Showing posts with label Diagnostics. Show all posts
Showing posts with label Diagnostics. Show all posts

Tuesday, July 23, 2013

Surgeon's smart knife detects cancer cells in tumor operations


When surgeons remove tumor tissue they try to leave a "margin" of healthy tissue to ensure all the cancer is removed. Sometimes this means the patient has to remain under general anaesthetic for another 30 minutes or so while tissue samples are sent for analysis to check if the margin is clear. Even then, it is still possible that some cancerous tissue remains, and the patient has to undergo further surgery to remove it.
Now, a new technique based on an "intelligent knife," called the "iKnife," promises to remove the need for lab analysis and the accompanying delay, and it also helps avoid repeat surgeries.
The iKnife sniffs the "smoke" created by the electrosurgical removal of cancerous tissue and tells the surgeon almost immediately if the tissue it has come from is healthy or cancerous.
This first study appears online this week in Science Translational Medicine, in which the iKnife is tested in the operating room.
In tissue samples from 91 patients, researchers at Imperial College London using the iKnife achieved 100% accuracy in diagnosing whether the samples were cancerous or not.
Study author Dr. Zoltan Takats is the inventor of the iKnife. Asked if his new surgical tool would be confined to use in only certain types of cancer, he told Medical News Today:
"It is a generally applicable tool, we believe it will be useful for many different types of cancer surgeries."
On the question of cost-effectiveness, Dr. Takats told us:
"We believe that it will be a cost-saver - due to elimination of intraoperative histology, shorter intervention times and lower rate of re-operations."

iKnife combines electrosurgery with new mass spectrometry techniques

The iKnife is a combination of an established technology called electrosurgery that was invented in the 1920s and a new technology that is still emerging, called rapid evaporative ionization mass spectrometry (REIMS).
In electrosurgery, the surgeon's knife delivers an electric current that heats the target tissue and cuts through it while causing minimum loss of blood.
The heat from the current vaporizes the tissue, which gives off a smoke that is normally sucked away with an extractor.
The mass spectrometer technology behind REIMS almost instantly identifies the chemicals present in human tissue by analyzing the smoke that is released during electrosurgery.
Cells produce thousands of metabolites in various concentrations, depeding on their cell type. So once the REIMS technology is primed with the profiles of healthy and cancerous cells, it can rapidly use these to screen the sample of smoke and inform the surgeon whether it is from a tumor or healthy tissue.
The iKnife being used by a surgeon
The iKnife device "sniffs" smoke created when cancerous tissue is surgically removed, and it then determines whether the tissue is cancerous or healthy. Photo: Imperial College London

iKnife relies on a library of chemical profiles

In the first stage of the study, the researchers created a reference library of chemical profiles consisting of both healthy and cancerous tissue types for the iKnife. They collected samples from surgery patients, taking note of the characteristics of thousands of cancerous and non-cancerous tissues, including brain, lung, breast, stomach, colon and liver tumors.
In the second stage of the study, the team transferred the technology to the operating room and tested it on 91 patients. In all cases, the iKnife correctly identified the tissue type. The results were confirmed with lab tests on the samples after surgery.

Results delivered in under 3 seconds

By comparing the chemical profile of the tissue it is sampling to the reference library, the iKnife can deliver a result in under 3 seconds, say the researchers.
But for this study, the surgeons carrying out the procedures were not allowed to see the nearly instant readings from the iKnife.
The researchers now hope to run a clinical trial that tests whether giving surgeons access to iKnife readings during operations improves outcomes for patients.
Dr. Takats says in a statement:
"These results provide compelling evidence that the iKnife can be applied in a wide range of cancer surgery procedures."
As the technology delivers almost instant results, it allows "surgeons to carry out procedures with a level of accuracy that hasn't been possible before", he adds, noting that they "believe it has the potential to reduce tumor recurrence rates and enable more patients to survive."

Other applications: "Is this beef or horsemeat?"

Although this latest study uses the iKnife to test cancerous tissue, Takats says there is no reason why it couldn't also be used to test for other features, such as whether there is an adequate blood supply, or to identify types of bacteria in the tissue.
Dr. Takats says he has already used the iKnife to distinguish horsemeat from beef.
He first raised the idea of combining electrosurgery with REIMS from real-time identification of tumor tissues in a paper published in 2009.
Funds from the National Institute for Health Research (NIHR) Imperial Biomedical Research Centre, the European Research Council and the Hungarian National Office for Research and Technology helped finance the study

Thursday, February 7, 2013

FDA Clears Sculptor Robotic Guidance Arm™ For Unicompartmental Knee Replacement Surgery

Stanmore Implants ('Stanmore'), specialists in the design and manufacture of patient specific and modular orthopaedic implants, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Sculptor Robotic Guidance Arm™ ("Sculptor RGA™") for precision implant placement in unicompartmental knee surgery, also known as partial knee resurfacing.

