Patent Description:
Various devices and other implantables are designed to be implanted subcutaneously or subdermally within a patient's body. Such positioning is considered under the skin, or in the layer of skin directly below the dermis and epidermis. To implant such a device, an incision can be made down to the subcutaneous layer (subcutis) of the skin. A dermal elevator, a widely used medical instrument, separates the subcutis and the fascia, creating the pocket in which the implant will be inserted. After the implant is placed, the incision is stitched shut. Surgical tape is often applied to minimize movement while the skin fuses around the implant.

However, such open procedures are less favorable in comparison to minimally invasive techniques. Minimally invasive techniques allow smaller incisions, shorter procedure time, quicker recovery time, less pain and less scarring. The present invention provides surgical tools for delivery of various subcutaneous implantables in a minimally invasive manner. In particular, the present invention provides tools for precise delivery of small implantables.

Other implantable devices, such as leads, are designed to be implanted in various locations throughout the body, such as beyond the subcutaneous layer. These devices are typically held in place by suturing of the device to the surrounding tissue. However, surgeons have varying suturing techniques, and there can be wide variation in anchoring success. Poor anchoring techniques may cause damage to the lead or early displacement from incorrect suture tension. The present invention provides anchoring devices to assist in desired anchoring of implantable devices, such as leads.

<CIT> describes devices, systems and methods provided for anchoring implantable medical devices to maintain an implanted position.

<CIT> describes an implantable therapy delivery system that has a therapy delivery element that is inserted or implanted into a human body and anchored or fixed to tissue to deliver a therapy to a patient.

<CIT> describes an implantable anchor for permanently anchoring a medical lead or catheter.

<CIT> describes a lead anchor including a body having an outer surface, a top end, a front side, a first end, and a second end opposite to the first end.

<CIT> describes an implantable anchor for anchoring a medical lead within a patient. The implantable anchor includes a body having at least one lumen for receiving a medical lead, a cam integrated with the body and rotatable to extend into the lumen for engaging, compressing and twisting the medical lead to inhibit the movement of the lead with respect to the anchor.

<CIT> describes an implantable anchor for anchoring a medical lead within a patient. The implantable anchor includes a body having a cavity for receiving a medical lead, and a separate, removable key for insertion into the cavity. The key, upon insertion into the cavity, engages and locks the medical lead into place and prevents the movement of the medical lead with respect to the anchor.

<CIT> describes a suture sleeve for facilitating the ligature of an implanted lead to a patient's vein or underlying tissue. The suture sleeve comprises a main sleeve body having a first longitudinal throughbore for receiving the lead. The suture sleeve is provided with a manually-actuated pushbutton-type locking mechanism.

<CIT> describes a suture sleeve for securing the leads of a multiple lead implantable medical device including lead gripping and anchoring portions.

The invention concerns an anchor as defined in claim <NUM>. No surgical methods form part of the invention.

According to one aspect of the present disclosure, a tunneling tool for forming a tissue channel and/or pocket beneath a portion of skin along a body comprises a distal end having a tunneling member and a guide. The tunneling member is configured for forming the tissue channel and/or pocket beneath the portion of skin while the guide remains above the skin and indicates the location of at least a portion of the tunneling member.

In some embodiments, the guide is positioned above the tunneling member such that the guide remains above the skin while the tunneling member enters subcutaneous tissue.

In some embodiments, the guide is aligned with the tunneling member such that a user can determine the location of the tunneling member based on the location of the guide.

In some embodiments, the guide comprises a first shape, the tunneling member comprises a second shape, and the first shape is similar to the second shape. The first shape can be the same as the second shape.

In some embodiments, the guide comprises a first width, the tunneling member comprises a second width, and the first width is similar to the second width. The first width can be the same as the second width.

In some embodiments, the guide comprises a first width, the tunneling member comprises a second width, and the first width is dissimilar to the second width. The first width can be less than the second width.

In some embodiments, the guide comprises a first length, the tunneling member comprises a second length, and the first length is similar to the second length. The first length can be the same as the second length.

In some embodiments, the guide comprises a first length, the tunneling member comprises a second length, and the first length is dissimilar to the second length. The first length can be shorter than the second length. The tunneling member can be configured to pass through the skin into the subcutaneous tissue without interference from the guide.

In some embodiments, the guide is positioned parallel to the tunneling member, and the position of the guide indicates a position of the tunneling member.

In some embodiments, the guide includes one or more markings. The tunneling member can comprise a distal tip, and the one or more markings can indicate a distance between the markings and the distal tip of the tunneling member. The one or more markings can be spaced at regular increments. The one or more markings can comprise two or more markings that are spaced approximately <NUM>, <NUM>, <NUM> and/or <NUM> apart. The one or more markings can be spaced at irregular increments.

In some embodiments, the tunneling tool comprises a shaft. The shaft can comprise a curved shape such that the proximal end is positioned higher than the distal end. The curved shape of the shaft can provide clearance between a hand of a user grasping the tunneling tool and a surface of the skin, such as when the tunneling member is inserted into the skin.

In some embodiments, a distance between the tunneling member and the guide is fixed.

In some embodiments, a distance between the tunneling member and the guide is adjustable.

In some embodiments, the tunneling member comprises a distal end including a mount, and the mount is configured to rotate about the distal end. The mount can rotate about the distal end between a stored position and a receiving position. The stored position can comprise the mount disposed within the tunneling member. The receiving position can comprise the mount extending from the tunneling member.

In some embodiments, the tunneling member comprises a distal tip. The distal tip can comprise a round shape and/or a pointed shape. The pointed distal tip can comprise a blade.

In some embodiments, the tunneling tool comprises a proximal portion including a handle.

In some embodiments, the guide comprises an open window.

In some embodiments, the tunneling tool comprises a storage receptacle for receiving and storing the guide.

In some embodiments, the tunneling member comprises an enlarged distal end.

According to another aspect of the present disclosure, an anchor for securing an elongate device to body tissue, the anchor comprises: an anchor body configured to receive the elongate device; a mechanism configured to removably attach the anchor body to the elongate device so as to resist movement of the elongate device in relation to the anchor body; and at least one tissue engagement element configured to assist in attaching the anchor body to the body tissue.

In some embodiments, the mechanism comprises a first portion and a second portion of the anchor body. The first portion can comprise a base with a lumen, and the lumen can be configured to receive the elongate device therethrough. The first portion can comprise a base, and the second portion can comprise a locking member constructed and arranged to mate with the base. The locking member can comprise a protrusion and a grip. The locking member protrusion can comprise one or more teeth. The base can be configured to receive the protrusion, such that a pressure applied to the grip forces the protrusion into the base, and the protrusion locks the elongate device in place. The mechanism can be constructed and arranged to prevent overclamping of the elongate device.

In some embodiments, the at least one tissue engagement element comprises one or more elements of the anchor body that are configured to prevent movement of the anchor body relative to the body tissue, such as to avoid suturing.

