CA2052483A1 - Skin fastener - Google Patents
Skin fastenerInfo
- Publication number
- CA2052483A1 CA2052483A1 CA002052483A CA2052483A CA2052483A1 CA 2052483 A1 CA2052483 A1 CA 2052483A1 CA 002052483 A CA002052483 A CA 002052483A CA 2052483 A CA2052483 A CA 2052483A CA 2052483 A1 CA2052483 A1 CA 2052483A1
- Authority
- CA
- Canada
- Prior art keywords
- fastener
- recited
- backspan
- prong
- fasteners
- 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.)
- Abandoned
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
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
Abstract
ABSTRACT OF THE DISCLOSURE A fastener for securing adjacent layers of body tissue to each other and being configured and composed of a material so as to emerge from the body tissue after a limited period of time. In a first embodiment, the fastener (100) includes a backspan (110) at least two prongs (120) extending from the backspan (110). Each prong 120 has a tapered tip 124 culminating in a sharp point 125. The prongs 120 each include a shaft having a cylindrical portion of uniform diameter. In one embodiment, the prong includes a serrated portion having a plurality of notches (123) spaced apart so as to define ridge portions (122) therebetween. 0398k
Description
~ 052~48~'3 SKIN FASTENER
BACKGROUND OF IHE ~VEN I~ON
1. Fie]d of the Invention This invention re]ates to surgical fasteners used to join body tissue and more particularly to surgical fasteners which are composed of a material and configured to work their way out of body tissue after a limited period of time. .
BACKGROUND OF IHE ~VEN I~ON
1. Fie]d of the Invention This invention re]ates to surgical fasteners used to join body tissue and more particularly to surgical fasteners which are composed of a material and configured to work their way out of body tissue after a limited period of time. .
2. Background of the Art Surgical fasteners have been used in operating procedures to eliminate the need for sutllr~g, which is.both time consnming a~d inconvenieDt. In many applications ~e surgeon can use a stapler apparatus, -i.e., a fastener implanting de~ice loaded ~ith one or more surgical fasteners, to accomplish in a few seconds what would have taken many minutes to perform by suturiDg. This Jeduction in operating t~e reduces blood loss and traùma to the patient.
Surgical fasteners have been in the forrn of metal staples which are bent by the delivery apparatus to hook together body tissue. Such staples are typically made ~om biocompatible met 15 such as stainless steel alloys or titanium Two-part fasterlers are also kl~own, as illus~ated in U.S. Patent No. 4,506,670, in which a barbed fastener is used in conjunction with a retaining pieu~ to hold the fastener in place.
2052~4~3 Typically, the two-part fastener comprises a backspan and hl~o barbed prongs which are engaged and locked into a separate retaiDer piece.
In use, the fastener is pressed into the body tissue so that the barbs penetrate tbe tissue and emerge from the other side where tbey are then locked into the retamer piece. T~e retainers prevent he fastener from working loose from the tissue. T~e two piece fasteners cannot be unlocked and are not easily removable. For this reason, they must be made of a bioabsorbable materia].
Possible materials inc]ude polymers and copolymers of glycolic ac;d (i.e. hydroxyacetic acid), t~e cyclic dimer of glycolic acid ("glycolide"), lactic acid, t~e cyclic dimer of lactic acid ("lactide") and related monomers. Polymers and copolymers of the foregoing kind and absorbable surgical devices made thelefrom are well known. See, e g., U.S.
PateDt Nos. 2,668,162; 2,703,316; 2,758,987; 3,225,766; 3,297,033;
Surgical fasteners have been in the forrn of metal staples which are bent by the delivery apparatus to hook together body tissue. Such staples are typically made ~om biocompatible met 15 such as stainless steel alloys or titanium Two-part fasterlers are also kl~own, as illus~ated in U.S. Patent No. 4,506,670, in which a barbed fastener is used in conjunction with a retaining pieu~ to hold the fastener in place.
2052~4~3 Typically, the two-part fastener comprises a backspan and hl~o barbed prongs which are engaged and locked into a separate retaiDer piece.
In use, the fastener is pressed into the body tissue so that the barbs penetrate tbe tissue and emerge from the other side where tbey are then locked into the retamer piece. T~e retainers prevent he fastener from working loose from the tissue. T~e two piece fasteners cannot be unlocked and are not easily removable. For this reason, they must be made of a bioabsorbable materia].
Possible materials inc]ude polymers and copolymers of glycolic ac;d (i.e. hydroxyacetic acid), t~e cyclic dimer of glycolic acid ("glycolide"), lactic acid, t~e cyclic dimer of lactic acid ("lactide") and related monomers. Polymers and copolymers of the foregoing kind and absorbable surgical devices made thelefrom are well known. See, e g., U.S.
PateDt Nos. 2,668,162; 2,703,316; 2,758,987; 3,225,766; 3,297,033;
3,422,181; 3,531,561; 3,565,869; 3,620,218; 3,626,948; 3,636,956; 3,736,646;
3,772,420; 3,773,919; 3,792,010; 3,797,499; 3,839,297; 3,867,190; 3,878,2&4;
3,982,543; 4,0$0,0~9; 4,137,921; 4,157,43?; 4,234,775; 4,237,~0; 4,3~0,565;
and 4,523,591; U.K Patent No. 779,291; D. K Gilding et al., "Biodegradable polymers for use in surgery - po]yg]ycol~c/poly(lactic acid) homo- and co-polymers: 1, Po]vmer, Vo]urne 20, pages 14~9-1464 (1979), and D.F.
Williams (ed.) Biocompatibility of Clinical Implant Materials, Vol. ~, ch.
9: "Biodegradab]e Po]vmers" (1981).
U.S. Patent No. 4,667,674 to Korthoff et a~ discloses a two part surgical fastener comprising a fastener member and a retainer member. The fastener member has a base, and a ~air of prongs extending perpendicular]y 2(~5~4~
from the base. The prongs are spaced inward from the respective ends of the base in order to preYent sp~ay~ng of the prongs, and to improve hemostasis.
T~e two piece fasteDers require the stap]e delivery apparatus to have access to both sides of the tissue. Usually, such devices have a U-shaped member into which tissue is inserted. T~e stapler apparatus has a fastener holder and an anvil which are p;votally connected at one end, and mounted on the legs of t~e U-shaped support structure. See, for exarnple, U.S. Patent No. 4,402,445 to Green which discloses a surgical fastener and means for applying same. In a surgical operation, the tissue to be joined is positioned between the fastener ~older and the anvil, which contains the fastener retainers. The fasteners are ejected from the ~older into the tissue, and the prongs are locked into the retainers.
