AU511397B2 - Control release suture - Google Patents

Description

FORM 1 Regulation 9

AUSTRALIA APPLICATION FOR A PANT

We, ETHICON INC, of Soerville, New Jersey, United States of

America, hereby apply for the grant of a patent for an invention

entitled: _which "CONTROL RELEASE SUTU", is described in the

accompanying complete specification.

This application is a separate application made by virtue of S. *o S S. e sub-section of Section 49A of the Patent Act 1952-1969 0S 0 0@ 0 in respect of an invention disclosed in the complete specific- *00

*000

0 0 0 ation in respect of application no. 73824/74. 00 0@ 0

t, Our address for service is Messrs. Griffith, Hassel and Frazer,

323 Castlereagh Street, Sydney, New South Wales, Australia.

0 DATED this llth day of October, 1977. OS

00 0°Oo*

SiBy their Patent Attorney

GRIFFITH, HASSEL FRAZER

TO: The Commissioner of Patents Commonwealth of Australia ~E~r1

v I:li; I, i--

COMMONWEALTHI OF AUSTRALIA Patents Act 1952-1962 29 76P INSTRUCTIONS DEiCLARATION IN SUPPORT OF A CONVENTION OR NON-CONVFNTION APPLICATION FOR A PATENT OR PATENT OF ADDITION Insert No. If available In support of the application No. Insert full name(s) madoi by (b)..!MTQN.Tq of applicant(s).

Insert title of invention

WaneR.Eeha Insert full name(s) 1, of declarant(s) who moust be PItStIN 1 S )N S, N OT o r 11'1: aLcorlpora te bodly. (Seec ad note). Insert address(es) SonervilleNwJre USA of declarant(s).

do solemnly and sincerely declare as follows Delete entirely if applicant is corporate body. lee.. eoitixely If 1. I am aiuthorised by the abovementioned applicant for the patent/ptent a lpliarAt is addition to make this declaration on its behalf. lperso.1bftopersons. The basc appliCaLion(s) as defined by Section 141 of the Act was/were made in thle

following untry or countries on the following date(s) by the following applicant(s)

namely

(ih) Delete'Ai*kely If Convention priority

lnsertpo~ntry in which first basic apiplication Va, flied. in i) on r- 19 Insertdate elf first basic ap plication Insert full namie(s) of basic applicant(s) Delete entirely If aplkliant(s) NOT invelitor(s) 3. (in) Walter.McGregtar 1

Insert full name(s) of atu.1 n 9~ e s N w e r e o

Inven toc(s) tnsert addrets(es) of ae-tR10 ir"ven ror(s) IT plpolicaiitCS),NOT

is/am the actual inventor(s) of the invention and the facts upon which the applicant(s)

is/k~ entitled to make the application are as follows

-as regards entitlement under Section 34 of the Act Recite manner in The said Applicant is the.Assignee of the said deriv tit e from acta Inventor(s) if ppplicant(s) NOT .jv.Qn-pA f rrq. tbp qs4i. Anvnor inventor(s) 1 iTj-kards entitlTeent undier Fat XVI of the Act Delete entirely if Convention priority NOT claimed. (p) (qI) Recite manner in 4. The basic application(s) referred to in paraiFTj51r'T--9Ltbs Declaration was/were whiichi applicant(s) derive(s) title from the first application(s) made in a Convention country in respecofL1 vetote basic applicant(s) if subject of the application. aplilcant(s) NOT basic applicat-W. In ae~ Newb o erey, u..iA, sii 24 th aCy ot Oct. luJ 77 Slgneture(s) of deciarant(s). (N.B.-No ;eal or stamp impression to be apilied).

To: TheCommiss ;ioncr of Patents,

Commonv tcaith of Australia.

RIFFITH, HASSEL FRAZER Box 2133 SYDNEY 2001 AUJSTRALIA

(11) AU-B ]-29.676/77

(12) PATENT SPECIFICATION ABRIDGEMENT (19) AU

(21) 29,676/77 511,397 (22) 13.10.77 (23) 13.10.77 (24) 26.10.73 (43) 19.1.78 (44) 14.8.80 2 (51) A61B 17/06 (54) Control release suture (62) 73,824/74 (71) Ethicon Inc., (72) McGregor, W. (74) GH (56) 73,824/74 487,416 87.4 57,847/73 87.4 40.7 55,864/73 473,919 87.4 (57) Claim 1. A package cortaining a multiplicity of needle-suture combinations Lhat are characterized by having an average straight suture pullout value of between 9 ounces and 15 ounces; each of said needle-suture combinations within said package comprising a needle having an opening of uniform diameter in the blunt end, and a suture having a uniform diameter greater than 7 mils, one end of which is received within said recess and swaged whereby said end is compressed and restrained withissaix' needle recess, said needle-suture combinations being chrract-rized by having individ l straight sutpre pullout values of between 3 ounces and 26 ounces.