In some embodiments, the mechanism comprises a portion of the anchor body that includes a material configured to increase a retention force on the elongate device. The anchor body material can comprise a material having a higher coefficient of friction. The anchor body material can comprise a soft durometer silicone. The anchor body material can comprise a material with a textured surface.

In some embodiments, the mechanism comprises one or more engagement elements of the anchor body configured to engage the elongate device. The one or more engagement elements can comprise barbs. The one or more engagement elements can be constructed and arranged as unidirectional gripping elements. The one or more engagement elements can be constructed and arranged as bidirectional gripping elements.

In some embodiments, the anchor body comprises a first portion and a second portion, such that the first portion and second portion are constructed and arranged to mate with the other. The mechanism can comprise the first portion and the second portion, and the first portion and the second portion can be configured to lock onto the elongate device. The mechanism can comprise the first portion and the second portion, and the first portion can comprise a first lever arm and a first jaw and the second portion can comprise a second lever arm and a second jaw. The first lever arm and the first jaw can be integrated into a single component. The first lever arm and the first jaw can be separate components. The first portion and the second portion can mate with the other, such that the first and second lever arms can be configured to align and the first and second jaws are configured to align. The aligned lever arms and the aligned jaws can comprise a lumen configured to receive the elongate device.

In some embodiments, the mechanism comprises two or more sets of lever arms corresponding to two or more sets of jaws.

In some embodiments, the anchor body comprises a first portion and a second portion, and the first portion and second portion are constructed and arranged to mate with the other to form a lumen therebetween, and the mechanism comprises the lumen. The mechanism can comprise a locking member configured to surround at least a portion of the anchor body, such that the locking member can hold the first portion and the second portion in the mated position. The mechanism can further comprise a sleeve, the lumen can be constructed and arranged to receive the sleeve, and the sleeve can be constructed and arranged to receive the elongate device. The sleeve can comprise a surface configured to increase a retention force on the elongate device.

In some embodiments, the mechanism comprises a first portion and a second portion of the anchor body, and the first portion and the second portion are constructed and arranged to translate in relation to the other. The translation of the first portion and the second portion can secure the anchor onto the elongate device. The first portion can comprise a base with a lumen and the second portion can comprise a cover. The lumen can be configured to receive the elongate device. The cover can be constructed and arranged to extend over at least a portion of the base. The cover can comprise two or more holes, and the two or more holes can align with the lumen of the base to receive the elongate device.

In some embodiments, the mechanism comprises at least one surface portion of the anchor body configured to increase a retention force applied to the elongate device.

In some embodiments, the tissue engagement element comprises one or more elements of the anchor body configured to prevent a movement of the anchor relative to the body tissue. The tissue engagement elements can be configured to avoid suturing of the anchor to tissue. The anchor body can comprise a spring that controls the clamping force of the tissue engagement elements on tissue. The spring can comprise a compression spring.

In some embodiments, anchor body comprises a base with a first lumen therethrough and at least one off-set portion with a second lumen therethrough, and the mechanism comprises the base, the first lumen and the second lumen. The first lumen and the second lumen can be constructed and arranged to receive the elongate device. The first lumen and the second lumen can be configured to align via a movement of the off-set portion, such that the elongate device can be advanced through the first lumen and the second lumen. The first lumen and the second lumen can be configured to misalign via a movement of the off-set portion, such that the position of the elongate device is maintained.

In some embodiments, the mechanism comprises two cams which rotate to engage the elongate device.

In some embodiments, the mechanism comprises two rotatable arms and an O-ring, and the O-ring is positioned around the two rotatable arms to engage the arms to the elongate device.

In some embodiments, the mechanism comprises a tortuous path for receiving and engaging the elongate device. The tortuous path can comprise a pathway of a conduit, a pathway of a tortuous element, and/or a pathway of the anchor body.

In some embodiments, the mechanism comprises an inner body and outer body of the anchor body, the inner body comprises a first lumen and the outer body comprises a second lumen, the first lumen and the second lumen are each configured to receive the elongate device, and rotation of the inner body engages the elongate device. The anchor can further comprise a tool configured to engage and rotate the inner body.

In some embodiments, the anchor further comprises a nose cone configured to relieve strain applied to the elongate device by flexion between the elongate device and the anchor.

In some embodiments, the anchor further comprises at least one suture retention ring.

In some embodiments, the anchor comprises a surface configured to increase retention force with the elongate device.

The novel features of the invention are set forth herein. An understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:.

Specific embodiments of the disclosed device, system, and method will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

<FIG> is a perspective illustration of an embodiment of a tunneling tool <NUM>, wherein the tunneling tool <NUM> is configured for tunneling into subcutaneous tissue structures within the body of a patient to form a tissue channel or pocket. The tunneling tool <NUM> has a distal end <NUM> and a proximal end <NUM>. In this embodiment, the proximal end <NUM> includes a handle <NUM> for gripping by a user, such as a physician or surgeon. Typically, the handle <NUM> is ergonomic and provides enhanced gross motor control of the tool <NUM>. In this embodiment, the distal end <NUM> includes a tunneling member <NUM> which is configured to pass through the surface of the skin and into the subcutaneous tissue structures therein. The length of insertion can be indicated by a guide <NUM> which is disposed above the tunneling member <NUM> and is configured to remain outside and above the skin while the tunneling member enters the subcutaneous tissue. The guide <NUM> is aligned with the tunneling member <NUM> so that the user (e.g. an implanting clinician) is able to determine the location of the tunneling member <NUM> beneath the skin based on the location of the guide <NUM>. In some embodiments, the guide <NUM> has a shape which matches, or at least is similar to, the tunneling member <NUM>. In some embodiments, the guide <NUM> has a width and/or length which matches, or at least is similar to, the width and/or length, respectively, of tunneling member <NUM>. In some embodiments, the guide <NUM> has a shape, width, and/or length with is dissimilar to tunneling member <NUM>'s shape, width, and/or length, respectively. In some embodiments, the guide <NUM> is oriented substantially parallel to the tunneling member. In each of these instances, the position of the guide <NUM> above the skin can help the user visualize the position of the tunneling member <NUM> thereunder. It may be appreciated that in some embodiments, the guide <NUM> has a different length (e.g. a shorter length) than the tunneling member <NUM>, such as the shorter length illustrated in <FIG>. In other words, the distal tip of the guide <NUM> is recessed from the distal tip of the tunneling member <NUM>. This shorter length allows the tunneling member <NUM> to pass through the skin and into the subcutaneous tissue without interference by the guide <NUM>.

