CA1330185C - Braided suture - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
A braided suture is provided which exhibits perceptibly enhanced flexibility and hand as well as reduced chatter and drag compared to these same characteristics in a suture possessing substantially the same overall denier but possessing significantly fewer sheath yarns and denier of individual filaments than the braided suture herein.

Description

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BACKGROUND OF THE INVENTION
This invention relates to a braided suture of improved construction.
Sutures intended for the repair of body tissues must meet certain requirements: they must be substantially non-toxic, capable of being readily sterilized, they must have good tensile strength and have acceptable knot-tying and knot-holding characteristics and if the sutures are of the absorbable or biodegradable variety, the absorption or biodegradation of the suture must be closely controlled.
Sutures have been constructed from a wide variety of materials including surgical gut, silk, cotton, a polyolefin such as polypropylene, polyamide, polyglycolic acid, polyesters such as polyethylene terephthalate and ~ -glycolide-lactide copolymer, etc. Although the optimum structure of a suture is that of a monofilament, since certain materials of construction would provide a stiff monofilament suture lacking acceptable knot-tying and knot-holding properties, sutures manufactured from such materials are preferably provided as braided structures.
Thus, for example, sutures manufactured from silk, polyamide, polyester and bio-absorbable glycolide-lactide copolymer are usually provided as multifilament braids.
Commercial examples of such sutures include DEXON* (Davis & Geck, Inc.,~ and VICRYL* (Ethicon, Inc.).

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~ 1 Currently available braided suture products are i acceptable in terms of their knot-tying and knot-holding properties. However, as removed from the package, they tend to be stiff and wiry and retain a "set" or "memory" such that at the time of use, it is usually necessary for the surgeon or assistant personnel to flex and stretch the suture to make it more readily handible. Furthermore, the surfaces of known sutures are perceptibly rough. Thus, if one passes one's hand or fingers along the braid, surface irregularities will be readily detected. The result of this rough surface is that the suture will exhibit drag or chatter as it is drawn through tissue, characteristics which militate against smooth, neat, accurately placed wound approximation so necessary to excellence in surgical practice.
In the case of one braided suture now on the market, due to the necessity of having to meet fiber strength requirements while at the same time retaining ,i -acceptable knot-tying and knot-holding properties, the ~l 20 suture is constructed from a greater amount of fiber and ; -consequently is of larger diameter than the accepted industry standard.
It is an object of this invention to provide a braided suture of improved characteristics, specifically one : ; -exhibiting greater flexibility, better hand and less chatter and drag, than braided sutures of known construction. ~-It is a particular object of the invention to 'i-~
provide a braided suture possessing a greater number of sheath yarns, a finer denier for the individual filaments ~---30 comprising an individual sheath yarn and a greater pick ~ ~ -count for a suture of any given overall denier (crossovers per linear inch).

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1 It is still another object of the invention to provide a braided absorbable suture possessing the aforesaid improved characteristics.

SUMNARY OF THE INVENTION
By way of satisfying the foregoing objects as well as other objects of the invention, there is provided in accordance with this invention a braided suture of improved construction possessing a significantly greater number of sheath yarns for a given overall denier, said sheath yarns being fabricated from individual filaments of finer denier than filaments which are typical of known types of braided suture, said improved suture exhibiting perceptibly improved flexibility and hand and reduced chatter and drag compared with braided sutures of known construction.
More particularly, in accordance with this invention, a braided suture of improved construction is ! -:
provided wherein for a given range of overall suture denier, i.. --the range of pick count, number of.sheath yarns and denier of individual.filaments comprising a sheath yarn are related to each other as follows:

Overall Number of Denier of Suture Pick Sheath Individual Denier Count Yarns Filaments ~-:......... .
from about 50 from about 50 from about 4 from about 0.2 to about 125 to about 100 to about 16to about 1.8 . .
greater than from about 50 from about 4 from about 0.2 about 125 to to about 100 to about 16 to about 1.8 about 200 .
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greater than from about 50 from about 4 from about 0.2 . - -about 200 to to about 100 to about 16to about 1.8 ~.
about 300 - . ...
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l Overall Number of Denier o' Suture Pick Sheath Individual Denier Count Yarns Filaments ~-, greater than from about 50 from about 10 from about 0.2 about 300 to to about 100 to about 20 to about 1.8 about 500 greater than from about 50 from about 14 from about 0.2 about 500 to to about 100 to about 20 to about 1.8 ~ -about 800 -greater than from about 50 from about 16 from about 0.2 ~ I
about 800 to to about 100 to about 32 to about 1.8 about 1200 t~
greater than from about 50 from about 20 from about 0.2 about 1200 to to about 100 to about 36 to about 1.8 ; - -about 2000 ;
greater than from about 50 from about 20 from about 0.2 - :
about 2000 to to about 200 to about 36 to about 1.8 about 4000 As a result of its possessing a greater number of i-sheath yarns for a suture of given overall denier and in ! ~
20 some cases, pick count, and together with the finer denier ~ -o~ the filaments making up a sheath yarn, the braided suture of the present invention exhibits far fewer surface --discontinuities thereby providing a suture which is considerably smoother than braided sutures of known construction.
The term "suture" is intended to embrace both the non-absorbable as well as the bio-absorbable varieties.
The term "braid" or "braided" as applied to the suture of this invention refers to an arrangement of I discrete units, or bundles, denominated "sheath yarns", made ~-up cf individual filaments with individual sheath yarns interlocking or interlacing each other in a regular criss-cross pattern.
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The term "pick count" refers to the number of crossovers of sheath yarns per linear inch of suture and, together with the overall denier of the suture, the denier of the individual filaments constituting a sheath yarn and the number of sheath yarns employed, defines the principal construction characteristics of the braided suture herein.
The braided suture of this invention can optionally possess, in addition to the braided structure itself, a core component around which the braid is constructed. In the case of this embodiment, it is preferred that the core constitute a larger proportion of overall suture denier than the core component of a known braided suture.
The invention will now be described with reference to the accompanying drawings in which:
FIG. 1 is a photomicrograph (200x) of a cross-sectional view of a comparison suture outside the scope of ~ 20 the present invention:
; FIG. 2 is a photomicrograph (50x) of a linear view of the suture of FIG. l;
F~G. 3 is a photomicrograph S200x) of a cross- -~
sectional view of a suture within the scope of the present invention; and ` FIG. 4 is a photomicrograph (50x) of a linear view of the suture of FIG. 3.
DESCRIPTION OF THE PREFERRED EMBODIMENTS -~
In a preferred embodiment, the braided suture of the present invention is fabricated from a bio-absorbable or biodegradable resin such as one derived from polyglycolic acid, glycolide, lactic acid, lactide, dioxanone, trimethylene carbonate, etc., and various combinations of these and related monomers. Sutures 35 prepared from resins of this type are known in the art, ~ i -e.g., as disclosed in U.S. Patent Nos. 2,668,162; -~
2,703,316; 2,758,987; 3,225,766; 3,297,033; 3,422,181;

~- 1 3 ~ 0 1 8 3 - 5a -3,531,561; 3,565,077; 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; 3,878,284; 3,982,543;

4,047,533; 4,060,089; 4,137,921; 4,157,437; 4,234,775;
4,237,920; 4,300,565; and, 4,523,591; U.K. Patent No.
779,291; D.K. Gilding et al., "Biodegradable polymers for use in surgery -- polyglycolic/poly(lactic acid) homo- and co-polymers: 1, Polvmer, Volume 20, pages 1459-1464 (1979), and D.F. Williams (ed.), Biocompatibility of Clinical Imlant Materials, Vol. II, ch.9: "Biodegradable Polymers" (1981).

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1 The defining characteristics of the braided suture of this invention, apart from the material of its construction, are:
(1) overall suture denier;
(2) the pattern of the interlocking yarns expressed as the pick count, which is to say, the number of crossovers of individual sheath yarns per linear inch of suture;
(3) the number of sheath yarns comprising the -braid;
(4) the denier of the ;ndividual filaments comprising each sheath yarn; and, (5) the denier of the core, where present.
(1) Overall Denier of the Suture The overall denier of the braided suture can vary from about 50 to about 4000. Within this range, the ranges of overall denier for particular sutures are: from about 50 to about 125 denier; from above about 125 to about 200 ¦ -denier; from above about 200 to about 300 denier; from above about 300 to about 500 denier; from above about 500 to about ;-~
800 denier; from above about 800 to about 1500 denier; from above about 1500 to about 2000 denier; and, from above about `
~ 2000 to about 3600 denier.
`~ (2) Pattern of the Interlockin~ Sheath Yarns rPick Count) `~ 25 For a suture of any range of overall denier, pick count can vary from about 50 to about 100 crossovers/inch with about 55-80 crossovers/inch being preferred. For sutures - ~
constructed within any range of overall denier, as larger -- - -~` numbers of sheath yarns are employed, the pick-count for r 30 acceptable sutures will also increase within the above ranges.