In some applications, bowever, it is not possible to have access to body tissue from two opposite directions. For example, in sl;in grafting applications oDe c~ only app]y fasteners from a stapler positioned above the skin.
The prior art inc~udes m~ny examples of surgical st~p]ers which do not enclose the body tissue between an anvil and fastener holder. For example, surgical staplers such as those described in U.S. Patent No.
3,643,851 and U.S. Patent No. 4,618,086 approach tne s~n from one direc~iorl~ However, they require the use of staples which are rnalleable enough to be crimped by an anvil so that the prongs hook into the tissue.
Typically, such staples are made of metal and are not bioabsorbable. They must be removed by another device such as a stapler extractor which is not only ~ne consuming but ~n cause discornfort and pain to the patient. The discomfort and pain in removal of the stap]es are especia~y acule when the fasteners are used in s~iin grafting a burn victim. T~e sensitivity of the bu~ patient's skin cannot be understated; any contact with their sl~
causes distress, let alone removal of fasterlers inserted through the skin and embedded in underlying body tissue.
Sing]e piece barbed fasteners made fiom bioabsorbable material are known. U.S. Patent No. 4,635,637 discloses a fastener having a base member and two substantial~y parallel shafts upstanding from the base member, the ends of the shafts each having a barb. The barbed fastener is disclosed as being useful in the repair of meniscal tissue. Pending patent application Serial Nos. 372,025 filed June 27, 1989 and 314,368 filed February 22, 19~9 also disclose bioabsorbable fasteners having barbs. If these fasteners are removed, then the patierlt will suffer from the same dist.-ess as described above wiLh respect to non-bioabsorbab]e staples.
The prior art fasteners discussed above were designed w~th the intention that significant vertical support was required. Thus, outwardly extending barbs were pro~ided on their prongs to ensure that they remained embedded in the body tissue for a suf~iciently long period of time.
~owever, such barbed fasteners remained in the tissue for a longer time than was necessary. T~e need therefore exists for a fasterler which rem~ins embedded in the tissue only for a sufEicient period of ~ne to al~ow he~ling to cornrnence but a~oids the discomfort and pain associated with the removal of prior fasteners.
~05~?,~L~3,'3 SUMl'~ARY OF THE INVENTI~:
The present invention overcomes the drawbacks and deficierlcies of the prior art. The present inventors discovered that in skin grafting, the emphasis is on lateral support across an incision or skin graft interface to provide su~icient lateral force between adjacent tissue sections. It was found that the vertical support provided by the barbed prongs was unnecessary and that this configuratlon ohen required actual removal of the fastèners, causing pain and discornfort. The present invention therefore oYercomes the problerns of prior art staples and fasteners by significantly limiting the extent of pain the patient will experience. The present invertion achieves this objective by providing a surgical fastener whuch is composed of a material and configured so as to work its way out of body tissue after a specific period of ~ime or caD be more easily removed beforehand.
The surgical fastener includes a backspan and at least two prongs which extend from the backspan, preferably perpendicular to the backspan and parallel to each other. Each prong includes a tapered tip portion to facilitate penetration into the body tissue and is configured to remain in the body for a relatively short period of time. The material of the prong also has a low coefficient of friction to facilitate ejection from the body tissue. In one embodiment, substantially the entire shaft portion up to the tapered tip portion has a portion of uniform diameter. That is, there are no barbs on the shaft which would retain the embedded fastener for a longer period of time than necessaly. In other embodimeDts, a serrated portion is 20524~3 fo-med in the uniforrn-diameter shaft porh'on to provide addihonal retentioD, but less retention than that of the barbs of the prior art.
The present invention also provides a met~od for sl;in grafting comprising inserting a plurality of fasteners each having spa6`ed apart prongs wherein at least one prong is devoid of barbs, securing a dressing over the fasteners to provide sufficient vertical force to hold the fasteners for a period of time until hea7,ing commences, and removing the dressing after healing commences, wherein a substantial number of the fasteners will be dis]odged when the dressing is removed and a substantial number of the remaimng fasteners will be automatically ejected by the body in a re]atively short period of time.
BRIEF DESCRIPrlON OF THE DRAWINGS:
Preferred embodiments of the invention are descTibed hereinbelow with reference to the drawings, wherein:
Fig. 1 is an eleYational ~ont view of one emborliment of a fastener of the present invention;
Fig. 2 is a top view of the fastener of Figure 1;
Fig. 3 is a side view of the fastener of Figure 1;
Fig. 4 is an elevation 1 view of another embodiment of the fastener of the present invention;
Fig. 5 is an e]evatiorlal frorlt view of yet another embodiment of a fastener of the present invention;
Fig. 6 is a top view of tbe fastener of Figure 5;
;~)5~ 9 Fig. 7 is an elevational f~ont view of still ano~her embodiment of a fastener of the present irvention;
Fig. 8 is a top view of the fastener of Figure 7;
Fig. 9 is an elevat;onal front view of yet another embodiment of a fastener of the present invention;
Fig. 10a and 10b are sectional perspective views illustrating the use of a fastener of the present invention;
Fig. 11 is a partially cut away e]evational view showing an implement for applying a fastener of the presene invention;
Figs. 12a and 12b are a top Yiew ar d an elevational front view, respectively, of an embodiment of a fastener of the present invention labelled to show one exarnp]e of the dimensions of a non-serrated fastener which c2n be utili7ed; and Fig. 13 is an enlarged view of aD embodiment of a prong of a fastener of the preserlt invention labelled to show one examp]e of the dimensions of a doub]e serrated fastener which can be utilized.
