Patent ID: 12214188

The headings provided herein are for convenience only and do not necessarily affect the scope of the embodiments. Further, the drawings have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the Figures may be expanded or reduced to help improve the understanding of the embodiments.

Moreover, while the disclosed technology is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to unnecessarily limit the described embodiments. On the contrary, the embodiments are intended to cover all suitable modifications, combinations, equivalents, and/or alternatives of the technology falling within the scope of this disclosure.

DETAILED DESCRIPTION

Overview

The present technology is directed generally to lead anchors, lead anchor actuation tools, and methods of anchoring a lead to a patient that mitigate lead movement while providing the ability to subsequently reposition the lead. In general, the lead anchors and methods are for use with neurological stimulation systems, such as spinal cord modulation systems. In particular embodiments, the lead anchor can include a retainer that releasably attaches a lead to a lead anchor. The lead anchor can in turn be attached to a patient with sutures. Specific details of several embodiments of the technology are described below with reference to representative anchors and tools to provide a thorough understanding of these embodiments, but other embodiments can have other arrangements. Several details describing structures or processes that are well-known and often associated with lead anchors and associated devices but that may unnecessarily obscure some significant aspects of the disclosure are not set forth in the following description for purposes of clarity. Moreover, although the following disclosure sets forth several embodiments of different aspects of the technology, several other embodiments of the technology can have different configurations or different components than those described in this section. As such, the technology may have other embodiments with additional elements and/or without several of the elements described below with reference toFIGS.1A-11B.

General Description

FIGS.1A and1Billustrate a lead anchor100according to representative embodiments of the present technology. The lead anchor100releasably engages or grips a lead10(e.g., an electrical stimulation or modulation lead) and anchors the lead10relative to a patient's tissue. The lead anchor100can include a longitudinally extending anchor body102having a longitudinally extending aperture or lumen104that receives the lead10. A retainer106is positioned in the anchor body102and is operable to grip at least a portion of the lead10extending through the anchor body102. The lead10is accordingly retained in position relative to the lead anchor100by the retainer106. The anchor body102can include multiple circumferential suture grooves110. The grooves110act to keep sutures, which are used to attach the anchor100to the patient, properly aligned around the anchor body102. Thus, the lead anchor100may be attached to a patient by suturing around the anchor body102with the suture threads captured in the grooves110. In some embodiments, the lead anchor100can include a retainer cover108to enclose the retainer106in the anchor body102. The anchor body102and the retainer cover108can be formed from a flexible material, such as a biocompatible material. An example of a suitable flexible biocompatible material is silicone rubber.

The lumen104can be sized to provide clearance between the inner surface of the anchor body102and the outer surface of the lead10such that the lead10may be moved into position relative to the lead anchor100as long as the retainer106is disengaged from the lead10(described further below with reference toFIGS.2A-2C). The clearance between the lumen104and lead10may be, for example and without limitation, in the range of from about 0.001 inch to about 0.005 inch.

As shown inFIGS.2A-2C, the retainer106can include an outer or first grip member112and an inner or second grip member114. The first grip member112can comprise a pair of opposed first wall portions116and a pair of generally coaxial first apertures118, each formed through a corresponding one of the pair of opposed first wall portions116. As used herein, the terms “generally” and “approximately” refer to values within 10% of the stated value, unless noted otherwise. Similarly, the second grip member114can comprise a pair of opposed second wall portions120and a pair of generally coaxial second apertures122, each formed through a corresponding one of the pair of opposed second wall portions120. In the depicted embodiment, the second wall portions120can be connected with a transverse portion126. The second grip member114is positioned between the pair of opposed first wall portions116. A pair of U-shaped flat resilient portions, such as spring portions124are positioned on opposite sides of retainer106, each connecting corresponding first and second wall portions116and120. The term U-shaped is used herein to generally refer to spring portions having an angle from about 0 degrees to about 90 degrees between the legs of the spring, including for example V-shaped springs. In some embodiments, the springs can have an angle of approximately 0-30 degrees. The first wall portions116can each include a transverse tab128each extending toward the other. In some embodiments, the transverse tabs128can be joined together (e.g., welded). In some embodiments, the transverse tabs128can be configured to leave a gap therebetween, as shown inFIGS.2A and2C.

