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Surgical staple
Surgical staple
Surgical staple
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34 surgical staples closing scalp following craniotomy
Projectional radiograph of surgical staples

Surgical staples are specialized staples used in surgery in place of sutures to close skin wounds or to resect and/or connect parts of an organ (e.g. bowels, stomach or lungs). The use of staples over sutures reduces the local inflammatory response, width of the wound, and time it takes to close a defect.[1]

A more recent development, from the 1990s, uses clips instead of staples for some applications; this does not require the staple to penetrate.[2]

History

[edit]

The technique was pioneered by "father of surgical stapling", Hungarian surgeon Hümér Hültl.[3][4] Hultl's prototype stapler of 1908 weighed 8 pounds (3.6 kg), and required two hours to assemble and load.

The technology was refined in the 1950s in the Soviet Union, allowing for the first commercially produced re-usable stapling devices for creation of bowel and anastomoses.[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 1964 to manufacture surgical staplers under its Auto Suture brand.[5] Until the late 1970s USSC had the market essentially to itself, but in 1977 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 1998, which became Covidien on June 29, 2007.

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 1990s.

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

[edit]
Laparoscopic stapling of sigmoid colon.
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

[edit]
A disposable skin stapler remover
A deformed skin staple after removal

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 vertical blade that, when hand-pressure is exerted, pushes the staple down through a slot in the shoe, deforming the staple open into an 'M' shape to facilitate its removal. In an emergency, it is also 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

[edit]

References

[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Surgical staple

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from Grokipedia
A surgical staple is a specialized, biocompatible metal used in surgical procedures to approximate tissue edges, close external wounds, or join internal organs and structures, serving as a rapid and efficient alternative to traditional suturing methods. These devices, typically delivered via surgical staplers, come in two primary types: external staples, which are applied to the skin or to secure incisions and promote healing, often made from for durability and removability; and internal staples, which are implanted within the body during procedures such as gastrointestinal resections, thoracic surgeries, or vascular anastomoses, commonly constructed from to minimize tissue reaction and . Invented in 1908 by Hungarian surgeons Victor Fischer and Hümér Hültl as a means to perform mechanical suturing and prevent complications like gastrointestinal spillage, surgical staples underwent significant refinement in the Soviet Union during the 1950s, leading to the first commercially produced reusable devices for bowel and vascular applications. By the late 20th century, these staples had become integral to modern surgery due to their advantages, including faster application times, consistent wound closure strength, reduced operative duration, and minimal tissue reaction compared to manual sutures, though they require precise deployment to avoid malfunctions such as misfiring or incomplete formation. Regulatory oversight by the U.S. (FDA) initially classified surgical staplers and staples as Class I devices in 1988, exempting them from premarket notification, but concerns over adverse events—including over 41,000 reports of malfunctions, injuries, and deaths between January 2011 and March 2018—prompted reclassification of internal-use devices to Class II in 2021, mandating special controls like enhanced labeling and performance testing to improve . As of 2025, the FDA continues to monitor the safety profile through post-market .

Overview

Definition and Purpose

Surgical staples are specialized devices designed to close wounds or join tissues during surgical procedures, functioning as an efficient alternative to traditional sutures. They consist of small, pre-formed metal or absorbable components delivered via a stapling instrument to secure tissue edges with precision and speed. Absorbable staples, typically made from bioabsorbable polymers like polylactide-polyclycolide, are increasingly used for subcuticular closure to eliminate removal needs, though non-absorbable metal staples remain predominant. This approach allows for rapid application, often up to ten times faster than manual suturing, while providing strong mechanical closure that supports immediate wound stability. The primary purposes of surgical staples include facilitating quick wound closure, achieving precise tissue approximation, promoting by compressing vessels at surgical sites, and aiding the healing process in both external incisions and internal applications such as organ resection or . By aligning tissue edges evenly, staples minimize gaps that could lead to or delayed recovery, and their design ensures low tissue reactivity to reduce inflammatory responses. In external uses, they are particularly effective for large lacerations or surgical cuts on the or , while internal staples support complex procedures like gastrointestinal connections. Over time, surgical staples have evolved from basic manual fasteners to sophisticated automated delivery systems, enhancing their reliability and ease of use in diverse clinical settings without requiring extensive operator expertise. A key concept in their design is the uniform distribution of tension across the edges, which helps minimize tissue trauma and promotes optimal healing by preventing uneven stress that could cause tearing or . This even force application contributes to lower risks of complications, such as infection or poor , compared to irregular closure methods.

