News Column

Researchers Submit Patent Application, "Fixation and Strain Relief Element for Temporary Therapy Delivery Device", for Approval

May 26, 2014



By a News Reporter-Staff News Editor at Cardiovascular Week -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Clark, Bryan A. (Forest Lake, MN); Jackson, Timothy R. (Minneapolis, MN); Liu, Lili (Maple Grove, MN); Foster, Arthur J. (Blaine, MN), filed on September 18, 2013, was made available online on May 15, 2014 (see also Cardiac Pacemakers, Inc.).

The patent's assignee is Cardiac Pacemakers, Inc.

News editors obtained the following quote from the background information supplied by the inventors: "Temporary implantable leads are often used to evaluate the usefulness of neurostimulation prior to implanting a chronically implantable system within a patient. In some instances, as a treatment for urinary incontinence, patients may be implanted with a trial percutaneous nerve evaluation lead in order to evaluate the efficacy of sacral nerve stimulation for a particular patient. In some cases, the trial lead may be introduced from the posterior side of the sacrum, through a foramen thereof, and into the vicinity of the sacral nerves in order to place an electrode into close proximity with the sacral nerves. At the percutaneous entry point on the patient's back, the lead can be coiled and then affixed to the skin with a small transparent dressing.

"While there are advantages to using temporary medical leads to evaluate the potential performance of neurostimulation, there are several potential complications. Examples of potential complications include lead migration and infection. Because, in many cases, the trial lead exits the skin and is only taped to the back of the patient, the lead can be accidently displaced by the patient as they move about performing daily activities. In order to reduce the risks of infection, the time period in which the lead remains implanted is often-times reduced."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "Example 1 is a method of securing a temporary neurostimulation lead relative to an entry point on a patient. The temporary neurostimulation lead is implanted within the patient such that the temporary neurostimulation lead extends through the entry point and is disposed proximate a desired nerve within the patient. A fixation device is advanced over the temporary neurostimulation lead to a position proximate the entry point. The fixation device includes an attachment portion configured to be releasably fixated to the patient and a lead fixation portion configured to secure the temporary neurostimulation lead. The attachment portion of the fixation device is adhesively fixated to the patient and the temporary neurostimulation lead is fixated to the lead fixation portion of the fixation device.

"Example 2 includes Example 1 and further specifies that the lead fixation portion includes a curved channel formed in an upper surface of the lead fixation portion. Example 2 specifies that fixating the temporary neurostimulation lead to the lead fixation portion of the fixation device includes fitting the temporary neurostimulation lead into the curved channel.

"Example 3 includes Example 1 and further specifies that the lead fixation portion includes one or more raised portions that are configured to frictionally engage a spiral-cut strain relief element. Example 3 specifies that fixating the temporary neurostimulation lead to the lead fixation portion of the fixation device includes wrapping the temporary neurostimulation lead within the spiral-cut strain relief and snapping the spiral-cut strain relief into the one or more raised portions.

"Example 4 includes Example 1 and further specifies that the lead fixation portion includes an upper surface and one or more resilient fingers extending from the upper surface and biased into contact with the upper surface. Example 4 specifies that fixating the temporary neurostimulation lead to the lead fixation portion of the fixation device includes lifting each of the one or more resilient fingers, placing the temporary neurostimulation lead under each of the one or more resilient fingers and allowing each of the one or more resilient fingers to return to their biased position in contact with the upper surface.

"Example 5 includes Example 1 and further specifies that the lead fixation portion includes a resilient polymeric body including a lumen therethrough to accommodate the temporary neurostimulation lead. Example 5 specifies that advancing the fixation device over the temporary neurostimulation lead to a position proximate the entry point includes advancing the fixation device over the temporary neurostimulation lead with the temporary neurostimulation lead extending through the lumen.

"Example 6 includes Example 5 and further specifies that fixating the temporary neurostimulation lead to the lead fixation portion of the fixation device includes disposing an external clamp over the resilient polymeric body to compress the resilient polymeric body into frictional contact with the temporary neurostimulation lead.

"Example 7 includes Example 5 and further specifies that the resilient fixation portion includes an upper portion that is rotatable relative to a lower portion, and that the lumen is defined at least in part by polymeric bands extending between the upper portion and the lower portion. Example 7 specifies that fixating the temporary neurostimulation lead to the lead fixation portion of the fixation device includes rotating the upper portion relative to the lower portion in order to tighten the polymeric bands around the temporary neurostimulation lead and securing the upper portion relative to the lower portion to maintain the polymeric bands in their tightened configuration.

