Gastrostomy catheter system

• US 5,458,583 A
• Filed: 06/12/1994
• Issued: 10/17/1995
• Est. Priority Date: 01/07/1993
• Status: Expired due to Term

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Medical Innovations Corporation (Kimberly-Clark Corporation)
• Inventors: Parks, Stephen, McNeely, Gwyn F., Decaria, Christine
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/289,841
• Time in Patent Office: 492 Days
• Field of Search: 604/96, 604/101, 606/191-194
• US Class Current: 604/103.13
• CPC Class Codes: A61J 15/0007 inserted by using a guide-wire guide wires A61M25/09
• 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 15/0061 fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
• CPC Class Codes: A61J 15/0073 Multi-lumen tubes
• 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 2025/0273 having slits to place the pad around a catheter puncturing site
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body

Abstract

A system and method for inserting a gastrostomy catheter through a passageway formed through the abdominal and stomach walls of a patient. The gastrostomy catheter is mounted onto a dilatation catheter with a dilatation member such as an inelastic balloon on the distal extremity thereof. An introducer needle is first advanced through the walls of the patient'"'"'s abdomen and stomach into the interior of the stomach and then a guidewire is advanced through the inner lumen of the needle into the stomach interior. The gastrostomy catheter-dilatation catheter assembly is advanced over the guidewire until the balloon on the dilatation catheter is in proper position crossing both the abdominal and gastric walls. Upon inflation of the balloon on the dilatation catheter, the passageway is expanded enough so that the gastrostomy catheter can be advanced therethrough to dispose the distal end of the gastrostomy catheter within the interior of the stomach. The balloon on the distal end of the gastrostomy catheter is inflated so as to form an internal retention member and the catheter withdrawn in order to urge the inflated balloon against the stomach wall. Preferably, the gastrostomy catheter has an external retention ring on the shaft thereof which is slid against the exterior of the patient'"'"'s abdomen to seal the passageway through the abdominal wall.

Claims

1. A gastrostomy catheter system comprising:

(a) outer gastrostomy catheter means adapted for long-term placement through a patient'"'"'s abdominal and stomach walls into the patient'"'"'s stomach cavity, said gastrostomy catheter means comprising;

(1) a gastrostomy tube having at least one lumen running the length of the gastrostomy tube and through which fluids may be introduced into the stomach cavity after the gastrostomy tube is in place; and

(2) means for securing the gastrostomy tube in place relative to the abdominal and stomach walls, said securing means comprising first inflatable means for securing the gastrostomy tube against the stomach wall and slidable retention means for securing the gastrostomy tube against the abdominal wall so as to essentially prevent movement of the gastrostomy robe relative to either wall; and

(b) inner dilatation catheter means for introducing the outer gastrostomy tube and the first inflatable means for securing the tube into the stomach cavity together with the dilatation catheter through an enlarged stoma formed by a second inflatable dilatation means, said dilatation catheter means being temporarily disposed in said lumen when introducing the gastrostomy tube and the first inflatable means for securing the tube in the stomach cavity, and thereafter being removable from said lumen to permit fluids to be introduced through the lumen into the stomach cavity and said dilatation catheter means comprising;

(1) an elongated catheter shaft having a sufficient length so that when the catheter shalt is disposed in the lumen of the gastrostomy tube, a distal portion of the catheter shaft will extend beyond the lumen of the gastrostomy tube and a proximal portion of the catheter shaft will be accessible at the opposite end of the lumen of the gastrostomy tube so as to permit removal of the catheter shaft after introducing the gastrostomy tube and first means for securing the tube in the stomach cavity; and

(2) a second inflatable dilatation means at said distal portion of the elongated catheter shaft and having an inflatable diameter larger than the first inflatable securing means, for radially expanding a passageway formed through the abdominal and stomach walls as the second inflatable dilatation means is inflated so that the passageway will thereafter accommodate introduction therethrough of the gastrostomy tube and first inflatable means for securing the tube, said dilatation means being located at the distal portion of the catheter shaft and being in fluid communication therewith so as to be inflatable by fluid communicated through the catheter shaft to the dilatation means.

2. The system of claim 1 wherein the second inflatable dilatation means is an inflatable member formed of relatively inelastic plastic materials.

3. The system of claim 2 wherein the dilatation member comprises a balloon that has a length of about 1 to about 15 cm and is adapted to have a maximum inflated diameter of about 5 to about 15 mm.

4. The system of claim 2 wherein the inflatable member is formed from a material selected from the group consisting of polyvinyl chloride, polyethylene, polyethylene, polyethylene terephthalate and polyolefinic ionomer.

5. The system of claim 1 wherein the gastrostomy tube comprises a guidewire lumen extending therein and an adapter releasably secured to a proximal end of the gastrostomy tube and which has an arm adapted for connection to a source of inflation fluid.

6. The system of claim 5 wherein the second inflatable dilatation means comprises an inflatable balloon formed of relatively inelastic material.

7. The system of claim 6 wherein the elongated catheter shaft of the dilatation catheter means comprises an inflation lumen extending therein which is in fluid communication with the interior of the inflatable balloon.

8. The system of claim 1 wherein the slidable retention means for securing the gastrostomy tube is comprised of an external retention member which is adapted to slide along said tube to the exterior of the patient'"'"'s abdominal wall.

9. The system of claims 1 or 8 wherein the first inflatable means for securing the gastrostomy tube comprises an internally inflatable member.

10. The system of claim 9 further comprising means for inflating the inflatable, member.

11. The system of claim 1 further comprising means for holding together the patient'"'"'s abdominal wall and stomach wall.

12. The system of claim 11 wherein the holding means is comprised of at least one T-fastener having an elongated suture fixed thereto with an end adapted to be passed through the patient'"'"'s stomach and abdominal walls and tied outside of the patient.

13. The system of claim 1 further comprising means to inflate the second inflatable dilatation means of the dilatation catheter means.