The first apertures118are generally aligned with the lumen104(seeFIG.1B). However, the second apertures122are offset from the first apertures118when the U-shaped spring portions124are in a relaxed state as shown inFIGS.2A-2C. The retainer106is normally in a relaxed or engaged state in which the lead10is pinched between the first apertures and the second apertures. Thus, to insert the lead10through the anchor body, or move the lead10within the lumen104, the retainer106is actuated (e.g., elastically deformed) to a disengaged state to release the compressive force on the lead10. To actuate the retainer106, a user can push the first grip member112and the second grip member114together to align the first and second apertures118and122, respectively. The user can push the first grip member112and the second grip member114together by squeezing the retainer106or by using a suitable tool, such as the lead anchor tool described below with reference toFIGS.8,10A, and10B.

In some embodiments, the retainer can comprise a continuous strip of material bent (e.g., stamped) into the configuration described herein. For example, the retainer106can comprise a material providing a resilient or spring-like behavior. Accordingly, the retainer106may be comprised of a metal, such as for example and without limitation, titanium, Elgiloy®, spring steel, or the like. In some embodiments, the retainer106can comprise 0.0075 inch thick Elgiloy® material. The retainer106may also be formed (e.g., machined, molded, or thermoformed) from resilient plastics, such as, for example and without limitation, ABS, Nylon, Delrin, UHMW polyethylene, and the like. In the depicted embodiment, the various retainer portions are oriented at right angles and/or parallel to each other. For example, the U-shaped spring portions124are generally orthogonal to the wall portions116and120, and the first wall portions116are generally parallel to the second wall portions120.

Although the retainer106is shown and described as having a pair of first wall portions116, a pair of second wall portions120, and a pair of U-shaped spring portions124symmetrically arranged, in some embodiments, a retainer can have one first wall portion and one second wall portion connected by a single U-shaped spring portion, for example.

As shown inFIG.3, the anchor body102can include a retainer pocket130positioned to receive the retainer106. The retainer pocket130includes a central region132extending at least part-way through the anchor body102to intersect the lumen104. The retainer pocket130also includes a pair of lateral ledge regions134, each at least partially containing a corresponding one of the U-shaped spring portions124. In some embodiments, the retainer106is glued into the retainer pocket130. For example, each U-shaped spring portion124can be glued to a corresponding ledge134. The retainer cover108can be glued to the U-shaped spring portions124and/or the perimeter of the retainer pocket130, for example.

FIGS.4A and4Billustrate a lead anchor200according to further representative embodiments of the present technology. The lead anchor200releasably carries a lead (such as the lead10, shown inFIG.1A) and anchors the lead relative to a patient's tissue. Accordingly, the lead anchor200can include a longitudinally extending anchor body202having a longitudinally extending aperture or lumen204that receives the lead. A retainer206is positioned in the anchor body202and is operable to grip at least a portion of the lead extending through the anchor body202. The anchor body202can include multiple circumferential suture grooves210to facilitate attaching the anchor200to a patient.

As shown inFIG.5, the anchor body202can include a retainer pocket230positioned to intersect the lumen204and receive the retainer206. The retainer206can comprise an inner grip block212having an inner aperture218and a pair of outer grip blocks214each having a corresponding outer aperture220. The retainer206can include a leaf spring224connecting the inner grip block212with the outer grip blocks214. The leaf spring224can be glued or mechanically fastened to the grip blocks212,214, for example. In some embodiments, the leaf spring224can comprise a flat strip of material providing a resilient or spring-like behavior. Accordingly, the leaf spring224may be comprised of a metal, such as for example and without limitation, titanium, Elgiloy®, spring steel, or the like. The grip blocks212and214can comprise plastic, such as, for example and without limitation, ABS, Nylon, Delrin, UHMW polyethylene, and the like.

The outer apertures220are generally coaxial with each other and aligned with the lumen204(seeFIG.4B). However, the inner aperture218is offset (e.g., upwardly) from the outer apertures220when the leaf spring224is in a relaxed state as shown inFIG.4B, for example. The retainer206is normally in a relaxed or engaged state in which the lead is pinched between the inner and outer apertures. Thus, to insert the lead through the anchor body, or move the lead within the lumen204, the retainer206is actuated (e.g., elastically deformed) to a disengaged state to release the compressive force on the lead. To actuate the retainer206, a user can push the inner grip block212and the outer grip blocks214together (as indicated by arrows S) to align the inner and outer apertures218and220, respectively. The user can push the inner grip block212and the outer grip blocks214together by manually squeezing the retainer206or by using a suitable tool, such as the lead anchor tool described below with reference toFIG.8.

