Sunday, November 7, 2010
New Surgical Applicator
Labels:
applicators
Researchers invent inkjet that prints out living skin
This is no horror movie, this is part of a recent presentation at the American College of Surgeons Clinical Congress, where Wake Forest Institute for Regenerative Medicine researchers had a super fun time showing off their results from a printer that uses living cells instead of ink. Fluid based inkjet technology used in the very printers you’ve got in your home or office is used to lay down cells, printing large sections of living tissue down on cut up or damaged areas of the body. These fine folks from the Institute note that “any loss of full-thickness skin of more than 4 cm in diameter will not heal by itself,” and that with this device, (refined and tested extensively, of course,) skin that might have been otherwise damaged horrifically can now be patched up to a much higher level of healthiness. Testing has occurred on mice revealing advanced healing by the second and third week of recovery and complete closure of the skin by the end of week three on wounds that would otherwise still be open to infection.
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
The printer works with two heads, one that dispenses skin cells mixed with fibrinogen (a blood coagulant) and type I collagen (connective tissue’s main component in scars), the other which sends out thrombin (another coagulant.) Together these create a chemical reaction and form fibrin, another protein that works on the clotting of blood. On top of this is one more layer printed by the printer: keratinocytes – the outer layer of skin we’ve all got right this moment.
Future research will be done on the pigs who, if you know your Gangs of New York lore, are great to practice stabbing on because they’ve got skin that very closely resembles human skin. Will this device ever hit your local wartime hospital or town hospital? Who can tell?
Labels:
Collagen,
fibrinogen,
thrombin
CryoLife Slips To Loss In Q3
(RTTNews) - CryoLife Inc. (CRY: News), an implantable biological medical device and cardiovascular tissue processing company, Thursday reported a loss for the third quarter, compared to a profit last year, mainly reflecting higher expenses.
CryoLife's net loss for the quarter was $3.03 million or $0.11 per share compared to a net income of $1.86 million or $0.07 per share last year.
For the recent third quarter, the company recorded charges of $3.7 million for acquired in-process research and development related to the Starch Medical transaction, $3.6 million related to the impairment of its investment in Medafor common stock and $1.6 million related to HemoStase inventory that the company does not believe that it will be able to distribute.
Excluding these charges, adjusted net income for the quarter was $2.6 million or $0.09 per share. On average, three analysts polled by Thomson Reuters expected the company to earn $0.09 per share in the quarter. Analysts' estimates typically excludes special items.
The Kennesaw, Georgia-based company's total revenues improved slightly to $28.44 million from $28.22 million in the comparable quarter last year. Three analysts were looking for a revenue of $29.30 million.
Total gross margins decreased to 54% from 60% last year, mainly due to the charge related to the write-off of the HemoStase inventory.
CryoLife's net loss for the quarter was $3.03 million or $0.11 per share compared to a net income of $1.86 million or $0.07 per share last year.
For the recent third quarter, the company recorded charges of $3.7 million for acquired in-process research and development related to the Starch Medical transaction, $3.6 million related to the impairment of its investment in Medafor common stock and $1.6 million related to HemoStase inventory that the company does not believe that it will be able to distribute.
Excluding these charges, adjusted net income for the quarter was $2.6 million or $0.09 per share. On average, three analysts polled by Thomson Reuters expected the company to earn $0.09 per share in the quarter. Analysts' estimates typically excludes special items.
The Kennesaw, Georgia-based company's total revenues improved slightly to $28.44 million from $28.22 million in the comparable quarter last year. Three analysts were looking for a revenue of $29.30 million.
Total gross margins decreased to 54% from 60% last year, mainly due to the charge related to the write-off of the HemoStase inventory.
Effects of an absorbable polysaccharide hemostat PerClot(r) on fracture healing of the cranial bone
Tuesday, October 26, 2010
EU Protocol for the use of CryoLife BioFoam
CryoLife protocol for EU rollout of BioFoam, Click Thumbnail to view.
ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
ARCHIVE
On 10/27/09, CryoLife (NYSE: CRY) announced that the FDA has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam Surgical Matrix protein hydro-gel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemo-static agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial. CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.
Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA
In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding. President & Chief Executive Officer, David Smithcommented, "We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone."
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery. In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.
Monday, October 25, 2010
Study shows use of superglue in chest surgery cuts recovery time in half
The minute he read about the experimental procedure, he says, “I wanted it.”
He became a patient of Paul Fedak, a cardiac surgeon who pioneered the technique in 2009 at Calgary’s Foothills Hospital Medical Centre. In June of this year, Dr. Fedak replaced Mr. Haddad’s aortic valve and joined his sternum using steel wire, and then sealed the bones with a sticky paste called Kryptonite.
