DESCRIPTION

Technical Field of the Invention

The present invention generally relates to appliances and devices used in connection with gastrostomy enteral feeding and, in particular, to a unique gastrostomy appliance for supporting and maintaining the

positioning of an enteral feeding tube within the stoma of a gastrostomy.

Background of the Invention 5 Use of a surgically formed feeding stoma, such as a gastrostomy, is finding increasing acceptance as an alternative procedure in patients requiring long term nutritional support. Gastrostomy enteral

10 feeding is often considered in patients requiring custodial care, such as the elderly, in whom intubation of a nasoesophageal feeding tube is undesirable or impractical.

The surgical arts have developed

15 improved gastrostomy procedures for creating a permanent mucosal-lined gastric tube. Such improved surgical techniques typically involve forming a gastric tube from the anterior .stomach wall, preferably near the greater

20 curvature of the stomach. Formation of the gastric tube is accomplished through use of a gastrointestinal anastomotic stapler to divide off an external portion of the anterior stomach wall. This divided portion is then

25 severed from the anterior stomach wall to define the gastric tube. The tube is circumferentially sutured about its base to maintain the tube in a position generally perpendicular to the anterior wall of the

30 stomach. The gastric tube is allowed to protrude through the abdominal incision which

was formed to obtain access to the anterior stomach wall. The fascia and skin are sutured closed around the protruding gastric tube. A stoma is formed by excising about 1-1.5 cm of 5 the terminal end of the tube and by suturing peripheral edges of the stoma to the subcuticular layer of the patient's skin. This procedure results in a mucosal-lined gastric tube providing direct access to the

10 patient's stomach. Through use of the feeding gastrostomy, an enteral feeding tube can be inserted into the stoma to initiate enteral feeding and removed at the conclusion of feeding.

15 It has been found that use of a large diameter enteral feeding tube in a muσosal-lined gastrostomy often results in skin excoriation caused by a larger diameter tube abrading against the stoma periphery. It

20 has also been determined that any enteral feeding tube intubated within the stoma of the gastrostomy must be maintained in a perpendicular position relative to the patient's skin to avoid necrosis of the

25 mucosal lining of the gastric tube.

To prevent excoriation and necrosis, small diameter enteral feeding tubes are now employed in a feeding gastrostomy, usually tubes no larger in size than 12 French.

30 However, a smaller diameter enteral feeding tube is less self-supportive than a larger

diameter tube making perpendicular positioning of the tube more difficult. Further, it is important that the enteral feeding tube, upon intubation within the gastric tube, be 5 maintained in a relatively stationary and concentric position during enteral feeding, which is likewise difficult with smaller feeding tubes.

Hence, prior to the development of

10 the present invention, a need existed for. a gastrostomy appliance for supporting a small diameter enteral feeding tube within the stoma of a feeding gastrostomy. A further need existed for an appliance which would maintain

15 the perpendicular positioning of the enteral feeding tube within the stoma relative to the patient's skin. A need also existed for a gastrostomy of enteral feeding tubes support appliance which can be easily removed and

20 replaced about an external proximal portion of the feeding tube protruding from the gastrostomy.

Summary of the Invention

25 The invention is a tube fixation device, preferably for administering fluids through a surgically formed stoma. The present invention is preferably used to secure a generally circular, deformable, elongated

30 enteral feeding tube. Typically, such a tube includes a feeding inlet end through which the

enteral fluid is supplied and a perforated outlet end for discharging that fluid into the patient. The feeding tube extends outwardly from the patient. 5 One of the two components of the preferred embodiment of the present invention, is a sleeve which is both disposed and movable along the feeding tube. Initially, it is generally proximate the feeding inlet end of

10 the tube. One end of the sleeve is sized. sufficiently small to frictionally engage the tube, but sufficiently large to permit the sleeve to move freely along that tube. The opposite end of the sleeve is known as the

15 interlocking end, for the reason that it interlockingly engages a second component of the present device in a manner to be described later.

