Apparatus and method for inserting implants into the body

An apparatus includes a first tubular member and a second tubular member coupled to the first tubular member. The first tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis. The lumen of the first tubular member is configured to receive at least a portion of an elongate implant. A distal end portion of the first tubular member is tapered along the longitudinal axis. The second tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis of the second tubular member. The second tubular member is coupled to the first tubular member such that the longitudinal axis of the first tubular member is substantially parallel to the longitudinal axis of the second tubular member. A distal end portion of the second tubular member is tapered along the longitudinal axis of the second tubular member.

BACKGROUND

The invention relates generally to medical devices and procedures, and more particularly to apparatus and methods for inserting elongate implants into the body.

Elongate implants, such as, for example, electrical stimulation leads and/or electrical sensing leads, are used in various medical procedures. For example, some known elongate implants can be implanted within a patient's body to stimulate a response from a bodily organ or tissue, such as, for example, the heart, a muscle group or the like. Some known elongate implants can be implanted within a patient's body to sense a response from a bodily organ or tissue. Accordingly, known elongate implants can be inserted into the patient's body in a known location and/or orientation (e.g., such that a portion of the elongate implant is in electrical contact with a nerve).

Known methods for inserting elongate implants within a patient's body can include first locating a desired target tissue using an electric stimulating probe and then inserting the elongate implant using a cannula. Such methods, however, often fail to detect movement of the cannula that can result in inaccuracies in the location and/or orientation of the elongate member.

Thus, a need exists for improved apparatus and methods for inserting elongate implants within a patient's body.

SUMMARY

Apparatus and methods for placing elongate implants within the body are described herein. In some embodiments, an apparatus includes a first tubular member and a second tubular member coupled to the first tubular member. The first tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis. The lumen of the first tubular member is configured to receive at least a portion of an elongate implant. A distal end portion of the first tubular member is tapered along the longitudinal axis. The second tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis of the second tubular member. The second tubular member is coupled to the first tubular member such that the longitudinal axis of the first tubular member is substantially parallel to the longitudinal axis of the second tubular member. A distal end portion of the second tubular member is tapered along the longitudinal axis of the second tubular member.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a first tubular member and a second tubular member coupled to the first tubular member. The first tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis. The lumen of the first tubular member is configured to receive at least a portion of an elongate implant. A distal end portion of the first tubular member is tapered along the longitudinal axis. The second tubular member defines a longitudinal axis and a lumen substantially coaxial with the longitudinal axis of the second tubular member. The second tubular member is coupled to the first tubular member such that the longitudinal axis of the first tubular member is substantially parallel to the longitudinal axis of the second tubular member. In some embodiments, the lumen of the second tubular member is configured to receive an electronic probe. A distal end portion of the second tubular member is tapered along the longitudinal axis of the second tubular member.

In some embodiments, an apparatus includes an implant delivery device configured to deliver an elongate implant into a body. The implant delivery device has a first portion and a second portion. The first portion defines a lumen configured to receive the elongate implant. A distal end portion of the first portion is configured to dilate a bodily tissue and defines an opening in fluid communication with the lumen. In some embodiments, for example, the distal end portion of the first portion is tapered along a longitudinal axis of the first portion. The second portion defines a lumen configured to receive a targeting probe, such as for example, an electronic probe. A distal end portion of the second portion defines an opening in fluid communication with the lumen of the second portion.

In some embodiments, an apparatus includes an implant delivery device configured to selectively position an elongate implant into a body. The implant delivery device defines a longitudinal axis and has a first portion and a second portion. The first portion defines a lumen configured to receive the elongate implant. A distal end surface of the first portion defines an opening in fluid communication with the lumen. A distal-most point of the distal end surface of the first portion is disposed at a first position along the longitudinal axis. The second portion defines a lumen configured to receive a targeting probe. A distal end surface of the second portion defines an opening in fluid communication with the lumen of the second portion. A distal-most point of the distal end surface of the second portion is disposed at a second position along the longitudinal axis, the second position spaced apart proximally from the first position. In some embodiments, the distal end surface of the first portion is configured to dilate a bodily tissue.

In some embodiments, an apparatus includes an elongate member configured to insert an electrical stimulation lead into a body, a sheath, and an actuator. The elongate member has a proximal end portion and a distal end portion. The elongate member defines a first lumen and a second lumen. The distal end portion of the elongate member is configured to dilate a bodily tissue and defines a first opening in fluid communication with the first lumen and a second opening in fluid communication with the second lumen. The sheath is slidably disposed about the elongate member. The actuator is coupled to the proximal end portion of the elongate member and is configured to move the elongate member relative to the sheath.

In some embodiments, a kit includes an implant delivery device configured to deliver an electrical stimulation lead into a body, the electrical stimulation lead, and a targeting probe. The implant delivery device includes an elongate member, a sheath, and an actuator. The elongate member has a proximal end portion and a distal end portion. The elongate member defines a first lumen and a second lumen. The distal end portion of the elongate member is configured to dilate a bodily tissue and defines a first opening in fluid communication with the first lumen and a second opening in fluid communication with the second lumen. The sheath is slidably disposed about the elongate member. The actuator is coupled to the proximal end portion of the elongate member and is configured to move the elongate member within the sheath. The electrical stimulation lead is configured to be disposed within the first lumen. The targeting probe is configured to be slidably disposed within the second lumen.

In some embodiments, a method includes inserting a targeting probe into a body, the targeting probe having a distal end portion and a central portion. An implant delivery device is inserted into the body. The implant delivery device includes an elongate member, an electrical stimulation lead, and a retention member. The elongate member defines a first lumen and a second lumen. The electrical stimulation lead is disposed within the first lumen. The retention member is configured to limit movement of the electrical stimulation lead within the first lumen. The implant delivery device is inserted after the targeting probe is inserted such that at least the central portion of the targeting probe is disposed within the second lumen and the distal end portion of the targeting probe is disposed outside of the second lumen. The elongate member of the implant delivery device is moved relative to the retention member such that a distal end portion of the electrical stimulation lead is disposed outside of the first lumen.

As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would use a medical device or a therapeutic device during a procedure. For example, the end of a medical device first to contact and/or be inserted into the patient's body would be the distal end, while the opposite end of the medical device (e.g., the end of the medical device being operated by the operator or the end of the medical device last to be inserted into the patient's body) would be the proximal end of the medical device.

