Deployable electrode lead anchor

Information

  • Patent Grant
  • 9427573
  • Patent Number
    9,427,573
  • Date Filed
    Thursday, June 23, 2011
    13 years ago
  • Date Issued
    Tuesday, August 30, 2016
    7 years ago
Abstract
One embodiment of an electrode lead comprises a lead body, at least one electrode at a distal end of the lead body, an actuatable member and at least one anchor wire. The actuatable member is positioned within a lumen of the lead body. The at least one anchor wire has a proximal end that is attached to the actuatable member. Movement of the actuatable member relative to the lead body moves the at least one anchor wire through at least one opening in the lead body.
Description
FIELD

Embodiments of the invention generally relate to a deployable anchor that facilitates securing an electrode lead to internal tissue of a patient and preventing migration of the electrode lead relative to the tissue of the patient. Embodiments of the anchor may also be retracted to simplify the removal of the electrode lead from the tissue of the patient.


BACKGROUND

Implantable electronic stimulator devices, such as neuromuscular stimulation devices, have been disclosed for use in the treatment of various pelvic conditions, such as urinary incontinence, fecal incontinence and sexual dysfunction. Such devices generally include one or more electrodes that are coupled to a control unit by electrode leads. Electrical signals are applied to the desired pelvic tissue of the patient through the electrode leads in order to treat the condition of the patient. The electrode leads are typically secured to the tissue using an anchor in the form of a helical coil. Exemplary implantable electronic stimulator devices and uses of the devices are disclosed in U.S. Pat. Nos. 6,354,991, 6,652,449, 6,712,772 and 6,862,480, each of which is hereby incorporated by reference in its entirety.


An anchor is typically attached to the distal end of the electrode lead to secure the electrode lead within tissue of the patient and prevent relative movement between the anchor and the tissue in which the anchor in embedded.


SUMMARY

Some embodiments of the invention are directed to an electrode lead comprising a lead body, at least one electrode at a distal end of the lead body, an actuatable member and at least one anchor wire. The actuatable member is positioned within a lumen of the lead body. The at least one anchor wire has a proximal end that is attached to the actuatable member. Movement of the actuatable member relative to the lead body moves the at least one anchor wire through at least one opening in the lead body.


Another embodiment is directed to a system that comprises an introducer sheath, an electrode lead and at least one anchor wire. The introducer sheath has a sheath wall and a longitudinal axis. The electrode lead comprises a lead body and at least one electrode at a distal end of the lead body. The distal end of a lead body is received within the sheath. The at least one anchor wire has a proximal end that is attached to the distal end of the lead body. The at least one anchor wire moves through at least one opening in the sheath wall responsive to movement of the lead body relative to the introducer sheath.


Yet another embodiment is directed to a method. In the method, an electrode lead is provided. In on embodiment, the electrode lead comprises a lead body, at least one electrode at a distal end of lead body and at least one anchor wire having a proximal end connected to the lead body. The distal end of the lead body is positioned within tissue of a patient. The distal end of the at least one anchor wire is moved radially from the lead body and into the tissue to anchor the distal end of the lead body to the tissue.


This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not indented to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in the Background.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is a side plan view of an exemplary electronic stimulator device, in accordance with the embodiments of the invention.



FIGS. 2 and 3 are simplified side views of a portion of an electrode lead illustrating anchors formed in accordance with embodiments of the invention.



FIG. 4 is a simplified side cross-sectional view of an exemplary introducer in accordance with embodiments of the invention.



FIG. 5 is a simplified side cross-sectional view of a portion of the electrode lead of FIG. 2 within an introducer sheath.



FIG. 6 is a simplified side view of a portion of the electrode lead of FIG. 3 within an introducer sheath shown in cross-section.



FIG. 7 is a simplified drawing of a portion of an electrode lead comprising an anchor formed in accordance with embodiments of the invention within an introducer sheath shown in cross-section.



FIGS. 8 and 9 respectively show simplified side and front views of the portion of the electrode lead of FIG. 7 within tissue of a patient after the introducer sheath has been removed.



FIGS. 10A-10C are simplified side cross-sectional views of an electrode lead illustrating the deployment of an anchor in accordance with embodiments of the invention.



FIGS. 11A and 11B are simplified side cross-sectional views of a portion of an electrode lead illustrating the deployment of an anchor in accordance with embodiments of the invention.



FIGS. 12A and 12B are simplified side cross-sectional views of a portion of an electrode lead illustrating the deployment of an anchor in accordance with embodiments of the invention.



FIG. 13 is a simplified front view of an actuatable member in accordance with embodiments of the invention.



FIGS. 14 and 15 are simplified front views of an electrode lead formed in accordance with embodiments of the invention implanted in tissue of a patient.



FIG. 16 is a flowchart illustrating a method in accordance with embodiments of the invention.





DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Embodiments of the invention are directed to an anchor that facilitates securing an electrode lead to internal tissue of a patient to prevent migration of the electrode lead from its intended position. The tissue in which the anchors of the present invention may be used includes adipose tissue, muscle tissue or any other tissue of the patient. In one embodiment, the tissue is located in the pelvic region of the patient. In some embodiments, the tissue, in which the anchor is to be embedded, is targeted for electrical stimulation or is adjacent a desired stimulation target site. Embodiments of the invention comprise the individual embodiments described below and combinations of two or more of the embodiments described below. Elements having the same or similar labels correspond to the same or similar elements.



