News Column

Researchers Submit Patent Application, "Hydraulically Actuated Handle Assembly for Medical Device Deployment System", for Approval

July 31, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Headley, Josh (Ellettsville, IN), filed on January 9, 2013, was made available online on July 17, 2014.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "Various medical devices, including stents, stent grafts, and venous filters, are deployed within the vasculature of a patient using deployment devices. Some of the medical devices are self-expanding, in a radial direction, and require restriction from radial expansion prior to deployment. According to some deployment systems, an outer sheath maintains a restricted position of the self-expanding medical device during advancement of the medical device to a deployment site. Once the medical device is positioned at or near the deployment site, the sheath is removed, or retracted, to permit radial expansion of the self-expanding medical device. The retraction of the sheath is typically facilitated through manipulation of a handle positioned at a proximal end of the deployment system.

"Although a variety of different deployment system handles exist, ranging from relatively simple to relatively complex devices, a conventional pull-type handle includes a proximal handle portion and a distal handle portion. The proximal handle portion is configured to maintain a relatively stationary position of a pusher catheter, which supports the self-expanding medical device, while the distal handle portion is configured to retract a sheath positioned over the self-expanding medical device. Prior to deployment, the proximal and distal handle portions are positioned away from one another, resulting in a relatively long pre-deployment length of the deployment system. Deployment of the medical device is initiated by proximally retracting the distal handle portion, which is connected to the sheath, toward the proximal handle portion. In addition to having a relatively long pre-deployment length, the conventional pull-type handle requires non-intuitive manipulation of the handle portions, which may be difficult for less experienced clinicians. Further, the expanded pre-deployment configuration may be relatively unstable, particularly for the deployment of relatively large medical devices.

"U.S. Pat. No. 6,113,608 to Monroe et al. discloses a stent delivery device having a hydraulically actuated retractable sheath. In particular, a pressurizing fluid is either supplied by an inflation lumen to a portion of a piston housing or is withdrawn from a portion of the piston housing to actuate a piston. As the piston moves, a retractable sheath, which is connected to the piston, moves as well and causes the sheath to retract. Although the handle of the Monroe et al. disclosure may be useful for some applications, it should be appreciated that there is a continuing need for efficient and effective handles for medical device deployment systems.

"The present disclosure is directed toward one or more of the problems or issues set forth above."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "In one aspect, a medical device deployment system includes an inner shaft having an elongate body, a proximal end, a distal end, and a medical device support region at the distal end of the elongate body. The inner shaft is telescopically received within a retractable sheath having an elongate tubular body defining a lumen extending from an open proximal end to an open distal end. A medical device is positioned over the inner shaft at the medical device support region. A handle assembly includes a hollow handle body defining a movement axis and having an open distal end receiving the inner shaft and the retractable sheath therethrough. A hollow washer is positioned within the hollow handle body and is movable along the movement axis. The open proximal end of the retractable sheath is attached to the hollow washer and the inner shaft is received through an opening defined by the hollow washer. The hollow handle body defines an expandable fluid chamber between the open distal end of hollow handle body and the hollow washer. A deployment port is positioned through the hollow handle body and is in fluid communication with the expandable fluid chamber. The medical device deployment system has a pre-deployment configuration in which the hollow washer has an initial position within the hollow handle body, the expandable fluid chamber has an initial volume, and the retractable sheath restricts radial expansion of the medical device. The medical device deployment system also has a post-deployment configuration in which the hollow washer has a retracted position proximally spaced from the initial position, the expandable fluid chamber has an expanded volume greater than the initial volume, and the retractable sheath is retracted such that the medical device is not restricted from radial expansion by the retractable sheath.

"In another aspect, a method of deploying a medical device within a body lumen using the medical device deployment system described above is also provided. The method includes a step of advancing a distal portion of the medical device deployment system toward a deployment site within the body lumen with the medical device deployment system in the pre-deployment configuration, in which the hollow washer has an initial position within the hollow handle body, the expandable fluid chamber has an initial volume, and the retractable sheath restricts radial expansion of the medical device. The method also includes increasing the initial volume of the expandable fluid chamber toward an expanded volume by introducing fluid into the expandable fluid chamber through the deployment port. In response, the retractable sheath is proximally retracted by moving the hollow washer toward a retracted position proximally spaced from the initial position. The medical device is then radially expanded responsive to the proximal retraction of the retractable sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 is a partially sectioned side diagrammatic view of a medical device deployment system, shown in a pre-deployment configuration, according to one embodiment of the present disclosure;

"FIG. 2 is a partially sectioned side diagrammatic view of the medical device deployment system of FIG. 1, shown in a post-deployment configuration;

"FIG. 3 is a side diagrammatic view of a vascular structure of a patient at one stage of a medical device deployment procedure using the medical device deployment system of the previous Figs.;

"FIG. 4 is a side diagrammatic view of the vascular structure at another stage of the medical device deployment procedure; and

"FIG. 5 is a side diagrammatic view of the vascular structure at another stage of the medical device deployment procedure."

For additional information on this patent application, see: Headley, Josh. Hydraulically Actuated Handle Assembly for Medical Device Deployment System. Filed January 9, 2013 and posted July 17, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1218&p=25&f=G&l=50&d=PG01&S1=20140710.PD.&OS=PD/20140710&RS=PD/20140710

Keywords for this news article include: Patents.

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Source: Politics & Government Week


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