Stabilization devices for use with low-profile feeding devices and related methods of using the same
11813228 · 2023-11-14
Assignee
Inventors
Cpc classification
A61J15/0057
HUMAN NECESSITIES
A61J15/0053
HUMAN NECESSITIES
International classification
Abstract
A stabilization device for a low-profile feeding device may include a pad and a stabilizer body. The low-profile feeding device may have a tube, an external bolster, and an internal bolster. The pad may include an opening extending from a top surface to a bottom surface thereof and configured for receiving the tube therethrough. The stabilizer body may be fixedly attached to the top surface of the pad and configured for extending over the external bolster. The stabilizer body may include a cavity configured for receiving a base portion of the external bolster therein, an opening extending from the cavity to a top surface of the stabilizer body and configured for allowing access to an access port of the external bolster, and a slit extending from the top surface toward a bottom surface of the stabilizer body and from the opening to a first end of the stabilizer body.
Claims
1. A feeding tube assembly for delivering fluids into a patient, the feeding tube assembly comprising: a pad configured for attaching to the patient, the pad comprising an opening extending from a top surface to a bottom surface of the pad; a low-profile feeding device comprising: a tube extending through the opening of the pad, the tube comprising a primary lumen; an external bolster fixedly attached to a proximal end portion of the tube and disposed adjacent to the top surface of the pad, the external bolster comprising an access port disposed along a top surface of the external bolster and in fluid communication with the primary lumen of the tube; and an internal bolster comprising an inflatable balloon fixedly attached to the tube and spaced apart from the external bolster; and a stabilizer body fixedly attached to the top surface of the pad and extending over the external bolster, the stabilizer body comprising: a cavity receiving a base portion of the external bolster therein; an opening extending from the cavity to a top surface of the stabilizer body and configured for allowing access to the access port; and a slit extending from the top surface toward a bottom surface of the stabilizer body and from the opening to a first end of the stabilizer body, wherein the external bolster further comprises: a tether extending away from the access port and through a first recess of the stabilizer body; a plug fixedly attached to the tether and configured for removably engaging the access port through the opening of the stabilizer body; and an inflation port extending away from the access port and through a second recess of the stabilizer body wherein the inflation port is in fluid communication with the inflatable balloon via a secondary lumen of the tube.
2. The feeding tube assembly of claim 1, wherein the pad further comprises an adhesive disposed on the bottom surface of the pad and configured for attaching the pad to the patient.
3. The feeding tube assembly of claim 1, wherein the pad further comprises a slit extending from the top surface to the bottom surface of the pad and from the opening to an outer periphery of the pad, and wherein the slit of the stabilizer body is aligned with the slit of the pad.
4. The feeding tube assembly of claim 1, wherein the stabilizer body is fixedly attached to the pad by an adhesive.
5. The feeding tube assembly of claim 1, wherein the tether has a rectangular cross-sectional shape, wherein the first recess of the stabilizer body has a rectangular cross-sectional shape, wherein the inflation port has a circular cross-sectional shape, and wherein the second recess of the stabilizer body has a C-shaped cross-sectional shape.
6. The feeding tube assembly of claim 1, wherein portions of the stabilizer body adjacent the slit of the stabilizer body are configured to be resiliently deformed from a natural state to a deformed state and to automatically return to the natural state.
7. The feeding tube assembly of claim 1, wherein the stabilizer body further comprises: a first window extending from the cavity to a first side of the stabilizer body and configured for allowing visualization of an ostomy site of the patient, the first window being spaced apart from the opening of the stabilizer body; and a second window extending from the cavity to an opposite second side of the stabilizer body and configured for allowing visualization of the ostomy site, the second window being spaced apart from the opening of the stabilizer body.
