US20100256696A1 - Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using - Google Patents

Abstract

An anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 61/167,358 filed on Apr. 7, 2009, which is incorporated herein by reference.
FIELD
• The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
BACKGROUND
• Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Deep brain stimulation has also been useful for treating refractory chronic pain syndromes and has been applied to treat movement disorders and epilepsy. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients. Moreover, electrical stimulation systems can be implanted subcutaneously to stimulate subcutaneous tissue including subcutaneous nerves such as the occipital nerve.
• Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.
BRIEF SUMMARY
• In at least one embodiment, an anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.
• In another embodiment, an anchoring unit for an implantable lead includes a body, at least one anchoring member, and at least one leaf spring. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end and a distal end. The proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient. The at least one leaf spring has a first end and a second end. The first end is coupled to the body and the second end is coupled to the distal end of the at least one anchoring member.
• In yet another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end and a second end and a longitudinal axis extending between the first end and the second end. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. The at least one anchoring member has a proximal end and a distal end. The proximal end extends from the body and the distal end is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. At least a portion of one anchoring member extends in a direction that forms an angle with the longitudinal axis of the body distal to the at least one anchoring member that is no greater than ninety degrees.
• In another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The at least one anchoring member extends from the body such that the at least one anchoring unit is arranged in a helical or spiral arrangement.
• In yet another embodiment, an anchoring unit for an implantable lead includes a body and at least one anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The at least one anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the at least one anchoring member extends from the body and the distal end of the at least one anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The distal end of the at least one anchoring member is wider than the proximal end of the at least one anchoring unit.
• In another embodiment, an anchoring unit for an implantable lead includes a body and a single anchoring member. The body is configured and arranged for positioning along a portion of an outer surface of the lead. The single anchoring member has a proximal end, a distal end, and a longitudinal axis. The proximal end of the single anchoring member extends from the body and the distal end of the single anchoring member is configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient. The single anchoring member extends from the body in a helical arrangement that extends at least one revolution around a circumference of the body.
BRIEF DESCRIPTION OF THE DRAWINGS
• Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.
• For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
• FIG. 1 is a schematic view of one embodiment of an electrical stimulation system, according to the invention;
• FIG. 2 is a schematic view of another embodiment of an electrical stimulation system, according to the invention;
• FIG. 3A is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention;
• FIG. 3B is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention;
• FIG. 4A is a schematic perspective view of a first embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members with an arcing longitudinal axis, according to the invention;
• FIG. 4B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 4A, according to the invention;
• FIG. 5A is a schematic perspective view of a second embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body in a helical arrangement, according to the invention;
• FIG. 5B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 5A, according to the invention;
• FIG. 6A is a schematic perspective view of a third embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body defining at least one slit and anchoring members coupled to the body in a helical arrangement, according to the invention;
• FIG. 6B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 6A, according to the invention;
• FIG. 7A is a schematic perspective view of a fourth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body, anchoring members coupled to the body, and connecting elements coupling distal ends of the anchoring members to one another, according to the invention;
• FIG. 7B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 7A, according to the invention;
• FIG. 8A is a schematic perspective view of a fifth and a sixth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and at least one anchoring member, according to the invention;
• FIG. 8B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 8A, according to the invention;
• FIG. 9A is a schematic perspective view of a seventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, the anchoring members increasing in width as the anchoring members extend away from the body, according to the invention;
• FIG. 9B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 9A, according to the invention;
• FIG. 10A is a schematic perspective view of an eighth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and anchoring members coupled to the body, each anchoring member having a distal end that also couples to the body via a leaf spring, according to the invention;
• FIG. 10B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 10A, according to the invention;
• FIG. 11A is a schematic perspective view of a ninth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and distally-biased anchoring members, according to the invention;
• FIG. 11B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 11A, according to the invention;
• FIG. 12A is a schematic perspective view of a tenth embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and curled anchoring members, each anchoring member curled to include a proximally-biased section and a distally-biased section, according to the invention;
• FIG. 12B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 12A, according to the invention;
• FIG. 13A is a schematic perspective view of an eleventh embodiment of an anchoring unit for an electrical stimulation system, the anchoring unit including a body and articulated anchoring members, each anchoring member including a proximally-biased section and a distally-biased section, according to the invention;
• FIG. 13B is a schematic bottom view, side view, and top view of the anchoring unit shown inFIG. 13A, according to the invention;
• FIG. 14 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which four similarly-shaped anchoring units are disposed, according to the invention;
• FIG. 15 is a schematic perspective view of one embodiment of a portion of a lead body of an electrical stimulation system on which nine differently-shaped anchoring units are disposed, according to the invention; and
• FIG. 16 is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, according to the invention.
DETAILED DESCRIPTION
• The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads having one or more anchoring units coupled to the lead to facilitate fixing of the lead within patient tissue, as well as methods of making and using the leads, anchoring units, and electrical stimulation systems.
• Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead. Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, all of which are incorporated by reference.
• FIG. 1 illustrates schematically one embodiment of anelectrical stimulation system100. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator)102, apaddle body104, and at least onelead body106 coupling thecontrol module102 to thepaddle body104. Thepaddle body104 and the one or morelead bodies106 form a lead. Thepaddle body104 typically includes an array ofelectrodes134. Thecontrol module102 typically includes anelectronic subassembly110 and anoptional power source120 disposed in a sealedhousing114. Thecontrol module102 typically includes a connector144 (FIGS. 2 and 3A, see also322 and350 ofFIG. 3B) into which the proximal end of the one or morelead bodies106 can be plugged to make an electrical connection via conductive contacts on thecontrol module102 and terminals (e.g.,310 inFIGS. 3A and 336 ofFIG. 3B) on each of the one or morelead bodies106. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein. For example, instead of apaddle body104, theelectrodes134 can be disposed in an array at or near the distal end of thelead body106 forming a percutaneous lead, as illustrated inFIG. 2. A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions312 (seeFIG. 3B) can be disposed between the one or morelead bodies106 and thecontrol module102 to extend the distance between the one or morelead bodies106 and thecontrol module102 of the embodiments shown inFIGS. 1 and 2.
• The electrical stimulation system or components of the electrical stimulation system, including one or more of thelead bodies106, thepaddle body104, and thecontrol module102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like.
• Theelectrodes134 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. The number ofelectrodes134 in the array ofelectrodes134 may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, ormore electrodes134. As will be recognized, other numbers ofelectrodes134 may also be used.
• The electrodes of thepaddle body104 or one or morelead bodies106 are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof. Thepaddle body104 and one or morelead bodies106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process. The non-conductive material typically extends from the distal end of the lead to the proximal end of each of the one or morelead bodies106. The non-conductive, biocompatible material of thepaddle body104 and the one or morelead bodies106 may be the same or different. Thepaddle body104 and the one or morelead bodies106 may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together.
• Terminals (e.g.,310 inFIGS. 3A and 336 ofFIG. 3B) are typically disposed at the proximal end of the one or morelead bodies106 for connection to corresponding conductive contacts (e.g.,314 inFIGS. 3A and 340 ofFIG. 3B) in connectors (e.g.,144 inFIGS. 1-3A and322 and350 ofFIG. 3B) disposed on, for example, the control module102 (or to other devices, such as conductive contacts on a lead extension, an operating room cable, or an adaptor). Conductive wires (“conductors”) (not shown) extend from the terminals (e.g.,310 inFIGS. 3A and 336 ofFIG. 3B) to theelectrodes134. Typically, one ormore electrodes134 are electrically coupled to a terminal (e.g.,310 inFIGS. 3A and 336 ofFIG. 3B). In some embodiments, each terminal (e.g.,310 inFIGS. 3A and 336 ofFIG. 3B) is only connected to oneelectrode134. The conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead, for example, for inserting a stylet rod to facilitate placement of the lead within a body of a patient. Additionally, there may also be one or more lumens (not shown) that open at, or near, the distal end of the lead, for example, for infusion of drugs or medication into the site of implantation of thepaddle body104. In at least one embodiment, the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens can be permanently or removably sealable at the distal end.
• In at least some embodiments, leads are coupled to connectors disposed on control modules. InFIG. 3A, alead308 is shown configured and arranged for insertion to thecontrol module102. Theconnector144 includes aconnector housing302. Theconnector housing302 defines at least oneport304 into which aproximal end306 of a lead308 withterminals310 can be inserted, as shown bydirectional arrow312. Theconnector housing302 also includes a plurality ofconductive contacts314 for eachport304. When thelead308 is inserted into theport304, theconductive contacts314 can be aligned with theterminals310 on thelead308 to electrically couple thecontrol module102 to the electrodes (134 ofFIG. 1) disposed at a distal end of thelead308. Examples of connectors in control modules are found in, for example, U.S. Pat. No. 7,244,150 and U.S. patent application Ser. No. 11/532,844, which are incorporated by reference.
• InFIG. 3B, aconnector322 is disposed on alead extension324. Theconnector322 is shown disposed at adistal end326 of thelead extension324. Theconnector322 includes a connector housing328. The connector housing328 defines at least oneport330 into which aproximal end332 of a lead334 withterminals336 can be inserted, as shown bydirectional arrow338. The connector housing328 also includes a plurality ofconductive contacts340. When thelead334 is inserted into theport330, theconductive contacts340 disposed in the connector housing328 can be aligned with theterminals336 on thelead334 to electrically couple thelead extension324 to the electrodes (134 ofFIG. 1) disposed at a distal end (not shown) of thelead334.
• In at least some embodiments, the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead. Thelead extension324 may include a plurality of conductive wires (not shown) that electrically couple theconductive contacts340 to aproximal end348 of thelead extension324 that is opposite to thedistal end326. In at least some embodiments, the conductive wires disposed in thelead extension324 can be electrically coupled to a plurality of terminals (not shown) disposed on theproximal end348 of thelead extension324. In at least some embodiments, theproximal end348 of thelead extension324 is configured and arranged for insertion into a connector disposed in another lead extension. In other embodiments, theproximal end348 of thelead extension324 is configured and arranged for insertion into a connector disposed in a control module. As an example, inFIG. 3B theproximal end348 of thelead extension324 is inserted into aconnector350 disposed in acontrol module352.
• Electrode placement can be important for obtaining efficacious patient response to stimulation. Sometimes a distal end of a lead may migrate from an intended treatment site over time due to patient movement. When a distal end of a lead migrates far enough away from the intended treatment site, a loss of efficacy may occur and surgical re-implantation may become necessary to re-establish efficacy.
• One way to reduce migration of the distal end of an implanted lead is to anchor the distal end of the lead within patient tissue. In at least some embodiments, anchoring units are described for use with implantable electrical stimulation systems. In at least some embodiments, one or more anchoring units may be disposed along a longitudinal axis of the lead body (see e.g.,FIGS. 13 and 14). One or more anchoring units may be positioned on the lead body distal to the electrodes, in-between two or more electrodes, proximal to the electrodes, or any combination thereof. The anchoring units may be different sizes and shapes. When multiple anchoring units are disposed on a lead body, the anchoring units may either be all of similar size and shape, or one or more of the anchoring units may have different sizes or shapes from other anchoring units disposed on the lead body. Furthermore, adjacent anchoring units disposed on the lead body may be evenly-spaced, or irregularly spaced from one another. In at least some embodiments, the shapes, sizes, or arrangements of anchoring units disposed on a lead body may be selected based, at least in part, on a specific indication or a specific anatomical location.
