Source: http://www.google.com/patents/US7660634?dq=5,758,352
Timestamp: 2014-09-02 09:14:24
Document Index: 350792475

Matched Legal Cases: ['Application No. 08151981', 'Application No. 08101856', 'Application No. 08101856', 'Application No. 08151981', 'Application No. 06717501', 'Application No. 06717501']

Patent US7660634 - Combination electrical stimulating and infusion medical device - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA combined electrical and chemical stimulation lead is especially adapted for providing treatment to intervertebral discs. The combination lead may be placed proximate to intervertebral disc cellular matrix and nucleus pulposus tissue to promote tissue regeneration and repair, as well as nociceptor and...http://www.google.com/patents/US7660634?utm_source=gb-gplus-sharePatent US7660634 - Combination electrical stimulating and infusion medical deviceAdvanced Patent SearchPublication numberUS7660634 B2Publication typeGrantApplication numberUS 11/625,186Publication dateFeb 9, 2010Filing dateJan 19, 2007Priority dateJan 11, 2005Fee statusPaidAlso published asUS7386350, US8195307, US20060155342, US20060155343, US20070179536, US20090099613, WO2006076200A2, WO2006076200A3Publication number11625186, 625186, US 7660634 B2, US 7660634B2, US-B2-7660634, US7660634 B2, US7660634B2InventorsBradley D. VilimsOriginal AssigneeVilims Bradley DExport CitationBiBTeX, EndNote, RefManPatent Citations (32), Non-Patent Citations (29), Referenced by (2), Classifications (18), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetCombination electrical stimulating and infusion medical deviceUS 7660634 B2Abstract A combined electrical and chemical stimulation lead is especially adapted for providing treatment to intervertebral discs. The combination lead may be placed proximate to intervertebral disc cellular matrix and nucleus pulposus tissue to promote tissue regeneration and repair, as well as nociceptor and neural tissue modulation. The stimulation lead includes electrodes that may be selectively positioned along various portions of the stimulation lead in order to precisely direct electrical energy to stimulate the target tissue. The lead also includes a central infusion passageway or lumen that communicates with various infusion ports spaced at selected locations along the lead to thereby direct the infusion of nutrients/chemicals to the target tissue.
1. A method for treating intervertebral disc ailments, said method comprising:
inserting an introducer needle into the disc to be treated;
introducing a combined electrical and chemical stimulation device through said introducer needle and into the disc, said device comprising:
a plurality of infusion ports formed on said stimulation lead and communicating with said central lumen, said infusion ports enabling infusion of chemical/nutrients from the central lumen to tissue located exterior of said stimulation lead;
a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes, and wherein said stimulation lead has a bend incorporated adjacent a distal end thereof;
maneuvering the stimulation lead through the disc in an arcuate pattern wherein the distal portion of said stimulation lead is placed adjacent the tissue to be treated;
inserting an electrical stimulation source into the patient, the electrical stimulation source communicating with said stimulation lead to generate electrical pulses for energizing said electrodes and to deliver electrical/thermal energy to target tissue; and
inserting a chemical stimulation source into the patient, said chemical stimulation source communicating with said stimulation lead to provide chemical/nutrients through said central lumen and through said infusion ports thereby delivering chemical/nutrients to the target tissue.
Said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end.
said stimulation lead further includes a stiffening member incorporated in said lead for increasing strength of said lead, said stiffening member extending within and substantially along a length of said stimulation lead and not within said central lumen.
4. A method of managing intervertebral disc pain, said method comprising:
providing a stimulation lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and infusion ports being selectively spaced and arranged with one another;
implanting the stimulation lead in the disc so that the plurality of electrodes and the plurality of infusion ports lie adjacent to a targeted area within the disc; and
delivering electrical energy from the electrodes to the disc;
delivering at least one chemical through the infusion ports into the disc;
said stimulation lead has a diameter that narrows from a proximal end of said lead toward said distal end thereof, and wherein at least some of said infusion ports and said electrodes are positioned between said proximal end and said distal end.
said implanting step further includes the step of imparting a bend angle on a distal end of the stimulation lead in order to assist in implanting the stimulation lead within the targeted area within the disc.
