CA1162127A - Plastic surgical staple - Google Patents

Plastic surgical staple

Info

Publication number
CA1162127A
CA1162127A CA000376608A CA376608A CA1162127A CA 1162127 A CA1162127 A CA 1162127A CA 000376608 A CA000376608 A CA 000376608A CA 376608 A CA376608 A CA 376608A CA 1162127 A CA1162127 A CA 1162127A
Authority
CA
Canada
Prior art keywords
staple
center beam
cam
staple legs
legs
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000376608A
Other languages
French (fr)
Inventor
Robert W. Mericle
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Inc
Original Assignee
Ethicon Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ethicon Inc filed Critical Ethicon Inc
Application granted granted Critical
Publication of CA1162127A publication Critical patent/CA1162127A/en
Expired legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10Homopolymers or copolymers of propene
    • C08L23/12Polypropene
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04Polyesters derived from hydroxycarboxylic acids, e.g. lactones
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L77/00Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain; Compositions of derivatives of such polymers
    • C08L77/02Polyamides derived from omega-amino carboxylic acids or from lactams thereof
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L81/00Compositions of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing sulfur with or without nitrogen, oxygen or carbon only; Compositions of polysulfones; Compositions of derivatives of such polymers
    • C08L81/06Polysulfones; Polyethersulfones

Abstract

ABSTRACT

PLASTIC SURGICAL STAPLE

A one-piece, self-locking, molded plastic staple useful as a tissue fixation device in surgical procedures. The staple has opposed, pointed, L-shaped legs hinged to a horizontal bridging member having expanding cam surfaces on each end. Each leg has an extending cam follower which traverses the cam surface and engages the end of the bridging member when the staple is closed by rotating the legs 90 degrees. The staples may be extruded or molded of absorbable or nonabsorbable polymeric materials.

Description

1~2~a2~7 PLASTIC SURGICAL S~APLE

BACKGROUND

In recent years, surgical staples have come into wide use as an alternative to sutures in closing incisions of skin, fascia, and internal organs. Staples have an advantage over sutures in some applications due to the speed and ease with which staples may be placed. In addition, special stapling instruments have been designed which place an entire row or ring of staples in a single operation to further simplify and speed up the surgical procedure.

Surgical staples currently in use are fabricated of tantalum or stainless steel wire having sufficient tensile strength and bending modulus to assure that the staple will remain closed after it has been set in place.
Although it has long been recognized that staples made of plastic or polymeric materials would be desirable for use in surgical applications, the development of such staples has been difficult due to inherent resiliency of such materials. Staples of known plastic compositions and of the same configuration as a metallic staple do not have sufficient strength and bending modulus to stay closed after being set in place. One approach to utilizing plastic materials in surgical stapling procedures has been to provide cooperating mechanical means to secure the staple in its set configuration. U.S. Patent No.
2,881,762 proposed a circular, open ring-type staple wherein the ends were designed to pierce the tissue, overlap and lock to form a closed ring through the tissue similar to a knotted suture. More recently, a two-piece staple was suggested in U.S. Patent No. 4~060/089 wherein a pronged fastener strip pierced the tissue and a cooperating retainer strip gripped the prongs on the ,1~E, '~

ti~

opposite side of the tissue. This device is limited in its application to situations where access to both sides of the tissue is available, and a special tool is required to apply the device.
It is an object of the present invention to provide a plastic staple which functions in a manner analagous to that of a metallic staple, i.e., a one-piece device which is applied from one side of the tissue. It is a further object of the present invention to provide a plastic staple which can be set with a tool of conventional design. It is yet a further object of the present invention to provide plastic staples fabricated of biologically absorbable polymers as well as of conventional nonabsorbable polymers. These and other objects of the present invention will be apparent from the ensuing description and claims.

SUM~ARY
A one-piece, self-locking, molded plastic staple is provided which comprises a central beam having outward and downward L-shaped staple legs secured to each end thereof by integral hinge means. The central beam has expanding side wall cam surfaces at each end thereof, and each leg has a resilient arm extending over the cam surface of the central beam and terminating in an inward facing cam follower.