• The anchoring units may be formed from any suitable biocompatible material including, for example, polyurethane, silicone rubber, polytetrafluoroethylene, polyethylene, nylon, metal, nitinol, and the like or combinations thereof. In at least some embodiments, at least a portion of the anchoring units are formed integrally with the lead body (e.g., by overmolding a body of an anchoring unit to the lead body, reflowing a body of an anchoring unit to the lead body, or the like). In at least some other embodiments, anchoring units may be coupled to the lead body at selected locations along a longitudinal axis of the lead using any suitable bonding process including, for example, chemical bonding, welding, interference fit, and the like or combinations thereof.
• FIG. 4A is a schematic perspective view of a first embodiment of ananchoring unit402 for an electrical stimulation system. Theanchoring unit402 includes abody404 and one ormore anchoring members406. Thebody404 includes afirst end408 and asecond end410 and is configured and arranged to be disposed over at least a portion of an outer surface of the lead body (see e.g.,FIGS. 13 and 14). In at least some embodiments, thefirst end408 is positioned more distally than thesecond end410 when theanchoring unit402 is disposed on the lead body (106 inFIG. 1). The anchoringmembers406 each include aproximal end412, adistal end414, and alongitudinal axis415 defined by afirst side416 and asecond side418.
• In some embodiments, the anchoring members form a spiral arrangement. InFIG. 4A, thefirst sides416 of the anchoringmembers406 are arcing leading edges and thesecond sides418 are lagging edges, thereby forming an arcinglongitudinal axis415. In at least some embodiments, the laggingsecond sides418 are also arcing. In at least some embodiments, thefirst sides416 of the anchoringmembers406 are similarly-arced to form a spiral pattern. In at least some embodiments, thefirst sides416 of the anchoringmembers406 are longer in length than thesecond sides418 of the anchoringmembers406. In at least some embodiments, thefirst side416 and thesecond side418 of the anchoringmembers402 taper inward such that the proximal ends412 are wider than the distal ends414.
• In at least some embodiments, thedistal end414 of at least one of the anchoringmembers406 tapers to form a point. In a preferred embodiment, the point is rounded. It may be an advantage to employ one ormore anchoring units402 with anchoringmembers406 that taper to points because a medical practitioner may be able to rotate the lead to further engage theanchor members406 within patient tissue during implantation, thereby increasing the anchoring ability of the lead.
• FIG. 4B is a schematic bottom view, side view, and top view of theanchoring unit402. In at least some embodiments, the anchoringmembers406 extend from thesecond end410 of thebody404 along a common transverse axis of thebody404. In at least some embodiments, the anchoringmembers406 are proximally biased. In other words, when theanchoring unit402 is disposed on the lead body (106 inFIG. 1) so that thefirst end408 is more distal on the lead body (106 inFIG. 1) than thesecond end410, the anchoringmembers406 form an angle with the longitudinal axis of thebody404 that is at least ninety degrees, as shown byangle Θ420.
• In some embodiments, the anchoring unit includes a single anchoring member that extends from the body in a helical arrangement.FIG. 5A is a schematic perspective view of a second embodiment of ananchoring unit502. Theanchoring unit502 includes abody504 and one anchoringmember506. Thebody504 includes afirst end508 and asecond end510 and the anchoringmember506 includes aproximal end512, adistal end514, a longitudinal axis515, afirst side516, and asecond side518.
• In at least some embodiments, theproximal end512 of the anchoringmember506 extends at least three-fourths of one complete revolution around a circumference of thebody504. In at least some embodiments, theproximal end512 of the anchoringmember506 extends at least one complete revolution around the circumference of thebody504. In at least some embodiments, theproximal end512 of the anchoringmember506 couples to thebody504 in a helical arrangement along a longitudinal axis of thebody504 such that thefirst side516 and thesecond side518 of the anchoringmember506 couple to thebody504 along different transverse points along the longitudinal axis of thebody504. In at least some embodiments, the pitch and the number of revolutions of the anchoringmember506 around a circumference of thebody504 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body (106 inFIG. 1) to which one or more of the anchoringunits502 may be coupled.
• In at least some embodiments, thefirst side516 and thesecond side518 of the anchoringmember502 taper outward such that thedistal end514 is wider than theproximal end512. In at least some embodiments, thefirst side516 and thesecond side518 of the anchoringmember502 taper inward such that theproximal end512 is wider than thedistal end514. In at least some embodiments, theproximal end512 and thedistal end514 are of approximately equal width.
• FIG. 5B is a schematic bottom view, side view, and top view of theanchoring unit502. In at least some embodiments, the anchoringmember506 is proximally biased. In other words, when theanchoring unit502 is disposed on the lead body (106 inFIG. 1) so that thefirst end508 is more distal on the lead body (106 inFIG. 1) than thesecond end510, the anchoringmember506 forms an angle with the longitudinal axis of thebody504 that is at least ninety degrees, as shown byangle Θ520.
• In some embodiments, the body includes one or more tapered anchoring members.FIG. 6A is a schematic perspective view of a third embodiment of ananchoring unit602. Theanchoring unit602 includes abody604 and at least one anchoringmember606. Thebody604 includes afirst end608 and asecond end610. The anchoringmember606 includes aproximal end612, adistal end614, alongitudinal axis615, afirst side616, and asecond side618. Thebody604 also defines one ormore slits620 along at least portion of thesecond end610 of thebody604 between adjacent anchoringmembers606. In at least some embodiments, the one ormore slits616 extend in a direction that is parallel to a longitudinal axis of thebody604. In at least some embodiments, the one ormore slits616 facilitate the anchoringmembers606 lying flat (e.g., during insertion of the lead into a patient).
• In at least some embodiments, thefirst side616 and thesecond side618 of the anchoringmember602 taper outward such that thedistal end614 is wider than theproximal end612. In at least some embodiments, the proximal ends612 of two ormore anchoring members606 extend from thebody604 in a helical pattern along a longitudinal axis of thebody604 such that thefirst side616 and thesecond side618 of each of two or more the anchoringunits602 extend from thebody604 along different transverse axes of thebody604. In at least some embodiments, the pitch and the number of revolutions of the anchoringmembers606 around a circumference of thebody604 may be tailored to the specific indication or the specific anatomical location of the implantation of the lead body (106 inFIG. 1) to which one or more of the anchoringunits602 may be coupled.
• FIG. 6B is a schematic bottom view, side view, and top view of theanchoring unit602. In at least some embodiments, the anchoringmembers606 are proximally biased. In other words, when theanchoring unit602 is disposed on the lead body (106 inFIG. 1) so that thefirst end608 is more distal on the lead body (106 inFIG. 1) than thesecond end610, the anchoringmembers606 form an angle with the longitudinal axis of thebody604 that is at least ninety degrees, as shown byangle Θ622.
