Method and apparatus for intramural delivery of a substance

• US 6,635,027 B1
• Filed: 01/26/2000
• Issued: 10/21/2003
• Est. Priority Date: 05/19/1997
• Status: Expired due to Fees

• Current Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Olson, Edward L., Cragg, Andrew H.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K.
• Application Number:
  US09/492,016
• Time in Patent Office: 1,364 Days
• Field of Search: 604/19, 604/22, 604/264, 604/96.01, 604/103.01, 604/103.07, 604/915, 604/916
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

An infusion catheter is formed with a catheter lumen extending from a proximal end connector assembly to a distal end valve that is normally closed but is penetrable to allow introduction of a guidewire through the catheter lumen and distal end valve and to thereby allow advancement of the infusion catheter over the guidewire, thereby allowing access of a distal infusion segment to a wide number of locations in the body. A plurality of, closely spaced, side wall infusion holes infusion holes extend from the catheter lumen through the catheter side wall in a high strength, catheter distal end, infusion segment. A therapeutic or diagnostic substance is pumped in a pulsatile manner through the catheter lumen under high pressure after removal of the guidewire and closure of the distal end valve. The infusion segment is preferably moved back and forth as jets of the therapeutic or diagnostic substance are emitted. In one embodiment, the infusion catheter is used in thrombectomy methods and apparatus for removing a thrombus from a blood vessel by high velocity injection of a therapeutic or diagnostic substance, e.g., a plasminogen activator, through the side wall infusion holes as power lysis jets that lyse the adjacent thrombin. In another embodiment, the infusion catheter is used in intramural infusate injection, wherein a therapeutic or diagnostic lining penetration infusate is ejected from the infusion holes as a plurality of lining penetration jets that penetrate through a body vessel wall lining and intramurally into the body vessel wall.

Claims

1. An intramural substance delivery system for delivering a therapeutic or diagnostic lining penetration infusate as a plurality of lining penetration jets through a body vessel wall lining and intramurally into the body vessel wall comprising:

an infusion catheter having a side wall and catheter lumen extending between a catheter proximal end and a catheter distal end, an elongated infusion segment having a plurality of closely spaced apart, infusion holes in said side wall that extend from said catheter lumen to the outer surface, said spaced apart infusion holes having a diameter of about 0.01 cm and distributed over a length of the infusion segment of about 0.2 cm to about 2.0 cm in a helical pattern and in a density of 20-32 infusion holes per centimeter length of said helical pattern, and a valve in said catheter distal end that is normally closed to close the catheter lumen distal end and penetrable by a guidewire for receiving said guidewire and allowing advancement of said infusion catheter over the guidewire to orient the infusion segment side wall of the infusion catheter with respect to a section of the body vessel wall and for allowing withdrawal of the guidewire proximally from said valve to allow said valve to close and from said catheter lumen to allow said catheter lumen to be filled with the lining penetration infusate; and

means for injecting a predetermined bolus of the lining penetration infusate at a predetermined rate into said catheter lumen at a pressure that effects ejection of the lining penetration infusate at high velocity through said infusion holes as fine lining penetration jets of lining penetration infusate to mechanically penetrate the lining of the vessel wall.

2. The intramural delivery system delivery system of claim 1, wherein said injecting means further comprises a pulsatile fluid pump and a supply of therapeutic or diagnostic substance coupled to said catheter lumen at the catheter proximal end.

3. The intramural delivery system of claim 2, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure that effects ejection of the therapeutic or diagnostic substance through said plurality of infusion holes as said lining penetration jets.

4. The intramural delivery system of claim 2, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance through said infusion holes and for repeating the injecting step about once every 10 seconds.

5. The intramural delivery system of claim 2, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance through said infusion holes to achieve a lining penetration jet velocity of about 500-4000 inches/sec.

6. The intramural delivery system of claim 1, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure that effects ejection of the therapeutic or diagnostic substance through said plurality of infusion holes as said lining penetration jets.

7. The intramural delivery system of claim 1, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance through said infusion holes and for repeating the injecting step about once every 10 seconds.

8. The intramural delivery system of claim 1, wherein said injecting means further comprises means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance through said infusion holes to achieve a lining penetration jet velocity of about 500-4000 inches/sec.

9. The intramural delivery system of claim 1, wherein said infusion catheter further comprises a biasing mechanism operable in a biasing state for biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall and in a non-biasing state for enabling advancement of said infusion catheter over said guidewire to orient said side wall of the infusion catheter in said infusion segment with respect to the section of the body vessel wall and for enabling withdrawal of said infusion catheter from the body vessel.

