Medical catheter assembly and method of using the same

• US 20070088259A1
• Filed: 07/31/2006
• Published: 04/19/2007
• Est. Priority Date: 05/01/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chu, Michael, Bouphavichith, Laddvanh
• Granted Patent: US 8,029,462 B2
• Time in Patent Office: Days
• US Class Current: 604/104
• 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: 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 15/0057 fixing a tube end, i.e. tube not 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 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A medical catheter assembly and method of using the same. In one embodiment, the assembly comprises a gastrostomy feeding tube having a proximal end, a distal end and a longitudinal bore, the distal end being shaped to include an internal bolster, the internal bolster having an anchoring state and a non-anchoring state. A suture extends from the internal bolster through the longitudinal bore to exit the tube at its proximal end, proximal displacement of the suture maintaining the internal bolster in its anchoring state. A protective sleeve made of a rigid material is removably insertable into the tube through its proximal end, the suture being inserted through the protective sleeve. The protective sleeve, when inserted into the tube, serves to protect the suture from being cut when the tube is cut to a desired length after having been implanted in a patient.

Claims

1. A medical catheter assembly comprising:

(a) a medical catheter, said medical catheter having a proximal end, a distal end and a longitudinal bore, said distal end being shaped to include an internal bolster, said internal bolster having an anchoring state and a non-anchoring state;

(b) a suture extending from said internal bolster through said longitudinal bore to exit said medical catheter at said proximal end wherein proximal displacement of said suture maintains said internal bolster in said anchoring state; and

(c) a protective sleeve made of a rigid material, said protective sleeve being removably insertable into said medical catheter through said proximal end, said suture being inserted through said protective sleeve.

2. The medical catheter assembly as claimed in claim 1 further comprising a body adapted for use as an external bolster, said medical catheter extending through said body.

3. The medical catheter assembly as claimed in claim 2 wherein said body comprises a sleeve through which said medical catheter extends, said sleeve extending upwardly and having a longitudinal bore.

4. The medical catheter assembly as claimed in claim 2 wherein said body comprises a base and a sleeve, said base having a transverse bore, said sleeve extending upwardly from said base and having a longitudinal bore, said longitudinal bore of said sleeve being aligned with said transverse bore of said base, said medical catheter extending through said transverse bore of said base and said longitudinal bore of said sleeve.

5. The medical catheter assembly as claimed in claim 4 wherein the bottom of said base has a concave surface.

6. The medical catheter assembly as claimed in claim 4 wherein said sleeve is shaped to include an external barb over which said proximal end of said medical catheter may be inverted.

7. The medical catheter assembly as claimed in claim 6 wherein said sleeve further comprises a transverse slot, said transverse slot intersecting said longitudinal bore, said medical catheter assembly further comprising a clamp movable within said transverse slot between a first position in which said clamp compresses to closure the medical catheter and a second position in which said clamp does not compress the medical catheter.

8. The medical catheter assembly as claimed in claim 3 further comprising a cap, said cap being removably mountable on said sleeve.

9. The medical catheter assembly as claimed in claim 8 wherein said cap has an opening, said opening being alignable with said longitudinal bore of said sleeve.

10. The medical catheter assembly as claimed in claim 8 wherein said cap further has an internal thread and wherein said sleeve further has an external thread whereby said cap is adapted to be removably screwed onto said sleeve by threaded engagement of said internal thread with said external thread.

11. The medical catheter assembly as claimed in claim 10 wherein said cap further has one or more recesses adapted to receive a tool for screwing said cap onto said sleeve and for unscrewing said cap from said sleeve.

12. The medical catheter assembly as claimed in claim 9 wherein said cap further has a medical luer fitting, said medical luer fitting being in fluid communication with said opening.

13. The medical catheter assembly as claimed in claim 1 wherein said internal bolster is a pigtail bolster.

14. The medical catheter assembly as claimed in claim 1 wherein said internal bolster has a malecot structure.

15. The medical catheter assembly as claimed in claim 1 wherein said internal bolster is an axially-collapsible, radially-expandable, mesh bolster.

16. The medical catheter assembly as claimed in claim 1 wherein said proximal end of said medical catheter is shaped to include an external flange.

17. The medical catheter assembly as claimed in claim 1 further comprising a cannula, said cannula being removably disposed within said longitudinal bore of said medical catheter for maintaining said medical catheter in said non-anchoring state.