A second component of the preferred

20 embodiment of the present invention is a base elbow unit through which the feeding tube passes ^' , and which is disposed along that tube proximate the perforated outlet end. The base elbow unit preferably is molded in one piece,

25 and comprises three main parts. The first part is a subdermal portion, which in normal use by the patient is placed below the skin level. Coaxial with the subdermal portion along a first axis is the second part of the

30 base elbow unit, a sleeve engaging portion for cooperative engagement with the sleeve when

the present device is in its fully assembled, operating configuration. The third part of the base elbow unit is a generally cylindrical tube-engaging portion, which is preferably 5 oriented along a second axis substantially perpendicular to the first axis. To ensure a secure, gripping engagement of the deformable feeding tube by the tube-engaging portion, the inner diameter of the tube-engaging portion is

10 slightly smaller than the outer diameter -of the feeding tube.

When the feeding tube is in its first, substantially straight position, the feeding tube passes through the subdermal and

15 sleeve engaging portions of the base elbow unit. The feeding tube may be bent into a second, acutely angled position in which the tube also passes through the tube engaging portion of the base elbow unit. In this

20 second, acutely angled position, the feeding tube is immobilized by locking engagement to the tube engaging portion.

The sleeve includes an interlocking tab adjacent its interlocking end. The sleeve

25 and its interlocking tab are movable along the feeding tube and away from the feeding inlet end to a position where the tab may lockingly engage the sleeve engaging portion of the base elbow unit when the tube is in its second,

30 acutely angled position.

To aid the user in securely gripping

the sleeve, the sleeve may optionally be provided with one or more circumferential ribs along its outer surface.

5 Brief Description of Drawings

FIG. 1 is a perspective view of the preferred tube fixation device of the present invention shown secured to the patient's skin; FIG. 2 is a side view, partially in 10 section, of the preferred tube fixation device of FIG. 1 and a patient's abdominal wall and anterior stomach wall illustrating use and placement of the present invention;

FIG. 3 is a side view of a preferred 15 embodiment of the present invention, including the circular, deformable, elongated enteral feeding tube in its first, substantially straight position, the sleeve with its interlocking tab, and the base elbow unit; 20 FIG. 4 is perspective view of the base elbow unit and of the feeding tube in its second, acutely angled position;

FIG. 4A is a side view, partially in section and taken along line 4A-4A of FIG. 4, 25 of the base elbow unit and the feeding tube of

FIG. 4, and showing the "necked-down" common interior of the sleeve engaging and subdermal portions of the base elbow unit;

FIGS. 5A and 5B are side views of 30 the base elbow unit of FIG. 4, and of the sleeve of the present invention moving

progressively towards a position where its interlocking tab may engage the sleeve engaging portion of the base elbow unit; and

FIG. 6 is a frontal view of the base 5 elbow unit and sleeve of the present invention, showing the locking engagement of the sleeve's interlocking tab on the sleeve engaging portion of the base elbow unit.

10 Detailed Description

While this invention is susceptible of embodiment in many different forms, there is shown in the drawings and will herein be described in detail a preferred embodiment of

15 the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the

20 embodiment illustrated.

Referring now to the drawings, FIGS. 1 and 2 disclose a preferred embodiment of the tube fixation device of the present invention, generally referenced by numeral 10, in its

25 fully assembled configuration. Tube fixation device 10 is generally adhered to the patient's abdominal wall A or other body surface through the use of an adhesive lined bandage (not shown) .

