WO2009080399A2 - Surgical device for laparoscopy and endoscopy - Google Patents

Surgical device for laparoscopy and endoscopy Download PDF

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Publication number
WO2009080399A2
WO2009080399A2 PCT/EP2008/064982 EP2008064982W WO2009080399A2 WO 2009080399 A2 WO2009080399 A2 WO 2009080399A2 EP 2008064982 W EP2008064982 W EP 2008064982W WO 2009080399 A2 WO2009080399 A2 WO 2009080399A2
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WO
WIPO (PCT)
Prior art keywords
lid
subassembly
surgical device
laparoscopy
closure
Prior art date
Application number
PCT/EP2008/064982
Other languages
French (fr)
Other versions
WO2009080399A3 (en
Inventor
Eduardo SÁNCHEZ DE BADAJOZ CHAMORRO
Adolfo JIMÉNEZ GARRIDO
Antonio SIMÓN MATA
Francisco GARCÍA VACAS
Original Assignee
Sanchez De Badajoz Chamorro Ed
Jimenez Garrido Adolfo
Simon Mata Antonio
Garcia Vacas Francisco
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Sanchez De Badajoz Chamorro Ed, Jimenez Garrido Adolfo, Simon Mata Antonio, Garcia Vacas Francisco filed Critical Sanchez De Badajoz Chamorro Ed
Publication of WO2009080399A2 publication Critical patent/WO2009080399A2/en
Publication of WO2009080399A3 publication Critical patent/WO2009080399A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3498Valves therefor, e.g. flapper valves, slide valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3431Cannulas being collapsible, e.g. made of thin flexible material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00982General structural features
    • A61B2017/00991Telescopic means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B2017/3443Cannulas with means for adjusting the length of a cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B2017/3445Cannulas used as instrument channel for multiple instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B2017/3445Cannulas used as instrument channel for multiple instruments
    • A61B2017/3449Cannulas used as instrument channel for multiple instruments whereby the instrument channels merge into one single channel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3462Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A61B2017/3466Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals for simultaneous sealing of multiple instruments

Definitions

  • Laparoscopy is one of the endoscopic procedures that has developed the most in the last quarter of the 20th century. This progress has been both at the level of surgical techniques and of materials and technology. It has also prepared the ground for telesurgery and the application of robotics to surgery.
  • laparoscopy derives from its Greek roots “lapara”, which means abdomen, and “skopein", to examine. In the strict sense, it defines a diagnostic procedure by which to examine the intraperitoneal cavity. Currently it is not limited to examination of the abdomen, but is also extended to minimally invasive abdomen surgery performed with the aid of an optical system.
  • the surgical device of this invention is the result of all the work and studies performed for years in the field of endoscopy. It is more than an instrument, since it can be used as a system for the entry of several instruments, including optics, into a single sheath or casing which can in turn adopt many diameters and shapes. It can also be used as a system to open space in order to maintain the surgical field. All this is performed through a mini-incision. Plus it is applicable to all surgical specialities. All these features make the surgical device which is the object of this invention a new concept in minimally invasive surgery.
  • Several laparoscopic or related devices are known in the state of the art, such as those described in documents EP1066798, EP1131009 or EP1248572; however, there are no documents in the state of the art including the features described in the present invention.
  • the present invention relates to a surgical device for laparoscopy and endoscopy comprising the following components:
  • shutoff cock a body, joined to the previous casing, into which a shutoff cock is inserted that allows gas to be supplied in order to provide a suitable atmosphere in the operation area, and tissue separation to be achieved, if necessary
  • the previous lid assembly is formed by three main parts:
  • the inner lid a first part, called the inner lid, which is fitted onto the body
  • the outer lid a second part, called the outer lid, which is mounted onto the previous lid, the union between the inner lid and the outer lid using several screws so that it is removable,
  • each of the subassemblies with double closing systems of the lid assembly is formed by:
  • a guiding body in the shape of a tube with a circular or oval-shaped section that makes up the central part
  • a tubular guide made in a rigid material that provides rigidity to the guiding body of the subassembly with a double closing system and serves as the support for a second closure, for which it has a countersink on one end
  • a second conical closure manufactured in an elastomeric material, that is arranged on the end of the guiding body opposite the first closure, and provides a second seal when an instrument is introduced into the subassembly with a double closing system
  • each subassembly with a double closing system also has a membrane approximately in the central position, with a flange that fits with interference into a housing on the lid assembly, said housing having the shape of a toric cavity.
  • the surgical device for laparoscopy and endoscopy described in the present invention has the tubular casing, with a circular section and a fixed depth of penetration into the tissues.
  • This casing is interchangeable, for which it has a closing joint inside the body of the device that guarantees it to be sealed.
  • the casing of the device is telescopic, having an adjustable depth L formed in this case by two parts that are fixed by means of an elastic ring device.
  • the joining of the lid assembly and the body of the surgical device for laparoscopy and endoscopy described by the present invention is materialized with a fast-action mechanism, preferably using a thread with several entries and actuated by a fraction of a turn, the thread being cut into the body, which together with a nut, which turns free with respect to the lid, forms the joining mechanism.
