Surgical staplers and staples are medical devices that may be used in place of sutures. They can close large wounds or incisions more quickly and be less painful than stitches for patients. They are often used in minimally invasive surgery. They can also be used to close wounds in areas where skin is tight against bone, in operations to remove organs or to reconnect parts of internal organs.
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Surgical staplers are generally made of plastic and loaded with a disposable cartridge of surgical staples. The staplers come in both reusable and disposable models. They resemble construction or industrial staplers and are designed to insert and close several staples at once.
The devices may be used internally to seal tissue during surgery. They are useful in minimally invasive surgery because they require only a narrow opening and can quickly cut and seal tissue and blood vessels. Skin staplers are used externally to close skin under high tension, such as on the skull or the trunk of the body.
Surgical staples offer several advantages over sutures.
Surgical staplers are frequently used to close incisions in the abdomen and uterus during Cesarean deliveries, or C-sections, since the staples allow women to heal faster and reduce scar tissue. Surgeons may also rely on surgical staplers when removing part of an organ or cutting through organs and tissue inside the body.
They are also used to connect or reconnect internal organs within an organ system. The devices are frequently used for surgeries involving the digestive tract, including the esophagus, stomach and intestines, in which a portion of these tube-like structures have been removed and the remaining portions must be reconnected.
Patients must pay special attention to medical staples in the skin to avoid infection. A study reviewed the surgical site infection rate of wound closure using staples versus sutures in elective knee and hip arthroplasties. The researchers found a significantly higher risk of surgical site infection in patients with staples compared to sutures.
Always follow your doctor&#;s instructions and do not remove any dressings until it&#;s safe to do so. Rinse the site twice daily to keep it clean. Your doctor will tell you how and when to dress the wound to prevent infection.
When to Call Your Doctor About Surgical Staple Complications
Surgical staples usually remain in place for one to two weeks, depending on the type of surgery and the placement of the staples. In some cases, internal staples may not be removed. They are either absorbed or become permanent additions to hold internal tissue together.
Removing surgical staples from the skin is generally not painful. But they should be removed only by a doctor. Never attempt to remove surgical staples on your own.
Removal requires a sterile setting and a specialized surgical staple remover or extractor. The device spreads one staple at a time, allowing the doctor to gently work it out of the skin.
Usually, a doctor will remove every other staple, and a second appointment is scheduled to remove the rest if the wound has not completely healed.
Surgical staplers work by compressing tissue, connecting two pieces of tissue with staggered rows of B- shaped surgical staples and, in some models, cutting away excess tissue to create a clean closure of the surgical wound.
There are various designs for different types of surgeries, with most categorized as either linear or circular.
When using linear staplers, the surgeon uses the handles at one end to close the &#;jaws&#; of the stapler at the other end over the tissue. When the surgeon fires the stapler, a row of staples binds the tissue together and a blade cuts the tissue between the staples. The process seals the open wound to prevent bleeding.
Linear staplers are used to connect tissue during minimally invasive surgeries or to remove an organ. Circular staplers are often used for surgeries involving the digestive tract from the throat to the colon.
Circular staplers fire two staggered rows of staples from a circular cartridge. This circular layout allows the stapler to connect two sections of the intestine, or another tube-like structure, after a portion has been removed. The staples cause tissue to pinch up as rings or donuts between the staples. A built-in blade then slices off the overlaying tissue, sealing the new connection.
Surgeons watch the closed wound for about 30 seconds to make sure the tissue has been squeezed together properly and confirm that there is no bleeding.
Common materials for surgical staples include stainless steel and titanium. These are both strong metals that tend to cause few problems for patients in surgical procedures.
But plastic staples are frequently used for people with metal allergies or to reduce scar tissue.
Staples made from plastic or metals don&#;t dissolve like many sutures, so extra attention must be paid to prevent infection.
Staples made from polylactide-polyglycolide copolymer are designed to be reabsorbed into the body. They are often used in cosmetic surgery because, like plastic staples, they result in less scaring.
Johnson and Johnson&#;s Ethicon division and Medtronic are the two largest surgical stapler manufacturers. Together, they produced about 80 percent of the stapler market in , according to an analysis by Future Market Insights. 3M also manufacturers skin staplers sold in the United States.
The devices accounted for close to $2 billion in revenue for manufacturers in , with most sold in North America.
