Method and apparatus for emplacement of a gastrostomy catheter

• US 5,073,166 A
• Filed: 02/15/1989
• Issued: 12/17/1991
• Est. Priority Date: 02/15/1989
• 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 K., Nuckolls, Damon M., Fishman, Udi
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/311,685
• Time in Patent Office: 1,035 Days
• Field of Search: 604/105-109, 604/93, 604/174, 604/78, 606/109, 128/DIG. 26
• US Class Current: 604/175
• 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 15/0038 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: A61M 2039/0255 for access to the gastric or digestive system
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 2039/0297 at least part of it being inflatable, e.g. for anchoring, sealing or removing
• CPC Class Codes: A61M 2210/10 Trunk
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

A gastrostomy feeding tube including a main, flexible cylindrical body with a proximal end adapted for receiving conventional medical apparatus and a distal end having a locking mechanism. A locking ring is slidably and frictionally attached to the main body of the tube. The locking mechanism includes hinged legs and a membrane surrounding the mechanism, which is attached in a sealed fashion to the tube and to a distal end of the locking mechanism. Other embodiments of the locking mechanism include teeth or detents. Locking knobs are provided within the distal end. A long, rigid insertion tool having grooves for receiving the locking knobs is utilized, and is inserted through a bore through the tube until the locking knobs pass into the grooves. A needle is inserted in a conventional fashion into a patient'"'"'s stomach, and a guide wire is passed therethrough, and the needle is then removed. The tube and insertion tool are passed over the guide wire, and the insertion tool is then pulled back slightly to pull the hinged legs of the locking mechanism into an expanded configuration, which is maintained by its membrane. The insertion tool is removed, and the tube is held in place by clamping of the patient'"'"'s skin and stomach between the locking ring and the locking mechanism, respectively. In an alternative embodiment, a locking button is firmly attached to the gastrostomy catheter, and a one-way valve is provided to prevent backflow of gastric juices or the like from the patient'"'"'s stomach. In both embodiments, a plug is provided for sealing the distal end of the tube.

Claims

1. An apparatus for providing access through an opening in a surface, comprising:

an elongate tube having a proximal end, a distal end, and a main body, with an access passage through the tube;

anchoring means attached to said distal end for anchoring said elongate tube at said opening, said anchoring means having a first configuration wherein an outer diameter of said anchoring means is substantially equal to an outer diameter of said tube, and having a second configuration wherein said anchoring means outer diameter is greater than said tube outer diameter;

means for retaining said anchoring means in said second configuration, said retaining means including means for increasing resistance to repositioning to said first configuration when a radial force is applied to said anchoring means;

means for manipulating said anchoring means into each of said first and second configurations, for insertion of said anchoring means and a portion of the tube through the opening while said anchoring means is in said first configuration, and for manipulating said anchoring means into said second configuration.

2. The apparatus of claim 1, wherein:

said anchoring means includes a first end, a second end, and a middle portion, said middle portion including a plurality of legs, each leg having a first section and a second section, wherein each said first section is attached in a hinged fashion to said first end, and each said second section is attached in a hinged fashion to said second end, and each said first section is attached in a hinged fashion to at least one said second section, such that when said first and second ends are pulled away from one another, said anchoring means takes on said first configuration such that each said first section is substantially collinear with one said second section, and such that when said first and second ends are pushed towards one another, said anchoring means takes on said second configuration such that each said first section is substantially parallel and adjacent to at least one said second section.

3. The apparatus of claim 2, wherein said retaining means comprises an elastic membrane encasing said anchoring means in a tight-fitting fashion.

4. The apparatus of claim 2, wherein said first end includes a plurality of annular ridges for maintaining said anchoring means in a fixed, sealed relationship with said tube.

5. The apparatus of claim 2, wherein:

said second end includes a bore in communication with said tube;

said manipulating means includes an insertion tool and means disposed within said second end bore for coating with said insertion tool for pushing said anchoring means into said first configuration and for pulling said anchoring means into said second configuration.

6. The apparatus of claim 5, wherein said insertion tool includes an elongate, longitudinally rigid body including a tip having means for transmitting longitudinal force to said coacting means for moving said anchoring means into said second configuration.

