CA2056085C

CA2056085C - Package for initial placement of low profile gastrostomy device and method of placement

Info

Publication number: CA2056085C
Application number: CA002056085A
Authority: CA
Inventors: George J. Picha; Dean J. Secrest
Original assignee: Applied Medical Technology Inc
Current assignee: Applied Medical Technology Inc
Priority date: 1990-12-13
Filing date: 1991-11-25
Publication date: 2001-01-23
Anticipated expiration: 2011-11-25
Also published as: CA2056085A1; EP0561945A1; DE69118913D1; DE69118913T2; AU9101291A; EP0561945B1; JP3045771B2; BR9107184A; US5084014A; WO1992010222A1; JPH06503243A; AU651417B2; EP0561945A4

Abstract

A low profile or skin level gastrostomy device (20) for initial endoscopic placement in an incision provided through the stomach (64) and abdominal walls (62) of a patient having a collapsed resilient end portion (24) packaged and compressed within a shroud (30) that allows the end portion (24) of the device (20) positioned within the stomach (61) to easily pass from the inner to the outer end of the incision. The shroud (30) is pulled or pushed outwardly through the incision until the device (20) is properly positioned therein. Subsequent to device placement, the shroud (30) is removed and discarded, allowing the now external end portion (24) of the device (20) to expand to its normal position so as to engage the outer surface of the abdominal wall (62) to maintain the device (20) in position. Such a gastrostomy device package (10) and method of placement avoid the need for establishing a fistulas stoma tract before placement of a low profile gastrostomy device, as is the usual case.

Description

PACKAGE FOR INITIAL PLACEMENT OF LOW PROFILE
GASTROSTOMY DEVICE AND METHOD OF PLACEMENT
BACKGROUND OF THE INVENTION
1 The present invention relates in general to gastrostomies providing long term 2 enteral feeding and, more particularly, to a gastrostomy device packaging technique and 3 installation method for initially placing a low profile gastrostomy device in a patient without 4 first establishing a fistulas stoma tract as heretofore required by the prior art.
Low profile or skin level gastrostomy devices and the advantages attendant to 6 their use are known in the art, as exemplified by U.S. patent 4,863,438.
This patent, 7 assigned to the assignee of the present invention, discloses a gastrostomy device having an 8 intragastric end located within a body cavity such as the stomach of the patient, a tubular 9 midportion extending from the intragastric end outwardly through the stomach and abdominal walls, and an external low profile end having a pair of winglike projections that engage the 11 outer surface or skin of the patient's abdominal wall to maintain the gastrostomy device in 12 proper position for intermittently receiving a conventional internal feeding tube projecting into 13 the stomach.
14 Such a prior art device is often referred to as a "replacement" gastrostomy device, since it is substituted for the usual gastrostomy tube that is initially placed in a patient 16 for six to eight weeks until a fistulas stoma tract is established. Once the stoma tract is 17 established, the 1 gastrostomy tube is removed, and the "replacement" gastros-2 tomy device is inserted into the stoma tract.
3 It is a goal of the present invention to eliminate 4 the need for. first establishing a fistulas stoma tract prior to installation of a low profile gastrostomy device of the 6 type disclosed in the earlier-noted patent. B,v eliminating 7 the use of a gastrostomy tube to establish the stoma tract, 8 medical costs associated therewith can be eliminated, Also, 9 initial placement of a low profile .gastrostomy device allows the patient to immediately benefit from the advantages 11 inherent in the use of a low profile gastrostomy device as 12 opposed to a gastrostomy tube.