It may be appreciated that, in some embodiments, the guide <NUM> includes one or more length indication markings <NUM>. The length marking(s) <NUM> may indicate any suitable increment of measure. In some embodiments, two or more length indication markings <NUM> are present, each spaced <NUM> -<NUM> apart. <FIG> illustrates four length indication markings <NUM>, each spaced <NUM> apart. However, it may be appreciated that one, two, three, four, five, six, seven, eight, nine, ten or more indication length markings may be present. Likewise, such markings <NUM> can be spaced apart by approximately <NUM>, <NUM>. <NUM>, or <NUM>, to name a few. Further, such markings <NUM> may be regularly or irregularly spaced. The guide <NUM> is aligned with the tunneling member <NUM> so that each marking <NUM> correlates to (e.g. indicates to a user) a distance between the marking <NUM> and the distal tip of the tunneling member <NUM>. Thus, as the tunneling member <NUM> tunnels through the subcutaneous tissue of the patient, creating a tissue channel, the user is continually aware of the length of the channel by correlating the edge of the skin at the entry point with the markings <NUM>. Consequently, the user is able to determine the precise length of the channel.

Creation of the tissue channel typically involves pushing the tool <NUM> forward so that the tunneling member <NUM> bluntly dissects the subcutaneous tissue. The handle <NUM> enables effective force transfer during the blunt dissection. Likewise, in some embodiments, the tool <NUM> further includes one or more grip indents <NUM>. These indents <NUM> provide additional surfaces to transfer force and also reduce any possibility of grip slippage. The indents <NUM> also provide for alternate grip positions to optimize user comfort and fine motor control.

<FIG> provides a side view illustration of the tunneling tool <NUM> of <FIG>. As shown, the tool <NUM> includes a shaft <NUM> between the proximal end <NUM> and distal end <NUM>. In this embodiment, the shaft <NUM> is curved so that proximal end <NUM> is raised above the distal end <NUM>. This curvature allows clearance between the hand of the user gripping the handle <NUM> and the surface of the skin when the tool <NUM> is in use. Typically, the underside of the guide <NUM> rests against or is aligned with the surface of the skin, as indicated by dashed line. In this embodiment, the shaft <NUM> extends up toward the handle <NUM> at an angle θ with the surface of the skin. In some embodiments, the angle θ ranges from <NUM> to <NUM> degrees, more preferably from <NUM> to <NUM> degrees. Or, the shaft <NUM> extends up toward the handle <NUM> so that the handle starts at a distance h from the surface of the skin. In some embodiments, the distance h is approximately <NUM> inches (<NUM>). In other embodiments, the distance h ranges from <NUM> to <NUM> inches (<NUM> to <NUM>), or from <NUM> to <NUM> inches (<NUM> to <NUM>).

In some embodiments, the tool <NUM> has a guide <NUM> and tunneling member <NUM> that are a fixed distance apart. In other embodiments, the distance between the guide <NUM> and tunneling member <NUM> is adjustable. In either case, the distance between the guide <NUM> and tunneling member <NUM> are typically <NUM> to <NUM> apart, optionally <NUM> to <NUM> apart. <FIG> illustrates a tool <NUM> having a guide <NUM>' which is removable and repositionable along the shaft <NUM>. The shaft <NUM> includes one or more receptacles <NUM> for receiving the removable guide <NUM>'. The receptacles <NUM> are disposed along the shaft <NUM> at various distances from the tunneling member <NUM>. This positioning allows the user to adjust the depth beneath the skin surface at which the tunneling member <NUM> creates the tissue channel. Each removable guide <NUM>' is held within the receptacle <NUM> with a fixation mechanism <NUM>. <FIG> illustrate an example removable guide <NUM>' having a fixation mechanism <NUM> comprising a double-sided ball detent. <FIG> is a side view of the guide <NUM>' and <FIG> is a top view of the guide <NUM>'. In this embodiment, each receptacle <NUM> includes a corresponding indent to receive the ball detent. This mating locks the guide <NUM>' in place. It may be appreciated that in other embodiments, the distance between the guide <NUM> and tunneling member <NUM> can be adjusted by other mechanisms. For example, the guide <NUM> may slide up and down the shaft <NUM> by manipulation of a lever or knob on the tool <NUM>.

<FIG> illustrates the tunneling tool <NUM> of <FIG> in use. As shown, a user U grips the handle <NUM> to manipulate the tool <NUM>. Here, the user U positions a thumb against an indent <NUM> for leverage. It may be appreciated that any suitable grip may be used, including positioning an index finger or other finger against one or more indents <NUM>. The distal end <NUM> of the tool <NUM> is positioned so that the tunneling member <NUM> is advanced through a small incision in the skin S. The tool <NUM> is then advanced by manipulating the handle <NUM> so that the tunneling member <NUM> bluntly dissects the subcutaneous tissue creating a tissue channel while the guide <NUM> remains above the skin S, as shown. Typically, the tunneling member <NUM> is advanced until it reaches an implantation area <NUM>. The implantation area <NUM> is the area within which a device or other implantable is desired to be positioned beneath the skin. Thus, the tunneling member <NUM> has created a tunnel from the incision point to the implantation area <NUM>.

The implantable can then be advanced to the implantation area <NUM>. <FIG> schematically illustrates an embodiment of an example implantable <NUM> which may be advanced through the tissue channel. It may be appreciated that a variety of implantables <NUM> may be used, including but not limited to stimulators, antennas, infusion ports and pumps, pills, catheters, biological monitors (e.g., glucose, cardiac, blood pressure, etc.). Typically, the implantable <NUM> has external dimensions that are similar to some aspects of the tunneling member <NUM> so that the implantable <NUM> may be passed through the tissue channel created by the tunneling member <NUM>. Preferably, the dimensions of the tunneling member <NUM> are chosen so as to create a very snug pocket around the implantable <NUM> when implanted. For example, in some instances the tunneling member <NUM> is undersized in comparison to the implantable <NUM> so as to allow the tissue channel to stretch slightly around the implantable <NUM>. In some instances, the implantable <NUM> is pushed by the distal tip of the tunneling member <NUM>, advancing the implantable <NUM> through the tissue channel to the implantation area <NUM>, as indicated by <FIG>.

In other embodiments, the implantable <NUM> is attachable to the tunneling tool <NUM>, as illustrated in <FIG>. In this embodiment, the distal end <NUM> of the tunneling tool <NUM> includes a mount <NUM> for mounting an implantable <NUM> thereon during delivery. In particular, the mount <NUM> includes a mounting end <NUM> which is configured to mate with the implantable <NUM>. <FIG> illustrates an embodiment of a distal end <NUM> of a tunneling tool <NUM> (with the guide removed for clarity), wherein a mount <NUM> is disposed within the tunneling member <NUM> and arranged in a stored position. In the stored position, the mounting end <NUM> is stored within the tunneling member <NUM> and an opposing end <NUM> faces outward, creating a blunt, atraumatic tip with the tunneling member <NUM>. The tool <NUM> is used in this arrangement to create the tissue channel. The tool <NUM> is then removed from the patient, and the mount <NUM> is manipulated to a receiving position wherein it is available to receive the implantable <NUM>. In this embodiment, as illustrated in <FIG>, the mount <NUM> is rotatable so that the mounting end <NUM> is rotated from within the tunneling member <NUM> to a position wherein the end <NUM> extends outward, beyond the distal tip of the tunneling member <NUM>, when in the receiving position. In this embodiment, the mounting end <NUM> includes a recess <NUM> which mates with a contour of the implantable <NUM>. This allows the tool <NUM> to be removably attached to the implantable <NUM> during delivery. Thus, once the tissue channel has been created, the tool <NUM> with the mounted implantable <NUM> is inserted into the tissue channel and advanced until the implantable <NUM> is desirably positioned within the implantation area <NUM>. The tool <NUM> is then withdrawn (e.g. after releasing tool <NUM> from implantable <NUM>), leaving the implantable <NUM> behind.

