Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
  • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
  • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
  • A61B17/07292—Reinforcements for staple line, e.g. pledgets

Definitions

• This invention relates to surgical stapling guns, and more particularly to a bioprosthesis film strip to prevent air leaks at the staples in lung surgery, and to a method of attaching the strip to a stapling gun.
• surgeons use linear stapling guns to staple together layers of tissue on each side of a proposed cut along which the diseased tissue is to be severed from the healthy tissue.
• These stapling guns consist of a pair of elongated jaws which are clamped over, e.g., a lung from which a cancerous lobe is to be removed.
• One of the jaws carries a cartridge containing parallel rows of biocompatible staples positioned end-to-end, while the other carries parallel rows of anvils for those staples.
• a scalpel is drawn lengthwise between the staple rows to sever one stapled lung portion from the other.
• Suitable materials for this purpose are natural materials such as glutaraldehyde fixed bovine pericardium, or man-made materials such as collagen absorbable hemostat, vicryl (polygalactin) mesh, or ePTFE (expanded polytetrafluoroethylene).
• one prior method involves suturing a strip of bioprosthetic film to a strip of polyethylene backing to form a sleeve.
• One of these sleeves is then slipped over each jaw of the stapler, with the strip facing inward.
• the edges of the strips must be cut free of the backing and sutures, which are discarded. This method requires caution on the part of the surgeon to avoid leaving remnants of the backing or sutures in the patient.
• the present invention fulfills the above-identified need by providing a flat bioprosthetic film strip with apertured ends.
• the perforated ends of the strip are simply turned out of the plane of the strip, and the jaw is slipped through them.
• the strip can be released from the jaws in the preferred embodiment by cutting the strip adjacent the apertures, and the entire strip can be left in the patient.
• Fig. 1 a is an elevational view of a lung showing a stapled and severed lobe
• Fig. lb is a section of the severed lobe edges along line lb-lb of Fig. la;
• Fig. 2 is a perspective view of a typical stapling gun used for the stapling operation of Fig. 1;
• Fig. 3 is a plan view of a preferred embodiment of a bioprosthetic film strip used in the invention.
• Fig. 4 is a perspective view of the jaws of the stapler of Fig. 2 with the strips of Fig. 3 attached;
• Fig. 5 is a plan view of a bioprosthetic film strip in an alternative embodiment of the invention
• Fig. 6 is a perspective view of a stapler using the strip of Fig. 5 a
• Fig. 7 is a side elevation of stapler jaws with the strip of Fig. 3 attached
• Fig. 8 is a section along line 8-8 of Fig. 7.
• Fig. 1 illustrates an environment in which the present invention is useful.
• a lung 10 has a lobe 12 which is diseased and must be surgically removed. This is done by compressing the lung 10 between the jaws of a stapler 14 (Fig. 2) along a line 16 and stapling the lung with two parallel sets of rows of surgical staples 18 on each side of the line 16.
• the lung tissue is then cut along line 16 by a scalpel blade 17 traveling along a channel 19 (Fig. 8) between the two sets of rows.
• a scalpel blade 17 traveling along a channel 19 (Fig. 8) between the two sets of rows.
• several overlapping stapled cuts are made at an angle to each other (see Fig. la).
• the staples 18 are conventionally driven through strips of a bioprosthetic sealing material 22 such as bovine pericardium, collagen absorbable hemostat, vicryl mesh or ePTFE. These materials effectively seal the punctured lung.
• a bioprosthetic sealing material 22 such as bovine pericardium, collagen absorbable hemostat, vicryl mesh or ePTFE.
• Fig. 2 illustrates the stapler 14 which is used in the above-described procedure.
• the stapler 14 includes a handle 24 and a pair of jaws 26, 28.
• the jaws 26, 28 can be widely separated, like the jaws of pliers, prior to use, and then closed and compressed against each other in use.
• the jaw 26 carries a cartridge of staples 18, while the jaw 28 carries the anvil 30.
• strips of the sealing material 22 (Figs. 3 and 4) are placed over the staples 18 on jaw 26, and over the anvil 30 on the jaw 28.
• the strips 22 must be so mounted on the jaws 26, 28 that they are firmly held on the jaws 26, 28 but can be quickly and simply detached from the jaws 26, 28 in order to allow the jaws 26, 28 to be separated following the stapling.