  • the inner lid and the outer lid of the lid assembly can be joined by a non-removable or semi-removable system of the cliptype.
  • the inner lid and the outer lid of the lid assembly are formed from a single piece.
  • the invention also describes a procedure for the use of the surgical device for laparoscopy and endoscopy described, wherein the operation performed is the following:
  • the incision is performed on the patient and then the casing is introduced together with the body and it is then stitched to the patient's body, - the lid assembly is then coupled to the body with a longitudinal movement and the nut is then screwed onto the body in order to ensure correct assembly and to guarantee the seal,
  • the cock is opened with a turn in order to introduce gas inside the surgical device, - the instruments are introduced through the different subassemblies with double closing systems.
  • Figure 1 shows the appearance of the surgical device in elevation view, plan view and an overview.
  • Figure 2 shows a section of the inside of the surgical device.
  • Figure 3 shows the arrangement of the surgical device during a surgical operation.
  • Figure 4 shows different configurations of the casing.
  • Figure 5 shows an overview of the body and lid subassemblies, assembled (left) or disassembled (right).
  • Figure 6 shows the section of the assembly of the body and lid subassemblies in detail.
  • Figure 7 shows the scanning area of the subassembly with a double closing system, as well as two different configurations regarding the possible number of subassemblies with double closing systems.
  • Figure 8 shows different views of the shape and components forming the subassembly with a double closing system in detail.
  • Figure 9 shows different views of the operation of the subassembly with a double closing system when inserting an instrument.
  • Figure 10 shows, in several images, the sequence of operations to be performed in order to place the surgical device.
  • FIG. 1 and Figure 2 show an overview of the invention.
  • the surgical device has several parts. On the one hand it has the casing (1 ), the purpose of which is to separate the tissues in order to access the surgical field; joined to this casing is the body (5), into which a shutoff cock (2) is inserted that allows supplying gas in order to provide a suitable atmosphere in the operation area, as well as to achieve tissue separation if necessary.
  • the surgical device is attached to the patient via the braces (6), that allow fast disassembly if necessary for cleaning, in the event of an emergency, etc.
  • a lid assembly (4) (or simply a lid (4)) is joined to the body (5), and a series of subassemblies (3) with a double closing system are assembled on said lid (4).
  • the purpose of the subassemblies (3) with double closing systems is to provide support and access to the instruments (8) required to perform the operation (camera (7), forceps, stapling device, etc.), guaranteeing gas sealing as well as the mobility required by said instruments (8).
  • Figure 3 shows the section of the preferred arrangement of the surgical device during an operation.
  • the purpose is to access the surgical field (12), which requires performing a mini-incision on the outer tissue layers (10) and (1 1 ) and introducing the surgical device up to the inner tissue layer (9). Gas is then introduced via the shutoff cock (2) in order to broaden the cavity ( Figures 1 and 2).
  • the camera (7) provides the required vision of the surgical field, and the instruments (8) are those used in the handling required for the operation.
  • Figure 4 shows different configurations of the casing (1 ).
  • the preferred design of the casing (1 ) is tubular with a circular section and a fixed depth L of penetration into the tissues.
  • the casing (1 ) is interchangeable in order to provide the surgical device with great versatility. To this end it has a closing joint (element (24) of Figure 6) inside the body that guarantees the seal; it is therefore assembled by introducing a distance D into the body of the surgical device.
  • the casing is telescopic (top right drawing in Figure 4), formed in this case by two parts (13) and (15) that are fixed by means of an elastic ring device (14); the depth L is therefore adjustable.
  • the shape of the casing section can also vary (oval or other shapes) (16) in order to adapt to the surgical field and therefore reduce the size of the incision.
  • FIG. 5 and Figure 6 show detailed views of the preferred structure of the body (5) and lid (4) subassembly.
  • the first of these parts is the body (5), which is attached to the patient with stitches fastened to the braces (6) and which, together with the lid (17), ensure that it does not move.
  • the shutoff cock (2) is inserted onto the body (5).
  • the surgical device may be extracted immediately at any time by cutting off the stitches.
  • the second part is the lid (4), which is removable from the body (5).
  • the subassemblies (3) with double closing systems are inserted on the lid (4) in order to introduce the instruments (8).
  • the lid (4) and the body (5) are joined by a fast-action mechanism, which can preferably be a thread with several entries and actuated by a fraction of a turn.
  • a thread (19) has thus been cut into the body (5), which together with the nut (18), which turns free with respect to the lid (4), forms the joining mechanism.
  • Any other mechanism is possible, such as a harpoon type or the like, as long as it complies with the requirement of being fast. This allows the establishment of an immediate access for cleaning, an emergency situation, etc.
  • Figure 6 shows a section of the body (5) and the lid (4) that shows the inside of both elements in detail.
  • the radial housings of the joints (23) prevent them from falling accidentally.
  • the lid (4) is formed by three parts.
  • a first part is the inner lid (22) which is fitted onto the body (5).
  • a second part is the outer lid (21 ) which is mounted onto the previous lid.
