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05/01/08 | 28 views | #20080103572 | Prev - Next | USPTO Class 607 | About this Page  607 rss/xml feed  monitor keywords

Implantable medical lead with threaded fixation

USPTO Application #: 20080103572
Title: Implantable medical lead with threaded fixation
Abstract: The disclosure is directed to securing electrodes of a medical lead adjacent to a target tissue site. The medical lead may include one or more threaded fixation structures disposed circumferentially about the outer surface of the lead body, or elongated member, that resembles a “screw” or “auger.” During implantation, a clinician may rotate the entire lead to “screw” the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration and improper therapy and provide a fine adjustment for depth of placement. The threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes. (end of abstract)
Agent: Shumaker & Sieffert, P. A. - Woodbury, MN, US
Inventor: Martin T. Gerber
USPTO Applicaton #: 20080103572 - Class: 607116 (USPTO)

The Patent Description & Claims data below is from USPTO Patent Application 20080103572.
Brief Patent Description - Full Patent Description - Patent Application Claims  monitor keywords

TECHNICAL FIELD

[0001]The invention relates to stimulation systems and, more particularly, to stimulation leads in stimulation systems.

BACKGROUND

[0002]Electrical stimulation systems may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, or gastroparesis. An electrical stimulation system typically includes one or more stimulation leads coupled to an external or implantable electrical stimulator. The stimulation lead may be percutaneously or surgically implanted in a patient on a temporary or permanent basis such that at least one stimulation electrode is positioned proximate to a target stimulation site. The target stimulation site may be, for example, a spinal cord, pelvic nerve, pudendal nerve, stomach, muscle, or within a brain or other organ of a patient. The electrodes located proximate to the target stimulation site may deliver stimulation therapy to the target stimulation site in the form of electrical signals.

[0003]Electrical stimulation of a sacral nerve may eliminate or reduce some pelvic floor disorders by influencing the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles. Pelvic floor disorders include urinary incontinence, urinary urge/frequency, urinary retention, pelvic pain, bowel dysfunction, and male and female sexual dysfunction. The organs involved in bladder, bowel, and sexual function receive much of their control via the second, third, and fourth sacral nerves, commonly referred to as S2, S3 and S4 respectively. Thus, in order to deliver electrical stimulation to at least one of the S2, S3, or S4 sacral nerves, a stimulation lead is implanted proximate to the sacral nerve(s).

[0004]Electrical stimulation of a peripheral nerve, such as stimulation of an occipital nerve, may be used to induce paresthesia. Occipital nerves, such as a lesser occipital nerve, greater occipital nerve or third occipital nerve, exit the spinal cord at the cervical region, extend upward and towards the sides of the head, and pass through muscle and fascia to the scalp. Pain caused by an occipital nerve, e.g. occipital neuralgia, may be treated by implanting a lead proximate to the occipital nerve to deliver stimulation therapy.

[0005]In many stimulation applications, including stimulation of a sacral nerve, it is desirable for a stimulation lead to resist migration following implantation. For example, it may be desirable for the electrodes disposed at a distal end of the implantable medical lead to remain proximate to a target stimulation site in order to provide adequate and reliable stimulation of the target stimulation site. In some applications, it may also be desirable for the electrodes to remain substantially fixed in order to maintain a minimum distance between the electrode and a nerve in order to help prevent inflammation to the nerve and in some cases, unintended nerve damage. Securing the stimulation lead at the target stimulation site may minimize lead migration.

SUMMARY

[0006]In general, the disclosure is directed toward securing electrodes of a medical lead adjacent to a target tissue site with a threaded fixation structure configured to engage tissue within a patient to resist migration of the medical lead. The medical lead may be similar to a "screw" or "auger-like." The threaded fixation structure defines one or more threads disposed circumferentially about the outer surface of a lead body. Specifically, the threads of the threaded fixation structure may be arranged in a helical pattern. During implantation, a clinician may rotate the entire lead to "screw" the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration. In addition, the threaded fixation structure may allow a fine adjustment mechanism for the depth of the elongated member within the tissue. The threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes. In some cases, the entire distal end of the lead may include the threaded fixation structure to engage a greater area of tissue. In other embodiments, the threaded fixation structure may be used with drug delivery catheters instead of electrical stimulation leads.

[0007]In one embodiment, the disclosure is directed to a medical lead that includes an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.

[0008]In another embodiment, the disclosure is directed to method that includes inserting a medical lead into a patient, wherein the lead comprises at least one stimulation electrode and at least one threaded fixation structure extending around a portion of an outer surface of the lead, and rotating the lead to engage the threaded fixation structure with tissue of the patient to resist migration of the lead.

[0009]In an additional embodiment, the disclosure is directed to a system that includes a medical lead having an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead. The system also includes a stimulator that delivers electrical stimulation therapy to a patient via the medical lead within the patient.

[0010]In another additional embodiment, the disclosure is directed to an apparatus that includes an elongated member having a proximal end and a distal end, a conduit disposed within the elongated member, an exit port disposed on an outer surface of the elongated member in fluidic communication with the conduit, and at least one threaded fixation structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.

[0011]The disclosure may provide one or more advantages. The threaded fixation structure may be engaged to the adjacent tissue of the patient and still allow the clinician to advance or retract the lead to finely adjust the lead position. A sheath may also be used to cover the threaded fixation structure until the clinician desires to expose the threaded fixation structure to the adjacent tissue, and the sheath may collapse the threaded fixation structure to reduce the lead diameter until lead fixation is desired. In addition, the clinician may remove the lead by rotating the lead and reducing tissue trauma.

[0012]The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

[0013]FIG. 1A is a schematic perspective view of a therapy system including an electrical stimulator coupled to a stimulation lead that has been implanted in a body of a patient proximate to a target stimulation site.

[0014]FIG. 1B is an illustration of the implantation of a stimulation lead at a location proximate to an occipital nerve.

[0015]FIG. 2 is a block diagram illustrating various components of an electrical stimulator and an implantable lead.

[0016]FIGS. 3A and 3B are perspective drawings of a sheath that covers a lead prior to implantation and is removed after the lead is correctly positioned in a patient.

[0017]FIGS. 4A-4C are perspective drawings illustrating exemplary stimulation leads with varying configurations of threaded fixation mechanisms.

[0018]FIGS. 5A-5B are perspective drawings illustrating exemplary stimulation leads with varying threaded fixation mechanisms over electrodes of the lead.

[0019]FIG. 6 is a perspective drawing illustrating an exemplary stimulation lead with threads from the distal tip to a location proximal to electrodes.

[0020]FIG. 7 is a perspective drawing illustrating an exemplary stimulation lead with torsional reinforcement members within the elongated member.

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