• In some embodiments, one or more connecting elements couple to adjacent anchoring members.FIG. 7A is a schematic perspective view of a fourth embodiment of ananchoring unit702. Theanchoring unit702 includes abody704 and at least one anchoringmember706. Thebody704 includes afirst end708 and asecond end710. Theanchoring unit702 includes abody704 and at least one anchoringmember706. Thebody704 includes afirst end708 and asecond end710. The anchoringmember706 includes aproximal end712, adistal end714, alongitudinal axis715, afirst side716, and asecond side718.
• In at least some embodiments, thefirst side716 and thesecond side718 of the anchoringmember706 taper such that theproximal end712 of the anchoringmember706 is wider than thedistal end714. In at least some embodiments, thedistal end714 of at least one of the anchoringmembers706 tapers to form a point. In a preferred embodiment, the point is rounded.
• In at least some embodiments, two or more of the anchoringmembers706 may be coupled to one another by a connectingelement720. For example, twoadjacent anchoring members706 may be coupled to one another by one or moreconnecting elements720. In at least some embodiments, thedistal end714 of each anchoringmember706 is coupled to thedistal end714 of each adjacent anchoringmember706 by connectingelements720. In at least some embodiments, a single connectingelement720 connects adjacent distal ends714 to one another. In at least some embodiments, a plurality of connectingelements720 connect adjacent distal ends714 to one another. In at least some other embodiments, a single connectingelement720 connects each of the adjacent distal ends714 together. In at least some embodiments, anopen space722 is formed between the connectingelement720 andadjacent anchoring members706.
• It will be understood that the one or moreconnecting elements720 may coupleadjacent anchoring members706 at locations along the longitudinal axis of the anchoringmembers706 other than the distal ends714. For example, the connecting element may couple to a given anchoringmember706 at a position between theproximal end712 and adistal end714 of the anchoringmember706. In at least some embodiments, the connectingmembers720 are formed with theanchoring unit702. In at least some other embodiments, the connectingmembers720 are formed subsequently assembled.
• Additionally, in at least some embodiments, the connectingelements702 are configured and arranged to fold flat against the lead body (106 inFIG. 1). For example, in at least some embodiments, the connectingelements720 are configured and arranged to fold into open spaces between the anchoringmembers706 when the anchoringmembers706 are folded against the lead body (106 inFIG. 1). In at least some embodiments, at least one of the connectingelements702 includes at least one bend to facilitate folding flat. In at least some embodiments, at least one of the connectingelements702 is articulated to facilitate folding flat. In at least some embodiments, the connectingelements720 increase the anchoring ability of theanchoring unit702 by further facilitating tissue ingrowth.
• FIG. 7B is a schematic bottom view, side view, and top view of theanchoring unit702. In at least some embodiments, the anchoringmembers706 extend from thesecond end710 of thebody704 along a common transverse axis of thebody704. In at least some embodiments, the anchoringmembers706 are proximally biased. In other words, when theanchoring unit702 is disposed on the lead body (106 inFIG. 1) so that thefirst end708 is more distal on the lead body (106 inFIG. 1) than thesecond end710, the anchoringmembers706 form an angle with the longitudinal axis of thebody704 that is at least ninety degrees, as shown byangle Θ724.
• In at least some embodiments, the connective element may include a membrane coupling at least two adjacent anchoring members to one another.FIG. 8A is a schematic perspective view of a fifth embodiment of ananchoring unit802. Theanchoring unit802 includes abody804 and at least one anchoringmember806. Thebody804 includes afirst end808 and asecond end810. Theanchoring unit802 includes abody804 and at least one anchoringmember806. Thebody804 includes afirst end808 and asecond end810. The anchoringmember806 includes aproximal end812, adistal end814, alongitudinal axis815, afirst side816, and asecond side818.
• In at least some embodiments, thefirst side816 and thesecond side818 of the anchoringmember806 taper such that theproximal end812 of the anchoringmember806 is wider than thedistal end814. In at least some embodiments, thedistal end814 of at least one of the anchoringmembers806 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, thefirst side816 and thesecond side818 of the anchoringmember806 taper such that thedistal end814 of the anchoringmember806 is wider than theproximal end812. In at least some embodiments, thefirst side816 and thesecond side818 of the anchoringmember806 are of approximately equal width.
• In at least some embodiments, two or more of the anchoringmembers806 may be coupled to one another by a connectingelement820. In some embodiments, the connectingelement820 comprises a membrane, or sheath, that couples two or more of the anchoringmembers806 to one another. In at least some embodiments, theconnective element820 has a thickness that is substantially thinner than the anchoringmembers806. In at least some embodiments, the connectingelement820 forms a complete revolution around thebody804. In at least some embodiments, theconnective element820 covers at least a portion of at least one of the anchoringmembers806. In at least some embodiments, the connectingelement820 substantially entirely covers each of the anchoringmembers806. In at least some embodiments, the connectingelement820 completely covers each of the anchoringmembers806. In at least some embodiments, at least a portion of at least one of the anchoringmembers806 may need to deform onto itself while in a folded position (e.g., during insertion of the lead into a patient).
• FIG. 8B is a schematic bottom view, side view, and top view of theanchoring unit802. In at least some embodiments, the anchoringmembers806 extend from thesecond end810 of thebody804 along a common transverse axis of thebody804. In at least some embodiments, the anchoringmembers806 are proximally biased. In other words, when theanchoring unit802 is disposed on the lead body (106 inFIG. 1) so that thefirst end808 is more distal on the lead body (106 inFIG. 1) than thesecond end810, the anchoringmembers806 form an angle with the longitudinal axis of thebody804 that is at least ninety degrees, as shown by angle Θ822.
• In a sixth embodiment of the anchoring unit, also shown byFIGS. 8A and 8B, theanchoring unit802 includes asingle anchoring member806 that extends around the entire circumference of thebody804. In some embodiments, the anchoringmember806 is a constant thickness. In at least some other embodiments, the thickness of the anchoringmember806 may vary. In at least some embodiments, the anchoringmember806 may define one or more cutouts for promoting tissue ingrowth.
• In some embodiments, the anchoring members include tapered anchoring members.FIG. 9A is a schematic perspective view of a seventh embodiment of ananchoring unit902. Theanchoring unit902 includes abody904 and at least one anchoringmember906. Thebody904 includes afirst end908 and asecond end910. Theanchoring unit902 includes abody904 and at least one anchoringmember906. Thebody904 includes afirst end908 and asecond end910. The anchoringmember906 includes aproximal end912, adistal end914, alongitudinal axis915, afirst side916, and asecond side918.
