Low profile gastrostomy device

• US 4,863,438 A
• Filed: 11/29/1985
• Issued: 09/05/1989
• Est. Priority Date: 11/29/1985
• Status: Expired due to Term

• Current Assignee: Applied Medical Research
• Original Assignee: Applied Medical Technology, Inc.
• Inventors: Gauderer, Michael L., Siedlak, Dennis, Picha, George J.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Daley, Kathleen A.
• Application Number:
  US06/803,386
• Time in Patent Office: 1,376 Days
• Field of Search: 604/93, 604/117, 604/101, 604/279, 604/104, 604/175, 604/297, 604/105, 604/96, 604/178, 604/271, 604/280, 604/247, 604/256
• US Class Current: 604/247
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61J 15/0092 Valves on feeding tubes tube valves A61M39/22
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2039/0255 for access to the gastric or digestive system
• CPC Class Codes: A61M 2039/027 having a particular valve, seal or septum
• CPC Class Codes: A61M 2039/0276 for introducing or removing fluids into or out of the body
• CPC Class Codes: A61M 2039/0279 for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• CPC Class Codes: A61M 2039/0297 at least part of it being inflatable, e.g. for anchoring, sealing or removing
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Device includes a flexible, hollow tube portion having a resiliently deformable mushroom shape tip at the inner end thereof to retain the tube in the stomach or other viscera of a patient and provide an enlarged internal chamber for the mounting of a one-way flapper valve therein and the seating of the flapper valve against the inner end of the tube portion to prevent reflux of gastric contents while permitting the influx of fluids into the stomach or other viscera of the patient through the tube portion. A pair of oppositely extending, relatively short, flat wings are integrally molded on the outer end of the tube portion to make the tube portion self-retaining and flush up against the skin. The wings are relatively narrow in width, whereby the tube portion may be rotated a part turn to bring the wings into contact with different areas of the skin if irritation should occur. A plug is integrally molded on the outer end of one of the wings by a flexible membrane which permits the plug to be inserted into the tube at the outer end thereof and removed therefrom as desired.

Claims

1. A device designed to be inserted through an opening in the wall of the abdomen and stomach or other viscera of a patient comprising a hollow tube member having an inner end and an outer end, and a longitudinal passage extending completely through said tube member from one end to the other, an enlarged resiliently deformable tip at the inner end of said tube member, said enlarged tip being hollow and having an end wall surrounding the inner end of said tube member, flapper valve means mounted interiorly of said enlarged tip, said flapper valve means having one end mounted on said end wall radially outwardly of said passage, said flapper valve means overlying the inner end of said passage for direct sealing engagement therewith for preventing reflux of fluids into said tube member from said enlarged tip while permitting the influx of fluids through said tube member and past said flapper valve means into said enlarged tip, and opening means in said enlarged tip permitting the passage of fluid entering said tip from said tube member through said flapper valve means.

2. The device of claim 1 wherein said flapper valve means has a pair of flanged projections extending from one side adjacent one end thereof radially outwardly of said inner end of said tube member, and said end wall has correspondingly shaped openings therein for receipt of said flanged projections for attaching said flapper valve means to said end wall.

3. The device of claim 2 further comprising adhesive means between said one end of said flapper valve means and said end wall of said tip radially outwardly of said inner end of said tube member to aid in mounting said flapper valve means to said end wall.

4. The device of claim 1 wherein said end wall is relatively flat around said inner end of said tube, and said flapper valve means is relatively flat on one side for flat sealing engagement with said end wall around said inner end of said tube.

5. The device of claim 4 wherein the other side of said flapper valve means has a substantially V-shaped groove therein extending substantially the full width of said flapper valve means adjacent the inner diameter of said tube passage at the inner end thereof to provide a bend line about which the other end of said flapper valve means is free to flex for opening and closing the inner end of said passage.

6. The device of claim 5 wherein said other side of said flapper valve means is substantially flat except for said V-shaped groove.

