CA1065226A - Swivelled wire sutures - Google Patents

Swivelled wire sutures

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Publication number
CA1065226A
CA1065226A CA260,711A CA260711A CA1065226A CA 1065226 A CA1065226 A CA 1065226A CA 260711 A CA260711 A CA 260711A CA 1065226 A CA1065226 A CA 1065226A
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CA
Canada
Prior art keywords
suture
needle
surgical
combination
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA260,711A
Other languages
French (fr)
Inventor
John R. Hoffman
Peter J. Marsland
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth Holdings LLC
Original Assignee
American Cyanamid Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by American Cyanamid Co filed Critical American Cyanamid Co
Application granted granted Critical
Publication of CA1065226A publication Critical patent/CA1065226A/en
Expired legal-status Critical Current

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  • Materials For Medical Uses (AREA)

Abstract

TITLE: SWIVELLED WIRE SUTURES

INVENTORS: JOHN RONALD HOFFMAN PETER JOHN MARSLAND
4 Polaris Drive 48 Chalk Hill Road New Milford, Fairfield Monroe, Fairfield County, Connecticut County, Connecticut ABSTRACT OF THE INVENTION
The breakage of monofilament stainless steel sut-ures and other monofilament sutures at the point of attach-ment to eyeless needles is markedly reduced by forming an enlargement on the end of the suture, and crimping the en-largement into the suture holding bore of a drilled-end needle in swivel relationship whereby the suture can both rotate and change alignment with respect to the needle.

Description

~OIj~Z26 BACKGROUND OF THE INVENTION
;i 5ingle use, eyeless, or drilled end needles, are meeting with increasing acceptance for surgical suture usages.
These are needle~ in which a concentric axial hole is formed in the base or back end of the needle into which the end of a suture is placed and crimped.
One of the problems in using a drilled end needle on a suture is that during use of the suture may be bent and twisted sharply at the point of attachment to the needle where the suture comes out of the hole in the end of the need-le, which may cause the suture to break. Bending particular-ly ha~ been recognized, and various expedients for solving the problem have been devised but new and improved systems are in demand.
DESCRIPTION OF THE PRIOR ART
_ U. S. Patent 1,558,037, Morton, SURGICAL NEEDLE AND
SUTURE ASSEMBLY AND METHOD OF MAKING THE SAME, October 20, 1925, shows a drilled end needle crimped on a suture.
U. S. Patent 1,981,651, Logan, SURGICAL NEEDLE AND
SUTURE, November 20, 1934, shows an internally threaded tube which is contracted at the back end and screwed onto the end of a surgical needle, so that the tube can be threaded over the end of a suture, which is then knotted, drawn into the tube, and the tube screwed onto the surgical needle. Both swollen ends and sleeves are disclosed to retain the suture in the contracted end of the threaded tube.
U. S. Patent 3,038,475, Orcutt, SURGICAL NEEDLES
AND MU~NUFACTURE OF SAME, June 12, 1962, shows curved and straight drilled end needles with hollow ground points.
U.S. Patent 3,125,095, Kaufman et al., FLEXIBLE

. .

.. ~

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~Otj~Z~;
STAINLESS STEEL SUTURES, March 17, 1964, shows a polyfilamentary stainless steel suture, crimped in a drilled end needle.
U. S. Patent 3,311,110, Singerman et al, FLEXIBLE COMPOSITE SUTURE
HAVING A TANDEM LINKAGE, March 28, 1967, shows a flexible monofilament leader ~ -between an eyeless surgical needle and a monofilament stainless steel suture.
Column 3 of this patent describes tests of flexibility at the needle-suture junction.
U.S. Patent 3,910,282, Messer and Singerman, NEEDLING MONOFILAMENT
SUTURES, October 7, 1975, shows a counterbore system to reduce flex and fatigue failure at the point of attachment of a suture to its needle.
British Patent 1,424,953, A. S. Taylor and M. H. Weinert, LASER
MANUFACTURE OF SUTURE NEEDLES, granted June 16, 1976, shows using a laser -beam to drill a hole in the end of a need'e blank, which hole is tapered by the nature of the laser drilling. The hole is then swaged to size and cylindrical shape.
It has now been found that breakage of surgical sutures at their juncture with a drilled end surgical needle is caused not only by the sharp flexing where the suture emerges from the drilled end of the needle but by torsional forces introduced by twisting of the needle with respect to the suture at the junction. During emplacement of a suture by a surgeon, frequently there is a certain degree of twisting of the needle with respect to the suture which tends to cause a torsional loading of the suture at its point of attachment to the needle. This is in addition to any stresses and strains that may be introduced by bending the suture with respect to the needle. Without getting into a complete mathematical analysis of the combination of such strains and stresses, it is obvious to students of stress analysis that markedly higher strain and stresses will be introduced into the suture at its attachment to the needle.
It has now been found that by forming a swivel at the junction, so that the suture may rotate with respect to the needle, stresses at the point of attachment are markedly reduced and failures are minimized. The improved results are particularly noticeable with monofilament sutures, and particular-
-2-.

