Apparatus and method for percutaneous placement of gastro-intestinal tubes

• US 6,030,364 A
• Filed: 10/03/1997
• Issued: 02/29/2000
• Est. Priority Date: 10/03/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Durgin, Russ, Caira, Sheila
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/943,829
• Time in Patent Office: 879 Days
• Field of Search: 604/158, 604/27, 604/160, 604/161, 604/164, 604/166, 604/171, 604/264, 604/198, 606/191
• US Class Current: 604/164.01
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61J 15/0023 inserted by using a sheath
• CPC Class Codes: A61J 15/0038 expandable, e.g. umbrella type
• CPC Class Codes: A61J 2200/60 biodegradable
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A method and apparatus for the percutaneous placement of gastro-intestinal tubes, the apparatus comprising a longitudinal penetration device; a hollow, tapered dilator; and a sheath having a central lumen extending therethrough. The penetration device is placed within the sheath, pushed distally to penetrate the target organ, and then removed from the sheath. After the penetration device is removed, the dilator is inserted into the central lumen of the sheath until it penetrates the target organ, so that the sheath and the penetration are radially dilated as the dilator passes through the sheath. The sheath is then pulled in the proximal direction to counter-balance the distal insertion force. A gastro-intestinal tube is inserted into the hollow center, and pushed distally until it exits the distal end of the dilator. The dilator and sheath are then removed from the target organ.

Claims

1. An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising:

a hollow dilator having a distal tapered section formed of longitudinal fingers, and an untapered tubular section proximal thereto, wherein the longitudinal fingers of the distal tapered section open radially in response to a force applied from inside the hollow center of the dilator;

a sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said sheath having a first inner diameter at the distal end, and a second inner diameter at the proximal end, wherein the second inner diameter is greater than the first inner diameter, and wherein said dilator is receivable within the central lumen of the sheath;

a penetration device having proximal and distal ends, and a piercing means on the distal end, wherein said penetration device is receivable within the central lumen of the sheath.

2. An apparatus as in claim 1, wherein the longitudinal fingers of the dilator are formed such that the finger width decreases distally.

3. An apparatus as in claim 1, wherein the distal tapered section of the dilator is formed such that the longitudinal fingers are normally tapered to a point.

4. An apparatus as in claim 1, wherein the distal tapered section of the dilator is formed such that the longitudinal fingers of the dilator are normally untapered.

5. An apparatus as in claim 1, wherein the dilator is made of metal, thermoplastic, thermostat, or a composite.

6. An apparatus as in claim 1, wherein the dilator has a hub on the proximal end.

7. An apparatus as in claim 6, wherein the hub portion has a locking mechanism.

8. An apparatus as in claim 1, wherein the sheath is made of an expandable material.

9. An apparatus as in claim 1, wherein the outside surface of the sheath is treated to provide increased friction between the sheath and the abdominal tissue.

10. An apparatus as in claim 1, wherein the sheath has a thin, rigid coating which splits as the dilator passes through the central lumen of the sheath.

11. An apparatus as in claim 10, wherein the thin, rigid coating is longitudinally scored.

12. An apparatus as in claim 11, wherein the hub portion of the sheath has a locking mechanism.

13. An apparatus as in claim 11, wherein the hub portion has a valve for controlling the escape of insufflation gas.

14. An apparatus as in claim 13, wherein the valve consists of a thin, elastomeric disc having an opening capable of receiving the penetration device and dilator.

15. An apparatus as in claim 1, wherein the sheath has an elastomeric coating which expands as the dilator passes through the central lumen of the sheath.

16. An apparatus as in claim 15, wherein the elastomeric coating is longitudinally scored.

17. An apparatus as in claim 1, wherein the sheath has a coating which extends past the distal end of the sheath, whereby the coating forms a valve capable of limiting the amount of insufflation gas that can enter the distal end of the sheath.

18. An apparatus as in claim 1, wherein the sheath has a hub portion on the proximal end.

19. An apparatus as in claim 1, wherein the sheath has a diameter at its distal end which is less than or equal to 5 mm.

20. An apparatus as in claim 1, wherein sheath has a diameter at its proximal end which is greater than or equal to 7 mm. and less than or equal to 20 mm.

21. An apparatus as in claim 1, wherein the sheath has a distal minor diameter section and a major diameter section proximal thereto, with the minor diameter section comprising longitudinal fingers;

wherein the longitudinal fingers of the distal minor diameter section of the sheath are capable of receiving the dilator as it passes through the central lumen of the sheath.

22. An apparatus as in claim 21, wherein the longitudinal fingers of the sheath are formed by slitting the sheath body longitudinally.

23. An apparatus as in claim 21, wherein the longitudinal fingers of the sheath are formed by removing longitudinal slices from the sheath body.

24. An apparatus as in claim 23, wherein the longitudinal slices are formed such that the finger width decreases distally.

25. An apparatus as in claim 21, wherein the minor diameter section of the sheath is formed by folding the longitudinal fingers.

26. An apparatus as in claim 21, wherein the minor diameter section of the sheath is formed by overlapping the longitudinal fingers.

