suture and needle technology

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Sutures Needles Packaging DR SREEJOY PATNAIK

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Page 1: SUTURE AND NEEDLE TECHNOLOGY

Sutures Needles Packaging

DR SREEJOY PATNAIK

Page 2: SUTURE AND NEEDLE TECHNOLOGY

Sutures

Page 3: SUTURE AND NEEDLE TECHNOLOGY

Sutures Module Agenda

• Objectives • Suture Overview • Suture Characteristics • Suture Types • Activity

Page 4: SUTURE AND NEEDLE TECHNOLOGY

Objectives

• Name the raw materials from which each ETHICON suture is derived • Classify each ETHICON suture as natural/synthetic, absorbable/

nonabsorbable, braided/monofilament • Recall absorption profiles and tensile strength retention profiles of all

ETHICON sutures • Identify which ETHICON sutures are coated, and the coating material (if

applicable) • Identify the colors in which each ETHICON suture

is available • Identify ETHICON sutures by sight and by feel • Describe antibacterial sutures, how they work and which pathogens they

are effective against

Page 5: SUTURE AND NEEDLE TECHNOLOGY

Suture History

1887 1947 1958 1969 1974 1976 1979 1989 1992 1993 1995 1996 1998 2003 2006

Page 6: SUTURE AND NEEDLE TECHNOLOGY

Suture Sizing

• Variety of sizes ranging from 7 to 11-0 • A number 7 size is the largest • An 11-0 size is the smallest • Sizes 6 and 7 are only available in

Surgical Steel

Page 7: SUTURE AND NEEDLE TECHNOLOGY

Suture material compared with human hairSuture Sizes

Page 8: SUTURE AND NEEDLE TECHNOLOGY

Example

• monofilament suture USP 10-0 knotted around human hair

Page 9: SUTURE AND NEEDLE TECHNOLOGY

Surgical Site Infection Background Review

• Antimicrobial • A substance that kills microorganisms (bacteria, fungus or virus) or

inhibits their growth • Cidal – kills i.e. bacteriocidal • Static – inhibits I.e. bacteriostatic

• Antibacterial • An antimicrobial substance that kills bacteria or inhibits their growth

Page 10: SUTURE AND NEEDLE TECHNOLOGY

SSI Background Review

• Antibiotic • Agent produces by microorganisms (bacteria, fungus, virus) or the

chemically synthesized equivalent of such an agent that inhibits and/or kills other microorganisms. Antibiotics have very specific MOA (mechanism of action) that determine their efficacy

• Antiseptic • Agent that inhibits and/or kills microorganisms (bacteria, fungus,

virus) on living tissue. Antiseptics are typically not derived from microbial sources and have different and less specific MOA (mechanism of action) than antibiotics.

Page 11: SUTURE AND NEEDLE TECHNOLOGY

SSI Background Review

• Which are the two most common pathogens likely to cause SSI’s? • Staphylococcus aureus • Staphylococcus epidermidis

• Methicillin-resistant - Resistance to antibiotics • Treatment options are limited – vancomycin, Sulfamethoxazole-TMP

and teicoplanin • Prevention is best option to protect patients

• Antibiotic prophylaxis, scrubbing, gowning, gloving, antimicrobial skin prep, aseptic technique and … •  … Plus Antibacterial Sutures

Page 12: SUTURE AND NEEDLE TECHNOLOGY

Suture Types

ShortShort/Medium

Medium

Twisted/Virtual Monofilament

Natural

Short/MediumLong

Monofilament

ShortMedium

Braided

Synthetic

Absorbable

Monofilament Braided

Natural

Monofilament Braided

Synthetic

Non-Absorbable

Page 13: SUTURE AND NEEDLE TECHNOLOGY

Fast Absorbing Gut

Short

Plain Gut

Short/Medium

Chromic Gut

Medium

Twisted/Virtual Monofilament

Natural

MONOCRYL* Plus

MONOCRYL*

Short/Medium

PDS * II Plus

PDS* II

Long

Monofilament

VICRYL RAPIDE* Plus

VICRYL RAPIDE*

Short

VICRYL* Plus

VICRYL*

Medium

Braided

Synthetic

Absorbable

Absorbable Suture Types

Page 14: SUTURE AND NEEDLE TECHNOLOGY

Absorption Process - Defined

• Two types: • Hydrolysis – absorbed in water (H20) • The human body is over 70% water • Less reactive • More consistent

