WO2009021297A1

WO2009021297A1 - Conductor platform for natural orifice surgery

Info

Publication number: WO2009021297A1
Application number: PCT/BR2007/000210
Authority: WO
Inventors: Ricardo Paiva Araujo Dos Scheiba-Zorron
Original assignee: Paiva Araujo Dos Scheiba-Zorro
Priority date: 2007-08-16
Filing date: 2007-08-16
Publication date: 2009-02-19
Also published as: EP2187831A1

Abstract

The present invention refers to a conductor platform used to per- form many surgical techniques for natural orifice surgery for digestive system (gallbladder, liver, intestines, stomach, etc), urinary system (kidneys, ure- thers, etc), gynecologic applications (utherus, ovars, etc), and many other surgical applications, comprising a perforated conductor tube (1), containing at least one main channel (2) and at least one accessory channel (3), a table holder (6) for stabilize the tube (1 ) to the surgical table, and multiple flexible instruments (4) consisted of a connection stem (8) with different possibilities of surgical instruments at its end, as knot-pushers (9), hook (10), graspers (11 ), clipators (12), scissors (13), dissectors (14) among others.

Description

Title: "CONDUCTOR PLATFORM FOR NATURAL ORIFICE SURGERY".

FIELD OF THE INVENTION

The invention relates to a conductor platform comprised by multiple flexible instruments to perform surgical techniques of digestive system (gallbladder, liver, intestines, stomach, etc), urinary system (kidneys, urethers, etc), gynecologic applications (utherus, ovars, etc), and many other surgical applications, by means of the so-called "natural orifice surgery". DESCRIPTION OF THE PRIOR ART

Surgical subspecialties are represented by many branches, as general surgery, oncology, urology, coloproctology, gynecology, among many others, which usually perform operations using available conventional surgical instruments (scissors, graspers) since more than 100 years of surgical history.

Since 1987, with the evolution of videosurgery (or laparoscopy), the same procedures could be performed by means of little incisions on the skin, (2 to 10mm), for insertion of many ports (or trocars) through which a rigid camera and fine instruments to act into the cavity and organs are inserted.

Laparoscopy made possible these operations, previously done by longer incisions of conventional surgery, to be carried out by small orifices, reducing the trauma and lowering complications for the patients, with less pain and hospital stay.

However, a new concept is evolving as a premise of being a lesser invasive surgery than laparoscopy: Natural Orifice Surgery (or NOTES, Natural Orifice Translumenai Endoscopic Surgery). According to this new method, restricted to animal studies in worldwide literature, surgery with no incisions could be performed, being executed through natural orifices of the human body, as mouth, anus, vagina and urethra.

SEIFERT et al first described on 2000, the endoscopic access through natural orifice (mouth/stomach), for three patients with acute necrotizing pancreatitis. Through an endoscopic incision of the stomach, using a flexible endoscope, access to the retroperitoneum was achieved, and ade- quate extraction of necrotic tissue was obtained, with good postoperative e- volution. Also the spleen could be removed by the method in one patient. This pioneer publication started the research for applications of natural orifice surgery methods for surgery. The first description of per-oral flexible endoscopic access to the peritoneal cavity was published by KALLOO et al of Johns Hopkins Hospital, Baltimore on 2004, for hepatic byopsy in animal model. The Apollo Group related with the project has been founded and nowadays represents specialists of five universities for natural orifice surgery research. The indication for natural orifice surgery is still in conceptual draft. It is full of clinical, physiopathological, and technological development challenges. Many questionings are subjects of experimental researches, and standard orientations are subjects of medical societies, originating "White Papers" and recognizing fundamental research lines to bring the methods to clinical practice (Rattner 2006).

New endoscopic suture devices could allow to break the intestinal barrier with more safety for patients, allowing clinical applications. Available suture devices are insufficient for safe full-thickness closure of gastric wall for example, because these devices were idealized for small mucosal sutures.