D4 30-1

CO'MMONWEA*LTH OF AUSTEA

PATENTS ACT 1952 -6939 rm

COMPLETE SPECIFICATION (OR IGINAL)

FOR OFFICE USE: Class Int. Class Application Number Lodged

Complete Specification Lodged Accepted Published

I actdz~a 49. d~

-RIated Art fr

TO BE COMPLETED BY APPLICANT N'ame of Applicant ETHICON.INC.

VOIAdress of Applicant: Somerville, New Jersey, USA

4ttuaI Inventor: Walter McGregor

Griffith, Hassel Frazer Address for Service: 323 Castlereagh St., SYDNEY N.S.W. 2000 AUSTRALIA

Complete Specificatlon for the invention entitled:

*CONTP3)L RELEASE SUTURE"

'The following statement is a full description of this invention, with the best method of performing it known to rooa~:-

The present invention relates to a package containing

a multiplicity of needle-suture combinations. This application

is divided out of application no. 73824/74.

According to the present invention there is provided

a package containing a multiplicity of needle-suture

combinations that are characterized by having an average suture

pullout value of between 9 ounces and 15 ounces; each of said

needle-suture combinations within said package comprising a S..

*r 0 needle having an opening of uniform diameter in the blunt end,

and a suture having a uniform diameter greater than 7 mils, 00 p.. one end of which is received within said recess and swaged

whereby said end is compressed and restrained within said

needle recess, said needle-suture combinations being 6 characterized by having individual suture pullout values

of between 3 ounces and 26 ounces. S. In many surgical procedures, surgeons use a

@055 technique which employs a non-needled suture and an eyed 6

needle. The needle is threaded by the nurse and the surgeon 2D' takes one pass through the tissue using a needleholder. He 0 slips the needle off the suture, returns the needle to the

la nurse, and is ready for another threaded needle from the nurse. An assistant follows behind and ties the suture.

Surgeons find that this technique is more simple

than using a needled item and cutting the suture with a

scissors after each pass. However, the time required for

threading results in a significant waste of expensive

operating room time.

The security of attachment of eyeless needles to 6 o

.oo absorbable surgical sutures or to nonabsorbable surgical "0 sutures is prescribed in the U.S. Pharmacopoeia, Vol. XVIII

6 o at Page 944 (also see U.S. Pharmacopoeia, Vol. XVII, Page 919).

It has been the practice of suture manufacturers in the S.

United States and abroad to securely attach the suture to S S S the needle by swaging or with an adhesive so that the mini-

15 mum pull-out standard recited in the U.S. Pharmacopoeia is So

met or exceeded. The conversion of the U.S. Pharmacopoeia 0e

minimum standard on needle attachment from kilograms to

S ounces is summarized in the following table.

MINIMUM LIMITS ON NEEDLE ATTACHMENT

AVERAGE INDIVIDUAL SIZE Kg. Oz. Kg. Oz.

8/o o.o68 2.39 0.036 1.26 0.091 3.20 0.045 1.58 6/o o.168 5.92 oo82 2.89 0 0.226 7.97 0.113 3.93 /0 0.453 15.97 0.226 7.97 2/0 o.679 .1 2J.63o.4112 .8 53 15.96 1.5 52 8?6 0.453 15.6 1 1.8 63.45 0 590 20.51 2 larger 63.48 0.680 23.98

It will be noted from the above table that separa-

tion of the suture from the needle is relatively easy if the suture is size 5/0 or smaller since the average force required is less than 8 ounces. On the other hand, the minimal average force required to spearate a size 4/0 sutute (diameter 7.0 mils.

to 9.5 mils.) from the needle is at least about 16 ounces

and because needles are swaged to make quite certain that the

minimum U.S. Pharmacopoeia standards are met, many individual

samples require forces in excess of 2 pounds to detach the

needle from the syte.

There is a need for a needle-suture combination that ia: has the convenience of the needle being preattached to the

suture and yet permits separation of the needle from the

suture without the necessity of cutting with a scissors.

One approach to this problem is described in Australian

Patent No. 477651. This approach involves manufacturing the

needle with an open channel at the blunt end thereof sized

to receive a suture. The suture is bonded to the channel with an adhesive that prevents "pull-out" of the suture as

it passes through tissue. After suturing, the surgeon may

easily remove the needle from the suture by turning the

needle so that the channel is at an angle of about 900 to the direction of the suture and peeling the suture out of the

channel.

This approach has one disadvantage in that many surgeons

prefer a drilled needle over a channel needle because of the

uniform cross-section at the end of the needle and the smooth

transition between the needle and the attached suture.