It may be appreciated that the tunneling member <NUM> may have a variety of distal tips. When blunt dissecting is desired, a round, blunt tip design may be used, as illustrated in <FIG>. Alternatively, when cutting, a tunneling member <NUM> having a cutting tip <NUM> may be used, an embodiment of which is illustrated in <FIG>. In this embodiment, the distal most tip of the tunneling member <NUM> includes a cutting tip <NUM> or blade configured to cut tissue while creating the tissue channel. The cutting tip <NUM> may be integral with the tunneling member <NUM> or removable and replaceable. In other embodiments, the distal tip of the tunneling member <NUM> has a tapered design, as illustrated in <FIG>. Such a tapered design may be used when passing through tissue that is too delicate for cutting yet too dense for blunt dissection.

It may be appreciated that the guide <NUM> may also have a variety of forms. <FIG> illustrates a guide <NUM> having an open window. Such an open window allows the user to see the surface of the skin while visualizing the perimeter of the tunneling member <NUM> under the skin. This may be useful when avoiding particular areas of the skin or when utilizing features of the skin to steer or anticipate changes in resistance when creating the tissue channel.

The open window guide <NUM> also lends itself to easy storage, as illustrated in an embodiment depicted in <FIG>. In this embodiment, the tunneling tool <NUM> includes a storage receptacle <NUM> for receiving and storing the guide <NUM> when not in use. In particular, the receptacle <NUM> comprises a groove <NUM> or indent in the handle <NUM> which receives portions of the open window guide <NUM>. <FIG> illustrates the guide <NUM> rotated upwards, away from the tunneling member <NUM>, and mated with the receptacle <NUM>. Such mating provides a smooth, ergonomic contour to the handle <NUM> which does not interfere with the grip of the user. The guide <NUM> may then be removed from the receptacle <NUM> and rotated downward so that it is desirably aligned with the tunneling member <NUM>.

It may be appreciated that in addition to using the tunneling tool <NUM> to create a tissue channel, the tunneling tool <NUM> may also be used to create a subcutaneous pocket (e.g. into which a non-elongate device is to be implanted). Once the tunneling member <NUM> is positioned into the subcutaneous tissue, the tunneling member <NUM> may be manipulated to create a pocket therein which is larger than the tissue channel. For example, the tool <NUM> may be rotated around an axis perpendicular to the skin surface so as to swing the tunneling member <NUM> through a radius. Similarly, the tool <NUM> may be moved laterally to create a wider tunnel. Further, the tunneling member <NUM> may have various shaped tips to create different types of tunnels or pockets (e.g. tapered tips or bulbous tips).

<FIG> are perspective, top, and side views, respectively, of an embodiment of a tunneling tool wherein the tunneling tool is configured for tunneling into subcutaneous tissue structured within the body. The tunneling tool <NUM> has a distal end <NUM> with a tunneling member <NUM> and a guide <NUM>, and a proximal end <NUM>. Tunneling tool <NUM> can be of similar construction and arrangement to tool <NUM> described hereabove in reference to <FIG>. In the embodiment shown in <FIG>, tunneling member <NUM> and guide <NUM> each comprise an enlarged distal end, such as the outwardly tapered distal end shown, and/or a bulbous distal end. Guide <NUM> can comprise a length that is less than the length of tunneling member <NUM>, and guide <NUM> can comprise a width that is less than the width of tunneling member <NUM>.

The anchors of the present disclosure are configured to lock onto an elongate device, such as a catheter, lead or other device implantable within the body. The anchor is then used to attach the elongate device to the surrounding tissue, thereby anchoring the device, either by suturing of features on the anchor or by the anchor itself. Typically, such elongate devices have a soft durometer and are easily kinked or damaged by direct suturing. Therefore, these anchors provide the ability to hold the device with minimal to no impingement or damage to the device and provide a platform upon which to robustly secure the anchor to its surroundings. For ease of description, the elongate device is referred to herein as a lead, however the invention is not so limited.

<FIG> is a perspective illustration of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead. In this embodiment, the anchor <NUM> comprises two components which mate together to lock onto the lead. A first component comprises a base <NUM> having a lumen, passageway <NUM>, for positioning a lead therethrough or therein. A second component comprises a locking member <NUM> which mates with the base <NUM>. In this embodiment, the locking member <NUM> comprises a protrusion <NUM> and a grip <NUM>. Referring to <FIG>, the protrusion <NUM> is insertable into the base <NUM> and can be pressed, by applying force to the grip <NUM>, into the base <NUM> so that it reaches the passageway <NUM> and mechanically compresses the lead <NUM> positioned therein. Such compression and frictional forces lock the anchor <NUM> onto the lead <NUM>.

<FIG> provide top view illustrations of the anchor <NUM> of <FIG> in open and closed configurations. <FIG> illustrates the anchor <NUM> in an open configuration wherein the anchor <NUM> is not locked to the lead <NUM>. In this configuration, the locking member <NUM> is in a first position wherein the protrusion <NUM> is engaged with the base <NUM> to ensure integrity of the anchor <NUM> but the protrusion <NUM> is not contacting the lead <NUM>. In this embodiment, the protrusion <NUM> includes one or more teeth 514a which engage with a flange, hole or lip <NUM> within the base <NUM> so that the locking member <NUM> cannot be removed. In this open configuration, the anchor <NUM> can be moved along the lead <NUM>, either by sliding along the length of the lead <NUM> or by disengaging and re-engaging with the lead <NUM> at any position along the lead body. Once the anchor <NUM> is desirably positioned along the lead <NUM>, the anchor <NUM> can be moved to a closed configuration, wherein the anchor <NUM> is fixed to the lead <NUM>. <FIG> illustrates the anchor <NUM> in a closed configuration wherein the locking member <NUM> is pressed into the base <NUM> so that the protrusion <NUM> contacts the lead <NUM> by a side approach to the passageway <NUM>. In this embodiment, the protrusion <NUM> includes one or more teeth 514b which engage with the lips <NUM> within the base <NUM> to hold the locking member <NUM> in this closed configuration. Thus, the teeth 514a, 514b are spaced apart to allow the locking member <NUM> to transition from the open configuration to the closed configuration. Likewise, the lips <NUM> are positioned so as to hold the locking member <NUM> at a fixed clamping position, a position that applies a desired level of force to the lead <NUM> so that the lead <NUM> is held in place without impingement or damage. The distance between the front of the protrusion <NUM> and the teeth 514b may be modulated to create more or less clamping force on the lead. This distance is known within the overall dimensional proportions of the assembly and can be used to predictively restrict overclamping of the lead.

