WO2010075032A2

WO2010075032A2 - Low-profile external fitting

Info

Publication number: WO2010075032A2
Application number: PCT/US2009/067877
Authority: WO
Inventors: Laura Lee Farrell; Joshua F. Krieger; Jamie A. Gratzer
Original assignee: Cook Inc
Current assignee: Cook Inc
Priority date: 2008-12-22
Filing date: 2009-12-14
Publication date: 2010-07-01
Anticipated expiration: 2011-06-22
Also published as: WO2010075032A3

Abstract

A low-profile gastric port device (100) configured to attach to a gastric tube (106, 107) that is cut to a length customized for a specific patient. The port device (100) comprises a first (102) and a second portion (104) connected to each other in a manner aligning the first portion passage (133) and the second portion passage (124) to form a continuous passage. Different embodiments may have a clamshell structure that closes around the tube, or a circumferential clamping structure configured to engage a tube end.

Description

LOW-PROFILE EXTERNAL FITTING

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application Ser. No. 61/139,768, filed December 22, 2008, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present system relates to medical devices, and more particularly, to low-profile external fittings for systems that deliver materials to the interior of a body cavity.

[0003] Patients for which normal ingestion of food becomes difficult or impossible may require placement of a feeding tube to assist in providing their nutritional needs. For some individuals, such as comatose patients, stroke victims, or those with a compromised gastrointestinal tract and the like, this may require placement of a tube that is introduced percutaneously into the stomach for delivery of nutritional products directly into the stomach or jejunum. The procedure, known as a Percutaneous Endoscopic Gastrostomy (PEG) can performed using several different techniques. Some techniques include the introduction of an endoscope into the stomach. The desired site where the stoma is to be created is indicated from above by depressing the abdomen and viewing the depressed site with the endoscope. Transillumination may also be utilized to locate the desired site through the abdominal wall. A sheathed needle or trocar punctures the abdominal wall and enters the stomach, creating a stoma. The needle is removed and a looped insertion wire/suture is introduced through the sheath where it is grasped by a snare or forceps deployed from the working channel of the endoscope. Once it is captured, the insertion wire/suture is pulled into the working channel of the endoscope. The endoscope is then withdrawn from the patient via the oral cavity, pulling the insertion wire/suture with it. [0004] In the standard Ponsky method (or "pull" method), the distal loop of a percutaneous gastrostomy feeding tube is coupled to the insertion wire/suture exiting the patient's mouth. With the insertion wire/suture now tethered to the gastrostomy feeding tube, the endoscopist retracts the portion of the insertion wire/suture exiting the stoma, thereby pulling the gastrostomy feeding tube into the patient's mouth and towards the stomach. With continued retraction of the insertion wire/suture, the distal end of the gastrostomy feeding tube is pulled out through the stoma. The gastrostomy feeding tube typically includes a tapered dilator portion to aid its passage through the stoma. Once the feeding tube has been properly positioned with the proximal end cap or bolster of the feeding tube against the internal wall of the stomach, it is secured by an external bolster positioned against the outside of the abdomen wall. [0005] In a variation of the PEG procedure known as the "push" method, the gastrostomy feeding tube is advanced or pushed down the esophagus by the physician and into position in the stomach using a wire guide that has been placed in the same manner as the insertion wire in the "pull" method. More specifically, the feeding tube is loaded on the portion of the wire guide exiting the patient's mouth by passing the end of the wire guide through a lumen extending through the length of the feeding tube. While holding the wire guide stationary, the physician pushes the feeding tube along the wire guide through the patient's mouth, into the stomach, and then out through the stoma. The feeding tube is then secured in the same manner as the "pull" method.