8. The feeding tube assembly of claim 1, wherein the stabilizer body further comprises: a first leg extending along a first side of the stabilizer body and fixedly attached to the pad; a second leg extending along an opposite second side of the stabilizer body and fixedly attached to the pad; and a cross member extending between the first leg and the second leg and over a portion of the external bolster; wherein the first leg and the second leg are spaced apart from one another by the cavity; and wherein the first leg, the second leg, and the cross member are integrally formed with one another.
9. A feeding tube assembly for delivering fluids into a patient, the feeding tube assembly comprising: a pad configured for attaching to the patient, the pad comprising an opening extending from a top surface to a bottom surface of the pad; a low-profile feeding device comprising: a tube extending through the opening of the pad, the tube comprising a primary lumen; an external bolster fixedly attached to a proximal end portion of the tube and disposed adjacent to the top surface of the pad, the external bolster comprising an access port disposed along a top surface of the external bolster and in fluid communication with the primary lumen of the tube; and an internal bolster fixedly attached to the tube and spaced apart from the external bolster; and a stabilizer body fixedly attached to the top surface of the pad and extending over the external bolster, the stabilizer body comprising: a cavity receiving a base portion of the external bolster therein, the cavity extending from the bottom surface of the stabilizer body to the opening of the stabilizer body; an opening extending from the cavity to a top surface of the stabilizer body and configured for allowing access to the access port; and a slit extending from the top surface toward a bottom surface of the stabilizer body and from the opening to a first end of the stabilizer body; a first recess receiving a first extension portion of the external bolster therein, the first recess extending from the bottom surface toward the top surface of the stabilizer body and from the cavity to the first end of the stabilizer body; and a second recess receiving a second extension portion of the external bolster therein, the second recess extending from the bottom surface toward the top surface of the stabilizer body and from the cavity to an opposite second end of the stabilizer body.
10. The feeding tube assembly of claim 9, wherein the slit of the stabilizer body extends from the first recess to the top surface of the stabilizer body.
11. A stabilization device for inhibiting movement of a low-profile feeding device relative to a patient, the low-profile feeding device having a tube, an external bolster, and an internal bolster, the stabilization device comprising: a pad configured for attaching to the patient, the pad comprising an opening extending from a top surface to a bottom surface of the pad and configured for receiving the tube therethrough; and a stabilizer body fixedly attached to the top surface of the pad and configured for extending over the external bolster, the stabilizer body comprising: a cavity configured for receiving a base portion of the external bolster therein, the cavity extending from the bottom surface of the stabilizer body to the opening of the stabilizer body; an opening extending from the cavity to a top surface of the stabilizer body and configured for allowing access to an access port of the external bolster; a slit extending from the top surface toward a bottom surface of the stabilizer body and from the opening to a first end of the stabilizer body; a first recess receiving a first extension portion of the external bolster therein, the first recess extending from the bottom surface toward the top surface of the stabilizer body and from the cavity to the first end of the stabilizer body; and a second recess receiving a second extension portion of the external bolster therein, the second recess extending from the bottom surface toward the top surface of the stabilizer body and from the cavity to an opposite second end of the stabilizer body.
12. The stabilization device of claim 11, wherein the pad further comprises an adhesive disposed on the bottom surface of the pad and configured for attaching the pad to the patient.
13. The stabilization device of claim 11, wherein the pad further comprises a slit extending from the top surface to the bottom surface of the pad and from the opening to an outer periphery of the pad, and wherein the slit of the stabilizer body is aligned with the slit of the pad.
14. The stabilization device of claim 11, wherein the stabilizer body is fixedly attached to the pad by an adhesive.
15. The stabilization device of claim 11, wherein the slit of the stabilizer body extends from the first recess to the top surface of the stabilizer body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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(15) The detailed description is set forth with reference to the accompanying drawings. The drawings are provided for purposes of illustration only and merely depict example embodiments of the disclosure. The drawings are provided to facilitate understanding of the disclosure and shall not be deemed to limit the breadth, scope, or applicability of the disclosure. The use of the same reference numerals indicates similar, but not necessarily the same or identical components. Different reference numerals may be used to identify similar components. Various embodiments may utilize elements or components other than those illustrated in the drawings, and some elements and/or components may not he present in various embodiments. The use of singular terminology to describe a component or element may, depending on the context, encompass a plural number of such components or elements and vice versa.
