Improved Radiological Marker for Implantable Devices

Description:

Technology: Surgeons and researchers at MUSC have created an enhanced radiologically visible feature and system  for orienting symmetrical implants in Deep Brain Stimulation (“DBS”) that reduces radiation and time required for determining the device’s orientation. This system utilizes a new feature that can be fixed in a substantially flush manner to a symmetrical DBS lead housing. The novel device is a helical element that turns at least once about the longitudinal axis of the symmetrical housing. The helical element is made of a radio-opaque material that is different from the material used in the symmetrical housing, such that the helical element can be visualized using an X-ray. Once visualized, the helical element’s position can be analyzed to determine the orientation of the implant housing.

 

Figure 1: Example of the novel helical element showing the orientation of a symmetrical cylindrical device in a two-dimensional image.

 

Overview: There are upwards of 8,000 new patients receiving DBS devices annually and the list of diseases that DBS can be used to treat continues to grow. For implants that require specific orientation for patient safety and optimal efficacy, such as directional leads in DBS devices, it is imperative to be able to discern the orientation of the implant. Current systems for ensuring implant orientation include use of keyed rigid guide cannula, asymmetrical radio-opaque marking on the exterior of the implant, and computed tomography (CT) imaging. The first system does not work for DBS because removal of the guide cannula can cause the DBS electrode to shift its orientation. The second system does not work for DBS because it only provides orientation information in some planes, but not all; for example, twisting a DBS about its longitudinal axis would not be discernable using exterior markings. The third system does work for DBS, but exposes the patient to undesirable levels of radiation. The helical element used in this new technology combats each of these issues by enabling the orientation to be determined in multiple planes with a single, two-dimensional X-ray image and not requiring a guide cannula to be removed after implantation.

 

Applications: Deep Brain Stimulation (DBS), Neurosurgery, X-Ray Imaging

 

Advantages:

1. More Accurate Orientation: Helical shape of device allows surgeon to accurately determine the orientation of the device in multiple planes

2. Improved Device Efficacy: Correctly oriented devices achieve their intended purpose in a safe, effective manner

3. Safer for Patient: Reduced number of X-rays needed to determine implant orientation decreases patient exposure to radiation

4. Time Saver: Using a single X-ray to orient the device reduces time spent positioning and imaging the device

 

Key Words: Symmetrical Devices, Orient, Implants, Deep Brain Stimulation (DBS), Parkinson’s disease

 

Inventors: Istvan Takacs

Patent Status: US Provisional Patent Application 62/868,330

MUSC-FRD Technology ID: P1970

 

 

Patent Information:
Category(s):
Device
For Information, Contact:
Troy Huth
Sr Licensing Manager
MUSC Foundation for Research Development
huth@musc.edu
Inventors:
Istvan Takacs
Keywords:
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