Low-profile enterostomy device

• US 6,902,541 B2
• Filed: 12/10/2001
• Issued: 06/07/2005
• Est. Priority Date: 02/18/2000
• Status: Expired due to Term

• Current Assignee: Zevex (Moog Incorporated)
• Original Assignee: Zevex (Moog Incorporated)
• Inventors: McNally, David J., Flores, Alejandro
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/016,669
• Publication Number:
  US 20020091365A1
• Time in Patent Office: 1,275 Days
• Field of Search: 604/332, 604/334, 604/335, 604/338, 604/27, 604/28, 604 30- 34, 604/43, 604/45, 604/48, 604/506, 604/93.01, 604/96.01, 604/97.01, 604/98.01, 604/99.01, 604 9902- 9904, 604/103.03, 604/264, 606/213, 606191-197
• US Class Current: 604/32
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61J 15/0065 Fixing means and tube being one part
• CPC Class Codes: A61J 15/0069 Tubes feeding directly to the intestines, e.g. to the jejunum

Abstract

An enterostomy device for providing fluids and nutrients through a stoma formed through the abdominal wall of a patient is described. The enterostomy device, which may be configured as either a gastrostomy device or a jejunostomy device, comprises a low-profile retaining member which is configured to be unobtrusively positioned within the stomach or the intestine, and which is configured to provide sufficient surface area for contacting the stomach or intestine to prevent unintentional removal or release of the enterostomy device from the patient. The enterostomy device is also structured with a low-profile port hub for facilitating the inflation of the retaining member and feeding and venting through the stoma.

Claims

1. An enterostomy device comprising:

a hollow stoma tube having a first end and a second end and a long axis extending therebetween;

a low-profile port hub secured to said first end of said stoma tube for selectively provided ingress and egress of fluids through said stoma tube, the low-profile port hub having an opening disposed in communication with and perpendicular to the hollow stoma tube;

a retaining member attached to said second end of said stoma tube and extending therefrom, said retaining member having an inflatable ring portion attached to the second end and spaced away from the stoma tube;

an inflation line positioned in proximity to said stoma tube and being in fluid communication with said inflatable ring of said retaining member; and

wherein said retaining member further comprises a skirt of flexible material encircling said second end of said stoma tube and attaching said second end to said inflating ring.

2. The enterostomy device of claim 1 wherein said inflatable ring and skirt are oriented in a generally perpendicular orientation to the longitudinal axis of said stoma tube upon full deployment.

3. The enterostomy device of claim 1 wherein said port hub comprises at least one port selectively positional to be in fluid communication with said stoma tube and selectively positionable to be in fluid with said inflation line.

4. The enterostomy device of claim 3 wherein said port hub is rotatable relative to said stoma tube, and wherein said stoma tube further comprises at least one opening, said port of said port hub being selectively movable between a position in alignment with said opening and a position out of alignment with said opening.

5. The enterostomy device of claim 4 wherein said stoma tube further includes a second opening, and said port is selectively moveable for alignment with a first opening and with said second opening.

6. The enterostomy device of claim 1 wherein said inflatable ring of said retaining member is a flattened toroidal ring.

7. The enterostomy device of claim 1 further comprising a flexible jejunostomy tube attached to and extending from said second end of said stoma tube.

8. An enterostomy device comprising:

a hollow stoma tube sized to be received through a stoma formed through the abdominal wall of a patient, said hollow stoma tube having a first end and a second end;

an inflation line configured with said stoma tube extending between said first end and said second end;

a retaining member attached to said second end of said stoma tube and being in fluid communication with said inflation line, said retaining member comprising an inflatable toroidal ring of biocompatible material coaxial with and secured to said stoma tube and extending therefrom;

at least one opening positioned at said first end of said stoma tube for delivery of substantially fluid substances through said stoma tube; and

wherein said retaining member further comprises a skirt of material attached to and extending from said second end of said stoma tube to said inflatable toroidal ring.

9. The enterostomy device of claim 8 further comprising a port hub disposed at the first end of the stoma tube, the port hub being rotatable relative to said stoma tube and having at least one port for selectively aligning with at least one opening formed though said stoma tube for selective delivery of said substantially fluid substances through said stoma tube.

10. The enterostomy device of claim 8 further comprising a jejunostomy tube secured to and extending from said second end of said stoma tube, in proximity to said retaining member.

11. A method of delivering fluids to a patient through a stoma formed through the abdominal wall of the patient comprising:

providing a gastrostomy device having a stoma tube, a port hub, and inflation line and a retaining member comprised of an inflatable ring extendable from said stoma tube, said retaining member being initially housed within said stoma tube for deployment;

positioning said stoma tube of said gastrostomy device through an existing stoma formed through the abdominal wall of the patient;

initiating ejection of said retaining member from said stoma tube; and

inflating said inflatable ring with said fluid until said inflatable ring is in contact with the lining of the patient'"'"'s stomach.

12. The method according to claim 11, further comprising injecting a substantially flowable substance through said stoma tube for delivery to the stomach.

13. The method according to claim 11, further comprising releasing fluid from said retaining member through said inflation line and removing said gastrostomy device from said stoma.

14. The method according to claim 11, wherein the method comprises selecting a stoma tube having a second end and the retaining member attached to the second end by a skirt of flexible material.

15. A method of delivering fluids to the intestine of a patient through a stoma formed through the abdominal wall of the patient, comprising:

providing a stoma tube having an opening form in conjunction with an inflation line having an opening and a port huh disposed thereon to selectively provide and prevent access to the opening of the stoma tube and the inflation line; and

rotating the port hub to selectively provide access to the opening in the stoma tube and the inflation line.

16. The method according to claim 15, wherein the method further comprises rotating the port hub so that access is provided to neither the opening of the stoma tube nor the opening of the inflation line.

17. A catheter for delivering fluids into a human body, the catheter having a balloon and comprising:

a stoma tube for delivering fluids, the stoma tube having an opening,

an inflation line configured with the stoma tube for inflating the balloon, the inflation line having an opening, and

a port hub, baying a rotatable opening and selectively disposed in communication with the stoma tube and the inflation line for selectively delivering fluids therethrough.

18. The catheter for delivering fluids of claim 17, wherein the inflation line and the stoma tube each have a long axis and wherein the openings of the inflation line and the stoma tube are disposed generally perpendicular to the long axis.

19. An enterostomy device comprising:

a hollow stoma tube sized to be received through a stoma formed through the abdominal wall of a patient, said hollow stoma tube having a first end with an opening and a second end;

an inflation line configured with said stoma tube extending between said first end with an opening and said second end;

a port hub rotatable so as to selectively provide access to the opening at the first end of the stoma tube and the opening at the first end of the inflation line.

20. The enterostomy device according to claim 19, wherein both the stoma tube has a long axis and the opening is disposed transverse to the long axis.

21. The enterostomy device according to claim 20, wherein the infusion line has a long axis and the opening of the infusion line is disposed transverse to the long axis.