DETAILED DESCRIPTION OF THE DISCLOSURE
(16) In the following description, specific details are set forth describing some embodiments consistent with the present disclosure. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are meant to be illustrative but not limiting. One skilled in the art may realize other elements that, although not specifically described here, are within the scope and the spirit of this disclosure. In addition, to avoid unnecessary repetition, one or more features shown and described in association with one embodiment may be incorporated into other embodiments unless specifically described otherwise or if the one or more features would make an embodiment non-functional. In some instances, well known methods, procedures, and components have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.
(17) Overview
(18) Embodiments of stabilization devices and related methods of using such stabilization devices with feeding devices are provided. The stabilization devices may be used with a low-profile feeding device and together with the low-profile feeding device may form a feeding tube assembly. A low-profile feeding device generally may include a tube, an external holster attached to a proximal end portion of the tube, and an internal bolster attached to the tube and spaced apart from the external bolster. As discussed above, the use of low-profile feeding devices may present certain problems associated with maintaining desired placement of the device relative to the patient throughout a period of use. The stabilization devices described herein advantageously may be used to inhibit movement of a low-profile feeding device relative to a patient.
(19) As described herein, a stabilization device may include a pad and a stabilizer body. The pad may be configured for attaching to a patient. The pad may include an opening extending from a top surface to a bottom surface of the pad and configured for receiving the tube of the low-profile feeding device therethrough. The stabilizer body may be fixedly attached to the top surface of the pad and configured for extending over the external bolster of the low-profile feeding device. In this manner, during use of the stabilization device, the pad may be attached to the patient, and at least a portion of the external bolster may be captured between the stabilizer body and the pad, thereby inhibiting movement of the low-profile feeding device relative to the patient. The stabilizer body may include a cavity and an opening. The cavity may be configured for receiving a base portion of the external bolster therein. The opening may extend from the cavity to a top surface of the stabilizer body and be configured for allowing access to an access port of the external bolster. In this manner, during use of the stabilization device, the access port may be accessible for attaching a feeding assembly or a venting assembly thereto while the stabilization device inhibits movement of the low-profile feeding device relative to the patient. Depending on the configuration of the low-profile feeding device, the stabilizer body also may include one or more recesses configured for receiving mating portions of the external bolster, such as a tethered plug or an inflation port thereof, while still allowing access to and use of such portions during use of the stabilization device. Respective shapes and arrangements of the cavity, opening, and recesses of the stabilizer body may be selected to correspond to shapes and arrangements of mating features of the external bolster, as described below.
(20) Still other benefits and advantages of the stabilization devices provided herein over conventional devices and techniques will be appreciated by those of ordinary skill in the art from the following description and the appended drawings.
(21) Low-Profile Feeding Devices
(22) Referring now to
(23) The low-profile feeding device 100 generally may include a tube 110 configured for extending through a stoma formed in a patient, an external bolster 130 configured for abutting the patient's abdominal wall and remaining outside of the patient during use of the device 100, and an internal bolster 160 configured for abutting the anterior wall of the patient's stomach and remaining within the stomach during use of the device 100. An example placement of the feeding device 100 with respect to the anatomy of a patient is depicted in
(24) The tube 110 may include a primary lumen 112 to facilitate delivery of fluids into the patient and/or venting of fluids from the patient. In some embodiments, the primary lumen 112 may extend through the tube 110 from a proximal end to a distal end thereof. The external bolster 130 may be fixedly attached to the tube 110. In some embodiments, the external bolster 130 may be fixedly attached to a proximal end portion of the tube 110. The internal bolster 160 also may be fixedly attached to the tube 110 and spaced apart from the external bolster 130. In some embodiments, the internal bolster 160 may be fixedly attached to a distal end portion of the tube 110. In some embodiments, the tube 110 and the external bolster 130 may be integrally formed with one another. In sonic embodiments, the tube 110 and the internal bolster 160 may be integrally formed with one another. In some embodiments, the tube 110, the external bolster 130, and the internal bolster 160 may be separately formed and fixedly attached to one another.
