 is fixed to shell 610 . Alternatively, fixation tool 690 may be retained such that when positioned within slot 684, it covers port 682 and is utilized to protect port 682 from debris, for example.

According to another aspect, the disclosed subject matter includes a method of assembling a connector assembly for percutaneous tubing. Percutaneous tubing includes an outer tube, such as a G tube, and an inner tube, such as a J tube. The method provides a shell having a sidewall forming an interior, a first shell end having a first opening formed therein, and a second shell end having a second opening formed therein. inserting percutaneous tubing through the first and second openings in the shell; having first and second body ends with tubing lumens formed therethrough; providing a connector body, the first body end having a connector tip; inserting an inner J-tube into the connector tip and through the connector body; and an outer G-tube to the connector tip. and providing a plug having a first plug end and a second plug end with a fluid lumen formed therethrough, the first plug end extending therefrom. coupling the inner J-tube with the plug tip; coupling the connector body with the plug; coupling the connector body with the shell.

Any suitable fabrication technique may be used to form any of the piping assemblies and associated components, including but not limited to injection molding, milling, and the like. The tubing assembly and associated components may be formed of any suitable material including, but not limited to, thermoplastics, thermosets, elastomers, and elastic polymers such as synthetic fibers. For example, without limitation, as practiced herein, connectors and components may include injection molded resins (eg, methyl methacrylate, acrylonitrile butadiene/styrene (MABS)). Elastomeric seals or ferrules may include, for example, without limitation, silicon. O-rings may include, for example, without limitation, ethylene propylene diene monomer (EPDM), polyurethane, polytetrafluoroethylene, silicone, or any other suitable material, and may include a parylene coating. Plug tips and/or valves may include, for example, without limitation, stainless steel.

An exemplary technique for assembling connector assembly 200 is shown in FIGS. 5-8. Referring to FIG. 5, a percutaneous tubing 110 having an outer G-tube 112 and an inner J-tube 114 is provided. Percutaneous tubing 110 has a free end 116 that extends from a target location, eg, a stoma as embodied herein. For example, as shown in FIG. 5, the free end 116 of the percutaneous tubing 110 extends through the opening of the first shell end 214 and the second shell to extend the percutaneous tubing 110 through the inside of the shell 210. It can be inserted through an opening in end 216 .

6 and referring now to the exploded views of FIGS. 4A-4C, inner J-tube 114 is inserted through connector body 230 into connector tip 237 proximal first body end 234 . , exiting the second body end 236 . Outer G-tube 112 is coupled with connector tip 237 by, for example, inserting connector tip 237 into G-tube 112 as implemented herein.

Referring to FIG. 7 and continuing to refer to the exploded views of FIGS. 4A-4C, plug tip 257 is inserted into J-tube 114 . Plug 250 may be biased toward connector body 230 such that connector body flange 244 and plug flange 264 align with protrusion 246 received within recess 266 . Notches 275 a , 275 b of clip 270 can be inserted into groove 245 of connector body 230 and into groove 265 of plug 250 to couple plug 250 to connector body 230 . For example, notches 275a, 275b of first clip portion 272 meet groove 245 to form ring-shaped clip 270 around flange 244 of connector body 230 and flange 264 of plug 250, as embodied herein. , 265, and the notches 275a, 275b of the second flip portion 274 can be inserted into the grooves 245, 265, respectively.

Alternatively, referring to the exploded view of the embodiment of FIGS. 17A-17C, the locking projections 672 with locking ribs 675 of the plug 650 hold the plug 650 and the connector body flanges 646 hold the plug 650 recesses 666. It may be adapted to engage a locking surface 674 for locking to the connector body 630 while positioned therein.

8 and referring now to the exploded view of the embodiment of FIGS. 4A-4C, the connector body 230 with the plug 250 inserted therein is such that the second plug end 256 is located at the second shell end. Extending from portion 216 , it may be biased inwardly of shell 210 . For example, as practiced herein, rotate shell 210 relative to connector body 230 such that engaged portion 218 of shell 210 engages engagement portion 238 of connector body 230 . By doing so, connector body 230 , plug 250 and J-tube 114 can be held in place and shell 210 can be coupled to connector body 230 . Shell 210 can be rotated with respect to connector body 230 so that aperture 220 is aligned with aperture 240 . Valve 280 may be inserted through aperture 220 and into aperture 240, and engagement feature 282 may engage connector body 230 by rotating valve 280 into engagement with connector body 230, for example as practiced herein. It may engage engagement features 242 of body 230 .