FIG. 1 is a side plan view of an exemplary electronic stimulator system 100, with which embodiments of the anchors of the present invention may be used. System 100 is configured for implantation into a pelvic region of a patient to provide muscle and/or nerve stimulation that is used to control and/or treat a pelvic condition of the patient, such as pelvic pain, urinary incontinence, fecal incontinence, erectile dysfunction or other pelvic condition that may be treated through electrical stimulation.


In one embodiment, the system 100 comprises a control unit 102 and one or more electrode leads 104, a proximal end 106 of which is coupled to the control unit 102 via a connector 108. Each electrode lead 104 comprises a lead body 110 and one or more stimulating electrodes 112 at a distal end 114 of the electrode lead 104 or lead body 110. The lead body 110 insulates electrical wires connecting the control unit 102 to the stimulating electrodes 112. The lead body 110 can be in the form of an insulating jacket typically comprising silicone, polyurethane or other flexible, biocompatible electrically insulating material. Additional electrode leads 104 or physiological sensors may be coupled to the control unit 102.


In one embodiment, the control unit 102 comprises circuitry for processing electrical signals received from the one or more stimulating electrodes 112 or physiological sensors. The control unit 102 is also configured to apply an electrical current or waveform to the tissue of the patient that is in contact with the one or more stimulating electrodes 112.


The electrode lead 104 can be anchored to pelvic tissue of the patient (e.g., internal urinary sphincter muscle) by means of a tissue anchor 120, which is formed in accordance with embodiments of the invention described below. The anchor 120 operates to secure the position of the distal end 114 of the electrode lead 104 in the desired tissue of the patient. In one embodiment, the anchor 120 is located at the distal end 114 proximate the one or more electrodes 112. While depicted as being located at the terminating side of the electrodes 112, the anchor 120 may be located between electrodes 112 or between the electrodes 112 and the proximal end 106 of the electrode lead.



FIG. 2 is simplified side view of a portion of a distal end 114 of electrode lead 104 that includes an anchor 130 in accordance with embodiments of the invention. The anchor 130 comprises at least one anchor wire 132 having a proximal end 134 that is attached to the lead body 110. A distal end 136 of each anchor wire 132 is configured to be fed into tissue of a patient to secure the distal end 114 of the electrode lead 104 to the tissue.


The one or more anchor wires 132 are generally formed of a suitable biocompatible material. In one embodiment, the anchor wires 132 are flexible, yet firm enough to pierce tissue of the patient upon deployment, as described below. In one embodiment, the wires 132 are formed of a memory shaped material, such as nickel titanium (i.e., NITINOL), that forces each of the anchor wires 132 to follow a desired trajectory as the wires 132 are deployed into the tissue of the patient, for example.


In one embodiment, the anchor wires 132 are attached to a sidewall 138 of the lead body 110. In one embodiment, each of the anchor wires 132 is displaced from adjacent anchor wires 132 along a longitudinal axis 140 of the lead body 110. In accordance with another embodiment, the anchor wires 132 are angularly displaced from each other about the longitudinal axis 140. For instance, the anchor wires 132 may be angularly displaced by 90 degrees from each other, as shown in FIG. 2, or other angular displacement.



FIG. 3 is a simplified side view of a distal end 114 of an electrode lead 104 that includes an anchor 142 in accordance with embodiments of the invention. One embodiment of the anchor 142 comprises a least one anchor wire 132 having a proximal end 134 as attached to a side wall 138 of the lead body 110. In one embodiment, the anchor wire 132 is initially wrapped around the lead body 110 and the axis 140 in a coil. In one embodiment, the anchor 142 includes a plurality of anchor wires 132 that are coiled around the lead body 110. This embodiment is not illustrated in order to simplify the drawing.


In one embodiment, the distal ends 114 of the electrode leads 104 illustrated in FIGS. 2 and 3 are configured to be deployed into tissue of a patient using an introducer. A simplified side cross-sectional view of an exemplary introducer 150 that may be used to deploy the electrode leads 104 of FIGS. 2 and 3 is provided in FIG. 4. In one embodiment, the introducer 150 is formed of biocompatible materials. A guide needle 152 having a proximal end 154 coupled to a handle 156 and a needle tip 158 at a distal end 160 may be received within an introducer sheath 162 of the introducer 150. The combination of the guide needle 152 and the introducer sheath 162 is used by the physician to create a pathway to the tissue of the patient that is targeted for electrical stimulation. Once the needle tip 158 of the guide needle 152 is positioned in or adjacent to the targeted tissue, the guide needle 152 is removed from the introducer sheath 162. This creates a pathway through the patient to the targeted tissue. The distal end 114 of the electrode lead 104 may then be inserted through the introducer sheath 162 to place the distal end 114 of the electrode lead 104 at the distal end 164 of the introducer sheath 162, in accordance with conventional techniques.



FIG. 5 illustrates a portion of the distal end 114 of the electrode lead 104 of FIG. 2 within the distal end 164 of the introducer sheath 162. In one embodiment, the distal end 164 of the introducer sheath 162 includes at least one opening 166 in a sheath wall 168. The one or more openings 166 are configured to receive the distal ends 136 of corresponding anchor wires 132 of the anchor 130. As the distal end 114 of the electrode lead 104 is advanced toward the distal end 164 of the introducer sheath by the physician along a longitudinal axis 170 of the introducer sheath, which generally corresponds to the axis 140 of the lead body 110, the distal ends 136 of the one or more anchor wires 132 travel through to the corresponding openings 166 in the sheath wall 168, as shown in FIG. 5. Continued motion of the distal end 114 of the electrode lead 104 relative to the introducer sheath 162 causes the distal ends 136 to extend into the tissue of the patient. In one embodiment, the anchor wire 132 travels in the direction that is generally radial to the longitudinal axis 170 of the introducer sheath 162 and/or the longitudinal axis 140 of the lead body 110.


