Urinary catheter

• US 5,919,170 A
• Filed: 06/07/1995
• Issued: 07/06/1999
• Est. Priority Date: 02/01/1993
• Status: Expired due to Term

• Current Assignee: Coloplast A/S
• Original Assignee: Mentor Corporation (Johnson & Johnson)
• Inventors: Woessner, Roger
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/486,379
• Time in Patent Office: 1,490 Days
• Field of Search: 604/264, 604/280, 604/52-54
• US Class Current: 604/264
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A urinary catheter including a tube with a co-extruded stripe, printed stripe or demarcation or series of marks to determine the alignment of a tip end of the catheter relative to the striped or marked portion of the catheter outside the body. The catheter can be a urethral catheter, such as a Coude-Tiemann curve tip catheter. This visible stripe or marks provide for manipulating passage of the catheter tip through obsructed or difficult urological pathways.

Claims

1. A catheter for catheterization of a tortuous body lumen comprising:

a distal end;

a proximal end;

a tube extending between the distal and proximal ends and defining a longitudinal axis;

a tip portion at the distal end of the catheter, the tip extending radially away from the longitudinal axis; and

a visible marking formed on the tube, wherein the tube is susceptible to twisting about the longitudinal axis upon contact with an obstruction within the lumen, the visible marking being modulated according to the twisting and thereby providing an indication of the twisting and the relative position of the tip portion.

2. The catheter of claim 1, wherein said tube defines a hole on a side of the tube adjacent the tip portion.

3. The catheter of claim 1, wherein said visible marking comprises a sequence of marks that extend longitudinally along the tube.

4. The catheter of claim 1, wherein said visible marking comprises a stripe that extends longitudinally along the tube.

5. A urinary catheter for insertion by an operator into a tortuous body lumen past an obstruction, said urinary catheter comprising:

a catheter tube having a longitudinal axis and a visible sequence of marks arranged generally parallel with said longitudinal axis of said catheter tube, said visible sequence of marks contrasting with said catheter tube so as to be readily apparent to the operator, said catheter tube having an insertion end and a manipulation end, said visible sequence of marks extending sufficiently toward said manipulation end of said catheter tube so as to be exposed outside the tortuous body lumen when said catheter tube is at least partially inserted within said tortuous body lumen; and

a tip connected to said insertion end of said catheter tube and extending radially from said catheter tube at a predetermined angle relative to said longitudinal axis, said catheter tube further defining a hole extending at least partially through said catheter tube generally proximate to said tip, wherein said visible sequence of marks provides a visual indication to the operator of the relative positions of said tip and said hole from outside the tortuous body lumen once the tip is inserted into the tortuous body lumen, thus allowing the operator to manipulate said manipulation end of said catheter tube so as to position and orient said tip and said hole relative to the obstruction so as to cause a minimum of tissue damage when the catheter tube is moved past the obstruction, and wherein the catheter tube is fabricated from a longitudinally flexible biocompatible plastic material such that upon insertion into and removal from the tortuous body lumen rotation of the manipulation end of the catheter tube will simultaneously rotate the tip and the visible sequence of marks a substantially equal amount, but such that insertion into and removal from a portion of the tortuous body lumen containing the obstruction will cause the visible sequence of marks to twist when the manipulation end of the catheter tube is rotated, said twisting of the visible sequence of marks being visible to the operator along a portion of the catheter tube exposed outside the tortuous body lumen thereby enabling the operator to determine the position and orientation of the tip and hole relative to the manipulation end and the obstruction.

6. The urinary catheter of claim 5 wherein the hole is a first hole, said urinary catheter further comprising:

a second hole extending at least partially through the catheter tube and disposed generally proximate to the tip, said second hole being located generally diametrically opposing the first hole, the visible sequence of marks enabling the operator to locate the position and orientation of the tip, the first hole, and said second hole during insertion and removal of the catheter tube from outside the tortuous body lumen such that tissue damage from said tip, the first hole, or said second hole is minimized.

7. The urinary catheter of claim 5 wherein the visible sequence of marks are generally aligned along the catheter tube in an arrangement forming a substantially linear pattern generally parallel with the longitudinal axis.

8. A catheter for insertion by an operator through a tortuous body lumen past an obstruction, said catheter comprising:

a tube having an insertion end, a manipulation end, a side portion, and a longitudinal axis, said side portion having a sequence of visible indicia contrasting with said side portion so as to be readily apparent to the operator, said sequence of visible indicia extending sufficiently along said tube such that a portion of said sequence of visible indicia is exposed outside the tortuous body lumen when said tube is at least partially inserted within the tortuous body lumen, said tube being susceptible to twisting about said longitudinal axis upon contact with an obstruction, and said visible indicia being modulated according to the twisting and thereby providing an indication of the twisting; and

a tip connected to and extending from said insertion end of said tube in a direction radially away from said longitudinal axis of said tube, said direction being at a predetermined angle relative to said sequence of visible indicia, said tube further defining a hole extending at least partially through said side portion and disposed generally proximate to said tip, said hole being positioned at a predetermined location relative to said tip and a predetermined angle relative to said sequence of visible indicia,

whereby the portion of the sequence of visible indicia disposed outside the tortuous body lumen provides a visual indication of the relative positions of the tip and the hole from outside the tortuous body lumen such that the operator selectively manipulates the manipulation end of the tube to position and orient the tip and the hole of the urinary catheter such that movement of the tube past the obstruction will cause a minimum of tissue damage.