Alternatively, referring to the embodiment of FIGS. 17A-17C, valve 680 may be inserted through aperture 620 and into aperture 640, and locking finger 687 may be inserted, for example, as described herein, with reference to the embodiment of FIGS. Rotating the valve 680 into engagement with the shell 610 may engage the engagement feature 617 of the shell 610 as embodied therein.

In the configuration of FIG. 8, second end 256 of plug 250 is in fluid communication with J-tube 114, and may be connected to injector 430 or pump 450, or other fluid source, or the like, as further described herein. device connector 400 for fluid communication with the device. Further, as embodied herein, the valve 280 is in fluid communication with the G-tube and the injector 430 or pump 450 via port 285 for fluid communication with the injector 430 or pump 450 . can be combined with

Referring to FIG. 1, as embodied herein, a removable cap 290 can be provided and sized to cover the second plug end 256 of the connector assembly 200, and can The open plug nub 263 fluid lumen opening proximal to the two plug ends 256 may be closed. Cap 290 may be a free cap, ie, separate from connector assembly 200 . Alternatively, cap 290 may be coupled to connector assembly 200, eg, shell 210 or plug 250, in some embodiments.

Further in accordance with the disclosed subject matter, a device connector is provided for mating with the connector assembly disclosed herein. A device connector may couple with a delivery device or a fluid source. For purposes of illustration and not limitation, any number of suitable device connector configurations may connect percutaneous tubing 110 to any suitable fluid delivery device, such as, but not limited to, an infusion device as shown in FIG. It may be used to couple to vessel 430 and/or pump 450 . 13A-14 show an exemplary device connector 400. FIG. As embodied herein, device connector 400 may generally include sidewall 412 having first end 414 and second end 416 , lever 470 and plug 490 .

Device connector 400 has a sidewall 412 forming its interior and an aperture sized to receive the end of tubing 410 extending from and in fluid communication with a delivery device (eg, as shown in FIG. 1). It may include a first end 414 having an interior. Tubing 410 is similarly placed in fluid communication with the interior of device connector 400 . Device connector 400 is sized and configured to sealingly engage and receive second plug end 256 of connector assembly 200 or second plug end 656 of connector assembly 600 . can have a second end 416 having an aperture therein configured to . Additionally, as implemented herein, sidewall 412 may include a plurality of ridges 466 that form a plurality of slots 468 in sidewall 412 . The ridges 466 and slots 468 may provide a more formable structure and may provide the device connector 400 with a textured surface for improved grip. Device connector 400 and/or connector assembly 200 or 600 may be provided with removable connection features for coupling device connector 400 to connector assembly 200 . Various quick connectors, such as lever 470, may be used as embodied herein. Lever 470 may be hinged to side wall 412 by lever projection 472 received in aperture 474 of side wall 412 . Lever 470 may also include a locking extension 476 that engages a mating portion of connector assembly 200 or 600, such as second plug end 256 or 656, respectively, as described herein. Lever 470 may thus provide releasable engagement of device connector 400 to connector assembly 200 or 600 .

For example, as shown in FIG. 14, the device connector 400 may further include a bias plate 488 positioned along the inner angled surface 469 of the device connector 400. As shown in FIG. A bias plate 488 may be positioned within slot 478 of lever 470 to bias locking extension 476 to the locked position. Bias plate 488 may include one or more notches 489 in one or more ends thereof. The notch 489 is sized and configured to receive a corresponding protrusion on the lever 470 , for example to align the bias plate 488 with the locking extension 476 and/or the free end 473 . can do. For example, as embodied herein, in the locking position, locking extension 476 is biased into alignment with an aperture in second end 416 of device connector 400, as shown in FIG. 13E. obtain. In this configuration, when the second plug end 256 of the connector assembly 200 is inserted into the aperture of the second end 416 of the device connector 400, the locking extension of the lever is pulled out, for example as shown in FIG. 476 may come along the frusto-conical portion 269 of the second plug end 256 and be inserted into the groove 268 of the second plug end. In this manner, as embodied herein, the fixation extension 476 axially connects the device connector 400 with the percutaneous tubing 110 for fluid communication with the interior of the device connector 400 and tubing 410. may be combined with assembly 200; Further, as embodied herein, locking extension 476 is freely slidable along the perimeter of groove 268 such that device connector 400 maintains axial engagement while It can rotate with respect to connector assembly 200 .

