SAFE USE OF ENERGIES IN LAPAROSCOPY

REVAZ BOTCHORISHVILI MD

DEPARTMENT OF GYNECOLOGICAL SURGERY

UNIVERSITY HOSPITAL OF CLERMONT-FERRAND,

INTERNATIONAL CENTER FOR ENDOSCOPIC

SURGERY (CICE)

FRANCE

ENERGIES IN SURGERY

‣ ELECTRICAL

‣MECHANICAL

‣ PLASMA

‣ LASER

‣HYDRIC

ELECTRICAL ENERGY

MONOPLAR = NON SPECIFIC INSTRUMENATION

‣HOOK, NEEDLE, ......

‣«ARGON BEEM»

‣BIPOLAR = SPECIFIC INSTRUMENTATION

‣«KLEPPINGER»

‣«RO BI»

‣«LIGASURE»

‣«BICLAMP» «BICISION»

‣«PLASMAKINETIC»

‣.......

MECHANICAL ENERGY‣«ULTRACISION»

‣«HARMONIC»

‣«LOTUS»

‣MIXTE DEVICE BIPOLAR-ULTRASONIC «THUNDERBEAT»

‣....

PLASMA ENERGY‣«PLASMAJET»

2015

Ignorance of electrosurgery among obstetriciansand gynaecologists

Zorana Mayooran,a Scott Pearce,b Jim Tsaltas,b Luk Rombauts,b T. Ian H. Brown,a

Anthony S. Lawrence,b Kym Fraser,c David L. Healyb

Objective The purpose of this study was to assess the level of skill of laparoscopic surgeons in electrosurgery.

Design Subjects were asked to complete a practical diathermy station and a written test of electrosurgicalknowledge.

Setting Tests were held in teaching and non-teaching hospitals.

Sample Twenty specialists in obstetrics and gynaecology were randomly selected and tested on the MonashUniversity gynaecological laparoscopic pelvi-trainer. Twelve candidates were consultants with 9–28 yearsof practice in operative laparoscopy, and 8 were registrars with up to six years of practice in operativelaparoscopy. Seven consultants and one registrar were from rural Australia, and three consultants were fromNew Zealand.

Methods Candidates were marked with checklist criteria resulting in a pass/fail score, as well as a weightedscoring system. We retested 11 candidates one year later with the same stations.

Main outcome measures No improvement in electrosurgery skill in one year of obstetric and gynaecologicalpractice.

Results No candidate successfully completed the written electrosurgery station in the initial test. A slightimprovement in the pass rate to 18% was observed in the second test. The pass rate of the diathermy stationdropped from 50% to 36% in the second test.

Conclusion The study found ignorance of electrosurgery/diathermy among gynaecological surgeons. One yearlater, skills were no better.

INTRODUCTION

Electrosurgery units have become a necessity in operatingtheatres. Stray current resulting from insulation failure, directcoupling, capacitive coupling and other malfunction ofelectrosurgical units may compromise patient safety. At the1993 meeting of the American College of Surgeons, 54% ofthe 506 surgeons surveyed reported they knew of a colleaguewho had encountered electrosurgery complications.1 Thesetypes of incidents are prevalent in laparoendoscopic proce-dures, where a surgeon’s field of view restricts the visibilityof an electrosurgical instrument to only its tip. Injuries to

non-targeted tissues are therefore unnoticed as they occuralong the shaft of the instrument and are unrecognised. Theyare often diagnosed post-operatively if the patient presentswith peritonitis, haemorrhage, organ or vessel perforation orinfection.2

Electrosurgical incidents arising from stray currents canbe minimised with the use of appropriate technology suchas return electrode monitoring systems, active electrodemonitoring units and tissue response generators.3–5 Thesemeasures will not, however, prevent all electrosurgicalburns. Additional contributors to electrosurgical incidentsare poor technique and inadequate knowledge of theprinciples of electrosurgery. Surgeons must therefore beprovided with adequate training in electrosurgery.3

Surgeons must be aware of the type and age of theelectrosurgical unit used, its safety mechanisms, the oper-ative environment and the type of tissue cauterised as theyare legally responsible. Oxygen-enriched atmospheres inotolaryngology, for instance, require minimal power settingsand sparing use of supplemental oxygen in an effort toprevent flash fires.6 In open surgery, non-hazardousoperating environments are essential. A patient treatedfor appendicitis was set on fire caused by the heat from theelectrosurgical instrument which ignited a skin cleaningsolution. The flames were doused with a couple of buckets

BJOG: an International Journal of Obstetrics and GynaecologyDecember 2004, Vol. 111, pp. 1413–1418

D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology www.blackwellpublishing.com/bjog

aDepartment of Electrical and Computer SystemsEngineering, Monash University, Clayton, Victoria,AustraliabDepartment of Obstetrics and Gynaecology, MonashUniversity, Clayton, Victoria, AustraliacInstitute for the Advancement of University Learning,Oxford University, UK

Correspondence: Professor D. L. Healy, Department of Obstetrics andGynaecology, Monash University, Monash Medical Centre, Level 5, 246Clayton Road, Clayton 3168 Victoria, Australia.

DOI: 10.1111/ j .1471-0528.2004.00334.x

William Bovie1881-1958

The first use of the Bovie electrosurgical generator in an operating room was on October 1, 1926, at Peter Bent Brigham Hospital in Boston, Massachusetts.

In Dr. Cushing's notes from October 1st.... «with Dr. Bovie's help I proceeded to take off most satisfactorily the remaining portion of tumor with practically none of the bleeding which was occasioned in the preceding operation».

Harvey W. Cushing1869-1939

Electrosurgery Book 4.indd 14-15 7/13/05 1:22:55 PM

The present status of e lectrosurgery Grant E . Ward M.D. , F.A.C.S. Balt imore, U.S.A.   The Amer ican Journal of Surgery , February 1929, Pages 230-233

. . . I t i s e v i d e n t t h a t o n l y t h o s e s u r g e o n s w h o h av e t a k e n t h e p a i n s t o s t u dy c a r e f u l l y t h e s c i e n c e a n d a r t o f e l e c t r o s u r g e r y s h o u l d a t t e m p t t o u s e i t . . . .

. . . I u r g e t h e e s t a b l i s h m e n t i n m e d i c a l s c h o o l s a n d l a r g e r h o s p i t a l s o f a d e p a r t m e n t o f e l e c t r o s u r g e r y f o r r e s e a r c h , s t u dy o f c l i n i c a l d a t a a n d t h e i n s t r u c t i o n o f s t u d e n t s a s t o t h e va l u e , l i m i t a t i o n s a n d d a n g e r s o f e l e c t r o s u r g e r y.

American College of Surgeons 1995

- 18% of surgeons have experienced at least one complication with electrosurgery

- 86% of surgeons use monopolar electrosurgery

-- 90% use the “coagulation” waveform rather than “cut” waveform

Tucker RD Surg Laparosc Endosc 1995 :5:311-317

Electrochirurgie en cœlioscopie: que savent les

internes de gynécologie-obstétrique français?

Mémoire pour le Diplôme Inter-Universitaire International de Cœlioscopie et Endoscopie

gynécologique. Faculté de médecine de Clermont-Ferrand.

Université d’Auvergne.

Marie Margaillan Année universitaire 2014-2015

193  internes  ont  répondu  au  ques2onnaire  en  ligne,  ce  qui  correspond  à  environ  des  19  %  des  internes  de  gynécologie-­‐obstétrique  français.

12

Cinq personnes ont donné une réponse approximative ou incomplète (utilisation d’énergies différentes, utilisation d’électricité en plus de la chaleur…). 98 internes ont répondu qu’ils ne connaissaient pas la différence. Onze ont répondu ne pas comprendre la question et 51 internes ont expliqué la différence entre la coagulation à la monopolaire et celle à la bipolaire, révélant ainsi qu’ils sont nombreux à ne pas savoir qu’il existe une différence entre coagulation et cautérisation. 26 ont apporté une réponse fausse (différences de température, d’intensité ou de courant, utilisation de substances chimiques pour la cautérisation, selon l’effet recherché, profondeur de l’effet…).

C. Caractéristiques du courant utilisé. Environ deux tiers des internes ne connaissent pas les caractéristiques du courant employé lors de l’utilisation de monopolaire ou de la bipolaire.

1. Type de courant électrique. 66 internes (34,2%) ont répondu qu’il s’agit d’un courant alternatif pour la bipolaire, 59 (30,6%) pour la monopolaire en coagulation, mais seulement 33 (17,1%) pour la monopolaire en section.

Graphique 3 : type de courant utilisé en électrochirurgie. Réponses apportées par les internes interrogés (193 internes).

33 59 66

71 44 36

89 90 91

monopolaire ensection

monopolaire encoagulation

bipolaire

Type de courant utilisé en électrochirurgie

alternatif continu je ne sais pas

13

Type de courant électrique

Taux de réponses justes, toutes années confondues

Taux de réponses justes chez les internes ayant passé moins de 6 mois au bloc

Taux de réponses justes chez les internes ayant passé plus de 2 ans au bloc

section monopolaire 17,0% 11,0% 28,3% coagulation monopolaire

30,6% 35,6% 45,7%

coagulation bipolaire 34,2% 40,0% 37,0% Tableau 2 : connaissances des internes sur le type de courant utilisé en fonction de leur expérience au bloc.

Type de courant électrique

Taux de réponses justes, toutes années confondues

Taux de réponses justes chez les internes de première année

Taux de réponses justes chez les internes de dernière année

section monopolaire 17,0% 18% 24,5% coagulation monopolaire

30,6% 45,5% 35,8%

coagulation bipolaire 34,2% 40,9% 30,2% Tableau 3 : connaissances des internes sur le type de courant utilisé en fonction de leur année d’internat.

Le courant continu n’est pas utilisé en chirurgie car il produit en plus de l’effet thermique un effet électrolytique, entrainant une production d’acides au niveau des électrodes avec risque de brûlures chimiques.

Ce qui distingue le mode section du mode coagulation lors de l’utilisation de la monopolaire n’est pas lié au type de courant mais à la façon dont celui-ci est appliqué.

L’effet de section est obtenu en produisant un échauffement important et très rapide des

cellules au pourtour de l’électrode. Le liquide intra-cellulaire atteint 100°C et l’ébullition de

celui-ci provoque la rupture des membranes cellulaires, à l’origine de la coupe.

Ainsi, le mode section pure utilise un courant alternatif permanent, sans interruption ni

modulation alors qu’en mode coagulation le courant n’est pas délivré constamment, et est

modulé et amorti.7 Dans cette situation, le liquide intra-cellulaire ne va pas entrer en

ébullition mais la chaleur produite est suffisamment importante (aux alentours de 55-60°C)

pour provoquer la coagulation des protéines et être à l’origine d’une hémostase.

La différence d’effet entre le mode de section et de coagulation est donc liée à la façon dont est délivré le courant.

16

Graphique 5 : proportion des internes pensant être capables ou non de régler seul et de façon correcte un générateur d’électrochirurgie, en fonction du temps passé au bloc opératoire.