Mechanism of Action

Surgical staples operate through a mechanical deformation process that secures tissues by approximating edges. Loaded into a compatible cartridge within a surgical , the staples—typically in an open U-shaped configuration—are advanced and fired by the device's trigger mechanism, which drives the staple legs through the tissue layers. Upon penetration, an or forming surface in the stapler crimps the legs inward, deforming the staple into a closed B-shape, locking the tissues in . This transformation from an open to a locked configuration ensures stable closure, with the staple height reducing from an open (e.g., 3.5 mm) to a closed one (e.g., 1.5 mm) to compress the tissue effectively. Biomechanically, the staple applies even pressure across the tissue interface to promote precise of edges, minimizing gaps that could lead to complications. This compression resists shear forces encountered during patient movement or physiological stress, maintaining integrity until progresses, while the staple's design facilitates tissue ingrowth into and around the deformed structure for long-term fixation. The material's flexibility, such as that provided by , allows controlled deformation without fracture, supporting these mechanical demands. In tissue interaction, the sharp tips of the staple legs pierce the , , and underlying layers, everting the wound edges outward to reduce tension and dead space, which aids in uniform and scar minimization. This eversion, combined with the compressive force, compresses small vessels to achieve , controlling at the site. The B-shaped formation traps tissue between the legs and crown, further reducing potential for fluid accumulation or separation.

History

Early Invention and Development

The of the surgical stapler occurred in 1908, when Hungarian surgeon Hümér Hültl collaborated with Victor Fischer to create the first mechanical device specifically for approximating tissues during gastrointestinal procedures. This bulky instrument, weighing approximately 3.5 kg and consisting of over 100 parts, was designed to form two parallel rows of staples for secure closure. It was first applied in a human patient on May 9, 1908, during a 40-minute gastric cancer resection, where it successfully facilitated without reported immediate complications. By 1909, Hültl had performed 21 such operations, establishing the stapler's potential as an alternative to manual suturing in bowel surgery. Early 20th-century experiments emphasized manual presses for gastrointestinal anastomoses, building on Hültl's to address the challenges of hand-sewn closures in intestinal resections. These devices were tested in animal models to evaluate tissue compression effects and responses, revealing effective and reduced operative time compared to sutures, though outcomes varied with staple placement precision. In humans, initial trials focused on bowel resection, with successful applications reported in gastric and intestinal surgeries by the and . However, significant limitations hindered widespread adoption, including the instruments' non-reusability without disassembly—requiring up to two hours for reloading—and heightened risks from incomplete sterilization via boiling, which could lead to during manual handling. Refinements in the Soviet Union beginning in the mid-1940s and through the 1950s transformed these early designs into more practical reusable tools, particularly for lung and vascular applications. Although earlier European developments, such as Aladár Petz's lightweight gastrointestinal stapler introduced in 1921, focused on bowel surgery, Soviet innovations in vascular stapling were independent and designed for a fundamentally different purpose and mechanism. In 1945, engineer developed the SSA-1, the inaugural vascular stapler for end-to-end vessel anastomoses, which was rigorously tested in canine models to confirm patency and minimal thrombosis. By the mid-1950s, the Scientific Research Institute for Experimental Surgical Apparatus and Instruments (SRIESA) produced devices such as the UKB bronchial stapler (1954) and UKL lung stapler (1957), enabling secure closures in pulmonary resections; these were applied in over 200 human lung procedures by 1958, with low leak rates. Stainless steel construction initially predominated, later incorporating titanium for durability, while animal experiments and human trials for bowel resection—conducted by teams including Vladimir Demikhov and Nikolai Androsov—demonstrated reliable inversion and hemostasis, though manual assembly remained labor-intensive.

