CA1241579A - Coated surgical staple - Google Patents
Coated surgical stapleInfo
- Publication number
- CA1241579A CA1241579A CA000487585A CA487585A CA1241579A CA 1241579 A CA1241579 A CA 1241579A CA 000487585 A CA000487585 A CA 000487585A CA 487585 A CA487585 A CA 487585A CA 1241579 A CA1241579 A CA 1241579A
- Authority
- CA
- Canada
- Prior art keywords
- staple
- staples
- coated
- wound
- molecular weight
- 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
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
-
- 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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S411/00—Expanded, threaded, driven, headed, tool-deformed, or locked-threaded fastener
- Y10S411/92—Staple
Abstract
Coated Surgical Staple Abstract Sterile surgical staples for use with a stapling instrument with the surface of the staple coated with a low molecular weight fluorocarbon polymer.
Description
lS79 Coated Surgical Staple The invention relates to the use of a low molecular weight fluorocarbon polymer as a coating for a metallic surgical staple, to the use of the coated staple in a stapler, and to the use of such coated staple in a procedure for closing wounds.
Description of the Prior Art Surgical stapling instruments which are actuated in a repe-titive manner to discharge anA form a series of surgical staples are well known. Such stapling instruments have found considerable acceptance in the closing of wounds to the skins of humans and animal. The staples themselves are metal staples and are made from stainless steel, tanta-lum, or other biologically acceptable metal. In prior commercial practice, the staples have often been coated with a soap composition or with a high molecular weight polytetrafluoroethylene TEFLON coating, to assist in both the placement of the staple and/or the function of the stapling instrument. There it, however, room for improve-ment in the performance of both materials. Soap, being bioabsorbable, tends to be absorbed from the implanted staple so that some tissue aAhesion to the staple can begin to occur after wound healing begins; this tends to maze staple removal more traumatic and painful. TEFLON*tends to collect at the anvil, anA in a multiple fire stapler, jamming can occur. In the commercialized version, the TEFLON*aoating is sprayed on the array of staples after the staples have been loaded into the stapler. The coating is present as discrete particles on only one side of the staple. It serve only as a mechanical lubricant and has little or no effect on the staple performance in the wound.
* Reg.TM
. .
~L24157~
Noiles, in U.S. Patent No. 4,275,813, discloses a coherent stack of surgical staples bonded together in parallel contiguous relationship by a plastic adhesive that can be, inter alia, "halogenated polyalkylenes such as polytetrafluoroethylene . . ."
Bogaty et al., in U.S. Patent No. 4,012,551, discloses razor blades having the cutting edges thereof coated with a mixture of two fluorocarbon polymers, one of which can be a low molecular weight fluorinated hydrocarbon polymer (referred to in the patent as a "fluorocarbon telomer").
Homsy et al., in an article entitled "REDUCTION OF TISSUE
AND BONE ADHESION TO COBALT ALLOY FIXATION APPLIANCES", 15 J. Biomed. Mater. Res. 6, 451 - 464 (1972), disclose the use of high molecular weight polytetrafluoroethylene as a coating on internal fixation appliances to reduce tissue adhesion to such appliances.
20 Zambelli et al., in U.S. Patent Jo. 3,977,081, disclose the use of a layer of polytetrafluoroethylene on a dental implant for the purpose of enabling an optimum epithelial adhesion to be generated between the implant and the surrounding mucosa and fibromucoqa.
Everett, in U.S. Patent No. 2,814,296, discloses polytetra-fluoroethylene coated surgical needles.
The commercial manufacturer of low molecular weight polyte-trafluoroethylene (referred to by the manufacturer as a "fluorotelomer") recommends that it be used in a number of industrial lubricating and relea e applications, including a heavy duty release agent for application to industrial equipment such as presses and rolls, especially in the manufacture and processing of hardboard, plywood, laminated wood products, and related materials. It is also 15~9 recommended for use as a thickener for synthetic oiLs and other types of liquid lubricants to produce greases.
8rief Summary_of the Invention The invention provides a surgical metallic staple coated with a thin layer of a low molecular weight fluorocarbon polymer, an array of such coated staples, a surgical stapler containing such coated staples, and.a method of closing a wound utilizing such a coated staple, especially in those wound closure cases wherein the staple will be removed after a preaetermined degree of healing has occurred.