La puissance du courant utilisé doit être très souvent modifiée. En effet, elle doit être adaptée au type de chirurgie, à l’effet recherché, à la structure sur laquelle elle est appliquée, ainsi qu’aux structures adjacentes. Ces réglages sont donc très variables, et demandent une expérience importante afin de pouvoir les effectuer en finesse. Ces résultats semblent confirmer le fait qu’être capable de choisir les réglages adaptés est une compétence difficile et longue à acquérir. Cependant, les internes pourraient certainement améliorer leur rapidité de formation en se forçant à être attentifs aux réglages effectués. En effet, le graphique ci-dessous met en évidence que seuls 12 internes sur les 193 (6,2%) regardent systématiquement les réglages avant de débuter une intervention pour laquelle ils vont aider. 22,8% des internes reconnaissent ne jamais regarder les réglages lorsqu’ils sont premier opérateur. Porter attention de façon systématique aux réglages serait probablement pour les internes la meilleure façon de se former, afin de pouvoir comparer les habitudes des différents chirurgiens avec lesquels ils travaillent, et les effets en résultant.

0%

20%

40%

60%

80%

100%

< 2 mois 3 à 6 mois 6 mois à 2 ans plus de 2 ans

Capacité à régler seul un générateur en fonction de l'expérience au bloc

non

oui

Electrosurgery

Objectif : To obtain desired tissu effect :

coagulation or cutting

- Minimal risk

- Maximal efficacy

100 ≠ 100

60 < 30

10 > 20

Electrosurgery and laparoscopy Closed cavityNarrow spaceNo insulationHumidity +Conductivity +

The electrical current

Electrosurgery - the principles

Courant direct

Courant alternatif

Electrosurgery - the principles

Voltage U Volt

Intensity I Ampere

Resistance/Impedance R Ohms

Power P Watt

Frequency Hz Hertz

Ohm’s Law : U = R x I

P = U x I

Electrosurgery - the principles

BASIC SKILLS

SURGERY 26:2 66 © 2007 Published by Elsevier Ltd.

ElectrosurgeryDavid J Hay

AbstractElectrosurgery (diathermy) has been in widespread use for many years. However, few surgeons understand its principles or dangers. This review explains the basic principles of electricity and electrosurgery and how the fundamental difference between them is the frequency of the alternating current. The very-high frequency (radio-frequency) of the alternating cur-rent allows it to be passed through tissue without the risk of electrocu-tion for the purposes of cutting and coagulation, but the same high frequency is associated with other dangers. The important concepts of capacitance and current density are explained and the danger of non-contract activation with high voltages is highlighted. The contribution explains how the tissue effect achieved is influenced by several factors, including the choice of electrode and the generator output mode. Although electrosurgical equipment may be inherently safe, the dangers arising from poor technique are discussed and recommendations for safe practice are made.

Keywords burns; capacitance; diathermy; electricity; electrosurgery; general surgery; laparoscopy

Surgical diathermy (electrosurgery) uses a high-frequency elec-tric current to cut or coagulate tissue. The equipment is safe and most injuries are due to poor technique.

Electricity

To understand electrosurgery, one must grasp the concept of electricity (the flow of electrons through a substance from atom to atom driven by a difference in voltage). Higher voltages drive the flow of more electrons. This flow is called current, measured in amperes (amps). The power generated (to do work or create heat) is measured in watts. This is the product of voltage and current and it is expressed:

volts amps = watts.

The flow of electricity may be likened to the flow of water (Figure 1). The power of a water wheel increases by the height of the reservoir above the wheel (voltage) and by the amount of water that can flow to the wheel (current). A high voltage and a small current can generate the same power as a low voltage and

David J Hay FRCS is a Consultant General Surgeon at Glan Clwyd Hospital, Rhyl, UK. Conflicts of interest: none declared.

a large current. However, high voltages can challenge insulation and can arc to surrounding structures.

Direct and alternating current: direct currents in battery- powered appliances flow in one direction only. The alternating current of the UK domestic mains supply changes its direction of flow 50 times per second. This rate of change is called frequency and it is expressed as cycles per second or Hertz (Hz).

Very-high-frequency radio waves alternate many thousands of times per second (kHz). Ultra-high-frequency transmissions for televisions are higher and microwaves are measured in millions of cycles per second (mHz, Figure 2).

Voltage, current and power

volts amps = watts

v A = V a = W

vA

Va

W

Figure 1

Radiofrequency spectrum

10 mHz

Long wave VHF UHF Microwaves

Mains

supply

Electrosurgery

Threshold of

depolarization

50 Hz 10 kHz 500 kHz

VHF: Very-high frequency; UHF: Ultra-high frequency.

Figure 2

Electrosurgery - the principles Electrosurgery = the flow of the electrons in the tissu

Na Cl+ -

° °+ -

Les bases électro-physiologiques

Electrophysiology

The biological effects of electric current

The effect of electrolysis

The faradic effect

The thermal effect

The biological effects of electric current

The effect of electrolysis

The faradic effect

The thermal effect

Na Cl+ -

° °+-

The effect of electrolysis

The effect of electrolysis

The faradic effect

The thermal effect

The biological effects of electric current

+ Na Cl-

° °+ -

+ ++

+

++

+

++

+

+

++

- --

-

-

-

--

-

-- -

A C -

The faradic effect

The faradic effect The faradic effect

Electrosurgery - the principles

Frequency Hz

The faradic effect

50 100 > 50 000 (HF)

D’Arsonval M.A.. Action physiologique des courants alternatifs à grand fréquence. Arch. Physiol.Norm. Path. 1893

300 - 500 KHZ HFR A D I O F R E Q U E N C Y

E l e c t r o m a g n e t i c i n t e r f e r a n c e

Current electrical generators

How to reduce HF interference

Separate the HF electrical generator

Armoring the video system

Reduce the power and the voltage

The effect of electrolysis

The faradic effect

The thermal effect

The biological effects of electric current

The thermal effect

The thermal effect

L’EFFET THERMIQUERésistance/Impédance

C u t t i n g a n d C o a g u l a t i o n

The thermal effect The thermal effect

Cutting..... That’s the yellow pedal... Coagulation..... That’s the blue

pedal!!!!!

Difference between cut and coagulation

54

37

43

70

100

500

température

Vaporisation : section et débris charbonnés

Vaporisation +pyrolyse : section sans débris charbonnés

Coagulation irréversible

Hyperthermie sans effet sur les cellules normales

temps

Coagulation réversible

Coagulation irréversible

The thermal effect

Cut

Explosion = Vaporisation = Cutting

Coagulation

Dessication = Coagulation

Cut

Weak Voltage - High intensity

Coagulation

High Voltage -Weak intensity

100 100

2 X 50 50 X 2

P= VxI

Texte

CUT

COAGULATION

Comparison between cut and coagulation :

tissu effect

Never use fulguration mode

Use the “cut” waveform rather than “coagulation” waveform

Different ways of delivering energy

Monopolar vs Bipolar

BASIC SKILLS

SURGERY 26:2 68 © 2007 Published by Elsevier Ltd.

In coagulation mode, the generator output pulses on and off (modulation) many thousands of times per second, allowing the generated heat to dissipate into the tissues, reducing the cutting effect whilst enhancing the coagulation. Modulation reduces the current that flows; therefore the voltage has to be increased sig-nificantly to drive the current through the tissues. Coagulation mode employs much higher voltages than cut mode (order of several thousand volts). The highest voltage mode is fulgura-tion or spray, which creates a rain of sparks that flash through the air to the tissue. The voltage may be as high as 4,000–5,000 volts. Under these circumstances, any insulation has only the most minimal effect. Spray coagulation is regarded as inherently dangerous (particularly in laparoscopic surgery) and it should be used with great caution.

Blend modes are less modulated than coagulation modes, and operate at voltages between those of cutting and coagulation. They allow cutting with a degree of haemostasis.

Types of electrosurgery

Argon plasma: in conventional fulguration, a high voltage strikes an arc in the air between the hand-held electrode and the tissue. With argon plasma, a stream of inert argon gas is passed over the tip of the electrosurgical instrument, confining the electrical current to an ionized stream, allowing precise directional con-trol whilst eliminating oxygen from the target area. This reduces smoke production, gives a clearer field of vision and prevents tissue carbonization.

Argon plasma coagulation has particular application in: • surgery on the liver and spleen • control of bleeding in the gastrointestinal tract • palliative ablation of malignant tumours.

Monopolar (Figure 6): in monopolar circuits, the current passes from the tip of the instrument (in the surgeon’s hand) to the tis-sue, to the return electrode and back to the generator. Depending on the positioning of the patient plate relative to the surgical operation, the current can have an effect on pacemakers and metal prostheses. There is also the danger of burning taking place away from the site of surgery.

Bipolar (Figure 6): the current passes to one jaw of the instru-ment held in the surgeon’s hand, through the tissue between

the jaws, to the opposite jaw and back to the generator. The patient’s body does not make up part of the electrosurgical circuit. The amount of tissue held in the instrument is very small, so much lower voltages can be used and capacitance effects do not apply. Bipolar electrosurgery does not interfere with cardiac pacemakers. Unlike monopolar current, it can be used safely on tissue pedicles (e.g. in circumcision).

Feedback-controlled bipolar (e.g. Ligasure™, Gyrus™): the advantages and safety of bipolar systems have been recognized and the technology developed. The voltage passing between the two jaws of the instrument is lower than in conventional bipolar electrosurgery, but the jaws of the instrument (and therefore the area of coagulating tissue) is larger; therefore a greater current is used. The generator senses the resistance of the tissues in the jaws of the instrument and switches off the electrical flow when coagulation is optimal. These devices are much more effective than conventional bipolar electrosurgery and offer a significant advance, especially in laparoscopic surgery.

Hazards of electrosurgery

Burns: accidental burns may occur at the patient plate (as out-lined above). Since 1980, electrosurgery generators monitor the patient plate or return electrode electronically. Some employ split plates to help detect partial separation.

Despite these devices, current can be diverted away from the return electrode and cause accidental burning at other points on the body. These alternative pathways occur when the current finds a different route back to the generator. To circumvent this, the patient’s body should not touch any metal object (e.g. part of the operating table).

Fire and explosion: alcohol-based skin preparations should be avoided because they can pool under surgical towels and be ignited by sparks from the active electrode. Electrosurgery sparks can ignite flammable gases in body cavities with disastrous results.

Generator output modes

Cut Blend Coagulation

The difference between the types of output modes is due to

modulation and voltage

Waveform of alternating current

Figure 5

Bipolar and monopolar electrosurgery

Generator

Bipolar Monopolar

Figure 6

Monopolar

Monopolar

Monopolar

Electrical pathway unpredictable

The current follows the path of least resistance

Monopolar

A non specific instrumentation

1973

Jacques Rioux ,

Diogene Cloutier

Bipolaire

BipolarElectrical pathway predictable

But thermal burns still possible

Bipolar

A specific instrumentation

Coagulation = Dessication = Impedance ⬆ = Efficacy ⬇

So instability of the thermal effect in the time !

Important to remember :

NEW BIPOLAIRE

RoBi® plus

BIPOLAIRE VS MONOPOLAIRE (ce que le chirurgien peut faire)

Utiliser les 2 !

Bipolar

- Coagulation

- Grasping

- Dissection

Monopolar

-Cutting (+mecanical c.)

- Coagulation - Dissection - Grasping - Suction-irrigation

Bipolar vs monopolar (what the surgeon can do)

5 PEDALS!

How to use monopolar intelligently >100°

<6°

I2

S2

Current density

Eth = K x T x

Power density

Power density Power density

Power density

Power density

Monopolar

Power density

Monopolar Complications

Burn injuries :

ü by return electrod

ü by leaking current or division of current

Leaking current : current that passes through a connectioin to the ground

or stray current

ü by return electrod

Burn injuries :

Burn injuries :

ü by leaking current or division of current

Electrosurgery Book 4.indd 14-15 7/13/05 1:22:55 PM

ü by leaking current or division of current

Burn injuries :

Return electrod monitoring

To avoid! To avoid!