DETAILED DESCRIPTION OF ~HE PREFERRED EMBODIMEN~S
Tunung now to the drawings, Figs 1, 2 and 3 il~ustrale one embodirnent of the skin fastener of the present invention. Fastener 100 includes a backspan 110 and two pronged portions 120 extending from backspan 110. Although the pronged portions 120 are shown parallel to each other and extending subst~ntially perpendicular to backspan 110, as iIl all tbe embodiments disclosed here~, one or both of the pronged portions 120 can 21~5;~
altemately be secured at a different ang]e lo backspan 110 to extend inward]y towards each ot~3er or outwald]y away from each other. In this embodiment, each prong 120 has a shaft portion 121 illustrative]y cylindrical in configuration, and a tapered tip portion 124 which culminates in a sbarp point 125 at the distal end to facilitate penetration of body tissue. Prongs 120 also inc]ude a serrated portion having ridges 122 alternating with recessed notch portions 123. Tl3e serrations extend circumferentially around shaft 121. Fastener 100 is a double serrated prong fastener in that t~3ere are two ridge portions 122 on each prong. The serrations provide additional rrr3ctional means to hold the fastener in body tissue for a longer period of time than if no serrations were present.
l~everthe]ess, these serrations do not constitute barbs. That is, the ridges do not exteDd radially beyond the circumferential surface of the cylindrical shaft portion 121, and they do not prevent fastener 100 from gradually wor~ing its way out of body tissue within a specific period of time. By not having barbs, the fasteners can also be more easily removed. The diameter of the tapered tip portion 124 does not exceed the diameter of the shaft portion 121. The base portion of each prong 120 may be provided with a cu~ed su~face 126.
In the embodiTnent shown in Figllre 1, the backspan 110 exlends lengthwise a greater distance than the distance between prongs 120. In other words, this embodiment possesses an overlap portion 112 which extends the area of tissue which is be3ng held down and is an optional feature of this invention since alternately the backspan 110 caD terminate at the prcngs 120. Members 111 at each end of the fastener backspan 110 can optio3lally be provided to proYide a guide means to maintam the proper ~ IDS~3~
orientation of the fastener inside a fastener applying instrument while the fastener is being implanted.
Fig. 4 illustrates an emborliment of t~e fastener of tbe present invention having a single serration. As with the double serrated embodiment 100, smgle serrated fastener 200 includes backspan 210 and prongs 220 having a shaft portion æ1 and circumferential serrations including ridge 222 and recessed notch portions 223. Each prong 220 of fastener 200 also includes a tapered tip portion 224 having a sharp point 225 at its distal end. The backspan 210 can also include overlap portions 212 to increase the surface area of tissue he]d down and guide members 211 for engagement by a fastener instrument. Fastener 200 differs from fastener 100 in that it includes a sing]e ridge 222 instead of double ridges on each prong. Thus the retention period of fastener 200 uill be less than that of fastener 100. As with tbe previous embodiment, the ridge 222 does not extend radially beyond the circurnferential surface of the cylindncal sbaft por~ion. Also, it may be noted that the serrated portion can optionally be located relatively funher up the half por~ion as shown so tbat there is cylindrical shaft portion 221 below as well as above the serrated portion.
Fastener 300 of Figures S and 6 illustrates an embodiment of the present invention which does not have guide members. Parallel prongs 320 illustratively extend perpendicularly from backspan 310. Each prong 320 has a shaft portion 321 preferably circular in cross sectioD. Prongs 320 each have a serrated area with a ridge 322 and notches 323. Tbe prong 320 includes a tip portion 3~ terminating in sbarp point 325. The backspan 310 includes overlap portion 312. Fastener 300, as shown, does not include a ~ 05~4~
guide member at tbe ends of tbe backspan such as in members 111 and 211.
Figs. 7 and 8 illustrate another embodiment of tbe present invention~ Fastener 400 includes a backspan 410 and pair of prongs 420 extending from tbe backspan 410. In this il~ustrated embodiment, prongs 420 are parallel to one anotber and extend substantially perpendicular to backspan 410. Each prong has a shaft portion 421 and a tapered tip portion 424 havtng a sharp distal point 425. Unlike the previous embodiments, fastener 400 does not include serrations so that each shaft portion 421 mairtains a substantially smooth continuous surface throughout its length M. Thus, fastener 400 is configured to remain imp~anted for a shorter period of time than tbe serrated versions of the fastener sbown in Figures 1-6. Overlap portion 412 is an optional feature.
Referri~g to Fig. 7, each prong 420 has an overall length L and the smootb c lindrical sh~ poltion 421 of each prong 420 has ]engLh N and tbe tapered portion 424 has ]ength M.
Fastener 400 can be fabricated in a variety of sizes. In a longer pronged version, Ihe ]ength M of the shaft porti-on -421 is about one-half of the overall prong length L, and in a sborter pronged version shaft por~ion 421 is about one third of the overall prong length L (Note that fasteners 100, 200 and 300 descnbed above can also be fabricated i~ a vanety of si7es i~cluding a long pronged version and a short pronged versiorL) Clearly, the ratio of the lengths of tbe shaft portions, ~p por~ion and overall prong can di~er from that descIibed above to accommodate various uses of the fasteners.
~52~7 Figure 9 il~ustrates yet another embo~liment of the present invention in which fastener 700 bas a backspan 710 and a pair of prongs 720, 720'. Bac~;span 710 is shown wilh tbe optional features of the over~ap portion 712 and guide members 711. In this embodiment, prong 720' is devoid of serrations and has a continuous smooth surface extending along the length of shaft portion 721' (from backspan 710 to tapered tip portion 724'.) Prong 720 has a double serration formed by ndges 722 and recesses 723 disposed in shaft portion 721. Tapered portion 724 terrninates in distal point 725. Due to this configuration7 prong 720' bas increased frictional characteristics compared to prong 7~0 and will therefore provide increased holding force of tbe tissue. This is useful to accommodate differences in tissue type or tissue condition (e.g. health) behYeen adjacent tissue sec~ions to be joined. Tbus, tbe configuration of the prorgs of Figure 9 are suitab]e when one of the tissue sections requires additional ver~ical retention force. C]early, other variations on the number of serrations on each individual prong of the fastener is contemp]ated by the present invention7 and will depend on i~s use. This advantageous~y improves ~he versatility of the fas~ener by enabling it to accornmodate differences in the tissue regions through which it is inserted and adapted to be retained.
That is, if additional retention properties are reqnired for only one prong, then additional serrations can be provided on that prong Figures 10a, 10b and 11 illustrate one use of the fastener of the-presènt invention. Fasteners 500, which can be any of tbe previously described embo~nents, but is shown as a version with no serrations for converLience, are imp]anted across the interface 550 betweerl a grafted layer ~s~
of s~;in 520 and orig~nal skin 530. Prongs 502 penetrate the under]y~ng tissue 510 and bac~;span 501 overlies the upper surface of layers 520 and 530. The fastener 500 thus provides sufficient lateral force across th interface 550. Each tip portion 504 tapers to shaIp point 505 to facilitate implementation. In Figure lOb a grafsed layer of skin 550 is placed over an existing wound and sl~n fasteners 500 are applied circumferentially around the skin layer 550 to fasten it to underlying skin layer 560.