9. A urinary catheter for insertion by an operator through a tortuous body lumen past an obstruction, said urinary catheter comprising:

a tube having an insertion end, a manipulation end, a side portion, and a longitudinal axis, said side portion having a visible stripe contrasting with said side portion so as to be readily apparent to the operator, said visible stripe extending sufficiently along said tube such that a portion of said visible stripe is exposed outside the tortuous body lumen when said tube is at least partially inserted within the tortuous body lumen; and

a tip connected to and extending from said insertion end of said tube in a direction radially away from said longitudinal axis of said tube, said direction being at a predetermined angle relative to said visible stripe, said tube further defining a hole extending at least partially through said side portion and disposed generally proximate to said tip, said hole being positioned at a predetermined location relative to said tip and a predetermined angle relative to said visible stripe,

whereby the portion of the visible stripe disposed outside the tortuous body lumen provides a visual indication of the relative positions of the tip and the hole from outside the tortuous body lumen such that the operator selectively manipulates the manipulation end of the tube to position and orient the tip and the hole of the urinary catheter such that movement of the tube past the obstruction will cause a minimum of tissue damage, said tube being susceptible to twisting about said longitudinal axis upon contact with an obstruction, and said visible stripe being modulated according to the twisting and thereby providing an indication of the twisting.

10. The urinary catheter of claim 9, wherein the visible stripe is co-extruded with the tube.

11. The urinary catheter of claim 9, wherein the visible stripe is printed on the side portion of the tube.

12. The urinary catheter of claim 9, wherein the visible stripe is marked on the side portion of the tube.

13. The urinary catheter of claim 9, wherein the tip is curved and tapered.

14. The urinary catheter of claim 9, wherein the tip is formed into a round member having a closed distal end.

15. A catheter for insertion by an operator into a tortuous body lumen past an obstruction, said catheter comprising:

a tube having a substantially circular cross-section, said tube having an insertion end terminating in a curved tip and a second end, said tube having a side portion and a longitudinal axis, said curved tip connected to and extending radially from said insertion end of said tube at a predetermined angle relative to said longitudinal axis;

a visible stripe contrasting with said side portion of said tube so as to be readily apparent to the operator, said visible stripe extending from said insertion end toward said second end of said tube such that a portion of said visible stripe is exposed outside the tortuous body lumen when said tube is at least partially inserted within said tortuous body lumen, said visible stripe being positioned at a predetermined position relative to said curved tip; and

a hole defined by and extending at least partially through said side portion of said tube generally proximate to said curved tip, said hole being oriented a predetermined angle from said visible stripe,

whereby the portion of the visible stripe exposed outside the tortuous body lumen enables the operator to locate the hole and the curved tip of the tube after insertion into the tortuous body lumen relative to the manipulation end of the tube, such that the operator selectively manipulates the position and orientation of the curved tip and the hole as the catheter passes the obstruction to cause a minimum of tissue damage, and wherein said tube is fabricated from a longitudinally flexible biocompatible plastic material such that upon insertion into and removal from the tortuous body lumen rotation of the manipulation end of the tube will simultaneously rotate the curved tip a substantially equal amount in the same direction, but such that insertion into and removal from a portion of the tortuous body lumen containing the obstruction will cause the visible stripe to twist when the manipulation end of the tube is rotated, the twisting of the visible stripe being visible to the operator from outside the tortuous body lumen, thereby enabling the operator to determine the orientation of the curved tip and the hole relative to the manipulation end.

16. The catheter of claim 15, wherein the catheter is a urological catheter.

17. The catheter of claim 16, wherein the hole is a first hole, said catheter further comprising:

a second hole extending at least partially through the side portion of the tube and disposed generally proximate to the curved tip, said second hole being located generally diametrically opposing the first hole, the visible stripe enabling the operator to locate the curved tip, the first hole, and the second hole during insertion and removal of the catheter from the tortuous body lumen such that tissue damage is minimized.

18. A method for inserting a catheter into a tortuous body lumen, the method comprising:

a) providing the catheter, the catheter comprising;

a distal end;

a proximal end;

a tube extending between the distal and proximal ends and defining a longitudinal axis;

a tip portion at the distal end of the catheter, the tip extending radially away from the longitudinal axis; and

a visible marking formed on the tube, wherein the tube is susceptible to twisting about the longitudinal axis upon contact with an obstruction within the lumen, the visible marking being modulated according to the twisting and thereby providing an indication of the twisting;

b) inserting the distal end of the catheter into the tortuous body lumen;

c) ascertaining the orientation of the tip portion based on the modulation of the visible marking; and

d) manipulating a portion of the catheter that is outside the tortuous body lumen based on the modulation of the visible marking to orient the tip portion such that tissue damage is minimized during movement of the catheter.