Modern Advancements and Commercialization

In the 1950s, Soviet researchers advanced surgical stapling technology through the Scientific Research Institute for Experimental Surgical Apparatus and Instruments, developing instruments such as the UKB for bronchial stumps in 1954 and the UKL for pulmonary hilum in 1957. These innovations were introduced to the United States by surgeon Mark M. Ravitch after his 1957 visit to the USSR, where he acquired a Soviet UKB stapler. In 1963, Ravitch partnered with entrepreneur Leon Hirsch to establish the United States Surgical Corporation (USSC), which licensed and refined the Soviet designs for Western markets. This collaboration culminated in the 1967 launch of the first commercial reusable stapler, the TA (thoraco-abdominal) model, marking the beginning of widespread commercialization. The 1970s and 1980s saw rapid evolution driven by market competition, with USSC and Johnson & Johnson's division introducing disposable staplers featuring plastic components to streamline sterilization and reduce cross-contamination risks. 's fully disposable single-use mechanical stapler debuted in , enhancing surgical efficiency. Endoscopic versions emerged in the 1980s to support the growing field of minimally invasive , allowing staple deployment through small ports with improved articulation. innovations, including powered firing mechanisms, were integrated to boost precision and operator control during complex procedures. Regulatory and material milestones advanced reliability in the , as staples were increasingly adopted for internal applications due to their superior and corrosion resistance compared to . By the , laparoscopic staplers expanded access to minimally invasive techniques, with articulating linear cutters enabling safer anastomoses in abdominal and thoracic cavities. In the , further advancements included powered stapling platforms, such as Ethicon's Echelon Flex Powered Stapler introduced in the , which automated firing for consistent performance in thick tissues. Integration with robotic systems, like Intuitive Surgical's EndoWrist Stapler cleared by the FDA in 2021, enhanced precision in minimally invasive procedures. Commercialization has transformed surgical practice by significantly shortening operative times compared to suturing—thus reducing exposure and healthcare costs. Adoption surged in bariatric and colorectal surgeries, where staplers enable rapid, secure tissue resection and , contributing to lower complication rates in these procedures.

Materials and

Common Materials

Surgical staples are primarily constructed from biocompatible metals that balance mechanical performance with physiological compatibility. , particularly the 316L grade, dominates in skin staples due to its exceptional strength and corrosion resistance, which ensure durability in external environments exposed to bodily fluids and air. This grade's low carbon content enhances its resistance to pitting and , making it suitable for short-term closure applications. In contrast, and its alloys, such as , are favored for internal staples owing to their high , which minimizes inflammatory responses, and their non-ferromagnetic nature, ensuring safety during (MRI) scans. Essential properties of these materials include robust tensile strength to resist deformation under stress, with typically exhibiting 900-1000 MPa to surpass skin tissue limits and maintain closure integrity. Elasticity is another critical attribute, allowing staples to flex with tissue movement and prevent excessive pressure that could lead to . Additionally, both and support sterility maintenance through their inherent resistance to bacterial adhesion and compatibility with sterilization processes like gamma or . Emerging biodegradable materials address the need for absorbable staples that degrade post-healing, reducing secondary procedures. Magnesium alloys offer controlled degradation while providing initial mechanical support comparable to traditional metals. Zinc-based alloys, such as Zn-1.0Cu-0.2Mn-0.1Ti, represent promising options with degradation rates of approximately 0.12 mm/year in fed-state simulated intestinal fluid (FeSSIF). As of 2025, Zn-based alloys continue to advance, with ternary compositions like Zn-1.0Cu-0.2Mn-0.1Ti showing promise for next-generation implants due to suitable degradation and mechanical properties. These alloys exhibit tunable profiles, often accelerated in acidic environments to match tissue recovery phases. Material selection hinges on factors like allergenicity, where titanium demonstrates low hypersensitivity risk compared to nickel-containing steels, cost-effectiveness for disposable versus implantable uses, and stringent regulatory approval to verify biocompatibility and safety for human implantation. For internal applications, FDA classification under special controls ensures performance testing for degradation and tissue interaction.