  • Both parts (22) and (21 ) are perforated to allow the passage of the subassemblies (3) with double closing systems.
  • each perforation creates a housing in the shape of a toric cavity (25) with an approximately circular section that can house and seal the subassemblies (3) with double closing systems. Since these housings are independent they guarantee that when moving any of the instruments (8) this does not affect the position of the adjacent instruments (8).
  • the joining of the inner lid (22) and the outer lid (21 ) is performed with several screws (20), in such a way that everything can be disassembled.
  • the third part is a nut (18) that assembles the lid (4) on the body (5).
  • the inner lid (22) and the outer lid (21 ) can be joined by a non-removable or semi-removable system of the clip type or the like, and they can even form a single piece in the event that they are manufactured by casting procedures.
  • Figure 7 shows the distribution of the subassemblies (3) with double closing systems on the surgical device, allowing several configurations. Said distribution will preferably be with a subassembly (3) in the centre of the lid (4) where the camera (7) will be inserted and several subassemblies (3) around this, in a sufficient number to effectively access and manipulate the surgical field.
  • the subassembly (3) is fixed to the lid (4) by means of a membrane (element (35) of Figure 8) that allows it to move, thus covering the volume (27) defined inside the casing (1 ). Therefore, any instrument (8) has sufficient mobility to access the exploratory field.
  • FIG. 8 shows several views of a detailed representation of the composition of the subassemblies (3).
  • Each subassembly (3) is a double closing system: one is the closure (33) in its inoperative position, and the other is the one formed when the instrument (8) is introduced through the conical closure (30).
  • Each subassembly (3) is formed by four essential components.
  • the central part of each subassembly (3) is the guiding body (31 ), which is basically a tube with a circular section with a membrane (35) approximately in the central position and with one end open and the other end closed, manufactured in elastomeric material.
  • the membrane (35) has a double purpose: on the one hand, it provides each subassembly (3) with sufficient mobility for the instrument (8) introduced therein, and on the other hand and at the same time, it ensures that the gas is sealed inside the surgical device.
  • the membrane (35) has a flange (34) that fits with interference in the housing (25) ( Figure 6) of the lid (4).
  • each subassembly (3) is a tubular guide (29) made in a rigid material, the purpose of which is double: on the one hand, to provide rigidity to the body of each subassembly (3), and on the other hand, to serve as the support for the second closure (30), for which it has a countersink on one end.
  • a third part is a conical closure (30), manufactured in an elastomeric material and arranged on the end of the guiding body (31 ) opposite the closure (33).
  • the conical closure (30) provides a second seal when the instrument (8) is introduced into the subassembly (3), since the first closure (33) opens.
  • the conical shape is necessary to ensure the adaptability of the seal to the different diameters of the instruments (8).
  • each subassembly (3) is a cylindrical tubular ring (28) that adjusts to the inside of the conical closure (30).
  • This ring also has a double purpose: on the one hand to prevent the conical closure (30) from folding upon itself and, on the other hand, to generate an adjustment with interference between the tubular guide (29) and the conical closure (30), that therefore allows them to be assembled to one another.
  • Figure 9 shows, from left to right, the operation sequence of the subassembly (3) when an instrument is introduced therein, like the camera (7), for example.
  • the atmospheric pressure P A that acts on the inside, and on the outside part, inside the surgical device, the pressure of the gas is Pi, where P I >P A -
  • Both pressures have been represented by a series of vectors, where those corresponding to Pi are longer than those for P A for greater clarity.
  • area (37) there is inner pressure Pi on both sides, there is therefore equilibrium and the body of the subassembly (3) does not deform.
  • the groove deforms and generates open areas (43) through which the gas circulates, which increases the pressure inside the subassembly (3). But the gas does not escape outside because it is confined in the area (42) by the second seal, where the difference in pressure between Pi and P A again favours closure.
  • Figure 10 shows the insertion of the surgical device during the operation sequence.
  • a first step the incision is performed on the patient (not shown in the figure), and then the casing (1 ) is introduced together with the body (5), which is then stitched to the patient's skin.
  • the lid (4) is then coupled on the body (5) with a longitudinal movement (44).
  • the nut (18) is then screwed (45) onto the body (5) in order to ensure correct assembly and to guarantee the seal in a second step.
  • the third step consists in opening the cock (2) with a twisting motion (46) in order to introduce gas inside the surgical device.
  • the fourth and final step consists in introducing (47) the instruments (8) and the camera (7) through the subassemblies (3).

Abstract

A surgical device for laparoscopy and endoscopy that can be used in operations with a single incision. It comprises a casing (1) that is introduced into the tissue through the incision, on which a body (5) is fixed, and on this body (5) a lid (4) on which a variable number of subassemblies (3) is inserted, the purpose of which is to provide access and support to the instruments (7, 8) required for the operation, at the same time as the closing system guarantees that the system is sealed. It has a gas inlet with a shutoff cock (2) through which to introduce any gas required in order to provide a suitable atmosphere in the operating area.