As such, as embodied herein, connector assembly 200 may provide a tight, sealed connection between percutaneous tubing 110 and device connector 400 to prevent accidental percutaneous tubing 110 from prevent or prevent disconnection and displacement of Moreover, this connection does not require a twist connection. Rather, a linear push fit can be utilized, for example as practiced herein. Once connected, the delivery device is coupled to connector assembly 200 and thus to percutaneous tubing 110 for delivery of therapeutic agents to the patient.

Referring to FIG. 14, lever 470 may have a free end 473 opposite locking extension 476 . To disconnect the device connector 400 from the connector assembly 200, the biasing force of the bias plate 488 is overcome to move the locking extension 476 out of alignment with the aperture of the second end 416 of the device connector 400 and thus the second end 416 of the device connector 400. Pressure can be applied to urge the free end 473 at least partially into the side wall 412 to move it away from the groove 268 of the plug end 256 of the plug. In this configuration, connector assembly 200 can be freely disconnected from device connector 400 .

Further, referring to FIG. 14, cover 490 of device connector 400 can be used to cover the aperture of second end 416 when connector assembly 200 is not connected. Cover 490 may include a grip portion 492 to facilitate gripping cover 490 . Cover 490 may include a cover end 494 that may be configured substantially similar to second plug end 256 of connector assembly 200, as described herein.

According to another aspect, the disclosed subject matter includes a bumper for a tubing assembly including percutaneous tubing. The bumper is configured to prevent or impede axial movement of the percutaneous tubing. The bumper has a base having an aperture formed therethrough sized to receive the percutaneous tubing, a first bumper base portion and a second bumper base portion, wherein the first bumper base portion and the second bumper base portion. connecting together a first bumper base portion and a second bumper base portion, each of the two bumper base portions having a notch forming a portion of the aperture; and a connector for A bumper may include any or all of the features described herein.

An exemplary bumper 300 for the piping system 100 is shown in FIGS. 9A-10. As further described herein, bumper 300 may be configured to be placed about percutaneous tubing 110 to impede or prevent axial movement of percutaneous tubing 110 . 9A-9C, bumper 300 may include a base 302 having an aperture 312 formed therethrough. A plurality of ridges 304 can be formed on the bottom surface of the base 302 . Base 302 may be generally flat and may include an arcuate perimeter 306, or other suitable shape.

In certain embodiments, the base 302 can be a single piece member such that the percutaneous tubing 110 is threaded through the aperture. Alternatively, a multi-piece construction can be provided. For example, referring to FIG. 10, as embodied herein, bumper 300 may include first bumper base portion 310 and second bumper base portion 320 . As shown in FIG. 10, first bumper base portion 310 may generally mirror second bumper base portion 320 . Each of the first bumper base portion and the second bumper base portion may have a notch 311 forming a portion of the aperture. First bumper base portion 310 and second bumper base portion 320 are configured such that bumper base portions 310 and 320 are joined by a protrusion 324 extending from one of bumper base portions 310 and 320, for example as implemented herein. can be connected together while being inserted into a receptacle 314 formed in the other of the two. Additionally or alternatively, first bumper base portion 310 may include projections 316 that are inserted into receptacles formed within second bumper base portion 320 .

Further, as embodied herein, first bumper base portion 310 and second bumper base portion 320 each refer to a portion of first bumper base portion 310 and second bumper base portion 320, respectively. Support walls 318 , 328 located proximal to notch 311 may be included. Referring to FIG. 10, the hood 340 includes ring projections 313a, 323a extending from each of the support walls 318, 328 and corresponding ring projections 313b, 323b extending from the hood 340, eg, as implemented herein. A pin 342 inserted therethrough may be hinged to the support walls 318 , 328 of each of the first bumper base portion 310 and the second bumper base portion 320 .