If desired, the anchor <NUM> can then be disengaged from the lead <NUM> by transitioning back to the open configuration. This transition is achieved by disengaging the teeth 514b from the lips <NUM>. In this embodiment, such disengagement is achieved by squeezing a first portion of the grip 510a and a second portion of the grip 510b together. Such squeezing draws each of the teeth 514b inward, away from the lips <NUM>, thereby allowing the teeth 514b to disengage and pass by the lips <NUM>, so that the anchor <NUM> is again in the open configuration. The specific geometry of the protrusion <NUM> and the relief cuts therein prevent a user from completely disengaging the locking member <NUM> from the base <NUM>, therefore maintaining the integrity of the assembly over multiple use cycles. The anchor <NUM> can be switched between the open configuration and the closed configuration as many times as desired for repositioning.

Once, the anchor <NUM> is desirably fixed to the lead <NUM>, as illustrated in <FIG>, the anchor <NUM> is then attached to the surrounding tissue. In this embodiment, the anchor <NUM> includes one or more suture retention detents <NUM> to receive suture. Thus, suture can be wrapped around the anchor <NUM> without slipping. It may be appreciated that in other embodiments, the anchor <NUM> includes one or more through-holes for receiving suture. And, in other embodiments, the anchor <NUM> has tissue grabbing jaws or other tissue engagement elements which take advantage of the relative movement between the base <NUM> and the locking member <NUM>, such as to eliminate the need for suturing.

It may be appreciated that the passageway <NUM> may alternatively be fully captured by the base <NUM>. In such instances, the anchor <NUM> is loaded onto the lead <NUM> from one end of the lead <NUM> and is moved along the lead length to the desired position.

It may be further appreciated that the locking member <NUM> may alternatively utilize other mechanisms for transitioning between the open configuration and the closed configuration and maintaining the closed configuration. For example, the locking member <NUM> may be spring loaded within the base <NUM> so as to bias the locking member <NUM> toward a particular configuration. Alternatively, the locking member <NUM> may include a rack and pinion mechanism to transition between the configurations and maintain the closed configuration.

It may also be appreciated that the surfaces of the anchor <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces may include portions of the passageway <NUM> and/or portions of the protrusion <NUM> which contact the lead <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a soft durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional and/or bidirectional gripping elements.

It may also be appreciated that in some embodiments, the anchor <NUM> is deployed via an injection tool. Such deployment may be desired to minimize the size of the incision used to manipulate an anchor. The anchor <NUM> may be delivered along the lead body such that the incision need only allow clearance for the anchor. In some embodiments, the injection tool also actuates the transition to the closed configuration upon deployment.

<FIG> is a perspective illustration of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead. In this embodiment, the anchor <NUM> is comprised of two components which mate together to lock onto the lead. A first component is comprised of a first lever arm 602a and a first jaw 604a that may be integrated into a single component (as depicted) or are the result of an assembly of individual parts. The second component is comprised of a second lever arm 602b and a second jaw 604b. The components mate together so that the first and second lever arms 602a, 602b are aligned and the first and second jaws 604a, 604b are aligned to form a lumen, passageway <NUM>, for receiving the lead. <FIG> provides an illustration showing an internal torsion spring <NUM> housed within the anchor <NUM>. The spring <NUM> biases the lever arms 602a, 602b away from each other and the jaws 604a, 604b toward each other. Thus, the spring <NUM> biases the anchor <NUM> toward a closed configuration. The selection of an appropriate torsion spring with particular material and geometric properties influences the degree of bias, i.e., the amount of force with which the jaws 604a and 604b are closed towards one another, such as when engaging lead <NUM>.

The anchor <NUM> is transitioned from the closed configuration to an open configuration by moving the lever arms 602a, 602b toward each other, as illustrated in <FIG> and indicated by arrows. Moving the lever arms 602a, 602b toward each other correspondingly moves the first and second jaws 604a, 604b away from each other. This enlarges the passageway <NUM>. In the open configuration, the anchor <NUM> can be positioned along a lead at any desired location. <FIG> illustrates the anchor <NUM> in the open configuration straddling the lead <NUM>, wherein the lead <NUM> is disposed within the passageway <NUM>. Since the passageway <NUM> is enlarged in the open configuration, the anchor <NUM> can be moved along the lead <NUM> as desired without friction. Once desirably positioned along the lead <NUM>, the anchor <NUM> can be transitioned to a closed configuration to fix the anchor <NUM> to the lead <NUM>, as illustrated in <FIG>. This is achieved by releasing the lever arms 602a, 602b so that torsion spring <NUM> moves the lever arms 602a, 602b apart and draws the jaws 604a, 604b together, clamping the jaws 604a, 604b onto the lead <NUM>. The lead <NUM> is held in place by mechanical compression and friction between the jaws 604a, 604b. The clamping force provided by the torsion spring <NUM> and/or the distance between the jaws 604a, 604b can be chosen so as to ensure that the lead <NUM> is held in place without impingement or damage. This construction reduces the potential for overclamping (e.g. overclamping which may damage lead <NUM>). In some embodiments, the clamping force may be limited by the purposeful interference of features within the geometry of the lever arms 602a, 602b. It may be appreciated that the surfaces of the anchor <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces include portions of the passageway <NUM> which contact the lead <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a soft durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional and/or bidirectional gripping elements.

The anchor <NUM> can be repositioned by pinching the opposing lever arms 602a, 602b to transition back to the open configuration, repositioning the anchor <NUM> along the lead <NUM>, and then releasing the lever arms 602a, 602b to fix the anchor <NUM> at the new location. Thus, the anchor <NUM> can be attached and reattached to the lead <NUM> without loading from an end of the lead <NUM>.

Once desirably positioned, the anchor <NUM> can be sutured to the surrounding tissue. In this embodiment, each lever arm 602a, 602b includes a suture eyelet <NUM> for passing suture therethrough and fixing the anchor <NUM> to the tissue. In other embodiments, the anchor <NUM> has tissue grabbing jaws which can eliminate the need for suturing.