Description

SURGICAL DEVICE FOR LAPAROSCOPY AND ENDOSCOPY
Background of the invention
Laparoscopy is one of the endoscopic procedures that has developed the most in the last quarter of the 20th century. This progress has been both at the level of surgical techniques and of materials and technology. It has also prepared the ground for telesurgery and the application of robotics to surgery.
The term laparoscopy derives from its Greek roots "lapara", which means abdomen, and "skopein", to examine. In the strict sense, it defines a diagnostic procedure by which to examine the intraperitoneal cavity. Currently it is not limited to examination of the abdomen, but is also extended to minimally invasive abdomen surgery performed with the aid of an optical system.
The first references to somebody using an endoscopic procedure take us back to Hippocrates (460-375, B.C.), who used a rectal speculum. In our era Abul Qasin Khalaf ibn al-Albas Al-Zahravi, Abulcasis, introduced a tube into the vagina and lit it by reflecting light off a mirror, and is therefore considered the precursor of endoscopy. The development of the first complete cystoscope, called "lichtleiter" (light conductor), built by Philip Bozzini in 1805, set the basis for modern endoscopy and consequently laparoscopy. But it was not until the mid sixties that this surgical procedure started its fast rise in popularity with the arrival of Kurt Semm in Germany, who is considered to be the father of laparoscopy. This surgeon and engineer designed an automatic insufflator to measure intraabdominal gas pressure and to measure the input rate, he mounted cold light externally, designed many instruments and even described new surgical techniques. Minimally invasive surgery has currently superseded open surgery in almost all surgical specialties.
This dramatic advance in laparoscopic technique has been possible thanks to many other authors who have also provided their studies, research and discoveries. This is the case of the following researchers, amongst others. Desormeaux, who developed the "lichtleiter" in 1865 with a system of lenses and mirrors and who introduced a kerosene lamp. Bruck, who developed a casing in 1867 in order to cool down the platinum cable. Nitze, who introduced the use of magnifying lenses in 1877. George Kelling, who introduced the first cystoscope in an animal's abdomen in 1901 and performed numerous studies on the pneumoperitoneum. Jacobeus used a valve trocar as the only entry device. Bernheim performed organoscopy in 1911 , a technique that consists in visualizing the peritoneal cavity through a proctoscope. Goetze developed an automatic needle to insufflate gas in 1918. Zollikofer insufflated carbon dioxide in 1924. Veress, in 1934, described a spring-loaded needle, which is the needle used today to insufflate gas into the cavities. Hopkins improved the contrast and resolution of optical systems in 1960 by introducing rod lenses.
The surgical device of this invention is the result of all the work and studies performed for years in the field of endoscopy. It is more than an instrument, since it can be used as a system for the entry of several instruments, including optics, into a single sheath or casing which can in turn adopt many diameters and shapes. It can also be used as a system to open space in order to maintain the surgical field. All this is performed through a mini-incision. Plus it is applicable to all surgical specialities. All these features make the surgical device which is the object of this invention a new concept in minimally invasive surgery. Several laparoscopic or related devices are known in the state of the art, such as those described in documents EP1066798, EP1131009 or EP1248572; however, there are no documents in the state of the art including the features described in the present invention.
Brief description of the invention The present invention relates to a surgical device for laparoscopy and endoscopy comprising the following components:
- a casing, the purpose of which is to separate the tissues in order to access the surgical field,
- a body, joined to the previous casing, into which a shutoff cock is inserted that allows gas to be supplied in order to provide a suitable atmosphere in the operation area, and tissue separation to be achieved, if necessary,
- braces that allow attaching the device to the patient and its fast disassembly for cleaning or extraction in the event of an emergency,
- a lid assembly, joined to the body, so that there is a series of subassemblies with a double closing system assembled on the lid, the purpose of which is to provide support and access to the instruments required to perform the operation, guaranteeing gas sealing as well as the mobility required by said instruments. The previous lid assembly is formed by three main parts:
- a first part, called the inner lid, which is fitted onto the body,
- a second part, called the outer lid, which is mounted onto the previous lid, the union between the inner lid and the outer lid using several screws so that it is removable,
- a nut that couples the lid assembly onto the body, where said inner lid and outer lid are perforated to allow the passage of the subassemblies with double closing systems and where a toric cavity with an approximately circular section is formed due to assembly at each perforation in order to house and seal the subassemblies with double closing systems.
