CA1144445A - Plastic surgical staple - Google Patents
Plastic surgical stapleInfo
- Publication number
- CA1144445A CA1144445A CA000371064A CA371064A CA1144445A CA 1144445 A CA1144445 A CA 1144445A CA 000371064 A CA000371064 A CA 000371064A CA 371064 A CA371064 A CA 371064A CA 1144445 A CA1144445 A CA 1144445A
- Authority
- CA
- Canada
- Prior art keywords
- staple
- leg
- locking bar
- extensions
- staple leg
- 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
Links
- 239000004033 plastic Substances 0.000 title claims abstract description 13
- 239000000203 mixture Substances 0.000 claims description 8
- 239000004677 Nylon Substances 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 4
- 229920001778 nylon Polymers 0.000 claims description 4
- -1 polypropylene Polymers 0.000 claims description 4
- 229920001155 polypropylene Polymers 0.000 claims description 4
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims description 3
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 claims description 3
- VPVXHAANQNHFSF-UHFFFAOYSA-N 1,4-dioxan-2-one Chemical compound O=C1COCCO1 VPVXHAANQNHFSF-UHFFFAOYSA-N 0.000 claims description 2
- 229920001577 copolymer Polymers 0.000 claims description 2
- 229920001519 homopolymer Polymers 0.000 claims description 2
- 229920002492 poly(sulfone) Polymers 0.000 claims description 2
- 229920000728 polyester Polymers 0.000 claims description 2
- 230000009977 dual effect Effects 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 11
- 239000002991 molded plastic Substances 0.000 abstract description 2
- 238000001356 surgical procedure Methods 0.000 abstract description 2
- 208000027418 Wounds and injury Diseases 0.000 description 10
- 238000013461 design Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 238000005452 bending Methods 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
- 210000003195 fascia Anatomy 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 206010072170 Skin wound Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000010304 firing Methods 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 229910052715 tantalum Inorganic materials 0.000 description 1
- GUVRBAGPIYLISA-UHFFFAOYSA-N tantalum atom Chemical compound [Ta] GUVRBAGPIYLISA-UHFFFAOYSA-N 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B15/00—Nails; Staples
- F16B15/0015—Staples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions 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
- C08L23/10—Homopolymers or copolymers of propene
- C08L23/12—Polypropene
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L77/00—Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain; Compositions of derivatives of such polymers
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L81/00—Compositions 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
- C08L81/06—Polysulfones; 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 secured to a horizontal bridging member. Each leg has an extension which is engaged by a locking bar extending between the extensions when the staple is closed by forcing the legs through a 90° arc. The staples may be extruded or molded of absorbable or nonabsorbable polymeric materials.
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 secured to a horizontal bridging member. Each leg has an extension which is engaged by a locking bar extending between the extensions when the staple is closed by forcing the legs through a 90° arc. The staples may be extruded or molded of absorbable or nonabsorbable polymeric materials.
Description
E TH - 4 6 ~
PLASTIC SURGICAL STAPLE
BACKGROUND
In recent years, surgical staples have come in~o wide use as an alternative to sutures in closing incisions of skin, fascia, and internal organs. S~aples 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 fur~her 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 ts set configuration. U.S. Patent No.
PLASTIC SURGICAL STAPLE
BACKGROUND
In recent years, surgical staples have come in~o wide use as an alternative to sutures in closing incisions of skin, fascia, and internal organs. S~aples 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 fur~her 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 ts 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 NoO 4~060,089 wherein a pronged fastener strip pierced the tissue and a cooperating retainer strip gripped the prongs on the ~ 5~
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 presen~ 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 bio-logically absorbable polymers as well as of conventional nona~sorbable polymers. These and other objects of the present invention will be apparent from the ensuing description and claims.
SUMMARY
A one-piece, self-locking molded plastic staple is pro-vided which, in its open configuration, comprises, in a vertical plane, two outward and downward pointed staple legs secured to a central bridging member by short, vertical leg support members. Each staple leg has an extension extending inward from the leg support member toward the center of and above the bridging member. A
horizontal staple leg locking bar is mounted to the central bridging member by a vertical support post ex-3Q tending between the staple leg extensions. The lockingbar is parallel to and coex~ensive with the central bridging member.
The staple is enplaced in the tissue with a conventional stapling mechanism comprising an anvil and forming die.