18. The medical catheter assembly as claimed in claim 17 wherein said cannula has a proximal end and a distal end, said medical catheter assembly further comprising a cannula hub, said cannula being fixed at its proximal end to said cannula hub.

19. The medical catheter assembly as claimed in claim 18 further comprising a body adapted for use as an external bolster, said medical catheter extending through said body, said cannula hub being removably mounted on said body.

20. The medical catheter assembly as claimed in claim 1 further comprising a trocar, said trocar being removably inserted into said medical catheter in such a way as to extend therethrough.

21. The medical catheter assembly as claimed in claim 18 further comprising a trocar and a trocar hub, said trocar having a proximal end and distal end, said proximal end of said trocar being fixed to said trocar hub, said trocar being removably inserted into said cannula and said medical catheter in such a way as to extend therethrough, said trocar hub being removably mounted on said cannula hub.

22. A medical catheter assembly comprising:

(a) a medical catheter, said medical catheter having a proximal end, a distal end and a longitudinal bore, said distal end being shaped to include an internal bolster, said internal bolster having an anchoring state and a non-anchoring state;

(b) a cannula removably inserted into said longitudinal bore of said medical catheter for maintaining said internal bolster in said non-anchoring state; and

(c) a body, said body comprising a sleeve, said sleeve having a longitudinal bore through which said medical catheter extends and a top end over which said proximal end of said medical catheter may be inverted.

23. The medical catheter assembly as claimed in claim 22 wherein said body further comprises a base, said sleeve extending upwardly from said base, said base having a transverse opening aligned with said longitudinal bore of said sleeve.

24. The medical catheter assembly as claimed in claim 23 wherein the bottom of said base has a concave surface.

25. The medical catheter assembly as claimed in claim 23 wherein said sleeve further includes an external barb over which said proximal end of said medical catheter may be inverted.

26. The medical catheter assembly as claimed in claim 23 wherein said sleeve further includes a transverse slot intersecting said longitudinal bore of said sleeve, said medical catheter assembly further comprising a clamp movable within said transverse slot between a first position in which said clamp compresses to closure the medical catheter and a second position in which said clamp does not compress the medical catheter.

27. The medical catheter assembly as claimed in claim 22 further comprising a trocar removably inserted into said cannula and said medical catheter so as to extend therethrough.

28. The medical catheter assembly as claimed in claim 22 further comprising a suture extending from said internal bolster through said longitudinal bore of said medical catheter to exit said medical catheter at said proximal end wherein proximal displacement of said suture maintains said internal bolster in said anchoring state.

29. A method of percutaneously implanting a gastrostomy feeding tube, said method comprising the steps of:

(a) providing a gastrostomy feeding tube assembly, said gastrostomy feeding tube assembly comprising;

(i) a gastrostomy feeding tube, said gastrostomy feeding tube having a proximal end, a distal end and a longitudinal bore, said distal end being shaped to include an internal bolster, said internal bolster having an anchoring state and a non-anchoring state;

(ii) a trocar, said trocar having a proximal end and a distal end, said trocar being removably mounted in said gastrostomy feeding tube in such a way as to extend through the distal end of said gastrostomy feeding tube;

(b) while said internal bolster is in said non-anchoring state, directly inserting the distal end of said trocar and said internal bolster of said gastrostomy feeding tube through the skin and into the stomach of a patient, said proximal end of said gastrostomy feeding tube not being inserted through the skin of the patient; and

(c) then, transforming said internal bolster from said non-anchoring state to said anchoring state.

30. The method as claimed in claim 29 further comprising, after said directly inserting step, the step of withdrawing said trocar from said gastrostomy feeding tube.

31. The method as claimed in claim 30 wherein said gastrostomy feeding tube assembly further comprises a body, said body comprising a base and a sleeve, said base having a transverse bore, said sleeve extending upwardly from said base and having a longitudinal bore, said longitudinal bore of said sleeve being aligned with said transverse bore of said base, said gastrostomy feeding tube extending through said transverse bore of said base and said longitudinal bore of said sleeve.

32. The method as claimed in claim 31 further comprising the step of inverting the proximal end of said gastrostomy feeding tube over the top of said sleeve.

33. The method as claimed in claim 32 further comprising, prior to said inverting step, the step of cutting said gastrostomy feeding tube to a reduced length.

34. The method as claimed in claim 33 wherein said gastrostomy feeding tube assembly further comprises a suture extending from said internal bolster through said longitudinal bore to exit said gastrostomy feeding tube at said proximal end wherein proximal displacement of said suture maintains said internal bolster in said anchoring state.