7. The apparatus of claim 5, wherein said insertion tool includes an elongate, longitudinally rigid body including a tip having a first longitudinal portion and a second portion at one end thereof and at an angle to said longitudinal portion, said insertion tool being configured for insertion through said tube such that said longitudinal portion receives said coacting means, and such that said lateral portion receives said coacting means upon rotation of said insertion tool, for longitudinal locking together of said insertion tool and said anchoring means, such that longitudinal force on said insertion tool is transmitted to said second end of said anchoring means so as to move said second end relative to said first end for moving said anchoring means into said first and second configurations.

8. The apparatus of claim 1, wherein said retaining means comprises a ring, slidably attached to said tube.

9. The apparatus of claim 1, wherein said retaining means comprises a ring, fixedly attached to said tube.

10. The apparatus of claim 1, further comprising a one-way valve disposed within said tube.

11. The apparatus of claim 10, wherein said valve comprises a flexible, substantially cylindrical member having an opening which is normally closed, said opening being adapted for opening when pressure is applied from one direction and for closing when no pressure is applied. and when pressure is applied from another direction.

12. The apparatus of claim 10, wherein said one-way valve is removable.

13. An apparatus for providing access through an opening in a surface, comprising:

an elongate tube having a proximal end, a distal end, and a main body, with an access passage through the tube;

anchoring means attached to said distal end for anchoring said elongate tube at said opening, said anchoring means having a first configuration wherein an outer diameter of said anchoring means is substantially equal to an outer diameter of said tube, and having a second configuration wherein said anchoring means outer diameter is greater than said tube outer diameter;

means for retaining said anchoring means in said second configuration;

means for manipulating said anchoring means into each of said first and second configurations, for insertion of said anchoring means and a portion of the tube through the opening while said anchoring means is in said first configuration, and for manipulating said anchoring means into said second configuration;

wherein said anchoring means includes a first end, a second end, and a middle portion, said middle portion including a plurality of legs, each leg having a first section and a second section, and wherein each said first section is attached in a hinged fashion to said first end, and each said second section is attached in a hinged fashion to said second end, and each said first section is attached in a hinged fashion to at least one said second section, such that when said first and second ends are pulled away from one another, said anchoring means takes on said first configuration such that each said first section is substantially collinear with one said second section, and such that when said first and second ends are pushed towards one another, said anchoring means takes on said second configuration such that each said first section is substantially parallel and adjacent to at least one said second section;

and wherein each of said first sections has a first length and each of said second sections has a second length which is shorter than said first length.

14. An apparatus for providing access through an opening in a surface, comprising:

an elongate tube having a proximal end, a distal end, and a main body, with an access passage through the tube;

anchoring means attached to said distal end for anchoring said elongate tube at said opening, said anchoring means having a first configuration wherein an outer diameter of said anchoring means is substantially equal to an outer diameter of said tube, and having a second configuration wherein said anchoring means outer diameter is greater than said tube outer diameter;

means for retaining said anchoring means in said second configuration; and

means for manipulating said anchoring means into each of said first and second configurations, for insertion of said anchoring means and a portion of the tube through the opening while said anchoring means is in said first configuration, and for manipulating said anchoring means into said second configuration;

wherein said anchoring means includes a first end, a second end, and a middle portion, said middle portion including a plurality of legs, each leg having a first section and a second section, wherein each said first section is attached in a hinged fashion to said first end, and each said second section is attached in a hinged fashion to said second end, and each said first section is attached in a hinged fashion to at least one said second section, such that when said first and second ends are pulled away from one another, said anchoring means takes on said first configuration such that each said first section is substantially collinear with one said second section, and such that when said first and second ends are pushed towards one another, said anchoring means takes on said second configuration such that each said first section is substantially parallel and adjacent to at least one said second section;

wherein each second end includes a bore in communication with said tube;

wherein said manipulating means includes an insertion tool and means disposed within said second end bore for coacting with said insertion tool for pushing said anchoring means into said first configuration and for pulling said anchoring means into said second configuration;

and wherein said insertion tool includes a bore for receiving a wire disposed in the opening in the surface.