Packages containing needle-suture combinations

manufactured in accordance with the present invention are

29 characterized by rn average suture pull-out value substantially lower than the minimum average force specified in the U.S. Pharmacopoeia. Moreover, as will be described hereinalter, changes have been made in the manufacturing processes whereby the variation of the pull-out value from the mean is reduced. It is an advantage of the product of the present invention, therefore, that the surgeon may readily remove the needle from the suture by exerting a force of 3 to 26 ounces and thereby save the time previously required to cut S the suture. The present invention is directed to packages containing 5 e S needle-suture combinations wherein the suture is of large size, S size 4/0 and larger (diameter greater than 7.0 mils.). The average pull-out value of the needle-suture combinations *5* is less than that required by the U.S. Pharmacopoeia and the

S needle may be removed from the suture by a straight pull of S 3 to 26 ounces. In acoordance with the present invention, a needle- S

suture combination characterized by suture "pull-out" value between 3 ounces and 26 ounces and having a perfectly uniform cross-section is manufactured by sizing one end of a braided suture with a resin; inserting the sized end of the suture into a drilled needle or preclosed channel needle and swaging the needle to predetermined dimensions. By proper control

of the diameter of that end of the suture which is placed in the needle, the diameter of the needle hole and the swaging process, the needle-suture combination produced will have a suture pull-out value between 3 ounces and 26 ounces. It has

been noted that if the bond between the needle and its attached suture is sufficient to with- stand a pull of 3 ounces, the suture will not separate from the needle as a surgeon passes the needle through tissue. Yet, the needle can easily be removed from the suture at ar. time by simply pulling on the needle with a force of about 26 ounces. It is an object of the present invention, there- fore, to make available to the surgeon a needle-suture combination useful in suturing, and characterized by a 0* needle-suture attachment that will permit facile removal

10 of the needle from the suture without cutting the suture with a scissors.

Another object of this invention is to provide

the surgeon with a needle-suture combination that will reduce the time that the surgical patient must spend in the operating room. :0 Yet another object of the invention is to provide the surgeon with a needle-suture combination that will

permit separation of the needle from the suture after

suturing by a slight pull upon the needle. 20 To achieve a controlled pull-out value of a needle- o

suture combination that is no less than about 3 ounces nor more than about 26 ounces, it is important that the physical dimensions of the needle, the hole in the end of the needle, and the diameter of the suture be uniform. The manufacture of surgical needles to precise dimensions has been done for many years, and it is -11 within the skill of the art to control the diameter of the needle and the size of the drilled hole to 0.0005 inches. The suture that must be attached to the needle, however, presents a more difficult problem. In the case of a synthetic mohofilament suture, for example, the diameter may vary with the spinning, drawing, or annealing conditions. Braided sutures and covered sutures present a more difficult problem as the construction of the braid and adjustment of the braider compound any variability that may be present in the yarn.

Moreover, the end of a braided or covered suture has a

characteristic not found in monofilament sutures in that it

will "broom" or open upon cutting. Since it is this cut end

of a braided suture that is inserted into the drilled needle

9 hole, it is necessary to hold the diameter of the suture .9. S @9 10 end to within tolerances similar to that for the drilled 0

9 9eS@ needle hole to assure a "pull-out" force within a narrowly-

defined range. In accordance with the present invention, the

diameter of a braided suture may be carefully controlled by

winding the braided strand on a rack under tension and

immersing that section of the suture strand which is to be 9 S. cut for insertion into the needle in an adhesive or bonding

resin while maintaining the strand under tension. The rack

is then removed from the resin solution and air dried. The S

dried adhesive composition which coats and impregnates the

braided suture stabilizes the diameter to that achieved *r 9 under tension. The binding resin or adhesive prevents

"brooming" when the suture is cut and the diameter of the

suture does not change even after the tension is relaxed.

The suture utilized in the present invention may

be absorbable, ie., catgut, extruded collagen, a braided

polyhydroxyacetic ester, a synthetic copolymer of

lactide and glycolide; or nonabsorbable, braided silk,

nylon, polypropylene, cotton, linen, or polyester.

The adhesive that is used to coat the suture while'

it is retained under tension may be any non-toxic adhesive composition, either organic, inorganic or a hybrid. Suitable organic materials are such natural products as starch, dex- trin, asphalt, animal and vegetable proteins, natural rubber, shellac; semi-synthetic products such as cellulose nitrate and the other cellulosics, polyamides derived from dimer acids, castor-oil based polyurethanes; such well-known synthetic resins as vinyl-type addition polymers, both resins and elastomers: polyvinyl acetate, polyvinyl alcohol, acrylics, unsaturated polyesters, butadiene/acrylonitrile, butadiene/ styrene, neoprene, butyl rubber, polyisobutylene; and polymers formed by condensation and other step-wise mechanisms, i.e., epoxies, polyurethanes, polysulfide rubbers, and the reaction products of formaldehyde with phenol, resorcinol, urea, and melamine. Particularly preferred as bonding compositions are the epoxide resins and polyester resins.

