# Patent

## Title
Cardiac lead having self-expanding fixation features

## Abstract

A cardiac lead for placement in the vicinity of a patient's heart is described. The lead includes a self-expanding fixation mechanism, which in a retracted position, is contained within a cavity disposed at a distal end of the lead. In an expanded position, the fixation mechanism extends axially from the distal end of the lead and expands radially into contact with a desired lumen site.

## Background
TECHNICAL FIELD
The present invention relates to implantable medical devices, in particular to cardiac leads and methods for delivering and affixing cardiac leads in a desired location in or near a patient's heart.
BACKGROUND
Cardiac function management systems are used to treat arrhythmias and other abnormal heart conditions. Such systems generally include cardiac leads, which are implanted in or about the heart, for delivering an electrical pulse to the cardiac muscle, for sensing electrical signals produced in the cardiac muscle, or for both delivering and sensing.
One difficulty with implanting leads in or about the heart is that the lead may become dislodged from its desired location during or after lead implantation. For example, the lead may become dislodged or otherwise repositioned when a clinician withdraws the guiding catheter used to initially implant the lead. Cardiac leads may also become dislodged by normal physiological activity. In an attempt to prevent cardiac leads from being dislodged, a variety of screws, anchors and other devices have been used to affix cardiac leads at a desired location at or near a patient's heart. Some of these devices, however, do not adequately affix the lead at the desired location. Other devices require a clinician to carry out complex, time-consuming steps during or after lead implantation to properly affix the lead at the desired location.
Accordingly, there is a need in the art for a cardiac lead having a fixation mechanism which effectively affixes the cardiac lead at a desired position without requiring complex steps during or after lead implantation.
SUMMARY
The present invention, according to one embodiment, is a cardiac lead including a conductive lead body having proximal and distal ends, a lead lumen and an actuator lumen, each lumen extending between the proximal and distal ends of the lead. The lead further includes an electrode coupled to the lead body and a self-expanding fixation mechanism coupled to the distal end of the lead, which has a retracted position in which the mechanism is substantially disposed within a cavity formed at the distal end of the lead, and an expanded position in which the mechanism extends distally from the distal end of the lead. The lead also includes an actuator which may be advanced through the actuator lumen disposed outside of the lead lumen to manipulate the fixation mechanism between the retracted and expanded positions.
According to another embodiment, the present invention is a cardiac lead including a conductive lead body having proximal and distal ends, a lead lumen extending between the proximal and distal ends for receiving a guiding member therein, and a cavity formed at the distal end of the lead. The lead lumen and cavity are in communication. The lead further includes an electrode coupled near the distal end of the lead body, and a self-expanding fixation mechanism as reported above, which further defines a channel such that a guiding member (e.g. stylet, guidewire, finishing wire) may extend through the lead lumen, the cavity and the fixation mechanism.
In yet another embodiment, the present invention is a cardiac lead including an electrode and means for fixing the distal end of the lead in the vicinity of the heart.
In a further embodiment, the present invention is a method of securing a cardiac lead within a body lumen. A cardiac lead is advanced to a desired lumen site within the patient. Then, the fixation mechanism reported herein may be deployed and allowed to expand into an expanded mode such that the expanded fixation mechanism contacts an inner wall of the body lumen. A conventional guiding catheter may be inserted prior to advancing the lead, and retracted after deploying the fixation mechanism. In the event that it become necessary or desirable to reposition the lead, the fixation mechanism can be returned back to the retracted position, the lead may be repositioned, and the fixation mechanism may be re-deployed. The fixation mechanism may also be utilized temporarily, and then retracted when the lead has become sufficiently fixed by tissue growth.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a cardiac lead implanted in a coronary vessel.
FIGS. 2A-2B show embodiments of the present invention in respective retracted and expanded positions.
FIG. 3 shows a cross-sectional view of an embodiment of the present invention in a retracted position within a vessel.
FIG. 4 shows a cross-sectional view of the embodiment shown in FIG. 3 in an expanded position within a vessel.
FIGS. 5A-5B show cross-sectional views of an embodiment of the present invention in a retracted position within a vessel.
FIG. 6 shows a cross-sectional view of an embodiment of the present invention within a vessel.
FIG. 7 shows a cross-sectional view of an embodiment of the present invention in an expanded position within a vessel.
FIG. 8 shows a cross-sectional view of an embodiment of the present invention in a retracted position within a vessel.
FIG. 9 shows a cross-sectional view of the embodiment shown in FIG. 8 in an expanded position within a vessel.
FIGS. 10A-10B show alternate embodiments of the present invention.
FIGS. 11A-11E show further embodiments of the present invention.
FIG. 12 is a flowchart illustrating one method of using embodiments of the present invention.
FIG. 13 shows an embodiment of the present invention implanted in a coronary vessel.