In turn, each of the subassemblies with double closing systems of the lid assembly is formed by:
- a guiding body in the shape of a tube with a circular or oval-shaped section that makes up the central part, - a tubular guide made in a rigid material that provides rigidity to the guiding body of the subassembly with a double closing system and serves as the support for a second closure, for which it has a countersink on one end,
- a first closure with an oblong section that ensures sealing when there is no instrument introduced in the subassembly with a double closing system, due to the existence of a deformable groove, with a reinforcing lip on the end next to the closure that prevents the edge from folding upon itself,
- a second conical closure, manufactured in an elastomeric material, that is arranged on the end of the guiding body opposite the first closure, and provides a second seal when an instrument is introduced into the subassembly with a double closing system,
- a cylindrical tubular ring that adjusts to the inside of the conical closure, which prevents the conical closure from folding upon itself and generates an adjustment with interference between the tubular guide and the second conical closure that allows them to be assembled to one another. It should be pointed out that the guiding body that makes up the central part of each subassembly with a double closing system also has a membrane approximately in the central position, with a flange that fits with interference into a housing on the lid assembly, said housing having the shape of a toric cavity. - A -
In a first stage, when there is no instrument introduced into the surgical device, it is the atmospheric pressure PA that acts on the inside of each subassembly with a double closing system, and on the lower outside part of each subassembly it is the pressure of the gas Pi, where PI>PA, such that: - on the outer area of the lower part of the subassembly with a double closing system, located under a groove, there is an inner pressure P| on both sides, therefore there is equilibrium, and therefore the guiding body that forms the central part of said subassembly does not deform,
- on the outer area of the lower part of the subassembly with a double closing system, located on top of said groove, Pi acts on one side and PA on the other, which produces an unbalance that results in the wall deforming inwards, causing said groove to close,
- and on the outer area of the lower part of the subassembly with a double closing system, located on top of said groove and next to the tubular guide, there is the same distribution of pressures as in the outer area, but in this case there is no deformation of the lower part of the subassembly with a double closing system since the tubular guide is rigid.
During the introduction of an instrument into a subassembly with a double closing system there is an adjustment of the second conical closure against the wall of the instrument in that area, and when the instrument is advanced further, it encounters the body of the subassembly with a double closing system in an area above the deformable groove. This causes the deformation of said groove, opening it, and generating open areas through which the gas circulates, and therefore the pressure increases inside the subassembly with a double closing system, but the gas does not escape outside because it is confined in the area by the second seal, where the difference in pressure between P| and PA again favours closure.
The surgical device for laparoscopy and endoscopy described in the present invention has the tubular casing, with a circular section and a fixed depth of penetration into the tissues. This casing is interchangeable, for which it has a closing joint inside the body of the device that guarantees it to be sealed.
In another configuration the casing of the device is telescopic, having an adjustable depth L formed in this case by two parts that are fixed by means of an elastic ring device. The joining of the lid assembly and the body of the surgical device for laparoscopy and endoscopy described by the present invention is materialized with a fast-action mechanism, preferably using a thread with several entries and actuated by a fraction of a turn, the thread being cut into the body, which together with a nut, which turns free with respect to the lid, forms the joining mechanism.
In the joint between said lid and said body there are two closing joints, where one of them guarantees the seal between the casing and the body, and the other joint has the same function between the body and the so-called inner lid of the lid assembly, said joints having radial housings that prevent them from falling accidentally.
In an alternative configuration, the inner lid and the outer lid of the lid assembly can be joined by a non-removable or semi-removable system of the cliptype. Another option is that the inner lid and the outer lid of the lid assembly are formed from a single piece. The invention also describes a procedure for the use of the surgical device for laparoscopy and endoscopy described, wherein the operation performed is the following:
- the incision is performed on the patient and then the casing is introduced together with the body and it is then stitched to the patient's body, - the lid assembly is then coupled to the body with a longitudinal movement and the nut is then screwed onto the body in order to ensure correct assembly and to guarantee the seal,
- the cock is opened with a turn in order to introduce gas inside the surgical device, - the instruments are introduced through the different subassemblies with double closing systems.
Brief description of the drawings
Figure 1 shows the appearance of the surgical device in elevation view, plan view and an overview. Figure 2 shows a section of the inside of the surgical device.
Figure 3 shows the arrangement of the surgical device during a surgical operation.
Figure 4 shows different configurations of the casing. Figure 5 shows an overview of the body and lid subassemblies, assembled (left) or disassembled (right).
Figure 6 shows the section of the assembly of the body and lid subassemblies in detail. Figure 7 shows the scanning area of the subassembly with a double closing system, as well as two different configurations regarding the possible number of subassemblies with double closing systems.
Figure 8 shows different views of the shape and components forming the subassembly with a double closing system in detail. Figure 9 shows different views of the operation of the subassembly with a double closing system when inserting an instrument.
Figure 10 shows, in several images, the sequence of operations to be performed in order to place the surgical device.
Detailed description of a preferred embodiment Although the invention is described both with a preferred embodiment and a preferred procedure, it is to be understood that the invention is not limited to said embodiment or procedure. On the contrary, it intends to cover all possible alternatives, modifications and equivalents that may be included within the nature and scope of the invention as defined in the attached claims. Figure 1 and Figure 2 show an overview of the invention. The surgical device has several parts. On the one hand it has the casing (1 ), the purpose of which is to separate the tissues in order to access the surgical field; joined to this casing is the body (5), into which a shutoff cock (2) is inserted that allows supplying gas in order to provide a suitable atmosphere in the operation area, as well as to achieve tissue separation if necessary. The surgical device is attached to the patient via the braces (6), that allow fast disassembly if necessary for cleaning, in the event of an emergency, etc. A lid assembly (4) (or simply a lid (4)) is joined to the body (5), and a series of subassemblies (3) with a double closing system are assembled on said lid (4). The purpose of the subassemblies (3) with double closing systems is to provide support and access to the instruments (8) required to perform the operation (camera (7), forceps, stapling device, etc.), guaranteeing gas sealing as well as the mobility required by said instruments (8).