• Enzymatic – digested by enzymes • Can lead to swelling and edema • Malnourished patients digest suture material more quickly (protein)

Page 15: SUTURE AND NEEDLE TECHNOLOGY

Critical Wound Healing Period (CWHP)

• Skin • Mucosa • Subcutaneous • Peritoneum • Fascia (40%)

5-10 Days

5-7 Days

7-14 Days

7-14 Days

60 Days

0 5 7 14 21 28 60

Tissue Healing Times in Days

Page 16: SUTURE AND NEEDLE TECHNOLOGY

Short-term Wound Support

• Situation in Short-term Wound Support • Skin & mucosa • Typically emergency procedures • Typically areas with increased blood flow

• Need • Fast-absorbing suture • Rapid loss of strength/mass • Good knot formation/snug down

Page 17: SUTURE AND NEEDLE TECHNOLOGY

1.Plain Gut Suture

Characteristics Surgical Gut Suture – Plain Material Beef Serosa or Sheep Submucosa Natural/Synthetic Natural Construction “Monofilament” Absorbable Coating Not Coated

Color Yellowish - Tan

Available Size Range 3 – 7/0, Fast Absorbing Gut sizes 5/0 - 6/0

Strength Retention Profile Approximately 7 - 10 days post-op Fast Absorbing Gut = Approximately 5 – 7 days post-op

Absorption Time Absorbed in 70 days, Fast Absorbing Gut in 21-42 days

Absorption Process Proteolytic enzymatic digestion

Frequent Uses Ligation of superficial vessels; suture subcutaneous and tissues that heal rapidly. Ophthalmology. Dermal (skin) suturing only.

Page 18: SUTURE AND NEEDLE TECHNOLOGY

2.Chromic Gut Suture

Characteristics Surgical Gut Suture - Chromic Material Beef Serosa or Sheep Submucosa Natural/Synthetic Natural Construction Monofilament Absorbable (with Chromic Salts) to slow absorption Coating Not Coated

Color Natural Brown and Dyed Blue

Available Size Range 3 – 7/0

Strength Retention Profile Strength retention for approximately 21 – 28 days post-op

Absorption Time Absorbed in 90 days

Absorption Process Proteolytic enzymatic digestion

Frequent Uses Ligation of superficial vessels; suturing of subcutaneous and other rapid healing tissues. Ophthalmology.

Page 19: SUTURE AND NEEDLE TECHNOLOGY

3. VICRYL RAPIDE Suture (coated)

Characteristics VICRYL RAPIDE Suture Material Polyglactin 910. Copolymer of 90% glycolide and 10% L-lactide Natural/Synthetic Synthetic Construction Braided Absorbable Coating 50% Polyglactin 370 and 50% Calcium Stearate

Color Undyed – Natural Beige Available Size Range 1 through 5/0

Strength Retention Profile 50% of original strength remains @ 5 days post-op 0% @ 14 days post-op

Absorption Time Essentially completely absorbed in 42 days

Absorption Process Hydrolysis

Frequent Uses Superficial soft tissue approximation of the skin and mucosa where short term wound support is required

Page 20: SUTURE AND NEEDLE TECHNOLOGY

Short-Medium-Term Wound Support

• Situation in Short-Medium-term Wound Support • Skin, mucosa, subcuticular • Ideal for subcuticular tissue closure • Typically areas with increased blood flow

• Need • High initial strength • Good cosmesis • Good handling & smooth passage through tissue • Good knot formation/snug down • Low reactivity

Page 21: SUTURE AND NEEDLE TECHNOLOGY

4. MONOCRYL Suture

Characteristics MONOCRYL Suture

Material Poliglecaprone 25 (copolymer of glycolide and e-Caprolactone)

Natural/Synthetic Synthetic Construction Monofilament Absorbable Coating Not Coated Color Undyed - Beige and Dyed - Violet Available Size Range 1 through 6/0

Strength Retention Profile

Undyed - 50-60% @ 7 days post-op 20-30% @ 14 days post-op Dyed - 60-70% @ 7 days post-op 30-40% @ 14 days post-op

Absorption Time Essentially complete in 91-119 days

Absorption Process Hydrolysis Frequent Uses General soft tissue approximation and/or ligation.

