Dilation catheter assembly and related methods

• US 7,029,450 B2
• Filed: 12/14/2001
• Issued: 04/18/2006
• Est. Priority Date: 12/14/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Gellman, Barry N.
• Primary Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US10/020,345
• Publication Number:
  US 20030114877A1
• Time in Patent Office: 1,586 Days
• Field of Search: 606/192, 606 32- 35, 606/27, 606/194, 606/159, 600/549
• US Class Current: 600/549
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 90/04 Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The invention, in one embodiment, is directed to a catheter assembly adapted to enable an operator to incise a human ureter from within, with reduced risk of damaging a crossing blood vessel. The dilation catheter includes an elongated body and a dilatable bladder. The dilatable bladder is adapted to dilate in a radially outward direction from the elongated body. A thermally responsive indicator incorporated with at least a portion of the dilation member exhibits a state change in response to a change in temperature. A temperature change indicates the existence of a nearby crossing vessel. In a surgical method, an operator repeatedly positions and inflates the dilatable bladder in a human ureter proximal to a desired incision location to map the location of any crossing vessels. The operator then determines an inner wall incision location that avoids the detected crossing vessels.

Claims

1. A catheter assembly comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder incorporated with said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body,

a thermally responsive indicator incorporated with at least a portion of said dilatable bladder, said thermally responsive indicator being adapted to visually change in response to a change in temperature, and

a surgical cutter adapted to enable an operator to cut mammal flesh at a location other than the location of said thermally responsive indicator.

2. The catheter assembly of claim 1, wherein said elongated body defines an internal lumen extending from a first end of said elongated body to a second end of said elongated body, said dilatable bladder is in fluid communication with said internal lumen, and inflates in response to a positive fluid pressure in said internal lumen.

3. The catheter of claim 1, wherein said catheter is adapted for insertion into a body of a mammal and said thermally responsive indicator detects a change in temperature when said thermally responsive indicator is located in proximity of a blood vessel.

4. The catheter of claim 1, wherein said catheter is adapted for insertion into a human body and said thermally responsive indicator indicates a change in temperature when a portion of said dilatable bladder is disposed in a ureter and brought into proximity of a femoral artery or vein.

5. The catheter assembly of claim 1, wherein said dilatable bladder has an inner surface and said thermally responsive indicator is disposed on at least a portion of said inner surface.

6. The catheter assembly of claim 1, wherein said dilatable bladder has an outer surface and said thermally responsive indicator is disposed on at least a portion of said outer surface.

7. The catheter assembly of claim 1, wherein said thermally responsive indicator includes a thermochromatic material.

8. The catheter assembly of claim 7, wherein said dilatable bladder is formed from a first material and said thermochromatic material is disposed within said first material.

9. The catheter assembly of claim 1, further comprising a detector element adapted for detecting the visual change of said thermally responsive indicator.

10. The catheter assembly of claim 9, wherein said elongated body defines a detector lumen extending between the first end portion of said elongated body and the second end portion of said elongated body, and being adapted for receiving said detector element.

11. The catheter assembly of claim 9, wherein said detector element is a fiber optic camera adapted to enable an operator to view the visual change of said thermally responsive indicator.

12. The catheter assembly of claim 1, wherein said dilatable bladder extends around a first portion of a periphery of said elongated body and said surgical cutter is adapted to enable an operator to cut mammal flesh contacting a second portion of the periphery of said elongated body, said first portion of the periphery of said elongated body and said second portion of the periphery of said elongated body being non-overlapping.

13. The catheter assembly of claim 1, wherein said thermally responsive indicator is adapted to change color in response to a change in temperature.

14. The catheter assembly of claim 1, wherein said thermally responsive indicator is adapted to visually change in response to a change in temperature from a source external of said bladder.

15. The catheter assembly of claim 1, wherein said thermally responsive indicator is adapted to visually change in response to a change in temperature from a first temperature present in a ureter adjacent at least one of a femoral artery and vein of a patient to a second temperature present in the ureter spaced from the femoral artery and vein of the patient.