There are not available means for safe execution of natural orifice surgery through gastric, rectal, vaginal or urethral access, and development of new technology and specific instruments to perform preliminary procedures with potential advantages for the patients becomes necessary. In summary, natural orifice translumenal endoscopic surgery u- ses a flexible endoscope (gastroscope or colonoscope), available in the market, that should be introduced in the human abdominal cavity. However, special devices for introducing the flexible endoscope and instruments, and e- ventually other flexible instruments are unavailable. SUMMARY OF THE INVENTION

The present invention consists, basically, in a conductor platform and multiple instruments and accessories, allowing the introduction of a flexi- ble endoscope (gastroscope or colonoscope), through human natural orifices, penetrating into the abdominal cavity and allowing the insertion and use of the specific flexible instruments through the device to perform surgical procedures. The group of instruments is composed by a perforated conductor tube, that could be fixed to the operating table by its table fixer, that allows the insertion of any flexible endoscope commercially available ant that allows the insufflation of gas into the cavity, in addition to allow the insertion of special flexible instruments designed for this purpose, and other accessories. OBJECTIVES OF THE INVENTION The objective of the present invention is to provide a perforated conductor tube for insertion of a flexible endoscope, for insufflating gas into the cavity, and to be fixed to the operating table by means of its table fixer, to perform natural orifice surgery.

Another objective of the invention is to allow new flexible surgical instruments designed for execution of natural orifice surgery. BRIEF DESCRIPTION OF THE FIGURES

Figure 1 represents the perforated conductor tube for natural orifice surgery, as seen from its axial view;

Figure 2 depicts the extremity of the perforated conductor tube for natural orifice surgery, as seen from its side view, showing the emergence of the flexible instruments;

Figure 3 depicts the perforated conductor tube for natural orifice surgery, as seen from its side view;

Figure 4 represents the table holder for perforated conductor tu- be for natural orifice surgery, as seen from its side view;

Figure 5A depicts the knot pusher, as seen from its side view, with details of its distal extremity;

Figure 5B depicts different possible forms of the extremity of the knot pusher. Figure 6A depicts the hook, as seen from its side view, with details of its distal extremity;

Figure 6B depicts different possible forms of the extremity of the hook;

Figure 7A depicts the grasper, as seen from its side view, with details of its distal extremity.

Figure 7B depicts different possible forms of the extremity of the grasper;

Figure 8A depicts the clipator, as seen from its side view, with details of its distal extremity;

Figure 8B depicts different possible forms of the extremity of the clipator; Figure 9A depicts the shears, as seen from its side view, with details of its distal extremity;

Figure 9B depicts different possible forms of the extremity of the shears;

Figure 1OA depicts the dissector, as seen from its side view, with details of its distal extremity;

Figure 1OB depicts different possible forms of the extremity of the dissector;

Figure 11 depicts the instruments disposed into the conductor tube; Figure 12 depicts an example of use of the conductor platform for natural orifice surgery, in an operation for transvaginal gallbladder extraction as seen from its side view, with details of insertion in the natural human orifice (vagina) and the procedure inside the abdomen;

Figure 13 depicts the external view of an example of use of the conductor platform for natural orifice surgery, in an operation for transvaginal gallbladder extraction as seen from its side view, with details of insertion of the invention in the natural human orifice (vagina); and

Figure 14 depicts an internal view of an example of use of the conductor platform for natural orifice surgery, in an operation for transvaginal gallbladder extraction with details of intraoperative video image after insertion of the invention in the natural human orifice (vagina). DETAILED DESCRIPTION OF THE INVENTION The present invention consists of a conductor platform system comprised by a perforated conductor tube and a group of flexible instruments to perform variable surgical techniques of digestive system (gallbladder, liver, intestines, stomach, etc), urinary system (kidneys, urethers, etc), gynecologic applications (utherus, ovars, etc), and many other surgical applications, by means of the so-called "natural orifice surgery", specially by the transvaginal access.

