PSDV Instructions for Use
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PERI-STRIPS DRY with VERITAS Collagen Matrix (PSDV) Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
(Circular reinforcement only) PSDV reinforcement can be used for reinforcement of staple lines during gastric, bariatric, and small bowel procedures.
(Linear reinforcement only) PSDV Reinforcement can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical
procedures, and during gastric, small bowel, mesentery, colon, and colorectal procedures.
PSDV Secure Grip Instructions for Use
PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP
PSDV-SG is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon, and colorectal procedures.
PSDV Important Risk Information
The use of PSDV Reinforcement is contraindicated in patients with known sensitivity to bovine or acrylic material.
Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact functionality of the device.
Discard all open unused components. Do not use product if there is damage to the pouch or seals.
Ensure the staple line is completely covered with the buttress or inadequate coverage after firing may result.
Do not use PSDV Reinforcement if the product has been exposed (1) to solutions above room temperature, (2) to chemicals, antibiotics, or other substances other than
specifically addressed in the instructions, (3) or if heat indicator has been activated.
Use care when removing loading unit components from the stapler to prevent buttress dislodgement.
Do not get the buttress wet before applying Gel, or the buttress may not adhere to the stapler properly.
Ensure the anvil and cartridge sides of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly. The cartridge and
anvil sides of the PSDV Reinforcement loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips.
Final tissue compression, including PSDV Reinforcement, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are
overlapped. PSDV Reinforcement increases the total thickness of the area stapled by 0.4 mm &#; 1.2 mm (0.016&#; &#; 0.048&#;).
(Circular reinforcement only) Cartridge cones may be used for entry into the surgical site on the cartridge side of the stapler during endoscopic surgery. Before
completion of surgery be sure to remove the cartridge cone from the surgical site.
Rx Only. For safe and proper use of this device, refer to the Instructions for Use.
PSDV Secure Grip Important Risk Information
Do not re-sterilize. Resterilization may cause changes to the tissue and negatively impact functionality of the device.
Discard all open, used, or unused components as sterility is no longer assured.
Do not use product if there is damage to the pouch or seals as sterility may be compromised.
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Ensure the staple line is completely covered with the buttress, or it may result in inadequate coverage after firing.
PSDV-SG is not designed, sold, or intended for use except as indicated; doing so may result in surgical complications.
PSDV-SG configurations differ; substitution of one product for another product may reduce product performance.
Do not use PSDV-SG if the product has been submerged in liquids or if heat indicator has been activated.
Use care when removing loading unit components from the stapler to prevent buttress dislodgement.
Do not get the anvil or cartridge buttress wet before applying, or the buttress may not adhere to the stapler properly.
Ensure the anvil and cartridge side of the loading unit are on the corresponding stapler jaws or the buttress may not adhere to the stapler properly.
Final tissue compression, including PSDV-SG, must meet the range specified by the stapler manufacturer; this is especially important if staple firings are overlapped.
PSDV-SG increases the total thickness of the area stapled by 0.45 mm&#;1.26 mm (0.018&#;&#;0.049&#;).
Follow Instructions for Use supplied by the stapler manufacturer.
Do not use PSDV-SG contrary to the stapler manufacturer&#;s instructions.
The cartridge and anvil sides of the PSDV-SG loading unit differ; substitution of one side for the other may interfere with alignment and adherence of the buttress strips.
The use of PSDV-SG has not been studied in lung or bronchus resection.
In this work, surgical staplers, which are internal use devices employed to deliver staplers to tissues inside the body during surgery for removing part of an organ, cutting through and sealing organs, and creating connections between structures, are covered.
Modern surgical staplers are designed to be disposable, with a maximum number of firing actions, as well as cartridges and other products used for surgical stapling. Today&#;s staples have a rectangular cross-section and become "B" shaped when compressed against the anvil of the stapler to reduce the risk of ischemia, allowing blood to flow through them to the tissue edges. The specific geometry has been developed to ensure hemostasis and to allow sufficient vascularization of the tissue, supporting wound healing [ 1 ].
Three major types of stapling devices used both in open and laparoscopic surgery can be identified: linear, linear cutting, and circular. Linear instruments form a straight staple line and may or may not include a blade, while circular instruments have staples set in a crown shape and always include a blade. The ever-increasing diffusion of laparoscopy and robotic surgery led to the diffusion of stapling devices dedicated to endoscopic techniques; linear and circular stapling devices are employed mostly in gastrointestinal procedures such as complex gasterectomies, bariatric treatments, and colorectal oncological resections. Devices have been compared in terms of procedure duration, hospital stay, wound infection, anastomotic leakage, and anastomotic structures.