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1 For a suture of a particular range of denier and number of sheath yarns, pick count is advantageously established to achieve a balance in the properties desired. In general, with increasing pick count, surface roughness of the 5 suture tends to increase and with decreasing pick count, the -ability of the external braided sheath to contain the core (if present) tends to decrease even reaching the point where the braid may become so loose as to result in the core protruding therethrough.
For sutures of any specific denier range and number of sheath yarns, it is preferable to have as low a pick count as possible in order to achieve optimum surface smoothness, consistent, of course, with the need to provide a compact braid which prevents the core (if present) from protruding through -the exterior sheath yarn structure.
(3) The Number of Sheath Yarns The number of sheath yarns bears some relation to :- -overall suture denier, the number generally increasing with -the weight of the suture. Thus, across the range of suture weight (denier) indicated above,the braided suture of this invention can be constructed with from about 4 up to as many as about 36 individual sheath yarns constructed from individual filaments having the deniers discussed below. ` ~ -Table I below sets forth broad and preferred 25 ranges for the numbers of sheath yarns which are suitable !- -for the construction of braided sutures of various ranges of overall denier.~ The pick counts of the sutures vary from -~
about 50 to about 100 and deniers of individual filaments i`
vary from about 0.2 to about 1.8 for the broad range of ,-;
number of sheath yarns and the pick counts vary from about 55 to about 80 and the deniers of individual filaments vary -from about 0.8 to about 1.4 for the preferred range of number of sheath yarns.

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-8- 1 3 3 ~ 1 8 3 1 Table I: Sheath Yarns Related to Suture Denier Number of Number of Overall Suture Suture Sheath Yarns Sheath Yarns Denier Size (Broad Range) (Preferred Range) 50 to about 125 7/0,8/0 4-16 6-14 greater than about 125 to about 200 6/0 4-16 6-14 -~-greater than about - .
200 to about 300 .5/0 4-16 6-14 greater than about . -300 to about 500 4/0 10-20 12-14 ~ :
greater than about .
500 to about 800 3/0 14-20 14-18 -greater than about 800 to about 1200 2/0 18-32 20-30 greater than about i ~ 1200 to about 2000 0 20-36 24-34 - grsater than about -~ . - -~.. -.
`~ 2000 to about 4000 1,2 20-36 24-34 !...... .~.. : :.
~:~ While the ~heath yarns need not be twisted, it is i. ;
generally preferred that they be provided with a twist so as :~ to minimize snagging during braid construction. i~
(4) Individual Filament Denier The individual filaments comprising each sheath ! -yarn can vary in weight from about 0.2 to about 1.8 denier .
and preferably from about 0.8 to about 1.4 denier. The number of such filaments present in a particular sheath yarn ' will depend on the overall denier of the suture as well as ;~
~ 30 the nur~er of sheath yarns utlli~ed in tho construction of `

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1 the suture. Table II sets forth some typical numbers ~f filaments per sheath yarn f~r both the broad and preferred ranges of filament weight:
¦ 5 Table II: Number of Filaments ~er Sheath Yarn ! approximate approximate Filament I minimum maximum Denier , j 45 450 0.2 150 0.5 1.5 3 40 1.8 (5) Core (O~tional~
For all but the lowest range of overall denier, the braided suture herein can optionally be constructed around a filamentous c~re which itself can be braided or which can be provided in some other configuration such as a twist, ply, cable, etc. The filament(s) comprising the core 20 need not be as fine as those comprising the sheath yarns. ~
It is particularly advantageous for sutures of heavier - : -denier to possess a core. Where a core is provided, it is generally preferred that it possess a weight which is significantly greater than that of a core of a known suture of equivalent overall denier.
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1 Table III below provides some typical core deniers for sutures of various deniers.

Table III: co~e Denier Related to Suture Denier Denier of Denier of . .- ~ :
Overall Suture Suture Optional Core optional Core ::
Denier Size (Broad Range) tPreferred Range) .
from about 50 to about 125 8/0,7/o none none ' , ::-greater-than about . .
125 to about 200 6/9 20-8Q 25-50 greater than about -200 to about 300 5/0 30-100 50-80 greater than about -300 to about 500 4/0 80-50 80-12 greater than about 500 to about 800 3/0 150-300 180-280 . greater than about 800 to about 1200 2/0 250-700 350-650 greater than about `.
1200 to about 2000 0 400-1200 500-1000 greater than about --~
2000 to about 40001,2 800-2400 1000-2200 It can be advantageous to apply one or more :~
~ coating compositions to the braided suture of this invention ;; to improve such properties as surface lubricity and knot .`-~
tie-down behavior.- A variety of suture coating compositions ;~ proposed for either or both purposes is known in the art, 30 e.g., those disclosed in U.S. Patent No. 4,047,S33 ~ ~`-~ :~