To avoid! To avoid!

A éviter ! To avoid!

CORRECT PLACEMENT

CORRECT PLACEMENTFLANC GAUCHE OU DROIT

Placement correct de la plaque

Burn injuries :

• by lateral thermal damage

• by direct coupling minimum distance : 1mm/kV (5mm for 5ooo V )

•capacitive coupling

• direct coupling

Figure 6: Kaplan-Meier prevalence of Insulation failure for robotic (black) (N =78) and laparoscopic (N =298) instruments (dotted)after 10 uses (p<0.005).

Figure 6

Figure 4Click here to download high resolution image

Accepted Manuscript

Insulation Failures in Robotic and Laparoscopic Instrumentation: A Prospective Evaluation

Mercedes Espada, Raquel Munoz, Brie N. Noble, Javier F. Magrina

PII: S0002-9378(11)00443-1 DOI: 10.1016/j.ajog.2011.03.055Reference: YMOB 8190

To appear in: American Journal of Obstetrics and Gynecology

Received date: 3 November 2010 Revised date: 7 February 2011 Accepted date: 29 March 2011 Please cite this article as: Espada, M., Munoz, R., Noble, B.N., Magrina, J.F., Insulation Failures in Robotic and Laparoscopic Instrumentation: A Prospective Evaluation, American Journal of Obstetrics and Gynecology (2011), doi: 10.1016/j.ajog.2011.03.055. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Accepted Manuscript

Insulation Failures in Robotic and Laparoscopic Instrumentation: A Prospective Evaluation

Mercedes Espada, Raquel Munoz, Brie N. Noble, Javier F. Magrina

PII: S0002-9378(11)00443-1 DOI: 10.1016/j.ajog.2011.03.055Reference: YMOB 8190

To appear in: American Journal of Obstetrics and Gynecology

Received date: 3 November 2010 Revised date: 7 February 2011 Accepted date: 29 March 2011 Please cite this article as: Espada, M., Munoz, R., Noble, B.N., Magrina, J.F., Insulation Failures in Robotic and Laparoscopic Instrumentation: A Prospective Evaluation, American Journal of Obstetrics and Gynecology (2011), doi: 10.1016/j.ajog.2011.03.055. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

2011

Prevention of direct coupling

Never activate the pedal if :

all the active parts of the electrode

cannot be seen on the screen !

Burn injuries :

• by lateral thermal damage

• by direct coupling minimum distance : 1mm/kV (5mm for 5ooo V )

•capacitive coupling

conductor

insulator

capacitive coupling

+

++++

+

+

+

++

+

+

conductor

insulator

+

++++

+

+

+

++

+

+

capacitive coupling

capacitive coupling

J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):141-7.

Genital tract electrical burns during hysteroscopic endometrial ablation: report of 13 cases in the United States and Canada.

Vilos GA, Brown S, Graham G, McCulloch S, Borg P.

Department of Obstetrics and Gynecology, St. Joseph's Health Centre, 268 Grosvenor Street, London, Ontario, Canada N6A 4V2.

We investigated 13 alleged thermal injuries to the genital tract of women undergoing hysteroscopic endometrial ablation. Possible mechanisms proposed to explain these injuries are hot-weighted speculum, povidone-iodine scrub solution, inadequate rinsing of Cidex sterilizing solution, and electrical burns. The history, nature, and distribution, as well as experimental evidence strongly support the hypothesis that these injuries are electrical due to capacitive coupled currents induced onto the sheath of the resectoscope, and/or stray currents generated by arcing or direct coupling from defective electrode insulation to the telescope, electrifying the entire resectoscope.

NO RISK OF CAPACITIVE CUPLING WITH PLASTIC TROCARS !

Monopolar

Cut 35-70 W Effect 1

Coagulation

Power levels (Everyday practice)

Bipolar

35 - 45 W Effect 3

Adapte the power to the electrode and to the tissu !

3 ApplicationKARL STORZ recommends use of the RoBi® grasping forceps and scissors in combination with HF surgery unit AUTOCON II 400 and the following settings: • OperatingmodeSoftCoagulation• ForGraspingforceps:maximum40watt, 150Vp,effectvalue4–5• ForScissors:maximum35watt,150Vp, 1

RoBi® Instrumente RoBi® Instruments Instrumentos RoBi®

Modelle/Models/Modelos 38110 xx, 38121/38122 xx, 38161 xx, 38210/38310/38410 xx, 38221/38321/38421xx, 38222/38322/38422 xx, 38161/38261/38361/38461 xx, 48110/48210 xx, 48161/48261 xx, 50510 xx, 50521 xx, 38151/38151x, 38500/38600/38700, 38510/38610/38710 xx, 38551/38651/38751 xx, 48400, 48410/48510/49710 xx, 48451/48551/49751xx, 50511xx, 50551xx

KARL STORZ GmbH & Co KG, Mittelstr. 8, 78532 Tuttlingen, Germany, Phone: +49 7461 708-0, Fax: +49 7461 708-105, E-Mail: info@karlstorz.de V 1.9.0 / 07-2013

D E ESGEBRAUCHSANWEISUNG INSTRUCTION MANUAL MANUAL DE INSTRUCCIONES

1 ZweckbestimmungRoBi® Scheren und Zangen werden zum Fassen bzw. Schneiden sowie zur bipolaren Koagulation von Gewebe während endoskopischer Eingriffe verwendet.

Indikation: RoBi® Instrumente sind für die Hämostase von Blutgefäßen indiziert.

Kontraindikationen: Kontraindikationen, die sich direkt auf das Produkt beziehen, sind der-zeit nicht bekannt. Die Verwendung von RoBi® Scheren und Zangen gilt als kontraindiziert, wenn nach Meinung eines verantwortlichen Arztes eine solche Anwendung eine Gefährdung des Patienten hervorrufen würde, z. B. auf Grund des Allgemeinzustandes des Patienten, oder die endo-skopische Methode als solche kontraindiziert ist.

RoBi® Instrumente dürfen nicht für Eingriffe am ZNS verwendet werden.

1 Intended useRoBi® scissors and forceps are used to grasp or cut tissue and for bipolar coagulation of tissue during endoscopic interventions.

Indication: RoBi® instruments are indicated for the hemostasis of blood vessels.

Contraindications: No contraindications relating directly to the product are currently known. Use of RoBi® scissors and forceps is considered to be contraindicated if, in the opinion of a qualified physician, such application would endanger the patient, e.g. due to the patient’s general condition, or if the endoscopic method as such is contraindicated. CLICKLINE scissors and forceps must not be used for interventions on the CNS.

1 Empleo previstoLas tijeras y pinzas RoBi® se utilizan para sujetar o seccionar, así como para la coagulación bipolar de tejidos durante las intervenciones endoscópicas.

Indicación: Los instrumentos RoBi® están indica-dos para la hemostasia de vasos sanguíneos

Contraindicaciones: No se conocen actualmente contraindicaciones que se refieran directamente al producto. La utilización de pinzas, tijeras y curetas RoBi® está contraindicada cuando, según la opinión del médico responsable, una utilización de este tipo podría representar un peligro para el paciente; p. ej., debido al estado general del paciente, o cuando los métodos endoscópicos como tales están con-traindicados.

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Symbolerläuterungen

3 WARNUNG: Nichtbeachtung kann Verletzungen oder Tod zur Folge haben.

2 VORSICHT: Nichtbeachtung kann zur Beschädigung oder Zerstörung des Produktes führen.

1 HINWEIS: Spezielle Informationen zur Bedienung des Instrumentes.

Vor Gebrauch Begleitpapiere beachten

Hersteller

Symbol description

3 WARNING: Failure to observe may result in injury or even death.

2 CAUTION: Failure to observe may result in damage to or even destruc-tion of the product.

1 NOTE: Special information on the operation of the instrument.

Read accompanying documents before use

Manufacturer

Explicación de los símbolos

3 CUIDADO: La inobservancia de este aviso podría conllevar lesiones o inclu-so la muerte.

2 ADVERTENCIA: La inobservancia de este aviso podría conllevar deterioros o incluso la destrucción del producto.

1 NOTA: Informaciones especiales para el manejo del instrumento.

Observar la documentación adjunta antes de usar el producto

Fabricante

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1 Maulteile2 Arbeitseinsatz3 Außenschaft4 LUER-Lock-Spülanschluss5 Verschlusskappe für Spülanschluss (Art.-Nr.

8240990 bzw. 29100: Pck. zu 10 St)6 Drehrad zum Drehen der Maulteile 7 Rastknopf zum Lösen des Arbeitseinsatzes8 HF-Anschluss9 Handgriff

1 Jaws2 Working Insert3 Outer sheath4 LUER lock port for irrigation5 Cap for irrigation port (Art. No. 8240990 or

29100: pack of 10)6 Wheel for turning the jaws 7 Locking button for releasing the working insert8 HF connection9 Handle

1 Mordazas2 Elemento inserible interior3 Vaina exterior4 Conexión de irrigación con cierre LUER5 Caperuza de cierre para conexión de irrigación

(n.º de art. 8240990 ó 29100: envase de 10 uds)6 Ruedecilla giratoria para hacer rodar las mordazas7 Botón de encastre para soltar el elemento

inserible interior8 Conexión de AF9 Mango

SMOKE EVACUATORS

SMOKE EVACUATORS

S-PILOT The solution for smoke evacuation

New possibilities for hemostasis and for cutting

LigaSure®

LIGASURE RO BI BIPOLAR

«THERMOFUSION»

LigaSure®LigaSure Atlas™ Sealer/Divider Providing a World of New Possibilities in Laparoscopic Surgery

• Versatile grasping for multiple tissue types

• Permanently fuses tissue bundles and vessels up to and including 7 mm in diameter without dissection

• Average thermal spread approximately 2 mm

• Grasps and holds sealed tissue for easy transection

THERMOFUSION

Average thermal spread approximately 2 mm

ERBE VIO BiClamp®

ERBE VIO BiClamp®

ERBE VIO BiClamp®

I-BLADE® delivers high uniform compression throughout the 40mm curved tip for seal consistency

Strong on sealing

Other bipolar devices rely solely on the

force of initial jaw closure to provide

compression — which results in a fall-off

in force from the proximal to the distal

end of the jaws.

ENSEAL® Technology

Temperature is controlled at the tissue interface

A polymer compound within the jaw uses Positive Temperature Coefficient (PTC)

technology to modulate energy flow. It maintains a constant temperature of

approximately 100°C, minimizing tissue sticking, charring and smoke.

Tissue Interface

1 Below 100°CParticles embedded in the

polymer form chainlike

pathways that conduct

energy. Cooler areas of

tissue between the blades

also conduct energy

until they, too, reach

approximately 100°C.

2 Approximately 100°CParticles in the polymer

have separated and no

longer conduct energy.

Energy flow through tissue

is arrested, so tissue doesn’t

overheat, minimizing

charring and smoke.

Offset electrodes help contain energy flow within jaws

Cross Section of Jaw

Other bipolar devices have simple positive and negative electrodes,

which allow energy to spread significantly into surrounding tissue.