"Example 8 includes Example 5 and further specifies that the lead fixation portion includes an under skin fixation feature and an activation portion that is operably connected to the under skin fixation feature. Example 8 specifies that adhesively fixating the attachment portion of the fixation device to the patient further includes squeezing the activation portion to move the under skin fixation feature into a configuration that permits the under skin fixation feature to be inserted under the skin, inserting the under skin fixation feature under the skin and releasing the activation portion to permit the under skin fixation feature to return to a biased position that anchors the under skin fixation feature under the skin.

"Example 9 is a fixation device configured to releasably secure a temporary neurostimulation lead relative to an entry point on a patient. The fixation device includes a polymeric device body having a lower surface and an upper surface, a dermatologically safe adhesive disposed on the lower surface for releasably securing the fixation device to the patient proximate the entry point and a lead fixation structure formed within the upper surface, the lead fixation structure configured to releasably secure the temporary neurostimulation lead.

"Example 10 includes Example 9 and further specifies that the lead fixation structure includes a curved channel configured to releasably secure a temporary neurostimulation lead therein.

"Example 11 includes Example 9 and further specifies that the lead fixation structure includes one or more raised portions that are configured to frictionally engage a spiral-cut strain relief element.

"Example 12 includes Example 11 and further specifies that the fixation device includes a spiral-cut strain relief element.

"Example 13 includes Example 9 and further specifies that the lead fixation structure includes one or more resilient fingers that extend from the upper surface and are biased into contact with the upper surface.

"Example 14 includes Example 9 and further specifies that the fixation device includes an external clamp that is configured to clamp onto the lead fixation structure to releasably secure the temporary neurostimulation lead.

"Example 15 includes Example 9 and further specifies that the polymeric device body includes an upper portion that is rotatable relative to a lower portion, with polymeric bands extending between the upper portion and the lower portion. Example 15 specifies that rotating the upper portion relative to the lower portion enables the polymeric bands to tighten around the temporary neurostimulation lead.

"Example 16 includes Example 9 and further specifies that the fixation device includes under an skin fixation element and an activation portion that is operably connected to the under skin fixation element. Example 16 specifies that squeezing the activation portion moves the under skin fixation element into a configuration that permits the under skin fixation element to be inserted under the skin and releasing the activation portion permits the under skin fixation element to return to a biased position that anchors the under skin fixation element under the skin.

"Example 17 is a fixation device that is configured to releasably secure a temporary neurostimulation lead relative to an entry point on a patient. The fixation device includes a polymeric device body having a lower surface and an upper surface and a dermatologically safe adhesive disposed on the lower surface for releasably securing the fixation device to the patient proximate the entry point. The fixation device includes a spiral-cut strain relief element including an elongate body and a spiral groove formed within the elongate body, the spiral groove configured to accommodate the temporary neurostimulation lead therein. A pair of raised portions are molded into the upper surface, the pair of raised portions being configured to frictionally engage the spiral-cut strain relief element.

"Example 18 includes Example 17 and further specifies that the fixation device includes a peel away layer disposed on the dermatologically safe adhesive in order to protect the adhesive.

"Example 19 includes Example 17 and further specifies that the pair of raised portions are integrally molded as part of the polymeric device body.

"Example 20 includes Example 17 and further specifies that the polymeric device body includes an elongate slot formed within the polymeric device body such that the elongate slot permits the fixation device to be slid laterally onto the temporary neurostimulation lead.

"While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 illustrates an embodiment of a temporary neurostimulation lead positioned proximate the sacral nerves of a patient.

"FIG. 2 is a perspective view of a fixation device in accordance with embodiments of the present invention.

"FIG. 3 is a perspective view of a fixation device in accordance with embodiments of the present invention.

"FIG. 4 is a schematic view of an external clamp in accordance with embodiments of the present invention.

"FIG. 5 is a schematic view of an external clamp in accordance with embodiments of the present invention.

"FIG. 6 is a perspective view of a fixation device in accordance with embodiments of the present invention.

"FIG. 7 is a schematic cross-sectional view of a fixation device in accordance with embodiments of the present invention.

"FIG. 8 is a schematic view of a fixation device in accordance with embodiments of the present invention.

"FIG. 9 is a schematic view of a fixation device in accordance with embodiments of the present invention.

"FIG. 10 is a flow diagram illustrating a method in accordance with embodiments of the present invention.

"FIG. 11 is a flow diagram illustrating a method in accordance with embodiments of the present invention.

"While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims."

For additional information on this patent application, see: Clark, Bryan A.; Jackson, Timothy R.; Liu, Lili; Foster, Arthur J. Fixation and Strain Relief Element for Temporary Therapy Delivery Device. Filed September 18, 2013 and posted May 15, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1276&p=26&f=G&l=50&d=PG01&S1=20140508.PD.&OS=PD/20140508&RS=PD/20140508

Keywords for this news article include: Therapy, Cardiac Pacemakers Inc..

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Cardiovascular Week


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