This deployment of the one or more anchor wires 132 of the anchor 130 is followed by the removal of the introducer sheath 162 in accordance with conventional techniques. For instance, the introducer sheath 162 may be split into separate halves that allow for the removal of the introducer sheath 162 without disrupting the placement of the anchor wires 132 in the tissue of the patient. The one or more anchor wires 132 that extend generally radially from the longitudinal axis 140 of the lead body 110 into the tissue of the patient operate to secure the position of the distal end 114 in the targeted tissue. The electrode lead 104 may then be used to perform electrical stimulation operations on the targeted tissue in accordance with conventional techniques.



FIG. 6 is a simplified side view of the distal end 114 of the electrode lead 104 of FIG. 3 within the distal end 164 of the introducer sheath 162. In accordance with this embodiment, the anchor 142 is deployed by the physician rotating the lead body 110 about the longitudinal axis 170 of the introducer sheath 162, or the longitudinal axis 140 of the lead body 110, relative to the introducer sheath 162. This rotation causes the distal end 136 of the anchor wire 132 to extend through the opening 166 in the sheath wall 168 and into the tissue (not shown) of the patient. The amount of the anchor wire 132 that is fed into the tissue of the patient depends on the amount the lead body 110 is rotated about the axis 170 or the axis 140 relative to the introducer sheath 162. In one embodiment, the distal end 136 of the anchor wire 132 is deployed in a direction that is generally radial to the longitudinal axis 170 or the longitudinal axis 140, as shown in FIG. 6.


After the one or more anchor wires 132 of the anchor 142 are deployed into the tissue of the patient through the rotation of the lead body 110 relative to the introducer sheath 162, the introducer sheath 162 may be removed from the patient without disturbing the anchor wires 132, such as by splitting the introducer sheath into separate halves. The resultant position of the distal end 114 of the electrode lead 104 is in the tissue by the one or more anchor wires 132.


In accordance with another embodiment, the anchor 142 is wound about the distal end 114 of the electrode lead 104 such that it is radially compressed toward the longitudinal axis 140 of the lead body 110 relative to a quiescent state of the anchor wire 132. During the implantation, this radial compression of the at least one anchor wire 132 of the anchor 142 is maintained by the introducer sheath 162, as illustrated in the simplified side view of FIG. 7 with the introducer sheath 162 shown in cross-section. In accordance with this embodiment, the electrode lead 104 is either pushed through an opening 172 at the distal end 164 of the introducer sheath 162, or the introducer sheath 162 is separated into pieces and removed from the patient to expose the distal end 114 of the electrode lead 104 to the tissue of the patient. In response to the removal of the introducer sheath 162, the at least one anchor wire 132 of the anchor 142 expands radially from the longitudinal axis 140 and the lead body 110 toward an expanded quiescent state, as illustrated in the side and front views of FIGS. 8 and 9, respectively. The expansion of the at least one anchor wire 132 into the tissue of the patient secures the position of the distal end 114 of the electrode lead 104 in the tissue of the patient.



FIGS. 10A-C are side cross-sectional views of a portion of a distal end 114 of an electrode lead 104 illustrating different stages of deployment of an anchor 180 formed in accordance with embodiments of the invention. In one embodiment, the anchor 180 comprises at least one anchor wire 132 that is configured to be fed from within the anchor body 110 into the tissue of the patient after the distal end 114 of the electrode lead 104 is positioned within the targeted tissue using conventional techniques, such as those described above. In one embodiment, one or more lumens 182 are formed in the lead body 110, which guide the one or more anchor wires 132 to openings 184 formed in the lead body 110. The one or more anchor wires 132 have a retracted position, in which the distal ends 136 are contained within the corresponding lumen 182, or are only slightly extended through the openings 184, as shown in FIG. 10A. In one embodiment, the distal end 114 of the electrode lead 104 is fed, such as through an introducer, to the target tissue while the anchor 180 is in the retracted position.


Once the distal end 114 of the electrode lead 104 is positioned as desired within the targeted tissue of the patient, the one or more anchor wires 132 may be deployed from within the lumen 182 and fed into the tissue of the patient, as illustrated in FIGS. 10B and 10C. In one embodiment, the one or more anchor wires 132 are initially fed in a radial direction relative to the longitudinal axis 140 of the lead body 110. The deployment of the one or more anchor wires 132 may be accomplished by the physician using a suitable actuatable member, such as those described below, to which the proximal end of the anchor wires 132 are attached. In one embodiment, as the anchor wires 132 are fed from within the lead body 110, the one or more anchor wires 132 coil within the tissue of the patient, as shown in FIG. 10C. The deployed state (FIG. 10C) of the one or more anchor wires 132 secure the position of the distal end 114 of the electrode lead 104 in the tissue of the patient. When it is desired to remove the electrode lead 104 from the patient, the anchor wires 132 may be retracted within the lumens 182 (FIG. 10A) to reduce damage to the tissue of the patient.



