1.INTRODUCTION
Laparoscopy by means of pneumoperitoneum si an emerging, efficient and effective surgical technique. Therefore, considering the technical and economical problems emerging for and during its implementation, we propose a variation to the “classical” laparoscopy technique. This new technique or method is referred to as Isobaric Laparoscopy because it can be applied regardless of the ge
neration of a pneumoperitoneum. This may solve or reduce major limitations of the laparoscopy technique.
2.TRADITIONAL LAPAROSCOPY (by means of pneumoperitoneum)
Laparoscopy is a mini-invasive surgical technique that is rapidly spreading because it allows performing different iterventions of abdominal surgery while preventing a major opening of the abdominal paries (laparotomy). Laparoscopy implies an expansion of the peritoneal cavity by insufflation of Carbon Dioxide. Therefore, as a prerequisite, it requires insight devices (laparoscope) and dedicated instruments, i.e. suitable for being introduced and manipulated within the abdominal cavity through appropriate small accesses, equipped with gas sealing valves (trocar). Laparoscopy techniques explained above are currently applied to the reduction of multiple pathologies of higher abdomen and pelvis (e.g. cholecistis, colon, reflux, pancreas, stomach, herniae, annexes, uterus, etc.). So, today laparoscopy is rather common and subject to being further expanded. Figures referring to gynaecology show that only 10 percent of interventions are performed with the laparoscopic method in Italy (compared to 28 percent in France, 30 percent in Germany, 38 percent in UK). Basically, the success of laparoscopy is due to its peculiar feature of being a “mini-invasive” allowing patients a fast psycho-physical recovery thanks to minimum surgical aggression. Surgeons applying the laparoscopic technique with correct indications and competencies are able to act in a more precise way on the points of intervention, to view anatomic structures more accurately and to better respect healthy anatomical parts.
3)Technical limits of laparoscopy are basically generated by:
3.1 Increase in intra-peritoenal pressure due to insufflation of CO2 and subsequent limitation of application to patients with peculiar anesthesiology conditions, e.g. ASA 2, ASA3. These are usually submitted to the laparotomy surgical technique. (Surg Endosc (1998) 12:93-94).
3.2 Peritoneal absorption of CO2 and subsequent emato-chemical problems.
3.3 Difficult application of the laparoscopic technique to oncologic pathology for problems associated to the diffusion of neoplastic cells (Am J Obstet Gynecol 1999; 181:536-541)
3.4 Non-direct surgical actions with application of reduced forces. Relevant reduction of tactile feedback.
3.5 Difficult conversion and adaptation of surgeons of the Laparotomy sc.hool to the news methodology.
3.6) The economical limits with a social impact of laparoscopy are basicalIy generated by:
3.7 Fluctuation of economic costs associated to laparoscopic instruments. Better physical recovery of patients who underwent laparoscopy is asscoiated to reduced hospitalization times (from 6.7 to 3.70 days on average). This initial social and economical advantage is subsequently impacted by the increase in costs associated to dedicated instruments. Sales policies of the so-called scientifical informers often leverage on shorter patient’s hospitalization times and social recovery to push and maximize the sales of laparoscopic surgery devices. When ethically balanced, this can in actuality determine overall benefits for the community, also from an economical standpoint. Almost all the instruments available for laparoscopy have become “disposable”. Therefore, the economical benefit produced by the technique is affected to the point it goes under the breakeven point, while the benefits, even economic, could be maintained high. The sale of laparoscopy instruments is operated in a quasi-monopoly regime. Major multinational corporations must support aggressive sales networks and impose devices with an extremely short duration life (disposable devices). For this reason, laparoscopic interventions are often very expensive, while their costs could be reduced of 40-50 percent.
4.THE PARADOX OF TRADITIONAL LAPAROSCOPIC SURGERY
Laparoscopy is a mini-invasive surgery technique. Mini-invasive surgery is aimed at better respecting the structures and organs of the human body during surgical actions. Therefore, patients who benefit most of this method are exactly the weakest ones, or the most compromised from a physio-pathological point of view. Yet these patients are those for whom laparoscopy (with Co2 insufflation) is contraindicated. Older patients, cardiopaths, persons with bronchial and pulmonary diseases, diabetic patients, obese persns etc., often do not receive the anaesthesiologist’s consent to be submitted to laparoscopy interventions and are destined to laparatomy!
5.RATIONALE FOR ISOBARIC LAPAROSCPIC SURGERY
• Definition:
Isobaric laparoscopy video surgery: a surgical technique similar to classical laparoscopic video surgery (pneumoperitoneum), but performed in cavities with atmospherical pressure, i.e. cavities where no free fluid exists with different pressure than the atmospherical one. The analysis of limits and problems associated to traditional laparoscopy, together with the awareness that tehcnology is the new surgical paradigm to pursue and to perfection, after taking into account observations at items 1 and 2, made us feel the need of giving a technological and scientifical contribuition to the perfectioning of tjis technique by introducing the concept of Isobaric Laparoscopy, which in itslef ha sthe potential for expanding the indications for application of the laparoscopic technique because it tends to reducethe limitations mentioned at item 1.
