Mechanically active infusion catheter

• US 6,852,097 B1
• Filed: 06/23/2000
• Issued: 02/08/2005
• Est. Priority Date: 06/24/1999
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Richard E. Fulton III
• Inventors: Fulton, Richard E. III
• Primary Examiner(s): Schwartz, Larry I.
• Assistant Examiner(s): ANDERSON, CATHARINE L
• Application Number:
  US09/599,987
• Time in Patent Office: 1,691 Days
• Field of Search: 606191-200, 606/1, 606/159, 606/169, 606/170, 606/171, 606/180, 604/22, 604266-269
• US Class Current: 604/266
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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

A device and method to dissolve or eliminate blood clots from a patient relies upon a non-rapid moving mechanism to physically dissolve clots without damaging endothelium of the arteries and veins of a patient. In one embodiment, in addition to mechanical agitation of a clot, a thrombolytic agent is administered simultaneously with such agitation. Preferably, intermittent agitation is utilized over a prolonged period of time to effectuate clot removal.

Claims

1. A pharmomechanical device, comprising:

a catheter having a corkscrew configuration throughout its length that is substantially incapable of damaging an endothelium of a vascular structure, said catheter rotating between 30 rpm and 600 rpm once it is inserted inside a patient, said catheter increasing the surface area of a clot in said vascular structure such that said clot can be dissolved by a lytic agent; and

means for providing mechanical motion to said catheter throughout a length of a vessel for a prolonged period of time while said lytic agent is acting.

2. The device as set forth in claim 1, wherein said period is at least about 5 hours.

3. The device as set forth in claim 1, wherein said period is at least about 10 hours.

4. The device as set forth in claim 1, wherein said period is at least about 24 hours.

5. The device as set forth in claim 1, wherein said means for providing mechanical motion operates intermittently and over a prolonged period of time.

6. The device as set forth in claim 5, wherein said means for providing mechanical motion provides for a time of inactivity at least as great as a time of activity of said device.

7. The device as set forth in claim 1, wherein said means for providing mechanical motion generates vibrations effective to disrupt a clot, but does not promote hemolysis or cause damage to an endothelium.

8. The device as set forth in claim 1, wherein said corkscrew configured catheter extends for a substantial length of said vessel.

9. The device as set forth in claim 1, further comprising an occluding element positioned so as to maintain desired concentration of a thrombolytic drug in a desired segment of a patient'"'"'s blood vessels.

10. The device as set forth in claim 6, wherein a ratio of an inactivation time to an activation time is greater than 1.

11. The device as set forth in claim 6, wherein a ratio of an inactivation time to an activation time is greater than 50.

12. The device as set forth in claim 1, further comprising a pump that delivers lytic agent in pulse waves, said pulse waves causing an intermittent mechanical motion of said catheter, and wherein an intermittent mechanical motion of the catheter is caused by the delivery of said lytic agent.

13. The device as set forth in claim 12, wherein said pump is programmed to deliver said lytic agent at a desired frequency or duration.

14. A pharmomechanical device, comprising:

a catheter having a length and having a corkscrew configuration throughout a substantial portion of said length, said catheter being substantially incapable of damaging an endothelium of a vascular structure, said catheter rotating between 30 rpm and 600 rpm once it is inserted inside a patient to increase the surface area of a clot in said vascular structure; and

a means for rotating said catheter.

15. The pharmomechanical device of claim 14, wherein said catheter rotates at less than about 300 rpm.

16. The pharmomechanical device of claim 14, wherein said catheter rotates at less than about 55 rpm.

17. A pharmomechanical device, comprising:

a catheter having a corkscrew configuration throughout substantially its entire length that is substantially incapable of damaging an endothelium of a vascular structure, said catheter rotating less than about 55 rpm once it is inserted inside a patient, said catheter increasing the surface area of a clot in said vascular structure such that said clot can be dissolved by a lytic agent; and

a pump that delivers lytic agent in pulse waves, said pulse waves causing an intermittent mechanical motion of said catheter.