In use, after insertion of the fasteners, gauze dressing 540 is applied over the grafted area and secured by surgical tape, or other s utable means. The gau2e dressing provides vertical holding means for the fasteners. Thus, tbe fasteners principally function So secure the tissue layers 520 and 530 laterally across interface 550. Barbs are not needed to secure grafted layer 520 into base layer 510 since sufficient vertical force is provided by the gauze 540 for the limi~ed time period necessary for healing to comrneDce. That is, tbe fasteners 500 are on]y required to remain in the tissue for a period of time sufficient for healing to begin:
typically three to thirteen days and preferab]y on3y thr.ee days. The smooth surfaced embo-liment of the present invention, i.e., the embodiment as illustrated in Figs 7 and 8, will typically remain implanted for about 3 to 6 days, although the time periods will differ depending on the configuration of the prong, its rnaterial somposition and the type and condition of tbe tissue in which it is embedded as will be described below. The serrated embodiments, OIl tbe otber band, will typically rernain implanted for a longer period of ~ne and about S to 10 days, although tbe time penods will also differ depending on the aforementioned Yariables. Tbe fasteners can be ejected by the body or dunng routine con act such as dressi~g changes or 20S~4~3~
sponge baths. This advantageously not only saves time which would otheIwise be required to remove each fastener but reduces t~e patient's discomfort and pain caused by such removal. By not having outwaldly extending barbs, the fasteners can also be rernoved more easily and will inflict less pain upon the patient.
An apparatus suitab]e for applying the skin fasteners of the present invention is disclosed in Fig. 11. The apparatus however, is illustrated for the readers convenience and is not part of the present inventiorl A fastener applying instmment 600 includes a nose portion 610 having a f;ring chamber 620 defined by walls 621 and terrninating in exit opening 622 at the distal end of the instrument. W~en used, the distal end of the instrument is positioned adjacent tbe body tissue to be fastened such that fastener 500 will be implanted into the tissue upon exiting from opening 622. Fastener S00 is slidab~y positioned in t~e interior of t~e firing c~amber 620 such that when pusher bar 630 moves distally (i.e.
towards exit operung 622), fastener 600 is dTiven out of the exit opening 622 and into the body tissue. Instruments for ~olding one or more fasteners and for driving pusher bars are well known to those with s~ll in the art.
As noted above, one factor affecting t~e retention period of the fastener is its configuration. The number of serrations formed in the prong will affect the retention tirne of the fastener; the retention time increasing as the number of serrations increase. The width and length of the prongs will also affen retention time; i.e. the longer fastener taldng a longer time to be forced out by the body because of the longer distance it rleeds to travel through thc tissue.
The rnateri~1 utili7ed for t~e fastener will also affect the retention period. The desired properties of the rnaterial include :~05~4~?, resiliency, sufficient rigidity to prov,de lateral force but not too britt]e so as to easi~y brealc during use. Bo~h bioabsorbab]e and non-bioabsorbable materials can be utili2ed. Examples of bioabsorbable material include homopolymers or copolymers of lactide, glycolide, polydioxanone, t~imethylene carbonate, polyet~ylene oxide or other bioabsorbable polymer materials or b]ends of these respective copolymers. One preferred material is made of a copolymer of lactide and glycolide made from appro~nately 25%
m glycolide and 75~o m lactide blended with a homopolymer of polyglycolide so the total cornposition is composed of approximately 42~o glycolide. Another bioabsorbable resinous material for constructing the fasteners is disclosed in U.S. Patent No. 4,523,591 to Kaplan et aL herein incorporated by reference. C]early, the materials disclosed in the patents and literature listed in the Bac~;ground section of this application can also be utilized.
N70n bioabsorbab]e materi21s contemp]ated inc]ude 2ny implantable material such as polyester, polypropy]ene, or polyethylene. Additives can also be rnL~sed with t~ese materi21s to provide inaeased sti~ening. ~5aterials providing a wetted surface u~ith a low coefficient of fnction will facilitate ease OI withdrawal from the tissue. Clearly, materials having a higher coefficient of friction will have a relatively ]onger retention period.
Another factor which can in~uence the retention period is the interaction between the type of rn~terial and the tissue du~ing healing.
Increased tissuc reactions such as svelling c~n expedite forcing the fastener towards the surface and out of the tissue. Tbe ~uckness and t~pe of tissue will also bc a factor ~ retention of tbe fastcner.
The fasteners of the invention can be made of various sizes depending on their nse. For example, the length of the backspan and prongs ~os~
can range from less tban one millimeter to over one inch in length, depending on the type of tissue in which they are used. For example, t~e face and finger regions require a shorter shaft while the abdomen region may require a longer shaft. The length and width of the fastener~is a function of the tissue used as well as the material.
Set forth below are several examples of dimensions of the fasteners. These dimensions provide orlly a few ex~nples of the virtually ~imitless nurnber of sizes in which the fasteners can be formed. Therefore, it should be understood that the following examples of the present invention illustrate only possib]e dimensions of the fastener, and the fasteners of .
the present invention are in no way limited to these dimensions. Reierence to Figures 12a, 12b and 13 will assist in understanding the dirnensions set forth below.
In one version tbe overall length T of backspan 910 of fastener 900 (F;gure 12a), raIlges from .3985 to .3925 incbes. I~ngth R ranges from .248 to .252 incbes and length S ranges from .2795 to .2825 incbes. Length J (Figure 12b) of fastener 900 ran~es from .Q30 to .032 inches; ]ength N of shaft portion 921 ranges from .082 to .084 inches; length O of tapered tip port;on 925 ranges from .082 to .084 inches and length P of prong 920 ranges from .164 to .168 inches.
In a shorter version of fastener 90û, length N can range ~om 042 to .044, Iength O from .082 to .084 and length P from 0.124 to 0.128 mches.
The prong 820 of the fastener of F;gure 13 has a shaft portion 821 of length A and a tapered tip portion 824 of length B, each r~nginE from 20S~4~3~3 .082 to 0.084 inches. Diameter F of shaft portion 821 ranges from 0.030 to 0.032 incbes. The height D of each notch 823 ranges from 0.008 to 0.011 inches, the depth G of each notch ranges from 0.005 to 0.007 inches, and the height E of each ridge 822 ranges from .005 to .007 inches.~ Angle H
measures 21 10'.
It uill be understood that the foregoing is only illustrative of the principles of the invention and that various modifications can be made by those skilled in the art wi~out departing from the scope and spirit of the present invention.