The invention will become more readily apparent upon

consideration of the following detailed description when

taken in connection witl. the accompanying drawings wherein:

Figure 1 is a perspective view of the needle-suture

combination. The length of the resin-coated end of the 6

suture has been exaggerated for clarity;

Figure 2 is an enlarged view illustrating separation of

the needle from the suture;

Figure 3 is a front elevation of apparatus useful in

winding sutures under tension;

Figure 4 is a perspective view of a braided suture

28 strand wound on a reel under tension;

Figure 5 is a front elevation; partly.in section.

which illustrates coating the braided ,suture strand while

under tension on the reel with a resin.solution;-

Figure 6 illustrates the reel with 'the tensioned

suture strand in place after 'the.'sizing step;

.'Figure 7 is a perspective view showing elements

of an apparatus useful in swaging the needle-suture combina-

tion:

Figure 8 is an enlarged fragmentary view of the

anvil of the swaging apparatus illustrated in Fig. 7 with a a drilled needle in place;

Figure.9 is a fragmentary end view of the anvil

shown in Fig. 8;

.Figure 10 is an enlarged sectional view of the

elements illustrated in Fig. 7 as seen from the left, with o

a needle and suture in position for swaging. The length

of the resin-coated end of the suture is exaggerated for

clarity; S• Figure 11 is a vertical sectional view along Line

20 11-11 of Fig. 10 showing the swaging apparatus in its closed

position;

Figure 12 is a vertical sectional view along

Line 12-12 of Fig. 11;

Figure 13 is an enlarged fragmentary..plan view of

the needle-suture combination, the maximum .dimension of the

needle being exaggerated to better show the effect of

swaging;:,and

Figure 14 is a fragmentary perspective view of the

needle-suture combination of Fig. 13.

The apparatus illustrated in Fig. 3 is designed

to wind a strand of suture material, such as braided silk,

on to an open rack under tension. It includes in part, a

spindle 10 that supports a spool 11 of braided silk 12.

The silk strand from the spool passes over a guide 14 and

through a mechanical friction brake 15. The tension applied

to the moving strand by the brake 15 may be adjusted by

sliding a movable weight 16 along its supporting rod 17. o.. 0 S.. From the mechanical brake 15, small size strands S S. 0 10 (size 3/0 and smaller) pass directly to the tensiometer 060 0

*r S as indicated by the dotted line in Fig. 1. Sutures that are 0@

.larger in diameter than size 3/0 (size 2/0 and larger) pass S from the mechanical brake 15 around the rollers of a magnet-

ic brake 18 which may be adjusted to increase or decrease the 00

tension applied to the moving strand by means of a rheostat @0 *0 000 20. The tension applied to the moving strand is monitored

by a tensiometer 22. 0 The tensioned strand is taken up on a rack 24

which is rotated about its vertical axis 26 by a motor (not S OOOO 20 shown). The rack as it rotates, is mechanically linked with

a screw 28 mounted for rotation in a lower bearing 30 and

upper bearing 31. This screw engages the threads of a nut

32 that is integral with a bracket 34. The pitch of the

screw and its angular velocity are such as to move the

bracket and associated idler pullies 35 and 36 upwardly in

the direction of the arrow, thereby winding the tensioned

strand evenly upon the rack.

To complete the description of the tensioning

apparatus, a cam-actuated dancer roll 38 moves vertically

up and down between idler rollers 39 and 40 as indicated by the arrows. The dancer roll compensates for any change in the tension that would otherwise occur by reason of varia- tion in the linear acceleration of the suture material as the rack rotates a constant angular velocity.

After the braided strand has been wound evenly

on the rack, the end is tied to retain the tension and

the rack with the braided strand in place is removed from

the tensioning apparatus and an adhesive or binder resin is applied (Figs. 4, 5, and The rack 24 is immersed to a

10 depth of about 1.5 inches in a container 42 of resin solu-

tion 43 for approximately 5 minutes as shown in Fig. 5 to

assure penetration of the binding resin into the interstices

of the braid. The rack is then removed from the container and air dried at room temperature. The extent of the resin

coating thus applied to the braided strand is indicated by a

the dotted Line Z-Z in Fig. 6.

The resin-coated sutures are then removed from

the rack by cutting along the Lines X-X and A-A of Fig. 6. The sutures so obtained have a length slightly less than the

20 width of the rack and are tipped at one end for a distance a

of about 0.75 inches. As best shown in Fig. 10, the resin- coated end 44 of the suture 12 is smaller in diameter than

the remainder of the suture.

If it is desired to manufacture a double-armed

suture, a suture having a needle attached to both ends,

the width of the rack 24 is adjusted appropriately and the

sutures are removed from the rack by making a single cut

along the Line X-X.

The swaging of the resin-coated end 44 of a suture

into a drilled needle .ill be described with reference to

ADDITIONAL EXAMPLES

Figs. 7 through 14. Swaging is accomplished by placing a

needle 46 having a drilled hole 47 at the blunt end thereof

on an anvil 48 and striking the drilled end of the needle

with a hammer 50 to compress the drilled hole.