Gentle on tissue

ENSEAL® Technology

UltraCision®

ULTRASONIC SCALPEL

Generator Transductor Sonde Tissu

ULTRASONIC SCALPEL

Harmonic scalpel

Original article

Experimental comparison of mesenteric vessel sealingand thermal damage between one bipolar and two ultrasonicshears devices

E. J. Noble1, N. J. Smart1, C. Challand1, K. Sleigh2, A. Oriolowo2 and K. B. Hosie1

Departments of 1Surgery and 2Pathology, Plymouth Hospitals NHS Trust, Plymouth, UKCorrespondence to: Mr K. B. Hosie, c/o Mr Hosie’s secretary, Department of Colorectal Surgery, Plymouth Hospitals NHS Trust, Derriford Road,Crownhill, Plymouth PL6 8DH, UK (e-mail: kenneth.hosie@phnt.swest.nhs.uk)

Background: Several instruments are available for open and laparoscopic dissection, includingelectrothermal bipolar vessel sealers and ultrasonically coagulating shears. The vessel sealing abilityof three devices in colorectal specimens was compared in an experimental study.Methods: Surgical specimens from patients scheduled for elective open or laparoscopic colorectal resec-tion were allocated to one of the three devices. After removal of the surgical specimen, up to eightmesenteric vessels were dissected ex vivo and sealed using the allocated instrument. The vessel seal wastested for the maximum pressure at which it leaked and then assessed by a pathologist for depth ofthermal tissue damage.Results: A total of 93 vessels from 18 patients were assessed ex vivo (LOTUSTM n = 33; HarmonicAce® n = 30; LigaSureTM n = 30), a median of 6 (range 1–8) vessels per surgical specimen witha mean(s.d.) diameter of 1·06(0·70) mm and wall thickness of 0·29(0·19) mm. Mean(s.d.) burstingpressures were 1170(440), 1470(670) and 1510(740) mmHg with LOTUSTM , Harmonic Ace®

and LigaSureTM respectively. ANCOVA showed no difference in bursting pressure between theinstruments (P = 0·058). The depth of thermal damage was significantly greater with LigaSureTM

(3·37(1·44) mm) than with LOTUSTM (2·18(0·99) mm; P < 0·001) or Harmonic Ace® (1·95(0·92) mm;P < 0·001).Conclusion: All three instruments were equally good at sealing blood vessels, with bursting pressureswell above physiological blood pressure levels. Registration number: NCT01121614 (http://www.clinicaltrials.gov).

Based on trial data presented to annual scientific meetings of the Association of Surgeons of Great Britain andIreland, Glasgow, UK, May 2009, the Association of Coloproctology of Great Britain and Ireland, Harrogate, UK,June 2009, and the European Society of Coloproctology, Prague, Czech Republic, September 2009; and publishedin abstract form as Colorectal Dis 2009; 11(Suppl 2): 39, Colorectal Dis 2009; 11(Suppl 1): 4 and Br J Surg; 2009 96(Suppl4): 15

Paper accepted 10 December 2010Published online 25 March 2011 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7433

Introduction

Surgical diathermy is the most established form of electri-cally powered surgery, but is associated with unpredictableand weak vessel sealing as well as increased lateral ther-mal damage1–3. Surgical devices using ultrasound andfeedback-monitored bipolar diathermy have been devel-oped to minimize such disadvantages.

Instrument technology based on ultrasonic energy to cutthrough and coagulate tissue does not rely on the flow ofelectrical current through the patient. Ultrasonic devicescontrol bleeding by ‘coaptive coagulation’, whereby thevibrating blade couples with protein, denaturing it to forma coagulum that seals small vessels. When the effect isprolonged, secondary heat is produced that seals largervessels.

© 2011 British Journal of Surgery Society Ltd British Journal of Surgery 2011; 98: 797–800Published by John Wiley & Sons Ltd

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occur at the Santorini plexus or vascular pedicles. Since theimmediate vascular control of all supplying vessels duringdissection cannot be achieved, the use of the harmonicscalpel alone isnot advisable.Apromisingdevelopment is theintroduction of a new harmonic generator (Harmonic ACETM,Ethicon, USA). Owing to a higher velocity of transaction, thedevice is more rapid in tissue dissection, and vessels !5 mmcan be sealed with decreased smoke formation or less lateralthermal damage to surrounding tissue [23]. However, datafrom larger series are not yet available.

2.3. Lasers for haemostasis

2.3.1. Holmium laserThe Holmium laser has been used for parenchymal tissueresection such as prostatectomy because of the significantlyreduced blood loss, even in high-risk patients. Not surprisinglythere have been several attempts to use the Holmium laser forrenal partial resection. Lotan et al. presented results obtainedwith the Holmium:yttrium aluminum garnet (YAG) laser forlaparoscopicpartialnephrectomyinaporcinemodel [24].A550-to1000-micronend-fireholmiumlaserfibresetat0.2 Jand60 Hzwas used to transect the lower pole of the kidney; theparenchymal surface was then sealed with fibrin glue. Theyconcluded that this laser provides an efficacious modality fortransecting thekidney in a porcinemodel. In another study, theHolmium laser was used in kidney, bladder, prostate, ureteralandvassal tissues [25].Whenused through the laparoscope, theHolmium:YAG laser provided precise cutting and—combinedwith electrocautery—allowed the dissection to proceed quicklyand smoothly.Haemostatic controlwas adequate in all surgicalprocedures. Clinical data, however, are very limited. In a smallclinical setting, three patients (complex cyst, non-functioninglower pole, renal mass) underwent nephron-sparing proce-dureswith theHolmium laser setting of 0.2 J/pulse at 60 Hz and0.8 J/pulse at 40 Hz [26]. Tissue sealants also were used toreinforce the lesion although haemostasis seemed sufficient.No complications were documented, and good haemostasiswithout the need for hilar occlusion resulted. This technique

promises to facilitate the laparoscopic management of renaltumours. It has to be noted, however, that laser applicationcauses significant tissue vaporisation and spreading of liquidduring manipulation. These effects may result in significanttumour cell spillage within the abdominal cavity; for the samereason, the harmonic scalpel is regarded as unsafe inoncological interventions.

2.3.2. Experimental lasersWith the use of an 810-nm, pulsed diode laser (20 W), a 50%liquid albumin-indocyanine green solderwaswelded to the cutedge of the renal parenchyma to seal the collecting system andachieve haemostasis in an animal model [27]. No evidence ofurinoma or haemorrhage occurred. Histopathologic analysisshowed preservation of the renal parenchyma immediatelybeneath the solder. Laser tissue welding provided reliablehaemostasis and closure of the collecting system whileprotecting the underlying parenchyma from the deleteriouseffect of the laser.

Likewise, a 980-nm diode laser (23W) without hilar occlu-sion was used in a laparoscopic, transperitoneal, lower-polepartial nephrectomy in five pigs [28]. In three cases, laserhaemostasiswas insufficient, and adjunctive haemostatic clipswere necessary to stop bleeding; therefore, it seems question-able that this particular laser type will survive further clinicaltrials or its indication may be limited to very small andexophytic tumours. Promising results for laparoscopic partialnephrectomy were obtained with a potassium-titanyl-phos-phate (KTP) laser without vascular hilar clamping in thesurvival calf model [29]. KTP laser is not absorbed by water,but the selective uptake of KTP laser energy by haemoglobinleads to haemostasis. In all 12 procedures, renal parenchymalresection and haemostasiswere achievedwith the laser only,without any adjunctive haemostatic sutures or bio-adhe-sives. At 1-month follow-up there was no evidence of urinaryleakage or arterio-venous fistula. This initial study oflaparoscopic, KTP laser, partial nephrectomy without hilarclamping confirms its technical feasibility with good short-term outcomes.

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Table 1 – Comparison of the bursting pressure of various haemostatic devices and agents

Burstingpressure/arterial

size (mm Hg)/[mm]

Collectingsystem

sealing (mm Hg)

Parenchymalsealing

Special instruments

Sutures [47] 900 [3–7 mm]Titanium clip [11,47] 593 [4 mm] Clip appliers; single usePolymer clip [11] 854 [4 mm] Clip applier; re-usableVascular endostapler [12] >310 [17 mm] Stapler arm + jaws; multiple loadsElectrocautery [11] 230 87 Single/re-usableHarmonic scalpel [11] 205 [4 mm] Special generator + single-use forcepsBipolar vesselssealer [11,47]

601 [4 mm] Standard generator;single/re-usable instruments

Fibrin glue [33–35] 378 [parenchyma] 166 22 hPa (17 mm Hg) Two components; application needlePolyethylene glycol >490 [1 mm] Solid clot 80 hPa (61 mm Hg) Single component; application needleFibrin-coatedcollagen fleece [40]

>290 (suture 900) Dense fleece;sutured bolster

59 hPa (46 mm Hg) Dry fleece; Endo-Doc carrierTM

Oxidised methylcellulose NA (suture 900) Sutured bolster Sutured polster Cellulous fleece; no special applicatorGelatine matrix [36–39] NA No clot formation Two components; application needle

NA = not available.

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OFLaparoscopic Surgery

Haemostasis in Laparoscopy

H. Cristoph Klingler a,*, M. Remzi a, M. Marberger a, G. Janetschek b

aDepartment of Urology, Medical University of Vienna, AustriabDepartment of Urology, Krankenhaus Elisabethinen Linz, Austria

1. Introduction

As in open surgery, uncontrolled bleeding duringlaparoscopy is one of the major surgical pitfalls.Haemorrhage may occur by gaining laparoscopicaccess, during surgical preparation or during ablativeand reconstructive surgery [1,2]. In addition, even

minor bleeding may jeopardize improved visionduring laparoscopy owing to significant light absorp-tion by dark blood staining of the adjacent tissuewithin themagnifiedopticalfieldduring laparoscopy.Not surprisingly, haemostasis during laparoscopicsurgery focusesonprimarypreventionofbleeding [3].A variety of techniques and instruments have been

e u r o p e a n u r o l o g y x x x ( 2 0 0 6 ) x x x – x x x

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journa l homepage: www.europeanurology.com

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Article info

Article history:Accepted January 31, 2006Published online ahead ofprint on ! ! !

Keywords:ComplicationsLaparoscopyHaemostasis

Abstract

Objective: Adequate haemostasis is essential for advanced laparoscopicprocedures since uncontrolled bleedingmay cause significant complica-tions and even required converting to laparotomy to obtain sufficienthaemostasis. The aim of this review is to give insight into the mostimportant tools and strategies to achieve sufficient haemostasis duringadvanced urologic laparoscopy.Methods and results: Lowering the risk of haemorrhage may be achievedprimarily by proper case selection, resulting in adequate laparoscopicpreparation and dissection technique or the use of local compression bysponge stick to control local bleeding. For early bleeding control, laparo-scopic clip appliers, staplers and suturing techniques may be utilised.Various energy sources such as monopolar and bipolar electrocautery,argon beam coagulators, laser or ultrasonic dissectors and topical seal-ing agents can be used to augment natural haemostasis.Conclusions: A wide armamentarium for achieving haemostasis duringlaparoscopy is available. Consequently, laparoscopic surgeons musthave detailed knowledge of the physical concepts of each surgicalinstrument or energy source and of proper use of tissue sealants forobtaining sufficient haemostasis. This knowledge will improve post-operative outcome, increase patient safety and guide laparoscopic tech-niques to further perspectives.

# 2006 Published by Elsevier B.V.

* Corresponding author. FEBU, Department of Urology, Medical University of Vienna,Wahringer Gurtel 18-20, A-1090 Vienna/Austria. Tel. 43 1 40 400 2616; Fax: +43 1 408 99 66.E-mail address: christoph.klingler@meduniwien.ac.at (H.C. Klingler).

