US3875946A - Controlled release suture - Google Patents

Controlled release suture Download PDF

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Publication number
US3875946A
US3875946A US446174A US44617474A US3875946A US 3875946 A US3875946 A US 3875946A US 446174 A US446174 A US 446174A US 44617474 A US44617474 A US 44617474A US 3875946 A US3875946 A US 3875946A
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United States
Prior art keywords
suture
needle
ounces
combination
swaged
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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 - Lifetime
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US446174A
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English (en)
Inventor
Robert Barclay Duncan
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Ethicon Inc
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Ethicon Inc
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Filing date
Publication date
Application filed by Ethicon Inc filed Critical Ethicon Inc
Priority to US446174A priority Critical patent/US3875946A/en
Priority to AU77631/75A priority patent/AU489268B2/en
Priority to DE19752507600 priority patent/DE2507600A1/de
Priority to JP50022507A priority patent/JPS50119487A/ja
Priority to IT48343/75A priority patent/IT1029862B/it
Priority to CA220,957A priority patent/CA1042301A/en
Priority to GB803475A priority patent/GB1477615A/en
Priority to FR7506050A priority patent/FR2261739B1/fr
Priority to BR1185/75A priority patent/BR7501185A/pt
Application granted granted Critical
Publication of US3875946A publication Critical patent/US3875946A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle

Definitions

  • the needle is threaded by the nurse and the surgeon takes one pass through the tissue using a needleholder. He slips the needle off the suture, returns the needle to the nurse, and is ready for another threaded needle from the nurse. An assistant follows behind and ties the suture.
  • 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.
  • 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.
  • Needle-suture combinations manufactured in accordance with the present invention are characterized by a suture pull-out value substantially lower than the minimum average force specified in the U.S. Pharmacopoeia.
  • the process of the present invention permits better control of the end product in that the force required to separate a suture of a particular size from its attached needle is uniform. Thus, in any batch of needled sutures manufactured during a single production run, the variation of the pull-out value from the mean is reduced.
  • the suture utilized in the present invention may be any known braided or monofilament suture materials, either absorbable, i.e., catgut, extruded collagen, a braided polyhydroxyacetic ester, a synthetic copolymer of L(-) lactide and glycolide', or non-absorbable, i.e., silk, nylon, polypropylene, cotton, linen, or polyester.
  • absorbable i.e., catgut, extruded collagen
  • a braided polyhydroxyacetic ester a synthetic copolymer of L(-) lactide and glycolide'
  • non-absorbable i.e., silk, nylon, polypropylene, cotton, linen, or polyester.
  • the needled sutures of the present invention are manufactured by conventional procedures. One end of a suture is inserted into a drilled needle, a channel needle or a preclosed channel needle and the needle is swaged to secure the suture. It has long been known that 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, needled sutures can be manufactured that satisfy the minimum limits on needle attachment as set forth in the U.S. Pharmacopoeia.
  • the needled sutures are swaged so that the force required to pull the suture out of the needle exceeds the minimum limits on needle attachment set forth in Table I, but is less than the actual tensile strength of the suture used.
  • the needles are swaged so that the suture may be pulled out of the needle by a force in the range of l to 6 pounds for size 4/0 suture and larger. If the suture is smaller than size 4/0, it is preferred that the needle be swaged so that the suture may be pulled out of the needle without breaking by a force in the range of 3 to ounces as indicated in the following table.
  • Needle-suture combinations having the pull-out values summarized in Table II may be manufactured by applying sufficient tension to the suture to move it relative to the needle barrel, and then releasing the tension when the force drops to within the following range for that size of suture.
  • FIG. 1 is an enlarged perspective view of a swaged and stressed needle-suture combination
  • FIG. 2 is an enlarged perspective view of the needlesuture combination of FIG. 1 and illustrates removal of the needle from the suture;
  • FIG. 3 is an enlarged sectional view of a needlesuture combination
  • FIG. 4 is an enlarged sectional view of the needlesuture combination of FIG. 3 showing displacement of the suture from the needle;
  • FIG. 5 is a diagram of apparatus useful in manufacturing the needled sutures of the present invention.
  • FIG. 6 is a graph of the displacement of a suture from the drilled hole as a function of the stress applied to the suture
  • FIG. 7 is a graph of the displacement of a suture from the drilled hole as a function of the stress applied to the suture
  • FIG. 8 is a graphic representation of the pull-out values determined on eleven prestressed needle-suture combinations
  • FIG. 9 is a graph of the displacement of a suture from the needle hole as a function of the stress applied.
  • FIG. 10 is a graph of the displacement of a suture from the needle hole as a function of the stress applied
  • FIG. 11 is a graphic representation of the pull-out values determined on ten needle-suture combinations.
  • needled sutures are manufactured in the conventional manner and prestressed to reduce the force required to separate the needle from the suture to a predetermined value.
  • the resulting controlled release suture is then packaged and sterilized.
  • Prestressing may be accomplished by the apparatus illustrated in FIG. 5, which is designed to apply a stress to a needle 11 and the attached suture 12 sufficient to partially withdraw the suture from the needle. It includes in part an arm 13 fitted with a gate 14 sized to retain stationary the needle while permitting movement of the suture relative thereto. The arm is pivoted for movement around the pivot pin 15. A clamp 16 fitted with movable jaws l7 and 17' is aligned with the gate and grips the suture. Movement of the clamp in the direction of the arrow applies stress to the suture causing it to move relative to the needle barrel 30 thereby displacing the end 18 of the suture from the bottom 20 of the needle hole by a distance 19 (see FIGS. 3 and 4).
  • the stress applied to the suture by the clamp is monitored by a force transducer 21 which acts with the clamp to stop the movement thereof when the applied stress drops to a predetermined value.
  • FIG. 6 illustrates the relationship between stress, strain, and the actual displacement of four size 0 black braided silk sutures as tension is applied to pull the sutures completely out of the needle.
  • the sutures are swaged to a 39 mil drilled needle.
  • the diameter of the drill hole is 19 mils and the depth of the drill hole (the length of the suture within the needle barrel) is 70 mils.
  • F IG. 7 illustrates the relationship between stress, strain, and the actual displacement of four size 0 black braided silk sutures as tension is applied to pull the sutures out of the needle.
  • the sutures are swaged to a 39 mil drilled needle.
  • the diameter of the drill hole is 19 mils and the depth of the drill hole (the length of the suture within the needle barrel) is 70 mils. In this instance, the sutures are not pulled completely out of the needle; when the tension drops to 1 pound, the movement of the clamp is stopped.
  • FIG. 9 illustrates the relationship between stress, strain, and the actual displacement of a size 0 polyester suture from a channel needle.
  • the needle is made of 39 mil wire and has a channel length (prior to closure) of 178 mils.
  • the suture As tension is applied to the suture by the clamp, the suture is elongated (about 0.02 inches) until the stress exceeds 6 pounds. At that point, the suture moves relative to the needle and the stress drops as the suture is withdrawn. Movement of the clamp is stopped when the stress reaches l pound at which point the displacement of the suture from the end of the needle channel is about 0.09 inches (about 50% displacement).
  • FIG. 10 depicts the relationship of stress, strain, and suture displacement when force is applied to a size 0 polypropylene suture swaged to a channel needle.
  • the needle is made of 39 mil wire and has a channel length (prior to closure) 188 mils.
  • the suture is stretched about 0.02 inches.
  • Increasing the stress above 4 pounds results in movement of the suture relative to the needle channel. Stress is removed when the force applied drops to l pound at which point the suture has been displaced from the channel needle a distance of about 0.08 inches (about 42% displacement).
  • EXAMPLE 1 Size 0 black braided silk suture strands are swaged to drilled needles manufactured of 39 mil wire and having a drilled hole in the blunt end l9 mils in diameter and 70 mils deep. The suture ends are inserted into the needles until they are in contact with the bottom of the drilled hole as shown in FIG. 3. The needles are then swaged so that the force required to pull out the suture is within the range of about from 2 to 5 pounds.