In accordance with the present invention, a gas-16 trostomy device package is provided to permit initial place-17 ment of a low profile gastrostomy device in an incision 18 extending from outside a living body into an internal body 19 cavity such as a stomach. The gastrostomy device includes a tubular mid-portion having an inner end providing an 21 intragastric portion and an outer end providing a collapsible 22 external portion. A shroud means surrounds and encloses the 23 external portion to maintain it in a collapsed condition 24 within the shroud means. The shroud means facilitates movement of the external portion of the gastrostomy device 26 through the incision and is removable to allow the external 27 portion to expand to a normal uncollapsed condition subse-28 ~quent to the placement of the gastrostomy device in the 29 incision.
Preferably, the shroud means is elongated and has 31 a distal end that is at least partially tapered to function .,a-.
3 20560&5 1 as a dilator, facilitating movement of the shroud through the 2 incision from the internal body cavity outwardly to the 3 external surface of the body. In one embodiment, the tapered 4 distal end of the shroud is provided with a wire loop so that it can be pulled outwardly through the incision. In another 6 embodiment, the tapered distal end is provided with a longi-7 tudinally extending bore that can receive a guidewire'so that 8 the distal end can be pushed outwardly through the incision.
9 Preferably, at least the external portion of the gastrostomy device is formed of resilient elastomeric materi-11 al, such as biocompatible silicone rubber, so that it can be 12 easily collapsed and compressed within the shroud means. The 13 external portion includes at least two winglike projections 14 extending radially away from the longitudinal axis of the gastrostomy device. When being retained within the shroud 16 means, the winglike projections are folded towards each other 17 so that they lie along generally parallel lines ad,iacent to 18 and bracketing the longitudinal axis. A sleeve of plastic 19 film material constituting a part of the shroud means extends over the winglike projections to retain them in their col-21 lapsed condition. After the gastrostomy device package is 22 properly positioned within the incision, the plastic film is 23 cut and peeled away so that the winglike projections can move 24 to their normal laterally extending positions so as to engage the outer surface or skin of the body, thereby retaining the 26 gastrostomy device in its proper position.
27 In further accordance with the invention, a method 28 of placing a gastrostomy device of the above-noted type 29 includes the steps of providing an incision extending from the external surface of a living body to an inner body cavity 31 such as the stomach, positioning within said cavity a gas-32 trostomy device package as noted above, inserting the shroud 33 means of the gastrostomy device into the incision and moving 34 the shroud means from the inner end of the incision out 1 through the outer end thereof so as to position the tubular 2 midportion of the device within the incision, and then 3 removing the shroud means to allow the external portion to 4 expand to a normal uncollapsed condition so that the now expanded external portion engages the outer surface of the 6 body to maintain the gastrostomy device in position: In 7 practicing the method of placing the gastrostomy device, the 8 shroud can either be pulled through the incision or pushed 9 through the incision, depending upon the type of gastrostomy device package utilized, as noted above.

13 A fuller understanding of the invention may be had 14 by referring to the following description and claims, taken in conjunction with the accompanying drawings, wherein:
16 FIG. 1 is a longitudinal, partial, cross-sectional 17 view of a first embodiment of a gastrostomy device package 18 in accordance with the present invention;
19 FIG. 2 is an exploded view of the gastrostomy device package of FIG. 1;
21 FIGS. 3A-3F sequentially illustrate the methodology 22 for placing the gastrostomy device of FIGS . 1 and 2 in an 23 incision in a living body, such as a human being;
24 , FIG. 4 is a longitudinal, partial, cross-sectional view of a second embodiment of a gastrostomy device package 26 in accordance with the present invention; and 2~~~~85 1 FIGS. 5A-5F sequentially illustrate the methodolo~~r 2 for placing the gastrostomy device of FIG. 4 in an incision 3 in a living body, such as a human being.

With reference to FIGS. 1 and 2, a first embodiment 6 of a gastrostomy device package in accordance with the 7 present invention is illustrated. The package 10 is general-8 ly elongated so as to extend along a lon.gitudina7. axis x-x, 9 as illustrated. The package 10 is comprised of two major portions, namely, a low profile gastrostomy device 20, often 11 referred to in the art as a "gastrostomy button," and a 12 shroud means 30 comprised primarily of a dilator member 40.
13 and a plastic film material 50 constituting a tubular sleeve 14 extending generally completely over the dilator 40. The gastrostomy device 20 illustrated is of the type disclosed 16 in earlier incorporated U.S. patent 4,863,438. The device 17 20 includes an intragastric portion 22 located at one end of 18 a tubular midportion 23 having at its other end a resilient 19 external portion 24. The device 20 is preferably formed of biocompatible silicone rubber material so as to be flexible 21 and elastomeric. The length of the tubular portion is sized 22 to be dimensionally compatible with the combined thickness 23 of, for example, a patient's stomach and abdominal walls.
24 The external portion 24 of the gastrostomy device 20 includes a pair of diametrically opposed winglike projec-26 tions 25, one of which has extending from it a plug retainer 27 26 which has a distal end providing a plu;~ 27, wherein the 28 plug retainer 26 can be folded over to permit, insertion of 29 the plug 27 into a feeding tube receptor port 28. As is known in the art, when positioned within, for example, a r-.