Production Processes

Surgical staples are primarily manufactured through a wire forming process, where metal wire is drawn into thin coils and then precisely cut into U-shaped staples to ensure uniformity in shape and size. This forming technique allows for high-volume production while maintaining the staple's structural integrity for reliable deployment during . Following the initial forming, many staples undergo overmolding of crowns to enhance compatibility with specific devices, providing a secure grip and alignment mechanism during loading and firing. Assembly of surgical staples involves precision stamping to achieve consistent leg lengths, typically ranging from 3 to 6 mm depending on the intended tissue thickness, followed by loading the formed staples into disposable cartridges or reload units for surgical staplers. This step ensures that staples are oriented correctly and spaced evenly within the cartridge to prevent jamming or misalignment in the device. Automated machinery is employed to handle these operations at scale, minimizing and maintaining tight tolerances. Quality assurance in surgical staple production adheres to ISO 13485 standards for medical device quality management systems, which mandate rigorous testing protocols to verify performance and safety. Key assessments include deformation consistency tests to ensure staples close uniformly under applied force, as well as biocompatibility evaluations such as cytotoxicity assays to confirm no adverse tissue reactions. These controls are critical to prevent failures like staple malformation or contamination that could compromise patient outcomes. Sterilization of surgical staples is achieved primarily through gas or methods, both designed to attain a (SAL) of 10^{-6}, meaning the probability of a non-sterile unit is less than one in a million. penetrates packaging effectively for complex assemblies like loaded cartridges, while offers rapid processing without residues, though it requires careful material selection to avoid degradation. Post-sterilization validation confirms microbial absence through testing.

Types

Skin Staples

Skin staples are specialized surgical fasteners designed for the external closure of superficial wounds, featuring a rectangular with a wide crown to evenly distribute tension and short legs for minimal penetration depth. The crown typically measures 6 to 7 mm in width for wide variants, while legs are approximately 3.5 to 4.5 mm long, allowing secure approximation of skin edges without compromising underlying tissues. These staples are usually constructed from medical-grade for durability and . They are deployed using disposable staplers, which may have fixed heads for standard procedures or rotating heads to enhance visibility and access in challenging anatomical positions. Variations in skin staples include conventional regular sizes with narrower crowns (around 4.8 to 5 mm) suited for thin-to-medium skin, and premium wide options (e.g., 35W models containing 35 staples) with broader crowns (6.5 to 6.9 mm) for thicker tissues or wider . Premium designs often incorporate aids, such as transparent casings or see-through windows in the , to monitor staple count and placement accuracy during application. These adaptations allow for tailored use across different wound profiles while maintaining sterility in single-use devices. Skin staples find specific application in closing lacerations on the , trunk, or extremities, where their rapid deployment—up to four times faster than suturing—proves advantageous in high-pressure trauma or settings. This efficiency facilitates quicker wound approximation in busy clinical environments without increasing risk. A key benefit unique to skin staples is their ability to provide precise edge alignment, which distributes tension evenly and promotes reduced scarring compared to traditional sutures by minimizing tissue distortion during .

Internal Staples

Internal staples are specialized surgical fasteners designed for joining or transecting deep tissues and organs, remaining implanted within the body to support healing without requiring removal. Unlike external staples, these are engineered for internal applications such as and resection, accommodating varying tissue thicknesses and minimizing complications like leaks or bleeding. Key configurations include linear staples, often deployed via GIA (gastrointestinal ) staplers, which create straight staple lines for tissue resection and end-to-side or side-to-side connections; circular staples, used in EEA (end-to-end ) devices for tubular structures like intestines or vessels; and endoscopic articulating staples for minimally invasive procedures, allowing angled deployment in confined spaces. Linear configurations typically feature staple line lengths of 30–90 mm with 2–3 rows, while circular ones range from 17–34 mm in diameter, and endoscopic variants offer shaft lengths up to 44 cm with up to 45° articulation. These designs incorporate longer legs, up to 5.5 mm in open height, and tiered staple heights (e.g., 2.0–5.0 mm) to compress thick or thin tissues uniformly, ensuring consistent deformation and tissue . Buttressing materials, such as polyglycolic acid or synthetic polymers, are integrated to reinforce staple lines by distributing tension, sealing staple holes, and reducing air leaks or hemorrhage in high-risk areas. For example, in vascular , white cartridges with 2.5 mm leg heights are used for precise vessel joining, as seen in devices like the TA30V3S; in gastrointestinal procedures, GIA linear staples facilitate bowel transection, while EEA circular staples enable end-to-end connections in surgeries like gastric bypass. Adaptations include reloadable cartridges, allowing up to 8 firings per device in complex operations, enhancing efficiency without device replacement. Staples are typically made from for its , though absorbable variants using materials like polylactide or are also available to eliminate the need for permanent implants.