- : ' ~ - . . . . :: . : : - -~0~52Z6 ly, those having a high Young's Modulus. A rigorous mathematical analysis would be illusory because it could not be founded upon perhaps rash assump-tions as to rotational and bending motions of the needle in a surgical procedure.
By attaching the needle to the suture so that the suture can swivel in the needle, improved results are obtained by the surgeon in that accident-al detachment of the needle from the suture is markedly reduced and addition-ally in flex tests in which torsion is a factor, improved test results can be obtained in the laboratory. The surgical needles used may be straight or curved, including 3/8 or 1/2 circle needles, and the needles may be tapered pointed, or three cornered cutting edge needles, or reverse cutting edge needles, or duck billed or side cutting needles, any of which may have flats on them for the needle holders, or other conventional shapes of surgical needles. Torsion is more apt to be a problem with curbed needles as the plane of curvature must be oriented with respect to the subject during use.
A swivel attachment is particularly useful with monofilament steel sutures as such sutures are quite torsionally stiff. The swivel end may be used with multi-filament sutures either braided or twisted. The advantages of this swivel attachment are greater with metallic sutures which have a higher torsional stiffness.
Thus, according to a first broad aspect of the present invention, there is provided an eyeless surgical needle in combination with a surgical suture comprising: a surgical suture having a suture retaining enlargement ;~ adjacent the end thereof, and a one-piece pointed, eyeless surgical needle having a cylindrical bore at the back end of the needle, with the suture retaining enlargement in said cylindrical bore, and the back end of the needle crimped smaller into retaining relationship with said enlargement, whereby the suture can swivel with relationship to the needle, but is re--~ tained in said cylindrical bore.
According to another broad aspect of the present im~ention, there is provided a method of forming an eyeless surgical suture needle - surgical suture combination comprising: flattening the end of a monofilament stainless :, - ~

~065Z'~;
steel suture to enlarge one diameter thereof, forming a bore hole in the back end of a one piece eyeless surgical needle which hole is slightly larger in diameter than the said enlarged diameter, inserting the end of the suture having the said enlarged diameter into said bore hole, and crimping the back end of the needle behind said enlarged diameter so that the crimped bore hole is smaller than said enlarged diameter, but larger than the suture dia-meter, whereby the suture and needle may swivel with respect to each other, but the suture is reatined in the said needle.
Other advantages and objects of the present invention are apparent from the following detailed description and drawings.
DRAWINGS
FIGURE 1 shows a curved surgical needle to which is attached a steel suture.
FIGURE 2 is an enlarged view in partial cross-section showing a flattened end of a wire suture ready to be assembled to a drilled-end surgical needle.
FIGURE 3 shows an axial or end view of a wire suture with a flattened end.
FIGURE 4 shows the flattened wire end inserted in the drilled-end needle, and crimped around the suture.
FIGURE 5 shows a spherical ball on the end of the suture.
; FIGURE 6 shows an axial v ew looking at the ball on the end of the suture.
As shown in FIGURE 1 a stainless steel monofilament surgical suture 11 is attached to an eyeless suture needle 12. The sizes of sutures in most countries conform to a Governmental or Industrial standard. In the United States, sizes conform to the United States Pharmacopeia standards. Because each of the several sizes has a maximum diameter and because the greater diameter of the suture the stronger, it is customary to merchandise sutures which are just under the maximum diameter and hence have the greatest strength for each : - -: .
.