10. The intramural delivery system of claim 9, wherein said biasing mechanism comprises an asymmetric balloon adapted to be inflated laterally of said infusion segment in said biasing state with an inflation fluid, thereby biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall.

11. The intramural delivery system of claim 9, wherein said biasing mechanism comprises an expandable wire adapted to be extended laterally of said infusion segment side wall in said biasing state, thereby biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall.

12. The intramural delivery system of claim 1, wherein said distal infusion segment is formed with a biasing mechanism to assume a coiled infusion configuration when extended in a body vessel lumen in a biasing state for biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall and a straight infusion configuration in a non-biasing state for enabling advancement of said infusion catheter over said guidewire to orient said side wall of the infusion catheter in said infusion segment with respect to the section of the body vessel wall and for enabling withdrawal of said infusion catheter from the body vessel.

13. An intramural substance delivery system for delivering a therapeutic or diagnostic lining penetration infusate as a plurality of lining penetration jets through a body vessel wall lining and intramurally into the body vessel wall comprising:

an infusion catheter having a side wall and catheter lumen extending between a catheter proximal end and a catheter distal end, an elongated infusion segment having a plurality of closely spaced apart, infusion holes in said side wall that extend from said catheter lumen to the outer surface, and a valve in said catheter distal end that is normally closed to close the catheter lumen distal end and penetrable by a guidewire for receiving said guidewire and allowing advancement of said infusion catheter over the guidewire to orient the infusion segment side wall of the infusion catheter with respect to a section of the body vessel wall and for allowing withdrawal of the guidewire proximally from said valve to allow said valve to close and from said catheter lumen to allow said catheter lumen to be filled with the lining penetration infusate; and

means for injecting a bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second into said catheter lumen at a pressure that effects ejection of the therapeutic or diagnostic substance through said plurality of infusion holes as fine lining penetration jets of lining penetration infusate to mechanically penetrate the lining of the vessel wall.

14. The intramural delivery system of claim 13, wherein said infusion catheter further comprises a biasing mechanism operable in a biasing state for biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall and in a non-biasing state for enabling advancement of said infusion catheter over said guidewire to orient said side wall of the infusion catheter in said infusion segment with respect to the section of the body vessel wall and for enabling withdrawal of said infusion catheter from the body vessel.

15. The intramural delivery system of claim 14, wherein said biasing mechanism comprises an asymmetric balloon adapted to be inflated laterally of said infusion segment in said biasing state with an inflation fluid, thereby biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall.

16. The intramural delivery system of claim 14, wherein said biasing mechanism comprises an expandable wire adapted to be extended laterally of said infusion segment side wall in said biasing state, thereby biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall.

17. The intramural delivery system of claim 14, wherein said distal infusion segment is formed with a biasing mechanism to assume a coiled infusion configuration when extended in a body vessel lumen in a biasing state for biasing said side wall and at least certain ones of said infusion holes of said infusion segment into close relation with the section of the vessel wall and a straight infusion configuration in a non-biasing state for enabling advancement of said infusion catheter over said guidewire to orient said side wall of the infusion catheter in said infusion segment with respect to the section of the body vessel wall and for enabling withdrawal of said infusion catheter from the body vessel.

18. The intramural delivery system delivery system of claim 13, wherein said injecting means further comprises a pulsatile fluid pump and a supply of therapeutic or diagnostic substance coupled to said catheter lumen at the catheter proximal end.

19. The intramural delivery system of claim 13, wherein said injecting means further comprises means for injecting the bolus of about 5 ml of therapeutic or diagnostic substance at the rate of about 25 ml per second through said infusion holes into said catheter lumen at a pressure of about 30-900 psi.

20. The intramural delivery system of claim 13, wherein said injecting means further comprises means for injecting the bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second through said infusion holes into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance at a lining penetration jet velocity of about 500-4000 inches/sec.

21. The intramural delivery system of claim 13, wherein said injecting means further comprises means for injecting the bolus of about 5 ml of therapeutic or diagnostic substance at the rate of about 25 ml per second through said infusion holes into said catheter lumen at a pressure of about 30-900 psi and means for repeating the injecting step about once every 10 seconds.

22. The intramural delivery system of claim 13, wherein said injecting means further comprises means for injecting the bolus of about 5 ml of therapeutic or diagnostic substance at a rate of about 25 ml per second through said infusion holes into said catheter lumen at a pressure of about 30-900 psi that effects ejection of the therapeutic or diagnostic substance at a lining penetration jet velocity of about 500-4000 inches/sec and means for repeating the injecting step about once every 10 seconds.