Applications

External Wound Closure

Surgical staples are commonly employed for external wound closure in various clinical contexts, including trauma-related lacerations, orthopedic procedures, and post-surgical incisions. In trauma settings, such as lacerations from accidents, staples provide rapid approximation of edges to control bleeding and facilitate . Orthopedic surgeries, including arthroplasty and repairs, often utilize staples for closing incisions on the limbs or where speed is essential. Post-surgical applications include cesarean sections and appendectomies, where staples seal linear incisions efficiently following deeper tissue repair. Outcomes associated with external staple closure emphasize efficient and favorable in appropriate scenarios. Staples typically remain in place for 7 to 14 days to allow sufficient epithelialization and tensile strength development before removal. Cosmetic results are generally positive, with staples promoting even eversion and minimal tissue strangulation, leading to reduced tension marks and visibility compared to alternatives in non-facial areas. Skin staples, such as those made from , are particularly suited for these superficial closures due to their design for everting skin edges. Evidence from clinical studies supports the efficacy of staples in external wound management, particularly regarding procedural efficiency and economic benefits. Randomized trials have demonstrated that staple closure is significantly faster than suturing, with rates up to five times quicker—for instance, one study reported 22.5 cm per minute for staples versus 4.2 cm per minute for sutures—reducing operative time in high-volume settings. In emergency environments, this speed translates to lower overall costs by minimizing personnel time and resource use. Staples are ideal for non-cosmetic regions like the scalp, where rapid closure outweighs aesthetic precision; however, they are contraindicated in contaminated wounds due to heightened infection risk from incomplete debridement.

Internal Surgical Procedures

Surgical staples play a crucial role in internal surgical procedures, where they facilitate rapid and secure tissue approximation in deep anatomical sites, such as organs and vessels, enabling efficient resection and . In gastrointestinal surgeries, linear staplers are commonly employed for procedures like , where they divide and seal bowel segments to create with consistent staple line integrity. For instance, during laparoscopic , these devices allow for precise transection of the colon while minimizing tissue trauma and supporting along resection lines. In , staples are utilized for end-to-end or end-to-side anastomoses, particularly in procedures involving small-caliber vessels, where mechanical stapling devices expedite vessel reconnection and reduce the risk of compared to traditional suturing. Thoracic applications include resection, such as or segmentectomy, where endoscopic linear staplers seal pulmonary and bronchi, aiding in the of air leaks and promoting immediate post-resection. Bariatric surgeries, like Roux-en-Y gastric bypass, often incorporate circular staplers to form gastrojejunal anastomoses, ensuring a lumen while sealing the staple line against potential leaks. The integration of surgical staples in minimally invasive enhances procedural efficiency by allowing simultaneous cutting and stapling through small incisions, which reduces operative time compared to hand-sewn techniques. This is particularly evident in laparoscopic colorectal and bariatric procedures, where powered staplers further optimize tissue compression and firing, shortening overall duration without compromising seal quality. Beyond , staples contribute to in resection lines by compressing vessels and promoting immediate , as demonstrated in pulmonary and gastrointestinal resections where reinforced staple lines significantly lower intraoperative bleeding rates. In endoscopic contexts, such as natural orifice transluminal endoscopic (NOTES), staples provide robust tissue sealing for enterotomies or defect closures, enhancing the safety of these advanced minimally invasive approaches. Evidence from comparative studies supports the of stapled anastomoses, with meta-analyses showing slightly reduced anastomotic rates for stapled techniques compared to hand-sewn methods in elective gastrointestinal procedures, attributed to uniform staple formation and better tissue . This benefit is most pronounced in colorectal and upper gastrointestinal surgeries, where stapling lowers postoperative complications like from .