-~~ r ~ ;S~Z6 standard size, The drawings and further description are de-signed to illustrate the relationship between the suture and the needles in the standard sizes. In the table gi~en below the configurations of sizes, flattened ends and needle bore diameters are shown. In areas where different suture stand-ards pertain, a minor modification in wire diameter may be used with analogous modifications in the other dimensions to fit the standards of a particular country.
The sutures may be either single or double armed --that is have a needle on one or both ends. As shown, a need-le is attached to only one end, as a needle attached to the other would be strictly comparable, and is well known to those skilled in the art.
As shown in FIGURE 2 the suture 11 has at its end a suture retaining enlargement 13. This is conveniently formed by cold forming the end of a metal suture. Conveniently, a long piece of wire can be both cut and have the end flattened at a single operation. The cold forming of the end is con-veniently to a thickness of from one-third to two-thirds of its original diameter so that in cold forming the wire expands ; its lateral diameter, so that it nearly fills the needle bore diameter at the back end of the drilled end needle.
Conveniently, the cold forming end appears as a flat disc, but its exact shape is not critical.
The eyeless suture needle 12 has formed in its rear end a cylindrical bore 14. Conveniently this hole is formed by using a small drill. It may be formed by a laser beam, chemical or electrical etching, or by a separate sleeve which is formed at the end of the solid portion of the needle.
Whatever the method of forming, the needle is one piece with : _ 5 _ .

I

~65ZZ6 , an ~xial hole at the rear end, foxming the cylindrical bore 14.
The length of the cylindrical bore should be at least three to five times its diameter, which permits inser-tion of the suture retaining enlargement on the end of the suture wire in the cylindrical bore, and then compressing to form the crimp 15 on the back end of the needle, The inside diameter of the crimp is smaller than the suture retaining enlar~ement, and is larger than the suture diameter so that the suture may swivel with the respect to the needle with low friction. Preferably the crimp has a slight flare 16 at the -~ point where the suture emerges from the bore as this permits additional bending and avoids having a sharp edge against which the suture may be drawn.
FIGURE 5 shows a slightly different modification in that the suture 17 has formed on the end thereof a retaining ball 18. This retaining ball may be formed by swedging the suture wire, as for example the end of the suture may be com-pressed back on itself in a suitable die so as to be enlarged to form a ball. The ball may be formed by a small drop of silver solder on the end of the suture. The appearance is essentially the same, as is shown in Figures 5 and 6.
A ball slides some what more freely in the crimped end of the cylindrical bore but is more costly to form and normally a flattened end is satisfactory and less expensive.
The easiest way of forming the suture retaining ; enlargement 13 is to use a cutting die with a shoulder so that after the cutting of the suture, the shoulder compresses the end of the suture against the top of a cutting die, and by having a stop to control the degree of the compression, the end of the suture can be cold formed to a desired thickness.
.

10~5Z~6 PXopoxtions which have been found to give good re-sults are shown in the following table, which shows suture size, wire diameter for that suture size, the cold formed flattened thickness of the suture retaining enlargement, and 5 the needle bore diameter.
Flat Suture Suture Dimension Needle bore - Size Wire Dia. Thickness Diameter _ _ _ 5/0 .0047-.0055" .0015" .0102-.0110"
4/0 .0073-.0085" .0030" .0152-.0162"
3/0 .0090-.0105' .0040" .0182-.0192"
2/0 .0115-.0134" .0055" .0212-.0222"
0 .0154-.0165" .0070" .0235-.0245"
.0180-.0194" .0090" .0284-.0299"
2 .0200-.0225" .0120" .0302-.0317"

