Catheter system for the delivery of a low volume bolus

• US 6,764,461 B2
• Filed: 08/21/1998
• Issued: 07/20/2004
• Est. Priority Date: 12/01/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Mickley, Timothy J., Ellis, Louis, Hendrickson, Gary L., Hektner, Thomas R.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thompson, Michael M
• Application Number:
  US09/138,131
• Publication Number:
  US 20020042593A1
• Time in Patent Office: 2,160 Days
• Field of Search: 604/96.01, 604/194, 604/103, 604/97, 604/52, 604/15, 604/57, 604/59, 604/181, 600/192, 600/196, 600/108, 606/213, 606/214
• US Class Current: 604/15
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An administering portion is disposed at the distal end of the catheter and is configured to administer a bolus of liquid in response to positive pressure in a distal portion of the lumen. The catheter system of the present invention has a dead space of less 0.32 cc and preferably less than 0.15 cc in which residual therapeutic agents remain after delivery. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in the lumen A positive pressure is created to drive the bolus to the administering tip to express the bolus from the distal end of the catheter.

Claims

1. An infusion catheter, comprising:

an infusion port for receiving an infusate;

an elongated flexible shaft portion having a proximal end and a distal end and an infusion lumen extending therein, the infusion lumen in fluid communication with the infusion port and having a collapsible volume which is collapsed for infusion;

a delivery mechanism disposed at the distal end of the shaft portion including at least one delivery port and spaced from the infusion port and in fluid communication with the infusion lumen;

an infusion actuator on the elongated shaft portion operably coupled to the infusion lumen to collapse the infusion lumen from an expanded volume to a collapsed volume to form a collapsed infusate volume between the infusion port and the delivery mechanism to expel the infusate therefrom; and

wherein the collapsible infusate volume between the infusion port and the delivery mechanism is configured with a dead space volume of less than 0.32 cubic centimeters (cc).

2. The catheter of claim 1 wherein the infusion actuator comprises:

a piston slidably disposed within the infusion lumen and movable from a proximal position to a distal position.

3. The catheter of claim 2 wherein the infusion lumen includes:

a distal lumen portion and a proximal lumen portion, the distal lumen portion having a cross-sectional area smaller than a cross-sectional area of the proximal lumen portion.

4. The catheter of claim 3 wherein the piston includes a plunger portion having an outer perimeter sized to closely match the inner perimeter of the proximal lumen portion.

5. The catheter of claim 4 wherein the piston includes a distal shaft coupled to a distal end of the plunger portion and being sized to fit within the inner perimeter of the distal lumen portion when the piston is advanced to the distal position.

6. The catheter of claim 5 wherein the plunger portion is adapted to be moved to the distal position by injection of pressurized fluid into the infusion lumen proximal of the plunger portion.

7. The catheter of claim 5 wherein the piston includes a proximal extension, extending proximally of the plunger portion and a sheath disposed thereabout, the sheath being formed of a material which exhibits reduced frictional interaction with the inner perimeter of the infusion lumen than the material forming the proximal extension.

8. The catheter of claim 5 wherein the distal lumen portion includes a pressure responsive valve arranged therein.

9. The catheter of claim 1 wherein the collapsible volume infusion lumen is formed of a collapsible reservoir in fluid communication with the infusion port and disposed within a pressurizeable chamber in the shaft portion and the pressurizeable chamber is pressurized to form the infusion actuator to expel infusate.

10. The catheter of claim 9 and further including a pressure port in fluid communication with the pressurizeable chamber.

11. The catheter of claim 10 wherein the collapsible reservoir includes a distal lumen portion and is configured to collapse under pressure introduced into the pressurizeable chamber through the pressure port and to expel contents of the collapsible reservoir through the distal lumen portion.

12. The catheter of claim 11 wherein the distal lumen portion includes a pressure responsive valve disposed therein.

13. The catheter of claim 9 and further comprising:

an expandable member disposed at the distal end of the shaft portion and having an interior in fluid communication with the pressurizeable chamber.

14. The catheter of claim 9 and further comprising:

an inflation port;

an inflation lumen in fluid communication with the inflation port and an expandable member at the distal end of the shaft portion; and

wherein the collapsible reservoir is disposed external to the inflation lumen and is collapsible to reduce a profile of the shaft portion.

15. The catheter of claim 1 wherein the infusion lumen includes a collapsible volume infusion reservoir in fluid communication with the infusion port.

16. The catheter of claim 15 wherein the collapsible volume infusion reservoir is formed of a collapsible membrane.

17. The catheter of claim 15 wherein the collapsible volume infusion reservoir is formed between a rigid outer member and an expandable inner membrane and the inner membrane is expandable to collapse the volume of the infusion reservoir.

18. The infusion catheter as in claim 1, wherein the collapsed infusate volume between the infusion port and the delivery mechanism is configured with the dead space volume of less than 0.23 cubic centimeters (cc).

19. The infusion catheter as in claim 1, wherein the collapsed infusate volume between the infusion port and the delivery mechanism is configured with the dead space volume of less than 0.15 cubic centimeters (cc).

20. The infusion catheter as in claim 1, wherein the collapsed infusate volume between the infusion port and the delivery mechanism is configured with the dead space volume of less than 0.08 cubic centimeters (cc).