The technique of natural orifice surgery is a new surgical approach emerging in recent literature, consisting in interventions or diagnostic pro- cedures through natural orifices of the human body (transgastric, transrectal, transvaginal, transurethral) with potential future benefits for the patients.

Restricted at this time to animal experimental studies, human clinical applications have not been published so far in the literature due to the lack of adequate equipments and devices to perform such procedures. The present invention has the intent to afford devices and instruments designed for these new surgical procedures, consisting of a conductor tube and multiple flexible instruments, allowing the execution of natural orifice surgery.

Natural Orifice Transluminal Endoscopic Surgery is emerging as an experimental alternative to standard approaches for the abdominal cavity, as open surgery (conventional laparotomy) and laparoscopy. With advances in technology and videosurgery, the morbidity related to incisions is low. Trying to minimize the trauma of minimally invasive surgery, research groups recently started the evaluation of possible no scar abdominal surgeries. Pioneer researchers, restricted to animal studies, gained abdominal access t- hrough natural orifices as mouth, anus, urethra and vagina.

The concept of natural orifice surgery combinen the advantages of laparoscopy with the less invasivity of flexible endoscopy, eliminating the need of surgical incisions and incision-related complications, as incision infections, hernia and pain. In natural orifice surgery, commercially available flexible endoscopes are used to create a limited controlled visceral incision, gaining access to abdominal cavity. With the endoscope in the cavity, endoscopic instruments are conducted and passed with the endoscope and allo- wing manipulation and intervention of internal organs. After the procedure, the devices are extracted, and the visceral incision is closed, avoiding abdominal skin incisions.

Therefore, the present invention provides a device capable of introduce a flexible endoscope (gastroscope or colonoscope) through a natural orifice of the human or animal body, penetrating into the abdominal cavity and allowing the crossing over and use of special flexible instruments inside the device for performing surgical procedures. The body of the invention consists of a perforated conductor tube fixed to the operating table by its table holder, the conductor tube allowing the insertion of a generic flexible endoscope, and the specially designed flexible surgical instruments for this purpose, the special channel that allows gas insufflation to the cavity and other accessories.

In an example of surgical aplication of the invention, as for gall- bladder extraction, the patient is submitted to general anesthesia, and installed in a Lloyd-Davies position. Disinfection of the vagina is achieved by topic iodopovidone, and an urinary catheter is installed. Incision of vaginal posterior sac is done after traction of the cervix with a conventional instrument. Operator is positioned between the legs of the patient, and first assistant behind and holding the controls of the colonoscope. A second assistant takes position on the left side of the patient to retract the gallbladder.

The perforated conductor tube 1 , as seen in Figures 1 to 3, is inserted through the posterior vaginal wound created and inserted into the abdominal cavity. Gas insufflation of abdominal cavity is performed through the adequate channel of the tube. A generic 2-channel flexible videocolonoscope 5 is inserted into the conductor tube 1 through one of its channels 2, and insufflation of the cavity with CO₂ begins through the device.

The perforated conductor tube comprises at least two distinct passing channels 2,3, with at least one principal channel 2 and at least one accessory channel 3, inside of which flexible instruments are passed to perform surgical techniques through the human natural orifice. The conductor tube 1 is inserted into the natural orifice (mouth, anus, vagina, and urethra), fastened to the operating table in the desired position by means of the table holder 6, as seen in Figure 4. The table holder is externally connected to the perforated conductor tube 1 by means of, for example, pressure loopes 7. The table holder 6 can be of any shape, preferably a C-clamp shape, capable of rotating on its longitudinal axis, so being adjustable for the surgery and natural orifice used.

Also inside said conductor tube 1 , and separated from the accessory channels 3 for flexible instruments, an endoscope or colonoscope 5 of any type is introduced, passing through the principal channel 2 during the procedure and providing the image camera for the operation. These flexible gastroscopes and colonoscopes 5 are commercially available, and are not the purpose of the invention.