Among the advantages that are obtained from using the invention are that the surgical stapler containing the subject coated staples is less apt to jam after extended operation than is the case with surgical staples coated wlth materials such as silicone and high molecular weight polytetrafluoroethylene, (even though the low molecular weight polytetrafluoroethylene may collect at the anvil, this does not interfere with the operation of the instrument) the staples of the invention penetrate tissue quite readily and therefore minimize trauma associated with their use, the staples of the invention have little or no tendency to adhere to tissue while implanted in the body, and they can be withdrawn with relatively little effort.
Also, the low molecular weight polytetrafluoroethylene is much more readily coated on individual staples, forms a more adherent coating thereon, and can ye used with less add-on, than TEFLON.
;;
- 3a-According to a still further broad aspect of the present invention, there is provided a sterile surgical staple for use of the stapling instrument in closing a wound of human or animal tissue. The staple comprises a pair of legs joined at one end by a crown which substantially the entire surface of the staple coated with a low molecular weight fluorocarbon polymer whereby it is easier to place the staple in the said to close a wound and it is easier to remove the staple from the skin when the wound is healed.
According to further broad aspect of the present invention, there is provided a surgical stapling instrument for implanting and forming surgical staples in the tissue of a patient. The instrument comprises a body, and means for closing staples as they are driven into the tissue. A
magazine is also provided to carrying a plurality of staples mounted on the body. Means is further provided for sequentially feeding staples from the magazine to the means for driving and closing the staples. The improvement in the instrument resides in that the surface of the staples are coated with a low molecular weight fluorocarbon polymer.
According to a further broad aspect of the present invention there is provided a method of closing a wound in an animal which comprises using the staples as defined above to hold an appriximated wound in position.
Brief Description of the Drawings Figure 1 is a perspective view of one form of sterile surgical staple in accordance with the invention;
7~
Figure 2 is a perspective view of yet another form of a sterile surgical staple in accordance with the invention;
Figure 3 is a perspective view of a stack of surgical staples of the invention;
Figure 4 is a cross-sectional view of an automatic stapling instrument showing sterile surgical staples of the invention loaded in said instrument Figure 5 is a perspective view of a wound closed using the sterile surgical staples of the invention;
Figure 6 is a cross-sectional view of a wound closed with a sterile surgical staple of the invention; and Figure 7 i8 a cross-sectional view of a wound depicting the sterile surgical staple being removed from the healed wound.
Detailed Descr~etion of the Invention In Figure 1 there is shown one configuration of a sterile surgical staple 10 of the invention. The staple comprises a pair of legs 11 and 12 connected at one end by a crown 13. In this embodiment, the crown is substantially perpen-: dicular to the legs. Substantially all of the surface of the legs and crown it coated with a low molecular weight fluorocarbon polymer 14. In Figure 2, the staple 15 comprises a pair of legs 16 and 17 joined at one end by a crown; however, in this configuration the crown comprises two sections 19 and 20 which extend angularly from the legs and are connected at the apex 21. Again, substantially the entire surface of the legs and crown is coated with a low molecular weight fluorocarbon polymer 22.
7~3 The low molecular weight fluorocarbon-coated staple is produced by initially forming the staple in its desired configuration by procedures known to the art. The staple is then cleaned, as by ultra-sonic cleaning, an is then coated with the fluorocarbon. The coating may be accom-plished by coating the staple with a dispersion of the low molecular weight fluorocarbon polymer in a suitable liquid vehicle, such as trifluorotrichloroethane or similar halo-genated liquid material, evaporating the liquid vehicle, and then, preferably, heating the coated staple to fuse the fluorocarbon polymer. The coating can be applied by immersing the staple in the dispersion, by spraying, or any other convenient method. After draining and air drying to remove most of the vehicle, the coated staple is then pre-ferably heated to a temperature of from about 570 to600F. (299 to 316C.) for 5 to 10 minutes to melt the polymer. This smooths out the coating, significantly improves the adhesion of the coating to the staple, and removes the remainder of the liquid vehicle for the polymer. Usually, the dispersion of polymer in the liquid vehicle will have a polymer solids content of from about 5 to 15 weight per cent (based on weight of the total disper-sion~, although the exact proportion has not been found to be narrowly critical. An add-on of about 0.05 to about 0.2 weight per cent of the staple is usual. After coating, the staple may be sterilized by the usual procedures, such as ethylene oxide sterilization or exposure to gamma radiation from a radioactive source-such as cobalt-60.
The low molecular weight fluorocarbon polymers are known in the art. They are sold commercially, usually in a dispersion of a halogenated liquid such as described above.
They usually have molecular weights in the range of from about 2000 to about 50,000. The polymers contemplated are predominantly polymers of tetrafluoroethylene.