[0006] Yet another method is simply to insert the feeding tube through the patient's abdominal wall using the Seldinger technique and bypass insertion through the mouth. However, this method typically requires the deployment of an internal retention device including, and/or in addition to attaching a bolster to the interior portion of the feeding tube, which may need to be delivered and attached endoscopically. [0007] As stated above, typically, a retention bolster is positioned against the inside and/or outside of the abdomen wall, or whichever body cavity or area the gastric port is being used in relation to. The bolster is present to keep in place and support the gastric port and prevent sudden or unexpected removal of the port from the stoma site. Bolsters for supporting ports, such as feeding tubes, inside or outside the body have generally focused on maintaining the secure anchoring of the device to the patient. To provide support, bolsters have employed flanges, cross-bars, discs, or balloons for contacting the surface of the tissue. In the past, however, bolsters have tended to increase the localized pressure at the exit site, especially when the port, either accidentally or intentionally, is moved thereabout.

[0008] For both ambulatory and bed-ridden patients, an external length of feeding tube and/or feeding apparatus may be connected to and removed from an external fitting (e.g., a gastric port) of the tube, with or without an external bolster. Existing feeding tubes with a proximal fitting (e.g., a gastric port on the portion of the tube that is outside the patient's body) are provided in fixed standard lengths. As a result, the length of the tube that extends outside the patient's body beyond the internal and/or external bolster varies depending upon the patient's anatomy and the physician-selected placement of the tube (which is largely based upon medical efficacy criteria). Because of this lack of adjustability, some patients have a high-profile externally-extending feeding tube (i.e., that protrudes noticeably out of the stoma, and/or that may extend some length outside the stoma). This can pose challenges to patients, whether ambulatory or not, regarding positioning of the tube that will not irritate the stoma, that will be comfortable, and that will not make the patient feel self- conscious for aesthetic reasons. Typical external bolsters or other external structures may have a dorsal-ventral profile (i.e., front-to-back thickness) of about 4 cm or more. - A -

[0009] A need therefore exists for a low-profile external fitting that is configured for use adjacent to a body surface to support a gastric port and is configured to provide for adjustable length of the tube and/or selectable placement of the external fitting.

BRIEF SUMMARY

[0010] The foregoing problems are solved and technical advance is achieved with a low-profile external fitting.

[0011] These and other advantages, as well as the low-profile external fitting itself, will become apparent in the details of construction and operation as more fully described below. Moreover, it should be appreciated that several aspects of the invention can be used with other types of gastric port systems or medical devices.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 is an illustration of an assembled low-profile external fitting;

[0013] FIG. 2 is an illustration of the lower piece of the low-profile external fitting of FIG. 1 ;

[0014] FIG. 3 is an illustration of the upper piece of the low-profile external fitting of FIG. 1 ;

[0015] FIG. 4 is an illustration from a lower side perspective view of an assembled low-profile external fitting of FIG. 1 ;

[0016] FIG. 5 is an illustration of a cross-sectional view of the low-profile external fitting of FIG. 1 ;

[0017] FIG. 6 is an illustration of another embodiment of a low-profile external fitting, showing an upper piece thereof;

[0018] FIG. 7 is an illustration of the embodiment of FIG. 6, showing a lower piece thereof;

[0019] FIG. 8 is an illustration of the low-profile external fitting of FIG. 6, shown assembled from a lower side perspective; [0020] FIG. 9 is an illustration in longitudinal section of the low-profile external fitting of FIG. 6;

[0021] FIG. 10 is an illustration in transverse section of the low-profile external fitting of FIG. 6;

[0022] FIG. 11 is an illustration of another embodiment of a low-profile external fitting;

[0023] FIG. 12 is an illustration of a proximal end perspective view of the low-profile external fitting illustrated in FIG. 11 ;

[0024] FIGS. 13 is a top perspective illustration of an opened view of the low-profile external fitting illustrated in FIG. 11 ;

[0025] FIG. 14 is a partial illustration from a top view of a proximal end detail of the low-profile external fitting illustrated in FIG. 11 ; [0026] FIG. 15 is an illustration of an opened view of the low-profile external fitting illustrated in FIG. 11 ;

[0027] FIG. 16 is a partial illustration in transverse section of the low- profile external fitting illustrated in FIG. 11 ; and [0028] FIGS. 17A-17B are, respectively, open and closed view illustrations of another embodiment of a low-profile external fitting.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED EMBODIMENTS