7. The device of claim 1 wherein said device is made of a resiliently deformable plastic-like material, and said tip includes an enlarged semi-spherical portion integrally molded on the inner end of said tube member, said semi-spherical portion including said end wall on which said flapper valve means is mounted, and a separately molded outer cap portion which is adhesively secured to said semi-spherical portion after the mounting of said flapper valve means to said end wall, said outer cap portion having said opening means therein.

8. The device of claim 7 wherein the end of said semi-spherical portion remote from said end wall has a counterbore therein, and said outer cap portion has a stepped shoulder thereon for receipt in said counterbore to provide overlapping surfaces therebetween which are bonded together by an adhesive.

9. The device of claim 7 further comprising flange means integrally molded on the outer end of said tube member, the axial distance between the opposed surfaces of said tip and flange means substantially corresponding to the distance between the inside wall of the stomach and the outer abdominal wall of a patient, whereby when said device is inserted through an opening in the abdomen and stomach and the tip has expanded against the inside wall of the stomach, said flange means rests generally flush with the outside abdominal wall to make said device self-retaining.

10. The device of claim 9 wherein said tube member has a length between said opposed surfaces of approximately 0.5 to 2.0 inches.

11. The device of claim 9 wherein said tube member has a length between said opposed surfaces of approximately 0.590 inches for smaller patients, approximately 1.1 inch for intermediate size patients, and approximately 1.7 inch for larger patients.

12. The device of claim 9 wherein said flange means comprises a pair of diameterically spaced, oppositely extending, substantially flat wings integrally molded on the outer end of said tube member.

13. the device of claim 12 wherein said wings are relatively narrow in width whereby if irritation of the skin should occur in the area of said wings, said tube member can be rotated a part turn to cause said wings to overlie a different non-irritated area of the skin.

14. The device of claim 13 wherein said wings have a width of approximately 0.400 inch.

15. The device of claim 14 further comprising a plug integrally connected to the radial outer end of one of said wings by a flexible membrane which permits said plug to be inserted into the outer open end of said passage to completely close off said passage at the outer end of said tube member and removed therefrom as desired.

16. A device designed to be inserted through an opening into the stomach or other viscera of a patient comprising a hollow tube member made of a resiliently deformable plastic-like material, said hollow tube member having inner and outer ends and a longitudinal passage extending through said tube member from one end to the other, an enlarged resiliently deformable tip at the inner end of said tube member, said enlarged tip being hollow and having a relatively flat, radially extending end wall surrounding the inner end of said tube member, resiliently deformable flapper valve means having one end mounted on said end wall radially outwardly of the open inner end of said passage, said flapper valve means extending over the open inner end of said passage in sealing engagement with said end wall for preventing reflux of fluids into said passage from said enlarged tip while permitting the influx of fluids through said passage into said enlarged tip, and opening means in said enlarged tip for the passage of fluids entering said enlarged tip through said flapper valve means from said tube member, said enlarged tip including an enlarged semi-spherical portion integrally molded on the inner end of said tube member, said semi-spherical portion including said end wall onto which said flapper valve mens is mounted, and a separately molded outer cap portion which is adhesively secured to said semi-spherical portion after the mounting of said flapper valve means to said end wall of said semi-spherical portion, said outer cap portion having said opening means therein, a pair of diametrically spaced, oppositely extending, substantially flat wings integrally molded to the outer end of said tube member, the relative spacing between the opposed surfaces of said enlarged tip and wings substantially corresponding to the distance between the inside wall of the stomach and outside abdominal wall of a patient whereby when the device is inserted through an opening in the abdomen and stomach and the enlaged tip has expanded against the inside wall of the stomach, said wings rest generally flush with the outside abdominal wall to make said device self-retaining, said wings being relatively narrow in width whereby if irritation of the skin should occur in the area of said wings, said tube member can be rotated a part turn to cause said wings to overlie a different non-irritated area of the skin, and a plug integrally connected to one of said wings by a flexible membrane which permits said plug to be inserted into the outer open end of said passage to completely close off said passage at the outer end of said tube member and removed therefrom as desired.