• In at least some embodiments, thefirst side916 and thesecond side918 of the anchoringmembers906 taper outward such that thedistal end914 is wider than theproximal end912. In at least some embodiments, the anchoringmembers906 extend from thesecond end910 of thebody904 along a common transverse axis of thebody904. In at least some embodiments, two anchoringmembers906 are disposed on opposing portions of thebody904 such that the two anchoringmembers906 extend in opposite directions from thebody904. In at least some embodiments, the sum of the arc lengths of the distal ends914 of the anchoringmembers906 are no greater than the circumference of thebody904. In at least some embodiments, the widest portions of the anchoringmembers906 have lengths that are at least as long as the diameter of thebody904.
• FIG. 9B is a schematic bottom view, side view, and top view of theanchoring unit902. In at least some embodiments, the anchoringmembers906 are proximally biased. In other words, when theanchoring unit902 is disposed on the lead body (106 inFIG. 1) so that thefirst end908 is more distal on the lead body (106 inFIG. 1) than thesecond end910, the anchoringmembers906 form an angle with the longitudinal axis of thebody904 that is at least ninety degrees, as shown by angle Θ920.
• In some embodiments, the anchoring members include a secondary connecting member, such as a leaf spring, coupling the anchoring member to the body of the anchoring unit.FIG. 10A is a schematic perspective view of an eighth embodiment of ananchoring unit1002. Theanchoring unit1002 includes abody1004 and at least oneanchoring member1006. Thebody1004 includes afirst end1008 and asecond end1010. Theanchoring unit1002 includes abody1004 and at least oneanchoring member1006. Thebody1004 includes afirst end1008 and asecond end1010. The anchoringmember1006 includes aproximal end1012, adistal end1014, alongitudinal axis1015, afirst side1016, and asecond side1018.
• In at least some embodiments, thefirst side1016 and thesecond side1018 of the anchoringmember1006 taper such that theproximal end1012 of the anchoringmember1006 is wider than thedistal end1014. In at least some embodiments, thedistal end1014 of at least one of theanchoring members1006 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, thefirst side1016 and thesecond side1018 of the anchoringmember1006 taper such that thedistal end1014 of the anchoringmember1006 is wider than theproximal end1012. In at least some embodiments, thefirst side1016 and thesecond side1018 of the anchoringmember1006 are of approximately equal width.
• In at least some embodiments, theanchoring unit1002 further includes at least one secondary connectingmember1020 coupling thebody1004 to thedistal end1014 of one of theanchoring members1006. In at least some embodiments, the at least one secondary connectingmember1020 is a leaf spring. In at least some embodiments, the secondary connectingmember1020 forms a solid surface between thebody1004 and the anchoringmember1006. In at least some other embodiments, the secondary connectingmember1020 forms at least onecutout1022 between thebody1004, anchoringmember1006, and the secondary connectingmember1020. It may be a particular advantage of theanchoring unit1002 that tissue ingrowth may occur in thecutouts1022 to at least partially fill thecutouts1022 with tissue to further increase the anchoring ability of theanchoring unit1002.
• In at least some embodiments, when theanchoring members1006 are folded against the lead body (e.g., during insertion of the lead), the secondary connectingmember1020 stretches, thereby storing potential energy. The stored potential energy may facilitate anchoring of the anchoringmember1006 within patient tissue when theanchoring unit1002 is released from the insertion needle and the stored potential energy is released.
• FIG. 10B is a schematic bottom view, side view, and top view of theanchoring unit1002. In at least some embodiments, the anchoringmembers1006 extend from thesecond end1010 of thebody1004 along a common transverse axis of thebody1004. In at least some embodiments, the anchoringmembers1006 are proximally biased. In other words, when theanchoring unit1002 is disposed on the lead body (106 inFIG. 1) so that thefirst end1008 is more distal on the lead body (106 inFIG. 1) than thesecond end1010, the anchoringmembers1006 form an angle with the longitudinal axis of thebody1004 that is at least ninety degrees, as shown byangle Θ1024.
• In some embodiments, the one or more anchoring members are distally biased.FIG. 11A is a schematic perspective view of a ninth embodiment of ananchoring unit1102. Theanchoring unit1102 includes abody1104 and at least oneanchoring member1106. Thebody1104 includes afirst end1108 and asecond end1110. Theanchoring unit1102 includes abody1104 and at least oneanchoring member1106. Thebody1104 includes afirst end1108 and asecond end1110. The anchoringmember1106 includes aproximal end1112, adistal end1114, alongitudinal axis1115, afirst side1116, and a second side1118.
• In at least some embodiments, thefirst side1116 and the second side1118 of the anchoringmember1106 taper such that theproximal end1112 of the anchoringmember1106 is wider than thedistal end1114. In at least some embodiments, thedistal end1114 of at least one of theanchoring members1106 tapers to form a rounded point. In at least some embodiments, thefirst side1116 and the second side1118 of the anchoringmember1106 taper such that thedistal end1114 of the anchoringmember1106 is wider than theproximal end1112. In at least some embodiments, thefirst side1116 and the second side1118 of the anchoringmember1106 are of approximately equal width.
• In at least some embodiments, when theanchoring unit1102 is separated from an insertion needle during insertion of the lead, the anchoringmembers1106 are configured and arranged to extend within patient tissue. In some instances, the anchoringmembers1106 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around theanchoring unit1102 and the hardness of the surrounding tissue. For example, anchoringmembers1106 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage. When theanchoring members1106 do extend to distally-biased positions, the anchoringmembers1106 may resist withdrawal of the lead to which theanchoring unit1102 is coupled. When patient tissue prevents theanchoring members1106 from extending to distally-biased positions, the anchoringmembers1106 fix theanchoring unit1102 in position by the force of theanchoring members1106 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above. It may be an advantage of distally-biasedanchoring members1106 that, should an explant be necessary for the lead to which theanchoring unit1102 is coupled, distally-biased anchoring members may be easier to remove from patient tissue than similarly-sized proximally-biased anchoring members.
• FIG. 11B is a schematic bottom view, side view, and top view of theanchoring unit1102. In at least some embodiments, the anchoringmembers1106 extend from thesecond end1110 of thebody1104 along a common transverse axis of thebody1104. In at least some embodiments, the anchoringmembers1106 are distally biased. In other words, when theanchoring unit1102 is disposed on the lead body (106 inFIG. 1) so that thefirst end1108 is more distal on the lead body (106 inFIG. 1) than thesecond end1110, the anchoringmembers1106 form an angle with the longitudinal axis of thebody1104 that is no more than ninety degrees, as shown by angle Θ1120.
• In some embodiments, the one or more anchoring members are capable of curling such that a portion of at least one of the anchoring members is distally biased and a portion of the same anchoring member is proximally biased.FIG. 12A is a schematic perspective view of a tenth embodiment of ananchoring unit1202. Theanchoring unit1202 includes abody1204 and at least oneanchoring member1206. Thebody1204 includes afirst end1208 and asecond end1210. Theanchoring unit1202 includes abody1204 and at least oneanchoring member1206. Thebody1204 includes afirst end1208 and asecond end1210. The anchoringmember1206 includes aproximal end1212, adistal end1214, a curledlongitudinal axis1215, afirst side1216, and asecond side1218. In at least some embodiments, the anchoringmembers1206 have an arc-shaped transverse profile.