1 human or animal patient undergoing medical treatment, an 2 enteral feeding tube can be inserted into port 28 through 3 the tubular midportion 23 and into the intragastric portion 4 22 to effect the flow of fluid either into or out of a body cavity, such as the patient's stomach, within which the 6 intragastric portion is located. It is to be noted that the 7 intragastric portion 22 includes within it, the usual normally 8 closed reflux valve (not shown) which prevents egress of 9 fluid outwardly through the tubular portion 23 when the enteral feeding tube is not maintaining the valve in an open 11 position.
12 With particular reference to FIG. 1, the flexible 13 wingl.ike projections 25, including the associated plug 14 retainer 26 and plug 27, are shown in a folded or collapsed condition so that they extend along parallel lines adjacent 16 to the axis x-x, as illustrated. The dilator 40 provides a 17 pair of opposed flats or recesses 44 against which the 18 winglil~e projections 25 are held in their folded or collapsed 19 position by the plastic film 50 in the preferred form of a tubular sleeve of heat-shrink or shrink-wrap type plastic 21 film. In its collapsed condition, the external portion 24 22 (FIG. 2) is contained within and compressed by the shroud 23 means 30, and, more specifically, the plastic film 50. It 24 is to be noted that, while the winglike projections 25 of FIG. 1 are shown folded and extending toward the right, they 26 could also be folded toward the left against opposite sides 27 of tubular midportion 23 and held in place by extending the 28 plastic film 50 leftward to overlap them and maintain them 29 in a collapsed condition. The dilator member 40 further includes a plug retainer recess or flat 46 having a plug 31 pecess 47 into which the plug 27 fits, as illustrated in FIG.
32 1. It is contemplated that the plug retainer 26 and plug 27 33 could be eliminated and, instead, a separate plug structure 34 could be provided after placement of the device 20 in a 20~608~
1 patient, as will become apparent. The dilator member 40 has 2 a tapered distal end 42 which is provided with a pull wire 3 loop 43 embedded within the dilator member, as illustrated.
4 With further reference to FIG. 1, the dilator 40 is also provided with a reduced diameter portion 48 which 6 forms an inboard part of a retainer tip 49 that extends and 7 snaps into the external end 24, i.e., port 28, of the ;tubular 8 portion 23, as illustrated. The gastrostomy device 20 is 9 provided with an annular or circular lip 29 that fits into the reduced diameter portion 48, constituting a circular 11 groove, so as to provide a releasable locking means holding 12 the gastrostomy device 20 in position relative to the dilator 13 40. It can also be seen that an open, or leftward end as 14 viewed in FIG. 1, of the plastic film 50 constituting a tubular sleeve extends beyond and over both the circular lip 16 29 and its associated annular groove constituted by reduced 17 diameter portion 48, so as to hold and compress the circular 18 lip 29 into the reduced diameter portion 48 of the dilator 19 40.
With reference to FIG. 2, a guide groove 45 is 21 provided, as illustrated, on a surface of the dilator member 22 40 spaced from the external end portion 24 of the gastrostomy 23 device 20 when in its position as illustrated in FIG. 1. The 24 guide groove provides an indicator point for partially cutting the plastic film 50 and peeling it around and away 26 from the dilator member 40, as illustrated in FIG. 2, so that 27 the gastrostomy device 20 and the dilator member 40 can be 28 separated from each other so as to allow the resilient 29 winglike projections 25 to return to a normal expanded position as illustrated in FIG. 2.
31 , Thus, FIG. 1 illustrates a gastrostomy device 32 package for initial placement of the gastrostomy device 20 33 in a patient, as discussed below, while FIG. 2 illustrates 34 the package in a disassembled form after the device has been ~0~608~
1 placed within an incision in the patient, as will now be 2 discussed.
3 With reference to FIGS. 3A-3F, a method of placing 4 in a patient the gastrostomy device as illustrated and discussed with regard to FIGS. 1 and 2 will now be set forth.
6 Turning to FIG. 3A, there is schematically illus-7 trated a patient having an inner body cavity such as a 8 stomach 61 within which is to be placed the gastrostomy 9 device in accordance with the present invention. It is to be noted that the gastrostomy device package and method of 11 placement disclosed and claimed herein can be used for 12 inserting a gastrostomy device into other viscera of the body 13 for other applications, such as, for example, urinary bladder 14 drainage, ileostomy, jejunostomy, and cystostomy.
The outer surface 60 or skin of the patient extends 16 over an abdominal wall 62, which in turn abuts the stomach 17 wall 64. In a first step for placing the gastrostomy device 18 package discussed earlier, the stomach 61 of the patient is 19 insufflated via an endoscope tube 65 extending down through the esophagus 63 of the patient, as illustrated. As illus-21 trated in FIG. 3B, a conventional trocar needle 66 is in-22 serted through the abdominal and stomach wall of the patient 23 to establish an incision that will receive a gastrostomy 24 button.
As shown in FIG. 3C, a pull wire 67 is inserted 26 down through the trocar needle 66 so that its end can be 27 captured by a snare 68 extending through the endoscope tube 28 65. With further reference to FIG. 3D, the pull wire 67 has 29 been pulled outwardly through the patient's mouth 69 so that the pull wire 43 of the gastrostomy device package can be 31 attached, as illustrated. Turning to FIG. 3E, the gastrosto-32 my device package 10, by use of the pull wire 67, has been 33 pulled down the esophagus 63 of the patient, and then through 34 the incision provided by the trocar needle 66. At this 2o~so~~