6.DETAILED DESCRIPTION OF LAPAROTENSER
Commercial name fom Lucini Surgical Concept s.r.l. LaparoTenser®
Kit Contents N°1 Kit Pluriplan® Middle Needles
N°1 Kit Pluriplan® Small Needles
N°1 kit Pluriplan® Big Needles (bariatric surgery) (option)
N°1 Anodised Container for sterilisation 600x300x210 mm
The above mentioned-components represent the essential, total and sufficient object of the device named LaparoTenser®. No other components are required for its regular operations during its entire working life. a) Functional features : the LaparoTenser® is a tenser for abdominal paries based on subcutaneous interaction, suitable for the implementation of ISOBARIC* video laparoscopy in absence of gas (CO2). The LaparoTenser® is the only paries tenser on the market that retracts peritoneum through a subcutaneous action (Pluriplan® needles are positioned into the subcutaneous tissue). This ensures minimum invasiveness (See attached publication: Surg.Endosc.), absolute absence of postoperative pain and the possibility of performing low-pressure laparoscopy as well. These intrinsic features allow surgeons and gynaecologists to cope with both advanced laparoscopic surgery (of higher abdomen, of lower abdomen, general oncology, colon thyroid and breast surgery, etc.) and traditional surgery (from cholecystectomy and annexectomy to hysterectomy mia alla myomectomy) with great flexibility and safety. The absence of CO2 in the peritoneum allows to sumit to laparoscopic interventions also the patients with special conditions (cardiopaths, persons with bronchial and pulmonary conditions, elderly, etc.) for whom classical laparoscopy would be detrimental or highly counterindicated anyway (approx 10 percent of surgical patients). b) Technical features : the LaparoTenser® is a medical device entirely manufactured with noble metallic alloys (Aisi 304-316, Ergal 65, Avional, Titanium, Zellamid 1400) treated to ensure maximum resistance against chemical and mechanical agents, also to ensure absolute electrical insulation, absolute biocompatibility of interacting portions with the patients (ionic bombardment with Ti iones). Pluriplan® needles are manufactured with X5 Cr Ni 1810 steel alloys appropriately forged and submitted to localthrmal treatments suitabl for obtaining the perfect elasticity required. The device is entirely mechanical and manual and is equiiped with mechanical servo controls. Appropriate valve systems have been provided to allow passage of steam through the componets during the sterilisation phase. The system is equipped with appropriate safety systems able to make its usage extremely easy and safe. c) Safety features: the LaparoTenser® is a tensing device for the abdominal paries based on subcutaneous interaction. Its main peculiar safety characteristics are the following:
c.1) no device component is introduced into the intraperitoneal cavity. This prevents from serious risks of intercepting of internal organs. This is a typical prerogative of subcutaneous tensers only. c.2) no component is in contact with the peritoneum. Thus, local ischemic attack are prevented or possible implantations of neoplastic cells in the case of oncological surgery (See Surg.Endos.). c.3) the device is equipped with an anti-shock system, which prevents possible overvoltages are discharged on the patient’s tissues (patented system. Thus, patient’s tissues are respected integrally. c.4) The system is equipped with a manual tensing mechanism with a continuous control of the couple applied (patented system). c.5) Pluriplan® needles are equipped with a breakpoint external to the patient. The patient is totally safeguarded in case of accident (patented system). (Casistics: on 3,800 interventions performed with LaparoTenser®, mortality = 0%, morbidity = 0%). d) Economical features : the LaparoTenser® is totally sterilisable in autoclave. It includes no disposable components, does not require specific accessories and is compatible with any scommonly used system or device. The possibility of performing interventions with total absence of CO2 allows using plain trocars (without valve) and traditional instruments. Therefore, it is possible to use multi-purpose instruments to prevent an excessive use of disposable devices, which strongly affect the balance of surgical and gynaecological divisions. Beyond any technical features and surgical potentials of the device, we find it correct to bring the attention of administrative bodies on the fact that using LaparoTenser® does not require disposable components and allows a relevant economical savings on operations. For detailed information of the technical features of LaparoTenser®, please refer to the technical manual and to the FDA report that are available to those who require it.
