Combined surgical needle-spiroid braided suture device

Claim 3

The method of claim 1 wherein the needle is manufactured from a material selected from the group consisting of Series 300 stainless steels, Series 400 Stainless steels and an alloy comprising from about 6 to about 25 weight percent iron, from about 18 to about 40 weight percent nickel, from about 6 to about 12 percent molybdenum and from about 15 to about 25 weight percent chromium, the balance of the alloy being cobalt.

Claim 4

The method of claim 1 wherein the shrinkable plastic is a polyvinylidene fluoride material.

Claim 5

The method of claim 1 wherein the tip region of the suture possesses an adhesive or resinous coating.

Claim 6

The method of claim 1 wherein the shrinkable tubing is sequentially placed around the shank end of the needle and the tip region of the suture and energy is applied to the shrinkable tubing after each placement.

Claim 7

The method of claim 1 wherein the spiroid braided suture exhibits a reduced level of tissue drag compared with that of a tubular braided suture of the same overall denier.

Claim 8

The method of claim 1 wherein the spiroid braided suture exhibits a level of tissue drag which does not exceed about 60% of the level of tissue drag of a tubular braided suture of the same overall denier.

Claim 9

The method of claim 1 wherein the spiroid braided suture exhibits a level of tissue drag which does not exceed about 40% of the level of tissue drag of a tubular braided suture of the same overall denier.

Claim 10

The method of claim 1 wherein for a given overall suture denier, the number of yarns and denier of individual filaments comprising a yarn of the spiroid braided suture are related to each other as follows: ______________________________________ Denier of Overall Suture Number of Individual Denier Yarns Filaments ______________________________________ from about from about 6 from about 0.2 50 to about 125 to about 15 to about 6.0 greater than about from about 6 from about 0.2 125 to about 200 to about 15 to about 6.0 greater than about from about 6 from about 0.2 200 to about 300 to about 15 to about 6.0 greater than about from about 6 from about 0.2 300 to about 500 to about 15 to about 6.0 greater than about from about 9 from about 0.2 500 to about 800 to about 20 to about 6.0 greater than about from about 12 from about 0.2 800 to about 1200 to about 25 to about 6.0 greater than about from about 12 from about 0.2 1200 to about 2000 to about 25 to about 6.0 greater than about from about 15 from about 0.2 2000 to about 4000 to about 25 to about 6.0. ______________________________________

Claim 11

The method of claim 1 wherein for a given overall suture denier, the number of yarns and denier of individual filaments comprising a yarn of the spiroid braided suture are related to each other as follows: ______________________________________ Denier of Overall Suture Number of Individual Denier Yarns Filaments ______________________________________ from about from about 6 from about 0.8 50 to about 125 to about 12 to about 3.0 greater than about from about 6 from about 0.8 125 to about 200 to about 12 to about 3.0 greater than about from about 6 from about 0.8 200 to about 300 to about 12 to about 3.0 greater than about from about 9 from about 0.8 300 to about 500 to about 12 to about 3.0 greater than about from about 12 from about 0.8 500 to about 800 to about 15 to about 3.0 greater than about from about 15 from about 0.8 800 to about 1200 to about 20 to about 3.0 greater than about from about 15 from about 0.8 1200 to about 2000 to about 20 to about 3.0 greater than about from about 24 from about 0.8 2000 to about 4000 to about 34 to about 3.0. ______________________________________

Claim 12

The method of claim 1 wherein the suture possesses a core, the maximum denier of the core for a given overall suture denier being as follows: ______________________________________ Overall Suture Maximum Denier Denier of Core ______________________________________ greater than about 25-40 125 to about 200 greater than about 40-60 200 to about 300 greater than about 60-100 300 to about 500 greater than about 125-200 500 to about 800 greater than about 200-300 800 to about 1200 greater than about 300-500 1200 to about 2000 greater than about 500-1000 2000 to about 4000. ______________________________________

Claim 13

The method of claim 1 wherein the suture possesses a core, the maximum denier of the core for a given overall suture denier being as follows: ______________________________________ Overall Suture Maximum Denier Denier of Core ______________________________________ greater than about 10-20 125 to about 200 greater than about 20-30 200 to about 300 greater than about 30-50 300 to about 500 greater than about 75-120 500 to about 800 greater than about 120-180 800 to about 1200 greater than about 180-300 1200 to about 2000 greater than about 300-600 2000 to about 4000. ______________________________________

Claim 14

A combined surgical needle-spiroid braided suture device which comprises: a) a surgical needle possessing a shank end of reduced diameter; b) a spiroid braided suture possessing a tip region for attachment to the shank end of the needle; and, c) a tubing engaging the shank end of the needle and the tip region of the suture, the tubing being fabricated from a shrinkable plastic material which undergoes contraction upon application of energy thereto.