The term “parallel” is used herein to describe a relationship between two objects (e.g., a first tubular member, a second tubular member, a lumen or the like) and/or the geometric constructions defined by two objects (e.g., a longitudinal axis) in which the two objects and/or the two geometric constructions are substantially non-intersecting if they extend substantially to infinity. For example, as used herein in the context of geometrical constructions, when a planar surface (i.e., a two-dimensional surface) is said to be parallel to a line (e.g., a longitudinal axis), every point along the line is spaced apart from the nearest portion of the planar surface by a substantially equal distance. Similarly, as used herein in the context of two objects, a first object (e.g., a first tubular member) is said to be parallel to a second object (e.g., a second tubular member) when a longitudinal axis of the first object and a longitudinal axis of the second object do not intersect if they were extended to infinity. Two objects and/or geometric constructions are described herein as being “parallel” or “substantially parallel” to each other when they are nominally parallel to each other, such as for example, when they are parallel to each other within a tolerance. Such tolerances can include, for example, manufacturing tolerances, measurement tolerances or the like.

The term “normal” is used herein to describe a relationship between two objects (e.g., a first tubular member, a second tubular member, a lumen or the like) and/or the geometric constructions defined by two objects (e.g., a longitudinal axis, a planar surface or the like) in which the two objects and/or the two geometric constructions intersect at an angle of approximately 90 degrees within at least one plane. For example, as used herein in the context of two objects, a first object is said to be normal to a second object when a longitudinal axis of the first object and a longitudinal axis of the second object intersect at an angle of approximately 90 degrees within a plane.

The terms “member” and “device” as used herein can refer to either a single item or multiple items that cooperatively perform a function. For example, as used herein, a “tubular member” can include a single component or can be constructed from multiple components coupled together. More particularly, when a tubular member includes a single component, the single component can be, but is not necessarily, monolithically constructed from a single material. When a tubular member is constructed from multiple components, in some embodiments, the various components can move relative to each other. Conversely, in other embodiments, the various components from which the tubular member is constructed can be in a fixed position relative to each other whether or not monolithically formed.

FIGS. 1 and 2are schematic illustrations of a medical device100according to an embodiment of the invention in a first configuration and a second configuration, respectively. The medical device100includes an implant delivery device102, a probe180and an elongate implant185. The implant delivery device102has a first tubular member110and a second tubular member130coupled to the first tubular member110by a coupling member146. The coupling member146can be any suitable coupling member such as, for example, a mechanical fastener, an adhesive fastener, a magnetic coupler or the like. Although the second tubular member130is shown as being coupled to the first tubular member110such that the second tubular member130is spaced apart from the first tubular member110, in other embodiments, at least a portion of the second tubular member130can be coupled to and in contact with at least a portion of the first tubular member110.

The first tubular member110defines a longitudinal axis AL1and has a proximal end portion (not shown inFIGS. 1 and 2) and a distal end portion112. The first tubular member110includes a side wall114having an outer surface117and an inner surface116. The inner surface116defines a lumen118that is substantially coaxial with the longitudinal axis AL1. The lumen118is configured to receive an elongate implant185, which can be, for example, an electrode, an electronic lead, a sensor or the like.

At least a portion of the distal end portion112of the first tubular member110is tapered along the longitudinal axis AL1. Said another way, the height H1of the first tubular member110at a distal-most point (or locus of points)122is less than the height H′1of the first tubular member110at a point spaced proximally from the distal-most point (or locus of points)122. Similarly stated, in embodiments in which the first tubular member110is cylindrically shaped, a diameter of the outer surface117of the first tubular member110decreases along the longitudinal axis AL1in a distal direction. In this manner, as described in more detail herein, when the medical device100is inserted into a patient's body B (seeFIG. 2), the distal end portion112of the first tubular member110can dilate a bodily tissue T.

The distal end portion112of the first tubular member110defines an opening124in fluid communication with the lumen118. In this manner, when the medical device100is disposed within a patient's body B, a portion of the elongate implant185can be conveyed from the lumen118into the patient's body B through the opening124. Said another way, when the medical device100is disposed within a patient's body B, the elongate implant185can be moved within the lumen118of the first tubular member110, through the opening124, and into the patient's body B.

The second tubular member130defines a longitudinal axis AL2and has a proximal end portion (not shown inFIGS. 1 and 2) and a distal end portion132. The second tubular member130is coupled to the first tubular member110such that the longitudinal axis AL2of the second tubular member130is substantially parallel to the longitudinal axis AL1of the first tubular member110. The second tubular member130includes a side wall134having an outer surface137and an inner surface136. The inner surface136of the second tubular member130defines a lumen138that is substantially coaxial with the longitudinal axis AL2. The lumen138is configured to receive a probe180, which can be, for example, an electronic targeting probe, a radio-opaque targeting probe, a guide wire or the like.

At least a portion of the distal end portion132of the second tubular member130is tapered along the longitudinal axis AL2. Said another way, the height H2of the second tubular member130at a distal-most point (or locus of points)142is less than the height H′2of the second tubular member130at a point spaced proximally from the distal-most point (or locus of points)142. Similarly stated, in embodiments in which the second tubular member130is cylindrically shaped, a diameter of the outer surface137of the second tubular member130decreases along the longitudinal axis AL2in a distal direction. In this manner, as described in more detail herein, when the medical device100is inserted into a patient's body B (seeFIG. 2), the distal end portion132of the second tubular member130can dilate a bodily tissue T.

The distal end portion132of the second tubular member130defines an opening144in fluid communication with the lumen138. In this manner, a distal end portion182of the probe180can extend from the lumen138into the patient's body B through the opening144to a depth DPwithout the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130being disposed within the body B. In some embodiments, the second tubular member130can be moved relative to the probe180such that the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130can be disposed into the patient's body B while the probe180remains in the patient's body at depth DP. Said another way, in some embodiments, the probe180can be moved within the lumen138such that the implant insertion device102can be moved about the probe180and into the body B. In other embodiments, distal end portion182of the probe180can be retracted from the patient's body B through the opening144.