FIGS. 11A and 11B are side cross-sectional views of a portion of a distal end 114 of an electrode lead 104 that includes an anchor 190 formed in accordance with embodiments of the invention. Anchor 190 is similar to anchor 180 (FIGS. 10A-C) in that it includes one or more anchor wires 132 that may be fed from one or more lumens 192 within the anchor body 110. In one embodiment, the proximal ends 134 of the one or more anchor wires are attached to an actuatable member 194. Movement of the actuatable member 194 relative to the lead body 110 along the longitudinal axis 140 transitions the one or more anchor wires 132 between a retracted position (FIG. 11A) and an extended or deployed position (FIG. 11B). As mentioned above with regard to anchor 180, the retracted position of the anchor 190 may position the distal ends 136 of the one or more anchor wires 132 within the lumen 192, or slightly extended through the openings 184 of the lead body 110. The distal end 114 of the electrode lead 110 is positioned within the target tissue using conventional techniques while the anchor 190 is in the retracted position. Once positioned within the targeted tissue of the patient, the actuatable member 194 is moved along the longitudinal axis 140 relative to the lead body 110 to move the distal ends 136 of the one or more anchor wires 132 through the openings 184 and into the tissue of the patient, as illustrated in FIG. 11B. When it is desired to remove the electrode lead 104 from the patient, the anchor wires 132 may be retracted within the lumen 192 (FIG. 11A) to reduce damage to the tissue of the patient.



FIGS. 12A and 12B are simplified side cross-sectional views of a portion of a distal end 114 of an electrode lead 104 that includes an anchor 200 formed in accordance with embodiments of the invention. The anchor 200 includes one or more anchor wires 132 that are contained within one or more lumens 192 of the lead body 110. In one embodiment, proximal ends 134 of the one or more anchor wires 132 are attached to an actuatable member 202. Additionally, the one or more anchor wires 132 are wound around the actuatable member 202, which is configured to rotate generally about the longitudinal axis 140 of the lead body 110. Initially, the anchor 200 is placed in a retracted state, in which the distal ends 136 of the one or more anchor wires 132 are located within the lumen 192 or openings 184 of the lead body 110, or are only slightly extended through the openings 184, as shown in FIG. 12A. Once the distal end 114 of the electrode lead 104 is positioned within the targeted tissue of the patient using an introducer or other conventional technique, the actuatable member 202 is rotated generally about the longitudinal axis 140 relative to the lead body 110 by the physician. The distal ends 136 of the one or more anchor wires are fed through the openings 184 of the lead body 110 responsive to the rotation of the actuatable member 202. Thus, the one or more anchor wires 132 move through the openings 184 of the lead body 110 and into the targeted tissue of the patient, as shown in FIG. 12B. This deployed position secures the position of the distal end 114 of the electrode lead 104 in the tissue of the patient. When it is desired to remove the electrode lead 104 from the patient, the anchor wires 132 may be retracted within the lumen 192 (FIG. 12A) to reduce damage to the tissue of the patient.


In one embodiment, a control member 204 may be used by the physician to move the actuatable member 194 (FIGS. 11A-B) along the longitudinal axis 140 relative to the lead body 110, or rotate the actuatable member 202 generally about the longitudinal axis 104 relative to the lead body 110. In one embodiment, the control member 204 is attached to the actuatable member and extends to a proximal end of the lead body 110 where it is accessible by the physician. The physician can slide the control member 204 along the longitudinal axis 140 relative to the lead body 110 to move the anchor 190 between the retracted (FIG. 11A) and deployed (FIG. 11B) positions. Similarly, the physician may rotate the control member 204 to move the anchor 200 between its retracted (FIG. 12A) and deployed (FIG. 12B) positions.


In one embodiment, the control member 204 has a distal end 206 that is removably attachable to the actuatable member 194 or 202. In one embodiment, the actuatable member 194 or 202 includes an aperture 208 that is configured to receive the distal end 206 of the control member 204. In one embodiment, the aperture 208 comprises a keyhole, as shown in the front view provided in FIG. 13. In one embodiment, the distal end 206 is configured to pass through or into the keyhole aperture 208 when angularly aligned with the keyhole aperture 208, and the distal end 206 of the control member 204 is prevented from passing through the keyhole aperture 208 when angularly misaligned with the keyhole aperture 208. This allows the physician to temporarily attach the distal end 206 to the actuatable member 194 or 202, move the actuatable member along the longitudinal axis 140 or rotate the actuatable member about the axis 140, and detach the control member 204 from the actuatable member so that it may be removed from within the lumen 192 of the lead body 110. Other configurations for the control member 204 and the actuatable member may also be used to provide this attachment function.



FIGS. 14 and 15 are front views of the distal end 114 of an electrode lead illustrating the deployment of anchor wires 132 in accordance with embodiments of the invention. The depicted anchor wires 132 may be components of anchors 130, 142, 180, 190 or 200, described above. In one embodiment, the anchor wires 132 at least initially extend in a radial direction from the lead body 110 relative to the longitudinal axis 140. In one embodiment, the plurality of anchor wires 132 are angularly displaced about the longitudinal axis. In one embodiment, the distal ends 136 of the anchor wires 132 are configured to coil in a plane that is approximately perpendicular to the longitudinal axis 140. In accordance with another embodiment, the anchor wires 132 are configured to coil in a plane that is approximately parallel to the longitudinal axis 140, as shown in FIG. 10C.



FIG. 16 is a flowchart illustrating a method in accordance with embodiments of the invention. At 210, an electrode lead 104 is provided comprising a lead body 110, at least one electrode 112 at a distal end 114 of the lead body 110, and at least one anchor wire 132 having a proximal end 134 connected to the lead body 110. In one embodiment, the proximal end 134 is considered to be connected to the lead body 110 through the connection to an actuatable member, such as actuatable member 194 or 202 located within a lumen 192 of the lead body 110, as shown in FIGS. 11A-B and 12A-B.


