Lead placement device

• US 7,328,071 B1
• Filed: 10/12/2005
• Issued: 02/05/2008
• Est. Priority Date: 10/12/2005
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Stehr, Richard E., Potter, Daniel J.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/249,968
• Time in Patent Office: 846 Days
• Field of Search: 606/129, 606/108, 607115-116, 607/119, 607122-123, 607/129, 607/131, 600372-374, 600/377, 600/585
• US Class Current: 607/131
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/72 Micromanipulators
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Lead placement apparatus to transmit electrical signals to stimulate selected body tissue includes an introducer handle supporting a tubular outer sheath of flexible resilient material including a rigid section and a deflectable section adjacent the distal end, enabling the deflectable section to deflect among a plurality of positions in orientations transverse of a longitudinal axis. An operative member on the introducer handle connected to the distal end of the outer sheath serves to move that distal end. An inner tubular sheath of flexible resilient material slidably received within the outer sheath includes a driving socket fixed to its distal end whereby, with a lead slidably received within the inner tubular sheath and including a driven socket fixed to its distal end for releasable mating engagement by the driving socket, an electrode at the distal tip of the lead can be advanced and directed to the selected body tissue for stimulation.

Claims

1. An implantable lead assembly comprising:

an introducer handle having a longitudinal axis;

an elongated tubular outer sheath of flexible resilient material having a longitudinal axis fixed to the introducer handle generally aligned with the longitudinal axis thereof and extending between proximal and distal ends, the outer sheath having a rigid section distant from the distal end and a deflectable section adjacent the distal end, enabling the deflectable section adjacent the distal end to deflect from a first position aligned with the longitudinal axis to a plurality of second positions in orientations transverse of the longitudinal axis;

at least one elongated steering member embedded in the outer sheath and extending between a proximal end at the introducer handle and a distal end at the distal end of the outer sheath;

an operative member mounted on the introducer handle for movement between a first position and any one of a plurality of second positions, the operative member attached to the proximal end of the steering member such that when in the first position, the distal end of the outer sheath is in the first position and when in one of the plurality of second positions, the distal end of the outer sheath is in an associated one of the plurality of the second positions;

an inner tubular sheath of flexible resilient material slidably received within the outer sheath extending between proximal and distal ends;

a knob fixed to the proximal end of the inner sheath;

a driving socket fixed to the distal end of the inner sheath;

a lead extending between proximal and distal ends slidably received within the inner tubular sheath, the lead having a helix tip electrode at the distal end; and

a driven socket fixed to the distal end of the lead and positioned for releasable mating engagement by the driving socket;

wherein with engagement of the driven socket by the driving socket and movement of the knob and inner sheath in the distal direction, the helix tip electrode for the lead can be advanced to the selected body tissue for stimulation thereof; and

wherein rotation of the knob rotates the inner sheath, the driving socket, and the driven socket such that the helix tip electrode rotatable engages with the selected body tissue.

2. An implantable lead assembly as set forth in claim 1

wherein the lead includes:

an electrical conductor received within the lead for the stimulating pulse generator extending between a proximal end and a distal end;

an electrical connector coupled to the proximal end of the electrical conductor for releasable attachment to a stimulating pulse generator; and

an electrode coupled to the distal end of the electrical conductor.

3. An implantable lead assembly as set forth in claim 1

wherein the outer sheath includes a pair of diametrically opposed steering members embedded in the outer sheath;

and

wherein the operative member is attached to the proximal ends of the steering members such that when in the first position, the distal end of the outer sheath is in the first position and when in the plurality of second positions, the distal end of the outer sheath is in the associated plurality of second positions.

4. An implantable lead assembly as set forth in claim 1

wherein the introducer handle has a longitudinally extending bore;

and

wherein the outer sheath extends through the bore of the introducer handle.

5. An implantable lead assembly as set forth in claim 1 including:

a ring electrode at the distal end of the outer sheath;

an electrode port on the introducer handle for connection to an electrical mapping system; and

a wire lead extending through the outer sheath connecting the ring electrode to the electrode port.

6. An implantable lead assembly as set forth in claim 1

wherein the driving socket and driven socket include mutually engageable mating features.

7. An implantable lead assembly as set forth in claim 1

wherein the driving socket has a concave distal end region;

wherein the driven socket has a convex proximal end region matingly engageable with the driving socket; and

wherein, when the driving socket and the driven socket are engaged, the driving socket is operable for advancing the distal end of the lead for the stimulating pulse generator to a selected body tissue location.

8. An implantable lead assembly as set forth in claim 1

wherein the lead is a positive fixation lead.