~L~4~
- In Figure 3 there is shown a stack 25 of staples. Each staple 26 comprises a pair ox legs 27 and 28 connected at one end by a suitable crown 29 with the surface of the legs and crown coated with a low molecular weight fluorocarbon polymer coating 30. The staples are stacked or butted side to side in a suitable array.
In Figure 4 there is shown an automatic disposable skin stapling instrument. The instrument is loaded with low molecular weight fluorocarbon polymer coated sterile surgical staples of the invention. In Figure 4 only the primary components of the surgical stapling instrument are shown. The stapling instrument 31 generally comprise a body 32 having a rear portion 33 which serves as the handle and a forward portion 34. The forward portion 34 of the instrument includes a surgical staple magazine indicated at 35. The inctrument is actuated by the trigger mechanism 36. The magazine 35 is affixed to the lower edge of the forward portion of the body. The magazine comprises a lower member 37 and an upper member 38 with an anvil plate 39 located between these members. The anvil plate 39 terminates at its forward end in a coextensive anvil surface 40. Slidably mounted on the plate is a row of low molecular weight fluorocarbon polymer coated staples 41 of the invention. Also slidably mounted on the anvil plate 39 is a feeder shoe 42 which is constantly urged towards the anvil surface 40 by the double coil spring 43. The forward end of the magazine 35 provides a channel 44 for a staple ariver 45 mounted within the forward portion of the instrument body. The staple driver 45 is affixed to a staple driver actuator 47. The trigger is operatively connected to the staple driver actuator to shift it and the skaple driver 45. A return spring 48 is located within toe forward portion of the instrument body.
~157~
The upper end of the return spring is in contact with the staple driver actuator 47 and the ]ower end of the return spring is mounted on a return spring seat 49. The return spring is intended to bias the staple driver to its retracted position and at the same time to bias the trigger 36 to its normal position. The forward portion 50 of the trigger joins and is integral with a pivot pin 51. A portion of the pivot pin is adapted to be received in the side walls of the instrument body. The central portion of the pivot pin is of a reduced diameter as at 52. It provides clearance for the feeder shoe.
Hence, the trigger 36 is pivotally fixed to the instrument body 32 and is operatively connected to the staple driver actuator 47 and the staple driver 45. Instruments of this type are more fully described in U.S. Patents 4,109,844 and 4,179,057 assigned to Senco Products Inc. In operation of the stapling instrument, the trigger 36 is pressed and a staple 41 formed about the anvil end 40 and inserted in the skin to close a wound. Once the staple is formed about the anvil 40, the trigger 36 is released and the instrument may be removed from the staple leaving the staple closing the wound.
In figure 5 there is a perspective view of a skin wound closure utilizing the staples of the invention. The incised section of the wound (60) is approximately in an everted orientation and the staples 61 formed along the length of the wound to close the wound.
Figure 6 shows a staple 70 joining two sections of skin tissue 71 together. The staple is in its formed position.
The staple has been bent at points along the crown 72 spaced from the legs 73 and 74 to form perpendicular areas 75 and 76 to allow the legs to be inserted into the skin. Once the wound is healed it is a relatively simple matter to remove the staple with an appropriate instrument. Such removal is schematically depicteA in cross section Figure 7. rhe extractor comprises a pair of parallel stationary prongs 81 and B2. These prongs are adapted so they will fit beneath the crown 72 of the staple at its 5 bent poin'cs. The extractor also includes a movable central lever 83 which may be pushed between the stationary prongs.
The prongs are placed beneath the crown and the central lever urged between the prongs or the prongs moved upwardly about the center lever. The staple shown in Figure 7 has 10 been extracted from the wound.
In the example below, the low molecular weight fluorocarbon polymer employed was VYDAX* Fluorotelomer 550, a 5 weight per cent dispersion in trichlorotrifluoroethane of a 15 polytetrafluoroethylene having an average molecular weight of about 3700. The polymer per se has a density at 77F. (25C.) of 2.16 grams per cubic centimeter, a softening point (by ASTM E-28-~8T) of 510F. (265C.), and a crystalline melting point Oe 572F. (300C.) EXAMPLE 1 and CONTROL EXAMPLE 1 In this Example, steel surgical skin staples were compared with a commercial product, i.e., the safe staples coated 25 with soap. The staples of the invention were coated by dipping the staples, held on a strainer, into VYDAX* 55b Fluorotelomer dispersion. The strainer holding the staples was removed from the VYDAX*dispersion, drained, air dried for 16 hours, and then heated in an oven for 10 minutes at 305C.