As shown inFIG. 1, when the medical device100is in the first configuration, the probe180is disposed within the lumen138such that the distal end portion182of the probe180is disposed outside of the opening144. Said another way, when the medical device100is in the first configuration, the distal end portion182of the probe180is spaced distally apart from the distal-most point (or locus of points)142of the second tubular member130. In this manner, the distal end portion182of the probe180can be inserted first into the patient's body B. In some embodiments, for example, the probe180can be inserted percutaneously through an incision in the skin. More particularly, when the medical device is in the first configuration, the probe180can be inserted into the patient's body B to a depth DPwithout the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130being disposed within the body B. In this manner, the probe180can be used to target the placement of the implant delivery device102within the patient's body B. Said another way, the probe180can be used to ensure that the implant delivery device102is positioned at a predetermined location (e.g., proximate a particular anatomical structure, at a desired depth or the like) within the patient's body B.

When the medical device100is in the first configuration, the elongate implant185is disposed within the lumen118of the first tubular member110such that the elongate implant185does not extend outside of the opening124. In this manner, the side wall114of the first tubular member110can prevent the elongate implant185from contacting portions of the patient's body B during insertion. Said another way, when the medical device100is in the first configuration, the side wall114of the first tubular member110can prevent the elongate implant185from being damaged during insertion.

When the distal end portion182of the probe180is positioned within the patient's body B as desired, the implant delivery device102can be moved relative to the probe180, as shown by the arrow AA inFIG. 2, such that the distal end portion112of the first tubular member110and the distal end portion132of the second tubular member130are disposed within the patient's body B. Said another way, the lumen138of the second tubular member130is moved distally about the probe180until the distal end portion182of the probe180is spaced apart distally from the distal-most point (or locus of points)142of the second tubular member130by a predetermined distance D. In this manner, the insertion of the medical device100is guided by the probe180. In some embodiments, for example, the implant delivery device102can be inserted into the patient's body B percutaneously through an incision in the skin.

When the medical device100is inserted into the patient's body B, as described above, the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130can dilate the bodily tissue T, as shown by the arrows BB inFIG. 2. After the medical device100is inserted to the desired depth within the body B, at least a portion of the elongate implant185can be conveyed from the lumen118of the first tubular member110into the patient's body B through the opening124, as shown by the arrow CC. In some embodiments, the elongate implant185can be positioned within the body B at a depth D1that is substantially the same as the depth DPof the probe180. In other embodiments, the elongate implant185can be positioned within the body B at a depth D1that is different from the depth DPof the probe180by a predetermined distance. In this manner, after the desired insertion depth and/or location is determined by the probe180, the medical device100can deliver the elongate implant185into the body B at the desired insertion depth and/or location. After the elongate implant185is conveyed from the lumen118of the first tubular member110, the medical device100can be removed from the patient's body B. Although only the distal end portion of the elongate implant185is shown as being conveyed from the lumen118, in other embodiments, the entire elongate implant185can be conveyed from the lumen118.

Although the height of the distal end portion112of the first tubular member10is shown as changing along the longitudinal axis AL1(e.g., H1to H′1), in some embodiments, a depth (i.e., a dimension normal to the height and normal to the longitudinal axis AL1) of the distal end portion112of the first tubular member110can decrease along the longitudinal axis AL1in a distal direction. In other embodiments, both the height and the depth of the distal end portion112of the first tubular member110can decrease along the longitudinal axis AL1in a distal direction. Said another way, in some embodiments, the distal end portion112of the first tubular member110can be tapered along the longitudinal axis AL1in two dimensions. Similarly, although the height of the distal end portion132of the second tubular member130is shown as changing along the longitudinal axis AL2(e.g., H2to H′2), in some embodiments, a depth (i.e., a dimension normal to the height and normal to the longitudinal axis AL2) of the distal end portion132of the second tubular member130can decrease along the longitudinal axis AL2in a distal direction. In other embodiments, both the height and the depth of the distal end portion132of the second tubular member130can decrease along the longitudinal axis AL2in a distal direction. Said another way, in some embodiments, the distal end portion132of the second tubular member130can be tapered along the longitudinal axis AL2in two dimensions.

Although the distal end portion112of the first tubular member110and the distal end portion132of the second tubular member130are shown as being tapered symmetrically along the longitudinal axes AL1and AL2, respectively, in other embodiments, the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130can be tapered asymmetrically along the longitudinal axes AL1and AL2, respectively. Said another way, in some embodiments, the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130can be beveled.

Similarly, although the distal end portion112of the first tubular member110and the distal end portion132of the second tubular member130are shown as being tapered along the longitudinal axes AL1and AL2, respectively, in other embodiments, the distal end portion112of the first tubular member110and/or the distal end portion132of the second tubular member130need not be tapered. For example,FIGS. 3 and 4are schematic illustrations of a medical device200according to an embodiment of the invention in a first configuration and a second configuration, respectively. The medical device200includes an implant delivery device202, a retention member260, a probe280and an elongate implant285.

The implant delivery device202has a first portion210and a second portion230and defines a longitudinal axis AL1. The first portion210of the implant delivery device202has a proximal end portion (not shown inFIGS. 3 and 4) and a distal end portion212. The first portion210of the implant delivery device202defines a lumen218having a longitudinal axis AL1that is substantially parallel with the longitudinal axis ALof the implant delivery device202. The lumen218of the first portion210is configured to receive an elongate implant285, which can be, for example, an electrode, an electronic lead, a sensor or the like. The distal end portion212of the first portion210defines an opening224in fluid communication with the lumen218. In this manner, when the medical device200is disposed within a patient's body B, at least a portion of the elongate implant285(e.g., the distal end portion) can be conveyed from the lumen218into the patient's body B through the opening224.

The retention member260has a proximal end portion (not shown inFIGS. 3 and 4) and a distal end portion262. The retention member260is movably disposed within the lumen218of the first portion210such that its distal end portion262is adjacent to the elongate implant285. In some embodiments, the retention member260can contact and/or engage a portion of the elongate implant285. In this manner, the retention member260can limit the movement of the elongate implant285within the lumen218of the first portion210. For example, in some embodiments, the retention member260can limit the movement of the elongate implant285within the lumen218in a proximal direction. In other embodiments, the retention member260can move within the lumen218of the first portion210thereby causing the elongate implant285to move within the lumen218and/or out of the lumen218through the opening224.