At 212, the distal end 114 of the lead body 110 is positioned within tissue of a patient. In one embodiment, the distal end 114 is positioned within tissue of the patient using an introducer, as described above. In one embodiment of step 212, an introducer sheath 162 is provided having a sheath wall 168 and a longitudinal axis 170. A distal end 164 of the introducer sheath 162 is then positioned in the targeted tissue of the patient. The distal end 114 of the lead body 110 is then fed into the introducer sheath 162 to position the distal end 114 proximate the distal end 164 of the introducer sheath 162 and the targeted tissue of the patient. In one embodiment, step 212 is performed while the at least one anchor wire 132 is in a retracted position.


At 214, a distal end 136 of the at least one anchor wire 132 is moved radially (i.e., relative to the longitudinal axis 140) from the lead body 110 and into the tissue to anchor the distal end 114 of the lead body 110 to the tissue. That is, the anchor comprising the at least one anchor wire 132 is moved from a retracted position to a deployed position in step 214.


In one embodiment of step 214, a proximal end 134 of the anchor wire 132 is attached to an actuatable member (194 or 202) within a lumen 192 of the lead body, as shown in FIGS. 11A-B and 12A-B. The actuatable member is then moved relative to the lead body 110. In one embodiment, the actuatable member is moved relative to the lead body 110 and the distal end 136 of the at least one anchor wire 132 is moved through an opening 184 in the lead body 110 responsive to moving the actuatable member. In one embodiment, the actuatable member (194) is moved along the longitudinal axis 140 relative to the lead body 110, as shown in FIGS. 11A-B. In accordance with another embodiment, the actuatable member (202) is rotated about the longitudinal axis 140 relative to the lead body 110, as shown in FIGS. 12A-B.


In one embodiment, the at least one anchor wire 132 is a component of anchor 130 (FIG. 2) or anchor 142 (FIG. 3). According to these embodiments, step 214 involves moving the lead body 110 relative to the introducer sheath 162 to deploy the at least one anchor wire 132 into the tissue of the patient. The introducer sheath 162 may then be removed from the tissue without disturbing the deployed anchor wire 132.


When the at least one anchor wire 132 is held in a compressed state by the introducer sheath 162 during the positioning step 212, step 214 of the method is performed by removing the introducer sheath from the tissue. This allows the compressed anchor wire 132 to expand toward its quiescent expanded state and into the tissue of the patient.


Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims
  • 1. An electrode lead comprising: a lead body having a tubular side wall;at least one electrode at a distal end of the lead body;an actuatable member within a lumen of the lead body; andat least one anchor wire having a proximal end attached to the actuatable member;wherein: movement of the actuatable member relative to the lead body moves the at least one anchor wire through at least one opening in the sidewall of the lead body; anda distal end of the at least one anchor wire moves radially from the lead body relative to a longitudinal axis of the lead body responsive to movement of the actuatable member.
  • 2. The electrode lead of claim 1, wherein: the actuatable member is configured to move relative to the lead body along a longitudinal axis of the lead body; andthe at least one anchor wire is deployed or retracted through the at least one opening responsive to movement of the actuatable member relative to the lead body along the longitudinal axis.
  • 3. The electrode lead of claim 2, further comprising a control member attached to the actuatable member and extending through the lumen of the lead body, wherein movement of the control member drives movement of the actuatable member along the longitudinal axis.
  • 4. The electrode lead of claim 3, wherein the control member has a distal end that is removably attachable to the actuatable member.
  • 5. The electrode lead of claim 4, wherein the actuatable member comprises an aperture that is configured to receive the distal end of the control member.
  • 6. The electrode lead of claim 5, wherein the aperture of the actuatable member comprises a keyhole, wherein the distal end of the control member may pass through the keyhole when angularly aligned with the keyhole, and the distal end of the control member is prevented from passing through the keyhole when angularly misaligned with the keyhole.
  • 7. The electrode lead of claim 1, wherein: the actuatable member is configured to rotate relative to the lead body about a longitudinal axis of the lead body; andthe at least one anchor wire is extended or retracted through the at least one opening responsive to rotation of the actuatable member about the longitudinal axis relative to the lead body.
  • 8. The electrode lead of claim 7, wherein the at least one anchor wire is wound around the actuatable member.
  • 9. A method comprising: providing an electrode lead comprising a lead body, at least one electrode at a distal end of the lead body and at least one anchor wire having a proximal end connected to the lead body;positioning the distal end of the lead body within tissue of a patient;moving a distal end of the at least one anchor wire radially from the lead body relative to a longitudinal axis of the lead body; andpiercing the tissue with the distal end of the anchor wire responsive to moving a distal end to anchor the distal end of the lead body to the tissue.
  • 10. The method of claim 9, wherein: providing an electrode lead further comprises providing an actuatable member within a lumen of the lead body, wherein the proximal end of the at least one anchor wire is attached to the actuatable member; andmoving a distal end of the at least one anchor wire comprises: moving the actuatable member relative to the lead body; andmoving the distal end of the at least one anchor wire through an opening in a tubular sidewall of the lead body responsive to moving the actuatable member.
  • 11. The method of claim 10, wherein moving the actuatable member relative to the lead body comprises moving the actuatable member along a longitudinal axis of the lead body relative to the lead body.
  • 12. The method of claim 10, wherein moving the actuatable member relative to the lead body comprises rotating the actuatable member about a longitudinal axis of the lead body relative to the lead body.
  • 13. The method of claim 10, wherein positioning the distal end of the lead body within tissue of a patient comprises: providing an introducer sheath having a sheath wall and a longitudinal axis;positioning a distal end of the sheath in the tissue of the patient; andfeeding the distal end of the lead body into the introducer sheath.
  • 14. The method of claim 13, wherein moving a distal end of the at least one anchor wire comprises: moving the distal end of the lead body relative to the introducer sheath; andmoving the distal end of the at least one anchor wire through at least one opening in the sheath wall and into the tissue responsive to moving the distal end of the lead body.
  • 15. The method of claim 14, wherein moving the distal end of the lead body comprises moving the distal end of the lead body along the longitudinal axis of the introducer sheath relative to the introducer sheath.
  • 16. The method claim 14, wherein moving the distal end of the lead body comprises rotating the distal end of the lead body about the longitudinal axis of the introducer sheath relative to the introducer sheath.
CROSS-REFERENCE TO RELATED APPLICATION

