IMPLANTABLE MEDICAL LEAD AND RELATED DEVICES AND METHODS

An implantable medical lead for electrical stimulation may include a body, which may include a flexible distal end, a flexible proximal end, and a rigid portion extending between the flexible distal end and the flexible proximal end. The body may include an aperture extending through the flexible distal end and the flexible proximal end and configured to receive a guidewire therethrough. The implantable medical lead may include an electrode coupled to the rigid portion and an electrical conductor electrically connected to the electrode and extending from the electrode through the flexible proximal end. A medical anchor to secure the implantable medical lead may include a body and a clamp element configured to move between an open position and a closed position. A surgical instrument to implant the implantable medical lead may include a first arm having a first clamp surface and a second arm having a second clamp surface.

background is only provided to illustrate one example technology area where some implementations described herein may be practiced.

SUMMARY

The present disclosure relates generally to an implantable medical lead for electrical stimulation, as well as related devices and methods. Various features and aspects disclosed herein provide a unique implantable medical lead compatible for use with tubes and open spinal procedures, thereby allowing clinicians to accurately and safely implant the medical lead via minimally invasive surgical procedures incorporating only a mini-incision and partial laminectomy.

In some embodiments, an implantable medical lead for electrical stimulation may include a body, which may include a flexible distal end and/or a flexible proximal end. In some embodiments, the implantable medical lead may include a rigid portion, which may extend between the flexible distal end and the flexible proximal end.

In some embodiments, the body may include an aperture extending through the flexible distal end and the flexible proximal end and configured to receive a guidewire therethrough. In some embodiments, the implantable medical lead may include an electrode coupled to the rigid portion. In some embodiments, the implantable medical lead may include an electrical conductor electrically connected to the electrode and extending from the electrode through the flexible proximal end.

In some embodiments, a top surface of the flexible distal end may be tapered downwardly in a distal direction. In some embodiments, a cross-section of the body may be dome-shaped or triangular. In some embodiments, the electrode may be disposed on a bottom surface of the body. In some embodiments, the flexible proximal end may be tapered inwardly such that a width of the body decreases in a proximal direction. In some embodiments, the bottom surface of the body may be flat.

In some embodiments, the body may include one or more circular radiopaque markers.

In some embodiments, the circular radiopaque markers may include a first circular radiopaque marker and a second circular radiopaque marker disposed within the flexible proximal end. In some embodiments, the first circular radiopaque marker and the second circular radiopaque marker may be equidistant from a longitudinal axis of the body and aligned. In some embodiments, the body may include one or more holes, and each of the holes may include a circular radiopaque marker.

In some embodiments, the implantable medical lead may include another electrode coupled to the rigid portion and another electrical conductor electrically connected to the other electrode and extending from the other electrode through the flexible proximal end. In some embodiments, the flexible proximal end may include a first opening and a second opening. In some embodiments, the electrical conductor may extend through the first opening and the other electrical conductor may extend through the second opening. In some embodiments, the aperture may be disposed above and in between the first opening and the second opening.

In some embodiments, the implantable medical lead may include multiple electrodes arranged in a first line and multiple other electrodes arranged in a second line parallel to the first line. In some embodiments, the multiple electrodes may include the electrode, and the multiple other electrodes may include the other electrode. In some embodiments, the electrical conductor may be electrically connected to the multiple electrodes, and the other electrical conductor may be electrically connected to the multiple other electrodes.

In some embodiments, a medical anchor to secure the implantable medical lead may include a body, which may include one or more of the following: a distal end, a proximal end, an opening extending through the distal end, a groove extending through the proximal end and proximate the opening, a first suture hole, and a second suture hole. In some embodiments, the first suture hole may oppose the second suture hole. In some embodiments, the opening and the groove may be configured to receive the electrical conductor.

In some embodiments, the medical anchor may include a clamp element, which may be hinged to the body of the medical anchor. In some embodiments, the clamp element may be configured to move between an open position and a closed position. In some embodiments, an inner surface of clamp element may include another groove configured to align with the groove when the clamp element is in the closed position. In some embodiments, the clamp element may be configured to clamp the electrical conductor between the clamp element and the body of the medical anchor when the clamp element is in the closed position to prevent the electrical conductor from sliding through the medical anchor.