9A-10, each of the support walls 318, 328 form a portion of a U-shaped channel 315 extending from the aperture 312 and extend from the first bumper base portion 310, as embodied herein. It may have curved walls 319, 329 sized to receive the percutaneous tubing 110 when connected together with the second bumper base portion 320 . Channels 315 may be aligned in a generally perpendicular orientation to the proximal flat surface of aperture 312 and then curved to align at an angle to the generally perpendicular orientation. For example, channel 315 may extend along each of support walls 318 , 328 such that it is aligned generally parallel to planar surface 302 at a distance from aperture 312 . In this manner, channel 315 may maintain percutaneous tubing 110 therein from an orientation substantially perpendicular to the stoma, thereby reducing contact with the skin surrounding the stoma and facilitating treatment of the stoma, and then , the percutaneous tubing 110 can be guided at an irregular angle at a distance from the aperture 312, such as for a lower profile. Further, as practiced herein, the patient can change the radial orientation of the percutaneous tubing 110 with respect to the aperture 312 without changing the orientation of the percutaneous tubing 110 with respect to the stoma. In this manner, as implemented herein, bumper 300 allows the patient to direct percutaneous tubing 110 in any radial orientation from aperture 312, such as in the horizontal plane of the patient's abdominal cavity. Become. Accordingly, as embodied herein, the bumper 300 can maintain a substantially flat profile for the portion of the percutaneous tubing 110 exiting the bumper 300, which is less noticeable and more comfortable for the patient. can be The bumper 300 disclosed herein allows the percutaneous tubing 110 to be oriented in any radial orientation, for example, to make room for clothing or accessories worn or used by the patient.

Additionally, as embodied herein, hood 340 may have a U-shaped surface 344 sized to receive a portion of percutaneous tubing 110 . 11-12, with the percutaneous tubing extending along the channel 315, as embodied herein, the hood 340 has a bumper against the percutaneous tubing, as shown in FIG. 12, and a closed position in which the bumper 300 is fixed relative to the percutaneous tubing 110, as shown in FIG. In this closed position, U-shaped surface 344 of hood 340 may overlap at least a portion of support walls 318, 328, thereby allowing hood 340 to enclose a portion of percutaneous tubing 110 within channel 315, thus: The percutaneous tubing 110 extending from the aperture 312 is guided to a desired angle, eg, a position proximal to and substantially parallel to the planar surface of the base 302 .

Any suitable fabrication technique may be used to form any of the piping assemblies and associated components, including but not limited to injection molding, milling, and the like. The tubing assembly and associated components may be formed of any suitable material including, but not limited to, thermoplastics, thermosets, elastomers, and elastic polymers such as synthetic fibers. The bumper may include, for example, without limitation, an injection molded resin (eg, MABS) and may include a thermoplastic elastomer (TPE) overmold.

Further, as embodied herein, the bumper 300 is positioned inside the patient's body along the percutaneous tubing 110, thus providing a cushion 330 positioned opposite the stoma from the bumper 300. can contain. As such, cushion 330 can provide a flexible anchor for holding a portion of percutaneous tubing 110 within the body. The cushion 330 can be made of a material that is softer and more flexible than the bumper 300, such as a polymeric material, and can have a silicone overmold.

18A-19B, an alternate embodiment of exemplary bumper 700 is shown. As described herein, bumper 700 may be configured to be placed about percutaneous tubing 110 to impede or prevent axial movement of percutaneous tubing 110 . 18A-18C, a bumper 700 can include a base 702 having an aperture 712 formed therethrough. A plurality of ridges 704 can be formed on the bottom surface of the base 702 . Base 702 may be generally flat and may include an arcuate perimeter 706, or other suitable shape. The ridges 704 can provide a gap between the base 702 and the stoma, which can improve airflow to the stoma, thereby improving treatment and/or closing the stoma. Reduce or prevent infection of the surrounding skin. As embodied herein, the ridges 704 may have rounded or arcuate shaped outer surfaces to improve comfort as the bumper 700 engages the peristomal skin. can be made Additionally, the ridges 704 provide traction to prevent or impede unwanted movement of the bumper 700 relative to the stoma, for example when the hood 740 is opened or closed, as described herein. An increased surface can be provided.