(25) As shown, the external bolster 130 may have a top surface 132, a bottom surface 134 disposed opposite the top surface 132 in a vertical direction, a first end 136, a second end 138 disposed opposite the first end 136 in a longitudinal direction, a first side 140, and a second side 142 disposed opposite the first side 140 in a lateral direction. In some embodiments, the external bolster 130 may include a base portion 144 that is fixedly attached to the tube 110 and one or more extension portions that are attached to and extend away from the base portion 144. For example, the external bolster 130 may include a first extension portion 146 and a second extension portion 148. In some embodiments, the first extension portion 146 and the second extension portion 148 may extend away from the base portion 144 in opposite directions, as shown, although other configurations of the extension portions 146, 148 may be used. In some embodiments, the first extension portion 146 and the second extension portion 148 may extend away from the base portion 144 in directions perpendicular to one another or forming other types of angled relationships. In some embodiments, the external bolster 130 may include four extension portions, which may be equally spaced apart from one another in a circumferential array or may have other arrangements. It will be appreciated that various configurations of the base portion 144 and extension portions of the external bolster 130 may be used, which may depend at least in part on functional requirements of the feeding device 100 (ex., depending on whether the device 100 is designed as a G-tube, a J-tube, a GJ-tube, or another type of feeding device).
(26) The external bolster 130 may include one or more access ports that are accessible outside of the patient during use of the feeding device 100. The access port(s) may allow for removable attachment of a feeding assembly, a venting assembly, or other type of assembly for communicating with the device 100 when needed. For example, the access port(s) may be configured for removable attachment with such assemblies via one or more connectors thereof. As shown, the external bolster 130 may include an access port 150 that is in fluid communication with the primary lumen 112 of the tube 110. In some embodiments, the access port 150 may be disposed along the top surface 132 of the external bolster 130, although other arrangements of the access port 150 on the external bolster 130 may be used. In some embodiments, the external bolster 130 may include a valve 152 configured for controlling fluid flow between the access port 150 and the primary lumen 112. The valve 152 may be movable between a closed state that prevents or inhibits fluid flow and an open state that allows fluid flow. Various configurations of the valve 152 may be used. In some embodiments, the external bolster 130 may include two or more access ports. For example, when the feeding device 100 is provided as a GJ-tube, the external bolster 130 may include a first, gastric access port, and a second, jejunal access port. In such embodiments, the gastric access port may be in fluid communication with the primary lumen 112 for communicating with the patient's stomach, and the jejunal access port may he in fluid communication with a secondary lumen of the tube 110 for communicating with the patient's small intestine.
(27) The internal bolster 160 may be configured for facilitating retention of the internal bolster 160 within the patient's stomach or intestine during use of the feeding device 100. In this manner, the internal bolster 160 may inhibit dislodgment of the feeding device 100. In some embodiments, the internal bolster 160 may include an expandable structure that is configured for transitioning between a compact configuration and an expanded configuration. The internal bolster 160 may be maintained in the compact configuration during insertion of the internal bolster 160 into the patient, transitioned to the expanded configuration once the internal bolster 160 is positioned within the stomach or intestine, and maintained in the expanded configuration during use of the feeding device 100. In some embodiments, as shown, the internal bolster 160 may include an inflatable balloon 162 that is configured for transitioning between a deflated, compact configuration and an inflated, expanded configuration. When in the expanded configuration, as shown in
(28) In some embodiments, the one or more extension portions of the external bolster 130 may include an inflation port. For example, an inflation port may be provided when the internal bolster 160 includes an inflatable balloon, such as the balloon 162. According to the illustrated embodiment, the first extension portion 146 may include an inflation port 154 that is in fluid communication with the balloon 162 via a secondary lumen extending through the tube 110 from the inflation port 162 to the balloon 162. The inflation port 154 may allow for removable attachment of an inflation device, such as a syringe, for selectively inflating and deflating the balloon 162, when needed. In some embodiments, the external bolster 130 may include an inflation valve configured for controlling fluid flow between the inflation port 154 and the secondary lumen. The inflation valve may be movable between a closed state that prevents or inhibits fluid flow and an open state that allows fluid flow.
