Transperineal imaging-guided prostate needle placement

Inventors

Wood, BradfordXu, ShengSEIFABADI, Reza

Assignees

US Department of Health and Human Services

Publication Number

US-11504154-B2

Publication Date

2022-11-22

Expiration Date

2037-07-28

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Abstract

Prostate biopsy systems are provided that include a 3D ultrasound probe support configured to receive an ultrasound probe for transperineal imaging. One or more template grids can have a plurality of apertures extending therethrough to receive and guide a biopsy needle along a trajectory associated with respective apertures when the template grid is fixed to the support and the biopsy system is positioned in the perineal area of a patient. Patient-specific template grids can also be developed and produced. This system enables fully transperineal prostate biopsy (i.e. both imaging and needle placement are perineal) and eliminates the need for an external racking device for image fusion as well as needle tracking. In addition, it reduces the infection risk associated to transrectal approach.

Core Innovation

The invention disclosed is a transperineal prostate biopsy system that integrates a 3D ultrasound probe support configured to receive and position the probe externally adjacent to a patient's perineum, along with one or more template grids fixed relative to the ultrasound probe support. These template grids have multiple apertures through which biopsy needles can be guided along predefined trajectories for needle placement. This setup enables fully transperineal prostate biopsy, where both imaging and needle placement occur perineally without requiring insertion into the rectum.

The system addresses the problem of the conventional prostate biopsy techniques which are typically performed under transrectal ultrasound (TRUS) guidance. TRUS methods suffer from poor spatial resolution and necessitate invasive insertion into the rectum, causing patient discomfort and increased infection risk. Fusion of TRUS with preoperative MRI for improved targeting usually requires external electromagnetic tracking devices, increasing complexity and cost. There is a need for improved imaging systems that reduce invasiveness, enhance accuracy, and eliminate the need for external tracking devices.

The disclosed system solves these problems by employing a 3D ultrasound probe with fixed template grids that allow sensorless fusion of ultrasound and MRI images as well as sensorless needle placement. The template grids can be structured in various configurations—extending upward above the probe or laterally to the sides—to provide multiple needle trajectories that cover the prostate extensively without interference from the ultrasound probe or patient anatomy such as the pubic arch. The system includes a movable frame with linear actuators to position the ultrasound probe adjacent to the perineum, enabling real-time transperineal 3D ultrasound imaging and accurate biopsy guidance using registered template grids and image fusion with preoperative scans.

Claims Coverage

The patent includes one independent system claim and one independent method claim, each featuring innovative elements related to transperineal biopsy guidance using fixed template grids and 3D ultrasound imaging.

Transperineal prostate biopsy system with laterally-extending template grids

A system comprising an ultrasound probe support positioned externally adjacent to a patient's perineum, coupled to one or more template grids fixed relative to the probe support. The template grids include at least two laterally-extending grids projecting in different lateral directions from the support, each having multiple apertures to guide biopsy needles along transperineal trajectories. The system includes a movable frame to position the ultrasound probe and obtain transperineal 3D ultrasound imaging.

Template grids with curved and pivotable configurations for needle guidance

The template grids can include an upper grid mounted above the ultrasound probe support with a concave side facing the patient, which can be curved and pivotably coupled to allow movement relative to the probe support. Similarly, the laterally-extending grids can be curved with concave sides facing the patient and pivotably coupled for positional adjustment, enabling various needle trajectories.

Template grid with central and laterally-extending portions defining needle trajectories

A template grid configuration comprising a central grid portion and a pair of laterally-extending grid portions, each with multiple apertures defining needle paths. The apertures in the central portion are generally parallel, and those in each laterally-extending portion are generally parallel, with needle trajectories angled inward to access different prostate regions.

Frame with movable stage using linear actuator for probe positioning

The frame includes a movable stage allowing the ultrasound probe support to move relative to a portion of the frame. This stage incorporates a linear actuator, manual or motorized, to move the probe towards or away from the patient, facilitating precise positioning adjacent the perineal area.

Method of performing transperineal prostate biopsy using fixed template grids

A method involving coupling an ultrasound probe to a support with fixed template grids having multiple apertures extending through them to guide biopsy needles along transperineal trajectories. The probe is positioned externally adjacent to the perineal area with restricted movement, a 3D ultrasound image is acquired, the template grids are registered to the ultrasound image, and an aperture is selected based on the targeted tissue area. A biopsy needle is inserted through the selected aperture to obtain a sample.

Registration and display of fused ultrasound and preoperative images for biopsy guidance

The method includes registering a preoperative high-resolution image (e.g., MRI or CAT scan) with the transperineal 3D ultrasound image and displaying them together to guide biopsy needle placement through the selected aperture trajectories.

The independent claims collectively cover a transperineal prostate biopsy system with fixed template grids that have apertures extending laterally and/or above an ultrasound probe support, a movable frame for positioning a 3D ultrasound probe adjacent to the perineum, and a corresponding method involving image acquisition, registration, fusion, aperture selection, and needle insertion without the need for external tracking devices.

Stated Advantages

Enables fully transperineal prostate biopsy with both imaging and needle placement being perineal, reducing invasiveness compared to transrectal approaches.

Eliminates the need for external tracking devices like electromagnetic tracking for MR-US image fusion and needle tracking, simplifying the procedure and reducing costs.

Reduces patient discomfort and the infection risk associated with transrectal ultrasound biopsy due to the non-invasive external perineal ultrasound imaging.

Provides increased needle trajectory options through various template grid configurations allowing comprehensive prostate coverage while avoiding interference from the probe or patient anatomy.

Allows sensorless fusion of transperineal 3D ultrasound images with preoperative high-resolution images, improving diagnostic accuracy and biopsy guidance.

Documented Applications

Prostate biopsy procedures using transperineal ultrasound imaging combined with needle guidance through fixed template grids.

Guidance of prostate needle placement during biopsy to obtain tissue samples from targeted prostate tissue areas.

Creation and use of patient-specific template grids designed from preoperative high-resolution volume scans and 3D models for customized biopsy needle trajectories.

Image fusion of real-time transperineal 3D ultrasound images with preoperative MRI or CAT scans to improve biopsy targeting accuracy.

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