The present application is based on and claims the benefit of U.S. provisional patent application Ser. No. 61/358,053, filed Jun. 24, 2010, and U.S. provisional patent application Ser. No. 61/360,157, filed Jun. 30, 2010. The present application is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 12/558,143, filed Sep. 11, 2009, now abandoned, which claims the benefit of U.S. provisional patent application Ser. Nos. 61/096,387 filed Sep. 12, 2008 and 61/160,765 filed Mar. 17, 2009, and is a continuation-in-part of U.S. application Ser. No. 12/170,582 filed Jul. 10, 2008, now abandoned, which in turn claims the benefit of U.S. provisional patent application Ser. No. 60/948,908, filed Jul. 10, 2007. The content of each of the above-referenced applications is hereby incorporated by reference in their entirety.

US Referenced Citations (232)
Number Name Date Kind
3628538 Vincent et al. Dec 1971 A
3640284 De Langis Feb 1972 A
3646940 Timm et al. Mar 1972 A
3650276 Burghele et al. Mar 1972 A
3662758 Glover May 1972 A
3667477 Susset et al. Jun 1972 A
3866613 Kenny et al. Feb 1975 A
3870051 Brindley Mar 1975 A
3926178 Feldzamen Dec 1975 A
3941136 Bucalo Mar 1976 A
3983865 Shepard Oct 1976 A
3983881 Wickham Oct 1976 A
4010758 Rockland et al. Mar 1977 A
4023574 Nemec May 1977 A
4030509 Heilman et al. Jun 1977 A
4044774 Corbin et al. Aug 1977 A
4106511 Erlandsson Aug 1978 A
4136684 Scattergood et al. Jan 1979 A
4139006 Corey Feb 1979 A
4153059 Fravel et al. May 1979 A
4157087 Miller et al. Jun 1979 A
4165750 Aleev et al. Aug 1979 A
4177819 Kofsky et al. Dec 1979 A
4222377 Burton Sep 1980 A
4290420 Manetta Sep 1981 A
4387719 Plevnik et al. Jun 1983 A
4402328 Doring Sep 1983 A
4406288 Horwinski et al. Sep 1983 A
4414986 Dickhudt et al. Nov 1983 A
4431001 Hakansson et al. Feb 1984 A
4457299 Cornwell Jul 1984 A
4492233 Petrofsky et al. Jan 1985 A
4515167 Hochman May 1985 A
4542753 Brenman et al. Sep 1985 A
4568339 Steer Feb 1986 A
4569351 Tang Feb 1986 A
4571749 Fischell Feb 1986 A
4580578 Barsom Apr 1986 A
4585005 Lue et al. Apr 1986 A
4602624 Naples et al. Jul 1986 A
4607639 Tanagho et al. Aug 1986 A
4628942 Sweeney et al. Dec 1986 A
4688575 DuVall Aug 1987 A
4703755 Tanagho et al. Nov 1987 A
4731083 Fischell Mar 1988 A
4739764 Lue et al. Apr 1988 A
4750494 King Jun 1988 A
4771779 Tanagho et al. Sep 1988 A
4785828 Maurer Nov 1988 A
4881526 Johnson et al. Nov 1989 A
4913164 Greene et al. Apr 1990 A
4941874 Sandow et al. Jul 1990 A
5013292 Lemay May 1991 A
5019032 Robertson May 1991 A
5082006 Jonasson Jan 1992 A
5094242 Gleason et al. Mar 1992 A
5103835 Yamada et al. Apr 1992 A
5112344 Petros May 1992 A
5193539 Schulman et al. Mar 1993 A
5193540 Schulman et al. Mar 1993 A
5199430 Fang et al. Apr 1993 A
5285781 Brodard Feb 1994 A
5291902 Carman Mar 1994 A
5312439 Loeb May 1994 A
5324316 Schulman et al. Jun 1994 A
5324324 Vachon et al. Jun 1994 A
5330507 Schwartz Jul 1994 A
5358514 Schulman et al. Oct 1994 A
5405367 Schulman et al. Apr 1995 A
5411548 Carman May 1995 A
5417226 Juma May 1995 A
5423329 Ergas Jun 1995 A
5452719 Eisman et al. Sep 1995 A
5484445 Knuth Jan 1996 A
5518504 Polyak May 1996 A
5520606 Schoolman et al. May 1996 A
5562717 Tippey et al. Oct 1996 A
5569351 Menta et al. Oct 1996 A
5571148 Loeb et al. Nov 1996 A
5611515 Benderev et al. Mar 1997 A
5611768 Tutrone, Jr. Mar 1997 A
5634462 Tyler et al. Jun 1997 A
5702428 Tippey et al. Dec 1997 A
5752978 Chancellor May 1998 A
5807397 Barreras Sep 1998 A
5824027 Hoffer et al. Oct 1998 A
5833595 Lin Nov 1998 A
5842478 Benderev et al. Dec 1998 A
5860425 Benderev et al. Jan 1999 A
5899909 Claren et al. May 1999 A
5927282 Lenker et al. Jul 1999 A
5931864 Chastain et al. Aug 1999 A
5954761 Machek et al. Sep 1999 A
5957920 Baker Sep 1999 A
5957965 Moumane et al. Sep 1999 A
5978712 Suda et al. Nov 1999 A
5984854 Ishikawa et al. Nov 1999 A
6002964 Feler et al. Dec 1999 A