While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION
FIG. 1 is a schematic view of a cardiac rhythm management system 10 including a pulse generator 12 coupled to a lead 14 having a proximal end 16 and a distal end 18. As shown in FIG. 1, distal portions of the lead 14 are disposed in the patient's heart 20, which includes a right atrium 22, a right ventricle 24, a left atrium 26, and a left ventricle 28. In the embodiment illustrated in FIG. 1, the distal end 18 of the lead 14 is transvenously guided through the right atrium 22, through the coronary sinus ostium 29, and into a branch of the coronary sinus 31 or great cardiac vein 33. The illustrated position of the lead 14 may be used for sensing or for delivering pacing and/or defibrillation energy to the left side of the heart 20, to treat arrhythmias or other cardiac disorders requiring therapy delivered to the left side of the heart 20.
FIGS. 2A and 2B show schematic illustrations of distal portions of a cardiac lead 50 according to one embodiment of the present invention. As shown, the cardiac lead 50 includes a proximal end 52, a distal end 54, and a body 55 defining a lead lumen 57 extending between a proximal and distal ends 52, 54. The distal end 54 of the cardiac lead 50 may include one or more electrodes 59 that are in electrical communication with a conductive element (not shown) extending through the lead lumen 57. The cardiac lead 50, in one embodiment, has an outer diameter of from about 2 to about 10 French. In another embodiment, the outer diameter of the cardiac lead 50 is less than about 6 French.
As further shown in FIG. 2A, the distal end 54 of the lead 50 defines a cavity 60 which contains a self-expanding fixation mechanism 62. In FIG. 2A, the self-expanding fixation mechanism 62 is shown in a retracted position 63 inside of the cavity 60. In FIG. 2B the fixation mechanism 62 is shown in an expanded position 65 such that it extends distally from the distal end 54 of the lead 50 and radially to a diameter exceeding a diameter of the body 55.
As shown in FIGS. 2A-2B, the fixation mechanism 62 is self-expanding such that upon being deployed from the cavity 60, it automatically expands to the expanded position 65. As described in greater detail below, in the expanded position 65, the self-expanding fixation mechanism 62 fixes the lead 50 at a desired location in a body lumen such as, for example, a coronary vessel. In the embodiment illustrated in FIGS. 2A-B, the self-expanding fixation mechanism 62 resembles a stent similar to the stents employed in vascular intervention procedures, except that the stent is crimped down at a proximal end and also at a distal end.
The fixation mechanism 62 may be formed from a variety of suitable self-expanding materials. Suitable self-expanding materials generally have shape-memory properties, and have sufficient resiliency to expand upon deployment. Suitable materials may include stainless steel as well as a variety of alloys and polymers. The fixation mechanism 62 may be constructed from any superelastic material that allows it to self-expand upon deployment from the cavity 60. Such self-expanding materials are well known in the art. In one embodiment, for example, the fixation mechanism 62 is made at least partially from nitinol. Additionally, in certain embodiments, the fixation mechanism 62 may also function as an electrode. In these embodiments, a conductive element (not shown) would extend through the cardiac lead 50 and would be electrically coupled to the fixation mechanism 62.
FIG. 3 is a cross-sectional view of a body lumen 64 such as, for example, a coronary vessel into which the lead 50 has been advanced. In FIG. 3, the fixation mechanism 62 is retained in the retracted position 63 by a wall defining the cavity 60. The fixation mechanism 62 includes a proximal base 66, a distal base 68, and a plurality of interconnected stent tines 70 extending between the proximal and distal bases 66, 68.