- 3 .0230-.0254" .0140" .0360-.0375"
4 .0260-.0285" .0165" .0425-.0440"
The same bore diameter may be used for different size needles so that different sizes of needles may be used with any particular suture. The degree of crimp is control-led so that with uniform suture retaining enlargements, the 20 crimp is tight enough to hold the suture retaining enlarge-ment on the end of the suture and yet permit rotation of the suture and needle with respect to each other. If desired, the crimp may be accurately controlled, so as to give a controlled degree of pull-off, that is a needle may be crimped so that 25 it pulls free from the suture with less than the breaking stress on the suture.
In surgical use after emplacing the suture it is necessary usually to tie a knot in the suture. In the tieing of the suture, the surgeon frequently desires to have the need-30 le removed from the end of the suture. This may be done by ~ ` ~

cutting the suture or if the pull-off strength is controlled, the suture is held into the needle tightly enough so that it permits emplacement of the suture and yet by increasing the pull on the needle, the needle pulls free from the suture.
Such controlléd pull-off requires close control of the suture retaining enlargement with respect to the crimp on the end of the needle so that the pull-off is within a desired range.
Preferably the crimp is essentially uniform all around the needle so that there is no off-center relationship which would tend to lock the suture enlargement in place.
With a uniform crimp, the needle twist with respect to the sutures permits minimizing torsional loads on the suture and thus gives a marked reduction in the likelihood of the suture breaking at its point of attachment to the needle during a surgical procedure.
The advantages of a swivelled end needle are not particularly apparent on an ordinary flex test in which the needle is flexed 90, that is a total of 45 on each side of the center, as a weight pulls the suture downward from the suspended needle. In surgical usages where both flexure and torsion occur, the number of failures during usage is remark-ably reduced. If a test be used in which the needle is both twisted and flexed at the same time, the advantages of the swivel connection appear outstanding. Its particular advan-tage is that as the surgeon twists the needle with respect tothe suture before pulling it through the tissue and frequent-ly before any axial load is applied to the suture, a suture can twist so tha* the applied load is purely axial, and there is no additional torsion introduced into the suture during its use.

Claims (7)

Having illustrated and described our novel suture as set forth above, as our invention we claim:
1. An eyeless surgical needle in combination with a surgical suture comprising: A surgical suture having a suture retaining enlargement adjacent the end thereof, and a one-piece pointed, eyeless surgical needle having a cylin-drical bore at the back end of the needle, with the suture retaining enlargement in said cylindrical bore, and the back end of the needle crimped smaller into retaining relationship with said enlargement, whereby the suture can swivel with relationship to the needle, but is retained in said cylindri-cal bore.
2. The suture-needle combination of Claim 1 in which the suture is a stainless steel monofilament wire and the suture retaining enlargement is a flattened portion of the wire.
3. The suture-needle combination of Claim 2 in which suture size, flat thickness, and needle bore hole dia-meter are about those shown in the table:

4. The suture-needle combination of Claim 1 in which the suture retaining enlargement is a ball at the end of the suture.
5. The suture-needle combination of Claim 4 in which the ball is silver solder on the end of a polyfila-mentary stainless steel suture.
6. The suture-needle combination of Claim 1 in which the crimp is of such tightness that the suture is held during suture emplacement, but pulls loose from the needle at a release tension below the tensile strength of the suture, whereby the surgeon may pull the needle off the suture after emplacement.
7. A method of forming an eyeless surgical suture needle--surgical suture combination comprising: Flattening the end of a monofilament stainless steel suture to enlarge one diameter thereof, forming a bore hole in the back end of a one piece eyeless surgical needle which hole is slightly larger in diameter than the said enlarged diameter, insert-ing the end of the suture having the said enlarged diameter into said bore hole, and crimping the back end of the needle behind said enlarged diameter so that the crimped bore hole is smaller than said enlarged diameter, but larger than the suture diameter, whereby the suture and needle may swivel with respect to each other, but the suture is retained in the said needle.
CA260,711A 1975-09-12 1976-09-08 Swivelled wire sutures Expired CA1065226A (en)

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Application Number Priority Date Filing Date Title
US61287675A 1975-09-12 1975-09-12

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CA1065226A true CA1065226A (en) 1979-10-30

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108903991A (en) * 2018-08-14 2018-11-30 广州科荟泽生物科技有限公司 Operation stitching device and its manufacturing method

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108903991A (en) * 2018-08-14 2018-11-30 广州科荟泽生物科技有限公司 Operation stitching device and its manufacturing method

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