FIGS.6A and6Billustrate another lead anchor retainer306according to representative embodiments of the present technology. The retainer306can be positioned in a suitable anchor body, such as the anchor body202described above with respect toFIG.5. The retainer306can comprise an inner grip block312having an inner aperture318and a pair of outer grip blocks314, each having a corresponding outer aperture320. The retainer306can include a connector plate324connecting the outer grip blocks314together. The connector plate324can be glued or mechanically fastened to the grip blocks314, for example. A resilient member, such as spring326, can connect to at least one of the outer grip blocks314and carries the inner grip block312therebetween such that the inner aperture318is offset from the outer apertures320when the spring326is in a relaxed state. In some embodiments, the spring326can comprise a U- or V-shaped portion328and a flat transverse portion330. The U-shaped portion328is attached to the outer grip block314and the transverse portion330is attached to the inner grip block312.

In some embodiments, the spring326can comprise a continuous strip of material bent (e.g., stamped) into the configuration shown and described herein. For example, the retainer326can comprise a material providing a resilient or spring-like behavior. Accordingly, the spring326may be comprised of a metal, such as for example and without limitation, titanium, Elgiloy®, spring steel, or the like. The grip blocks312and314can comprise plastic, such as, for example and without limitation, ABS, Nylon, Delrin, UHMW polyethylene, and the like.

The outer apertures320are generally coaxial with each other and aligned with a lumen of the anchor body. However, the inner aperture318is offset (e.g., upwardly) from the outer apertures320when the spring326is in a relaxed state as shown inFIGS.6A and6B, for example. The retainer306is normally in a relaxed or engaged state in which the lead is pinched between the inner and outer apertures. Thus, to insert the lead through the anchor body, or move the lead within the lumen, the retainer306is actuated (e.g., elastically deformed) to a disengaged state to release the compressive force on the lead. To actuate the retainer306, a user can push the inner grip block312(e.g., downwardly relative to the outer grip blocks314) to align the inner and outer apertures318and320, respectively. The user can align the apertures318,320by manually squeezing the retainer306(as indicated by arrows S) or by using a suitable tool, such as the lead anchor tool described below with reference toFIG.8.

FIG.7illustrates a lead anchor retainer406according to further representative embodiments of the present technology that is generally similar to the lead anchor retainer306described with respect toFIGS.6A and6B. In this embodiment, a resilient member, such as spring426, includes a pair of opposed U-shaped resilient portions428connected by a transverse portion430. The U-shaped resilient portions428each connect to a corresponding outer grip block414and the transverse portion430carries the inner grip block412therebetween such that the inner aperture418is offset from the outer apertures420when the spring426is in a relaxed state. In some embodiments, the retainer406can also include a connector plate, such as the connector plate324(FIG.6A), connecting the outer grip blocks414together.

FIG.8illustrates a lead anchor actuation tool500according to representative embodiments of the present technology. The lead anchor tool500can comprise a frame502having a collar portion504and a pair of anchor support arms506extending from the collar portion504. Each anchor support arm506can include a finger portion508extending transversely from the support arm506. In some embodiments, the finger portions508can be at least partially arcuate, as shown inFIG.8. A moveable plunger510is carried by the collar portion504. The plunger510is slidable in an aperture515formed through the collar portion504. The plunger510can include an elongate plunger rod512having a proximal end portion514and a distal end portion516. A resilient member, such as compression spring518is positioned around a portion of the plunger510to urge the distal end portion516away from the finger portions508. In some embodiments, the proximal end portion514includes or is in the form of a push knob. The compression spring518can be positioned around the plunger rod512between the collar portion504and a spring retainer, such as a washer or a circlip520, secured to the plunger rod512. The plunger510can be moveably retained relative to the collar portion504by a rod retainer (not visible) attached to the plunger rod512under the collar portion504, or the distal end portion516can have a diameter larger than that of the aperture515. Accordingly, the plunger510has a limited range of axial motion and is “captured” by the collar portion504.

In another embodiment, the plunger rod512can include a threaded portion that mates with a threaded hole in the collar portion504, whereby turning the knob514in a clockwise direction causes the distal end portion516to move toward the finger portions508and turning the knob514in a counter-clockwise direction causes the distal end portion516to move away from the finger portions508.