In practice, the resin-coated end 44 of the suture

is inserted into the drilled hole 47 of the needle as best

shown in Fig. 10; the drilled end of the needle is positioned

in a depression 49 on the surface of the anvil; and the

1 assembly is swaged by moving the anvil and hammer together

in the direction of the arrows as shown in Fig. 11. Stops

51 and 52 on the hammer and anvil respectively limit the 0 motion of the hammer and anvil thereby controlling the

clearance Y and the deformation of the needle during the

swaging step. The following examples will serve to illus-

trate the invention. *C* Seo *0

EXAMPLE I A size 4/0 black braided silk strand characterized

by a diameter (determined optically) of 7.8 mils, is wound

S* on a rack 19-1/4 inches in width under a tension of 0.6 pounds, using the apparatus illustrated in Fig. 3. One end 'of the rack is immersed in a container of Xylae as illustrated in

Fig. 5 to remove from the braid any wax that may be present.

The rack is removed from the container and the Xylol is

permitted to evaporate from the braided silk at room tempera-

ture.

254 That end of the rack that has been washed with

Xylol is then immersed in a container of a resin solution

containing 18 per cent by weight of a linear saturated

polyester polymer having a molecular weight in the range of -11-

It is apparent from the above data that suture pullout

20,000-30,000 and characterized by a ring and ball softening

point of 158 0 C. (VITELIPP-222 manufactured by :o-dyear

Chemical Division of the Goodyear Tire Rubber Company,

P.O. Box 2008, New Brunswick, New Jersey 08903). The rack

is immersed to a depth of about 1-1/4 inches for about

minutes.

The rack is removed from the redin solution and

air dried at room temperature for a minimum of 1/2 hour. 0 0

0*S6 eg The sutures are then removed from the rack by cutting along @0

the Lines X-X and A-A. The sutures so obtained are approxi- 06 mately 18 inches in length and the resin-coated end measures

0 about 1 inch 1/4 inch. The diameter of the resin-coated :ee

0*0 end is 7.5 mils. (determined optically).

o: A needle-suture combination having a pull-out value

15 between 3 and 26 ounces is manufactured by inserting the :6,06 0 resin-coated end of this suture into a needle of the type

illustrated'in Fig. 7 characterized by an outside diameter

of 22 mils. and a drilled hole in the blunt end 10.4 mils. 0 in diameter. The needle is placed in an anvil that has a

width W (Fig. 9) of 24 mils. The heighth H (Fig. 9) of

the depression in the anvil is 11 mils. The clearance Y is

so adjusted that the cross-section of the swaged needle as

viewed in Fig. 11 measures 24.3 mils. by 16.3 mils.

During the manufacturing process, every twenty-

fifth needle-suture combination is pulled and the force

required to separate the needle from the suture recorded.

The average straight pull-out value for this production run

(Batch FA-0744) is 12.34 ounces. The pull-out values vary

from a minimum of 4 ounces to a maximum of 26 ounces. -12-

Wee

EXAMPLE II

A size 3/0 black braided silk strand characterized

by a diameter (determined optically) of 9.9 mils, is wound

on a rack 19-1/4 inches in width under a tension of 0.9

pounds, uving the apparatus illustrated in Fig. 3. One

end of the rack is immersed in a container of Xylol as

illustrated ift Fig. 5 to remove from the braid any* wax

that may be present.- The rack is removed from the container

and the Xylol is permitted to evaporate from the braided

1 silk at room temperature. 0 It end of the rack that has been washed with o. Xylol is then immersed in a container of a resin solution

as described in Example I above.

The rack is removed from the resin solution and

e air dried at room temperature for a minimum of 1/2 hour.

The sutures are then removed from the rack by cutting along

the Lines X-X and A-A. The sutures so obtained are approx- ease

0660 imately 18 in-hes in length and the resi.n-coated end measures

about 1 inch 1/4 inch. The diameter of the resin-coated

(determined optically) is 9.5 mils. 20 A needle-suture combination having a pull-out

value between 3 and 26 ounces is manufactured by inserting

the resin-coated end of this suture into a needle of the

type illust.ated in Fig. 7 characterized by an outside

diameter of 24 mils. and a drilled hole in the blunt end 13 mils. in diameter. The needle is placed in an anvil

that has a width W (Fig. 9) of 27 mils. The heighth H

(Fig. 9) of the depression in the anvil is 12 mils.

The 3learance Y is so adjusted that the cross-section of the swaged needle as viewed in Fig. 11 measures 27 mils. by 17 mils.

During the manufacturing process, every twenty-

fifth needle-suture combination is pulled and the force

required to separate the needle from the suture recorded.

The average straight pull-out value for this production run

(Batch FA-0428) is 12.42 ounces. The pull-out values vary from a minimum of 4 ounces to a maximum of 26 ounces.