The staples were then loade-l into a corlrlercial surgical skin stapler, sterilized by exposure to gamma radiation, and then uced in the following experiment:
* Reg.TM
.. .
, ~2~S7~9 g Three healthy mature female Beagle dog were anesthetized and prepared for aseptic surgery. Eight dorsal and five ventral midline full thickness skin incisions approximately 3.Ocm in length were made in each dog. The cut edges of each incision were brought into apposition with subcuticu-lar suture of 4-0 VICRYL. The dorsal skin incisions were closed with wide size soaped and Vydax* coated staples and the ventral incisions were closed with regular size soaped and Vydax* coated staples.
Four and seven days following surgery the dogs were anesthetized and the staples extracted. Photographs of the extractions were taken at the four day time period.
RESULTS:
Visual and tactile differences in extraction characteris-tics between the soaped and Vydax~coated skin staples were more pronounced at seven than four days postoperatively.
The wide staples in the thicker dorsal skin providsd extractions that were more demonstrably different than did the regular staples in the thinner ventral skin. Variances in wound healing also affected extraction differences.
Wounds with greater amounts of escar formation masked differences in the staple extractions.
It was concluded that at seven days postoperatively Vydax coated (wide size) skin staples appeared to require less force for extraction than did soaped (wide size) spin staples, based in differences in visual and tactile observations. This distinction could not be made at four days, After healing and scar tissue formation, the low molecular weight fluorocarbon polymer coated staples of the invention ; had apparently developed less adhesion to the healing tissue than the commercial soap-coated staples.
STH 623 * ~eg.TU
4~579 It has been noted in other experiments that the coated staples of this invention have little or no tendency to jam the stapler after repeated use. This is an improvement over high molecular weight silicone-coated surgical staples, which have not been commercialized for this reason.
Example 2 and Controls 2 and 3 Straight, pointed surgical staple wire blanks coated with VYDAX Fluorotelomer 550 by the procedure described above in Example 1, were compared to uncoated controls and TEFLON-coated controls (the TEFLON was sprayed on, to duplicate as closely as possible the commerical product), in the following experimert:
The force to insert and extract the staples in dog skin and in moleskin (adhesive-backed cotton flannel was meacured. The results are shown below in the table:
Table I
Dog Skin Moleskin Insertion Extraction Extraction Uncoated, Control 2 25 Average 236 gms. 7.9 gms 83 gms Range 190 - 350 2 - 24 36 - 43 Number Tested 12 92 15 TEFLON Coated, Control 3 30 Average -- -- 41 gms.
Range -- -- 18 - 64 Number Tested -- -- 12 VYDAX Coated, Example 2 35 Average 167 3.3 12 Range 100 - 205 0.1 - 10 1 - 38 Number Tested 12 112 15
Description of the Prior Art Surgical stapling instruments which are actuated in a repe-titive manner to discharge anA form a series of surgical staples are well known. Such stapling instruments have found considerable acceptance in the closing of wounds to the skins of humans and animal. The staples themselves are metal staples and are made from stainless steel, tanta-lum, or other biologically acceptable metal. In prior commercial practice, the staples have often been coated with a soap composition or with a high molecular weight polytetrafluoroethylene TEFLON coating, to assist in both the placement of the staple and/or the function of the stapling instrument. There it, however, room for improve-ment in the performance of both materials. Soap, being bioabsorbable, tends to be absorbed from the implanted staple so that some tissue aAhesion to the staple can begin to occur after wound healing begins; this tends to maze staple removal more traumatic and painful. TEFLON*tends to collect at the anvil, anA in a multiple fire stapler, jamming can occur. In the commercialized version, the TEFLON*aoating is sprayed on the array of staples after the staples have been loaded into the stapler. The coating is present as discrete particles on only one side of the staple. It serve only as a mechanical lubricant and has little or no effect on the staple performance in the wound.
* Reg.TM
. .
~L24157~
Noiles, in U.S. Patent No. 4,275,813, discloses a coherent stack of surgical staples bonded together in parallel contiguous relationship by a plastic adhesive that can be, inter alia, "halogenated polyalkylenes such as polytetrafluoroethylene . . ."
Bogaty et al., in U.S. Patent No. 4,012,551, discloses razor blades having the cutting edges thereof coated with a mixture of two fluorocarbon polymers, one of which can be a low molecular weight fluorinated hydrocarbon polymer (referred to in the patent as a "fluorocarbon telomer").