In some embodiments, the first suture hole and the second suture hole may be disposed within the distal end and extend through a top surface of the body of the medical anchor and a bottom surface of the body of the medical anchor. In some embodiments, the body of the medical anchor may include a cutout portion extending between a first wall and a second wall. In some embodiments, the first wall and the second wall may be configured to contact a first side and a second side, respectively, of the clamp element when the clamp element is in the closed position. In some embodiments, the first wall and the second wall may be spaced apart by a floor of the body of the medical anchor. In some embodiments, the groove may extend through the floor. In some embodiments, the inner surface of the clamp element may be configured to contact the floor when the clamp element is in the closed position.

In some embodiments, a surgical instrument to implant the implantable medical lead for electrical stimulation. In some embodiments, a first arm may include a first distal end, which may include a first clamp surface. In some embodiments, the first clamp surface may include a circular peg configured to insert into a circular hole of an implantable medical lead. In some embodiments, the surgical instrument may include an aperture extending through the first arm proximal to the first distal end. In some embodiments, the aperture may be configured to receive one or more electrical conductors and a guidewire therethrough.

In some embodiments, the surgical instrument may include a second arm coupled to the first arm. In some embodiments, the second arm may include a second distal end. In some embodiments, the second distal end may include a second clamp surface opposing the first clamp surface. In some embodiments, the second clamp surface may include another circular peg configured to insert into another circular hole of the implantable medical lead. In some embodiments, the second arm may include a groove opposing the aperture.

In some embodiments, the first clamp surface may include a first rounded indent. In some embodiments, the second clamp surface may include a second rounded indent. In some embodiments, the first peg and the second peg may extend from the first rounded indent and the second rounded indent, respectively. In some embodiments, the surgical instrument may be scissor-tong shaped.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

DESCRIPTION OF EMBODIMENTS

Referring now toFIGS.1A-1J, an implantable medical lead10for electrical stimulation is illustrated, according to some embodiments. In some embodiments, the implantable medical lead10may include a body12, which may include a flexible distal end14and/or a flexible proximal end16. In some embodiments, the flexible distal end14and/or the flexible proximal end16may reduce a risk of trauma or damaging the spinal cord during insertion into the epidural space. In further detail, the flexible distal end14and/or the flexible proximal end16may be configured to bend and make the turn from a cannula into foramen of the spine without damaging delicate structures near the spinal cord. The cannula is described further with respect toFIGS.2A-2C, according to some embodiments.

In some embodiments, the implantable medical lead10may include a rigid portion18, which may extend between the flexible distal end14and the flexible proximal end16. The rigid portion18is illustrated by a first shading inFIGS.1A-1J, the flexible distal end14is illustrated by a second shading inFIGS.1A-1J, and the flexible proximal end16is illustrated by a third shading inFIGS.1A-1J, according to some embodiments. In some embodiments, the rigid portion18may have a longitudinal axis20. As used in the present disclosure, the term “distal” refers to a portion of a device further from the clinician, and the term “proximal” refers to a portion of a device closer to the clinician.

In some embodiments, the flexible distal end14and/or the flexible proximal end16may be constructed of plastic, an elastomer, or another suitable material. In these and other embodiments, the flexible proximal end16may be constructed of a material that allows the flexible proximal end16to bend or flex from a first position, illustrated inFIG.1G, to a second position, illustrated inFIG.1H. In some embodiments, the first position may correspond to an angle between about 30° and about 45° below the longitudinal axis20. In some embodiments, the second position may correspond to an angle between about 30° and about 45° above the longitudinal axis20, which may facilitate insertion of the body12through the cannula and into the foramen of the spine.

In some embodiments, the flexible distal end14may be constructed of a same or different material than the flexible proximal end16that allows the flexible distal end14to bend from a first position to a second position. In some embodiments, the first position may correspond to an angle between about 30° and about 45° below the longitudinal axis20. In some embodiments, the second position may correspond to an angle between about 30° and about 45° above the longitudinal axis20, which may facilitate insertion of the body12through the cannula and into the foramen of the spine. In some embodiments, the body12may be generally flat or aligned with the longitudinal axis20along an entire length of the body12when the body12is in a resting or unbiased position without application of force, as illustrated, for example, inFIG.1D.

In some embodiments, the rigid portion18may be constructed of plastic, metal, or another suitable material. In some embodiments, the rigid portion18may be constructed of a plastic with a greater durometer than a plastic of the flexible distal end14and/or the flexible proximal end16. In some embodiments, the body12may include an aperture22extending through the flexible distal end14and the flexible proximal end16and configured to receive a guidewire therethrough. In some embodiments, the aperture22may extend longitudinally through the body12.