As the staple is closed by rotating the staple legs about the hinge means, the resilient arms rotate and are de-flected as the cam followers traverse the cam surface until the cam follower overrides the end of the central beam, whereupon the arms close and engage the ends of the beam to lock the staple legs in their rotated position.

1~21~

The staple is emplaced in the tissue with a conventional stapling mechanism comprising an anvil and forming die.
The anvil supports the ce~tral beam of the stapel while the forming die acts upon each leg member, causing the legs to rotate about the hinge means. As the staple closes, the legs pierce the tissue and form a box-like configuration enclosing a segment of tissue with the ends of the staple leg approaching one another within the tissue.

The staple may be machined or molded of any suitable polymeric material including both biologically absorbable and nonabsorbable compositions. Preferred absorbable materials include polymers of lactide and glycolide.
Preferred nonabsorbable materials include nylon and polypropylene.

~ccording to a further broad aspect of the present inven-tion there is provided a self-locking surgical staple.
The staple comprises a center beam having opposing side walls and two staple legs, one extending from each end of the center beam. The staple legs are joined to the center beam by hinge means adapted to permit the staple legs to rotate relative to the center beam. The staple legs terminate in tissue piercing segments w~lich assume substantially end-to-end alignment when the staple legs are rotated relative to the center beam. Cam means is cooperatively disposed on the side walls and the staple legs and adapted to lock the staple legs in position with the tissue piercing segments in substantially end-to-end alignment when the staple legs are rotated.

'\ ' ) Z~
-3a-DESCRIPTION OF DR~WINGS

FIGURE 1 is a view in perspective of a surgical staple according to the present invention.

FIGURE 2 is a plan top view of the staple of Figure 1.

FIGURE 3 ls a side elevational view in partial section of the staple of Figure 1.

FIGURE 4 is a sectional view through line 4-4 of Figure 2.

FIGURE 5 is a sectional view through line 5-5 of Figure 2.

FIGURE 6 is a view showing the staple of Figure 1 in i.ts relation to the forming anvil, the forming die and the wound which is to be closed.

11~212~?' FIGURE 7 is a view similar to FIGURE 6 showing the staple in the process of being formed.

FIGURE 8 is a similar view showing the staple completely formed and closing the wound.

FIGURE 9 is a view similar to FIGURE 5 showing the wound after the forming tool has been removed.

FIGURE 10 is a view in perspective showing the staple of FIGURE l in its fully closed and locked position.

FIGURE 11 is a perspective view of a wound properly closed by a plurality of staples according to the invention.
FIGURE 12 is a view in perspective showing a plurality of the staples of FIGURE 1 on a stringer for use in a repeat-ing stapler unit.

DESCRIPTION

With reference to FIGURES 1~3, there is illustrated staple 10 of the present invention comprising center beam 11 and staple legs 12 which are joined at their base through hinges 14. Center beam ll has expanding side walls forming cam surfaces 13 and dwell surfaces 15 at each end thereof. Extending from the hinge end of each staple leg are arms 16 which overlie cam surfaces 13 and terminate in inward facing cam followers 17. The distal ends of staple legs 12 are sharpened to form tissue piercing points l9.
The base of beam ll is optionally channeled at 20 as illustrated to form an anvil guide as further described below.

1~2i~7 Cam followers 17 are beveled at 18 as illustrated in Figure 4 to provide a cam face angled for engagement with the cam surfaces of the center beam. FIGURE 4 is a view of Figure 2 in cross secticn through line 4-4.

FIGURE 5 is a view in cross section through line 5-5 of FIGURE 2 and illustrates the relative dimensions of central beam 11 and arms 16. Beam 11 preferably has a height to width ratio of at least about 1.5 to provide the desired structural rigidity.

The emplacement of staple 10 to approximate the tissue of a skin wound is illustrated progressively in FIGURES 6 through 9. The staple is closed by use of a conventional staple-forming tool which includes anvil 21 and a bridging die 22 as illustrated in part in FIGURES 6-8.