Mr. Haddad was out of the hospital in seven days. Within six weeks, the 59-year-old resident of Milk River, Alta., was back to work as a real-estate broker. Mr. Haddad didn’t bother to fill his prescription for pain meds, he says. “I’ve been pain free since before I left hospital.”
His surgery was standard except that Dr. Fedak took a few minutes to apply adhesive to the ends of the chest bones before stitching up the soft tissue. According to Dr. Fedak, breastbones heal much faster when secured with wire as well as Kryptonite glue.
Instead of it taking six to eight weeks for the bone to fuse back together, “we do it in 24 hours.” The glue makes it rock solid within a day.
A study released Sunday suggests the use of adhesive in chest surgery reduces the normal recovery time by half. Patients have less physical disability in the first six weeks after surgery and can breathe deeply sooner, Dr. Fedak reports. He adds that patients are able to cough with less discomfort and require significantly less medication such as narcotics to manage pain.
No complications or side effects from the glue were reported among the 55 patients in the randomized controlled trial.
The procedure has the potential to improve post-operative care for an estimated 1.4 million open-chest surgeries performed worldwide each year, according to the Heart and Stroke Foundation of Canada.
Dr. Fedak has applied to the Canadian Institutes of Health Research to fund a larger clinical trial involving 2,000 patients throughout North America, which should start in six months, he says.
Although medical adhesives are widely used in hip replacements and other procedures, most bone cements contain toxic ingredients that are dangerous for use in the chest, notes Dr. Fedak. In contrast, Kryptonite is an adhesive polymer composed of calcium carbonate and fatty acids derived from castor bean oil. It is “bio-compatible” and turns into a porous bonelike substance as it cures, he says.
Dr. Fedak doesn’t recommend the adhesive for patients at high risk for internal bleeding and other complications after surgery, because doctors might need to re-enter the breastbone and the procedure would take longer if the breastbone is well-bonded. Otherwise, he says, “you could use this on almost any patient.”
Regulators in Canada and the United States have approved the use of Kryptonite, which is made by the Doctors Research Group in the United States.
The glue is expensive, adding $700 to $1,000 to the cost of performing surgery. The need for public funding is a barrier to routine use, Dr. Fedak says. But he suggests that using Kryptonite could result in net savings to the health-care system by reducing recovery time and major post-op complications, including breastbones that separate after surgery.
“If a patient leaves the hospital a day early, that would be thousands of dollars of savings,” he points out.
Patients from around the world have contacted him, seeking repairs to sternums that didn’t heal properly after surgery, Dr. Fedak says. Although he is cautious about expanding the use of Kryptonite prematurely, he adds, reconstructions to damaged sternums “work very well.”
Mr. Haddad says he’s been the envy of his friends since he was glued back together with Kryptonite. He mentions a neighbour who took more than six months to bounce back after recent heart surgery.
“He is absolutely annoyed that he wasn’t in the [Kryptonite] study.”
Labels:
bone hemostasis,
super glues
Thursday, October 21, 2010
Vascular Solutions Announces Record Third Quarter Results. Edited
Vascular Solutions, Inc. (Nasdaq: VASC) today reported financial results for the third quarter ended September 30, 2010. Highlights of the third quarter include:
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Achieved record net revenue of $19.9 million, an increase of 15% from the third quarter of 2009.
Highlighted the clinical success of the GuideLiner® catheter at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington D.C. in September, with GuideLiner catheter sales increasing by 37% sequentially from the second quarter of 2010.
Achieved net income of $1,464,000, or $0.09 per diluted share.
Issued guidance for 14% to 16% revenue growth to between $20.8 million and $21.2 million in the fourth quarter of 2010 and net income of between $0.94 and $1.00 per share (including $14.3 to $15.0 million, or $0.83 to $0.87 per share, of income tax benefit as the result of the Company's potential recognition of its remaining net operating loss carryforwards as a deferred asset in the fourth quarter).
Commenting on the results, Vascular Solutions' Chief Executive Officer Howard Root said: "Contrary to what many companies in our sector are reporting, we are pleased to report 15% revenue growth in the third quarter to a new record quarterly level, resulting from substantial new product launches and continued sales expansion of our existing products. Of special note, our GuideLiner catheter has generated unprecedented interest in a Vascular Solutions' product since its U.S. launch less than a year ago, and that interest is translating into broader sales opportunities and increased visibility at major medical meetings. With a full pipeline of internally-developed new products in development, along with acquisition and product distribution candidates in evaluation, we are very optimistic about our ability to continue with our consistent sales growth and success.".....
Net sales of hemostat products (primarily consisting of the D-Stat® Dry, D-Stat Flowable and D-Stat Radial products) were $6.1 million in the third quarter, a decrease of 5% from the third quarter of 2009. "During the third quarter one of our primary competitors in the patch market was subjected to an injunction preventing their sales in the U.S. as the result of a patent infringement verdict initiated by another competitor, but that injunction was quickly subjected to an administrative stay while the case is presented to the Federal Circuit. We expect that administrative stay to be subject to a substantive decision by the Federal Circuit very soon, which, if the injunction or judgment is allowed to stand, would open up approximately 15% of the patch market to our sales force," commented Mr. Root.....