Claim 15

A combined surgical needle-spiroid braided suture device which comprises: a) a surgical needle possessing a shank end of reduced diameter; b) a spiroid braided suture possessing a tip region for attachment to the shank end of the needle; and, c) a tubing engaging the shank end of the needle and the tip region of the suture, the tubing being fabricated from a shrinkable plastic material which undergoes contraction upon application of energy thereto.

Claim 16

The combined surgical needle-spiroid braided suture device of claim 13 wherein the needle is manufactured from a material selected from the group consisting of Series 300 stainless steels, Series 400 stainless steels and an alloy comprising from about 6 to about 25 weight percent iron, from about 18 to about 40 weight percent nickel, from about 6 to about 12 percent molybdenum and from about 15 to about 25 weight percent chromium, the balance of the alloy being cobalt.

Claim 17

The combined surgical needle-spiroid braided suture device of claim 13 wherein the shrinkable plastic material is a polyvinylidene fluoride material.

Claim 18

The combined surgical needle-spiroid braided suture device of claim 13 wherein the tip region of the spiroid braided suture possesses an adhesive or resinous coating.

Claim 19

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture exhibits a reduced level of tissue drag compared with that of a tubular braided suture of the same overall denier.

Claim 20

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture exhibits a level of tissue drag which does not exceed about 60% of the level of the tissue drag of a tubular braided suture of the same overall denier.

Claim 21

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture exhibits a level of tissue drag which does not exceed about 40% of the level of tissue drag of a tubular braided suture of the same overall denier.

Claim 22

The combined surgical needle-spiroid braided suture device of claim 19 wherein the spiroid braided suture exhibits a level of tissue drag which does not exceed about 20% of the level of tissue drag of a tubular braided suture of the same overall denier.

Claim 23

The combined surgical needle-spiroid braided suture device of claim 13 where the pull-out force for the device is as defined for tubular braided needle attachment.

Claim 24

The combined surgical needle-spiroid braided suture device of claim 13 wherein the pull-out force for the device is as defined for removable needle attachment.

Claim 25

The combined surgical needle-spiroid braided suture device of claim 13 wherein for a given overall suture denier, the number of yarns and denier of individual filaments comprising a yarn of the spiroid braided suture are related to each other as follows: ______________________________________ Denier of Overall Suture Number of Individual Denier Yarns Filaments ______________________________________ from about from about 6 from about 0.2 50 to about 125 to about 15 to about 6.0 greater than about from about 6 from about 0.2 125 to about 200 to about 15 to about 6.0 greater than about from about 6 from about 0.2 200 to about 300 to about 15 to about 6.0 greater than about from about 6 from about 0.2 300 to about 500 to about 15 to about 6.0 greater than about from about 9 from about 0.2 500 to about 800 to about 20 to about 6.0 greater than about from about 12 from about 0.2 800 to about 1200 to about 25 to about 6.0 greater than about from about 12 from about 0.2 1200 to about 2000 to about 25 to about 6.0 greater than about from about 15 from about 0.2 2000 to about 4000 to about 25 to about 6.0. ______________________________________

Claim 26

The combined surgical needle-spiroid braided suture device of claim 13 wherein for a given overall suture denier, the number of yarns and denier of individual filaments comprising a yarn of the spiroid braided suture are related to each other as follows: ______________________________________ Denier of Overall Suture Number of Individual Denier Yarns Filaments ______________________________________ from about from about 6 from about 0.8 50 to about 125 to about 12 to about 3.0 greater than about from about 6 from about 0.8 125 to about 200 to about 12 to about 3.0 greater than about from about 6 from about 0.8 200 to about 300 to about 12 to about 3.0 greater than about from about 9 from about 0.8 300 to about 500 to about 12 to about 3.0 greater than about from about 12 from about 0.8 500 to about 800 to about 15 to about 3.0 greater than about from about 15 from about 0.8 800 to about 1200 to about 20 to about 3.0 greater than about from about 15 from about 0.8 1200 to about 2000 to about 20 to about 3.0 greater than about from about 24 from about 0.8 2000 to about 4000 to about 34 to about 3.0. ______________________________________

Claim 27

The combined surgical needle-spiroid braided suture of claim 13 wherein the suture possesses a core, the maximum denier of the core for a given overall suture denier being as follows: ______________________________________ Overall Suture Maximum Denier Denier of Core ______________________________________ greater than about 25-40 125 to about 200 greater than about 40-60 200 to about 300 greater than about 60-100 300 to about 500 greater than about 125-200 500 to about 800 greater than about 200-300 800 to about 1200 greater than about 300-500 1200 to about 2000 greater than about 500-1000 2000 to about 4000. ______________________________________