In some embodiments, the anchor <NUM> has more than one set of lever arms 602a, 602b and corresponding jaws 604a, 604b, as illustrated in <FIG>. This multiple arm configuration allows some sets to be utilized for holding the lead <NUM> and other sets to be utilized for grasping the surrounding tissue to hold the anchor <NUM> in place. <FIG> provides a perspective view of an anchor <NUM> having three sets of lever arms 602a, 602b and corresponding jaws 604a, 604b. The sets are aligned in a series utilizing a common pin <NUM> around which three corresponding torsion springs <NUM> are disposed. <FIG> provides a top view of the anchor <NUM> of <FIG> illustrating the springs <NUM>. The springs <NUM> may have the same strength or differing strengths. In some embodiments, the springs <NUM> corresponding to jaws 604a, 604b configured for grasping surrounding tissue have a stronger spring force than the springs <NUM> corresponding to jaws 604a, 604b configured for grasping the lead <NUM>. <FIG> provides an end view illustration of an embodiment having longer tissue grasping jaws 604a', 604b' straddling jaws 604a, 604b primarily intended for grasping the lead. The jaws 604a, 604b intended to grasp the lead have a contact surface <NUM> configured for holding the lead within the passageway <NUM>. The lever arms 602a, 602b may be moved independently, or actuation of a single pair of lever arms 602a, 602b may actuate the entire series of lever arms 602a, 602b, thereby opening all of the jaws 604a, 604b in unison. It may be appreciated that any combination of independent arms and linked arms may occur in various embodiments.

<FIG> is a perspective illustration of another embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead. In this embodiment, the anchor <NUM> is comprised of a sleeve <NUM>, an anchor body <NUM> and a locking mechanism <NUM>. The anchor body <NUM> is comprised of a first body portion 704a and a second body portion 704b which mate together forming a body lumen <NUM> therebetween. The body lumen <NUM> is configured to receive the sleeve <NUM>. The locking mechanism <NUM> is positionable at least partially around the anchor body <NUM> so as to hold the first body portion 704a and a second body portion 704b in the mated position.

The sleeve <NUM> is typically comprised of a soft durometer material, such as a silicone material. In this embodiment, the sleeve <NUM>, illustrated in <FIG>, comprises an elongate shaft <NUM> having a lumen <NUM> therethrough. The shaft <NUM> is sized and configured to fit within the body lumen <NUM> of the anchor body <NUM>. The lumen <NUM> is sized and configured to receive the lead. In this embodiment, the shaft <NUM> has a tapered tip <NUM> to create a transition and strain relief for the lead as it exits the anchor <NUM> and to create a transition through tissue layers. In this embodiment, the sleeve <NUM> also includes a backstop <NUM>. The sleeve <NUM> is shaped so that the anchor body <NUM> is held between the tapered tip <NUM> and the backstop <NUM> and does not slip out from the anchor body <NUM>.

The anchor <NUM> is transitionable between an open configuration and a closed configuration by manipulation of the locking mechanism <NUM>. <FIG> provides a cross-sectional view of the anchor <NUM> and locking mechanism <NUM>. In this embodiment, the locking mechanism <NUM> comprises a snap closure mechanism including at least one arm <NUM> which extends around the anchor body <NUM>. The arm <NUM> includes a pair of teeth 724a, 724b which individually engage a lip <NUM> on the anchor body <NUM>. In the open configuration, one of the teeth 724a engages to the lip <NUM>, allowing movement between the first body portion 704a and the second body portion 704b. In this configuration, the lead is insertable into the lumen <NUM> of the sleeve <NUM> and can move freely therein. Thus, the anchor body <NUM> can be moved along the lead to any desired location. Once the anchor body <NUM> is desirably positioned, the anchor <NUM> can be transitioned to the closed configuration. This transition is achieved by moving the arm <NUM> so that the other of the teeth 724b engages the lip <NUM> on the anchor body <NUM>. This engagement tightens the mechanism <NUM> against the anchor body <NUM> and presses the first body portion 704a and the second body portion 704b together. Pressing of the body portions 704a, 704b together engages the lumen <NUM> with the lead, fixing the anchor <NUM> to the lead. The features of the locking mechanism <NUM>, such as the distance between the teeth 724a, 724b, can be chosen so as to ensure that the lead is held in place without significant impingement or damage, reducing the potential for overclamping. It may be appreciated that the locking mechanism <NUM> may take other forms, such as a strap. <FIG> illustrates a lead <NUM> so positioned within the anchor <NUM>.

Once desirably positioned, the anchor <NUM> can be sutured to the surrounding tissue. In some embodiments, the anchor body <NUM> includes integrated suture eyelets <NUM>, as illustrated in <FIG>. Suture can be passed through each eyelet <NUM> for fixing the anchor <NUM> to the tissue. In this embodiment, the anchor body <NUM> also has a narrow waist which allows for suture retention.

It may be appreciated that the surfaces of the sleeve <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces typically include portions of the lumen <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a softer durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional and/or bidirectional gripping elements. Overall, a soft durometer of the sleeve <NUM> distributes forces evenly along the lead <NUM>, reducing potential for damage. Likewise, a soft durometer sleeve allows for easy customization of an associated coefficient of friction.

<FIG> is a perspective illustration of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead. In this embodiment, the anchor <NUM> is comprised of two components which translate (e.g. slide) in relation to each other to lock the anchor <NUM> onto the lead. A first component comprises a base <NUM> having a lumen, passageway <NUM>, for positioning a lead therethrough or therein. A second component comprises a cover <NUM> which extends at least partially over the base <NUM>. In this embodiment, the cover <NUM> includes at least two through holes <NUM> which are alignable with the passageway <NUM>, as shown. <FIG> illustrates the anchor <NUM> of <FIG> with a transparent view. As shown, the anchor <NUM> includes a spring <NUM> which biases the base <NUM> and the cover <NUM> apart, particularly biasing the through holes <NUM> and the passageway <NUM> into misalignment, while fixing the base <NUM> to the cover <NUM> to maintain integrity of the anchor <NUM>. Pressing the base <NUM> into the cover <NUM>, against the bias of the spring <NUM>, aligns the through holes <NUM> of the cover <NUM> with the passageway <NUM> of the base <NUM>. The lead <NUM> can then be loaded through the holes <NUM> and the passageway <NUM>, as illustrated in <FIG>. Release of the anchor <NUM> allows the spring <NUM> to push the base <NUM> and cover <NUM> apart, wherein the lead <NUM> is held in place by the misalignment of the holes <NUM> and passageway <NUM>. The tortuous path of the lead <NUM> can be adjusted by at least the strength of the spring <NUM> (e.g. the retention force applied to lead <NUM> can be determined and/or adjusted by the strength of spring <NUM>).

It may be appreciated that one or more surface portions of the anchor <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces may include portions of the passageway <NUM> and/or portions of the through holes <NUM> which contact the lead <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a soft durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional and/or bidirectional gripping elements.

If desired, the anchor <NUM> can then be disengaged from the lead <NUM> by pressing the base <NUM> into the cover <NUM> again so as to re-align the through holes <NUM> of the cover <NUM> with the passageway <NUM> of the base <NUM> (e.g. eliminating or at least reducing the retention force applied to lead <NUM>). The anchor <NUM> can then be moved along the lead <NUM> to any desired location. The anchor <NUM> is then released to lock it in place along the lead <NUM>. The anchor <NUM> can be repositioned as many times as desired.