16. The catheter assembly of claim 1, wherein the elongated body includes a first portion and a second portion different than the first portion of the elongated body, and the bladder is entirely incorporated with the first portion of the elongated body.

17. The catheter assembly of claim 1, wherein

the elongated body includes a first portion and a second portion different than the first portion of the elongated body, the bladder is entirely incorporated with the first portion of the elongated body, the cutter is disposed on the second portion of the elongated body.

18. A catheter assembly comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder incorporated with said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body,

a thermally responsive indicator incorporated with at least a portion of said dilatable bladder, said thermally responsive indicator being adapted to visually change in response to a change in temperature,

a cutting lumen extending from the first end portion of said elongated body to the second end portion of said elongated body, wherein an outer wall of said elongated body includes a cutting aperture in communication with said cutting lumen, and

a surgical cutting wire anchored in said cutting lumen at a location between said cutting aperture and said second end portion of said elongated body, and extending axially from said location past said cutting aperture toward said first end portion of said elongated body, wherein said cutting lumen at said first end portion of said elongated body is adapted to enable an operator to extend said surgical cutting wire to cause a looped portion of said surgical cutting wire to protrude radially through said cutting aperture.

19. A catheter assembly comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder incorporated with said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body,

a thermally responsive indicator incorporated with at least a portion of said dilatable bladder, said thermally responsive indicator being adapted to visually change in response to a change in temperature,

a cutting lumen extending from the first end portion of said elongated body to the second end portion of said elongated body, wherein an outer wall includes a cutting aperture in communication with said cutting lumen, and

a surgical cutting element adapted to extend axially from said first end portion through said cutting lumen toward said cutting aperture, wherein said cutting lumen at said first end portion of said elongated body is adapted to enable an operator to extend and retract said surgical cutting element radially through said cutting aperture.

20. A catheter assembly comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder incorporated with said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body,

a thermally responsive indicator incorporated with at least a portion of said dilatable bladder, said thermally responsive indicator being adapted to visually change in response to a change in temperature, and

a surgical cutting wire extending external to said elongated body from a first location proximal to a first end of said elongated body to a second location proximal to a second end of said elongated body, said surgical cutting wire disposed in a fixed relationship to said second location and in a moveable relationship with said first location, said first location being adapted to enable an operator to extend and retract said surgical cutting element to adjust an amount of radial protrusion of said cutting element from said elongated body.

21. A catheter assembly comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder incorporated with said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body, the dilatable bladder having an outer surface, and

a thermally responsive indicator incorporated with at least a portion of said dilatable bladder, said thermally responsive indicator being adapted to visually change in response to a change in temperature, and

a surgical cutting wire extending adjacent to said outer surface of said dilatable bladder from a first location proximal to the first end portion of said elongated body to a second location proximal to the second end portion of said elongated body, said surgical cutting wire disposed in a fixed relationship to said second location and in a moveable relationship to said first location.

22. The catheter assembly of claim 21, wherein said surgical cutting wire is adapted to extend in response to inflation of said dilatable bladder and retract in response to deflation of said dilatable bladder.

23. A catheter assembly, comprising,

an elongated body having a first end portion and a second end portion,

a dilatable bladder coupled to said elongated body between the first end portion of the elongated body and the second end portion of the elongated body, the dilatable bladder being adapted to dilate in a radially outward direction from said elongated body,

a thermally responsive indicator, at least a portion of said thermally responsive indicator being disposed on at least a portion of said dilatable bladder, said at least a portion of said thermally responsive indicator being adapted to visually change in response to a change in temperature, and

a detector element adapted for detecting the visual change of said at least a portion of said thermally responsive indicator.

24. The catheter assembly of claim 23, wherein said elongated body defines an internal lumen extending from the first end portion of said elongated body to the second end portion of said elongated body, said dilatable bladder is in fluid communication with said internal lumen, and inflates in response to a positive fluid pressure in said internal lumen.

25. The catheter assembly of claim 23, wherein said catheter is adapted for insertion into a body of a mammal and said at least a portion of said thermally responsive indicator indicates a change in temperature when said at least a portion of said thermally responsive indicator is brought into proximity of a blood vessel.

