Transesophageal medical lead

• US 5,967,977 A
• Filed: 10/03/1997
• Issued: 10/19/1999
• Est. Priority Date: 10/03/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Legatt, Kristi M., Mullis, Deniz Ayaz
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US08/943,850
• Time in Patent Office: 746 Days
• Field of Search: 600/374, 600/375, 600/380, 600/381, 600/393, 607/122, 607/124, 607/126
• US Class Current: 600/380
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61N 1/0517 Esophageal electrodes

Abstract

A mechanically expandable esophageal medical lead has an elongated flexible body which carries at a distal end thereof one or more electrically conducting members. The conducting members are moveable laterally with respect to the body portion of the medical lead by means of a mechanical structure contained therein. The degree and extent of mechanical movement can be controlled through manipulation of a pull wire axial movement mechanism.

Claims

1. A transesophageal medical lead, comprising:

(a) an elongated, flexible lead body having first proximal and first distal ends, the lead body having a plurality of elongated lumens disposed therewithin and extending at least substantially between the first distal and first proximal ends of the lead body;

(b) at least one external electrical connector;

(c) a pull wire having second distal and second proximal ends, the pull wire being slidably disposed in a first of the plurality of lumens, the second distal end of the pull wire being fixedly attached at or near the first distal end of the lead body;

(d) at least one electrical conductor having third distal and third proximal ends and disposed in a second of the plurality of lumens, the third proximal end of the at least one electrical conductor being mechanically and electrically connected to the at least one external electrical connector;

(e) a distention mechanism located at or near the first distal end of the lead body, comprising;

(1) at least one flexible arm having at least one cardiac sensing, monitoring or defibrillating electrode disposed or mounted thereon, the at least one electrode being mechanically and electrically connected to a point at or near the third distal end of the at least one electrical conductor;

(2) a stiffening mechanism having a central axially-extending aperture disposed therewithin, the pull wire slidably engaging and passing through the central aperture of the stiffening mechanism;

wherein the distention mechanism is laterally expandable and retractable respecting the lead body through retraction of the pull wire by a user, the stiffening mechanism providing the amount of structural compression required in the region of the distention mechanism to prevent the at least one arm from bowing outwardly in an undesired direction or orientation when the pull wire is retracted by the user, the medical lead being transnasally or transorally insertable in an esophagus of a subject when the distention mechanism is retracted.

2. The medical lead of claim 1, wherein the distention mechanism includes at least two flexible arms, each arm having at least one cardiac sensing, monitoring or defibrillating electrode disposed or mounted thereon, each electrode being mechanically and electrically connected to a corresponding electrical conductor disposed in one of the plurality of lumens, the proximal end of each corresponding electrical conductor being mechanically and electrically connected to a corresponding external electrical connector, the distal end or a point near the distal end of each corresponding electrical conductor being electrically and mechanically connected to its corresponding electrode.

3. The medical lead of claim 2, wherein each arm has a plurality of electrodes attached thereto or mounted thereon.

4. The medical lead of claim 1, wherein the spacing between electrodes may be varied by selecting appropriate external connectors.

5. The medical lead of claim 1, wherein the distention mechanism includes at least three flexible arms, each arm having at least two cardiac sensing, monitoring or defibrillating electrodes disposed or mounted thereon, each electrode being mechanically and electrically connected to a corresponding electrical conductor disposed in one of the plurality of lumens, the proximal end of each corresponding electrical conductor being mechanically and electrically connected to a corresponding external electrical connector, the distal end or a point near the distal end of each corresponding electrical conductor being electrically and mechanically connected to its corresponding electrode.

6. The medical lead of claim 5, wherein the spacing between electrodes may be varied by selecting appropriate external connectors.

7. The medical lead of claim 1, wherein the lead body comprises at least one of polyurethane, silicone, silastic and rubber.

8. The medical lead of claim 1, wherein the pull wire axial movement mechanism comprises a rotating pull wire mechanism and a stationary pull wire mechanism.