Homsy et al., in an article entitled "REDUCTION OF TISSUE
AND BONE ADHESION TO COBALT ALLOY FIXATION APPLIANCES", 15 J. Biomed. Mater. Res. 6, 451 - 464 (1972), disclose the use of high molecular weight polytetrafluoroethylene as a coating on internal fixation appliances to reduce tissue adhesion to such appliances.
20 Zambelli et al., in U.S. Patent Jo. 3,977,081, disclose the use of a layer of polytetrafluoroethylene on a dental implant for the purpose of enabling an optimum epithelial adhesion to be generated between the implant and the surrounding mucosa and fibromucoqa.
Everett, in U.S. Patent No. 2,814,296, discloses polytetra-fluoroethylene coated surgical needles.
The commercial manufacturer of low molecular weight polyte-trafluoroethylene (referred to by the manufacturer as a "fluorotelomer") recommends that it be used in a number of industrial lubricating and relea e applications, including a heavy duty release agent for application to industrial equipment such as presses and rolls, especially in the manufacture and processing of hardboard, plywood, laminated wood products, and related materials. It is also 15~9 recommended for use as a thickener for synthetic oiLs and other types of liquid lubricants to produce greases.
8rief Summary_of the Invention The invention provides a surgical metallic staple coated with a thin layer of a low molecular weight fluorocarbon polymer, an array of such coated staples, a surgical stapler containing such coated staples, and.a method of closing a wound utilizing such a coated staple, especially in those wound closure cases wherein the staple will be removed after a preaetermined degree of healing has occurred.
Among the advantages that are obtained from using the invention are that the surgical stapler containing the subject coated staples is less apt to jam after extended operation than is the case with surgical staples coated wlth materials such as silicone and high molecular weight polytetrafluoroethylene, (even though the low molecular weight polytetrafluoroethylene may collect at the anvil, this does not interfere with the operation of the instrument) the staples of the invention penetrate tissue quite readily and therefore minimize trauma associated with their use, the staples of the invention have little or no tendency to adhere to tissue while implanted in the body, and they can be withdrawn with relatively little effort.
Also, the low molecular weight polytetrafluoroethylene is much more readily coated on individual staples, forms a more adherent coating thereon, and can ye used with less add-on, than TEFLON.
;;
- 3a-According to a still further broad aspect of the present invention, there is provided a sterile surgical staple for use of the stapling instrument in closing a wound of human or animal tissue. The staple comprises a pair of legs joined at one end by a crown which substantially the entire surface of the staple coated with a low molecular weight fluorocarbon polymer whereby it is easier to place the staple in the said to close a wound and it is easier to remove the staple from the skin when the wound is healed.
According to further broad aspect of the present invention, there is provided a surgical stapling instrument for implanting and forming surgical staples in the tissue of a patient. The instrument comprises a body, and means for closing staples as they are driven into the tissue. A
magazine is also provided to carrying a plurality of staples mounted on the body. Means is further provided for sequentially feeding staples from the magazine to the means for driving and closing the staples. The improvement in the instrument resides in that the surface of the staples are coated with a low molecular weight fluorocarbon polymer.
According to a further broad aspect of the present invention there is provided a method of closing a wound in an animal which comprises using the staples as defined above to hold an appriximated wound in position.
Brief Description of the Drawings Figure 1 is a perspective view of one form of sterile surgical staple in accordance with the invention;
7~
Figure 2 is a perspective view of yet another form of a sterile surgical staple in accordance with the invention;
Figure 3 is a perspective view of a stack of surgical staples of the invention;
Figure 4 is a cross-sectional view of an automatic stapling instrument showing sterile surgical staples of the invention loaded in said instrument Figure 5 is a perspective view of a wound closed using the sterile surgical staples of the invention;
Figure 6 is a cross-sectional view of a wound closed with a sterile surgical staple of the invention; and Figure 7 i8 a cross-sectional view of a wound depicting the sterile surgical staple being removed from the healed wound.
Detailed Descr~etion of the Invention In Figure 1 there is shown one configuration of a sterile surgical staple 10 of the invention. The staple comprises a pair of legs 11 and 12 connected at one end by a crown 13. In this embodiment, the crown is substantially perpen-: dicular to the legs. Substantially all of the surface of the legs and crown it coated with a low molecular weight fluorocarbon polymer 14. In Figure 2, the staple 15 comprises a pair of legs 16 and 17 joined at one end by a crown; however, in this configuration the crown comprises two sections 19 and 20 which extend angularly from the legs and are connected at the apex 21. Again, substantially the entire surface of the legs and crown is coated with a low molecular weight fluorocarbon polymer 22.