30 Because tube fixation device 10 may have other uses, it should be understood that

the device is intended for insertion into any surgically-formed ostomy. For example, device 10 may be used for peritoneal dialysis, suprapubic dialysis, and gastrostomy. 5 FIG. 3 discloses the preferred tube fixation device in a disassembled state and carried on a segment of an elongated, generally circular, deformable enteral feeding tube 12. The tube 12 is typically of a small

10 diameter, on the order of about French 12,, and is preferably made of a latex-like material. "Deformable*' in the context of the present invention is intended to mean (1) the ability of the tube to bend along its length, and then

15 return to a straight shape without kinking; and (2) the ability of the tube to compress from its unstressed, normal diameter to a narrower, stressed diameter, and to then return to that normal diameter after the

20 source of stress is removed. This deformable characteristic will be important for reasons which will later become apparent.

One component is a sleeve 14 which is shown proximate the feeding inlet end 16 of

25 the enteral feeding tube 12. The sleeve itself includes two ends, namely a feeding tube-engaging end and a interlocking end. The feeding tube-engaging end 18 is disposed nearest the feeding inlet end 16 of the tube

30 12. It is sized of a sufficiently small diameter such that it frictionally engages the

feeding tube 12. It is also of a sufficiently small diameter such that the sleeve 14 may move readily along the length of the enteral feeding tube 12 when that tube is in the 5 normal, straight position shown in FIG. 3.

The opposite end of the sleeve 14 is an interlocking end 20. This interlocking end 20 is preferably of a much larger diameter than the feeding tube-engaging end 18. In the

10 embodiment shown in the FIGURES, the interlocking end 20 is cut at an angle of approximately 45 degrees to the axis of the sleeve 14. Interlocking end 20 also includes an interlocking tab 22, which cooperates with

15 the third component of the three-component embodiment of the invention.

One other component of the present invention, is a base elbow unit 24. The base elbow unit 24 is one piece, is preferably

20 molded of plastic, and includes three distinct parts. The first part is a subdermal portion 26, which aids in anchoring the present device when implanted by medical personnel through the ostomy in the patient's body.

25 The second part of the base elbow unit 24 is a sleeve engaging portion 28 which abuts and is coaxial with, along a first axis, the subdermal portion 26. The outer diameter of the sleeve engaging portion 28 is somewhat

30 larger than that of the subdermal portion 26.

Thus, the juncture of the sleeve engaging

portion 28 with the subdermal portion 26 forms a flange 30. To ensure a minimum of irritation, this flange 30, which generally abuts the surface of the patient's skin, is 5 smooth and includes beveled or radial edges.

The third part of the base elbow unit is a tube engaging portion 32. As may best be seen in FIG. 4, this tube engaging portion 32 is of a generally elongated and

10 semi-cylindrical, horseshoe shape, with an opening 34 along its length permitting insertion of tube 12. Tube engaging portion 32 is preferably manufactured of a resilient material, such as a nylon or delrin-type

15 polymer. This resiliency enables the opposite, inwardly facing surfaces 36 and 38 (FIG. 4) of the tube engaging portion 32, which surfaces 36 and 38 define the outer edges of opening 34, to move away from one

20 another. This in turn eases the insertion of tube 12 into tube engaging portion 32.

Cylindrical tube engaging portion 32 is disposed along a second axis C which is substantially perpendicular to first axis B.

25 To aid in the immobilization of the tube 12 when the present device is in the fully assembled position and in use by a patient, the first and second axes formed by the tube 12 should define an acute angle, i.e., 90

30 degrees or less.

Enteral feeding tube 12 is shown in

FIGS. 4 and 4A in what will be termed the assembled or the second, acutely angled position. In contrast, when the subdermal portion 26 of the base elbow unit 24 is 5 initially inserted into the ostomy of the patient, the present device is not in its fully assembled position; rather, the tube is in the first, substantially straight position. As indicated above, when the tube is in this

10 first, substantially straight position, it can move relatively freely through the sleeve 14 and base elbow unit 24. This in turn enables medical personnel to place the perforated outlet end 41 of the enteral feeding tube 12

15 at the desired depth within the patient's body.