17. The device of claim 16 wherein said flapper valve means has a pair of flanged projections extending from one side adjacent one end thereof, and said end wall has correspondingly shaped openings therein radially outwardly of said inner end of said tube for receipt of said flanged projections for mounting of said flapper valve means to said end wall, said flapper valve means being relatively flat on said one side for sealing engagement with said end wall, and the other side of said flapper valve means having a substantially V-shaped groove therein exending substantially the full width of said flapper valve means substantially in line with the inner diameter of said passage at the open inner end of said tube member to provide a bend line about which the other end of said flapper valve means is free to flex for openng and closing of said passage at said inner end of said tube member, said other side of said flapper valve means being substantially flat except for said V-shaped groove.

18. A device designed to be inserted through an opening in the wall of the abdomen and stomach or other viscera of a patient comprising a hollow tube member having an inner end and an outer end, and a longitudinal passage extending completely through said tube member from one end to the other, an enlarged resiliently deformable tip at the inner end of said tube member, valve means within said device for preventing reflux of fluids through said tube member from said enlarged tip while permitting the influx of fluids through said tube member into said enlarged tip, opening means in said enlarged tip permitting the passage of fluid entering said tip from said tube member through said valve means, a pair of diametrically spaced, oppositely, extending, substantially flat wings integrally molded on the outer end of said tube member, the axial distance between the opposed surfaces of said tip and said wings substantially corresponding to the distance between the inside wall of the stomach and the outer abdominal wall of a patient, whereby when said device is inserted through an opening in the abdomen and stomach and the tip has expanded against the inside wall of the stomach, said wings rest generally flush with the outside abdominal wall to make said device self-retaining, said wings being relatively narrow in width whereby if irritation of the skin should occur in the area of said wings, said tube member can be rotated a part turn to cause said wings to overlie a different non-irritated area of the skin.

19. The device of claim 18 further comprising a plug integrally connected to the radial outer end of one of said wings by a flexible membrane which permits said plug to be inserted into the outer open end of said passage to completely close off said passage at the outer end of said tube member and removed therefrom as desired.

20. The device of claim 18 wherein said enlrged tip has an end wall surrounding the inner end of said tube member, and said valve means comprises a valve member having one end mounted on said end wall radially outwardly of said passage, said valve means overlying the inner end of said passage for preventing reflux of fluids into said tube member from said enlarged tip while permitting the influx of fluids through said tube member and past said valve means into said enlarged tip.

21. A device designed to be inserted through an opening in the wall of the abdomen and stomach or other viscera of a patient comprising a hollow tube member having an inner end and an outer end, and a longitudinal passage extending completely through said tube member from one end to the other, an enlarged resiliently deformable tip at the inner end of said tube member, valve means within said device for preventing reflux of fluids through said tube member from said enlarged tip while permitting the inflx of fluids through said tube member into said enlarged tip, opening means in said enlarged tip permitting the passage of fluid entering said tip from said tube member through said valve means, a pair of diametrically spaced, oppositely extending, substantially flat wings integrally molded on the outer end of said tube member, the axial distance between the opposed surfaces of said tip and said wings substantially corresponding to the distance between the inside and outside walls of the viscera of a patient, whereby when said device is inserted through an opening in the viscera and the tip has expanded against the inside wall of the viscera, said wings rest generally flush with the outside wall to make said device self-retaining, said wings being relatively narrow in width whereby if irritation of the skin should occur in the area of said wings, said tube member can be rotated a part turn to cause said wings to overlie a different non-irritated area of the skin.

22. The device of claim 21 wherein said device is made of a resiliently deformable plastic-like material, and said tip includes an enlarged portion integrally molded on the inner end of said tube member.

23. The device of claim 22 wherein said enlarged portion is generally semi-spherical and has a separately molded outer cap portion adhesively secured thereto, said outer cap portion having said opening means therein.

24. The device of claim 23 wherein said enlarged portion has a counterbore therein, and said outer cap portion has a stepped shoulder therein for receipt in said counterbore to provide overlapping surfaces therebetween which are bonded together by an adhesive.