The second portion230of the implant delivery device202has a proximal end portion (not shown inFIGS. 3 and 4) and a distal end portion232. The second portion230of the implant delivery device202defines a lumen238having a longitudinal axis AL2that is substantially parallel with the longitudinal axis ALof the implant delivery device202and the longitudinal axis AL1of the lumen218. The lumen238is configured to receive a probe280, which can be, for example, an electronic targeting probe, a radio-opaque targeting probe, a guide wire or the like. The distal end portion232of the second portion230defines an opening244in fluid communication with the lumen238. In this manner, at least a distal end portion282of the probe280can extend from the lumen238into the patient's body B through the opening244.

The first portion210of the implant delivery device202has a longitudinal length L1. The second portion230of the implant delivery device202has a longitudinal length L2that is less than the longitudinal length L1of the first portion210. In this manner, when the proximal end (not shown) of the first portion210and the proximal end (not shown) of the second portion230are longitudinally aligned (i.e., disposed at the same longitudinal position), the distal end portion232of the second portion230is spaced apart proximally from the distal end portion212of the first portion210. Said another way, the first portion210is disposed relative to the second portion230such that the distal end portion212of the first portion230extends distally from the distal end portion232of the second portion230by a distance ΔL.

As shown inFIG. 3, when the medical device200is in the first configuration, the probe280is disposed within the lumen238of the second portion230such that the distal end portion282of the probe280is disposed outside of the opening244. In this manner, the distal end portion282of the probe280can be inserted into the patient's body B to a depth DPwithout the distal end portion212of the first portion210of the implant delivery device202and/or the distal end portion232of the second portion230of the implant delivery device202being disposed within the body B. Said another way, the probe280can be used to target the placement of the implant delivery device202within the patient's body. Said yet another way, the probe280can be used to ensure that the implant delivery device202is positioned at a predetermined location (e.g., proximate a particular anatomical structure, at a desired depth or the like) within the patient's body B. In some embodiments, the distal end portion282of the probe280can be inserted into the patient's body B to a depth DPsuch that the distal end portion212of the first portion210and/or the distal end portion232of the second portion230is being disposed within the body B.

When the distal end portion282of the probe280is positioned within the patient's body B as desired, the implant delivery device202can be moved distally relative to the probe280, as shown by the arrow DD inFIG. 4, thereby placing the medical device in its second configuration. Said another way, the lumen238of the second portion230is moved distally about the probe280until the distal end portion282of the probe280is longitudinally aligned with the distal end portion212of the first portion210. Said yet another way, the lumen238of the second portion230is moved distally about the probe280until the distal end portion282of the probe280extends from the distal end portion232of the second portion230by the distance ΔL. In other embodiments, however, the lumen238of the second portion230is moved distally about the probe280until the distal end portion282of the probe280extends from the distal end portion232of the second portion230by a different distance than the distance ΔL. Accordingly, when the medical device200is in the second configuration, at least the distal end portion212of the first portion210is disposed within the patient's body B at a desired depth and/or location.

After the distal end portion212of the first portion210is disposed within the patient's body B at the desired depth and/or location, the implant delivery device202can be moved relative to the retention member260and the elongate implant285, as shown by the arrow EE inFIG. 5, thereby placing the medical device200in its third configuration. Said another way, the first portion210is moved proximally about the retention member260such that the distal end portion262of the retention member260contacts and/or engages the elongate implant285. In this manner, the retention member260limits the movement of the elongate implant285within the lumen218of the first portion210and/or limits the movement of the elongate implant285relative to the body B. Accordingly, continued proximal movement of the first portion210causes at least a portion of the elongate implant285to be conveyed from the lumen218and into the body B through the opening224, as shown by the arrow FF.

Moreover, because the retention member260limits the movement of the elongate implant285relative to the body B, the elongate implant285is implanted in the patient's body B at a depth D1that is substantially the same as the depth DP. In this manner, the depth and/or location of the elongate implant285can be guided by the probe280. In other embodiments, however, the retention member260can move within the lumen218(e.g., relative to the implant delivery device202to move the elongate implant285either distally or proximally relative to the patient's body B. In such embodiments, the elongate implant285is implanted in the patient's body B at a depth D1different than the depth DP.

Although the probe280is shown as moving with the implant delivery device202when the implant delivery device is moved to its third configuration (e.g.,FIG. 5), in other embodiments, the probe280can remain disposed in the patient's body B at the depth DP. Said another way, when the medical device200is moved from its second configuration to its third configuration, the probe280can move relative to the second portion230of the implant delivery device202within the lumen238. In yet other embodiments, the probe280can be entirely removed from the implant delivery device202after the medical device is in its second configuration.

FIGS. 6 and 7show a side view and a partial cross-sectional side view, respectively, of a medical device300according to an embodiment of the invention. The medical device300includes an implant delivery device302, a retention member360(seeFIG. 7), a sheath350, an actuator370, a probe380and an elongate implant385(seeFIG. 7). The elongate implant385and the probe380are each movably disposed within the implant delivery device302. The retention member360is movably disposed within the implant delivery device302and is configured to selectively retain the elongate implant385within the implant delivery device302. At least a portion of the implant delivery device302is movably disposed within the sheath350. The proximal end portion351of the sheath350and/or the proximal end portion (not shown inFIGS. 6 and 7) of the implant delivery device302are coupled to the actuator370. A detailed description of these components is provided below with respect toFIGS. 8-17.

As shown inFIGS. 8-11, the implant delivery device302has a first tubular member310defining a longitudinal axis AL1and a second tubular member330defining a longitudinal axis AL2. The first tubular member310is coupled to the second tubular member330such that the longitudinal axis AL1is substantially parallel to the longitudinal axis AL2. Similarly stated, first tubular member310is coupled to the second tubular member330longitudinally along an interface portion346. The interface portion346defines a coupling line L (seeFIG. 11) that is substantially parallel to the longitudinal axis AL1and the longitudinal axis AL2. Similarly stated, an outer surface317of the first tubular member310and an outer surface337of the second tubular member330are coupled together such that they collectively define the coupling line L. Although the first tubular member310and the second tubular member330are described as being two separate components coupled together, in other embodiments, the first tubular member310and the second tubular member330can be monolithically formed.