• biocompatible adhesives or adhesive tape were used to temporarily secure the strips 22 to the jaws 26, 28 but allow them to separate from the jaws when the jaws were opened. This was also unsatisfactory because it introduced additional foreign substances into the body, and because a repeatable acceptable compromise between sufficient adhesion for handling and sufficient releasability to avoid damaging the strips 22 after stapling was difficult to attain.
• the above- described disadvantages are eliminated by providing strips 22 which extend longitudinally beyond the stapling area of the jaws 26, 28, and which have at least one hole, of a diameter approximating the diameter of the j aws, formed in the extended portion.
• Fig. 3 shows that preferred embodiment of the invention.
• the strip 22 has a central portion 32 whose length corresponds to the length of the stapling area of the jaw 26 or 28.
• the strip 22 has an extension 34a or 34b.
• the extensions 34a has formed therein an opening 36a of appropriate size and shape (preferably rounded to provide an interference fit along the corners of the square jaws 26, 28) to allow passage of the jaw 26 or 28 therethrough.
• the opening 36a in extension 34a is small enough to fit snugly over the distal end of jaw 26 or 28.
• an opening 36b is formed, and the strip 22 is cut along line 39.
• the opening 36b in extension 34b is large enough to fit somewhat loosely, though with a small interference fit, over the proximal end of jaw 26 or 28.
• the actual size of the openings 36a and 36b is dictated by several factors. On the one hand, the openings 36 must be large enough to allow the surgeon or stapler operator to slip or slide the strip 22 along the jaws 26, 28, yet small enough to hold the strip in position on the jaws 26, 28. On the other hand, the openings 36a arid 36b must not be so small as to cause difficulty in slipping the strip 22 onto the jaws 26, 28, or to risk tearing the strip 22 during installation.
• the openings 36a and 36b may be about 0.5-1.0 cm in diameter, the exact size depending upon the size and geometry of the jaws 26, 28.
• the strip 22 may, for example, be about 2 cm wide for a staple cartridge width of 1 cm.
• the staple cartridge 18 extends all the way to the proximal end of the jaw 26. Because the end portion 34b of the strip 22 lies at an angle to the jaw 26 or 28 (Fig. 7) when in stapling position, the end portion 34b is pre-cut along line 39 (Fig. 3).
• the opening 36b By bending the outer end of the extension 34b out of the plane of the strip 22, the opening 36b can be slipped over the end of the jaw, but the tongue 35 remains in the plane of strip 22 and covers the staple cartridge 18 or anvil 30 all the way to the proximal end of the jaw 26 or 28.
• the extensions 34a and 34b are bent out of the plane of the strip 22, as shown in Fig. 4, and are simply slipped over the jaw 26 or 28.
• the resiliency of the flexible strip material e.g. bovine pericardium
• the scalpel blade 17 is actuated to cut the lung tissue and the strips 22 along the dotted line 37.
• scalpel cuts are made by the operator at 38 in the protruding end portions 34a and 34b. Because in a typical stapler, the blade 17 does not travel all the way to the distal end of the stapling cartridge 18 (see Fig. 7), a further scalpel cut is needed at 43 after the jaws 26, 28 are removed to completely sever the healthy lung tissue and stapled strip halves from the diseased lung tissue and the stapled strip halves associated therewith.
• Figs. 5a and 6 illustrate another preferred embodiment of the invention.
• the stapler 14 has one or more pins 40 formed at the proximal end of at least one of the jaws 26, 28.
• the extension 34b has formed therein not a large opening 36b, but rather one or more small openings 42 that are preferably slightly smaller in diameter than the pins 40.
• the strips 22 are attached to the jaws 26, 28 by slipping opening 36 in extension 34a over the jaw 26 or 28, and then slipping the openings 42 of both strips 22 over the pins 40 on the jaw 26.
• the resilience of the strip material holds the strip 22 on the pins 40 prior to stapling but allows the strip 22 to easily be pulled free of the pins 40 when the jaws 26, 28 are opened following stapling.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)
• Materials For Medical Uses (AREA)

Applications Claiming Priority (3)

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• 1998
  • 1998-03-03 JP JP53865298A patent/JP2001514539A/ja not_active Ceased
  • 1998-03-03 EP EP98910121A patent/EP1011477A1/de not_active Withdrawn
  • 1998-03-03 CA CA002282761A patent/CA2282761A1/en not_active Abandoned
  • 1998-03-03 WO PCT/US1998/004028 patent/WO1998038923A1/en not_active Ceased
  • 1998-03-03 AU AU64442/98A patent/AU6444298A/en not_active Abandoned

Non-Patent Citations (1)

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