Figure 3 shows the section of the preferred arrangement of the surgical device during an operation. The purpose is to access the surgical field (12), which requires performing a mini-incision on the outer tissue layers (10) and (1 1 ) and introducing the surgical device up to the inner tissue layer (9). Gas is then introduced via the shutoff cock (2) in order to broaden the cavity (Figures 1 and 2). The camera (7) provides the required vision of the surgical field, and the instruments (8) are those used in the handling required for the operation.
Figure 4 shows different configurations of the casing (1 ). In principle the preferred design of the casing (1 ) is tubular with a circular section and a fixed depth L of penetration into the tissues. The casing (1 ) is interchangeable in order to provide the surgical device with great versatility. To this end it has a closing joint (element (24) of Figure 6) inside the body that guarantees the seal; it is therefore assembled by introducing a distance D into the body of the surgical device. In an alternative configuration the casing is telescopic (top right drawing in Figure 4), formed in this case by two parts (13) and (15) that are fixed by means of an elastic ring device (14); the depth L is therefore adjustable. The shape of the casing section can also vary (oval or other shapes) (16) in order to adapt to the surgical field and therefore reduce the size of the incision.
Figure 5 and Figure 6 show detailed views of the preferred structure of the body (5) and lid (4) subassembly. The first of these parts is the body (5), which is attached to the patient with stitches fastened to the braces (6) and which, together with the lid (17), ensure that it does not move. The shutoff cock (2) is inserted onto the body (5). The surgical device may be extracted immediately at any time by cutting off the stitches. The second part is the lid (4), which is removable from the body (5). The subassemblies (3) with double closing systems are inserted on the lid (4) in order to introduce the instruments (8). The lid (4) and the body (5) are joined by a fast-action mechanism, which can preferably be a thread with several entries and actuated by a fraction of a turn. A thread (19) has thus been cut into the body (5), which together with the nut (18), which turns free with respect to the lid (4), forms the joining mechanism. Any other mechanism is possible, such as a harpoon type or the like, as long as it complies with the requirement of being fast. This allows the establishment of an immediate access for cleaning, an emergency situation, etc.
Figure 6 shows a section of the body (5) and the lid (4) that shows the inside of both elements in detail. There are two closing joints, preferably of the toric type: the joint (24) that guarantees the seal between the casing (1 ) and the body (5), and the joint (23) with the same function between the body (5) and the part (22) of the lid (4). The radial housings of the joints (23) prevent them from falling accidentally.
The lid (4) is formed by three parts. A first part is the inner lid (22) which is fitted onto the body (5). A second part is the outer lid (21 ) which is mounted onto the previous lid. Both parts (22) and (21 ) are perforated to allow the passage of the subassemblies (3) with double closing systems. As a result of assembly, each perforation creates a housing in the shape of a toric cavity (25) with an approximately circular section that can house and seal the subassemblies (3) with double closing systems. Since these housings are independent they guarantee that when moving any of the instruments (8) this does not affect the position of the adjacent instruments (8). The joining of the inner lid (22) and the outer lid (21 ) is performed with several screws (20), in such a way that everything can be disassembled. And, finally, the third part is a nut (18) that assembles the lid (4) on the body (5). In an alternative embodiment the inner lid (22) and the outer lid (21 ) can be joined by a non-removable or semi-removable system of the clip type or the like, and they can even form a single piece in the event that they are manufactured by casting procedures.
Figure 7 shows the distribution of the subassemblies (3) with double closing systems on the surgical device, allowing several configurations. Said distribution will preferably be with a subassembly (3) in the centre of the lid (4) where the camera (7) will be inserted and several subassemblies (3) around this, in a sufficient number to effectively access and manipulate the surgical field. The subassembly (3) is fixed to the lid (4) by means of a membrane (element (35) of Figure 8) that allows it to move, thus covering the volume (27) defined inside the casing (1 ). Therefore, any instrument (8) has sufficient mobility to access the exploratory field. This movement is approximately a pivoting movement with its centre at point (26) and, since the instrument (8) is free to penetrate the double closing system, accessibility to the surgical field is guaranteed. Figure 8 shows several views of a detailed representation of the composition of the subassemblies (3). Each subassembly (3) is a double closing system: one is the closure (33) in its inoperative position, and the other is the one formed when the instrument (8) is introduced through the conical closure (30). Each subassembly (3) is formed by four essential components. The central part of each subassembly (3) is the guiding body (31 ), which is basically a tube with a circular section with a membrane (35) approximately in the central position and with one end open and the other end closed, manufactured in elastomeric material. The membrane (35) has a double purpose: on the one hand, it provides each subassembly (3) with sufficient mobility for the instrument (8) introduced therein, and on the other hand and at the same time, it ensures that the gas is sealed inside the surgical device. To do this, the membrane (35) has a flange (34) that fits with interference in the housing (25) (Figure 6) of the lid (4). On the closed end there is an area, closure (33), with an oblong section and a planar groove (36); this is the inoperative position and ensures sealing when there is no instrument (8) introduced in the subassembly (3). There is also a reinforcing lip (32) on the end next to the closure that prevents the edge from folding upon itself.