Page 22: SUTURE AND NEEDLE TECHNOLOGY

5. MONOCRYL Plus Suture Characteristics MONOCRYL Plus Suture

Material Poliglecaprone 25 (copolymer of glycolide and e-Caprolactone) TRICLOSAN

Natural/Synthetic Synthetic Construction Monofilament Absorbable Coating Not Coated Color Undyed - Beige and Dyed - Violet Available Size Range 1 through 6/0

Strength Retention Profile

Undyed - 50-60% @ 7 days post-op 20-30% @ 14 days post-op Dyed - 60-70% @ 7 days post-op 30-40% @ 14 days post-op

Absorption Time Essentially complete in 91-119 days Absorption Process Hydrolysis Frequent Uses General soft tissue approximation and/or ligation.

Page 23: SUTURE AND NEEDLE TECHNOLOGY

MONOCRYL Plus Suture

• Bactericidal – kills bacteria • Bacteriostatic – inhibits bacteria growth • Kills • Staphylococcus aureus • Staphylococcus epidermidis • Methicillin-resistant Staphylococcus aureus (MRSA) • Methicillin-resistant Staphylococcus epidermidis (MRSE) • E. coli • Klebsiella pneumoniae

• The performance, safety and handling are equivalent to MONOCRYL Suture

Page 24: SUTURE AND NEEDLE TECHNOLOGY

How Did We Do It?

• Tyvek patch • Contains triclosan which is

absorbed by the suture during the sterilization process • As a result, ETHICON, INC.

has an improved claim against additional pathogens/bacteria

• MONOCRYL Suture doesn’t know it is MONOCRYL Plus Suture until the tyvek patch is added

Page 25: SUTURE AND NEEDLE TECHNOLOGY

Medium-term Wound Support

• Situation in Medium-term Wound Support • All tissue layers that align with the critical wound healing period of

21-28 days • All tissue types

• Need • Consistent strength around the CWHP • Good handling & passage through tissue • Good knot formation/snug down • Low reactivity

Page 26: SUTURE AND NEEDLE TECHNOLOGY

5. Coated VICRYL Suture

Characteristics Coated VICRYL Suture

Material Polyglactin 910 (copolymer of glycolide and L-lactide)

Natural/Synthetic Synthetic Construction Braided Absorbable Coating 50% Polyglactin 370 and 50% Calcium Stearate Color Violet and Undyed – Natural Beige Available Size Range 3 through 10/0

Strength Retention Profile 75% of original strength @ 14 days post-op 50% of original strength @ 21 days post-op 25% of original strength @ 28 days post-op

Absorption Time Essentially absorbed in 56 – 70 days Absorption Process Hydrolysis Frequent Uses General soft tissue approximation and/or ligation, including use in ophthalmology

Page 27: SUTURE AND NEEDLE TECHNOLOGY

6. Coated VICRYL Plus Suture

Characteristics Coated VICRYL Plus Suture

Material Polyglactin 910 (copolymer of glycolide and L-lactide)

Natural/Synthetic Synthetic

Construction Braided Absorbable Coating Polyglactin 370, calcium stearate and IRGACARE MP (triclosan) Color Violet and Undyed – Natural Beige Available Size Range 2 through 5/0

Strength Retention Profile 75% of original strength @ 14 days post-op 50% of original strength @ 21 days post-op 25% of original strength @ 28 days post-op

Absorption Time Absorbed in 56 – 70 days Absorption Process Hydrolysis Frequent Uses General soft tissue approximation and/or ligation

Page 28: SUTURE AND NEEDLE TECHNOLOGY

Coated VICRYL Plus Suture

• Bactericidal – kills bacteria • Bacteriostatic – inhibits bacteria growth • Kills • Staphylococcus aureus • Staphylococcus epidermidis • Methicillin-resistant Staphylococcus aureus (MRSA) • Methicillin-resistant Staphylococcus epidermidis (MRSE)

• Different bacteria claim than MONOCRYL Plus Suture

Page 29: SUTURE AND NEEDLE TECHNOLOGY

Coated VICRYL Plus Suture

• Frequently Asked Questions • Does the triclosan wear off as it passes through the tissue? • Allergic reactions • Does it affect wound healing? • The performance and handling are equivalent to Coated VICRYL

Suture.