In operation, the finger portions508are positionable against a side of a lead anchor, such as the lead anchor200, and the distal end portion516of the plunger rod512is positionable against a retainer of the lead anchor200, such as the retainer206. A user can grasp the tool500with a forefinger positioned under the collar portion504and a thumb positioned on the knob514. The user can then actuate the retainer206by pressing the knob514with his/her thumb. Pressing the knob514causes the distal end portion516to press on the retainer206, thereby aligning the retainer apertures to allow insertion or movement of a lead therethrough. Once the user releases the knob514, the spring518moves the distal end portion516away from the retainer206, so that the retainer engages the lead as described herein. The tool can then be removed from the lead anchor200. Although the figure appears to show the anchor actuation tool500with finger portions508positioned in the suture grooves210of the anchor200, other surfaces can be pressed together to actuate the retainer206. For example, a different type of tool could alternatively engage the raised ribbed portions211. In a preferred embodiment, two flat surfaces (e.g., forceps or similar tool) can be used to press the raised rib portions211and the raised surface of retainer206together to squeeze the anchor.

FIGS.9A and9Billustrate another lead anchor600according to representative embodiments of the present technology. The lead anchor600is similar to the lead anchor100described above with respect toFIGS.1A and1B. For example, the lead anchor600can include the same or a similar longitudinally extending anchor body102and retainer106, with the addition of a retention tab602. The retention tab602can be attached to the outer grip member112of the retainer106. For example, a clip portion604(FIG.9B) of the retention tab602can engage the transverse tabs128(seeFIG.2A). In some embodiments, the clip portion604can be welded to the transverse tabs128(e.g., spot welded).

With continued reference toFIG.9B, the retention tab602can include an arm portion606extending from the clip portion604. The arm portion606can carry an angled tip portion608. In some embodiments, the tip portion608is angled toward the retainer106(i.e., upward in the present figures) to help control tissue depth and ergonomics. The tip portion608can be rounded or blunt in order to facilitate moving and maneuvering the retention tab602through a patient's fascia. In some embodiments, the arm portion606includes a narrow section612to increase engagement with the fascia by providing increased area around the perimeter613of the tip portion608to help prevent unintended movement against the fascia. The arm portion606and the tip portion608can include suture holes610to facilitate suturing the retention tab602to the patient. In some embodiments, the retention tab602can comprise a ductile material such that it can bend and lock the lead anchor600in position. In some embodiments, narrow sections, such as section612, can be positioned along the arm portion606to tailor where it is intended to more easily bend.

FIGS.10A and10Billustrate a lead anchor actuation tool700according to representative embodiments of the present technology. The lead anchor tool700can comprise a hemostat702having first and second jaw portions704and706each of which can be angled with respect to the handles708. Referring toFIG.10B, each jaw portion704and706can comprise a channel714and716, respectively. The first jaw portion704can include a notch724positioned in the lower flange718of channel714to receive the arm portion606of the retention tab602(seeFIGS.9A and9B). The second jaw portion706can include a transverse rib726positioned on the web720inside the channel716. The rib726is positioned to engage the inner member114of the retainer106(seeFIG.2) ensuring consistent orientation of the anchor and optimizing stability/control of the anchor during placement.

As illustrated inFIGS.11A and11B, the lead anchor actuation tool700can be used to squeeze the retainer106as indicated by arrows F to disengage the retainer106allowing the anchor600to be moved along the lead10as indicated by arrows M. The lead anchor actuation tool700can be used to maneuver the retention tab602into the patient's fascia with a rotating motion indicated by arrow R. Once the anchor600is in position, the retention tab602can be deformed (e.g., bent in the direction of arrow R) to lock the anchor in position.

The present technology also includes methods of anchoring a lead to a patient using a lead anchor. A representative method comprises moving a retainer disposed in an anchor body to a disengaged state; inserting a lead into the anchor body while the retainer is in the disengaged state; and relaxing the retainer to an engaged state. The method can further comprise placing the retainer in the disengaged state and repositioning the lead with respect to the anchor body. The method can comprise actuating the retainer manually or by using a suitable tool. The method can further comprise attaching the anchor body to a patient. In some embodiments, moving the retainer to a disengaged state can include aligning inner and outer apertures of the retainer.

Several embodiments described herein offer advantages over traditional lead anchors. For example, certain embodiments include a retainer that retains the lead in position with fewer parts than traditional lead anchors have. Accordingly, the disclosed lead anchors can be smaller than traditional lead anchors, which results in a device that is more comfortable for the patient. With fewer parts, the lead anchor can be more economical to produce when compared to traditional lead anchors having additional parts. The disclosed lead anchors are also easy to use. Via a simple manual squeezing operation, or via one movement of a suitable tool, the retainer may be engaged or disengaged in order to position, reposition, or secure a lead within the lead anchor body.

