Flexible retainer flange for gastrostomy tube and the method of installing it

• US 5,356,391 A
• Filed: 06/22/1992
• Issued: 10/18/1994
• Est. Priority Date: 06/22/1992
• Status: Expired due to Term

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Medical Innovations Corporation (Kimberly-Clark Corporation)
• Inventors: Stewart, Daren L.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/901,894
• Time in Patent Office: 848 Days
• Field of Search: 604/49, 604/54, 604/104, 604/105, 604/174, 604/175, 604/264, 604/280, 128/DIG. 26
• US Class Current: 604/175
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0023 inserted by using a sheath
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 15/0061 fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
• 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: Y10S 128/26 Cannula supporters

Abstract

A gastrostomy tube having a collapsible, internal retention flange is disclosed, and the gastrostomy tube is inserted into a patient'"'"'s stomach by a percutaneous endoscopic or other suitable technique. The internal retention flange comprises a dome shape that will not only reduce patient risk during the placement procedure, but will also allow for a more consistent and less traumatic external removal procedure.

Claims

1. A gastrostomy tube comprising:

a catheter member comprising a distal end for placement within a patient'"'"'s stomach, and a proximal end extending outside of the patient to provide access for feeding the patient through the catheter member; and

a dome-shaped flange means mounted to the distal end within the stomach and having a first diameter for retaining the gastrostomy tube in place within the stomach of the patient, the dome-shaped flange means comprising a sufficiently resilient and flexible reinforcing means for collapsing the dome-shaped flange means upon itself to form a second diameter smaller than the first diameter so as to become elongated in form to permit passage of the dome-shaped flange means through a body opening without the aid of an insertion and removal tool when the dome-shaped flange means is drawn through a body opening having a diameter less than the first diameter in response to a traction force applied to the catheter member.

2. The gastrostomy device of claim 1, in which the dome-shaped flange means is secured to the catheter by one of adhesives, heat sealing, sonic bonding, or by being integrally formed therewith.

3. The gastrostomy device of claim 1, in which the reinforcing means comprises a reinforcement member having a shape including cruciform, elliptical, triangular, rectangular, striated, and asterism.

4. The gastrostomy device of claim 3, in which the reinforcement member is formed on the dome-shaped flange means by one of heat sealing, adhesive sealing, sonic bonding and integrally forming by injection molding.

5. The gastrostomy device of claim 3, in which the dome-shaped flange means is about 20-35 mils thick, the reinforcement member is about 20-25 mils thick, and a central area of the dome-shaped flange means is about 40-60 mils thick.

6. The gastrostomy device of claim 1, in which the dome-shaped flange means and catheter member are constructed of a biocompatible polymer selected from the class consisting of a silicone elastomer, silicone copolymer and polyurethane.

7. The gastrostomy tube of claim 1, providing an extension of the catheter member from the patient, a feeding port being mounted on the extension, and a gasket mounted along the catheter member, and forming a sliding friction fit therewith to accommodate for peristaltic expansion and stomach movements, and to prevent the catheter member from being drawn into the patient.

8. A gastrostomy tube comprising:

a catheter member comprising a distal end for placement within a patient'"'"'s stomach, and a proximal end extending outside of the patient to provide access for feeding the patient through the catheter member; and

a flange means mounted at the distal end of the catheter member for retaining the gastrostomy tube in place within the stomach of the patient, the flange means comprising a flexible thin-walled retention dome member having an approximately hemispherical shape, and being reinforced by a reinforcing member completely joined to a surface of the dome member, and the reinforcing member having a shape that together with the dome member defines a first thickened central portion, and remaining portions of the dome ember without the reinforcing member defining other thinner, peripheral portions, the flange means and catheter member being constructed of a biocompatible polymer, and the other thinner peripheral portions of the dome ember causing the dome member to collapse upon itself so as to form an elongate shape without the aid of an insertion and removal tool when passing through a body opening smaller than the uncollapsed dome member during placement or removal of the gastrostomy tube, and the first thickened central portion causing the dome member to expand from its collapsed shape back to its hemispherical shape solely due to its flexibility and without requiring the use of a tool after passing completely through the body opening, so as to thereafter conform to the patient'"'"'s stomach, and thereby securing the gastrostomy tube in place therein.

9. The gastrostomy device of claim 8, in which the biocompatible polymer is selected from the class consisting of:

silicone elastomer, silicone copolymer and polyurethane.

10. A method of installing a gastrostomy tube, the gastrostomy tube comprising:

a.) a catheter member for positioning within a patient'"'"'s stomach, the catheter defining distal and proximal ends, the proximal end extending from the patient for attachment to a feeding means; and

,

b.) a flange mounted at the distal end of the catheter for retaining the gastrostomy tube in place in the patient, the flange defining a flexible, thin-walled retention dome structure having an approximately hemispherical shape, and being stabilized by a reinforcement, positioned thereon, the dome and reinforcement defining a thickened central portion on the dome and a thinner, partially reinforced peripheral portion, the thin-walled structure having an approximately hemispherical shape, and being stabilized by a reinforcement, positioned thereon, the dome and reinforcement defining a thickened central portion on the dome and a thinner, partially reinforced peripheral portion, the thin-walled structure of the dome causing the dome to collapse to a compact shape during placement of the gastrostomy tube, the method comprising;

i. placing the gastrostomy tube in the patient'"'"'s stomach, and in an initial position, collapsing the dome during placement of the gastrostomy tube;

ii. securing the gastrostomy tube within the patient'"'"'s stomach during use, by expanding the dome from its collapsed position during placement to maintain its hemispherical shape, solely due to its plastic memory, and without requiring use of a tool, and conforming the dome to the patient'"'"'s stomach; and

,

iii. removing the gastrostomy tube from the patient'"'"'s stomach, collapsing the dome in a uniform manner from its peripheral portion to the central portion within the stoma, due to the thin-walled structure of the dome, thereby facilitating removal of the gastrostomy tube solely by an external traction force applied longitudinally along the axis of the catheter tube, without requiring use of a removal tool, with reduced pain and trauma to the patient.

11. The method of claim 10, in which during removal of the gastrostomy from the patient, an initial collapse of the flange occurs, and this initial collapse can be felt by a health care worker, thereby enabling less subsequent force to be applied to the gastrostomy tube during the remaining portion of the removal procedure.

12. The method of claim 11, in which the flange is secured to the catheter by one of heat sealing, adhesives, sonic bonding, or by integrally forming by insert molding.

13. The method of claim 12, in which the reinforcement has a shape including, cruciform, elliptical, rectangular, triangular, striated and asterism.

14. The method of claim 13, in which the reinforcement is formed on the dome by one of heat sealing, adhesive sealing, sonic bonding and integrally forming by insert molding.

15. The method of claim 14, in which the dome is about 20-35 mils thick, the reinforcement about 20-25 mils thick, and the dome central area is about 40-60 mils thick.

16. The method of claim 15, in which the flange and catheter are constructed of a biocompatible polymer selected from the class consisting of a silicone elastomer, silicone copolymer, and polyurethane.

17. The method of claim 10, providing an extension of the catheter from the patient, a feeding port being mounted on the extension, and a gasket mounted along the catheter, and forming a sliding friction fit therewith to accommodate for peristaltic expansion and stomach movements, and to prevent the catheter from being drawn into the patient.