FIG. 4 is a cross-sectional view of the distal end 54 of the lead 50 shown in FIG. 3, in which the fixation mechanism 62 is in the expanded position 65. In the expanded position 65, the distal base 68 and stent tines 70 extend distally relative to the cavity 60, and the fixation mechanism 64 contacts the body lumen 64 with sufficient radial force to adequately secure the cardiac lead 50 to the body lumen 64. The proximal base 66 is retained within the cavity 60 by a tapered portion at the opening of the cavity so that the fixation mechanism 62 remains associated with the distal end 54 of the lead 50.
In one embodiment of the present invention, the cardiac lead 50 is configured such that conventional lead implantation procedures may be utilized while still allowing for the actuation of the fixation mechanism 62. More particularly, the lead 50 may be configured to allow the passage of a guiding member such as a guidewire or stylet through the lead lumen, without interfering with the deployment and/or retraction of the fixation mechanism 62.
In FIGS. 5A-5B, for example, the cavity 60 is in communication with the lead lumen 57 (See FIGS. 2A-2B) via an opening (not shown) between the lead lumen 57 and the cavity 60, which allows the passage of a guiding member 72. As further shown in FIG. 5B, the fixation mechanism 62 defines a channel extending through the proximal and distal bases 66, 68 and the tines 70, through which the guiding member 72 may pass during lead implantation. In this manner, the lead 50 may be implanted using a guiding member 72 (e.g., a guidewire or stylet) which extends past the distal end of the fixation mechanism 62.
In an alternate embodiment, the cardiac lead 50 may be configured such that the cavity 60 and the lead lumen 57 are not in communication. For example, in the embodiment shown in the cross-sectional illustration of FIG. 6, the lead body 55 (see FIGS. 2A-2B) may include first and second lumens 80, 82. The first lumen 80 is adapted to receive the guiding member 72 and may optionally include a distal opening disposed proximally to the fixation mechanism 62 for receiving a guiding member 72 such as a guidewire.
The second lumen 82 is in communication with the cavity 60, and may be used to facilitate deployment of the fixation mechanism 62 as described in further detail below. Although the first and second lumens 80, 82 are shown as being substantially parallel, other configurations may be suitable for embodiments of the present invention. For example, the first and second lumens may extend concentrically through the lead 50 and diverge near the distal end 54 of the lead 50. Alternatively, a single lumen 57 could extend through the lead 50 and diverge into two discrete branches 80, 82 near the distal end 54 of the lead 50.
A variety of approaches may be used to deploy and/or retract the fixation mechanism 62 depending on the configuration of the lead 50. In the embodiment shown in FIG. 7 in which the lead lumen is in communication with the cavity 60, a stylet 90 or similar device may be inserted through the lead lumen and into the cavity 60 until it contacts the proximal base 66. Corresponding structure between the stylet 90 and the base 66 may be utilized to facilitate actuation of the fixation mechanism 62 between extended and retracted positions.
In a further embodiment shown in FIGS. 8-9, the cavity 60 is defined by a sheath 100 that extends from a distal end 54 of the lead device 50. The sheath 100 operates in one of at least two ways. First, as shown in FIGS. 8-9, the sheath 100 may be actuated relative to the fixation mechanism 62 such that the fixation mechanism is deployed when the sheath 100 is actuated. For example, the sheath 100 may be configured such that the application of a force in the direction of the proximal end of the lead device 50 results in retraction of the sheath 100 over the distal end 54 of the lead 50, which deploys the fixation mechanism 62 into the expanded mode 65. In this embodiment, the fixation mechanism 62 remains in a fixed axial position relative to the distal end 54 of the lead, and the movement of the sheath 100 dictates whether the fixation mechanism 62 is in the retracted 63 or expanded position 65. In an alternate embodiment, the sheath 100 may be retracted into the distal end 54 of the lead 50.