(29) In some embodiments, the one or more extension portions of the external bolster 130 may include a tether having a plug fixedly attached thereto. The plug may be configured for removably engaging an access port of the external bolster 130 when the access port is not being used for delivering or removing fluids. According to the illustrated embodiment, the second extension portion 148 may include a tether 156 having a plug 158 fixedly attached thereto. The plug 158 may be configured for removably engaging the access port 150. The tether 156 may be provided as a flexible member configured for transitioning between a natural configuration (
(30) In some embodiments, the one or more extension portions of the external bolster 130 may include one or more tabs extending away from the base portion 144. The tabs may be configured for limiting rocking of the feeding device 100 in a direction corresponding to the extent of the tab. In sonic embodiments, a tab may extend away from the base portion 144 in a direction opposite an extension portion having a different configuration, such as an inflation port or a tethered plug. In some embodiments, a tab may extend away from the base portion 144 in a direction perpendicular to the extent of an extension portion having a different configuration, such as an inflation port or a tethered plug. Various shapes, configurations, and arrangements of the tabs, if present, may be used for the external bolster 130.
(31) Stabilization Devices and Feeding Tube Assemblies
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(33) The stabilization device 202 may include a pad 210 and a stabilizer body 230. The pad 210 may be configured for attaching to a patient and may provide a base structure for the stabilizer body 230. As shown in
(34) As shown, the pad 210 may include an opening 226 extending from the top surface 212 to the bottom surface 214 of the pad 210. The opening 226 may be configured for receiving the tube of the low-profile feeding device therethrough. For example, when the stabilization device 202 is used with the low-profile feeding device 100, the tube 110 may extend through the opening 226 of the pad 210. In some embodiments, the pad 210 may include a slit 228 adapted to ease assembly of the stabilization device 202 with the low-profile feeding device. The slit 228 may extend from the top surface 212 to the bottom surface 214 of the pad 210 and from the opening 226 to the outer periphery of the pad 210. For example, the slit 228 may extend from the opening 226 to the second end 218 of the pad 210, as shown, although other arrangements of the slit 228 may be used. During assembly, the slit 228 may allow the adjacent portions of the pad 210 to be separated from one another for positioning of the tube of the low-profile feeding device, such as the tube 110 of the feeding device 100, within the opening 226 of the pad 210. When the low-profile feeding device is assembled to the stabilization device 202, the external bolster, such as the external bolster 130 of the feeding device 110, may be disposed adjacent to the top surface 212 of the pad 210. It will be appreciated that the dimensions of the pad 210 as well as the opening 226 and the slit 228 thereof may be varied for different applications. Further, although the pad 210 is depicted as having a generally rectangular shape with rounded corners, it will be appreciated that different shapes of the pad 210 may be used.
