Device for intubation of percutaneous endoscopic ostomy

• US 4,795,430 A
• Filed: 01/15/1988
• Issued: 01/03/1989
• Est. Priority Date: 01/15/1988
• Status: Expired due to Fees

• Current Assignee: CORPAK MedSystems, Inc. (Avanos Medical, Inc.)
• Original Assignee: Corpak Inc (Avanos Medical, Inc.)
• Inventors: Quinn, David G., Andersen, Erik, Edwards, Robert B. II
• Primary Examiner(s): Grieb, William H.
• Application Number:
  US07/144,527
• Time in Patent Office: 354 Days
• Field of Search: 604/96, 604/97, 604/98, 604/99, 128/4, 128/6
• US Class Current: 604/102.02
• CPC Class Codes: A61J 15/0019 inserted by using a pull-wire
• CPC Class Codes: A61J 15/0042 inflatable
• CPC Class Codes: A61J 15/0073 Multi-lumen tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A unique device for intubating an ostomy, formed by a percutaneous endoscopic technique including a multi-lumen tube, having at least a fluid delivery lumen and an inflation lumen. The tube includes a port near one end to dispose the inflation lumen to ambient air and an outlet at an other end to convey fluid from within the fluid lumen into a patient. A retention member, preferably an inflatable cuff, is joined near the other end of the tube and is inflatable and deflatable through the inflation lumen. In a deflated state, the cuff assumes an edge-free outer configuration to facilitate intubation of the device into the patient. In a fully inflated state, the cuff assumes an outer configuration defining an edged, generally flat surface to more diffusely contact and abut against inner tissue surfaces surrounding the gastrostomy. Joined to the one end of the tube is an elongated tapered sleeve which encloses the one end of the tube. The tapered end of the sleeve carries a suture loop for use in intubating the device. The sleeve includes a skirt portion which creates a circumferential air-tight seal about the tube to selectively seal the ambient air port. The skirt portion is air pressure responsive to permit escape of air from the inflation lumen through the port but preventing the ingress of air into the inflation lumen through the port.

Claims

1. A device for intubating an ostomy, such as a gastrostomy, formed by a percutaneous endoscopic technique, comprising:

a tube having at least a fluid lumen and an inflation lumen, the tube having a port near one end to dispose the inflation lumen to ambient air and an outlet at an other end to convey fluid from within the fluid lumen into the patient;

a retention member joined near the other end of the tube, the member being inflatable through the inflation lumen, the member in a deflated state having a generally edge-free outer configuration to facilitate intubation, the member in an inflated state defining at least one edged and generally flat retention and anchoring surface;

an elongated sleeve joined to and enclosing the one end of the tube, the sleeve being edge-free to define an edge-free outer configuration for gently parting gastroenteral tissues during intubation;

means for sealing selectively the ambient air port of the tube, the sealing means permitting escape of air from the inflation lumen through the port but preventing ingress of air into the inflation lumen;

wherein prior to intubation of the device into a patient the retention member is compressed to deflate the member by expelling air out of the inflation lumen through the port, the sealing means seals the port to prevent re-inflation of the member, the one end of the tube is drawn through the patient in a retrograde manner until the deflated retention member abuts against inner tissue surfaces of the gastrostomy, air is introduced into the inflation lumen to re-inflate the member and anchor the device against the inner tissue surfaces of the gastrostomy, and the inflation lumen is sealed to prevent deflation of the retention member.

2. The device of claim 1 wherein the means for selectively sealing the port includes:

a skirt portion joined to the sleeve, the skirt portion forming an air-tight seal about the circumference of the tube, the skirt portion expanding outwardly in response to greater air pressure within the inflation lumen to permit expulsion of air out of the port and contracting inwardly in response to greater air pressures outside the inflation lumen to seal the port.

3. The device of claim 1 wherein the inflatable retention member includes a substantially foam filled annular cuff.

4. The device of claim 3 wherein the annular cuff has at least one generally flattened surface for abutment against the inner surfaces of the gastrostomy.

5. The device of claim 1 wherein a loop of suture is carried on a terminal end of the sleeve to draw the device in a retrograde manner through the esophagus and the gastrostomy.

6. The device of claim 5 wherein the terminal end of the sleeve has a conical shape.

7. In a method for intubating an ostomy formed by a percutaneous endoscopic technique, the technique including inserting a fiberoptic endoscope into a patient'"'"'s mouth, advancing the endoscope into the patient to illuminate and externally visualize a desired endoscope positioning, forming the ostomy through abdominal and gastric walls of the patient at the desired endoscope positioning, and passing one end of a suture externally through the ostomy and drawing the one end of the suture up through and out of the patient'"'"'s mouth, an other end of the suture remaining outside the gastrostomy, the improvement comprising the steps of:

tying the suture to one end of a tube having at least an inflation lumen and a fluid lumen, the tube having a port near the one end to dispose the inflation lumen to ambient air and an outlet at an other end to convey fluid from the fluid lumen into the patient, an enclosed elongated sleeve joined to the one end of the tube, the sleeve having means for selectively sealing the port to permit escape of air from the inflation lumen but preventing ingress of air into the inflation lumen;

deflating an inflatable retention member joined near the other end of the tube, the member being inflatable through the inflation lumen, the means for sealing the port preventing re-inflation of the member;

intubating the tube by pulling on the other end of the suture to draw and lead the one end of the tube in a retrograde manner through the patient until the retention member abuts against inner tissue surfaces of the ostomy; and

,

inflating the retention member to anchor the member against the inner tissue surfaces of the ostomy.

8. The method of claim 7 wherein the step of deflating the retention member includes:

compressing a foam-filled inflatable retention cuff until air is expelled out of the cuff and the inflation lumen.

9. The method of claim 7 wherein the step of inflating the retention member includes:

introducing ambient air into the inflation lumen.

10. The method of claim 9 wherein the step of introducing air into the inflation lumen includes:

severing the tube externally to the ostomy to expose the inflation lumen to ambient air.

11. The method of claim 10 wherein after the step of severing the tube, further including the step of:

13. The method of claim 7 wherein the step of tying the suture to the one end of the tube includes:

tying the suture to a suture loop carried from a terminal end of the enclosed sleeve.

14. The method of claim 7 wherein after the step of inflating the retention member, further including the step of:

sealing the inflation lumen to prevent the retention member from deflating.

15. The method of claim 7 wherein the ostomy includes a gastrostomy.

16. The method of claim 7 wherein the ostomy includes a cystostomy.

12. joining a tube connector device to the severed end of the tube.