0302-2838/$ – see front matter # 2006 Published by Elsevier B.V. doi:10.1016/j.eururo.2006.01.058

EURURO 1216 1–10

Mesenteric vessel sealing and thermal damage with bipolar and ultrasonic shears devices 799

Results

Eighteen patients were recruited and the surgicalspecimens were allocated to one of three groups. A totalof 93 vessels were assessed ex vivo (LOTUSTM n = 33;Harmonic Ace® n = 30; LigaSureTM n = 30). There was amedian of 6 (range 1–8) vessels per surgical specimen, witha mean(s.d.) diameter of 1·06(0·70) mm and wall thicknessof 0·29(0·19) mm.

Bursting pressure

Overall mean(s.d.) bursting pressures were 1170(440),1470(670) and 1510(740) mmHg with LOTUSTM , Har-monic Ace® and LigaSureTM (P = 0·058). There was nodifference in bursting pressure for veins between the threegroups (Table 1). For arteries, the bursting pressure was sig-nificantly lower for LOTUSTM than for Harmonic Ace®

and LigaSureTM .

Thermal damage

The outcome was the same when the data were analysedseparately for veins and arteries, or with all vessels together.Results from the analysis of all vessels together arepresented here as this involved larger numbers. One-way ANOVA provided strong evidence of differencesin thermal damage caused by the three instruments(R2 = 0·24, P < 0·001) (Fig. 1). Bonferroni post hoc analysisshowed that the depth of thermal damage was significantlygreater with LigaSureTM than with either ultrasonicinstrument: mean(s.d.) 3·37(1·44) mm for LigaSureTM

versus 2·18(0·99) mm for LOTUSTM (P < 0·001) and1·95(0·92) mm for Harmonic Ace® (P < 0·001).

Table 1 Bursting pressure results

Diameter(mm)

Wall thickness(mm)

Bursting pressure(mmHg)

LOTUSTM

Vein (n = 19) 0·97(0·54) 0·24(0·13) 1145(436)Artery (n = 14) 1·13(0·77) 0·38(0·28) 1206(477)

Harmonic Ace®

Vein (n = 12) 1·01(0·80) 0·23(0·10) 1113(561)Artery (n = 18) 1·25(0·68) 0·39(0·20) 1704(646)*

LigaSureTM

Vein (n = 21) 0·91(0·79) 0·21(0·16) 1295(704)Artery (n = 9) 1·16(0·63) 0·37(0·11) 2005(592)*

Values are mean(s.d.). Data followed a normal distribution (P > 0·050 forall data sets; Shapiro–Wilk normality test). *P = 0·005 versus LOTUSTM

(ANCOVA). There was no difference in bursting pressure for veinsbetween the three instruments (P = 0·628, ANCOVA).

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(mm

)

Ace® LOTUS™ LigaSure™

Fig. 1 Thermal damage: all vessels. Values are mean(s.d.)

Discussion

This ex vivo comparison of the vessel sealing ability oftwo types of ultrasonic instrument and a bipolar vesselsealing instrument found no clinically relevant differencesin bursting pressure or collateral thermal tissue damage.

All three instruments sealed mesenteric blood vesselseffectively with no sealing failures. Mean bursting pressureswere over 1000 mmHg for all three devices. This comparesfavourably with other published data from porcine vesselsealing studies4,5–16, which tended to have lower meanbursting pressures, but involved sealing larger bloodvessels than in the present trial9,14,16. Here, histologicalmeasurement of vessel size was performed after fixationin formalin, as the authors believed this to be the mostreliable method. Tissue retraction during fixation mayhave led to underestimation of vessel size. Previous reportshave not always been clear on techniques employed formeasuring vessel size. The vessel sizes (diameter and wallwidth) tested in this trial were evenly matched betweenthe three instrument groups, which adds weight to thecomparisons.

Only one of 93 vessels had a bursting pressure below360 mmHg, the (arbitrary) level used in previous publica-tions to signify adequate quality of vessel seal. This was avein with a diameter of 0·4 mm sealed by the HarmonicAce®, but the bursting pressure recorded was 210 mmHg,which is still supraphysiological.

The LigaSureTM device caused significantly morethermal damage to blood vessels than the Harmonic Ace®

or LOTUSTM . These findings are consistent with mostanimal studies of vessel sealing7,9,10,12–17. However, theLOTUSTM has been investigated in only one vessel sealingporcine study4, where thermal damage was not assessed.Lateral spread of thermal energy to surrounding tissues is

© 2011 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2011; 98: 797–800Published by John Wiley & Sons Ltd

Safety and efficacy of new integrated bipolar and ultrasonicscissors compared to conventional laparoscopic 5-mm sealingand cutting instruments

Daniel Seehofer • Martina Mogl • Sabine Boas-Knoop •

Juliane Unger • Anja Schirmeier • Sascha Chopra •

Dennis Eurich

Received: 14 September 2011 / Accepted: 20 February 2012 / Published online: 24 March 2012! The Author(s) 2012. This article is published with open access at Springerlink.com

AbstractBackground Hemostasis is a central issue in laparoscopic

surgery. Ultrasonic scissors and bipolar clamps are com-

monly used, with known advantages with each technique.Methods The prototype of new surgical scissors, deliv-

ering ultrasonically generated frictional heat energy and

bipolar heat energy simultaneously (THUNDERBEAT"

[TB]), was compared to ultrasonic scissors (Harmonic

ACE" [HA]) and an advanced bipolar device (LigaSure"

[LS]) using a pig model. As safety parameters, temperatureprofiles after single activation and after a defined cut were

determined. As efficacy parameters, seal failures and the

maximum burst pressure (BP) were measured after in vivosealing of vessels of various types and diameters (catego-

ries 2–4 and 5–7 mm). Moreover, the vertical width of the

tissue seal was measured on serial histological slices ofselected arteries. The cutting speed was measured during

division of isolated arteries and during dissection of a

defined length of compound tissue (10 cm of mesentery).Burst-pressure measurement and histological analysis were

performed by investigators blinded to the used sealingdevice.

Results Using the TB, the burst pressure in larger arterieswas significantly higher (734 ± 64 mmHg) than that of the

HA (453 ± 50 mmHg). No differences in the rate of seal

failures were observed. The cutting speed of the TB wassignificantly higher than that of all other devices. Safety

evaluation revealed temperatures below 100 #C in the

bipolar device. The maximum temperature of the HA andthe TB was significantly higher. No relevant differences

were observed between the HA and the TB.

Conclusions The ultrasonic and bipolar technique of theTB has the potential to surpass the dissection speed of

ultrasonic devices with the sealing efficacy of bipolar

clamps. However, heat production that is comparable toconventional ultrasonic scissors should be minded for

clinical use.

Keywords Instruments ! Technical ! Abdominal !Vascular (blood vessels)

Effective hemostasis is one of the central issues of lapa-roscopic surgery. Techniques such as suture ligation, which

are easily used in open surgery, are technically demandingand time-consuming if applied laparoscopically. In addi-

tion, bleeding might be difficult to control laparoscopically,

and a clear view of the bleeding source is often difficult toobtain. Thus, advanced laparoscopic procedures are largely

dependent on either mechanical methods of hemostasis

(clips or vascular staplers) or on energy-based surgicaldevices. Nowadays, various different electrosurgical devi-

ces are commercially available. For small vessels, mono-

polar or conventional bipolar electrocautery is oftenapplied and represents basic instruments in laparoscopic

surgery. However, for safe dissection of medium-size

vessels, advanced bipolar or ultrasonic devices are used

D. Seehofer and M. Mogl contributed equally to this work.

D. Seehofer (&) ! M. Mogl ! S. Boas-Knoop ! A. Schirmeier !S. Chopra ! D. EurichDepartment of General, Visceral and Transplantation Surgery,Charite-Universitatsmedizin Berlin, Campus Virchow-Klinikum,Augustenburger Platz 1, 13353 Berlin, Germanye-mail: daniel.seehofer@charite.de

J. UngerDepartment of Laboratory Animal Sciences, Charite-Universitatsmedizin Berlin, Campus Virchow-Klinikum, Berlin,Germany

123

Surg Endosc (2012) 26:2541–2549

DOI 10.1007/s00464-012-2229-0

and Other Interventional Techniques

Results

In total, 301 arterial vessels were sealed using the three

devices. The different vessels used for the burst pressure

measurement were equally distributed among the threegroups; no significant differences were seen for a single

type of vessel. The rate of bleeding after division of

isolated arteries in vivo (seal failures) was not significantly

different among the devices. The percentage of seal fail-ures correlated with the increase in vessel size.

The burst pressure of the TB in the larger-artery cate-gory (5–7 mm) was superior to that of the HA. The highestmean burst pressure was measured in the TB group

(734 ± 64 mmHg); this was slightly higher than in the LS

(615 ± 40 mmHg) group and significantly higher than inthe HA group (454 ± 50 mmHg, Fig. 3). However, all

devices were equally able to reliably seal vessels with adiameter of 2–4 mm with a very high burst pressure and

there were no significant differences among the instru-

ments (Fig. 3). Since the additional clinical merit of veryhigh burst pressure values is unclear, the rate of burst

pressure values below 300 mmHg, including primary seal

failures, was analyzed. This rate was B10 % in all devicesin small vessels. It increased in the larger-vessel group

predominantly for the HA, where the rate of burst pressures

below 300 mmHg was 39.5 %, whereas it was significantlylower in the LS (11.1 %) and the TB (10.2 %) group.

Histological analysis of the seal width as an indirect

parameter of seal reliability revealed the broadest seal withthe bipolar device (LS). The length of the seal created with

the TB was shorter than that of the LS but significantly

longer than the seal width of the HA (Fig. 4). Other his-tological findings were similar in the HA and the TB group.

Fig. 3 Burst pressure measured after in vivo sealing and division ofarteries (p values significant by post-hoc comparison are indicated)

Fig. 4 A–C Exemplary slidesof arterial seals (hematoxylinand eosin stain) showing theseal width and the typical aspectof gas vapor formation,predominantly in the ultrasonicdevices (HA and TB).D Histological length of thearterial seal (p values significantby post-hoc comparison areindicated)

Surg Endosc (2012) 26:2541–2549 2545

123

Overall, gas pockets as a particular feature of tissue boiling

during dissection were observed mainly in vessels dividedwith the HA or the TB, and only rarely in vessels sealed

with the LS (Fig. 4).

The dissection speed of the TB was significantly fasterthan that of the LS. The dissection speed for isolated

arteries of both size categories (Fig. 5) as well as the dis-

section speed for compound tissue (Fig. 6) was signifi-cantly higher using the TB than for the other devices. Thus,

10 cm of mesentery was divided by the TB in 20 ± 1 s,whereas it took twice as long with the LS (52 ± 6 s). The

HA also revealed a markedly slower dissection speed than

the TB (Figs. 4, 5). No seal failure was observed with anyof the devices during dissection of the small-bowel

mesentery.

Heat production of the TB and the HA was comparable.The temperature profile of the HA and the TB was similar

(Table 2) with respect to the maximum heat production and

the kinetics of cooling down to 60 !C (Fig. 7). Moreover,the lateral heat flash was similar between the HA and the

TB as shown in exemplary thermal camera shots at the time

of maximum temperature (Fig. 7). The maximum temper-ature during activation and shortly thereafter was around

200 !C in the HA and TB groups. However, the indirect

measurements revealed slightly different maximum valuesand intervals. Whereas the TB had slightly lower values for

the thermosensor measurements, the HA had lower values

in the thermocamera measurements. However, none ofthese differences was significant. Apart from small changes

in the maximum temperature for view seconds, the further

temperature profile was almost identical for the TB and theHA as shown in the exemplary temperature curves in

Fig. 7. In contrast, the temperature in the LS group during

and after activation was constantly below 100 !C. Lateralthermal damage was investigated in small-bowel

specimens after division of the mesentery 5 mm from thebowel wall. No histological damage to the small bowel

wall was observed in any device during analysis of serial

slides (Table 2). This confirms that 5 mm is a sufficientsafety margin for all devices.