Labels:
D-Stat,
Vascular Solutions
Sunday, October 17, 2010
Robotic technology speeds recovery and improves outcomes
■ Robotic surgery reduces blood loss, decreases length of hospital stay, decreases postoperative pain, and improves recovery time.
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
■ Robotic surgery is particularly useful in gynecologic surgery because of the limited space within the pelvic cavity.
■ The versatility of robotic instruments has expanded the range of gynecologic conditions amenable to minimally invasive surgery.
■ The cost of setting up and maintaining robotic surgical systems can be prohibitive.
■ Studies that evaluate long-term outcomes of robotic surgery are needed to further validate the place of robots in the OR.
Over the past two decades, minimally invasive surgery has progressed beyond all expectations. Many operations that used to require laparotomy are now routinely performed using laparoscopic techniques. Appendectomies, cholecystectomies, and even hysterectomies are done through keyhole-size incisions that are aesthetically pleasing to the patient and less costly in terms of postoperative pain, length of hospital stay, and blood loss. Conventional laparoscopic surgery, however, is not without its limitations. Difficulties such as tremor amplification, reverse fulcrum, and loss of dexterity create problems for the surgeon, limiting the potential of the laparoscope.1 Fortunately, with the help of robotic technology, many of these problems can be overcome. With names that conjure up images of the great works of Italian masters, robots are challenging surgeons to learn the art and the science of a new type of surgery. Robotic technology is revolutionizing minimally invasive surgery.
HISTORY OF ROBOTIC SURGERY
Robotic surgery was first conceived as a way to facilitate surgery performed on military personnel injured in the field. The intent was to enable surgeons to operate remotely, reducing the risk to the surgeon and increasing the speed of delivery of potentially lifesaving treatment to the patient. With the development of a remote console (surgeon control center), a patient side cart (engages robotic arms), and a vision cart (camera display), surgery that did not require the surgeon to lay hands on the patient became possible. As robotic capabilities became more sophisticated, robotic surgery moved away from the battlefield and directly into the OR. Although many robotic models have been developed over the years, currently the only FDA-approved robotic platform is the da Vinci Surgical System. The da Vinci platform was approved for use in urology in 2000 and then for gynecology in 2005.2 This article focuses primarily on the application of robotic technology to gynecology, given the tremendous potential of robot-assisted laparoscopic surgery in this field.
INCREASED FLEXIBILITY AND PRECISION IN GYNECOLOGIC SURGERY
Robotic surgery is particularly useful in gynecologic surgery because of its flexibility within the limited space of the pelvic cavity. Traditional laparoscopic instruments are awkward to maneuver in the tight confines of the pelvis. This difficulty is compounded by other problems associated with conventional laparoscopy including the following: reverse fulcrum (counterintuitive movements), tremor amplification, ergonomic challenges, and tissue visualization that is only two- dimensional (2D). Robotic platforms overcome many of these problems. The surgeon moves the robotic arms and cameras using hand controls and foot pedals. Movements of robotic instruments mimic those of the surgeon's hands, eliminating the reverse fulcrum effect. Previously, operators needed to move their hands in the opposite direction of the one they desired, but robotics allow surgeons to move their hands in the direction they want the instruments to move. This feature improves precision and control, facilitating procedures on very delicate tissues.3
The EndoWrist instrument tip of the da Vinci robotic system moves in multiple directions, offering the operator 7 degrees of freedom, greater articulation, and a degree of dexterity comparable to that of the human hand. This improves the surgeon's ability to grasp, cut, dissect, cauterize, and suture fragile tissues within the tight confines of the pelvic cavity. Tremor is eliminated as well.
IMPROVED VISUALIZATION AND COMFORT
The da Vinci Surgical System has cameras that provide the surgeon with 3D, high-definition images of the operative field, improving visualization of blood vessels, tissues, and nerves. The surgeon can magnify images and zoom in on targets while looking through the vision screen. This improved clarity increases accuracy and compensates somewhat for the loss of haptic (tactile) feedback that is inherent in robotic surgery.
Robotic technology also reduces the ergonomic challenges of classic laparoscopy. The surgeon is seated at the remote console, obviating the need to be a contortionist to manipulate the instruments into the desired position. This increases surgeon comfort and decreases fatigue, helping the surgeon focus attention on the work at hand and providing for complex gynecologic surgeries that require longer OR time. As a result of these developments, the range of gynecologic conditions amenable to minimally invasive surgery has increased along with the number of patients who benefit from this technique. Surgeries such as sacrocolpopexy, myomectomy, and cancer staging can now be done without laparotomy.4
RISKS AND BENEFITS
As the scope of robotic gynecologic surgery continues to expand, increasing numbers of patients will ask PAs about the risks and benefits of this surgery. Already, radio and television commercials promote robotics as a reason to select a particular hospital. Tuned-in patients will no doubt start to question PAs about the efficacy of robotic hysterectomy, tubal reversal, and myomectomy: Is my uterus really safe in the hands of a "droid"? Consequently, knowing some of the published data relating to this surgery is both useful and necessary.