• In at least some embodiments, thefirst side1216 and thesecond side1218 of the anchoringmember1206 taper such that theproximal end1212 of the anchoringmember1206 is wider than thedistal end1214. In at least some embodiments, thedistal end1214 of at least one of theanchoring members1206 tapers to form a rounded point. In at least some embodiments, thefirst side1216 and thesecond side1218 of the anchoringmember1206 taper such that thedistal end1214 of the anchoringmember1206 is wider than theproximal end1212. In at least some embodiments, thefirst side1216 and thesecond side1218 of the anchoringmember1206 are of approximately equal width.
• In at least some embodiments, the anchoringmembers1206 are configured and arranged to lie flat during insertion of the lead and curl upon separation from an insertion needle. In at least some embodiments, the anchoringmembers1206 have an arc-shaped transverse profile that facilitates theanchoring members1206 lying flat against the lead. In at least some embodiments, when theanchoring unit1202 is separated from an insertion needle during insertion of the lead, the anchoringmembers1206 are configured and arranged to curl up such that theanchoring members1206 extend within patient tissue. The anchoring members may include a metal, such as nitinol, or a polymer that is configured and arranged to curl when unconstrained. In some instances, the anchoringmembers1206 are able to extend to distally-biased positions and in other instances they are not, depending on, for example, the amount of open space around theanchoring unit1202 and the hardness of the surrounding tissue. For example, anchoringmembers1206 may not be able to extend to distally-biased positions when positioned in a narrow space between hard tissues, such as bones or cartilage. When theanchoring members1206 do extend to distally-biased positions, the anchoringmembers1206 may resist withdrawal of the lead to which theanchoring unit1202 is coupled. When patient tissue prevents theanchoring members1206 from extending to distally-biased positions, the anchoringmembers1206 fix theanchoring unit1202 in position by the force of theanchoring members1206 pressing against tissue in a manner similar to the proximally-biased anchoring members, discussed above.
• FIG. 12B is a schematic bottom view, side view, and top view of theanchoring unit1202. In at least some embodiments, the anchoringmembers1206 extend from thesecond end1210 of thebody1204 along a common transverse axis of thebody1104. In at least some embodiments, at least one of theanchoring members1206 is configured and arranged to curl up such that a portion of that anchoring member is proximally biased and a portion of that anchoring member is distally biased.
• In some embodiments, the one or more anchoring members extend from the body at the second end of the body, which, as discussed above, is the end of the body that is positioned more proximally than the first end when the anchoring unit is disposed on the lead body (106 inFIG. 1). In some embodiments, the one or more anchoring members are articulated.FIG. 13A is a schematic perspective view of an eleventh embodiment of ananchoring unit1302. Theanchoring unit1302 includes abody1304 and at least oneanchoring member1306. Thebody1304 includes afirst end1308 and asecond end1310. Theanchoring unit1302 includes abody1304 and at least oneanchoring member1306. Thebody1304 includes afirst end1308 and asecond end1310. The anchoringmember1306 includes aproximal end1312, adistal end1314, a longitudinal axis1315, afirst side1316, and asecond side1318.
• At least one of theanchoring members1306 includes at least onearticulation1320 dividing the anchoringmember1306 into a plurality of sections. In at least one embodiment, thearticulation1320 divides the anchoringmember1306 into aproximal section1322 and adistal section1324. In at least some embodiments, theproximal section1322 includes at least onecutout1326. It may be a particular advantage of theanchoring unit1302 that tissue may at least partially fill thecutouts1326 defined in theproximal section1322 of the anchoringmember1306 to further increase the anchoring ability of theanchoring unit1302. In at least some embodiments, thedistal sections1324 of theanchoring members1306 are configured and arranged to fold into thecutouts1326 defined in theproximal sections1322 of the anchoring members1306 (e.g., during insertion of the lead).
• In at least some embodiments, theproximal section1322 of at least one of theanchoring members1306 is wider than thedistal section1324 of the anchoringmember1306. In at least some embodiments, thedistal end1314 of at least one of theanchoring members1306 tapers to form a point. In a preferred embodiment, the point is rounded. In at least some embodiments, theproximal section1314 of at least one of theanchoring members1306 is narrower than thedistal section1316 of the anchoringmember1306. In at least some embodiments, theproximal section1314 of at least one of theanchoring members1306 is of approximately equal width to thedistal section1316 of the anchoringmember1306.
• FIG. 13B is a schematic bottom view, side view, and top view of theanchoring unit1302. In at least some embodiments, theproximal sections1322 of theanchoring members1306 are proximally biased and thedistal sections1324 of theanchoring members1306 are distally biased. In other words, when theanchoring unit1302 is disposed on the lead body (106 inFIG. 1) so that thefirst end1308 is more distal on the lead body (106 inFIG. 1) than thesecond end1310, theproximal sections1314 of theanchoring members1306 form an angle with the longitudinal axis of thebody1304 that are greater than ninety degrees, as shown byangle Θ₁1328 and thedistal sections1324 of theanchoring members1306 form an angle with the longitudinal axis of thebody1304 that are no greater than ninety degrees, as shown byangle Θ₂1330.
• Unless indicated otherwise, the following characteristics of the anchoring units, or its components, or the corresponding lead apply equally to each of the embodiments shown inFIG. 4C-13B. In at least some embodiments, the body is substantially tubular-shaped with a diameter and a longitudinal axis that is perpendicular to a transverse axis of the body. In at least some embodiments, the diameter of the body of the anchoring unit is approximately equal to the diameter of the lead body (106 inFIG. 1). In at least some embodiments, the longitudinal axis of at least one of the anchoring member is at least half the length of the diameter of the body. In at least some embodiments, the longitudinal axis of at least one of the anchoring members is no less than the length of the diameter of the body. In at least some embodiments, the body is cuff-shaped. In at least some embodiments, the anchoring members extend from the second end of the body (except for anchoring member1306). In at least some embodiments, the anchoring members are proximally biased (except for anchoringmembers1106,1206, and1306).
• In at least some embodiments, the longitudinal axis of the anchoring members extend to a distal end. In some embodiments, the anchoring members may have a distal end that is of approximately equal width as the proximal end (except for anchoringmembers406,606,806,906, and1306). In at least some embodiments, the distal end may be narrower than the proximal end (except for anchoringmembers606,806, and906). In at least some embodiments, the distal end may be wider than the proximal end (except for anchoringmembers406,806, and1306).