3,772,420; 3,773,919; 3,792,010; 3,797,499; 3,839,297; 3,867,190; 3,878,2&4;
3,982,543; 4,0$0,0~9; 4,137,921; 4,157,43?; 4,234,775; 4,237,~0; 4,3~0,565;
and 4,523,591; U.K Patent No. 779,291; D. K Gilding et al., "Biodegradable polymers for use in surgery - po]yg]ycol~c/poly(lactic acid) homo- and co-polymers: 1, Po]vmer, Vo]urne 20, pages 14~9-1464 (1979), and D.F.
Williams (ed.) Biocompatibility of Clinical Implant Materials, Vol. ~, ch.
9: "Biodegradab]e Po]vmers" (1981).
U.S. Patent No. 4,667,674 to Korthoff et a~ discloses a two part surgical fastener comprising a fastener member and a retainer member. The fastener member has a base, and a ~air of prongs extending perpendicular]y 2(~5~4~
from the base. The prongs are spaced inward from the respective ends of the base in order to preYent sp~ay~ng of the prongs, and to improve hemostasis.
T~e two piece fasteDers require the stap]e delivery apparatus to have access to both sides of the tissue. Usually, such devices have a U-shaped member into which tissue is inserted. T~e stapler apparatus has a fastener holder and an anvil which are p;votally connected at one end, and mounted on the legs of t~e U-shaped support structure. See, for exarnple, U.S. Patent No. 4,402,445 to Green which discloses a surgical fastener and means for applying same. In a surgical operation, the tissue to be joined is positioned between the fastener ~older and the anvil, which contains the fastener retainers. The fasteners are ejected from the ~older into the tissue, and the prongs are locked into the retainers.
In some applications, bowever, it is not possible to have access to body tissue from two opposite directions. For example, in sl;in grafting applications oDe c~ only app]y fasteners from a stapler positioned above the skin.
The prior art inc~udes m~ny examples of surgical st~p]ers which do not enclose the body tissue between an anvil and fastener holder. For example, surgical staplers such as those described in U.S. Patent No.
3,643,851 and U.S. Patent No. 4,618,086 approach tne s~n from one direc~iorl~ However, they require the use of staples which are rnalleable enough to be crimped by an anvil so that the prongs hook into the tissue.
Typically, such staples are made of metal and are not bioabsorbable. They must be removed by another device such as a stapler extractor which is not only ~ne consuming but ~n cause discornfort and pain to the patient. The discomfort and pain in removal of the stap]es are especia~y acule when the fasteners are used in s~iin grafting a burn victim. T~e sensitivity of the bu~ patient's skin cannot be understated; any contact with their sl~
causes distress, let alone removal of fasterlers inserted through the skin and embedded in underlying body tissue.
Sing]e piece barbed fasteners made fiom bioabsorbable material are known. U.S. Patent No. 4,635,637 discloses a fastener having a base member and two substantial~y parallel shafts upstanding from the base member, the ends of the shafts each having a barb. The barbed fastener is disclosed as being useful in the repair of meniscal tissue. Pending patent application Serial Nos. 372,025 filed June 27, 1989 and 314,368 filed February 22, 19~9 also disclose bioabsorbable fasteners having barbs. If these fasteners are removed, then the patierlt will suffer from the same dist.-ess as described above wiLh respect to non-bioabsorbab]e staples.
The prior art fasteners discussed above were designed w~th the intention that significant vertical support was required. Thus, outwardly extending barbs were pro~ided on their prongs to ensure that they remained embedded in the body tissue for a suf~iciently long period of time.
~owever, such barbed fasteners remained in the tissue for a longer time than was necessary. T~e need therefore exists for a fasterler which rem~ins embedded in the tissue only for a sufEicient period of ~ne to al~ow he~ling to cornrnence but a~oids the discomfort and pain associated with the removal of prior fasteners.
~05~?,~L~3,'3 SUMl'~ARY OF THE INVENTI~:
The present invention overcomes the drawbacks and deficierlcies of the prior art. The present inventors discovered that in skin grafting, the emphasis is on lateral support across an incision or skin graft interface to provide su~icient lateral force between adjacent tissue sections. It was found that the vertical support provided by the barbed prongs was unnecessary and that this configuratlon ohen required actual removal of the fastèners, causing pain and discornfort. The present invention therefore oYercomes the problerns of prior art staples and fasteners by significantly limiting the extent of pain the patient will experience. The present invertion achieves this objective by providing a surgical fastener whuch is composed of a material and configured so as to work its way out of body tissue after a specific period of ~ime or caD be more easily removed beforehand.
The surgical fastener includes a backspan and at least two prongs which extend from the backspan, preferably perpendicular to the backspan and parallel to each other. Each prong includes a tapered tip portion to facilitate penetration into the body tissue and is configured to remain in the body for a relatively short period of time. The material of the prong also has a low coefficient of friction to facilitate ejection from the body tissue. In one embodiment, substantially the entire shaft portion up to the tapered tip portion has a portion of uniform diameter. That is, there are no barbs on the shaft which would retain the embedded fastener for a longer period of time than necessaly. In other embodimeDts, a serrated portion is 20524~3 fo-med in the uniforrn-diameter shaft porh'on to provide addihonal retentioD, but less retention than that of the barbs of the prior art.
The present invention also provides a met~od for sl;in grafting comprising inserting a plurality of fasteners each having spa6`ed apart prongs wherein at least one prong is devoid of barbs, securing a dressing over the fasteners to provide sufficient vertical force to hold the fasteners for a period of time until hea7,ing commences, and removing the dressing after healing commences, wherein a substantial number of the fasteners will be dis]odged when the dressing is removed and a substantial number of the remaimng fasteners will be automatically ejected by the body in a re]atively short period of time.