Claim 28

The combined surgical needle-spiroid braided suture of claim 13 wherein the suture possesses a core, the maximum denier of the core for a given overall suture denier being as follows: ______________________________________ Overall Suture Maximum Denier Denier of Core ______________________________________ greater than about 10-20 125 to about 200 greater than about 20-30 200 to about 300 greater than about 30-50 300 to about 500 greater than about 75-120 500 to about 800 greater than about 120-180 800 to about 1200 greater than about 180-300 1200 to about 2000 greater than about 300-600 2000 to about 4000. ______________________________________

Claim 29

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture is fabricated from a non-absorbable material.

Claim 30

The combined surgical needle-spiroid braided suture device of claim 27 wherein the non-absorbable material is cotton, silk, polyamide or polyolefine.

Claim 31

The combined surgical needle-spiroid braided suture device of claim 27 wherein the individual filaments of the suture are fabricated from a bio-absorbable polymer.

Claim 32

The combined surgical needle-spiroid braided suture device of claim 27 wherein the individual filaments of the suture 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.

Claim 33

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture is fabricated from a material which is susceptible to hydrolysis, the suture possessing a storage stabilizing amount of at least one water soluble, liquid polyhydroxy compound and/or ester thereof as storage stabilizing agent.

Claim 34

The combined surgical needle-spiroid braided of claim 31 wherein the water soluble, liquid polyhydroxy oxy compound is glycerol.

Claim 35

The combined surgical needle-spiroid braided suture device of claim 31 wherein the water soluble, liquid polyhydroxy compound is admixed with a thickener.

Claim 36

The combined surgical needle-spiroid braided suture device of claim 33 wherein the thickener is a saturated aliphatic hydroxycarboxylic acid of the general formula ##STR2## wherein R is a hydrogen or methyl and R' is a metal selected from the group consisting of alkali metal and alkaline earth metal and n is 0 or 1 and hydrates thereof.

Claim 37

The combined surgical needle-spiroid braided suture device of claim 34 wherein the saturated aliphatic hydroxycarboxylic acid salt is calcium lactate.

Claim 38

The combined surgical needle-spiroid braided suture device of claim 32 wherein the glycerol is admixed with calcium lactate.

Claim 39

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture is surface-coated with a composition enhancing one or more functional properties of the suture.

Claim 40

The combined surgical needle-spiroid braided suture device of claim 37 wherein the suture is surface-coated with a composition which enhances the surface lubricity and/or knot tie-down performance of the suture.

Claim 41

The combined surgical needle-spiroid braided suture device of claim 38 wherein the composition is a bioabsorbable coating composition obtained by copolymerizing a polyether glycol with a mixture of lactide monomer and glycolide monomer or a preformed copolymer of lactide and glycolide.

Claim 42

The combined surgical needle-spiroid braided suture device of claim 39 wherein the polyether glycol is selected from the group consisting of low molecular weight polyalkylene glycol and polyethylene oxide-polypropylene oxide copolymer.

Claim 43

The combined surgical needle-spiroid braided suture device of claim 13 wherein the spiroid braided suture contains at least one medico-surgically useful substance.

Claim 44

The combined surgical needle-spiroid braided suture device of claim 41 wherein the medico-surgically useful substance is a Human Growth Factor.

Claim 45

The combined surgical needle-spiroid braided suture device of claim 13 wherein the suture is filled with a filling composition comprising a surgical wound healing enhancing amount of at least one Human Growth Factor and as carrier therefor at least one water soluble, liquid polyhydroxy compound and/or ester thereof.

Claim 46

The combined surgical needle-spiroid braided suture device of claim 43 wherein the carrier is glycerol.

Claim 47

The combined surgical needle-spiroid braided suture device of claim 43 wherein the filling composition includes a thickener.

Claim 48

The combined surgical needle-spiroid braided suture device of claim 45 wherein the thickener is a saturated aliphatic hydroxycarboxylic acid of the general formula ##STR3## wherein R is a hydrogen or methyl and R' is a metal selected from the group consisting of alkali metal and alkaline earth metal and n is 0 or 1 and hydrates thereof.

Claim 49

The combined surgical needle-spiroid braided suture device of claim 46 wherein the thickener is calcium lactate.

Claim 50

The combined surgical needle-spiroid braided suture device of claim 45 wherein the carrier is glycerol and the thickener is calcium lactate.