The second part forming each subassembly (3) is a tubular guide (29) made in a rigid material, the purpose of which is double: on the one hand, to provide rigidity to the body of each subassembly (3), and on the other hand, to serve as the support for the second closure (30), for which it has a countersink on one end.
A third part is a conical closure (30), manufactured in an elastomeric material and arranged on the end of the guiding body (31 ) opposite the closure (33). The conical closure (30) provides a second seal when the instrument (8) is introduced into the subassembly (3), since the first closure (33) opens. The conical shape is necessary to ensure the adaptability of the seal to the different diameters of the instruments (8).
The fourth part of each subassembly (3) is a cylindrical tubular ring (28) that adjusts to the inside of the conical closure (30). This ring also has a double purpose: on the one hand to prevent the conical closure (30) from folding upon itself and, on the other hand, to generate an adjustment with interference between the tubular guide (29) and the conical closure (30), that therefore allows them to be assembled to one another.
Figure 9 shows, from left to right, the operation sequence of the subassembly (3) when an instrument is introduced therein, like the camera (7), for example. During a first stage there is no instrument introduced into the subassembly (3), therefore it is the atmospheric pressure PA that acts on the inside, and on the outside part, inside the surgical device, the pressure of the gas is Pi, where PI>PA- Both pressures have been represented by a series of vectors, where those corresponding to Pi are longer than those for PA for greater clarity. In area (37) there is inner pressure Pi on both sides, there is therefore equilibrium and the body of the subassembly (3) does not deform. However, in area (38) Pi acts on one side and PA on the other; this produces an imbalance that results in the wall deforming inwards, causing said groove (36) to close. The same occurs in area (39) as in area (38), but in this case there is no deformation since the tubular guide (29) is rigid. When an instrument is introduced, in this case the camera (7), there is an adjustment of the conical closure (30) against the wall of the camera (7) in the area identified as (40). When the camera (7) is advanced further, it encounters the body of the subassembly (3) in the area (41 ); this causes the deformation of the groove (36), thus deforming the material and opening said groove (36). The groove deforms and generates open areas (43) through which the gas circulates, which increases the pressure inside the subassembly (3). But the gas does not escape outside because it is confined in the area (42) by the second seal, where the difference in pressure between Pi and PA again favours closure.
When the instrument is extracted the sequence is reversed and the seal is recovered when the groove (36) closes again.
Figure 10 shows the insertion of the surgical device during the operation sequence. In a first step the incision is performed on the patient (not shown in the figure), and then the casing (1 ) is introduced together with the body (5), which is then stitched to the patient's skin. The lid (4) is then coupled on the body (5) with a longitudinal movement (44). The nut (18) is then screwed (45) onto the body (5) in order to ensure correct assembly and to guarantee the seal in a second step. The third step consists in opening the cock (2) with a twisting motion (46) in order to introduce gas inside the surgical device. The fourth and final step consists in introducing (47) the instruments (8) and the camera (7) through the subassemblies (3).

Claims

1 - Surgical device for laparoscopy and endoscopy comprising:
- a casing (1 ), the purpose of which is to separate the tissues in order to access the surgical field,
- a body (5), joined to the casing (1 ), into which a shutoff cock (2) is inserted that allows gas to be supplied in order to provide a suitable atmosphere in the operation area, and tissue separation to be achieved, if necessary,
- braces (6) that allow attaching the device to the patient and its fast disassembly for cleaning or extraction in the event of an emergency,
- a lid assembly (4), joined to the body (5), characterized in that there is a series of subassemblies (3) with a double closing system assembled on the lid (4), the purpose of which is to provide support and access to the instruments (8) required to perform the operation, guaranteeing gas sealing as well as the mobility required by said instruments (8).
2 - Surgical device for laparoscopy and endoscopy according to the previous claim, characterized in that the lid assembly (4) is formed by three parts:
- a first part (22), called the inner lid, which is fitted onto the body (5), - a second part (21 ), called the outer lid, which is mounted onto the previous lid, the union between the inner lid (22) and the outer lid (21 ) using several screws (20) so that it is removable,
- a nut (18) that couples the lid assembly (4) onto the body (5), where the inner lid (21 ) and outer lid (22) are perforated to allow the passage of the subassemblies (3) with double closing systems and where a toric cavity (25) with an approximately circular section is formed due to assembly at each perforation in order to house and seal the subassemblies (3).