7.APPLIED CONSTRUCTION SYSTEMS AND PROCEDURES
Operational procedures and instructions for the manufacturing of the product described above are certified as well as our quality system (UNI EN ISO 9001;2008 UNI CEI EN 13485;2004). Reference procedure is P09. In practice, in order to guarantee our customers intenal procedures ensure the following:
a) All product components are controlled and traced. b) All finished products are tested and traced. c) All of the equipment and machinery are certified, tested and calibrated periodically. d) All products are thoroughly cleansed and disinfected at the end of the manufacturing process. e) All products are specifically controlled at the end of the manufacturing process to verify all aspects comply with applicable safety regulations.
8. COMPLIANCE STATEMENTS (CEE , FDA)
CEE
8.1 Lucini Surgical Concept s.r.l. Via E. Mattei 17/19 20037 Paderno Dugnano (MI) Italia
declares, assuming full responsibility thereof, that the product:
LaparoTenser®
comply with to the following norms and regulations:
93/42 CEE MEDICAL DEVICES
2007/47/CE Addendum 93/42/CE
Annex VII
Annex IX Regola 6
DM Classe I
FDA
Lucini Surgical Concept s.r.l. Via S.Alberto 4/6/8 20020 Lainate (MI) Italia
declares, assuming full responsibility thereof, that the product:
LaparoTenser®
is approved from the Food and Drug Administration (FDA)
Establishment Registration Number:(9614792)
Device Listing: (E534243)
510K (K970712)
Owner/Operator Number (9029562)
Owner/Operator Lucini Surgical Concept srl
Proprietary Device name laparotenser
9. REFERENCES
The LaparoTenser® and the Isobaric Laparoscopy was presented: Congresso della Società Europea di Chirurgia endoscopica (EAES Madrid, settembre 1994), al Congresso Internazionale di Chirurgia Miniinvasiva di Milano (Aprile 1995), al Congresso Regionale ACOI (Varese, Aprile 1995 ) , alla Fiera Internazionale: Interhospital 95 (Hannover, aprile 1995), al Congresso Nazionale ACOI (Sorrento, Maggio 1995), al Third International Simposium on New Technology and Advanced Techniques in Surgery (Lussemburgo, giugno 1995), al 2° Adria Alps International Congress (Pavia, settembre 1995), alla Fiera Internazionale : Medica 1996, Congresso Nazionale ACOI (Courmayeur, Marzo 1997), al GasLESS International' 97 (Luglio 4-6,97 Tokyo), al Congresso Mondiale di Chirurgia Endoscopica (maggio- giugno 1998 Roma), al 74° Congresso della Società Italiana di Ginecologia e Ostetricia
( Milano 20-23 settembre 1998) , al 7th Congress of the European Society for Gyneacological Endoscopy ( Losanna 6-9 dicembre 1998), al 7th International Congress of the European Association for Endoscopic Surgery (Linz 23-26 June 1999), al 5° Congresso Nazionale della Società Italiana di Chirurgia Endoscopica ( Torino 19-21 settembre 1999), 4° Congresso Latino Americano de Cirurgia Endoscopica (Alace 2000), 10th International Congress and endo Expo (New York 5-8 Dicembre 2001), Gynecological Endoscopy and Inoovativr Surgery (Berlino, 25-28 Aprile 2002), X Congresso Associazione Ginecologi Universitare Italiani (Perugia, 9-13 novembre 2002), World Meeting on Minimally Invasive Surgery in Gyneacology (Roma, 24-28 Giugno 2003), World Meeting on Minimally Invasive Surgery in Gyneacology (Roma, 24-28 Giugno 2003),
The World Meeting on Gynecological Pelvic Pain and Endometriosis Segi
Annual Congress (Milano 10-13 maggio 2006), 1st AAGL International Congress in conjunction with SEGI (Palermo 20-23 giugno 2007), The 36th Global Congress of Minimally Invasive Gynecology (Washington,DC November 13-17, 2007).The 39th Global Congress of Minimally Invasive Gynecology (Las Vegas November 8-12, 2010).
10.EXCLUSIVITY STATEMENT OF PRODUCT OFFERED
With reference to the technical specifications described above and the divulgative leaflet attached, we declare that the device mentioned and named LaparoTenser® has been engineered, manufactured and marketed by our company. Therefore, no other company or third party is authorized to sell the LaparoTenser® device. To the best of our knowledge, based on the reseaches of appropriate boards, there are no other devices on the market featuring the same technical characteristics as the LaparoTenser®.
11.PATENT REFERENCES
We hereby declare that LaparoTenser® and Pluriplan® needles names and trademarks are the exclusive property of Lucini Surgical Concept s.r.l. We also declare that LaparoTenser® and Pluriplan® needles are covered by patent rights exclusively belonging to Lucini Surgical Concept s.r.l.. The LaparoTenser® device and the Pluriplan® needles are covered by
EU patent no. 1.274.585 – 29507627.5
US patent no. 5.603.689. No other person or legal entity besides our company is authorisd to distribute the LaparoTenser® and/or Pluriplan® needles without our written authorisation.
