Abstract: A stimulation therapy device provides an electrical stimulation therapy to branches of the tibial nerve of a patient. The device comprises a support member configured to be worn around the ankle or foot of the patient, first and second pairs of electrodes attached to the support member, and a stimulation circuit attached to the support member. The stimulation circuit is configured to deliver electrical stimulation pulses through the first and second pairs of electrodes.

Abstract: Embodiments of the invention generally relate to an anchor used to secure a position of a device or component relative to internal tissue of a patient and prevent migration of the component relative to the tissue of the patient. In one embodiment, the anchor is combined with an electrode lead that is configured for implantation in a patient. The electrode lead comprises a lead body having a proximal end and a distal end, a stimulating electrode and the anchor. The stimulating electrode is attached to the lead body at the distal end. The anchor is attached to the distal end of the lead body. In one embodiment, the anchor comprises a plurality of fiber loops each including a fiber having first and second ends attached to the lead body, and an intermediate portion between the first and second ends that is displaced from the lead body.

Abstract: Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

Abstract: Embodiments of the invention generally relate to an anchor used to secure a position of a device or component relative to internal tissue of a patient and prevent migration of the component relative to the tissue of the patient. In one embodiment, the anchor is combined with an electrode lead that is configured for implantation in a patient. The electrode lead comprises a lead body having a proximal end and a distal end, a stimulating electrode and the anchor. The stimulating electrode is attached to the lead body at the distal end. The anchor is attached to the distal end of the lead body. In one embodiment, the anchor comprises a plurality of fiber loops each including a fiber having first and second ends attached to the lead body, and an intermediate portion between the first and second ends that is displaced from the lead body.

Abstract: Implantable medical devices to relieve problems associated with incontinence and related pelvic disorders and methods of implanting same are disclosed. Stimulation leads for placement in the pelvic floor have fixation mechanisms for stabilization of the stimulation electrodes to inhibit dislodgement from a selected stimulation site. In certain embodiments, the fixation mechanisms encourage fibrosis about the lead to chronically stabilize the position of the stimulation lead and/or stimulation electrode(s). In certain embodiments, the fixation mechanisms are isolated from body tissue during routing of the stimulation lead through a tissue pathway and then exposed to body tissue to encourage fibrosis.

Abstract: One embodiment of an electrode lead comprises a lead body, at least one electrode at a distal end of the lead body, an actuatable member and at least one anchor wire. The actuatable member is positioned within a lumen of the lead body. The at least one anchor wire has a proximal end that is attached to the actuatable member. Movement of the actuatable member relative to the lead body moves the at least one anchor wire through at least one opening in the lead body.

Abstract: Methods and instruments forming a tissue pathway between the first and second skin incisions to draw a permanent or temporary elongated medical device or implant, e.g., a medical electrical lead, through the tissue pathway are disclosed. A tunneling instrument comprises an elongated sleeve and a needle that are mounted together to be used as the tunneling instrument to form the tissue pathway and separated so that the sleeve may be employed to engage the lead connector to pull the medical electrical lead through the tissue pathway.

Abstract: An implantable medical stimulation device is provided including non-weld connections between one or more feed-through conductors and electrical contacts of a connector block for the device. The device can be configured for implantation into a pelvic region of a patient to provide muscle and/or nerve stimulation that is used to control and/or treat a pelvic condition of the patient, such as pelvic pain, urinary incontinence, fecal incontinence, erectile dysfunction or other pelvic conditions. The non-weld connections serve to simplify connectivity by providing an insertable wedge-like member, or a crimping member, adapted to facilitate selective electrical connectivity.

Abstract: Various surgical introducer needle and anchor systems are provided. The systems can include an introducer needle and a tissue support implant or sling device. The implant device can include one or more anchoring devices. The introducer needle device can include a handle assembly and a needle assembly. The needle assembly can include a generally hollow needle, and a wire traversable therein. The wire can include a distal tip adapted to selectively retract or withdraw from the engaged anchoring device upon deployment of the anchor and/or implant.

Abstract: Embodiments of the invention generally relate to an anchor used to secure a position of a device or component relative to internal tissue of a patient and prevent migration of the component relative to the tissue of the patient. In one embodiment, the anchor is combined with an electrode lead that is configured for implantation in a patient. The electrode lead comprises a lead body having a proximal end and a distal end, a stimulating electrode and an anchor. The stimulating electrode is attached to the lead body at the distal end. The anchor is attached to the distal end of the lead body and comprises an anchor body and mesh attached to the anchor body.

Abstract: Improved methods and apparatuses for treatment of incontinence or pelvic organ prolapse are provided. A neo ligament for increasing the supportive function of the tissues supporting the urethra, bladder neck, or rectum is disclosed. Methods of using such a neoligament to treat incontinence are disclosed. Additionally, a self tensioning elastic tissue bolster for support of the tissues that support the urethra, rectum, and bladder neck are disclosed. A method of treating incontinence by injecting proliferative agents into supportive structures is disclosed. Methods and apparatus for transvaginal and transperitieai pelvic floor bolster treatment of incontinence and bladder pillar systems are also disclosed.

Abstract: Minimally invasive surgical instruments and procedures introducing neural stimulation leads comprise an inner member and an outer member and provide for a convenient coupling of an external stimulator lead at the inner member handle for application of test stimuli to nerves and tissue proximate the distal end of the inner member. A conductive inner member shaft proximal end extends into or proximally through the non-conductive handle and is configured to provide an inner member connector within or extending proximally to the handle for connection with a test stimulator. The inner member shaft is electrically conductive to conduct such test stimuli to nerves and tissue proximate the exposed shaft distal end. The outer member is preferably non-conductive and may thereby electrically insulate the shaft body proximal to the exposed shaft distal end. Ergonomically shaped inner member handles, caps, and inner member-outer member interlocking mechanisms are disclosed.

Abstract: Embodiments of the invention generally relate to an anchor used to secure a position of a device or component relative to internal tissue of a patient and prevent migration of the component relative to the tissue of the patient. In one embodiment, the anchor is combined with an electrode lead that is configured for implantation in a patient. The electrode lead comprises a lead body having a proximal end and a distal end, a stimulating electrode and an anchor. The stimulating electrode is attached to the lead body at the distal end. The anchor is positioned at the distal end of the lead body and comprises one or more protruding elements that are configured to embed within tissue of the patient.

Abstract: A needle delivery system for electrodes includes a needle and a handle. The needle is configured to be inserted into the human body and to deliver and place an electrode therewithin. The needle is inserted along a direction substantially parallel to the surface of the skin. The handle draws a line of skin upward in a direction substantially normal to the direction of insertion of the needle. The handle includes a guide hole to guide the placement of the needle into the line of the skin.

Abstract: Implantable medical devices to relieve problems associated with incontinence and related pelvic disorders and methods of implanting same are disclosed. Stimulation leads for placement in the pelvic floor have fixation mechanisms for stabilization of the stimulation electrodes to inhibit dislodgement from a selected stimulation site. In certain embodiments, the fixation mechanisms encourage fibrosis about the lead to chronically stabilize the position of the stimulation lead and/or stimulation electrode(s). In certain embodiments, the fixation mechanisms are isolated from body tissue during routing of the stimulation lead through a tissue pathway and then exposed to body tissue to encourage fibrosis.