The first tubular member310has a proximal end portion (not shown inFIGS. 8-11) and a distal end portion312. The first tubular member310includes a side wall314having the outer surface317and an inner surface316. The inner surface316defines a lumen318that is substantially coaxial with the longitudinal axis AL1. The lumen318is configured to receive an elongate implant385, which can be, for example, an electrode, an electronic lead, a sensor or the like. As shown inFIG. 9, the lumen318of the first tubular member310has a diameter φ1. In other embodiments, the lumen318and/or the side wall314can have a non-circular cross-sectional shape, such as, for example, an elliptical shape.

The distal end portion312of the first tubular member310includes a distal end surface320that is tapered asymmetrically along the longitudinal axis AL1. Said another way, the distal end portion312of the first tubular member310is beveled such that the distal end surface320is oblique. Accordingly, the distal end surface320of the first tubular member310includes an edge321having a distal-most point (or tip)322. Additionally, because the distal end portion312is beveled, the distal end surface320has a non-circular shape (e.g., an elliptical shape as shown inFIG. 10). Moreover, the beveled arrangement of the distal end portion312is such that the edge321has a substantially continuous shape and is devoid of a sharp point. Said another way, the edge321and the distal-most point322collectively form a blunt tip. In this manner, as described in more detail herein, when the medical device300is inserted into a patient's body, the distal end portion312of the first tubular member310can dilate, displace and/or stretch a bodily tissue without piercing or cutting the tissue.

As shown inFIG. 11, the distal end surface320and the coupling line L as it extends distally from the distal end surface320of the first tubular member310collectively define an angle Θ1that is greater than ninety degrees. Said another way, the coupling line L includes the distal-most point322of the distal end surface320. Said yet another way, the distal end portion312of the first tubular member310is tapered and/or beveled away from the coupling line L. In this manner, as described in more detail herein, the distal end portion312of the first tubular member310can dilate, displace and/or stretch the bodily tissue in a predetermined direction and/or orientation.

The distal end surface320of the first tubular member310defines an opening324in fluid communication with the lumen318. In this manner, the elongate implant385can be conveyed from the lumen318into the patient's body B through the opening324. Said another way, when the medical device300is disposed within a patient's body, the elongate implant385can be moved within the lumen318of the first tubular member310, through the opening324, and into the patient's body.

The second tubular member330has a proximal end portion (not shown inFIGS. 8-11) and a distal end portion332. The second tubular member330includes a side wall334having the outer surface337and an inner surface336. The inner surface336of the second tubular member330defines a lumen338that is substantially coaxial with the longitudinal axis AL2. The lumen338is configured to receive a probe380, which can be, for example, an electronic targeting probe, a radio-opaque targeting probe, a guide wire or the like. As shown inFIG. 9, the lumen338of the second tubular member330has a diameter φ2. In other embodiments, the lumen338and/or the side wall334can have a non-circular cross-sectional shape, such as, for example, an elliptical shape. Although the diameter φ2is shown as being smaller than the diameter φ1, in other embodiments, the diameter φ2can be equal to or greater than the diameter φ1.

The distal end portion332of the second tubular member330includes a distal end surface340that is tapered asymmetrically along the longitudinal axis AL2. Said another way, the distal end portion332of the second tubular member330is beveled such that the distal end surface340is oblique. Accordingly, the distal end surface340of the second tubular member330includes an edge341having a distal-most point (or tip)342. Additionally, because the distal end portion332is beveled, the distal end surface340has a non-circular shape (e.g., an elliptical shape as shown inFIG. 10). Moreover, the beveled arrangement of the distal end portion332of the second tubular member330is such that the edge341has a substantially continuous shape and is devoid of a sharp point. Said another way, the edge341and the distal-most point342collectively form a blunt tip. In this manner, as described in more detail herein, when the medical device300is inserted into a patient's body, the distal end portion342of the second tubular member330can dilate, displace and/or stretch a bodily tissue without piercing or cutting the tissue.

As shown inFIG. 11, the distal end surface340of the second tubular member330and the coupling line L as it extends distally from the distal end surface340of the second tubular member330collectively define an angle Θ2that is greater than ninety degrees. Said another way, the coupling line L includes the distal-most point342of the second tubular member330. Said yet another way, the distal end portion332of the second tubular member330is tapered and/or beveled away from the coupling line L. In this manner, as described in more detail herein, the distal end portion332of the second tubular member330can dilate, displace and/or stretch the bodily tissue in a predetermined direction and/or orientation. In some embodiments, the angle Θ2of the second tubular member330is the same as the angle Θ1of the first tubular member310. In other embodiments, the angle Θ2of the second tubular member330is the different from the angle Θ1of the first tubular member310.

The distal end surface340of the second tubular member330defines an opening344in fluid communication with the lumen338. In this manner, at least a distal end portion382of the probe380can extend from the lumen338into the patient's body through the opening344.

The first tubular member310of the implant delivery device302has a longitudinal length L1. The second tubular member330of the implant delivery device302has a longitudinal length L2that is less than the longitudinal length L1of the first tubular member310. In this manner, when the proximal end (not shown) of the first tubular member310and the proximal end (not shown) of the second tubular member330are longitudinally aligned (i.e., disposed at the same longitudinal position), the distal end tubular member332of the second tubular member330is spaced apart proximally from the distal end tubular member312of the first tubular member310. Said another way, the first tubular member310is disposed relative to the second tubular member330such that the distal-most point322of the first tubular member330extends distally from the distal-most point342of the second tubular member330by a distance ΔL.

As shown inFIGS. 12 and 13, the retainer360has a distal end portion362having a distal end surface361. The retainer360includes a side wall364having an outer surface367and an inner surface366. The inner surface366defines a lumen368that is configured to receive a portion of the elongate implant385. More particularly, when the elongate implant385is disposed within the lumen368of the retainer360, the distal end surface361of the retainer360can contact and/or engage a shoulder391of an anchor portion389of the elongate implant385. In this manner, the retainer360can limit the movement of the elongate implant385within the lumen318of the first tubular member310. For example, in some embodiments, the retainer can limit the movement of the elongate implant385within the lumen318in a proximal direction. In other embodiments, the retainer360can move distally within the lumen318of the first tubular member310such that the distal end surface361of the retainer360moves the anchor portion389of the elongate implant385distally, thereby causing the elongate implant385to move within the lumen318and/or out of the lumen318through the opening324.