6026326 Bardy Feb 2000 A
6027456 Feler et al. Feb 2000 A
6039686 Kovac Mar 2000 A
6042534 Gellman et al. Mar 2000 A
6051017 Loeb et al. Apr 2000 A
6055456 Gerber Apr 2000 A
6061596 Richmond et al. May 2000 A
6104955 Bourgeois Aug 2000 A
6104960 Duysens et al. Aug 2000 A
6110101 Tihon et al. Aug 2000 A
6131575 Lenker et al. Oct 2000 A
6135945 Sultan Oct 2000 A
6141594 Flynn et al. Oct 2000 A
6161029 Spreigl et al. Dec 2000 A
6178356 Chastain et al. Jan 2001 B1
6185452 Schulman et al. Feb 2001 B1
6208894 Schulman et al. Mar 2001 B1
6240315 Mo et al. May 2001 B1
6240316 Richmond et al. May 2001 B1
6243607 Mintchev et al. Jun 2001 B1
6266557 Roe et al. Jul 2001 B1
6266564 Hill et al. Jul 2001 B1
6304786 Heil et al. Oct 2001 B1
6328686 Kovac Dec 2001 B1
6341236 Osorio et al. Jan 2002 B1
6354991 Gross et al. Mar 2002 B1
6360750 Gerber et al. Mar 2002 B1
6366814 Boveja et al. Apr 2002 B1
6382214 Raz et al. May 2002 B1
6397109 Cammilli et al. May 2002 B1
6407308 Roe et al. Jun 2002 B1
6418930 Fowler Jul 2002 B1
6505082 Scheiner et al. Jan 2003 B1
6582441 He et al. Jun 2003 B1
6600956 Maschino et al. Jul 2003 B2
6612977 Staskin et al. Sep 2003 B2
6641524 Kovac Nov 2003 B2
6650943 Whitehurst et al. Nov 2003 B1
6652449 Gross et al. Nov 2003 B1
6652450 Neisz et al. Nov 2003 B2
6652499 Edgren et al. Nov 2003 B1
6658297 Loeb Dec 2003 B2
6659936 Furness et al. Dec 2003 B1
6662045 Zheng et al. Dec 2003 B2
6712772 Cohen et al. Mar 2004 B2
6735474 Loeb et al. May 2004 B1
6745079 King Jun 2004 B2
6802807 Anderson et al. Oct 2004 B2
6862480 Cohen et al. Mar 2005 B2
6896651 Gross et al. May 2005 B2
6911003 Anderson et al. Jun 2005 B2
6941171 Mann et al. Sep 2005 B2
6952613 Swoyer et al. Oct 2005 B2
6964643 Hovland et al. Nov 2005 B2
6964699 Carns et al. Nov 2005 B1
6971393 Mamo et al. Dec 2005 B1
7079882 Schmidt Jul 2006 B1
7120499 Thrope et al. Oct 2006 B2
7319905 Morgan et al. Jan 2008 B1
7328068 Spinelli et al. Feb 2008 B2
7330764 Swoyer et al. Feb 2008 B2
7343202 Mrva et al. Mar 2008 B2
7376467 Thrope et al. May 2008 B2
7613516 Cohen et al. Nov 2009 B2
7628795 Karwoski et al. Dec 2009 B2
7647113 Wirbisky et al. Jan 2010 B2
7771345 O'Donnell Aug 2010 B1
20010002441 Boveja May 2001 A1
20010003799 Boveja Jun 2001 A1
20010018549 Scetbon Aug 2001 A1
20020055761 Mann et al. May 2002 A1
20020099259 Anderson et al. Jul 2002 A1
20020161382 Neisz et al. Oct 2002 A1
20020161423 Lokhoff et al. Oct 2002 A1
20020165566 Ulmsten Nov 2002 A1
20030018365 Loeb Jan 2003 A1
20030023296 Osypka Jan 2003 A1
20030028232 Camps et al. Feb 2003 A1
20030060868 Janke et al. Mar 2003 A1
20030100930 Cohen et al. May 2003 A1
20030171644 Anderson et al. Sep 2003 A1
20030199961 Bjorklund et al. Oct 2003 A1
20030236557 Whitehurst et al. Dec 2003 A1
20030236558 Whitehurst et al. Dec 2003 A1
20040015057 Rocheleau et al. Jan 2004 A1
20040015204 Whitehurst et al. Jan 2004 A1
20040015205 Whitehurst et al. Jan 2004 A1
20040039453 Anderson et al. Feb 2004 A1
20040059392 Parramon et al. Mar 2004 A1
20040068203 Gellman et al. Apr 2004 A1
20040093053 Gerber et al. May 2004 A1
20040242956 Scorvo Dec 2004 A1
20040248979 Brettman et al. Dec 2004 A1
20050038489 Grill Feb 2005 A1
20050043580 Watschke et al. Feb 2005 A1
20050065395 Mellier Mar 2005 A1
20050113877 Spinelli et al. May 2005 A1
20050119710 Furness et al. Jun 2005 A1
20050143618 Anderson et al. Jun 2005 A1
20050149156 Libbus et al. Jul 2005 A1
20050216069 Cohen et al. Sep 2005 A1
20050228346 Goode et al. Oct 2005 A1
20050245787 Cox et al. Nov 2005 A1
20050245874 Carrez et al. Nov 2005 A1
20050250977 Montpetit et al. Nov 2005 A1
20050251240 Doan Nov 2005 A1
20050283235 Kugler et al. Dec 2005 A1
20060004421 Bennett et al. Jan 2006 A1
20060004429 Mrva et al. Jan 2006 A1
20060149345 Boggs, II et al. Jul 2006 A1
20060241733 Zhang et al. Oct 2006 A1
20060287571 Gozzi et al. Dec 2006 A1
20070021650 Rocheleau et al. Jan 2007 A1