BRIEF DESCRIPrlON OF THE DRAWINGS:
Preferred embodiments of the invention are descTibed hereinbelow with reference to the drawings, wherein:
Fig. 1 is an eleYational ~ont view of one emborliment of a fastener of the present invention;
Fig. 2 is a top view of the fastener of Figure 1;
Fig. 3 is a side view of the fastener of Figure 1;
Fig. 4 is an elevation 1 view of another embodiment of the fastener of the present invention;
Fig. 5 is an e]evatiorlal frorlt view of yet another embodiment of a fastener of the present invention;
Fig. 6 is a top view of tbe fastener of Figure 5;
;~)5~ 9 Fig. 7 is an elevational f~ont view of still ano~her embodiment of a fastener of the present irvention;
Fig. 8 is a top view of the fastener of Figure 7;
Fig. 9 is an elevat;onal front view of yet another embodiment of a fastener of the present invention;
Fig. 10a and 10b are sectional perspective views illustrating the use of a fastener of the present invention;
Fig. 11 is a partially cut away e]evational view showing an implement for applying a fastener of the presene invention;
Figs. 12a and 12b are a top Yiew ar d an elevational front view, respectively, of an embodiment of a fastener of the present invention labelled to show one exarnp]e of the dimensions of a non-serrated fastener which c2n be utili7ed; and Fig. 13 is an enlarged view of aD embodiment of a prong of a fastener of the preserlt invention labelled to show one examp]e of the dimensions of a doub]e serrated fastener which can be utilized.
DETAILED DESCRIPTION OF ~HE PREFERRED EMBODIMEN~S
Tunung now to the drawings, Figs 1, 2 and 3 il~ustrale one embodirnent of the skin fastener of the present invention. Fastener 100 includes a backspan 110 and two pronged portions 120 extending from backspan 110. Although the pronged portions 120 are shown parallel to each other and extending subst~ntially perpendicular to backspan 110, as iIl all tbe embodiments disclosed here~, one or both of the pronged portions 120 can 21~5;~
altemately be secured at a different ang]e lo backspan 110 to extend inward]y towards each ot~3er or outwald]y away from each other. In this embodiment, each prong 120 has a shaft portion 121 illustrative]y cylindrical in configuration, and a tapered tip portion 124 which culminates in a sbarp point 125 at the distal end to facilitate penetration of body tissue. Prongs 120 also inc]ude a serrated portion having ridges 122 alternating with recessed notch portions 123. Tl3e serrations extend circumferentially around shaft 121. Fastener 100 is a double serrated prong fastener in that t~3ere are two ridge portions 122 on each prong. The serrations provide additional rrr3ctional means to hold the fastener in body tissue for a longer period of time than if no serrations were present.
l~everthe]ess, these serrations do not constitute barbs. That is, the ridges do not exteDd radially beyond the circumferential surface of the cylindrical shaft portion 121, and they do not prevent fastener 100 from gradually wor~ing its way out of body tissue within a specific period of time. By not having barbs, the fasteners can also be more easily removed. The diameter of the tapered tip portion 124 does not exceed the diameter of the shaft portion 121. The base portion of each prong 120 may be provided with a cu~ed su~face 126.
In the embodiTnent shown in Figllre 1, the backspan 110 exlends lengthwise a greater distance than the distance between prongs 120. In other words, this embodiment possesses an overlap portion 112 which extends the area of tissue which is be3ng held down and is an optional feature of this invention since alternately the backspan 110 caD terminate at the prcngs 120. Members 111 at each end of the fastener backspan 110 can optio3lally be provided to proYide a guide means to maintam the proper ~ IDS~3~
orientation of the fastener inside a fastener applying instrument while the fastener is being implanted.
Fig. 4 illustrates an emborliment of t~e fastener of tbe present invention having a single serration. As with the double serrated embodiment 100, smgle serrated fastener 200 includes backspan 210 and prongs 220 having a shaft portion æ1 and circumferential serrations including ridge 222 and recessed notch portions 223. Each prong 220 of fastener 200 also includes a tapered tip portion 224 having a sharp point 225 at its distal end. The backspan 210 can also include overlap portions 212 to increase the surface area of tissue he]d down and guide members 211 for engagement by a fastener instrument. Fastener 200 differs from fastener 100 in that it includes a sing]e ridge 222 instead of double ridges on each prong. Thus the retention period of fastener 200 uill be less than that of fastener 100. As with tbe previous embodiment, the ridge 222 does not extend radially beyond the circurnferential surface of the cylindncal sbaft por~ion. Also, it may be noted that the serrated portion can optionally be located relatively funher up the half por~ion as shown so tbat there is cylindrical shaft portion 221 below as well as above the serrated portion.
Fastener 300 of Figures S and 6 illustrates an embodiment of the present invention which does not have guide members. Parallel prongs 320 illustratively extend perpendicularly from backspan 310. Each prong 320 has a shaft portion 321 preferably circular in cross sectioD. Prongs 320 each have a serrated area with a ridge 322 and notches 323. Tbe prong 320 includes a tip portion 3~ terminating in sbarp point 325. The backspan 310 includes overlap portion 312. Fastener 300, as shown, does not include a ~ 05~4~
guide member at tbe ends of tbe backspan such as in members 111 and 211.
Figs. 7 and 8 illustrate another embodiment of tbe present invention~ Fastener 400 includes a backspan 410 and pair of prongs 420 extending from tbe backspan 410. In this il~ustrated embodiment, prongs 420 are parallel to one anotber and extend substantially perpendicular to backspan 410. Each prong has a shaft portion 421 and a tapered tip portion 424 havtng a sharp distal point 425. Unlike the previous embodiments, fastener 400 does not include serrations so that each shaft portion 421 mairtains a substantially smooth continuous surface throughout its length M. Thus, fastener 400 is configured to remain imp~anted for a shorter period of time than tbe serrated versions of the fastener sbown in Figures 1-6. Overlap portion 412 is an optional feature.
Referri~g to Fig. 7, each prong 420 has an overall length L and the smootb c lindrical sh~ poltion 421 of each prong 420 has ]engLh N and tbe tapered portion 424 has ]ength M.
Fastener 400 can be fabricated in a variety of sizes. In a longer pronged version, Ihe ]ength M of the shaft porti-on -421 is about one-half of the overall prong length L, and in a sborter pronged version shaft por~ion 421 is about one third of the overall prong length L (Note that fasteners 100, 200 and 300 descnbed above can also be fabricated i~ a vanety of si7es i~cluding a long pronged version and a short pronged versiorL) Clearly, the ratio of the lengths of tbe shaft portions, ~p por~ion and overall prong can di~er from that descIibed above to accommodate various uses of the fasteners.