Surgical Procedure

Placement Techniques

Placement of surgical staples begins with thorough preparation to ensure optimal closure and tissue integrity. The edges must be meticulously aligned using or fingers to achieve eversion and approximation without tension, followed by with sterile saline to remove debris and reduce risk. Stapler selection is critical and depends on tissue thickness; for internal procedures, cartridges with varying closed staple heights (e.g., 1.0–2.0 mm for thin to thick tissues like colon) are chosen to match the compressed tissue gap, preventing malformation or inadequate , while staplers use fixed staples with leg lengths of approximately 3.5–4.5 mm. For external skin closure, the procedure involves loading a disposable cartridge into the manual skin stapler if not preloaded. The device jaws are positioned perpendicular to the edge, with one operator using (e.g., Adson or mouse-tooth) to evert and hold the edges slightly bulging for alignment. The stapler is fired by squeezing the handle, deploying a single staple that forms a rectangular to appose the tissue; staples are placed at intervals of 5–10 mm (approximately 2–3 per centimeter) starting from the center or one end, progressing to ensure even closure without gaps. Post-placement inspection confirms proper staple formation, with the crossbar elevated 1–2 mm above the surface for and reduced scarring. Internal staple placement, commonly used in gastrointestinal or thoracic procedures, employs linear or circular for transection and . After aligning bowel segments or tissues (e.g., via traction sutures in three points for ), the loaded stapler jaws encompass the tissue, applying controlled compression for 10–30 seconds to express fluid and elongate fibers for better staple penetration. Firing deploys multiple staggered staples (e.g., two rows) while a knife blade divides the tissue if using a cutting variant; for end-to-side , enterotomies are created, and the stapler is inserted parallel to the lumens before firing and trimming excess. Inspection verifies complete staple lines without defects, often requiring multiple firings for longer segments. Stapling tools include manual devices for precise control in open procedures and powered staplers (e.g., those with adaptive firing technology) for consistent force in minimally invasive or robotic surgeries, reducing surgeon fatigue. For curved incisions or irregular edges, such as in lacerations or bowel curves, the stapler is angled incrementally, with an assistant maintaining alignment to avoid twisting; staples may use low-profile heads for contoured areas. Best practices emphasize minimizing tissue trauma: compression should be light to avoid ischemia, limited to 15–20 seconds pre-firing, and staples deployed in pairs at tension points for reinforcement in high-stress areas like the . Always verify no foreign bodies (e.g., clips) interfere with jaws, and select staple types suited to the application, such as for or for internal use, with absorbable options like polylactide available for certain subcuticular or internal applications.

Removal Methods

The removal of surgical staples, particularly for external closure, is a straightforward outpatient procedure performed once the has achieved sufficient tensile strength to prevent dehiscence. Timing for skin staple removal varies by anatomical location to balance healing progress with minimizing risk and scarring; for instance, staples on the face are typically removed after 3–5 days, while those on the legs or trunk may remain for 10–14 days. In general, removal occurs between 7 and 14 days post-placement, guided by clinical assessment of and absence of inflammation.
Anatomical LocationRecommended Removal Timing
Face3–5 days
Scalp or Arm7–10 days
Trunk or Leg10–14 days
Hand, Foot, or Palm/Sole10–21 days
The primary tool for skin staple removal is a sterile staple extractor, a manual device featuring hinged jaws or a narrow plate that fits under the staple's bridge to lift and dislodge it without pulling on surrounding tissue. Supporting supplies include non-sterile gloves, normal saline for cleaning, , and optional adhesive strips (Steri-Strips) for reinforcement post-removal. The procedure follows a sequential approach to ensure safety and efficacy. First, verify the provider's order and patient identity, then position the patient comfortably under good lighting and perform hand hygiene. Inspect and gently clean the wound site with saline to remove any debris, confirming no signs of infection such as erythema, swelling, or purulent drainage. Place the extractor's jaws under the center of the first staple, squeeze the handles to elevate the staple ends from the skin, and apply gentle side-to-side traction to release it without disrupting the wound edges; proceed alternately, removing every other staple initially to assess stability before completing the set. After all staples are extracted, inspect the wound for even approximation, apply Steri-Strips if needed to support healing, and cover with a sterile dressing or leave open per protocol. Document the procedure and educate the patient on monitoring for complications. Key considerations include evaluating wound readiness through visual and tactile assessment—edges should be well-apposed with no gaping or discharge—before proceeding, as premature removal risks dehiscence, particularly in patients with risk factors like diabetes or obesity. In cases of chronic wounds or delayed healing, staples may be left in longer or replaced to maintain closure. Unlike skin staples, internal staples are generally left in place due to their biocompatible materials (e.g., titanium) or absorbable composition, with removal reserved for complications via endoscopic or surgical intervention.