(35) The stabilizer body 230 may he fixedly attached to the pad 210. For example, the stabilizer body 230 may be fixedly attached to the top surface 212 of the pad 210, as shown in
(36) The stabilizer body 230 may include a cavity 244 and an opening 246. The cavity 244 may be configured for receiving the base portion of the external bolster therein. For example, when the stabilization device 202 is used with the low-profile feeding device 100, the base portion 144 of the external bolster 130 may be received within the cavity 244, as shown in
(37) The stabilizer body 230 also may include one or more recesses configured for receiving mating portions, such as extension portions, of the external bolster of the low-profile feeding device. For example, the stabilizer body 230 may include a first recess 256 and a second recess 258. Each of the first recess 256 and the second recess 258 may extend from the cavity 244. In some embodiments, as shown, the first recess 256 may extend from the cavity 244 to the first end 236 of the stabilizer body 230, and the second recess 258 may extend from the cavity 244 to the second end 238 of the stabilizer body 230. Further, each of the first recess 256 and the second recess 258 may extend from the bottom surface 234 toward the top surface 232 of the stabilizer body 230. The first recess 256 may be configured for receiving a first extension portion of the external bolster therein, and the second recess 258 may be configured for receiving a second extension portion of the external bolster therein. For example, when the stabilization device 202 is used with the low-profile feeding device 100, part of the first extension portion 146 may be received within the first recess 256, and part of the second extension portion 148 may be received within the second recess 258, as shown in
(38) In some embodiments, the stabilizer body 230 may include a slit 260 adapted to ease assembly of the stabilization device 202 with the low-profile feeding device. The slit 260 may extend from the opening 246 to the outer periphery of the stabilizer body 230. For example, the slit 260 may extend from the opening 246 to the second end 238 of the stabilizer body 230, as shown, although other arrangements of the slit 260 may be used. In this manner, the slit 260 of the stabilizer body 230 may be aligned with the slit 228 of the pad 210. As shown, the slit 260 also may extend from the first recess 256 to the top surface 232 of the stabilizer body 230, although other arrangements of the slit 260 may be used. During assembly, the slit 260 may allow the adjacent portions of the stabilizer body 230 to be separated from one another for positioning of the tube of the low-profile feeding device, such as the tube 110 of the feeding device 100, within the opening 246 of the stabilizer body 230 and then through the opening 226 of the pad 210. In this manner, the slit 228 of the pad 210 and the slit 260 of the stabilizer body 230 may allow the stabilization device 202 and the low-profile feeding device to be easily assembled with one another, while providing a close fit between mating features of the stabilizer body 230 and the external bolster of the low-profile feeding device (e.g., as shown in
(39) In some embodiments, as shown, the stabilizer body 230 may include a first half and a second half that are mirror images of one another. In other words, the stabilizer body 230 may be provided as a symmetric structure about a central plane of the stabilizer body 230. As shown in
(40) In some embodiments, the stabilizer body 230 may be provided with one or more viewing windows to allow visualization of the ostomy site of the patient during use of the stabilization device 202 with the low-profile feeding device. For example, the stabilizer body 230 may include a first window 280 extending from the cavity 244 to the first side 240 of the stabilizer body 230, and a second window 282 extending from the cavity 244 to the second side 242 of the stabilizer body 230. Each of the windows 280, 282 may be configured for allowing visualization of the ostomy site In some embodiments, as shown, each of the windows 280, 282 may be spaced apart from the opening 246. In other words, the first window 280 may be separated from the opening 246 by a portion of the stabilizer body 230, and the second window 282 similarly may be separated from the opening 246 by a portion of the stabilizer body 230. It will be appreciated that other arrangements of viewing windows may be used depending on the number and arrangement of the recesses of the stabilizer body 230.
(41) Although specific embodiments of the disclosure have been described, one of ordinary skill in the art will recognize that numerous other modifications and alternative embodiments are within the scope of the disclosure. For example, while various illustrative implementations and structures have been described in accordance with embodiments of the disclosure, one of ordinary skill in the art will appreciate that numerous other modifications to the illustrative implementations and structures described herein are also within the scope of this disclosure.
(42) Although embodiments have been described in language specific to structural features and/or methodological acts, it is to be understood that the disclosure is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as illustrative forms of implementing the embodiments. Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments could include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.