~52~7 Figure 9 il~ustrates yet another embo~liment of the present invention in which fastener 700 bas a backspan 710 and a pair of prongs 720, 720'. Bac~;span 710 is shown wilh tbe optional features of the over~ap portion 712 and guide members 711. In this embodiment, prong 720' is devoid of serrations and has a continuous smooth surface extending along the length of shaft portion 721' (from backspan 710 to tapered tip portion 724'.) Prong 720 has a double serration formed by ndges 722 and recesses 723 disposed in shaft portion 721. Tapered portion 724 terrninates in distal point 725. Due to this configuration7 prong 720' bas increased frictional characteristics compared to prong 7~0 and will therefore provide increased holding force of tbe tissue. This is useful to accommodate differences in tissue type or tissue condition (e.g. health) behYeen adjacent tissue sec~ions to be joined. Tbus, tbe configuration of the prorgs of Figure 9 are suitab]e when one of the tissue sections requires additional ver~ical retention force. C]early, other variations on the number of serrations on each individual prong of the fastener is contemp]ated by the present invention7 and will depend on i~s use. This advantageous~y improves ~he versatility of the fas~ener by enabling it to accornmodate differences in the tissue regions through which it is inserted and adapted to be retained.
That is, if additional retention properties are reqnired for only one prong, then additional serrations can be provided on that prong Figures 10a, 10b and 11 illustrate one use of the fastener of the-presènt invention. Fasteners 500, which can be any of tbe previously described embo~nents, but is shown as a version with no serrations for converLience, are imp]anted across the interface 550 betweerl a grafted layer ~s~
of s~;in 520 and orig~nal skin 530. Prongs 502 penetrate the under]y~ng tissue 510 and bac~;span 501 overlies the upper surface of layers 520 and 530. The fastener 500 thus provides sufficient lateral force across th interface 550. Each tip portion 504 tapers to shaIp point 505 to facilitate implementation. In Figure lOb a grafsed layer of skin 550 is placed over an existing wound and sl~n fasteners 500 are applied circumferentially around the skin layer 550 to fasten it to underlying skin layer 560.
In use, after insertion of the fasteners, gauze dressing 540 is applied over the grafted area and secured by surgical tape, or other s utable means. The gau2e dressing provides vertical holding means for the fasteners. Thus, tbe fasteners principally function So secure the tissue layers 520 and 530 laterally across interface 550. Barbs are not needed to secure grafted layer 520 into base layer 510 since sufficient vertical force is provided by the gauze 540 for the limi~ed time period necessary for healing to comrneDce. That is, tbe fasteners 500 are on]y required to remain in the tissue for a period of time sufficient for healing to begin:
typically three to thirteen days and preferab]y on3y thr.ee days. The smooth surfaced embo-liment of the present invention, i.e., the embodiment as illustrated in Figs 7 and 8, will typically remain implanted for about 3 to 6 days, although the time periods will differ depending on the configuration of the prong, its rnaterial somposition and the type and condition of tbe tissue in which it is embedded as will be described below. The serrated embodiments, OIl tbe otber band, will typically rernain implanted for a longer period of ~ne and about S to 10 days, although tbe time penods will also differ depending on the aforementioned Yariables. Tbe fasteners can be ejected by the body or dunng routine con act such as dressi~g changes or 20S~4~3~
sponge baths. This advantageously not only saves time which would otheIwise be required to remove each fastener but reduces t~e patient's discomfort and pain caused by such removal. By not having outwaldly extending barbs, the fasteners can also be rernoved more easily and will inflict less pain upon the patient.
An apparatus suitab]e for applying the skin fasteners of the present invention is disclosed in Fig. 11. The apparatus however, is illustrated for the readers convenience and is not part of the present inventiorl A fastener applying instmment 600 includes a nose portion 610 having a f;ring chamber 620 defined by walls 621 and terrninating in exit opening 622 at the distal end of the instrument. W~en used, the distal end of the instrument is positioned adjacent tbe body tissue to be fastened such that fastener 500 will be implanted into the tissue upon exiting from opening 622. Fastener S00 is slidab~y positioned in t~e interior of t~e firing c~amber 620 such that when pusher bar 630 moves distally (i.e.
towards exit operung 622), fastener 600 is dTiven out of the exit opening 622 and into the body tissue. Instruments for ~olding one or more fasteners and for driving pusher bars are well known to those with s~ll in the art.
As noted above, one factor affecting t~e retention period of the fastener is its configuration. The number of serrations formed in the prong will affect the retention tirne of the fastener; the retention time increasing as the number of serrations increase. The width and length of the prongs will also affen retention time; i.e. the longer fastener taldng a longer time to be forced out by the body because of the longer distance it rleeds to travel through thc tissue.
The rnateri~1 utili7ed for t~e fastener will also affect the retention period. The desired properties of the rnaterial include :~05~4~?, resiliency, sufficient rigidity to prov,de lateral force but not too britt]e so as to easi~y brealc during use. Bo~h bioabsorbab]e and non-bioabsorbable materials can be utili2ed. Examples of bioabsorbable material include homopolymers or copolymers of lactide, glycolide, polydioxanone, t~imethylene carbonate, polyet~ylene oxide or other bioabsorbable polymer materials or b]ends of these respective copolymers. One preferred material is made of a copolymer of lactide and glycolide made from appro~nately 25%
m glycolide and 75~o m lactide blended with a homopolymer of polyglycolide so the total cornposition is composed of approximately 42~o glycolide. Another bioabsorbable resinous material for constructing the fasteners is disclosed in U.S. Patent No. 4,523,591 to Kaplan et aL herein incorporated by reference. C]early, the materials disclosed in the patents and literature listed in the Bac~;ground section of this application can also be utilized.
N70n bioabsorbab]e materi21s contemp]ated inc]ude 2ny implantable material such as polyester, polypropy]ene, or polyethylene. Additives can also be rnL~sed with t~ese materi21s to provide inaeased sti~ening. ~5aterials providing a wetted surface u~ith a low coefficient of fnction will facilitate ease OI withdrawal from the tissue. Clearly, materials having a higher coefficient of friction will have a relatively ]onger retention period.
Another factor which can in~uence the retention period is the interaction between the type of rn~terial and the tissue du~ing healing.
Increased tissuc reactions such as svelling c~n expedite forcing the fastener towards the surface and out of the tissue. Tbe ~uckness and t~pe of tissue will also bc a factor ~ retention of tbe fastcner.
The fasteners of the invention can be made of various sizes depending on their nse. For example, the length of the backspan and prongs ~os~
can range from less tban one millimeter to over one inch in length, depending on the type of tissue in which they are used. For example, t~e face and finger regions require a shorter shaft while the abdomen region may require a longer shaft. The length and width of the fastener~is a function of the tissue used as well as the material.