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Plus Antibacterial Sutures

• Coated VICRYL Plus Suture •  minimum of 7 days

• PDS* Plus Antibacterial (polydioxanone) Suture •  23 days S. aureus •  17 days E. coli

• MONOCRYL Plus Suture •  31 days S. aureus •  21 days for E. coli

Page 31: SUTURE AND NEEDLE TECHNOLOGY

Triclosan

• Is it safe? • Is it being overused and/or misused? • Does triclosan promote antibiotic resistance?

Page 32: SUTURE AND NEEDLE TECHNOLOGY

Longer-Term Wound Support

• Situation in Longer-term Wound Support • Tissue that requires extended support • Slow healing tissue/ compromised patients • Typically fascia tissue

• Need • Strength beyond the CWHP of 21 days • Good handling & passage through tissue • Good knot formation/snug down • Low reactivity

Page 33: SUTURE AND NEEDLE TECHNOLOGY

7. PDS II Suture

Characteristics PDS II Suture Material Polydioxanone Natural/Synthetic Synthetic Construction Monofilament Absorbable Coating Not Coated Color Undyed Clear and Dyed Violet

Available Size Range 2 through 9/0 dyed 1 through 7/0 undyed

Strength Retention Profile

Size 4-0 and smaller Size 3-0 and larger 60% of original strength @ 2 weeks post-op 80% @ 2 weeks 40% of original strength @ 4 weeks post-op 70% @ 4 weeks 35% of original strength @ 6 weeks post-op 60% @ 6 weeks

Absorption Time 182-238 days (6-8 months) Absorption Process Hydrolysis

Frequent Uses Soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur; ophthalmic surgery, fascia closure

Page 34: SUTURE AND NEEDLE TECHNOLOGY

8.PDS Plus Suture

Characteristics PDS Plus Suture Material Polydioxanone

IRGACARE MP (triclosan) Natural/Synthetic Synthetic Construction Monofilament Absorbable Coating Not Coated Color Undyed Clear and Dyed Violet Available Size Range 2 through 9/0 dyed

1 through 7/0 undyed Strength Retention Profile Size 4-0 and smaller Size 3-0 and larger

60% of original strength @ 2 weeks post-op 80% @ 2 weeks 40% of original strength @ 4 weeks post-op 70% @ 4 weeks 35% of original strength @ 6 weeks post-op 60% @ 6 weeks

Absorption Time 182-238 days (6-8 months) Absorption Process Hydrolysis Frequent Uses Soft tissue approximation, including use in pediatric cardiovascular tissue

where growth is expected to occur; ophthalmic surgery, fascia closure

Page 35: SUTURE AND NEEDLE TECHNOLOGY

PDS Plus Antibacterial Suture

• Bactericidal – kills bacteria • Bacteriostatic – inhibits bacteria growth • Kills • Staphylococcus aureus • Staphylococcus epidermidis • Methicillin-resistant Staphylococcus aureus (MRSA) • Methicillin-resistant Staphylococcus epidermidis (MRSE) • E. coli • Klebsiella pneumoniae

Page 36: SUTURE AND NEEDLE TECHNOLOGY

PDS II Suture IFU Changes

• Old Data • 70% 2 weeks • 50% 4 weeks • 25% 6 weeks

• Absorption at 183 days

• New in vivo studies showed significant improvement in the breaking strength retention profile of PDS II Suture

• Both PDS II Suture and PDS Plus Suture

Page 37: SUTURE AND NEEDLE TECHNOLOGY

Non-Absorbable Suture Types

Surgical Stainless Steel

Monofilament

PERMA-HAND* Silk

Braided

Natural

ETHILON* PROLENE* PRONOVA

Monofilament

NUROLON* ETHIBOND EXCEL* MERSILENE

Braided

Synthetic

Non-Absorbable

Page 38: SUTURE AND NEEDLE TECHNOLOGY

9.PERMA-HAND* Silk Suture

Characteristics PERMA-HAND Suture Material Natural protein fibre of raw silk spun by silkworms Natural/Synthetic Natural Construction Braided Non-Absorbable Coating Bees wax Color Black and White Available Size Range 5 through 9/0 Strength Retention Profile Strength retention for approximately 1 year Absorption Time Non-Absorbable Absorption Process Non-Absorbable

Frequent Uses Ligation and general closure; general surgery. Ophthalmology, plastic surgery and neurosurgery

