Fluidic media introduction apparatus

• US 6,475,182 B1
• Filed: 08/26/1998
• Issued: 11/05/2002
• Est. Priority Date: 03/12/1997
• Status: Expired due to Term

• Current Assignee: Edward Gough, Gregory M. Cruise, Olexander Hnojewyj, Stuart D. Edwards
• Original Assignee: Edward Gough, Gregory M. Cruise, Olexander Hnojewyj, Stuart D. Edwards
• Inventors: Hnojewyj, Olexander, Edwards, Stuart D, Cruise, Gregory M, Gough, Edward
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/140,017
• Time in Patent Office: 1,532 Days
• Field of Search: 604/82-92, 604/93.01, 604/96.01, 604/98.01, 604/104-109, 604/174, 604/187, 604/191, 604/257, 604/264, 604/19, 604/48, 604/506, 604/507-510, 604/164.13, 604/181-182, 604/185, 604/218, 604/239-243, 604/523, 604/528, 604/533, 604/912, 222/145.5, 222/145.6, 606/213-15, 530/381-382
• US Class Current: 604/82
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: B01F 25/4231 using baffles
• CPC Class Codes: B01F 25/4233 using plates with holes, the holes being displaced from one plate to the next one to force the flow to make a bending movement
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type

Abstract

A fluidic media introduction apparatus for closing an opening in a vessel wall includes an elongated member with a fluidic media introduction port and a guide wire lumen. The guide wire lumen extends from a proximal portion to a distal portion of the elongated member. A fluidic media mixing chamber is positioned in the elongated member and coupled to a fluidic media introduction port. A fluidic media delivery lumen is coupled to the mixing chamber. A fluidic media advancement port is positioned at the distal portion of the elongated member. An inflatable member is coupled to the distal portion of the elongated member.

Claims

1. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port including a plurality of baffles positioned in an interior of the mixing chamber comprising an array of spaced apart walls,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an inflatable member fixedly coupled to the distal portion of the catheter at a fixed distance from the closure media advancement port.

2. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port including a plurality of baffles positioned in an interior of the mixing chamber, a portion of the plurality of baffles being coupled to an exterior surface of the guide wire lumen,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an inflatable member fixedly coupled to the distal portion of the catheter at a fixed distance from the closure media advancement port.

3. The apparatus of claim 2, wherein a plurality of the baffles are coupled to an interior surface of the mixing chamber.

4. An assembly for introducing a closure material to seal a puncture site in a vessel, the closure material comprising a mixture of a first and a second fluid composition, the assembly comprising

a catheter having a proximal end and a distal end, at least one fluid delivery port adjacent the catheter distal end to occupy a position outside the vessel adjacent the puncture site, an expandable member distal to the fluid delivery port to extend through the puncture site and occupy a position inside the vessel while the at least one fluid delivery port occupies a position adjacent the vessel puncture site outside the vessel, a fluid delivery lumen in the catheter in fluid communication with the fluid delivery port, and a guide wire lumen in the catheter sized to accommodate passage of a guide wire,

one or more dispensers adjacent the catheter proximal end in fluid communication with the catheter lumen for dispensing the first and second fluid compositions into the catheter lumen,

an actuator for causing the first and second fluid compositions to be dispensed from the one or more dispensers for passage through the catheter lumen, and

a mixing chamber in a downstream flow direction from the actuator and in an upstream flow direction from the catheter lumen for mixing the first and second fluid compositions prior to passage through the catheter lumen, the mixing chamber including a plurality of baffles.

5. The assembly of claim 4

wherein the baffles define a spiral pattern.

6. An assembly for introducing a closure material to seal a puncture site in a vessel, the closure material comprising a mixture of a first and a second fluid composition, the assembly comprising

a catheter having a proximal end and a distal end, at least one fluid delivery port adjacent the catheter distal end to occupy a position outside the vessel adjacent the puncture site, an expandable member distal to the fluid delivery port to extend through the puncture site and occupy a position inside the vessel while the at least one fluid delivery port occupies a position adjacent the vessel puncture site outside the vessel, a fluid delivery lumen in the catheter in fluid communication with the fluid delivery port, and a guide wire lumen in the catheter sized to accommodate passage of a guide wire,

one or more dispensers adjacent the catheter proximal end in fluid communication with the catheter lumen for dispensing the first and second fluid compositions into the catheter lumen,

an actuator for causing the first and second fluid compositions to be dispensed from the one or more dispensers for passage through the catheter lumen, and

a mixing chamber in a downstream flow direction from the actuator and in an upstream flow direction from the catheter lumen for mixing the first and second fluid compositions prior to passage through the catheter lumen, the guide wire lumen extending through the mixing chamber.

7. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an inflatable member fixedly coupled to the distal portion of the catheter at a fixed distance from the closure media advancement port comprising a balloon sized to be inflatable within an interior of a blood vessel, and

a plurality of baffles positioned in an interior of the mixing chamber.

9. The apparatus of claim 7 or 8, wherein the plurality of baffles are formed in a spiral pattern.

10. The apparatus of claim 7 or 8, wherein the baffles are positioned in the mixing chamber to create a swirling of the closure media in the mixing chamber.

8. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an expandable member coupled to the distal portion of the catheter comprising a basket, and

a plurality of baffles positioned in an interior of the mixing chamber.

11. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port including a plurality of baffles positioned in an interior of the mixing chamber comprising an array of spaced apart walls, the mixing chamber being in a surrounding relationship to the guide wire lumen,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an inflatable member coupled to the distal portion of the catheter.

12. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port, the mixing chamber is in a surrounding relationship to the guide wire lumen,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an inflatable member coupled to the distal portion of the catheter comprising a balloon sized to be inflatable within an interior of a blood vessel.

13. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port, the mixing chamber being in a surrounding relationship to the guide wire lumen,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an expandable member coupled to the distal portion of the catheter comprising a basket.

14. An apparatus for introducing a closure media to seal a puncture site in a vessel comprising

a catheter including a closure media introduction port,

a guide wire lumen extending from a proximal portion to a distal portion of the catheter,

a mixing chamber coupled to the closure media introduction port including a plurality of baffles positioned in an interior of the mixing chamber comprising an array of spaced apart walls, the mixing chamber being in a surrounding relationship to the guide wire lumen,

a closure media delivery lumen coupled to the mixing chamber, a closure media advancement port positioned at the distal portion of the catheter, and

an expandable member coupled to the distal portion of the catheter.