1 point, the shroud means 30 (see FIGS. 1 and 21 is removed.
2 Turning to FIG. 3F, and as earlier discussed with 3 regard to FIG. 2, the intragastric portion 22 of the gastros-4 tomy device 20 is now located within the stomach 61 of the patient, while the tubular midportion extends through the 6 stomach wall 64 and abdominal wall 62, with the winglike 7 projections 25 in their extended, uncollapsed, normal posi-8 tion engaging the outer surface 60 of the abdominal wall 62, 9 wherein the gastrostomy device 20 is now retained in posi-tion.
11 By use of the gastrostomy device package illus-12 trated in FIGS. 1 and 2 and the methodology for placing it 13 as illustrated in FIGS. 3A-3F, the use of the traditional 14 gastrostomy tube to establish a fistulas stoma tract is avoided. Thus, the cost and patient trauma associated 16 therewith are eliminated, and the benefits afforded by the 17 low profile gastrostomy device 20 are available at an earlier 18 point in time to the patient requiring a gastrostomy.
19 Turning to FIG. 4, another embodiment of the present invention is illustrated. An alternative gastrostomy 21 device package 110 can also be used for initial placement of 22 the gastrostomy device 20, which is identical to that illus-23 trated in FIGS. 1 and 2. As shown in FIG. 4, an alternative 24 shroud means 130 includes additional components to permit installation of the gastrostomy device 20 by use of a guide-26 wire type method of the type disclosed in U . S . Patent No .
27 4,758,219, incorporated herein by reference in its entirety.
28 As contrasted to the gastrostomy device package 10 29 illustrated in FIGS. 1 and 2, a tapered dilator member 140 has extending longitudinally through it a bore 141 that is 31 pf a diameter that will accept a guidewire (to be subsequent-32 ly illustrated). A secondary or lateral bore 192 extending 33 between the central bore 141 and the exterior of the dilator 34 140 as illustrated provides an alternative guidewire path so 1 as to avoid passing a guidewire through the gastrostomy 2 device 20, as may be desirable in some cases. The distal 3 end of the dilator member 140 is connected to one end of a 4 flexible guide tube 174. The other end of the guide tube 174 is provided with a tapered dilator tip 176 having a central 6 bore 178. Thus, the shroud means 130 of the embodiment of 7 the invention illustrated in FIG. 4 includes the dilator 8 member 140, the guide tube 174, and the dilator tip 176.
9 The shroud means 130 also includes a tubular sleeve of shrink-wrap type plastic film 150, serving the same function 11 in terms of retention of the winglike projections 25 as dis-12 cussed earlier with regard to FIGS. 1 and 2. It can be seen 13 that the dilator member 140 has a tapered outer surface 14 portion extending toward the guide tube 174 to which it is connected. Also, the dilator tip 176 is tapered to a point.
16 These sequential tapers facilitate movement of the shroud 17 means 130 from the inward to the outward end of an incision 18 in a patient, as will now be .further illustrated with regard 19 FIGS. 5A-5F.
With reference to FIG. 5A, an endoscope tube 65 21 inserted into the esophagus 63 of the patient is used to 22 insufflate the stomach 61 so that the stomach wall 64 is held 23 tightly against the abdominal wall 62. Turning to FIG. 5B, 24 a conventional trocar needle 66 is used to establish an incision from the outer surface 60 of the abdominal wall 62 26 into the stomach 61. As shown in FIG. 5C, a guidewire 167 27 is fed down through the trocar needle and then retrieved by 28 a snare 68, wherein the endoscope tube 65 with guidewire 167 29 is withdrawn from the esophagus 63.
As shown in FIG. 5D, the guidewire 167 extends 31 through the trocar needle 66, through the patient's esophagus 32 63, and out of the patient's mouth. The gastrostomy device 33 package 110 is then, in effect, threaded over the guidewire 34 167, using either central bore 141 or lateral bore 142, and 11.
20~608~
1 then pushed downwardly along the guidewire 167 through the 2 esophagus 63 of the patient so that the dilator tip 176 and 3 its associated flexible guide tube 174 are pushed outwardly 4 through the incision in the abdominal wall of the patient.
With reference to FIG. 5E, the guide tube 174 has 6 been pushed and then pulled completely through the incision, 7 which now retains the gastrostomy device package 7.10, as 8 illustrated. At this point, and as discussed earlier in 9 connection with FIG. 4, the shroud means 130 is then removed by cutting and peeling away plastic material 150 so that, as 11 shown in FIG. 5F, the winglike projections 25 will expand to 12 their normal position so as to engage the outer surface 60 13 or skin of the patient, whereby the tubular midportion 23 14 extends through the abdominal wall of the patient, the intragastric portion 22 being maintained in its desired 16 position within the patient's stomach 61.
17 From the foregoing, it may be seen that the two 18 embodiments of the gastrostomy device package illustrated in 19 FIGS. l, 2 and 4 and their associated methodologies of placement illustrated in FIGS. 3A-3F and FIGS. 5A-5F provide 21 for initial placement of a low profile gastrostomy device.
22 It should be evident that this disclosure is by way 23 of example, and that various changes may be made by adding, 24 modifying or eliminating details without departing from the fair scope of the teaching contained in this disclosure. The 26 invention is therefore not limited to the particular details 27 of the disclosure except to the extent that the following 28 claims are necessarily so limited.