Discussion

Advanced surgical procedures, especially if performedlaparoscopically, require electrosurgical instruments that

achieve reliable hemostasis and can perform comfortableand fast tissue dissection. Moreover, a favorable safety

profile is relevant. Despite continuous progress in the

technical development of instruments, all available instru-ments still have disadvantages. For relevant arteries

(C4 mm), many surgeons still prefer to use additional

vascular clips for safety reasons, especially because of acertain rate of seal failures in larger vessels and the

resulting bleeding is more difficult to control. Besides

surgical clips, advanced bipolar clamps and ultrasonicscissors are most commonly used for hemostasis in lapa-

roscopic surgery.

As shown in the present experiments, the combination ofbipolar energy and ultrasonic energy in a single device

(THUNDERBEAT") yielded better sealing abilities

in comparison with that of a solely ultrasonic device(Harmonic ACE") and increased dissection speed com-

pared to an advanced bipolar clamp (LigaSure"). The

results of the burst pressure measurements for the HA andFig. 5 Time needed for division of arteries in both vessel categories(p values significant by post-hoc comparison are indicated)

Fig. 6 Time needed for sealing and cutting of a standardized lengthof 10 cm of small bowel mesentery (p values significant by post-hoccomparison are indicated)

2546 Surg Endosc (2012) 26:2541–2549

123

Overall, gas pockets as a particular feature of tissue boiling

during dissection were observed mainly in vessels dividedwith the HA or the TB, and only rarely in vessels sealed

with the LS (Fig. 4).

The dissection speed of the TB was significantly fasterthan that of the LS. The dissection speed for isolated

arteries of both size categories (Fig. 5) as well as the dis-

section speed for compound tissue (Fig. 6) was signifi-cantly higher using the TB than for the other devices. Thus,

10 cm of mesentery was divided by the TB in 20 ± 1 s,whereas it took twice as long with the LS (52 ± 6 s). The

HA also revealed a markedly slower dissection speed than

the TB (Figs. 4, 5). No seal failure was observed with anyof the devices during dissection of the small-bowel

mesentery.

Heat production of the TB and the HA was comparable.The temperature profile of the HA and the TB was similar

(Table 2) with respect to the maximum heat production and

the kinetics of cooling down to 60 !C (Fig. 7). Moreover,the lateral heat flash was similar between the HA and the

TB as shown in exemplary thermal camera shots at the time

of maximum temperature (Fig. 7). The maximum temper-ature during activation and shortly thereafter was around

200 !C in the HA and TB groups. However, the indirect

measurements revealed slightly different maximum valuesand intervals. Whereas the TB had slightly lower values for

the thermosensor measurements, the HA had lower values

in the thermocamera measurements. However, none ofthese differences was significant. Apart from small changes

in the maximum temperature for view seconds, the further

temperature profile was almost identical for the TB and theHA as shown in the exemplary temperature curves in

Fig. 7. In contrast, the temperature in the LS group during

and after activation was constantly below 100 !C. Lateralthermal damage was investigated in small-bowel

specimens after division of the mesentery 5 mm from thebowel wall. No histological damage to the small bowel

wall was observed in any device during analysis of serial

slides (Table 2). This confirms that 5 mm is a sufficientsafety margin for all devices.

Discussion

Advanced surgical procedures, especially if performedlaparoscopically, require electrosurgical instruments that

achieve reliable hemostasis and can perform comfortableand fast tissue dissection. Moreover, a favorable safety

profile is relevant. Despite continuous progress in the

technical development of instruments, all available instru-ments still have disadvantages. For relevant arteries

(C4 mm), many surgeons still prefer to use additional

vascular clips for safety reasons, especially because of acertain rate of seal failures in larger vessels and the

resulting bleeding is more difficult to control. Besides

surgical clips, advanced bipolar clamps and ultrasonicscissors are most commonly used for hemostasis in lapa-

roscopic surgery.

As shown in the present experiments, the combination ofbipolar energy and ultrasonic energy in a single device

(THUNDERBEAT") yielded better sealing abilities

in comparison with that of a solely ultrasonic device(Harmonic ACE") and increased dissection speed com-

pared to an advanced bipolar clamp (LigaSure"). The

results of the burst pressure measurements for the HA andFig. 5 Time needed for division of arteries in both vessel categories(p values significant by post-hoc comparison are indicated)

Fig. 6 Time needed for sealing and cutting of a standardized lengthof 10 cm of small bowel mesentery (p values significant by post-hoccomparison are indicated)

2546 Surg Endosc (2012) 26:2541–2549

123

UltraCision®

Ureteral Injury Due to a Harmonic Scalpel DuringLaparoscopic Salpingo-oophorectomy

Patrick F. Vetere, MD, Costas Apostolis, MD

ABSTRACT

We present an unusual complication of a ureteral injuryoccurring during a bilateral laparoscopic salpingo-oopho-rectomy with the Harmonic scalpel (HS). The case illus-trates in the same patient the versatility of the HS as alaparoscopic surgical instrument and energy source whileat the same time demonstrating the potential for adverse,unexpected complications.

Key Words: Laparoscopy, Harmonic scalpel, Ureteral in-jury.

INTRODUCTION

Laparoscopic surgery has many advantages over tradi-tional abdominal methods, including smaller incisions,less postoperative pain, less blood loss, lower infectionrates, shorter hospital stays, faster recovery time, andfaster return to work. Increasing use of laparoscopic sur-gery has led to reports of increasing numbers of urinarytract complications after such procedures. Most importantamong these injuries are those involving the ureter. Withthe increasing use of laparoscopic surgery, particularlylaparoscopic hysterectomies, a concomitant increase hasoccurred in ureteral injuries reported to happen duringthis procedure.1 However, laparoscopic salpingo-oopho-rectomy is a procedure that also places the ureter at riskand is performed much more frequently than laparoscopichysterectomy. The case detailed below is an example ofsuch an occurrence. Interestingly, it is only the secondcase of this type of injury occurring specifying use of theHarmonic scalpel that could be found after an Englishliterature review utilizing PubMed and Ovid databasesfrom 1995 through 2008. This particular case also illus-trates the advantages and potential disadvantages of theuse of this instrument and energy source in gynecologicendoscopic surgery.

CASE REPORT

The patient is a 49-year-old, G0P0, perimenopausal fe-male with a last menstrual period (LMP) of 9/19/07 whowas admitted in October of 2007 for an enlarging, com-plex right adnexal mass measuring 4cm in size. For theyear prior to the LMP, the patient had been having infre-quent menses and hot flashes. Serial ultrasounds and CTscans of the abdomen and pelvis over a 6-month perioddemonstrated enlargement of the mass with no evidenceof ascites or pelvic adenopathy. The patient’s past historywas significant for 1 laparotomy and 2 laparoscopies forresection of extensive pelvic endometriosis and lysis ofadhesions. In addition, myomectomies were performedduring one of the laparoscopies. Subsequent to the priorprocedures, the patient underwent 2 inguinal herniorrha-phies with endometriosis resected from the inguinal canalon both occasions. The gynecologic history was also sig-nificant for 3 hysteroscopies for Asherman’s syndrome

Address correspondence to: Patrick F. Vetere, MD, Associate Residency ProgramDirector, Department of Obstetrics & Gynecology, Winthrop University Hospital,259 First Street, Mineola, NY 11501, USA. Telephone: (516) 663-2264, Fax: (516)742-7821, E-mail: pvetere@winthrop.org

DOI: 10.4293/108680810X12674612014987

© 2010 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published bythe Society of Laparoendoscopic Surgeons, Inc.

JSLS (2010)14:115–119 115

CASE REPORT

JSLS (2010)14:115–119

Harmonic scalpel

«The resulting high temperatures with dissections at power setting 4 and especially 5 cause significant collateral and proximity injury to important structures, at least within 1.0 cm of the dissection plane. Contrary to high-frequency electrosurgery, ultrasonically induced collateral/proximity damage is not macroscopically visible. Thus, the tissues and structures appear normal despite extensive histologic injury, which in the case of thin-walled structures (e.g., the bile duct and ureter) may be transmural.»

How Safe is High-Power Ultrasonic Dissection?Tarek A. Emam, MB BCh, MCh, and Alfred Cuschieri, MD, ChM, FRSE, FRCS

From the Department of Surgery and Molecular Oncology & Surgical Skills Unit, Ninewells Hospital & Medical School, Universityof Dundee, Dundee, Scotland

ObjectiveTo evaluate the safety of ultrasonic dissection.

Summary Background DataHigh-power ultrasonic dissection is in widespread use forboth open and laparoscopic operations and is generally per-ceived to carry a low risk of collateral damage, but there is nopublished evidence for this.

MethodsUnder controlled experimental conditions, ultrasonic dissec-tions were performed in pigs using Ultracision (Ethicon) or Au-tosonix (Tyco/USSC) at the three power settings (3, 4, and 5)in random fashion to mobilize the cardia and fundus, bileduct, hepatic artery, portal vein, aorta from the inferior venacava, renal vessels, colon, and ureters. The dissections (openand laparoscopic) were carried out on pigs at each powersetting with each device. Thermal mapping of the tissues dur-ing dissection was performed with an infrared thermal cameraand associated software. The animals were killed at the endof each experiment and specimens were harvested for quanti-tative histology.

ResultsExtreme and equivalent temperature gradients were gener-ated by ultrasonic dissection with both systems. Heat produc-

tion was directly proportional to the power setting and theactivation time. The core body temperature of the animalsafter completion of the laparoscopic dissections rose by anaverage of 2.3°C. The zone around the jaws that exceeded60°C with continuous ultrasonic dissection for 10 to 15 sec-onds at level 5 measured 25.3 and 25.7 mm for Ultracisionand Autosonix, respectively. At this power setting and an acti-vation time of 15 seconds, the temperature 1.0 cm away fromthe tips of the instrument exceeded 140°C. Although therewas no discernible macroscopic damage, these thermalchanges were accompanied by significant histologic injurythat extended to the media of large vessels and caused par-tial- to full-thickness mural damage of the cardia, ureter, andbile duct. Collateral damage was absent or insignificant afterdissections at power level 3 with both systems and an activa-tion time not exceeding 5 seconds.

ConclusionsHigh-power ultrasonic dissections at level 5 and to a lesserextent level 4 result in considerable heat production thatcauses proximity collateral damage to adjacent tissues whenthe continuous activation time exceeds 10 seconds. Ultra-sonic dissections near important structures should be con-ducted at level 3. At power levels of 4 and 5, the ultrasonicenergy bursts to the tissue should not exceed 5 seconds atany one time.