26. The catheter assembly of claim 23, wherein said catheter is adapted for insertion into a human body and said at least a portion of said thermally responsive indicator indicates a change in temperature when a portion of said dilatable bladder is disposed in a ureter and is brought into proximity of a femoral artery or vein.

27. The catheter assembly of claim 23, wherein a portion of said elongated body is adapted to form said dilatable bladder.

28. The catheter assembly of claim 23, wherein said dilatable bladder has an inner surface and said at least a portion of said thermally responsive indicator is disposed on at least a portion of said inner surface.

29. The catheter assembly of claim 23, wherein said dilatable bladder has an outer surface and said at least a portion of said thermally responsive indicator is disposed on at least a portion of said outer surface.

30. The catheter assembly of claim 23, wherein said thermally responsive indicator includes a thermochromatic material.

31. The catheter assembly of claim 23, wherein said dilatable bladder is formed from a first material and said thermochromatic material is disposed within said first material.

32. The catheter assembly of claim 23, further comprising, a detector lumen extending between the first end portion of said elongated body and the second end portion of said elongated body, and being adapted for receiving said detector element.

33. The catheter assembly of claim 23, wherein said detector element is a fiber optic camera adapted to enable an operator to view the visual change of said at least a portion of said thermally responsive indicator.

34. The catheter assembly of claim 23, further comprising,

a surgical cutter adapted to enable an operator to cut mammal flesh at a location other than a location of said at least a portion of said thermally responsive indicator when said at least a portion of said thermally responsive indicator indicates a change in temperature.

35. The catheter assembly of claim 23, wherein said dilatable bladder extends around a first portion of a periphery of said elongated body and said catheter assembly further comprises a surgical cutter adapted to enable an operator to incise mammal flesh contacting a second portion of the periphery of said elongated body, said first portion of the periphery of said elongated body and said second portion of the periphery of said elongated body being non-overlapping.

36. The catheter assembly of claim 23, further comprising,

a cutting lumen extending from the first end portion of said elongated body to the second end portion of said elongated body, wherein an outer wall of said elongated body includes a cutting aperture in communication with said cutting lumen, and

a surgical cutting wire anchored in said cutting lumen at a location between said cutting aperture and said second end portion of said elongated body, and extending axially from said location past said cutting aperture toward said first end portion of said elongated body, wherein said cutting lumen at said first end of said elongated body is adapted to enable an operator to extend said surgical cutting wire to cause a looped portion of said surgical cutting wire to protrude radially through said cutting aperture.

37. The catheter assembly of claim 23, further comprising,

a cutting lumen extending from the first end portion of said elongated body to the second end portion of said elongated body, wherein an outer wall includes a cutting aperture in communication with said cutting lumen, and

a surgical cutting element adapted to extend axially from said first end portion through said cutting lumen toward said cutting aperture, wherein said cutting lumen at said first end portion of said elongated body is adapted to enable an operator to extend and retract said surgical cutting element radially through said cutting aperture.

38. The catheter assembly of claim 23, further comprising,

a surgical cutting wire extending external to said elongated body from a first location proximal to the first end portion of said elongated body to a second location proximal to the second end portion of said elongated body, said surgical cutting wire disposed in a fixed relationship to said second location and in a moveable relationship with said first location, said first location being adapted to enable an operator to extend and retract said surgical cutting element to adjust an amount of radial protrusion of said cutting element from said elongated body.

39. The catheter assembly of claim 23, wherein said dilatable bladder has an outer surface and said catheter assembly further comprises, a surgical cutting wire extending adjacent to said outer surface of said dilatable bladder from a first location proximal to the first end portion of said elongated body to a second location proximal to the second end portion of said elongated body, said surgical cutting wire disposed in a fixed relationship to said second location and in a moveable relationship to said first location.

40. The catheter assembly of claim 39, wherein said surgical cutting wire is adapted to extend in response to inflation of said dilatable bladder and retract in response to deflation of said dilatable bladder.

41. The catheter assembly of claim 23, wherein said at least a portion of said thermally responsive indicator is adapted to change color in response to a change in temperature.