9. An implantable lead assembly as set forth in claim 1

wherein the driving socket is cup shaped including:

a base member with a bore for fitting engagement on the distal end of the inner sheath; and

an outstanding cylindrical wall extending distally to a rim with circumferentially spaced cutouts; and

wherein the driven socket is generally cylindrical including;

a plurality of circumferentially spaced outwardly projecting boss members;

wherein the circumferentially spaced cutouts of the driving socket are slidably matingly engageable with the boss members of the driven socket for advancing the distal end of the lead for the stimulating pulse generator to a selected body tissue location.

10. Lead placement apparatus for positioning the lead of a body implantable stimulating pulse generator adapted to transmit electrical signals between a proximal end portion of the lead and a distal end portion thereof to thereby stimulate selected body tissue comprising:

an introducer handle having a longitudinal axis;

an elongated tubular outer sheath of flexible resilient material having a longitudinal axis fixed to the introducer handle generally aligned with the longitudinal axis thereof and extending between proximal and distal ends, the outer sheath having a rigid section distant from the distal end and a deflectable section adjacent the distal end, enabling the deflectable section adjacent the distal end to deflect from a first position aligned with the longitudinal axis to a plurality of second positions in orientations transverse of the longitudinal axis;

at least one elongated steering member embedded in the outer sheath and extending between a proximal end at the introducer handle and a distal end at the distal end of the outer sheath;

an operative member mounted on the introducer handle for movement between a first position and any one of a plurality of second positions, the operative member attached to the proximal end of the steering member such that when in the first position, the distal end of the outer sheath is in the first position and when in one of the plurality of the second positions, the distal end of the outer sheath is in an associated one of the plurality of the second positions;

an inner tubular sheath of flexible resilient material slidably received within the outer sheath extending between proximal and distal ends;

a knob fixed to the proximal end of the inner sheath; and

a driving socket fixed to the distal end of the inner sheath;

wherein, with a lead for the stimulating pulse generator extending between proximal and distal ends slidably received within the inner tubular sheath and including a driven socket fixed to the distal end thereof for releasable mating engagement by the driving socket, with engagement of the driven socket by the driving socket and movement of the knob and inner sheath in the distal direction, a helix tip electrode at the distal tip of the lead can be advanced to the selected body tissue for stimulation thereof; and

wherein rotation of the knob rotates the inner tubular sheath, the driving socket, and the driven socket such that the helix tip electrode engages with the selected body tissue.

11. A lead placement apparatus as set forth in claim 10

wherein the outer sheath includes a pair of diametrically opposed steering members embedded in the outer sheath;

and

wherein the operative member is attached to the proximal ends of the steering members such that when in the first position, the distal end of the outer sheath is in the first position and when in the plurality of second positions, the distal end of the outer sheath is in the associated plurality of second positions.

12. A lead placement apparatus as set forth in claim 10

wherein the introducer handle has a longitudinally extending bore;

and

wherein the outer sheath extends through the bore of the introducer handle.

13. A lead placement apparatus as set forth in claim 10

wherein the operative member is a lever pivotally mounted on the introducer handle for rotation about a pivot axis including a first free end for manual operation spaced in one direction away from the pivot axis and a second end spaced in an opposite direction away from the pivot axis and attached to the proximal end of the steering member;

and

wherein pivotal movement of the lever about the pivot axis moves the distal end of the outer sheath from the first position to the plurality of second positions.

14. A lead placement apparatus as set forth in claim 10

wherein the operative member is a lever pivotally mounted on the introducer handle for rotation about a pivot axis including a first free end for manual operation spaced in one direction away from the pivot axis;

and

wherein the proximal end of the steering member is fixed to the lever at a location radially spaced from the pivot axis.

15. A lead placement apparatus as set forth in claim 10 including:

a ring electrode at the distal end of the outer sheath;

an electrode port on the introducer handle for connection to an electrical mapping system; and

a wire lead extending through the outer sheath connecting the ring electrode to the electrode port.

16. A lead placement apparatus as set forth in claim 10

wherein the driving socket and driven socket include mutually engageable mating features.

17. A lead placement apparatus as set forth in claim 10

wherein the driving socket has a concave distal end region;

wherein the driven socket has a convex proximal end region matingly engageable with the driving socket; and

wherein, when the driving socket and the driven socket are engaged, the driving socket is operable for advancing the distal end of the lead for the stimulating pulse generator to a selected body tissue location.

18. A lead placement apparatus as set forth in claim 10

wherein the driving socket is cup shaped including:

a base member with a bore for fitting engagement on the distal end of the inner sheath; and

an outstanding cylindrical wall extending distally to a rim with circumferentially spaced cutouts; and

wherein the driven socket is generally cylindrical including;

a plurality of circumferentially spaced outwardly projecting boss members;

wherein the circumferentially spaced cutouts of the driving socket are slidably matingly engageable with the boss members of the driven socket for advancing the distal end of the lead for the stimulating pulse generator to a selected body tissue location.