The outcome of the repair made by staples or suture techniques has attracted much interest in the scientific community. Recently, the mechanical behavior of repairs made with staples, sutures, and hybrid methods (staple and suture together) was evaluated carefully, showing that staples can resist high loads but are less deformable and rigid than handsewn sutures. This suggests safer employment in the case of small defects or diastasis, where the presumed tissue displacement is minimal. A hybrid repair improves its efficiency, becoming crucial in case of larger defects where the expected tissue displacement is maximal [ 2 ].
4,5,Although being more complex to operate and resulting in longer procedure times, in several studies covering gastric, bariatric, and colorectal surgery, linear staplers appeared to be preferred in clinical use due to their lower rate of anastomosis leakage and anastomosis strictures, with a sensible reduction in patients&#; postoperative morbidity [ 3 6 ].
Regardless of its specific configuration, a surgical stapler is always characterized by an actuation handle: the surgeon can operate the device manually through a sequence of squeezing a handle or sliding a knob. The effective function of stapling, cutting, and ejecting the staples is performed by the loading unit: two jaws are coupled in different ways to act, one as a cartridge loader for the staples and the other as an anvil to allow the closing of the staples. In the case of circular staplers, the anvil jaw is detachable, granting its insertion into the anastomosis site. The actuation handle and the loading unit are usually connected to each other: the input from the surgeon is translated into the mechanical or electro-mechanical firing system through the use of various keyed shafts [ 7 ]. Additional pins can be inserted into the jaws or be comprised into the loading unit to serve as alignment or safety devices, ensuring the correct compression of the tissue before firing or avoiding retention after staple delivery.
Each device is completely in accordance with the aims of surgical stapling, which consist, from a medical point of view, of creating an adequate lumen, preserving adequate vascularization, preventing tension in tissues, avoiding leakage, providing hemostasis, and ensuring mechanical reliability [ 8 ].
Non-absorbable staples are the ones most widely used in clinics thanks to their low artifact production in CT and their non-magnetic behavior, which causes minimal distortions in MRI. Titanium is the leading material, both pure or in alloys, thanks to its high resistance and lighter weight compared to stainless steel. Furthermore, titanium is corrosion-resistant but, most importantly, anti-allergic, and it can also be employed in patients suffering from chromate-nickel allergies [ 1 9 ].
The general design of stapling devices includes an anvil, a cartridge assembly to support an array of staples, a mechanism to push the cartridge close to the anvil, an alignment pin for capturing tissue between the cartridge and the anvil, and a firing mechanism for ejecting the surgical staples. The firing process is guided by a sequence of pressing the handle: the first press grants tissue compression and allows the surgeon to verify the correct alignment of the jaws, while the second press releases the staples. A button placed on the stapler permits the opening of the jaws at the end of the operation, setting the tissue free and allowing the reloading process.
The main particularity of cutting staplers is the addition of a blading element that allows for making a resection in the middle of the rows of staples. Instead, for endo cutting staplers, the instrument is composed of a disposable articulating end effector comprising the cartridge, the anvil, and a disposable handling unit containing the firing mechanism and the safety control system. The circular staplers have the same components with the particularity of a circular anvil and arrangement of the staples with a blading element. The powered stapling devices have the distinction of a powered actuation, meaning that the firing mechanism is controlled by an electro-mechanical system that gains energy from a battery. Figure 1 shows a description and representation of each type of device.
The use of absorbable staples is mainly spreading in dermal suturing and in performing ligations [ 10 15 ]. Currently, considering the bariatric, gastrointestinal, vascular, and thoracic surgery fields, which are the main fields of application of staplers, the only commercially available absorbable staple is Medtronic Polysorb [ 16 18 ], while other bioresorbable magnesium and zinc alloys are still a matter of research. Although studies claim to match the clinical requirements for a secure anastomosis, their technology is yet to be implemented by manufacturers on a production scale [ 19 20 ].
Another field of application for staplers is deep dermal suturing. In particular, in plastic surgery, the use of staplers has been adopted and provides wound healing outcomes that are better than those of conventional suturing [ 15 ].
22,Staplers are also used in orthopedics to secure soft tissues to bone [ 21 23 ]. Few applications have been found comprising staples in the process of suturing soft tissues in meniscal or rotator cuff repair, the latter involving scaffold placement [ 24 25 ].
When comparing devices of each type, a variety of features must be considered since each manufacturer proposes its own combination of specifications. In this work, all available characteristics of surgical staplers will be presented to compare the available alternatives for the three different classes of staplers.
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