Page 39: SUTURE AND NEEDLE TECHNOLOGY

10.Surgical Steel Suture

Characteristics Surgical Steel Suture Material 316L Stainless Steel Natural/Synthetic Metal Alloy Construction Monofilament Non-Absorbable Coating Not Coated Color Metallic Silver Available Size Range 7 – 10/0 Strength Retention Profile Indefinite Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable

Frequent Uses Abdominal wall and skin closure; retention; tendon repair; orthopaedic & neurosurgery. Sternum closure in cardiovascular surgery

Page 40: SUTURE AND NEEDLE TECHNOLOGY

11.ETHILON* Nylon Suture

Characteristics ETHILON Suture Material Nylon 6 Natural/Synthetic Synthetic Construction Monofilament Non-Absorbable Coating Not Coated Color Black, Green and Clear Available Size Range 2 through 11/0 Strength Retention Profile Approximately 20% loss per year. Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable Frequent Uses Skin closure: retention; Plastic surgery, ophthalmology and microsurgery

Page 41: SUTURE AND NEEDLE TECHNOLOGY

12.ETHIBOND EXCEL Suture

Characteristics ETHIBOND EXCEL Suture Material Polyester Natural/Synthetic Synthetic Construction Braided Non-Absorbable Coating Polybutilate Color Green and White Available Size Range 5 through 7/0 Strength Retention Profile Indefinite Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable Frequent Uses General surgery, cardiovascular and plastic surgery; retention

Page 42: SUTURE AND NEEDLE TECHNOLOGY

13. MERSILENE Suture

Characteristics MERSILENE Suture Material Polyester Natural/Synthetic Synthetic Construction Braided and Monofilament Non-Absorbable Coating Not Coated Color Green and White

Available Size Range Braided 5 through 6/0 Monofilament 10/0 – 11/0

Strength Retention Profile Indefinite Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable Frequent Uses General surgery, cardiovascular and plastic surgery; retention

Page 43: SUTURE AND NEEDLE TECHNOLOGY

14. PROLENE* Polypropylene Suture

Characteristics PROLENE Suture Material Polypropylene Natural/Synthetic Synthetic Construction Monofilament Non-Absorbable Coating Not Coated Color Blue and Clear Available Size Range 2 through 10/0 Strength Retention Profile Indefinite Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable Frequent Uses General, plastic, cardiovascular surgery and skin closure; ophthalmology

Page 44: SUTURE AND NEEDLE TECHNOLOGY

15. PRONOVA * Poly (Hexafluoroprop- ylene - VDF) Suture

Characteristics PRONOVA Suture Material Polymer blend of poly (vinylidene fluoride) and poly (vinylidene fluoride-co-

hexafluoropolypropylene) Natural/Synthetic Synthetic Construction Monofilament Non-Absorbable Coating Not Coated Color Blue and Clear Available Size Range 2 through 10/0 Strength Retention Profile Indefinite Absorption Time Non-absorbable suture is encapsulated in tissues Absorption Process Non-Absorbable Frequent Uses Vascular anastomoses and general surgical indications

Page 45: SUTURE AND NEEDLE TECHNOLOGY

ETHICON Suture Material Colors • SUTURES COLOUR

• PLAIN GUT YELLOWISH TAN • CHROMIC GUT BROWN • MONOCRYL Suture CLEAR or VIOLET • Coated VICRYL Suture VIOLET or UNDYED (natural) • PDS II Suture VIOLET or CLEAR • SILK Suture BLACK • NUROLON Suture BLACK • ETHILON Suture BLACK (green or clear) • MERSILENE Suture GREEN or WHITE • ETHIBOND EXCEL Suture GREEN or WHITE • PROLENE Suture BLUE or CLEAR • PRONOVA Suture BLUE or CLEAR

Page 46: SUTURE AND NEEDLE TECHNOLOGY

Needles

Page 47: SUTURE AND NEEDLE TECHNOLOGY

Agenda

• Objectives • Characteristics of an Ideal Needle • Elements of Needle Design • Anatomy • Measurements of a Needle

Page 48: SUTURE AND NEEDLE TECHNOLOGY

Objectives

• Describe the characteristics of an ideal needle • Identify the elements of needle design • Explain the anatomy of a needle

Page 49: SUTURE AND NEEDLE TECHNOLOGY

Surgical Needles – Definition

• Surgical needles are necessary for the placement of sutures in tissues, therefore, they must be designed to carry suture material through tissues with minimal trauma