In some embodiments, the implantable medical lead10may include one or more electrodes24, which may be coupled to the rigid portion18such that the electrodes24are conductively exposed. In some embodiments, some of the electrodes24may be disposed in a first line26and some of the electrodes24may be disposed in a second line28parallel to the first line26, which may facilitate. In some embodiments, the electrodes24may be coupled to the rigid portion18in any suitable arrangement or pattern.

In some embodiments, one or more electrical conductors29may be electrically connected to the electrodes32. In some embodiments, the electrical conductors29may extend from the electrodes32through the flexible proximal end16. In some embodiments, a particular electrical conductor29may be electrically coupled to one or more particular electrodes32in the first line26, and another particular electrical conductor29may be electrically coupled to one or more other particular electrodes32in the second line28.

In some embodiments, a shape of the body12may be configured to facilitate insertion of the implantable medical lead10into the epidural space. In some embodiments, the shape of the body12may also increase contact of the electrodes32with a targeted tissue, while reducing a risk of developing scar tissue on the body12. In further detail, in some embodiments, a top surface30of the flexible distal end14may be tapered downwardly in a distal direction, as illustrated, for example, inFIGS.1F and1I, which may facilitate insertion of the implantable medical lead10into the epidural space. In some embodiments, a proximal end of a tapered surface31that is tapered downwardly in the distal direction may include a rounded edge34, which may facilitate smooth insertion. In some embodiments, the flexible distal end14may be beveled or chamfered.

In some embodiments, the tapered surface31may extend near or to a distal-most surface of the flexible distal end14. In some embodiments, the tapered surface31may be planar and tapered downwardly in the distal direction at a single angle. In some embodiments, the tapered surface31may be tapered downwardly in the distal direction at more than one angle, as illustrated, for example inFIG.1F, having a steeper proximal portion compared to a distal portion of the tapered surface31, for example. In some embodiments, the aperture22may be disposed within the tapered surface31.

In some embodiments, the electrodes24may be disposed on a bottom surface32of the body12. In some embodiments, when the implantable medical lead10is inserted into the epidural space, the top surface30may be posterior to the bottom surface32. In some embodiments, the bottom surface32may be anterior to the top surface30when the implantable medical lead10is inserted into the epidural space. As used in the present disclosure, the term “above” may refer to a posterior direction when the implantable medical lead10is inserted into the epidural space, and the term “below” may refer to an anterior direction when the implantable medical lead10is inserted into the epidural space. In some embodiments, the bottom surface32of the body12may be flat, which may facilitate contact of the electrodes24on the bottom surface32with the targeted tissue. In some embodiments, the electrodes24may be located on a portion of the body12other than the bottom surface32.

As illustrated, for example, inFIGS.1C and1J, the flexible proximal end16may be tapered inwardly such that a width36of the body12decreases in a proximal direction, which may decrease a size of the body12and increase maneuverability within the epidural space.FIG.1Cillustrates a length38of the body12and the width36of the body12, according to some embodiments. In some embodiments, a height40of the body12, illustrated, for example, inFIG.1D, may be for application to a human spinal cord. In some embodiments, the body12may be configured to be applied to cervical vertebrae in the human spinal cord, thoracic vertebrae in the human spinal cord, or lumbar vertebrae in the human spinal cord.

In some embodiments, the body12may include one or more radiopaque markers42, which may be circular. In some embodiments, a clinician may determine that the implantable medical lead10is inserted within the epidural space in a straight manner by observing the radiopaque markers42that are circular as perfect circles. In some embodiments, the radiopaque markers42may include a first radiopaque marker42aand a second radiopaque marker42b, which may be disposed within the flexible proximal end16. In some embodiments, the first radiopaque marker42aand the second radiopaque marker42bmay be equidistant from a center or a longitudinal axis of the body12and aligned with each other, which may provide a clear indication of a position of the implantable medical lead10to the clinician, who may observe the first radiopaque marker42aand the second radiopaque marker42bas perfect circles when the implantable medical lead10is inserted correctly.

In some embodiments, the body12may include one or more holes44configured to receive one or more pegs of a surgical instrument, which the clinician may use to insert the implantable medical lead10. In some embodiments, each of the holes44may be circular and constructed of a radiopaque material. In further detail, in some embodiments, a circular bottom of each of the holes44may be constructed of the radiopaque material and/or a circular edge of each of the holes44may be constructed of the radiopaque material. Thus, the holes44may each serve as the radiopaque markers42.