Surgical Stapler Manufacturers and Select Brands
Johnson & Johnson subsidiary Ethicon recalled 92,496 surgical staplers in April over concerns that they might not fire with enough force to completely form staples.
The U.S. Food and Drug Administration branded the recall as a Class I recall, the FDA&#;s most serious type. The agency warned in a statement that the devices could cause serious injuries or death. Some people who have been injured by malfunctioning devices have suffered serious injuries and filed surgical stapler lawsuits.
The recall affected two models of the company&#;s Endo-Surgery Intraluminal Staplers used in gastrointestinal tract surgeries.
Ethicon recalled more than 92,000 Endo-Surgery Intraluminal Staplers on April 11, .
Ethicon reported that two patients had been injured by the devices, according to the FDA. In both cases, the devices misfired, cutting portions of the rectum. Misfires or other malfunctions can prolong operations or require doctors to perform unplanned surgery to correct the damage.
The FDA warned that the misfires could increase complications from surgical staplers, including the risk for bleeding, infection, permanent damage to organs.
In , Ethicon recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads. The devices were used in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries.
The company reported that an inspection had found the surgical staplers&#; cartridges may not insert a complete line of staples when fired.
Medtronic issued two recalls of its Endo GIA staplers and staple cartridges from select production lots, or batches, in and . Both recalls involved possible missing components. The company said the defects could affect staple alignment and lead to serious complications.
At least five people were injured by staplers included in the recall, according to the company. The recall involved defects in staple cartridges that were spotted during the manufacturing process. The company reported &#;no confirmed complaints&#; about the devices from doctors or patients.
The U.S. Food and Drug Administration began tightening restrictions and reporting safety concerns over surgical staplers in . It issued new guidance for using the devices to doctors and hospitals, took steps to reclassify certain surgical staplers from low- to moderate-risk devices and reported tens of thousands of previously unknown cases of stapler malfunctions and injuries.
The new classification would require premarket review and clearance of the devices from the FDA before manufacturers could sell them.
The FDA actions followed a series of surgical stapler problems coming to light earlier in . Kaiser Health News reported that more than half of all surgical stapler malfunctions from through , 56,000 of them, had been reported to a hidden FDA database instead of a database accessible by the public.
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The FDA consolidated the two databases so all the reports could be viewed by the public. The total number of reported surgical stapler malfunctions over the eight-year period rose from 41,000 to nearly 110,000.
Timeline of FDA ActionsThe FDA received over 41,000 individual medical device reports to its public database for surgical staplers and staples for internal use. The reports included 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions.
The FDA sent a letter to health care providers expressing concerns about an increasing number of adverse events associated with surgical staplers and staples for internal use.
Ethicon recalled circular staplers for insufficient firing and failure to completely form staples. The FDA identified the recall as Class I.
The FDA issued a draft guidance to help manufacturers develop labeling with information about specific risks, limitations and directions for use of the device.
The FDA issued a proposed order that would reclassify surgical staplers for internal use from Class I (low risk) to Class II (moderate risk) medical devices with special controls.
The FDA held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate. (The advisory panel reportedly recommended switching the devices to a higher-risk classification with additional safety requirements.)
A Kaiser Health News report revealed that the FDA acknowledged that more than 56,000 additional surgical stapler malfunctions were quietly reported to the agency from through , bringing the total to 110,000 malfunctions or injuries during that time period.
Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds or connect or remove parts of the bowels or lungs. The use of staples over sutures reduces the local inflammatory response, width of the wound, and time it takes to close.[1]
A more recent development, from the s, uses clips instead of staples for some applications; this does not require the staple to penetrate.[2]
History
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The technique was pioneered by "father of surgical stapling", Hungarian surgeon Hümér Hültl.[3][4] Hultl's prototype stapler of weighed 8 pounds (3.6 kg), and required two hours to assemble and load.
The technology was refined in the s in the Soviet Union, allowing for the first commercially produced re-usable stapling devices for creation of bowel and anastomeses.[4] Mark M. Ravitch brought a sample of stapling device after attending a surgical conference in USSR, and introduced it to entrepreneur Leon C. Hirsch, who founded the United States Surgical Corporation in to manufacture surgical staplers under its Auto Suture brand.[5] Until the late s USSC had the market essentially to itself, but in Johnson & Johnson's Ethicon brand entered the market and today both are widely used, along with competitors from the Far East. USSC was bought by Tyco Healthcare in , which became Covidien on June 29, .
