Devices for guided tissue manipulation and/or tissue removal procedures

Abstract

The present disclosure includes a customized guide device in the form of a guide template configured to fit over a given area of ​​a patient's body and to provide guidance during a tissue manipulation or tissue removal procedure in that given area, which may include introducing Target tissue administration of agent, target tissue biopsy, target tissue resection, or target tissue ablation. The customized guide template is generally constructed by an additive manufacturing process (i.e., three-dimensional (3D) printing) or a subtractive manufacturing process (i.e., milling) based on a manufacturing instruction file, which may include the Imaging data for a given region. The manufacturing instruction file may further include additional data, such as the type of procedure to be performed (ie, biopsy of tissue abnormality, destruction or excision of tissue abnormality, etc.).

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 62 / 671,609, filed May 15, 2018, the contents of which are hereby incorporated by reference in their entirety. [0003] government power [0004] This invention was made with government support under grant NIH (National Institutes of Health) R44CA210810 awarded by the National Cancer Institute, part of the National Institutes of Health, which has certain rights in this invention. technical field [0005] The present disclosure relates generally to devices for assisting medical procedures, and more particularly, to a customized guide device in the form of a guide template configured to fit over a given area of ​​a patient's body and to provide Provides guidance on target tissue removal or manipulation. Background technique [0006] Most tissue manipulation and / or removal procedures require a high degree of precision to...

AI Technical Summary

Problems solved by technology

[0010] For example, while a typical skilled practitioner can detect tumors and microcalcifications with ultrasound, available navigation systems may still rely on manual positioning where the manipulative components of a biopsy or tissue removal system (i.e., ultrasound transducer wand and living tissue inspection or electrosurgical devices) are each freely manipulated by the hand

In other words, the surgeon must use both hands continuously and consistently throughout the operation, which can have significant disadvantages

For example, a surgeon must simultaneously manipulate an ultrasound transducer wand and position / manipulate a biopsy or electrosurgical device while viewing an image of the working end of the device relative to the target tissue, due to proper alignment of the working end of the device and the target The organization's trial and error process, which can lead to operator frustration and / or fatigue

Furthermore, because breast tissue is relatively soft, manipulation in the form of contact with biopsy or electrosurgical equipment and / or ultrasound transducers may cause the target lesion to move within the breast and result in inaccurate penetration of the target tissue (using for biopsy purposes) or incomplete destruction or removal of target tissue

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