EXAMPLE III A size 3/0 black braided silk strand was tipped

S" as described in Example II above and swaged to a needle

characterized by an outside diameter of 39 mils. and a

10 drilled hole in the blunt end of 13 mils. The needl- is

placed in an anvil that has a width W (Fig. 9) of 42.5 mils.

The heighth H (Fig. 9) of the depression in the anvil is

19 mils. The clearance Y is so adjusted that the cross- section of the swaged needle as viewed in Fig. 11 measures

S 15 42.5 mils. by 32 mils

The needle-suture combinations so obtained are placed in sealed envelopes, eight needle-suture combina-

tions in one envelope. One dozen of these envelopes are

packaged in one box. Fift: boxes, or 4,800 needle-suture

combinations, are manufactured in one production run. The

product is sterilized by Cobalt-60 radiation. Sixty needle-suture samples randomly selected

from this production batch of 4,800 needle-suture combina-

tions (Batch FA-0175) are tested by pulling to separate the

needle from the suture and the force required is recorded. The average straight pull-out value for this .oduct run is 10.64 ounces. The pull-out values vary from a minimum of

4 ounces to a maximum of 21 ounces.

la

EXAMPLE IV

A size 2/O black braided silk strand characterized

by a diameter (determined optically) of 12.9 mils. is wound

on a rack 19-1/4 inches in width under a tension of 1.4

pounds, using the apparatus illustrated in Fig. 1. One

end of the rack is immersed in a container of Xylol as

illustrated in Fig. 5 to remove from the braid any wax that

may be present. :The rack is removed from the container and so em the Xylol is permitted to evaporate from the braided silk at em

room temperature. .me. 10 That end of the rack that has been washed with mOOS o em a. 046 Xylol is then immersed in a container of a resin solution :0.C me

Soo as described in Example I above. 'j C 000 a 004 0 The rack is removed from the resin solution and 0 air dried at room temperature for a minimum of 1/2 hour. 0e0O0 mo 15 The sutures are then removed from the rack by cutting along 0000 the Lines X-X and A-A. The sutures so obtained are approx- a imately 18 inches in length and the resin-coated end

measures about 1 inch 1/4 inch. The diameter of the

resin-coated end (determined optically) is 12.6 mils. 0 20 A needle-suture combination having a pull-out

value between 3 and 26 ounces is manufactured by inserting

the resin-coated'end of this suture into a needle of the

type illustrated in Fig. 7 characterized by an outside

diameter of 26 mils. and a drilled hole in the blunt end

1 6 mils. in diameter. The needle is placed in an anvil

that has a width W.(Fig. 9) of 28.5 mils. The heighth H

(Fig. 9) of the depression in the anvil is 13 mils. The

clearance Y is so adjusted that the cross-section of the

swaged needle as:viewed in Fig. 11 measures 28 mils. by

18 mils.

The needle-suture combinations so obtained are

placed in sealed envelopes, eight needle-suture combina-

tions in one envelope. One dozen of these envelopes

are packaged in one box. Fifty boxes, or 4,800 needle-

suture combinations, are manufactured in one production

run. The product is sterilized by Cobalt-60 radiation.

Sixty needle-suture samples randomly selected from

this production batch of 4,800 needle-suture combinations

(Batch FA-0048) are tested by pulling to separate the needle

from the suture and the force required is recorded. The

average straight pull-out value for this production run is

13.72 ounces. The pull-out values vary from a minimum of

3 ounces to a maximum of 21.5 ounces. go•

EXAMPLE V

*A size 2/0 black braided silk strand wan tipped *0 15 as described in Example IV above and swaged to a needle

characterized by an outside diameter of 39 mils. and a

drilled hole in the blunt end of 16 mils. The needle is

placed in an anvil that has a width W (Fig. 9) of 42.5 mils.

The heighth H (Fig. 9) of the depression in the anvil is

S 20 19 mils. The clearance Y is so adjusted that the cross-

section of the swaged needle as viewed in Fig. 11 measures 42.5 mils. by 32 mils.

During the manufacturing process, every twenty-

fifth needle-suture combination is pulled and the force

required to separate the needle from the suture recorded.

The average straight pull-out value for this product run

(Batch FA-0139) is 11.93 ounces. The pull-out values vary

from a minimum of 5 ounces to a maximum of 25 ounces.

EXAMPLE VI

A size 0 black braided silk strand characterized

by a diameter (determined optically) of 15.8 mils. is wound

on a rack 19-1/4 inches in width under a tension of 2 pounds,

using the apparatus illustrated in Fig. 1. One end of the

rack is immersed in a container of Xylol as illustrated in

Fig. 5 to remove from the braid any wax that may be present.

The rack is removed from the container and the Xylol is

permitted to evaporate from the braided silk at room tempera-

ture. That end of the rack that has been washed with S. S Xylol is then immersed in a container of a resin solution

S as described in Example I above.

The rack is removed from the resin solution and 5@ S air dried at room temperature for a minimum of 1/2 hour.