High-power ultrasonic dissection systems that cut andcoagulate tissues have been introduced in both open andendoscopic surgery. They carry undoubted advantages overhigh-frequency electrosurgery in that they do not generatesmoke. It is generally assumed that ultrasonic dissectionsystems disperse less energy to surrounding tissue duringactivation and thus have a reduced propensity for collateralor proximity thermal damage. The two most widely used

systems, Ultracision (Ethicon) and Autosonix (USSC,Tyco), incorporate piezoelectric transducers that induce avibration frequency at the functional tip (through differenttransmission systems along the shaft) of 55 kHz over a 50-to 100-!m arc (movement of the tips). At this level, theultrasonic energy can cut and coagulate, especially when thefunctional end consists of shears such that the tissue iscompressed between the sharp and blunt blades. Thus, thebenefit is that of a multifunctional instrument that can cutand achieve local hemostasis of vessels of up to 2 to 3 mm,ostensibly with minimal injury to surrounding tissues.1–3 Byreducing instrument traffic through the ports, these high-power ultrasonic dissection systems expedite considerablythe conduct of complex laparoscopic operations, especiallycolorectal resections.

Funding for experiments provided by Ethicon Endosurgery.Correspondence: Alfred Cuschieri, MD, ChM, FRSE, FRCS, Department

of Surgery, Ninewells Hospital & Medical School, Dundee DD1 9SY,Scotland.

E-mail: a.cuschieri@dundee.ac.ukAccepted for publication May 29, 2002.

ANNALS OF SURGERYVol. 237, No. 2, 186–191© 2003 Lippincott Williams & Wilkins, Inc.

ORIGINAL ARTICLES

186

HARMONIC LIGASURE

Residual heat of laparoscopic energy devices: how long mustthe surgeon wait to touch additional tissue?

Henry R. Govekar • Thomas N. Robinson •

Greg V. Stiegmann • Francis T. McGreevy

Received: 21 February 2011 / Accepted: 26 April 2011 / Published online: 19 May 2011! Springer Science+Business Media, LLC 2011

AbstractBackground Energy devices are essential laparoscopic

tools. Residual heat is defined as the increased instrument

temperature after energy activation is completed. Thisstudy aimed to determine the length of time a surgeon

needs to wait before touching other tissue using four

common laparoscopic energy sources.Methods Thermal imaging quantified instrument and tis-

sue temperature ex vivo using monopolar coagulation,

argon beam coagulation, ultrasonic dissection, and bipolartissue fusion devices. To simulate realistic operative usage,

each instrument was activated for 5 s four consecutive

times with 5 s pauses between fires. Thermal conductivityto bovine liver tissue was measured 2.5, 5, 10, and 20 s

after final activation.

Results The maximum increase in instrument tip tem-perature was 172 ± 63"C for the ultrasonic dissection,

81 ± 18"C for the monopolar coagulation, 46 ± 19"C for

the bipolar tissue fusion, and 1 ± 1"C for the argon beamcoagulation (P \ 0.05 for all comparisons). Touching the

instrument tip to tissue at four intervals after the finalactivation (2.5, 5, 10, and 20 s) found that ultrasonic

energy raised the tissue temperature higher (maximum

change, 58"C) than the other three energy devices at allfour time points (P \ 0.05).

Conclusions Ultrasonic energy instruments have greater

residual heat than monopolar electrosurgery, bipolar tissuefusion, and argon beam. The ultrasonic energy instrument

tips heated tissue more than 20"C from baseline even 20 s

after activation; whereas all the other energy sources raisedthe tissue temperature less than 20"C by 5 s. These prac-

tical findings may alter a surgeon’s usage of these common

energy devices.

Keywords Complications ! Electrosurgery ! Monopolar !Radiofrequency ! Ultrasonic

Electrosurgery is used in virtually every laparoscopic

operation. The incidence of an inadvertent injury from

laparoscopic energy sources reportedly ranges from 0.6 to5 per 1,000 [1, 2]. These injuries can lead to catastrophic

complications [3]. Residual heat is defined as the increased

instrument temperature after energy activation is com-pleted. The clinical importance of residual heat is that

when the hot instrument touches additional tissue, heat istransferred to that tissue (a phenomenon called thermal

conductivity), creating the potential for inadvertent injury.

This study aimed to determine the length of time asurgeon needs to wait before touching other tissue using

four common laparoscopic energy sources. The energy

sources studied were monopolar, bipolar tissue fusion,ultrasonic, and argon beam devices. The specific aims of

this study were to measure the peak temperature of each

instrument after consecutive activations and to determinehow long a surgeon needs to wait for the instrument to cool

before touching additional tissue.

Presented at the SAGES 2011 Annual Meeting, March 30–April 2,2011, San Antonio, TX.

H. R. Govekar ! T. N. Robinson (&) ! G. V. StiegmannDepartment of Surgery, University of Colorado Denver Schoolof Medicine, 12631 East 17th Ave., MS C313, Aurora,CO 80045, USAe-mail: thomas.robinson@ucdenver.edu

F. T. McGreevyConMed Electrosurgery, Centennial, CO, USA

123

Surg Endosc (2011) 25:3499–3502

DOI 10.1007/s00464-011-1742-x

and Other Interventional Techniques

(Table 2; Fig. 2). Ultrasonic energy increased the tissue

temperature the most (maximum increase, 58!C at 5 s) and

for the longest time (tissue remained 24!C above baseline20 s after the final activation). The ultrasonic energy tips

continued to increase the tissue temperature even after the

final activation was completed (the 54!C change at 2.5 sincreased to a 58!C change at 5 s), a phenomenon that did

not occur with the other three energy sources.

Discussion

The residual heat of laparoscopic electrosurgical instru-

ments is relevant. The current study found that three energy

sources (monopolar, bipolar tissue fusion, and ultrasonicdevices) raised tissue temperature by a clinically relevant

20!C if the wait after the final activation until additional

tissue is touched is only 2.5 s. Ultrasonic energy instrumenttips had the highest temperature increase (173!C),

increasing tissue temperature the most (58!C at 5 s) and for

the longest interval after activation (24!C at 20 s).Residual heat is one of five described patterns of lapa-

roscopic energy complications. The other four are insula-tion failure, capacitive coupling, direct coupling, and direct

application [4–6]. Previous studies have investigated peak

temperatures of laparoscopic instruments [7] and the ther-mal spread during activation of these instruments [8].

However, the most clinically relevant information for a

surgeon is an understanding of how long he or she mustwait before touching additional tissue after activation of an

energy device is completed.

The importance of the current study is the acknowl-edgment that laparoscopic energy instruments retain a

significant amount of heat after completion of energy

activation. In fact, this residual heat is sufficiently high to

raise the temperature of additional tissue enough to cause

injury. We defined a temperature change of 20!C frombaseline to be clinically significant, an estimate that may be

too conservative. Previous work has shown that tempera-

ture increases exceeding 42!C, or about 5!C from baseline,causes damage to both cell membranes and denatures

proteins [9–11]. However, the clinical relevance of

increased tissue temperature depends on both the maxi-mum temperature and the length of time the tissue is

exposed to elevated temperature.

The current study found that an increase of tissue tem-perature by more than 20!C occurred with three instru-

ments (ultrasonic, bipolar tissue fusion, and monopolar

devices) 2.5 s after activation and that ultrasonic instru-ment tips raised tissue temperature more than 20!C even

20 s after activation. This information is important to

laparoscopic surgeons because it highlights the fact thatthese common energy instruments require time to cool

between activations.

This study had three main limitations. First, the tissueused was cadaveric bovine tissue stored at room tempera-

ture. As a result, the baseline tissue temperature was10–15!C cooler than body temperature, and our model did

not account for blood flow. Second, this study used the

thermography temperature differential as the primary out-come measure. The clinical relevance of increased tem-

perature measured by thermography is less certain than

histology or an in vivo animal survival model, in whichresidual instrument temperature on the bowel can be fol-

lowed for a clinically relevant outcome such as perforation.

Third, we used only one instrument at one energy settingwith a one-time pattern of activation from each of the four

categories of energy devices. Therefore, we cannot

Fig. 2 Increased tissuetemperature at varying intervalsafter energy activation

Surg Endosc (2011) 25:3499–3502 3501

123

The ultrasonic energy tips continued to increase the tissue temperature even after the final activation was completed (the 54°C change at 2.5 s increased to a 58°C change at 5 s), a phenomenon that did not occur with the other three energy sources.

Surg Endosc. 2008 Jun;22(6):1464-9. Epub 2007 Nov 20.

Temperature safety profile of laparoscopic devices: Harmonic ACE (ACE), Ligasure V (LV), and plasma trisector (PT). Kim FJ, et al Department of Surgery, Division of Urology, University of Colorado Health Sciences Center, 777 Bannock Street (MC0206), Denver, Colorado 80204, USA.

The LV and PT consistently yielded temperatures that were < 100 degrees C independent of type of tissue or "on"/ "off" mode. Conversely, the ACE reached temperatures higher than 200 degrees C, with a surprising surge after the instrument was deactivated. The LV and PT cooling times were virtually equivalent, but the ACE required almost twice as long to cool.

Because of the high temperatures generated by the ACE device, particular care should be taken when it is used during laparoscopy.

the LS were more or less comparable to those obtained inprevious experiments [11, 12]. For minor differences, a

different setup for burst pressure measurement, different

sealing parameters, or other confounding variables mightbe the cause [13]. Two known confounding factors are the

intraluminal hematocrit and the intraluminal protein con-

tent, which have been shown to influence the burst pressureafter sealing with both the Harmonic ACE! and the Lig-

aSure V! [14]. To definitely exclude nonphysiological

conditions or confounding parameters, all sealing proce-dures in the present study were performed in vivo using a

standardized and randomized protocol.

TB has been shown to achieve burst pressures compa-rable to peak values of mechanical occlusion by surgical

clips as reported by Newcomb et al. [15]. In this study,

surgical clips achieved a mean burst pressure of757 mmHg in the large-vessel category of 6–7 mm.

Interestingly, most mean burst pressure values obtained by

Newcomb et al. were very similar to our results withrespect to the devices used in both studies. However, as in

most other studies [12, 15], a relatively wide distribution of

individual burst pressure data for each device was observedin our experiments as well. One reason might be traction on

the arteries during activation of the instruments, especially

Table 2 Summary of the safety data*

LS HA TB

(a) Thermosensor

Maximum temperatureb ("C) (95% CI) 86 ± 2c (81–91) 192 ± 7 (175–208) 172 ± 7 (158–187)

Time to decline to 60 "C (s) (95 % CI) 34 ± 3c (29–40) 54 ± 3 (48–60) 60 ± 3 (53–66)

(b) Thermocamera

Maximum temperatured ("C) (95 % CI) 85 ± 3c (80–90) 209 ± 7 (196–223) 229 ± 9 (209–241)

Time to decline to 60 "C (s) (95 % CI) 8 ± 1c (6–10) 33 ± 1 (31–35) 34 ± 1 (32–36)

(c) Histological damage of small bowel (distance = 5 mm) (n) 0/8 0/8 0/8

* (a) Thermosensor: Heat production measured by thermosensor after cutting 10 cm of the small bowel mesentery. (b) Thermocamera: Heatprofile during single activation and division of mesenteric tissue determined by an infrared camera. (c) Histological damage of small bowel:Samples with histological damage to the small bowel after standardized division of the small bowel mesentery 5 mm distant to the bowel wallb After repeated activation, see Material and methodsc p \ 0.05 versus HA and TBd After single activation

Fig. 7 A Exemplary thermalcamera views of the threeinstruments at the time ofmaximum heat production(upper row). The color scaleencoding the respectivetemperature (in "C) is depictedon the right-hand side of thefigure. B Exemplarytemperature curves measuredwith the thermocamera duringand after single activation of thedevices. C Temperature curvesof the thermosensor afterrepeated activation during fastdissection of 10 cm of smallbowel mesentery

Surg Endosc (2012) 26:2541–2549 2547

123

the LS were more or less comparable to those obtained inprevious experiments [11, 12]. For minor differences, a

different setup for burst pressure measurement, different

sealing parameters, or other confounding variables mightbe the cause [13]. Two known confounding factors are the

intraluminal hematocrit and the intraluminal protein con-

tent, which have been shown to influence the burst pressureafter sealing with both the Harmonic ACE! and the Lig-

aSure V! [14]. To definitely exclude nonphysiological

conditions or confounding parameters, all sealing proce-dures in the present study were performed in vivo using a

standardized and randomized protocol.