Referring now to FIGURE 6, staple 10 is positioned in the forming tool by suitable means with center beam 11 supported by anvil 21 and the extremities of die 22 abutting staple legs 12. Anvil 21 includes a central stepped section to engage channel 20 of beam 11 and assure that the staple is centered on the anvil prior to closure.
The forming tool and staple are placed directly over wound 24 in tissue 25. Since the staple legs extend below the level of the anvil, the legs are caused to make initial contact with and may penetrate the tissue slightly as the forming tool is moved into position.

The staple is closed and the wound secured by lowering die 22 beyond anvil 21 as illustrated in FIGURES 7 and 8. In FIGURE 7, as the staple begins to close, legs 12 penetrate the skin in a tissue gathering arc and arms 16 rotate upward with cam followers 17 riding against cam surfaces 13 of beam 11. Beveled face 18 of the cam follower conforms to the angle of the cam surface and permits L;Z7 easier passage of the arms during this motion. As arms 16 rotate upward, opposing arms extending from each leg are forced apart by the camming action. As the degree of rotation exceeds about 90 degrees, the cam followers traverse dwell surface 15 and override the end of beam 11, whereupon the arms snap back to their original spaced relation~hip and the cam followers engage the end surface of beam 11 as best illustrated in FIGURE 10. The staple is thereupon securely locked in its closed position. Once the staple is so locked, die 22 is raised and the forming tool removed leaving the staple securely fastened in the tissue across the wound with the edges o the wound pro-perly everted as illustrated in FIGURE 9. FIGURE 11 illustrates a complete incision properly closed with a series of staples in accordance with the present invention.

Dwell surfaces 15 are optional but preferably included to provide mass and strength to the edges of the end walls of beam 11, and to eliminate the possibility of the end wall failing under stress once the arms of staple legs are engaged in the locked position. For similar considera-tions, bevel 18 of the cam followers does not extend to the base of arm 16 in order to assure the structural integrity of the cam follower.

As illustrated and described above, the external parts of the staple may generally be of a rectangular configuration while the tissue piercing segments of the staple legs are preferably of circular cross section for ease of penetration and to minimize tissue trauma.

The staples of the present invention may be molded as a series of staples joined by stringer as illustrated in FIGURE 12. Stringer 26 permits a plurality of staples to be loaded into a repeating staple setting instrument ~3Zl27 which, in addition to the setting die and anvil previously described, also includes knife means for severing individ-ual staples from the stringer as the staples are moved to the setting position in the instrument. The instrument preferably also provides means for collecting the severed stringer pieces to prevent their accidental loss into the wound site.

In FIGURE 12, the staples are widely spaced on the stringer for clarity of illustration while in actual practice, the staples would be in close proximity. Other methods for providing a plurality of joined staples may also be used as, for example, molding a plurality of staples with adjacent arms tacked together at one or two spots. Individual staples may be severed from such a molding without concern for collecting severed stringer pieces.

While the staple of the present invention has been described and illustrated in a skin closure application, the staple may be used for closing fascia or internal organs as well. Since the staple is adapted for use with staple emplacement tools of a conventional design, the use of individual staples in cartridge ed, repeating stapling instruments or in instruments which set a plurality of staples in a straight line or in a circle with a single firing is also included within the scope of this inven-tion. It is understood that some modification of existing stapling instruments may be required to physically accom-modate the staples of the present invention, but suchmodification is well within the present skill of surgical instrument manufacturers.

The staples of the present invention may be constructed in sizes corresponding to the size of conventional metallic staples. In an average size staple, the central beam may 2~27 be from about 0.25 to 0.6 cm in length, while the L-shaped staple leg members and arm extensions are sized propor-tionately as illustrated, for example, in FIGURE 1.

The staples may be fabricated by any suitable plastic forming technique including extrusion and injection molding depending upon staple design and composition of material which may be any of polymeric compositions known to be biocompatible in surgical applications. Nylon, polypropylene, polyester and polysulfone are illustrative of materials which may be used to form nonabsorbable staples. Homopolymers and copolymers of lactide, glycolide and p-dioxanone are illustrative of materials which may be used to fabricate absorbable staples for internal application. Other suitable polymeric composi-tions are known to those familiar with the art and may also be used in accordance with the present invention.