Partial knee resurfacing only replaces the parts of the knee that are worn out and painful rather than cutting away the entire joint This preservation technique retains the natural ligaments around the knee, reduces surgical damage to tissue and is less invasive compared to total knee replacement. Sculptor RGA™ utilises a robotic guidance arm to assist the surgeon's operation of a cutting tool, limiting the removal of bone to a pre-defined safe area using Stanmore's patent protected 'Active Constraint™' technology.

Stanmore's unique personalised procedural approach to surgery seamlessly integrates advanced technologies. From proprietary planning software, personalised implants are designed in-house, then manufactured and placed precisely. During surgery, bone is removed corresponding to the implant shape whilst a tracking arm determines and monitors the location of the patient ensuring that the surgeon accurately prepares the bone surface to match the implant precisely.

This new and unique approach to the treatment of osteoarthritis of the knee has been used at a number of leading centres in the UK since the first patient specific personalised knee was implanted in July 2011 and builds upon the earlier clinical work undertaken using the Active Constraint™ technology featured in the Sculptor RGA™ device. Active Constraint™ technology has been shown to provide better functional outcome at 7 year follow up for partial knee surgery compared to the saws and jigs currently used in most knee surgery procedures, which are prone to a much higher degree of placement error.

The Sculptor RGA™ will be introduced in the United States for unicompartmental knee surgery in a limited release to a select group of surgeons from mid-2013, as Stanmore continues its evidence based approach to new product introduction. The Company is also developing additional applications for Sculptor RGA™ with the goal of broader commercialisation next year.

Brian Steer, Executive Chairman of Stanmore, said:

"Following this FDA clearance for Sculptor RGA™ we are excited by the opportunity to bring our personalised approach to knee surgery to patients in the United States. Robotic technology represents a major advance in orthopaedics, providing accurate placement that is critical to implant longevity and reproducibility along with tangible cost benefits, making access to robotic surgery more widely available to patients. Stanmore is now looking forward to working further with surgeons to continue to develop innovative solutions for the global orthopaedic market."

Wednesday, January 2, 2013

Robotic-Assisted Radical Bladder Surgery Potentially Benefits Bladder Cancer Patients

About 30 percent of the more than 70,000 bladder cancer cases expected in 2012 are muscle invasive. In such cases, radical cystectomy is the preferred treatment. In a pilot trial, a team of investigators assessed the efficacy of open radical cystectomy (ORC) vs. robotic-assisted laparoscopic radical cystectomy (RARC). While there were no significant differences in treatment outcomes, RARC resulted in decreased estimated blood loss and shorter hospital stay compared to ORC. The results are published in the February 2013 issue of The Journal of Urology.

"In the last decade minimally invasive approaches including robotic-assisted approaches have emerged as viable surgical options for many urological malignancies with the promise of decreased morbidity with shorter hospital stays, faster recovery, and less narcotic analgesic requirements," says lead investigator Dipen J. Parekh, MD, Professor and Chairman of the University of Miami Miller School of Medicine's Department of Urology and Director of robotic surgery; formerly at the University of Texas Health Science Center at San Antonio.

The goal of the clinical trial was to provide preliminary data from a single institution's randomized trial that evaluated the benefits of robotic-assisted vs. open surgery in patients with invasive bladder cancer. The trial, conducted between July 2009 and June 2011, involved 47 patients and was performed at the University of Texas Health Science Center at San Antonio. Primary eligibility was based on candidacy for an open or robotic approach at the discretion of the treating surgeon. Forty patients were randomized individually and equally to either an ORC or RARC group using a computer randomization program. Each of the two study groups was similar in distribution of age, gender, race, body mass index, previous surgeries, operative time, postoperative complications, and final pathological stage.

Investigators evaluated five surgery outcome factors: Estimated blood loss, operative time from incision to closure, transfusion requirements, time to return of bowel function, and length of stay.

The robotic group experienced significantly decreased blood loss, accompanied by a trend toward faster return of bowel function, fewer hospitalizations beyond five days, and fewer transfusions.

"The strength of our study is the prospective randomized nature that eliminates selection biases that may have been present in prior retrospective analyses," says Dr. Parekh. "We also believe that our study demonstrates that a prospective randomized trial comparing traditional open and robotic approaches in bladder cancer is possible."

This investigative team has joined with several institutions nationally to build on its study and has started an advanced randomized clinical trial among multiple institutions to further compare and assess open vs. robotic-assisted radical cystectomy among patients with invasive bladder cancer. It plans to collect intermediate and long-term survival data from these same patients as well as data on quality of life, daily living activities, handgrip strength, and mobility.