Safety and patency of mechanical (stapled) bowel anastomoses has been widely studied. It is generally the case in such studies that sutured anastomoses are either comparable or less prone to leakage.[6] It is possible that this is the result of recent advances in suture technology, along with increasingly risk-conscious surgical practice. Certainly modern synthetic sutures are more predictable and less prone to infection than catgut, silk and linen, which were the main suture materials used up to the s.
One key feature of intestinal staplers is that the edges of the stapler act as a haemostat, compressing the edges of the wound and closing blood vessels during the stapling process. Recent studies have shown that with current suturing techniques there is no significant difference in outcome between hand sutured and mechanical anastomoses (including clips), but mechanical anastomoses are significantly quicker to perform.[7][2]
In patients that are subjected to pulmonary resections where lung tissue is sealed with staplers, there is often postoperative air leakage.[8] Alternative techniques to seal lung tissue are currently investigated.[9]
Types and applications
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Close-up demonstration of a surgical skin stapler.The first commercial staplers were made of stainless steel with titanium staples loaded into reloadable staple cartridges.
Modern surgical staplers are either disposable and made of plastic, or reusable and made of stainless steel. Both types are generally loaded using disposable cartridges.
The staple line may be straight, curved or circular. Circular staplers are used for end-to-end anastomosis[broken anchor] after bowel resection or, somewhat more controversially, in esophagogastric surgery.[10] The instruments may be used in either open or laparoscopic surgery, different instruments are used for each application. Laparoscopic staplers are longer, thinner, and may be articulated to allow for access from a restricted number of trocar ports.
Some staplers incorporate a knife, to complete excision and anastomosis in a single operation. Staplers are used to close both internal and skin wounds. Skin staples are usually applied using a disposable stapler, and removed with a specialized staple remover. Staplers are also used in vertical banded gastroplasty surgery (popularly known as "stomach stapling").
Vascular stapler for reducing warm ischemia in organ transplantation. With this model each stapler end can be mounted on donor and recipient by independent surgical teams without care for reciprocal orientation, being the maximal possible vascular axis torsion &#;30°. Activating guide-wire is connected just immediately before firing (video)While devices for circular end-to-end anastomosis of digestive tract are widely used, in spite of intensive research [11][12][13][14][15] circular staplers for vascular anastomosis never had yet significant impact on standard hand (Carrel) suture technique. Apart from the different modality of coupling of vascular (everted) in respect to digestive (inverted) stumps, the main basic reason could be that, particularly for small vessels, the manuality and precision required just for positioning on vascular stumps and actioning any device cannot be significantly inferior to that required to carry out the standard hand suture, then making of little utility the use of any device. An exception to that however could be organ transplantation where these two phases, i.e.device positioning at the vascular stumps and device actioning, can be carried out in different time, by different surgical team, in safe conditions when the time required does not influence donor organ preservation, i.e. at the back table in cold ischemia condition for the donor organ and after native organ removal in the recipient. This is finalized to make as brief as possible the donor organ dangerous warm ischemia phase that can be contained in the couple of minutes or less necessary just to connect the device's ends and actioning the stapler.
Although most surgical staples are made of titanium, stainless steel is more often used in some skin staples and clips. Titanium produces less reaction with the immune system and, being non-ferrous, does not interfere significantly with MRI scanners, although some imaging artifacts may result. Synthetic absorbable (bioabsorbable) staples are also now becoming available, based on polyglycolic acid, as with many synthetic absorbable sutures.
Removal of skin staples
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Where skin staples are used to seal a skin wound it will be necessary to remove the staples after an appropriate healing period, usually between 5 and 10 days, depending on the location of the wound and other factors. The skin staple remover is a small manual device which consists of a shoe or plate that is sufficiently narrow and thin to insert under the skin staple. The active part is a small blade that, when hand-pressure is exerted, pushes the staple down through a slot in the shoe, deforming the staple into an 'M' shape to facilitate its removal. In an emergency it is possible to remove staples with a pair of artery forceps.[16] Skin staple removers are manufactured in many shapes and forms, some disposable and some reusable.
See also
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References
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