After proper placement of the perforated outlet end 41 within the patient's body, the tube is moved from the first,

20 substantially straight position of FIG. 3 to the second, acutely angled position of FIGS. 4 and 4A. Both the deformability of the enteral feeding tube 12 and the resiliency of the tube engaging portion 32 enhance the ease with

25 which that tube 12 may be inserted into the tube engaging portion 32. Because the outer diameter of the tube 12 is somewhat larger than the inner diameter of the tube engaging portion 32, and because of the opposing

30 stresses acting upon the tube and tube engaging portion in the position shown in FIG.

4, the tube engaging portion 32 clampingly engages the tube 12 to immobilize it.

As may be seen in FIGS. 4 and 4A, the inner diameter of the cavity 40 defined by 5 the sleeve engaging portion 28 and the subdermal portion 26 of the base elbow unit 24 is at a maximum near the upper end of the sleeve engaging portion 28 and tapers to approximately the diameter of the tube 12 at

10 the lower end of the subdermal portion 26...

For hygienic purposes, a bactericide or antiseptic is generally placed within this cavity 40 to ensure that bacteria do not grow within it.

15 After the tube has been placed in its second, acutely angled position and after any bactericide had been placed within cavity 40, sleeve 14 is moved away from the feeding inlet end 16 of tube 12 and towards the base

20 elbow unit 24. The inner diameter of the sleeve must be greater than the outer diameter of the tube engaging portion 32 so that the sleeve can slide over the tube engaging portion 32.

25 As may be seen in FIGS. 5A, 5B, and

6, the sleeve engaging portion 28 includes an upper tip portion 48 which serves as a mating end for the interlocking tab 22 of the sleeve 14. As the sleeve 14 is pushed towards the

30 sleeve engaging portion 28 of the base elbow unit 24, the angled flats 44 of the sleeve 14

abut and ride upwardly along corresponding flats 46 of the sleeve engaging portion. Because of the angular relationship of these flats, movement of the sleeve towards the 5 sleeve engaging portion results in the rotation of the sleeve from any offset position, as shown in FIG. 5A, to the properly oriented, true position as shown in FIG. 5B. In this true position, the interlocking tab 22

10 abuts and is aligned with the upper tip 48 of the sleeve engaging portion 28. From this true position of FIG. 5B, a final thrust or push of the sleeve 14 towards the sleeve engaging portion 28 results in the

15 interlocking tab 22 overriding the upper tip

48 so that the tab 22 assumes the detent position depicted in FIG. 6.

In this detent position, the sleeve covers the cavity 40, and thereby affords some

20 protection against the entry of dirt. In this position, the sleeve also affords some protection to any antiseptic or bactericide placed within the cavity 40. Finally, the sleeve 14 in the detent position protects the

25 tube 12 at what may be its most vulnerable point, i.e., at the point where the tube 12 is bent at an acute angle.

As may be seen in FIGS. 3 and 6, interlocking tab 22 includes a lip 50 which

30 engages the upper tip 48. The lip 50 aids in preventing accidental separation of the sleeve

14 from the sleeve engaging portion 28. In fact, in a properly constructed device in accordance with this preferred embodiment, a relatively strong, straight pull on the sleeve 5 14 while in the detent position should fail to separate it from the sleeve engaging portion 28.

Rather, the sleeve 14 is separable from sleeve engaging portion 28 by imparting a

10 twisting motion. Specifically, the sleeve 14 is grasped and turned in either a clockwise or counterclockwise direction. This results in separation of these two elements because the twisting both moves the lip 50 of the

15 interlocking tab 22 away from and off-center of the tip 48, and also causes angled flats 44 of the sleeve to engage the angled flats 46 of the sleeve engaging portion 28, resulting in an essentially "camming"' action. To aid in

20 the secure grasping of the sleeve 14, one or more circumferential ribs 52 may be molded onto or otherwise integrally secured to the sleeve.

While the specific embodiments

25 have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying

30 Claims.