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1. INDIAN DENTAL ACADEMY
Leader in continuing dental education
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2. Abstract
Accidental sticks from suture needles are an
unpublicized but common problem for anyone
involved in suturing. Designing a suture needle that
has activated and deactivated states could
significantly decrease transmission of diseases, such
as Hepatitis C or HIV-1, as a result of accidental
sticks with a contaminated needle. A safe suture
needle does not exist in the market today. The JABE
200, a hollow sheath with two cutaways that expose
a fluid filled balloon connected to a sharp metal tip,
is only armed when the needle holder clamps down
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3. on the balloon, forcing the metal tip to protrude from
the sheath. When the holder is unclamped, this
“safer” suture needle would be unable to puncture
the user’s skin because the sharp metal tip is
retracted into the sheath. Future work includes
making smaller scale prototypes and testing the
mechanism on various types of tissues.
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4. Problem Statement
In order to prevent accidental needle “sticks” to a
medical staff member, a reversibly arming suture
needle must be developed. The device must
encompass all features of a conventional needle
with the added safety of needle retraction. The
goal is to permanently eliminate the risk of needle
puncture and infection to the operator during
procedures.
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5. Demand for a Safer Suture




Suture injuries account for 30% of injuries to
physicians, a higher percentage than any other sharp
object
Contaminated suture needles account for 96% of
injury-causing needles
56% of injuries occur during use
Palm side of left hand is most common site of injury—
about 45% occur here
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6. 
Needle injuries cause transmission of HIV-1,
Hepatitis C, and other bloodborne pathogens

Patents



Dr. Sidney Sontag
No known needle on the market that has a position
in which it cannot puncture skin
Large Market Potential for Safe Suture Needle
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7. Existing Technology

Blunted needles



Ethicon
Auto Suture Company
Cut- or puncture-resistant gloves and glove liners




Genibel Glove Company
ViaGARD Medical Products
Whizard Protective Wear
Zimmer Patient Care division
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8. Difficulties




Arranging first meeting with client
Delays in hearing from industry
representatives
Existing patents to our promising design
ideas
Deciding on a final design
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9. Needle Anatomy and Choice

Three Needle Parts: Point,
Body and Swage

Wide Variety of Needle
Points



(A) Cutting: Skin, Muscle,
Bone
(B) Blunt: Alternative to
sharp cutting-edge needle
(C) Tapered: Thin Tissue,
Peritoneum, GI Tract
A
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B
C

10. Suturing Techniques




Proper handling and choice of suturing needles and
tools (needle holder positioning) is critical (Figure 1)
Superficial Skin Wounds:

Interrupted Suture Stitch
Deep Subcutaneous Wounds:

Vertical Mattress Suture (double pass, Figure 2)
Wound-Edge Eversion:
 Securing tissue properly so scars become less
visible (Figure 3)
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11. Suturing Techniques
¼ distance
Figure 1
Figure 3
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Figure 2

12. Suturing Techniques: Tying
Knotting Technique:



1.
High Risk of Needle
Puncture from rapid
hand movement
Double tying surgeons 2.
knot
Wrap suture material
around needle holder
three times and pull
needle away from
surgeon
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3.
4.

13. Manufacturing A Needle
1. Stainless Steel (T316L) wire
drawn to diameter (Figure 4)
2. Wire cut to desired length
3. Sharpening of Point (Figure 5)
Figure 4
4. Hardening & tempering
5. Swage end drilled hollow;
suture material clamped in
6. Final point sharpening
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Figure 5

14. Properties of Skin

Heterogeneous, layered structure (Figure 6)




Epidermis prevents water loss
Dermis provides most of bulk and strength
Collagen most abundant material in dermis
(Figure 7)
Cellular elements only 10-20% tissue volume
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15. Properties of Skin
Figure 6 (left). Structure of the skin. The
skin consists of two layers—the superficial
epidermis and the deeper dermis (Corrin,
2001).
Figure 7 (top). Structure of collagen.
Collagen, the primary structural material of
skin, is a protein consisting of three
polypeptide strands arranged in a triple helix
(Walshaw, 2001).
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16. Design Compromise:
Safety and Ease of Use
Ease
of Use
C o n c e n tr ic
T ip
JA B E 200
L im itin g
S h e a th
S a fe ty
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17. Alternative Designs:
Limiting Sheath