TB has been shown to achieve burst pressures compa-rable to peak values of mechanical occlusion by surgical

clips as reported by Newcomb et al. [15]. In this study,

surgical clips achieved a mean burst pressure of757 mmHg in the large-vessel category of 6–7 mm.

Interestingly, most mean burst pressure values obtained by

Newcomb et al. were very similar to our results withrespect to the devices used in both studies. However, as in

most other studies [12, 15], a relatively wide distribution of

individual burst pressure data for each device was observedin our experiments as well. One reason might be traction on

the arteries during activation of the instruments, especially

Table 2 Summary of the safety data*

LS HA TB

(a) Thermosensor

Maximum temperatureb ("C) (95% CI) 86 ± 2c (81–91) 192 ± 7 (175–208) 172 ± 7 (158–187)

Time to decline to 60 "C (s) (95 % CI) 34 ± 3c (29–40) 54 ± 3 (48–60) 60 ± 3 (53–66)

(b) Thermocamera

Maximum temperatured ("C) (95 % CI) 85 ± 3c (80–90) 209 ± 7 (196–223) 229 ± 9 (209–241)

Time to decline to 60 "C (s) (95 % CI) 8 ± 1c (6–10) 33 ± 1 (31–35) 34 ± 1 (32–36)

(c) Histological damage of small bowel (distance = 5 mm) (n) 0/8 0/8 0/8

* (a) Thermosensor: Heat production measured by thermosensor after cutting 10 cm of the small bowel mesentery. (b) Thermocamera: Heatprofile during single activation and division of mesenteric tissue determined by an infrared camera. (c) Histological damage of small bowel:Samples with histological damage to the small bowel after standardized division of the small bowel mesentery 5 mm distant to the bowel wallb After repeated activation, see Material and methodsc p \ 0.05 versus HA and TBd After single activation

Fig. 7 A Exemplary thermalcamera views of the threeinstruments at the time ofmaximum heat production(upper row). The color scaleencoding the respectivetemperature (in "C) is depictedon the right-hand side of thefigure. B Exemplarytemperature curves measuredwith the thermocamera duringand after single activation of thedevices. C Temperature curvesof the thermosensor afterrepeated activation during fastdissection of 10 cm of smallbowel mesentery

Surg Endosc (2012) 26:2541–2549 2547

123

UN

CO

RR

EC

TE

D P

RO

OF

occur at the Santorini plexus or vascular pedicles. Since theimmediate vascular control of all supplying vessels duringdissection cannot be achieved, the use of the harmonicscalpel alone isnot advisable.Apromisingdevelopment is theintroduction of a new harmonic generator (Harmonic ACETM,Ethicon, USA). Owing to a higher velocity of transaction, thedevice is more rapid in tissue dissection, and vessels !5 mmcan be sealed with decreased smoke formation or less lateralthermal damage to surrounding tissue [23]. However, datafrom larger series are not yet available.

2.3. Lasers for haemostasis

2.3.1. Holmium laserThe Holmium laser has been used for parenchymal tissueresection such as prostatectomy because of the significantlyreduced blood loss, even in high-risk patients. Not surprisinglythere have been several attempts to use the Holmium laser forrenal partial resection. Lotan et al. presented results obtainedwith the Holmium:yttrium aluminum garnet (YAG) laser forlaparoscopicpartialnephrectomyinaporcinemodel [24].A550-to1000-micronend-fireholmiumlaserfibresetat0.2 Jand60 Hzwas used to transect the lower pole of the kidney; theparenchymal surface was then sealed with fibrin glue. Theyconcluded that this laser provides an efficacious modality fortransecting thekidney in a porcinemodel. In another study, theHolmium laser was used in kidney, bladder, prostate, ureteralandvassal tissues [25].Whenused through the laparoscope, theHolmium:YAG laser provided precise cutting and—combinedwith electrocautery—allowed the dissection to proceed quicklyand smoothly.Haemostatic controlwas adequate in all surgicalprocedures. Clinical data, however, are very limited. In a smallclinical setting, three patients (complex cyst, non-functioninglower pole, renal mass) underwent nephron-sparing proce-dureswith theHolmium laser setting of 0.2 J/pulse at 60 Hz and0.8 J/pulse at 40 Hz [26]. Tissue sealants also were used toreinforce the lesion although haemostasis seemed sufficient.No complications were documented, and good haemostasiswithout the need for hilar occlusion resulted. This technique

promises to facilitate the laparoscopic management of renaltumours. It has to be noted, however, that laser applicationcauses significant tissue vaporisation and spreading of liquidduring manipulation. These effects may result in significanttumour cell spillage within the abdominal cavity; for the samereason, the harmonic scalpel is regarded as unsafe inoncological interventions.

2.3.2. Experimental lasersWith the use of an 810-nm, pulsed diode laser (20 W), a 50%liquid albumin-indocyanine green solderwaswelded to the cutedge of the renal parenchyma to seal the collecting system andachieve haemostasis in an animal model [27]. No evidence ofurinoma or haemorrhage occurred. Histopathologic analysisshowed preservation of the renal parenchyma immediatelybeneath the solder. Laser tissue welding provided reliablehaemostasis and closure of the collecting system whileprotecting the underlying parenchyma from the deleteriouseffect of the laser.

Likewise, a 980-nm diode laser (23W) without hilar occlu-sion was used in a laparoscopic, transperitoneal, lower-polepartial nephrectomy in five pigs [28]. In three cases, laserhaemostasiswas insufficient, and adjunctive haemostatic clipswere necessary to stop bleeding; therefore, it seems question-able that this particular laser type will survive further clinicaltrials or its indication may be limited to very small andexophytic tumours. Promising results for laparoscopic partialnephrectomy were obtained with a potassium-titanyl-phos-phate (KTP) laser without vascular hilar clamping in thesurvival calf model [29]. KTP laser is not absorbed by water,but the selective uptake of KTP laser energy by haemoglobinleads to haemostasis. In all 12 procedures, renal parenchymalresection and haemostasiswere achievedwith the laser only,without any adjunctive haemostatic sutures or bio-adhe-sives. At 1-month follow-up there was no evidence of urinaryleakage or arterio-venous fistula. This initial study oflaparoscopic, KTP laser, partial nephrectomy without hilarclamping confirms its technical feasibility with good short-term outcomes.

e u r o p e a n u r o l o g y x xx ( 2 0 0 6 ) x x x – x x x 5

EURURO 1216 1–10

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Table 1 – Comparison of the bursting pressure of various haemostatic devices and agents

Burstingpressure/arterial

size (mm Hg)/[mm]

Collectingsystem

sealing (mm Hg)

Parenchymalsealing

Special instruments

Sutures [47] 900 [3–7 mm]Titanium clip [11,47] 593 [4 mm] Clip appliers; single usePolymer clip [11] 854 [4 mm] Clip applier; re-usableVascular endostapler [12] >310 [17 mm] Stapler arm + jaws; multiple loadsElectrocautery [11] 230 87 Single/re-usableHarmonic scalpel [11] 205 [4 mm] Special generator + single-use forcepsBipolar vessels

sealer [11,47]601 [4 mm] Standard generator;

single/re-usable instrumentsFibrin glue [33–35] 378 [parenchyma] 166 22 hPa (17 mm Hg) Two components; application needlePolyethylene glycol >490 [1 mm] Solid clot 80 hPa (61 mm Hg) Single component; application needleFibrin-coated

collagen fleece [40]>290 (suture 900) Dense fleece;

sutured bolster59 hPa (46 mm Hg) Dry fleece; Endo-Doc carrierTM

Oxidised methylcellulose NA (suture 900) Sutured bolster Sutured polster Cellulous fleece; no special applicatorGelatine matrix [36–39] NA No clot formation Two components; application needle

NA = not available.

UN

CO

RR

EC

TE

D P

RO

OFLaparoscopic Surgery

Haemostasis in Laparoscopy

H. Cristoph Klingler a,*, M. Remzi a, M. Marberger a, G. Janetschek b

aDepartment of Urology, Medical University of Vienna, AustriabDepartment of Urology, Krankenhaus Elisabethinen Linz, Austria

1. Introduction

As in open surgery, uncontrolled bleeding duringlaparoscopy is one of the major surgical pitfalls.Haemorrhage may occur by gaining laparoscopicaccess, during surgical preparation or during ablativeand reconstructive surgery [1,2]. In addition, even

minor bleeding may jeopardize improved visionduring laparoscopy owing to significant light absorp-tion by dark blood staining of the adjacent tissuewithin themagnifiedopticalfieldduring laparoscopy.Not surprisingly, haemostasis during laparoscopicsurgery focusesonprimarypreventionofbleeding [3].A variety of techniques and instruments have been

e u r o p e a n u r o l o g y x x x ( 2 0 0 6 ) x x x – x x x

avai lab le at www.sciencedi rect .com

journa l homepage: www.europeanurology.com

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Article info

Article history:Accepted January 31, 2006Published online ahead ofprint on ! ! !

Keywords:ComplicationsLaparoscopyHaemostasis

Abstract

Objective: Adequate haemostasis is essential for advanced laparoscopicprocedures since uncontrolled bleedingmay cause significant complica-tions and even required converting to laparotomy to obtain sufficienthaemostasis. The aim of this review is to give insight into the mostimportant tools and strategies to achieve sufficient haemostasis duringadvanced urologic laparoscopy.Methods and results: Lowering the risk of haemorrhage may be achievedprimarily by proper case selection, resulting in adequate laparoscopicpreparation and dissection technique or the use of local compression bysponge stick to control local bleeding. For early bleeding control, laparo-scopic clip appliers, staplers and suturing techniques may be utilised.Various energy sources such as monopolar and bipolar electrocautery,argon beam coagulators, laser or ultrasonic dissectors and topical seal-ing agents can be used to augment natural haemostasis.Conclusions: A wide armamentarium for achieving haemostasis duringlaparoscopy is available. Consequently, laparoscopic surgeons musthave detailed knowledge of the physical concepts of each surgicalinstrument or energy source and of proper use of tissue sealants forobtaining sufficient haemostasis. This knowledge will improve post-operative outcome, increase patient safety and guide laparoscopic tech-niques to further perspectives.

# 2006 Published by Elsevier B.V.

* Corresponding author. FEBU, Department of Urology, Medical University of Vienna,Wahringer Gurtel 18-20, A-1090 Vienna/Austria. Tel. 43 1 40 400 2616; Fax: +43 1 408 99 66.E-mail address: christoph.klingler@meduniwien.ac.at (H.C. Klingler).

0302-2838/$ – see front matter # 2006 Published by Elsevier B.V. doi:10.1016/j.eururo.2006.01.058

EURURO 1216 1–10

«PLASMAKINETIC ENERGY» ?

PLASMAJET

Some rules.....Inspect insulation carefully

Use lowest possible power setting

Use a low voltage waveform “cut”

Use brief instrument activation

Do not activate in open circuit

Do not activate in close proximity or direct contact with another instrument or vulnerable tissu

SURGICAL TECHNIQUE

OR

TECHNOLOGICAL SURGERY