15 The sutures are then removed from the rack by cutting S

along the Lines X-X and A-A. The sutures so obtained are

approximately 18 inches in length and the resin-coated end

measures about 1 inch 1/4 inch. The diameter of the

S.. resin-coated end (determined optically) is 1.5.6 mils. S

A needle-suture combination having a pull-out value

between 3 and 26 ounces is manufactured by inserting the S resin-coated end of this suture into a needle of the type

S illustrated in Fig. 7 characterized by an outside diameter

of 39 mils. and a drilled hole in the blunt end 18.7 mils. in diameter. The needle is placed in an anvil that has a

width W (Fig. 9) of 41 mils. The heighth H (Fig. 9) of

the-depression in the anvil is 19 mils. The clearance Y

is so adjusted that the cross-section of the swaged needle

as viewed in Fig. 11 measures 41 mils. by 32 mils.

The needle-suture combinations so obtained are

placed in sealed envelopes, eight needle-suture combinations

in one envelope. One dozn of these envelopes are packaged in one box. Fifty boxes, or 4,800 needle-suture combina- tions, are manufactured in one production run. The product is sterilized by Cobalt-60 radiation. Sixty needle-suture samples randomly selected from this production batch of 4,800 needle-suture combinations (Batch FA-0266) are tested by pulling to separate the needle from thG suture and the force required is recorded. The

00 average straight pull-out value for this product run is 0

13.1 ounces. The pull-out values vary from a minimum of ounces to a maximum of 24 ounces. 0 o0 0*. S*o 0 @0 0

0 .0S EXAMPLE VII 0 0

A needle-suture combination having a pull-out 0

ooo• 15 value between 3 and 26 ounces is manufactured by'inserting 0

o a nylon monofilament strand characterized by a diameter 0000

o** 0 0. (determined optically) of 9.8 mils. into a needle of the

0 type illustrated in Fig. 7 characterized by an outside

o 00 diameter of 39 mils. and a drilled hole in the blunt end 0 20 13 mils. in diameter. The needle is placed in an anvil r

0o 0 that has a width W (Fig. 9) of 42 mils. The heighth H 0 (Fig. 9) of the dep:ression in the anvil is 19 mils. The clearance Y is so adjusted that the cross-section of the swaged needle as viewed in Fig. 11 measures 42 mils. by 32.5 mils. The average straight pull-out value for a run of 50 samples is 12.5 ounces. The pull-out values vary from a minimum of.5 punces to maximm of 17.5 ounces.

ti:..L

The average straight pull-out value for a second

run of 50 samples is 12.9 ounces. The pull-out value of

this second run varied from a minimum of 6.5 ounces to a

maximum of 17.5 ounces.

EXAMPLE VIII

A needle-suture combination having a pull-out

value between 3 and 26 ounces is manufactured by inserting

a size 3/0 polypropylene monofilament strand having a

diameter (determined optically) of 9.7 mils. into a needle

S of the type illustrated in Fig. 7. The needle has an

10 outside diameter of 39 mils. and a drilled hole in the blunt

Send 13 mils. in diameter. The needle is placed in an anvil

that has a width W (Fig. 9) of 42 mils. The heighth H

(Fig. 9) of the depression in the anvil is 19 mils. The

clearance Y is so adjusted that the cross-section of the

swaged needle as viewed in Fig. 11 measures 42 mils. by

31 mils, 00*

The average straight pull-out value for a run of

53 samples is 11.2 ounces. The pull-out values vary from a

minimum of 4.5 ounces to a maximum of 18.5 ounces. 20 Depending upon the stage of manufacture (before

or after sterilization) needle-suture combinations made in

accordance with the foregoing examples may have an average

straight pull-out value as low as 9.35 ounces and as high

as 14.7 ounces. Such products are acceptable to 'the surgeon

as a controlled release suture.

The needle-suture combinations of the present in-

vention may be used by the surgeon employing conventional

suturing technique as illustrated in Fig. 1. After the suture has been placed, the needle may be separated by a wrist motion snapping the needle off the end of the suture es best illustrated in Fig. 2. The force required to pull the needle from the end of the suture is in the range of from about 3 ounces to about 26 ounces.

The extent to which a suture is compressed during

swaging may be calculated from the information given in the

patent examples.

Referring now to Figs. 8, 11, and 13, it will be

apparent that thickness of the wall enclosing the needle

hole is obtained by subtracting the diameter of the drill

hole 47 from the wire diameter 46. The swaged thickness *9 is the minimum diameter after swaging. In Example I, the 9 swaged dimensions as viewed in Fig. 11 measure 24.3 mils.