21. The infusion catheter of claim 1 wherein the infusion port is at the proximal end of the shaft portion.

22. An infusion catheter comprising:

an infusion port;

an elongated shaft portion having a proximal end, a distal end and an infusion lumen and the infusion lumen having a collapsible volume; and

a delivery mechanism including at least one delivery port disposed proximate to the distal end of the shaft portion and in fluid communication with the infusion lumen and the delivery mechanism includes an expandable balloon expandable to dispense infusate from the infusion catheter through the at least one delivery port; and

a piston operable in the infusion lumen to collapse the volume of the infusion lumen.

23. The infusion catheter of claim 22 and further comprising:

an outer membrane about the expandable balloon having at least one pore to form the at least one delivery port in fluid communication with the infusion lumen and the expandable balloon being in fluid communication with an inflation lumen to expand the balloon to dispense infusate through the at least one pore of the outer membrane.

24. The infusion catheter of claim 23 wherein the outer membrane includes a plurality of pores to define the at least one delivery port for the infusate.

25. The infusion catheter of claim 22 wherein the catheter further comprises a guidewire lumen along a length of the elongated shaft portion spaced from the infusion lumen.

26. The infusion catheter of claim 22 including a proximal infusion port in fluid communication with the infusion lumen and spaced from the at least one delivery port.

27. An infusion catheter, comprising:

an elongate shaft having a proximal end, a distal end, and an infusion lumen having a collapsible infusate volume;

an infusion port in fluid communication with the infusion lumen;

at least one delivery port in fluid communication with the infusion lumen and spaced from the infusion port; and

a pressurizeable chamber coupled to the infusion lumen and having a pressure port opened thereto through a manifold at the proximal end of the catheter shaft to provide pressure to the pressurizeable chamber to collapse the infusate volume of the infusion lumen.

28. The infusion catheter as in claim 27 wherein

a dead space volume of the infusion catheter is 0.32 cc or less.

29. The infusion catheter as in claim 27 wherein a dead space volume of the infusion catheter is 0.15 cc or less.

30. The infusion catheter of claim 27 wherein the pressurizeable chamber is formed of an expandable membrane opened to the pressure port and the infusion lumen is formed between a rigid portion and the expandable membrane which is expanded to collapse the volume of the infusion lumen.

31. The infusion catheter of claim 27 wherein the catheter an expandable balloon at the distal end of the elongate catheter shaft and the pressure port is in fluid communication with the expandable balloon to expand the balloon and the pressurizeable chamber to pressurize the chamber to dispense infusate.

32. The infusion catheter of claim 27 wherein the infusion lumen includes a collapsible portion of a collapsible structure disposed in the pressurizeable chamber which is pressurized to collapse the infusion lumen.

33. An infusion catheter comprising:

an elongate catheter shaft having a proximal end, a distal end and an infusion lumen having a collapsible portion formed of a collapsible structure;

at least one delivery port in fluid communication with the infusion lumen; and

an infusion actuator operable to exert a collapsing force to collapse the collapsible portion of the infusion lumen to dispense infusate.

34. The infusion catheter of claim 33 wherein the infusion actuator includes a tension mechanism coupled to the collapsible portion of the infusion lumen to collapse the infusion lumen for infusion.

35. The infusion catheter of claim 33 wherein a torque mechanism coupled to the collapsible portion of the infusion lumen to collapse the infusion lumen for infusion.

36. The infusion catheter of claim 33 wherein the infusion actuator includes an elongated sleeve slidably about the collapsible portion of the infusion lumen and movable between a retracted position and an actuating position to collapse the collapsible portion of the infusion lumen for infusion.

37. The infusion catheter of claim 33 including an infusion port proximate to the proximal end of the elongate catheter shaft in fluid communication with the infusion lumen and spaced from the at least one delivery port.

38. The infusion catheter of claim 33 wherein the elongate catheter shaft further comprises a guidewire lumen spaced from the infusion lumen.

39. An infusion catheter comprising:

an elongate catheter shaft having a collapsible infusate volume;

at least one delivery port in fluid communication with the infusion lumen; and

a pressurizeable chamber coupled to the infusion lumen and having a pressure port opened thereto at the proximal end of the catheter shaft to provide pressure to the pressurizeable chamber to collapse the infusate volume of the infusate lumen.

40. The infusion catheter of claim 39 including an infusion port in fluid communication with the infusion lumen proximate to the proximal end of the catheter shaft and spaced from the at least one delivery port.

41. The infusion catheter of claim 39 wherein the pressurizeable chamber is formed of an expandable membrane opened to the pressure port and the infusion lumen is formed between a rigid portion and the expandable membrane which is expanded to collapse the volume of the infusion lumen.

42. An infusion catheter comprising:

an elongate catheter shaft having a proximal end, a distal end and an infusion lumen having a collapsible infusate volume;

at least one delivery port in fluid communication with the infusion lumen; and

a pressurizeable chamber coupled to the infusion lumen and having a pressure port opened thereto at the proximal end of the catheter shaft wherein the infusion lumen includes a collapsible portion formed of a collapsible structure disposed in the pressurizeable chamber which is pressurized to collapse the volume of the infusion lumen.

43. The infusion catheter of claim 42 wherein the infusion lumen includes multiple collapsible segments collapsible at different collapsing pressures to collapse the volume of the infusion lumen.