3 - Surgical device for laparoscopy and endoscopy according to any of the previous claims, characterized in that each of the subassemblies (3) with double closing systems of the lid assembly (4) is formed by: - a guiding body (31 ) in the shape of a tube with a circular or oval-shaped section that makes up the central part,
- a tubular guide (29) made in a rigid material that provides rigidity to the guiding body (31 ) of the subassembly (3) and serves as the support for a second closure (30), for which it has a countersink on one end,
- a first closure (33) with an oblong section that ensures sealing when there is no instrument (8) introduced in the subassembly (3), due to the existence of a deformable groove (36), with a reinforcing lip (32) on the end next to the closure that prevents the edge from folding upon itself, - a second conical closure (30), manufactured in an elastomeric material, that is arranged on the end of the guiding body (31 ) opposite the closure (33), and provides a second seal when an instrument (8) is introduced into the subassembly (3),
- a cylindrical tubular ring (28) that adjusts to the inside of the conical closure (30), which prevents the conical closure from folding upon itself and generates an adjustment with interference between the tubular guide (29) and the conical closure (30) that allows them to be assembled to one another.
4 - Surgical device for laparoscopy and endoscopy according to the previous claim, characterized in that the guiding body (31 ) of each subassembly
(3) with a double closing system also has a membrane (35) approximately in the central position, with a flange (34) that fits with interference into a housing (25) on the lid (4), said housing (25) having the shape of a toric cavity.
5 - Surgical device for laparoscopy and endoscopy according to any one of Claims 3 and 4, characterized in that in a first stage, when there is no instrument (8) introduced, it is the atmospheric pressure PA that acts on the inside of each subassembly (3), and on the lower outside part of each subassembly (3) it is the pressure of the gas Pi, where PI>PA, such that: - on the outer area (37) of the lower part of the subassembly (3), located under the groove (36), there is an inner pressure Pi on both sides, therefore there is equilibrium and the guiding body (31 ) of the subassembly (3) does not deform,
- on the outer area (38) of the lower part of the subassembly (3), located on top of the groove (36), Pi acts on one side and PA on the other, which produces an unbalance that results in the wall deforming inwards, causing said groove (36) to close,
- and on the outer area (39) of the lower part of the subassembly (3), located on top of the groove (36) and next to the tubular guide (29), there is the same distribution of pressures as in the outer area (38), but in this case there is no deformation of the lower part of the subassembly (3) since the tubular guide
(29) is rigid.
6 - Surgical device for laparoscopy and endoscopy according to any one of Claims 3 and 4, characterized in that when an instrument (8) is introduced into a subassembly (3) there is an adjustment of the conical closure (30) against the wall of the instrument (8) in the area identified as (40), and when the instrument
(8) is advanced further, it encounters the body of the subassembly (3) in the area
(41 ) above the deformable groove (36), causing the deformation of said groove (36), opening it, and generating open areas (43) through which the gas circulates, and therefore the pressure increases inside the subassembly (3), but the gas does not escape outside because it is confined in the area (42) by the second seal, where the difference in pressure between Pi and PA again favours closure.
7 - Surgical device for laparoscopy and endoscopy according to any of the previous claims, characterized in that the casing (1 ) is tubular with a circular section and a fixed depth of penetration into the tissues, said casing (1 ) being interchangeable, for which it has a closing joint (24) inside the body (5) that guarantees it to be sealed.
8 - Surgical device for laparoscopy and endoscopy according to any of Claims 1 to 6, characterized in that the casing (1 ) is telescopic, thus having the adjustable depth L formed in this case by two parts (13) and (15) that are fixed by means of an elastic ring device (14).
9 - Surgical device for laparoscopy and endoscopy according to any of the previous claims, characterized in that the lid (4) and the body (5) are joined by a fast-action mechanism, using a thread with several entries and actuated by a fraction of a turn, the thread (19) being cut into the body (5), which together with the nut (18), which turns free with respect to the lid (4), forms the joining mechanism.
10 - Surgical device for laparoscopy and endoscopy according to any of the previous claims, characterized in that in the joint between said lid (4) and said body (5) there are two closing joints (23, 24), where the joint (24) guarantees the seal between the casing (1 ) and the body (5), and the joint (23) has the same function between the body (5) and the part (22) of the lid (4), said joints (23, 24) having radial housings that prevent them from falling accidentally.
11 - Surgical device for laparoscopy and endoscopy according to any of Claims 2 to 10, characterized in that the inner lid (22) and the outer lid (21 ) of the lid (4) can be joined by a non-removable or semi-removable system of the clip type.
12 - Surgical device for laparoscopy and endoscopy according to any of Claims 2 to 10, characterized in that the inner lid (22) and the outer lid (21 ) of the lid (4) are formed from a single piece.
13 - Procedure for the use of Surgical device for laparoscopy and endoscopy according to any of the previous claims, characterized in that the operation sequence is the following:
- the incision is performed on the patient and then the casing (1 ) is introduced together with the body (5) and it is then stitched to the patient's body, - the lid assembly (4) is then coupled to the body (5) with a longitudinal movement (44) and the nut (18) is then screwed (45) onto the body in order to ensure correct assembly and to guarantee the seal,
- the cock (2) is opened with a turn (46) in order to introduce gas inside the surgical device, - the instruments (8) are introduced through the different subassemblies
(3) with double closing systems.
PCT/EP2008/064982 2007-12-20 2008-11-05 Surgical device for laparoscopy and endoscopy WO2009080399A2 (en)

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