Page 50: SUTURE AND NEEDLE TECHNOLOGY

Characteristics of the Ideal Needle

• Made of high quality stainless steel • As slim as possible without compromising strength • Stable in the grasp of a needle holder • Able to carry suture material through tissue with

minimal trauma • Sharp enough to penetrate tissue with minimal resistance • Rigid enough to resist breaking during surgery • Sterile and corrosion - resistant to prevent introduction of

microorganisms or foreign materials into the wound

Page 51: SUTURE AND NEEDLE TECHNOLOGY

Elements of Needle Design – Strength

• Determined by how it resists deformation during repeated passage through tissue • Tissue trauma can be induced if a needle bends during

penetration • Compromises tissue apposition • Greater needle strength equals less

tissue trauma

Page 52: SUTURE AND NEEDLE TECHNOLOGY

Elements of Needle Design – Ductility

• Refers to the needle’s resistance to breaking under a given amount of bending • Needle breakage can prevent apposition of wound edges • Searching for a part of a broken needle can cause additional

trauma and add to anesthesia time

Page 53: SUTURE AND NEEDLE TECHNOLOGY

Elements of Needle Design – Sharpness

• Related to the angle of the point as well as the taper ratio of the needle • Too sharp and a surgeon may not feel they have adequate

control of needle passage • Too dull and a surgeon will face a less then desirable

cosmetic outcome

Page 54: SUTURE AND NEEDLE TECHNOLOGY

Elements of Needle Design – Stability

• Stability of the needle in the grasp of the needle holder • Rocking, twisting and turning gives less desirable cosmetic

outcomes

Page 55: SUTURE AND NEEDLE TECHNOLOGY

Elements of Needle Design – The ETHICON Advantage

• Strength: ETHALLOY* Needle Alloy/Manufacturing process • Ductility: Ethalloy alloy • Sharpness: MULTIPASS* Needles • Stability: Ribs/I-Beam

*Trademark

Page 56: SUTURE AND NEEDLE TECHNOLOGY

Anatomy

• Three basic components • The Eye • The Body • The Point

Page 57: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Eye

• The Eye • Closed eye • French eye (Split or Spring) • Swaged

• Disadvantages • Time consuming • Tissue disruption • Repeated use

Page 58: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Eye

• Swaged Needles • Drilled • Channeled • Advantages

• Handling and preparation are minimized • Minimal trauma • Security

• ETHICON’s swaged needles • ATRALOC* Surgical Needle • CONTROL RELEASE* Needle or Needle Suture - facilitates fast

separation when desired

*Trademark

Page 59: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Body

• Straight Needle • Half-Curved Needle • Curved Needle • Compound Curve Needle (80º tip, 45 º body)

Page 60: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Body

• Straight Needle • Preferred when suturing easily accessible tissue • Skin closure, meniscus repair, tendon repair, nerve repair and

in ophthalmic cases

Page 61: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Body

• Half-Curved Needle (Ski Needle) • Skin closure • Laparoscopic procedures

Page 62: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Body

• Curved Needle • Allow predictable turnout • Requires less space

for maneuvering • 1/4 Circle • 3/8 Circle • 1/2 Circle • 5/8 Circle

Page 63: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Body

• Compound Curve Needle • Ophthalmic Surgery

Page 64: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Needle Points • Conventional Cutting Needles • Reverse Cutting Needles • Side Cutting Needles (Spatula Needles) • Taper Point Needles • Tapercut Needles • Blunt Point Needles • ETHICON Needle Codes

Page 65: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Conventional Cutting Needles •  Two cutting edges plus a third cutting edge on the inside concave

curvature of the needle •  Prone to cutout of tissue because the inside edge cuts to the edges

of the incision or wound •  PC PRIME* Needle

(Precision Cosmetic) • Narrow point • Fine wire diameter • Fine taper ratio

*Trademark

Page 66: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Reverse Cutting Needles • The third cutting edge is located on the outer convex curvature

of the needle • More strength than similar-sized Conventional

Cutting Needles • Danger of cutout is greatly reduced • The hole left by the needle

leaves a wide wall of tissue against which the suture is to be tied • ETHICON Needles

• MICRO-POINT* Surgical Needle • OS Needle • FS/PS Series

*Trademark

Page 67: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Side Cutting Needles (Spatula Needles) • Flat on both the top and bottom-eliminates undesirable tissue cutout • Designed for Ophthalmic procedures to separate or split through the

layers of scleral or corneal tissue • ETHICON’s needles

• SABRELOC* Spatula Needles • CS ULTIMA*

Ophthalmic Needles • TG PLUS

*Trademark

Page 68: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Taper Point Needles • Round bodied needles that pierce and spread tissue without cutting it • Needle point tapers to a sharp tip and the needle body flattens to an

oval or rectangular shape • Used in easily penetrated tissue when the smallest hole and minimal

tissue cutting is desired.