In some embodiments, the flexible proximal end16may include a first opening46and/or a second opening48. In some embodiments, a particular electrical conductor29may extend through the first opening46and/or another particular electrical conductor29may extend through the second opening48. In some embodiments, the aperture22may be disposed above and in between the first opening46and the second opening48, which may accommodate a dome or triangle shape of the body12to improve insertion of the body12into the epidural space. In some embodiments, the first opening46, the second opening, and the aperture22may be disposed on a proximal face or proximal-most surface of the flexible proximal end16.

Referring now toFIGS.2A-2C, in some embodiments, a cannula50may be inserted by the clinician through the skin of the patient and into the epidural space, creating a small incision. In some embodiments, the implantable medical lead10may be configured to fit in and move through the cannula50into the epidural space. In some embodiments, in order to insert the cannula50and place the implantable medical lead10in the epidural space, only a small portion of the lamina may be removed, or no lamina may be removed at all. This is in contrast to a typical laminotomy used to insert a medical lead having a flat, rectangular paddle shape, which results in a fairly large incision.

As mentioned, a full laminectomy involves a large resection and removal of vertebral bone and tissue. Because the surgical lead is surgically implanted in this manner, a trained Interventional Pain Management physician may not perform the procedure. The unique design features of the lead allow for the lead to be placed with any minimally invasive techniques that allows for a limited laminotomy for epidural space access, where the lead can be guided with fluoroscopy over a guide wire and with the steering tools. For example, the implantable medical lead10may be inserted into the epidural space using a surgical procedure, which may be minimally invasive. In some embodiments, the implantable medical lead10may be inserted into the epidural space by a surgeon trained in minimally invasive surgical procedures. In some embodiments, during the minimally invasive surgical procedure, an endoscope or tube may be used to reach the epidural space through a very small incision, and the guidewire55and/or the radiopaque markers42may facilitate proper placement of the implantable medical lead10without an “open” surgical procedure. In some embodiments, the cannula50may correspond to a cannula of the endoscope or tube. In some embodiments, the implantable medical lead10may correspond to a cannulated electrical stimulation lead.

In some embodiments, a distal opening52of the cannula50may be generally perpendicular to a proximal opening54of the cannula50, which may facilitate guidance of the implantable medical lead10into the epidural space. A guidewire55is illustrated extending through the aperture22, according to some embodiments.

Referring now toFIGS.3A-3F, a surgical instrument56to implant the implantable medical lead10for electrical stimulation is illustrated, according to some embodiments. In some embodiments, a first arm58of the surgical instrument56may include a first distal end60, which may include a first clamp surface62. In some embodiments, the first clamp surface62may include one or more pegs64each configured to insert into a particular hole44of the implantable medical lead10. In some embodiments, the pegs64may be circular, and the particular hole44may be circular.

In some embodiments, the surgical instrument56may include an aperture66extending through the first arm58proximal to the first distal end60and which may be elongated. In some embodiments, the aperture66may be configured to receive one or more electrical conductors29and the guidewire55therethrough. In some embodiments, the aperture66may be elongated, and the electrical conductors29and/or the guidewire55may be loosely disposed within the aperture66, which may allow the surgical instrument56to move independently of the electrical conductors29and/or the guidewire55.

In some embodiments, the surgical instrument56may include a second arm68coupled to the first arm58. In some embodiments, the second arm68may include a second distal end70. In some embodiments, the second distal end70may include a second clamp surface72opposing the first clamp surface62. In some embodiments, the surgical instrument56may be configured to clamp the body12between the first clamp surface62and the second clamp surface72. In some embodiments, the second clamp surface72may include one or more of the pegs64, which may be configured to insert into another of the holes44of the implantable medical lead10. In some embodiments, the pegs64and the other of the holes44may be circular. In some embodiments, the second arm68may include a groove76opposing the aperture66, and the groove76may provide space for the electrical conductors29and/or the guidewire55.

In some embodiments, the first clamp surface62may include a rounded indent77and/or the second clamp surface72may include flat or planar surface. Thus, in some embodiments, the rounded indent77may be configured to receive the body12of the implantable medical lead10when the surgical instrument56clamps the body12, which may be rounded. In some embodiments, one or more particular pegs64may extend from the first rounded indent77and one or more other particular pegs64may extend from the second clamp surface, which may be flat.

In some embodiments, the surgical instrument56may be scissor-tong shaped, with the first arm58and the second arm68pivotally coupled to each other. In some embodiments, the first arm58and the second arm68may be configured to fit within the cannula50, and the surgical instrument56may be configured to insert the implantable medical lead10into the patient through the cannula50.