7~3 The low molecular weight fluorocarbon-coated staple is produced by initially forming the staple in its desired configuration by procedures known to the art. The staple is then cleaned, as by ultra-sonic cleaning, an is then coated with the fluorocarbon. The coating may be accom-plished by coating the staple with a dispersion of the low molecular weight fluorocarbon polymer in a suitable liquid vehicle, such as trifluorotrichloroethane or similar halo-genated liquid material, evaporating the liquid vehicle, and then, preferably, heating the coated staple to fuse the fluorocarbon polymer. The coating can be applied by immersing the staple in the dispersion, by spraying, or any other convenient method. After draining and air drying to remove most of the vehicle, the coated staple is then pre-ferably heated to a temperature of from about 570 to600F. (299 to 316C.) for 5 to 10 minutes to melt the polymer. This smooths out the coating, significantly improves the adhesion of the coating to the staple, and removes the remainder of the liquid vehicle for the polymer. Usually, the dispersion of polymer in the liquid vehicle will have a polymer solids content of from about 5 to 15 weight per cent (based on weight of the total disper-sion~, although the exact proportion has not been found to be narrowly critical. An add-on of about 0.05 to about 0.2 weight per cent of the staple is usual. After coating, the staple may be sterilized by the usual procedures, such as ethylene oxide sterilization or exposure to gamma radiation from a radioactive source-such as cobalt-60.
The low molecular weight fluorocarbon polymers are known in the art. They are sold commercially, usually in a dispersion of a halogenated liquid such as described above.
They usually have molecular weights in the range of from about 2000 to about 50,000. The polymers contemplated are predominantly polymers of tetrafluoroethylene.
~L~4~
- In Figure 3 there is shown a stack 25 of staples. Each staple 26 comprises a pair ox legs 27 and 28 connected at one end by a suitable crown 29 with the surface of the legs and crown coated with a low molecular weight fluorocarbon polymer coating 30. The staples are stacked or butted side to side in a suitable array.
In Figure 4 there is shown an automatic disposable skin stapling instrument. The instrument is loaded with low molecular weight fluorocarbon polymer coated sterile surgical staples of the invention. In Figure 4 only the primary components of the surgical stapling instrument are shown. The stapling instrument 31 generally comprise a body 32 having a rear portion 33 which serves as the handle and a forward portion 34. The forward portion 34 of the instrument includes a surgical staple magazine indicated at 35. The inctrument is actuated by the trigger mechanism 36. The magazine 35 is affixed to the lower edge of the forward portion of the body. The magazine comprises a lower member 37 and an upper member 38 with an anvil plate 39 located between these members. The anvil plate 39 terminates at its forward end in a coextensive anvil surface 40. Slidably mounted on the plate is a row of low molecular weight fluorocarbon polymer coated staples 41 of the invention. Also slidably mounted on the anvil plate 39 is a feeder shoe 42 which is constantly urged towards the anvil surface 40 by the double coil spring 43. The forward end of the magazine 35 provides a channel 44 for a staple ariver 45 mounted within the forward portion of the instrument body. The staple driver 45 is affixed to a staple driver actuator 47. The trigger is operatively connected to the staple driver actuator to shift it and the skaple driver 45. A return spring 48 is located within toe forward portion of the instrument body.
~157~
The upper end of the return spring is in contact with the staple driver actuator 47 and the ]ower end of the return spring is mounted on a return spring seat 49. The return spring is intended to bias the staple driver to its retracted position and at the same time to bias the trigger 36 to its normal position. The forward portion 50 of the trigger joins and is integral with a pivot pin 51. A portion of the pivot pin is adapted to be received in the side walls of the instrument body. The central portion of the pivot pin is of a reduced diameter as at 52. It provides clearance for the feeder shoe.
Hence, the trigger 36 is pivotally fixed to the instrument body 32 and is operatively connected to the staple driver actuator 47 and the staple driver 45. Instruments of this type are more fully described in U.S. Patents 4,109,844 and 4,179,057 assigned to Senco Products Inc. In operation of the stapling instrument, the trigger 36 is pressed and a staple 41 formed about the anvil end 40 and inserted in the skin to close a wound. Once the staple is formed about the anvil 40, the trigger 36 is released and the instrument may be removed from the staple leaving the staple closing the wound.
In figure 5 there is a perspective view of a skin wound closure utilizing the staples of the invention. The incised section of the wound (60) is approximately in an everted orientation and the staples 61 formed along the length of the wound to close the wound.