Set forth below are several examples of dimensions of the fasteners. These dimensions provide orlly a few ex~nples of the virtually ~imitless nurnber of sizes in which the fasteners can be formed. Therefore, it should be understood that the following examples of the present invention illustrate only possib]e dimensions of the fastener, and the fasteners of .
the present invention are in no way limited to these dimensions. Reierence to Figures 12a, 12b and 13 will assist in understanding the dirnensions set forth below.
In one version tbe overall length T of backspan 910 of fastener 900 (F;gure 12a), raIlges from .3985 to .3925 incbes. I~ngth R ranges from .248 to .252 incbes and length S ranges from .2795 to .2825 incbes. Length J (Figure 12b) of fastener 900 ran~es from .Q30 to .032 inches; ]ength N of shaft portion 921 ranges from .082 to .084 inches; length O of tapered tip port;on 925 ranges from .082 to .084 inches and length P of prong 920 ranges from .164 to .168 inches.
In a shorter version of fastener 90û, length N can range ~om 042 to .044, Iength O from .082 to .084 and length P from 0.124 to 0.128 mches.
The prong 820 of the fastener of F;gure 13 has a shaft portion 821 of length A and a tapered tip portion 824 of length B, each r~nginE from 20S~4~3~3 .082 to 0.084 inches. Diameter F of shaft portion 821 ranges from 0.030 to 0.032 incbes. The height D of each notch 823 ranges from 0.008 to 0.011 inches, the depth G of each notch ranges from 0.005 to 0.007 inches, and the height E of each ridge 822 ranges from .005 to .007 inches.~ Angle H
measures 21 10'.
It uill be understood that the foregoing is only illustrative of the principles of the invention and that various modifications can be made by those skilled in the art wi~out departing from the scope and spirit of the present invention.
Claims (17)
1. A fastener for securing adjacent layers of body tissue to each other comprising prong means for penetrating tissue and means for retaining said fastener in the body tissue for a limited period of time so as to be ejected by the body from the body tissue, said fastener being devoid of barbs.
2. A fastener as recited in claim 1, wherein said fastener is positioned in said tissue without engaging a retainer.
3. A fastener as recited in claim 2, wherein said fastener is composed of a material having a coefficient of friction sufficiently low to enable the fastener to travel outwardly through the tissue and out of the body.
4. A fastener as recited in claim 3, wherein said material is bioabsorbable.
5. A fastener as recited in claim 3, wherein said retaining means comprises a serration formed in a shaft portion of the prong of the fastener.
6. A fastener as recited in claim 5, wherein said penetrating means comprises a tapered tip portion with a sharpened point.
7. A fastener as recited in claim 1 further comprising:
a backspan; and at least two prongs extending from said backspan, each prong having a tapered tip portion and a shaft portion which includes a first portion of substantially uniform diameter, said tapered portion not exceeding the diameter of said first portion.
a backspan; and at least two prongs extending from said backspan, each prong having a tapered tip portion and a shaft portion which includes a first portion of substantially uniform diameter, said tapered portion not exceeding the diameter of said first portion.
8. The fastener as recited in claim 7, wherein each prong includes at least two notches spaced apart so as to define a ridge portion therebetween.
9. The fastener as recited in claim 8, wherein said first portion is substantially circular in cross section and said ridge portion extends circumferentially around said shaft portion, said ridge portion being of substantially the same diameter as the first portion.
10. A fastener as recited in claim 7, wherein said shaft portion possesses a length substantially half the total length of the prong and approximately the same length as that of the tapered tip portion.
11. The fastener as recited in claim 1, further comprising a backspan and at least two prongs extending from said backspan, said prongs extending parallel to each other and substantially perpendicularly from the backspan.
12. The fastener as recited in claim 1, further comprising a backspan and at least two prongs extending from said backspan said prongs extending obliquely from said backspan.
13. A method for securing adjacent layers of body tissue to each other comprising:
a. inserting a plurality of fasteners into body tissue to provide lateral force between adjacent layers, the fastener having a shaft portion of substantially uniform diameter;
b. placing a bandage over the fastener to apply a vertical force to the fastener and body tissue;
wherein a number of fasteners will be forced out from the body tissue by the body after a limited period of time.
a. inserting a plurality of fasteners into body tissue to provide lateral force between adjacent layers, the fastener having a shaft portion of substantially uniform diameter;
b. placing a bandage over the fastener to apply a vertical force to the fastener and body tissue;
wherein a number of fasteners will be forced out from the body tissue by the body after a limited period of time.
14. A method as recited in claim 13, wherein a number of said fasteners will be dislodged upon removal of the bandage.
15. A method as recited in claim 13, wherein at least one of said prongs has an intermediate portion having a ridge formed therein.
16. A method as recited in claim 13, wherein the body tissue layers are layers of skin and the method comprises:
aligning a first section of skin alongside a second section of skin;
inserting a plurality of fasteners having first and second downwardly extending prongs into said skin sections so that said first prong penetrates through said first skin section into said underlying body tissue and said second prong penetrates through said second skin section into said underlying body tissue, said first and second prongs being thereby disposed on opposing sides of the interface between the skin sections.
aligning a first section of skin alongside a second section of skin;
inserting a plurality of fasteners having first and second downwardly extending prongs into said skin sections so that said first prong penetrates through said first skin section into said underlying body tissue and said second prong penetrates through said second skin section into said underlying body tissue, said first and second prongs being thereby disposed on opposing sides of the interface between the skin sections.
17. A method as recited in claim 16, further comprising the step of removing the bandage after a specified time period, whereby removal of the bandage will remove several of said fasteners, and a plurality of said remaining fasteners will be subsequently ejected by the body in a limited period of time.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/601,335 | 1990-10-22 | ||
| US07/601,335 US5108422A (en) | 1990-10-22 | 1990-10-22 | Skin fastener |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2052483A1 true CA2052483A1 (en) | 1992-04-23 |
Family
ID=24407115
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002052483A Abandoned CA2052483A1 (en) | 1990-10-22 | 1991-09-30 | Skin fastener |
Country Status (4)
| Country | Link |
|---|---|
| US (2) | US5108422A (en) |
| EP (1) | EP0485744B1 (en) |
| CA (1) | CA2052483A1 (en) |
| DE (1) | DE69116104T2 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| EP0485744A1 (en) | 1992-05-20 |
| EP0485744B1 (en) | 1996-01-03 |
| DE69116104D1 (en) | 1996-02-15 |
| DE69116104T2 (en) | 1996-06-05 |
| US5658312A (en) | 1997-08-19 |
| US5108422A (en) | 1992-04-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 19990930 |