Claims

1. A gastrostomy device package comprising:
a gastrostomy device with a tubular midportion having an inner end providing an intragastric portion locatable in an internal cavity of a living body, and an outer end providing a collapsible external portion locatable at the outer surface of said living body; and a shroud means surrounding and enclosing said external portion to maintain said external portion in a collapsed condition within said shroud means, said shroud means being removable to allow said external portion to expand to a normal uncollapsed condition subsequent to the placement of the gastrostomy device in said living body.

2. A package according to claim 1, wherein the shroud means is elongated and has a distal end that is at least partially tapered.

3. A package according to claim 2, wherein said distal end is provided with a wire loop.

4. A package according to claim 2, wherein said distal end is provided with a longitudinal bore extending therethrough for receiving a guidewire along which said distal end can be moved.

5. A package according to claim 1, wherein said collapsed external portion is compressed within said shroud means.

6. A package according to claim 1, wherein said external portion is formed of resilient elastomeric material.

7. A package according to claim 1, wherein said shroud means includes a heat shrinkable plastic film material constituting a shrink-wrap package containing said external portion.

8. A gastrostomy device package comprising:
a gastrostomy device with an elongated tubular midportion coaxially extending along a longitudinal axis, said midportion having an inner end providing an intragastric portion locatable in an internal cavity of a living body, and an outer end providing a collapsible external portion locatable at the outer surface of said living body, said external portion including at least two winglike projections extending radially away from said axis when said external portion is in a normal uncollapsed condition; and a shroud means including a tubular sleeve of plastic film material surrounding and enclosing said external portion to maintain said external portion in a collapsed condition within said sleeve wherein said projections extend along lines generally parallel to said longitudinal axis so that the lateral extension of said external portion is reduced, said sleeve being removable to allow said projections to expand and extend radially away from said axis when said external portion is in a normal uncollapsed condition subsequent to the placement of the gastrostomy device in said living body.

9. A package according to claim 8, wherein said projections are in adjacent, generally parallel relationship with each other when said external portion is in a collapsed condition within said sleeve.

10. A package according to claim 8, wherein said projections are diametrically opposed to each other relative to said longitudinal axis.

11. A package according to claim 8, wherein said projections are formed of resilient elastomeric material.