Bioprothesis film strip for surgical stapler and method of attaching the same

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.

In various soft tissue surgery applications such as, for example, the resection of diseased lung tissue, 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. Once the staples have been placed, a scalpel is drawn lengthwise between the staple rows to sever one stapled lung portion from the other.

Because of the nature of lung tissue, air leakage occurs at the points where the staples pierce the lung tissue, This leakage continues until the lung tissue heals around the staples, thus requiring lengthy hospitalization of the patient. To mitigate this problem, it has been proposed to drive the staples through a bioprosthetic film, which can act as a gasket or sealant to the lung tissue punctured by the staples. Suitable materials for this purpose are natural materials such as glutaraldehyde fixed bovine pericardium, or man-made materials such as collagen absorbable hemostat, vicryl (polygalacrin) mesh, or ePTEE (expanded polytetrafluoroethylene).

A problem arises when strips of these materials are to be applied to the jaws of the stapler in such a way that they can be conveniently released from the jaws after the stapling operation. For example, 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. After the stapling operation, the edges of the strips must be cut free of the hacking 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.

Other methods of attachment have involved the use of glue or adhesive tape, but none of these are simple and satisfactory, A need therefore exists for a method of attaching a bioprosthetic film strip to a stapler jaw which is easy, reliable and allows the strip to be readily severed from the jaw.

The present invention fulfills the above-identified need by providing a flat bioprosthetic film strip with apertured ends. In one preferred embodiment of the invention, the perforated ends of the strip are simply turned our of the plane of the strip, and the jaw is slipped through them.

After the stapling, 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.

In another preferred embodiment of the invention, the scrip can be secured to the jaw at the proximal end or at both ends with the aid of retaining pins from which ft can slip off when the jaws are opened following the stapling procedure.

FIG. 1 a is an elevational view of a lung showing a stapled and severed lobe;

FIG. 1 b is a section of the severed lobe edges along line 1 b - 1 b of FIG. 1 a ;

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; and

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; and

FIG. 8 is a section along line 8-8 of FIG. 7 .

FIG. 1 illustrates an environment in which the present invention is useful. In that figure, it will be assumed that 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. Typically, several overlapping stapled cuts are made at an angle to each other (see FIG. 1 a ).

In order to prevent excessive air leak from the lung tissue 20 (FIG. 1 b ) where it has been perforated by the staples 18 , 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.

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 . In the use of the stapler 14 , 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.

Prior art solutions to this problem have included several different approaches. In one approach, a polymer backing was sutured to the strips 22 along their longitudinal edges, so that the strip and backing would form a sleeve which could be slipped over the jaws 26 , 28 . Following application of the staples, the sutures were cur, and the backing was removed, This was unsatisfactory because it required the cutting of a substantial number of sutures and the removal of the backing, all while holding the stapler in the closed position - a task sometimes exacerbated by misalignment of the sleeve with the jaw. Thus, this prior art approach presented a risk of accidentally leaving backing and suture fragments in the patient.

In another approach, biocompatible adhesives or adhesive rape 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.

In accordance with a preferred embodiment of the invention, 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 jaws, formed in the extended portion.

FIG. 3 shows that preferred embodiment of the invention. In that embodiment, the strip 22 has a central portion 32 whose length corresponds to the length of the stapling area of the jaw 26 or 28 . At each end of the central portion 32 , the strip 22 has an extension 34 a or 34 b. In the embodiment of FIG. 3, the extensions 34 a has formed therein an opening 36 a 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. Preferably, the opening 36 a in extension 34 a is small enough to fit snugly over the distal end of jaw 26 or 28 . In the extension 34 b, an opening 36 b is formed, and the strip 22 is cut along line 39 . When the outer end of the extension 34 b is lifted out of the plane of strip 22 , the tongue 35 remains in the plane of the strip 22 , The opening 36 b in extension 34 b is large enough w fit somewhat loosely, though with a small interference fit, over the proximal end of jaw 26 or 28 .

The actual size of the openings 36 a and 36 b 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 36 a and 36 b 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. As a practical matter, the openings 36 a and 36 b 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.

In a typical stapler (FIGS. 2 and 7 ), the staple cartridge 18 extends all the way to the proximal end of the jaw 26 . Because the end portion 34 b of the strip 22 lies at an angle to the jaw 26 or 28 (FIG. 7) when in stapling position, the end portion 34 b is pre-cut along line 39 (FIG. 3 ). By bending the outer end of the extension 34 b out of the plane of the strip 22 , the opening 36 b 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 (he proximal end of the jaw 26 or 28 .

In use, the extensions 34 a and 34 b 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) holds the strip 22 securely to the jaw 26 or 28 . Following the stapling operation, the scalpel blade 17 is actuated to cut the lung tissue and the strips 22 along the dotted line 37 . To release the strips 22 from the stapler, scalpel cuts are made by the operator at 38 in the protruding end portions 34 a and 34 b . 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. 5 a and 6 illustrate another preferred embodiment of the invention. In that embodiment, 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 34 b has formed therein not a large opening 36 b, but rather one or more small openings 42 that are preferably slightly smaller in diameter than the pins 40 .

In the embodiment of FIGS. 5 and 6, the strips 22 are attached to the jaws 26 , 28 by slipping opening 36 in extension 34 a 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 scrip 22 to easily be pulled free of the pins 40 when the jaws 26 , 28 are opened following stapling. It would also he possible to use pins 40 on both jaws 26 , 28 and small openings 42 on both ends of the strip 22 , in which case the opening 36 is unneeded (FIG. 5 b ). In that case, the strips 22 can be secured by simply hooking the openings 42 over the pins 40 and pushing the strips 22 against the stapling surfaces of the jaws 26 , 28 . With the diameter of the openings 42 being slightly smaller than the diameter of the pins 40 , a firm but readily releasable engagement of the openings 42 with the pins 40 is achieved.

It is understood that the exemplary bioprosthesis film strips for surgical stapler described herein and shown in the drawings represent only presently preferred embodiments of the invention. Indeed, various modifications and additions may be made to such embodiments without departing from the spirit and scope of the invention. Thus other modifications and additions may be obvious to those skilled in the art and may be implemented to adapt the present invention for use in a variety of different applications.