In certain embodiments, the base can be a single piece member such that the percutaneous tubing 110 is threaded through the aperture. Alternatively, a multi-piece construction can be provided. 19A and 19B, as embodied herein, base 702 can include base portion 710 and substrate portion 750 for housing base portion 710 . For example, as shown in FIGS. 19A and 19B, substrate portion 750 may have a recess 754 formed therein and sized to receive base portion 710 . Substrate portion 750 may have apertures 752 and channels 755 arranged to match apertures 712 and channels 715 , respectively, of base portion 710 received within substrate portion 750 . Further, as embodied herein, the substrate portion 750 is sized to be received within corresponding slots 722 of the base portion 710 to secure the base portion 710 within the substrate portion 750. A keyed protrusion 758 may be included.

Additionally, as implemented herein, base portion 710 may include support wall 718 located proximal to aperture 712 . 19A and 19B, hood 740 may be slidably coupled to base 702 within tracks 720 that may be formed by support walls 718. Referring to FIGS. For example, rails 764 on either side of hood 740 can be inserted into and slide in tracks 720 that can be formed on either side of support wall 718, as implemented herein. The support walls 718 can engage one or more engaged portions 743 of the hood 740 to limit lateral movement of the hood 740 to the closed position, as described herein. , may include one or more lateral protrusions 724 . Further, as embodied herein, track ridges 729 disposed along each of tracks 720 proximal to lateral ridges 724 are used to secure hood 740 in the closed position. It may be sized to be received within rail recesses 762 formed between protrusions 760 and 763 along each of rails 764 . By biasing the hood 740 away from the lateral projections 724, for example, to bias the track projections 729 out of engagement with the recesses 762 of the rails 764, the hood 740 It can be moved towards the open position. The protrusions 760 abut corresponding track protrusions 728 to limit lateral movement of the hood 740 toward the open position to retain the rails 764 disposed within the tracks 720 . be able to. In this manner, hood 740 may be configured to remain engaged with base member 710 to prevent or impede inadvertent removal of hood 740 from base member 710, for example.

18A-19B, each side of support wall 718 forms a portion of U-shaped channel 715 extending from aperture 712 and is adapted to receive percutaneous tubing 110, as embodied herein. It may have a contoured recess 719 that is sized. Contoured recesses 719 may be aligned in a generally perpendicular orientation with respect to the proximal planar surface of aperture 712 and then curved to align at an angle to the generally perpendicular orientation. For example, contoured recess 719 may extend along support wall 718 such that it is aligned generally parallel to planar surface 702 at a distance from aperture 712 . In this manner, the contoured recess 719 may retain the percutaneous tubing 110 therein from an orientation substantially perpendicular to the stoma, thereby reducing contact with the skin surrounding the stoma and allowing treatment of the stoma. The percutaneous tubing 110 can then be guided at a distance from the aperture 712 towards an irregular angle, such as for a lower profile. Further, as practiced herein, the patient can change the radial orientation of the percutaneous tubing 110 with respect to the aperture 712 without changing the orientation of the percutaneous tubing 110 with respect to the stoma. In this manner, as implemented herein, bumper 700 allows the patient to direct percutaneous tubing 110 in any radial orientation from aperture 712, such as in the horizontal plane of the patient's abdominal cavity. Become. Accordingly, as implemented herein, bumper 300 can maintain a substantially flat profile for the portion of percutaneous tubing 110 exiting bumper 700, which is less noticeable and more comfortable for the patient. can be The bumper 700 disclosed herein allows the percutaneous tubing 110 to be oriented in any radial orientation, for example, to make room for clothing or accessories worn or used by the patient.

Additionally, as embodied herein, hood 740 may have a U-shaped surface 744 sized to receive a portion of percutaneous tubing 110 . 20 and 21, with percutaneous tubing extending along channel 715, as embodied herein, hood 740 has a bumper against the percutaneous tubing, as shown in FIG. 21, and a closed position in which the bumper 700 is fixed relative to the percutaneous tubing 110, as shown in FIG. As such, in the open position, bumper 700 is free to rotate about percutaneous tubing 110 and move along percutaneous tubing 110, thereby moving percutaneous tubing 110 from bumper 700 flat. Orientation in any direction along plane 702 may be possible. In the closed position, U-shaped surface 744 of hood 740 may overlap at least a portion of support wall 718 , thereby allowing hood 740 to enclose a portion of percutaneous tubing 110 within channel 715 , thus allowing percutaneous tubing 110 to pass through aperture 712 . Extending percutaneous tubing 110 is guided to a desired angle, eg, a position proximal to and substantially parallel to the planar surface of base 702 . In this manner, in the closed position, the percutaneous tubing 110 can be placed at an angle of approximately 90° relative to the direction the percutaneous tubing 110 exits the stoma when in the original position.