In embodiments in which the cavity 60 is defined by a movable sheath 100, an actuator such as a stylet wire 90 may be configured to retract the sheath 100 proximally to deploy the fixation mechanism 62. Alternatively, the sheath 100 may remain fixed relative to the distal end 54 of the cardiac lead 50. In this embodiment, the fixation mechanism 62 moves relative to the sheath 76 to provide the retracted or compressed position 63 and the expanded position 65. In one embodiment, the cardiac lead 50 includes an actuator coupled to the sheath 100, which operates to both retract the sheath 100 to allow the fixation mechanism 62 to assume the expanded position 65 and advance the sheath 100 to return the fixation mechanism 62 to the compressed position 63.
The sheath 100 may be formed from a range of biocompatible materials having sufficient strength to retain the fixation mechanism 62 in a compressed mode 63. For example, the sheath 100 may be formed from a wide variety of suitable biocompatible polymeric materials such as medical grade silicone or polyurethane.
As shown in FIGS. 10A-10B and 11A-11D, the fixation mechanism 62 may be formed in a variety of configurations in addition to the stent-like configuration previously described. In FIGS. 10A-10B, the fixation mechanism 62 includes a plurality of interconnected tines to form, for example, a net-like structure (FIG. 10A) or a web-like structure (FIG. 10B).
In FIGS. 11A-11D, the fixation mechanism 62 is configured with one or more discrete tines, for example, one or more sinusoidal tines (FIG. 11A), one or more hook tines (FIG. 11B), one or more loop tines (FIG. 11C), one or more leaf tines (FIG. 11D) or one or more finger tines (FIG. 11(e). In the illustrated embodiments, the tines are secured by a base 102, which remains at least partially disposed within the cavity 60. The structure of the fixation mechanism 62 is self-expanding after deployment from the cavity 60, is sized and shaped to fix the distal end 54 of the cardiac lead 50 at the desired lumen location, and is configured to provide for conventional implantation of the lead 50.
The lead 50 and the fixation mechanism 62 may be dimensioned to provide for optimal fixation without disturbing lead implantation or functionality. In one embodiment, the lead 50 has a diameter of less than about 6 French. In this embodiment, the fixation mechanism 62 may be configured to have a major dimension (e.g. diameter) less that the diameter of the lead 50 when in a retracted position, and greater than the diameter of the lead in an expanded position in order to contact the vessel wall.
FIG. 12 shows a method of implanting the lead 50 according to an embodiment of the present invention. Initially, one or more guiding catheters may be optionally guided into a desired vessel (block 120). The cardiac lead 50, which is configured such that the fixation mechanism 62 is in the compressed mode 63, may then be guided through the guiding catheter(s) to a desired vessel site (block 122). After positioning the distal end 54 of the lead at the desired site, the fixation mechanism 62 may then be deployed into the expanded mode 65 to contact an inner surface of the patient's lumen and to affix the distal end 54 of the lead device 50 at the desired site (block 124). After fixation, the guiding catheter and guide member may be removed without dislodging the distal end 54 of the lead device 50 (block 126).
After removal of the guiding catheter and/or guide member, the fixation mechanism 62 may be retracted or remain permanently fixed. Likewise, if a clinician desires to the reposition the lead, the fixation device 62 may be retracted into the cavity 60 to allow the lead to be repositioned (blocks 128 and 130). The fixation mechanism 62 may then be re-deployed (block 132). Additionally, after sufficient tissue in-growth has occurred, it may be desirable to retract the fixation mechanism 62 permanently. However, the fixation mechanism 62 is capable of substantially permanent deployment to prevent the lead device 50 from becoming dislodged or otherwise repositioned during use.
FIG. 13 is a schematic view of a cardiac rhythm management system 10, showing a cardiac lead 50 secured within a coronary vessel, according to one embodiment of the present invention. As shown in FIG. 13, the fixation mechanism 62 has been deployed and has radially-expanded to contact an inner surface of the vessel wall.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