The present technology includes lead anchors for use with neurological stimulation systems, such as spinal cord modulation systems. In representative embodiments, the lead anchor comprises a longitudinally extending anchor body and a retainer. The anchor body can include a lumen positioned to receive a spinal cord lead therethrough and a retainer pocket intersecting the lumen. The retainer is positioned in the retainer pocket and includes a first grip member, having at least one first aperture, and a second grip member, having at least one second aperture. At least one spring portion (e.g., having a U-shape) connects the first and second grip members.

In one aspect of the disclosed technology, the at least one first aperture is generally aligned with the lumen. In another aspect of the disclosed technology, the at least one second aperture is offset from the first aperture when the at least one spring portion is in a relaxed state. In yet another aspect of the disclosed technology, the first grip member comprises a pair of opposed first wall portions and a pair of generally coaxial first apertures, each formed through a corresponding one of the pair of opposed first wall portions. In one aspect of the disclosed technology, the second grip member comprises a pair of opposed second wall portions and a pair of generally coaxial second apertures, each formed through a corresponding one of the pair of opposed second wall portions, wherein the second grip member is positioned between the pair of opposed first wall portions. In a further aspect of the disclosed technology, the at least one U-shaped spring portion comprises two U-shaped spring portions, each positioned on opposite sides of the pair of opposed first wall portions. In one aspect of the disclosed technology, the retainer comprises a continuous strip of material. In another aspect of the disclosed technology, the retainer pocket includes a central region intersecting the lumen and a pair of lateral ledge regions, each at least partially containing a corresponding one of the U-shaped spring portions.

In another representative embodiment, the lead anchor comprises a longitudinally extending anchor body and a retainer. The anchor body can include a lumen positioned to receive a spinal cord lead therethrough and a retainer pocket intersecting the lumen. The retainer is positioned in the retainer pocket and includes an inner grip block, having an inner aperture, and at least one outer grip block, having an outer aperture. A spring connects the inner and outer grip blocks.

In one aspect of the disclosed technology, the outer aperture is generally aligned with the lumen. In another aspect of the disclosed technology, the inner aperture is offset from the outer aperture when the spring is in a relaxed state. In yet another aspect of the disclosed technology, the at least one outer grip block comprises a pair of outer grip blocks and a pair of generally coaxial outer apertures, each formed through a corresponding one of the pair of outer grip blocks. In a further aspect of the disclosed technology, the lead anchor can include a connector plate positioned opposite the spring for joining the outer grip blocks. In one aspect of the disclosed technology, the spring connects to both of the outer grip blocks and carries the inner grip block therebetween such that the inner aperture is offset from the outer apertures when the spring is in a relaxed state. In another aspect of the disclosed technology, the spring includes a pair of opposed U-shaped spring portions, each connected to a corresponding one of the outer grip blocks.

The present technology includes tools for actuating lead anchors. In a representative embodiment, the lead anchor tool comprises a frame, a movable plunger carried by the frame, and a resilient member. The frame can include a collar portion and at least one anchor support arm extending from the collar portion. The anchor support arm can include a finger portion extending transversely from the support arm. The moveable plunger is carried by the collar portion. The plunger can include an elongate plunger rod having a proximal end portion and a distal end portion. The resilient member is positioned to urge the distal end portion of the plunger away from the finger portion.

In one aspect of the disclosed technology, the finger portion is positionable against a side of a lead anchor and the distal end portion is positionable against a retainer of the lead anchor. In another aspect of the disclosed technology, the proximal end portion includes a push knob. In yet another aspect of the disclosed technology, the resilient member comprises a compression spring positioned along the plunger rod between the collar portion and a retainer secured to the plunger rod. In a further aspect of the disclosed technology, the at least one anchor support arm comprises two anchor support arms.

From the foregoing, it will be appreciated that specific embodiments of the disclosed technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Certain aspects of the disclosure described in the context of particular embodiments may be combined or eliminated in other embodiments. Further, while advantages associated with certain embodiments have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the present disclosure. Accordingly, the present disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Remarks

The above description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in some instances, well-known details are not described in order to avoid obscuring the description. Further, various modifications may be made without deviating from the scope of the embodiments.

Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not for other embodiments.

The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. It will be appreciated that the same thing can be said in more than one way. Consequently, alternative language and synonyms may be used for any one or more of the terms discussed herein, and any special significance is not to be placed upon whether or not a term is elaborated or discussed herein. Synonyms for some terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification, including examples of any term discussed herein, is illustrative only and is not intended to further limit the scope and meaning of the disclosure or of any exemplified term. Likewise, the disclosure is not limited to various embodiments given in this specification. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions, will control.