Page 69: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Tapercut needles • Combines the features and benefits of the reverse cutting edge tip

and taper point needles. • Three cutting edges extend approximately 1/32” back from the point.

These blend into a round taper body. • Penetrates dense, tough tissue without exceeding the diameter of the

suture material. The taper body portion provides smooth passage through tissue and eliminates the danger of cutting into surrounding tissue • Ethicon’s needles

• V Series • CC Series

Page 70: SUTURE AND NEEDLE TECHNOLOGY

Anatomy – The Point

• Blunt Point Needles • Dissect friable tissue rather than cutting it • Taper body with a rounded, blunt point that will not cut tissue • Used when suturing the kidney, liver or in deep spaces prone to

space and visibility limitations • ETHIGUARD* Blunt Point Needles

*Trademark

Page 71: SUTURE AND NEEDLE TECHNOLOGY

ETHICON Needle Codes

Page 72: SUTURE AND NEEDLE TECHNOLOGY

Measurements of a Needle

• Determine the size of a needle • Measured in inches or in metric units • Chord Length – the straight line distance from the point to the swage • Needle Length – the distance measured along the needle itself from

the point to the end • Radius – the distance from the center of the circle to the body of the

needle if the curvature of the needle were continued to make a full circle • Diameter – the gauge or thickness of the needle wire

Page 73: SUTURE AND NEEDLE TECHNOLOGY

Measurements of a Needle

Page 74: SUTURE AND NEEDLE TECHNOLOGY

Packaging

Page 75: SUTURE AND NEEDLE TECHNOLOGY

Agenda

• Packaging Overview • Relay System • Modular Suture Storage Racks • Dispenser Boxes • Primary Packets

• Expiration Date • Suture Sterilization • Anticipating Suture Needs • Sterility • Handling

Page 76: SUTURE AND NEEDLE TECHNOLOGY

Objectives

• Identify each part of the product code • Identify product boxes • Explain what product is each dispenser box

Page 77: SUTURE AND NEEDLE TECHNOLOGY

Packaging Overview

Page 78: SUTURE AND NEEDLE TECHNOLOGY

Integral Part of Each Product

• Protect content • Provide convenience to the user • Sterile products

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Purpose

• Protect and preserve product • Prevent product damage • Provide identifiable product information • Convenient, safe and sterile transfer of the product • Meet the needs of all members of surgical team

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RELAY* Suture Delivery System

Page 81: SUTURE AND NEEDLE TECHNOLOGY

RELAY Delivery System

• Developed by ETHICON • Stores and delivers sutures • Reduces unnecessary handling • Provides control over suture storage, usage, inventory

rotation, needle counting and cost containment

Page 82: SUTURE AND NEEDLE TECHNOLOGY

Dispenser Boxes

• Dispenses sutures from opening at bottom of box • Product information on side of box • Three most important criteria • Suture size • Suture material • Type and size of needle

Page 83: SUTURE AND NEEDLE TECHNOLOGY

Additional Information

• Surgical application • Product code number • Suture size • Metric equivalent • Shape and quantity

of needles • Needle point geometry • Lot number • Expiration date

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Product Code Number

• The first letter of the product code denotes the suture type • Absorbable

• VR – VICRYL RAPIDE Suture • Y – MONOCRYL Suture • J – Coated VICRYL Suture • V – Uncoated VICRYL Suture • Z – PDS II Suture

• Non-Absorbable • G – Green ETHILON Suture • X – ETHIBOND EXCEL Suture • R – MERSILENE Suture • A – Silk Strands

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Product Code Number

• The last letter of the code denotes the number in each box

• G – 1 dozen • D – 1 dozen • T – 2 dozen • H – 3 dozen

• The numbers denote suture/needle combo

• Length • Color • Needle

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Suture Material

• Material • Suture materials are designated by

color and construction characteristics (e.g. undyed, braided, etc.)

