Splittable lead introducer with mechanical opening valve

• US 5,441,504 A
• Filed: 11/23/1993
• Issued: 08/15/1995
• Est. Priority Date: 04/09/1992
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lach, Linda L., Pohndorf, Peter J., Greene, Corinne A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/157,751
• Time in Patent Office: 630 Days
• Field of Search: 606/129, 606/185, 606/191, 606/198, 604/164, 604/165, 604/167, 604/161, 128/642, 128/772, 607/116, 607/119, 607/122
• US Class Current: 606/129
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A transvenous lead introducer having a mechanical valve assembly disposed thereon. In a preferred embodiment, a longitudinally splittable introducer sheath is provided with a sliding valve at or near one end. The sliding valve may be spring-biased to a normally closed position. A semicircular notch may be provided in the forward end of the sliding valve, so that the sheath may be effectively sealed even when a guide wire runs through the sheath. In an alternative embodiment, the sliding valve is adapted to have its forward end inserted into a notch in the cylindrical sheath body. The mechanical valve assembly is further configured to permit use with a splittable lead introducer sheath.

Claims

1. An introducer for introducing a lead or catheter comprising:

an introducer sheath having a hollow cylindrical body configured to permit the introduction of a lead or catheter therethrough, said sheath open at its proximal and distal ends;

a tab disposed at the proximal end of said introducer sheath, extending radially outward therefrom;

sliding valve means disposed on said tab, said sliding valve means adapted to slide from a first, open position wherein a forward end of said sliding valve means is disposed over said tab, to a second, closed position wherein said forward end of said sliding valve means is disposed over said open proximal end of said introducer sheath;

such that said sliding valve means, in said closed position, substantially prevents the passage of air and blood through said introducer sheath; and

means for permitting removal of said introducer from said lead or catheter without requiring said introducer to be removed over an end of said lead or catheter.

2. An introducer in accordance with claim 1 wherein said means for permitting removal of said introducer from said lead or catheter without requiring said introducer to be removed over an end of said lead or catheter comprises a score line within said introducer sheath.

3. An introducer in accordance with claim 1, wherein said sliding valve means comprises a valve element spring-biased to assume a normally closed position by a spring element coupled to said valve element.

4. An introducer system for introducing a lead or catheter into a body comprising:

an introducer sheath having a hollow body configured to permit the introduction of a lead or catheter therethrough, said introducer sheath open at its proximal and distal ends;

a member disposed at the proximal end of said introducer sheath, extending radially outward therefrom;

sliding valve means disposed on said member, said sliding valve means adapted to slide from a first, open position wherein a forward end of said sliding valve means is disposed over said member, to a second, closed position wherein said forward end is disposed over said open proximal end of said introducer sheath such that said sliding valve means, in said closed position, substantially prevents the passage of air and blood through said sheath;

means for permitting removal of said introducer sheath and said sliding valve means from said lead or catheter without requiring said introducer sheath and said sliding valve means to be removed over an end of said lead or catheter; and

a dilator removably inserted in said introducer sheath, having a conically tapered end and a flared endpiece adapted to facilitate insertion of a guidewire into said dilator, said dilator being adapted to be inserted, tapered end first, into the proximal end of said introducer sheath, such that said flared endpiece is brought into contact with said member.

5. An introducer system in accordance with claim 4 wherein said means for permitting removal of said introducer sheath and said sliding valve means from said lead or catheter without requiring said introducer sheath and said sliding valve means to be removed over an end of said lead or catheter comprise a splittable line on said sheath.

6. An introducer system in accordance with claim 5 wherein said means for permitting removal of said introducer sheath and said sliding valve means from said lead or catheter comprise a sheath slitter.

7. An introducer system for introducing a lead or catheter into a body comprising:

a longitudinally separable introducer sheath having a proximal end and a distal end, said introducer sheath further having a lumen extending therethrough, said lumen configured to permit a lead or catheter to be positioned therethrough;

separable valve means positioned on said proximal end of said introducer sheath, said valve means adapted to slide from a first, open position wherein said valve means is disposed away from said lumen, to a second, closed position wherein said valve means is disposed over said lumen such that said valve means, in said closed position, substantially prevents the passage of air and blood through said introducer sheath; and

a vessel dilator removably inserted in said introducer sheath, said dilator having a hollow body, said dilator having a first end and a second end, said first end being tapered and having an endpiece and adapted to facilitate insertion of a guidewire into said dilator, said dilator being adapted to be inserted, said first end first, into said proximal end of said introducer sheath.

8. An introducer system in accordance with claim 7 wherein said introducer sheath further comprises means for permitting removal of said introducer sheath from said lead or catheter without requiring said introducer sheath to be removed over an end of said lead or catheter.

9. An introducer system for introducing a lead or catheter comprising:

an introducer sheath having a hollow cylindrical body, said sheath open at its proximal and distal ends;

a tab disposed at the proximal end of said introducer sheath;

a sliding valve member disposed on said tab, said sliding valve member slidable from a first position, wherein a forward end of said sliding valve member is disposed over said tab, to a second position, wherein said forward end of said sliding valve member is disposed over said open proximal end of said introducer sheath; and

means for permitting removal of said introducer system from said lead or catheter without requiring said introducer system to be removed over an end of said lead or catheter.

10. An introducer system in accordance with claim 9 further comprising a vessel dilator disposed through said introducer sheath, having a hollow body, a conically tapered end and a flared endpiece.

11. An introducer system in accordance with claim 9 wherein said means for permitting removal of said introducer system from said lead or catheter without requiring said introducer system to be removed over an end of said lead or catheter comprises a score line within said introducer sheath.

12. An introducer system in accordance with claim 9 wherein a guidewire is disposed through said introducer sheath and wherein the forward end of the sliding valve member has a notch formed therein, adapted to engage the guidewire therein when the sliding valve member is slid to the second position before the guidewire is removed from the introducer sheath, such that passage of air and blood through the introducer sheath is substantially prevented.

13. An introducer system in accordance with claim 9 wherein the means for permitting removal of the introducer system from the lead or catheter comprise a splittable tab.

14. An introducer system in accordance with claim 9 wherein the means for permitting removal of the introducer system from the lead or catheter comprise a sheath slitter.

15. An introducer system for introducing a lead or catheter into a body comprising:

a longitudinally separable introducer sheath having a proximal end and a distal end, said introducer sheath further having a lumen extending therethrough, said lumen configured to permit a lead or catheter to be positioned therethrough; and

longitudinally separable valve means positioned on said proximal end of said introducer sheath, said valve means adapted to slide from a first, open position wherein said valve means is disposed away from said lumen, to a second, closed position wherein said valve means is disposed over said lumen such that said valve means, in said closed position, substantially prevents the passage of air and blood through said introducer sheath.

16. An introducer system in accordance with claim 15 further comprising a vessel dilator removably inserted in said introducer sheath, said dilator having a hollow body, said dilator having a first end and a second end, said first end being tapered and having an endpiece and adapted to facilitate insertion of a guidewire into said dilator, said dilator being adapted to be inserted, said first end first, into said proximal end of said introducer sheath.