Once, the anchor <NUM> is desirably fixed to the lead <NUM>, the anchor <NUM> is then attached to the surrounding tissue. In some embodiments, the anchor <NUM> includes one or more suture retention holes or eyelets to receive suture. <FIG> illustrates an embodiment of an anchor <NUM> having suture retention eyelets <NUM> built into the cover <NUM>. The suture can be wrapped through the eyelets <NUM> to tie the anchor <NUM> to the tissue. <FIG> provides a side view of the anchor <NUM> of <FIG>.

In some embodiments, the anchor <NUM> has tissue engagement elements (e.g. tissue grabbing jaws) which engage anchor <NUM> with tissue, such as to eliminate the need for suturing. In such embodiments, the anchor <NUM> may include an additional compression spring which controls the clamping force of the tissue grabbing jaws separately from the jaws which hold the lead. <FIG> illustrates an embodiment of an anchor <NUM> having tissue grabbing jaws. In this embodiment, the anchor <NUM> is comprised of three components which slide in relation to each other to lock the anchor <NUM> onto the lead, and secure the anchor <NUM> to the surrounding tissue. Again, a first component comprises a base <NUM> having a lumen, passageway <NUM>, for positioning a lead therethrough or therein. A second component comprises a cover <NUM> which extends at least partially over the base <NUM>. In this embodiment, the cover <NUM> includes at least two through holes <NUM> which are alignable with the passageway <NUM> when cover <NUM> is positioned around base <NUM>. The cover <NUM> also includes at least one tissue engagement element, tissue grabbing jaw <NUM>, which extends from the bottom of the cover <NUM>. In this embodiment, the jaw <NUM> comprises a pointed protrusion or spike, each spike directed inwardly toward the center of the cover <NUM>. A third component comprises an insert <NUM> which is insertable into the cover <NUM> and mateable with the base <NUM>. The insert <NUM> is shaped so as to fit through an opening, passageway <NUM>, in the bottom of the cover <NUM>, as indicated in <FIG>. The insert <NUM> includes a passageway <NUM> which is alignable with the through holes <NUM> of the cover <NUM> and the passageway <NUM> of the base <NUM>. The insert <NUM> also includes at least one tissue grabbing jaw <NUM>. In this embodiment, the jaw <NUM> comprises a pointed protrusion or spike. The insert <NUM> is configured so that when it is inserted into the cover <NUM>, the tissue grabbing jaws <NUM>, <NUM> face each other and are able to grab tissue therebetween. <FIG> illustrates the anchor <NUM> of <FIG> assembled, with a cross-section and transparent view.

In this embodiment, the three components are held together in a biased configuration by various springs. The anchor <NUM> includes at least one spring <NUM> which biases the base <NUM> and the cover <NUM> apart. <FIG> illustrates two springs <NUM>, each located on a portion of the base <NUM>. It may be appreciated that these springs <NUM> are attached to the cover <NUM> but have been drawn separated for clarity. In addition, the anchor <NUM> includes at least one spring <NUM>' which biases the insert <NUM> and the cover <NUM> apart and the insert <NUM> toward the base <NUM>. Thus, <FIG> illustrates the spring <NUM>' located along a portion of the insert <NUM> so that the springs <NUM>, <NUM>' work in the same direction. The springs <NUM>, <NUM>' have the same or differing compression strength. Differing compression strengths allow the anchor <NUM> to have differing or independent strengths in locking onto the lead and grabbing onto the surrounding tissue. In some embodiments, spring <NUM>' has a stronger compression strength than spring <NUM>. This difference provides a stronger tissue gripping strength than lead fixating strength, which may allow for more protection of the lead body from impingement or damage by the anchor while providing more robust fixation of the anchor to the surrounding tissue.

In this embodiment, the anchor <NUM> is actuated by pressing the base <NUM> and insert <NUM> into the cover <NUM>, against the bias of the springs <NUM>, <NUM>'. This actuation aligns the through holes <NUM> of the cover <NUM> with the passageway <NUM> of the base <NUM> and the passageway <NUM> of the insert <NUM>. The lead <NUM> can then be loaded through the holes <NUM> and the passageways <NUM>, <NUM> as illustrated in <FIG>. Release of the anchor <NUM> allows the springs <NUM>, <NUM>' to push the base <NUM>, insert <NUM> and cover <NUM> apart, wherein the lead <NUM> is held in place by the misalignment of the holes <NUM> and passageways <NUM>, <NUM>. This frictional hold on the lead <NUM> can be adjusted by at least the strength of the spring <NUM>. It may be appreciated that the surfaces of the anchor <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces may include portions of the passageways <NUM>, <NUM> and/or portions of the through holes <NUM> which contact the lead <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a soft durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional or bidirectional.

<FIG> is a perspective illustration of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead. In this embodiment, the anchor <NUM> is comprised of an anchor body <NUM> having a base portion <NUM> and at least one off-set portion <NUM>. The base portion <NUM> has a lumen <NUM> extending therethrough and the off-set portion <NUM> has a lumen <NUM> extending therethrough, wherein the lumens <NUM>, <NUM> are alignable by movement of the off-set portion <NUM> so to receive the lead (e.g. the lead can be passed through both lumens <NUM>,<NUM> when they are aligned). Once the anchor <NUM> has been desirably positioned along the lead, the off-set portion <NUM> is moved to misalign the lumens <NUM>, <NUM>, holding the lead in place by friction of the tortuous path through the lumens <NUM>, <NUM>.

In this embodiment, the anchor body <NUM> can be comprised of a flexible material, such as an elastic, resiliently biased and/or shape-memory material. The anchor body <NUM> is a single component construction wherein the base portion <NUM> forms the foundation of the anchor body <NUM> and an off-set portion <NUM> extends upwards from the base portion <NUM> in an arch shape. Since the off-set portion <NUM> is flexible, the off-set portion <NUM> may be pressed down, toward the base portion <NUM> (as indicated by arrow), to align the lumens <NUM>, <NUM> and allow insertion of the lead <NUM> therethrough, as illustrated in <FIG>. In this configuration, the anchor body <NUM> can slide along the lead <NUM> until it is desirably positioned. Once it is desirably positioned, the off-set portion <NUM> is released. A resiliently biased material can be used to cause the off-set portion <NUM> to move upwards away from the base portion <NUM>, misaligning the lumens <NUM>, <NUM> and drawing a portion of the lead <NUM> upwards, as illustrated in <FIG>. This creates a tortuous path for the lead <NUM> which holds the lead <NUM> in place by mechanical interference. <FIG> provides a top view of the lead <NUM> and anchor <NUM> of <FIG>. It may be appreciated that the controlled tortuous lead path can be varied to define different retention forces. And, the anchor body <NUM> may include more than one off-set portion <NUM>. Likewise, the tortuous lead path firmly holds the lead in place while reducing potential for lead damage.