  • the swaged needle-suture combinations are prestressed in a Table Model lNSTRON Tensile Tester (Model TT-DL) using a Type CT Tension Cell (fullscale range 100 pounds), and the machine is set so that full-scale deflection is obtained at 20 pounds.
  • Two line contact jaws are used to secure the needled sutures in the lNSTRON machine. The upperjaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the lNSTRON machine is operated at a cross-head speed of 0.] inches per minute and a chart speed of 5 inches per minute until the tension drops to one pound.
  • EXAMPLE 2 Size 0 monofilament polypropylene suture strands are swaged to drilled needles manufactured of 39 mil wire and having a drilled hole in the blunt end 19 mils in diameter and mils deep. The ends are inserted into the needles until they are in contact with the bottom of the drilled hole as shown in FIG. 3. The needles are swaged so that the force required to pull the suture out of the needle is within the range of from about 3 to 5 pounds.
  • the swaged needle-suture combinations are prestressed in a Table Model lNSTRON Tensile Tester (Model TT-DL) using a Type CT Tension Cell (fullscale range pounds), and the machine is set so that full-scale deflection is obtained at 20 pounds.
  • Two line contact jaws are used to secure the needled sutures in the lNSTRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the lNSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to l pound.
  • EXAMPLE 3 A size 2 black braided silk suture strand is swaged to a channel needle manufactured of 39 mil wire.
  • the length of the channel (the length of the suture within the needle barrel) is seven thirty-seconds inches.
  • the needles are swaged so that the force required to pull out the suture is about 5 pounds.
  • the swaged needle-suture combination is prestressed in a Table Model lNSTRON Tensile Tester as described in Example 1 above, until the tension required to pull the suture from the needle drops to 21 ounces.
  • a size 1 black braided silk suture strand is swaged to a drilled needle manufactured of 32 mil wire and having a drilled hole in the blunt end 22 mils in diameter and 70 mils deep. The end of the suture is inserted into the needle until it is in contact with the bottom of the drilled hole as shown in FIG. 3. The needle is then swaged so that the force required to pull the suture out of the needle is within the range of about from 3 to 6 pounds.
  • the swaged needle-suture combination is then prestressed in a Table Model INSTRON Tensile Tester (Model TT-DL) using a Type CT Tension Cell (fullscale range 100 pounds), and the machine is set so that full-scale deflection is obtained at 20 pounds.
  • Two line contact jaws are used to secure the needled suture in the INSTRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the INSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to 20 ounces.
  • EXAMPLE Size 3/0 black braided silk suture strands are swaged to channel needles manufactured of 22 mil wire and having a channel in the blunt end five thirty-seconds inch in length (five thirty-seconds inch suture engagement). The needles are swaged to close the channel so that the force required to pull out the suture is within the range of about from 1 to 2 pounds.
  • the swaged needle-suture combinations are prestressed in a Table Model INSTRON Tensile Tester as described above until the tension drops to l 1 ounces.
  • the swaged needle-suture combinations are prestressed in a Table Model INSTRON Tensile Tester as described in Example 1 above until the tension drops to 8 ounces.
  • EXAMPLE 7 Size 5/0 black braided silk suture strands are swaged to channel needles manufactured of 14 mil wire (channel engagement seven sixty-fourths inch). The needles are swaged so that the force required to pull out the suture is within the range of 7 to 15 ounces.
  • the swaged needle-suture combinations are prestressed in a Table Model lNSTRON Tensile Tester (Model TT-DL) using a Type G-0l-3 Tension Cell (full-scale range 50 pounds), and the machine is set so that full-scale deflection is obtained at 5 pounds.
  • Two line contact jaws are used to secure the needled sutures in the INSTRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 psi. air pressure.
  • the INSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to 4 ounces.
  • the swaged needle-suture combinations are prestressed in a Table Model INSTRON Tensile Tester (Model TT-DL) using a Type G-0l-3 Tension Cell (full-scale range 50 pounds), and the machine is set so that full-scale deflection is obtained at pounds.
  • Two line contact jaws are used to secure the needled sutures in the lNSTRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the INSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to 3 ounces.
  • the swaged needle-suture combinations are prestressed in a Table Model lNSTRON Tensile Tester (Model TT-DL) using a B Tension Cell and the associated upper jaw (red).
  • the instrument is calibrated with a 100 gram weight on the B cell clamp to full-scale deflection on the X-l scale.
  • Two line contact jaws are used to secure the needled sutures in the lNSTRON machine.
  • the upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the lNSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to 1.8 ounces.
  • the swaged needle-suture combinations are prestressed in a Table Model INSTRON Tensile Tester (Model TT-DL) using a Type B Tension Cell and the associated upper jaw (red).
  • the instrument is calibrated with a 100 gram weight on the B cell clamp to full-scale deflection on the X-l scale.
  • Two line contact jaws are used to secure the needled sutures in the [N- STRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the INSTRON machine is operated at a crosshead speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the tension drops to 1.3
  • the swaged needle-suture combinations are prestressed in a Table Model lNSTRON Tensile Tester (Model TT-DL) using a Type CT Tension Cell (fullscale range pounds), and the machine is set so that full-scale deflection is obtained at 20 pounds.
  • Two line contact jaws are used to secure the needled sutures in the INSTRON machine. The upper jaw grips the needle and the lower jaw grips the suture about 0.25 inches below the needle. Both jaws are closed under 20 p.s.i. air pressure.
  • the lNSTRON machine is operated at a cross-head speed of 0.1 inches per minute and a chart speed of 5 inches per minute until the stress drops to 14 ounces.
  • the needle-suture combinations of the present invention may be used by the surgeon employing conven tional 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 as best illustrated in FIG. 2. The force required to pull the needle from the end of the suture is related to the suture size and is in the range of from about 1 ounce to about 26 ounces.
  • a method of manufacturing a swaged needle suture combination comprising a needle having pointed and blunt ends, said needle having an opening in the blunt end thereof and a suture, one end of which is received within said opening, the improvement comprising pre-stressing the suture with respect to said needle by applying sufiicient tension to the suture to move it relative to said needle; and releasing the tension when the force drops to a value within the following range for 2.
  • a swaged needle-suture combination comprising a needle having pointed and blunt ends, said needle having an opening in the blunt end thereof and a suture, one end of which is received within said opening said suture being pre-stressed with respect to said needle so that the suture is displaced from the inner end of said opening whereby the suture may be pulled out of the needle by a force that is within the following range for that size of suture Suture Size Ounces 8/0 l. 2. 7/0 l. 3. 6/0 2. 5. /0 3. 7. 4/0 3. l5. 3/0 3. 23. 2/0 3. 26. H0 l0. 26.
  • polyester is a copolymer of glycolide and L(-) lactide.
  • suture is a braided nylon suture.
  • suture is a braided suture.
  • suture is a braided silk suture.
  • the needle is a taper point needle.