As shown inFIG. 13, the side wall364of the retainer360defines a longitudinal opening369. Said another way, the side wall364of the retainer360has a “C-shaped” cross-section. This arrangement allows the elongate implant385to be disposed within the lumen368of the retainer360from the side, rather than solely from an end portion of the retainer360. After the elongate implant385is disposed within the retainer360, the elongate implant385and the retainer360can collectively be disposed within the lumen318of the first tubular member310of the implant delivery device302(see e.g.,FIG. 7). In other embodiments, the side wall364of the retainer360can be devoid of a longitudinal opening such that the retainer360has a circular cross-sectional shape.

As shown inFIGS. 14 and 15, the sheath360has a proximal end portion351(seeFIG. 6) and distal end portion352. The sheath350includes a side wall354having an outer surface357and an inner surface356. The inner surface356defines a first lumen358and a second lumen359. The first lumen358is configured to be movably disposed about the first tubular member310of the implant delivery device302. Said another way, the diameter (not shown inFIGS. 14 and 15) of the first lumen358of the sheath350is greater than the outer diameter (not shown inFIGS. 8-11) of the first tubular member310such that the first tubular member310can be moved within the first lumen358. Similarly, the second lumen359is configured to be movably disposed about the second tubular member330of the implant delivery device302. Said another way, the diameter (not shown inFIGS. 14 and 15) of the second lumen359of the sheath350is greater than the outer diameter (not shown inFIGS. 8-11) of the second tubular member330such that the second tubular member330can be moved within the second lumen359. In this manner, the implant delivery device302can be movably disposed within the sheath350. Although the first lumen358and the second lumen359are each shown as having a substantially circular cross-sectional shape, in other embodiments, the first lumen358and/or the second lumen359can have any suitable shape such that the implant delivery device302can be movably disposed within the sheath350as described above.

As shown inFIG. 6, the actuator370includes a handle371and a lever372. The handle371is configured such that a user can manipulate the medical device300with one hand. The actuator370is coupled to the proximal end portion351of the sheath350and/or the proximal end portion (not shown inFIGS. 6 and 7) of the implant delivery device302such that movement of the lever372relative to the handle371causes the implant delivery device302to move relative to the sheath350. More particularly, In this manner, as described herein, the elongate implant385can be conveyed from the lumen318of the first tubular member310into the patient's body. In some embodiments, the actuator370can include a ratchet mechanism, a detent, or the like to selectively move the implant delivery device302relative to the sheath350.

As shown inFIG. 16, the elongate implant385has a distal end portion387that includes an electrode array388and an anchoring portion389. The electrode array388includes at least one electrode configured to electrically stimulate a target tissue, such as, for example, nervous tissue. In some embodiments, for example, the electrode array388can be configured to stimulate peripheral nerves, spinal roots and/or other structures near the central nervous system. In other embodiments, the electrode array388can stimulate a bodily organ or tissue, such as for example a muscle, a nerve, a heart or the like. In yet other embodiments, the electrode array388can include at least one electrode configured to receive an electronic signal produced by the body. For example, in some embodiments, the electrode array388can be configured to receive electronic signals to record activity of the nervous system.

The anchoring portion389includes a shoulder391and at least one flexible tine390. As described in more detail herein, the flexible tines390are configured to move and/or deform when the elongate implant385is conveyed from the lumen318of the first tubular member310into the patient's body such that the flexible tines390can retain the elongate implant385within the patient's body. Said another way, the flexible tines390are configured to move and/or deform to engage a bodily tissue when the elongate implant385is inserted into the patient's body to maintain a location of the electrode array388within the patient's body. As described above, the shoulder391of the anchoring portion389is configured to contact and/or engage the distal end surface361of the retainer360such that the retainer360can limit movement of the elongate implant385within the lumen318of the first tubular member310.

As shown inFIG. 17, the probe380has a distal end portion382that includes an electrode384. Similar to the electrode array388of the elongate implant385, the electrode384of the probe380is configured to electrically stimulate a target tissue, such as, for example, nervous tissue. In some embodiments, for example, the electrode384can be configured to stimulate peripheral nerves, spinal roots and/or other structures near the central nervous system. In other embodiments, the electrode384can stimulate a bodily organ. In yet other embodiments, the electrode384can be configured to receive an electronic signal produced by the body. In this manner, as described in more detail herein, the probe380can be used to stimulate a target tissue and/or receive a signal from a target tissue to target the placement of the implant delivery device302within the patient's body. Said another way, the probe380can be used to ensure that the implant delivery device302is positioned at a predetermined location (e.g., proximate a particular anatomical structure, at a desired depth or the like) within the patient's body.

The operation of the medical device300is discussed below with reference toFIGS. 18-22, which are cross-sectional views of the distal end portion of the medical device300in various configurations. As shown inFIG. 18, when the medical device300is in the first configuration, the probe380is disposed apart from the implant delivery device302. Accordingly, the distal end portion382of the probe380can be inserted into the patient's body B to a desired depth DPand/or location without requiring the manipulation of the implant delivery device302. In some embodiments, the probe380can be inserted percutaneously through an incision I in the skin. In this manner, the user can iteratively test the suitability of various locations within the patient's body B before inserting the implant delivery device302. For example, in some embodiments, the user can stimulate a bodily tissue via the electrode384of the probe380to locate the desired target N, which can be, for example, a nerve, a muscle or the like. Said another way, the probe380can be used to target the placement of the implant delivery device302within the patient's body B. Said yet another way, the probe380can be used to ensure that the implant delivery device302is positioned at a predetermined location (e.g., proximate a particular anatomical structure, at a desired depth or the like) within the patient's body B.