It may be appreciated that the surfaces of the anchor <NUM> which contact the lead <NUM> may be modified to increase retention force. These surfaces may include portions of the lumen <NUM> and/or portions of the lumen <NUM> which contact the lead <NUM>. Such surfaces may be textured, have a higher coefficient of friction, such as a soft durometer silicone, and/or include gripping features such as barbs. These gripping features may be unidirectional and/or bidirectional gripping elements. This may provide additional variation in tortuous paths and therefore variations in holding forces.

Once, the anchor <NUM> is desirably fixed to the lead <NUM>, the anchor <NUM> is then attached to the surrounding tissue. In this embodiment, the anchor <NUM> includes one or more suture retention grooves <NUM> to receive suture. Thus, suture can be passed through tissue and wrapped around the anchor <NUM> without slipping. It may be appreciated that in other embodiments, the anchor <NUM> includes one or more suture through-holes for receiving suture. And, in other embodiments, the anchor <NUM> has tissue grabbing jaws which can eliminate the need for suturing.

<FIG> are two perspective views and a top transparent view, respectively, of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead, for anchoring the lead underneath the skin of a patient as described herein. Anchor <NUM> includes a strain relief, nose cone <NUM>, which can comprise a soft durometer material that surrounds an inserted lead <NUM>. Nose cone <NUM> can be configured to relieve strain applied to lead <NUM> due to flexion between lead <NUM> and anchor <NUM>. Anchor <NUM> comprises an anchor body <NUM> including two cams, locking extensions 1005a,b shown. Locking extensions 1005a,b can each include a projection, pins 1003a,b, respectively, each of which rotatably engage holes 1008a-b, respectively, such that locking extensions 1005a,b can be rotated relative to anchor body <NUM>. Locking extensions 1005a,b can comprise a first portion 1006a,b, respectively, and a second portion 1007a,b, respectively. <FIG> shows anchor <NUM> in an open configuration, such that first portions 1006a,b do no significantly engage lead <NUM>. First portions 1006a,b are configured to be rotated from the position shown in <FIG> (e.g. via pinching), the rotation causing first portions 1006a,b to frictionally engage and lock lead <NUM> in place (relative to anchor <NUM>), as shown in <FIG> (e.g. bulges in first portions 1006a-b effectively lock lead <NUM> in at least one direction, and a cam arm prevents movement in the opposite direction). In some embodiments, second portions 1007a,b each comprise an offset proximal end, such that the offset proximal ends are configured to extend away from anchor body <NUM> when in the locked position shown in <FIG>. The offset proximal ends of second portions 1007a,b can be pinched together to transition anchor <NUM> from the locked state of <FIG> to the unlocked state of <FIG>. In some embodiments, anchor body <NUM> includes one or more projections <NUM> that extend laterally from anchor body <NUM>, such as to provide a pushing surface for a surgical tool (e.g. hemostats).

<FIG> are a perspective view and a perspective transparent view, respectively, of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead, for anchoring the lead underneath the skin of a patient as described herein. Anchor <NUM> comprises an anchor body <NUM>, including an O-ring <NUM> and two rotatable arms, locking extensions 1105a,b shown. Locking extensions 1105a,b can each include a projection, pins 1103a,b, respectively, each of which rotatably engage holes 1008a-b, respectively, such that locking extensions 1105a,b can be rotated relative to anchor body <NUM>. Locking extensions 1105a,b can comprise a first portion 1106a,b, respectively, and a second portion 1107a,b, respectively. Second portions 1107a,b are constructed and arranged to receive O-ring <NUM> (e.g. second portions 1107a,b include recesses constructed and arranged to receive O-ring <NUM>). O-ring <NUM> can be configured to compress rotate locking extensions 1105a-b, such that second portions 1107a,b press against an inserted lead <NUM>, such as to prevent movement of lead <NUM> relative to anchor body <NUM>. To allow for subsequent desired movement of lead <NUM>, O-ring <NUM> can be stretched to release (or at least reduce) the compression of first portions 1106a,b and/or second portions 1107a,b against lead <NUM>. First portions 1106a,b and/or second portions 1107a,b can include teeth, a roughened surface, and/or other friction increasing modification configured to increase retention force with lead <NUM>. One or more portions of locking extensions 1105a-b can be pinched together or separate apart, such as with a surgical tool (e.g. hemostats). In some embodiments, anchor body <NUM> includes one or more suture retention rings <NUM>, such that anchor <NUM> can be sutured to the patient's tissue.

<FIG> is a perspective view of an embodiment of an anchor <NUM> which locks onto an elongate device, such as a lead, for anchoring the lead underneath the skin of a patient as described herein. Anchor <NUM> comprises an anchor body <NUM>, a conduit <NUM>, and a tortuous element <NUM>, which each include lumens or other pathways that collectively define a tortuous path TP. Anchor <NUM> is constructed and arranged to slidingly receive a lead <NUM> (not shown) via the tortuous path TP for securing lead <NUM>, such as when lead <NUM> is inserted into conduit <NUM>, exits opening 1205a, is advanced through tortuous element <NUM>, and exits 1205b. In some embodiments, anchor body <NUM> is configured to flex or otherwise resiliently (and temporarily) deform to align tortuous element <NUM> with conduit <NUM> to ease insertion of lead <NUM>. After the insertion of lead <NUM>, anchor <NUM> takes the shape shown in <FIG>, and captures (e.g. frictionally engages) lead <NUM>. Any portion of tortuous path TP can include teeth, a roughened surface, and/or other friction increasing modification configured to increase retention force with lead <NUM>. Anchor body <NUM> can include one or more suture retention rings <NUM>, such that anchor <NUM> can be sutured to the patient's tissue. Anchor <NUM> can include a strain relief, nose cone <NUM>, which can comprise a soft durometer material that surround lead <NUM>.

Claim 1:
An anchor for securing an elongate device (<NUM>) to body tissue, the anchor (<NUM>) comprising:
an anchor body (<NUM>) configured to receive the elongate device (<NUM>), wherein the anchor body (<NUM>) has a single component construction and comprises:
a base portion (<NUM>) comprising a first lumen (<NUM>) therethrough;
an off-set portion (<NUM>) comprising a second lumen (<NUM>) therethrough;
a strain relief nose cone configured to surround the elongate device (<NUM>); and
at least one tissue engagement element configured to assist in attaching the anchor body (<NUM>) to the body tissue,
wherein the anchor body (<NUM>) is configured to removably attach to the elongate device (<NUM>) and to resist movement of the elongate device (<NUM>) in relation to the anchor body (<NUM>) via a tortuous path for receiving and engaging the elongate device (<NUM>),
wherein the off-set portion (<NUM>) creates the tortuous path by misalignment of the second lumen (<NUM>) to the first lumen (<NUM>), and
wherein a position of the elongate device (<NUM>) is maintained with respect to the anchor body (<NUM>) by the tortuous path through the first and second lumens (<NUM> and <NUM>).