19. The method of claim 18, wherein the tube defines a hole on a side of the tube adjacent the tip portion.

20. The method of claim 19, wherein the method further comprises manipulating a portion of the catheter that is outside the tortuous body lumen based on the modulation of the visible marking to orient the hole such that tissue damage is minimized during movement of the catheter.

21. The method of claim 18, wherein the tortuous body lumen contains an obstruction.

22. The method of claim 21, wherein the method further comprises manipulating a portion of the catheter that is outside the tortuous body lumen based on the modulation of the visible marking to orient the tip portion such that movement of the distal end past the obstruction causes minimal tissue damage.

23. A method for an operator to insert a catheter into a tortuous body lumen containing an obstruction, said catheter having an upper portion, a lower portion, a manipulation end, an insertion end, and a side portion, said insertion end terminating in a tip extending generally away from said upper portion, said catheter defining a hole disposed along said side portion of said catheter generally proximate to said tip, said method comprising the steps of:

providing the catheter with a visible stripe contrasting with the side portion of the catheter so as to be readily apparent to the operator, said visible stripe disposed on and extending longitudinally along the catheter such that a portion of said visible stripe is exposed and visible outside the tortuous body lumen when the catheter is at least partially inserted within the tortuous body lumen;

inserting the insertion end of the catheter into the tortuous body lumen;

observing said portion of said visible stripe on the catheter disposed outside the tortuous body lumen to determine based upon that observation whether the insertion end of the catheter has encountered the obstruction; and

manipulating the catheter to position the tip and the hole relative to the obstruction so that movement of the catheter past the obstruction will cause the least amount of tissue damage.

24. The method of claim 23 wherein the obstruction is a tissue body and the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the obstruction by the hole.

25. The method of claim 23 wherein the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the tortuous body lumen by the hole.

26. The method of claim 23 wherein the obstruction is a tissue body and the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the obstruction by the tip of the catheter tube.

27. The method of claim 23 wherein the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the tortuous body lumen by the tip of the catheter tube.

28. The method of claim 23 wherein the tip of the catheter extends radially from the insertion end of the catheter at a predetermined angle relative to the longitudinal axis of the catheter tube.

29. The method of claim 28 wherein the tip of the catheter tube forms a curve relative to the catheter tube.

30. A method for an operator to insert a catheter into a tortuous body lumen containing an obstruction, said catheter having an upper portion, a lower portion, a manipulation end, an insertion end, and a side portion, said insertion end terminating in a tip extending generally away from said upper portion, said catheter defining a hole disposed along said side portion of said catheter generally proximate to said tip, said method comprising the steps of:

providing the catheter with a sequence of visible indicia contrasting with the side portion of the catheter so as to be readily apparent to the operator, said sequence of visible indicia disposed on and extending longitudinally along the catheter such that a portion of said sequence of visible indicia is exposed and visible outside the tortuous body lumen when the catheter is at least partially inserted within the tortuous body lumen;

inserting the insertion end of the catheter into the tortuous body lumen;

observing said portion of said sequence of visible indicia on the catheter disposed outside the tortuous body lumen to determine based upon that observation whether the insertion end of the catheter has encountered the obstruction; and

manipulating the catheter to position the hole relative to the obstruction so that movement of the catheter past the obstruction will cause the least amount of tissue damage.

31. The method of claim 30 wherein the obstruction is a tissue body and the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the obstruction by the hole.

32. The method of claim 30 wherein the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the tortuous body lumen by the hole.

33. The method of claim 30 wherein the obstruction is a tissue body and the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the obstruction by the tip of the catheter tube.

34. The method of claim 30 wherein the step of manipulating the catheter is accomplished so as to cause the least amount of tissue damage to the tortuous body lumen by the tip of the catheter tube.

35. The method of claim 30 wherein the tip of the catheter extends radially from the insertion end of the catheter at a predetermined angle relative to the longitudinal axis of the catheter tube.

36. The method of claim 35 wherein the tip of the catheter tube forms a curve relative to the catheter tube.

37. A method for an operator to insert a catheter into a tortuous body lumen containing an obstruction, said method comprising the steps of:

providing a catheter tube having a substantially circular cross-section, said catheter tube having a manipulation end and an insertion end, said catheter tube having an upper portion, a lower portion, and a side portion, said insertion end terminating in a curved tip extending generally away from said lower portion,

said catheter tube further having a visible stripe of contrasting color so as to be readily apparent to the operator, said visible stripe disposed on and extending longitudinally along said upper portion of said catheter tube such that a portion of said visible stripe is exposed and visible outside the tortuous body lumen when said catheter tube is at least partially inserted within the tortuous body lumen,

said catheter tube defining a hole extending at least partially through said side portion of said catheter tube and disposed generally proximate to said curved tip;

inserting said insertion end of said catheter tube into the tortuous body lumen;

observing said visible stripe at a location on said catheter tube disposed outside the tortuous body lumen to determine based upon that observation of said visible stripe whether said insertion end of said catheter tube has encountered the obstruction; and

manipulating said catheter tube to position said hole relative to the obstruction so that movement of said catheter tube past the obstruction will cause the least amount of tissue damage.