Advantages and Disadvantages

Benefits Compared to Sutures

Surgical staples offer significant advantages over traditional suturing methods in terms of application speed, which can substantially reduce operative time. Studies have demonstrated that staples can be applied up to five times faster than sutures, with closure rates for staples reaching approximately 22.5 cm per minute compared to 4.2 cm per minute for sutures, saving an average of three minutes per 10 cm incision. In specific procedures, such as laparoscopic , mean closure time with staples is about 77 seconds, versus 277 seconds for sutures, representing roughly a threefold reduction. This efficiency is particularly beneficial in time-sensitive surgeries, minimizing patient exposure to and reducing overall procedural duration. Another key benefit is the consistency provided by staples, which ensure uniform closure with standardized spacing and depth, thereby reducing variability and associated with manual suturing techniques. This uniformity contributes to lower tissue reactivity, as staples cause minimal inflammatory response compared to sutures, promoting faster initial . Furthermore, staples facilitate better edge eversion and reduced cross-hatching, leading to minimal scarring in many cases; randomized trials have shown superior esthetic outcomes and quicker with staples in procedures like . Surgical staples also demonstrate cost-effectiveness relative to sutures, driven by lower material and labor expenses, especially for longer incisions. A randomized prospective found that total costs for stapling skin lacerations averaged $7.84 to $17.69 per case, significantly less than $21.58 for suturing, with the economic advantage increasing proportionally with length. Regarding healing outcomes, randomized controlled trials indicate equivalence between staples and sutures, with no significant differences in infection rates or overall healing efficacy in orthopaedic and general surgical contexts. In addition, staples are particularly advantageous for minimally invasive procedures, where their rapid deployment suits small port-site closures without compromising strength. They also lower the risk of needlestick injuries to surgeons, as stapling eliminates the use of needles during closure, unlike suturing which poses a notable in the operating room.

Risks and Complications

Surgical staples, while effective for wound closure, carry risks of device malfunction, including misfiring, which occurs at rates ranging from 0.022% to 2.3% across observational studies and can lead to malformed staples that fail to properly appose tissues. Misfiring may result in incomplete and subsequent bleeding, as well as tissue dehiscence if the staple height is inadequately set. In July 2025, the FDA announced a correction for certain Endo-Surgery stapler cartridges due to potential lockout malfunctions that could prevent cutting or stapling, highlighting ongoing device safety concerns. Surgical site infections (SSIs) represent another common complication; a 2019 reported SSI rates of 5.8% for staples versus 2.7% for sutures ( 2.05, 95% CI 1.38–3.06), indicating a higher with staples, though findings were fragile and low-bias studies showed no significant difference. Recent studies from 2022 to 2025 have further suggested higher SSI rates with staples compared to sutures in procedures such as , hip , and abdominal operations. Dehiscence, or separation, can also arise from improper staple formation, exacerbating healing delays. Allergic reactions to metals in surgical staples, such as or , are infrequent but documented, manifesting as or delayed in susceptible individuals. In gastrointestinal applications, severe risks include staple line leaks or fistulas, with incidence rates averaging 2.1% and reaching up to 5% or higher in bariatric procedures. These leaks can lead to or if untreated, while incomplete may cause significant postoperative . Chronic pain from staple migration is a rare but serious long-term issue, potentially causing obstructions like years after surgery or intraluminal migration leading to cholangitis. Mitigation strategies emphasize on device operation and preoperative checks to ensure proper staple selection and functionality, which can reduce misfiring incidents. Studies indicate that in specific contexts, such as closure, staples may confer lower rates (around 1%) compared to alternatives, likely due to reduced tissue manipulation. Patient-specific factors, including and , elevate complication risks; obese individuals face higher SSI and dehiscence rates from impaired , while diabetics experience delayed healing and increased susceptibility.

