Dilator for introducer system having injection port

• US 6,228,052 B1
• Filed: 02/29/1996
• Issued: 05/08/2001
• Est. Priority Date: 02/29/1996
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Pohndorf, Peter J.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thompson, Michael M.
• Application Number:
  US08/608,920
• Time in Patent Office: 1,895 Days
• Field of Search: 604/49, 604/51-3, 604/93, 604/96, 604/103-104, 604/158, 604/160-161, 604/163-164, 604/170-171, 604/173, 604/263-264, 604/272, 604/280 , 604/283-284, 128/656-8, 606/191, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

An introducer system for a lead, catheter, probe or the like, employing a dilator and introducer sheath assembly for dilating a body vessel in preparation for introducing the lead, etc., through the lumen of the introducer sheath that provides for the injection of radiopaque contrast media to observe the cause of an impediment to advancement of the assembly into the vessel lumen. The dilator is formed of an elongated dilator body having a guide wire lumen therein for receiving and being advanced over the guide wire and a hub assembly at the proximal end of the guide wire body. An injection lumen is also formed in the dilator body isolated from the guide wire lumen and in fluid communication with a side port formed in the hub assembly and an injection port formed in the distal end of the dilator body. Preferably, the injection port is formed in a tapered distal end portion of the dilator. In use, the guide wire and the dilator/introducer sheath assembly may be retained in situ in the event that the introduction of the assembly is impeded, and contrast media may be injected under pressure through the side port, injection lumen and out the injection lumen so that the impediment may be visualized.

Claims

1. An introducer system for use with a catheter or lead comprising:

a sheath having a first end and a second end, the sheath being compatible for insertion within a body, the first end configured to insert the sheath within the body with the second end extending out of the body, the sheath having a central lumen configured to permit introduction of at least one lead or catheter therethrough;

means for permitting removal of the sheath from a lead or catheter disposed therethrough without requiring the sheath to be removed from an end of the lead or catheter disposed therethrough; and

a dilator having a first distal end and a second proximal end, the first distal end of the dilator being tapered, the dilator configured to be disposed through the central lumen of the sheath;

means integrally formed with the dilator for introducing contrast media adjacent the first distal end thereof with the sheath in place over the dilator body for visualizing an impediment in the blood vessel to the advancement of the sheath and dilator over a guide wire without removing the dilator or the guide wire from the body.

2. The introducer system of claim 1 wherein the visualizing means further comprises:

a contrast injection lumen formed in the dilator body extending between the proximal end thereof and the distal end thereof, the contrast injection lumen terminating in an injection port in the distal end thereof; and

injection means in fluid communication with the contrast injection lumen for injecting a radiopaque contrast media into the blood vessel lumen through the further contrast media injection lumen while the dilator remains in position in the blood vessel.

5. The introducer system of claim 2 wherein said means for visualizing further comprises:

a contrast injection lumen formed in said dilator body extending between said proximal end thereof and said tapered distal end portion, said contrast injection lumen terminating in an injection port in said tapered distal end portion; and

injection means in fluid communication with said contrast injection lumen for injecting a radiopaque contrast media into the blood vessel lumen through the further contrast media injection lumen while the dilator remains in position in the blood vessel.

7. The introducer system of claim 1 wherein said means for visualizing further comprises:

a contrast injection lumen formed in said dilator body extending between said proximal end thereof and said distal end thereof, said contrast injection lumen terminating in an injection port in said distal end thereof; and

injection means in fluid communication with said contrast injection lumen for injecting a radiopaque contrast media into the blood vessel lumen through the further contrast media injection lumen while the dilator remains in position in the blood vessel.

8. The introducer system of claim 7 wherein:

said dilator is formed with a hub assembly coupled to said proximal end of said dilator body having a guide wire lumen port and a side port for attachment to a source of contrast media; and

said injection means further comprises a side port lumen in said side port of said hub assembly in fluid communication with the proximal end of said contrast injection lumen.

3. An introducer system for dilating a body vessel to percutaneously position an introducer sheath into the body vessel lumen over a guide wire in the blood vessel lumen and for visualizing an impediment in the body vessel lumen impeding advancement of the distal end thereof comprising:

a dilator having an elongated tubular dilator body extending between a proximal end and a distal end and having a guide wire lumen formed therein extending between guide wire lumen openings in said proximal and distal ends for receiving a guide wire therein for dilating the body vessel lumen diameter on advancement of said dilator distal end over the guide wire in the body vessel lumen;

an elongated introducer sheath having a tubular body enclosing a sheath lumen therein and extending between openings in a sheath distal end and a sheath proximal end, said sheath lumen having a lumen diameter for receiving said tubular dilator body inserted therein and forming an introducer sheath and dilator assembly with a dilator distal end portion extending distally of the sheath distal end, the sheath having means for permitting removal of the sheath from a lead or catheter disposed therethrough without requiring the sheath to be removed from an end of the lead or catheter disposed therethrough; and

means integrally formed with said dilator for introducing contrast media adjacent the distal end portion extending distally of the sheath distal end thereof with the sheath in place over said tubular dilator body for visualizing an impediment in the blood vessel to the advancement of the introducer sheath and dilator assembly over the guide wire without removing the assembly or the guide wire from the blood vessel.