15. A method for emplacement of a catheter into a patient, said catheter including a distal end having an expandable and collapsible anchor, including the steps of:

(1) interlocking an insertion tool with the anchor without applying longitudinal force to the anchor;

(2) passing the interlocked insertion tool and anchor into the patient such that the anchor enters the patient in its collapsed configuration;

(3) manipulating the insertion tool such that the anchor is expanded; and

(4) removing the insertion tool without applying longitudinal force to the anchor, leaving the anchor within the patient.

16. The method of claim 15, further including, after step 4, the steps of:

(5) inserting a removal tool and again interlocking the anchor therewith;

(6) manipulating the anchor into its collapsed configuration; and

(7) removing the removal tool and the anchor from the patient.

17. The method of claim 16, wherein the removal tool is the same tool as the insertion tool.

18. The method of claim 15, further including, before step 2, the step of:

(8) inserting a needle into the patient, thereby forming an opening;

wherein step (2) includes the step of passing the anchor through the opening.

19. The method of claim 18, wherein the anchor in its collapsed configuration has a diameter substantially the same as a diameter of the catheter, for preventing enlargement of the opening upon insertion of the catheter.

20. The method claim 18, including providing rigidity to the anchor for preventing accidental removal thereof from the opening.

21. A method of emplacement of a catheter into a patient, said catheter including a distal end having an expandable and collapsible anchor, including the steps of:

(1) inserting a needle into the patient, the needle having a lumen therethrough, thereby forming an opening;

(2) inserting a guide wire through the lumen of the needle;

(3) removing the needle;

(4) interlocking an insertion tool with the anchor;

(5) passing the interlocked insertion tool and anchor into the patient such that the anchor enters the patient in its collapsed configuration;

(6) manipulating the insertion tool such that the anchor is expanded; and

(7) removing the insertion tool, leaving the anchor within the patient;

wherein the insertion tool is provided with a bore therethrough, and wherein step 5 includes the step of passing the bore over the guide wire for guiding it into the opening.

22. The method of claim 21 further including the step of providing the guide wire with a bight at its distal end, the bight being flexible for taking on a straightened configuration for passing through the lumen of the needle, but resuming the bight shape when no force is placed thereon, such that the guide wire is maintained within the opening in the patient by means of the bight after the needle is removed.

23. An anchor, comprising:

a first section;

a second section;

a middle section having a first end attached in a hinged fashion to said first section and a second end attached in a hinged fashion to said second section, said middle section having at least two configurations, namely an expanded configuration wherein the anchor has an enlarged diameter and a first collapsed configuration wherein the anchor has a reduced diameter;

means for grasping said second section and moving it in a first direction relative to said first section, such that said middle section takes on its expanded configuration, said grasping means also being for moving said second section in a second direction relative to said first section, such that said middle section takes on said first collapsed configuration; and

means, attached to said anchor, for maintaining said middle section in said expanded configuration, said maintaining means including means for increasing resistance to repositioning to said first collapsed configuration when a radial force is applied to said middle section.

24. The anchor of claim 23, wherein said middle section in said first collapsed configuration has a diameter substantially equal to a diameter of said first section, and in said expanded configuration has a diameter larger than said diameter of said first section.

25. The anchor of claim 24, wherein said middle section includes:

at least one first segment attached by a first hinge to said first section;

at least one said second segment attached by a second hinge to said second section; and

means for attaching said first segment in a hinged fashion to said second segment.

26. The anchor of claim 25, wherein said first and second segments are substantially collinear when said middle section is in said first collapsed configuration, and are substantially parallel when said middle section is in said expanded configuration.

27. The anchor of claim 25, wherein said maintaining means comprises means for preventing relative motion of said first and second segments.

28. The anchor of claim 25, wherein:

said first and second segments are configured for positioning at less than a right angle relative to an axis of said first section when said middle section is in said expanded configuration.

29. The anchor of claim 24, wherein said first and second segments are substantially parallel when said middle section is in said first collapsed configuration, and are at an angle to one another when said middle section is in said expanded configuration.