7. A method, as claimed in claim 4, wherein:
8. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:
providing a stimulation lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and said infusion ports being selectively spaced and arranged with one another;
implanting the stimulation lead in the disc so that the plurality of electrodes and the plurality of infusion ports lie adjacent to a targeted area within the disc;
delivering electrical energy from the electrodes to the disc; and
delivering at least one chemical through the infusion ports into the disc; and
said stimulation lead has a diameter that progressively narrows from a proximal end of said lead toward said distal end thereof, and wherein at least some of said infusion ports and said electrodes are positioned between said proximal end and said distal end.
10. A method for treating intervertebral disc ailments, said method comprising:
introducing a combined electrical and chemical stimulation device through said introducer needle and into the disc, said device comprising;
a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes and wherein said stimulation lead has a bend incorporated adjacent a distal end thereof;
inserting a chemical stimulation source into the patient, said chemical stimulation source communicating with said stimulation lead to provide chemical/nutrients through said central lumen and through said infusion ports thereby delivering chemical/nutrients to the target tissue;
said stimulation lead has a straight first portion with at least some of said infusion ports and said electrodes positioned thereon, and a curved shape incorporated at said distal end; and
11. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:
providing a stimulating lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and said infusion ports being selectively spaced and arranged with one another, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes;
12. A method of stimulating a healing response from a damaged intervertebral disc, said method comprising:
providing a stimulating lead having a plurality of electrodes and a plurality of infusion ports, said electrodes and said infusion ports being selectively spaced and arranged with one another, at least one of said infusion ports being located proximally of at least two adjacent electrodes of said plurality of electrodes, and another one of said infusion ports being located distally of said at least two adjacent electrodes;
delivering at least one chemical through the infusion ports into the disc.
13. A method for treating intervertebral disc ailments, said method comprising:
a stimulation lead having an elongate configuration, and a central lumen extending therethrough;
a plurality of infusion ports formed on said stimulation lead and communicating with said central lumen, said infusion ports enabling infusion of chemicals from the central lumen to tissue located exterior of said stimulation lead;
a plurality of electrodes positioned on said stimulation lead adjacent said infusion ports, said electrodes communicating with a source of electrical energy for providing electrical/thermal stimulation of tissue adjacent said electrodes, at least one of said infusion ports being located between two adjacent electrodes of said plurality of electrodes;
maneuvering the stimulation lead through the wherein the distal portion of said stimulation lead is placed adjacent the tissue to be treated;
inserting a chemical stimulation source into the patient, said chemical stimulation source communicating with said stimulation lead to provide chemicals through said central lumen and through said infusion ports thereby delivering chemicals to the target tissue.
CROSS REFERENCE TO RELATED APPLICATION The present application is a divisional of U.S. patent application Ser. No. 11/033,591, filed Jan. 11, 2005, now U.S. Pat. No. 7,386,350, entitled �COMBINATION ELECTRICAL STIMULATING AND INFUSION MEDICAL DEVICE�, which is incorporated herein by this reference.
TECHNICAL FIELD OF THE INVENTION The present invention relates generally to electrical stimulation leads and chemical infusion catheters for treatment of medical conditions, and more particularly, to a system, method and device for providing combined electrical stimulation and chemical/drug infusion for treatment of intervertebral disc ailments.
BACKGROUND OF THE INVENTION It is known that immersing certain cell types within an electrical field will cause these cells to proliferate thus facilitating tissue repair. One known use of an electrical field for such repair is �in bone� stimulators that are implanted in fractures and/or spinal fusions. Another type of treatment has recently developed for spinal conditions wherein target tissue is stimulated by an electrical lead using radio-frequency energy to induce a thermal lesion in the target tissue. In this type of procedure, the therapeutic benefit is intended to derive from heating the target tissue and not from immersing the tissue in an electric field. Thus, the electrical lead in this treatment is strictly for use in heating the tissue, and there is no therapeutic electrical field generated. Chemical treatment of target tissues has also been developed by use of various types of infusion catheters.
SUMMARY OF THE INVENTION In accordance with the present invention, a combined electrical and chemical stimulation device is provided that is especially adapted for treatment of intervertebral disc ailments. The stimulation device is in the form of a stimulation lead designed to be placed in the disc percutaneously through an introducer needle using an extra-pedicular approach; however, micro-surgical or open-surgical techniques may also be utilized. More specifically, the device of the present invention is specifically designed to facilitate placement proximate to the metabolically active cellular, nuclear, annular interface layer by use of one or more selected embodiments including a straight, curved or bent tip, as well as a variable stiffness tip. Selection of one of these embodiments allows the physician to precisely navigate the lead through the nucleus of the disc. In yet another embodiment of the present invention, the stimulation lead may be placed directly into the nuclear annular interface by use of a introducer needle having a bent tip, and use of a stimulation lead having a straight tip that can take a substantially linear path to reach the target tissue.