9. The medical lead of claim 1, wherein the stiffening mechanism comprises at least one sleeve and at least one coil.

10. The medical lead of claim 1, wherein the stiffening mechanism comprises a proximal end coil, a distal end coil and a distention mechanism coil.

11. The medical lead of claim 1, wherein the stiffening mechanism comprises a proximal sleeve, a middle sleeve and a distal sleeve.

12. The medical lead of claim 1, wherein a lead body coil extends between at least substantial portions of the distal and proximal ends of the lead body, the lead body coil being disposed within the first of the plurality of lumens, the lead body coil permitting the transfer of a substantial amount of torque from the proximal end of the lead to the distal end of the lead.

13. The medical lead of claim 12, wherein the lead body coil has a central lumen disposed therewithin, the pull wire being disposed within at least portions of the central lumen of the lead body coil.

14. The medical lead of claim 1, wherein the distention mechanism expands or retracts symmetrically or asymmetrically.

15. A transesophageal medical lead, comprising:

(a) means for forming an elongated, flexible lead body having first proximal and first distal ends, the lead body forming means having a plurality of means for forming elongated lumens disposed therewithin and extending at least substantially between the first distal and first proximal ends of the lead body forming means;

(b) at least one external means for electrically connecting;

(c) means for pulling having second distal and second proximal ends, the pulling means being slidably disposed in a first of the plurality of lumen forming means, the second distal end of the pulling means being fixedly attached at or near the first distal end of the lead body forming means;

(d) at least one means for conducting electricity having third distal and third proximal ends and disposed in a second of the plurality of lumen forming means, the third proximal end of the at least one electricity conducting means being mechanically and electrically connected to the at least one external electrically connecting means;

(e) a means for distending located at or near the first distal end of the lead body forming means, comprising;

(1) at least one flexible rib means having at least one means for sensing, monitoring or defibrillating disposed or mounted thereon, the at least one sensing means being mechanically and electrically connected to a point at or near the third distal end of the at least one electricity conducting means;

(2) a means for stiffening having a central axially-extending aperture disposed therewithin, the pulling means slidably engaging and passing through the central aperture of the stiffening means;

wherein the distending means is laterally expandable and retractable respecting the lead body forming means through retraction of the pulling means by a user, the stiffening means providing the amount of structural compression required in the region of the distending means to prevent the at least one rib means from bowing outwardly in an undesired direction or orientation when the pulling means is retracted by the user, the medical lead being transnasally or transorally insertable in an esophagus of a subject when the distending means is retracted.

16. The medical lead of claim 15, wherein the distending means includes at least two flexible rib means, each rib means having at least one sensing, monitoring or defibrillating means disposed or mounted thereon, each sensing, monitoring or defibrillating means being mechanically and electrically connected to a corresponding electricity conducting means disposed in one of the plurality of lumen forming means, the proximal end of each corresponding electricity conducting means being mechanically and electrically connected to a corresponding external means for electrically connecting, the distal end or a point near the distal end of each corresponding electricity conducting means being electrically and mechanically connected to its corresponding sensing, monitoring or defibrillating means.

17. The medical lead of claim 16, wherein each rib means has a plurality of sensing, monitoring or defibrillating means attached thereto or mounted thereon.

18. The medical lead of claim 15, wherein the spacing between sensing, monitoring or defibrillating means may be varied by selecting appropriate external means for electrically connecting.

19. The medical lead of claim 15, wherein the distending means includes at least three flexible rib means, each rib means having at least two sensing, monitoring or defibrillating means disposed or mounted thereon, each sensing, monitoring or defibrillating means being mechanically and electrically connected to a corresponding electricity conducting means disposed in one of the plurality of lumen forming means, the proximal end of each corresponding electricity conducting means being mechanically and electrically connected to a corresponding external means for electrically connecting, the distal end or a point near the distal end of each corresponding electricity conducting means being electrically and mechanically connected to its corresponding sensing, monitoring or defibrillating means.

20. The medical lead of claim 19, wherein the spacing between sensing, monitoring or defibrillating means may be varied by selecting appropriate external means for electrically connecting.