30. An anchor, comprising:

a first section;

a second section;

a middle section having a first end attached in a hinged fashion to said first section and a second end attached in a hinged fashion to said second section, wherein said middle section includes at least one first segment attached by a first hinge to said first section, at least one said second segment attached by a second hinge to said second section; and

means for attaching said first segment in a hinged fashion to said second segment;

said middle section having at least two configurations, namely an expanded configuration of enlarged diameter and a first collapsed configuration of reduced diameter, wherein said middle section in said first collapsed configuration has a diameter substantially equal to a diameter of said first section, and in said expanded configuration has a diameter larger than said diameter of said first section;

means for grasping said second section and moving it in a first direction relative to said first section, such that said middle section takes on its expanded configuration, said grasping means also being for moving said second section in a second direction relative to said first section, such that said middle section takes on said first collapsed configuration; and

means for maintaining said middle section in said expanded configuration, wherein said maintaining means comprises means for preventing relative motion of said first and second segments, wherein said preventing means includes an elastic membrane positioned over said middle section and attached to at least one of said first and second sections, said membrane being in a stretched state when said middle section is in said expanded configuration, for exerting an axially inward force on said middle section.

31. The anchor of claim 30, wherein said attaching means comprises a stop attached by third hinge to said first segment and by a fourth hinge to said second segment, said stop having a first surface for abutting an end of said first segment and having a second surface for abutting an end of said second segment when said middle section is in said expanded configuration, for preventing relative motion of said first and second segments.

32. The anchor of claim 31, wherein:

said middle section defines an interior and an exterior of said anchor;

said first and second hinges are positioned adjacent said interior; and

said third and fourth hinges are positioned adjacent said exterior, such that when said second section is moved in said first direction, said first and second segments of said middle section are urged towards said exterior.

33. The anchor of claim 30, wherein:

said first section includes a first surface at an end thereof;

said first segment of said middle section includes a second surface at an end thereof;

said second segment of said middle section includes a third surface at an end thereof; and

said second section includes a fourth surface at an end thereof;

wherein said first, second, third and fourth surfaces are configured such that, when said middle section is in said expanded configuration, said first surface abuts said second surface and said third surface abuts said fourth surface, said first segment lies at a first predetermined angle relative to said first section, and said second segment lies at a second predetermined angle relative to said second section.

34. The anchor of claim 33, wherein said first predetermined angle is greater than ninety degrees, and said second predetermined angle is less than ninety degrees.

35. The anchor of claim 33, wherein said first predetermined angle is approximately 98 degrees, and said second predetermined angle is approximately 82 degrees.

36. The anchor of claim 33, wherein each of said first and second predetermined angles is selected such that said force is at a nonzero angle relative to at least one of said first and second segments of said middle section.

37. An anchor, comprising:

a first section;

a second section;

a middle section having a first end attached in a hinged fashion to said first section and a second end attached in a hinged fashion to said second section, wherein said middle section includes at least one first segment attached by a first hinge to said first section, at least one said second segment attached by a second hinge to said second section; and

means for attaching said first segment in a hinged fashion to said second segment;

said middle section having at least two configurations, namely an expanded configuration of enlarged diameter and a first collapsed configuration of reduced diameter, wherein said middle section in said first collapsed configuration has a diameter substantially equal to a diameter of said first section, and in said expanded configuration has a diameter larger than said diameter of said first section;

means for grasping said second section and moving it in a first direction relative to said first section, such that said middle section takes on its expanded configuration, said grasping means also being for moving said second section in a second direction relative to said first section, such that said middle section takes on said first collapsed configuration; and

means for maintaining said middle section in said expanded configuration, wherein said maintaining means comprises means for preventing relative motion of said first and second segments, wherein said preventing means includes means for interlocking said first and second segments to one another when said middle section is in said expanded configuration.

38. The anchor of claim 37, wherein said interlocking means includes complementary detents formed on each of said first and second segments.

39. The anchor of claim 38, wherein said interlocking means includes:

first teeth disposed on said first section and angled in a third direction; and

second teeth disposed on said second section and angled in a fourth direction;

wherein said first and second teeth engage one another when said middle section is in said expanded configuration, for preventing relative motion of said first and second sections, thereby also preventing relative motion of said first and second segments.

40. The anchor of claim 39, wherein said first, second and fourth directions are the same, and said third direction is opposite to said fourth direction.