When the distal end portion382of the probe380is positioned within the patient's body B as desired, the implant delivery device302can be placed about the probe380such that a portion of the probe380is disposed within the lumen338of the second tubular member330. The implant delivery device302can then be moved distally relative to the probe380, as shown by the arrow GG inFIG. 19, thereby placing the medical device300in its second configuration. Said another way, the lumen338of the second tubular member330is moved distally about the probe380until the distal end portion382of the probe380is longitudinally aligned with the distal end portion312of the first tubular member310and/or the distal end portion387of the elongate implant385. In this manner, the elongate implant385can be inserted into the patient's body B at a depth D1that is substantially the same as the depth DP. Accordingly, when the medical device300is in the second configuration, at least the distal end portion312of the first tubular member310is disposed within the patient's body B such that the electrode array388of the elongate implant385is at a desired depth and/or location within the patient's body B.

In some embodiments, when the implant delivery device302is placed about the probe380, the proximal end portion of the probe380can extend proximally from the actuator370. Moreover, the proximal end portion of the probe380and/or the actuator370can include an indexing mechanism (not shown inFIGS. 18-22) to gage the depth of insertion of the distal end portion312of the first tubular member310relative to the probe380when the implant delivery device302is moved distally relative to the probe380. In other embodiments, the proximal end portion of the probe380and/or the actuator370can include a detent or locking mechanism to ensure that the elongate implant385is inserted into the patient's body B at a depth D1that is substantially the same as the depth DP.

When the implant delivery device302is inserted into the patient's body (i.e., when the medical device is moved from its first configuration to its second configuration), the distal end portion312of the first tubular member310dilates, displaces and/or stretches bodily tissue T as shown by the arrows HH inFIG. 19. As described above, the edge321of the first tubular member310is devoid of a sharp point such that the distal end portion312of the first tubular member310can dilate, displace and/or stretch the bodily tissue T without cutting and/or tearing the bodily tissue T. Moreover, the beveled arrangement of the distal end portion312of the first tubular member310is such that the bodily tissue T can be dilated, displaced and/or stretched in a predetermined direction and/or orientation. Said another way, the beveled arrangement of the distal end portion312of the first tubular member310is such that the bodily tissue T can be dilated, displaced and/or stretched in a direction away from the target N and/or the distal end portion382of the probe380. In this manner, when the implant delivery device302is removed the force exerted by the bodily tissue T as it returns to its initial form urges the elongated implant385towards the target N.

After the distal end portion312of the first tubular member310is disposed within the patient's body B at the desired depth and/or location, the probe380can be removed from the medical device300, thereby placing the medical device in a third configuration as shown inFIG. 20. More particularly, after the distal end portion312of the first tubular member310is disposed within the patient's body B at the desired depth and/or location, the probe380can be removed from the lumen318of the first tubular member310in a proximal direction. In other embodiments, the probe380can remain in the medical device300.

After the distal end portion312of the first tubular member310is disposed within the patient's body B at the desired depth and/or location, the medical device300can be placed in a fourth configuration by moving the implant delivery device302relative to the sheath350and the retainer360, as shown by the arrow II inFIG. 21. Said another way, the implant delivery device302is moved proximally within the sheath350until the distal end portion352of the sheath350is spaced proximally from the distal-most point322of the implant delivery device302by a distance D1. In this manner, the sheath350can be maintained in a constant position within the patient's body B, thereby resulting in accurate placement of the elongate implant within the body. Said yet another way, the implant delivery device302is moved proximally about the retainer360until the distal end surface361of the retainer360is spaced proximally from the distal-most point322of the implant delivery device302by a distance D2.

The medical device300can be moved from the third configuration (FIG. 20) to the fourth configuration (FIG. 21) by moving the lever372of the actuator370. In some embodiments, the actuator370can include a ratchet mechanism, a detent, or the like to selectively move the implant delivery device302relative to the sheath350and/or the retainer360. Said another way, in some embodiments, the actuator370can be configured to move the implant delivery device302relative to the sheath350and/or the retainer360in a controlled and/or incremental fashion. Moreover, in some embodiments, the actuator370can include a locking mechanism to releasably lock the actuator in a predetermined position.

As shown inFIG. 21, when the medical device300is moved from the third configuration to the fourth configuration, the distal end surface361of the retainer360contacts the shoulder391of the anchor portion389of the elongate implant385such that the elongate implant385moves distally within the lumen318. Accordingly, when the medical device300is in the fourth configuration, the electrode array388of the elongate implant385is disposed outside of the lumen318through the opening324and adjacent the target N of the patient's body B. As described above, when the implant delivery device302moves proximally within the patient's body B, as shown by the arrow II, the bodily tissue T returns to its initial form, as indicated by the arrows JJ. In this manner, the movement of the bodily tissue T exerts a force on the elongate implant385thereby urging the elongated implant385towards the target N.

When the medical device300is in the fourth configuration, the tines390of the anchor portion389of the elongate implant385remain within the lumen318of the first tubular member310. Accordingly, when the medical device is in the fourth configuration, the elongate implant385can be moved within the patient's body B by moving the entire medical device300to adjust the location and/or orientation of the electrode array388. In some embodiments, for example, the electrode array388can be electrically activated when the medical device300is in the fourth configuration to validate the location of the electrode array388within the patient's body B.

A shown inFIG. 22, when the location and/or orientation of the electrode array388has been validated, the medical device300can be placed in a fifth configuration to complete the insertion of the elongate implant385within the patient's body B. The medical device300is moved from the fourth configuration to the fifth configuration by moving the implant delivery device302relative to the sheath350and the retainer360, as shown by the arrow KK inFIG. 22. Said another way, the implant delivery device302is moved proximally within the sheath350until the distal end portion352of the sheath350is spaced proximally from the distal-most point322of the implant delivery device302by a distance D′1less than the distance D1. Said yet another way, the implant delivery device302is moved proximally about the retainer360until the distal end surface361of the retainer360is spaced distally from the distal-most point322of the implant delivery device302(i.e., the distal end surface361of the retainer360is disposed outside of the lumen318). When the medical device300is in the fifth configuration, the tines390of the anchor portion389of the elongate implant385are disposed outside of the lumen318of the first tubular member310. In this manner, the elongate implant385can be anchored into the patient's body B in its desired location and/or orientation (e.g., adjacent the target N). After the elongate implant385is anchored, the implant delivery device302can be removed from the patient's body B via the handle371of the actuator370.