• In at least some embodiments, at least one of the anchoring members is formed integrally with the body. In at least some embodiments, at least one of the anchoring units is formed separately from the body and is coupleable to the body. In at least some embodiments, the anchoring members may include one or more features (e.g., barbs, ridges, fissures, knobs, grooves, and the like) coupled to, or formed with, the anchoring members for facilitating the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient.
• Any suitable number of anchoring members may be coupled to, or formed with, the body including, for example, one, two, three, four, five, six, seven, eight, nine, ten or more anchoring members. As will be recognized, other numbers of anchoring members may also be coupled to, or formed with, the body.
• In at least some embodiments, the anchoring unit may induce the formation of tissue ingrowth around at least a portion of the anchoring unit within the usable lifespan of the anchoring unit. In at least some embodiments, the usable lifespan may vary depending on the indication and location of the lead to which the anchoring unit is coupled while implanted in a patient. It may be an advantage to have tissue ingrowth around at least a portion of the anchoring unit because the tissue ingrowth may further increase the anchoring ability of the anchoring unit when the anchoring unit is implanted in a patient. In the embodiments shown inFIGS. 6A-7B and10A-10B, additional tissue ingrowth may occur between open spaces between components of the anchoring unit (e.g., slits620,open space722, and cutout1022).
• In at least some embodiments, the anchoring members are flexible. In at least some embodiments, when the anchoring unit is coupled to a lead body (106 inFIG. 1), the anchoring members are configured and arranged to fold flat against the lead body (106 inFIG. 1) during insertion of the lead. For example, when, in at least some embodiments, a lead is inserted into a conventionally-sized insertion needle during implantation of the lead, the anchoring members fold against the lead body (106 inFIG. 1) without interfering with one another so that the lead is able to fit into a cannula of the conventionally-sized insertion needle. In at least some embodiments, at least one of the anchoring members is contoured to facilitate the folding of the anchoring members. In the embodiments shown inFIGS. 8A-8B, at least a portion of at least one of the anchoringmembers806 may need to deform onto itself while in a folded position.
• In at least some embodiments, one or more anchoring units may be disposed on the lead body (106 ofFIG. 1). In at least some embodiments, multiple anchoring units may be employed which have similarly-shaped anchoring members.FIG. 14 is a schematic perspective view of one embodiment of fouranchoring units1402 disposed on a portion of alead body1404. In at least some embodiments, the anchoringunits1402 are evenly-spaced from one another. In at least some embodiments, at least some of the anchoringunits1402 are irregularly spaced from one another. In at least some embodiments, at least one of the anchoringunits1402 may be of a different size from the remaininganchoring units1402. In at least some embodiments, the anchoring members of different anchoring units are aligned with respect to one another along the longitudinal axis of the lead body. In at least some other embodiments, the anchoring members of different anchoring units are staggered, unaligned, or randomly positioned with respect to other anchoring members along the lead body.
• In at least some embodiments, multiple anchoring units may be disposed on a portion of the lead body, at least some of which have differently-shaped anchoring members.FIG. 15 is a schematic side view of one embodiment of ninedifferent anchoring units402,502,602,702,802,902,1002,1102, and1302 disposed on a portion of thelead body1502. In at least some embodiments, the anchoringunits402,502,602,702,802,902,1002,1102, and1302 are evenly-spaced from one another. In at least some embodiments, at least some of the anchoringunits402,502,602,702,802,902,1002,1102, and1302 are irregularly spaced from one another. In at least some embodiments, at least one of the anchoringunits402,502,602,702,802,902,1002,1102, and1302 may be of a different size from the remaininganchoring units402,502,602,702,802,902,1002,1102, and1302.
• FIG. 16 is a schematic overview of one embodiment of components of anelectrical stimulation system1600 including anelectronic subassembly1610 disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein.
• Some of the components (for example,power source1612,antenna1618,receiver1602, and processor1604) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired. Anypower source1612 can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Patent Application Publication No. 2004/0059392, incorporated herein by reference.
• As another alternative, power can be supplied by an external power source through inductive coupling via theoptional antenna1618 or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis.
• If thepower source1612 is a rechargeable battery, the battery may be recharged using theoptional antenna1618, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to arecharging unit1616 external to the user. Examples of such arrangements can be found in the references identified above.
• In one embodiment, electrical current is emitted by theelectrodes134 on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. Aprocessor1604 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, theprocessor1604 can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, theprocessor1604 can select which electrodes can be used to provide stimulation, if desired. In some embodiments, theprocessor1604 may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, theprocessor1604 may be used to identify which electrodes provide the most useful stimulation of the desired tissue.
• Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from anexternal programming unit1608 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, theprocessor1604 is coupled to areceiver1602 which, in turn, is coupled to theoptional antenna1618. This allows theprocessor1604 to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired.
• In one embodiment, theantenna1618 is capable of receiving signals (e.g., RF signals) from anexternal telemetry unit1606 which is programmed by aprogramming unit1608. Theprogramming unit1608 can be external to, or part of, thetelemetry unit1606. Thetelemetry unit1606 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. As another alternative, thetelemetry unit1606 may not be worn or carried by the user but may only be available at a home station or at a clinician's office. Theprogramming unit1608 can be any unit that can provide information to thetelemetry unit1606 for transmission to theelectrical stimulation system1600. Theprogramming unit1608 can be part of thetelemetry unit1606 or can provide signals or information to thetelemetry unit1606 via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to thetelemetry unit1606.
• The signals sent to theprocessor1604 via theantenna1618 andreceiver1602 can be used to modify or otherwise direct the operation of the electrical stimulation system. For example, the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct theelectrical stimulation system1600 to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the stimulation system does not include anantenna1618 orreceiver1602 and theprocessor1604 operates as programmed.
• Optionally, theelectrical stimulation system1600 may include a transmitter (not shown) coupled to theprocessor1604 and theantenna1618 for transmitting signals back to thetelemetry unit1606 or another unit capable of receiving the signals. For example, theelectrical stimulation system1600 may transmit signals indicating whether theelectrical stimulation system1600 is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery. Theprocessor1604 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics.
• The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.