35. The method as claimed in claim 34 wherein said gastrostomy feeding tube assembly further comprises a protective sleeve made of a rigid material, said protective sleeve being removably insertable into said medical catheter through said proximal end, said suture being inserted through said protective sleeve.

36. The method as claimed in claim 35 further comprising the steps of inserting said protective sleeve into said gastrostomy feeding tube prior to said step of cutting said gastrostomy feeding tube and then removing said protective sleeve from said gastrostomy feeding tube after said cutting step.

37. The method as claimed in claim 36 wherein said gastrostomy feeding tube assembly further comprises a cannula, said cannula being removably inserted into said gastrostomy feeding tube for maintaining said internal bolster in said non-anchored state and wherein said internal bolster transforming step comprises removing said cannula from said gastrostomy feeding tube.

38. A method of percutaneously implanting a gastrostomy feeding tube, said method comprising the steps of:

(a) providing an entry needle assembly, said entry needle assembly comprising a trocar portion and a cannula portion, said trocar portion being removably inserted through said cannula portion, said trocar portion having a proximal end and a distal end, said cannula portion having a proximal end and a distal end;

(b) inserting the distal ends of said trocar portion and said cannula portion of said entry needle assembly through the skin and into the stomach of a patient so as to create a tract;

(c) then, removing said trocar portion of said entry needle assembly from the patient while keeping said cannula portion of said entry needle assembly in place;

(d) then, inserting a guide wire through said cannula portion of said entry needle assembly and into the patient'"'"'s stomach;

(e) then, removing said cannula portion of said entry needle assembly while keeping said guide wire in place;

(f) providing a gastrostomy feeding tube, said gastrostomy feeding tube having a proximal end, a distal end and a longitudinal bore, said distal end being shaped to include an internal bolster, said internal bolster having an anchoring state and a non-anchoring state;

(g) then, while said internal bolster is in said non-anchoring state, inserting the gastrostomy feeding tube over the guide wire until said internal bolster is inserted into the stomach of the patient, said proximal end of said gastrostomy feeding tube not being inserted into the patient; and

(h) then, transforming said internal bolster from said non-anchoring state to said anchoring state.

39. The method as claimed in claim 38 further comprising, after said transforming step, the step of cutting said gastrostomy feeding tube to a reduced length.

40. The method as claimed in claim 38 further comprising, after said cutting step, the step of inverting the proximal end of said cut gastrostomy feeding tube over the top end of a sleeve through which said cut gastrostomy feeding tube has been inserted.

41. The method as claimed in claim 39 wherein a suture extends from said internal bolster through said longitudinal bore to exit said gastrostomy feeding tube at said proximal end thereof and wherein proximal displacement of said suture maintains said internal bolster in said anchoring state, said method further comprising, prior to said cutting step, the step of inserting a protective sleeve made of a rigid material into said gastrostomy feeding tube, said suture extending through said protective sleeve and, after said cutting step, the step of removing said protective sleeve from said gastrostomy feeding tube.

42. The method as claimed in claim 38 further comprising, after said cannula portion removing step and before said gastrostomy feeding tube inserting step, the step of dilating said tract.

43. A method of implanting a medical catheter, said method comprising the steps of:

(a) providing a medical catheter assembly, said medical catheter assembly comprising

(i) a medical catheter, said medical catheter having a proximal end, a distal end and a longitudinal bore, said distal end being shaped to include an internal bolster, said internal bolster having an anchoring state and a non-anchoring state;

(ii) a suture extending from said internal bolster through said longitudinal bore to exit said medical catheter at said proximal end wherein proximal displacement of said suture maintains said internal bolster in said anchoring state; and

(iii) a protective sleeve made of a rigid material, said protective sleeve being removably insertable into said medical catheter through said proximal end, said suture being inserted through said protective sleeve;

(b) with the internal bolster in said non-anchoring state, inserting the distal end of said medical catheter into the patient, the proximal end of said medical catheter extending out of the patient;

(c) transforming said internal bolster from said non-anchoring state to said anchoring state;

(d) inserting the protective sleeve into said medical catheter through said proximal end to a desired depth;

(e) then, while maintaining said protective sleeve at said desired depth, cutting the medical catheter at said desired depth to yield a proximal portion and a distal portion of the cut medical catheter;

(f) then, removing said protective sleeve from the distal portion of the cut medical catheter; and

(g) then, securing the proximal end of the distal portion of the cut medical catheter to an external bolster.