Figure 6 shows a staple 70 joining two sections of skin tissue 71 together. The staple is in its formed position.
The staple has been bent at points along the crown 72 spaced from the legs 73 and 74 to form perpendicular areas 75 and 76 to allow the legs to be inserted into the skin. Once the wound is healed it is a relatively simple matter to remove the staple with an appropriate instrument. Such removal is schematically depicteA in cross section Figure 7. rhe extractor comprises a pair of parallel stationary prongs 81 and B2. These prongs are adapted so they will fit beneath the crown 72 of the staple at its 5 bent poin'cs. The extractor also includes a movable central lever 83 which may be pushed between the stationary prongs.
The prongs are placed beneath the crown and the central lever urged between the prongs or the prongs moved upwardly about the center lever. The staple shown in Figure 7 has 10 been extracted from the wound.
In the example below, the low molecular weight fluorocarbon polymer employed was VYDAX* Fluorotelomer 550, a 5 weight per cent dispersion in trichlorotrifluoroethane of a 15 polytetrafluoroethylene having an average molecular weight of about 3700. The polymer per se has a density at 77F. (25C.) of 2.16 grams per cubic centimeter, a softening point (by ASTM E-28-~8T) of 510F. (265C.), and a crystalline melting point Oe 572F. (300C.) EXAMPLE 1 and CONTROL EXAMPLE 1 In this Example, steel surgical skin staples were compared with a commercial product, i.e., the safe staples coated 25 with soap. The staples of the invention were coated by dipping the staples, held on a strainer, into VYDAX* 55b Fluorotelomer dispersion. The strainer holding the staples was removed from the VYDAX*dispersion, drained, air dried for 16 hours, and then heated in an oven for 10 minutes at 305C.
The staples were then loade-l into a corlrlercial surgical skin stapler, sterilized by exposure to gamma radiation, and then uced in the following experiment:
* Reg.TM
.. .
, ~2~S7~9 g Three healthy mature female Beagle dog were anesthetized and prepared for aseptic surgery. Eight dorsal and five ventral midline full thickness skin incisions approximately 3.Ocm in length were made in each dog. The cut edges of each incision were brought into apposition with subcuticu-lar suture of 4-0 VICRYL. The dorsal skin incisions were closed with wide size soaped and Vydax* coated staples and the ventral incisions were closed with regular size soaped and Vydax* coated staples.
Four and seven days following surgery the dogs were anesthetized and the staples extracted. Photographs of the extractions were taken at the four day time period.
RESULTS:
Visual and tactile differences in extraction characteris-tics between the soaped and Vydax~coated skin staples were more pronounced at seven than four days postoperatively.
The wide staples in the thicker dorsal skin providsd extractions that were more demonstrably different than did the regular staples in the thinner ventral skin. Variances in wound healing also affected extraction differences.
Wounds with greater amounts of escar formation masked differences in the staple extractions.
It was concluded that at seven days postoperatively Vydax coated (wide size) skin staples appeared to require less force for extraction than did soaped (wide size) spin staples, based in differences in visual and tactile observations. This distinction could not be made at four days, After healing and scar tissue formation, the low molecular weight fluorocarbon polymer coated staples of the invention ; had apparently developed less adhesion to the healing tissue than the commercial soap-coated staples.
STH 623 * ~eg.TU
4~579 It has been noted in other experiments that the coated staples of this invention have little or no tendency to jam the stapler after repeated use. This is an improvement over high molecular weight silicone-coated surgical staples, which have not been commercialized for this reason.
Example 2 and Controls 2 and 3 Straight, pointed surgical staple wire blanks coated with VYDAX Fluorotelomer 550 by the procedure described above in Example 1, were compared to uncoated controls and TEFLON-coated controls (the TEFLON was sprayed on, to duplicate as closely as possible the commerical product), in the following experimert:
The force to insert and extract the staples in dog skin and in moleskin (adhesive-backed cotton flannel was meacured. The results are shown below in the table:
Table I
Dog Skin Moleskin Insertion Extraction Extraction Uncoated, Control 2 25 Average 236 gms. 7.9 gms 83 gms Range 190 - 350 2 - 24 36 - 43 Number Tested 12 92 15 TEFLON Coated, Control 3 30 Average -- -- 41 gms.
