Method of assembling a percutaneous gastrostomy device

• US 20050143691A1
• Filed: 02/17/2005
• Published: 06/30/2005
• Est. Priority Date: 12/10/2001
• Status: Active Grant

• Current Assignee: Everest Holdings LLC
• Original Assignee: Appliced Medical Research
• Inventors: Picha, George J., Mandic, Davor G.
• Granted Patent: US 8,048,056 B2
• Time in Patent Office: Days
• US Class Current: 604/175
• CPC Class Codes: A61J 15/0015 Gastrostomy feeding-tubes insertion tools or methods A61B17/34
• CPC Class Codes: A61J 15/0038 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

Abstract

The present invention is directed to a gastrostomy device comprising, a tubular portion defining a longitudinal axis, an internal bolster having a radial wing secured to the tubular portion, the internal bolster being flexible to permit elastic deformation between a first orientation generally aligned with the longitudinal axis, with the wing wrapped into a generally cylindrical configuration and a second orientation with the wing unfurled and extending generally transverse to the tubular portion longitudinal axis and a constraining member encasing the internal bolster to retain the internal bolster in the first orientation, with the wing wrapped into the generally cylindrical configuration, and to cover at least a major portion of the wrapped wing, wherein the removal of the casing permits the internal bolster to move from the first orientation to the second orientation. The internal bolster may be deployed by the use of a ripcord to tear through the wall of the capsule, freeing the internal bolster of the gastrostomy device into the patient stomach and deploying the internal bolster to a second orientation with the wing unfurled and extending generally transverse to said tubular portion longitudinal axis. Alternatively, the internal bolster may be deployed by the constraining member being dissolved by the patient'"'"'s bodily fluids located inside the patient'"'"'s stomach.

Claims

1-17. -17. (canceled)

18. A method of assembling a percutaneous gastrostomy device comprising the steps of:

providing a tube having a longitudinal axis;

an internal bolster having a radial wing secured to said tube, said internal bolster being secured to said distal end, said internal bolster having a radial wing secured to said tubular portion, said internal bolster being flexible to permit elastic deformation between a first orientation generally aligned with said longitudinal axis, with the wing wrapped into a generally cylindrical configuration and a second orientation with the wing unfurled and extending generally transverse to said tubular portion longitudinal axis, said bolster having a radially extending pocket formed on an upper surface of said wing;

a rod member;

a capsule; and

providing an assembly fixture comprising a first assembly block having a longitudinal bore extending from one end of said first block and partially therethrough and communicating with a conical passage which converges inwardly from another end of said block;

inserting a distal end of said rod into said pocket to flex the pocket in axial alignment with said rod;

providing a second assembly block having a cavity therein adapted to receive said capsule, said second block being adapted to be received in said longitudinal bore;

inserting said capsule into said cavity;

inserting said second block into said longitudinal bore;

inserting said wing into said capsule by advancing rod into said conical passage to progressively fold the wing over the pocket and the rod to form a folded assembly; and

further advancing the folded assembly into the capsule.

19-20. -20. (canceled)

21. An assembly method for a percutaneous gastrostomy device comprising:

providing a tubular portion having a distal end and a proximal end;

securing an internal bolster to the distal end of the tubular portion;

folding the internal bolster around the distal end of the tubular portion; and

encasing the folded internal bolster with a dissolvable constraining member to retain the internal bolster into the folded position.

22. The assembly method of claim 21, wherein the tubular portion and the internal bolster are integrally molded together.

23. The assembly method of claim 21, wherein the tubular portion and the internal bolster are integrally molded from silicone rubber.

24. The assembly method of claim 21, further comprising inserting a rod member through the tubular portion.

25. The assembly method of claim 24, further comprising inserting a proximal end of the rod member into a pocket provided on the internal bolster.

26. The assembly method of claim 21, further comprising providing a rod member alongside and generally parallel to the tubular portion.

27. The assembly method of claim 21, wherein the internal bolster is folded into a generally cylindrical configuration.

28. The assembly method of claim 21, further comprising threading a ripcord through the tubular portion, through an opening in the internal bolster, and through the dissolvable constraining member.

29. The assembly method of claim 28, further comprising securing a pull tab to both ends of the ripcord.

30. The assembly method of claim 21, further comprising providing a locking ring on a portion of the tubular portion to prevent a gastrostomy device from being drawn into a patient'"'"'s body.

31. The assembly method of claim 21, wherein the internal bolster has a first part that is generally semi-oval and a second part that defines a radial wing.

32. The assembly method of claim 31, wherein the radial wing includes a pocket for receipt of a proximal end of a rod member to permit deformation of the internal bolster from a first orientation to a second orientation.

33. An assembly method for a percutaneous gastrostomy device comprising:

providing an assembly fixture having a capsule holder and a funnel;

placing a capsule in the capsule holder;

fitting the capsule holder into a first end of the funnel; and

guiding an internal bolster of a percutaneous gastrostomy device through a second end of the funnel and into an open end of the capsule.

34. The assembly method of claim 33, wherein fitting the capsule holder into a first end of the funnel comprises fitting a rigid cylindrical body into a corresponding cylindrical recess provided in the first end of the funnel.

35. The assembly method of claim 33, wherein guiding an internal bolster through a second end of the funnel includes guiding a folded internal bolster through a conical recess provided in the second end of the funnel and into the capsule.

36. An assembly method for a percutaneous gastrostomy device comprising:

providing a tubular portion having a distal end and a proximal end;

securing an internal bolster to the distal end of the tubular portion;

inserting a rod member into the proximal end of the tubular portion and into a pocket provided in the internal bolster;

threading a ripcord through a capsule, through the internal bolster, through the tubular portion, through a handle provided on the rod member; and

fastening both ends of the ripcord to a pull tab.

37. The assembly method of claim 36, further comprising:

inserting the capsule and ripcord into an assembly fixture;

folding the internal bolster;

inserting the folded internal bolster, rod member, and ripcord into the assembly fixture and into the capsule; and

removing the assembly from the assembly fixture with the folded internal bolster contained inside the capsule and the ripcord exposed.

38. The assembly method of claim 36, further comprising threading the ripcord through the capsule twice.

39. The assembly method of claim 36, further comprising positioning the ripcord within a slot provided along an outer surface of the capsule.