[0029] For the purposes of promoting an understanding of the principles of the gastric port system, reference will now be made to the embodiments illustrated herein. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. [0030] Referring to FIG. 1 , a first embodiment of an assembled low- profile external fitting (LPEF) 100 is illustrated. It includes an upper piece 102 and a lower piece 104. The LPEF 100 is shown affixed to a tube 106 having a longitudinal lumen 114 therethrough configured for the passage of materials (e.g., a nutrient mixture through a gastric or jejunal feeding tube, either or both of which may be included herein whenever either is mentioned). The tube 106 may traverse a stoma in a body wall. The body wall may border any body cavity that would benefit from the advantages disclosed herein. For example, the body wall may separate a first region (e.g., a region on the connector side of the LPEF 100 external to the patient's body) from a second region (e.g., a region on the tube side of the LPEF inside the patient's abdominal cavity). FIG. 1 also shows cantilever tabs 116 connecting the upper and lower LPEF pieces 102,104. The LPEF 100 may be made of biocompatible polymers, alloys, or other materials suitable for forming the desired configurations, preferably at the lowest possible cost and risk for a patient.

[0031] FIG. 2 illustrates the lower piece 104 of the LPEF 100 and FIG. 3 illustrates the upper piece 102 of the LPEF 100, including attachment means for attaching the upper and lower pieces 102, 104. A tab-receiving aperture 120 is shown and is configured to receive tabs 116 in order to secure the upper piece 102 to the lower piece 104 of the LPEF 100. It should be understood that the upper piece 102 may be secured to the lower piece 104 by alternative means alone or with the tabs 116. Attachment may be provided in this and other embodiments by other fastening means such as, for example, screws, rivets, magnets, adhesives, and/or other attachment means known in the art. FIG. 2 also illustrates fingers 122, which are disposed around the inner circumference of, and projecting toward the center of a central passage 124 of the lower piece 104. They preferably are at least semi-flexible and may be formed from a flexible plastic or other polymer or metal, and preferably are configured to flex when connecting the fixture pieces together with a tube. The fingers 122 are configured to create a pressure fit between the tube 106 and the LPEF 100, to minimize risk of separation of the tube 106 from the LPEF 100. [0032] The upper piece 102, illustrated in FIG. 3, may include tabs 116, as well as a luer connection 130 for connection to another device to facilitate delivery of nutritional material or other material. The luer connection 130 is positioned on the proximal end of the upper piece 102. (As used with reference to the presently-described embodiments, the term "proximal" corresponds to being nearer a person treating a patient, and particularly to the direction corresponding to the end of a tube extending out of a patient stoma, while the term "distal" corresponds to being nearer to/ inside the patient.)

[0033] Although a luer connection 130 is shown, it should be understood that such an element of the upper piece 102 could easily be replaced with, for example, a feeding tube adapter or other connection means. A distal male insert extension 132 may extend from the upper piece 102 and be configured to fit within the tube 106. In this manner, when the LPEF 100 is assembled with a tube, the fingers 122 will capture the tube in a pressure fit against the extension 132 to form what preferably is a fluid-tight seal that substantially prevents separation of the tube 106 from the LPEF 100. The extension 132 includes a lumen 133 configured to provide substantially patent fluid communication with a tube lumen 107. [0034] Referring now to FIG. 4, the LPEF 100 is illustrated from a lower side perspective as assembled. As shown, the cantilever tabs 116 are engaged with the apertures 120. No tube is shown in FIG. 4, but it will appreciated that the space between the fingers 122 and the extension 132 will correspond to the wall thickness of a tube (e.g., the space will preferably be about the same as, or slightly less than the difference between the ID and OD of the tube - i.e., its wall thickness). This relationship is shown more clearly in FIG. 5, which is a longitudinal section view of the LPEF 100 with a tube 106 engaged between the fingers 122 and the extension 132.