21. The medical lead of claim 15, wherein the lead body forming means comprises at least one of polyurethane, silicone, silastic and rubber.

22. A method of making a transesophageal medical lead, the medical comprising an elongated, flexible lead body having first proximal and first distal ends, the lead body having a plurality of elongated lumens disposed therewithin and extending at least substantially between the first distal and first proximal ends of the lead body, at least one external electrical connector, a pull wire having second distal and second proximal ends, the pull wire being slidably disposed in a first of the plurality of lumens, the second distal end of the pull wire being fixedly attached at or near the first distal end of the lead body, at least one electrical conductor having third distal and third proximal ends and disposed in a second of the plurality of lumens, the third proximal end of the at least one electrical conductor being mechanically and electrically connected to the at least one external electrical connector, a distention mechanism located at or near the first distal end of the lead body, the distention mechanism comprising at least one flexible arm having at least one cardiac sensing, monitoring or defibrillating electrode disposed or mounted thereon, the at least one electrode being mechanically and electrically connected to a point at or near the third distal end of the at least one electrical conductor, the distention mechanism further comprising a stiffening mechanism having a central axially-extending aperture disposed therewithin, the pull wire slidably engaging and passing through the central aperture of the stiffening mechanism, the distention mechanism being laterally expandable and retractable respecting the lead body through retraction of the pull wire by a user, the stiffening mechanism providing the amount of structural compression required in the region of the distention mechanism to prevent the at least one arm from bowing outwardly in an undesired direction or orientation when the pull wire is retracted by the user, the medical lead being transnasally or transorally insertable in an esophagus of a subject when the distention mechanism is retracted, the method comprising the steps of:

(a) providing the lead body;

(b) providing the at least one external electrical connector;

(c) providing the pull wire;

(d) providing the at least one electrical conductor;

(e) providing the distention mechanism having the at least one flexible arm, the at least one cardiac sensing, monitoring or defibrillating electrode disposed or mounted thereon, and the stiffening mechanism, and

(f) assembling the lead body, the at least one external electrical connector, the pull wire, the at least one electrical conductor, and the distention mechanism to form the medical lead.

23. A method of using a transesophageal medical lead in a patient, the medical comprising an elongated, flexible lead body having first proximal and first distal ends, the lead body having a plurality of elongated lumens disposed therewithin and extending at least substantially between the first distal and first proximal ends of the lead body, at least one external electrical connector, a pull wire having second distal and second proximal ends, the pull wire being slidably disposed in a first of the plurality of lumens, the second distal end of the pull wire being fixedly attached at or near the first distal end of the lead body, at least one electrical conductor having third distal and third proximal ends and disposed in a second of the plurality of lumens, the third proximal end of the at least one electrical conductor being mechanically and electrically connected to the at least one external electrical connector, a distention mechanism located at or near the first distal end of the lead body, the distention mechanism comprising at least one flexible arm having at least one cardiac sensing, monitoring or defibrillating electrode disposed or mounted thereon, the at least one electrode being mechanically and electrically connected to a point at or near the third distal end of the at least one electrical conductor, the distention mechanism further comprising a stiffening mechanism having a central axially-extending aperture disposed therewithin, the pull wire slidably engaging and passing through the central aperture of the stiffening mechanism, the distention mechanism being laterally expandable and retractable respecting the lead body through retraction of the pull wire by a user, the stiffening mechanism providing the amount of structural compression required in the region of the distention mechanism to prevent the at least one arm from bowing outwardly in an undesired direction or orientation when the pull wire is retracted by the user, the medical lead being transnasally or transorally insertable in an esophagus of a subject when the distention mechanism is retracted, the method comprising the steps of:

(a) inserting the distal end of the lead transnasally or transorally into the esophagus of the subject, the distention mechanism being in a retracted state;

(b) expanding the distention mechanism in the esophagus so that it assumes an expanded state;

(c) sensing, monitoring or defibrillating a heart of the patient with the medical lead;

(d) retracting the distention mechanism to the retracted state, and

(e) removing the lead from the esophagus of the subject.