## Claims

1. A cardiac lead comprising:
a lead body including a proximal end configured to be connected to a pulse generator, a distal end defining a cavity, and a guide lumen extending from the proximal end to the distal end;
an electrode operatively coupled to the lead body;
a fixation mechanism adapted to transition from an expanded configuration to a retracted configuration, the fixation mechanism comprising a proximal base, a distal base, and a plurality of interconnected tines connected to and extending between the proximal and distal bases, wherein the proximal base is retained within the cavity so that the fixation mechanism remains associated with the distal end of the lead body; and wherein the fixation mechanism defines a channel extending through the proximal and distal bases, the channel facilitating extension of a guiding member beyond the distal end of the lead body;
an actuator operable to manipulate the fixation mechanism from the expanded configuration to the retracted configuration; and
a guiding member adapted to extend through the channel defined by the fixation member and beyond the distal end of the lead body.

2. The cardiac lead of claim 1, wherein in the retracted configuration, the fixation mechanism is substantially disposed within the cavity and wherein in the expanded position, the fixation mechanism extends distally from the distal end of the lead body.

3. The cardiac lead of claim 1, wherein the tines are crimped down at the proximal base and at the distal base of the fixation mechanism.

4. The cardiac lead of claim 1, wherein the actuator is connected to the fixation mechanism.

5. The cardiac lead of claim 1, wherein the actuator is connected to the fixation mechanism and is operable to move the fixation mechanism longitudinally from the expanded configuration to the retracted configuration.

6. The cardiac lead of claim 1, wherein the actuator comprises a stylet.

7. The cardiac lead of claim 1, further comprising an actuator lumen extending from the proximal end to the distal end.

8. The cardiac lead of claim 1, wherein the guiding member comprises a guidewire.

9. A cardiac lead comprising:
a lead body including a proximal end configured to be connected to a pulse generator, a distal end, and a guide lumen extending from the proximal end to the distal end;
an electrode operatively coupled to the lead body;
a sheath defining a cavity at the distal end of the lead body, the sheath adapted to transition from a retracted position to an extended position;
a fixation mechanism adapted to transition from an expanded configuration to a compressed configuration, the fixation mechanism comprising a proximal base, a distal base, and a plurality of interconnected tines connected to and extending between the proximal and distal bases, wherein the proximal base is configured to be retained within the cavity so that the fixation mechanism remains associated with the distal end of the lead body, and wherein the fixation mechanism defines a channel extending through the proximal and distal bases, the channel facilitating extension of a guiding member beyond the distal end of the lead body; and
an actuator operable to manipulate the sheath from the extended position to the retracted position.

10. The cardiac lead of claim 9, wherein the sheath is configured to move relative to the fixation mechanism, wherein the fixation mechanism is longitudinally fixed relative to the distal end of the lead body.

11. The cardiac lead of claim 9, wherein the sheath is longitudinally fixed relative to the distal end of the lead body, and the fixation member is adapted to move between the expanded configuration to the compressed configuration relative to the sheath.

12. The cardiac lead of claim 9, wherein the tines are crimped down at the proximal base and at the distal base of the fixation mechanism.

13. The cardiac lead of claim 9, wherein the actuator is a stylet.

14. The cardiac lead of claim 9, wherein the sheath is configured to transition the fixation mechanism from the expanded configuration to the compressed configuration.

15. The cardiac lead of claim 9, further comprising an actuator lumen extending from the proximal end to the distal end, wherein the actuator is adapted to advance through the actuator lumen.

16. The cardiac lead of claim 9, further comprising a guiding member adapted to extend through the channel defined by the fixation mechanism and beyond the distal end of the lead body.

17. A cardiac rhythm management system comprising:
a pulse generator;
a cardiac lead including a lead body having a proximal end connected to the
pulse generator, a distal end defining a cavity, a guide lumen extending from
the proximal end to the distal end; and an electrode operatively coupled to the
lead body;
a fixation mechanism adapted to transition from an expanded configuration to a retracted configuration, the fixation mechanism comprising a proximal base, a distal base, and a plurality of interconnected tines connected to and extending between the proximal and distal bases, wherein the proximal base is retained within the cavity so that the fixation mechanism remains associated with the distal end of the lead body; and wherein the fixation mechanism defines a channel extending through the proximal and distal bases, the channel facilitating extension of a guiding member beyond the distal end of the lead body; and
an actuator operable to manipulate the fixation mechanism from the expanded configuration to the retracted configuration.

18. The cardiac rhythm management system according to claim 17, wherein in the retracted configuration, the fixation mechanism is substantially disposed within the cavity and wherein in the expanded position, the fixation mechanism extends distally from the distal end of the lead body.

19. The cardiac rhythm management system according to claim 17, further comprising a sheath defining the cavity at the distal end of the lead body, the sheath adapted to transition from a retracted position to an extended position.

20. The cardiac rhythm management system according to claim 19, wherein the actuator is operable to manipulate the sheath from the retracted position to the extended position such that the fixation mechanism transitions from the expanded configuration to the compressed configuration.

21. The cardiac rhythm management system of claim 19, wherein the sheath is configured to move relative to the fixation mechanism, wherein the fixation mechanism is longitudinally fixed relative to the distal end of the lead body.

22. The cardiac rhythm management system of claim 19, wherein the sheath is longitudinally fixed relative to the distal end of the lead body, and the fixation member is adapted to move between the expanded configuration to the compressed configuration relative to the sheath.

23. The cardiac rhythm management system according to claim 17, further comprising a guiding member adapted to extend through the channel defined by the fixation member and beyond the distal end of the lead body.