Referring now toFIGS.4A-5D, a medical anchor78to secure the implantable medical lead10within a body of the patient is illustrated, according to some embodiments. In some embodiments, the medical anchor78may include a body80, which may include one or more of the following: a distal end82; a proximal end84; one or more openings86extending through the distal end82; one or more grooves88extending through the proximal end84and proximate the openings86; a first suture hole90; and a second suture hole92. In some embodiments, the first suture hole90may oppose the second suture hole92to provide securement of the medical anchor78on both sides of the body80. In some embodiments, suture may be inserted through the first suture hole90and/or the second suture hole92and secured to tissue of the patient to prevent migration of the implantable medical lead10after implantation. In some embodiments, each of the openings86and each of the grooves88may be configured to receive a particular electrical conductor29. In some embodiments, each of the openings36may include a tunnel.

In some embodiments, the medical anchor78may include a clamp element94, which may be hinged to the body80at a distal end of the clamp element94. In some embodiments, the clamp element94may be configured to move between an open position, illustrated, for example, inFIG.4A, and a closed position, illustrated, for example, inFIG.4B. In some embodiments, an inner surface96of the clamp element94may include one or more other grooves98configured to align with the grooves88when the clamp element94is in the closed position. In some embodiments, the clamp element94may be configured to clamp the electrical conductors29between the clamp element94and the body80when the clamp element94is in the closed position to prevent the electrical conductors29from sliding through the medical anchor78. In some embodiments, the clamp element94may be moved to the closed position after the implantable medical lead10is in a desired position.

In some embodiments, the first suture hole90and the second suture hole92may be disposed within the distal end82and extend through a top surface100of the body80and a bottom surface102of the body80. In some embodiments, the body80may include a cutout portion104extending between a first wall106and a second wall108. In some embodiments, the first wall106and the second wall108may be configured to contact a first side110and a second side112, respectively, of the clamp element94when the clamp element94is in the closed position. In some embodiments, the first wall106and the second wall108may be spaced apart by a floor114of the body80. In some embodiments, the grooves88may extend through the floor114. In some embodiments, the inner surface96of the clamp element94may be configured to contact the floor114when the clamp element94is in the closed position, which may prevent fluid from entering the implantable medical lead10.

In some embodiments, the floor114may extend proximal to the first wall106and the second wall108. In some embodiments, the clamp element94may include opposing arms115, which may be configured to contact an edge of the body80proximate the floor114when the clamp element94is in the closed position. In some embodiments, a top surface of the body80and/or a top surface of the clamp element94may be rounded or dome-shaped to improve insertion of the medical anchor78into the epidural space. In some embodiments, a bottom of the body80may be flat. In some embodiments, when the clamp element94is in the closed position, the top surface of the clamp element94may be aligned with the top surface of the body80and/or a bottom surface of the clamp element94may be aligned with a bottom surface of the body80such that the medical anchor is smooth and does not irritate or injure the patient.

Referring now toFIGS.6A-6I, a medical anchor146is illustrated, according to some embodiments. In some embodiments, the medical anchor146may be similar or identical to the medical anchor78in terms of one or more features and/or operation.

In some embodiments, the medical anchor146may include an upper section148and a lower section150that fold via a hinge portion152disposed between the upper section148and the lower section150. In some embodiments, the upper section148and the lower section150may include a clamshell shape that moves between an open position and a closed position. In some embodiments, the hinge portion152may extend outwardly from a distal face153of the medical anchor146and/or may be constructed of a flexible material configured to bend.

In some embodiments, an inner surface of the upper section148may include one or more grooves154configured to align with one or more other grooves155of an inner surface of the lower section150. In some embodiments, when the medical anchor146is in the closed position, the electrical conductors29may be pinched or clamped within the grooves154and the other grooves155.

In some embodiments, the medical anchor146may include one or more openings156, which may be disposed between the upper section148and the lower section150and/or extend through the hinge portion152. In some embodiments, the grooves152may extend from a proximal end158of the upper section148to the openings156. In some embodiments, the other grooves154may extend from a proximal end160of the lower section150to the openings156.

In some embodiments, instead of being disposed at a distal end as illustrated inFIG.6B, the hinge portion152may be disposed on a side of the medical anchor146between the upper section148and the lower section150. In further detail, in some embodiments, the hinge portion152may extend generally parallel to the grooves155and/or generally perpendicular to the distal face153. In some embodiments, the hinge portion152may be generally parallel to a longitudinal axis of the medical anchor146. In these and other embodiments, the openings156may not be positioned within the hinge portion152but may be formed in response to movement of the medical anchor146into the closed position. In these and other embodiments, the electrical conductors29may be laid in the other grooves155such that when the medical anchor146is in the closed position, the electrical conductors29may be pinched or clamped within the grooves154and the other grooves155.