27. An apparatus for percutaneously placing a gastro-intestinal tube within a target organ comprising:

a hollow, needle-nosed dilator having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section formed of longitudinal fingers proximal and an untapered tubular section proximal thereto, whereby the distal tapered section consists of a distal straight section and a proximally-adjacent graduated section such that;

the straight section has a minor diameter; and

the untapered tubular section has a major diameter which is greater than the minor diameter, and the graduated section has a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section;

wherein the longitudinal fingers of the distal tapered section radially expand in response to a distal force from inside the hollow center of the dilator.

28. An apparatus as in claim 27, wherein the dilator has a piercing means detachably-secured to the distal end.

29. An apparatus as in claim 28, wherein the piercing means of the needle-nosed dilator is made of a biocompatible polymer-based material.

30. An apparatus as in claim 28, wherein the piercing means of the needle-nosed dilator is made of a biodegradable material.

31. An apparatus as in claim 27, wherein the distal tapered section is covered with an elastomeric coating.

32. An apparatus as in claim 31, wherein the elastomeric coating is longitudinally scored.

33. An apparatus as in claim 27, wherein the tapered section is covered with a thin, rigid coating.

34. An apparatus as in claim 33, wherein the thin, rigid coating is longitudinally scored.

35. A method for percutaneously placing a medical device within a target organ, said method comprising:

penetrating a target organ wall with an assembly of a sheath and a penetration device, the sheath having proximal and distal ends, and a central lumen extending from the proximal end to the distal end, and the penetration device having a piercing means at the distal end, and wherein the assembly is such that the penetration device is within the central lumen of said sheath such that the piercing means extends past the distal end of the sheath;

removing the penetration device from within the central lumen of the sheath in such a manner that the sheath remains within the target organ after removal of the penetration device;

inserting into the central lumen of the sheath a hollow dilator having a tapered distal end; and

pushing said dilator distally through the central lumen of the sheath until it penetrates the target organ wall, while simultaneously pulling proximally on the sheath, whereby the diameter of the penetration in the target organ wall is increased.

36. The method as in claim 35, further comprising:

placing a gastro-intestinal tube having a proximal and a distal end into the hollow center of the dilator;

pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube end exits the dilator;

removing the dilator from the target organ, while leaving the gastro-intestinal tube in place; and

removing the sheath from the target organ.

37. A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising:

insufflating a target organ;

penetrating a target organ wall with an assembly of an penetration device and a sheath in which the penetration device has a proximal end, a distal end, and a piercing means at its distal end, and the sheath has a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, the sheath further having a distal minor diameter section comprising longitudinal fingers formed such that the diameter at the distal end of the sheath is capable of penetrating body tissue, wherein the penetration device is within the central lumen of said sheath with the piercing means is distal of the distal end of the sheath;

removing said penetration device from said sheath in such a manner that the sheath remains within the target organ wall after removal of the penetration device;

inserting into the central lumen of the sheath a hollow dilator having a distal minor diameter section formed of longitudinal fingers and an untapered tubular section proximal thereto;

pushing said dilator through the central lumen of said sheath until the dilator penetrates the target organ wall, while simultaneously pulling proximally on the sheath to counter-balance the distal force, whereby the diameter of the penetration in the target organ wall is thereby increased;

placing a gastro-intestinal tube into the hollow center of said dilator;

pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the longitudinal fingers of the dilator are opened radially;

removing said sheath from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ; and

removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.

38. A method as in claim 37, wherein the dilator is pushed distally through the sheath with a distal force while the sheath is simultaneously pulled with a proximal force which is approximately the same as the distal force.

39. A method as in claim 37, wherein the dilator is pushed distally through the sheath with a distal force while the sheath is simultaneously pulled with a proximal force such that the planar position of the target organ wall remains substantially the same.

40. A method for percutaneously placing a medical device within a target organ, said method comprising:

penetrating the body tissue and target organ wall with a hollow needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a straight section towards the distal end wherein the straight section is radially expandable and has a diameter capable of piercing the target organ, said straight section further having a piercing means detachably-secured to the distal end;

placing the medical device into the hollow center of said dilator;

pushing the medical device distally through the dilator until the distal end of the device exits the dilator, wherein the straight section of the dilator is radially expanded as the device passes through the central lumen of the dilator; and

removing said dilator from the body tissue and target organ while maintaining the position of the medical device within the target organ.

41. A method for percutaneously placing a gastro-intestinal tube within a target organ, said method comprising:

insufflating a target organ;

penetrating the body tissue and target organ wall with a hollow thin-walled needle-nosed dilator having a proximal end, a distal end, and a central lumen extending from the proximal end to the distal end, said dilator further having a distal tapered section and an untapered tubular section proximal thereto, wherein the distal tapered section formed of longitudinal fingers and consists of a distal straight section and a proximally-adjacent graduated section, the the straight section having a diameter capable of penetrating body tissue, the untapered tubular section having a major diameter capable of receiving a gastro-intestinal tube, and the graduated section having a diameter which decreases distally from the diameter of the untapered tubular body to the minor diameter of the straight section;

placing a gastro-intestinal tube into the hollow center of said dilator;

pushing the gastro-intestinal tube distally through the dilator until the distal end of the tube exits the dilator, whereby the diameter of the penetration in the target organ wall is increased; and

removing said dilator from the body tissue in such a manner that the gastro-intestinal tube remains within the target organ.