Arrangement for implanting a miniaturized cardiac lead having a fixation helix
First Claim
1. An introducer system for positioning and fixedly engaging a distal fixation helix of a lead at an implantation site within a patient'"'"'s body, comprising:
- a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead;
an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath; and
a handle operable between a first handle position enabling advancement and retraction of the lead through the handle and a second handle position fixedly engaging a proximal end of the lead within the handle, wherein the lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second handle position.
1 Assignment
0 Petitions
Accused Products
Abstract
An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.
141 Citations
25 Claims
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1. An introducer system for positioning and fixedly engaging a distal fixation helix of a lead at an implantation site within a patient'"'"'s body, comprising:
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a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead;
an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath; and
a handle operable between a first handle position enabling advancement and retraction of the lead through the handle and a second handle position fixedly engaging a proximal end of the lead within the handle, wherein the lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second handle position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. An introducer system for positioning and fixedly engaging a distal fixation helix of a lead at an implantation site within a patient'"'"'s body, comprising:
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a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead;
an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath;
a hub body, extending from a proximally extending portion having a threaded portion positioned thereon to a connecting portion, the outer sheath and the hub body being fixedly engaged through threaded interaction of mating threads formed between the outer sheath and the connecting portion of the hub body;
a handle shaft having an axial bore extending through the length of the handle shaft from a proximal portion to a distal portion, the distal portion of the axial bore formed to receive the proximally extending portion of the hub body;
a first engaging member positioned within the proximal portion of the axial bore;
a cap that is advanced distally towards the handle shaft to engage the first engaging member against the lead to position the cap in a first cap position fixedly engaging the lead within the handle shaft and is retracted proximally from the handle shaft to disengage the second engaging member from the lead to position the cap in a second cap position enabling advancement of the lead through the handle shaft; and
a second engaging member positioned within the distal portion of the axial bore and advancing through grooves formed by the threaded portion of the hub body to distally advance the handle shaft when the cap is in the first cap position as the handle shaft is rotated about the proximally extending portion, wherein the proximal end of the torque transfer sheath is fixedly positioned within the proximal portion of the handle shaft and the rotation of the handle shaft about the proximally extending portion of the hub body when the cap is in the first cap position transmits torque through the torque transfer sheath to the lead to screw the fixation helix extending from the distal end of the outer sheath body into the implantation site. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for positioning and fixedly engaging a distal fixation helix of a lead at an implantation site within a patient'"'"'s body, comprising the steps of:
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inserting a lead through a handle and a torque transfer sheath while the handle is in a first handle position enabling advancement and retraction of the lead through the handle and extending a distal fixation helix of the lead outward a predetermined distance from an outer sheath distal end;
fixedly engaging the lead body within the handle;
retracting the lead and the torque transfer sheath within the outer sheath to advance the fixation helix within the outer sheath;
positioning the outer sheath at the implantation site; and
rotating the handle to rotate and advance the lead and the torque transfer sheath simultaneously through the outer sheath to extend the fixation helix outward a predetermined distance from the end of the outer sheath and to rotate the fixation helix through the predetermined distance to be fixedly engaged at the implantation site. - View Dependent Claims (23, 24, 25)
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Specification