15 by 16.3 mils. (swaged thickness 16.3 mils.). The minimum

9 clearance is the minimum dimension of the opening that

o* remains within the needle hole following swaging and is o

obtained by subtracting the wall thickness from the swaged I thickness. The compression, the percent compression g@9 20 of the suture from its original diameter is obtained by 9

.oo*o* dividing the minimum clearance by the original suture dia- 4 meter. These factors which determine the percent compression

of the suture within the needle hole upon swaging are

summarized in the following table:

c o::

0 00 0 ec. egg0 00 go 0O 00 00 0 0 S S 0 500 000 0@ 0 0 eg0 0 *0g 0 0 0 0 0 CO 0 0 0 S 0000 S'j

EXAMPLE II III IV V VI VII VIII

Wire Diameter 22- 24 39. 26 39 39, 39 39

Drill Hole 10.4 13 13 16 1,6 18.7 13 13

Wall Thickness 11.6 11 26 10 23 20.3 R6 26

Swvaged Thickness 16. 3 17 32 32 32 32.5 35 li 18 Minimum Clearance 4.7 6 6 9 11.7 6.5 6.4

Suture Diameter 7.5 9.5 9.5 12.6 12.6 15.6 9.8 9.7

Percent Compression 62 63 63 63 71 75 66 66

Dril Hol 0 13 13 16 16 1. 31

Thckes 16 17 32 18 32 32 325 3. Swge

Minmu Claac 4.7* 6 6* 8 901765.

Wutre Diameter 225 9 95 12.6 129 39. 9. 97

Wal Thcns616 1 61 3 2. 6 66

Percent Compression 62 63 63 63 71 75666

ADDITIONAL EXAMPLES

A number of sutures having various compositions and

sizes were swagedto surgical needles in accordance with the

procedure of the present application to provide individual

suture pullout values of 3 to 26 ounces, and average suture

pullout values of 9 to 15 ounces for each suture lot. The

present compression (calculated in accordance with the method

set forth in the present application required to obtain the

desired pullout values was determined experimentally. The

sutures evaluated and the percent compression corresponding to

the desired pullout values for each suture type were as follows: .0

L: Suture Needle drill Suture 0 Type Size Diameter hole diameter compression USP mils mils

Braided nylon 1 18 21.7 79-88

Braided silk 2-0 12 16.0 63-86 3-0 8.8 13.0 71-88

Braided VICRYL* 1 18- 21.7 80-92 O 0* 1-0 15 18.7 73-90 12 16.0 57-82 8.8 13.0 59-79 0. S29 77-90 Braided polyester 1-0 15 18.7 12 16.0 77-83 8.8 13.0 78-85 O

Polypropylene 1 18 21.7 89-98 (monofilament) 1-0 15 18.7 81-93 12 16.0 78-97

,~A12UQA/Ta8 *Ci~o. rcLJ~

It is apparent from the above data that suture pullout

value is not dependent solely on suture percent compression,

but varies widely depending upon factors such as suture

composition and size, and probably variations in the surface

characteristics, roughness, of the suture and needle

hole. Accordingly, the novel sutures of the present invention

which allow the needle to be deliberately removed by a simple

tug are best characterized by individual and average suture

pullout values rather than percent suture compression. The

degree of suture compression required to provide the desired

suture pullout is readily determined experimentally for each o eo

particular lot of sutures and needles. 000

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Claims (4)

THE CLAIMS DEFINING THE INVENTION AS AS FOLLOWS:

1. A package containing a multiplicity of needle-suture

combinations that are characterized by having an average

suture pullout value of between 9 ounces and 15 ounces;

each of said needle-suture combinations within said package

comprising a needle having an opening of uniform diameter in

the blunt end, and a suture having a uniform diameter greater

than 7 mils, one end of which is received within said recess

and swaged whereby said end is compressed and restrained

within said needle recess, said needle-suture combinations

e being characterized by having individual suture pullout 0000 values of between 3 ounces and 26 ounces. or* a

2. A package of claim 1 wherein each of the sutures

within the package is a multifilament suture, one end of which

o 000 is coated with a resin and of smaller diameter than the rest *00

0 of the suture which extends from the needle, said resin-coated

end being received within said recess and swaged whereby the

resin-coated end is compressed and restrained within said 400 to needle recess. 00 009

3. The package of claim 2 wherein each of the sutures is 0 0*00 a braided suture.

t 00

4. The package of claim 3 wherein each of the sutures is 0

a braid of a material selected from the group consisting of 600G.: 0

silk, polyester and nylon.

The package of claim 4 wherein the suture is a polyester

selected from the group consisting of polyhydroacetic ester

and a copolymer of glycolide and L lactide.

6. The package of claim 2 wherein .nend each -f suture-

FG-coated wi.t an epoxy resin.

7. The package of claim 1 wherein each of the sutures

contained within the package is a monofilament suture.

The package of claim 7 wherein the sutures are selected ftrj th group consizt:ing -o6f nylon and polypropylene monofilanients.

DATED this 11th day of October, 1977.

ETHICON INC. By the Patent Attorney of GRIFFITH, HASSEL FRAZER.

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