Range -- -- 18 - 64 Number Tested -- -- 12 VYDAX Coated, Example 2 35 Average 167 3.3 12 Range 100 - 205 0.1 - 10 1 - 38 Number Tested 12 112 15
Claims (4)
1. A sterile surgical staple for use with a stapling instrument in closing a wound of human or animal tissue comprising a pair of legs joined at one end by a crown with substantially the entire surface of said staple coated with a low molecular weight fluorocarbon polymer whereby it is easier to place said staple in said skin to close a wound and it is easier to remove said staple from said skin when the wound has healed.
2. The staple of claim 1 wherein the polymer is polytetrafluoroethylene.
3. In a surgical stapling instrument for implanting and forming surgical staples in the tissue of a patient, said instrument comprising a body, means for closing staples as they are driven into said tissue, a magazine for carrying a plurality of staples mounted on said body, and means for sequentially feeding staples from said magazine to said means for driving and closing the staples, the improvement which comprises the surface of said staples being coated with a low molecular weight fluorocarbon polymer.
4. The improvement according to claim 3 wherein the polymer is polytetrafluoroethylene.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/635,763 US4655222A (en) | 1984-07-30 | 1984-07-30 | Coated surgical staple |
US635,763 | 1984-07-30 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1241579A true CA1241579A (en) | 1988-09-06 |
Family
ID=24549028
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000487585A Expired CA1241579A (en) | 1984-07-30 | 1985-07-26 | Coated surgical staple |
Country Status (10)
Country | Link |
---|---|
US (1) | US4655222A (en) |
EP (1) | EP0170512B1 (en) |
JP (1) | JPH0611262B2 (en) |
KR (1) | KR920008816B1 (en) |
AU (1) | AU578485B2 (en) |
BR (1) | BR8503594A (en) |
CA (1) | CA1241579A (en) |
DE (1) | DE3573716D1 (en) |
MX (1) | MX168360B (en) |
ZA (1) | ZA855694B (en) |
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US3080564A (en) * | 1959-09-10 | 1963-03-12 | Strekopitov Alexey Alexeevich | Instrument for stitching hollow organs |
US3209754A (en) * | 1961-08-10 | 1965-10-05 | Ernest C Wood | Surgical clip |
DE1791114B1 (en) * | 1967-09-19 | 1971-12-02 | Vnii Chirurgitscheskoj Apparat | Surgical device for stapling tissues |
US4275813A (en) * | 1979-06-04 | 1981-06-30 | United States Surgical Corporation | Coherent surgical staple array |
JPS56151055A (en) * | 1980-03-26 | 1981-11-21 | Daikin Ind Ltd | Suturing gut for operation |
US4351466A (en) * | 1980-10-16 | 1982-09-28 | United States Surgical Corporation | Disposable instrument for surgical fastening |
DK103483A (en) * | 1982-04-15 | 1983-10-16 | Ethicon Inc | SILICONE COATED SURGICAL PAPER |
US4467805A (en) * | 1982-08-25 | 1984-08-28 | Mamoru Fukuda | Skin closure stapling device for surgical procedures |
-
1984
- 1984-07-30 US US06/635,763 patent/US4655222A/en not_active Expired - Lifetime
-
1985
- 1985-07-26 CA CA000487585A patent/CA1241579A/en not_active Expired
- 1985-07-29 EP EP85305391A patent/EP0170512B1/en not_active Expired
- 1985-07-29 ZA ZA855694A patent/ZA855694B/en unknown
- 1985-07-29 JP JP60166040A patent/JPH0611262B2/en not_active Expired - Lifetime
- 1985-07-29 BR BR8503594A patent/BR8503594A/en not_active IP Right Cessation
- 1985-07-29 DE DE8585305391T patent/DE3573716D1/en not_active Expired
- 1985-07-29 AU AU45560/85A patent/AU578485B2/en not_active Ceased
- 1985-07-30 KR KR1019850005470A patent/KR920008816B1/en not_active IP Right Cessation
- 1985-07-30 MX MX206141A patent/MX168360B/en unknown
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US4655222A (en) | 1987-04-07 |
AU578485B2 (en) | 1988-10-27 |
KR920008816B1 (en) | 1992-10-09 |
JPH0611262B2 (en) | 1994-02-16 |
KR860000857A (en) | 1986-02-20 |
BR8503594A (en) | 1986-04-29 |
MX168360B (en) | 1993-05-19 |
EP0170512B1 (en) | 1989-10-18 |
EP0170512A1 (en) | 1986-02-05 |
JPS6176145A (en) | 1986-04-18 |
DE3573716D1 (en) | 1989-11-23 |
AU4556085A (en) | 1986-02-06 |
ZA855694B (en) | 1987-03-25 |
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