Claims (20)

1. An anchoring unit for an implantable lead, the anchoring unit comprising:

a body configured and arranged for positioning along a portion of an outer surface of a lead, the body having a first end and a second end and a longitudinal axis extending therebetween, the first end being configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end; and

a plurality of anchoring members, each anchoring member having a proximal end and a distal end, the proximal end of each anchoring member extending from the body and the distal end of each anchoring member configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient; and

at least one connecting element coupling together at least two of the anchoring members.

2. The anchoring unit ofclaim 1, wherein the at least one connecting element comprises a sheath that at least partially covers at least one of the plurality of anchoring members.

3. The anchoring unit ofclaim 2, wherein the sheath completely covers at least one of the plurality of anchoring members.

4. The anchoring unit ofclaim 1, wherein the at least one connecting element comprises at least one bend or articulation.

5. The anchoring unit ofclaim 1, wherein at least one of the plurality of anchoring members is configured and arranged to fold flat against the outer surface of the lead when the body is coupled to the lead and the lead is inserted in a cannula of an insertion needle.

6. The anchoring unit ofclaim 1, wherein at least one of the plurality of anchor mg members extends from the second end of the body.

7. The anchoring unit ofclaim 1, wherein at least one of the plurality of anchoring members extends from the second end of the body such that the at least one anchoring member forms an angle with the longitudinal axis of the body that is at least ninety degrees.

8. The anchoring unit ofclaim 1, wherein at least one of the plurality of anchoring members extends from the first end of the body.

9. The anchoring unit ofclaim 1, wherein the distal end and the proximal end of at least one of the plurality of anchoring members have equal widths.

10. The anchoring unit ofclaim 1, wherein at least one of the plurality of anchoring members tapers such that the distal end of the at least one of the plurality of anchoring members has a width that is less than a width of the proximal end of the at least one of plurality of anchoring members.

11. The anchoring unit ofclaim 1, wherein the at least one connecting element couples together the distal ends of the at least two anchoring members.

12. The anchoring unit ofclaim 1, wherein the at least one connecting element couples together at least two adjacent anchoring members.

13. The anchoring unit ofclaim 1, wherein at least one of the plurality of connecting elements has a thickness that is substantially less than at least one of the plurality of anchoring members.

14. The anchoring unit ofclaim 1, wherein tissue ingrowth forms over at least a portion of the anchoring unit during the useful lifespan of the anchoring unit.

15. A lead assembly comprising:

a lead having a distal end and a proximal end, the lead comprising

a plurality of electrodes disposed on the distal end of the lead,

a plurality of terminals disposed on the proximal end of the lead,

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and

the anchoring unit ofclaim 1;

16. An electrical stimulating system comprising:

the lead assembly ofclaim 15;

a control module configured and arranged to electrically couple to the proximal end of the lead of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead of the lead assembly, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead of the lead assembly, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the lead of the lead assembly.

17. The electrical stimulating system ofclaim 16, wherein the connector is disposed on the control module.

18. The electrical stimulating system ofclaim 16, wherein the connector is disposed on a distal end of a lead extension.

19. The electrical stimulating system ofclaim 18, wherein the lead extension has a proximal end that couples with a second connector disposed on the control module.

20. A method of stimulating patient tissue comprising:

providing the lead assembly ofclaim 15;

inserting the lead assembly into a patient such that the electrodes of the lead assembly are in proximity to the patient tissue to be stimulated;

coupling the lead assembly to a control module;

generating electrical signals using the control module; and

propagating the generated electrical signals to the electrodes of the lead assembly.

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