[0035] A method of use will be appreciated with reference to FIG. 5. A tube 106 is provided, already placed appropriately in a patient (such as, for example, a percutaneous gastric or jejunal feeding tube disposed through a stoma in the patient's abdominal wall). The proximal end of the tube 106 is trimmed to a desirable customized length that preferably will allow for medical efficacy, comfort, and aesthetic desire of the patient. This customizability for an individual patient provides numerous advantages for the patient and for personnel treating the patient, including that the position of both proximal and distal structures of the installed, assembled device can more readily and carefully be controlled/determined that with prior art "one size fits all" devices. A user may then direct the lower piece 104 over the proximal end of the tube 106, which passes through the distal face of the aperture 120. The fingers 122 contact the outer circumference of the tube 106. Then, the upper piece 102 is directed into engagement with the tube 106 and the lower piece 104. Specifically, the cantilevered tabs 116 lockingly engage the apertures 120, and the extension 132 compresses the tube 106 radially into a compression fit against the fingers 122. Then, the LPEF 100 is assembled and ready for periodic or continuous with an external connection thereto (preferably being capped when not so connected). The LPEF 100 most preferably provides a patient with an external fitting that is low-profile, such that it is less likely to be caught on clothing and/or noticeable by others under the patient's clothing. [0036] For a tube 106 including an attached insertion wire, suture, or similar introduction-assistance means, a suture retention track is provided, as shown in FIG. 5. A suture 139 (configured for use during introduction and/or removal of the tube 106) may be secured by passing between the inner surface of the tube 106 and the outer surface of the extension 132, then having its external length wound around a peripheral groove 135 formed by a slight indentation around the outer periphery of the upper and/or lower pieces 102, 104. In addition to safely and discretely stowing the suture 139, this feature also provides extra security for the attachment of the LPEF 100 to the tube 106. [0037] Referring to FIGS. 6-10, a second embodiment of an assembled low-profile external fitting (LPEF) 200 is illustrated. It includes an upper piece 202, shown alone in FIG. 6, and a lower piece 204, shown alone in FIG. 7. FIG. 8 shows the upper and lower pieces 202, 204 assembled together. In FIG. 10, which is a longitudinal section view along line 10-10 of FIG. 9, the LPEF 200 is shown affixed to a dual-lumen tube 206 having first and second longitudinal lumens 214, 215 therethrough configured for the passage of materials (e.g., a nutrient mixture through a gastric or jejunal feeding tube). FIG. 2 also shows cantilever tabs 216 connecting the upper and lower LPEF pieces 202, 204.

[0038] As shown in FIG. 6, a plurality of tab-receiving apertures 220 on the upper piece 202 is configured to receive tabs 216 of the lower piece 204 (see FIG. 7) in order to secure them together to form the LPEF 200. It should be understood that the upper piece 202 may be secured to the lower piece 204 by alternative means, either alone or with the tabs 216. For example, other fastening means such as, for example, screws, rivets, magnets, and/or adhesives may be used. As shown in FIG. 7, the lower piece 204 also includes a central passage 224. [0039] FIG. 6 also illustrates male lumen-engagement extensions 222, which project out of the lower face of the upper piece 202 and are configured to extend through the central passage 224 of the lower piece 204 and engage into the lumens 214, 215 of the tube 206. They may be formed from a flexible plastic or other polymer or metal, and preferably are configured to flex when connecting the fixture pieces together with a tube. The extensions 222 are configured to create a pressure fit between the tube 206 and the outer circumference of the central passage 224, to minimize risk of separation of the tube 206 from the LPEF 200.

[0040] The upper piece 202 of the LPEF 200, illustrated in longitudinal section in FIG. 10, includes two lumens 231 , 233 to facilitate fluid communication (e.g., delivery or extraction of nutritional or other material). The exterior end of each of the lumens 231 , 233 may include, for example, a luer connection, a feeding tube adapter, or other connection means. The distal male extensions 222 extend from the upper piece 202 such that, when the LPEF 200 is assembled with a tube 206, the extensions 222 will capture the tube 206 in a pressure fit against the extension 232 to form what preferably is a fluid-tight seal that substantially prevents separation of the tube 206 from the LPEF 200 and provides a patent passage of fluid communication between the device lumens 231 , 232 and the tube lumens 214, 215. It should be appreciated that another embodiment - using only a single lumen, or more than two lumens -may be practiced within the scope of the present invention.

