Lead insertion tool for hemostatic introducer system
A tool for protecting a cardiac stimulating lead from damage upon passing through a hemostasis valve of a vascular introducer in the course of an implantation procedure comprises a splittable, peal-away sheath that is rendered sufficiently rigid by a tool dilator or placement of the lead body within the sheath so that the combination can be forced through a self-closing aperture formed through the hemostatic valve member. The use of the tubular sheath in breaching the self-closing aperture shields the lead electrodes and any covering that may be present from becoming distorted as well as from contamination by silicon oil commonly found in vascular introducers having a hemostasis valve.
1. A lead insertion tool comprising:
(a) a lead introducer having an elastomeric hemostasis valve with a self-closing aperture;
(b) a tubular sheath having a relatively thin wall at least one longitudinal groove formed inwardly thereof to facilitate rupture of the sheath along said groove and a lumen sized to receive a medical lead therethrough; and
(c) a tool dilator having a generally rigid shaft which when inserted through the lumen of the tubular sheath renders the sheath sufficiently rigid to allow insertion of the sheath and dilator through the self-closing aperture of the lead introducer.
2. The lead insertion tool as in claim 1 wherein the elastomeric hemostasis valve is contained in a plastic hub on a proximal end of said lead introducer and said plastic hub includes a side port located distal of the elastomeric hemostasis valve and the tubular sheath is of a length sufficient to pass through the self-closing aperture without blocking said side port.
3. The lead insertion tool as in claim 1 wherein said sheath includes a Luer fitting on a proximal end thereof.
4. The lead insertion tool as in claim 3 wherein the sheath includes a pair of wings extending generally perpendicularly from a longitudinal axis of the sheath to facilitate gripping and rupture of the sheath along said longitudinal groove and to serve as a stop preventing passage of the sheath fully beyond the hemostasis valve.
5. The lead insertion tool as in claim 3 wherein said tool dilator includes a Luer fitting for mating with the Luer fitting on the sheath.
6. The lead insertion tool as in any one of claims 1 - 5 wherein the shaft of the dilator is sized to substantially occlude the lumen of the tubular sheath.
7. The lead insertion tool as in claim 6 wherein the generally rigid shaft of the tool dilator includes a lumen adapted to receive a guidewire therethrough.
8. A lead insertion tool comprising:
(a) a lead introducer having an elastomeric hemostasis valve with a self-closing aperture formed therethrough; and
(b) a tubular sheath having a relatively thin wall with at least one longitudinal groove formed inwardly thereof to facilitate rupture of the sheath along said groove and a lumen sized to receive a lead body therethrough with a predetermined clearance fit, the tubular sheath being sufficiently rigid to be insertable through the self-closing aperture of the hemostasis valve.
9. The lead insertion tool of claim 8 wherein the elastomeric hemostasis valve is contained in a plastic hub on a proximal end of said lead introducer and said plastic hub includes a side port located distal of the elastomeric hemostasis valve and the tubular sheath is of a length sufficient to pass through the self-closing aperture without blocking said side port.
10. A method for facilitating insertion of a relatively limp medical lead through a self-closing aperture in an elastomeric hemostasis valve of a lead introducer comprising the steps of:
(a) providing a lead introducer having an elastomeric hemostasis valve with a self-closing aperture;
(b) providing a lead insertion tool having a tubular sheath with a wall defining a lumen, the wall having at least one longitudinal groove formed inwardly thereof to facilitate rupture of the sheath along said groove, said lumen sized to receive a lead body therethrough with a predetermined clearance fit, said tubular sheath being sufficiently rigid when surrounding said lead body to allow insertion through the self-closing aperture of the hemostasis valve;
(c) inserting a distal end portion of a medical lead into the lumen of the tubular sheath;
(d) inserting the tubular sheath containing the distal end portion of the medical lead through the self-closing aperture of the elastomeric hemostasis valve;
(e) sliding the tubular sheath in a proximal direction along the lead body and out from the self-closing aperture leaving the lead body in place; and
(f) removing the tubular sheath by tearing same along the longitudinal wall.
11. A method for facilitating insertion of a relatively limp medical lead through a self-closing aperture in an elastomeric hemostasis valve of a lead introducer comprising the steps of:
(a) providing a lead insertion tool having a tubular sheath with a wall defining a lumen, the wall having at least one longitudinal groove formed inwardly thereof to facilitate rupture of the sheath along said groove, said lumen sized to receive a lead body therethrough with a predetermined clearance fit, said tubular sheath being sufficiently rigid when surrounding said lead body to allow insertion through the self-closing aperture of the hemostasis valve;
(b) providing a tool dilator having a generally rigid shaft of a predetermined length and diameter;
(c) inserting the tool dilator into the lumen of the tubular sheath;
(d) passing the tubular sheath with the tool dilator through a self-closing aperture of a hemostasis valve;
(e) removing the tool dilator from the lead insertion tool; and
(f) inserting a distal end of the medical lead through the lumen of the lead insertion tool.
12. The method of claim 11 and further including the steps of:
(a) withdrawing the lead insertion tool from the self-closing aperture; and
(b) splitting the lead insertion tool along the longitudinal groove to remove the lead insertion tool from surrounding relation with respect to the medical lead.