Strengths


Increases operator
awareness
Weaknesses



Extra step
Small hinge required
Requires consistent
tissue thickness
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18. Alternative Designs:
Trigger-Activating Needle

Strengths



Arming only slight
variation from procedure
Requires no additional
equipment
Weaknesses


Patent already exists
Possible structural
concerns
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19. Alternative Designs:
Concentric Sheath Tip

Strengths


Automatic arming
Weaknesses


Automatic arming
Could trap tissue
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20. JABE 200 TS—



Resulted from a further iteration of design
process after prototyping
Combination of limiting sheath and trigger
activated designs
Overview:



Outer metal sheath with bilateral windows
Fluid filled balloon-like trigger
Mobile inner needle tip attached to one end of
balloon
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21. Mechanism and Explanation




Needle holder placed at windows in sheath
Tightening needle holder forces fluid
within balloon into body of sheath
Pressure of the fluid causes the tip to
protrude out of end of sheath
When pressure on needle holder is released,
needle tip retracts into sheath
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22. Advantages of JABE 200




Defaults to “disarmed” position, requiring
user to consciously activate the tip
Arming mechanism varies little from current
procedure, so no technique change necessary
Requires no additional equipment
Basic concept independently conceived by
two different medical professionals
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23. Disadvantages of JABE 200




Small balloon size will be difficult to
manufacture and may curtail volume changes
Does not protect when needle initially exits
Increased cost
Selecting one cutaway location that
accommodates every user will be challenging
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24. Progressive Prototyping


Crude models made of preliminary concepts
Models inspired JABE 200



Water-filled dropper bulbs, metal connector, and heat
shrink comprise balloon arming mechanism
PVC tubing bent to form sheath
Nail, clay, and LDPE tubing comprise needle
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25. Elizabeth fitting the
“Trigger-activated”
model with a metal
plate
Briar & Elizabeth
cutting leaves in the
“Concentric Tip”
design
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26. Jeff & Angela
carefully filling
dropper bulbs with
water
Shaping PVC with
the Dremel® tool
created a lot of dust
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27. Future for Team SWAGE
Design Refinement, Testing and Evaluation




Further volume displacement and material
strength research
Determining proper wall thicknesses
Prototyping on a smaller scale
Testing on fabric and living tissues to evaluate
amount of tissue trauma and force requirements
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28. Needle Manufacturing, Design and Patenting





Production of actual-sized needle design
Testing and evaluation of needle on tissue samples
having a variety of wound geometries.
Veterinary or Hospital surgery staff trials
Final needle refinements
Patenting process
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29. References
• Corrin, L. A. 10 October 2001. “Skin Structure”.
http://www.geocities.com/ukhsgroup/skinstructure.htm.
• Haughton, Victor, personal communication, 8 October 2001.
• International Health Care Worker Safety Center . 9 October 2001. “Sharp
object injury reports by category”. http://hsc.virginia.edu/epinet/soi.html.
• NVC Communications Co. (15 October 2001). Needles: The Manufacturing
Process [On-line]. Available http://www.nvccom.co.jp/needle/pro.html.
• Trott, A.T. Wounds and Lacerations: Emergency Care and Closure. 2nd ed.
Mosby-Year Book, St. Louis. 1997.
• Walshaw, J. (15 October 2001) Tertiary Structure—Fibrous and Structural Proteins.
Available http://www.cryst.bbk.ac.uk/PPS95/course/7_tertiary/struc.html
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30. Acknowledgements
We would like to give special thanks to the
following individuals for helping us throughout
the design process:



Dr. Victor Haughton
Dr. Sidney Sontag
Mitchell Tyler
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31. Thank you
For more details please visit
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