Any suitable fabrication technique may be used to form any of the piping assemblies and associated components, including but not limited to injection molding, milling, and the like. The tubing assembly and associated components may be formed of any suitable material including, but not limited to, thermoplastics, thermosets, elastomers, and elastic polymers such as synthetic fibers. The bumper may include, for example, without limitation, an injection molded resin (eg, MABS) and may include a TPE overmold.

Further, as embodied herein, the bumper 700 is positioned inside the patient's body along the percutaneous tubing 110, thus providing a cushion 730 positioned opposite the stoma from the bumper 700. can contain. As such, cushion 730 can provide a flexible anchor for holding a portion of percutaneous tubing 110 within the body. The cushion 730 can be formed of a material that is softer and more flexible than the bumper 700, such as a polymeric material, and can have a silicone overmold.

The connector assemblies and tubing systems of the disclosed subject matter may be used for the delivery of any of a variety of suitable liquid substances of corresponding volume or dosage.

Although the disclosed subject matter has been described herein with respect to certain preferred embodiments, it will occur to those skilled in the art that various modifications and improvements may be made to the disclosed subject matter without departing from the scope of the disclosed subject matter. It should be understood that it is possible to Moreover, individual features of one embodiment of the disclosed subject matter may be described herein or shown in the drawings of one embodiment, and may be illustrated in individual features of one embodiment, if not in other embodiments. may be combined with one or more features of another embodiment, or features of multiple embodiments.

In addition to the specific embodiments claimed in the accompanying claims, the disclosed subject matter encompasses the dependent features claimed in the appended claims, and any other possibilities of the dependent features described above. Other embodiments with certain combinations are also covered. As such, the particular features provided in the dependent claims, and the particular features disclosed above, are particularly directed to other embodiments in which the disclosed subject matter may be combined in any other possible combination. can be combined with each other in other ways within the scope of the disclosed subject matter. Accordingly, the foregoing descriptions of specific embodiments of the disclosed subject matter have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the disclosed subject matter to these disclosed embodiments.

It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and systems of the disclosed subject matter without departing from the scope or spirit of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that come within the scope of the appended claims and their equivalents.

Claims (9)

A bumper for a percutaneous tubing, comprising a percutaneous tubing, the bumper configured to prevent or impede axial movement of the percutaneous tubing,
The bumper
A base comprising a bumper base portion, the bumper base portion configured to be received at least partially within the substrate portion, the bumper base portion having an aperture formed therein for percutaneous a base defining an aperture sized to receive the tubing, the size of the aperture being substantially equal to the size of the percutaneous tubing ;
A hood fixed to the base and relative to the aperture between an open position in which the bumper is freely movable relative to the percutaneous tubing and a closed position in which the bumper is fixed relative to the percutaneous tubing. a hood that is movable with the
with
A bumper that allows free rotation around the percutaneous tubing when the hood is in the open position. further comprising a plurality of ridges formed on the bottom surface of the base,
A bumper according to claim 1. the base has an arcuate perimeter,
A bumper according to claim 1. 2. The bumper of claim 1, wherein the base portion includes a protrusion and the base includes a slot formed within the bumper base portion for receiving the protrusion. the bumper base portion includes a support wall;
5. A bumper according to claim 4 , wherein the hood is slidably coupled to the base within a track formed by the support walls . the support wall has a curved wall surface forming a portion of a U-shaped channel extending from the aperture;
the curved wall receiving the percutaneous tubing , the size of the curved wall substantially equal to the size of the percutaneous tubing;
6. Bumper according to claim 5 . 7. The bumper of claim 6, wherein the hood has a U-shaped surface, the U-shaped surface receiving the percutaneous tubing, and wherein the size of the U-shaped surface is substantially equal to the size of the percutaneous tubing . 7. A bumper according to claim 6 , wherein a track is formed on each side of the support wall. 9. A bumper according to claim 8, wherein the hood is slidable along the track between open and closed positions.

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