The anvil supports the central bridging member while the ET~-468 .
1~4~45 forming die acts upon each leg member, causing the legs and leg support members to pivot 90. As the staple closes, the legs pierce the tissue and form a box-like configuration enclosing a segment of tissue with the points of the staple leg approaching one another within the tissue. As the staple is being closed, the leg extension members deflect the locking bar until the ends of the bar are bypassed, whereupon the bar snaps in place between the leg extensions locking the staple in the closed position.
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.
DESCRIP~ION OF DRAWINGS
FIGURE 1 is an elevational view of a surgical staple according to the present invention.
FIGURE 2 is an end elevational view of the staple of FIGURE 1.
FIGURE 3 is a view showing the staple of FIGURE 1 in its relation to the forming anvil, the forming die and the wound which is to be closed.
FIGURE 4 is a view similar to FIGURE 3 showing the staple in the process of being formed.
FIGURE 5 is a similar view showing the staple completely formed and closing the wound.
, ETH-4~8 S
_~ _ FIGURE 6 is a view similar to FIGURE 5 showing the wound after the forming tool has been removed.
FIGURE 7 is a perspective view of a wound properly closed by a plurality of staples according to the invention.
FIGURE 8 is a side and top view of a portion of the closed staple illustrating a locking engagement for the staple leg.
FIGURE 9 is a view similar to FIGURE 3 illustrating another locking engagement.
FIGURE 10 is a similar view illustrating a further locking engagement.
- FIGURE 11 is an elevational view of another embodiment of a surgical staple according to the present invention.
FIGURE 12 is a view of the staple of FIGURE 11 in a partially closed configuration.
DESCRIPTION
With reference to FIGURES 1 and 2, there is illustrated staple 10 of the present invention having horizontal bridging member 11 spanning the width of the staple and terminating at each end in an upward extending staple leg support member 12. L-shaped staple leg 13 extends horizontally outward and downward from each leg support member and terminates in tissue piercing point 14.
Horizontal staple leg extensions 15 extend inwardly ~rom each leg support member toward the center of the staple, termina~ing with a central space between the ends thereof.
ETH - 4 6 ~3 Center post 16 extends upward between the staple leg extensions from the horizontal bridging member, and horizontal staple leg locking bar 17 is secured to the upper end of the center post in a spaced relationship to staple leg extensions 15.
Additional features included in the preferred embodiment of the staple illustrated in FIGURE 1 include V-notches 18 and relief grooves 19 which facilitate the operation of the staple as hereinafter explained. Also as illustrated in FIGURE 1 r staple leg extensions 15 are tapered at 20 on the upper surface thereof for reasons explained below.
The emplacement of staple 10 to approximate the tissue of a skin wound is illustrated progressively in FIGURES 3 through 6. 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 3-5.
Referring llOW to FIGURE 3, staple 10 is positioned in the forming too:L by suitable means with bridging member 11 supported by anvil 21 and the extremities 23 of die 22 abutting staple legs 13. 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 the tissue as the forming tool is positioned over the wound.
The staple is closed and the wound secured by lowering die 22 beyond anvil 21 as illustrated in FIGURES 4 and 5. In FIGURE 4, as the staple begins to close, legs 13 penetrate into the skin in a tissue gathering arc as staple leg support members 12 pivot about the ends of bridging member 11. V-notches 18 form hinge points to facilitate this pivoting action. Simultaneously, staple leg extensions 15 rotate upward against locking bar 17 which is deflected to 119~44~5 permit passage of the extensions. Relief grooves 19 form hinge points which relieve stress during the deflection of the locking bar. Taper 20 on the upper surface of the staple leg extensions also permits easier passage of the extensions past the locking bar.
As die 22 is fully depressed as illustrated in FIGURE 5, staple leg members 13 pivot a full 90 within the tissue.
Staple leg extensions 15 by-pass the ends of locking bar 17, and the resiliency of the plastic material causes the locking bar to return to its initial horizontal position, now between leg extensions 15, effectively locking the staple in its formed or 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 of the wound properly everted as illustrated in FIGURE 6. FIGURE 7 illustrates a complete incision properly closed with a series of staples in accordance with the present invention.
The staples~ of the present invention are preferably rectangular in cross section except for the staple legs which may be made cylindrical and/or tapered if desired for ease of tissue penetration. The staple leg extensions 15 and the ends of locking bar }7 are either flat or provided with recessed surfaces in the locked position to prevent the subsequent disengagement of these surfaces once the staple has been formed.
30 FIGURES 8-10 illustrate various mating arrangements which may be employed between the staple leg extensions and the ends of the locking bar. In FIGURE 8, the inside of leg extension 15 is provided with a raised rib 26 while the end of bar 17 is provided with a corresponding recessed 35 groove. This arrangement restricts lateral displacement ETH 46?, of the staple leg extension once the staple has been formed into its locked position.
FIGURE 9 illustrates a tongue and groove in-terlock at 27 between the end of locking bar 17 and the inside of leg extension 15. This arrangement restricts the vertical displacement of locking bar 17 once the staple has been closed.
FIGURE 10 illustrates one arrangement for restricting both lateral and vertical movement of the leg extension and locking bar once the staple has been closed. In this embodiment, leg extension 15 is provided with a short raised rib 28 at the very tip thereof having a length of about one-half the thickness of locking bar 17. The end of the locking bar is provided with a corresponding groove to receive rib 28 as illustrated. A horizontal tongue and groove interlock immediately below rib 28 completes the arrangement.
FIGURES 11 and 12 illustrate a variation of the staple of FIGURE 1, wherein locking bar 17 is provided with a series of ratchet teeth 31 on the lower surface thereof, and leg extensions 15 have angled tips 30 adapted to engage said ratchet teeth as the staple is closed. Such a clip has an advantage over the clip of FIGURE 1 in special situations where 1ess than full closure of the clip may be desired.
The clip of FIGURE 11 may accordingly be closed to the degree as illustrated, for example, in FIGURE 12, and the applier removed to leave the clip in the partially closed configuration. The clip of FIGURE 11 may also be fully closed if desired.
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 ETH-46~
_~_ organs as well. Since the staple is adapted for use with staple emplacement tools of a conventional design, the use of the staple in cartridge fed, repeating stapling instru-ments 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 invention. It is u~derstood that some modification of existing stapling instruments may be required to physically accommodate the staples of the present invention, but such modification is well within the present skill of the instrument manufac-turers.
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 horizontal bridg-ing member may be from about 0.25 to 0.6 cm, while the L-shaped staple leg members are sized proportionately 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 material of fabrication which may be any of several polymeric composi-tions 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 compositions 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 ETH-~6~
_9 .
absorption is not an important factor. Where such staples are used externally, they are easily removed after the wound has sufficiently healed by merely clipping center post 16 to remove locking bar 17 from the staple. The staple legs may thereupon be rotated back to their original position as illustrated in FIGURE 1 and removed from the tissue with minimal discomfort to the patient.
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 presen~ 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 bio-logically absorbable polymers as well as of conventional nona~sorbable polymers. These and other objects of the present invention will be apparent from the ensuing description and claims.
SUMMARY
A one-piece, self-locking molded plastic staple is pro-vided which, in its open configuration, comprises, in a vertical plane, two outward and downward pointed staple legs secured to a central bridging member by short, vertical leg support members. Each staple leg has an extension extending inward from the leg support member toward the center of and above the bridging member. A
horizontal staple leg locking bar is mounted to the central bridging member by a vertical support post ex-3Q tending between the staple leg extensions. The lockingbar is parallel to and coex~ensive with the central bridging member.
The staple is enplaced in the tissue with a conventional stapling mechanism comprising an anvil and forming die.
The anvil supports the central bridging member while the ET~-468 .
1~4~45 forming die acts upon each leg member, causing the legs and leg support members to pivot 90. As the staple closes, the legs pierce the tissue and form a box-like configuration enclosing a segment of tissue with the points of the staple leg approaching one another within the tissue. As the staple is being closed, the leg extension members deflect the locking bar until the ends of the bar are bypassed, whereupon the bar snaps in place between the leg extensions locking the staple in the closed position.
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.
DESCRIP~ION OF DRAWINGS
FIGURE 1 is an elevational view of a surgical staple according to the present invention.
FIGURE 2 is an end elevational view of the staple of FIGURE 1.
FIGURE 3 is a view showing the staple of FIGURE 1 in its relation to the forming anvil, the forming die and the wound which is to be closed.
FIGURE 4 is a view similar to FIGURE 3 showing the staple in the process of being formed.
FIGURE 5 is a similar view showing the staple completely formed and closing the wound.
, ETH-4~8 S
_~ _ FIGURE 6 is a view similar to FIGURE 5 showing the wound after the forming tool has been removed.
FIGURE 7 is a perspective view of a wound properly closed by a plurality of staples according to the invention.
FIGURE 8 is a side and top view of a portion of the closed staple illustrating a locking engagement for the staple leg.
FIGURE 9 is a view similar to FIGURE 3 illustrating another locking engagement.
FIGURE 10 is a similar view illustrating a further locking engagement.
- FIGURE 11 is an elevational view of another embodiment of a surgical staple according to the present invention.
FIGURE 12 is a view of the staple of FIGURE 11 in a partially closed configuration.
DESCRIPTION
With reference to FIGURES 1 and 2, there is illustrated staple 10 of the present invention having horizontal bridging member 11 spanning the width of the staple and terminating at each end in an upward extending staple leg support member 12. L-shaped staple leg 13 extends horizontally outward and downward from each leg support member and terminates in tissue piercing point 14.
Horizontal staple leg extensions 15 extend inwardly ~rom each leg support member toward the center of the staple, termina~ing with a central space between the ends thereof.
ETH - 4 6 ~3 Center post 16 extends upward between the staple leg extensions from the horizontal bridging member, and horizontal staple leg locking bar 17 is secured to the upper end of the center post in a spaced relationship to staple leg extensions 15.
Additional features included in the preferred embodiment of the staple illustrated in FIGURE 1 include V-notches 18 and relief grooves 19 which facilitate the operation of the staple as hereinafter explained. Also as illustrated in FIGURE 1 r staple leg extensions 15 are tapered at 20 on the upper surface thereof for reasons explained below.
The emplacement of staple 10 to approximate the tissue of a skin wound is illustrated progressively in FIGURES 3 through 6. 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 3-5.
Referring llOW to FIGURE 3, staple 10 is positioned in the forming too:L by suitable means with bridging member 11 supported by anvil 21 and the extremities 23 of die 22 abutting staple legs 13. 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 the tissue as the forming tool is positioned over the wound.
The staple is closed and the wound secured by lowering die 22 beyond anvil 21 as illustrated in FIGURES 4 and 5. In FIGURE 4, as the staple begins to close, legs 13 penetrate into the skin in a tissue gathering arc as staple leg support members 12 pivot about the ends of bridging member 11. V-notches 18 form hinge points to facilitate this pivoting action. Simultaneously, staple leg extensions 15 rotate upward against locking bar 17 which is deflected to 119~44~5 permit passage of the extensions. Relief grooves 19 form hinge points which relieve stress during the deflection of the locking bar. Taper 20 on the upper surface of the staple leg extensions also permits easier passage of the extensions past the locking bar.
As die 22 is fully depressed as illustrated in FIGURE 5, staple leg members 13 pivot a full 90 within the tissue.
Staple leg extensions 15 by-pass the ends of locking bar 17, and the resiliency of the plastic material causes the locking bar to return to its initial horizontal position, now between leg extensions 15, effectively locking the staple in its formed or 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 of the wound properly everted as illustrated in FIGURE 6. FIGURE 7 illustrates a complete incision properly closed with a series of staples in accordance with the present invention.
The staples~ of the present invention are preferably rectangular in cross section except for the staple legs which may be made cylindrical and/or tapered if desired for ease of tissue penetration. The staple leg extensions 15 and the ends of locking bar }7 are either flat or provided with recessed surfaces in the locked position to prevent the subsequent disengagement of these surfaces once the staple has been formed.
30 FIGURES 8-10 illustrate various mating arrangements which may be employed between the staple leg extensions and the ends of the locking bar. In FIGURE 8, the inside of leg extension 15 is provided with a raised rib 26 while the end of bar 17 is provided with a corresponding recessed 35 groove. This arrangement restricts lateral displacement ETH 46?, of the staple leg extension once the staple has been formed into its locked position.
FIGURE 9 illustrates a tongue and groove in-terlock at 27 between the end of locking bar 17 and the inside of leg extension 15. This arrangement restricts the vertical displacement of locking bar 17 once the staple has been closed.
FIGURE 10 illustrates one arrangement for restricting both lateral and vertical movement of the leg extension and locking bar once the staple has been closed. In this embodiment, leg extension 15 is provided with a short raised rib 28 at the very tip thereof having a length of about one-half the thickness of locking bar 17. The end of the locking bar is provided with a corresponding groove to receive rib 28 as illustrated. A horizontal tongue and groove interlock immediately below rib 28 completes the arrangement.
FIGURES 11 and 12 illustrate a variation of the staple of FIGURE 1, wherein locking bar 17 is provided with a series of ratchet teeth 31 on the lower surface thereof, and leg extensions 15 have angled tips 30 adapted to engage said ratchet teeth as the staple is closed. Such a clip has an advantage over the clip of FIGURE 1 in special situations where 1ess than full closure of the clip may be desired.
The clip of FIGURE 11 may accordingly be closed to the degree as illustrated, for example, in FIGURE 12, and the applier removed to leave the clip in the partially closed configuration. The clip of FIGURE 11 may also be fully closed if desired.
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 ETH-46~
_~_ organs as well. Since the staple is adapted for use with staple emplacement tools of a conventional design, the use of the staple in cartridge fed, repeating stapling instru-ments 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 invention. It is u~derstood that some modification of existing stapling instruments may be required to physically accommodate the staples of the present invention, but such modification is well within the present skill of the instrument manufac-turers.
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 horizontal bridg-ing member may be from about 0.25 to 0.6 cm, while the L-shaped staple leg members are sized proportionately 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 material of fabrication which may be any of several polymeric composi-tions 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 compositions 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 ETH-~6~
_9 .
absorption is not an important factor. Where such staples are used externally, they are easily removed after the wound has sufficiently healed by merely clipping center post 16 to remove locking bar 17 from the staple. The staple legs may thereupon be rotated back to their original position as illustrated in FIGURE 1 and removed from the tissue with minimal discomfort to the patient.
Claims (20)
1. A one-piece, self-locking, plastic surgical staple comprising, in a vertical plane, a horizontal bridging member spanning the width of the staple and terminating at each end in an upward extending staple leg support member, an L-shaped staple leg extending horizontally outward and downward from each leg support member and terminating in a tissue-piercing point, a staple leg extension extending inwardly from each staple leg at the leg support member and terminating with a space between opposing ends of said extensions, a center post extending vertically upward from said bridging member and through said space between the opposing ends of said extensions, and a horizontal staple leg locking bar secured to said center post and extending horizontally in a closely spaced relationship adjacent said staple leg extensions and staple leg support members, said staple leg support members and staple legs secured thereto being adapted to pivot with respect to said horizontal bridging member to close said staple legs, whereupon said staple leg extensions deflect said locking bar and are thereafter engaged by said locking bar to maintain said staple legs in their closed position.
2. The staple of Claim 1 wherein an integral hinge is provided at the juncture of each staple leg support member and said horizontal bridging member.
3. The staple of Claim 1 wherein a relief groove is pro-vided at each juncture of the locking bar and the center post.
4. A staple of Claim 1 wherein the length of said locking bar is coextensive with the width of said horizontal bridging member and the length of said leg support members.
5. The staple of Claim 1 wherein each staple leg exten-sion is tapered away from the locking bar.
6. The staple of Claim 1 having members of a generally rectangular cross section.
7. The staple of Claim 1 wherein the staple leg members have a circular cross section.
8. The staple of Claim 1 wherein said staple leg members are adapted to pivot 90° with respect to said horizontal bridging member, and said staple leg extensions bypass said locking bar and are thereafter engaged by the ends of said locking bar to maintain said staple legs in their closed position.
9. The staple of Claim 8 wherein said leg extensions and the ends of said locking bar are provided with interlocking means which are engaged when the staple is closed.
10. The staple of Claim 9 wherein said interlocking means comprise V-shaped surfaces adapted to nest when said staple is closed.
11. The staple of Claim 9 wherein said interlocking means comprise a tongue and groove adapted to engage when said staple is closed.
12. The staple of Claim 1 wherein said staple leg locking bar includes a series of ratchet teeth on the lower sur-face thereof, and said staple leg extensions include angled tips adapted to engage said ratchet teeth as said clip is closed.
13. The staple of Claim 1 comprising an absorbable poly-meric composition.
14. The staple of Claim 13 wherein said absorbable poly-meric composition is a homopolymer or copolymer of lactide, glycolide, or p-dioxanone.
15. The staple of Claim 1 comprising a nonabsorbable polymeric composition.
16. The staple of Claim 15 wherein said nonabsorbable polymeric composition is selected from the group consisting of nylon, polyester, polypropylene, and polysulfone.
17. In combination with a stapling tool having a forming anvil and a cooperating forming die, a one-piece self-locking plastic surgical staple comprising, in a vertical plane and prior to closure, a horizontal bridging member spanning the width of the staple and terminating at each end in an upward extending staple leg support member, an L-shaped staple leg extending horizontally outward and downward from each leg support member and terminating in a tissue piercing point, a staple leg extension extending inwardly from each staple leg and leg support member and terminating with a space between opposing ends of said extensions, a center post extending vertically upward from said bridging member and through said space between the opposing ends of said extensions, and a horizontal staple leg locking bar secured to said center post and extending horizontally in a closely spaced relationship adjacent said staple leg extensions and staple leg support members, said forming anvil having a width substantially equal to the width of said horizontal bridging member, said forming die having two downward projecting extremities spaced to engage the staple legs when the staple is centered on the anvil, the distance between said extremities corresponding substantially to the width of the staple after closure, said anvil and said forming die being adapted to close said staple by pivoting said staple leg support members and staple legs with respect to said horizontal bridging member, whereupon said staple leg extensions deflect said locking bar and are thereafter engaged by said locking bar to maintain said staple legs in their closed position.
18. The combination of Claim 16 wherein said staple leg support members are adapted to pivot 90° with respect to said horizontal bridging members, to deflect and bypass the ends of said bridging member, said staple, when closed, having a dual box-like configuration formed by the staple legs on one side of the horizontal bridging member and the staple leg extensions and locking bar on the other side of the horizontal bridging member.
19. The combination of Claim 17 wherein the tissue-piercing points of the staple legs extend beyond the plane of the anvil when the staple is centered on the anvil prior to closure.
20. The combination of Claim 18 wherein the staple leg extensions and locking bar include interlocking means which are engaged when said staple is closed to form said box-like configuration.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US122,557 | 1980-02-19 | ||
US06/122,557 US4317451A (en) | 1980-02-19 | 1980-02-19 | Plastic surgical staple |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1144445A true CA1144445A (en) | 1983-04-12 |
Family
ID=22403403
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000371064A Expired CA1144445A (en) | 1980-02-19 | 1981-02-17 | Plastic surgical staple |
Country Status (6)
Country | Link |
---|---|
US (1) | US4317451A (en) |
JP (1) | JPS56151033A (en) |
CA (1) | CA1144445A (en) |
DE (1) | DE3105957A1 (en) |
FR (1) | FR2475886A1 (en) |
GB (1) | GB2069650B (en) |
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US4060089A (en) * | 1975-09-03 | 1977-11-29 | United States Surgical Corporation | Surgical fastening method and device therefor |
US4109844A (en) * | 1976-11-18 | 1978-08-29 | Senco Products, Inc. | Surgical stapling instrument |
SU736969A1 (en) * | 1976-12-17 | 1980-05-30 | Всесоюзный Научно-Исследовательский И Испытательский Институт Медицинской Техники | Surgical suturing apparatus |
-
1980
- 1980-02-19 US US06/122,557 patent/US4317451A/en not_active Expired - Lifetime
-
1981
- 1981-02-17 FR FR8103074A patent/FR2475886A1/en active Granted
- 1981-02-17 CA CA000371064A patent/CA1144445A/en not_active Expired
- 1981-02-18 DE DE19813105957 patent/DE3105957A1/en not_active Withdrawn
- 1981-02-18 JP JP2164681A patent/JPS56151033A/en active Pending
- 1981-02-18 GB GB8105011A patent/GB2069650B/en not_active Expired
Also Published As
Publication number | Publication date |
---|---|
FR2475886B1 (en) | 1984-12-28 |
FR2475886A1 (en) | 1981-08-21 |
JPS56151033A (en) | 1981-11-21 |
DE3105957A1 (en) | 1982-01-07 |
US4317451A (en) | 1982-03-02 |
GB2069650A (en) | 1981-08-26 |
GB2069650B (en) | 1983-11-09 |
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Date | Code | Title | Description |
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MKEX | Expiry |