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l It is also within the scope of this invention to impregnate the suture with, or otherwise apply thereto, one or more medico-surgically useful substances, e.g., those which accelerate or beneficially modify the healing process -when the suture is applied to a wound or surgical site. SG, for example, the braided suture herein can be provided with a therapeutic agent which will be deposited at the sutured site. The therapeutic agent can be chosen for its antimicrobial properties, capability for promoting wound repair and/or tissue growth or for specific indications such as thrombosis. Antimicrobial agents such as broad spectrum antibiotics (gentamycin sulphate, erythromycin or derivatized glycopeptides) which are slowly released into the tissue can be applied in this manner to aid in combating clinical and sub-clinical infections in a surgical or trauma wound site. To promote wound repair and/or tissue growth, one or several growth promoting factors can be introduced into the suture, e.g., fibroblast growth factor, bone growth ~- factor, epidermal growth factor, platelet derived growth factor, macrophage derived grown factor, alveolar deri~ed growth factor, monocyte derived growth factor, magainin, and so forth. Some therapeutic indications are: glycerol with tissue or kidney plasminogen activator to cause thrombosis, superoxide dismutase to scavenge tissue damaging free -` 25 radicals, tumor necrosis factor for cancer therapy or colony stimulating factor and interferon, interleukin-2 or other lymphokine to enhance the immune system. ~-In the examples which follow, Comparison Examples l to ll are illustrative of known type sutures while Examples l to 12 are illustrative of sutures constructed n ; - ~ -accordance with this invention. ~ ~
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~ 12- 13~185 1 ComPariSOn Exam~les 1-7 - -The following braided suture configurations are disclosed in U.S. Patent No. 3,565,077:

Overall Denier of . -- -~;
Comparison Suture Pick Number of Individual Denier Example Denier Count Sheath Yarns Filaments of Core '~' ,. ~:
1 175 40 6 6 25 ~ ;;:

3 500 40 8. 6 100 4 800 50 12 6 200 :
5 1200 50 16 6 400 .

.~ - Sutures possessing approximately these ,~
20 configu,rations are relatively inflexible, rough-surfaced and !~
`~ exhibit a relatively high level of chatter and drag.

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1 Comparison ExamPles 8~
The following braided suture configurations are -those of four commercially available sutures:

Number Overall of Denier of Denier Comparison Suture Suture Pick Sheath Individual of Example Denier Size Count Yarns Filaments Core 8 259 5/0 47 8 2.1 29 9 698 3~0 52 12 2.1 55 1566 0 50 16 2.1 252 11 2122 1 44 16 2.2 330 ' Micrographs obtained by scanning electron microscopy (SEM) of the suture of Comparison Example 10 (Figures 1 and 2: cross-sectional view at 200x and linear view at 50x, respectively) clearly show the structural ~
details of the suture. The suture braid is made up of j - relatively few sheath yarns and the circumferential ,~ ~ 20 indentations, plainly evident in Figure 1, cause the braid surface to be relatively rough.

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1 Exam~les 1-8 These examples illustrate various size braided sutures constructed in accordance with the present invention.
~. .~.;-Number . - -.-.--Overall of Denier of D~nier .
Suture Su'_ure Pick Sheath Individual of . ~.
Example Denier Size Count Yarns Filaments Core - ~:~' 1 96 7/o 828 1.2 --~
2 173 6/0 75'12 1.2 29 :~ .
3 240 5/O 658 1.2 48 : . -4 389 4/o 7512 1.2 101 5 600 3/O 6516 1.2 216 - .
61080 2/0 7224 1.2 504 71378 0 6528 1.2 706 82028 1 6532 1.21260 l; ~ .'.s Comparing the details of construction of the !~
~:~ 20 foregoing braided sutures with those of the known braided .
: sutures as set forth in Comparison Examples 1-11, it will be noted that for sutures of comparable overall denier, the .. ... :.--suture of this invention possesses a significantly greater .~ pick count and number of sheath yarns and a significantly !` .
.~ 25 finer denier for.the individual filaments ma~ing up a sheath yarn than the equivalent characteristics of the known suture. ....
,~ As a result of their unique construction .. ~
; characteristics, the sutures of this.invention exhibit :." ,,., . .. .:
. .3o perceptibly improved flexibility and hand and reduced chatter and drag compared with the known sutures of . .
.`:: Comparison Examples 1~

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1 Exam~les 9 - 12 The following braided sutures were fabricated in accordance with the present invention:

Number Overall of Denier of Denier suture Suture Pick Sheath Individual of Example Denier Size Count Yarns Filaments Core -. -.
9 240 5/0 688 1.240 0 10 600 3/0 71 16 1.2 180 1374 0 67 ' 281.2 702 2 2230 1 5732 1.2 ' 975 In contxast to the suture of Comparison Example 10, su~ra, SEM micrographs of the suture of Example 11 (Figures 3 and 4: cross-6ectional view at 200X and linear view at 50x, respectively) show a smooth circumferential , surface as the result of the increased number of sheath j .
:~ yarns and smaller diameter of individual filaments.
Figure 1 as compared to Figure 3 sh~ws the .
; relatively larger core present in the suture of Example 11 as compared to that of Comparison Example 10.
Comparison between Figures 2 and 4 shows the increased number of picks (crossovers/inch) of the suture of ~ :
: ;25 Example 11 as compared to that of Comparison Example 10. ,:
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Claims (39)

1. A braided suture of improved construction wherein for a given range of overall suture denier, the range of pick count, number of sheath yarns and denier of individual filaments comprising a sheath yarn are related to each other as follows:

2. The braided suture of Claim 1 wherein for a given overall suture denier, the range of pick count, number of sheath yarns and denier of individual filaments comprising a sheath yarn are related to each other as follows:

3. The braided suture of Claim 1 possessing a core.

4. The braided suture of Claim 2 possessing a core.

5. The braided suture of Claim 3 wherein the overall suture denier and core denier are related to each other as follows:

6. The braided suture of Claim 5 wherein the overall suture denier and core denier are related to each other as follows:

7. The braided suture of Claim 1 wherein the individual filaments are fabricated from a non-absorbable material.

8. The braided suture of Claim 1 wherein the non-absorbable material is cotton, silk, polyamide or polyolefin.

9. The braided suture of Claim 1 wherein the individual filaments are fabricated from a bio-absorbable polymer.

10. The braided suture of Claim 9 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

11. The braided suture of Claim 2 wherein the individual filaments are fabricated from a bio-absorbable polymer.

12. The braided suture of Claim 11 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

13. The braided suture of Claim 3 wherein the individual filaments are fabricated from a bio-absorbable polymer.

14. The braided suture of Claim 11 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

15. The braided suture of Claim 4 wherein the individual filaments are fabricated from a bio-absorbable polymer.

16. The braided suture of Claim 15 wherein the individual filaments are fabricated in whole or in part from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

17. The braided suture of Claim 5 wherein the individual filaments are fabricated from a bio-absorbable polymer.

18. The braided suture of Claim 17 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

19. The braided suture of Claim 6 wherein the individual filaments are fabricated from a bio-absorbable polymer.

20. The braided suture of Claim 19 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

21. The braided suture of Claim 1 surface coated with a composition enhancing one or more functional properties of the suture.

22. The braided suture of Claim 1 containing at least one medico-surgically useful substance.

23. The braided suture of Claim 3 wherein the core is braided.

24. The braided suture of Claim 4 wherein the core is braided.

25. A braided suture according to claim 23 or 24, comprising a braided sheath and a braided core.

26. The braided suture of Claim 25 wherein individual filaments are fabricated from a non-absorbable material.

27. The braided suture of Claim 26 wherein the non-absorbable material is cotton, silk, polyamide or polyolefin.

28. The braided suture of Claim 25 wherein individual filaments are fabricated from a bio-absorbable polymer.

29. The braided suture of Claim 28 wherein the individual filaments are fabricated from a polymer derived at least in part from one or more monomers selected from the group consisting of glycolic acid, glycolide, lactic acid and lactide.

30. The braided suture of Claim 25 surface coated with a composition enhancing one or more functional properties of the suture.

31. The braided suture of Claim 25 containing at least one medico-surgically useful substance.

32. The braided suture of Claim 25 exhibiting at least one of improved flexibility, improved hand, reduced chatter and reduced drag compared with braided sutures of known construction.

33. The braided suture of Claim 25 possessing a significantly greater number of sheath yarns for a given overall denier than braided sutures of known construction.

34. The braided suture of Claim 25 being fabricated from individual filaments of finer denier than filaments which are typical of known types of braided sutures.

35. The braided suture of Claim 25 possessing a greater pick count than braided sutures of known construction.

36. The braided suture of Claim 25 exhibiting far fewer surface discontinuities and thereby being considerably smoother than braided sutures of known construction.

37. The braided suture of Claim 25 wherein the core constitutes a larger proportion of overall suture denier than a core of a known braided suture.

38, The braided suture of Claim 25 wherein the overall suture denier and core denier are related to each other as follows:

39. The braided suture of Claim 38 wherein the overall suture denier and core denier are related to each other as follows: