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Johns Hopkins University and Acoustic Medsystems, Inc. | Date: 2015-02-03

Disclosed is a system and method for registering images from two medical imaging modalities in a six-degree-of-freedom coordinate space, for the purpose of providing real time registered imagery for optimization of medical procedures. The system and method uses fiducial that is visible to the first imager and in a fixed position and orientation relative to the second imager. The first imager may be an X-ray device such as a C-arm fluoroscope, and the second imager may be a Transrectal Ultrasound (TRUS) device.

Agency: NSF | Branch: Fixed Price Award | Program: | Phase: ENGINEERING RESEARCH CENTERS | Award Amount: 200.00K | Year: 2013

Prostate cancer affects over 241,740 U.S. males annually, making it the most prevalent cancer type and second leading cause of cancer mortality in men. One frequently utilized method of treating prostate cancer is brachytherapy (BT), or implantation of radioactive seeds into the prostate. The success of brachytherapy chiefly depends on the ability to intra-operatively tailor the radiation dose to the patients individual anatomy, i.e. adequately cover the prostate with sufficient radiation while simultaneously avoiding excessive radiation to surrounding organs. Many of the challenges that limit brachytherapy can be addressed by incorporating closed-loop feedback in the brachytherapy implant procedure. That is as seeds are implanted into the prostate, their actual positions are measured and fed back to the treatment planning system, which recalculates the dosimetry and re-optimizes the plan.

This proposal leverages prior and ongoing research between the CISST ERC and Acoustic MedSystems to provide an integrated, commercially-viable system with following capabilities: (1) precise intra-operative localization of the implanted radioactive seeds; (2) intra-operative dosimetry and rapid re-optimization of the brachytherapy implant plan; and (3) the ability to accurately and efficiently execute the updated implant plan.

The major goal of the improved process is to minimize human errors with a procedure that has a feedback mechanism for accurate and optimized dosimetry and robotic assistance in the delivery of needles in accordance with a re-optimized implant as the procedure progresses.

Acoustic Medsystems, Inc. and The Regents Of The University Of California | Date: 2014-12-11

Transurethral ultrasound treatment system and methods that provide targeted treatment zones outside urethra via an applicator with multiple sectors, a urethral cooling balloon, and bladder positioning balloon for directed application in muscle tissue. In one embodiment, the system and methods are configured to generate thermal lesions via simultaneous sonication or activation of two separate sectors from a tubular device, with an inactive zone directed toward vaginal wall or nerves.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2015

DESCRIPTION provided by applicant Stress urinary incontinence SUI in women is an increase of pelvic floor compliance which results in decrease of urethral pressure typically through childbirth and presents as urine leakage during exertion SUI has significant impact on womenandapos s health including an association with increased levels of depression Curative options are limited to the invasive surgical insertion of a tape implant which limits the mobility of the urethra Bulking agents injected in the peri urethral tissue are a longstanding effective but temporary treatment Pharmaceuticals are relatively new prohibitively expensive and there is no track record of long term efficacy The remaining million women are relegated to the palliative approaches of wearing absorptive pads or diapers A substantial clinical need exists for a noninvasive alternative to traditional surgical approaches with the promise of less morbidity and recovery time faster procedure time and lower cost Recent clinical investigations of minimally invasive thermal techniques have demonstrated targeted thermal modification of tissue can reduce symptoms of SUI These techniques have shown promise but are more invasive than the current surgical options and are less effective Therapeutic and interstitial ultrasound devices are an innovative technology under development by our group for delivering thermal therapy for treating cancer as well as uterine fibroids with demonstrated capabilities to provide dynamic spatial control of selective heating patterns greater radial thermal penetration and fast treatment times We propose to develop this ultrasound technology specifically for the treatment of SUI this technology has potential to provide a superior minimally invasive heating technique for treating SUI with the promise of more accurate and thorough targeting protection of critical non targeted tissue e g urethra vaginal wall more accessibility to a larger numbe of SUI patients and faster procedure times The objective of this Phase I research plan is to extend existing technology and develop transurethral therapeutic ultrasound applicators specific for selective and conformal thermal therapy of specific tissue structures required for successful treatment of SUI Empirical design bench experiments biothermal and acoustic modeling together with experimental testing in both ex vivo tissues and a pilot in vivo study in older ewes GU tract will be used for design feedback and to characterize device performance as well as assess the technical and potential clinical feasibility These results will be applied to the development and understanding of refined devices and potential treatment approaches in preparation for the ultimate goal of product development and clinical implementation during Phase II PUBLIC HEALTH RELEVANCE Stress urinary incontinence SUI is a condition which affects more than million American women Those who seek treatment results in close to surgical and other therapeutic interventions each year The condition presents as inadvertent urinary leakage during exertion such as exercise lifting or laughing The curative interventions currently available are either invasive surgery implants or too expensive The vast majority seek palliative therapies such as absorptive pads and diapers as their only alternative The problems associated with SUI extend beyond the apparent symptoms of inadvertent urinary leakage The associated effects on freedom of activity embarrassment self esteem and mental health SUI has a direct association with depression in sufferers are significant There is a strong need for a noninvasive and relatively inexpensive method to address the condition in these womenandapos s lives This proposed new high intensity ultrasound treatment would address both of those issues Therapeutic ultrasound requires no incisions and may be performed with topical anesthetic The proposed design of the delivery device will be inexpensive outpatient office based quick and simple minute single treatment procedure allowing many women to receive a curative treatment for a lower payment than they spend annually on palliative absorptive pads and diapers Moreover the proposed technique aims to treat SUI using the concept of personalized medicine where treatment energy pattern is administered according to the respective anatomy of the patient As such this treatment will provide a potential cure for the nearly million women who remain untreated

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 177.41K | Year: 2013

DESCRIPTION (provided by applicant): Prostate cancer affects one in every six men and remains the second leading cause of cancer related mortality in men. Permanent interstitial brachytherapy, the permanent placement of radioactive seeds in the prostate, is widely used in the treatment of prostate cancer. Despite the recent uptake in robotic surgery (with reported increased urinary morbidity) which has impacted both brachytherapy and conventional surgery, brachytherapy remains a widely used treatment. In the historical perspective, brachytherapy has been a definitive treatment option with potentially excellent long term results. The success of brachytherapy depends on adequately irradiating the prostate while avoiding excessive radiation to surrounding organs, most importantly the urethra and rectum. Despite improved outcomes from modifications in brachytherapy technique, contemporary reports document considerable variability in brachytherapy practice, with resultant suboptimal outcomes and toxicity. A recognized major contributor to these poor outcomes is the lack of real- time image guidance to visualize source placement and dose intra-operatively as it evolves due to seed positioning errors and the onset of prostatic edema. The proposed work is the development of a multi-modal image-guidance build in an intelligent platform with capability for real-time, precise, and quantitative evaluation of source position and target dosimetry during the course of a brachytherapy procedure, thereby allowing the physicianto continuously correct for source position alterations and adaptively achieve an optimal implant, resulting in both reduced toxicity and improved cancer control. The proposed work is the development, design and evaluation of a real-time imaging system based on integrated photo-acoustic and transrectal ultrasound image guidance and advanced image processing software that will produce real-time, precise, and quantitative evaluation of seed positions and dosimetry during the brachytherapy procedure and visualize prostate anatomy simultaneously. The proposed system will integrate imaging and planning tools that are already routinely used in current brachytherapy practice with an inclusion of low cost laser source. The real-time imaging will enable the physician to continuously correct for source position errors and adaptively achieve an optimal implant without disruption of existing surgical workflow, resulting in both reduced toxicity and improved cancer control. The research plan will be carried out in three aims: 1) study the optical properties of both prostate and metallic seed, 2) develop integrated photo-acoustic and transrectal ultrasound imaging system, and 3) perform system integration, testing and validation in tissue-mimicking phantoms, ex vivo prostrates and a limited in vivo animal study. The proposed integrated system will be first of its kind to have the capability of real-time imaging of brachytherapy implant and simultaneously visualizing prostate anatomy. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Prostate cancer is diagnosed in approximately 240,000 men per year in the United States, making it the most common cancer afflicting men and second in the overall population. Brachytherapy (implantation of radioactive seeds into the prostate) is widely used in the treatment of prostate cancer, yet studies show that it is possible for men to receive suboptimal brachytherapy treatment, with doses either too high (leading to side effects and sometimes serious toxicity) or insufficient (leading to risk of cancer recurrence). A major contributor to these outcomes is the lack of existing techniques for physicians to visualize or quantify radiation dose within the prostate as seeds are implanted; the goal of the proposed research is to developa system that achieves this capability in a manner that can be readily implemented in operating rooms on a widespread scale nationwide. Over 50,000 brachytherapy procedures are performed in the U.S. annually. Prevalence of the use of brachytherapy is in part due to its minimally invasive nature and relatively brief time commitment on the part of the patient when compared to external beam radiation or surgery. The success of prostate brachytherapy hinges on adequately dosing the prostate while avoiding excessive radiation to adjacent organs, most notably the urethra and rectum. Despite some improvements in technique, the basic methods of prostate brachytherapy have changed little over the past decade, and contemporary multi-center reports document considerable variability in brachytherapy practice with resultant toxicity and suboptimal outcomes. A recognized major contributor to these poor outcomes are source positioning errors and the onset of prostatic edema, which create regions of both inadequate dose aswell as excessive dose. It is broadly recognized that there is a need for accurate image guidance, dynamic visualization of source positions, and intraoperative dose reconstruction as it evolves during the procedure. This work directly addresses these needs.

An ultrasound device and method for the treatment of intervertebral disc tissue for remediation of back pain. An applicator comprises a catheter and/or needle with a distal tip including one or more ultrasound transducer crystals. The crystals produce high-powered ultrasound energy that is transmitted and absorbed in the disc tissue. The resulting temperature elevation of the disc tissue shrinks the collagen fibers in the surrounding tissue, and/or destroying small nerves that may have invaded and innervated the surrounding degenerated tissue, and can provide increased structural integrity and disc support for the fragmented nucleus pulposus to relieve pressure on the spinal nerves.

Systems and methods for transvaginal high intensity concentrated ultrasound. Urinary incontinence is treated through application of high intensity ultrasound to tissue structures to affect a change in the tissue.

A multi-angular ultrasound device. Multi-angular ablation patterns are achieved by a catheter based ultrasound transducer having a plurality of transducer zones. A multi-chambered balloon is positioned on the catheter.

Acoustic Medsystems, Inc. and The Regents Of The University Of California | Date: 2014-06-17

A high-power ultrasound heating applicator for minimally-invasive thermal treatment of uterine fibroids or myomas. High-Intensity interstitial ultrasound, applied with minimally-invasive laparoscopic or hysteroscopic procedures, is used to effectively treat fibroids within the myometrium in lieu of major surgery. The applicators are configured with high-power capabilities and thermal penetration to treat large volumes of fibroid tissue (>70 cm^(3)) in short treatment times (3-20 minutes), while maintaining three-dimensional control of energy delivery to thermally destroy the target volume.

Acoustic Medsystems, Inc. and The Regents Of The University Of California | Date: 2015-01-14

An apparatus and method for shielding non-target tissues and organs during thermotherapy, brachytherapy or other treatment of a diseased target tissue. The apparatus includes a catheter shaft having input and output lumens and at least one inflatable balloon. A plurality of input lumens within the catheter shaft allows the passage of liquid or gas through an input port and into the interior of the balloon thereby inflating the balloon. The gas or liquid can then be cycled through the inflated balloon through an output port and output lumen and out of the catheter shaft. Temperature sensors or other sensors may be attached to the balloon or catheter to monitor temperature or other conditions at the treatment site. The catheter is positioned between the target tissue or organ and sensitive non-target tissues in proximity to the target tissue and inflated causing a physical separation of tissues as well as a physical shield.

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