[0041] Referring again to FIGS. 8, 9, and 10, the LPEF 200 is illustrated from a lower side perspective, an end view (showing select internal structures in broken lines), and a longitudinal section perspective along line 10-10 (of FIG. 9), respectively, as assembled. As shown, the cantilever tabs 216 are engaged with the tab-receiving apertures 220. FIG. 9 illustrates that the lumens 231 , 233 of the LPEF 200 each provide a path of fluid communication with lumens 214, 215 of a dual-lumen tube . [0042] A method of use will be appreciated with reference to FIGS. 6- 10. A tube 206 is provided, already placed appropriately in a patient (such as, for example, a percutaneous gastric or jejunal feeding tube disposed through a stoma in the patient's abdominal wall). The proximal end of the tube 206 is trimmed to a desirable length that preferably will allow for medical efficacy, comfort, and aesthetic desire of the patient. A user may then direct the lower piece 204 over the proximal end of the tube 206, which passes through the distal face of the central passage 224. Then, the upper piece 202 is directed into engagement with the tube 206 and the lower piece 204, as shown in FIG 9. Specifically, the cantilevered tabs 216 lockingly engage the apertures 220, and the extensions 222 compress the tube 206 radially into a compression fit against circumference of the central passage 224. Then, the LPEF 200 is assembled and ready for periodic or continuous with one or two external connections thereto (preferably being capped or otherwise closed when not so connected). The LPEF 200 most preferably provides a patient with an external fitting that is low-profile, such that it is less likely to be caught on clothing and/or noticeable by others under the patient's clothing, so as to provide physical comfort and minimal self-consciousness/discomfort.

[0043] Referring to FIGS. 11-16, a third embodiment of a low-profile external fitting (LPEF) 300 is illustrated. It may be constructed in two "clamshell" type configurations (end-hinged or side-hinged) and includes an upper piece 302 and a lower piece 304. The LPEF 300 is configured to allow passage of a tube (not shown) such as, for example, a gastric or jejunal feeding tube. As shown in FIGS. 12 and 15, the upper and lower pieces 302, 304 are connected by a hinge 350 along one lateral side. (As described below, FIGS. 17A-17B show two views of another embodiment 400 similar in many respects to this third embodiment, but with a hinge 450 positioned at one end). FIG. 16 shows, in transverse section along line 16-16 of FIG. 11 , an alternative snap-tab 316 of the the lower piece 304 engaging a tab-receiving aperture 320 on the upper piece 302.

[0044] The tab-receiving aperture 320 is shown and is configured to receive tabs 316 in order to secure the upper piece 302 to the lower piece 304 of the LPEF 300. It should be understood that the upper piece 302 may be secured to the lower piece 304 by alternative means alone or in addition to the tabs 316. Securement may be provided by other fastening means such as, for example, screws, rivets, magnets, and/or adhesives. As shown in FIGS. 11 , 14, and 16, other snap configurations may be used, and one or more guide tabs 317 may be provided to align and secure the upper and lower pieces 302, 304 in a proper orientation. [0045] FIG. 15 illustrates the LPEF 300 opened along its hinge 350. Complementary upper and lower tube-track structures 362, 364 are disposed, respectively, in the upper and lower pieces 302, 304 of the LPEF 300, forming, respectively, upper and lower portion passage elements. As will be appreciated from the inside open view of FIG. 15 and from the proximal end closed view of FIG. 12, the upper and lower tube- track structures 362, 364 are each generally semi-cylindrical and complement each other to form a generally cylindrical passage configured to direct the tube through a generally perpendicular turning transition. Specifically, the tube track is configured to allow passage of a tube (that preferably has been trimmed to a desired length) through a central passage 324 in the lower piece 304, generally perpendicular to the longitudinal axis of the LPEF 300. Then, the tube will gently (i.e., preferably without kinking or crimping) curve toward the proximal opening, fitting snugly within the tube-track defined by the upper and lower tube- track structures 362, 364, approximately parallel with the longitudinal axis of the LPEF 300 and perpendicular to the length of tube in the patient stoma. Once the tube is positioned, the LPEF 300 may be closed and the tab-lock 316, 320 engaged (FIGS. 11 , 12). This configuration of the LPEF 300 provides for a low-profile exit of the tube from a patient stoma, and the proximal end of the tube may be equipped as medically appropriate (e.g., with a feeding tube adapter plug), or - for a "non-trim to use" tube - a tube connection means may be provided already installed at the proximal tube end.