As described above, the medical device300can be moved from the fourth configuration (FIG. 21) to the fifth configuration (FIG. 22) by moving the lever372of the actuator370. In some embodiments, for example, the actuator370can include a motion-limiter to limit the movement of the implant delivery device302within the sheath350. Similarly, in some embodiments, the actuator370can include a locking mechanism to prevent the implant delivery device302from “springing back” relative to the sheath350.

Although the medical device300is shown and described above as including one probe380and one elongate implant385, in other embodiments, the medical device300can include multiple probes and/or elongate implants. For example, in some embodiments a kit can include an implant delivery device of the types shown and described above. The kit can also include multiple elongate implants of the types shown and described above. In some embodiments, for example, the kit can include multiple elongate implants, each having different characteristics (e.g., size, type of electrode array, polarity, etc.). Similarly, in some embodiments, a kit can include multiple probes of the types shown and described above. In some embodiments, for example, the kit can include multiple probes, each having different characteristics (e.g., length, diameter, type of stimulating electrode, non-electronic, etc.).

The medical devices shown and described herein can be constructed from any suitable material or combination of materials. For example, in some embodiments, an implant delivery device, such as implant delivery device302, can be a constructed from a rigid material, such as Nylon, a composite material, a metal alloy or the like. In other embodiments, an implant delivery device, such as implant delivery device302, can be a constructed from a flexible material. In this manner, the implant delivery device can follow a curved passageway within a patient's body.

FIG. 23is a flow chart of a method400of inserting an elongate implant into a patient's body according to an embodiment of the invention. The method includes inserting a targeting probe into a body,402. The targeting probe, which can be any targeting probe of the types shown and described above, has a distal end portion and a central portion. For example, in some embodiments, the targeting probe can be a targeting probe380shown and described above with reference toFIGS. 6-22. In some embodiments, a signal can be sent from an electrical stimulator to the targeting probe,404In this manner, the targeting probe can be used to locate a desired target, such as a nerve or a muscle, within the body.

An implant delivery device is inserted into the body,406. In some embodiments, the implant delivery device can be inserted percutaneously. The implant delivery device can be any implant delivery device of the types shown and described above, and includes an elongate member, an electrical stimulation lead, and a retention member. The elongate member defines a first lumen and a second lumen. The electrical stimulation lead is disposed within the first lumen. The retention member is configured to limit movement of the electrical stimulation lead within the first lumen. The implant delivery device is inserted after the targeting probe is inserted such that at least the central portion of the targeting probe is disposed within the second lumen and the distal end portion of the targeting probe is disposed outside of the second lumen.

In some embodiments, the implant delivery device is inserted such that a distal end portion of the elongate member dilates, displaces and/or stretches a bodily tissue. For example, in some embodiments, the implant delivery device can include a tapered elongate member configured to dilate the bodily tissue.

In some embodiments, for example, the implant delivery device is inserted such that the distal end portion of the targeting probe is aligned with a distal end portion of the electrical stimulation lead. Similarly, in some embodiments, the implant delivery device is inserted such that an electrode of the electrical stimulation lead is aligned with an electrode of the targeting probe. In some embodiments, the targeting probe can be removed from the body after the implant delivery device is inserted,408.

The elongate member of the implant delivery device is moved relative to the retention member such that a distal end portion of the electrical stimulation lead is disposed outside of the first lumen,410. In some embodiments, for example, the elongate member is moved by a first distance such that an anchor portion of the electrical stimulation lead remains disposed within the first lumen. In some embodiments, a target tissue (e.g., a nerve, a muscle or the like) can be stimulated after the elongate member is moved relative to the retention member,412. In this manner, the location and/or orientation of the electrical stimulation lead within the body can be validated.

In some embodiments, the implant delivery device can optionally be moved within the body in response to the stimulation of the target tissue,414. In this manner, the location and/or orientation of the electrical stimulation lead can be adjusted in response to the stimulation of the target tissue. Once the location and/or orientation of the electrical stimulation lead has been validated, the method can optionally include moving the elongate member of the implant delivery device relative to the retention member by a second distance greater than the first distance,416.

While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments. While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.

For example, although the distal end portions of the medical devices shown and described above are tapered linearly along a longitudinal axis, in other embodiments, the distal end portion of a medical device can be tapered in a non-linear manner. For example, in some embodiments a medical device can include a first tubular member that is tapered along its longitudinal axis in a curved manner (e.g., a parabolic curve).

Although the medical devices shown and described above are shown as including at least one tubular member defining a lumen having a longitudinal axis that is coaxial with the longitudinal axis of the tubular member, in other embodiments, a medical device can include a tubular member defining a lumen having a longitudinal axis that is non-coaxial with the longitudinal axis of the tubular member. In yet other embodiments, a medical device can include a tubular member defining a lumen having a longitudinal axis that is non-parallel with the longitudinal axis of the tubular member.

Although the medical device300is shown and described above as including a first tubular member310fixedly coupled to a second tubular member330, in other embodiments, a medical device can include a first tubular member that is movably coupled to a second tubular member. In this manner, a distance between the distal end surface of the first tubular member and a distal end surface of the second tubular member can be adjustable. In yet other embodiments, a medical device can include a first tubular member that is removably coupled to a second tubular member.

Although the medical devices are shown and described herein as having a distal end portion having an edge devoid of sharp points, in other embodiments, a medical device can have a distal end portion having one or more sharp points configured to cut a bodily tissue.

Although the medical device300is shown and described above as include a lever-actuated actuator370, in other embodiments a medical device can include an automatically actuated actuator. In some embodiments, for example, an actuator can be an electronic actuator that is automatically actuated. Similarly, in some embodiments, a medical device can include an actuator that is biased in a certain position.

Although the medical devices are shown and described above as including an implant delivery device and/or an elongated implant configured to implanted into a patient's body, in some embodiments, a medical device can include a simulated implant delivery device and/or a simulated elongated implant. In such embodiments, for example, the simulated implant delivery device and/or the simulated elongated implant can be configured for use on a simulated target (e.g., a cadaver, a simulated body or the like). In some embodiments, for example, a simulated implant delivery device can correspond to an actual implant delivery device of the types shown and described above and can be used, for example, to train a user in the insertion of elongate implants into a body. Similarly, In some embodiments, for example, a simulated elongate implant can be devoid of an operational electrode array and can be used, for example, to train a user in the insertion of elongate implants into a body.