4. The introducer system of claim 3 wherein:

said elongated tubular dilator body has a tapered distal end portion extending proximally of said distal end, and a dilator outer surface major diameter extending between said dilator body proximal end and said tapered distal end portion, said tapered distal end portion formed with a progressively increasing taper diameter from said distal end to said dilator outer surface major diameter for dilating the body vessel lumen diameter on advancement of said dilator distal end portion through the body vessel lumen.

6. The introducer system of claim 3 wherein:

said dilator is formed with a hub assembly coupled to said proximal end of said dilator body having a guide wire lumen port and a side port for attachment to a source of contrast media; and

said injection means further comprises a side port lumen in said side port of said hub assembly in fluid communication with the proximal end of said contrast injection lumen.

9. An introducer system for dilating a body vessel to percutaneously position an introducer sheath into the body vessel lumen over a guide wire in the blood vessel lumen and for visualizing an impediment in the body vessel lumen impeding advancement of the distal end thereof comprising:

a dilator having an elongated tubular dilator body extending between a proximal end and a distal end and having a guide wire lumen formed therein extending between guide wire lumen openings in said proximal and distal ends for receiving a guide wire therein for dilating the body vessel lumen diameter on advancement of said dilator distal end over the guide wire in the body vessel lumen;

an elongated introducer sheath having a tubular body enclosing a sheath lumen therein and extending between openings in a sheath distal end and a sheath proximal end, said sheath lumen having a lumen diameter for receiving said tubular dilator body inserted therein and forming an introducer sheath and dilator assembly with [a] the dilator distal end portion extending distally of the sheath distal end the sheath having means for permitting removal of the sheath from a lead or catheter disposed therethrough without requiring the sheath to be removed from an end of the lead or catheter disposed therethrouqh; and

a contrast injection lumen formed in said dilator body isolated from said guide wire lumen extending between said proximal end thereof and said distal end portion, said contrast injection lumen terminating in an injection port in said distal end, for introducing contrast media adjacent the distal end portion thereof with the sheath in place over said tubular dilator body for visualizing an impediment in the blood vessel to the advancement of the introducer sheath and dilator assembly over the guide wire without removing the assembly or the guide wire from the blood vessel.

10. The introducer system of claim 9 wherein:

said elongated tubular dilator body has a tapered distal end portion extending proximally of said distal end, and a dilator outer surface major diameter extending between said dilator body proximal end and said tapered distal end portion, said tapered distal end portion formed with a progressively increasing taper diameter from said distal end to said dilator outer surface major diameter for dilating the body vessel lumen diameter on advancement of said dilator distal end portion through the body vessel lumen.

11. The introducer system of claim 10 wherein said contrast injection lumen formed in said dilator body terminates in said injection port in said tapered distal end portion.

12. The introducer system of claim 11 wherein:

said dilator is formed with a hub assembly coupled to said proximal end of said dilator body having a guide wire lumen port and a side port having a side port lumen in fluid communication with the proximal end of said contrast injection lumen.

13. A method of introducing an introducer sheath into a body and visualizing an impediment in the body vessel impeding the advancement of the sheath comprising the steps of:

introducing a guide wire distal end into a body with a guide wire proximal end outside an opening to the body;

providing an introducer sheath having means for permitting removal of the sheath from a lead or catheter disposed therethrough without requiring the sheath to be removed from an end of the lead or catheter disposed therethrough, the introducer sheath having an introducer sheath lumen therethrough;

providing a dilator having a guide wire lumen formed therein extending between proximal and distal guide wire lumen openings in the proximal end and distal ends and a contrast media injection lumen formed in the dilator body separate from the guide wire lumen and extending between the proximal end and terminating in an injection port in the distal end;

assembling the dilator into the introducer sheath lumen to form an introducer sheath and dilator assembly;

advancing the distal guide wire lumen opening of the introducer sheath and dilator assembly distally over the guide wire proximal end and into the body vessel; and

upon encountering an impediment in the body vessel to advancement of the introducer sheath and guide wire assembly, injecting contrast media through the contrast media injection lumen and distally to the injection port for enabling visualizing of the impediment.