[0046] FIG. 15 also illustrates a pair of support struts 322, which projecting toward complementary receiving strut orifices 323 of the lower piece 304. They may be formed from a flexible plastic or other polymer or metal, and may be configured to flex at least slightly. [0047] Referring now to FIG. 13, the LPEF 300 is illustrated from a lower side perspective in an opened configuration. As shown, the tab- engagement aperture 320 is generally centered along the length of the LPEF 300, but it should be appreciated that its position may be disposed elsewhere on the device. The underside 304a of the lower portion 304 preferably is rounded to present a smooth, substantially atraumatic surface that will not chafe or otherwise irritate the patient's skin. As also shown in FIG. 13, a proximal tube aperture 325 may include two portions that are configured to engage and provide additional structural stability around the tube where it proximally exits the LPEF 300.

[0048] For embodiments where a suture (not shown) is attached to the tube, notches 327 may be provided in the rim 323 of the proximal aperture 325, as shown in FIG. 12. The suture can be routed through the notches and secured around the rim 323.

[0049] FIGS. 17A-17B illustrate another embodiment of an LPEF 400 that is substantially similar to the embodiment shown in FIGS. 11-16. It includes an upper portion 402 and a lower portion 404 connected by a hinge 450 at an end opposite the proximal end opening 425. The underside of the lower portion 404 includes a cushioning structure 465 to enhance the patient's comfort. The cushioning structure 465 may be constructed of a low-friction fabric or other material such as, for example, silicon or another biocompatible material that preferably has a low risk of irritating patient skin or causing allergic response, and that does not significantly increase the device cost for the patient. The cushioning structure 465 includes a central passage aperture 467 corresponding to a central passage opening 424 in the lower portion 404, configured (as in the LPEF 300) for passage therethrough of a proximal tube end). [0050] As shown in FIG. 17A, in this embodiment, flexible flanged struts 469 may be engaged through the bottom of the lower portion 404. As shown, the flanged struts 469 attach the cushioning structure 465 to the lower portion 404 and provide a semi-flexible spacer between the central areas of the upper and lower portions 402, 404. Friction-fit tabs 416 are configured to snap into engagement with notches 420 when the LPEF 400 is closed to engage a tube (not shown).

[0051] Preferred embodiments of LPEFs of the present invention will have a dorsal-ventral profile of less than 3.9 cm, with a preferred range being about 1.8 to about 3.2 cm. (As used here, "dorsal-ventral profile" refers to front-to-back thickness from the top face of the upper portion to the bottom face of the lower portion.)

[0052] Those of skill in the art will appreciate that combinations and variations of the features described in different embodiments herein may be used in different ways than explicitly illustrated, all within the scope of the present invention. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention.

Claims

1. A low-profile gastric port device comprising:

a first portion comprising a first portion passage and a first connection means element;

and a second portion comprising a second portion passage and a second connection means element complementarily engageable with the first connector means element;

the first and second portions configured for connection to each other in a manner aligning their respective passages to form a continuous passage;

wherein the first and second portions are configured to engage and retain a portion of a tube that is cut to a customized desired length and to provide for patent fluid passage through the tube; and

wherein a dorsal-ventral profile of the device does not exceed about 1.8 cm to about 3.2 cm.