Multiple research studies have shown that minimally in vasive surgery significantly reduces blood loss, decreases post operative pain, shortens hospital stay, and decreases morbidity. Patients need less analgesia, recover faster, and benefit from a quicker return to their usual activities. These benefits hold true for a wide range of gynecologic surgeries and apply to both robot-assisted and conventional laparoscopic surgery. Recent studies, however, demonstrate that the advantages for patients may be even greater using robotics.3-5
Several studies have shown that robotic surgery is superior to conventional laparoscopic surgery for suturing, knot tying, and lysis of adhesions. These findings support the premise that robot-assisted surgery is a cut above conventional laparoscopic surgery, especially for those patients who have scarring or adhesions.2Payne and Dauterive compared surgical outcomes for 200 total laparoscopic hysterectomies to robot-assisted hysterectomies. They concluded that robotic surgery halved blood loss, shortened hospital stay, and reduced conversions to laparotomy. Laparotomy remains the primary method of performing myomectomy, as conventional laparoscopy is difficult due to problems with enucleation, removal, and multi-layer suturing. Robotic surgery overcomes many of these problems, offering patients an effective treatment for their fibroids plus the advantages of minimally invasive surgery.4
Robot-assisted gynecologic surgery for cancer staging has many benefits. Boggess and colleagues compared robot-assisted staging with laparoscopic staging for endometrial cancer. The robotic approach was associated with decreased length of hospital stay, an increase in the number of nodes retrieved, and less blood loss. Robotics had the added benefit of allowing staging on obese women who otherwise would have needed laparotomy.6
As the United States population ages, PAs are likely to encounter increasing numbers of patients with pelvic organ prolapse. Repair of prolapse is not usually conducive to conventional laparoscopic techniques, as surgeons encounter technical difficulties with mesh placement, knot tying, tissue dissection, and suturing. The robotic approach alleviates many of these difficulties, making minimally invasive surgery a more viable option.7
OTHER FACTORS TO CONSIDER
Several other important factors need to be considered by PAs when discussing robotics with patients. Robotic surgery is more expensive than conventional laparoscopic surgery and laparotomy. Learning curves are steep for surgeons, initially resulting in longer operating times for patients as new skills are learned. Robotic surgery precludes haptic feedback, as it denies the surgeon the ability to palpate the tissues. The lack of direct physical and visual contact between the patient and operator may raise ethical concerns, particularly in situations where the surgeon is situated at a considerable distance from the patient. Information may not be secure and communication may break down. Finally, studies that evaluate long-term outcomes of robot-assisted gynecologic surgery are needed to assess survival, effects on quality of life, postoperative function, and durability.8 Nonetheless, a growing body of evidence supports the premise that robots represent a significant advance in the field of gynecologic surgery, reaping considerable benefits for patients and clinicians. Source: JAAPA
Labels:
Robotic Surgey
Thursday, October 14, 2010
Stöpler to Distribute Z-Medica QuikClot Products for the First Time to Hospitals in The Netherlands
WALLINGFORD, Conn.--(Healthcare Sales & Marketing Network)-- Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Stöpler, a supplier of medical instruments, equipment and disposables to hospitals in the Netherlands, Belgium and Luxembourg. Stöpler will have the exclusive rights to sell and distribute Z-Medica’s full line of QuikClot® hemostatic agents to hospitals and healthcare professionals in The Netherlands.
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
QuikClot products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Stöpler in European markets since then.
“Bleeding is a problem across the globe, and Z-Medica is aiming to reach beyond the U.S. borders with revolutionary gauze products that are proven effective in some of the most traumatic of circumstances,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We are proud to work with partners like Stöpler, who see the need to have QuikClot in every hospital and carried by all healthcare professionals.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“Our focus is on providing healthcare professionals throughout The Netherlands access to premium brands such as QuikClot, and we are thrilled with the opportunity to provide our partners with this line of life saving devices,” said Eric Knuiman, General Manager of Stöpler. “We foresee great demand for this product as it is not only safe and effective, but also diverse in its applications.”
Wednesday, October 13, 2010
Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients
Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement—or quantum leap forward—in health care.
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices.
Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.
“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU.
“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”
“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.
“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.
“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.
According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.
“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”
The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies.
Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science.
Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996. In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985. He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.
In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.
The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering
Labels:
Clinical Papers,
vascular closure
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