41. The anchor of claim 39, wherein:

said middle section has a second collapsed configuration; and

said first hinge is configured for allowing said first segment to lie adjacent and parallel to said first section when said middle section is in said first collapsed configuration, and is configured also for allowing said first segment to lie at an angle relative to said first section when said middle segment is in said expanded configuration, and is further configured for allowing said first segment to lie collinear with said first section when said middle section is in said second collapsed configuration.

42. The anchor of claim 41, wherein said angle is less than ninety degrees.

43. The anchor of claim 41, wherein said first hinge is configured for accommodating at least 180 degrees of relative positions of said first segment and said first section.

44. The anchor of claim 39, wherein said first teeth are positioned on a first side of said second teeth when said middle section is in said first collapsed configuration, are positioned adjacent said second teeth when said middle section is in said expanded configuration, and are positioned on a second side of said second teeth when said middle section is in said second collapsed configuration.

45. An anchor, comprising:

a first section;

a second section;

a middle section having a first end attached in a hinged fashion to said first section and a second end attached in a hinged fashion to said second section, wherein said middle section includes at least one first segment attached by a first hinge to said first section, at least one said second segment attached by a second hinge to said second section; and

means for attaching said first segment in a hinged fashion to said second segment;

said middle section having at least two configurations, namely an expanded configuration of enlarged diameter and a first collapsed configuration of reduced diameter, wherein said middle section in said first collapsed configuration has a diameter substantially equal to a diameter of said first section, and in said expanded configuration has a diameter larger than said diameter of said first section;

means for grasping said second section and moving it in a first direction relative to said first section, such that said middle section takes on its expanded configuration, said grasping means also being for moving said second section in a second direction relative to said first section, such that said middle section takes on said first collapsed configuration; and

means for maintaining said middle section in said expanded configuration, wherein said maintaining means comprises means for preventing relative motion of said first and second segments, wherein said preventing means includes means for interlocking said first and second sections to one another when said middle section is in said expanded configuration.

46. An apparatus for inserting a tube through an opening, the tube including a proximal end and a distal end, including:

anchoring means attached to said distal end of the tube for anchoring the tube at said opening, said anchoring means having a first resting configuration wherein an outer diameter of said anchoring means is no greater than approximately a diameter of said tube, and having a second resting configuration wherein said outer diameter of said anchoring means is greater than said diameter of said tube;

means for manipulating said anchoring means into each of said first and second configurations, for insertion of said anchoring means through the opening while said anchoring means is in said first configuration, and for maintaining the tube in place relative to the opening while said anchoring means is in said second configuration; and

means, attached to said anchoring means, for maintaining said anchoring means in said second resting configuration, said maintaining means including means for increasing resistance to repositioning to said first resting configuration when a radial force is applied to said anchoring means.

47. The apparatus of claim 46, wherein:

said tube includes a lumen;

said anchoring means includes a bore in communication with said lumen of said tube; and

wherein said manipulating means is for manipulating said anchoring means between said a first configuration of enlarged diameter and a second configuration of reduced diameter from within said bore, said manipulating means passing through said lumen of said tube.

48. A method of emplacement of a tube into an opening, the tube including a lumen and a distal end and an anchor attached to the distal end, where the anchor has a bore in communication with the lumen, including the steps of:

(1) interlocking an insertion tool with the anchor without applying longitudinal force to the anchor;

(2) passing the anchor through the opening by means of the insertion tool, with the anchor in a first configuration wherein an outer diameter of the anchor is no greater than approximately an outer diameter of the tube;

(3) manipulating the anchor from within the bore, by means of the insertion tool, such that the anchor is moved into an expanded configuration wherein the outer diameter of the anchor is greater than the outer diameter of the tube, such that the tube seats within the opening with the anchor on one side of the opening; and

(4) unlocking the insertion tool from the anchor, without applying longitudinal force to the anchor, and removing the insertion tool.

49. The method of claim 48, wherein step 2 is accomplished by a rigid insertion tool.

50. The method of claim 48, including the step of enlarging the opening by passing the tube therethrough, wherein a diameter of the enlarged opening is substantially equal to an outer diameter of the tube.