20070043416 Callas et al. Feb 2007 A1
20070123952 Strother et al. May 2007 A1
20070156219 Sommer et al. Jul 2007 A1
20070179559 Giftakis et al. Aug 2007 A1
20070185541 DiUbaldi et al. Aug 2007 A1
20070239224 Bennett et al. Oct 2007 A1
20070253997 Giftakis et al. Nov 2007 A1
20070253998 Giftakis et al. Nov 2007 A1
20070255333 Giftakis et al. Nov 2007 A1
20070255341 Giftakis et al. Nov 2007 A1
20070260288 Gross et al. Nov 2007 A1
20070265675 Lund et al. Nov 2007 A1
20080009914 Buysman et al. Jan 2008 A1
20080071321 Boggs, II et al. Mar 2008 A1
20080132969 Bennett et al. Jun 2008 A1
20090012592 Buysman Jan 2009 A1
20090043356 Longhini et al. Feb 2009 A1
20090157091 Buysman Jun 2009 A1
20100049289 Lund et al. Feb 2010 A1
20100076254 Jimenez et al. Mar 2010 A1
20120095478 Wang et al. Apr 2012 A1
Foreign Referenced Citations (23)
Number Date Country
8506522.6 Jun 1985 DE
0245547 Nov 1987 EP
1 661 600 May 2006 EP
1119314 Jun 2006 EP
2295109 Mar 2011 EP
2309388 Jul 1997 GB
9012617 Nov 1990 WO
9604955 Feb 1996 WO
9632916 Oct 1996 WO
9817190 Apr 1998 WO
0000082 Jan 2000 WO
0019940 Apr 2000 WO
0239890 May 2002 WO
02069781 Sep 2002 WO
02078592 Oct 2002 WO
03002192 Jan 2003 WO
2006047833 May 2006 WO
2007097994 Aug 2007 WO
2007126632 Nov 2007 WO
2007145913 Dec 2007 WO
2009017680 Feb 2009 WO
2009075800 Jun 2009 WO
2010107751 Sep 2010 WO
Non-Patent Literature Citations (17)
Entry
Prosecution Documents associated with U.S. Appl. No. 12/558,143 including: Office Action mailed Dec. 13, 2011; Office Action mailed Sep. 29, 2011; and Office Action mailed Jun. 20, 2011.
Yamanishi et al., “Electrical Stimulation for Stress Incontinence”, Int. Urogynecol J (1998) 9:281-290 Springer-Verlag London Ltd.
International Search Report and Written Opinion dated Apr. 21, 2011 from International Application No. PCT/US2011/023677, filed Feb. 4, 2011.
Dietz et al., “Mechanical Properties of Urogynecologic Implant Materials”, Int. Urogynecol J. (2003) 14:239-243.
Iglesia et al., “The Use of Mesh in Gynecologic Surgery”, Int. Urogynecol J. (1997) 8:105-115.
Partial European Search Report from European Patent Application No. 10176162.5, mailed Jan. 21, 2011.
European Search Report and Written Opinion of 06011641.5, mailed Aug. 21, 2006.
International Search Report and Written Opinion of PCT/US2007/004474, filed Feb. 22, 2007.
International Search Report and Written Opinion of PCT/US2007/000112, filed Jan. 3, 2007.
U.S. Appl. No. 12/406,434, filed Mar. 18, 2009.
Caldwell, K.P.S. et al. “Urethral Pressure Recordings in Male Incontinents Under Electrical Stimulation.” Investigative Urology vol. 5, No. 6, pp. 572-579, May 1968.
Caldwell, K.P.S. et al. “Stress Incontinence in Females: Report on 31 Cases Treated by Electrical Implant.” J. Obstet. Gynaec. Brit. Cwlth vol. 75, pp. 777-780, Jul. 1968.
Caldwell, K.P.S. “Electrical Stimulation.”, Sphincter Research Unit, Royal Devon and Exeter Hospital, Exeter (England), Urol. Int. 29: 225, 1974. (1 page).
Caldwell, K.P.S. “The Use of Electrical Stimulation in Urinary Retention and Incontinence [Abridged].” Section of Urology, vol. 61, pp. 35-39, Jul. 1968.
Notification of the First Office Action from Chinese patent application No. 200780007709.2, mailed Sep. 27, 2010.
Extended European Search Report and Opinion for European patent application No. 10176162.5, dated Apr. 28, 2011.
Yamamoto et al., “Optimal parameters for effective electrical stimulation of the anal sphincters in a child with fecal incontinence: preliminary report,” Pediatr Surg Int (1993) 8:132-137.
Related Publications (1)
Number Date Country
20110313427 A1 Dec 2011 US
Provisional Applications (5)
Number Date Country
61358053 Jun 2010 US
61360157 Jun 2010 US
61096387 Sep 2008 US
61160765 Mar 2009 US
60948908 Jul 2007 US
Continuation in Parts (2)
Number Date Country
Parent 12558143 Sep 2009 US
Child 13167541 US
Parent 12170582 Jul 2008 US
Child 12558143 US