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US446174A 1974-02-27 1974-02-27 Controlled release suture Expired - Lifetime US3875946A (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
US446174A US3875946A (en) 1974-02-27 1974-02-27 Controlled release suture
AU77631/75A AU489268B2 (en) 1974-02-27 1975-01-28 Controlled release suture
DE19752507600 DE2507600A1 (de) 1974-02-27 1975-02-21 Chirurgische nadel-nahtmaterial- kombination und verfahren zu ihrer herstellung
IT48343/75A IT1029862B (it) 1974-02-27 1975-02-25 Perfezionamento nelle combinazioni di ago e filo di suturaper impiege chirurgico
JP50022507A JPS50119487A (enrdf_load_stackoverflow) 1974-02-27 1975-02-25
CA220,957A CA1042301A (en) 1974-02-27 1975-02-26 Suture having controlled release from its attached needle
GB803475A GB1477615A (en) 1974-02-27 1975-02-26 Controlled releasure suture
FR7506050A FR2261739B1 (enrdf_load_stackoverflow) 1974-02-27 1975-02-26
BR1185/75A BR7501185A (pt) 1974-02-27 1975-02-27 Processo de fabricacao de uma combinacao de agulha-sutura firmada por compressao e combinacao de agulha-sutura firmada por compressao

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Application Number Priority Date Filing Date Title
US446174A US3875946A (en) 1974-02-27 1974-02-27 Controlled release suture

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US3875946A true US3875946A (en) 1975-04-08

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US446174A Expired - Lifetime US3875946A (en) 1974-02-27 1974-02-27 Controlled release suture

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US (1) US3875946A (enrdf_load_stackoverflow)
JP (1) JPS50119487A (enrdf_load_stackoverflow)
BR (1) BR7501185A (enrdf_load_stackoverflow)
CA (1) CA1042301A (enrdf_load_stackoverflow)
DE (1) DE2507600A1 (enrdf_load_stackoverflow)
FR (1) FR2261739B1 (enrdf_load_stackoverflow)
GB (1) GB1477615A (enrdf_load_stackoverflow)
IT (1) IT1029862B (enrdf_load_stackoverflow)

Cited By (70)

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US4054144A (en) * 1976-05-28 1977-10-18 American Cyanamid Company Short-crimp surgical needle
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FR2261739B1 (enrdf_load_stackoverflow) 1978-07-13
GB1477615A (en) 1977-06-22
FR2261739A1 (enrdf_load_stackoverflow) 1975-09-19
IT1029862B (it) 1979-03-20
DE2507600A1 (de) 1975-08-28
CA1042301A (en) 1978-11-14
AU7763175A (en) 1976-07-29
BR7501185A (pt) 1975-12-02

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