title: Sealing vessels up to 7 mm in diameter solely with ultrasonic technology.
abstract: BACKGROUND
  Ultrasonic energy is a mainstay in the armamentarium of surgeons, providing multifunctionality, precision, and control when dissecting and sealing vessels up to 5 mm in diameter. Historically, the inability to seal vessels in the 5-7 mm range has been perceived as an inherent limitation of ultrasonic technology. The purpose of this study was to evaluate sealing of vessels up to 7 mm in diameter with an ultrasonic device that modulates energy delivery during the sealing period.
  
  
  METHODS
  In ex vivo benchtop and in vivo acute and survival preclinical models, a new ultrasonic device, Harmonic ACE(®)+7 Shears (Harmonic 7), was compared with advanced bipolar devices in sealing vessels 1-7 mm in diameter with respect of burst pressure, seal reliability, and seal durability. Lateral thermal damage and transection time were also evaluated.
  
  
  RESULTS
  Ex vivo tests of Harmonic 7 demonstrated significantly greater median burst pressures than an advanced bipolar device both for vessels <5 mm in diameter (1,078 mmHg and 836 mmHg, respectively, P=0.046) and for those in the range of 5-7 mm (1,419 mmHg and 591 mmHg, P<0.001). In vivo tests in porcine and caprine models demonstrated similar rates of hemostasis between Harmonic 7 and advanced bipolar devices, with high success rates at initial transection and seal durability of 100% after a 30-day survival period.
  
  
  CONCLUSIONS
  Sealing 5-7 mm vessels is not a limitation of the type of energy used but of how energy is delivered to tissue. These studies document the ability of ultrasonic energy alone to reliably seal large vessels 5-7 mm in diameter, with significantly greater burst pressure observed in in vitro studies than those observed with an advanced bipolar technology when energy delivery is modulated during the sealing cycle. Furthermore, the seals created in 5-7 mm vessels are shown to be reliable and durable in in vivo preclinical studies.
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Timm
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Ryan M
authors.initials: RM
authors.lastname: Asher
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Karalyn R
authors.initials: KR
authors.lastname: Tellio
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Alissa L
authors.initials: AL
authors.lastname: Welling
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clymer
authors.affiliation: Ethicon Inc., Cincinnati, OH, USA.
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Amaral
keywords: 7 mm; Harmonic; burst pressure; ultrasonic; vessel sealing
references.citation: J Surg Res. 2011 May 15;167(2):e177-84
references.pmid: 21324491
references.citation: J Laparoendosc Adv Surg Tech A. 2013 Aug;23(8):669-72
references.pmid: 23755852
references.citation: Gut. 1991 Feb;32(2):188-90
references.pmid: 1864540
references.citation: Med Devices (Auckl). 2013 Sep 16;6:151-4
references.pmid: 24072978
references.citation: J Surg Res. 2014 Jan;186(1):73-80
references.pmid: 24035229
references.citation: Br J Neurosurg. 2012 Dec;26(6):856-63
references.pmid: 22742665
references.citation: Surg Endosc. 2009 Jan;23(1):90-6
references.pmid: 18483824
references.citation: Urology. 2008 Apr;71(4):744-8
references.pmid: 18289646
references.citation: Surg Innov. 2010 Jun;17(2):85-91
references.pmid: 20504782
references.citation: J Mech Behav Biomed Mater. 2014 Feb;30:41-9
references.pmid: 24231188
references.citation: Br J Oral Maxillofac Surg. 2008 Jun;46(4):265-9
references.pmid: 18342999
references.citation: J Urol. 2003 Feb;169(2):697-700
references.pmid: 12544345
references.citation: J Laparoendosc Adv Surg Tech A. 2012 May;22(4):378-86
references.pmid: 22364404
references.citation: Surg Endosc. 2012 Dec;26(12):3626-33
references.pmid: 22773229
references.citation: Surg Endosc. 2002 May;16(5):814-9
references.pmid: 11997829
references.citation: Surg Endosc. 2011 Feb;25(2):577-85
references.pmid: 20614136
references.citation: Ann Surg. 2002 Jan;235(1):27-30
references.pmid: 11753039
references.citation: Gastrointest Endosc. 2008 Mar;67(3):502-8
references.pmid: 18294513
references.citation: J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):605-10
references.pmid: 18640881
references.citation: Ultrasound Med Biol. 2003 Feb;29(2):301-9
references.pmid: 12659918
references.citation: Surg Gynecol Obstet. 1965 Oct;121(4):823-31
references.pmid: 5320121
references.citation: Surg Endosc. 2008 Mar;22(3):750-6
references.pmid: 17694412
references.citation: Surg Radiol Anat. 2012 Dec;34(10):973-5
references.pmid: 22820922
references.citation: PLoS One. 2013 Sep 18;8(9):e73032
references.pmid: 24058457
references.citation: Head Neck. 2013 Apr;35(4):535-40
references.pmid: 22522305