2. The low-profile gastric port device of claim 1 , where one of the first portion passage and the second portion passage comprises a generally tubular extension dimensioned to fit snugly into a first end of a gastric feeding tube, and the other of the first portion passage and the second portion passage comprises a plurality of flanges configured to circumferentially engage and retain the tube end against the tubular extension.

3. The low-profile gastric port device of claim 1 , further comprising a gastric tube, a proximal end of which has been cut to a customized desired length.

4. The low-profile gastric port device of claim 3, where the desired length corresponds to a shorter external length in an installed location.

5. The low-profile gastric port device of claim 1 , where the first and second connection means elements comprise an engageable tab and aperture.

6. The low-profile gastric port device of claim 1 , where the first and second portions are hingedly connected.

7. The low-profile gastric port device of claim 1 , where the continuous passage is configured to provide a lumen, the lumen configured to provide a patent path of fluid communication with a tube lumen.

8. The low-profile gastric port device of claim 1 , where the continuous passage is configured to allow passage therethrough of a tube without substantial kinking along a generally perpendicular transition.

9. The low-profile gastric port device of claim 1 , further comprising a cushioning member.

10. The low-profile gastric port device of claim 1, further comprising a tube having a longitudinal tube lumen through a substantial length of the tube.

11. The low-profile gastric port device of claim 10, where the first portion passage comprises an extension around a portion of the first portion passage, and where the extension is configured to engage into a portion of the tube lumen.

12. The low-profile gastric port device of claim 11 , where the second portion passage is configured to circumferentially engage the first portion passage extension and a tube portion engaged thereby.

13. The low-profile gastric port device of claim 11 , where the first portion passage comprises two passages.

14. The low-profile gastric port device of claim 13, where the tube lumen comprises two lumens, each of which is in fluid communication with at least one of the two passages.

15. The low-profile gastric port device of claim 1 , where each of the first and second portion passages comprises a curved generally semi- cylindrical track complementing each other such that the continuous passage is configured to closely encompass a tube having a generally cylindrical exterior and to direct the tube through a generally perpendicular turning transition.

16. A low-profile gastric port device comprising:

an upper portion including a proximal connector means extending from an upper face thereof, a distal extension extending from a lower face thereof, a patent path of fluid communication through the proximal connector means and the distal extension, and a lower-face attachment means;

a lower portion including a central opening configured to allow passage therethrough of the distal extension, and an upper-face attachment means configured to complementarily engage the lower-face attachment means; and

a tube having a tube wall circumferentially defining a longitudinal lumen, where a proximal end of the tube lumen is configured to sealingly engage around the distal extension, and where the tube wall includes a thickness that is about the same as a difference between an outer diameter of the distal extension and an inner diameter of the central opening.

17. The low-profile gastric port device of claim 16, where the central opening of the lower portion comprises a plurality of semi-flexible fingers configured to engage an outer circumference of the tube.

18. A method of installing a low-profile gastric port device comprising the steps of:

providing the low-profile gastric port device of claim 16;

directing the proximal tube end through the central opening of the lower portion;

engaging the distal extension of the upper portion into the proximal tube lumen; and

directing the upper and lower portions together such that the distal extension and engaged tube fit engagingly into the central opening and the upper and lower face attachment means engage each other.

19. A low-profile gastric port device comprising:

an upper portion including a first curved track defining a generally semi-cylindrical face along a longitudinal axis of the upper portion, a first proximal opening structure, and a first attachment means;

a lower portion including a central opening configured to allow passage therethrough of a tube, a second proximal opening structure configured to complement the first proximal opeing structure to form a proximal opening, a second curved track defining a generally semi- cylindrical face along a longitudinal axis of the lower portion between the central opening and the second proximal opening structure, where the second curved track is complementary to the first curved track in a manner providing a generally cylindrical tube passage from a lower face of the lower portion to the proximal opening, and a second attachment means configured to complementarily engage the first attachment means; and

a hinge structure connecting the upper and lower portions.

20. The low-profile gastric port device of claim 19, further comprising a cushioning structure disposed on the lower portion.