Nonabsorbable staples of, for example, polypropylene or nylon may be used in internal applications where absorp-tion is not an important factor. Where such staples are used externally, they are easily removed after the wound has sufficiently healed by inserting an appropriate tool under the center beam and forcing the staple legs back to their original position as illustrated in FIGURE 1.
During such removal, the resilient arms of the staple legs twist until the cam followers are forced past the end of the center beam, allowing the staple legs to pivot about the hinge point and return to their original position.
The preceding description and the Figures of the illus-tration have been directed to a particularly preferred embodiment of the present invention, and many variations thereof which will be apparent to those skilled in the _g_ art are included within the total scope of the present invention. For example, in addition to permissible variations mentioned above, it will be apparent that the details of the staple leg cam and locking means may be varied consiberably. Each staple leg may, for example, employ only a single arm extension and cam follower, or the other suitable staple leg cam and locking means may be employed. In yet other variations, the center beam and staple legs may be molded as individual pieces and joined together by means of hinge pins extending through the arms of the staple leg and into the sidewall near the end of the center beam. These and other structural variations are contemplated by and included within the scope of the present invention.

Claims (10)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A self-locking surgical staple comprising:
a center beam, said center beam having opposing side walls and two staple legs, one extending from each end of said center beam;
said staple legs being joined to said center beam by hinge means adapted to permit said staple legs to rotate relative to said center beam;
said staple legs terminating in tissue piercing segments which assume substantially end-to-end alignment when said staple legs are rotated relative to said center beam; and cam means cooperatively disposed on said side walls and said staple legs adapted to lock said staple legs in position with said tissue piercing segments in substantially end-to-end alignment when said staple legs are rotated.
2. The staple of claim 1 wherein said center beam has opposing end walls and said hinge means comprises an integral web extending from each of said end walls to said staple legs.
3. The staple of claim 2 wherein said center beam has a top surface and opposing base, and said web extends from said base.
4. The staple of claim 1 wherein said cam means further includes at least one arm extending from each staple leg over a cam surface of a side wall and terminating in an inward facing cam follower confronting said side wall.
5. The staple of claim 4 wherein said cam followers include a locking surface and are adapted to override the cam surfaces and ends of said center beam as said staple legs are rotated relative to said center beam, whereupon said locking surface engages the end wall of said center beam to lock the staple legs in their rotated position.
6. The staple of claim 4 wherein said cam followers are beveled to provide a face conforming to the angle of said cam surfaces.
7. The staple of claim 1 wherein said cam means includes:
a pair of expanding side wall cam surfaces at each end of said center beam; and a pair of arms extending from each staple leg over said cam surfaces and terminating in an inward facing cam follower confronting the side wall of said center beam.
8. The staple of claim 2 wherein the distance between said end walls is from about 0.25 to 0.6 cm.
9. The staple of claim 1 wherein the cam means includes at least one side wall cam surface expanding toward each end of said beam.
10. The staple of claim 1 wherein said staple legs are L-shaped, the vertical arm of the Ls are parallel to the center beam and extend from opposite ends of the center beam and the horizontal arm of the Ls are disposed on the same side of the center beam when the staple is in the unlocked position.
CA000376608A 1980-05-02 1981-04-30 Plastic surgical staple Expired CA1162127A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14694380A 1980-05-02 1980-05-02
US146,943 1980-05-02

Publications (1)

Publication Number Publication Date
CA1162127A true CA1162127A (en) 1984-02-14

Family

ID=22519676

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000376608A Expired CA1162127A (en) 1980-05-02 1981-04-30 Plastic surgical staple

Country Status (5)

Country Link
JP (1) JPS56168737A (en)
CA (1) CA1162127A (en)
DE (1) DE3117277A1 (en)
FR (1) FR2481594A1 (en)
GB (1) GB2075144B (en)

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Also Published As

Publication number Publication date
GB2075144A (en) 1981-11-11
FR2481594A1 (en) 1981-11-06
GB2075144B (en) 1983-10-12
DE3117277A1 (en) 1982-06-24
FR2481594B1 (en) 1985-01-04
JPS56168737A (en) 1981-12-25

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