In some embodiments, the upper section148may include a first suture hole162configured to align with a first suture hole164of the lower section150when the medical anchor146is in the closed position. In some embodiments, the upper section148may include a second suture hole166configured to align with a second suture hole168of the lower section150when the medical anchor146is in the closed position. In some embodiments, suture may be inserted through one or more of the first suture hole162, the first suture hole164, the second suture hole166, and the second suture hole168and secured to tissue of the patient to prevent migration of the implantable medical lead10after implantation. In some embodiments, the first suture hole162may be disposed on an opposite side of the upper section148from the second suture hole166and/or the first suture hole164may be disposed on an opposite side of the lower section150from the second suture hole168.

In some embodiments, the upper section148may be configured to snap to the lower section150to secure the medical anchor146in the closed position. In further detail, in some embodiments, the upper section148may include two arms170, which may oppose each other. In some embodiments, the two arms170may extend downwardly from the upper section148and/or may include curved ends172configured to snap onto a flange174of the lower section150. In some embodiments, a shape of the flange174may be a same shape as a shape of a space176between the curved ends172and the inner surface of the upper section148. Thus, in some embodiments, when the medical anchor146is in the closed position, fluid may not enter through the space176. In some embodiments, a proximal face178of the medical anchor146may be smooth, which may reduce damage or irritation of tissue of the patient.

Referring now toFIGS.7A-7D, a method of using a cannula130and the guidewire55to implant an implantable medical lead134within a patient is illustrated, according to some embodiments. In some embodiments, the cannula130and the implantable medical lead134may be similar or identical to the cannula50and the implantable medical lead10, respectively, in terms of one or more features and/or operation.

In some embodiments, the cannula130may be inserted through the skin of the patient and into the epidural space, as illustrated, for example, inFIG.7A. In some embodiments, after the cannula130is inserted into the epidural space, the guidewire55may be inserted through the cannula130and into the epidural space beyond a distal end of the cannula130, as illustrated, for example, inFIG.7B. In some embodiments, an introducer132may be used, and the guidewire55may be inserted through the cannula130and the introducer132into the epidural space beyond the distal end of the cannula130. In some embodiments, after the guidewire55is inserted into the epidural space, the introducer132may be withdrawn proximally and removed, as illustrated, for example, inFIG.7C. In some embodiments, the method may not include use of the introducer132, and the guidewire55may be inserted directly into the cannula130.

In some embodiments, after the cannula130and the guidewire55are inserted into the patient at a desired location, the implantable medical lead134may be inserted through the cannula130into the epidural space. In some embodiments, a surgical instrument, such as the surgical instrument56ofFIGS.3A-3F, may be used to insert the implantable medical lead134through the cannula130and into the epidural space. In other embodiments, the clinician may feed the implantable medical lead134through the cannula another suitable driver or his or her hand. In some embodiments, the guidewire55may extend through an aperture of the implantable medical lead134, and the implantable medical lead134may move along the guidewire55into a desired position proximate spinal nerve tissue to be stimulated. In some embodiments, a position of the implantable medical lead134may then be verified using one or more radiopaque markers, such as, for example, the radiopaque markers42. Although “T11”, “T12” and “L1” are illustrated inFIGS.7A-7D, it is understood that an insertion point of the implantable medical lead134may vary.

In some embodiments, the cannula130may be removed after the implantable medical lead134is positioned within the epidural space at a desired location. In some embodiments, an anchor, such as, for example, the medical anchor78or the medical anchor146, may then be used to keep the implantable medical lead134in position.

Referring now toFIG.8A, in some embodiments, after the implantable medical lead134is secured to the tissue via the anchor, one or more electrical conductors29may then be coupled to an implantable pulse generator (IPG)136. In some embodiments, a subcutaneous pocket may be created for the IPG136, and the IPG may be inserted within the subcutaneous pocket.

Referring now toFIG.8B, in some embodiments, after the implantable medical lead134is secured to the tissue via the anchor, one or more electrical conductors29may then be coupled to a radiofrequency receiver (RF)138, which may be operatively coupled to an RF transmitter140. In some embodiments, the RF transmitter140may be operatively coupled to a controller144configured to control the RF transmitter140.