Multiple flexible instruments 4 were designed and developed for natural orifice surgery purpose, form example, knot pushers 9, hooks 10, graspers 11 , clipators 12, scissors 13 and dissectors 14.

As it can be seen on Figure 5A, a knot pusher 9 is one of the specially designed flexible instruments 4. This knot pusher 9 is comprised by a flexible stem 8, with a length longer than the total length of the conductor tube 1 by which it passes, and with a substantially smaller caliber than the diameter of the accessory channel 3. The knot pusher also comprises, on the other end, a perforated knot pusher extremity 9 with different conventional shapes, as illustrated on Figure 5B, allowing the conduction and tightening of the knot in the organ or internal structure of the body of the patient.

Likewise, the specially designed flexible hook instrument 10, as illustrated on Figure 6A, the graspers 11 , as illustrated on Figure 7A, the clipators 12, as illustrated on Figure 8A, the scissors, as illustrated on Figure 9A, and dissectors, as illustrated on Figure 10A and 14, are also comprised by a flexible stem 8, with a length longer than the total length of the conductor tube 1 and with a caliber substantially smaller than the accessory channel 3 diameter. As already stated, their ends corresponds to their respective functions and uses, as illustrated on Figures 6B, 7B, 8B, 9B e 10B respectively, in their different shapes. These instruments 4 are introduced into the perforated conductor tube through the accessory channels 3 specially designed for this purpose, as illustrated on Figure 11 , by this way allowing, for example, the dissection of the gallbladder after insertion of the invention into a natural orifice, for e- xample the vagina. Dissection of the cystic duct and artery is obtained by conjoined action using the flexible instruments 4, and the coagulated artery with monopolar energy. Cystic duct ligation is performed by generic commercially available endoclips, using the specially designed flexible clipator 12, or ligating the duct with external wire endoloop, using the specially designed flexible knot pusher 9.

After the section of cystic duct and artery with the specially designed flexible scissors 13, the gallbladder is dissected from its liver bed u- sing the other special instruments above mentioned. The gallbladder is extracted by the natural orifice (for example, the vagina), using the specially designed flexible graspers 11 to hold it. These procedures can be observed on Figures 12 e 13.

All the specially designed flexible instruments 4 and the perforated conductor tube 1 can also be used for surgical techniques through other natural orifices of the human or animal body, as the vagina, mouth, anus and urethra, and also be used through skin incisions, performing the procedures with the same instruments.

Therefore, it is important to emphasize that the system above described is only one of the embodiments and examples of surgical situations, not being limitative of their applications, purposes and techniques, the conductor tube and the flexible instruments or their shapes and positioning. The real scope of the object of the invention is defined in the accompanying claims.

Claims

1. Conductor platform for natural orifice surgery, characterized by comprising: at least one conductor tube (1) consisting of at least one main channel (2) and at least one accessory channel (3); a table holder (6) externally connectable to the conductor tube (1); and multiple flexible instruments (4) comprising a connection stem (8) with a substantially smaller diameter than the diameter of the accessory channel (3) and a length longer than the length of the conductor tube (1 ) .

2. Conductor platform according to claim 1 , characterized in that the conductor tube (1) also has at least one gas flow channel.

3. Conductor platform according to claim 1 , characterized in that the accessory channels (3) have a substantially smaller diameter than the diameter of the main channels (2).

4. Conductor platform according to claim 1 , characterized in that the table holder (6) has a C-clamp shape, rotatable around its longitudinal axis and connectable to the conductor tube (1) by pressure loops (7).

5. Conductor platform according to claim 1 , characterized in that the multiple flexible instruments (4) are surgical instruments.

6. Conductor platform according to claim 1 or claim 5, characterized in that the multiple flexible instruments (4) have different distal ends comprised by the group of knot pushers (9), hook (10), graspers (11), clipa- tors (12), scissors (13), dissectors (14), among others.