Regulations and Safety

Regulatory Standards

In the United States, implantable surgical staples and surgical staplers for internal use are classified by the (FDA) as Class II medical devices, subject to general and special controls to ensure safety and effectiveness, while external skin staplers are Class I, exempt from premarket notification. Implantable surgical staples fall under 21 CFR 878.4750, while surgical staplers for internal use are regulated under 21 CFR 878.4740, both requiring premarket notification via the 510(k) process to demonstrate substantial equivalence to a legally marketed predicate device. Manufacturers must comply with key international and national standards for , materials, and . establishes requirements for quality management systems specific to design, development, production, and servicing, ensuring consistent practices. Material specifications for surgical staples, often made from or , align with ASTM F899 for wrought stainless steels used in surgical applications, which defines to prevent and ensure durability. is evaluated according to , a series of standards that guide biological risk assessments, including , , and implantation tests tailored to the device's contact duration and tissue interaction. Under the Medical Device Regulation (EU MDR 2017/745), surgical staples are classified as Class IIb devices due to their implantable nature and potential risks, necessitating conformity assessment by a involving IX or XI procedures, with an emphasis on rigorous post-market surveillance to monitor performance and adverse events. Labeling requirements for surgical staples and staplers mandate clear instructions for use, including device specifications, compatible staple sizes, firing mechanisms, and warnings about risks such as misfiring or tissue damage if used improperly, as outlined in FDA guidance to support safe clinical application. In the , labeling under MDR I must include similar details in an official language of the , along with (UDI) for traceability.

Known Issues and Recalls

In 2019, the U.S. (FDA) issued guidance addressing safety risks associated with surgical staplers and staples for internal use, emphasizing issues such as staple line opening, staple malformation, misfiring, and difficulty in firing. This action followed an analysis of reports, which identified over 41,000 incidents related to these devices between January 2011 and March 2018, including more than 10,000 injuries and 366 deaths documented in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and other reporting channels. Several recalls have highlighted specific device failures. In May 2019, Endo-Surgery initiated a Class I recall for its curved intraluminal circular staplers due to risks of insufficient firing and failure to completely form staples, which could lead to serious injury; this affected over 92,000 units and was linked to at least two reported serious injuries requiring additional . Similarly, in 2020, (a ) recalled certain Endo GIA Ultra Universal staplers after identifying a assembly error that could contribute to staple malformation, potentially compromising anastomotic integrity and increasing risks of bleeding or leakage. Ongoing concerns include warnings for powered surgical staplers, where the FDA has stressed the importance of enhanced user feedback mechanisms to alert surgeons of potential misfires or incomplete staple formation during procedures. Litigation has arisen in multiple cases alleging manufacturer for complications such as and formation stemming from stapler malfunctions, with plaintiffs claiming inadequate design and warnings contributed to these outcomes. In response to these issues, manufacturers have implemented post-recall improvements, including enhanced designs with adaptive firing technologies that adjust to tissue thickness to minimize malformation risks and improve staple deployment consistency. More recently, in July 2025, Endo-Surgery issued a Class I correction for certain lots of Endopath disposable surgical cartridges due to a potential for inadvertent instrument lockout during use, which could lead to surgical delays, , and adverse outcomes; this action affected 678,526 units and was associated with one death and one serious injury.

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