DETAILED DESCRIPTION Referring to FIGS. 1 and 2, the system 10 of the present invention is shown that includes a combination electrical and chemical stimulation device 12, a stimulation source 14 that communicates with the stimulation device 12 for delivering electrical energy and chemicals to the stimulation device, and an interventional device such as an introducer needle 32 that allows introduction of the stimulation lead into the disc. The stimulation device 12 is shown as inserted within an intervertebral disc D. The combination device 12 more particularly includes a percutaneous electrical and chemical stimulation lead 16 in the form of an elongate tubular member having a desired length and diameter allowing the lead 16 to be placed within the intervertebral disc of the patient to be treated. The working distal portion 20 of the stimulation lead 16 provides the desired stimulation through a plurality of electrodes 22 which are selectively positioned on the distal portion 20, along with a plurality of infusion ports 30 which allow delivery of chemicals/nutrients to target tissue. The proximal portion of the stimulation device 12 can be referred to as a lead extension 18 that connects to the stimulation source 14. The lead extension 18 can be made of the same type and diameter material as the stimulation lead 16, or may be made of a different type of material and diameter.
Referring specifically to FIG. 2, in a first embodiment of the stimulation lead, a plurality of circumferentially extending electrodes 22 are positioned at the distal portion 20. The electrodes 22 are also spaced longitudinally along the distal portion 20. The electrodes produce an array of electrical field energy, and the target tissue is immersed in the electrical field. One or more electrical conductors 23 extend through the interior of the stimulation lead 16 in order to transmit the electrical impulses to the electrodes 22. It is preferable to utilize a single conductor 23 along the major length of the lead, and then provide branch conductors (not shown) at the distal portion 20 that then extend to contact the various electrodes. The branch conductors could be a linearly arranged set of wire extensions extending between each electrode, or any other advantageous combination of wire conductors to interconnect the electrodes. Use of a single conductor is a more robust design as opposed to multiple smaller conductors that are more prone to breakage as a result of the motion cycles of the ISD. It is also contemplated that the electrodes could be a single electrode wound in a helical pattern about the distal portion 20. Thus in this helical pattern, only one conductor 23 would be required with no additional branch conductors. In order to generate the desired intensity and size electrical field, the electrodes 22 can be disposed on the distal portion in a pattern or arrangement that best suits the electrical field to be generated. For example, in the helical pattern, the electrode could be wound with a tighter pattern to generate a more intense field, while a looser more spaced pattern would generate a less intense field. Of course, the particular signal or impulse current provided to the electrodes also determines the intensity of the field generated.
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No. 12/033,232, Vilims.26Walsh et al.; "In Vivo Growth Factor Treatment of Degenerated Intervertebral Discs"; SPINE, vol. 29, No. 2, pp. 156-163.27Wang et al.; "Up-regulation of Chondrocyte Matrix Genes and Products by Electric Fields"; Clinical Ortho. & Related Research; Oct. 2004, 427S: S163-S173.28Written Opinion for International (PCT) Patent Application No. PCT/US06/00312, mailed Jul. 19, 2006.29Yoon et al.; "The Effect of Bone Morphogenetic Protein-2 on Rat Intervertebral Disc Cells in Vitro"; SPINE, vol. 28, No. 16, pp. 1773-1780.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8082043 *Oct 31, 2007Dec 20, 2011Neurotherm, Inc.Method for treating intervertebral disc degenerationUS8323277Oct 12, 2011Dec 4, 2012Vilims Bradley DCombination electrical stimulating and infusion method* Cited by examinerClassifications U.S. Classification607/117, 607/3International ClassificationA61N1/18, A61N1/30Cooperative ClassificationA61M5/172, A61N1/36071, A61M2205/3523, A61N1/0558, A61M2210/1003, A61N1/36103, A61N1/0553, A61M5/14276European ClassificationA61N1/05L8, A61N1/36Z, A61N1/36E4, A61N1/36, A61M5/172, A61M5/142P10Legal EventsDateCodeEventDescriptionMar 13, 2013FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google