• Length • Suture length is shown in both inches

and the approximate metric equivalent

• Color • Suture material can be dyed

or undyed

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Needle Types

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Color Code Information

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Package Insert • The package insert found inside

of each new box of suture product is a very valuable tool to find the following information • Description – materials used to

make suture • Indication – recommended tissues

where the suture is to be used • Actions – how suture acts when used • Contraindications – where suture

should not be used • Warnings – important considerations • Precautions • Adverse Reactions • How Supplied

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Primary Packets

• Individual sutures and multiple suture strands • Fast and easy opening in a peelable motion • Single layer over wrap made of foil or coated Tyvek on one

side to polyethylene film on the other • Absorbable sutures are always

in foil to provide a moisture barrier • Most non-absorbable sutures

are encased in Tyvek

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Primary Packets

• Product information • Color code information • Product code number • Material • Size • Needle type • Number of needles per packet

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Primary Packets

3.  One single-strand of material with single- or double-armed swaged needle(s) • One-step RELAY suture

packets • Allows the needle to be

armed without touching it •  Increases the safety of

handling needles intraoperatively

• Needle park • Provides a standard

location for, and easy access to, the needle

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Primary Packets

4.  Multiple suture strands •  Swaged to a single-needle or double-armed •  For procedures requiring numerous interrupted sutures •  Saves time •  Labeled with the symbol MS •  May contain 3 – 10 swaged sutures

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Expiration Date

• Determined by product stability studies • FDA requires all synthetic absorbable suture products have

an expiration date • Synthetic absorbable sutures continue to meet requirements

even at five years of storage • RELAY System is design as FIFO inventory control system

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Sterilization

• Sutures sterilized are either irradiated with cobalt 60 or exposed to ethyl oxide gas • Alter proteins, enzymes and other components • Cold sterilization

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Irradiated Sterilization

• Exposes products to ionizing radiation • Beta rays produced by high energy electron accelerators OR • Gamma rays from radioisotopes

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Gas Sterilization

• Products that cannot withstand the effects of irradiation are gas sterilized • Uses ethylene oxide gas • ETHICON replaces CFCs with more environmentally friendly

compounds

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Resterilization

• DO NOT RESTERILIZE • Packaging and product cannot withstand high temperatures or

extreme pressure without affecting integrity • ETHICON will disclaim any responsibility for sterilization and/or other

product failures resulting from resterilization • Only ETHI-PACK* Pre-cut Steel Sutures and spools or card

reels of nonabsorbable materials should be sterilized

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Anticipating Customer Needs

• Maintain quality standards while lowering costs • Anticipate surgeon’s needs • Surgeon preference cards

• Surgeon’s suture routine • Suture materials • Sizes • Needles • Product code numbers

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Factors to consider when deciding on number of suture packets necessary

• Multiple strands of suture material = fewer packets • Opening sufficient packets for time’s sake • Leftover sutures, must be discarded

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Hand-off Method

• Grasp the two flaps of peelable overwrap • Peel flaps apart 1/3 of the way down • Scrub person takes it with gloved hand or sterile instrument • Avoiding contact with the nonsterile overwrap

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Flipping Method

• Flipping is a rapid and efficient method of ejecting sterile product from its overwrap onto the sterile field without contacting the unsterile outer packet or reaching over the field

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Suture Preparation

• Sequence of tissue layers • Organize sutures in sequence • Goal should be to have no unused strands at the end

of the procedure

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Preservation of Tensile Strength

• Absorbable sutures • Protect absorbable sutures from heat and moisture

• Store at room temp • Do not soak • Surgical gut can be dipped in tepid water • Synthetic absorbable sutures must be kept dry

• Straighten strands with a gentle, steady, even pull • Do not “test” suture strength • Do not resterilize

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Preservation of Tensile Strength

• Nonabsorbable sutures • Silk – store strands in a dry towel. Dry strands are stronger than

wet strands • Surgical Stainless Steel – handle carefully to avoid kinks and bends • Polyester Fiber – unaffected by moisture. May be used wet or dry • Nylon – straighten kinks or bends by caressing strand between

gloved fingers • Polypropylene – unaffected by moisture. May be used wet or dry

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• THANK YOU ALL

• THANKS TO ETHICON, INC • A JOHNSON & JOHNSON COMPANY